Recommendations on medication errors

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 regulatory information: 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.

These communications are displayed in the alphabetical order.

Amglidia: Guide to be given to prescribers to ensure Amglidia is used correctly

Reference Number: EMA/133231/2018

Awiqli : measures intended to reduce risk of confusion with dosing requirements

Reference Number: EMA/137463/2024

Blincyto: measures to avoid medication errors

Reference Number: EMA/677776/2015Summary:

Educational materials to help use the medicine correctly

Deferasirox Mylan: Measures to avoid medication errors

Reference Number: EMA/64561/2020

Exjade: measures to avoid medication errors

Reference Number: EMA/174254/2016

Farydak: compliance card to be given to patients to ensure correct use and avoid medication errors

Reference Number: EMA/599292/2015

Fiasp: colour change for insulin injection Fiasp to avoid mix ups with Tresiba

Reference Number: EMA/166410/2018

Gencebok: potential for dosing errors

Reference Number: EMA/354319/2020

Insulin and a non-insulin active substance: guidance on prevention of medication errors

Reference Number: EMA/134144/2015

Insulins (high-strength): guidance on prevention of medication errors

Reference Number: EMA/134145/2015

Ionsys: measures to ensure that it is handled and used correctly

Reference Number: EMA/734228/2015

Jylamvo: healthcare professionals to receive educational guide to ensure medicine is used correctly

Reference Number: EMA/81869/2017Summary:

Healthcare professionals should carefully explain to patients when and how to take their dose

Keppra: EMA recommends measures to ensure safe use of oral solution

Reference Number: EMA/668736/2016

Leuprorelin-containing depot medicinal products: new measures to avoid handling errors with leuprorelin depot medicines

Reference Number: EMA/330921/2020

Lynparza: warning that new tablets are used at different doses to the capsules

Reference Number: EMA/107399/2018

Methotrexate: new measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

Reference Number: EMA/414775/2019

Myalepta: Educational material for patients and healthcare professionals to ensure Myalepta is used correctly

Reference Number: EMA/512520/2018Summary:

Material will include training video on how to prepare and give medicine

Noxafil: EMA warns that tablets and oral suspension have different doses and are not interchangeable

Reference Number: EMA/425762/2016

Obizur: educational brochure and video to be given to healthcare professionals to ensure it is used correctly

Reference Number: EMA/770206/2015Summary:

Measures will help avoid medication errors

Peyona: potential for dosing errors

Reference Number: EMA/480123/2020Summary:

Peyona, a medicine for treating apnoea of prematurity, is a solution that contains the active substance caffeine citrate 20 mg/ml.

Strensiq: European Medicines Agency recommends measures to ensure safe and effective use

Reference Number: EMA/386551/2015

Suliqua: Educational materials for healthcare professionals and patients using the diabetes medicine Suliqua

Reference Number: EMA/747766/2016Summary:

Measures intended to reduce risk of confusion between two pens of different strengths

Trisenox: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox

Reference Number: EMA/189409/2019

Uptravi: educational brochure for healthcare professionals and diary for patients

Reference Number: EMA/89167/2016Summary:

Measures to prevent medication errors due to weekly dose increases during initial titration phase

Vaxchora: avoiding errors when making up and using the vaccine

AdoptedReference Number: EMA/68844/2020

Velcade: questions and answers on recommendations to prevent administration errors

Reference Number: EMA/34910/2012 Summary:

The European Medicines Agency is aware of three fatal cases of administration error that occurred with Velcade in the European Union, where the medicine was accidentally given intrathecally (into the space that surrounds the spinal cord) instead of intravenously (into a vein). The Agency’s Committee for Medicinal Products for Human Use (CHMP) is reminding healthcare professionals that Velcade should only be given by injection into a vein and is recommending precautionary measures to prevent further administration errors from occurring.