Opinion

At the end of my second year of medical school was what I call “The Lost Month.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

At the end of my second year of medical school was what I call “The Lost Month.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

At the end of my second year of medical school was what I call “The Lost Month.”

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.¹ Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.¹ Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

No matter how you spin it, hospitalists are key to making the world of the hospital go ‘round, making their daily work of paramount interest to both hospitals and health systems.

In an effort to drive quality, safety, and efficiency, hospitals most commonly measure hospitalist work and reward it through ties to compensation. There are several trends in performance incentive metrics highlighted by the SHM 2020 State of Hospital Medicine (SoHM) Report. As hospitals support the subsidy required for hospitalist salaries, there is an increasing ask for hospitalist groups to partner with hospital operations to achieve certain goals. The lever of compensation, when appropriately applied to meaningful metrics, is one way of promoting desired behaviors.

Hospitalists are the primary attending physicians for patients in the hospital while also bridging the patient and their needs to the services of other subspecialists, allied health professionals, and when needed, postacute services. In this way, patients are efficiently moved along the acute care experience with multiple process and outcome measures being recorded along the way.

Some of these common performance incentive measures are determined by the Centers for Medicare and Medicaid Services while others may be of interest to third party payers. Often surrogate markers of process metrics (i.e. order set usage for certain diagnoses) are measured and incentivized as a way of directionally measuring small steps that each hospitalist can reliably control toward a presumably associated improvement in mortality or readmissions, for instance. Still other measures such as length of stay or timely completion of documentation have more to do with hospital operations, regulatory governance, and finance.

There are a variety of performance incentive metrics reported in the 2020 SoHM Report. Survey respondents could choose all measures that applied as compensation measures for their group in the past year. The most common metrics reported include patient satisfaction (48.7%), citizenship (45.8%), accuracy or timeliness of documentation (32.8%), and clinical process measures (30.7%).

DjelicS/Getty Images

It is important to acknowledge that most of these metrics are objective measurements and can be measured down to the individual physician. However, some of the objective measures, such as patient satisfaction data, must rely on agreed upon methods of attribution – which can include anything from attributing based on admitting physician, discharging attending, or the attending with the greatest number of days (i.e. daily charges) seeing the patient. Because of challenges with attribution, groups may opt for group measurement of metrics for some of the compensation metrics where attribution is most muddy.

For performance incentive metrics that may be more subjective, such as citizenship, it is important for hospitalist leaders to consider having a method of determining a person’s contribution with a rubric as well as some shared decision making among a committee of leaders or team members to promote fairness in compensation.

Hospital leaders must also recognize that what is measured will lead to “performance” in that area. The perfect example here is the “early morning discharge time/orders” which is a compensation metric in 27.6% of hospitalist groups. Most agree that having some early discharges, up to maybe 25%-30% of the total number of discharges before noon, can be helpful with hospital throughput. The trick here is that if a patient can be discharged that early, it is likely that some of those patients could have gone home the evening prior. It is important for hospitalist physician leaders and administrators to think about the behaviors that are incentivized in compensation metrics to ensure that the result is indeed helpful.

Other hospitalist compensation metrics such as readmissions are most effectively addressed if there are multiple physician teams working toward the same metric. Hospitalist work does effect readmissions within the first 7 days of discharge based on available evidence.¹ Preventing readmissions from days 8-30 following discharge are more amenable to outpatient and home-based interventions. Also, effective readmission work involves collaboration among the emergency physician team, surgeons, primary care, and subspecialty physicians. So while having this as a compensation metric will gain the attention of hospitalist physicians, the work will be most effective when it is shared with other teams.

Overall, performance incentive metrics for hospitalists can be effective in allowing hospitals and hospitalist groups to partner toward achieving important outcomes for patients. Easy and frequent sharing of data on meaningful metrics with hospitalists is important to effect change. Also, hospital leadership can facilitate collaboration among nursing and multiple physician groups to promote a team culture with hospitalists in achieving goals related to performance incentive metrics.

Dr. McNeal is the division director of inpatient medicine at Baylor Scott & White Medical Center in Temple, Tex.
 

Reference

1. Graham, et al. Preventability of Early Versus Late Hospital Readmissions in a National Cohort of General Medicine Patients. Ann Intern Med. 2018 Jun 5;168(11):766-74.

In recent years, Percocet (oxycodone/paracetamol) has experienced a meteoric rise to prominence because of the presence of conspicuous references in pop culture and the ever-evolving hip-hop scene,¹ so much so that even propafenone is being mislabeled as the agent.² It is of utmost importance for clinicians to be made aware of the adverse effects and the treatment protocols associated with Percocet as well as propafenone.

Propafenone is identified as a class 1C antiarrhythmic with adverse effects associated with that particular class of drugs (e.g., generalized tonic-clonic seizures coupled with widened QRS complex), however, Percocet’s toxidrome is the product of the opioid/nonopioid (in the form of oxycodone/acetaminophen) components found within the formulation. Percocet is often recreationally used with MDMA (“molly”) or ecstasy as popularized by the lyrics of “Mask Off” by Future (“Percocets, Molly, Percocets”).^3,4

Addressing the challenge of imitation Percocet pills

Differentiating the untoward effects of Percocet and propafenone isn’t too challenging because the agents belong to separate classes – the problem is the use of deceitful labels on propafenone with both medications sporting the “512 imprint” on their respective pills. Initial symptoms of propafenone ingestion may include weakness and dizziness followed by seizures.⁵As an emergent situation, the patient should be immediately treated with a sodium bicarbonate infusion to effectively reverse the sodium channel blockade associated with the widened QRS.

However, a more likely scenario is that of Percocet counterfeit pills designed to illicitly emulate the properties of officially marketed Percocet. As expected, Percocet overdose management will require that the clinician be familiar with treating general opioid toxicity (in this case, derived from the oxycodone component), in particular respiratory or CNS depression. Symptoms of opioid overdose also include the loss of consciousness with pupillary miosis. Therapy entails the use of naloxone and/or mechanical ventilation for respiratory support. The patient can also exhibit cardiovascular compromise. If further information is elicited during a patient interview, it may reveal a history of drug procurement from the streets.

Epidemiologists from Georgia collaborated with the state’s department of public health’s office of emergency services, forensic experts, and drug enforcement professionals to evaluate almost 40 cases of counterfeit Percocet overdoses during the period spanning the second week of June 2017. Of these cases, a cluster triad was identified consisting of general opioid toxicity symptoms (for example, CNS or respiratory depression with concomitant pupillary constriction, a history of drug procurement, and a history of ingesting only one or two pills with rapid deterioration.⁶ Unfortunately, the screening process is often hindered by the fact that synthetic opioids such as Percocet are not readily identified on urine drug screens (UDS).

Despite shortcomings in assessment procedures, a UDS will yield positive results for multiple drugs, a feature that is common to seasoned opioid users and serves as an instrumental diagnostic clue in the investigative process. To address the crisis and prevent further spread, numerous Georgia agencies (e.g., drug trafficking and legal authorities) worked with the health care community to expediently identify cases of interest and bring forth public awareness concerning the ongoing perils of counterfeit drug intake. Future investigations might benefit from the implementation of DNA-verified UDS, because those screens are versatile enough to detect the presence of synthetic urine substitutes within the context of opioid use.^7,8 Moreover, an expanded panel could be tailored to provide coverage for semisynthetics, including hydrocodone, oxycodone, hydromorphone, and oxymorphone.⁹

As a well-received painkiller from the opioid family, Percocet derives its analgesic properties from the fast-acting oxycodone; hepatic failure is also possible from Percocet (because of the acetaminophen component) or counterfeit Percocet overdose but is less common unless the Tylenol content approaches 4 grams. By binding to the brain’s opiate receptors, Percocet modulates pain pathways leading to a dulling of pain sensation along with euphoria, which is particularly attractive to drug seekers. Chronic Percocet use corresponds with a myriad of psychological and physical consequences, and the Drug Enforcement Administration recognizes oxycodone as a Schedule II drug.

A chronic Percocet user may try to disrupt the cycle of symptoms by abruptly ceasing use of the offending agent. This can precipitate the development of classical opioid-based withdrawal symptoms, including but not limited to nausea, vomiting, irritability, tachycardia, body aches, and episodes of cold sweats. Physicians have noted that misuse (i.e., deviations from intended prescribed) might include crushing and snorting as well as “doctor-shopping” behaviors for a continuous supply of Percocet.
 

Treatment recommendations

According to Sarah Wakeman, MD, medical director of the substance use disorders initiative at Massachusetts General Hospital in Boston, there are apparently two clinical manifestations of Percocet use. The primary consequence is derived from the oxycodone component of Percocet; as an opioid, oxycodone toxicity leads to disrupted breathing and oxygenation, negatively impacting vital organs such as the brain or the heart. Patients experiencing a lack of oxygen will often display cyanosis and may not respond appropriately to stimuli. For individuals suspected of succumbing to overdose, Dr. Wakeman reportedly advised that the clinician or trained professional rub his or her knuckles along the breastbone of the potential user – a drug overdose patient will fail to wake up. On the other hand, a Percocet user may exhibit the symptoms of liver failure depending on the overall level of acetaminophen in the formulation. To prevent relapses, Percocet use disorder is best managed in a professional setting under the direction of trained clinicians; users are provided medications to address ongoing cravings and symptoms associated with the withdrawal process. A detoxification center can tailor the treatment with opioid-based medications such as methadone, buprenorphine, and naltrexone to help patients be weaned off Percocet.

Clinicians may further improve the efficacy of a therapeutic regimen by incorporating a personalized plan with a comprehensive substance UDS panel for monitoring and treatment purposes. This may prove to be beneficial in the event of suspected polysubstance use, as is the case with patients who dabble with Percocet and “molly.” Preparations can also be instituted at the outset of therapy with genetic testing implemented in high-risk patients who exhibit an inclination for opioid use disorder.¹⁰ Genetic polymorphisms provide robust clinical assets for evaluating patients most at risk for relapse. For individuals with biological susceptibility, arrangements can be made to incorporate nonopioid treatment alternatives.
 

References

1. Thomas BB. The death of Lil Peep: How the U.S. prescription drug epidemic is changing hip-hop. The Guardian. 2017 Nov 16.

2. D’Orazio JL and Curtis JA. J Emer Med. 2011 Aug 1;41(2):172-5.

3. Levy L. These are the drugs influencing pop culture now. Vulture. 2018 Feb 6.

4. Kounang N and Bender M. “What is Percocet? Drug facts, side effects, abuse and more.” CNN. 2018 Jul 12.

5. The dangers of Percocet use and overdose. American Addiction Centers. Last updated 2020 Feb 3. https://americanaddictioncenters.org/percocet-treatment/dangers-of-use-and-overdose.

6. Edison L et al. MMWR. 2017 Oct 20;66(41):1119-20.

7. Choudhry Z et al. J Psychiatry. 2015. doi: 10.4172/2378-5756.10000319.

8. Islam F and Choudhry Z. Current Psychiatry. 2018 Dec;17(12):43-4.

9. Jupe N. Ask the Experts: DOT 5-panel drug test regimen. Quest Diagnostics. 2018 Mar 21. https://blog.employersolutions.com/ask-experts-dot-5-panel-drug-test-regimen/.

10. Ahmed S et al. Pharmacogenomics. 2019 Jun 28;20(9):685-703.

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam reported no relevant disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He reported no relevant disclosures.

In recent years, Percocet (oxycodone/paracetamol) has experienced a meteoric rise to prominence because of the presence of conspicuous references in pop culture and the ever-evolving hip-hop scene,¹ so much so that even propafenone is being mislabeled as the agent.² It is of utmost importance for clinicians to be made aware of the adverse effects and the treatment protocols associated with Percocet as well as propafenone.

Propafenone is identified as a class 1C antiarrhythmic with adverse effects associated with that particular class of drugs (e.g., generalized tonic-clonic seizures coupled with widened QRS complex), however, Percocet’s toxidrome is the product of the opioid/nonopioid (in the form of oxycodone/acetaminophen) components found within the formulation. Percocet is often recreationally used with MDMA (“molly”) or ecstasy as popularized by the lyrics of “Mask Off” by Future (“Percocets, Molly, Percocets”).^3,4

Addressing the challenge of imitation Percocet pills

Differentiating the untoward effects of Percocet and propafenone isn’t too challenging because the agents belong to separate classes – the problem is the use of deceitful labels on propafenone with both medications sporting the “512 imprint” on their respective pills. Initial symptoms of propafenone ingestion may include weakness and dizziness followed by seizures.⁵As an emergent situation, the patient should be immediately treated with a sodium bicarbonate infusion to effectively reverse the sodium channel blockade associated with the widened QRS.

However, a more likely scenario is that of Percocet counterfeit pills designed to illicitly emulate the properties of officially marketed Percocet. As expected, Percocet overdose management will require that the clinician be familiar with treating general opioid toxicity (in this case, derived from the oxycodone component), in particular respiratory or CNS depression. Symptoms of opioid overdose also include the loss of consciousness with pupillary miosis. Therapy entails the use of naloxone and/or mechanical ventilation for respiratory support. The patient can also exhibit cardiovascular compromise. If further information is elicited during a patient interview, it may reveal a history of drug procurement from the streets.

Epidemiologists from Georgia collaborated with the state’s department of public health’s office of emergency services, forensic experts, and drug enforcement professionals to evaluate almost 40 cases of counterfeit Percocet overdoses during the period spanning the second week of June 2017. Of these cases, a cluster triad was identified consisting of general opioid toxicity symptoms (for example, CNS or respiratory depression with concomitant pupillary constriction, a history of drug procurement, and a history of ingesting only one or two pills with rapid deterioration.⁶ Unfortunately, the screening process is often hindered by the fact that synthetic opioids such as Percocet are not readily identified on urine drug screens (UDS).

Despite shortcomings in assessment procedures, a UDS will yield positive results for multiple drugs, a feature that is common to seasoned opioid users and serves as an instrumental diagnostic clue in the investigative process. To address the crisis and prevent further spread, numerous Georgia agencies (e.g., drug trafficking and legal authorities) worked with the health care community to expediently identify cases of interest and bring forth public awareness concerning the ongoing perils of counterfeit drug intake. Future investigations might benefit from the implementation of DNA-verified UDS, because those screens are versatile enough to detect the presence of synthetic urine substitutes within the context of opioid use.^7,8 Moreover, an expanded panel could be tailored to provide coverage for semisynthetics, including hydrocodone, oxycodone, hydromorphone, and oxymorphone.⁹

As a well-received painkiller from the opioid family, Percocet derives its analgesic properties from the fast-acting oxycodone; hepatic failure is also possible from Percocet (because of the acetaminophen component) or counterfeit Percocet overdose but is less common unless the Tylenol content approaches 4 grams. By binding to the brain’s opiate receptors, Percocet modulates pain pathways leading to a dulling of pain sensation along with euphoria, which is particularly attractive to drug seekers. Chronic Percocet use corresponds with a myriad of psychological and physical consequences, and the Drug Enforcement Administration recognizes oxycodone as a Schedule II drug.

A chronic Percocet user may try to disrupt the cycle of symptoms by abruptly ceasing use of the offending agent. This can precipitate the development of classical opioid-based withdrawal symptoms, including but not limited to nausea, vomiting, irritability, tachycardia, body aches, and episodes of cold sweats. Physicians have noted that misuse (i.e., deviations from intended prescribed) might include crushing and snorting as well as “doctor-shopping” behaviors for a continuous supply of Percocet.
 

Treatment recommendations

According to Sarah Wakeman, MD, medical director of the substance use disorders initiative at Massachusetts General Hospital in Boston, there are apparently two clinical manifestations of Percocet use. The primary consequence is derived from the oxycodone component of Percocet; as an opioid, oxycodone toxicity leads to disrupted breathing and oxygenation, negatively impacting vital organs such as the brain or the heart. Patients experiencing a lack of oxygen will often display cyanosis and may not respond appropriately to stimuli. For individuals suspected of succumbing to overdose, Dr. Wakeman reportedly advised that the clinician or trained professional rub his or her knuckles along the breastbone of the potential user – a drug overdose patient will fail to wake up. On the other hand, a Percocet user may exhibit the symptoms of liver failure depending on the overall level of acetaminophen in the formulation. To prevent relapses, Percocet use disorder is best managed in a professional setting under the direction of trained clinicians; users are provided medications to address ongoing cravings and symptoms associated with the withdrawal process. A detoxification center can tailor the treatment with opioid-based medications such as methadone, buprenorphine, and naltrexone to help patients be weaned off Percocet.

Clinicians may further improve the efficacy of a therapeutic regimen by incorporating a personalized plan with a comprehensive substance UDS panel for monitoring and treatment purposes. This may prove to be beneficial in the event of suspected polysubstance use, as is the case with patients who dabble with Percocet and “molly.” Preparations can also be instituted at the outset of therapy with genetic testing implemented in high-risk patients who exhibit an inclination for opioid use disorder.¹⁰ Genetic polymorphisms provide robust clinical assets for evaluating patients most at risk for relapse. For individuals with biological susceptibility, arrangements can be made to incorporate nonopioid treatment alternatives.
 

References

1. Thomas BB. The death of Lil Peep: How the U.S. prescription drug epidemic is changing hip-hop. The Guardian. 2017 Nov 16.

2. D’Orazio JL and Curtis JA. J Emer Med. 2011 Aug 1;41(2):172-5.

3. Levy L. These are the drugs influencing pop culture now. Vulture. 2018 Feb 6.

4. Kounang N and Bender M. “What is Percocet? Drug facts, side effects, abuse and more.” CNN. 2018 Jul 12.

5. The dangers of Percocet use and overdose. American Addiction Centers. Last updated 2020 Feb 3. https://americanaddictioncenters.org/percocet-treatment/dangers-of-use-and-overdose.

6. Edison L et al. MMWR. 2017 Oct 20;66(41):1119-20.

7. Choudhry Z et al. J Psychiatry. 2015. doi: 10.4172/2378-5756.10000319.

8. Islam F and Choudhry Z. Current Psychiatry. 2018 Dec;17(12):43-4.

9. Jupe N. Ask the Experts: DOT 5-panel drug test regimen. Quest Diagnostics. 2018 Mar 21. https://blog.employersolutions.com/ask-experts-dot-5-panel-drug-test-regimen/.

10. Ahmed S et al. Pharmacogenomics. 2019 Jun 28;20(9):685-703.

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam reported no relevant disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He reported no relevant disclosures.

In recent years, Percocet (oxycodone/paracetamol) has experienced a meteoric rise to prominence because of the presence of conspicuous references in pop culture and the ever-evolving hip-hop scene,¹ so much so that even propafenone is being mislabeled as the agent.² It is of utmost importance for clinicians to be made aware of the adverse effects and the treatment protocols associated with Percocet as well as propafenone.

Propafenone is identified as a class 1C antiarrhythmic with adverse effects associated with that particular class of drugs (e.g., generalized tonic-clonic seizures coupled with widened QRS complex), however, Percocet’s toxidrome is the product of the opioid/nonopioid (in the form of oxycodone/acetaminophen) components found within the formulation. Percocet is often recreationally used with MDMA (“molly”) or ecstasy as popularized by the lyrics of “Mask Off” by Future (“Percocets, Molly, Percocets”).^3,4

Addressing the challenge of imitation Percocet pills

Differentiating the untoward effects of Percocet and propafenone isn’t too challenging because the agents belong to separate classes – the problem is the use of deceitful labels on propafenone with both medications sporting the “512 imprint” on their respective pills. Initial symptoms of propafenone ingestion may include weakness and dizziness followed by seizures.⁵As an emergent situation, the patient should be immediately treated with a sodium bicarbonate infusion to effectively reverse the sodium channel blockade associated with the widened QRS.

However, a more likely scenario is that of Percocet counterfeit pills designed to illicitly emulate the properties of officially marketed Percocet. As expected, Percocet overdose management will require that the clinician be familiar with treating general opioid toxicity (in this case, derived from the oxycodone component), in particular respiratory or CNS depression. Symptoms of opioid overdose also include the loss of consciousness with pupillary miosis. Therapy entails the use of naloxone and/or mechanical ventilation for respiratory support. The patient can also exhibit cardiovascular compromise. If further information is elicited during a patient interview, it may reveal a history of drug procurement from the streets.

Epidemiologists from Georgia collaborated with the state’s department of public health’s office of emergency services, forensic experts, and drug enforcement professionals to evaluate almost 40 cases of counterfeit Percocet overdoses during the period spanning the second week of June 2017. Of these cases, a cluster triad was identified consisting of general opioid toxicity symptoms (for example, CNS or respiratory depression with concomitant pupillary constriction, a history of drug procurement, and a history of ingesting only one or two pills with rapid deterioration.⁶ Unfortunately, the screening process is often hindered by the fact that synthetic opioids such as Percocet are not readily identified on urine drug screens (UDS).

Despite shortcomings in assessment procedures, a UDS will yield positive results for multiple drugs, a feature that is common to seasoned opioid users and serves as an instrumental diagnostic clue in the investigative process. To address the crisis and prevent further spread, numerous Georgia agencies (e.g., drug trafficking and legal authorities) worked with the health care community to expediently identify cases of interest and bring forth public awareness concerning the ongoing perils of counterfeit drug intake. Future investigations might benefit from the implementation of DNA-verified UDS, because those screens are versatile enough to detect the presence of synthetic urine substitutes within the context of opioid use.^7,8 Moreover, an expanded panel could be tailored to provide coverage for semisynthetics, including hydrocodone, oxycodone, hydromorphone, and oxymorphone.⁹

As a well-received painkiller from the opioid family, Percocet derives its analgesic properties from the fast-acting oxycodone; hepatic failure is also possible from Percocet (because of the acetaminophen component) or counterfeit Percocet overdose but is less common unless the Tylenol content approaches 4 grams. By binding to the brain’s opiate receptors, Percocet modulates pain pathways leading to a dulling of pain sensation along with euphoria, which is particularly attractive to drug seekers. Chronic Percocet use corresponds with a myriad of psychological and physical consequences, and the Drug Enforcement Administration recognizes oxycodone as a Schedule II drug.

A chronic Percocet user may try to disrupt the cycle of symptoms by abruptly ceasing use of the offending agent. This can precipitate the development of classical opioid-based withdrawal symptoms, including but not limited to nausea, vomiting, irritability, tachycardia, body aches, and episodes of cold sweats. Physicians have noted that misuse (i.e., deviations from intended prescribed) might include crushing and snorting as well as “doctor-shopping” behaviors for a continuous supply of Percocet.
 

Treatment recommendations

According to Sarah Wakeman, MD, medical director of the substance use disorders initiative at Massachusetts General Hospital in Boston, there are apparently two clinical manifestations of Percocet use. The primary consequence is derived from the oxycodone component of Percocet; as an opioid, oxycodone toxicity leads to disrupted breathing and oxygenation, negatively impacting vital organs such as the brain or the heart. Patients experiencing a lack of oxygen will often display cyanosis and may not respond appropriately to stimuli. For individuals suspected of succumbing to overdose, Dr. Wakeman reportedly advised that the clinician or trained professional rub his or her knuckles along the breastbone of the potential user – a drug overdose patient will fail to wake up. On the other hand, a Percocet user may exhibit the symptoms of liver failure depending on the overall level of acetaminophen in the formulation. To prevent relapses, Percocet use disorder is best managed in a professional setting under the direction of trained clinicians; users are provided medications to address ongoing cravings and symptoms associated with the withdrawal process. A detoxification center can tailor the treatment with opioid-based medications such as methadone, buprenorphine, and naltrexone to help patients be weaned off Percocet.

Clinicians may further improve the efficacy of a therapeutic regimen by incorporating a personalized plan with a comprehensive substance UDS panel for monitoring and treatment purposes. This may prove to be beneficial in the event of suspected polysubstance use, as is the case with patients who dabble with Percocet and “molly.” Preparations can also be instituted at the outset of therapy with genetic testing implemented in high-risk patients who exhibit an inclination for opioid use disorder.¹⁰ Genetic polymorphisms provide robust clinical assets for evaluating patients most at risk for relapse. For individuals with biological susceptibility, arrangements can be made to incorporate nonopioid treatment alternatives.
 

References

1. Thomas BB. The death of Lil Peep: How the U.S. prescription drug epidemic is changing hip-hop. The Guardian. 2017 Nov 16.

2. D’Orazio JL and Curtis JA. J Emer Med. 2011 Aug 1;41(2):172-5.

3. Levy L. These are the drugs influencing pop culture now. Vulture. 2018 Feb 6.

4. Kounang N and Bender M. “What is Percocet? Drug facts, side effects, abuse and more.” CNN. 2018 Jul 12.

5. The dangers of Percocet use and overdose. American Addiction Centers. Last updated 2020 Feb 3. https://americanaddictioncenters.org/percocet-treatment/dangers-of-use-and-overdose.

6. Edison L et al. MMWR. 2017 Oct 20;66(41):1119-20.

7. Choudhry Z et al. J Psychiatry. 2015. doi: 10.4172/2378-5756.10000319.

8. Islam F and Choudhry Z. Current Psychiatry. 2018 Dec;17(12):43-4.

9. Jupe N. Ask the Experts: DOT 5-panel drug test regimen. Quest Diagnostics. 2018 Mar 21. https://blog.employersolutions.com/ask-experts-dot-5-panel-drug-test-regimen/.

10. Ahmed S et al. Pharmacogenomics. 2019 Jun 28;20(9):685-703.

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation, Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam reported no relevant disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He reported no relevant disclosures.

A 67-year-old man with stage 3 chronic kidney disease (CKD) develops abdominal pain over 24 hours. He has had low grade fevers and nausea. He has a history of colon cancer and had a resection four years ago. Abdominal exam reveals tenderness to palpation, including rebound tenderness in his right lower quadrant. Labs: hemoglobin: 13; hematocrit: 39; white blood cells: 18,000; platelets: 333; blood urea nitrogen: 28; creatinine: 1.8 (estimated glomerular filtration rate: 37); sodium: 136; potassium: 3.9; bicarbonate: 24; chlorine: 105; and lipase: 10.

What testing would you recommend?

A) Ultrasound

B) Non contrast computed tomography (CT)

C) Contrast CT

D) MRI without gadolinium

The correct answer here is to get a contrast CT scan, as it will give you the most appropriate diagnostic information.

For years, we have hesitated to order contrast studies in our patients with CKD, for fear of causing contrast-induced nephrotoxicity. We might choose less helpful studies that avoid contrast, or might not obtain imaging that is needed. Over the years I have especially seen this in the case of avoiding computed tomography angiography (CTA) for evaluation of pulmonary embolus and choosing the much less useful ventilation/perfusion scan. The problem arises with the fact that patients with CKD are more likely to develop worsening renal function when they get sick.

The assumption had been that when kidney injury occurred after contrast that it was due to the contrast. Many recent studies refute this assumption. Lee and colleagues performed an analysis of six retrospective studies involving a total of 55,963 participants. They found that patients with CKD receiving contrast material did not have an increased risk of deteriorating renal function compared with those without CKD (odds ratio, 1.07; 95% confidence interval, 0.98-1.17).¹

The early studies reporting contrast-induced renal disease were in patients who received high osmolality contrast agents.² Most patients now receive low osmolality agents, with less nephrotoxicity.³
 

Key points of guidelines

This year, the American College of Radiology and the National Kidney Foundation put out joint guidelines that helped clarify why there is a diminished concern for contrast-induced kidney disease in the modern era.⁴ Below are some of the key points of these guidelines:

• The risk of contrast-induced acute kidney injury (AKI) from intravenous iodinated contrast media is lower than previously thought.
• Necessary contrast material–enhanced CT without a suitable alternative should not be avoided solely on the basis of contrast-induced chronic kidney insufficiency risk.
• Contrast-induced AKI risk should be determined primarily by using CKD stage and AKI.
• Patients at high risk for contrast-induced kidney injury include those with recent AKI and those with estimated glomerular filtration rate (eGFR) less than 30 mL/min per 1.73 m².

Data supporting guidelines

The data from several studies used to support these recommendations were impressive, showing just how low the risk for contrast-induced AKI is in most patients. In these studies, the risk of contrast-induced AKI has been estimated to be near 0% for patients with an eGFR greater than or equal to 45 and 0%-2% for patients with an eGFR of 30-44.^5-7 This information and recommendations make imaging much easier. In most of our patients, we can get contrast studies when we need them. The group to be concerned about are patients with eGFRs less than 30. The guidelines single out this group as the patients where risk/benefit needs to be calculated before proceeding with the study, and to use prophylactic saline hydration in patients not undergoing dialysis.

Myth: Contrast-induced renal disease is common.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Lee YC et al. Contrast-induced acute kidney injury among patients with chronic kidney disease undergoing imaging studies: A meta-analysis. Am J Roentgenol. 2019 Oct;213(4):728-35.

2. Luk L et al. Intravenous contrast-induced nephropathy: The rise and fall of a threatening idea. Adv Chronic Kidney Dis. 2017 May;24(3):169-75.

3. Goldfarb S et al. Low-osmolality contrast media and the risk of contrast-associated nephrotoxicity. Invest Radiol. 1993;28(Suppl 5):7-10.

4. Davenport MS, et al. Use of intravenous iodinated contrast media in patients with kidney disease: Consensus statements from the American College of Radiology and the National Kidney Foundation. Kidney Med. 2020 Jan 22;2(1):85-93.

5. Davenport MS et al. Contrast material–induced nephrotoxicity and intravenous low-osmolality iodinated contrast material. Radiology. 2013;267(1):94-105.

6. McDonald RJ et al. Intravenous contrast material–induced nephropathy: Causal or coincident phenomenon? Radiology. 2013;267(1):106-18.

7. McDonald JS et al. Risk of intravenous contrast material–mediated acute kidney injury: A propensity scorematched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014;271(1):65-73.

A 67-year-old man with stage 3 chronic kidney disease (CKD) develops abdominal pain over 24 hours. He has had low grade fevers and nausea. He has a history of colon cancer and had a resection four years ago. Abdominal exam reveals tenderness to palpation, including rebound tenderness in his right lower quadrant. Labs: hemoglobin: 13; hematocrit: 39; white blood cells: 18,000; platelets: 333; blood urea nitrogen: 28; creatinine: 1.8 (estimated glomerular filtration rate: 37); sodium: 136; potassium: 3.9; bicarbonate: 24; chlorine: 105; and lipase: 10.

What testing would you recommend?

A) Ultrasound

B) Non contrast computed tomography (CT)

C) Contrast CT

D) MRI without gadolinium

The correct answer here is to get a contrast CT scan, as it will give you the most appropriate diagnostic information.

For years, we have hesitated to order contrast studies in our patients with CKD, for fear of causing contrast-induced nephrotoxicity. We might choose less helpful studies that avoid contrast, or might not obtain imaging that is needed. Over the years I have especially seen this in the case of avoiding computed tomography angiography (CTA) for evaluation of pulmonary embolus and choosing the much less useful ventilation/perfusion scan. The problem arises with the fact that patients with CKD are more likely to develop worsening renal function when they get sick.

The assumption had been that when kidney injury occurred after contrast that it was due to the contrast. Many recent studies refute this assumption. Lee and colleagues performed an analysis of six retrospective studies involving a total of 55,963 participants. They found that patients with CKD receiving contrast material did not have an increased risk of deteriorating renal function compared with those without CKD (odds ratio, 1.07; 95% confidence interval, 0.98-1.17).¹

The early studies reporting contrast-induced renal disease were in patients who received high osmolality contrast agents.² Most patients now receive low osmolality agents, with less nephrotoxicity.³
 

Key points of guidelines

This year, the American College of Radiology and the National Kidney Foundation put out joint guidelines that helped clarify why there is a diminished concern for contrast-induced kidney disease in the modern era.⁴ Below are some of the key points of these guidelines:

• The risk of contrast-induced acute kidney injury (AKI) from intravenous iodinated contrast media is lower than previously thought.
• Necessary contrast material–enhanced CT without a suitable alternative should not be avoided solely on the basis of contrast-induced chronic kidney insufficiency risk.
• Contrast-induced AKI risk should be determined primarily by using CKD stage and AKI.
• Patients at high risk for contrast-induced kidney injury include those with recent AKI and those with estimated glomerular filtration rate (eGFR) less than 30 mL/min per 1.73 m².

Data supporting guidelines

The data from several studies used to support these recommendations were impressive, showing just how low the risk for contrast-induced AKI is in most patients. In these studies, the risk of contrast-induced AKI has been estimated to be near 0% for patients with an eGFR greater than or equal to 45 and 0%-2% for patients with an eGFR of 30-44.^5-7 This information and recommendations make imaging much easier. In most of our patients, we can get contrast studies when we need them. The group to be concerned about are patients with eGFRs less than 30. The guidelines single out this group as the patients where risk/benefit needs to be calculated before proceeding with the study, and to use prophylactic saline hydration in patients not undergoing dialysis.

Myth: Contrast-induced renal disease is common.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Lee YC et al. Contrast-induced acute kidney injury among patients with chronic kidney disease undergoing imaging studies: A meta-analysis. Am J Roentgenol. 2019 Oct;213(4):728-35.

2. Luk L et al. Intravenous contrast-induced nephropathy: The rise and fall of a threatening idea. Adv Chronic Kidney Dis. 2017 May;24(3):169-75.

3. Goldfarb S et al. Low-osmolality contrast media and the risk of contrast-associated nephrotoxicity. Invest Radiol. 1993;28(Suppl 5):7-10.

4. Davenport MS, et al. Use of intravenous iodinated contrast media in patients with kidney disease: Consensus statements from the American College of Radiology and the National Kidney Foundation. Kidney Med. 2020 Jan 22;2(1):85-93.

5. Davenport MS et al. Contrast material–induced nephrotoxicity and intravenous low-osmolality iodinated contrast material. Radiology. 2013;267(1):94-105.

6. McDonald RJ et al. Intravenous contrast material–induced nephropathy: Causal or coincident phenomenon? Radiology. 2013;267(1):106-18.

7. McDonald JS et al. Risk of intravenous contrast material–mediated acute kidney injury: A propensity scorematched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014;271(1):65-73.

A 67-year-old man with stage 3 chronic kidney disease (CKD) develops abdominal pain over 24 hours. He has had low grade fevers and nausea. He has a history of colon cancer and had a resection four years ago. Abdominal exam reveals tenderness to palpation, including rebound tenderness in his right lower quadrant. Labs: hemoglobin: 13; hematocrit: 39; white blood cells: 18,000; platelets: 333; blood urea nitrogen: 28; creatinine: 1.8 (estimated glomerular filtration rate: 37); sodium: 136; potassium: 3.9; bicarbonate: 24; chlorine: 105; and lipase: 10.

What testing would you recommend?

A) Ultrasound

B) Non contrast computed tomography (CT)

C) Contrast CT

D) MRI without gadolinium

The correct answer here is to get a contrast CT scan, as it will give you the most appropriate diagnostic information.

For years, we have hesitated to order contrast studies in our patients with CKD, for fear of causing contrast-induced nephrotoxicity. We might choose less helpful studies that avoid contrast, or might not obtain imaging that is needed. Over the years I have especially seen this in the case of avoiding computed tomography angiography (CTA) for evaluation of pulmonary embolus and choosing the much less useful ventilation/perfusion scan. The problem arises with the fact that patients with CKD are more likely to develop worsening renal function when they get sick.

The assumption had been that when kidney injury occurred after contrast that it was due to the contrast. Many recent studies refute this assumption. Lee and colleagues performed an analysis of six retrospective studies involving a total of 55,963 participants. They found that patients with CKD receiving contrast material did not have an increased risk of deteriorating renal function compared with those without CKD (odds ratio, 1.07; 95% confidence interval, 0.98-1.17).¹

The early studies reporting contrast-induced renal disease were in patients who received high osmolality contrast agents.² Most patients now receive low osmolality agents, with less nephrotoxicity.³
 

Key points of guidelines

This year, the American College of Radiology and the National Kidney Foundation put out joint guidelines that helped clarify why there is a diminished concern for contrast-induced kidney disease in the modern era.⁴ Below are some of the key points of these guidelines:

• The risk of contrast-induced acute kidney injury (AKI) from intravenous iodinated contrast media is lower than previously thought.
• Necessary contrast material–enhanced CT without a suitable alternative should not be avoided solely on the basis of contrast-induced chronic kidney insufficiency risk.
• Contrast-induced AKI risk should be determined primarily by using CKD stage and AKI.
• Patients at high risk for contrast-induced kidney injury include those with recent AKI and those with estimated glomerular filtration rate (eGFR) less than 30 mL/min per 1.73 m².

Data supporting guidelines

The data from several studies used to support these recommendations were impressive, showing just how low the risk for contrast-induced AKI is in most patients. In these studies, the risk of contrast-induced AKI has been estimated to be near 0% for patients with an eGFR greater than or equal to 45 and 0%-2% for patients with an eGFR of 30-44.^5-7 This information and recommendations make imaging much easier. In most of our patients, we can get contrast studies when we need them. The group to be concerned about are patients with eGFRs less than 30. The guidelines single out this group as the patients where risk/benefit needs to be calculated before proceeding with the study, and to use prophylactic saline hydration in patients not undergoing dialysis.

Myth: Contrast-induced renal disease is common.
 

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. Lee YC et al. Contrast-induced acute kidney injury among patients with chronic kidney disease undergoing imaging studies: A meta-analysis. Am J Roentgenol. 2019 Oct;213(4):728-35.

2. Luk L et al. Intravenous contrast-induced nephropathy: The rise and fall of a threatening idea. Adv Chronic Kidney Dis. 2017 May;24(3):169-75.

3. Goldfarb S et al. Low-osmolality contrast media and the risk of contrast-associated nephrotoxicity. Invest Radiol. 1993;28(Suppl 5):7-10.

4. Davenport MS, et al. Use of intravenous iodinated contrast media in patients with kidney disease: Consensus statements from the American College of Radiology and the National Kidney Foundation. Kidney Med. 2020 Jan 22;2(1):85-93.

5. Davenport MS et al. Contrast material–induced nephrotoxicity and intravenous low-osmolality iodinated contrast material. Radiology. 2013;267(1):94-105.

6. McDonald RJ et al. Intravenous contrast material–induced nephropathy: Causal or coincident phenomenon? Radiology. 2013;267(1):106-18.

7. McDonald JS et al. Risk of intravenous contrast material–mediated acute kidney injury: A propensity scorematched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014;271(1):65-73.

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

A version of this article originally appeared on Medscape.com.

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

A version of this article originally appeared on Medscape.com.

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

A version of this article originally appeared on Medscape.com.

If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.

dulezidar/Thinkstock

A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.

Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.

Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.

I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
 

Possible solutions

1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.

2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.

3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.

4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.

5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.

Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
 

6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.

7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.

8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.

9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.

10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit. Gaining weight will suppress your immune system and make you more susceptible to COVID-19.

11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.

Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.

We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
 

Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.

If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.

dulezidar/Thinkstock

A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.

Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.

Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.

I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
 

Possible solutions

1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.

2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.

3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.

4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.

5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.

Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
 

6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.

7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.

8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.

9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.

10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit. Gaining weight will suppress your immune system and make you more susceptible to COVID-19.

11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.

Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.

We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
 

Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.

If you have been faithfully following the COVID-19 stay-at-home restrictive orders, you may have become a victim of “COVID-15,” the additional, unexpected, unwanted 10- to 15-pound weight gain that is making your clothes not fit so well any more.

dulezidar/Thinkstock

A change in routine; being home in comfy, stretchable clothing in front of the TV; and having unhealthy, processed foods ready to grab have set us up to lose the battle with COVID-15. We are set up to gain the weight because of excessive or unhealthful eating, taking an extra daily shot of alcohol, and being inactive, bored, depressed, anxious, and isolated from coworkers and family. Beware – weight gain can be “catching”; we tend to adopt the same poor eating habits and eat the same junk foods as those around us.

Since psychiatry can be a sedentary profession, I’ve (R.W.C.) kept myself very active and physically fit. Prior to the pandemic, I played tennis and ran every day. I was obese only once in my life. I had not realized that I had gained a lot of weight.

Thankfully, a physician called me “obese.” Initially, I was angry at the doctor, however, I realized that he did me the biggest favor of my life. I changed my diet and eating habits, and for the past 20 years, kept my weight between 135-140 pounds and my BMI at 23 consistently – until the pandemic stress caused me to fall into the same bad eating habits that have caused many others to gain the COVID-15.

I was surprised to see that when I weighed myself, and I had gained 12 pounds! I immediately modified my diet and increased my physical activity. I have now lost the extra 12 pounds and will offer suggestions that may help you and your patients exceed your prepandemic physical condition.
 

Possible solutions

1. Keep a food journal. Write down what you eat, the amount of food you eat, the time you are eating, and your mood at that moment. Keeping a small notebook to record what and when you eat is important because upon review, it will make you face reality and be accountable for what you put in your mouth. Until you review your journal, you may have underestimated the amount, as well as the kinds, of food and drinks you actually consume. A food journal can show your areas of struggle and unhealthy eating habits and help you make necessary changes in your habits and diet to eventually lose weight. You will be less likely to eat junk food or have an extra serving of food. If you do not want to use paper and pencil, you can download an app on your phone, such as myplate tracker to keep track of your food and calorie intake. Do your journaling immediately after you eat and include snacks; do not wait until night time to record your food and journal. Include your mood or how you felt during your meal or snack (for example, were you bored, sad, or anxious) since this information will indicate why you may be overeating.

2. Develop healthful eating habits. Eat a maximum of three meals and three snacks per day but eat only when you are hungry (that is, when your stomach growls or you feel light headed). Limiting yourself to eating only when you are hungry will help eliminate emotional eating to fill a loss in your life or to deal with feelings of stress, anxiety, sadness, or isolation, which have been exacerbated by the pandemic. Buy eat only healthful foods and not items with empty calories, such as chips, cake, and items with sugar. When you are eating, devote yourself to that activity only, eat slowly, and savor each bite. Do not watch television during your meal time.

3. Record the amount and type of exercise you engage in each day and determine the number of calories burned. Walk, run, or bicycle outside, or exercise inside with stretching, weights, or an exercycle. You may use a website, such as diet tool on WebMD.com to calculate daily calories burned. To lose weight, calories burned during a day must exceed caloric intake. You may want to invest in a Fitbit or an Apple Watch and use the health section to determine your caloric intake versus output. Analyzing your caloric data will provide a concrete measure of your progress.

4. Do not overconsume calories or underconsume protein. Protein plays a key role in the creation and maintenance of every cell of your body, and because the body does not store protein, it is important to consume it every day. To meet basic protein requirements, the DRI (Dietary Reference Intake) recommends 0.36 grams of protein per pound (0.8 grams per kg) of body weight. This amounts to: 56 grams per day for the average sedentary man, and 46 grams per day for the average sedentary woman. There is also an app entitled the Protein Tracker that can simplify your calculations.

5. Drink water. It is important to be hydrated to regulate body temperature, keep joints lubricated, prevent infections, deliver nutrients to cells, and keep organs functioning properly. Being well hydrated also improves sleep, cognition, and mood. Your daily water intake by ounce should be equal to your weight in pounds multiplied by two-thirds (or 67%) to determine the amount of water to drink daily. For example, if you weigh 175 pounds, you would multiply 175 by two-thirds and learn that you should be drinking about 117 ounces of water every day. You can also meet some of your daily water requirements by consuming fruits and vegetables, such as tomatoes, watermelon, lettuce, etc.

Also, drink 2 cups (16 oz.) of water before every meal: Often when you feel hungry, it is because your body simply needs water. Science has proven that drinking 2 cups of water before every meal helps you to eat less during meal time and lose weight. If you do this three times daily – at breakfast, lunch, and dinner – you have already consumed 48 ounces of water.
 

6. Keep track of your progress. In addition to keeping and analyzing your food journal, weigh yourself once or twice a week. Do not weigh yourself every day; you will not see any results on a day-to-day basis, but once a week gives your body time to regulate and show progress. Always calibrate/zero your scale before each use, and weigh yourself at the same time of the day (preferably after you first wake up in the morning) while wearing the same type of clothing. Keep a record of your weight in your journal to track your progress. Do not panic if the scale indicates you gained 1, 2, or 3 pounds, your weight can fluctuate because of glycogen storage, sodium retention, human bias, reporting or recall errors, and home scales can have a plus or minus 3 pound margin of error. Look at your weight trend over time. You may prefer buying a scale that indicates both weight and body mass index.

7. Celebrate and reward yourself with nonfood items. A healthful fitness and diet regime requires energy and dedication, so if you are able to follow a healthful routine, reward yourself with nonfood rewards for your good choices and new habits as an incentive to maintain your healthful behavior.

8. Don’t buy it if you can’t stop eating it. The biggest decision you make is when you decide what you are going to buy. Don’t lie to yourself in the store that you will only eat one at a time. Only buy what you can afford to binge eat if you can’t stop yourself from eating any particular type of food.

9. Have someone hide the food you can’t resist. You can’t eat what you can’t find. If you can’t avoid having irresistible food around, ask another adult to hide the food from you.

10. Learn what harm foods can cause in your body. Read about the effects of high blood sugar and high blood pressure can cause in your body. Find out which foods boost your immune system. Demonize the bad foods in your mind. Make up your mind before you go into the store that you are going to read food labels and find the best quality food with the lowest amount of sugar or saturated fat. Appreciate the flavor of vegetables and fruit. Gaining weight will suppress your immune system and make you more susceptible to COVID-19.

11. Treat sugar as if it were an addictive drug. You can’t have just one. If you reduce your craving for sugar by slowly reducing your intake of sugar, you will find that you don’t crave sugar any more. This won’t be easy, but once it is done, you will be preventing many of the ravages that sugar takes on your body over time. But you can’t have one piece of pie because the craving will come back. At some point, it may be more likely that you find that piece of pie too sweet.

Here are a few other ideas: Buy a gift for yourself or new clothes, makeup, a plant or flowers, running shoes, exercise clothes, fitness tracker, water bottle, book, movie or network subscription. Improve your home décor. Or treat yourself to online lessons for painting, music, and so on. Or you might adopt a dog, donate food to a shelter or food bank; or organize and declutter your home since staying busy will give you a reason not to eat. In nice weather, enjoy the outdoors by going for a walk, run, bikeride or by gardening.

We are all worried about getting COVID-19. Preventing COVID-15 will go a long way toward boosting our immune systems to help protect us from the coronavirus.
 

Dr. Cohen is board-certified in psychiatry and has had a private practice in Philadelphia for more than 35 years. His areas of specialty include sports psychiatry, agoraphobia, depression, and substance abuse. In addition, Dr. Cohen is a former professor of psychiatry, family medicine, and otolaryngology at Thomas Jefferson University in Philadelphia. He has no conflicts of interest. Ms. Cohen holds an MBA from Temple University in Philadelphia with a focus on health care administration. Previously, Ms. Cohen was an associate administrator at Hahnemann University Hospital and an executive at the Health Services Council, both in Philadelphia. She currently writes biographical summaries of notable 18th- and 19th-century women. Ms. Cohen has no conflicts of interest.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

An intriguing pattern has emerged for cannabis enthusiasts as a result of lockdowns and statewide safety restrictions for COVID-19.

Consumers, as of late, have been shopping for larger marijuana baskets per trip to the dispensaries in various states, including California, Colorado, Nevada, and Washington, . However, they are also cutting down on the number of trips, perhaps, as a preventive measure to reduce the risk of exposure to coronavirus during this pandemic. Sales dipped considerably by the end of March only to experience a resurgence after the issuing of stimulus checks and unemployment benefits.

For the past few years, cannabis consumption remained steady while the industry continued to thrive with robust sales of the drug. It is a recession-proof phenomenon, therefore presenting a unique opportunity for clinicians with respect to patient education and individualized care.¹

An unfortunate carryover of the governmental restrictions, self-isolation, and social estrangement is that consumers are now turning to the dark web as a source for continuous supply of cannabis. Prepandemic, according to the U.N. 2020 World Drug Report, there was already a 30% increase in sales of cannabis between 2009 and 2018. COVID-19 has fractured the drug’s supply chain and created an inescapable void that is being filled by drug traffickers.² A clinical dilemma is posed when a user procures counterfeit cannabis or a drug batch with impurities.
 

Riding the cytokine storm

Cytokines are a host of proteins with designated regulatory and immune responses that play an instrumental role in cell signaling. The aptly named “cytokine storm” conjures up the image of an imperiled immune system spiraling out of control; it is, in fact, an extreme immune response that culminates into a massive influx of cytokines released into the bloodstream. Without the presence of an immunologic threat, cytokines are responsible for maintaining homeostasis and the functionality of immune cells. However, acute cytokine release (i.e., cytokine storm), as is the case with severe COVID-19, jeopardizes organ function (for example, interstitial lung disease) with clinical symptoms, such as fever, cough, dyspnea, and myalgia.

Benefits and drawbacks of immunosuppressive agents

To inhibit cytokine release (e.g., interleukin-6 cytokine levels), immunosuppressive agents such as tocilizumab have been leveraged to damper the body’s overactive inflammatory response to perceived immunologic stressors, in particular, COVID-19. While the aforementioned agent was remarkably effective with respect to lung consolidation clearance in most of the patients tested, a host of untoward effects prevent its general applicability and use. However, a team of researchers from the University of Nebraska, Omaha, with the Texas Biomedical Research Institute, San Antonio, might have stumbled upon a strategic workaround for mitigating the immune response.

They have proposed that cannabidiol (CBD) be used in lieu of other agents with potentially toxic effects. Animal and human trials have established that CBD confers a relatively high margin of safety coupled with favorable tolerance, providing a viable option for effectively targeting the inflammatory processes of SARS-CoV-2–based pulmonary disease. Furthermore, efficacy increased when CBD was combined with a terpene formulation, especially with respect to the more traditional steroid therapy.³

SARS-CoV-2 exhibits binding affinity for the ACE2 receptor, which is expressed in the lungs as well as other known predilection sites of infection. Ongoing studies attempt to modulate ACE2 expression, thereby eliminating its conspicuous role as “viral gateways,” perhaps even more so in patients with lung pathologies (e.g., people with chronic obstructive pulmonary disease [COPD] and smokers) as they already are prone to increased respiratory morbidity. CBD lacks tetrahydrocannabinol (THC), or the psychoactive component of cannabis sativa, rendering the agent to be particularly attractive from a therapeutic perspective. In addition to being devoid of abuse potential, CBD exhibits remarkable anti-inflammatory properties. It should be noted that considerable overlap exists between tobacco and cannabis users, and it is too early to determine the impact on COVID-19. As opposed to cannabis’s effect on ACE2 levels, smoking exhibits a proinflammatory role by up-regulating ACE2 expression.3 However, there are currently numerous conflicting reports in circulation about the positive effect of nicotine on COVID-19 outcome; confounding variables will need to be explored further in patients with a history of using nicotine and cannabis together.

From an immunologic perspective, the endocannabinoid system (ECS) plays an integral role in cell signaling by interacting with natural chemicals of the body, namely, cannabinoids with designated targets at the cannabinoid receptor 1 (CB1) and the CB2, respectively. The CB2 receptor is of particular interest as it is intimately involved in immune homeostasis; the primary goal of these COVID-19 studies is to modulate the endocannabinoid system via targeted CB2 therapies to produce an immunosuppressant effect.⁴ CB2 activation, be it by means of THC or CBD agonism, may prove to be beneficial by inhibiting the cytokine influx.

Unfortunately, there is a general dearth of data on COVID-19–exposed cannabis users, whether the drug is consumed for medication or recreational purposes. It has been suggested that cannabis intake might contribute toward the development of a cough, complicating the overall clinical outcome for those infected with the virus. The presence of a cough, even in an otherwise asymptomatic individual, facilitates viral spread. As for those cannabis users experiencing COVID-19 symptomatology, they can expect rapid clinical deterioration, including pronounced fatigue and a change in mental status.

According to pulmonary specialists and representatives of the American Lung Association, recreational cannabis use may be associated with a bronchitis-like inflammation (comparable with chronic bronchitis/COPD for chronic users) of the airways, along the lines of cigarette smoking.⁵ As far as cannabis smokers are concerned, the rationale for lung irritation is believed to stem from the relatively large portion of unburnt plant content that is inhaled in a given joint. If there is a superimposed infection, as is the case with COVID-19, the patient may experience further risk of adverse respiratory effects. This serves as a diagnostic dilemma for physicians, especially when they encounter patients who recently started dabbling with cannabis as a means of placating themselves or because they’ve heard rumors that it will somehow protect them from COVID-19. The entire assessment plan is slowed down as a result of the confounding variable (onset of a cough), which may arise independently of COVID-19 in cannabis users. Vulnerable populations include smokers and those with COPD or asthma, as they are more likely to require ventilator assistance during the course of COVID-19 therapy.⁵ Asthmatics and COPD patients are prone to bronchospasms because of sensitive airways.


 

COVID-19 safety protocols for cannabis users

Because of increased risk of respiratory morbidity, clinicians advise that consumption of recreational cannabinoids be scaled back during the course of the pandemic. In light of conflicting news from several media outlets regarding the efficacy of cannabis intake with respect to COVID-19, preexisting users might unwittingly increase their consumption as a preemptive measure against being exposed to the infection. To prevent transmission among users, clinicians should discourage patients from sharing joints. This recommendation is thematically consistent with general precautionary measures about the dangers of sharing utensils, drinking cups/glasses, and so on, amid the pandemic.

Despite promising preliminary research results, CBD cannot be wholeheartedly recommended at this time; patients already on medically administered cannabinoids are urged to discuss the risk-benefit ratio with their respective health care clinicians. Cannabinoid therapies present a massive opportunity from the perspective of immunomodulation, especially when considering the prevalence of drug use. However, to improve clinical guidelines with respect to COVID-19 outcomes, it would be prudent to increase the overall volume of preclinical knowledge by gathering retrospective data (from case-control designs) and randomized prospective trials.

A more comprehensive list of advice from physicians concerning casual or chronic cannabis users may also include: adopting a dedicated delivery or dispensing system for cannabis products, making considerations for decontamination (i.e., disinfecting mouthpieces), ensuring cleansing precautions are maintained (washing thoroughly before and after use or procurement), switching to inhalation alternates (e.g., tinctures, edibles, and/or oils) to decrease further irritation to the lungs. For bong users, it is recommended that they apply rubbing alcohol to clean their device followed with a minute of air-drying.⁶

Conclusion

The literature from preclinical studies appears to largely favor the use of CBD, but there remains an element of uncertainty with respect to implementing cannabinoids for the treatment of coronavirus.

COVID-19 cannabinoid intervention is a hot topic with renewed interest from the industry and the public at large, but viral-focused therapies remain a relatively underused area worth exploring with case-control designs and randomized prospective trials. As cannabis legalization is picking up momentum across five additional states, the time is ripe to systematically investigate the therapeutic applications of the drug beyond merely preclinical data. Aside from educational reform initiatives, clinicians might proactively launch a platform that integrates telemedicine as well as digital apps, directly linking the patient to the clinician and monitoring the efficacy of program initiatives in real time.
 

References

1. Long A. Consumers’ cannabis buying patterns change markedly in wake of COVID-19 pandemic. Marijuana Business Daily. 2020 Sep 22. https://mjbizdaily.com/consumers-cannabis-buying-patterns-change-markedly-in-wake-of-covid-pandemic/.

2. Bures B. How the coronavirus pandemic is increasing global demand for marijuana. Chicago Tribune. 2020 Jul 1. https://www.chicagotribune.com/marijuana/sns-tft-coronavirus-increases-global-marijuana-demand-20200701-oygaxryb7vhcjfeu44cgacicaa-story.html.

3. Walters J. Marijuana and COVID-19: Top studies. CannaMD. 2020 Aug 19. https://www.cannamd.com/marijuana-covid-19-top-studies/.

4. El Biali M et al. Med Cannabis Cannabinoids. 2020 Aug 19. doi: 10.1159/000510799.

5. LaMotte S. “Smoking weed and coronavirus: Even occasional use raises risk of COVID-19 complications.” CNN Health. 2020 Apr 10. https://www.cnn.com/2020/04/10/health/smoking-weed-coronavirus-wellness/index.html

6. Yafai S and Etengoff S. The case for cannabis: Advising cannabis users about COVID-19. Emergency Medicine News. 2020 May 20;42(5B).

Dr. Islam is a medical adviser for the International Maternal and Child Health Foundation (IMCHF), Montreal, and is based in New York. He also is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Mr. Choudhry is a research assistant at the IMCHF. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF and is Mr. Choudhry’s father. Dr. Islam, Mr. Choudhry, and Dr. Choudhry reported no relevant disclosures.

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

While the concept of home-based care and remote monitoring of patients may not be a new concept, the importance of this option for managing patients has taken on great importance during this COVID-19 pandemic.

Courtesy Dr. Noel Deep

We are currently living and working in unprecedented times and the impact of the pandemic is quite evident, and it plays an important part in every health care worker’s daily life. The high volumes of patients presenting to emergency rooms and urgent care/walk-in clinics and seeking posthospitalization visits with their physicians is stressing the health care environment. In such difficult times, the hospital-at-home model of care provides a valuable and viable option to provide appropriate care to those patients who may require close monitoring of their health without being hospitalized and using valuable inpatient resources that could then be used for the higher-acuity patients. As a physician who lives this every day and as a practicing internist and a part-time administrator, I welcome the hospital-at-home approach that complements the care provided in the emergency room, inpatient and ambulatory practice settings. I believe this type of approach to patient care would benefit those patients who, while being acutely ill, may not require the 24/7 intensive care that more critically ill individuals may need. As long as the patients are provided with appropriate telemonitoring devices such as a blood pressure cuff, pulse oximeter, and thermometer, and have access to video telemonitoring, the appropriately selected patients would benefit from this method of care provision for their acute illness.
 

Mental health benefits

I see several benefits for patients who can be triaged/assigned to this telemonitoring model of care. A patient would probably be happier being at home because they could sleep in their own bed and eat their own food and be able to walk around their house or even venture outdoors to enjoy the fresh air and nature. Being able to do these things will contribute positively to their emotional and psychological well-being.

For some elderly individuals, having access to the familiarity of their surroundings would mean these patients would have fewer incidences of hospital-associated delirium or falls. Additionally, they would be able to enjoy the company of their family members, which, during this COVID pandemic, is not possible in many hospitals. This would reduce emotional tensions for the patients and their families and the risk of transmission of infections to the patients and their visitors in the hospitals.
 

Freeing up resources

More importantly, this model would help physicians and hospitals provide the much needed care to the appropriate patients in the appropriate settings, thereby leading to decreased use of emergency rooms, health care workers, and personal protective equipment – all of which are currently in high demand.

Having a dedicated team of physicians, nurses, respiratory therapists, and other health care workers available to monitor these home-based patients on a daily or more frequent basis, depending on their health status, would result in these patients receiving equivalent care to what they would have received in a hospital.

Another positive outcome of using this home-based care model in the pandemic is that it would free up hospital beds for non–COVID-19 patients who might need hospitalization for management of their acute illnesses or exacerbation of chronic health conditions.
 

Possible limitations

This model of care has some limitations, including that it is not geared toward high volumes in my opinion and will not work in every home. Patients need to have Internet capabilities, phone services, and other features in their homes that make it possible for them to access this type of care. Additionally, patients may not be able to get their insurance companies to pay for these services. While the Centers for Medicare & Medicaid Services recently authorized patients to be transferred from EDs or inpatient wards to hospital-level care at home, for how long will reimbursements for this kind of care continue? If insurance will not pay for this monitoring at home, then will physician practices and hospital based practices provide this non reimbursed service?

Also, patients and their families may not be accepting of this model of care because they may feel it is inferior to inpatient hospitalization.

Despite these limitations, as long as Medicare and other health insurance programs provide reimbursement for such hospital-at-home services, I foresee this concept being highly used and benefiting health care entities in the United States.
 

Dr. Deep is a general internist in a multispecialty group practice with Aspirus Antigo (Wis.) Clinic and the chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo. He is also assistant clinical professor at the Medical College of Wisconsin, Central Wisconsin Campus, and the governor of the Wisconsin chapter of the American College of Physicians. Dr. Deep serves on the editorial advisory board of Internal Medicine News. Contact him at [email protected].

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

As COVID-19 cases soared to new daily highs across the United States, November 2020 brought some exciting and promising vaccine efficacy results. Currently, the United States has four COVID-19 vaccines in phase 3 trials: the Moderna vaccine (mRNA-1273), the Oxford/AstraZeneca vaccine (AZD1222), Pfizer/BioNTech’s (BNT162), and the Johnson & Johnson vaccine (JNJ-78436735).

While Pfizer/ BioNTech and Moderna received fast-track designation by the Food and Drug Administration, AZD1222 and JNJ-78436735 trials were resumed after a temporary hold. Pfizer/BioNTech and Moderna have also submitted an emergency-use authorization application to the FDA after favorable results from a completed phase 3 clinical trial. The results so far seem promising, with Oxford/AstraZeneca’s combined analysis from different dosing regimens resulting in an average efficacy of 70%. Pfizer/ BioNTech and Moderna have each reported vaccines that are 90% and 95% effective respectively in trials.

However, even with a safe and effective vaccine, there must be an equal emphasis on a successful coronavirus vaccine program’s three pillars in the communities that are the hardest hit: participation in the vaccine trials by minority populations, equitable allocation and distribution of vaccine for minority populations, and immunization uptake by minority populations.
 

1. Participation in the vaccine trials by minority populations

With a great emphasis on the inclusion of diverse populations, the Moderna vaccine clinical trials gained participation by racial and ethnic minorities. As of Oct. 21, 2020, the Moderna vaccine trial participants were 10% African American, 20% Hispanic, 4% Asian, 63% White, and 3% other.¹ Pharmaceutical giant Pfizer also had approximately 42% of overall – and 45% of U.S. – participants from diverse backgrounds. The proportional registration of racially and ethnically diverse participants in other vaccine trials is also anticipated to be challenging.

Though there has been an improvement in minority participation in COVID-19 vaccine trials, it is still below the ideal representation when compared with U.S. census data.² Ideally, participants in a clinical trial should represent the U.S. population to get a full picture of a medical product’s risks and benefits. However, recruitment rates in clinical trials have remained low among minorities for various reasons. Historically, African Americans make up only 5% of participants in U.S. clinical trials, while they represent 13% of the country’s general population; likewise, Hispanics are also underrepresented.³

The legacy of distrust in the medical system is deep-rooted and is one of the most substantial barriers to clinical trial participation. A plethora of unethical trials and experiments on the African American population have left a lasting impact. The most infamous and widely known was the “Tuskegee Study,” conducted by the United States Public Health Service to “observe the natural history of untreated syphilis” in Black populations. In the study, performed without informed consent, Black men with latent or late syphilis received no treatment, even after penicillin was discovered as a safe and reliable cure for syphilis. This human experimentation lasted for 40 years, resulting in 128 male patients who died from syphilis or its complications, 40 of their spouses infected, and 19 of their children with acquired congenital syphilis.

In another case, the father of modern gynecology, J. Marion Sims, allegedly performed experimental surgeries on enslaved Black women without consent. For more than 4 decades, North Carolina’s statewide eugenics program forcibly sterilized almost 7,600 people, many of whom were Black. Another story of exploitation involves Henrietta Lacks, whose cancer cells are the source of the HeLa cell line, responsible for some of the most important medical advances of all time. Though her cells were commercialized and generated millions for medical researchers, neither Ms. Lacks nor her family knew the cell cultures existed until more than 20 years after her death from cervical cancer. Many years later, victims and families of the Tuskegee experiment, individuals sterilized by the Eugenics Board of North Carolina, and the family of Henrietta Lacks received compensation, and Sims’s statue was taken down in 2018. Not too long ago, many criticized the FDA’s “Exception from Informed Consent policy” for compromising patients’ exercise of autonomy, and concern for overrepresenting African Americans in the U.S. EFIC trials.

Racial disparities in medical treatment and unconscious biases among providers are among the reasons for mistrust and lack of trial participation by minority populations today. Francis Collins, director of the National Institutes of Health, said that recent social upheaval sparked by the death of George Floyd has likely added to feelings of mistrust between minority groups and government or pharmaceutical companies. “Yet we need their participation if this is going to have a meaningful outcome,” he said.

While “Operation Warp Speed” is committed to developing and delivering a COVID-19 vaccine rapidly while adhering to safety and efficacy standards, the challenges to enrolling people from racial and ethnic minorities in trials have been a concern. The political partisanship and ever-shifting stances on widespread COVID-19 testing, use of facemasks, endorsement of unproven drugs for the disease, and accusations against the FDA for delaying human trials for the vaccine have contributed to the skepticism as well. Tremendous pressure for a rushed vaccine with unrealistic timelines, recent holds on AZD1222 and JNJ-78436735 as well as the AZD1222 dosage error during trials have also raised skepticism of the safety and efficacy of vaccine trials.
 

2. Equitable allocation and distribution of vaccine for minority populations

Enrollment in clinical trials is just a beginning; a more significant challenge would be the vaccine’s uptake when available to the general public. We still lack a consensus on whether it is lawful for race to be an explicit criterion for priority distribution of the COVID-19 vaccine. Recently the Centers for Disease Control and Prevention suggested that the vaccine amount allotted to jurisdictions might be based on critical populations recommended for vaccination by the Advisory Committee on Immunization Practices with input from the National Academies of Sciences, Engineering, and Medicine.

The NASEM framework lays out four-phased vaccine distribution approaches, emphasizing social equity by prioritizing vaccines for geographic areas identified through CDC’s social vulnerability index (SVI) or another more specific index. SVI has been a robust composite marker of minority status and language, household composition and transportation, and housing and disability, and predicted COVID-19 case counts in the United States in several studies. The National Academy of Medicine has also recommended racial minorities receive priority vaccination because they have been hard hit and are “worse off” socioeconomically.
 

3. Immunization uptake by minority populations

Though minority participation is crucial in developing the vaccine, more transparency, open discussions on ethical distribution, and awareness of side effects are required before vaccine approval or emergency-use authorization. Companies behind the four major COVID-19 vaccines in development have released their trials’ protocols, details on vaccine efficacy, and each product’s makeup to increase acceptance of the vaccine.

According to a recent Pew research study, about half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020, a 21–percentage point drop, and Black adults were much less likely to say they would get a vaccine than other Americans.³ This is concerning as previous studies have shown that race and ethnicity can influence immune responses to vaccination. There is evidence of racial and ethnic differences in immune response following rubella vaccination, Hib–tetanus toxoid conjugate vaccine, antibody responses to the influenza A virus components of IIV3 or 4, and immune responses after measles vaccination.^4-9

On the other hand, significant differences in reporting rates of adverse events after human papillomavirus vaccinations were found in different race and ethnicity groups in the Vaccine Adverse Event Reporting System.¹⁰ Thus, there is ample evidence that race and ethnicity affect responsiveness to a vaccine. Inequity in participation in a clinical trial may lead to an ineffective or one with a suboptimal response or even an unsafe vaccine.

When we look at other immunization programs, according to various surveys in recent years, non-Hispanic Blacks have lower annual vaccination rates for flu, pneumonia, and human papillomavirus vaccinations nationally, compared with non-Hispanic White adults.¹¹ It is a cause of concern as a proportion of the population must be vaccinated to reach “community immunity” or “herd immunity” from vaccination. Depending on varying biological, environmental, and sociobehavioral factors, the threshold for COVID-19 herd immunity may be between 55% and 82% of the population.¹² Hence, neither a vaccine trial nor an immunization program can succeed without participation from all communities and age groups.
 

Role of hospitalists

Hospitalists, who give immunizations as part of the hospital inpatient quality reporting program, are uniquely placed in this pandemic. Working on the front lines, we may encounter questions, concerns, rejections, and discussions about the pros and cons of the COVID-19 vaccine from patients.

Investigators at Children’s National Hospital and George Washington University, both in Washington, recently recommended three steps physicians and others can take now to ensure more people get the COVID-19 vaccine when it is available. Engaging frontline health professionals was one of the suggested steps to encourage more people to get the vaccine.¹³ However, it is imperative to understand that vaccine hesitancy might be an issue for health care providers as well, if concerns for scientific standards and involvement of diverse populations are not addressed.

We are only starting to develop a safe and effective immunization program. We must bring more to unrepresented communities than just vaccine trials. Information, education, availability, and access to the vaccines will make for a successful COVID-19 immunization program.

Dr. Saigal is a hospitalist and clinical assistant professor of medicine in the division of hospital medicine at the Ohio State University Wexner Medical Center, Columbus.

References

1. Moderna. COVE study. 2020 Oct 21. https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

2. U.S. Census Bureau. Quick facts: Population estimates, July 1, 2019. https://www.census.gov/quickfacts/fact/table/US/PST045219

3. Pew Research Center. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine. 2020 Sep 17. https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

4. Haralambieva IH et al. Associations between race sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946-53.

5. McQuillan GM et al. Seroprevalence of measles antibody in the U.S. population 1999-2004. J Infect Dis. 2007;196:1459–64. doi: 10.1086/522866.

6. Christy C et al. Effect of gender race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96:584-7.

7. Poland GA et al. Measles antibody seroprevalence rates among immunized Inuit Innu and Caucasian subjects. Vaccine. 1999;17:1525-31.

8. Greenberg DP et al. Immunogenicity of Haemophilus influenzae type b tetanus toxoid conjugate vaccine in young infants. The Kaiser-UCLA Vaccine Study Group. J Infect Dis. 1994;170:76-81.

9. Kurupati R et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct prevaccination gene expression profiles in blood. Oncotarget. 2016;7(39):62898-911.

10. Huang J et al. Characterization of the differential adverse event rates by race/ethnicity groups for HPV vaccine by integrating data from different sources. Front Pharmacol. 2018;9:539.

11. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=22

12. Sanche S et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020;26(7).

13. American Medical Association. How to ready patients now so they’ll get a COVID-19 vaccine later. 2020 May 27. https://www.ama-assn.org/delivering-care/public-health/how-ready-patients-now-so-they-ll-get-covid-19-vaccine-later

Since the start of the pandemic, we have been conducting an extra hour of Virtual Rounds at the Center for Women’s Mental Health. Virtual Rounds has been an opportunity to discuss cases around a spectrum of clinical management issues with respect to depression, bipolar disorder, and a spectrum of anxiety disorders like obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder. How to apply the calculus of risk-benefit decision-making around management of psychiatric disorder during pregnancy and the postpartum period has been the cornerstone of the work at our center for over 2 decades.

When we went virtual at our center in the early Spring, we decided to keep the format of our faculty rounds the way they have been for years and to sustain cohesiveness of our program during the pandemic. But we thought the needs of pregnant and postpartum women warranted being addressed in a context more specific to COVID-19, and also that reproductive psychiatrists and other clinicians could learn from each other about novel issues coming up for this group of patients during the pandemic. With that backdrop, Marlene Freeman, MD, and I founded “Virtual Rounds at the Center” to respond to queries from our colleagues across the country; we do this just after our own rounds on Wednesdays at 2:00 p.m.

As the pandemic has progressed, Virtual Rounds has blossomed into a virtual community on the Zoom platform, where social workers, psychologists, nurse prescribers, psychiatrists, and obstetricians discuss the needs of pregnant and postpartum women specific to COVID-19. Frequently, our discussions involve a review of the risks and benefits of treatment before, during, and after pregnancy.

Seemingly, week to week, more and more colleagues raise questions about the treatment of anxiety and insomnia during pregnancy and the postpartum period. I’ve spoken in previous columns about the enhanced use of telemedicine. Telemedicine not only facilitates efforts like Virtual Rounds and our ability to reach out to colleagues across the country and share cases, but also has allowed us to keep even closer tabs on the emotional well-being of our pregnant and postpartum women during COVID-19.

The question is not just about the effects of a medicine that a woman might take to treat anxiety or insomnia during pregnancy, but the experience of the pandemic per se, which we are measuring in multiple studies now using a variety of psychological instruments that patients complete. The pandemic is unequivocally taking a still unquantified toll on the mental health of Americans and potentially on the next generation to come.

Midcycle awakening during pregnancy

Complaints of insomnia and midcycle awakening during pregnancy are not new – it is the rule, rather than the exception for many pregnant women, particularly later in pregnancy. We have unequivocally seen a worsening of complaints of sleep disruption including insomnia and midcycle awakening during the pandemic that is greater than what we have seen previously. Both patients and colleagues have asked us the safest ways to manage it. One of the first things we consider when we hear about insomnia is whether it is part of an underlying mood disorder. While we see primary insomnia clinically, it really is important to remember that insomnia can be part and parcel of an underlying mood disorder.

With that in mind, what are the options? During the pandemic, we’ve seen an increased use of digital cognitive behavioral therapy for insomnia (CBT-I) for patients who cannot initiate sleep, which has a very strong evidence base for effectiveness as a first-line intervention for many.

If a patient has an incomplete response to CBT-I, what might be pursued next? In our center, we have a low threshold for using low doses of benzodiazepines, such as lorazepam or clonazepam, because the majority of data do not support an increased risk of major congenital malformations even when used in the first trimester. It is quite common to see medicines such as newer nonbenzodiazepine sedative hypnotics such as Ambien CR (zolpidem) or Lunesta (eszopiclone) used by our colleagues in ob.gyn. The reproductive safety data on those medicines are particularly sparse, and they may have greater risk of cognitive side effects the next day, so we tend to avoid them.

Another sometimes-forgotten option to consider is using low doses of tricyclic antidepressants (i.e., 10-25 mg of nortriptyline at bedtime), with tricyclics having a 40-year history and at least one pooled analysis showing the absence of increased risk for major congenital malformations when used. This may be a very easy way of managing insomnia, with low-dose tricyclics having an anxiolytic effect as well.

Anxiety during pregnancy

The most common rise in symptoms during COVID-19 for women who are pregnant or post partum has been an increase in anxiety. Women present with a spectrum of concerns leading to anxiety symptoms in the context of the pandemic. Earlier on in the pandemic, concerns focused mostly on how to stay healthy, and how to mitigate risk and not catch SARS-CoV-2 during pregnancy, as well as the very complex issues that were playing out in real time as hospital systems were figuring out how to manage pregnant women in labor and to keep both them and staff safe. Over time, anxiety has shifted to still staying safe during the pandemic and the potential impact of SARS-CoV-2 infection on pregnancy outcomes. The No. 1 concern is what the implications of COVID-19 disease are on mother and child. New mothers also are anxious about how they will practically navigate life with a newborn in the postpartum setting.

Early on in the pandemic, some hospital systems severely limited who was in the room with a woman during labor, potentially impeding the wishes of women during delivery who would have wanted their loved ones and/or a doula present, as an example. With enhanced testing available now, protocols have since relaxed in many hospitals to allow partners – but not a team – to remain in the hospital during the labor process. Still, the prospect of delivering during a pandemic is undoubtedly a source of anxiety for some women.

This sort of anxiety, particularly in patients with preexisting anxiety disorders, can be particularly challenging. Fortunately, there has been a rapid increase over the last several years of digital apps to mitigate anxiety. While many of them have not been systematically studied, the data on biobehavioral intervention for anxiety is enormous, and this should be used as first-line treatment for patients with mild to moderate symptoms; so many women would prefer to avoid pharmacological intervention during pregnancy, if possible, to avoid fetal drug exposure. For patients who meet criteria for frank anxiety disorder, other nonpharmacologic interventions such as CBT have been shown to be effective.

Frequently, we see women who are experiencing levels of anxiety where nonpharmacological interventions have an incomplete response, and colleagues have asked about the safest way to treat these patients. As has been discussed in multiple previous columns, selective serotonin reuptake inhibitors (SSRIs) should be thought of sooner rather than later, particularly with medicines with good reproductive safety data such as sertraline, citalopram, or fluoxetine.

We also reported over 15 years ago that at least 30%-40% of women presenting with histories of recurrent major depression at the beginning of pregnancy had comorbid anxiety disorders, and that the use of benzodiazepines in that population in addition to SSRIs was exceedingly common, with doses of approximately 0.5-1.5 mg of clonazepam or lorazepam being standard fare. Again, this is very appropriate treatment to mitigate anxiety symptoms because now have enough data as a field that support the existence of adverse outcomes associated with untreated anxiety during pregnancy in terms of both adverse obstetric and neonatal outcomes, higher rates of preterm birth, and other obstetric complications. Hence, managing anxiety during pregnancy should be considered like managing a toxic exposure – the same way that one would be concerned about anything else that a pregnant woman could be exposed to.

Lastly, although no atypical antipsychotic has been approved for the treatment of anxiety, its use off label is extremely common. More and more data support the absence of a signal of teratogenicity across the family of molecules including atypical antipsychotics. Beyond potential use of atypical antipsychotics, at Virtual Rounds last week, a colleague asked about the use of gabapentin in a patient who was diagnosed with substance use disorder and who had inadvertently conceived on gabapentin, which was being used to treat both anxiety and insomnia. We have typically avoided the use of gabapentin during pregnancy because prospective data have been limited to relatively small case series and one report, with a total of exposures in roughly the 300 range.

However, our colleagues at the Harvard School of Public Health have recently published an article that looked at the United States Medicaid Analytic eXtract (MAX) dataset, which has been used to publish other articles addressing atypical antipsychotics, SSRIs, lithium, and pharmacovigilance investigations among other important topics. In this study, the database was used to look specifically at 4,642 pregnancies with gabapentin exposure relative to 1,744,447 unexposed pregnancies, without a significant finding for increased risk for major congenital malformations.

The question of an increased risk of cardiac malformations and of increased risk for obstetric complications are difficult to untangle from anxiety and depression, as they also are associated with those same outcomes. With that said, the analysis is a welcome addition to our knowledge base for a medicine used more widely to treat symptoms such as anxiety and insomnia in the general population, with a question mark around where it may fit into the algorithm during pregnancy.

In our center, gabapentin still would not be used as a first-line treatment for the management of anxiety or insomnia during pregnancy. But these new data still are reassuring for patients who come in, frequently with unplanned pregnancies. It is an important reminder to those of us taking care of patients during the pandemic to review use of contraception, because although data are unavailable specific to the period of the pandemic, what is clear is that, even prior to COVID-19, 50% of pregnancies in America were unplanned. Addressing issues of reliable use of contraception, particularly during the pandemic, is that much more important.

In this particular case, our clinician colleague in Virtual Rounds decided to continue gabapentin across pregnancy in the context of these reassuring data, but others may choose to discontinue or pursue some of the other treatment options noted above.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Since the start of the pandemic, we have been conducting an extra hour of Virtual Rounds at the Center for Women’s Mental Health. Virtual Rounds has been an opportunity to discuss cases around a spectrum of clinical management issues with respect to depression, bipolar disorder, and a spectrum of anxiety disorders like obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder. How to apply the calculus of risk-benefit decision-making around management of psychiatric disorder during pregnancy and the postpartum period has been the cornerstone of the work at our center for over 2 decades.

When we went virtual at our center in the early Spring, we decided to keep the format of our faculty rounds the way they have been for years and to sustain cohesiveness of our program during the pandemic. But we thought the needs of pregnant and postpartum women warranted being addressed in a context more specific to COVID-19, and also that reproductive psychiatrists and other clinicians could learn from each other about novel issues coming up for this group of patients during the pandemic. With that backdrop, Marlene Freeman, MD, and I founded “Virtual Rounds at the Center” to respond to queries from our colleagues across the country; we do this just after our own rounds on Wednesdays at 2:00 p.m.

As the pandemic has progressed, Virtual Rounds has blossomed into a virtual community on the Zoom platform, where social workers, psychologists, nurse prescribers, psychiatrists, and obstetricians discuss the needs of pregnant and postpartum women specific to COVID-19. Frequently, our discussions involve a review of the risks and benefits of treatment before, during, and after pregnancy.

Seemingly, week to week, more and more colleagues raise questions about the treatment of anxiety and insomnia during pregnancy and the postpartum period. I’ve spoken in previous columns about the enhanced use of telemedicine. Telemedicine not only facilitates efforts like Virtual Rounds and our ability to reach out to colleagues across the country and share cases, but also has allowed us to keep even closer tabs on the emotional well-being of our pregnant and postpartum women during COVID-19.

The question is not just about the effects of a medicine that a woman might take to treat anxiety or insomnia during pregnancy, but the experience of the pandemic per se, which we are measuring in multiple studies now using a variety of psychological instruments that patients complete. The pandemic is unequivocally taking a still unquantified toll on the mental health of Americans and potentially on the next generation to come.

Midcycle awakening during pregnancy

Complaints of insomnia and midcycle awakening during pregnancy are not new – it is the rule, rather than the exception for many pregnant women, particularly later in pregnancy. We have unequivocally seen a worsening of complaints of sleep disruption including insomnia and midcycle awakening during the pandemic that is greater than what we have seen previously. Both patients and colleagues have asked us the safest ways to manage it. One of the first things we consider when we hear about insomnia is whether it is part of an underlying mood disorder. While we see primary insomnia clinically, it really is important to remember that insomnia can be part and parcel of an underlying mood disorder.

With that in mind, what are the options? During the pandemic, we’ve seen an increased use of digital cognitive behavioral therapy for insomnia (CBT-I) for patients who cannot initiate sleep, which has a very strong evidence base for effectiveness as a first-line intervention for many.

If a patient has an incomplete response to CBT-I, what might be pursued next? In our center, we have a low threshold for using low doses of benzodiazepines, such as lorazepam or clonazepam, because the majority of data do not support an increased risk of major congenital malformations even when used in the first trimester. It is quite common to see medicines such as newer nonbenzodiazepine sedative hypnotics such as Ambien CR (zolpidem) or Lunesta (eszopiclone) used by our colleagues in ob.gyn. The reproductive safety data on those medicines are particularly sparse, and they may have greater risk of cognitive side effects the next day, so we tend to avoid them.

Another sometimes-forgotten option to consider is using low doses of tricyclic antidepressants (i.e., 10-25 mg of nortriptyline at bedtime), with tricyclics having a 40-year history and at least one pooled analysis showing the absence of increased risk for major congenital malformations when used. This may be a very easy way of managing insomnia, with low-dose tricyclics having an anxiolytic effect as well.

Anxiety during pregnancy

The most common rise in symptoms during COVID-19 for women who are pregnant or post partum has been an increase in anxiety. Women present with a spectrum of concerns leading to anxiety symptoms in the context of the pandemic. Earlier on in the pandemic, concerns focused mostly on how to stay healthy, and how to mitigate risk and not catch SARS-CoV-2 during pregnancy, as well as the very complex issues that were playing out in real time as hospital systems were figuring out how to manage pregnant women in labor and to keep both them and staff safe. Over time, anxiety has shifted to still staying safe during the pandemic and the potential impact of SARS-CoV-2 infection on pregnancy outcomes. The No. 1 concern is what the implications of COVID-19 disease are on mother and child. New mothers also are anxious about how they will practically navigate life with a newborn in the postpartum setting.

Early on in the pandemic, some hospital systems severely limited who was in the room with a woman during labor, potentially impeding the wishes of women during delivery who would have wanted their loved ones and/or a doula present, as an example. With enhanced testing available now, protocols have since relaxed in many hospitals to allow partners – but not a team – to remain in the hospital during the labor process. Still, the prospect of delivering during a pandemic is undoubtedly a source of anxiety for some women.

This sort of anxiety, particularly in patients with preexisting anxiety disorders, can be particularly challenging. Fortunately, there has been a rapid increase over the last several years of digital apps to mitigate anxiety. While many of them have not been systematically studied, the data on biobehavioral intervention for anxiety is enormous, and this should be used as first-line treatment for patients with mild to moderate symptoms; so many women would prefer to avoid pharmacological intervention during pregnancy, if possible, to avoid fetal drug exposure. For patients who meet criteria for frank anxiety disorder, other nonpharmacologic interventions such as CBT have been shown to be effective.

Frequently, we see women who are experiencing levels of anxiety where nonpharmacological interventions have an incomplete response, and colleagues have asked about the safest way to treat these patients. As has been discussed in multiple previous columns, selective serotonin reuptake inhibitors (SSRIs) should be thought of sooner rather than later, particularly with medicines with good reproductive safety data such as sertraline, citalopram, or fluoxetine.

We also reported over 15 years ago that at least 30%-40% of women presenting with histories of recurrent major depression at the beginning of pregnancy had comorbid anxiety disorders, and that the use of benzodiazepines in that population in addition to SSRIs was exceedingly common, with doses of approximately 0.5-1.5 mg of clonazepam or lorazepam being standard fare. Again, this is very appropriate treatment to mitigate anxiety symptoms because now have enough data as a field that support the existence of adverse outcomes associated with untreated anxiety during pregnancy in terms of both adverse obstetric and neonatal outcomes, higher rates of preterm birth, and other obstetric complications. Hence, managing anxiety during pregnancy should be considered like managing a toxic exposure – the same way that one would be concerned about anything else that a pregnant woman could be exposed to.

Lastly, although no atypical antipsychotic has been approved for the treatment of anxiety, its use off label is extremely common. More and more data support the absence of a signal of teratogenicity across the family of molecules including atypical antipsychotics. Beyond potential use of atypical antipsychotics, at Virtual Rounds last week, a colleague asked about the use of gabapentin in a patient who was diagnosed with substance use disorder and who had inadvertently conceived on gabapentin, which was being used to treat both anxiety and insomnia. We have typically avoided the use of gabapentin during pregnancy because prospective data have been limited to relatively small case series and one report, with a total of exposures in roughly the 300 range.

However, our colleagues at the Harvard School of Public Health have recently published an article that looked at the United States Medicaid Analytic eXtract (MAX) dataset, which has been used to publish other articles addressing atypical antipsychotics, SSRIs, lithium, and pharmacovigilance investigations among other important topics. In this study, the database was used to look specifically at 4,642 pregnancies with gabapentin exposure relative to 1,744,447 unexposed pregnancies, without a significant finding for increased risk for major congenital malformations.

The question of an increased risk of cardiac malformations and of increased risk for obstetric complications are difficult to untangle from anxiety and depression, as they also are associated with those same outcomes. With that said, the analysis is a welcome addition to our knowledge base for a medicine used more widely to treat symptoms such as anxiety and insomnia in the general population, with a question mark around where it may fit into the algorithm during pregnancy.

In our center, gabapentin still would not be used as a first-line treatment for the management of anxiety or insomnia during pregnancy. But these new data still are reassuring for patients who come in, frequently with unplanned pregnancies. It is an important reminder to those of us taking care of patients during the pandemic to review use of contraception, because although data are unavailable specific to the period of the pandemic, what is clear is that, even prior to COVID-19, 50% of pregnancies in America were unplanned. Addressing issues of reliable use of contraception, particularly during the pandemic, is that much more important.

In this particular case, our clinician colleague in Virtual Rounds decided to continue gabapentin across pregnancy in the context of these reassuring data, but others may choose to discontinue or pursue some of the other treatment options noted above.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Since the start of the pandemic, we have been conducting an extra hour of Virtual Rounds at the Center for Women’s Mental Health. Virtual Rounds has been an opportunity to discuss cases around a spectrum of clinical management issues with respect to depression, bipolar disorder, and a spectrum of anxiety disorders like obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder. How to apply the calculus of risk-benefit decision-making around management of psychiatric disorder during pregnancy and the postpartum period has been the cornerstone of the work at our center for over 2 decades.

When we went virtual at our center in the early Spring, we decided to keep the format of our faculty rounds the way they have been for years and to sustain cohesiveness of our program during the pandemic. But we thought the needs of pregnant and postpartum women warranted being addressed in a context more specific to COVID-19, and also that reproductive psychiatrists and other clinicians could learn from each other about novel issues coming up for this group of patients during the pandemic. With that backdrop, Marlene Freeman, MD, and I founded “Virtual Rounds at the Center” to respond to queries from our colleagues across the country; we do this just after our own rounds on Wednesdays at 2:00 p.m.

As the pandemic has progressed, Virtual Rounds has blossomed into a virtual community on the Zoom platform, where social workers, psychologists, nurse prescribers, psychiatrists, and obstetricians discuss the needs of pregnant and postpartum women specific to COVID-19. Frequently, our discussions involve a review of the risks and benefits of treatment before, during, and after pregnancy.

Seemingly, week to week, more and more colleagues raise questions about the treatment of anxiety and insomnia during pregnancy and the postpartum period. I’ve spoken in previous columns about the enhanced use of telemedicine. Telemedicine not only facilitates efforts like Virtual Rounds and our ability to reach out to colleagues across the country and share cases, but also has allowed us to keep even closer tabs on the emotional well-being of our pregnant and postpartum women during COVID-19.

The question is not just about the effects of a medicine that a woman might take to treat anxiety or insomnia during pregnancy, but the experience of the pandemic per se, which we are measuring in multiple studies now using a variety of psychological instruments that patients complete. The pandemic is unequivocally taking a still unquantified toll on the mental health of Americans and potentially on the next generation to come.

Midcycle awakening during pregnancy

Complaints of insomnia and midcycle awakening during pregnancy are not new – it is the rule, rather than the exception for many pregnant women, particularly later in pregnancy. We have unequivocally seen a worsening of complaints of sleep disruption including insomnia and midcycle awakening during the pandemic that is greater than what we have seen previously. Both patients and colleagues have asked us the safest ways to manage it. One of the first things we consider when we hear about insomnia is whether it is part of an underlying mood disorder. While we see primary insomnia clinically, it really is important to remember that insomnia can be part and parcel of an underlying mood disorder.

With that in mind, what are the options? During the pandemic, we’ve seen an increased use of digital cognitive behavioral therapy for insomnia (CBT-I) for patients who cannot initiate sleep, which has a very strong evidence base for effectiveness as a first-line intervention for many.

If a patient has an incomplete response to CBT-I, what might be pursued next? In our center, we have a low threshold for using low doses of benzodiazepines, such as lorazepam or clonazepam, because the majority of data do not support an increased risk of major congenital malformations even when used in the first trimester. It is quite common to see medicines such as newer nonbenzodiazepine sedative hypnotics such as Ambien CR (zolpidem) or Lunesta (eszopiclone) used by our colleagues in ob.gyn. The reproductive safety data on those medicines are particularly sparse, and they may have greater risk of cognitive side effects the next day, so we tend to avoid them.

Another sometimes-forgotten option to consider is using low doses of tricyclic antidepressants (i.e., 10-25 mg of nortriptyline at bedtime), with tricyclics having a 40-year history and at least one pooled analysis showing the absence of increased risk for major congenital malformations when used. This may be a very easy way of managing insomnia, with low-dose tricyclics having an anxiolytic effect as well.

Anxiety during pregnancy

The most common rise in symptoms during COVID-19 for women who are pregnant or post partum has been an increase in anxiety. Women present with a spectrum of concerns leading to anxiety symptoms in the context of the pandemic. Earlier on in the pandemic, concerns focused mostly on how to stay healthy, and how to mitigate risk and not catch SARS-CoV-2 during pregnancy, as well as the very complex issues that were playing out in real time as hospital systems were figuring out how to manage pregnant women in labor and to keep both them and staff safe. Over time, anxiety has shifted to still staying safe during the pandemic and the potential impact of SARS-CoV-2 infection on pregnancy outcomes. The No. 1 concern is what the implications of COVID-19 disease are on mother and child. New mothers also are anxious about how they will practically navigate life with a newborn in the postpartum setting.

Early on in the pandemic, some hospital systems severely limited who was in the room with a woman during labor, potentially impeding the wishes of women during delivery who would have wanted their loved ones and/or a doula present, as an example. With enhanced testing available now, protocols have since relaxed in many hospitals to allow partners – but not a team – to remain in the hospital during the labor process. Still, the prospect of delivering during a pandemic is undoubtedly a source of anxiety for some women.

This sort of anxiety, particularly in patients with preexisting anxiety disorders, can be particularly challenging. Fortunately, there has been a rapid increase over the last several years of digital apps to mitigate anxiety. While many of them have not been systematically studied, the data on biobehavioral intervention for anxiety is enormous, and this should be used as first-line treatment for patients with mild to moderate symptoms; so many women would prefer to avoid pharmacological intervention during pregnancy, if possible, to avoid fetal drug exposure. For patients who meet criteria for frank anxiety disorder, other nonpharmacologic interventions such as CBT have been shown to be effective.

Frequently, we see women who are experiencing levels of anxiety where nonpharmacological interventions have an incomplete response, and colleagues have asked about the safest way to treat these patients. As has been discussed in multiple previous columns, selective serotonin reuptake inhibitors (SSRIs) should be thought of sooner rather than later, particularly with medicines with good reproductive safety data such as sertraline, citalopram, or fluoxetine.

We also reported over 15 years ago that at least 30%-40% of women presenting with histories of recurrent major depression at the beginning of pregnancy had comorbid anxiety disorders, and that the use of benzodiazepines in that population in addition to SSRIs was exceedingly common, with doses of approximately 0.5-1.5 mg of clonazepam or lorazepam being standard fare. Again, this is very appropriate treatment to mitigate anxiety symptoms because now have enough data as a field that support the existence of adverse outcomes associated with untreated anxiety during pregnancy in terms of both adverse obstetric and neonatal outcomes, higher rates of preterm birth, and other obstetric complications. Hence, managing anxiety during pregnancy should be considered like managing a toxic exposure – the same way that one would be concerned about anything else that a pregnant woman could be exposed to.

Lastly, although no atypical antipsychotic has been approved for the treatment of anxiety, its use off label is extremely common. More and more data support the absence of a signal of teratogenicity across the family of molecules including atypical antipsychotics. Beyond potential use of atypical antipsychotics, at Virtual Rounds last week, a colleague asked about the use of gabapentin in a patient who was diagnosed with substance use disorder and who had inadvertently conceived on gabapentin, which was being used to treat both anxiety and insomnia. We have typically avoided the use of gabapentin during pregnancy because prospective data have been limited to relatively small case series and one report, with a total of exposures in roughly the 300 range.

However, our colleagues at the Harvard School of Public Health have recently published an article that looked at the United States Medicaid Analytic eXtract (MAX) dataset, which has been used to publish other articles addressing atypical antipsychotics, SSRIs, lithium, and pharmacovigilance investigations among other important topics. In this study, the database was used to look specifically at 4,642 pregnancies with gabapentin exposure relative to 1,744,447 unexposed pregnancies, without a significant finding for increased risk for major congenital malformations.

The question of an increased risk of cardiac malformations and of increased risk for obstetric complications are difficult to untangle from anxiety and depression, as they also are associated with those same outcomes. With that said, the analysis is a welcome addition to our knowledge base for a medicine used more widely to treat symptoms such as anxiety and insomnia in the general population, with a question mark around where it may fit into the algorithm during pregnancy.

In our center, gabapentin still would not be used as a first-line treatment for the management of anxiety or insomnia during pregnancy. But these new data still are reassuring for patients who come in, frequently with unplanned pregnancies. It is an important reminder to those of us taking care of patients during the pandemic to review use of contraception, because although data are unavailable specific to the period of the pandemic, what is clear is that, even prior to COVID-19, 50% of pregnancies in America were unplanned. Addressing issues of reliable use of contraception, particularly during the pandemic, is that much more important.

In this particular case, our clinician colleague in Virtual Rounds decided to continue gabapentin across pregnancy in the context of these reassuring data, but others may choose to discontinue or pursue some of the other treatment options noted above.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].