Published: 7 October 2013
No day is ever the same. Whether it be answering queries from consumers, healthcare professionals or the Minister’s Office, preparing articles for publication, or researching safety issues, a pharmacovigilance advisor has a significant and varied role in protecting the health of New Zealanders.
One of our most important tasks is identifying medicine related safety issues. These issues arise from a variety of sources, such as reports submitted to the Centre for Adverse Reactions Monitoring (CARM), clinical trials, journal publications, consultation with other regulatory agencies, and reports submitted by pharmaceutical companies.
With so many important safety issues coming to our attention, we prioritise these within the New Zealand context to minimise any associated harm and to ensure any new safety information or recommendations are promptly communicated.
As well as researching and investigating safety issues, we also inform the Minister of Health on safety issues and respond to queries from the media. Reports must also be prepared for the Minister of Health’s expert advisory committee. We are always trying to improve pharmacovigilance in New Zealand by developing new tools such as the Early Warning System and Suspected Medicine Adverse Reaction Search.
All of these safety issues must be communicated effectively. Safety information is predominantly communicated by updating data sheets and consumer medicine information. However, Dear Healthcare Professional letters or direct website updates are also used. Additionally, articles are contributed to Prescriber Update, a free publication produced quarterly for healthcare professionals to inform on the safer, more effective use of medicines and medical devices. We are now looking forward to seeing how the Early Warning System will help us with our communications.
The pharmacovigilance team, as part of clinical risk management, works closely with other sections of Medsafe including compliance, product regulation and border control.
As medicines evaluators, it is our job to assess the safety, quality, and effectiveness of all medicines proposed for supply in New Zealand. We also assess any changes to currently supplied medicines in New Zealand.
Medicines evaluators assess the medicines through extensive analysis of data supplied by the organisation that wishes to supply the medicine in New Zealand. The data can be as little as a few pages for a minor change or boxes full of dossiers for new medicine applications.
Depending on the change, we could be evaluating such aspects as:
Each evaluation requires assessment against appropriate international guidelines and is often completed through a question and answer process with the applicant.
As a medicine evaluator, most work is pre-market assessment, evaluating the new or changed medicine before it reaches the market. We work closely with many of the other branches of Medsafe, such as clinical risk and compliance, to ensure New Zealanders get the best possible access to safe and effective medicines.