Post Market Survey of Antiretroviral Medicines in Kenya

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Kenya is currently experiencing a mixed HIV/ AIDS epidemic with characteristics of both a ‘generalized’ epidemic among the mainstream population, and a ‘concentrated’ epidemic among specific most-at-risk populations (MARPs) and geographies.

HIV/AIDS is one of the leading causes of death in Kenya and its control remains a challenge. It was declared a national disaster and a public health emergency in 1999 by the Government of Kenya. Since then, the Government has put in place structures to ensure scaling up of HIV prevention, care and treatment services. To ensure improvement in the quality of life, reduction of morbidity and mortality due to HIV and AIDS, access to appropriate treatment plays a pivotal role. Quality, safety and efficacy of antiretrovirals need to be considered to ensure that a patient receives optimal benefits from the prescribed treatment and resistance to antiretrovirals is contained. Quality of the medicinal product not only needs to be assured during manufacture, but also during storage and dispensing. Moreover, access to quality, effective treatment remains the core mandate of any public health program and this needs to be complemented with an effective regulatory system.

To mitigate the challenges in the management of HIV and drug resistant HIV, National AIDS/STI Control Program (NASCOP) and the Pharmacy and Poisons Board (PPB),the National Drug Regulatory Authority, conducted a post market survey of antiretrovirals in the Kenyan market. The aim of the survey was to provide baseline information on availability, registration status, quality of ARV medicines and conformity to national ART guidelines in public, private and faith-based health sectors in Kenya.

The survey demonstrated the commitment of the parent Ministries of Health towards ensuring patient safety. Its findings will go a long way in designing appropriate strategies to ensure quality, safety and efficacy of antiretrovirals for the public as proposed in the Ministry of Medical Services 2008-2012 and Ministry of Public Health and Sanitation 2008- 2012 strategic plans.

To ensure that patients continuously receive high quality pharmaceutical care, it is envisaged that this type of survey will be conducted periodically in order to inform policy in drug regulation, quality assurance, procurement and other applicable strategies.

It is hoped that the report will inform actions to be taken by regulators, other relevant policy makers and stakeholders to eradicate poor quality, sub-standard, counterfeit and unregistered antiretroviral medicines from Kenya.

We recognise and applaud the multi-stakeholder collaboration and support from CDC, WHO, MSH, PPB, NASCOP and NQCL for their technical expertise and financial commitment in the execution of the survey, finalization of the report and dissemination of the findings. We look forward to their partnership in the implementation of the proposed recommendations.

Dr. S. K. Sharif MBChB, M.Med, M.Sc, DLSHPM, MBS

Director of Public Health & Sanitation


Dr. F. Kimani MBChB, M.Med, MBS

Director of Medical Services