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Risk minimization educational materials

The results of the survey on additional risk management measures' materials


Article by Estonian colleagues on measuring effectiveness of risk minimisation measures in Estonia using large volume e-health data


As part of the collaboration agreement between medicines agencies in the Baltic States, we publish an original article by our Estonian colleagues regarding the use of large volume e‑health data in assessing the effectiveness of risk minimisation measures for medicines Measuring effectiveness of risk minimisation measures in Estonia using health care databases”. The article was created during the Estonian Presidency of the Council of the European Union.

The authors of the article are employees of the State Agency of Medicines of Estonia – Katrin Kurvits, aRMM assessment specialist, Maia Uusküla, Member of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, Head of the Bureau of Pharmacovigilance, and Ott Laius, Head of the Department of Post-authorisation Safety.

In the article, the authors emphasise the following with regard to availability and analysis of electronic prescription data:

“To evaluate whether Risk minimisation measures (RMMs) serve their purpose, the knowledge on how the drug is used in clinical practice is necessary. Health care databases provide good opportunity for that – they contain data on large number of patients over many years, data are readily available and can be analysed rather quickly. Increasing variety of data available enhances the possibility to perform more in-depth studies.”

The article was also published in the latest issue of “Cito!” (4/2017 (71)) (in Latvian), the State Agency’s of Medicines publication for doctors, pharmacists and other healthcare specialists.