Pharmacovigilance of new drugs ‘should be more proactive’ in New Zealand

Pharmacovigilance needs to be stepped up in New Zealand, leading expert has warned

The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand by the country’s Centre for Adverse Reactions Monitoring (CARM) needs to be more proactive, warns a leading expert.

The nation’s “passive system of pharmacovigilance”, should be upgraded to a more active approach, argued Professor Kevin Dew, of Victoria University’s Department of Social and Cultural Studies.

“To enhance pharmacovigilance in situations where adverse drug reactions are a major cause of death, we need to think outside the box,” wrote Prof Dew in a commentary on New Zealand’s Newsroom website. “People given prescription drugs need to know who to report concerns about the drug to, and how to do so. Pharmacovigilance agencies like CARM should be resourced so they can take a more active role in identifying potential post-marketing problems, such as accessing (with permission) the online posts of patient support groups to see if there are any leads.”

While pharmaceutical manufacturers spend many millions on clinical trials, in order to access drugs for safety and effectiveness, the absolute test of a drug’s safety and effectiveness came after its launch, he said.

Interactions a new formulation may have

Many drug trials were said not to provide for the testing of all possibilities, such as interactions a new formulation may have with other drugs, or potential adverse effects on some groups of people who were not included in the trials.

New Zealand’s passive system of pharmacovigilance relied on CARM receiving reports of potential problems through voluntary reporting. But the Centre did not proactively seek potential problems that may be linked to new drug launches.

Passive system of pharmacovigilance

Prof Dew claimed few people who were not health professionals knew about CARM and if they encountered a problem linked to drug, they would probably inform their GP or other health professionals. Worldwide, the side effects to medications were significantly under-reported by health professionals, according to research, he added.

Canvassing the views of health professionals could significantly enhance pharmacovigilance, as revealed by the case of the drug Eltroxin, used to treat hypothyroidism, Prof Dew said. Monitoring regional newspapers and other media outlets could also help to improve standards of pharmacovigilance.

Read Prof Dew’s full article here.

Meanwhile, in May, the European Medicines Agency sent the European Commission its first report on the tasks undertaken during the first year of application of the EU’s new pharmacovigilance legislation.