Kenya & IGAD collaborate to implement post market surveillance & pharmacovigilance to improve patient safety

The Pharmacy and Poisons Board (PPB) in collaboration with the Intergovernmental Authority
on Development (IGAD), has implemented several post-marketing surveillance (PMS) and
pharmacovigilance (PV) activities within the IGAD member states which include Kenya,
Uganda, Djibouti, Sudan, Ethiopia, Somalia and South Sudan.

A close-out meeting for the project supported by United States Agency for International
Development (USAID) through IGAD on post-marketing surveillance and pharmacovigilance
activities at IGAD regional level and country level in Kenya, was held on  –   at the
PPB.

The activities conducted in the last two years includes a baseline assessment survey of
Pharmacovigilance systems in IGAD member states, development and implementation of
harmonized IGAD PV Indicator Assessment and Monitoring tool and development of draft PV
rules which are pending enactment based on gaps identified during the baseline assessment.

Other activities are the establishment and operationalization of pharmacovigilance expert review
and advisory committee (PERAC), sensitization of health care workers at cross border health
facilities of Mandera, Marsabit, and Turkana Counties, establishment and implementation of
therapeutic committees at cross border health facilities, and development of draft Harmonised
PV curriculum for in service training of healthcare workers by the IGAD pharmacovigilance
expert working group (EWG).

The successful implementation of all the activities is attributed to structured and systematic
collaboration of the PPB, IGAD member states and the IGAD secretariat as well as the kind
financial and technical support of the USAID through The Medicines, Technologies, and
Pharmaceutical Services (MTaPs), the U.S. Pharmaceutical Convention (USP) and Promoting
the Quality of Medicines Plus (PQM+).

In addition, various post-marketing surveillance activities were conducted among them the
development of protocol on risk-based – PMS of selected health products, in collaboration with
USP/PQM+. The selected health products included; Oxytocin, Gentamicin, Magnesium suphate
and alcohol-based hand sanitizers.

Other PMS activities were implementation of quality survey of the selected products at the cross-
border counties of Turkana, West-Pokot, Mandera and Busia where ninety-eight (98) Samples
were collected and are at final stages of testing.
The member states in IGAD were twinned to enable work sharing and technical support for
member states which have less developed regulatory systems.
In this regard, Kenya supported Sudan and South Sudan to apply Medicines risk-based
surveillance tool (MedRS) which was critical for development of the PMS survey protocol.

Pharmacovigilance (PV), defined by the World Health Organization (WHO) as ‘science
and activities related to the detection, assessment, understanding and prevention of
adverse effects or any other drug-related problems,’ plays a key role in ensuring that
appropriate patients receive medical products that are safe in the context of the benefits
these products provide.