Kenya goes digital to report drug-safety issues

Two blister packages of artesunate; the one on the right is genuine, the other is counterfeit Copyright: CDC

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[NAIROBI] Kenya has developed an electronic reporting system to speed up the tracking of adverse drug effects and substandard medicinal products.

The Pharmacovigilance Electronic Reporting System — believed to be the first such patient-safety initiative in Africa — allows healthcare professionals and patients to report suspected adverse drug reactions and poor-quality drugs by submitting forms electronically.

The system, developed by Kenya’s Pharmacy and Poisons Board, can be used on desktop computers, with plans to add it to mobile phones later.


  • Kenya has been tracking drug safety nationally since 2009
  • Online reporting is replacing a ‘tedious’ paper-based system
  • The real-time system will boost control of a major problem in Kenya

The board has been monitoring adverse drug reactions since 2004 and a National Pharmacovigilance System was launched in 2009. But reporting had been done manually using printed forms.

Jayesh Pandit, head of pharmacovigilance at the Pharmacy and Poisons Board, says this was a "tedious process" as forms had to be printed, sent to healthcare facilities around the country and then returned for manual entry into a WHO-recommended database.

"Now users can either log in directly to the web application online or download the appropriate application for their device, which enables both online and offline access to the reporting form, and so can be used where Internet access is unreliable," says Pandit.

Data collected on the system will be evaluated on a monthly basis and published, he adds.

Bitange Ndemo, permanent secretary at the country’s Ministry of Information and Communication, says the system will boost data collection from around the country for analysis by the Pharmacy and Poisons Board. He adds that reporting using mobile phones is planned for and will be free of charge to Kenyans.

Willis Akhwale, head of disease control and prevention at the Ministry of Public Health and Sanitation, says the initiative is crucial for empowering health professionals. "The information in the database will enable health workers to make informed decisions that will lead to better healthcare for the Kenyan people," he says.

Akhwale says the online system will help monitor the impact of people self-medicating with prescription drugs illegally sold over the counter, assist in tracking drug resistance, boost the fight against substandard medicines and curb the use of expired drugs.

According to USAID, the Pharmacy and Poisons Board has already received more than 6,000 adverse drug-reaction reports and 370 poor-quality medicine reports on the new system. This has resulted in the quarantine, recall or withdrawal of some medicines, changes in labeling, inspections of manufacturing practices and, in one case, the closure of a drug company that did not meet regulatory requirements.

The system, which was launched last month (23 April), is largely funded by USAID’s Health Commodities and Services Management programme.

This article has been produced by SciDev.Net’s Sub-Saharan Africa news desk.