The Pharmacy and Poisons Board (PPB) is the National Medicines Regulatory Authority in Kenya, established under the Pharmacy and Poisons Act, Cap 244 Laws of Kenya. The PPB is mandated with ensuring the provision of quality, safe and efficacious health products, and technologies (HPTs) through the regulation of the practice of pharmacy, manufacturing, and trade in medical products. The core functions include evaluation and registration of HPTs, regulation of advertisements and promotion of HPTs, inspection, surveillance and enforcement activities, licensing of personnel, pharmaceutical premises, Pharmacy training institutions, clinical research authorization, and advising the government on any matter relating to regulation of HPTs.
Post marketing Surveillance (PMS) is a key medicines regulatory function for ensuring and assuring the quality, safety, and efficacy of medical products the entire product life cycle, post-authorization. Effective implementation of PMS requires collaboration and coordination between the PPB and all relevant stakeholders including the National Quality Control Laboratory (NQCL) and Public Health Programs (PHPs).
Background
A key component of assuring the quality of medical products and health technologies is implementation of a comprehensive Post Marketing quality Surveillance (PMS) system that involves monitoring the safety and quality of medical products after they have been licensed for use in the market. PMS enables the detection of Substandard and Falsified (SF) products, evaluation of the registration status, labelling requirements and effects of storage conditions on the quality and stability of products.
The Pharmacy and Poisons Board (PPB) with the support of the previous USAID PQM program conducted seven rounds of quality surveys of antimalarial medicines since the year 2010. The most recent survey was conducted in 2019. To-date, a total of 4,332 antimalarial samples have been collected and subjected to the three-level testing in accordance with the provisions of the risk-based PMS protocols.
Additionally, several other PMS surveys covering different product categories have been implemented by PPB in collaboration with various stakeholders. The medicine categories and medical devices include antiretrovirals, anti-TBs, anthelmintics, antibiotics, anti-diabetic agents, anti-hypertensives, reproductive health products, products for erectile dysfunction, anticoagulants, central nervous system agents, syringes, and male latex condoms.
Despite the many surveys that have been implemented, PMS reports have not been widely disseminated to the stakeholders. Neither have the findings of the individual surveys been pooled together and synthesized to provide an overall picture and body of evidence to inform policy and regulatory decisions. To support PPB in the quality data management and dissemination, PQM+ is seeking for a consultant to work with PPB to analyze post-market quality data for anti-malarial products to establish trends over the years to inform policy and regulatory decisions. The consultant will also draft a manuscript for publication in a high-impact, peer reviewed scientific journal.
Key responsibilities/Tasks
The selected consultant will support and work collaboratively with the PPB and NQCL to
a) Seek and process administrative approvals
b) Analyze data from all the previous quality surveys of antimalarial products
c) Establish a database for post-marketing surveillance of medical products and health technologies
d) Draft a manuscript for publication in a peer reviewed scientific journal
e) Develop abstract for PPB to share on their experience in conducting regular PMS for antimalarial medicines
f) Carry out in depth analysis of the data to establish trends and enhance visualization of the data e.g. establishing molecules that are prone to failure, test parameters that are prone to fail and identify determinants of poor quality antimalarials
Outputs
The following are the expected outputs from the intervention
1. Compiled PMS data from previous antimalarial PMS reports
2. Established database on quality of antimalarial medicines
3. Manuscript submitted for publication in an international journal
4. Abstract for presentation in professional associations meetings on experience of antimalarial PMS activities in Kenya
Requirements
1. Masters or PhD degree in Pharmacy or any other Health related course,
2. Pharmacy or health related background,
3. Proven experience in health research data analysis,
4. Experience in scientific research writing and publication,
5. Experience with obtaining administrative, ERC/IRB approvals.
Time frame for the work: The Level of effort for the work is 20 days to be conducted within a timeframe of approximately two (2) months between August 2021 and September 2021.
How to apply
Please send CV, 3-References, and Hourly Rate in US$ to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of August 6,2021 When submitting your application, write “ PMS Data analysis consultant - Kenya ” in the email Subject Line.
Introduction
The U.S. Agency for International Development (USAID) Promoting the Quality of Medicines Plus (PQM+) program is a five-year program with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries. PQM+ provides technical assistance to build in-country capacity of medical products regulatory authorities’ quality assurance systems spanning manufacturing, distribution and use in health systems. PQM+ also provides technical support to manufacturers of for malaria; tuberculosis (TB); neglected tropical diseases; other infectious diseases; family planning and reproductive health; and maternal, newborn, and child health.
