Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation.

Introduction: Preventing prenatal exposure to teratogenic medications is an important goal of regulatory risk mitigation efforts. In the USA, as of March 2024, 11 teratogenic medications have a required Risk Evaluation and Mitigation Strategy (REMS) program. It is unclear whether these programs target those medications with the most significant impact on public health and adverse pregnancy outcomes.

Removing the FDA's Boxed Hepatotoxicity Warning and Liver Function Testing Requirement for Ambrisentan.

Importance: Endothelin receptor antagonists are first-line therapy for pulmonary arterial hypertension (PAH). The first 2 agents approved in the class, bosentan and ambrisentan, initially carried boxed warnings for hepatotoxicity and required monthly liver function tests (LFTs) as part of a risk evaluation and mitigation strategy (REMS); however, in 2011, as further safety data emerged on ambrisentan, the boxed hepatotoxicity warning and LFT requirements were removed.

Objective: To analyze changes in the use of and LFT monitoring for ambrisentan and bosentan after changes to the ambrisentan labeling and REMS.

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).

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.

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.

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.

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.

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.

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.