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Risk management materials and clinical work – do they meet?

Nordic pharmacovigilance experts gathered in Oslo for the traditional pharmacovigilance seminar at the beginning of April. Availability of risk management materials and electronic systems were much-discussed topics at the event.

According to a Danish survey conducted in 2013, up to one-third of healthcare professionals were only somewhat aware or not at all aware of risk management materials related to medicines, or even read such materials.

– Risk management materials should be easily accessible and take up as little time of actual clinical work as possible,’ says Anu Gummerus, pharmacovigilance expert at DRA who also attended the seminar.

Risk management materials include training materials, information leaflets for physicians and patients, patient reminder cards and various medicine-related checklists. With regard to medication safety, it would be important that such materials are utilised in full also in clinical work by healthcare professionals and in the patients’ everyday life.

In addition to the lectures, highlights at the seminar included discussions between colleagues from the pharma industry and the authorities. DRA was represented by pharmacovigilance experts Anu Gummerus and Niina Suni and marketing manager Kenneth Hollmén.

All Nordic countries share an intent to have risk management materials available in electronic format in near future, to ensure that care staff and patients have access to up-to-date information at the right time. This intent was demonstrated strongly at the seminar.

– It was also interesting to find out how practices differ across the Nordic region. In Norway, risk management materials are distributed via the patient information system, while Finland lags behind: here, healthcare professionals are sent materials either as paper copies by post, or by e-mail,’ Anu Gummerus explains.

Not surprisingly, a Fimea representative present at the seminar noted that in Finland, healthcare professionals also look forward to the integration of risk management materials with the patient information system.

Reform of pharmacovigilance reporting systems underway

Electronic systems were also discussed in other contexts. The Swedish Medical Products Agency (MPA) described the reform of the database for reporting adverse drug reactions associated with medicines for human use. The large amount of data already in the database (including the names and pharmaceutical forms of all medicines) makes recording adverse reactions easier and clearer for the reporting party and the party receiving the report. A similar project aimed at harmonising various registers and collecting information is underway in Norway.

‘Hopefully we will also see measures which facilitate reporting of adverse reactions in Finland, for example a similar database reform, or perhaps an app for smartphones,’ says Niina Suni, pharmacovigilance expert at DRA.

Pharmacovigilance inspections reveal deficiencies

The MPA gave a presentation on pharmacovigilance inspections conducted by the Agency and related observations and findings. In 2019, the MPA carried out 11 inspections, identifying nine critical findings and 162 major findings. The critical and major findings concerned for example partial lack of pharmacovigilance systems, quality issues, QPPV tasks or signal management. In addition, 135 minor findings were recorded. These figures indicate that there is still work to be done in pharmacovigilance.