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Adverse Reaction Reporting and IMMP

Pharmacovigilance in New Zealand

What is pharmacovigilance?
Centre for Adverse Reactions Monitoring
Medicines Adverse Reactions Committee
Medsafe

 

What is pharmacovigilance?

Pharmacovigilance is the process of identifying and responding to medicine safety issues. The goal of the process is the safer use of medicines, and this is usually achieved by dissemination of accurate, timely and clinically relevant information.

Three bodies are involved in pharmacovigilance activities in New Zealand, the Centre for Adverse Reactions Monitoring (CARM), the Medicines Adverse Reactions Committee (MARC) and Medsafe.

Centre for Adverse Reactions Monitoring (CARM)
PO Box 913, Dunedin    Phone (03) 479 7247, Fax (03) 479 7150
E-mail: carmnz@stonebow.otago.ac.nz

CARM receives reports of adverse reactions to medicines occurring within New Zealand. Most reports are sent by medical practitioners, but reports are also received from pharmacists (hospital and community), nurses, dentists and members of the public. A response is sent to each report, and some reports result in a Danger or Warning being entered against the patient’s name in the National Health Index.

The Centre maintains a database of adverse reaction reports going back to 1965, and has a link to the international database of adverse reactions held at the WHO Collaborating Centre in Uppsala, Sweden. New Zealand has one of the highest rates of reporting of adverse reactions.

CARM is located in Dunedin at the Otago Medical School. It operates under contract to Medsafe.

Medicines Adverse Reactions Committee

The MARC is a ministerial advisory committee which makes recommendations on appropriate action to be taken on medicine safety issues.

Members of the Committee are practising medical practitioners in a range of speciality areas, including general practice, and one clinical pharmacist. The agenda material of MARC is largely reports received by CARM and articles from the international medical literature. However, the Committee also obtains comment from New Zealand specialists, reports from pharmaceutical companies and regular publications from the WHO and overseas regulatory bodies.

The most frequent recommendation is for an article about an issue to be published. Other common recommendations include asking a company to update a medicine data sheet with new safety information, contacting a professional body or a pharmaceutical company for comment on an issue, and writing to hospital medicine review committees.

Medsafe

The role of the pharmacovigilance staff at Medsafe is to ensure that medicine safety issues are adequately dealt with in a timely fashion. Achieving this objective involves working closely with the staff of CARM for issues of importance, providing an interface between CARM and MARC, preparing agenda material for MARC, publishing articles on medicine safety, ensuring recommendations of MARC reach a satisfactory conclusion, and responding to queries from the media, medical practitioners and members of the public.