Making fewer medication errors – Education and training remain key

In focus / 02 April 2024

Medication errors significantly contribute to the global number of ADRs per year. How may we best prepare the pharmacovigilance community to tackle the problem?

The Institute of Medicine report “To Err is Human: Building a Safer Health System,” published in 1999, estimated that 98,000 people die each year from medical errors in the US. Of these, many errors were related specifically to medications. Since then, there have been many international and national efforts to reduce this avoidable harm. While global progress on the matter is difficult to ascertain as there is no uniform collection of data or harmonised definition of medication error, national estimates of medication errors do exist for some countries. In the UK for example, a Quality Commission in England study from 2022 estimated that 237 million medication errors occur at some point in the medication process in England per year, and that NHS costs of definitely avoidable ADRs are £98.5 million per year, consume 181,626 bed-days, causes 712 deaths, and contributes to 1,708 deaths in England alone.


About the Medication Errors Special Interest Group

In response to the World Health Organisation’s Global Patient Safety Challenge, the International Society of Pharmacovigilance (ISoP) established the Medication Errors Special Interest Group (SIG-ME) in 2017 under the leadership of Dr Brian Edwards and Ms. Angela Caro. The SIG acts as a forum for the exchange of knowledge, technology, and experience between ISOP members in different countries. Currently, the SIG has about fifty members, holds monthly meetings, and holds presentations which can be viewed on the ISoP YouTube channel.


Many factors contribute to this problem, one of which is the consistency and precision of the coding of medication errors. For example, a sub-group within the special interest group on medication errors (SIG-ME) conducted a study investigating the accuracy and consistency of MedDRA® medication error coding practices in healthcare dictionaries. Their analysis of a sample of MedDRA® coded reports on medication errors for COVID-19 vaccines found that two-thirds of the reports were either unclear, incomplete, or inadequately coded. The researchers concluded that further training about medication errors and reinforcing MedDRA® coding guidelines is required to improve medication error reporting. The sub-group now intends to map MedDRA with healthcare coding dictionaries to help with systematic data collection.

ISoP believes more attention needs to be paid to medication error prevention, and we at the SIG-ME aim to address this by developing education and training opportunities for all involved in advancing medicine safety. One of our many training initiatives that ISOP will develop will be based on the revised guidance in the good pharmacovigilance practice (GVP) Module XVI Risk Minimisation measures. We have also liaised with the American Programme for Pharmacovigilance (Am2P) to create a medication errors module and SIG-ME participates in training at the ISOP Annual Meetings. Finally, the SIG-ME is the lead SIG in arranging Global Patient Safety Day for ISoP, comprising free presentations from around the world which are open to members and non-members alike to attend.


Given that safety is determined by human performance, designing processes with the people at the centre is critical for a quality system. By systematically addressing those human factors which contribute to medication errors, ISoP believes this is the most effective approach to achieving the WHOs ambitious goal of reducing medication errors by 50%.

That is why ISoP’s latest collaboration with the healthcare technical committee of the International Ergonomics Association (IEA) is so important. Currently, there are human factors experts investigating and applying solutions to reduce medication errors, but no coordinated global network with a focus on those in pharmacovigilance. The collaboration intends to develop education and training on the application of the science of human factors to risk minimisation, as well as human factor studies specifically for drug devices.

One project involving the IEA is training for the role of the medication safety officer (MSO), who champions the priority, integration, and implementation of safe medication practices across a healthcare institution. By involving IEA, ISoP plans to design a specific curriculum for MSOs targeting pharmacists practicing in hospital and primary health care settings. By building on and learning from the MSO experience in the US, UK and elsewhere, ISoP is keen to encourage the global expansion of this role to other countries. ISOP is planning a webinar between the UK, Ireland, and Egypt chapters to discuss this further.

Lastly, collaboration and cooperation with like-minded partners will go far in reducing medication errors worldwide. ISoP has joined forces with other institutes focusing on medication errors such as the Institute Safe Medication Practices (ISMP) and European Collaborative Action on medication errors and traceability (ECAMET). ISoP is an associate member of the International Medication Safety Network (IMSN) and has contributed to two IMSN projects. The first concerns the safe use of oxytocin in pregnancy, whereas the second project focuses on the safety of neuromuscular blockers, considered high-alert medications, as they carry a heightened risk of causing significant patient harm when used in error.

ISoP will continue to include topics about medication errors in the academic events of the society such as at the ISoP Annual Meeting in Montreal in early October 2024 this year, as well as the free access virtual Patient Safety Day in September. If you want to know more about previous ISoP activities, please visit our webpage and YouTube Channel. We would also be delighted if you wish to join us in the Society and SIG-ME. Your volunteering can make a difference!


Read more:

Institute of Medicine. To Err Is Human: Building a Safer Health Care System. National Academies Press; 1999.

RA Elliott, E Camacho, D Jankovic, MJ Sculpher, R Faria, "Economic analysis of the prevalence and clinical and economic burden of medication error in England", BMJ Quality & Safety, 2021.

The SIG-ME YouTube channel –

Am2P courses –

The Healthcare Systems Ergonomics and Patient Safety conference –

K Kralova, CA Wilson, N Richebourg, J D’Souza, “Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data”, Drug Safety, 2023.

CA Gonzalez, et al., “Estimating the impact of label design on reducing the risk of medication errors by applying HEART in drug administration”, European Journal of Clinical Pharmacology, 2024.

IMSN Oxytocin Safety Interest Group Recommendations for Global Implementation Safe Oxytocin Use Practice.

Brian Edwards
Vice President, ISoP

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