News Category: Regulatory news
Tuesday 2 May 2017: Doctors across Europe can now learn more about the importance of reporting suspected adverse drug reactions (ADRs) via a free e-learning module. Prompt reporting helps to make medicines safer and is part of a doctor’s responsibility. This includes informing patients and carers on how they can help by reporting suspected side effects themselves.
Regulators like the Health Products Regulatory Authority (HPRA) rely on the reporting of suspected ADRs to make sure medicines on the market are acceptably safe. However, all reporting systems suffer from underreporting, and training healthcare professionals to report suspected ADRs is important to both raise awareness and to help to strengthen the system.
The e-learning module has now received the highest order of accreditation from the European Accreditation Council for CME (EACCME®). This means doctors are awarded 1 EACCME credit upon completion of the 45 minute ADR e-learning module. The ADR e-learning module was created by the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. A survey conducted by SCOPE found that many European countries lacked sustainable educational materials about ADR reporting. This e-learning aims to support healthcare professionals and medicines regulators by providing clear guidance which is rewarded with CME/CPD points.
Dr. Joan Gilvarry, Director of Human Products Monitoring at the HPRA, said: “The key aim of our work is to make sure medicines are effective and acceptably safe. The reporting of suspected ADRs is vital in helping us achieve this aim. Doctors are critical to this as their position on the front line of care means they are often the first to recognise an adverse drug reaction. We’ve created this e-learning module to help doctors so they can have confidence that their reports are making a difference.
“All healthcare professionals, and indeed patients themselves, can help to make medicines safer by reporting any suspected side effects easily and quickly through our online report form which is available on our website www.hpra.ie. Other countries collect reports in similar methods.”
Notes to Editor
- This is a link to the e-learning module hosted on the SCOPE website. Learners are asked to complete a short survey upon completion of the e-learning.
- National reporting systems for the collection of suspected adverse drug reactions (commonly known as side effects) have acted as early warning systems to help identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until reports were received by medicines regulators.
- It is the role of the HPRA to protect and enhance public and animal health by regulating medicines, medical devices and other health products. Our aim is to make sure that the health products we regulate are as safe as possible and do what they are intended to do.
- The SCOPE Joint Action project aims to support EU member states in the operation of their pharmacovigilance systems which help safeguard public health. It is funded through contributions from European Commission and the involved Member States.
- The SCOPE Joint Action project social media campaign to raise awareness levels of national ADR reporting systems is being taken forward through the Heads of Medicines Agencies Working Group for Communications Professionals.
- The European Union of Medical Specialists (Union Européenne des Médecins Spécialistes – UEMS) is a non-governmental organisation representing national associations of medical specialists in the European Union and in associated countries. Current membership includes 37 countries.