| アブストラクト | PURPOSE: Newly approved novel drugs in Europe receive a black triangle label to promote pharmacovigilance. With growing momentum for earlier drug approvals and reliance on real-world evidence, we studied if the black triangle label promotes more judicious prescribing. METHODS: We examined whether general practitioners prescribed escitalopram, tadalafil, and vardenafil with a black triangle more cautiously than the same or similar drugs without a black triangle in The Health Improvement Network (UK). We performed interrupted time-series analyses to estimate changes in new prescription rates and nested case-control studies to compare characteristics of new users before and after removal of a black triangle. RESULTS: Prescribing rates to the 33 441 new users of these new drugs were highest shortly after initial approval and declined subsequently; there were no increases in rates of new prescriptions after a black triangle's removal (new prescriptions/million/month postlabel: escitalopram -1.5 [95% CI, -1.9 to -1.2]; tadalafil and vardenafil: -0.1 [95% CI, -0.6 to 0.4]). Among drugs in the same class, loss of a patent had more impact on prescribing rates than loss of a black triangle. People who began taking black triangle drugs were less likely to be young or to have multiple comorbidities or recent hospitalization compared with those starting the same drugs after the label's removal. However, these differences generally reflected secular trends seen also in similar, unlabeled medicines. CONCLUSIONS: Accelerated drug approvals could cause more uncertainty about drug effectiveness and safety, but specific labeling of newly approved medicines is unlikely to promote more judicious prescribing. |
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| 組織名 | Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New;Brunswick, NJ, USA.;Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for;Health, Health Care Policy and Aging Research, New Brunswick, NJ, USA.;Department of Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.;Department of Pharmacy Practice and Administration, Ernest Mario School of;Pharmacy, Rutgers University, Piscataway, NJ, USA.;Department of Biostatistics, Rutgers School of Public Health, Newark, NJ, USA.;Rutgers Biomedical and Health Sciences, Newark, NJ, USA.;Department of Biostatistics and Epidemiology, Perelman School of Medicine,;University of Pennsylvania, Philadelphia, PA, USA. |
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