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 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 Status First published Last updated Effective Date
Educational brochure for healthcare professionals and diary for patients using Uptravi BG = bălgarski   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi ES = español   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi CS = čeština   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi DA = dansk   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi DE = Deutsch   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi ET = eesti keel   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi EL = elliniká   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi EN = English   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi FR = français   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi IT = italiano   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi LV = latviešu valoda   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi LT = lietuvių kalba   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi HU = magyar   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi MT = Malti   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi NL = Nederlands   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi PL = polski   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi PT = português   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi RO = română   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi SK = slovenčina   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi SL = slovenščina   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi FI = suomi   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi SV = svenska   31/05/2016    
Educational brochure for healthcare professionals and diary for patients using Uptravi HR = Hrvatski   31/05/2016    
Measures to avoid medication errors with Exjade BG = bălgarski   22/04/2016    
Measures to avoid medication errors with Exjade ES = español   22/04/2016    
Measures to avoid medication errors with Exjade CS = čeština   22/04/2016    
Measures to avoid medication errors with Exjade DA = dansk   22/04/2016    
Measures to avoid medication errors with Exjade DE = Deutsch   22/04/2016    
Measures to avoid medication errors with Exjade ET = eesti keel   22/04/2016    
Measures to avoid medication errors with Exjade EL = elliniká   22/04/2016    
Measures to avoid medication errors with Exjade EN = English   22/04/2016    
Measures to avoid medication errors with Exjade FR = français   22/04/2016    
Measures to avoid medication errors with Exjade IT = italiano   22/04/2016    
Measures to avoid medication errors with Exjade LV = latviešu valoda   22/04/2016    
Measures to avoid medication errors with Exjade LT = lietuvių kalba   22/04/2016    
Measures to avoid medication errors with Exjade HU = magyar   22/04/2016    
Measures to avoid medication errors with Exjade MT = Malti   22/04/2016    
Measures to avoid medication errors with Exjade NL = Nederlands   22/04/2016    
Measures to avoid medication errors with Exjade PL = polski   22/04/2016    
Measures to avoid medication errors with Exjade PT = português   22/04/2016    
Measures to avoid medication errors with Exjade RO = română   22/04/2016    
Measures to avoid medication errors with Exjade SK = slovenčina   22/04/2016    
Measures to avoid medication errors with Exjade SL = slovenščina   22/04/2016    
Measures to avoid medication errors with Exjade FI = suomi   22/04/2016    
Measures to avoid medication errors with Exjade SV = svenska   22/04/2016    
Measures to avoid medication errors with Exjade HR = Hrvatski   22/04/2016    
Educational brochure and video to be given to healthcare professionals to ensure Obizur is used correctly (English only)   15/12/2015    
Measures to avoid medication errors with Blincyto (English only)   08/12/2015    
Measures to ensure that Ionsys is handled and used correctly (English only)   30/11/2015    
Compliance card to be given to patients using Farydak - Compliance card will ensure correct use and avoid medication errors (English only)   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance BG = bălgarski   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance ES = español   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance CS = čeština   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance DA = dansk   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance DE = Deutsch   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance ET = eesti keel   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance EL = elliniká   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance EN = English   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance FR = français   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance IT = italiano   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance LV = latviešu valoda   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance LT = lietuvių kalba   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance HU = magyar   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance MT = Malti   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance NL = Nederlands   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance PL = polski   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance PT = português   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance RO = română   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance SK = slovenčina   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance SL = slovenščina   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance FI = suomi   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance SV = svenska   27/11/2015    
Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance HR = Hrvatski   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins BG = bălgarski   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins ES = español   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins CS = čeština   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins DA = dansk   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins DE = Deutsch   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins ET = eesti keel   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins EL = elliniká   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins EN = English   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins FR = français   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins IT = italiano   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins LV = latviešu valoda   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins LT = lietuvių kalba   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins HU = magyar   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins MT = Malti   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins NL = Nederlands   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins PL = polski   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins PT = português   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins RO = română   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins SK = slovenčina   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins SL = slovenščina   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins FI = suomi   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins SV = svenska   27/11/2015    
Guidance on prevention of medication errors with high-strength insulins HR = Hrvatski   27/11/2015    
European Medicines Agency recommends measures to ensure safe and effective use of Strensiq (English only)   26/06/2015    
Questions and answers on recommendations to prevent administration errors with Velcade (bortezomib) (English only)   20/01/2012