In the European Union (EU), national competent authorities and the European Medicines Agency (EMA) play a key role in identifying and reducing the risk of medication errors before and after the authorisation of a medicine. EMA applies a consistent approach to communicating to patients and healthcare professionals on any additional measures recommended by the Agency to reduce the risk of medication errors with a specific medicine.
A medication error is a mistake in the use of a medicine that can be harmful for a patient. Medication errors occur at the time of prescribing, dispensing, storing, preparing and administering of a medicine. While the overall number of medication errors leading to harm is small, the impact on patients and health care systems can be high.
The routine risk-minimisation measures to prevent medication errors national competent authorities and EMA apply include ensuring that:
- the proposed name of a medicine does not sound similar to the name of another medicine;
- the labelling of a medicine does not look similar to the labelling of other medicines;
- the instructions in the product information on the use of the medicine are clear so as not lead to medication errors.
For more information on regulatory measures for the pharmaceutical industry, see Medication errors.
In cases where the risk of medication errors is high and routine measures are not considered sufficient, additional measures are taken to ensure that the medicine is used correctly, including educational programmes for healthcare professionals and patients.
Reporting medication errors
Although regulators assess the potential risk of medication errors before marketing approval, medication errors may still occur after a medicine is authorised and used. Patients and healthcare professionals should report any errors they experience to prevent further ones. Timely reporting allows regulatory authorities to implement risk-minimisation measures at an early stage as necessary.
Patients may directly report any suspected side effects including those caused by medication errors. For more information, see How to report a side effect.
Communications to patients and healthcare professionals
In order to promote the safe use of medicines, EMA systematically communicates on any additional measure decided upon at EU level to prevent medication errors. The purpose of these documents is to increase awareness of the additional measures recommended by EMA in order to ensure that a specific medicine is used correctly and to reduce the risk of medication errors. These communications are accessible below and via the European public assessment reports of these medicines.