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Aptiom Receives FDA approval for Partial-Onset Seizures in Children
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
FDA has approved Aptiom (eslicarbazepine) for an expanded indication to treat partial-onset seizures in children.
Indications: Aptiom was previously approved form the treatment of partial onset seizures in adults. The new approval is for children ages 4 years to 17 years with the same disorder. It is a once daily immediate release anti-epilepsy drug that can be taken whole or crushed, with or without food. The approval is based in part on extrapolation of previous data to support its use in the pediatric population.
Dosage and administration. The recommended dosage of APTIOM is based on
body weight and is administered orally once daily. The package insert says to increase the dose in weekly intervals based on clinical response and tolerability to the recommended maintenance dosage. The initial pediatric dose is 200 mg/day for a patient 11 to 21 kg, with 200 mg/day as a maximum titration increment. Maximum dose for a child in this weight range in 400 to 600 mg/day.
Adverse effects. The most common reactions in adults include dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. Adverse reactions are similar in pediatric patients.
Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
http://www.sunovion.us/featured-news/press-releases/20170914a.pdf. Accessed October 16, 2017
Why is Psychogenic Nonepileptic Seizure Diagnosis Missed?
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
The diagnosis of psychogenic nonepileptic seizure (PNES) is often delayed—and a history of head trauma can contribute to that delay.
- 49 adult patients who were admitted to the epilepsy unit at the Jefferson Comprehensive Epilepsy Center for PNES were studied to determine how long it took for a correct diagnosis to be reached.
- Of the 49 patients, 39 were women, 10 were men; the study period was 2012 to 2016.
- On average, it took 3 years (median) to arrive at the correct diagnosis.
- A comparison of patients who received an early diagnosis to those whose diagnosis was delayed found that a history of head trauma was the only significant difference between the 2 groups.
- 2 of 19 patients had an early diagnosis (7%) and 11 of 28 patients experienced a delayed diagnosis, which was associated with head trauma (P=0.02).
Asadi-Pooya AA, Tinker J. Delay in diagnosis of psychogenic nonepileptic seizures in adults: A post hoc study [published online ahead of print Sept 15, 2017]. Epilepsy Behav. doi: 10.1016/j.yebeh.2017.08.005.
Federal Report Finds Increased Prevalence of Epilepsy
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Three million adults and 470,000 children have epilepsy according to the latest statistics from the Centers for Disease Control and Prevention (CDC). These figures, based on the 2015 National Health Interview Survey, translate into 1.2% of the US population, an all-time high. Previous estimates, based on 2010 data, indicated that 2.3 million adults and 450,000 children had the disorder.
- The CDC report provides the first ever estimates of the prevalence of epilepsy state by state, with the agency reporting higher volumes in more densely populated states, as expected.
- The lowest prevalence of the neurological disease was noted in Wyoming, with 5900 active cases.
- California was estimated to have 427,700 cases of the disease.
- CDC believes increases from 2010 to 2015 are likely due to population growth.
- Among the limitations of the analysis is the fact that the estimates are based on self-reports, which are subject to bias.
- Underreporting by the public may reflect their reluctance to admit to a disorder because of its stigma and because they fear it could lead to driver’s license restrictions.
Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy — United States, 2015. MMWR; 2017;66(31):821-825.
Study: EHR malpractice claims rising
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
[email protected]
On Twitter @legal_med
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
[email protected]
On Twitter @legal_med
Malpractice claims involving the use of electronic health records (EHRs) are on the rise, according to data from The Doctors Company.
Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016, according an analysis published Oct. 16 by The Doctors Company, a national medical malpractice insurer.
The majority of EHR-related claims during 2014-2016 stemmed from incidents in a doctor’s office or a hospital clinic (35%), while the second most common location was a patient’s room. Malpractice claims involving EHRs were most commonly alleged against ob.gyns, followed by family physicians, and orthopedists. Diagnosis errors and improper medication management were the top most frequent allegations associated with EHR claims.
The analysis shows that while digitization of medicine has improved patient safety, it also has a dark side – as evidenced by the emergence of new kinds of errors, said Robert M. Wachter, MD, a professor at the University of California, San Francisco, and a member of the board of governors for The Doctors Company.
“This study makes an important contribution by chronicling actual errors, such as wrong medications selected from an autopick list, and helps point the way to changes ranging from physician education to EHR software design,” Dr. Wachter said in a statement.
[email protected]
On Twitter @legal_med
Key clinical point:
Major finding: Cases in which EHRs were a factor grew from 2 claims during 2007-2010 to 161 claims from 2011 to December 2016
Data source: Review of 163 claims from 2007 to 2016 in The Doctors Company database.
Disclosures: The study was funded by The Doctors Company.
DDSEP® 8 Quick quiz - October 2017 Question 2
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2: Answer: E
This patient has elevated transaminases with normal alkaline phosphatase and total bilirubin levels. His AST is greater than his ALT. He does not meet criteria for having nonalcolholic steatohepatitis because of his history of drinking at least five drinks per day. Additionally, his AST:ALT ratio would be atypical for classic NASH presentation. This patient does not have chronic hepatitis B as his serologies reveal that he is hepatitis B immune. This patient’s labs are not suggestive of iron overload with a normal serum ferritin and normal iron saturation. Although this patient has emphysema diagnosed at a young age and an undetectable alpha-1-antitrypsin level, this patient’s liver enzyme elevations are not due to alpha-1-antitrypsin deficiency. Alpha-1-antitrypsin is a glycoprotein that functions as a serine protease inhibitor and is produced predominantly in hepatocytes and then secreted from the cell.
In alpha-1-antitrypsin mutations that affect the liver (most commonly the ZZ phenotype), there is an amino acid substitution that results in the production of an abnormal alpha-1-antitrypsin molecule that polymerizes within the hepatocyte preventing secretion from the cell and resulting in abnormal accumulation of the alpha-1-antitrypsin in hepatocytes with resulting hepatic damage over time. This patient, however, has the alpha-1-antitrypsin phenotype null/null, which results in the absence of alpha-1-antitrypsin production. As such, null/null individuals are at very high risk for emphysema due to the complete absence of the alpha-1-antitrypsin enzyme. However, since null/null individuals produce no alpha-1-antitrypsin at all, there is no abnormally polymerized alpha-1-antitrypsin protein build-up. Based upon the clinical history and laboratory data, this patient’s liver enzyme elevations are most likely due to alcohol abuse.
References
1. Fairbanks K.D., Tavill A.S. Liver disease in alpha-1-antitrypsin deficiency: A review. Am J Gastro. 2008;103:2136-41.
2. Silverman E.A., Sandhaus R.A. Alpha-1 antitrypsin deficiency. N Engl J Med. 2009;360;2749-5.
Q2. A 38-year-old man presents for evaluation of elevated liver enzymes. His past medical history is notable for being diagnosed with emphysema when he was 32 years old. He continues to smoke ½ pack of cigarettes per day and he drinks approximately five beers per day with binge drinking on weekends. He denies a history of drug use. His laboratory data are notable for the following: aspartate aminotransferase, 139 U/L; alanine aminotransferase, 76 U/L; total bilirubin, 0.8 mg/dL; alkaline phosphatase, 104 U/L; and serum albumin, 4.1 g/dL. Additional laboratory testing showed the following: HCV Ab, negative; HBsAg, negative; HBsAb, positive; HBc Total Ab, positive; alpha-1 antitrypsin phenotype, null/null; alpha-1 antitrypsin level, undetectable; antismooth muscle antibody, negative; antinuclear antibody, negative; ferritin, 114 mcg/L; iron saturation, 37%.
Hepatic ultrasound reveals an enlarged echogenic liver with patent portal and hepatic veins.
Use multimodal analgesia protocols after minimally invasive gynecologic surgery
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
Minimally invasive gynecologic surgeons can combat the opioid epidemic by devising creative, multimodal approaches to analgesia, according to the authors of an extensive narrative review.
Acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration all significantly reduce postoperative pain, as does reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case, reported Marron Wong, MD, of Newton (Mass.)-Wellesley Hospital and her associates.
“In the midst of the opioid crisis currently affecting the United States, we believe that it is imperative for [minimally invasive gynecologic surgeons] to use these available tools,” Dr. Wong and her associates wrote in the Journal of Minimally Invasive Gynecology.
The experts reviewed studies identified through PubMed, EMBASE, and the Cochrane Database. They focused on randomized controlled trials and highlighted the role of multimodal approaches. “Reasonable evidence” supports the preemptive and postoperative use of NSAIDs and acetaminophen, as well as the preemptive use of gabapentin, pregabalin and dexamethasone, they concluded (J Minim Invasive Gynecol. 2017 Sep 27. doi: 10.1016/j.jmig.2017.09.016).
Preemptive liposomal bupivacaine also is promising, the reviewers said. In a randomized controlled trial, transverse abdominis plane (TAP) infiltration with liposomal bupivacaine was associated with significant and clinically meaningful reductions in pain, morphine use, and postoperative nausea and vomiting, compared with transverse abdominis plane infiltration with regular bupivacaine (Gynecol Oncol. 2015 Sep;138[3]:609-13).
“Local infiltration [also] has been shown to decrease pain as well as opioid intake,” the reviewers wrote. “Pre-closure infiltration has been shown to have more effect than pre-incisional dosing.” Bupivicaine has a longer duration of action (120-240 minutes) than lidocaine (30-60 minutes), which can be extended further by adding epinephrine, they noted.
The adverse effects of alpha-2 agonists (bradycardia and hypotension) and N-methyl-d-aspartate receptor antagonists (vivid dreams, hallucination, emergence confusion) limit their use, the reviewers found.
Another recent systematic review drew similar conclusions, recommending NSAIDs, acetaminophen, anti-epileptics, and dexamethasone for nonopioid pain management in benign minimally invasive hysterectomy (Am J Obstet Gynecol. 2017 Jun;216[6]:557-67). That review found no positive results for local anesthesia, suggesting that the benefits of local anesthesia are limited to minor procedures, Dr. Wong and her associates noted.
The authors reported having no financial disclosures.
FROM THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY
Key clinical point:
Major finding: Medical options include acetaminophen, NSAIDs, antiepileptics, and local anesthetic incision infiltration. Surgical measures include reducing laparoscopic trocar size to less than 10 mm and evacuating pneumoperitoneum at the end of a case.
Data source: An extensive narrative review, primarily of randomized controlled trials.
Disclosures: The authors reported having no financial disclosures.
ACR: Use comparative effectiveness research for clinical decisions, not payers’ cost decisions
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
The goal of comparative effectiveness research should be to find the best products to meet a clinical situation instead of a tool to be used by payers to make cost-based coverage decisions, the American College of Rheumatology recently said.
The ACR’s Committee on Rheumatologic Care recently updated its position statement on CER, noting that high-quality comparative effectiveness research and cost-effectiveness analysis “can and should inform individual provider and patient decisions about the relative value of diagnostic and therapeutic options.”
One concern that Dr. Fahey noted, specific to the rheumatology space, is that there currently are few CER data to draw upon, which as a result, makes it harder to have meaningful conversations about clinical value.
“Quite frankly right now, a lot of times those decisions are already heavily influenced by the payer’s formulary structure and what is on their preferred tier and what is on their second, third, or fourth tier,” he said. “We just don’t have enough comparative effectiveness data yet to be a huge influence. The formulary and step edits for each individual payer are still based extremely heavily on their cost and rebates. This is why, circling back to the whole question to begin with ... when we updated the position statement, we sort of reinforced our concern that this should be made to guide clinical decisions and not payer-type coverage decisions.”
He noted that the ACR does have registries that are building real-world data about the various products, but there is still a ways to go to have an effective database that would be usable for quality CER information.
“We are hopeful that, over time, especially with things like registries, the ACR has a registry that compiles real-world data from our members about our patients, that we will be able to come up with a more real-world comparison between different medications,” Dr. Fahey said. “The concern is that the payers will use the results of comparative effectiveness research to make very black-and-white decisions about their formulary and about treatment options and things like that.”
The position statement says that the ACR is doing its part to help collect information. In 2014, it launched the Rheumatology Informatics System for Effectiveness (RISE), which “allows rheumatologists throughout the country to seamlessly and effortlessly transfer anonymous patient outcome data to a national registry.” According to the position statement, “thus far, RISE has collected more than one million patient encounters, positioning RISE to become the premier source for real-world CER data in rheumatology.”
“It would be fantastic if we already had the data about which medication provided the best value,” Dr. Fahey said. “Our drugs are extremely expensive, at least our biologic drugs, and we understand that the goal is to provide both good quality care but cost efficient care.”
Use MADRS to dose ketamine for refractory depression
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
NEW ORLEANS – Ketamine infusions are becoming more and more routine for refractory depression, but the literature is just not clear about the optimal treatment regimen.
Studies have run the gamut from daily, to weekly, to monthly infusions, with scant information on how to predict who will respond and how to maintain response.
“Almost everybody feels significantly better an hour after the infusion. The question is how long will they continue to feel better, and how to find the ones who will stay well. That’s what we’ve tried to answer here,” said principal investigator and psychiatrist Ranjith Chandrasena, MD, the research center’s scientific director.
Ketamine is dosed at 0.5 mg/kg IV over 45 minutes, delivered in an ambulatory care center under the supervision of a respiratory therapist and a physician assistant, with vital signs monitored every 10 minutes. Patients are cleared ahead of time for anesthesia, since ketamine at higher doses is an anesthetic.
In the induction phase, patients are offered up to three ketamine infusions weekly; if MADRS scores don’t remain below 16 points a month after the last induction dose, ketamine is judged to be ineffective, and the patient is taken off the protocol. A score below 16 “pretty much translates to normal functioning,” Dr. Chandrasena said.
Patients who remain below 16 points a month after their last induction dose are moved onto maintenance and qualify for repeat infusions when their MADRS creeps above 16 points, so long as it’s stayed below 16 for a month or more in the interim. The majority of patients on maintenance go 6 or more weeks between infusions. MADRS scores are assessed weekly over the phone.
For patients on maintenance, scores have dropped from a mean of 28.72 points at baseline to 10.73 points, an impressive improvement in patients with long-standing depression who have failed multiple treatments.
Global Assessment of Functioning scores have improved as well, from a baseline of under 40 points to over 60 points, with improvements in social functioning and the ability to work. A few patients had made serious suicide attempts before starting ketamine; with treatment, “there has been success in keeping patients out of the hospital, with no suicide attempts reported,” Dr. Chandrasena said.
Ketamine’s been well tolerated at the center; no one has been discontinued because of side effects, and only one person has had noticeable hallucinations. “People are telling us that it’s a very pleasant experience,” he said.
But to cut costs and reduce the addiction risk, the investigators are considering nasal esketamine instead of IV ketamine, and rapastinel, an N-methyl-d-aspartate receptor antagonist that doesn’t have the dissociative effects of ketamine. Patients also are being taught how to recognize the signs of relapse, to see whether the medication reduces the need for weekly phone assessments.
“We would like someone to replicate our study. If the results are promising, that would be the time to do a double-blind placebo-controlled trial using this” protocol, Dr. Chandrasena said.
Almost two-thirds of the subjects were women, about a third were men, and a few were transgendered. Ages ranged from 19 to above 70 years, with most patients 30-70 years old.
There was no industry funding for the work, and the investigators had no disclosures.
AT IPS 2017
Key clinical point:
Major finding: Score-based dosing has led to marked improvements in 19 of 44 patients (43%), with remissions sustained for up to 74 weeks and counting.
Data source: Pilot study of 44 patients with refractory depression.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.
Don’t discount your face
I admit it ... I am a victim too. The hype was real. Offer a service, at a hefty discount, and increase your patient volume. I didn’t need to increase my patient load. But with more overhead, getting the new providers in my practice busy fast was alluring. There are, however, so many inherent risks to discounting. So I offer you this column as my own version of a consumer alert on discount coupon sites.
After falling victim to this fad myself, I realize that it was the worst business decision I have ever made – from the perspectives of the risks to the patient and the risks to the business.
The risks to the patient are transparent. The most obvious risk is the abundance of inexperienced injectors doing procedures. Self explanatory. Discount sites obtain medical license information prior to approving any medical treatment; however, not everyone with a medical license should be doing cosmetic procedures.
The second risk is a lack of proper evaluation and management, which leads to poor medical management and dissatisfaction. We should be approaching each cosmetic patient with treatments and procedures that are right for them, their skin, their medical history, their anatomy, and their specific needs. There is no screening through these sites. Patients buy the service, and even if the procedure is not right for them, they expect the service. Even if there is a statement on a site that services are contingent on screening, the promise of the service has already been made. If you do not provide the service, often the now-disgruntled patient will complain about you, your staff, your ethics, to anyone and everyone. If you do the procedure despite your best intentions, you are setting yourself up for disaster ... complications, unsatisfied patients, and unmet expectations. There is a reason consultations are necessary.
Third, the margins on this type of service are negligible. If a practice if offering injectable treatments at a too-good-to-be-true price, it probably is. Neurotoxins might be diluted, fillers could be mixed, products may be purchased from substandard overseas manufacturers, and subpar treatments and bad results can happen.
First, there are the legal implications of fee-splitting in some states, such as New York and California. The laws are set up to avoid conflicts of interest and kickbacks among health care organizations. An organization cannot be paid for referring a patient to a medical practice. Second, a customer who is willing to buy a discounted cosmetic procedure offers a reason enough not to do that treatment. Many online bargain shoppers are dissatisfied customers or patients that you do not want do a cosmetic procedure on in the first place. Finally, the cost of acquiring new patients through marketing is daunting for small businesses and what these discounters offer are “free” marketing tools. Through geolocation and search engine optimization, they increase brand visibility and deliver a steady influx of customers. However, very few of the massive surge of these initial clients become return customers and, given the hefty discount and processing fees involved, the business model may not prove to be worthwhile.
Everyone loves a deal, myself included. However, for your practice, there are health and ethical issues with these discount businesses. Good treatments aren’t cheap, and cheap treatments aren’t good.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Sisler J. Discount deals becoming medical rage. CMAJ. 2012 Feb 21;184(3):E167-8.
Krieger LM. Discount cosmetic surgery: industry trends and strategies for success. Plast Reconstr Surg. 2002 Aug;110(2):614-9.
Atiyeh BS et al. Aesthetic/Cosmetic surgery and ethical challenges. Aesthetic Plast Surg. 2008 Nov;32(6):829-39.
Groupon’s Hidden Influence on Reputation. MIT Technology Review. Sept. 12, 2011.
I admit it ... I am a victim too. The hype was real. Offer a service, at a hefty discount, and increase your patient volume. I didn’t need to increase my patient load. But with more overhead, getting the new providers in my practice busy fast was alluring. There are, however, so many inherent risks to discounting. So I offer you this column as my own version of a consumer alert on discount coupon sites.
After falling victim to this fad myself, I realize that it was the worst business decision I have ever made – from the perspectives of the risks to the patient and the risks to the business.
The risks to the patient are transparent. The most obvious risk is the abundance of inexperienced injectors doing procedures. Self explanatory. Discount sites obtain medical license information prior to approving any medical treatment; however, not everyone with a medical license should be doing cosmetic procedures.
The second risk is a lack of proper evaluation and management, which leads to poor medical management and dissatisfaction. We should be approaching each cosmetic patient with treatments and procedures that are right for them, their skin, their medical history, their anatomy, and their specific needs. There is no screening through these sites. Patients buy the service, and even if the procedure is not right for them, they expect the service. Even if there is a statement on a site that services are contingent on screening, the promise of the service has already been made. If you do not provide the service, often the now-disgruntled patient will complain about you, your staff, your ethics, to anyone and everyone. If you do the procedure despite your best intentions, you are setting yourself up for disaster ... complications, unsatisfied patients, and unmet expectations. There is a reason consultations are necessary.
Third, the margins on this type of service are negligible. If a practice if offering injectable treatments at a too-good-to-be-true price, it probably is. Neurotoxins might be diluted, fillers could be mixed, products may be purchased from substandard overseas manufacturers, and subpar treatments and bad results can happen.
First, there are the legal implications of fee-splitting in some states, such as New York and California. The laws are set up to avoid conflicts of interest and kickbacks among health care organizations. An organization cannot be paid for referring a patient to a medical practice. Second, a customer who is willing to buy a discounted cosmetic procedure offers a reason enough not to do that treatment. Many online bargain shoppers are dissatisfied customers or patients that you do not want do a cosmetic procedure on in the first place. Finally, the cost of acquiring new patients through marketing is daunting for small businesses and what these discounters offer are “free” marketing tools. Through geolocation and search engine optimization, they increase brand visibility and deliver a steady influx of customers. However, very few of the massive surge of these initial clients become return customers and, given the hefty discount and processing fees involved, the business model may not prove to be worthwhile.
Everyone loves a deal, myself included. However, for your practice, there are health and ethical issues with these discount businesses. Good treatments aren’t cheap, and cheap treatments aren’t good.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Sisler J. Discount deals becoming medical rage. CMAJ. 2012 Feb 21;184(3):E167-8.
Krieger LM. Discount cosmetic surgery: industry trends and strategies for success. Plast Reconstr Surg. 2002 Aug;110(2):614-9.
Atiyeh BS et al. Aesthetic/Cosmetic surgery and ethical challenges. Aesthetic Plast Surg. 2008 Nov;32(6):829-39.
Groupon’s Hidden Influence on Reputation. MIT Technology Review. Sept. 12, 2011.
I admit it ... I am a victim too. The hype was real. Offer a service, at a hefty discount, and increase your patient volume. I didn’t need to increase my patient load. But with more overhead, getting the new providers in my practice busy fast was alluring. There are, however, so many inherent risks to discounting. So I offer you this column as my own version of a consumer alert on discount coupon sites.
After falling victim to this fad myself, I realize that it was the worst business decision I have ever made – from the perspectives of the risks to the patient and the risks to the business.
The risks to the patient are transparent. The most obvious risk is the abundance of inexperienced injectors doing procedures. Self explanatory. Discount sites obtain medical license information prior to approving any medical treatment; however, not everyone with a medical license should be doing cosmetic procedures.
The second risk is a lack of proper evaluation and management, which leads to poor medical management and dissatisfaction. We should be approaching each cosmetic patient with treatments and procedures that are right for them, their skin, their medical history, their anatomy, and their specific needs. There is no screening through these sites. Patients buy the service, and even if the procedure is not right for them, they expect the service. Even if there is a statement on a site that services are contingent on screening, the promise of the service has already been made. If you do not provide the service, often the now-disgruntled patient will complain about you, your staff, your ethics, to anyone and everyone. If you do the procedure despite your best intentions, you are setting yourself up for disaster ... complications, unsatisfied patients, and unmet expectations. There is a reason consultations are necessary.
Third, the margins on this type of service are negligible. If a practice if offering injectable treatments at a too-good-to-be-true price, it probably is. Neurotoxins might be diluted, fillers could be mixed, products may be purchased from substandard overseas manufacturers, and subpar treatments and bad results can happen.
First, there are the legal implications of fee-splitting in some states, such as New York and California. The laws are set up to avoid conflicts of interest and kickbacks among health care organizations. An organization cannot be paid for referring a patient to a medical practice. Second, a customer who is willing to buy a discounted cosmetic procedure offers a reason enough not to do that treatment. Many online bargain shoppers are dissatisfied customers or patients that you do not want do a cosmetic procedure on in the first place. Finally, the cost of acquiring new patients through marketing is daunting for small businesses and what these discounters offer are “free” marketing tools. Through geolocation and search engine optimization, they increase brand visibility and deliver a steady influx of customers. However, very few of the massive surge of these initial clients become return customers and, given the hefty discount and processing fees involved, the business model may not prove to be worthwhile.
Everyone loves a deal, myself included. However, for your practice, there are health and ethical issues with these discount businesses. Good treatments aren’t cheap, and cheap treatments aren’t good.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Sisler J. Discount deals becoming medical rage. CMAJ. 2012 Feb 21;184(3):E167-8.
Krieger LM. Discount cosmetic surgery: industry trends and strategies for success. Plast Reconstr Surg. 2002 Aug;110(2):614-9.
Atiyeh BS et al. Aesthetic/Cosmetic surgery and ethical challenges. Aesthetic Plast Surg. 2008 Nov;32(6):829-39.
Groupon’s Hidden Influence on Reputation. MIT Technology Review. Sept. 12, 2011.
Fungi and bacteria cooperate to form inflammatory gut biofilms
Fungi and bacteria in the gastrointestinal tract collaboratively form biofilms that may exacerbate inflammation in patients with inflammatory bowel disease (IBD), a review article concluded.
In particular, the investigators found compared with healthy family members.
Furthermore, these three organisms “worked together to form robust biofilms capable of exacerbating intestinal inflammation,” wrote authors Christopher L. Hager, MD, and Mahmoud A. Ghannoum, PhD, of the center for medical mycology at Case Western Reserve University, Cleveland, and University Hospitals Cleveland Medical Center.
This “interkingdom interaction” suggests a potential role for antifungals combined with probiotics as a treatment strategy for patients with IBD, they said in their review article discussing both their own studies to date and those by other research groups.
“These studies clearly demonstrate that mycobiome/bacteriome interactions play an important role in the perpetuation of GI inflammation,” they wrote (Dig Liver Dis. 2017 Nov;49[11]:1171-6). “Not only have we shown that fungi are important for overall GI tract health, we have also shown that overgrowth of the fungus due to imbalance has deleterious effects on the gastric mucosa.”
Dr. Ghannoum and his colleagues first highlighted the importance of the mycobiome in a 2010 study that used deep sequencing to characterize the human oral fungal community (PLOS Pathogens. 2010 Jan 8. doi: 10.1371/journal.ppat.1000713). They found that humans were colonized with Candida, as was expected, but also with species including Aspergillus, Cryptococcus, and Fusarium, which was unexpected, Dr. Hager and Dr. Ghannoum wrote in their review.
In their more recent work, Dr. Ghannoum, Dr. Hager, and their coinvestigators compared CD patients with their healthy relatives and found increased levels of E. coli, S. marcescens, and the fungus C. tropicalis in the gastrointestinal tract (mBio. 2016 Sep 20. doi: 10.1128/mBio.01250-16). In vitro, those three organisms cooperate to form biofilms that could activate the host immune response, they said.
“These findings suggest a possible role of these pathogenic organisms in the initiation and perpetuation of chronic intestinal inflammation, such as that observed in patients with inflammatory bowel disease,” they wrote. “Not only has this opened up the possibility of new therapeutic approaches in patients with IBD (i.e., antifungals/antibiotics), it has also paved the way for groundbreaking research on probiotic development aimed at disrupting GI biofilm formation, thus ending a vicious cycle of chronic intestinal inflammation.”
Developing new probiotic therapies that leverage mycobiome-level observations could help overcome some limitations of current treatment options for IBD, such as biologic therapies and antibiotics, the authors wrote.
Biologics can block immune pathways implicated in mucosal inflammation and lead to potentially deleterious secondary infections, they explained. Likewise, antibiotics can be effective in controlling inflammatory symptoms but raise the concern of potentially increasing antibiotic resistance.
Although new probiotic research could provide a new avenue of treatment, development of clinical studies could be limited in part, they said, because probiotics are considered to be food supplements rather than drugs regulated by the Food and Drug Administration.
“Conducting such trials is challenging due to the lack of funding, leaving companies with very little impetus to perform long, expensive, placebo-controlled studies,” the authors wrote.
The authors declared no conflicts of interest.
Fungi and bacteria in the gastrointestinal tract collaboratively form biofilms that may exacerbate inflammation in patients with inflammatory bowel disease (IBD), a review article concluded.
In particular, the investigators found compared with healthy family members.
Furthermore, these three organisms “worked together to form robust biofilms capable of exacerbating intestinal inflammation,” wrote authors Christopher L. Hager, MD, and Mahmoud A. Ghannoum, PhD, of the center for medical mycology at Case Western Reserve University, Cleveland, and University Hospitals Cleveland Medical Center.
This “interkingdom interaction” suggests a potential role for antifungals combined with probiotics as a treatment strategy for patients with IBD, they said in their review article discussing both their own studies to date and those by other research groups.
“These studies clearly demonstrate that mycobiome/bacteriome interactions play an important role in the perpetuation of GI inflammation,” they wrote (Dig Liver Dis. 2017 Nov;49[11]:1171-6). “Not only have we shown that fungi are important for overall GI tract health, we have also shown that overgrowth of the fungus due to imbalance has deleterious effects on the gastric mucosa.”
Dr. Ghannoum and his colleagues first highlighted the importance of the mycobiome in a 2010 study that used deep sequencing to characterize the human oral fungal community (PLOS Pathogens. 2010 Jan 8. doi: 10.1371/journal.ppat.1000713). They found that humans were colonized with Candida, as was expected, but also with species including Aspergillus, Cryptococcus, and Fusarium, which was unexpected, Dr. Hager and Dr. Ghannoum wrote in their review.
In their more recent work, Dr. Ghannoum, Dr. Hager, and their coinvestigators compared CD patients with their healthy relatives and found increased levels of E. coli, S. marcescens, and the fungus C. tropicalis in the gastrointestinal tract (mBio. 2016 Sep 20. doi: 10.1128/mBio.01250-16). In vitro, those three organisms cooperate to form biofilms that could activate the host immune response, they said.
“These findings suggest a possible role of these pathogenic organisms in the initiation and perpetuation of chronic intestinal inflammation, such as that observed in patients with inflammatory bowel disease,” they wrote. “Not only has this opened up the possibility of new therapeutic approaches in patients with IBD (i.e., antifungals/antibiotics), it has also paved the way for groundbreaking research on probiotic development aimed at disrupting GI biofilm formation, thus ending a vicious cycle of chronic intestinal inflammation.”
Developing new probiotic therapies that leverage mycobiome-level observations could help overcome some limitations of current treatment options for IBD, such as biologic therapies and antibiotics, the authors wrote.
Biologics can block immune pathways implicated in mucosal inflammation and lead to potentially deleterious secondary infections, they explained. Likewise, antibiotics can be effective in controlling inflammatory symptoms but raise the concern of potentially increasing antibiotic resistance.
Although new probiotic research could provide a new avenue of treatment, development of clinical studies could be limited in part, they said, because probiotics are considered to be food supplements rather than drugs regulated by the Food and Drug Administration.
“Conducting such trials is challenging due to the lack of funding, leaving companies with very little impetus to perform long, expensive, placebo-controlled studies,” the authors wrote.
The authors declared no conflicts of interest.
Fungi and bacteria in the gastrointestinal tract collaboratively form biofilms that may exacerbate inflammation in patients with inflammatory bowel disease (IBD), a review article concluded.
In particular, the investigators found compared with healthy family members.
Furthermore, these three organisms “worked together to form robust biofilms capable of exacerbating intestinal inflammation,” wrote authors Christopher L. Hager, MD, and Mahmoud A. Ghannoum, PhD, of the center for medical mycology at Case Western Reserve University, Cleveland, and University Hospitals Cleveland Medical Center.
This “interkingdom interaction” suggests a potential role for antifungals combined with probiotics as a treatment strategy for patients with IBD, they said in their review article discussing both their own studies to date and those by other research groups.
“These studies clearly demonstrate that mycobiome/bacteriome interactions play an important role in the perpetuation of GI inflammation,” they wrote (Dig Liver Dis. 2017 Nov;49[11]:1171-6). “Not only have we shown that fungi are important for overall GI tract health, we have also shown that overgrowth of the fungus due to imbalance has deleterious effects on the gastric mucosa.”
Dr. Ghannoum and his colleagues first highlighted the importance of the mycobiome in a 2010 study that used deep sequencing to characterize the human oral fungal community (PLOS Pathogens. 2010 Jan 8. doi: 10.1371/journal.ppat.1000713). They found that humans were colonized with Candida, as was expected, but also with species including Aspergillus, Cryptococcus, and Fusarium, which was unexpected, Dr. Hager and Dr. Ghannoum wrote in their review.
In their more recent work, Dr. Ghannoum, Dr. Hager, and their coinvestigators compared CD patients with their healthy relatives and found increased levels of E. coli, S. marcescens, and the fungus C. tropicalis in the gastrointestinal tract (mBio. 2016 Sep 20. doi: 10.1128/mBio.01250-16). In vitro, those three organisms cooperate to form biofilms that could activate the host immune response, they said.
“These findings suggest a possible role of these pathogenic organisms in the initiation and perpetuation of chronic intestinal inflammation, such as that observed in patients with inflammatory bowel disease,” they wrote. “Not only has this opened up the possibility of new therapeutic approaches in patients with IBD (i.e., antifungals/antibiotics), it has also paved the way for groundbreaking research on probiotic development aimed at disrupting GI biofilm formation, thus ending a vicious cycle of chronic intestinal inflammation.”
Developing new probiotic therapies that leverage mycobiome-level observations could help overcome some limitations of current treatment options for IBD, such as biologic therapies and antibiotics, the authors wrote.
Biologics can block immune pathways implicated in mucosal inflammation and lead to potentially deleterious secondary infections, they explained. Likewise, antibiotics can be effective in controlling inflammatory symptoms but raise the concern of potentially increasing antibiotic resistance.
Although new probiotic research could provide a new avenue of treatment, development of clinical studies could be limited in part, they said, because probiotics are considered to be food supplements rather than drugs regulated by the Food and Drug Administration.
“Conducting such trials is challenging due to the lack of funding, leaving companies with very little impetus to perform long, expensive, placebo-controlled studies,” the authors wrote.
The authors declared no conflicts of interest.
FROM DIGESTIVE AND LIVER DISEASE
Key clinical point: Fungi and bacteria interact in the gastrointestinal tract to form biofilms that may exacerbate inflammation, suggesting a potential role for antifungals combined with probiotics as a treatment strategy for patients with inflammatory bowel disease.
Major finding: Compared with healthy family members, patients with Crohn’s disease in one key study had higher levels of the fungus Candida tropicalis and of two bacteria, Escherichia coli and Serratia marcescens, all of which worked together to form robust biofilms.
Data source: A review article summarizing the limited number of investigations to date, most published in 2010 or later.
Disclosures: The authors declared no conflicts of interest.