Recommendations on medication errors

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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.

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Document(s) Language Publication date
Blincyto: measures to avoid medication errors (English only) 2015-12-08
Exjade: measures to avoid medication errors BG = bălgarski 2016-04-22
Exjade: measures to avoid medication errors ES = español 2016-04-22
Exjade: measures to avoid medication errors CS = čeština 2016-04-22
Exjade: measures to avoid medication errors DA = dansk 2016-04-22
Exjade: measures to avoid medication errors DE = Deutsch 2016-04-22
Exjade: measures to avoid medication errors ET = eesti keel 2016-04-22
Exjade: measures to avoid medication errors EL = elliniká 2016-04-22
Exjade: measures to avoid medication errors EN = English 2016-04-22
Exjade: measures to avoid medication errors FR = français 2016-04-22
Exjade: measures to avoid medication errors IT = italiano 2016-04-22
Exjade: measures to avoid medication errors LV = latviešu valoda 2016-04-22
Exjade: measures to avoid medication errors LT = lietuvių kalba 2016-04-22
Exjade: measures to avoid medication errors HU = magyar 2016-04-22
Exjade: measures to avoid medication errors MT = Malti 2016-04-22
Exjade: measures to avoid medication errors NL = Nederlands 2016-04-22
Exjade: measures to avoid medication errors PL = polski 2016-04-22
Exjade: measures to avoid medication errors PT = português 2016-04-22
Exjade: measures to avoid medication errors RO = română 2016-04-22
Exjade: measures to avoid medication errors SK = slovenčina 2016-04-22
Exjade: measures to avoid medication errors SL = slovenščina 2016-04-22
Exjade: measures to avoid medication errors FI = suomi 2016-04-22
Exjade: measures to avoid medication errors SV = svenska 2016-04-22
Exjade: measures to avoid medication errors HR = Hrvatski 2016-04-22
Farydak: compliance card to be given to patients to ensure correct use and avoid medication errors (English only) 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors BG = bălgarski 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors ES = español 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors CS = čeština 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors DA = dansk 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors DE = Deutsch 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors ET = eesti keel 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors EL = elliniká 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors EN = English 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors FR = français 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors IT = italiano 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors LV = latviešu valoda 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors LT = lietuvių kalba 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors HU = magyar 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors MT = Malti 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors NL = Nederlands 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors PL = polski 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors PT = português 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors RO = română 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors SK = slovenčina 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors SL = slovenščina 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors FI = suomi 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors SV = svenska 2015-11-27
Insulin and a non-insulin active substance: guidance on prevention of medication errors HR = Hrvatski 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors ES = español 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors CS = čeština 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors DA = dansk 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors DE = Deutsch 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors ET = eesti keel 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors EL = elliniká 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors EN = English 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors FR = français 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors IT = italiano 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors LV = latviešu valoda 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors LT = lietuvių kalba 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors HU = magyar 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors MT = Malti 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors NL = Nederlands 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors PL = polski 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors PT = português 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors RO = română 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors SK = slovenčina 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors SL = slovenščina 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors FI = suomi 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors SV = svenska 2015-11-27
Insulins (high-strength): guidance on prevention of medication errors HR = Hrvatski 2015-11-27
Ionsys: measures to ensure that it is handled and used correctly (English only) 2015-11-30
Keppra: EMA recommends measures to ensure safe use of oral solution (English only) 2016-10-14
Noxafil: EMA warns that tablets and oral suspension have different doses and are not interchangeable (English only) 2016-06-24
Obizur: educational brochure and video to be given to healthcare professionals to ensure it is used correctly (English only) 2015-12-15
Strensiq: European Medicines Agency recommends measures to ensure safe and effective use (English only) 2015-06-26
Uptravi: educational brochure for healthcare professionals and diary for patients BG = bălgarski 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients ES = español 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients CS = čeština 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients DA = dansk 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients DE = Deutsch 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients ET = eesti keel 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients EL = elliniká 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients EN = English 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients FR = français 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients IT = italiano 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients LV = latviešu valoda 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients LT = lietuvių kalba 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients HU = magyar 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients MT = Malti 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients NL = Nederlands 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients PL = polski 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients PT = português 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients RO = română 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients SK = slovenčina 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients SL = slovenščina 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients FI = suomi 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients SV = svenska 2016-05-31
Uptravi: educational brochure for healthcare professionals and diary for patients HR = Hrvatski 2016-05-31
Velcade: questions and answers on recommendations to prevent administration errors (English only) 2012-01-20