Transcript Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya

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
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
Thank you very much
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: [email protected]
www.pharmacyboardkenya.org
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
Pharmacy and Poisons Board