How Do Risk Evaluation and Mitigation Strategies Impact Clinical Practice? A National Survey of Physicians.

The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS-covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5-7) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226 for MM drugs). Although 765 (68%) respondents thought the certification process provided useful drug information, 757 (67%) wanted materials to include benefit data and 944 (84%) non-REMS-related risk data. A majority (704, 63%) thought the safe use requirements facilitated discussion with patients, but a similar number (637, 57%) attributed delayed medication access to these requirements. In multivariable modeling, MM drug and isotretinoin respondents were less likely than sodium oxybate respondents to agree that the certification process provided useful drug information (MM drug: odds ratio (OR) = 0.37, 95% confidence interval (CI) = 0.25-0.55; isotretinoin: OR = 0.39, 95% CI = 0.25-0.61), and isotretinoin, clozapine, and bosetan respondents were more likely than sodium oxybate respondents to agree that the safe use requirements often delayed medication access (isotretinoin: OR = 5.83, 95% CI = 3.70-9.19; clozapine: OR = 1.65, 95% CI = 1.08-2.54; bosentan: OR = 1.78, 95% CI = 1.12-2.85). Most physicians believe REMS programs convey useful drug safety information and facilitate discussion with patients but also seek information on benefits and non-REMS-related risks and better integration of REMS processes into clinical workflows.

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.

INTRODUCTION: Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Such programs can include requirements for patient monitoring, restrictions on dispensing or administration, and physician and pharmacy training and certification. However, there has been only scattered evidence on the impact of REMS programs on informed decision making, medication access, or patient outcomes. OBJECTIVE: The objective of this article was to describe a study that researchers at Brigham and Women's Hospital and Harvard Medical School will conduct in partnership with the Food and Drug Administration's Office of Surveillance and Epidemiology to investigate systematically how REMS programs have operated in practice. METHODS: Investigations include health insurance claims-based analyses to understand patterns of drug use, adherence to safety requirements, and patient outcomes under REMS programs; surveys and interviews to understand physician and patient experiences with REMS; and REMS program material-based and interview-based analyses to understand the effectiveness of risk communication in REMS programs. CONCLUSIONS: These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.

Making inpatient medication reconciliation patient centered, clinically relevant, and implementable: a consensus statement on key principles and necessary first steps.

This white paper identifies potential solutions to help ensure the utility and sustainability of this critical patient safety issue.

Making inpatient medication reconciliation patient centered, clinically relevant and implementable: a consensus statement on key principles and necessary first steps.

Medication errors and adverse events caused by them are common during and after a hospitalization. The impact of these events on patient welfare and the financial burden, both to the patient and the healthcare system, are significant. In 2005, The Joint Commission put forth medication reconciliation as National Patient Safety Goal (NPSG) No. 8 in an effort to minimize adverse events caused during these types of care transitions. However, the meaningful and systematic implementation of medication reconciliation, as expressed through NPSG No. 8, proved to be extraordinarily difficult for healthcare institutions around the country. Given the importance of accurate and complete medication reconciliation for patient safety occurring across the continuum of care, the Society of Hospital Medicine convened a stakeholder conference in 2009 to begin to identify and address: (1) barriers to implementation; (2) opportunities to identify best practices surrounding medication reconciliation; (3) the role of partnerships among traditional healthcare sites and nonclinical and other community-based organizations; and (4) metrics for measuring the processes involved in medication reconciliation and their impact on preventing harm to patients. The focus of the conference was oriented toward medication reconciliation for a hospitalized patient population; however, many of the themes and concepts derived would also apply to other care settings. This paper highlights the key domains needing to be addressed and suggests first steps toward doing so. An overarching principle derived at the conference is that medication reconciliation should not be viewed as an accreditation function. It must, first and foremost, be recognized as an important element of patient safety. From this principle, the participants identified ten key areas requiring further attention in order to move medication reconciliation toward this focus. 1 There is need for a uniformly acceptable and accepted definition of what constitutes a medication and what processes are encompassed by reconciliation. Clarifying these terms is critical to ensuring more uniform impact of medication reconciliation. 2 The varying roles of the multidisciplinary participants in the reconciliation process must be clearly defined. These role definitions should include those of the patient and family/caregiver and must occur locally, taking into account the need for flexibility in design given the varying structures and resources at healthcare sites. 3 Measures of the reconciliation processes must be clinically meaningful (i.e., of defined benefit to the patient) and derived through consultation with stakeholder groups. Those measures to be reported for national benchmarking and accreditation should be limited in number and clinically meaningful. 4 While a comprehensive reconciliation system is needed across the continuum of care, a phased approach to implementation, allowing it to start slowly and be tailored to local organizational structures and work flows, will increase the chances of successful organizational uptake. 5 Developing mechanisms for prospectively and proactively identifying patients at risk for medication-related adverse events and failed reconciliation is needed. Such an alert system would help maintain vigilance toward these patient safety issues and help focus additional resources on high risk patients. 6 Given the diversity in medication reconciliation practices, research aimed at identifying effective processes is important and should be funded with national resources. Funding should include varying sites of care (e.g., urban and rural, academic and nonacademic, etc.). 7 Strategies for medication reconciliation-both successes and key lessons learned from unsuccessful efforts-should be widely disseminated. 8 A personal health record that is integrated and easily transferable between sites of care is needed to facilitate successful medication reconciliation. 9 Partnerships between healthcare organizations and community-based organizations create opportunities to reinforce medication safety principles outside the traditional clinician-patient relationship. Leveraging the influence of these organizations and other social networking platforms may augment population-based understanding of their importance and role in medication safety. 10 Aligning healthcare payment structures with medication safety goals is critical to ensure allocation of adequate resources to design and implement effective medication reconciliation processes. Medication reconciliation is complex and made more complicated by the disjointed nature of the American healthcare system. Addressing these ten points with an overarching goal of focusing on patient safety rather than accreditation should result in improvements in medication reconciliation and the health of patients.

Using single-item health literacy screening questions to identify patients who read written nonsteroidal anti-inflammatory medicine information provided at pharmacies.

Our goal was to assess the relationships between single-item health literacy screening questions and reading prescription nonsteroidal anti-inflammatory drug (NSAID) written medicine information (WMI) provided at pharmacies. The health literacy of 382 patients from primary care physician practices in Alabama was estimated using validated health literacy screening questions related to understanding written medical information (SQ1); confidence in completing medical forms alone (SQ2); and need for assistance in reading hospital materials (SQ3). Reading WMI was measured by a "Yes" response to the question, "Often the drug store gives you written information such as pamphlets or handouts along with your prescription. Have you read about the risks of NSAIDs in this written material provided by the drug store?" Relationships were assessed using generalized linear latent and mixed models. Two-thirds (67.6%) of patients read WMI. Higher estimated health literacy was associated with increased odds of reading WMI. Adjusted odds ratios (95% CI) were 2.08 (1.08-4.03); 2.09 (1.12-3.91); and 1.98 (1.04-3.77) using SQ1-SQ3. Current WMI may be unable to meet the needs of those with inadequate health literacy. Health literacy screening questions can be used to triage patients at risk for not reading WMI so they can be assisted with supplemental educational strategies.

Medication assistance programs: do all in need benefit equally?

OBJECTIVE: To determine if medication assistance programs (MAPs) provided by pharmaceutical companies were used differently by African Americans and Whites. RESEARCH DESIGN: A cross-sectional survey was conducted among patients of primary care practices from 2005 to 2007 within the Alabama Nonsteroidal Anti-Inflammatory Drug (NSAID) Patient Safety Study. SETTING: Telephone survey. PARTICIPANTS: Respondents were 568 African American and White patients reporting annual household incomes < $50,000. MAIN OUTCOME MEASURE: Use of MAPs. RESULTS: Of all patients, 12.8% used MAPs, 39.5% were African American, 75.2% were female, 69.1% were aged > 65 years, 79.8% had annual household incomes < $25,000, and 35.5% indicated that their income was inadequate to meet their basic needs. MAPs were used by 11.2% African-Americans and 14.0% Whites. After multivariable adjustment, MAP use was higher among respondents with incomes not adequate to meet basic needs (odds ratio [OR]: 2.19, 95% confidence interval [CI]: 1.17-4.08) but lower among African Americans than Whites (OR: 0.49, 95% CI: 0.25-0.95). Physician characteristics did not independently predict MAP use. CONCLUSIONS: Overall MAP use was low even among the most vulnerable, and especially among African Americans. As currently used, MAPs may contribute to disparities in medication access.

Patient-reported communications with pharmacy staff at community pharmacies: the Alabama NSAID Patient Safety Study, 2005-2007.

OBJECTIVES: To examine the prevalence of patient-pharmacy staff communication about medications for pain and arthritis and to assess disparities in communication by demographic, socioeconomic, and health indicators. DESIGN: Descriptive, nonexperimental, cross-sectional study. SETTING: Alabama between 2005 and 2007. PATIENTS: 687 Patients participating in the Alabama NSAID Patient Safety Study (age >or=50 years and currently taking a prescription nonsteroidal anti-inflammatory drug [NSAID]). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Communication with pharmacy staff about prescription and over-the-counter (OTC) NSAIDs was examined before and after adjustment for demographic, socioeconomic, and health indicators. RESULTS: For the entire cohort (n = 687), mean (+/-SD) age was 68.3 +/- 10.0 years, 72.8% were women, 36.4% were black, and 31.2% discussed use of prescription pain/arthritis medications with pharmacy staff. Discussing use of prescription pain/arthritis medications with pharmacy staff differed by race/gender (P < 0.001): white men (40.3%), white women (34.6%), black men (30.2%), and black women (19.8%). Even after multivariable adjustment, black women had the lowest odds of discussing their medications with pharmacy staff (odds ratio 0.40 [95% CI 0.24-0.56]) compared with white men. For the 63.0% of participants with recently overlapping prescription and OTC NSAID use, communication with pharmacy staff about OTC NSAIDs use was only 13.7% and did not vary significantly by race/gender group. CONCLUSION: Given the complex risks and benefits of chronic NSAID use, pharmacists, pharmacy staff, and patients all are missing an important opportunity to avoid unsafe prescribing and decrease medication adverse events.

Effect of racial differences on ability to afford prescription medications.

PURPOSE: The association of race with not filling prescription medications because of cost for African-American and white patients 65 years or older was examined. METHODS: African-American and white patients age 65 years or older were recruited from the practices of 48 Alabama primary care physicians participating in the Alabama Nonsteroidal Antiinflammatory Drug Patient Safety Study. All eligible patients were asked questions related to their ability to pay for prescription medications, comorbidities, insurance status, and socioeconomic status. Baseline and follow-up telephone surveys were completed between August 2005 and April 2006. Mediation analysis was conducted to determine whether patients' perceived income inadequacy mediated the association between race and not filling medications using staged logistic regression models and adjusting for age, comorbidities, and traditional markers of socioeconomic position (income, education, and insurance status). RESULTS: Of 399 participants, 32% were African-American, 74% were women, and 53% had an annual household income of <$15,000. Patients not filling prescription medications were more likely to be African-American (50% versus 25%) and to report inadequate income to meet basic needs (61% versus 17%) (p < 0.001 for both comparisons). After adjusting for all covariates except the mediator, the odds ratio (OR) for African Americans not filling a prescription medication was 2.3 when compared with white patients. Adding the mediator (perceived income inadequacy) to the model reduced the OR to 1.4. CONCLUSION: African Americans reported markedly greater difficulty in affording prescription medications than did white patients, even after accounting for income, education, health insurance status, and comorbidities. The inability of African Americans to afford prescription medications may be better predicted by perceived income inadequacy than more traditional measures of socioeconomic status.