Abstract
Objective To assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring. Design Retrospective cohort study. Setting DHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018. Intervention Quality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey's honestly significant difference if significant. Results In total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0-6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a € adequate instruction' which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001). Conclusions Monitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.
| Original language | English |
|---|---|
| Article number | e036498 |
| Number of pages | 9 |
| Journal | BMJ Open |
| Volume | 10 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 11 May 2020 |
Funding
Funding No funding was received for this study. AB’s employment at University of Copenhagen was funded by a grant from the National Health and Medical Research Council of Australia (APP1122332). Competing interests MLDB and CEH are employed by the University of Copenhagen at the Copenhagen Centre for Regulatory Science (CORS). CORS is a cross-faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring pharmaceuticals, LEO pharma) as well as patient organisations (Rare Diseases Denmark). The centre is purely devoted to the scientific aspects of the regulatory field and with a patient-oriented focus and the research is not company-specific product or directly company related. In addition MLDB is part-time employed by Utrecht University as senior researcher conducting research under the umbrella of the Utrecht-WHO Collaborating Centre for Pharmaceutical Policy and Regulation. This Centre receives no direct funding or donations from private parties, including pharma industry. Research funding from public–private partnerships, for example, IMI, The Escher Project (http://escher.lygature.org/) is accepted under the condition that no company specific product or company related study is conducted. The centre has received unrestricted research funding from public sources, for example, WHO, Netherlands Organisation for Health Research and Development (ZonMW), the Dutch National Health Care Institute (ZIN), EC Horizon 2020, the Dutch Medicines Evaluation Board (MEB) and the Dutch Ministry of Health. M-MGH and AFB were affiliated to the University of Copenhagen while the research described in this paper was preformed, M-MGH is currently employed at Sandoz A/S and Arnela Boskovic is currently employed at Novo Nordisk A/S, neither of the companies were involved in any aspect of the described work.
Keywords
- adverse events
- health & safety
- public health
