Keeping Track of Adverse Reactions

19 November 2009 (Last Updated November 19th, 2009 18:30)

Denmark is pushing drug monitoring beyond release to market. Natalie Coomber discovers more, ahead of Arena International's Pharmacovigilance and Risk Management conference in December.

Keeping Track of Adverse Reactions

Post-marketing surveillance is no easy task and one so complex inevitably comes with a high price tag. Engaging health practitioners and consumers into reporting when a particular drug results in an adverse reaction is merely the crucial first stage in a long battle.

Ahead of VIBpharma's Pharmacovigilance and Risk Management event being held on 1 and 2 December in Brussels, Belgium, Natalie Coomber spoke with Danish Medicines Agency chief medical officer, consumer safety division and Pharmacovigilance Working Party delegate, EMEA Doris Stenver to discuss the leading approach that Denmark has implemented and its plans for increasing awareness in future.

Natalie Coomber: What strategy is Denmark taking to improving its approach to pharmacovigilance (PV)?

Doris Stenver: We have a national action plan that was launched by our Minister of Health in January 2009.

The major objective for that plan is to achieve an overall improvement of PV in Denmark with the contribution of all relevant stakeholders, healthcare practitioners, pharmacies and patient organisations.

"We need to improve the reporting of adverse drug reactions as we have severe underreporting."

NC: What areas of PV need improving in Denmark?

DS: We need to improve the reporting of adverse drug reactions as we have severe underreporting. This is an international phenomenon but we would like to increase the awareness of Danish healthcare professionals of their particular role in the whole system.

NC: Do you think there is enough engagement with hospital doctors to encourage them to report adverse reactions?

DS: One of the aims of the Danish national action plan is to increase the awareness of hospital doctors because there have been a decreasing number of reports from this sector. This is very worrying as new drugs are introduced in the hospital setting.

In the coming months we will launch a campaign within hospitals to get more reports from this group of doctors. We are piloting this now but from the start of 2010 we will run this out over selected hospitals.

NC: What are the next steps once a drug has been reported?

DS: There is a Danish national database where the information is collected and within 15 days we must report any serious adverse reaction to the EU centralised database. The pharmaceutical company will receive a report from the national authorities and it is obliged to prepare a periodic safety update report.

It must then comment on the adverse events including whether there is a need to update the labelling. Questions must be asked as to whether any new information in the report could change the way we look at the risk benefits of the product. If that is the case, ways to minimise the risk must be identified.

NC: What strategies are there for minimising the risk?

DS: Information may have to be added in the summary of product characteristics. For instance, information may be needed that says a particular patient group should not use the medication if they are of a particularly high risk.

"Denmark was the first EU country that had a legal basis for direct consumer reporting to our agency."

NC: With so many new drugs being launched have you noticed an increase in the number of adverse drug reactions taking place?

DS: It is not possible to make a simple relationship between the number of new medicinal products launched and the number of adverse reactions. An increase in the awareness of reporting adverse reactions in one country will dramatically alter the number of adverse reactions reported, for instance. There may also be technological factors such as if a reporting system becomes an integrated part of a hospital network's technology.

NC: How does the Danish approach to PV vary from other EU countries?

DS: Denmark was the first EU country that had a legal basis for direct consumer reporting to our agency. We did so in 2003 and this consumer reporting is likely to be used as the EU standard when the European Commission proposal for PV legislation is passed. There are many initiatives across the EU where we can share workload, learn from each other and minimise resource expenditure.