RESUMO
Purpose of the Research: This paper aims at comparing different approaches to measure potentially inappropriate medication (PIM) with routinely collected data on prescriptions, patient age institutionalization status (ie in nursing home or in the community). A secondary objective is to measure the rate and prevalence of PIM dispensing and to identify problematic practices in Switzerland. Material and Methods: The studied population includes about 90,000 insured over 17 years old from a Swiss health maintenance organization in 2019 and 2020. We computed and compared the number of PIM per patient for Beers criteria, Priscus list, Laroche, NORGEP and Prescrire approaches. We also created a composite indicator that accounts for the specificities of the Swiss context (adaptation to the Swiss drugs' market, recommendations in force related to sleeping pills, anxiolytics and NSAIDs). We also stratified the analysis per physician, including initiation and cessation of PIM prescription. Results: Our comparison revealed similarities between the approaches, but also that each of them had specific gaps that provides further motivation for the development of a composite approach. PIM rate was particularly high for sleeping pills, anxiolytics, NSAIDs, even when analyses were limited to chronic use. Drugs with anticholinergic effect were also frequently prescribed. Based on our composite indicator, 27% of insured over 64 years old received at least one PIM in 2020, and 8% received more than one. Our analyses also reveal that for sleeping pills and anxiolytics, half of the volume (or prevalence?) occurs in the <65 population. We observed strong variations between physicians and a significant proportion of new users among patients with PIM. Conclusion: Our results show that PIMs prescribing is very frequent in Switzerland and is driven mostly by a few drug categories. There is important physician variation in PIM prescribing that warrants the development of intervention targeted at high PIM-prescribers.
RESUMO
INTRODUCTION: This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. METHODS: The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x2-tests were performed for the analysis. RESULTS: From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. CONCLUSION: There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.
