Any time patients enter or leave the hospital, they risk being harmed by errors in their medications.¹ Adverse events from medication errors during transitions of care are common but often preventable. One key approach is to systematically review every patient’s medication list on admission and discharge and resolve any discrepancies. These transitions are also an opportunity to address other medication-related problems, such as adherence, drug interactions, and clinical appropriateness.

This article summarizes the types and prevalence of medication problems that occur during hospital-based transitions of care, and suggests strategies to decrease the risk of medication errors, focusing on medication reconciliation and related interventions that clinicians can use at the bedside to improve medication safety.

DEFINING TERMS

A medication discrepancy is any variance noted in a patient’s documented medication regimen across different medication lists or sites of care. While some differences reflect intentional and clinically appropriate changes to the regimen, others are unintentional and reflect inaccurate or incomplete information. These unintentional discrepancies are medication errors.

Depending on the clinical circumstances and medications involved, such errors may lead to an adverse drug event (ADE), defined as actual harm or injury resulting from a medication. Sometimes a medication error does not cause harm immediately but could if left uncorrected; this is called a potential ADE.

An important goal during transitions of care is to reduce unintentional medication discrepancies, thereby reducing potential and actual ADEs.

ERRORS ARISE AT DISCHARGE—AND EVEN MORE AT ADMISSION

Hospital discharge is a widely recognized transition in which patient harm occurs. As many as 70% of patients may have an unintentional medication discrepancy at hospital discharge, with many of those discrepancies having potential for harm.² Indeed, during the first few weeks after discharge, 50% of patients have a clinically important medication error,³ and 20% experience an adverse event, most commonly an ADE.⁴ ADEs are associated with excess health care utilization,^5–7 and many are preventable through strategies such as medication reconciliation.^5,8

Importantly, more errors arise at hospital admission than at other times.^9,10

Errors in medication histories are the most common source of discrepancies, affecting up to two-thirds of admitted patients.^11,12 More than one-quarter of hospital prescribing errors can be attributed to incomplete medication histories at the time of admission,¹³ and nearly three times as many clinically important medication discrepancies are related to history-taking errors on admission rather than reconciliation errors at discharge.⁹

Most discrepancies occurring at the time of admission have the potential to cause harm, particularly if the errors persist beyond discharge.¹⁴ Therefore, taking a complete and accurate medication history on hospital admission is critical to ensuring safe care transitions.

MEDICATION RECONCILIATION: BARRIERS AND FACILITATORS

Medication reconciliation is a strategy for reducing medication discrepancies in patients moving across care settings. Simply put, it is the process by which a patient’s medication list is obtained, compared, and clarified across different sites of care.¹⁵ It has consistently been shown to decrease medication errors compared with usual care,¹⁶ and it is strongly supported by national and international organizations.^17–21

In clinical practice, many physicians and institutions have found medication reconciliation difficult to implement, owing to barriers at the level of the patient, provider, and system (Table  1). In response to these challenges, two initiatives have synthesized best practices and offer toolkits that hospitals and clinicians can use: the Medications at Transitions and Clinical Handoffs (MATCH) program²² and the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS).²³

Lack of resources is a widely acknowledged challenge. Thus, the MARQUIS investigators²³ suggested focusing on the admission history, where most errors occur, and applying the most resource-intensive interventions in patients at highest risk of ADEs, ie, those who are elderly, have multiple comorbid conditions, or take numerous medications.¹⁶

Although the risk of an ADE increases with the number of medications a patient takes,⁴ the exact number of drugs that defines high risk has not been well established. Targeting patients who take 10 or more maintenance medications is a reasonable initial approach,²⁴ but institutions should tailor risk stratification to their patient populations and available resources. Patients taking high-risk medications such as anticoagulants and insulin could also be prioritized for review, since these medications are more likely to cause serious patient harm when used without appropriate clinical oversight.⁷

Using pharmacy staff to perform medication history-taking, reconciliation, and patient counseling has been shown to produce favorable patient outcomes, particularly for higher-risk patients.^16,23

The MARQUIS investigators found they could boost the chances of success by sharing stories of patient harm to foster “buy-in” among frontline staff, providing formal training to clinicians on how to take a medication history, and obtaining the support of nursing leaders to champion improvement efforts.²³

Additionally, patients should be empowered to maintain an accurate medication list. We address strategies for improving patient engagement and adherence in a later section.

BEST PRACTICES FOR IMPROVING MEDICATION SAFETY

Medication reconciliation is one of several measures necessary to optimize medication safety during transitions of care. It typically includes the following actions:

• Interview the patient or caregiver to determine the list of medications the patient is currently taking (or supposed to be taking); consult other sources if needed.
• List medications that are being ordered during the clinical encounter.
• Compare these two lists, making note of medications that are stopped, changed, or newly prescribed.
• Resolve any discrepancies.
• Communicate the reconciled list to the patient, appropriate caregivers, and providers of follow-up care.

At a rudimentary level, medication reconciliation encompasses medication list management along the continuum of care. However, we recommend leveraging medication reconciliation as an opportunity to further enhance medication safety by reviewing the appropriateness of each medication, seizing opportunities to streamline or simplify the regimen, assessing patient and caregiver understanding of medication instructions and potential ADEs, and delivering appropriate counseling to enhance medication use. Table 2 outlines our framework for medication management during hospital-based transitions.

STEP 1: OBTAIN A COMPLETE PREADMISSION MEDICATION LIST

The “best-possible medication history” is obtained in a systematic process of interviewing the patient or caregiver plus reviewing at least one other reliable source.²³ The resulting list should include all medications the patient is taking (prescription and nonprescription), doses, directions for use, formulations if applicable, indications, start and stop dates, and medication allergies and reactions.

Review existing information. Before eliciting a history from the patient, review his or her recorded medical history and existing medication lists (eg, prior discharge summaries, records from other facilities, records from outpatient visits, pharmacy fill data). This will provide context about the regimen and help identify issues and questions that can be addressed during the history-taking.

Ask open-ended questions. Instead of just asking the patient to confirm the accuracy of the existing medication list, we recommend actively obtaining the full medication list from the patient or caregiver. The conversation should begin with an open-ended question such as, “What medications do you take at home?” This approach will also allow the clinician to gauge the patient’s level of understanding of each medication’s indication and dosing instructions. Using a series of prompts such as those recommended in Table 3 will elicit a best-possible medical history, while verifying all of the medications on the existing list.

Clarify discrepancies. Resolve differences between the existing medication lists and the patient’s or caregiver’s report during the preadmission interview. Examples include errors of omission (a medication is missing), errors of commission (an additional medication is present), and discrepancies in the strength, formulation, dosing instructions, and indications for the drugs. If necessary, other sources of information should be consulted, such as the patient’s medication bottles, pharmacy or pharmacies, primary care physician, and a family member or caregiver.

Assess adherence. The extent to which patients take their medications as directed is an important component of the history, but is often left out. Medication nonadherence rates in the United States are 40% to 70%,²⁵ contributing to poor patient outcomes and imposing extraordinary costs on the health care system.²⁶

Asking open-ended, nonjudgmental questions at the time of hospital admission will help to uncover medication-taking behaviors as well as barriers to adherence (Table 3). The patient’s responses should be taken into account when determining the treatment plan.

Document your findings. After completing the medication history and clarifying discrepancies, document the preadmission list in the medical record. All members of the health care team should have access to view and update the same list, as new information about the preadmission medications may be uncovered after the initial history.

Make clinical decisions. Complete the admission medication reconciliation by deciding whether each medication on the list should be continued, changed, held, or discontinued on the basis of the patient’s clinical condition. Well-designed information technology applications enable the provider to document each action and the rationale for it, as well as carry that information into the order-entry system. Medications marked as held or discontinued on admission should be revisited as the patient’s clinical condition changes and at discharge.

STEP 2: AVOID RECONCILIATION ERRORS

Reconciliation errors reflect discrepancies between the medication history and the medications that are ordered after admission.

Reconciliation errors are less common than medication history errors, accounting for approximately one-third of potentially harmful medication errors in hospitalized medical patients.⁹ These include errors of omission (a medication is omitted from the orders), errors of commission (a medication is prescribed with no indication for continuation), and therapeutic duplication.

Preventing errors of omission

Medications are often held at transition points for appropriate clinical reasons. Examples include holding anticoagulants and antiplatelet agents in patients who have gastrointestinal bleeding or an upcoming procedure, antihypertensives in patients with hemodynamic instability, and other chronic medications in patients with an acute illness.

Poor documentation and communication of these decisions can lead to a failure to resume the medications—an error of omission—at hospital discharge.

Hospitalized patients are at risk of unintentional discontinuation of their chronic medications, including antiplatelet drugs, anticoagulants, statins, and thyroid replacement, particularly if admitted to the intensive care unit.¹² These errors can be minimized by a standardized medication reconciliation process at each transition and clear documentation of the medication plan.

Communication among providers can be improved if the admitting clinician documents clearly whether each preadmission medication is being continued, changed, or stopped, along with the reason for doing so, and makes this information available throughout the hospital stay. Upon transfer to another unit and at discharge, the physician should review each; preadmission medication that was held and the patient’s current clinical status and, based on that information, decide whether medications that were held should be resumed. If a medication will be restarted later, specific instructions should be documented and communicated to the patient and the physicians who are taking over his or her care.

Preventing errors of commission

Failure to perform a complete reconciliation at each transition of care and match each medication with an appropriate indication can lead to errors of commission.

One study showed that 44% of patients were prescribed at least one unnecessary drug at hospital discharge, one-fourth of which were started during the hospitalization.²⁷ Commonly prescribed unnecessarily were gastrointestinal agents, central nervous system drugs, nutrients, and supplements.

It is critical to assess each medication’s ongoing need, appropriateness, and risk-benefit ratio at every transition. Medications no longer indicated should be discontinued in order to simplify the regimen, avoid unnecessary drug exposure, and prevent ADEs.

For example, proton pump inhibitors or histamine 2 receptor blockers are often started in the hospital for stress ulcer prophylaxis. One-third of patients are then discharged home on the medication, and 6 months later half of those patients are still taking the unnecessary drug.²⁸ This situation can be avoided by limiting use of these medications to appropriate circumstances, clearly marking the indication as stress ulcer prophylaxis (as opposed to an ongoing condition that will require continuing it after discharge), and discontinuing the agent when appropriate.

All drugs, even common and seemingly benign ones, carry some risk and should be discontinued when no longer needed. Thus, medications added during the hospitalization to control acute symptoms should also be reviewed at each transition to prevent inappropriate continuation when symptoms have resolved.

One study, for example, found that many patients were discharged with inappropriate prescriptions for atypical antipsychotics after receiving them in the intensive care unit, likely for delirium.²⁹ Documenting that an acute issue such as delirium has resolved should prompt the discontinuation of therapy.

Preventing therapeutic duplication

Therapeutic duplication occurs in about 8% of discharges.¹ These errors often result from formulary substitutions or altering the dosage form in the acute setting. For example, patients who receive a prescription for the substituted agent at discharge and also resume their prehospitalization medications end up with duplicate therapy.

Therapeutic substitution is common at the time of admission to the hospital as a result of formulary restrictions. Drug classes that are frequently substituted include statins, antihypertensives, urinary antispasmodics, and proton pump inhibitors. Physicians should be familiar with the preferred agents on the hospital formulary and make careful note when a substitution occurs. Furthermore, hospital systems should be developed to remind the physician to switch back to the outpatient medication at discharge.

Similar problems occur when home medications are replaced with different dosage forms with different pharmacokinetic properties. For example, a long-acting medication may be temporarily replaced with an intravenous solution or immediate-release tablet for several reasons, including nothing-by-mouth status, unstable clinical condition, need for titration, and need to crush the tablet to give the drug per tube. The differing formulations must be reconciled throughout the patient’s hospital course and at discharge to avoid therapeutic duplication and serious medication errors. Deliberate changes to the dosage form should be clearly communicated in the discharge medication list so that patients and other clinicians are aware.

Hospital systems should also have the capability to identify duplications in the medication list and to warn prescribers of these errors. The ability to group medications by drug class or sort the medication list alphabetically by generic name can help uncover duplication errors.

STEP 3: REVIEW THE LIST IN VIEW OF THE CLINICAL PICTURE

Transitions of care should prompt providers to review the medication list for possible drug-disease interactions, confirm compliance with evidence-based guidelines, and evaluate the risks and benefits of each medication in the context of the patient’s age and acute and chronic medical issues. This is also an opportunity to screen the full list for potentially inappropriate medications and high-alert drugs such as insulin or anticoagulants, which are more likely than other drugs to cause severe harm when used in error.

Acute kidney injury. New drug-disease interactions can arise during a hospitalization and can affect dosing and the choice of drug. The onset of acute kidney injury, for example, often necessitates adjusting or discontinuing nephrotoxic and renally excreted medications. ADEs or potential ADEs have been reported in 43% of hospitalized patients with acute kidney injury.³⁰

Because acute kidney injury is often transient, medications may need to be held or adjusted several times until renal function stabilizes. This can be challenging across the continuum of care and requires close monitoring of the serum creatinine level and associated drug doses and levels, if applicable. Well-designed clinical decision support tools can integrate laboratory data and alert the prescriber to a clinically important increase or decrease in serum creatinine that may warrant a change in therapy. Modifications to the regimen and a plan for timely follow-up of the serum creatinine level should be clearly documented in the discharge plan.

Liver disease. Similar attention should be given to drugs that are hepatically metabolized if a patient has acute or chronic liver impairment.

Geriatric patients, particularly those who present with altered mental status, falls, or urinary retention, should have their medication list reviewed for potentially inappropriate medications, which are drugs that pose increased risk of poor outcomes in older adults.^31,32 Patients and providers may have been willing to accept the risk of medications such as anticholinergics or sedative-hypnotics when the drugs were initiated, but circumstances can change over time, especially in this patient population. Hospitalization is a prime opportunity to screen for medications that meet the Beers criteria³¹ for agents to avoid or use with caution in older adults.

As-needed medications. Medications prescribed on an as-needed basis in the hospital should be reviewed for continuation or discontinuation at discharge. How often the medication was given can inform this decision.

For example, if as-needed opioids were used frequently, failure to develop a plan of care for pain can lead to persistent symptoms and, possibly, to readmission.^33,34 Similar scenarios occur with use of as-needed blood pressure medications, laxatives, and correction-dose insulin.

If an as-needed medication was used consistently during hospitalization, the physician should consider whether a regularly scheduled medication is needed. Conversely, if the medication was not used during the inpatient admission, it can likely be discontinued.

STEP 4: PREPARE THE PATIENT AND FOLLOW-UP PROVIDER

Once a clinician has performed medication reconciliation, including obtaining a best-possible medical history and carefully reviewing the medication list and orders for errors and clinical appropriateness, the next steps are to ensure the patient understands what he or she needs to do and to confirm that suitable follow-up plans are in place. These measures should be taken at all transitions of care but are critically important at hospital discharge.

Preparing the patient and caregiver

An accurate, reconciled medication list should be given to the patient, caregiver, or both, and should be reviewed before discharge.¹⁷

Approximately one-third of Americans have low health literacy skills, so medication lists and associated materials should be easy to understand.³⁵ Medication lists should be written in plain language and formatted for optimal readability (Table 4), clearly stating which medications to continue, change, hold temporarily, and stop.

Patients recall and comprehend about half of the information provided during a medical encounter.³⁶ Thus, medication teaching should focus on key points including changes or additions to the regimen, specific instructions for follow-up and monitoring, and how to handle common and serious side effects.

To confirm patient understanding, clinicians should use “teach-back,” ie, provide the patient with information and then ask him or her to repeat back key points.^37,38 The patient and family should also be encouraged to ask questions before discharge.

If not already addressed during the hospital stay, barriers to medication adherence and ability to obtain the medications should be attended to at this time (Table 5). Also, the plan to pick up the medications should be verified with the patient and caregiver. Verify that there is transportation to a particular pharmacy that is open at the time of discharge, and that the patient can afford the medications.

Ensuring appropriate follow-up

Studies have shown that timely in-home or telephone follow-up after discharge can decrease adverse events and postdischarge health care utilization.^39,40 Telephone follow-up that includes thorough medication reconciliation can help detect and resolve medication issues early after discharge and can close gaps related to monitoring and follow-up.

Medication reconciliation by telephone can be time-consuming. Depending on the number of medications that need to be reviewed, calls can take between 10 and 60 minutes. Postdischarge phone calls should be performed by clinical personnel who are able to identify medication-related problems. A pharmacist should be an available resource to assist with complex regimens, to help resolve medication discrepancies, and to address patient concerns. Table 6 provides tips for conducting follow-up phone calls.

Resolving discrepancies identified during follow-up calls can be difficult, as changes to the medication regimen are often not communicated effectively to other members of the care team. Physicians should document the complete medication list and plan in the discharge summary, and there should be a method for the caller to record updates to the medication list in the medical record so that they are apparent at the outpatient follow-up visit.

An additional challenge is that it is frequently unclear which physician “owns” which medications. Therefore, designating a contact person for each medication until follow-up can be very valuable. At a minimum, a “physician owner” for high-alert medications such as insulin, anticoagulants, and diuretics should be identified to provide close follow-up, titration, and monitoring.

There should also be a plan for the patient to obtain refills of essential long-term medications, such as antiplatelet agents following stent placement.

SUMMARY AND RECOMMENDATIONS

Medication-related problems during hospital admission and discharge are common and range from minor discrepancies in the medication list to errors in history-taking, prescribing, and reconciliation that can lead to potential or actual patient harm. Putting systems in place to facilitate medication reconciliation can decrease the occurrence of medication discrepancies and ADEs, thereby improving patient safety during these critical transitions between care settings and providers. Institutional medication reconciliation programs should focus resources on the admission history-taking step, target the highest-risk patients for the most intensive interventions, and involve pharmacy personnel when possible.

On an individual level, clinicians can incorporate additional interventions into their workflows to optimize medication safety for hospitalized patients. Using a structured approach to obtain a complete and accurate medication list at the time of hospital admission will help providers identify medication-related problems and prevent the propagation of errors throughout the hospital stay and at discharge. Focusing additional time and effort on a comprehensive review of the medication list for errors of omission and commission, patient-specific needs, and high-alert drugs will further decrease the risk of medication errors. Finally, providing discharge counseling targeting patient barriers to adherence and ensuring a proper handover of medication information and rationale for medication changes to outpatient providers will improve the chances of a safe transition.

Any time patients enter or leave the hospital, they risk being harmed by errors in their medications.¹ Adverse events from medication errors during transitions of care are common but often preventable. One key approach is to systematically review every patient’s medication list on admission and discharge and resolve any discrepancies. These transitions are also an opportunity to address other medication-related problems, such as adherence, drug interactions, and clinical appropriateness.

This article summarizes the types and prevalence of medication problems that occur during hospital-based transitions of care, and suggests strategies to decrease the risk of medication errors, focusing on medication reconciliation and related interventions that clinicians can use at the bedside to improve medication safety.

DEFINING TERMS

A medication discrepancy is any variance noted in a patient’s documented medication regimen across different medication lists or sites of care. While some differences reflect intentional and clinically appropriate changes to the regimen, others are unintentional and reflect inaccurate or incomplete information. These unintentional discrepancies are medication errors.

Depending on the clinical circumstances and medications involved, such errors may lead to an adverse drug event (ADE), defined as actual harm or injury resulting from a medication. Sometimes a medication error does not cause harm immediately but could if left uncorrected; this is called a potential ADE.

An important goal during transitions of care is to reduce unintentional medication discrepancies, thereby reducing potential and actual ADEs.

ERRORS ARISE AT DISCHARGE—AND EVEN MORE AT ADMISSION

Hospital discharge is a widely recognized transition in which patient harm occurs. As many as 70% of patients may have an unintentional medication discrepancy at hospital discharge, with many of those discrepancies having potential for harm.² Indeed, during the first few weeks after discharge, 50% of patients have a clinically important medication error,³ and 20% experience an adverse event, most commonly an ADE.⁴ ADEs are associated with excess health care utilization,^5–7 and many are preventable through strategies such as medication reconciliation.^5,8

Importantly, more errors arise at hospital admission than at other times.^9,10

Errors in medication histories are the most common source of discrepancies, affecting up to two-thirds of admitted patients.^11,12 More than one-quarter of hospital prescribing errors can be attributed to incomplete medication histories at the time of admission,¹³ and nearly three times as many clinically important medication discrepancies are related to history-taking errors on admission rather than reconciliation errors at discharge.⁹

Most discrepancies occurring at the time of admission have the potential to cause harm, particularly if the errors persist beyond discharge.¹⁴ Therefore, taking a complete and accurate medication history on hospital admission is critical to ensuring safe care transitions.

MEDICATION RECONCILIATION: BARRIERS AND FACILITATORS

Medication reconciliation is a strategy for reducing medication discrepancies in patients moving across care settings. Simply put, it is the process by which a patient’s medication list is obtained, compared, and clarified across different sites of care.¹⁵ It has consistently been shown to decrease medication errors compared with usual care,¹⁶ and it is strongly supported by national and international organizations.^17–21

In clinical practice, many physicians and institutions have found medication reconciliation difficult to implement, owing to barriers at the level of the patient, provider, and system (Table  1). In response to these challenges, two initiatives have synthesized best practices and offer toolkits that hospitals and clinicians can use: the Medications at Transitions and Clinical Handoffs (MATCH) program²² and the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS).²³

Lack of resources is a widely acknowledged challenge. Thus, the MARQUIS investigators²³ suggested focusing on the admission history, where most errors occur, and applying the most resource-intensive interventions in patients at highest risk of ADEs, ie, those who are elderly, have multiple comorbid conditions, or take numerous medications.¹⁶

Although the risk of an ADE increases with the number of medications a patient takes,⁴ the exact number of drugs that defines high risk has not been well established. Targeting patients who take 10 or more maintenance medications is a reasonable initial approach,²⁴ but institutions should tailor risk stratification to their patient populations and available resources. Patients taking high-risk medications such as anticoagulants and insulin could also be prioritized for review, since these medications are more likely to cause serious patient harm when used without appropriate clinical oversight.⁷

Using pharmacy staff to perform medication history-taking, reconciliation, and patient counseling has been shown to produce favorable patient outcomes, particularly for higher-risk patients.^16,23

The MARQUIS investigators found they could boost the chances of success by sharing stories of patient harm to foster “buy-in” among frontline staff, providing formal training to clinicians on how to take a medication history, and obtaining the support of nursing leaders to champion improvement efforts.²³

Additionally, patients should be empowered to maintain an accurate medication list. We address strategies for improving patient engagement and adherence in a later section.

BEST PRACTICES FOR IMPROVING MEDICATION SAFETY

Medication reconciliation is one of several measures necessary to optimize medication safety during transitions of care. It typically includes the following actions:

• Interview the patient or caregiver to determine the list of medications the patient is currently taking (or supposed to be taking); consult other sources if needed.
• List medications that are being ordered during the clinical encounter.
• Compare these two lists, making note of medications that are stopped, changed, or newly prescribed.
• Resolve any discrepancies.
• Communicate the reconciled list to the patient, appropriate caregivers, and providers of follow-up care.

At a rudimentary level, medication reconciliation encompasses medication list management along the continuum of care. However, we recommend leveraging medication reconciliation as an opportunity to further enhance medication safety by reviewing the appropriateness of each medication, seizing opportunities to streamline or simplify the regimen, assessing patient and caregiver understanding of medication instructions and potential ADEs, and delivering appropriate counseling to enhance medication use. Table 2 outlines our framework for medication management during hospital-based transitions.

STEP 1: OBTAIN A COMPLETE PREADMISSION MEDICATION LIST

The “best-possible medication history” is obtained in a systematic process of interviewing the patient or caregiver plus reviewing at least one other reliable source.²³ The resulting list should include all medications the patient is taking (prescription and nonprescription), doses, directions for use, formulations if applicable, indications, start and stop dates, and medication allergies and reactions.

Review existing information. Before eliciting a history from the patient, review his or her recorded medical history and existing medication lists (eg, prior discharge summaries, records from other facilities, records from outpatient visits, pharmacy fill data). This will provide context about the regimen and help identify issues and questions that can be addressed during the history-taking.

Ask open-ended questions. Instead of just asking the patient to confirm the accuracy of the existing medication list, we recommend actively obtaining the full medication list from the patient or caregiver. The conversation should begin with an open-ended question such as, “What medications do you take at home?” This approach will also allow the clinician to gauge the patient’s level of understanding of each medication’s indication and dosing instructions. Using a series of prompts such as those recommended in Table 3 will elicit a best-possible medical history, while verifying all of the medications on the existing list.

Clarify discrepancies. Resolve differences between the existing medication lists and the patient’s or caregiver’s report during the preadmission interview. Examples include errors of omission (a medication is missing), errors of commission (an additional medication is present), and discrepancies in the strength, formulation, dosing instructions, and indications for the drugs. If necessary, other sources of information should be consulted, such as the patient’s medication bottles, pharmacy or pharmacies, primary care physician, and a family member or caregiver.

Assess adherence. The extent to which patients take their medications as directed is an important component of the history, but is often left out. Medication nonadherence rates in the United States are 40% to 70%,²⁵ contributing to poor patient outcomes and imposing extraordinary costs on the health care system.²⁶

Asking open-ended, nonjudgmental questions at the time of hospital admission will help to uncover medication-taking behaviors as well as barriers to adherence (Table 3). The patient’s responses should be taken into account when determining the treatment plan.

Document your findings. After completing the medication history and clarifying discrepancies, document the preadmission list in the medical record. All members of the health care team should have access to view and update the same list, as new information about the preadmission medications may be uncovered after the initial history.

Make clinical decisions. Complete the admission medication reconciliation by deciding whether each medication on the list should be continued, changed, held, or discontinued on the basis of the patient’s clinical condition. Well-designed information technology applications enable the provider to document each action and the rationale for it, as well as carry that information into the order-entry system. Medications marked as held or discontinued on admission should be revisited as the patient’s clinical condition changes and at discharge.

STEP 2: AVOID RECONCILIATION ERRORS

Reconciliation errors reflect discrepancies between the medication history and the medications that are ordered after admission.

Reconciliation errors are less common than medication history errors, accounting for approximately one-third of potentially harmful medication errors in hospitalized medical patients.⁹ These include errors of omission (a medication is omitted from the orders), errors of commission (a medication is prescribed with no indication for continuation), and therapeutic duplication.

Preventing errors of omission

Medications are often held at transition points for appropriate clinical reasons. Examples include holding anticoagulants and antiplatelet agents in patients who have gastrointestinal bleeding or an upcoming procedure, antihypertensives in patients with hemodynamic instability, and other chronic medications in patients with an acute illness.

Poor documentation and communication of these decisions can lead to a failure to resume the medications—an error of omission—at hospital discharge.

Hospitalized patients are at risk of unintentional discontinuation of their chronic medications, including antiplatelet drugs, anticoagulants, statins, and thyroid replacement, particularly if admitted to the intensive care unit.¹² These errors can be minimized by a standardized medication reconciliation process at each transition and clear documentation of the medication plan.

Communication among providers can be improved if the admitting clinician documents clearly whether each preadmission medication is being continued, changed, or stopped, along with the reason for doing so, and makes this information available throughout the hospital stay. Upon transfer to another unit and at discharge, the physician should review each; preadmission medication that was held and the patient’s current clinical status and, based on that information, decide whether medications that were held should be resumed. If a medication will be restarted later, specific instructions should be documented and communicated to the patient and the physicians who are taking over his or her care.

Preventing errors of commission

Failure to perform a complete reconciliation at each transition of care and match each medication with an appropriate indication can lead to errors of commission.

One study showed that 44% of patients were prescribed at least one unnecessary drug at hospital discharge, one-fourth of which were started during the hospitalization.²⁷ Commonly prescribed unnecessarily were gastrointestinal agents, central nervous system drugs, nutrients, and supplements.

It is critical to assess each medication’s ongoing need, appropriateness, and risk-benefit ratio at every transition. Medications no longer indicated should be discontinued in order to simplify the regimen, avoid unnecessary drug exposure, and prevent ADEs.

For example, proton pump inhibitors or histamine 2 receptor blockers are often started in the hospital for stress ulcer prophylaxis. One-third of patients are then discharged home on the medication, and 6 months later half of those patients are still taking the unnecessary drug.²⁸ This situation can be avoided by limiting use of these medications to appropriate circumstances, clearly marking the indication as stress ulcer prophylaxis (as opposed to an ongoing condition that will require continuing it after discharge), and discontinuing the agent when appropriate.

All drugs, even common and seemingly benign ones, carry some risk and should be discontinued when no longer needed. Thus, medications added during the hospitalization to control acute symptoms should also be reviewed at each transition to prevent inappropriate continuation when symptoms have resolved.

One study, for example, found that many patients were discharged with inappropriate prescriptions for atypical antipsychotics after receiving them in the intensive care unit, likely for delirium.²⁹ Documenting that an acute issue such as delirium has resolved should prompt the discontinuation of therapy.

Preventing therapeutic duplication

Therapeutic duplication occurs in about 8% of discharges.¹ These errors often result from formulary substitutions or altering the dosage form in the acute setting. For example, patients who receive a prescription for the substituted agent at discharge and also resume their prehospitalization medications end up with duplicate therapy.

Therapeutic substitution is common at the time of admission to the hospital as a result of formulary restrictions. Drug classes that are frequently substituted include statins, antihypertensives, urinary antispasmodics, and proton pump inhibitors. Physicians should be familiar with the preferred agents on the hospital formulary and make careful note when a substitution occurs. Furthermore, hospital systems should be developed to remind the physician to switch back to the outpatient medication at discharge.

Similar problems occur when home medications are replaced with different dosage forms with different pharmacokinetic properties. For example, a long-acting medication may be temporarily replaced with an intravenous solution or immediate-release tablet for several reasons, including nothing-by-mouth status, unstable clinical condition, need for titration, and need to crush the tablet to give the drug per tube. The differing formulations must be reconciled throughout the patient’s hospital course and at discharge to avoid therapeutic duplication and serious medication errors. Deliberate changes to the dosage form should be clearly communicated in the discharge medication list so that patients and other clinicians are aware.

Hospital systems should also have the capability to identify duplications in the medication list and to warn prescribers of these errors. The ability to group medications by drug class or sort the medication list alphabetically by generic name can help uncover duplication errors.

STEP 3: REVIEW THE LIST IN VIEW OF THE CLINICAL PICTURE

Transitions of care should prompt providers to review the medication list for possible drug-disease interactions, confirm compliance with evidence-based guidelines, and evaluate the risks and benefits of each medication in the context of the patient’s age and acute and chronic medical issues. This is also an opportunity to screen the full list for potentially inappropriate medications and high-alert drugs such as insulin or anticoagulants, which are more likely than other drugs to cause severe harm when used in error.

Acute kidney injury. New drug-disease interactions can arise during a hospitalization and can affect dosing and the choice of drug. The onset of acute kidney injury, for example, often necessitates adjusting or discontinuing nephrotoxic and renally excreted medications. ADEs or potential ADEs have been reported in 43% of hospitalized patients with acute kidney injury.³⁰

Because acute kidney injury is often transient, medications may need to be held or adjusted several times until renal function stabilizes. This can be challenging across the continuum of care and requires close monitoring of the serum creatinine level and associated drug doses and levels, if applicable. Well-designed clinical decision support tools can integrate laboratory data and alert the prescriber to a clinically important increase or decrease in serum creatinine that may warrant a change in therapy. Modifications to the regimen and a plan for timely follow-up of the serum creatinine level should be clearly documented in the discharge plan.

Liver disease. Similar attention should be given to drugs that are hepatically metabolized if a patient has acute or chronic liver impairment.

Geriatric patients, particularly those who present with altered mental status, falls, or urinary retention, should have their medication list reviewed for potentially inappropriate medications, which are drugs that pose increased risk of poor outcomes in older adults.^31,32 Patients and providers may have been willing to accept the risk of medications such as anticholinergics or sedative-hypnotics when the drugs were initiated, but circumstances can change over time, especially in this patient population. Hospitalization is a prime opportunity to screen for medications that meet the Beers criteria³¹ for agents to avoid or use with caution in older adults.

As-needed medications. Medications prescribed on an as-needed basis in the hospital should be reviewed for continuation or discontinuation at discharge. How often the medication was given can inform this decision.

For example, if as-needed opioids were used frequently, failure to develop a plan of care for pain can lead to persistent symptoms and, possibly, to readmission.^33,34 Similar scenarios occur with use of as-needed blood pressure medications, laxatives, and correction-dose insulin.

If an as-needed medication was used consistently during hospitalization, the physician should consider whether a regularly scheduled medication is needed. Conversely, if the medication was not used during the inpatient admission, it can likely be discontinued.

STEP 4: PREPARE THE PATIENT AND FOLLOW-UP PROVIDER

Once a clinician has performed medication reconciliation, including obtaining a best-possible medical history and carefully reviewing the medication list and orders for errors and clinical appropriateness, the next steps are to ensure the patient understands what he or she needs to do and to confirm that suitable follow-up plans are in place. These measures should be taken at all transitions of care but are critically important at hospital discharge.

Preparing the patient and caregiver

An accurate, reconciled medication list should be given to the patient, caregiver, or both, and should be reviewed before discharge.¹⁷

Approximately one-third of Americans have low health literacy skills, so medication lists and associated materials should be easy to understand.³⁵ Medication lists should be written in plain language and formatted for optimal readability (Table 4), clearly stating which medications to continue, change, hold temporarily, and stop.

Patients recall and comprehend about half of the information provided during a medical encounter.³⁶ Thus, medication teaching should focus on key points including changes or additions to the regimen, specific instructions for follow-up and monitoring, and how to handle common and serious side effects.

To confirm patient understanding, clinicians should use “teach-back,” ie, provide the patient with information and then ask him or her to repeat back key points.^37,38 The patient and family should also be encouraged to ask questions before discharge.

If not already addressed during the hospital stay, barriers to medication adherence and ability to obtain the medications should be attended to at this time (Table 5). Also, the plan to pick up the medications should be verified with the patient and caregiver. Verify that there is transportation to a particular pharmacy that is open at the time of discharge, and that the patient can afford the medications.

Ensuring appropriate follow-up

Studies have shown that timely in-home or telephone follow-up after discharge can decrease adverse events and postdischarge health care utilization.^39,40 Telephone follow-up that includes thorough medication reconciliation can help detect and resolve medication issues early after discharge and can close gaps related to monitoring and follow-up.

Medication reconciliation by telephone can be time-consuming. Depending on the number of medications that need to be reviewed, calls can take between 10 and 60 minutes. Postdischarge phone calls should be performed by clinical personnel who are able to identify medication-related problems. A pharmacist should be an available resource to assist with complex regimens, to help resolve medication discrepancies, and to address patient concerns. Table 6 provides tips for conducting follow-up phone calls.

Resolving discrepancies identified during follow-up calls can be difficult, as changes to the medication regimen are often not communicated effectively to other members of the care team. Physicians should document the complete medication list and plan in the discharge summary, and there should be a method for the caller to record updates to the medication list in the medical record so that they are apparent at the outpatient follow-up visit.

An additional challenge is that it is frequently unclear which physician “owns” which medications. Therefore, designating a contact person for each medication until follow-up can be very valuable. At a minimum, a “physician owner” for high-alert medications such as insulin, anticoagulants, and diuretics should be identified to provide close follow-up, titration, and monitoring.

There should also be a plan for the patient to obtain refills of essential long-term medications, such as antiplatelet agents following stent placement.

SUMMARY AND RECOMMENDATIONS

Medication-related problems during hospital admission and discharge are common and range from minor discrepancies in the medication list to errors in history-taking, prescribing, and reconciliation that can lead to potential or actual patient harm. Putting systems in place to facilitate medication reconciliation can decrease the occurrence of medication discrepancies and ADEs, thereby improving patient safety during these critical transitions between care settings and providers. Institutional medication reconciliation programs should focus resources on the admission history-taking step, target the highest-risk patients for the most intensive interventions, and involve pharmacy personnel when possible.

On an individual level, clinicians can incorporate additional interventions into their workflows to optimize medication safety for hospitalized patients. Using a structured approach to obtain a complete and accurate medication list at the time of hospital admission will help providers identify medication-related problems and prevent the propagation of errors throughout the hospital stay and at discharge. Focusing additional time and effort on a comprehensive review of the medication list for errors of omission and commission, patient-specific needs, and high-alert drugs will further decrease the risk of medication errors. Finally, providing discharge counseling targeting patient barriers to adherence and ensuring a proper handover of medication information and rationale for medication changes to outpatient providers will improve the chances of a safe transition.

Any time patients enter or leave the hospital, they risk being harmed by errors in their medications.¹ Adverse events from medication errors during transitions of care are common but often preventable. One key approach is to systematically review every patient’s medication list on admission and discharge and resolve any discrepancies. These transitions are also an opportunity to address other medication-related problems, such as adherence, drug interactions, and clinical appropriateness.

This article summarizes the types and prevalence of medication problems that occur during hospital-based transitions of care, and suggests strategies to decrease the risk of medication errors, focusing on medication reconciliation and related interventions that clinicians can use at the bedside to improve medication safety.

DEFINING TERMS

A medication discrepancy is any variance noted in a patient’s documented medication regimen across different medication lists or sites of care. While some differences reflect intentional and clinically appropriate changes to the regimen, others are unintentional and reflect inaccurate or incomplete information. These unintentional discrepancies are medication errors.

Depending on the clinical circumstances and medications involved, such errors may lead to an adverse drug event (ADE), defined as actual harm or injury resulting from a medication. Sometimes a medication error does not cause harm immediately but could if left uncorrected; this is called a potential ADE.

An important goal during transitions of care is to reduce unintentional medication discrepancies, thereby reducing potential and actual ADEs.

ERRORS ARISE AT DISCHARGE—AND EVEN MORE AT ADMISSION

Hospital discharge is a widely recognized transition in which patient harm occurs. As many as 70% of patients may have an unintentional medication discrepancy at hospital discharge, with many of those discrepancies having potential for harm.² Indeed, during the first few weeks after discharge, 50% of patients have a clinically important medication error,³ and 20% experience an adverse event, most commonly an ADE.⁴ ADEs are associated with excess health care utilization,^5–7 and many are preventable through strategies such as medication reconciliation.^5,8

Importantly, more errors arise at hospital admission than at other times.^9,10

Errors in medication histories are the most common source of discrepancies, affecting up to two-thirds of admitted patients.^11,12 More than one-quarter of hospital prescribing errors can be attributed to incomplete medication histories at the time of admission,¹³ and nearly three times as many clinically important medication discrepancies are related to history-taking errors on admission rather than reconciliation errors at discharge.⁹

Most discrepancies occurring at the time of admission have the potential to cause harm, particularly if the errors persist beyond discharge.¹⁴ Therefore, taking a complete and accurate medication history on hospital admission is critical to ensuring safe care transitions.

MEDICATION RECONCILIATION: BARRIERS AND FACILITATORS

Medication reconciliation is a strategy for reducing medication discrepancies in patients moving across care settings. Simply put, it is the process by which a patient’s medication list is obtained, compared, and clarified across different sites of care.¹⁵ It has consistently been shown to decrease medication errors compared with usual care,¹⁶ and it is strongly supported by national and international organizations.^17–21

In clinical practice, many physicians and institutions have found medication reconciliation difficult to implement, owing to barriers at the level of the patient, provider, and system (Table  1). In response to these challenges, two initiatives have synthesized best practices and offer toolkits that hospitals and clinicians can use: the Medications at Transitions and Clinical Handoffs (MATCH) program²² and the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS).²³

Lack of resources is a widely acknowledged challenge. Thus, the MARQUIS investigators²³ suggested focusing on the admission history, where most errors occur, and applying the most resource-intensive interventions in patients at highest risk of ADEs, ie, those who are elderly, have multiple comorbid conditions, or take numerous medications.¹⁶

Although the risk of an ADE increases with the number of medications a patient takes,⁴ the exact number of drugs that defines high risk has not been well established. Targeting patients who take 10 or more maintenance medications is a reasonable initial approach,²⁴ but institutions should tailor risk stratification to their patient populations and available resources. Patients taking high-risk medications such as anticoagulants and insulin could also be prioritized for review, since these medications are more likely to cause serious patient harm when used without appropriate clinical oversight.⁷

Using pharmacy staff to perform medication history-taking, reconciliation, and patient counseling has been shown to produce favorable patient outcomes, particularly for higher-risk patients.^16,23

The MARQUIS investigators found they could boost the chances of success by sharing stories of patient harm to foster “buy-in” among frontline staff, providing formal training to clinicians on how to take a medication history, and obtaining the support of nursing leaders to champion improvement efforts.²³

Additionally, patients should be empowered to maintain an accurate medication list. We address strategies for improving patient engagement and adherence in a later section.

BEST PRACTICES FOR IMPROVING MEDICATION SAFETY

Medication reconciliation is one of several measures necessary to optimize medication safety during transitions of care. It typically includes the following actions:

• Interview the patient or caregiver to determine the list of medications the patient is currently taking (or supposed to be taking); consult other sources if needed.
• List medications that are being ordered during the clinical encounter.
• Compare these two lists, making note of medications that are stopped, changed, or newly prescribed.
• Resolve any discrepancies.
• Communicate the reconciled list to the patient, appropriate caregivers, and providers of follow-up care.

At a rudimentary level, medication reconciliation encompasses medication list management along the continuum of care. However, we recommend leveraging medication reconciliation as an opportunity to further enhance medication safety by reviewing the appropriateness of each medication, seizing opportunities to streamline or simplify the regimen, assessing patient and caregiver understanding of medication instructions and potential ADEs, and delivering appropriate counseling to enhance medication use. Table 2 outlines our framework for medication management during hospital-based transitions.

STEP 1: OBTAIN A COMPLETE PREADMISSION MEDICATION LIST

The “best-possible medication history” is obtained in a systematic process of interviewing the patient or caregiver plus reviewing at least one other reliable source.²³ The resulting list should include all medications the patient is taking (prescription and nonprescription), doses, directions for use, formulations if applicable, indications, start and stop dates, and medication allergies and reactions.

Review existing information. Before eliciting a history from the patient, review his or her recorded medical history and existing medication lists (eg, prior discharge summaries, records from other facilities, records from outpatient visits, pharmacy fill data). This will provide context about the regimen and help identify issues and questions that can be addressed during the history-taking.

Ask open-ended questions. Instead of just asking the patient to confirm the accuracy of the existing medication list, we recommend actively obtaining the full medication list from the patient or caregiver. The conversation should begin with an open-ended question such as, “What medications do you take at home?” This approach will also allow the clinician to gauge the patient’s level of understanding of each medication’s indication and dosing instructions. Using a series of prompts such as those recommended in Table 3 will elicit a best-possible medical history, while verifying all of the medications on the existing list.

Clarify discrepancies. Resolve differences between the existing medication lists and the patient’s or caregiver’s report during the preadmission interview. Examples include errors of omission (a medication is missing), errors of commission (an additional medication is present), and discrepancies in the strength, formulation, dosing instructions, and indications for the drugs. If necessary, other sources of information should be consulted, such as the patient’s medication bottles, pharmacy or pharmacies, primary care physician, and a family member or caregiver.

Assess adherence. The extent to which patients take their medications as directed is an important component of the history, but is often left out. Medication nonadherence rates in the United States are 40% to 70%,²⁵ contributing to poor patient outcomes and imposing extraordinary costs on the health care system.²⁶

Asking open-ended, nonjudgmental questions at the time of hospital admission will help to uncover medication-taking behaviors as well as barriers to adherence (Table 3). The patient’s responses should be taken into account when determining the treatment plan.

Document your findings. After completing the medication history and clarifying discrepancies, document the preadmission list in the medical record. All members of the health care team should have access to view and update the same list, as new information about the preadmission medications may be uncovered after the initial history.

Make clinical decisions. Complete the admission medication reconciliation by deciding whether each medication on the list should be continued, changed, held, or discontinued on the basis of the patient’s clinical condition. Well-designed information technology applications enable the provider to document each action and the rationale for it, as well as carry that information into the order-entry system. Medications marked as held or discontinued on admission should be revisited as the patient’s clinical condition changes and at discharge.

STEP 2: AVOID RECONCILIATION ERRORS

Reconciliation errors reflect discrepancies between the medication history and the medications that are ordered after admission.

Reconciliation errors are less common than medication history errors, accounting for approximately one-third of potentially harmful medication errors in hospitalized medical patients.⁹ These include errors of omission (a medication is omitted from the orders), errors of commission (a medication is prescribed with no indication for continuation), and therapeutic duplication.

Preventing errors of omission

Medications are often held at transition points for appropriate clinical reasons. Examples include holding anticoagulants and antiplatelet agents in patients who have gastrointestinal bleeding or an upcoming procedure, antihypertensives in patients with hemodynamic instability, and other chronic medications in patients with an acute illness.

Poor documentation and communication of these decisions can lead to a failure to resume the medications—an error of omission—at hospital discharge.

Hospitalized patients are at risk of unintentional discontinuation of their chronic medications, including antiplatelet drugs, anticoagulants, statins, and thyroid replacement, particularly if admitted to the intensive care unit.¹² These errors can be minimized by a standardized medication reconciliation process at each transition and clear documentation of the medication plan.

Communication among providers can be improved if the admitting clinician documents clearly whether each preadmission medication is being continued, changed, or stopped, along with the reason for doing so, and makes this information available throughout the hospital stay. Upon transfer to another unit and at discharge, the physician should review each; preadmission medication that was held and the patient’s current clinical status and, based on that information, decide whether medications that were held should be resumed. If a medication will be restarted later, specific instructions should be documented and communicated to the patient and the physicians who are taking over his or her care.

Preventing errors of commission

Failure to perform a complete reconciliation at each transition of care and match each medication with an appropriate indication can lead to errors of commission.

One study showed that 44% of patients were prescribed at least one unnecessary drug at hospital discharge, one-fourth of which were started during the hospitalization.²⁷ Commonly prescribed unnecessarily were gastrointestinal agents, central nervous system drugs, nutrients, and supplements.

It is critical to assess each medication’s ongoing need, appropriateness, and risk-benefit ratio at every transition. Medications no longer indicated should be discontinued in order to simplify the regimen, avoid unnecessary drug exposure, and prevent ADEs.

For example, proton pump inhibitors or histamine 2 receptor blockers are often started in the hospital for stress ulcer prophylaxis. One-third of patients are then discharged home on the medication, and 6 months later half of those patients are still taking the unnecessary drug.²⁸ This situation can be avoided by limiting use of these medications to appropriate circumstances, clearly marking the indication as stress ulcer prophylaxis (as opposed to an ongoing condition that will require continuing it after discharge), and discontinuing the agent when appropriate.

All drugs, even common and seemingly benign ones, carry some risk and should be discontinued when no longer needed. Thus, medications added during the hospitalization to control acute symptoms should also be reviewed at each transition to prevent inappropriate continuation when symptoms have resolved.

One study, for example, found that many patients were discharged with inappropriate prescriptions for atypical antipsychotics after receiving them in the intensive care unit, likely for delirium.²⁹ Documenting that an acute issue such as delirium has resolved should prompt the discontinuation of therapy.

Preventing therapeutic duplication

Therapeutic duplication occurs in about 8% of discharges.¹ These errors often result from formulary substitutions or altering the dosage form in the acute setting. For example, patients who receive a prescription for the substituted agent at discharge and also resume their prehospitalization medications end up with duplicate therapy.

Therapeutic substitution is common at the time of admission to the hospital as a result of formulary restrictions. Drug classes that are frequently substituted include statins, antihypertensives, urinary antispasmodics, and proton pump inhibitors. Physicians should be familiar with the preferred agents on the hospital formulary and make careful note when a substitution occurs. Furthermore, hospital systems should be developed to remind the physician to switch back to the outpatient medication at discharge.

Similar problems occur when home medications are replaced with different dosage forms with different pharmacokinetic properties. For example, a long-acting medication may be temporarily replaced with an intravenous solution or immediate-release tablet for several reasons, including nothing-by-mouth status, unstable clinical condition, need for titration, and need to crush the tablet to give the drug per tube. The differing formulations must be reconciled throughout the patient’s hospital course and at discharge to avoid therapeutic duplication and serious medication errors. Deliberate changes to the dosage form should be clearly communicated in the discharge medication list so that patients and other clinicians are aware.

Hospital systems should also have the capability to identify duplications in the medication list and to warn prescribers of these errors. The ability to group medications by drug class or sort the medication list alphabetically by generic name can help uncover duplication errors.

STEP 3: REVIEW THE LIST IN VIEW OF THE CLINICAL PICTURE

Transitions of care should prompt providers to review the medication list for possible drug-disease interactions, confirm compliance with evidence-based guidelines, and evaluate the risks and benefits of each medication in the context of the patient’s age and acute and chronic medical issues. This is also an opportunity to screen the full list for potentially inappropriate medications and high-alert drugs such as insulin or anticoagulants, which are more likely than other drugs to cause severe harm when used in error.

Acute kidney injury. New drug-disease interactions can arise during a hospitalization and can affect dosing and the choice of drug. The onset of acute kidney injury, for example, often necessitates adjusting or discontinuing nephrotoxic and renally excreted medications. ADEs or potential ADEs have been reported in 43% of hospitalized patients with acute kidney injury.³⁰

Because acute kidney injury is often transient, medications may need to be held or adjusted several times until renal function stabilizes. This can be challenging across the continuum of care and requires close monitoring of the serum creatinine level and associated drug doses and levels, if applicable. Well-designed clinical decision support tools can integrate laboratory data and alert the prescriber to a clinically important increase or decrease in serum creatinine that may warrant a change in therapy. Modifications to the regimen and a plan for timely follow-up of the serum creatinine level should be clearly documented in the discharge plan.

Liver disease. Similar attention should be given to drugs that are hepatically metabolized if a patient has acute or chronic liver impairment.

Geriatric patients, particularly those who present with altered mental status, falls, or urinary retention, should have their medication list reviewed for potentially inappropriate medications, which are drugs that pose increased risk of poor outcomes in older adults.^31,32 Patients and providers may have been willing to accept the risk of medications such as anticholinergics or sedative-hypnotics when the drugs were initiated, but circumstances can change over time, especially in this patient population. Hospitalization is a prime opportunity to screen for medications that meet the Beers criteria³¹ for agents to avoid or use with caution in older adults.

As-needed medications. Medications prescribed on an as-needed basis in the hospital should be reviewed for continuation or discontinuation at discharge. How often the medication was given can inform this decision.

For example, if as-needed opioids were used frequently, failure to develop a plan of care for pain can lead to persistent symptoms and, possibly, to readmission.^33,34 Similar scenarios occur with use of as-needed blood pressure medications, laxatives, and correction-dose insulin.

If an as-needed medication was used consistently during hospitalization, the physician should consider whether a regularly scheduled medication is needed. Conversely, if the medication was not used during the inpatient admission, it can likely be discontinued.

STEP 4: PREPARE THE PATIENT AND FOLLOW-UP PROVIDER

Once a clinician has performed medication reconciliation, including obtaining a best-possible medical history and carefully reviewing the medication list and orders for errors and clinical appropriateness, the next steps are to ensure the patient understands what he or she needs to do and to confirm that suitable follow-up plans are in place. These measures should be taken at all transitions of care but are critically important at hospital discharge.

Preparing the patient and caregiver

An accurate, reconciled medication list should be given to the patient, caregiver, or both, and should be reviewed before discharge.¹⁷

Approximately one-third of Americans have low health literacy skills, so medication lists and associated materials should be easy to understand.³⁵ Medication lists should be written in plain language and formatted for optimal readability (Table 4), clearly stating which medications to continue, change, hold temporarily, and stop.

Patients recall and comprehend about half of the information provided during a medical encounter.³⁶ Thus, medication teaching should focus on key points including changes or additions to the regimen, specific instructions for follow-up and monitoring, and how to handle common and serious side effects.

To confirm patient understanding, clinicians should use “teach-back,” ie, provide the patient with information and then ask him or her to repeat back key points.^37,38 The patient and family should also be encouraged to ask questions before discharge.

If not already addressed during the hospital stay, barriers to medication adherence and ability to obtain the medications should be attended to at this time (Table 5). Also, the plan to pick up the medications should be verified with the patient and caregiver. Verify that there is transportation to a particular pharmacy that is open at the time of discharge, and that the patient can afford the medications.

Ensuring appropriate follow-up

Studies have shown that timely in-home or telephone follow-up after discharge can decrease adverse events and postdischarge health care utilization.^39,40 Telephone follow-up that includes thorough medication reconciliation can help detect and resolve medication issues early after discharge and can close gaps related to monitoring and follow-up.

Medication reconciliation by telephone can be time-consuming. Depending on the number of medications that need to be reviewed, calls can take between 10 and 60 minutes. Postdischarge phone calls should be performed by clinical personnel who are able to identify medication-related problems. A pharmacist should be an available resource to assist with complex regimens, to help resolve medication discrepancies, and to address patient concerns. Table 6 provides tips for conducting follow-up phone calls.

Resolving discrepancies identified during follow-up calls can be difficult, as changes to the medication regimen are often not communicated effectively to other members of the care team. Physicians should document the complete medication list and plan in the discharge summary, and there should be a method for the caller to record updates to the medication list in the medical record so that they are apparent at the outpatient follow-up visit.

An additional challenge is that it is frequently unclear which physician “owns” which medications. Therefore, designating a contact person for each medication until follow-up can be very valuable. At a minimum, a “physician owner” for high-alert medications such as insulin, anticoagulants, and diuretics should be identified to provide close follow-up, titration, and monitoring.

There should also be a plan for the patient to obtain refills of essential long-term medications, such as antiplatelet agents following stent placement.

SUMMARY AND RECOMMENDATIONS

Medication-related problems during hospital admission and discharge are common and range from minor discrepancies in the medication list to errors in history-taking, prescribing, and reconciliation that can lead to potential or actual patient harm. Putting systems in place to facilitate medication reconciliation can decrease the occurrence of medication discrepancies and ADEs, thereby improving patient safety during these critical transitions between care settings and providers. Institutional medication reconciliation programs should focus resources on the admission history-taking step, target the highest-risk patients for the most intensive interventions, and involve pharmacy personnel when possible.

On an individual level, clinicians can incorporate additional interventions into their workflows to optimize medication safety for hospitalized patients. Using a structured approach to obtain a complete and accurate medication list at the time of hospital admission will help providers identify medication-related problems and prevent the propagation of errors throughout the hospital stay and at discharge. Focusing additional time and effort on a comprehensive review of the medication list for errors of omission and commission, patient-specific needs, and high-alert drugs will further decrease the risk of medication errors. Finally, providing discharge counseling targeting patient barriers to adherence and ensuring a proper handover of medication information and rationale for medication changes to outpatient providers will improve the chances of a safe transition.

I’m not sure if I recall seeing kids in long lines outside of school waiting to receive the polio vaccine, or if these are just memories from movie film clips. I’ve never seen a patient with an active polio infection, and I’ve seen only a few with postpolio syndromes. I’ve never seen a patient with tetanus, smallpox, diphtheria, or typical measles. I’ve seen three cases of pertussis that I know of, and the long delay in diagnosing the first one (my wife) was clearly because at that time clinicians caring for adults were not attuned to a disease that had virtually disappeared from the American landscape. Once I was sensitized to its presence, it was far easier to make the diagnosis in the second case I encountered (myself). The list of infectious diseases that have almost vanished in the last 75 years with the development of specific vaccines is not long, but it is striking. We can easily lose sight of that when focusing on the less-than-perfect effectiveness of the pneumococcal and annual influenza vaccines.

My message in recounting these observations is that, growing up in the traditional Western medical establishment, I find it hard from a historical perspective to view vaccines as anything but a positive contribution to our public and personal health. And yet a vocal minority, generally outside the medical establishment, maintains that vaccination is a potentially dangerous practice to be avoided whenever possible. Their biological arguments are tenuous and rarely supported by controlled clinical outcomes or observational data. The elimination of trace amounts of mercury-containing preservatives from some vaccines has done little to dampen their concerns. The arguments against routine vaccination and mandated vaccination of schoolchildren to maintain herd immunity have acquired a libertarian tone. While I may share the philosophy behind their perspective—for example, I wear my seat belt while driving, but I don’t think I should be fined if I don’t—my not wearing a seat belt does not increase the chance that those who encounter me on a plane, in a movie theater, or at an amusement park will die when subsequently driving their car.

In all likelihood, I will retire from medicine before I ever see a case of typical diphtheria. I don’t think that is an accident of nature or the effect of better hygiene. I’m hoping that the generation of physicians to follow will see far less cervical cancer, and that physicians in Asia will see far less hepatitis B-associated hepatocellular carcinoma as a result of effective vaccination against the viruses associated with these cancers.

As Drs. Faria Farhat and Glenn Wortmann and Dr. Atul Khasnis discuss in their papers in this issue of the Journal, we have more to learn about how to most effectively use vaccines in special populations. It is clearly not a one-strategy-fits-all world. The decision to vaccinate these patients is usually less about public health than about the health of the individual patient.

The real-world effectiveness of many vaccines is less than it appeared to be in controlled clinical trials. Unfortunately, the patients who most need protection against infections, the immunosuppressed, have a blunted response to many vaccines and perhaps should not receive live vaccines. But we have too little evidence on how and when to optimally vaccinate these patients. It still feels a bit like a casino, not a clinic, when I discuss with a modestly immunosuppressed patient whether he or she should be vaccinated with a live vaccine to reduce the risk of shingles and postherpetic neuralgia.

If we have the opportunity, vaccinating before starting immunosuppressive drugs (or before splenectomy) makes sense. But often that is not an option. We are frequently faced with the need to extrapolate efficacy and safety experiences from clinical trials of vaccines that are conducted with healthier patients and with relatively short follow-up. The two vaccination papers in this issue of the Journal provide us with useful information about immunologic and other issues involved when making the decision to vaccinate special patient populations.

Buckle up wisely.

I’m not sure if I recall seeing kids in long lines outside of school waiting to receive the polio vaccine, or if these are just memories from movie film clips. I’ve never seen a patient with an active polio infection, and I’ve seen only a few with postpolio syndromes. I’ve never seen a patient with tetanus, smallpox, diphtheria, or typical measles. I’ve seen three cases of pertussis that I know of, and the long delay in diagnosing the first one (my wife) was clearly because at that time clinicians caring for adults were not attuned to a disease that had virtually disappeared from the American landscape. Once I was sensitized to its presence, it was far easier to make the diagnosis in the second case I encountered (myself). The list of infectious diseases that have almost vanished in the last 75 years with the development of specific vaccines is not long, but it is striking. We can easily lose sight of that when focusing on the less-than-perfect effectiveness of the pneumococcal and annual influenza vaccines.

My message in recounting these observations is that, growing up in the traditional Western medical establishment, I find it hard from a historical perspective to view vaccines as anything but a positive contribution to our public and personal health. And yet a vocal minority, generally outside the medical establishment, maintains that vaccination is a potentially dangerous practice to be avoided whenever possible. Their biological arguments are tenuous and rarely supported by controlled clinical outcomes or observational data. The elimination of trace amounts of mercury-containing preservatives from some vaccines has done little to dampen their concerns. The arguments against routine vaccination and mandated vaccination of schoolchildren to maintain herd immunity have acquired a libertarian tone. While I may share the philosophy behind their perspective—for example, I wear my seat belt while driving, but I don’t think I should be fined if I don’t—my not wearing a seat belt does not increase the chance that those who encounter me on a plane, in a movie theater, or at an amusement park will die when subsequently driving their car.

In all likelihood, I will retire from medicine before I ever see a case of typical diphtheria. I don’t think that is an accident of nature or the effect of better hygiene. I’m hoping that the generation of physicians to follow will see far less cervical cancer, and that physicians in Asia will see far less hepatitis B-associated hepatocellular carcinoma as a result of effective vaccination against the viruses associated with these cancers.

As Drs. Faria Farhat and Glenn Wortmann and Dr. Atul Khasnis discuss in their papers in this issue of the Journal, we have more to learn about how to most effectively use vaccines in special populations. It is clearly not a one-strategy-fits-all world. The decision to vaccinate these patients is usually less about public health than about the health of the individual patient.

The real-world effectiveness of many vaccines is less than it appeared to be in controlled clinical trials. Unfortunately, the patients who most need protection against infections, the immunosuppressed, have a blunted response to many vaccines and perhaps should not receive live vaccines. But we have too little evidence on how and when to optimally vaccinate these patients. It still feels a bit like a casino, not a clinic, when I discuss with a modestly immunosuppressed patient whether he or she should be vaccinated with a live vaccine to reduce the risk of shingles and postherpetic neuralgia.

If we have the opportunity, vaccinating before starting immunosuppressive drugs (or before splenectomy) makes sense. But often that is not an option. We are frequently faced with the need to extrapolate efficacy and safety experiences from clinical trials of vaccines that are conducted with healthier patients and with relatively short follow-up. The two vaccination papers in this issue of the Journal provide us with useful information about immunologic and other issues involved when making the decision to vaccinate special patient populations.

Buckle up wisely.

I’m not sure if I recall seeing kids in long lines outside of school waiting to receive the polio vaccine, or if these are just memories from movie film clips. I’ve never seen a patient with an active polio infection, and I’ve seen only a few with postpolio syndromes. I’ve never seen a patient with tetanus, smallpox, diphtheria, or typical measles. I’ve seen three cases of pertussis that I know of, and the long delay in diagnosing the first one (my wife) was clearly because at that time clinicians caring for adults were not attuned to a disease that had virtually disappeared from the American landscape. Once I was sensitized to its presence, it was far easier to make the diagnosis in the second case I encountered (myself). The list of infectious diseases that have almost vanished in the last 75 years with the development of specific vaccines is not long, but it is striking. We can easily lose sight of that when focusing on the less-than-perfect effectiveness of the pneumococcal and annual influenza vaccines.

My message in recounting these observations is that, growing up in the traditional Western medical establishment, I find it hard from a historical perspective to view vaccines as anything but a positive contribution to our public and personal health. And yet a vocal minority, generally outside the medical establishment, maintains that vaccination is a potentially dangerous practice to be avoided whenever possible. Their biological arguments are tenuous and rarely supported by controlled clinical outcomes or observational data. The elimination of trace amounts of mercury-containing preservatives from some vaccines has done little to dampen their concerns. The arguments against routine vaccination and mandated vaccination of schoolchildren to maintain herd immunity have acquired a libertarian tone. While I may share the philosophy behind their perspective—for example, I wear my seat belt while driving, but I don’t think I should be fined if I don’t—my not wearing a seat belt does not increase the chance that those who encounter me on a plane, in a movie theater, or at an amusement park will die when subsequently driving their car.

In all likelihood, I will retire from medicine before I ever see a case of typical diphtheria. I don’t think that is an accident of nature or the effect of better hygiene. I’m hoping that the generation of physicians to follow will see far less cervical cancer, and that physicians in Asia will see far less hepatitis B-associated hepatocellular carcinoma as a result of effective vaccination against the viruses associated with these cancers.

As Drs. Faria Farhat and Glenn Wortmann and Dr. Atul Khasnis discuss in their papers in this issue of the Journal, we have more to learn about how to most effectively use vaccines in special populations. It is clearly not a one-strategy-fits-all world. The decision to vaccinate these patients is usually less about public health than about the health of the individual patient.

The real-world effectiveness of many vaccines is less than it appeared to be in controlled clinical trials. Unfortunately, the patients who most need protection against infections, the immunosuppressed, have a blunted response to many vaccines and perhaps should not receive live vaccines. But we have too little evidence on how and when to optimally vaccinate these patients. It still feels a bit like a casino, not a clinic, when I discuss with a modestly immunosuppressed patient whether he or she should be vaccinated with a live vaccine to reduce the risk of shingles and postherpetic neuralgia.

If we have the opportunity, vaccinating before starting immunosuppressive drugs (or before splenectomy) makes sense. But often that is not an option. We are frequently faced with the need to extrapolate efficacy and safety experiences from clinical trials of vaccines that are conducted with healthier patients and with relatively short follow-up. The two vaccination papers in this issue of the Journal provide us with useful information about immunologic and other issues involved when making the decision to vaccinate special patient populations.

Buckle up wisely.

Vaccination is the standard of care as part of health maintenance for healthy people and for patients with myriad medical conditions. In an article in this issue of Cleveland Clinic Journal of Medicine, Drs. Faria Farhat and Glenn Wortmann¹ make recommendations about vaccinations in special populations, including people with a disordered immune system or who are otherwise at heightened risk of infection (eg, because of older age, international travel, comorbidities, and medications).

See related article

But special populations are not all the same in their responses to vaccination. For example, patients with systemic autoimmune diseases are a heterogeneous group with disease-specific immunologic perturbations and immunosuppression that vary by medication and dose, all affecting the response to vaccination. Also, two or more “special” situations may coexist in the same patient.

AREAS OF UNCERTAINTY FOR CLINICAL PRACTICE

Several groups have issued guidelines and recommendations about vaccination in immunocompromised patients, but many areas of uncertainty exist in clinical practice. Most of these arise from a lack of data on immunogenicity and outcomes.

For example, although two pneumococcal vaccines are used in adults, no studies have compared the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13, which is T–cell-dependent) with that of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, which is T–cell-independent) in immunocompromised adults.

Also, whether to use zoster vaccine in immunosuppressed patients ages 50 through 59 is debated. The vaccine is approved by the US Food and Drug Administration (FDA) for this age group, but the Advisory Committee on Immunization Practices (ACIP) does not recommend it, and the Infectious Diseases Society of America (IDSA) suggests that it be “considered” in patients on low-intensity immunosuppressive treatment.²

Testing to ensure optimal response to vaccination has been recommended in several articles and guidelines. However, antibody titers do not necessarily correlate with protection, and at this time no consensus exists about the timing of or need for testing for the response to immunization, the methods to use, how to interpret the results in terms of an adequate or inadequate response, or the role of booster immunization in routine clinical practice.

IS VACCINATION COST-EFFECTIVE?

Also relevant is whether vaccination is cost-effective.

Although vaccination with the PCV13 vaccine is possibly more cost-effective than PPSV23 in US adults based on a model that included immunosuppressed patients, the results of this study were sensitive to several assumptions, and the authors did not extrapolate their conclusion to immunocompromised individuals.³

In another cost-effectiveness analysis, immunocompromised patients were vaccinated with PCV13 at diagnosis and, starting a year later, were followed according to current PPSV23 vaccination guidelines. The PCV13 vaccine’s efficacy against invasive pneumococcal disease and pneumonia based on the modeled program led to cost savings, added quality-adjusted life-years, and prevented invasive pneumococcal disease, mostly in patients with human immunodeficiency virus  (HIV) infection and those on dialysis (unpublished data cited in a 2012 US Centers for Disease Control and Prevention [CDC] report).⁴

No cost-effectiveness studies of influenza vaccination in immunocompromised adults have been conducted in the United States.

The various recommendations by the FDA, the ACIP, and the IDSA regarding the appropriate age at which to give zoster vaccine may also have been influenced by cost-effectiveness studies. These have reported mixed results and have not specifically focused on special populations.⁵

IMPROVING VACCINATION RATES

Rates of vaccination in special populations are suboptimal, and remedial measures to improve coverage have been proposed. One-page vaccine questionnaires or handouts for patients as well as “pop-up” reminders for vaccination in the electronic health record for physicians have resulted in higher rates of indicated vaccinations. Both the CDC and the American College of Physicians (ACP) offer downloadable tools—the CDC Vaccine Schedules App⁶ and the ACP Immunization Advisor,⁷ respectively—that are based on the 2012 ACIP guidelines and are extremely useful for busy practitioners. The CDC also offers patients a vaccine questionnaire⁸ that allows them to determine which vaccinations they may need and also to learn about those vaccines.

MOVING AHEAD

The development of vaccines is ongoing and will be driven by identification of new molecular targets. Advances in therapies for immunocompromised patients such as those with HIV infection will, we hope, decrease the risk of opportunistic infections. The list of vaccine-preventable diseases may continue to grow, as may the list of special populations. Optimal vaccination and outcomes may emerge from expected improved vaccine coverage as a result of the increased health insurance coverage resulting from the much-maligned Patient Protection and Affordable Care Act and ongoing studies regarding efficacy, safety, and cost-effectiveness, especially pertaining to specific patient populations.

Vaccination is the standard of care as part of health maintenance for healthy people and for patients with myriad medical conditions. In an article in this issue of Cleveland Clinic Journal of Medicine, Drs. Faria Farhat and Glenn Wortmann¹ make recommendations about vaccinations in special populations, including people with a disordered immune system or who are otherwise at heightened risk of infection (eg, because of older age, international travel, comorbidities, and medications).

See related article

But special populations are not all the same in their responses to vaccination. For example, patients with systemic autoimmune diseases are a heterogeneous group with disease-specific immunologic perturbations and immunosuppression that vary by medication and dose, all affecting the response to vaccination. Also, two or more “special” situations may coexist in the same patient.

AREAS OF UNCERTAINTY FOR CLINICAL PRACTICE

Several groups have issued guidelines and recommendations about vaccination in immunocompromised patients, but many areas of uncertainty exist in clinical practice. Most of these arise from a lack of data on immunogenicity and outcomes.

For example, although two pneumococcal vaccines are used in adults, no studies have compared the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13, which is T–cell-dependent) with that of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, which is T–cell-independent) in immunocompromised adults.

Also, whether to use zoster vaccine in immunosuppressed patients ages 50 through 59 is debated. The vaccine is approved by the US Food and Drug Administration (FDA) for this age group, but the Advisory Committee on Immunization Practices (ACIP) does not recommend it, and the Infectious Diseases Society of America (IDSA) suggests that it be “considered” in patients on low-intensity immunosuppressive treatment.²

Testing to ensure optimal response to vaccination has been recommended in several articles and guidelines. However, antibody titers do not necessarily correlate with protection, and at this time no consensus exists about the timing of or need for testing for the response to immunization, the methods to use, how to interpret the results in terms of an adequate or inadequate response, or the role of booster immunization in routine clinical practice.

IS VACCINATION COST-EFFECTIVE?

Also relevant is whether vaccination is cost-effective.

Although vaccination with the PCV13 vaccine is possibly more cost-effective than PPSV23 in US adults based on a model that included immunosuppressed patients, the results of this study were sensitive to several assumptions, and the authors did not extrapolate their conclusion to immunocompromised individuals.³

In another cost-effectiveness analysis, immunocompromised patients were vaccinated with PCV13 at diagnosis and, starting a year later, were followed according to current PPSV23 vaccination guidelines. The PCV13 vaccine’s efficacy against invasive pneumococcal disease and pneumonia based on the modeled program led to cost savings, added quality-adjusted life-years, and prevented invasive pneumococcal disease, mostly in patients with human immunodeficiency virus  (HIV) infection and those on dialysis (unpublished data cited in a 2012 US Centers for Disease Control and Prevention [CDC] report).⁴

No cost-effectiveness studies of influenza vaccination in immunocompromised adults have been conducted in the United States.

The various recommendations by the FDA, the ACIP, and the IDSA regarding the appropriate age at which to give zoster vaccine may also have been influenced by cost-effectiveness studies. These have reported mixed results and have not specifically focused on special populations.⁵

IMPROVING VACCINATION RATES

Rates of vaccination in special populations are suboptimal, and remedial measures to improve coverage have been proposed. One-page vaccine questionnaires or handouts for patients as well as “pop-up” reminders for vaccination in the electronic health record for physicians have resulted in higher rates of indicated vaccinations. Both the CDC and the American College of Physicians (ACP) offer downloadable tools—the CDC Vaccine Schedules App⁶ and the ACP Immunization Advisor,⁷ respectively—that are based on the 2012 ACIP guidelines and are extremely useful for busy practitioners. The CDC also offers patients a vaccine questionnaire⁸ that allows them to determine which vaccinations they may need and also to learn about those vaccines.

MOVING AHEAD

The development of vaccines is ongoing and will be driven by identification of new molecular targets. Advances in therapies for immunocompromised patients such as those with HIV infection will, we hope, decrease the risk of opportunistic infections. The list of vaccine-preventable diseases may continue to grow, as may the list of special populations. Optimal vaccination and outcomes may emerge from expected improved vaccine coverage as a result of the increased health insurance coverage resulting from the much-maligned Patient Protection and Affordable Care Act and ongoing studies regarding efficacy, safety, and cost-effectiveness, especially pertaining to specific patient populations.

Vaccination is the standard of care as part of health maintenance for healthy people and for patients with myriad medical conditions. In an article in this issue of Cleveland Clinic Journal of Medicine, Drs. Faria Farhat and Glenn Wortmann¹ make recommendations about vaccinations in special populations, including people with a disordered immune system or who are otherwise at heightened risk of infection (eg, because of older age, international travel, comorbidities, and medications).

See related article

But special populations are not all the same in their responses to vaccination. For example, patients with systemic autoimmune diseases are a heterogeneous group with disease-specific immunologic perturbations and immunosuppression that vary by medication and dose, all affecting the response to vaccination. Also, two or more “special” situations may coexist in the same patient.

AREAS OF UNCERTAINTY FOR CLINICAL PRACTICE

Several groups have issued guidelines and recommendations about vaccination in immunocompromised patients, but many areas of uncertainty exist in clinical practice. Most of these arise from a lack of data on immunogenicity and outcomes.

For example, although two pneumococcal vaccines are used in adults, no studies have compared the immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13, which is T–cell-dependent) with that of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, which is T–cell-independent) in immunocompromised adults.

Also, whether to use zoster vaccine in immunosuppressed patients ages 50 through 59 is debated. The vaccine is approved by the US Food and Drug Administration (FDA) for this age group, but the Advisory Committee on Immunization Practices (ACIP) does not recommend it, and the Infectious Diseases Society of America (IDSA) suggests that it be “considered” in patients on low-intensity immunosuppressive treatment.²

Testing to ensure optimal response to vaccination has been recommended in several articles and guidelines. However, antibody titers do not necessarily correlate with protection, and at this time no consensus exists about the timing of or need for testing for the response to immunization, the methods to use, how to interpret the results in terms of an adequate or inadequate response, or the role of booster immunization in routine clinical practice.

IS VACCINATION COST-EFFECTIVE?

Also relevant is whether vaccination is cost-effective.

Although vaccination with the PCV13 vaccine is possibly more cost-effective than PPSV23 in US adults based on a model that included immunosuppressed patients, the results of this study were sensitive to several assumptions, and the authors did not extrapolate their conclusion to immunocompromised individuals.³

In another cost-effectiveness analysis, immunocompromised patients were vaccinated with PCV13 at diagnosis and, starting a year later, were followed according to current PPSV23 vaccination guidelines. The PCV13 vaccine’s efficacy against invasive pneumococcal disease and pneumonia based on the modeled program led to cost savings, added quality-adjusted life-years, and prevented invasive pneumococcal disease, mostly in patients with human immunodeficiency virus  (HIV) infection and those on dialysis (unpublished data cited in a 2012 US Centers for Disease Control and Prevention [CDC] report).⁴

No cost-effectiveness studies of influenza vaccination in immunocompromised adults have been conducted in the United States.

The various recommendations by the FDA, the ACIP, and the IDSA regarding the appropriate age at which to give zoster vaccine may also have been influenced by cost-effectiveness studies. These have reported mixed results and have not specifically focused on special populations.⁵

IMPROVING VACCINATION RATES

Rates of vaccination in special populations are suboptimal, and remedial measures to improve coverage have been proposed. One-page vaccine questionnaires or handouts for patients as well as “pop-up” reminders for vaccination in the electronic health record for physicians have resulted in higher rates of indicated vaccinations. Both the CDC and the American College of Physicians (ACP) offer downloadable tools—the CDC Vaccine Schedules App⁶ and the ACP Immunization Advisor,⁷ respectively—that are based on the 2012 ACIP guidelines and are extremely useful for busy practitioners. The CDC also offers patients a vaccine questionnaire⁸ that allows them to determine which vaccinations they may need and also to learn about those vaccines.

MOVING AHEAD

The development of vaccines is ongoing and will be driven by identification of new molecular targets. Advances in therapies for immunocompromised patients such as those with HIV infection will, we hope, decrease the risk of opportunistic infections. The list of vaccine-preventable diseases may continue to grow, as may the list of special populations. Optimal vaccination and outcomes may emerge from expected improved vaccine coverage as a result of the increased health insurance coverage resulting from the much-maligned Patient Protection and Affordable Care Act and ongoing studies regarding efficacy, safety, and cost-effectiveness, especially pertaining to specific patient populations.

Most vaccinations are given during childhood, but some require boosting during adulthood or are indicated for specific patient populations such as international travelers or those with certain medical conditions. Although generally safe, some vaccines contain live, attenuated organisms that can cause disease in immunocompromised patients. Thus, knowledge of the indications for and contraindications to specific vaccinations is critical to protect adults in special circumstances who are at risk.

See related commentary

Vaccines have helped eliminate or significantly reduce the burden of more than a dozen illnesses.^1–3 The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention  (CDC) makes recommendations about vaccinations for normal adults and children as well as for certain groups at high risk of vaccine-preventable infections.⁴ Tables 1 and 2 summarize the recommendations for vaccination by medical condition.⁴  In addition, several applications are available online, including downloadable apps from the (www.cdc.gov/vaccines/schedules/Schedulers/adult-scheduler.html) and the American College of Physicians (http://immunization.acponline.org/app/).

HUMANITY’S GREATEST ADVANCES IN PREVENTING INFECTIOUS DISEASE

Immunization and improved sanitation are humanity’s greatest advances in preventing sickness and death from infectious diseases. Since Jenner’s discovery in 1796 that milkmaids who had contracted cowpox (vaccinia) were immune to smallpox, vaccination has eliminated smallpox, markedly decreased the incidence of many infectious diseases, and, most recently, shown efficacy in preventing cervical cancer (with the human papillomavirus vaccine) and hepatocellular cancer (with the hepatitis B vaccine).^1–3

Unfortunately, vaccination rates remain low for most routine vaccinations indicated for adults. For example, about 60% of adults over age 65 receive pneumococcal vaccination, and fewer than 10% of black patients over age 60 receive zoster vaccination.⁵ Various factors may account for these low rates, including financial disincentives.⁶

Nevertheless, vaccination remains one of medicine’s most effective defenses against infectious diseases and is especially important in the special populations discussed below. By being steadfast proponents of vaccination, especially for the most vulnerable patients, physicians can help ensure the optimum protection for their patients.

VACCINATING PREGNANT PATIENTS

When considering vaccination during pregnancy, one must consider the risk and benefit of the vaccine and the risk of the disease in both the mother and the child.

In general, if a pregnant woman is at high risk of exposure to a particular infection, the benefits of vaccinating her against it outweigh the risks. Vaccinating the mother can also protect against certain infections in early infancy through transfer of vaccine-induced immunoglobin G (IgG) across the placenta.⁷ In general, inactivated vaccines are considered safe in pregnancy, while live-attenuated vaccines are contraindicated.⁴ Special considerations for pregnant women include:

Tetanus, diphtheria, and acellular pertussis (Tdap). One dose of Tdap vaccine should be given during each pregnancy, preferably at 27 to 36 weeks of gestation, regardless of when the patient received a previous dose.⁸

Inactivated influenza vaccine should be given as early as possible during the influenza season (October to March) to all pregnant women, regardless of trimester.

Inactivated polio vaccine may be considered for pregnant women with known exposure to polio or travel to endemic areas.

Hepatitis A, hepatitis B, pneumococcal polysaccharide, meningococcal conjugate, and meningococcal polysaccharide vaccines can be given to women at risk of these infections. If a pregnant patient requires pneumococcal polysaccharide vaccine, it should be given during the second or third trimester, as the safety of this vaccine during the first trimester has not been established.⁹

Smallpox, measles-mumps-rubella, and varicella-containing vaccines are contraindicated in pregnancy. Household contacts of a pregnant woman should not receive smallpox vaccine, as it is the only vaccine known to cause harm to the fetus.¹⁰

Human papillomavirus vaccination is not recommended during pregnancy.

Yellow fever live-attenuated vaccine. The safety of this vaccine during pregnancy has not been established, and it is in the US Food and Drug Administration (FDA) pregnancy category C. However, this vaccine is required for entry into certain countries, and it may be offered if the patient is truly at risk of contracting yellow fever. Because pregnancy may affect immunologic response, serologic testing is recommended to document an immune response. If the patient’s itinerary puts her at low risk of yellow fever, then writing her a vaccine waiver letter can be considered.¹¹

VACCINATING IMMUNOCOMPROMISED PATIENTS (NON-HIV)

People who do not have human immunodeficiency virus (HIV) but have a condition such as functional asplenia (sickle cell disease), anatomic asplenia, or complement component deficiency are at higher risk of infection with the encapsulated bacteria Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.

Corticosteroids, chemotherapy, radiation for hematologic or solid-organ malignancies, and immune modulators can alter the immune system and pose a risk with the use of live-attenuated vaccines. A corticosteroid dosage equivalent to 2 mg/kg of body weight per day or higher or 20 mg/day of prednisone or higher is generally considered immunosuppressive.

Candidates for organ transplantation should receive vaccinations as early as possible during the disease course leading to transplantation. Vaccinations should be given as soon as the decision is made that the patient is a candidate for transplantation, which could be years or months before the patient actually receives the transplant. In addition to reviewing previously administered vaccinations, pretransplant serologic testing for hepatitis B, varicella, measles, mumps, and rubella antibodies helps to evaluate the need for vaccination.¹²

Recipients of hematopoietic stem cell transplantation are at risk of infections with encapsulated bacteria and certain other vaccine-preventable infections. Antibody titers are significantly reduced after stem cell transplantation because of ablation of bone marrow, and thus certain vaccines should be readministered 3 to 6 months after transplantation (eg, influenza, pneumococcal, and H influenzae vaccines). If the recipient is presumed to be immunocompetent, then varicella or measles-mumps-rubella vaccine can be given 24 months after transplantation.¹³

Apart from adhering to the routine vaccination schedule and avoiding live-attenuated vaccines, specific recommendations apply to persons with immunocompromising conditions¹⁴:

Quadrivalent meningococcal conjugate vaccine should be given to adults of all ages with asplenia or complement component deficiency. The schedule includes two doses at least 2 months apart initially and then revaccination every 5 years.

H influenzae type b vaccine should be given to people with asplenia and recipients of hematopoietic stem cells. One dose is recommended for those with asplenia (functional, anatomic, or elective splenectomy) or sickle cell disease if they have not already received it. A three-dose schedule is considered for hematopoietic stem cell transplant recipients 6 to 12 months after successful transplantation.

Pneumococcal conjugate (PCV13) and pneumococcal polysaccharide (PPSV23) vaccinations are recommended for people who have immunocompromising conditions. PCV13, the newer pneumococcal vaccine, was approved by the FDA in 2010 for use in children and was recommended by the ACIP in 2012 for adults age 19 and older with immunocompromising conditions.

People who have not previously received either of these vaccines and are age 19 or older with immunocompromising conditions including asplenia, chronic renal failure, nephrotic syndrome, cerebrospinal fluid leakage, or cochlear implant should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later. One-time revaccination 5 years after the first dose of PPSV23 is recommended for patients with immunocompromising conditions.

For those who have previously been vaccinated with PPSV23, a dose of PCV13 can be given 1 or more years after the last dose of PPSV23. These dosing intervals are important, as lower opsonophagocytic antibody responses have been noted if repeat doses of either pneumococcal vaccine are given sooner than the recommended interval.¹⁵

Inactivated influenza vaccine is recommended annually, except for patients who are unlikely to respond or those who have received anti-B-cell antibodies within 6 months. Live-attenuated influenza vaccine should not be given to immunocompromised patients.

VACCINATING PATIENTS WHO HAVE HIV

People with HIV should be routinely screened for immunity against certain infections and should be offered vaccination if not immune. The response to vaccines may vary depending on the CD4 count, with a good response in patients whose infection is well controlled with antiretroviral agents and with a preserved CD4 count.¹⁶ Special considerations for HIV patients include the following:

Hepatitis A vaccine may be offered to all HIV patients who have no evidence of immunity against hepatitis A, with negative antihepatitis A total and IgG antibodies.

Human papillomavirus vaccine is recommended for men and women with HIV through age 26.

Varicella and measles-mumps-rubella are live-attenuated vaccines and may be considered in patients who are nonimmune and with CD4 counts of 200 cells/µL or higher. However, the ACIP does not make a recommendation regarding the zoster vaccine in HIV patients with CD4 cell counts of 200 cells/µL or higher. In general, live-attenuated vaccines should be avoided in patients with CD4 counts less than 200 or with severe immunocompromised status because of risk of acquiring severe, life-threatening infections.

Pneumococcal vaccine should be given to HIV patients if they have not received it before. The schedule is one dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. If a patient has been previously vaccinated with PPSV23, then PCV13 is recommended at least 1 year after PPSV23.

Inactivated influenza vaccine is recommended annually. Live-attenuated influenza vaccine should not be given.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. These patients require higher doses of hepatitis B vaccine (40 μg/mL) than immunocompetent patients, who receive 20 μg/mL. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Meningococcal vaccine. HIV infection is not an indication for meningococcal vaccine unless the patient has other risk factors, such as anatomic or functional asplenia, persistent complement component deficiency, occupational exposure, and travel to endemic areas.

VACCINATING PATIENTS WHO ARE OLDER THAN 60

The immune system deteriorates with age, as does immunity gained from previous vaccinations. Vaccination in this age group reduces the risk of illness and death.¹⁷

Zoster vaccine should be offered to people age 60 and older regardless of previous episodes of herpes zoster unless there is a contraindication such as severe immunodeficiency. The zoster vaccine can reduce the incidence of postherpetic neuralgia by 66.5% and herpes zoster by 51% in patients over age 60.¹⁸

Pneumococcal conjugate vaccine. PCV13 should be offered to all adults age 65 or older. If a person age 65 or older has not received any pneumococcal vaccine before then, PCV13 should be given first, followed by a dose of PPSV23 at least 6 to 12 months after PCV13.

Pneumococcal polysaccharide vaccine. If PPSV23 was given before age 65 for another indication, a dose of PCV 13 should be given at age 65 or later, as long as 6 to 12 months have passed since the previous dose of PPSV 23. The patient should receive the last dose of PPSV23 vaccine 5 years after the first dose of PPSV23.⁴

Influenza vaccine. People 65 or older are at higher risk of complications from influenza, and vaccine should be offered annually. High-dose inactivated influenza vaccine can be used in this age group.⁴

Tdap. If never given before, Tdap is recommended regardless of the interval since the most recent Td vaccination, followed by a Td booster every 10 years.

VACCINATING PATIENTS WHO HAVE CHRONIC KIDNEY DISEASE

Patients with chronic kidney disease are at risk of certain infections, so vaccination is an important preventive measure.¹⁹ Immunizations should be offered to all patients with chronic kidney disease regardless of the disease stage, but they are recommended during the early stages of progressive renal disease to increase the likelihood of vaccine-induced immunity.²⁰

Pneumococcal conjugate vaccine. PCV13 is recommended for adults 19 or older with chronic renal disease or nephrotic syndrome. One dose of PCV13 should be given, followed by a dose of PPSV23 at least 8 weeks later. If the patient has been previously vaccinated with PPSV23, then PCV13 at least 1 year after PPSV23 is recommended.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. Adult patients on hemodialysis require higher doses of hepatitis B vaccine. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Influenza vaccine should be offered annually to patients with chronic kidney disease.

VACCINATING IMMUNOCOMPROMISED INTERNATIONAL TRAVELERS

International travel for business or pleasure is increasingly common, and immunocompromised patients require specific attention as they may face unanticipated pathogens or have special requirements. Transplant recipients should ideally receive routine and travel-related vaccines as early as possible before transplantation. Vaccination is generally avoided in the first 6 months after organ transplantation to avoid confusion with early graft dysfunction or rejection.²¹ However, it should be considered as soon as a patient develops an illness that might lead to transplantation.

Evaluation of patients for vaccination should include an assessment of the travel-specific epidemiologic risk, the nature of the vaccine (live-attenuated or other), and the immune status. As discussed above, live-attenuated vaccines should be avoided in immunocompromised patients, and thus the injectable typhoid vaccine should be given in lieu of the attenuated oral vaccine.

Yellow fever vaccine is required before entrance to certain countries but should not be given to immunocompromised patients, although it can probably be given to asymptomatic HIV-infected adults with a CD4 count higher than 200 cells/μL who are exposed to substantial risk.²² For patients who cannot receive the vaccine, some governments will accept a physician’s letter stating the patient has a contraindication to vaccination.

VACCINATING HOUSEHOLD MEMBERS OF IMMUNOCOMPROMISED PATIENTS

Protecting immunocompromised patients from infectious diseases involves vaccinating not only the patient but also household members so that they do not acquire infections and then bring them into the household. Immunocompetent members of a household can receive inactivated vaccines based on the recommended ACIP schedule.

Annual inactivated influenza vaccination is recommended, although the live-attenuated influenza virus vaccine can be substituted if the immunocompromised patient is not within 2 months of hematopoietic stem cell transplantation, does not have graft-vs-host disease, and does not have severe combined immune deficiency.

Other live-attenuated vaccines can usually be given if indicated, including measles-mumps-rubella vaccine, rotavirus vaccine in infants, varicella vaccine, and zoster vaccine.¹⁴

Most vaccinations are given during childhood, but some require boosting during adulthood or are indicated for specific patient populations such as international travelers or those with certain medical conditions. Although generally safe, some vaccines contain live, attenuated organisms that can cause disease in immunocompromised patients. Thus, knowledge of the indications for and contraindications to specific vaccinations is critical to protect adults in special circumstances who are at risk.

See related commentary

Vaccines have helped eliminate or significantly reduce the burden of more than a dozen illnesses.^1–3 The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention  (CDC) makes recommendations about vaccinations for normal adults and children as well as for certain groups at high risk of vaccine-preventable infections.⁴ Tables 1 and 2 summarize the recommendations for vaccination by medical condition.⁴  In addition, several applications are available online, including downloadable apps from the (www.cdc.gov/vaccines/schedules/Schedulers/adult-scheduler.html) and the American College of Physicians (http://immunization.acponline.org/app/).

HUMANITY’S GREATEST ADVANCES IN PREVENTING INFECTIOUS DISEASE

Immunization and improved sanitation are humanity’s greatest advances in preventing sickness and death from infectious diseases. Since Jenner’s discovery in 1796 that milkmaids who had contracted cowpox (vaccinia) were immune to smallpox, vaccination has eliminated smallpox, markedly decreased the incidence of many infectious diseases, and, most recently, shown efficacy in preventing cervical cancer (with the human papillomavirus vaccine) and hepatocellular cancer (with the hepatitis B vaccine).^1–3

Unfortunately, vaccination rates remain low for most routine vaccinations indicated for adults. For example, about 60% of adults over age 65 receive pneumococcal vaccination, and fewer than 10% of black patients over age 60 receive zoster vaccination.⁵ Various factors may account for these low rates, including financial disincentives.⁶

Nevertheless, vaccination remains one of medicine’s most effective defenses against infectious diseases and is especially important in the special populations discussed below. By being steadfast proponents of vaccination, especially for the most vulnerable patients, physicians can help ensure the optimum protection for their patients.

VACCINATING PREGNANT PATIENTS

When considering vaccination during pregnancy, one must consider the risk and benefit of the vaccine and the risk of the disease in both the mother and the child.

In general, if a pregnant woman is at high risk of exposure to a particular infection, the benefits of vaccinating her against it outweigh the risks. Vaccinating the mother can also protect against certain infections in early infancy through transfer of vaccine-induced immunoglobin G (IgG) across the placenta.⁷ In general, inactivated vaccines are considered safe in pregnancy, while live-attenuated vaccines are contraindicated.⁴ Special considerations for pregnant women include:

Tetanus, diphtheria, and acellular pertussis (Tdap). One dose of Tdap vaccine should be given during each pregnancy, preferably at 27 to 36 weeks of gestation, regardless of when the patient received a previous dose.⁸

Inactivated influenza vaccine should be given as early as possible during the influenza season (October to March) to all pregnant women, regardless of trimester.

Inactivated polio vaccine may be considered for pregnant women with known exposure to polio or travel to endemic areas.

Hepatitis A, hepatitis B, pneumococcal polysaccharide, meningococcal conjugate, and meningococcal polysaccharide vaccines can be given to women at risk of these infections. If a pregnant patient requires pneumococcal polysaccharide vaccine, it should be given during the second or third trimester, as the safety of this vaccine during the first trimester has not been established.⁹

Smallpox, measles-mumps-rubella, and varicella-containing vaccines are contraindicated in pregnancy. Household contacts of a pregnant woman should not receive smallpox vaccine, as it is the only vaccine known to cause harm to the fetus.¹⁰

Human papillomavirus vaccination is not recommended during pregnancy.

Yellow fever live-attenuated vaccine. The safety of this vaccine during pregnancy has not been established, and it is in the US Food and Drug Administration (FDA) pregnancy category C. However, this vaccine is required for entry into certain countries, and it may be offered if the patient is truly at risk of contracting yellow fever. Because pregnancy may affect immunologic response, serologic testing is recommended to document an immune response. If the patient’s itinerary puts her at low risk of yellow fever, then writing her a vaccine waiver letter can be considered.¹¹

VACCINATING IMMUNOCOMPROMISED PATIENTS (NON-HIV)

People who do not have human immunodeficiency virus (HIV) but have a condition such as functional asplenia (sickle cell disease), anatomic asplenia, or complement component deficiency are at higher risk of infection with the encapsulated bacteria Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.

Corticosteroids, chemotherapy, radiation for hematologic or solid-organ malignancies, and immune modulators can alter the immune system and pose a risk with the use of live-attenuated vaccines. A corticosteroid dosage equivalent to 2 mg/kg of body weight per day or higher or 20 mg/day of prednisone or higher is generally considered immunosuppressive.

Candidates for organ transplantation should receive vaccinations as early as possible during the disease course leading to transplantation. Vaccinations should be given as soon as the decision is made that the patient is a candidate for transplantation, which could be years or months before the patient actually receives the transplant. In addition to reviewing previously administered vaccinations, pretransplant serologic testing for hepatitis B, varicella, measles, mumps, and rubella antibodies helps to evaluate the need for vaccination.¹²

Recipients of hematopoietic stem cell transplantation are at risk of infections with encapsulated bacteria and certain other vaccine-preventable infections. Antibody titers are significantly reduced after stem cell transplantation because of ablation of bone marrow, and thus certain vaccines should be readministered 3 to 6 months after transplantation (eg, influenza, pneumococcal, and H influenzae vaccines). If the recipient is presumed to be immunocompetent, then varicella or measles-mumps-rubella vaccine can be given 24 months after transplantation.¹³

Apart from adhering to the routine vaccination schedule and avoiding live-attenuated vaccines, specific recommendations apply to persons with immunocompromising conditions¹⁴:

Quadrivalent meningococcal conjugate vaccine should be given to adults of all ages with asplenia or complement component deficiency. The schedule includes two doses at least 2 months apart initially and then revaccination every 5 years.

H influenzae type b vaccine should be given to people with asplenia and recipients of hematopoietic stem cells. One dose is recommended for those with asplenia (functional, anatomic, or elective splenectomy) or sickle cell disease if they have not already received it. A three-dose schedule is considered for hematopoietic stem cell transplant recipients 6 to 12 months after successful transplantation.

Pneumococcal conjugate (PCV13) and pneumococcal polysaccharide (PPSV23) vaccinations are recommended for people who have immunocompromising conditions. PCV13, the newer pneumococcal vaccine, was approved by the FDA in 2010 for use in children and was recommended by the ACIP in 2012 for adults age 19 and older with immunocompromising conditions.

People who have not previously received either of these vaccines and are age 19 or older with immunocompromising conditions including asplenia, chronic renal failure, nephrotic syndrome, cerebrospinal fluid leakage, or cochlear implant should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later. One-time revaccination 5 years after the first dose of PPSV23 is recommended for patients with immunocompromising conditions.

For those who have previously been vaccinated with PPSV23, a dose of PCV13 can be given 1 or more years after the last dose of PPSV23. These dosing intervals are important, as lower opsonophagocytic antibody responses have been noted if repeat doses of either pneumococcal vaccine are given sooner than the recommended interval.¹⁵

Inactivated influenza vaccine is recommended annually, except for patients who are unlikely to respond or those who have received anti-B-cell antibodies within 6 months. Live-attenuated influenza vaccine should not be given to immunocompromised patients.

VACCINATING PATIENTS WHO HAVE HIV

People with HIV should be routinely screened for immunity against certain infections and should be offered vaccination if not immune. The response to vaccines may vary depending on the CD4 count, with a good response in patients whose infection is well controlled with antiretroviral agents and with a preserved CD4 count.¹⁶ Special considerations for HIV patients include the following:

Hepatitis A vaccine may be offered to all HIV patients who have no evidence of immunity against hepatitis A, with negative antihepatitis A total and IgG antibodies.

Human papillomavirus vaccine is recommended for men and women with HIV through age 26.

Varicella and measles-mumps-rubella are live-attenuated vaccines and may be considered in patients who are nonimmune and with CD4 counts of 200 cells/µL or higher. However, the ACIP does not make a recommendation regarding the zoster vaccine in HIV patients with CD4 cell counts of 200 cells/µL or higher. In general, live-attenuated vaccines should be avoided in patients with CD4 counts less than 200 or with severe immunocompromised status because of risk of acquiring severe, life-threatening infections.

Pneumococcal vaccine should be given to HIV patients if they have not received it before. The schedule is one dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. If a patient has been previously vaccinated with PPSV23, then PCV13 is recommended at least 1 year after PPSV23.

Inactivated influenza vaccine is recommended annually. Live-attenuated influenza vaccine should not be given.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. These patients require higher doses of hepatitis B vaccine (40 μg/mL) than immunocompetent patients, who receive 20 μg/mL. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Meningococcal vaccine. HIV infection is not an indication for meningococcal vaccine unless the patient has other risk factors, such as anatomic or functional asplenia, persistent complement component deficiency, occupational exposure, and travel to endemic areas.

VACCINATING PATIENTS WHO ARE OLDER THAN 60

The immune system deteriorates with age, as does immunity gained from previous vaccinations. Vaccination in this age group reduces the risk of illness and death.¹⁷

Zoster vaccine should be offered to people age 60 and older regardless of previous episodes of herpes zoster unless there is a contraindication such as severe immunodeficiency. The zoster vaccine can reduce the incidence of postherpetic neuralgia by 66.5% and herpes zoster by 51% in patients over age 60.¹⁸

Pneumococcal conjugate vaccine. PCV13 should be offered to all adults age 65 or older. If a person age 65 or older has not received any pneumococcal vaccine before then, PCV13 should be given first, followed by a dose of PPSV23 at least 6 to 12 months after PCV13.

Pneumococcal polysaccharide vaccine. If PPSV23 was given before age 65 for another indication, a dose of PCV 13 should be given at age 65 or later, as long as 6 to 12 months have passed since the previous dose of PPSV 23. The patient should receive the last dose of PPSV23 vaccine 5 years after the first dose of PPSV23.⁴

Influenza vaccine. People 65 or older are at higher risk of complications from influenza, and vaccine should be offered annually. High-dose inactivated influenza vaccine can be used in this age group.⁴

Tdap. If never given before, Tdap is recommended regardless of the interval since the most recent Td vaccination, followed by a Td booster every 10 years.

VACCINATING PATIENTS WHO HAVE CHRONIC KIDNEY DISEASE

Patients with chronic kidney disease are at risk of certain infections, so vaccination is an important preventive measure.¹⁹ Immunizations should be offered to all patients with chronic kidney disease regardless of the disease stage, but they are recommended during the early stages of progressive renal disease to increase the likelihood of vaccine-induced immunity.²⁰

Pneumococcal conjugate vaccine. PCV13 is recommended for adults 19 or older with chronic renal disease or nephrotic syndrome. One dose of PCV13 should be given, followed by a dose of PPSV23 at least 8 weeks later. If the patient has been previously vaccinated with PPSV23, then PCV13 at least 1 year after PPSV23 is recommended.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. Adult patients on hemodialysis require higher doses of hepatitis B vaccine. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Influenza vaccine should be offered annually to patients with chronic kidney disease.

VACCINATING IMMUNOCOMPROMISED INTERNATIONAL TRAVELERS

International travel for business or pleasure is increasingly common, and immunocompromised patients require specific attention as they may face unanticipated pathogens or have special requirements. Transplant recipients should ideally receive routine and travel-related vaccines as early as possible before transplantation. Vaccination is generally avoided in the first 6 months after organ transplantation to avoid confusion with early graft dysfunction or rejection.²¹ However, it should be considered as soon as a patient develops an illness that might lead to transplantation.

Evaluation of patients for vaccination should include an assessment of the travel-specific epidemiologic risk, the nature of the vaccine (live-attenuated or other), and the immune status. As discussed above, live-attenuated vaccines should be avoided in immunocompromised patients, and thus the injectable typhoid vaccine should be given in lieu of the attenuated oral vaccine.

Yellow fever vaccine is required before entrance to certain countries but should not be given to immunocompromised patients, although it can probably be given to asymptomatic HIV-infected adults with a CD4 count higher than 200 cells/μL who are exposed to substantial risk.²² For patients who cannot receive the vaccine, some governments will accept a physician’s letter stating the patient has a contraindication to vaccination.

VACCINATING HOUSEHOLD MEMBERS OF IMMUNOCOMPROMISED PATIENTS

Protecting immunocompromised patients from infectious diseases involves vaccinating not only the patient but also household members so that they do not acquire infections and then bring them into the household. Immunocompetent members of a household can receive inactivated vaccines based on the recommended ACIP schedule.

Annual inactivated influenza vaccination is recommended, although the live-attenuated influenza virus vaccine can be substituted if the immunocompromised patient is not within 2 months of hematopoietic stem cell transplantation, does not have graft-vs-host disease, and does not have severe combined immune deficiency.

Other live-attenuated vaccines can usually be given if indicated, including measles-mumps-rubella vaccine, rotavirus vaccine in infants, varicella vaccine, and zoster vaccine.¹⁴

Most vaccinations are given during childhood, but some require boosting during adulthood or are indicated for specific patient populations such as international travelers or those with certain medical conditions. Although generally safe, some vaccines contain live, attenuated organisms that can cause disease in immunocompromised patients. Thus, knowledge of the indications for and contraindications to specific vaccinations is critical to protect adults in special circumstances who are at risk.

See related commentary

Vaccines have helped eliminate or significantly reduce the burden of more than a dozen illnesses.^1–3 The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention  (CDC) makes recommendations about vaccinations for normal adults and children as well as for certain groups at high risk of vaccine-preventable infections.⁴ Tables 1 and 2 summarize the recommendations for vaccination by medical condition.⁴  In addition, several applications are available online, including downloadable apps from the (www.cdc.gov/vaccines/schedules/Schedulers/adult-scheduler.html) and the American College of Physicians (http://immunization.acponline.org/app/).

HUMANITY’S GREATEST ADVANCES IN PREVENTING INFECTIOUS DISEASE

Immunization and improved sanitation are humanity’s greatest advances in preventing sickness and death from infectious diseases. Since Jenner’s discovery in 1796 that milkmaids who had contracted cowpox (vaccinia) were immune to smallpox, vaccination has eliminated smallpox, markedly decreased the incidence of many infectious diseases, and, most recently, shown efficacy in preventing cervical cancer (with the human papillomavirus vaccine) and hepatocellular cancer (with the hepatitis B vaccine).^1–3

Unfortunately, vaccination rates remain low for most routine vaccinations indicated for adults. For example, about 60% of adults over age 65 receive pneumococcal vaccination, and fewer than 10% of black patients over age 60 receive zoster vaccination.⁵ Various factors may account for these low rates, including financial disincentives.⁶

Nevertheless, vaccination remains one of medicine’s most effective defenses against infectious diseases and is especially important in the special populations discussed below. By being steadfast proponents of vaccination, especially for the most vulnerable patients, physicians can help ensure the optimum protection for their patients.

VACCINATING PREGNANT PATIENTS

When considering vaccination during pregnancy, one must consider the risk and benefit of the vaccine and the risk of the disease in both the mother and the child.

In general, if a pregnant woman is at high risk of exposure to a particular infection, the benefits of vaccinating her against it outweigh the risks. Vaccinating the mother can also protect against certain infections in early infancy through transfer of vaccine-induced immunoglobin G (IgG) across the placenta.⁷ In general, inactivated vaccines are considered safe in pregnancy, while live-attenuated vaccines are contraindicated.⁴ Special considerations for pregnant women include:

Tetanus, diphtheria, and acellular pertussis (Tdap). One dose of Tdap vaccine should be given during each pregnancy, preferably at 27 to 36 weeks of gestation, regardless of when the patient received a previous dose.⁸

Inactivated influenza vaccine should be given as early as possible during the influenza season (October to March) to all pregnant women, regardless of trimester.

Inactivated polio vaccine may be considered for pregnant women with known exposure to polio or travel to endemic areas.

Hepatitis A, hepatitis B, pneumococcal polysaccharide, meningococcal conjugate, and meningococcal polysaccharide vaccines can be given to women at risk of these infections. If a pregnant patient requires pneumococcal polysaccharide vaccine, it should be given during the second or third trimester, as the safety of this vaccine during the first trimester has not been established.⁹

Smallpox, measles-mumps-rubella, and varicella-containing vaccines are contraindicated in pregnancy. Household contacts of a pregnant woman should not receive smallpox vaccine, as it is the only vaccine known to cause harm to the fetus.¹⁰

Human papillomavirus vaccination is not recommended during pregnancy.

Yellow fever live-attenuated vaccine. The safety of this vaccine during pregnancy has not been established, and it is in the US Food and Drug Administration (FDA) pregnancy category C. However, this vaccine is required for entry into certain countries, and it may be offered if the patient is truly at risk of contracting yellow fever. Because pregnancy may affect immunologic response, serologic testing is recommended to document an immune response. If the patient’s itinerary puts her at low risk of yellow fever, then writing her a vaccine waiver letter can be considered.¹¹

VACCINATING IMMUNOCOMPROMISED PATIENTS (NON-HIV)

People who do not have human immunodeficiency virus (HIV) but have a condition such as functional asplenia (sickle cell disease), anatomic asplenia, or complement component deficiency are at higher risk of infection with the encapsulated bacteria Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.

Corticosteroids, chemotherapy, radiation for hematologic or solid-organ malignancies, and immune modulators can alter the immune system and pose a risk with the use of live-attenuated vaccines. A corticosteroid dosage equivalent to 2 mg/kg of body weight per day or higher or 20 mg/day of prednisone or higher is generally considered immunosuppressive.

Candidates for organ transplantation should receive vaccinations as early as possible during the disease course leading to transplantation. Vaccinations should be given as soon as the decision is made that the patient is a candidate for transplantation, which could be years or months before the patient actually receives the transplant. In addition to reviewing previously administered vaccinations, pretransplant serologic testing for hepatitis B, varicella, measles, mumps, and rubella antibodies helps to evaluate the need for vaccination.¹²

Recipients of hematopoietic stem cell transplantation are at risk of infections with encapsulated bacteria and certain other vaccine-preventable infections. Antibody titers are significantly reduced after stem cell transplantation because of ablation of bone marrow, and thus certain vaccines should be readministered 3 to 6 months after transplantation (eg, influenza, pneumococcal, and H influenzae vaccines). If the recipient is presumed to be immunocompetent, then varicella or measles-mumps-rubella vaccine can be given 24 months after transplantation.¹³

Apart from adhering to the routine vaccination schedule and avoiding live-attenuated vaccines, specific recommendations apply to persons with immunocompromising conditions¹⁴:

Quadrivalent meningococcal conjugate vaccine should be given to adults of all ages with asplenia or complement component deficiency. The schedule includes two doses at least 2 months apart initially and then revaccination every 5 years.

H influenzae type b vaccine should be given to people with asplenia and recipients of hematopoietic stem cells. One dose is recommended for those with asplenia (functional, anatomic, or elective splenectomy) or sickle cell disease if they have not already received it. A three-dose schedule is considered for hematopoietic stem cell transplant recipients 6 to 12 months after successful transplantation.

Pneumococcal conjugate (PCV13) and pneumococcal polysaccharide (PPSV23) vaccinations are recommended for people who have immunocompromising conditions. PCV13, the newer pneumococcal vaccine, was approved by the FDA in 2010 for use in children and was recommended by the ACIP in 2012 for adults age 19 and older with immunocompromising conditions.

People who have not previously received either of these vaccines and are age 19 or older with immunocompromising conditions including asplenia, chronic renal failure, nephrotic syndrome, cerebrospinal fluid leakage, or cochlear implant should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later. One-time revaccination 5 years after the first dose of PPSV23 is recommended for patients with immunocompromising conditions.

For those who have previously been vaccinated with PPSV23, a dose of PCV13 can be given 1 or more years after the last dose of PPSV23. These dosing intervals are important, as lower opsonophagocytic antibody responses have been noted if repeat doses of either pneumococcal vaccine are given sooner than the recommended interval.¹⁵

Inactivated influenza vaccine is recommended annually, except for patients who are unlikely to respond or those who have received anti-B-cell antibodies within 6 months. Live-attenuated influenza vaccine should not be given to immunocompromised patients.

VACCINATING PATIENTS WHO HAVE HIV

People with HIV should be routinely screened for immunity against certain infections and should be offered vaccination if not immune. The response to vaccines may vary depending on the CD4 count, with a good response in patients whose infection is well controlled with antiretroviral agents and with a preserved CD4 count.¹⁶ Special considerations for HIV patients include the following:

Hepatitis A vaccine may be offered to all HIV patients who have no evidence of immunity against hepatitis A, with negative antihepatitis A total and IgG antibodies.

Human papillomavirus vaccine is recommended for men and women with HIV through age 26.

Varicella and measles-mumps-rubella are live-attenuated vaccines and may be considered in patients who are nonimmune and with CD4 counts of 200 cells/µL or higher. However, the ACIP does not make a recommendation regarding the zoster vaccine in HIV patients with CD4 cell counts of 200 cells/µL or higher. In general, live-attenuated vaccines should be avoided in patients with CD4 counts less than 200 or with severe immunocompromised status because of risk of acquiring severe, life-threatening infections.

Pneumococcal vaccine should be given to HIV patients if they have not received it before. The schedule is one dose of PCV13, followed by a dose of PPSV23 at least 8 weeks later. If a patient has been previously vaccinated with PPSV23, then PCV13 is recommended at least 1 year after PPSV23.

Inactivated influenza vaccine is recommended annually. Live-attenuated influenza vaccine should not be given.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. These patients require higher doses of hepatitis B vaccine (40 μg/mL) than immunocompetent patients, who receive 20 μg/mL. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Meningococcal vaccine. HIV infection is not an indication for meningococcal vaccine unless the patient has other risk factors, such as anatomic or functional asplenia, persistent complement component deficiency, occupational exposure, and travel to endemic areas.

VACCINATING PATIENTS WHO ARE OLDER THAN 60

The immune system deteriorates with age, as does immunity gained from previous vaccinations. Vaccination in this age group reduces the risk of illness and death.¹⁷

Zoster vaccine should be offered to people age 60 and older regardless of previous episodes of herpes zoster unless there is a contraindication such as severe immunodeficiency. The zoster vaccine can reduce the incidence of postherpetic neuralgia by 66.5% and herpes zoster by 51% in patients over age 60.¹⁸

Pneumococcal conjugate vaccine. PCV13 should be offered to all adults age 65 or older. If a person age 65 or older has not received any pneumococcal vaccine before then, PCV13 should be given first, followed by a dose of PPSV23 at least 6 to 12 months after PCV13.

Pneumococcal polysaccharide vaccine. If PPSV23 was given before age 65 for another indication, a dose of PCV 13 should be given at age 65 or later, as long as 6 to 12 months have passed since the previous dose of PPSV 23. The patient should receive the last dose of PPSV23 vaccine 5 years after the first dose of PPSV23.⁴

Influenza vaccine. People 65 or older are at higher risk of complications from influenza, and vaccine should be offered annually. High-dose inactivated influenza vaccine can be used in this age group.⁴

Tdap. If never given before, Tdap is recommended regardless of the interval since the most recent Td vaccination, followed by a Td booster every 10 years.

VACCINATING PATIENTS WHO HAVE CHRONIC KIDNEY DISEASE

Patients with chronic kidney disease are at risk of certain infections, so vaccination is an important preventive measure.¹⁹ Immunizations should be offered to all patients with chronic kidney disease regardless of the disease stage, but they are recommended during the early stages of progressive renal disease to increase the likelihood of vaccine-induced immunity.²⁰

Pneumococcal conjugate vaccine. PCV13 is recommended for adults 19 or older with chronic renal disease or nephrotic syndrome. One dose of PCV13 should be given, followed by a dose of PPSV23 at least 8 weeks later. If the patient has been previously vaccinated with PPSV23, then PCV13 at least 1 year after PPSV23 is recommended.

Hepatitis B vaccine should be given to nonimmune patients without past or present hepatitis B infection. Adult patients on hemodialysis require higher doses of hepatitis B vaccine. The options include Recombivax HB 40 μg/mL given on a three-dose schedule at 0, 1, and 6 months, and Engerix B, two 20-μg/mL injections given simultaneously on a four-dose schedule at 0, 1, 2, and 6 months.

Influenza vaccine should be offered annually to patients with chronic kidney disease.

VACCINATING IMMUNOCOMPROMISED INTERNATIONAL TRAVELERS

International travel for business or pleasure is increasingly common, and immunocompromised patients require specific attention as they may face unanticipated pathogens or have special requirements. Transplant recipients should ideally receive routine and travel-related vaccines as early as possible before transplantation. Vaccination is generally avoided in the first 6 months after organ transplantation to avoid confusion with early graft dysfunction or rejection.²¹ However, it should be considered as soon as a patient develops an illness that might lead to transplantation.

Evaluation of patients for vaccination should include an assessment of the travel-specific epidemiologic risk, the nature of the vaccine (live-attenuated or other), and the immune status. As discussed above, live-attenuated vaccines should be avoided in immunocompromised patients, and thus the injectable typhoid vaccine should be given in lieu of the attenuated oral vaccine.

Yellow fever vaccine is required before entrance to certain countries but should not be given to immunocompromised patients, although it can probably be given to asymptomatic HIV-infected adults with a CD4 count higher than 200 cells/μL who are exposed to substantial risk.²² For patients who cannot receive the vaccine, some governments will accept a physician’s letter stating the patient has a contraindication to vaccination.

VACCINATING HOUSEHOLD MEMBERS OF IMMUNOCOMPROMISED PATIENTS

Protecting immunocompromised patients from infectious diseases involves vaccinating not only the patient but also household members so that they do not acquire infections and then bring them into the household. Immunocompetent members of a household can receive inactivated vaccines based on the recommended ACIP schedule.

Annual inactivated influenza vaccination is recommended, although the live-attenuated influenza virus vaccine can be substituted if the immunocompromised patient is not within 2 months of hematopoietic stem cell transplantation, does not have graft-vs-host disease, and does not have severe combined immune deficiency.

Other live-attenuated vaccines can usually be given if indicated, including measles-mumps-rubella vaccine, rotavirus vaccine in infants, varicella vaccine, and zoster vaccine.¹⁴

In the April 2015 issue, on page 214 in the article by Jin XW, McKenzie ML, Yen-Lieberman B, “Can the test for human papillomavirus DNA be used as a stand-alone, first-line screening test for cervical cancer?”, the source for the information on predictive values was not cited. The final bulleted item should have read as follows:

• HPV testing by itself performed better than Pap-HPV cotesting, with positive predictive values of 12.25% vs 11.04% and negative predictive values of 99.58% vs 99.52% (data presented to the FDA Medical Devices Advisory Committee, Microbiology Panel. March 12, 2014. FDA Executive Summary).

This oversight has been corrected in the online version of the article.

In the April 2015 issue, on page 214 in the article by Jin XW, McKenzie ML, Yen-Lieberman B, “Can the test for human papillomavirus DNA be used as a stand-alone, first-line screening test for cervical cancer?”, the source for the information on predictive values was not cited. The final bulleted item should have read as follows:

• HPV testing by itself performed better than Pap-HPV cotesting, with positive predictive values of 12.25% vs 11.04% and negative predictive values of 99.58% vs 99.52% (data presented to the FDA Medical Devices Advisory Committee, Microbiology Panel. March 12, 2014. FDA Executive Summary).

This oversight has been corrected in the online version of the article.

In the April 2015 issue, on page 214 in the article by Jin XW, McKenzie ML, Yen-Lieberman B, “Can the test for human papillomavirus DNA be used as a stand-alone, first-line screening test for cervical cancer?”, the source for the information on predictive values was not cited. The final bulleted item should have read as follows:

• HPV testing by itself performed better than Pap-HPV cotesting, with positive predictive values of 12.25% vs 11.04% and negative predictive values of 99.58% vs 99.52% (data presented to the FDA Medical Devices Advisory Committee, Microbiology Panel. March 12, 2014. FDA Executive Summary).

This oversight has been corrected in the online version of the article.

The Dartmouth Institute for Health Policy and Clinical Practice and other institutions have long tried to quantify the prevalence and geographic variation of low-value care. Researchers have roughly defined low-value care as tests and procedures for which the potential benefit does not outweigh the potential harm, though the calculus can change significantly from patient to patient.

William Schpero, a former health policy fellow at the Dartmouth Institute and now a PhD student in health policy and management at Yale University, says he and colleagues initially identified three theoretical reasons for the geographical variation. An increase in the use of low-value care, they reasoned, might be driven by patients demanding more intensive treatments, by financial incentives to providers, or by providers supplying more services.

After adjusting for differences in the health status of patient populations, however, the Dartmouth Institute’s work consistently revealed large unexplained geographical variations, a finding that also held true for patients in the last six months of life. These variations, Schpero says, suggest that patient demand is not a major driver. A collaborative Dartmouth and Harvard study, released by the National Bureau of Economic Research in 2013, instead pointed to a more likely rationale, at least during the last two years of a patient’s life.

By linking patient and physician surveys to Medicare claims data, the report examined how physician and patient preferences affected overall healthcare spending in different geographic regions. The paper identified “cowboys,” or physicians who used treatments that were more intensive than those recommended by guidelines, and “comforters,” or physicians who recommended more low-cost treatment protocols.

Older physicians and smaller practices, the study suggested, were more likely to recommend higher levels of follow-up care and fall into the “cowboys” category.

It was this difference in physician culture and beliefs about effective treatment, not patient preferences, that drove most of the variation in healthcare spending. Monetary incentives, meanwhile, had only a marginal effect. If all physicians were to follow professional guidelines for effective care and not exceed recommended treatments, the report suggested, Medicare spending for end-of-life care could be reduced by 36 percent, “which is a huge, huge number,” Schpero says.

The Dartmouth Institute for Health Policy and Clinical Practice and other institutions have long tried to quantify the prevalence and geographic variation of low-value care. Researchers have roughly defined low-value care as tests and procedures for which the potential benefit does not outweigh the potential harm, though the calculus can change significantly from patient to patient.

William Schpero, a former health policy fellow at the Dartmouth Institute and now a PhD student in health policy and management at Yale University, says he and colleagues initially identified three theoretical reasons for the geographical variation. An increase in the use of low-value care, they reasoned, might be driven by patients demanding more intensive treatments, by financial incentives to providers, or by providers supplying more services.

After adjusting for differences in the health status of patient populations, however, the Dartmouth Institute’s work consistently revealed large unexplained geographical variations, a finding that also held true for patients in the last six months of life. These variations, Schpero says, suggest that patient demand is not a major driver. A collaborative Dartmouth and Harvard study, released by the National Bureau of Economic Research in 2013, instead pointed to a more likely rationale, at least during the last two years of a patient’s life.

By linking patient and physician surveys to Medicare claims data, the report examined how physician and patient preferences affected overall healthcare spending in different geographic regions. The paper identified “cowboys,” or physicians who used treatments that were more intensive than those recommended by guidelines, and “comforters,” or physicians who recommended more low-cost treatment protocols.

Older physicians and smaller practices, the study suggested, were more likely to recommend higher levels of follow-up care and fall into the “cowboys” category.

It was this difference in physician culture and beliefs about effective treatment, not patient preferences, that drove most of the variation in healthcare spending. Monetary incentives, meanwhile, had only a marginal effect. If all physicians were to follow professional guidelines for effective care and not exceed recommended treatments, the report suggested, Medicare spending for end-of-life care could be reduced by 36 percent, “which is a huge, huge number,” Schpero says.

The Dartmouth Institute for Health Policy and Clinical Practice and other institutions have long tried to quantify the prevalence and geographic variation of low-value care. Researchers have roughly defined low-value care as tests and procedures for which the potential benefit does not outweigh the potential harm, though the calculus can change significantly from patient to patient.

William Schpero, a former health policy fellow at the Dartmouth Institute and now a PhD student in health policy and management at Yale University, says he and colleagues initially identified three theoretical reasons for the geographical variation. An increase in the use of low-value care, they reasoned, might be driven by patients demanding more intensive treatments, by financial incentives to providers, or by providers supplying more services.

After adjusting for differences in the health status of patient populations, however, the Dartmouth Institute’s work consistently revealed large unexplained geographical variations, a finding that also held true for patients in the last six months of life. These variations, Schpero says, suggest that patient demand is not a major driver. A collaborative Dartmouth and Harvard study, released by the National Bureau of Economic Research in 2013, instead pointed to a more likely rationale, at least during the last two years of a patient’s life.

By linking patient and physician surveys to Medicare claims data, the report examined how physician and patient preferences affected overall healthcare spending in different geographic regions. The paper identified “cowboys,” or physicians who used treatments that were more intensive than those recommended by guidelines, and “comforters,” or physicians who recommended more low-cost treatment protocols.

Older physicians and smaller practices, the study suggested, were more likely to recommend higher levels of follow-up care and fall into the “cowboys” category.

It was this difference in physician culture and beliefs about effective treatment, not patient preferences, that drove most of the variation in healthcare spending. Monetary incentives, meanwhile, had only a marginal effect. If all physicians were to follow professional guidelines for effective care and not exceed recommended treatments, the report suggested, Medicare spending for end-of-life care could be reduced by 36 percent, “which is a huge, huge number,” Schpero says.

Sometimes, simply knowing what a test costs can make all the difference.

Many physicians have sheepishly admitted that they know little about the price tags attached to the procedures and tests they order on a routine basis—or how that might impact their patients financially. In Medscape’s Physician Compensation Report for 2012, only 38% of surveyed doctors said they regularly discussed the cost of treatment with their patients. The following year, the rate had dropped to 30%.

One medical resident, Neel Shah, MD, MPP discovered how important those discussions can be.

After a woman admitted to the ED tested positive on a pregnancy test, a follow-up hormone test warned of potential trouble with her pregnancy, and Dr. Shah asked her to return to the hospital for an ultrasound.

“She refused to come in until I could tell her how much the ultrasound would cost,” he recalls. Other providers had told him that bringing up costs with patients would decrease their trust, because they didn’t want doctors to focus on anything but providing care. “With her, it was very clear that my inability to tell her what things cost actually eroded her trust in me and, in her mind, she was being reasonable,” he says.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends.”

–Neel Shah, MD, MPP

Dr. Shah had already grown disillusioned in medical school, watching providers around him make clinical decisions without regard to the cost for patients, and he took a hiatus to study politics at Harvard’s Kennedy School of Government. When he and a collaborator subsequently launched the nonprofit organization Costs of Care to point out the downsides of that lack of transparency, however, they received a less-than-enthusiastic reception from some quarters.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends,” says

Dr. Shah, who is now an assistant professor at Harvard Medical School in Boston.

The group gained traction as its cost-awareness manifesto began to resonate with the public, however, and the essays on its site have been picked up by multiple media groups. Dr. Shah’s own experience with his pregnant patient, however, made one of the strongest impressions on him.

Getting an answer to her about the cost of an ultrasound took nearly 24 hours, he recalls, “because nobody around me knew.” In the interim, he fretted that his patient might have an ectopic pregnancy and bleed to death. She didn’t, but the outcome could have been very different, he says.

“That really struck home for me, for sure,” he adds. “I think about that all the time.”

Sometimes, simply knowing what a test costs can make all the difference.

Many physicians have sheepishly admitted that they know little about the price tags attached to the procedures and tests they order on a routine basis—or how that might impact their patients financially. In Medscape’s Physician Compensation Report for 2012, only 38% of surveyed doctors said they regularly discussed the cost of treatment with their patients. The following year, the rate had dropped to 30%.

One medical resident, Neel Shah, MD, MPP discovered how important those discussions can be.

After a woman admitted to the ED tested positive on a pregnancy test, a follow-up hormone test warned of potential trouble with her pregnancy, and Dr. Shah asked her to return to the hospital for an ultrasound.

“She refused to come in until I could tell her how much the ultrasound would cost,” he recalls. Other providers had told him that bringing up costs with patients would decrease their trust, because they didn’t want doctors to focus on anything but providing care. “With her, it was very clear that my inability to tell her what things cost actually eroded her trust in me and, in her mind, she was being reasonable,” he says.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends.”

–Neel Shah, MD, MPP

Dr. Shah had already grown disillusioned in medical school, watching providers around him make clinical decisions without regard to the cost for patients, and he took a hiatus to study politics at Harvard’s Kennedy School of Government. When he and a collaborator subsequently launched the nonprofit organization Costs of Care to point out the downsides of that lack of transparency, however, they received a less-than-enthusiastic reception from some quarters.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends,” says

Dr. Shah, who is now an assistant professor at Harvard Medical School in Boston.

The group gained traction as its cost-awareness manifesto began to resonate with the public, however, and the essays on its site have been picked up by multiple media groups. Dr. Shah’s own experience with his pregnant patient, however, made one of the strongest impressions on him.

Getting an answer to her about the cost of an ultrasound took nearly 24 hours, he recalls, “because nobody around me knew.” In the interim, he fretted that his patient might have an ectopic pregnancy and bleed to death. She didn’t, but the outcome could have been very different, he says.

“That really struck home for me, for sure,” he adds. “I think about that all the time.”

Sometimes, simply knowing what a test costs can make all the difference.

Many physicians have sheepishly admitted that they know little about the price tags attached to the procedures and tests they order on a routine basis—or how that might impact their patients financially. In Medscape’s Physician Compensation Report for 2012, only 38% of surveyed doctors said they regularly discussed the cost of treatment with their patients. The following year, the rate had dropped to 30%.

One medical resident, Neel Shah, MD, MPP discovered how important those discussions can be.

After a woman admitted to the ED tested positive on a pregnancy test, a follow-up hormone test warned of potential trouble with her pregnancy, and Dr. Shah asked her to return to the hospital for an ultrasound.

“She refused to come in until I could tell her how much the ultrasound would cost,” he recalls. Other providers had told him that bringing up costs with patients would decrease their trust, because they didn’t want doctors to focus on anything but providing care. “With her, it was very clear that my inability to tell her what things cost actually eroded her trust in me and, in her mind, she was being reasonable,” he says.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends.”

–Neel Shah, MD, MPP

Dr. Shah had already grown disillusioned in medical school, watching providers around him make clinical decisions without regard to the cost for patients, and he took a hiatus to study politics at Harvard’s Kennedy School of Government. When he and a collaborator subsequently launched the nonprofit organization Costs of Care to point out the downsides of that lack of transparency, however, they received a less-than-enthusiastic reception from some quarters.

“If you’re trying to tell doctors or clinicians in general that we ought to be doing things differently, as a young person, it’s not a great way to make friends,” says

Dr. Shah, who is now an assistant professor at Harvard Medical School in Boston.

The group gained traction as its cost-awareness manifesto began to resonate with the public, however, and the essays on its site have been picked up by multiple media groups. Dr. Shah’s own experience with his pregnant patient, however, made one of the strongest impressions on him.

Getting an answer to her about the cost of an ultrasound took nearly 24 hours, he recalls, “because nobody around me knew.” In the interim, he fretted that his patient might have an ectopic pregnancy and bleed to death. She didn’t, but the outcome could have been very different, he says.

“That really struck home for me, for sure,” he adds. “I think about that all the time.”

Reform advocates agree that a doctor’s time is a scarce resource that can contribute to waste when it is stretched too thin.

“It’s not just about overtreatment; it’s about getting the right treatment, and the right treatment depends on the right diagnosis, and the right diagnosis depends on really taking the time to think carefully with the patient about what’s going on,” says Vineet Arora, MD, MAPP, FHM, a hospitalist and researcher at the University of Chicago. A doctor “pulled in 10 different ways in the hospital” simply may not have the bandwidth to devote sufficient time to a complex patient; ordering a test can then seem like an enticing way to save some time.

Although electronic health records may have simplified the process for ordering CT scans and other tests, Dr. Arora says, they sometimes supersede important conversations that should take place with radiologists or other specialists about whether those tests are truly necessary. Meanwhile, providers face a proliferation of reporting duties. Recent surveys, in fact, suggest that doctors are “drowning” in paperwork and computer-based reporting requirements. Placing additional demands on a doctor’s time, Dr. Arora says, can limit his or her availability for other duties.

With hospitalists caring for increasingly complex patients with more complicated therapeutics, UCSF’s Christopher Moriates, MD, agrees that insufficient time can be an important barrier to change. It is not, however, insurmountable. If the ethos of medicine is “First, do no harm,” he says, it’s critical for doctors to remember that waste is harm.

“If we’re really going to stand by that,” he says, “then it rises to be something that we really need to take on.”

Reform advocates agree that a doctor’s time is a scarce resource that can contribute to waste when it is stretched too thin.

“It’s not just about overtreatment; it’s about getting the right treatment, and the right treatment depends on the right diagnosis, and the right diagnosis depends on really taking the time to think carefully with the patient about what’s going on,” says Vineet Arora, MD, MAPP, FHM, a hospitalist and researcher at the University of Chicago. A doctor “pulled in 10 different ways in the hospital” simply may not have the bandwidth to devote sufficient time to a complex patient; ordering a test can then seem like an enticing way to save some time.

Although electronic health records may have simplified the process for ordering CT scans and other tests, Dr. Arora says, they sometimes supersede important conversations that should take place with radiologists or other specialists about whether those tests are truly necessary. Meanwhile, providers face a proliferation of reporting duties. Recent surveys, in fact, suggest that doctors are “drowning” in paperwork and computer-based reporting requirements. Placing additional demands on a doctor’s time, Dr. Arora says, can limit his or her availability for other duties.

With hospitalists caring for increasingly complex patients with more complicated therapeutics, UCSF’s Christopher Moriates, MD, agrees that insufficient time can be an important barrier to change. It is not, however, insurmountable. If the ethos of medicine is “First, do no harm,” he says, it’s critical for doctors to remember that waste is harm.

“If we’re really going to stand by that,” he says, “then it rises to be something that we really need to take on.”

Reform advocates agree that a doctor’s time is a scarce resource that can contribute to waste when it is stretched too thin.

“It’s not just about overtreatment; it’s about getting the right treatment, and the right treatment depends on the right diagnosis, and the right diagnosis depends on really taking the time to think carefully with the patient about what’s going on,” says Vineet Arora, MD, MAPP, FHM, a hospitalist and researcher at the University of Chicago. A doctor “pulled in 10 different ways in the hospital” simply may not have the bandwidth to devote sufficient time to a complex patient; ordering a test can then seem like an enticing way to save some time.

Although electronic health records may have simplified the process for ordering CT scans and other tests, Dr. Arora says, they sometimes supersede important conversations that should take place with radiologists or other specialists about whether those tests are truly necessary. Meanwhile, providers face a proliferation of reporting duties. Recent surveys, in fact, suggest that doctors are “drowning” in paperwork and computer-based reporting requirements. Placing additional demands on a doctor’s time, Dr. Arora says, can limit his or her availability for other duties.

With hospitalists caring for increasingly complex patients with more complicated therapeutics, UCSF’s Christopher Moriates, MD, agrees that insufficient time can be an important barrier to change. It is not, however, insurmountable. If the ethos of medicine is “First, do no harm,” he says, it’s critical for doctors to remember that waste is harm.

“If we’re really going to stand by that,” he says, “then it rises to be something that we really need to take on.”

In April 2013, The Joint Commission issued a Sentinel Event Alert that provided hospitals with recommendations for assessing their individual circumstances and developing a systematic, coordinated approach regarding medical device alarms.

The recommendations correspond with those of the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute. Most of the information and guidance provided in these alerts is drawn from The Joint Commission’s Sentinel Event Database, a voluntary reporting system for serious adverse events in healthcare.

The recommendations include the following:

1. Create a process for safe alarm management and response in high-risk areas;
2. Inventory alarm-equipped medical devices used for high-risk areas and conditions, and identify default alarm settings;
3. Have guidelines for tailoring alarm settings and limits for individual patients; and
4. Inspect, check, and maintain alarm-equipped devices.

The Joint Commission alert also recommended training and education for all clinical care team members on safe alarm management and response in high-risk areas. Organizations should also consider ways to reduce nuisance alarm signals.

“Patient harm and death that is caused by factors related to alarm management has persisted as the top patient safety issue,” says Ronald Wyatt, MD, MHA, medical director of the division of healthcare improvement at The Joint Commission in Oakbrook Terrace, Ill.

In addition to the alert and existing accreditation standards regarding alarm safety, The Joint Commission issued 2014 National Patient Safety Goals to help healthcare organizations address this issue.

Beginning in January 2014, hospitals were required to identify the most important alarms to manage based on their own internal situations. In phase 2, beginning in January 2016, hospitals will be expected to develop and implement specific components of alarm policies and procedures that address such items as clinically appropriate settings, when settings can be changed, and who is allowed to make such changes. Requirements only apply to organizations accredited by The Joint Commission.

In April 2013, The Joint Commission issued a Sentinel Event Alert that provided hospitals with recommendations for assessing their individual circumstances and developing a systematic, coordinated approach regarding medical device alarms.

The recommendations correspond with those of the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute. Most of the information and guidance provided in these alerts is drawn from The Joint Commission’s Sentinel Event Database, a voluntary reporting system for serious adverse events in healthcare.

The recommendations include the following:

1. Create a process for safe alarm management and response in high-risk areas;
2. Inventory alarm-equipped medical devices used for high-risk areas and conditions, and identify default alarm settings;
3. Have guidelines for tailoring alarm settings and limits for individual patients; and
4. Inspect, check, and maintain alarm-equipped devices.

The Joint Commission alert also recommended training and education for all clinical care team members on safe alarm management and response in high-risk areas. Organizations should also consider ways to reduce nuisance alarm signals.

“Patient harm and death that is caused by factors related to alarm management has persisted as the top patient safety issue,” says Ronald Wyatt, MD, MHA, medical director of the division of healthcare improvement at The Joint Commission in Oakbrook Terrace, Ill.

In addition to the alert and existing accreditation standards regarding alarm safety, The Joint Commission issued 2014 National Patient Safety Goals to help healthcare organizations address this issue.

Beginning in January 2014, hospitals were required to identify the most important alarms to manage based on their own internal situations. In phase 2, beginning in January 2016, hospitals will be expected to develop and implement specific components of alarm policies and procedures that address such items as clinically appropriate settings, when settings can be changed, and who is allowed to make such changes. Requirements only apply to organizations accredited by The Joint Commission.

In April 2013, The Joint Commission issued a Sentinel Event Alert that provided hospitals with recommendations for assessing their individual circumstances and developing a systematic, coordinated approach regarding medical device alarms.

The recommendations correspond with those of the Association for the Advancement of Medical Instrumentation (AAMI) and ECRI Institute. Most of the information and guidance provided in these alerts is drawn from The Joint Commission’s Sentinel Event Database, a voluntary reporting system for serious adverse events in healthcare.

The recommendations include the following:

1. Create a process for safe alarm management and response in high-risk areas;
2. Inventory alarm-equipped medical devices used for high-risk areas and conditions, and identify default alarm settings;
3. Have guidelines for tailoring alarm settings and limits for individual patients; and
4. Inspect, check, and maintain alarm-equipped devices.

The Joint Commission alert also recommended training and education for all clinical care team members on safe alarm management and response in high-risk areas. Organizations should also consider ways to reduce nuisance alarm signals.

“Patient harm and death that is caused by factors related to alarm management has persisted as the top patient safety issue,” says Ronald Wyatt, MD, MHA, medical director of the division of healthcare improvement at The Joint Commission in Oakbrook Terrace, Ill.

In addition to the alert and existing accreditation standards regarding alarm safety, The Joint Commission issued 2014 National Patient Safety Goals to help healthcare organizations address this issue.

Beginning in January 2014, hospitals were required to identify the most important alarms to manage based on their own internal situations. In phase 2, beginning in January 2016, hospitals will be expected to develop and implement specific components of alarm policies and procedures that address such items as clinically appropriate settings, when settings can be changed, and who is allowed to make such changes. Requirements only apply to organizations accredited by The Joint Commission.

As you may have heard, H.R. 876, a bill unanimously passed in the House recently, requires a hospital to give adequate oral and written notification of a patient’s observation status. The bill has now moved to the Senate.

“Notice of Observation Treatment and Implication for Care Eligibility Act,” known as the NOTICE Act, was sponsored by Rep. Lloyd Doggett (D-Texas) and co-sponsored by Rep. Earl Blumenauer (D-Ore.), Rep. Charles Rangel (D-N.Y.), and Rep. Todd Young (R-Ind.), all known to be admirable patient care advocates.

The bill proposes requiring that any patient who has been classified as observation status for more than 24 hours be given oral and written notice within 36 hours of that classification. That notice must include the reason for and implications of that status, including lack of coverage for services and cost sharing under Medicare Part B, as well as the name and title of the hospital staff who gave the oral notification. Written notification must be signed by the patient or, if the patient refuses, by the staff who presented it.

Although it is essential that patients are aware of observation status and its implications, this bill would not solve the underlying problem and would only create divisions between patients and the staff caring for them. Two issues stand out:

1. Observation status is not currently a medical determination; and
2. Hospitalized medical patients should not be considered outpatients.

When a patient is admitted to the hospital, acute inpatient versus observation status is often assigned by a non-clinician in the form of a “verbal” order before the attending hospitalist meets or even hears of the patient. This order must be signed promptly by that hospitalist to prevent penalization for lack of medical record compliance. Increasingly, more of these orders are for observation status, as hospitals fear bounty-hunting recovery audit contractors (RACs) in pursuit of “Medicare fraud.”

Under H.R. 876, the situation is further intensified for both clinicians and patients. Picture yourself in the middle of a busy day at your hospital, admitting and discharging patients, stabilizing critically ill patients, and discussing goals of care with patients given life-altering diagnoses. Your pager goes off.

“Mrs. H. on 6th Floor East wants to talk to you right away,” the conversation starts. Mrs. H is in tears, and her family is angry. “We were just told that Grandma is observation status, not admitted to the hospital! This makes no sense!”

Forty-five minutes later, you have agreed, commiserated, and let them know you have absolutely no control over the designation. To you, Mrs. H. is medically ill enough to require hospitalization, and she and her family agree, but Medicare regulations and fear of RAC audits keep her on observation status. What have you accomplished during that time?

H.R. 876 is not the problem, and it is clearly well intentioned. I regularly inform patients when I’m aware of their observation status, because it’s a lousy situation for the patient. We should all be doing as much.

But H.R. 876 is not the solution, either, because it does not address the core problems with observation policy. Now is the time for us all to step forward, voicing our support of SHM as it works to change observation status as we now know it. It is not an easy task. The ultimate goal is to be able to consider all hospitalized medical patients what they really are: inpatients.

Dr. Johnson is clinical associate professor in the department of internal medicine at the University of Iowa Carver College of Medicine. She is a member of the SHM Public Policy Committee and was one of the authors of the SHM PPC white paper on observation status released in July 2014.

As you may have heard, H.R. 876, a bill unanimously passed in the House recently, requires a hospital to give adequate oral and written notification of a patient’s observation status. The bill has now moved to the Senate.

“Notice of Observation Treatment and Implication for Care Eligibility Act,” known as the NOTICE Act, was sponsored by Rep. Lloyd Doggett (D-Texas) and co-sponsored by Rep. Earl Blumenauer (D-Ore.), Rep. Charles Rangel (D-N.Y.), and Rep. Todd Young (R-Ind.), all known to be admirable patient care advocates.

The bill proposes requiring that any patient who has been classified as observation status for more than 24 hours be given oral and written notice within 36 hours of that classification. That notice must include the reason for and implications of that status, including lack of coverage for services and cost sharing under Medicare Part B, as well as the name and title of the hospital staff who gave the oral notification. Written notification must be signed by the patient or, if the patient refuses, by the staff who presented it.

Although it is essential that patients are aware of observation status and its implications, this bill would not solve the underlying problem and would only create divisions between patients and the staff caring for them. Two issues stand out:

1. Observation status is not currently a medical determination; and
2. Hospitalized medical patients should not be considered outpatients.

When a patient is admitted to the hospital, acute inpatient versus observation status is often assigned by a non-clinician in the form of a “verbal” order before the attending hospitalist meets or even hears of the patient. This order must be signed promptly by that hospitalist to prevent penalization for lack of medical record compliance. Increasingly, more of these orders are for observation status, as hospitals fear bounty-hunting recovery audit contractors (RACs) in pursuit of “Medicare fraud.”

Under H.R. 876, the situation is further intensified for both clinicians and patients. Picture yourself in the middle of a busy day at your hospital, admitting and discharging patients, stabilizing critically ill patients, and discussing goals of care with patients given life-altering diagnoses. Your pager goes off.

“Mrs. H. on 6th Floor East wants to talk to you right away,” the conversation starts. Mrs. H is in tears, and her family is angry. “We were just told that Grandma is observation status, not admitted to the hospital! This makes no sense!”

Forty-five minutes later, you have agreed, commiserated, and let them know you have absolutely no control over the designation. To you, Mrs. H. is medically ill enough to require hospitalization, and she and her family agree, but Medicare regulations and fear of RAC audits keep her on observation status. What have you accomplished during that time?

H.R. 876 is not the problem, and it is clearly well intentioned. I regularly inform patients when I’m aware of their observation status, because it’s a lousy situation for the patient. We should all be doing as much.

But H.R. 876 is not the solution, either, because it does not address the core problems with observation policy. Now is the time for us all to step forward, voicing our support of SHM as it works to change observation status as we now know it. It is not an easy task. The ultimate goal is to be able to consider all hospitalized medical patients what they really are: inpatients.

Dr. Johnson is clinical associate professor in the department of internal medicine at the University of Iowa Carver College of Medicine. She is a member of the SHM Public Policy Committee and was one of the authors of the SHM PPC white paper on observation status released in July 2014.

As you may have heard, H.R. 876, a bill unanimously passed in the House recently, requires a hospital to give adequate oral and written notification of a patient’s observation status. The bill has now moved to the Senate.

“Notice of Observation Treatment and Implication for Care Eligibility Act,” known as the NOTICE Act, was sponsored by Rep. Lloyd Doggett (D-Texas) and co-sponsored by Rep. Earl Blumenauer (D-Ore.), Rep. Charles Rangel (D-N.Y.), and Rep. Todd Young (R-Ind.), all known to be admirable patient care advocates.

The bill proposes requiring that any patient who has been classified as observation status for more than 24 hours be given oral and written notice within 36 hours of that classification. That notice must include the reason for and implications of that status, including lack of coverage for services and cost sharing under Medicare Part B, as well as the name and title of the hospital staff who gave the oral notification. Written notification must be signed by the patient or, if the patient refuses, by the staff who presented it.

Although it is essential that patients are aware of observation status and its implications, this bill would not solve the underlying problem and would only create divisions between patients and the staff caring for them. Two issues stand out:

1. Observation status is not currently a medical determination; and
2. Hospitalized medical patients should not be considered outpatients.

When a patient is admitted to the hospital, acute inpatient versus observation status is often assigned by a non-clinician in the form of a “verbal” order before the attending hospitalist meets or even hears of the patient. This order must be signed promptly by that hospitalist to prevent penalization for lack of medical record compliance. Increasingly, more of these orders are for observation status, as hospitals fear bounty-hunting recovery audit contractors (RACs) in pursuit of “Medicare fraud.”

Under H.R. 876, the situation is further intensified for both clinicians and patients. Picture yourself in the middle of a busy day at your hospital, admitting and discharging patients, stabilizing critically ill patients, and discussing goals of care with patients given life-altering diagnoses. Your pager goes off.

“Mrs. H. on 6th Floor East wants to talk to you right away,” the conversation starts. Mrs. H is in tears, and her family is angry. “We were just told that Grandma is observation status, not admitted to the hospital! This makes no sense!”

Forty-five minutes later, you have agreed, commiserated, and let them know you have absolutely no control over the designation. To you, Mrs. H. is medically ill enough to require hospitalization, and she and her family agree, but Medicare regulations and fear of RAC audits keep her on observation status. What have you accomplished during that time?

H.R. 876 is not the problem, and it is clearly well intentioned. I regularly inform patients when I’m aware of their observation status, because it’s a lousy situation for the patient. We should all be doing as much.

But H.R. 876 is not the solution, either, because it does not address the core problems with observation policy. Now is the time for us all to step forward, voicing our support of SHM as it works to change observation status as we now know it. It is not an easy task. The ultimate goal is to be able to consider all hospitalized medical patients what they really are: inpatients.

Dr. Johnson is clinical associate professor in the department of internal medicine at the University of Iowa Carver College of Medicine. She is a member of the SHM Public Policy Committee and was one of the authors of the SHM PPC white paper on observation status released in July 2014.