Pharmacovigilance Reporting Goes Digital in Kenya

The Permanent Secretary in the Ministry of Information and Communication, Dr. Bitange Ndemo. {Photo credit: MSH.}Photo credit: MSH.

Monitoring and reporting of adverse drug reactions (ADRs) and poor-quality human medicines has gone digital in Kenya. 

Medical experts and patients can now detect, assess, and report unpleasant reactions to pharmaceutical products in real time to the Pharmacy and Poisons Board’s (PPB) National Pharmacovigilance Centre. The goal is to ensure and enhance patient safety. 

PPB began establishing a process of monitoring and reporting ADRs in 2004, and the National Pharmacovigilance System was officially launched on June 9, 2009. 

However, since then, reporting has been done manually using printed forms—a yellow form for reporting suspected ADRs and a pink form for reporting suspected poor-quality medicines.

“This was a tedious process because we had to make sure that the forms are printed, then transported to various health care facilities throughout the country, ensuring every department within the facility has these forms, then feedback collected using the same process,” said Dr. Jayesh Pandit, who heads the Department of Pharmacovigilance at the PPB. “Moreover, when reports come back to the National Pharmacovigilance Centre, we then have to manually enter them into the WHO recommended database, which all added to our costs and loss of time,” said Dr. Pandit. 

[Dr. Jayesh Pandit, head of the Department of Pharmacovigilance at the PPB. (Photo credit: MSH)]Dr. Jayesh Pandit, head of the Department of Pharmacovigilance at the PPB. (Photo credit: MSH)

The new digital system, which was launched on April 23, 2013, does not require any paperwork. The application can be downloaded either on a computer or a smart phone, or the report can be made directly to the PPB on their website. It is believed that the digital system will make reporting easier, more cost effective, and prompt, and will serve to build its own database for future reference.

The system is based on an open-share Linux software platform, designed by the PPB and developed in Kenya by Intellisoft Consulting, a local IT firm with financial and technical support from the Health Commodities and Services Management Program, led by Management Sciences for Health (MSH), with funding from USAID

“In general, USAID, through the Health Commodities and Service Management program at MSH, has been supporting the PPB to strengthen and implement an integrated pharmacovigilance system in collaboration with [the World Health Organization], among other organizations,” said Dr. Ndinda Kusu, the Deputy Chief of Party at the HCSM program in Kenya. 

[Dr. Jayesh M. Pandit, Dr. K.C. Koskei (Chief Pharmacist and Registrar at PPB), and Dr. Bitange Ndemo during the official unveiling of the electronic reporting tool in Kenya. (Photo credit: MSH)]Dr. Jayesh M. Pandit, Dr. K.C. Koskei (Chief Pharmacist and Registrar at PPB), and Dr. Bitange Ndemo during the official unveiling of the electronic reporting tool in Kenya. (Photo credit: MSH)

So far, the PPB has received over 6,000 ADR reports and over 370 poor-quality medicines reports. This influx of information has resulted in quarantining, recalling, or withdrawing some medicines; changes in labeling; line inspections for continuous good manufacturing practices; and, in one case, the closure of a pharmaceutical company that was not meeting regulatory requirements. 

Dr. Pandit says that negotiations are underway to have an application for the system on mobile phones, particularly Nokia, Android, Apple, and BlackBerry platforms.

The Permanent Secretary in the Ministry of Information and Communication, Dr. Bitange Ndemo, said that he will ensure that Kenyans access this digital pharmacovigilance reporting system and report from their mobile phones free of charge. 

“There is no single medicine in the world that is 100 percent safe,” said Dr. Pandit. “It is not possible to know everything about a particular medicine just through clinical trials. That is why pharmacovigilance becomes an important process for further monitoring of all drugs in the market.”

By launching the system, Kenya becomes the first country in Africa---and in the world---to use a digital reporting tool for pharmacovigilance based on mobile technology.

Yvonne Otieno is a communications specialist with the Health Commodities and Services Management (HCSM) program at MSH.

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