Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implementation of authority requirements or recommendations into the package leaflet – a comparative study in three European countries ***

Dr. Barbara Oberwallner (Abschlußjahr: 2017)

Summary
Language: English

Introduction and objectives: European legislation, recommendations and guidelines have been developed concerning the package leaflet. Leaflets need to be updated regularly to comply with the requirements and represent the current state of knowledge. The aim of this thesis was to examine package leaflets from Austria, Germany, and the UK for selected parameters and compare implementation in the three countries.

Issues under examination and methods: Leaflets were collected from national databases (Arzneispezialitätenregister, AMIS, eMC) and company websites, based on APIs selected from the WHO model list of Essential Medicines, recent PRAC recommendations, and CMDh recommendations following assessment of paediatric studies. Analysed parameters included revision date, leaflets on company websites, implementation of the QRD template, selected recommendations from the Readability Guideline, and recent PRAC or CMDh recommendations.

Results: Significant differences were observed between the countries regarding revision date (p < 0.001), leaflets available on company websites (p = 0.041), conformity of those leaflets to those in the database (p = 0.042), and implementation of the QRD template (p < 0.001). Compliance to the Readability Guideline ranged from 36 % (consecutive bullet points) to 88 % (font size). Country-specific differences were also detected for implementation of several of the analysed PRAC and CMDh recommendations. The implementation rate of PRAC recommendations was higher compared to CMDh recommendations 3 and 6 months after publication (p < 0.001).

Discussion: The Austrian Arzneispezialitätenregister was the most up-to-date, well maintained, and most recently established database. By comparison, variability of revision dates was highest in the German AMIS database due to a proportion of outdated leaflets. This influenced parameters connected to the revision date, such as implementation of the QRD template or PRAC/CMDh recommendations. One of the reasons may be missing information supply to the database. The British eMC database is administered by a private company, contains print layouts and serves as a central location for the product information that companies can directly link to. Publication of recommendations in English only may lead to comparatively early implementation into UK leaflets. Then again, UK guidelines that question the QRD template may result in more deviations from it.

Conclusions: Factors such as the presentation of recommendations, their legal status and given timelines, the classification of variations and the presence of conflicting requirements might influence compliance to recommendations or the time required for their implementation. Country-specific differences may be attributed to the different functionality of databases, differences in the interpretation of European guidance and language-based (dis-)advantages. The comparison sheds light on these differences, offers explanations, and facilitates improvement. Suggestions include more authority checks, update of guidelines, provision of best practice examples, electronic package leaflets, and more flexibility with recommendations that do not measurably improve readability. Eventually, authorities, pharmaceutical industry and patient representatives should work together efficiently and pragmatically to improve the benefit of package leaflets for the health of patients.

Pages: 72, Annexes: pages: 28