It is pharmacovigilance's task to detect and assess adverse reactions as well as any other medicine-related problems and to initiate measures to minimise or prevent them. Since 2014, reports of medication errors have been evaluated systematically by the BfArM, among others with regard to the causes for these errors. The BfArM receives around 1000 such reports per year, with an upward trend; the number of direct reports increases annually by an average of 40 percent compared to the previous year. Direct reports are reports that are sent directly to the BfArM, e.g., by the pharmaceutical drug commissions of the healthcare professions. Both reporting sources and types of report are subject to a dynamic development, e.g., also due to the inclusion of reports from research projects such as ADRED or KIDSafe .
Medication errors can occur throughout the entire medication process (e.g., when prescribing, dispensing, or administering medicinal products) and can have numerous causes. All individuals participating in these processes, including patients or their relatives, can be the source of such errors. The complex nature of the processes leads to a wide range of conceivable mistakes.

Dosing Errors are the Most Common

Dosing errors are the medication errors reported most frequently accounting for approximately 40 percent of reports made to the BfArM. Such dosing errors can occur when taking the medicinal product, especially when preparing it for administration, or as a result of an error that had already been made before (e.g., during prescription or dispensing). If the medicinal product is overdosed or underdosed or if the prescribed dosage is not adhered to, this can subsequently lead to undesired consequences for patients.
In recent years, the BfArM has focussed especially on this error source. Cases show that in addition to the contributing factors it is always important to report information on the type of error (potential error, intercepted error, error with or without patient harm), the patient, the medication process concerned (prescribing, dispensing, administering, etc.), and on the medicinal product. Depending on the nature of the error, the report is completed by a description of the harm that occurred or could potentially have occurred. Recommendations on how to avoid such errors are appreciated.

Countermeasures – from Training Courses to Adaptation of Package Leaflet

Training courses for the persons involved can be advisable if human factors like miscalculations, incorrect transcription or margins for interpretation were the cause for the medication error. However, the medicinal product itself can also contribute to the emergence of dosing errors. Examples for this include modified or unsuitable administration devices, confusion due to similar appearance of the outer packaging of different dose strengths or ambiguous strength or dosage information in the product details. If evaluation leads to the conclusion that a regulatory countermeasure by the BfArM is considered necessary, the BfArM initiates the corresponding risk-minimising measure. In addition to the drug name, the product information including the packaging labels play a special role. The product information, i.e. the technical information and directions for use (package inserts) are the most significant sources of information regarding a medicinal product and are drawn up prior to market entry on the basis of clinical studies and are subsequently updated consistently thereafter based on new evidence.

Confusingly similar: Look-alikes and Sound-alikes

A further risk is also presented by potentially similar-looking or similar-sounding medicinal products, so-called look-alikes and sound-alikes (LASA). The name of a medicinal product is a major identifying and distinguishing feature. Therefore, mix-ups because of designations that are too similar must be ruled out, regardless of the respective visual appearance. (Invented) names or additions with descriptive content should reflect the properties of a medicinal product and should not suggest falso notions regarding indication or site and route of administration. The design of the packaging should also help prevent misuse due to confusion, ambiguity, or trivialisation.

Goal: Developing Solutions Together

In cases where labelling or appearance contribute to the occurrence of medication errors, the BfArM can develop solutions in order to prevent such errors from occurring in the future. In order to do so, the BfArM will ideally be cooperating with the marketing authorisation holders and those submitting the reports. Rarely, the BfArM might not be able to agree with a pharmaceutical entrepreneur on the appropriate measures, in such cases, further regulatory steps on a national or European level may become necessary.
Evaluation of the BfArM's case reports of the in connection with LASA shows an average of ca. 20 percent, although a downward trend has been observed over the past eight years. This can be due in part to the risk awareness within the pharmaceutical industry but also to BfArM measures including their respective risk communication. Among others, the BfArM has published guidelines on the naming of medicinal products together with the Paul-Ehrlich-Institut.

Dr. Claudia Kayser

Studied and obtained her doctorate in Pharmacy at the Free University in Berlin.
Has been working at the BfArM since October 1997 as pharmaceutical pharmacological and regulatory assessor in one of the BfArM's licensing divisions and since November 2011 in the Pharmacovigilance Division with special emphasis on medication safety. Collaboration in the European Pharmacovigilance Business Team until 2020 and in the AG AMTS of the German Coalition for Patient Safety (Aktionsbündnis für Patientensicherheit, APS) since 2017, as well as permanent guest status at the meetings of the Drug Commission of German Pharmacists (Arzneimittelkommission der deutschen Apotheker, AMK). Coordination of the measures of the BMG's Action Plan AMTS since 2012.