Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Role of Regulation in Optimizing...

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



Introduction

• Pharmacy and Poisons Board is the National Drug Regulatory Authority in Kenya established by Cap 244 laws of 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



• Medicines play a critical role on the life of human beings hence have to be well regulated.



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



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



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.

•



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)



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.



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



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



Thank you very much



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: [email protected]

www.pharmacyboardkenya.org

mailto:[email protected]

http://www.pharmacyboardkenya.org/



“You need not be certain…

Just be suspicious”

Report all SUSPECTED adverse medicine reactions and poor quality medicines

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