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Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Role of Regulation in Optimizing Medicine use
KNH/UON Pharmacy SymposiumOptimizing Medicine use to Improve Patient Outcome
Dr. Fred Siyoi
Deputy Registrar 16th May 2014
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Introduction
• Pharmacy and Poisons Board is the National Drug Regulatory Authority in Kenya established by Cap 244 laws of Kenya.
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Vision and Mission
• Mission-To safeguard the health of public by ensuring the Quality, Safety and Efficacy of Medicines
• Vision- To be a global centre of regulatory excellence
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
• Medicines play a critical role on the life of human beings hence have to be well regulated.
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Effective medicines regulation promotes and protects public health by ensuring that
• Medicines are of the required quality, safety and efficacy;• Medicines are appropriately manufactured, stored,
distributed and dispensed;• Illegal manufacturing and trade are detected and
adequately sanctioned;• Health professionals and patients have the necessary
information to enable them to use medicines rationally;• Promotion and adverting is fair, balanced and aimed at
rational drug use;• Access to medicines is not hindered by unjustified
regulatory work
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Constitutional Requirements of Health
• The constitution of Kenya guarantees every citizen the highest standard of health.
Section 43. (1) Every person has the right— • (a) to the highest attainable standard of health, which
includes the right to health care services, including reproductive health care;
• which also includes access to the highest quality of medicines
Section 46. (1) Consumers have the right—• (c) to the protection of their health, safety, and economic
interests
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Ensuring Quality of medicines
• The manufacturing of medicines must be under good manufacturing practices standards
• All products have to be tested in a known laboratory before it is registered by the Board
• After registration, the products are routinely monitored through post market surveillance where samples are collected randomly and analyzed in the laboratory.
•
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Ensuring safety of medicines
• The board evaluates and approves clinical trial applications for studies taking place in Kenya
• Before registration of a product in Kenya, the dossier is evaluated to ensure the product is safe to be used by Kenyans.
• There is also Pharmacovigilance which continuously monitors the safety of medicines in the country.
• The Board together with other organizations also does studies e.g Cohort Event Monitoring (CEM) to look at safety of marketed medicines(AL, TDF)
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Ensuring efficacy of medicines
• The board does this through;• evaluates and approves clinical trial• There is also Pharmacovigilance which continuously
monitors the safety of medicines in the country.
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Regulating Training and Practice of Pharmacy
1. The Board reviews and approves curriculum of institutions offering pharmacy.
2. The board also regulates the practice of pharmacy by giving annual practice licenses to pharmacy practionners after they have attained the required CPD points so as to ensure continuous development of the practionner
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Challenges
1. The Act we operate under has been overtaken by events
2. New technologies and changing technologies
3. Fewer employees
4. Living in a global village
5. Politics
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Kenya
Our contact …
Directorate of Medicines Information and PharmacovigilancePharmacy and Poisons Board
Lenana Road
P.O. Box: 27663-00506 Tel: +254-(020) 3562107
Nairobi KENYA 2716905/6
Fax: +254-(020) 2713431 / 2713409
e-mail: pv@pharmacyboardkenya.org
www.pharmacyboardkenya.org
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