Published: 8 June 2018

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The Medsafe Files – Episode Six: Global Pharmacovigilance

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Prescriber Update 39(2): 29-30
June 2018

Introduction

Before a medicine is marketed, experience of its safety and efficacy is limited to use in clinical trials. Typically, these trials involve a few hundred to a few thousand carefully selected individuals.

Some adverse reactions occur only rarely and do not become apparent until the medicine has been used by a much larger and more diverse population. A single country such as New Zealand may not have sufficient use of a medicine to be able to detect rare adverse drug reactions or reactions that occur only in certain risk groups. By pooling adverse reaction reports from many countries in a single database, it is possible to identify emerging safety signals relatively quickly.

This information helps to build a more complete safety profile of the medicine, enabling healthcare professionals and consumers to make well-informed therapeutic choices.

History of the WHO PIDM

Following the thalidomide disaster of the late 1950s to early 1960s, the World Health Organization (WHO) initiated a global monitoring system to detect early signs of possible harms caused by medicines after their release for general use¹.

A three-year pilot project was set up in 1968 to determine the feasibility of a global adverse drug reaction (ADR) reporting programme. After a successful pilot phase, the WHO formally established the WHO Programme for International Drug Monitoring (PIDM)^2,3.

In 1978, the Uppsala Monitoring Centre (UMC) was established in Sweden to maintain the international database of Individual Case Safety Reports (ICSRs) Vigibase on behalf of WHO.

Now in its 50th year, the WHO PIDM comprises 131 full member countries, with a further 26 countries registered as associate members. As at May 2018, VigiBase contains over 17 million ICSRs.

More information on the WHO PIDM is available on the WHO website. (www.who-umc.org/).

How the WHO PIDM works

National pharmacovigilance centres from participating countries, including New Zealand’s Centre for Adverse Reactions Monitoring (CARM), collect and assess reports of adverse drug reactions, and submit the anonymised reports to VigiBase.

National medicines regulatory authorities and/or pharmacovigilance centres of participating countries can use VigiBase to support their investigation of local medicine safety issues.

UMC periodically screens VigiBase for emerging signals. Signals are often detected earlier in Vigibase than smaller local databases. These signals are communicated to the national pharmacovigilance centres of participating countries for local review.

Signals identified in VigiBase are published in the WHO Pharmaceutical Newsletter (www.who.int/medicines/publications/newsletter/en/). This newsletter also contains information on safety issues and regulatory action taken by countries participating in the WHO PIDM.

VigiBase data is also publicly available (www.vigiaccess.org/).

How does New Zealand benefit?

Membership of the WHO PIDM enables New Zealand to participate in a global pharmacovigilance network that facilitates information sharing about emerging medicine safety issues.

A key benefit is access to VigiBase, a valuable resource used by CARM and Medsafe for investigating medicine safety issues.

Membership enables New Zealand to contribute to the annual work programme and priority setting of the WHO PIDM and provides a platform for sharing new initiatives and learning from other countries’ experiences.

New Zealand’s participation in the WHO PIDM helps Medsafe to respond rapidly to emerging medicine safety issues, to ensure that the benefit-risk balance of medicines approved for use in New Zealand remains favourable.

References

1. World Health Organization. 1963. 16th World Health Assembly, Part 1: Resolutions and Decisions. Geneva: World Health Organization.
2. Venulet J, Helling-Borda M. 2010. WHO's international drug monitoring – the formative years, 1968–1975: Preparatory, pilot and early operational phases. Drug Safety 33(7): e1–e23.
3. Kunac DL, Harrison-Woolrych M, Tatley MV. 2008. Pharmacovigilance in New Zealand: the role of the New Zealand Pharmacovigilance Centre in facilitating safer medicines use. New Zealand Medical Journal 121(1283): 76–89.