Direct reporting by patients of drug side effects provides useful information

Medical practitioners can report side effects of drugs to the Netherlands Pharmacovigilance Centre Lareb, and since April 2003 patients have also been allowed to report them directly to Lareb. Florence van Hunsel’s research shows that patients’ contributions provide useful information on the impact of side effects on quality of life and help to identify as yet unknown side effects. Lareb has launched a campaign to increase public awareness of the reporting facility. Van Hunsel will be awarded a PhD on 18 November 2011 by the University of Groningen.

The Netherlands Pharmacovigilance Centre Lareb records and analyses all reports of drug side effects that it receives from professionals such as GPs and hospital pharmacists with the aim of identifying unknown side effects. Since 2003 patients have also been able to report side effects of their medication to Lareb via the Internet.

Debate

Allowing patients to report side effects is not something that has always been taken for granted. In the past there has been debate about the added value of patients voluntarily reporting drug side effects. As Van Hunsel notes, ‘The question was whether the reports would add any useful information to the system.’ To answer that question Van Hunsel subjected the voluntary side effects reporting system to an in-depth evaluation.

Quality of life

In her study Van Hunsel compared the drug side effects recorded by professionals with those reported directly by patients. She discovered that patients’ reports often coincided with those from professionals and sometimes provided useful additional information. Van Hunsel explains: ‘Professionals report side effects to Lareb from their clinical point of view, and they can also send in results of lab tests if they wish. Reports by patients sometimes supplement that information with an understanding of how the side effects affect their daily lives.’ These reports also enable new side effects to be identified and drug safety to be improved.

Value

The number of reports by patients rose from 4% in 2003 to just under 16% in 2010. Most patients share their experience out of altruism, in the hope that other people will be spared similar side effects. The voluntary reporting facility gives patients more confidence in drug treatment and enables them to make a valuable contribution to drug safety. But as Van Hunsel notes, ‘It’s a shame that many patients don’t realize they can report side effects directly. Lareb has therefore launched a PR campaign to increase public awareness of this.’

European Union

These research results are particularly significant now that new European legislation will require Member States to set up national recording centres for patients to report drug side effects. Van Hunsel says that few European Member States currently have good recording systems for patients. The Dutch system works well, so it can serve as a model for other Member States.

Curriculum vitae

Florence van Hunsel (Heerlen, 1981) studied Pharmacy at Utrecht University. Since 2005 she has been working as a researcher at the Netherlands Pharmacovigilance Centre Lareb and as an external PhD student in the Pharmacotherapy and Pharmaceutical Patient Care research group at the University of Groningen. During her PhD research project she gained a Master’s degree in Epidemiology from VU University Amsterdam. Florence van Hunsel will be awarded a PhD on 18 November 2011 for her thesis The contribution of direct patient reporting to pharmacovigilance. Her supervisors are Prof. A.C. van Grootheest and Prof. LT.W. de Jong-van den Berg.

Note for the press

Contact information: Lareb Secretariat, tel. 073-646 9700, or Florence van Hunsel, tel. 073-646 9708, e-mail: florence.vanhunsel gmail.com.