Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Medication errors and the European Pharmacovigilance legislation - specific focus on Biomedicines
Claudia Pönisch (Abschlußjahr: 2013)
Summary
Language: English
According to a report from the European Medicines Agency, medication errors are key issues and responsible for approximately 19-56 % of all adverse drug reactions in hospital patients.
The EMA has published on its website that the rate of medication errors e.g. in the hospital setting at prescription, should be 0.3-9.1% in the EU, in accordance with the World Alliance for Patient Safety in 2010.
Therefore, EU legislation has been converted inter alia to take greater account of medication errors. In this context of the EU legislation, the EMA has developed a database containing all suspected spontaneous ADRs for authorised medicines in the EEA, which is available online for the public.
The new European Union pharmacovigilance legislation with the amendment of the Directive 2001/83/EC in the Directive 2010/84/EC has redefined the term adverse reaction. Medication errors are now particularly to be observed by physicians, pharmacists, other healthcare professionals, patients and consumers.
Medication errors can lead to adverse drug reactions on some occasions.
With the introduction of the new legal basis of reporting requirements for medication errors in July 2012, all medication errors that lead to adverse drug reactions should be submitted electronically from all national EU regulatory authorities and the pharmaceutical companies in the Member States to the EudraVigilance database, established under the responsibility of the EMA. The Medical Dictionary for Regulatory Activities is the international standard coding tool for medical terminology, within which, medication errors are classified as a High Level Group Term with different Preferred Terms.
Thus, MedDRA is an appropriate coding system and method to present medication errors according to the Draft WHO Medication Errors Classification, including the five categories of prescribing, dispensing, preparation, administration and monitoring, containing selected MedDRA PTs of the HLGT medication errors without the High Level Term overdose and with specified MedDRA PTs of the HLGT product quality issues.
The Paul-Ehrlich-Institut is the National Competent Authority in Germany, which is responsible for the post-marketing, surveillance and monitoring of Biomedicines, e.g. monoclonal Antibodies. An increasing number of monoclonal Antibodies has been introduced in the EU in recent years.
Hence, it makes sense to investigate the medication errors with respect to the mAbs.
The main target was to analyse all types of medication errors as PTs in MedDRA reported to the EudraVigilance database concerning the newest class of Biomedicines, comprising in 30 mAbs authorised in the EU during the period from 01/01/2005 to 31/08/2013.
In this context, particular focus was placed on the mAbs with an unusual administration route deviating from the generally preferred intravenous gavage, e.g. subcutaneous.
Summarising, the results of the EudraVigilance database search confirmed the usefulness of the MedDRA system for the detection and classification of medication errors and, above all, the compatibility with internationally accepted WHO categories of medical errors.
Overview of all types of medication errors stratified by each WHO Category (total number without overdoses N=296)
- Prescribing: 9/296, thereof 5 unspecified drug prescribing error
- Dispensing: 9/296, thereof 6 incorrect storage of drug
- Preparation: 14/296, thereof 7 wrong technique in drug usage process
- Administration: 264/296, thereof 95 inappropriate drug schedule
- Monitoring: 0/296
There is an opportunity to reduce medication errors by using adequate risk minimising measures. In cooperation with the NCA, educational materials for patients and physicians as well as SmPC and DHPC reflect useful measures to cut down preventable medical errors. Nevertheless, the appropriateness of these risk minimising measures is a future task of the pharmacovigilance.
Pages: 52