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.

Applying the theory of planned behavior to predict COVID-19 booster vaccination intentions of college students.

Objective: The purpose of this study was: (a) to determine COVID-19 vaccination rates among college students, (b) to assess what proportion of college students self-report currently or previously having COVID-19, and (c) to test theory of planned behavior (TPB)-based constructs in predicting the COVID-19 booster vaccination behavioral intentions. Methods: A non-experimental, cross-sectional study design was applied. Participants: The sample consisted of 288 college students ages 18 years and older. Results: The stepwise multiple regression revealed that attitude (ß = .329; p < .001) and subjective norm (ß = .244; p < .001) were statistically significant predictors of intention to receive the COVID-19 booster, accounting for 86.7% (Adjusted R2 = .867, F (2, 204 = 673.002, p < .001) of the variance. Conclusions: College students are at high risk for more severe complications of COVID-19 infection due to low vaccination rates. The instrument designed for this study may be used to design TPB-based interventions to increase COVID-19 vaccination and booster intentions of college students.