1. Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Role of Regulation in Optimizing Medicine use KNH/UON Pharmacy Symposium Optimizing Medicine use to Improve Patient Outcome Dr. Fred Siyoi Deputy Registrar 16 th May 2014

2. 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.

3. 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

4. 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.

5. 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

6. 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

7. 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.

8. 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)

9. 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.

10. 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

11. 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

12. Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Thank you very much

13. Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Our contact … Directorate of Medicines Information and Pharmacovigilance Pharmacy 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.orgpv@pharmacyboardkenya.org www.pharmacyboardkenya.org

14. Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya “ You need not be certain… Just be suspicious ” Report all SUSPECTED adverse medicine reactions and poor quality medicines