Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem
| Autor: | Michael S. Sinha, Eric G. Campbell, Paula Rausch, Brian M. Lappin, Gerald J. Dal Pan, Jerry Avorn, Sebastian Schneeweiss, Aaron S. Kesselheim, Esther H. Zhou |
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| Rok vydání: | 2019 |
| Předmět: |
Drug
Zolpidem media_common.quotation_subject MEDLINE Toxicology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Product Surveillance Postmarketing medicine Humans Pharmacology (medical) Social media 030212 general & internal medicine Practice Patterns Physicians' Medical prescription Drug Approval Health communication media_common Pharmacology United States Food and Drug Administration business.industry medicine.disease United States Clinical trial Health Communication Sleep Aids Pharmaceutical Safety Communications Medical emergency business medicine.drug |
| Zdroj: | Drug Safety. 42:1287-1295 |
| ISSN: | 1179-1942 0114-5916 |
| Popis: | Because clinical trials conducted for US Food and Drug Administration (FDA) approval occur in carefully monitored settings and often have strict inclusion criteria for participation, new information about drug safety is commonly discovered once a medication is FDA approved and used by larger numbers of patients. The FDA issues Drug Safety Communications when new information arises about the safety of marketed drugs that may change decision making by healthcare providers and patients. Since their inception, over 250 Drug Safety Communications have been issued alerting consumers and prescribers in the USA about safety risks related to prescription and over-the-counter medications. Researchers at the Brigham and Women's Hospital in Boston in conjunction with officials from the FDA undertook a multi-modal study of the content, dissemination, and uptake of FDA messaging, focusing on two 2013 Drug Safety Communications related to zolpidem (Ambien; Sanofi, Paris, France). Traditional and social media analyses note incomplete dissemination of key DSC messages. Surveys of patients and interviews of physicians and patients suggest important limitations in patient-provider communication that have hindered sharing of safety information with patients. Finally, pharmacoepidemiologic analyses of zolpidem dispensing patterns after the Drug Safety Communications were released suggest possible opportunities for enhancing uptake of new safety knowledge that may lead to changes in clinical practice, where appropriate. |
| Databáze: | OpenAIRE |
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