Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures

Brown, Beatrice L; Kesselheim, Aaron S.; Sarpatwari, Ameet

doi:10.1371/journal.pmed.1004190

Cited by 3 publications

(1 citation statement)

References 16 publications

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“…This finding was consistent with the fact that the REMS program for MM drugs requires women of reproductive potential to use two forms of contraception absent abstinence and undergo regular pregnancy testing, including 2 tests prior to initial dispensing, weekly tests for the first month, and monthly tests thereafter, with pharmacy dispensing only possible within 7 days of a negative pregnancy test. 17 The increase in negative responses for the MM drugs is not unexpected, because the REMS programs are mitigating the risk of known human teratogens and verifying the safe use conditions are likely associated with greater burden to prescribers. However, the mean age of female patients diagnosed with MM is 70 years, with most at low to no risk of pregnancy, which may fuel frustration among physicians.…”

Section: Articlementioning

confidence: 99%

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

Sarpatwari,

Lu,

Russo

et al. 2024

Clin Pharma and Therapeutics

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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.

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Section: Articlementioning

confidence: 99%