Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark

Hostenkamp, Gisela; Fischer, Katharina Elisabeth; Borch‐Johnsen, Knut

doi:10.1016/j.healthpol.2016.09.020

Cited by 6 publications

(7 citation statements)

References 25 publications

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“…Our findings support the conclusion that a black triangle‐type label may not substantially limit prescribing in practice. These results contrast with other studies showing that changes in drug labeling in “response” to new safety information can affect prescribing behavior . Other studies have also shown the relatively greater impact of market forces compared with drug regulation alone …”

Section: Discussionmentioning

confidence: 99%

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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

Gerhard

Davidow

et al. 2017

Pharmacoepidemiology and Drug

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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 post-label: escitalopram −1.5 [95% CI −1.9, −1.2]; tadalafil and vardenafil: −0.1 [95% CI −0.6, 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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Section: Discussionmentioning

confidence: 99%

“…These results contrast with other studies showing that changes in drug labeling in "response" to new safety information can affect prescribing behavior. 25,26 Other studies have also shown the relatively greater impact of market forces compared with drug regulation alone. 27 Our study has several strengths.…”

Section: Discussionmentioning

confidence: 99%

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

Gerhard

Davidow

et al. 2017

Pharmacoepidemiology and Drug

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show abstract

“…The FDA also outlined in their published recommendations, that patients treated with a combination of rosiglitazone and insulin were observed to be at higher risk of myocardial ischemia [56]. Following the withdrawal, 8.4 % of rosiglitazone users were switched to pioglitazone [54] which has been linked with an increased risk of bladder cancer, but there is insufficient evidence to withdraw it from the market [54,58,59].…”

Section: Other Oral Antidiabetic Medicinesmentioning

confidence: 99%

Trends in global prescribing of antidiabetic medicines in primary care: A systematic review of literature between 2000–2018

Ramzan

Timmins

Hasan

et al. 2019

Primary Care Diabetes

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Clinicians makes informed treatment choices based on available evidence and treatment guidelines. The aim of this review is to examine changes in the use of diabetes medicines prescribed to treat type 2 diabetes mellitus (T2DM) in the primary care setting. The use of antidiabetic medicines has evolved between 2000 and 2018. The number of drug classes available for treatment has increased steadily over these years, impacting on prescribing patterns. It was not possible to determine how clinicians make choices about the medicines they prescribe for T2DM, or what influences those choices.

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“…Most known cases are medications and technologies withdrawn from the market due to links to medical complications. In such cases, issuing public warnings about risks and side-effects when discovered has been found to influence public trust [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

Understanding and addressing populations whose prior experience has led to mistrust in healthcare

Even

Shvarts

2023

Isr J Health Policy Res

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Background Policy makers need to maintain public trust in healthcare systems in order to foster citizen engagement in recommended behaviors and treatments. The importance of such commitment has been highlighted by the recent COVID-19 pandemic. Central to public trust is the extent of the accountability of health authorities held responsible for long-term effects of past treatments. This paper addresses the topic of manifestations of trust among patients damaged by radiation treatments for ringworm. Methods For this mixed-methods case study (quan/qual), we sampled 600 files of Israeli patients submitting claims to the National Center for Compensation of Scalp Ringworm Victims in the years 1995–2014, following damage from radiation treatments received between 1946 and 1960 in Israel and/or abroad. Qualitative data were analyzed with descriptive statistics, and correlations were analyzed with chi-square tests. Verbal data were analyzed by the use of systematic content analysis. Results Among 527 patients whose files were included in the final analysis, 42% held authorities responsible. Assigning responsibility to authorities was more prevalent among claimants born in Israel than among those born and treated abroad (χ2 = 6.613, df = 1, p = 0.01), claimants reporting trauma (χ2 = 4.864, df = 1, p = 0.027), and claimants living in central cities compared with those in suburban areas (χ2 = 18.859, df = 6, p < 0.01). Men, younger claimants, patients with a psychiatric diagnosis, and patients from minority populations expressed mistrust in health regulators. Conclusions Examining populations' perceived trust in healthcare institutions and tailoring health messages to vulnerable populations can promote public trust in healthcare systems.

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Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark

Cited by 6 publications

References 25 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

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

Trends in global prescribing of antidiabetic medicines in primary care: A systematic review of literature between 2000–2018

Understanding and addressing populations whose prior experience has led to mistrust in healthcare

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