E-DRUG: specific drug safety issues for developing countries?
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dear E-druggers,
From 30 August - 1 September a meeting of the Drug Information Association
(DIA) will be held in Johannesburg, South Africa on the topic of drug
safety. Drug regulators, industry and academia will discuss how drug safety
can be improved. As the meeting takes place in a developing country, this
is maybe a good opportunity for E-druggers to consider the specific needs
of developing countries in drug safety.
Traditionally, developed countries use spontaneous Adverse Drug Reaction
(ADR) reporting and Phase IV / post-marketing surveillance systems (PMS) to
find new, serious and rare side effects. Clinical trials are typically done
on only 1500 people, and this is too small a sample to find rare
side-effects. So the rare side-effects of most drugs are not yet (publicly)
known during registration.
Should developing countries do ADR and PMS as well (as a low priority?) or
should they be doing something different? ADR and PMS are difficult to
implement, cost money, and typically address the problems of New Chemical
Entities (NCEs). Maybe developing countries should leave the safety testing
of most of the NCEs to the developed world, and concentrate on OCEs (Old
Chemical Entities, or better known as generic essential drugs) and a NCEs
that are directly relevant for developing countries (HIV, TB, malaria,
(tropical) diseases of poverty)?
Are rare or unknown ADRs a priority for developing countries? Most probably
they suffer much more from known ADRs of essential drugs. Irrational
prescribing, medication errors and lack of compliance might cause a much
bigger problem than the rare or unknown ADRs. Obviously, we should monitor
for specific genetic problems (G6PD) and co-morbidity / drug-disease
interactions with HIV, TB and malaria.
ADR reporting systems are very passive and have extremely low coverage.
Maybe developing countries should become more pro-active and start active
pharmaco-vigilance systems. Communicating known ADRs to prescribers,
pharmacists and consumers could be more relevant than searching for (yet)
unknown ADRs.
Finally, in the USA 106,000 people die every year from ADRs. How many would
die in developing countries where there are far less health workers and
most drugs are taken OTC or UTC (under the counter) rather than on
prescription. We need much more operational research into this!
Your comments and thoughts are welcome; please participate virtually: I can
summarize your viewpoints wednesday 1 september to the DIA participants.
kind regards
Wilbert Bannenberg
SA Drug Action Programme
South Africa
Email: WilbertBannenberg@compuserve.com
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