Rwanda, Tanzania, Ethiopia and Kenya have launched a programme to monitor drugs released into the market.
Under a project, dubbed “Pharmacovigilance Infrastructure and Post-Marketing Surveillance System Capacity building for Regional Medicine Regulatory Harmonisation,” participating countries will train pharmacists and other medical personnel on safety, particularly the collection, analysis, monitoring and prevention of adverse effects of drugs and therapies.
Under a project, dubbed “Pharmacovigilance Infrastructure and Post-Marketing Surveillance System Capacity building for Regional Medicine Regulatory Harmonisation,” participating countries will train pharmacists and other medical personnel on safety, particularly the collection, analysis, monitoring and prevention of adverse effects of drugs and therapies.
A
consortium that has been formed will build partnerships between local
academic institutions and national medicine regulatory authorities as it
seeks to strengthen the region’s drug safety and post-marketing
surveillance system for medicines.
Among the drugs the
project is expected to monitor are the HPV vaccine rollout in Ethiopia
and a mass drug administration campaign targeting lymphatic filariasis
or elephantiasis in the Coastal counties of Kenya.
According
to Prof Ellen Aklillu of the Karolinska Institutet — one of the partner
in the project — little is known about the safety levels of drugs
released for large-scale use on the continent after clinical trials
targeting a small population.
Additionally, the drugs
were often given to target populations in mass drug administration and
vaccination campaigns without pre-screening.
“Drugs are
given, and no follow-up is done on each individual. We need to find out
what happens for instance if a patient is taking drugs for TB and he or
she has other conditions,” said Prof Aklillu.
She added that areas to be monitored will include how the drug
interacts with pregnant women, breastfeeding mothers, children and the
elderly.
She said variation in people’s genetic make-up
was very wide, and that drugs were not likely to react with all of them
the same way, necessitating the need for comprehensive and wide
monitoring of the their use.
Warning
In
June, the US Food and Drugs Administration and the European Medicines
Agency warned against the use of antiretroviral medication Dolutegravir,
also known as Tivicay, by pregnant HIV-positive women.
In
response to the warning, the Kenyan government directed county
governments not to give the drug to pregnant women with HIV in the first
trimester or those hoping to conceive.
Director of
Medical Services Jackson Kioko also instructed county health directors
to give Efavirenz, a first-line treatment, to women of childbearing age.
He said DTG, also known as Tivicay, was not recommended for pregnant and breastfeeding women “due to limited safety data."
The
World Health Organisation guidelines released in 2016 recommend
Efavirenz, also known as Sustiva, as the preferred option in pregnancy.
The
project is funded by the European-Developing Countries Clinical Trials
Platform, which is a funding mechanism under the EU's Horizon 2020
research programme.
Other partners include the Swedish Karolinska Institutet, the Dutch Stichting Lareb, and the University of Nairobi.
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