Regional countries move to monitor drugs released into market

Thursday November 01 2018

Fake medicine. Four countries in the region have launched a programme to monitor drugs released into the market. PHOTO | FILE | NMG


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.

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.


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.