Dataset Information

Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation.

ABSTRACT: 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.

SUBMITTER: Horton DB

PROVIDER: S-EPMC5670006 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation.

Horton Daniel B DB Gerhard Tobias T Davidow Amy A Strom Brian L BL

Pharmacoepidemiology and drug safety 20170831 11

<h4>Purpose</h4>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.<h4>Methods</h4>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 Improvem ...[more]

PMID: 28857309

Similar Datasets

Project description:Importance:Benzodiazepines are implicated in a growing number of overdose-related deaths. Objectives:To quantify patterns in outpatient benzodiazepine prescribing and to compare them across specialties and indications. Design, Setting, and Participants:This serial cross-sectional study (January 1, 2003, through December 31, 2015) used nationally representative National Ambulatory Medical Care Survey data. The yearly population-based sample of outpatient visits among adults, ranging from 20?884 visits in 2003 (representing 737 million visits) to 24?273 visits in 2015 (representing 841 million visits) was analyzed. Prescribing patterns were examined by specialty and indication and used to calculate the annual coprescribing rate of benzodiazepines with other sedating medications. Data were analyzed from July 1, 2017, through November 30, 2018. Main Outcomes and Measures:Annual benzodiazepine visit rate. Results:Among the 386 457 ambulatory care visits from 2003 through 2015, a total of 919 benzodiazepine visits occurred in 2003 and 1672 in 2015, nationally representing 27.6 million and 62.6 million visits, respectively. The benzodiazepine visit rate doubled from 3.8% (95% CI, 3.2%-4.4%) to 7.4% (95% CI, 6.4%-8.6%; P?<?.001) of visits. Visits to primary care physicians accounted for approximately half of all benzodiazepine visits (52.3% [95% CI, 50.0%-54.6%]). The benzodiazepine visit rate did not change among visits to psychiatrists (29.6% [95% CI, 23.3%-36.7%] in 2003 to 30.2% [95% CI, 25.6%-35.2%] in 2015; P?=?.90), but increased among all other physicians, including primary care physicians (3.6% [95% CI, 2.9%-4.4%] to 7.5% [95% CI, 6.0%-9.5%]; P?<?.001). The benzodiazepine visit rate increased slightly for anxiety and depression (26.6% [95% CI, 22.6%-31.0%] to 33.5% [95% CI, 28.8%-38.6%]; P?=?.003) and neurologic conditions (6.8% [95% CI, 4.8%-9.5%] to 8.7% [95% CI, 6.2%-12.1%]; P?<?.001), but more so for back and/or chronic pain (3.6% [95% CI, 2.6%-4.9%] to 8.5% [95% CI, 6.0%-11.9%]; P?<?.001) and other conditions (1.8% [95% CI, 1.4%-2.2%] to 4.4% [95% CI, 3.7%-5.2%]; P?<?.001); use did not change for insomnia (26.9% [95% CI, 19.3%-36.0%] to 25.6% [95% CI, 15.3%-39.6%]; P?=?.72). The coprescribing rate of benzodiazepines with opioids quadrupled from 0.5% (95% CI, 0.3%-0.7%) in 2003 to 2.0% (95% CI, 1.4%-2.7%) in 2015 (P?<?.001); the coprescribing rate with other sedating medications doubled from 0.7% (95% CI, 0.5%-0.9%) to 1.5% (95% CI, 1.1%-1.9%) (P?<?.001). Conclusions and Relevance:The outpatient use of benzodiazepines has increased substantially. In light of increasing rates of overdose deaths involving benzodiazepines, understanding and addressing prescribing patterns may help curb the growing use of benzodiazepines.

Project description:The relevance of race and ethnicity to genetics and medicine has long been a matter of debate. An emerging consensus holds that race and ethnicity are social constructs and thus poor proxies for genetic diversity. The goal of this study was to evaluate the relationship between race, ethnicity, and clinically relevant pharmacogenomic variation in cosmopolitan populations. We studied racially and ethnically diverse cohorts of 65,120 participants from the United States All of Us Research Program (All of Us) and 31,396 participants from the United Kingdom Biobank (UKB). Genome-wide patterns of pharmacogenomic variation-6311 drug response-associated variants for All of Us and 5966 variants for UKB-were analyzed with machine learning classifiers to predict participants' self-identified race and ethnicity. Pharmacogenomic variation predicts race/ethnicity with averages of 92.1% accuracy for All of Us and 94.3% accuracy for UKB. Group-specific prediction accuracies range from 99.0% for the White group in UKB to 92.9% for the Hispanic group in All of Us. Prediction accuracies are substantially lower for individuals who identified with more than one group in All of Us (16.7%) or as Mixed in UKB (70.7%). There are numerous individual pharmacogenomic variants with large allele frequency differences between race/ethnicity groups in both cohorts. Frequency differences for toxicity-associated variants predict hundreds of adverse drug reactions per 1000 treated participants for minority groups in All of Us. Our results indicate that race and ethnicity can be used to stratify pharmacogenomic risk in the US and UK populations and should not be discounted when making treatment decisions. We resolve the contradiction between the results reported here and the orthodoxy of race and ethnicity as non-genetic, social constructs by emphasizing the distinction between global and local patterns of human genetic diversity, and we stress the current and future limitations of race and ethnicity as proxies for pharmacogenomic variation.

Dataset Information

Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation.

Publications

Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets