Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

Christina E. Hoeve (), Reynold D. C. Francisca, Inge Zomerdijk, Miriam C. J. M. Sturkenboom and Sabine M. J. M. Straus
Additional contact information
Christina E. Hoeve: Medicines Evaluation Board
Reynold D. C. Francisca: Medicines Evaluation Board
Inge Zomerdijk: Medicines Evaluation Board
Miriam C. J. M. Sturkenboom: University Utrecht Medical Center
Sabine M. J. M. Straus: Medicines Evaluation Board

Drug Safety, 2020, vol. 43, issue 1, No 6, 45-55

Abstract: Abstract Introduction Medication errors can have serious consequences for patients. To prevent the occurrence of medication errors in clinical practice, safety concerns may be included in the risk management plan and subsequently be addressed with routine and/or additional risk minimisation measures. Objective This study aims to describe safety concerns around medication errors and the risk minimisation measures for centrally authorised products in the European Union. Methods All safety concerns included in the risk management plans of originator centrally authorised products, authorised between 1 January, 2010 and 31 December, 2017, were collected from the European Public Assessment Report registry. Medication error safety concerns were categorised by Anatomical Therapeutic Classification code, year of authorisation, type of medication error and type of risk minimisation measure. Results During the study period, 311 centrally authorised products were approved, of which 84 had at least one medication error safety concern. The proportion of centrally authorised products with medication error safety concerns showed variation between 2010 and 2017 ranging from 15.2% to 36.4%. In total, 95 medication error safety concerns were identified. The type of medication error was highly variable, drug administration error was listed most frequently (n = 17). For 27 out of 95 medication error safety concerns, corresponding to 23 centrally authorised products, additional risk minimisation measures were required. All additional risk minimisation measures consisted of educational material targeted at healthcare professionals (85.2%) and/or patients (51.9%). For 78.3% of centrally authorised products with additional risk minimisation measures for medication errors, studies to evaluate the effectiveness of the additional risk minimisation measures were agreed upon. Conclusions Medication error safety concerns were listed for almost a quarter of centrally authorised products approved during the study period. Further research is needed to evaluate the effectiveness and continued need for additional risk minimisation measures for medication errors.

Date: 2020
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-019-00874-7 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:43:y:2020:i:1:d:10.1007_s40264-019-00874-7

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-019-00874-7

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().