Wisdom to share on medicine safety

David Coulter
David Coulter
Increasing international demand for monitoring the safety of medicines is music to the ears of Dunedin's Dr David Coulter, but he knows there is still a long way to go.

Many New Zealanders would not be aware that New Zealand was regarded as a world leader in medicine safety monitoring or pharmacovigilance, far ahead of countries such as the United States.

In recent years, Dr Coulter (76) has drawn on his background in pharmacovigilance in New Zealand to undertake voluntary work with the World Health Organisation, helping to set up medicine safety monitoring programmes, known as cohort event monitoring (CEM) in African countries.

Last year, he went to Tanzania to undertake training for a CEM programme there for antiretroviral medicines used in the treatment of HIV Aids.

CEM is much more thorough than spontaneous reporting of reactions to drugs because it requires health professionals to answer detailed questions about all patients taking a particular medicine.

It is estimated between 10,000 and 15,000 patients are enough to indicate whether there are problems with a medicine.

Much of spontaneous reporting was guesswork and could lead to people coming to incorrect conclusions on insufficient data, Dr Coulter said.

Spontaneous reporting probably picked up only about 5% of the data needed and was unlikely to include minor reactions which could be a prelude to something "much more serious" which could reveal itself later.

One of the issues in monitoring medications in poor countries was working out how medicines being taken for, say, HIV Aids affected people when they might have a variety of other conditions, such as malaria, malnutrition, tuberculosis, or anaemia.

They could also be taking several different medications.

A CEM programme was likely to be introduced in the Ukraine this year, Dr Coulter said.

It would be the first European country to have such a programme, and he hoped it would lead to programmes in other countries, as the European Union had made a large grant to the World Health Organisation for the development of medicine monitoring in European developing countries.

Asked why most countries had not introduced CEM, Dr Coulter said there was a perception that it was too costly, but that had to be put alongside the much greater cost of adverse drug reactions.

In the United States, which does not have CEM, one study estimated adverse reactions to medicine were in the top six causes of death.

Perceived problems with privacy were another reason some developed countries were reluctant to introduce CEM, but such questions had been dealt with in New Zealand by ensuring people were properly informed about what was involved.

Dr Coulter said, in his experience, in cohorts totalling half a million people, he only recalled one person asking to opt out of a monitoring programme.

Generally, people appreciated the efforts to improve the safety of medicines.

In the coming year, Dr Coulter will be attending a three-day meeting in Geneva of the WHO advisory committee on the safety of medicinal products which will be looking at the development of programmes.

His enthusiasm for spreading the word is not waning.

"I think it would be a tremendous waste if I didn't pass on what we've learned and what we know works. It is a big encouragement in itself, seeing that the methodology used and developed for us can be used in other countries, and to suit local conditions."

elspeth.mclean@odt.co.nz

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