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.
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Amglidia: Guide to be given to prescribers to ensure Amglidia is used correctly (PDF/181.58 KB)
First published: 29/08/2018
Last updated: 29/08/2018
EMA/133231/2018 -
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Blincyto: measures to avoid medication errors (PDF/106.9 KB)
First published: 08/12/2015
Last updated: 08/12/2015
EMA/677776/2015 -
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Deferasirox Mylan: Measures to avoid medication errors (PDF/138.66 KB)
First published: 24/06/2020
EMA/64561/2020 -
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Exjade: measures to avoid medication errors (PDF/95.92 KB)
First published: 22/04/2016
Last updated: 22/04/2016
EMA/174254/2016 -
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Farydak: compliance card to be given to patients to ensure correct use and avoid medication errors (PDF/107.75 KB)
First published: 27/11/2015
Last updated: 27/11/2015
EMA/599292/2015 -
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Fiasp: colour change for insulin injection Fiasp to avoid mix ups with Tresiba (PDF/1.33 MB)
First published: 23/03/2018
Last updated: 23/03/2018
EMA/166410/2018 -
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Gencebok: potential for dosing errors (PDF/135.36 KB)
First published: 27/08/2020
EMA/354319/2020 -
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Insulin and a non-insulin active substance: guidance on prevention of medication errors (PDF/74.51 KB)
First published: 27/11/2015
Last updated: 27/11/2015
EMA/134144/2015 -
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Insulins (high-strength): guidance on prevention of medication errors (PDF/81.81 KB)
First published: 27/11/2015
Last updated: 27/11/2015
EMA/134145/2015 -
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Ionsys: measures to ensure that it is handled and used correctly (PDF/83.41 KB)
First published: 30/11/2015
Last updated: 30/11/2015
EMA/734228/2015 -
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Jylamvo: healthcare professionals to receive educational guide to ensure medicine is used correctly (PDF/87.56 KB)
First published: 19/04/2017
Last updated: 19/04/2017
EMA/81869/2017 -
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Keppra: EMA recommends measures to ensure safe use of oral solution (PDF/97.1 KB)
First published: 14/10/2016
Last updated: 14/10/2016
EMA/668736/2016 -
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Leuprorelin-containing depot medicinal products: new measures to avoid handling errors with leuprorelin depot medicines (PDF/126.97 KB)
First published: 26/06/2020
EMA/330921/2020 -
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Lynparza: warning that new tablets are used at different doses to the capsules (PDF/79.43 KB)
First published: 23/04/2019
EMA/107399/2018 -
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Methotrexate: new measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases (PDF/123.06 KB)
First published: 22/08/2019
EMA/414775/2019 -
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Myalepta: Educational material for patients and healthcare professionals to ensure Myalepta is used correctly (PDF/113.82 KB)
First published: 06/08/2018
Last updated: 06/08/2018
EMA/512520/2018 -
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Noxafil: EMA warns that tablets and oral suspension have different doses and are not interchangeable (PDF/75.15 KB)
First published: 24/06/2016
Last updated: 24/06/2016
EMA/425762/2016 -
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Obizur: educational brochure and video to be given to healthcare professionals to ensure it is used correctly (PDF/75.71 KB)
First published: 15/12/2015
Last updated: 15/12/2015
EMA/770206/2015 -
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Peyona: potential for dosing errors (PDF/121.14 KB)
First published: 16/09/2020
EMA/480123/2020 -
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Strensiq: European Medicines Agency recommends measures to ensure safe and effective use (PDF/86.86 KB)
First published: 26/06/2015
Last updated: 26/06/2015
EMA/386551/2015 -
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Suliqua: Educational materials for healthcare professionals and patients using the diabetes medicine Suliqua (PDF/130.45 KB)
First published: 30/03/2017
Last updated: 30/03/2017
EMA/747766/2016 -
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Trisenox: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox (PDF/228.92 KB)
First published: 13/12/2019
EMA/189409/2019 -
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Uptravi: educational brochure for healthcare professionals and diary for patients (PDF/353.84 KB)
First published: 31/05/2016
Last updated: 31/05/2016
EMA/89167/2016 -
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Vaxchora: avoiding errors when making up and using the vaccine (PDF/179.13 KB)
Adopted
First published: 08/04/2020
EMA/68844/2020 -
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Velcade: questions and answers on recommendations to prevent administration errors (PDF/157.13 KB)
First published: 20/01/2012
Last updated: 20/01/2012
EMA/34910/2012