Quality Control of Medicines and
Organization of Market Surveillance in Kenya
Dr. H. K. Chepkwony, PhD
Director, National Quality Control Laboratory (NQCL); Kenya
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
3-5a
Sampling and testing for Quality Control Laboratories, Nairobi, September 20092 |
OutlineOutline
Quality Control of Medicines in Kenya
Pharmacy and Poisons Board (PPB)
National Quality Control Laboratory (NQCL)
Organization of Market Surveillance in Kenya
Conclusion
Sampling and testing for Quality Control Laboratories, Nairobi, September 20093 |
Definition of Quality Control (QC)Definition of Quality Control (QC)
Component of Quality Assurance concerned with:
Sampling
Specifications
Testing
Organization
Documentation
Release procedures
QC ensures that tests are performed before materials or products are released for use. QC is not confined to laboratory operations only.
Sampling and testing for Quality Control Laboratories, Nairobi, September 20094 |
Why QC?Why QC?
QC is crucial at every stage of the drug supply chain, including:
Manufacturing
Packaging
Distribution
Sale: Wholesale & Retail
Drug use
(NB: Drug Supply Chain can either be legal or illegal!)
Sampling and testing for Quality Control Laboratories, Nairobi, September 20095 |
MoMS
Dept. of Pharmacy
Quality Assurance ProcurementQuality Control/
Testing
PPB KEMSA NQCL
Drug Registration PharmacovigilanceInspectorate
Policy Formulation: KNPP 1994,KNPP 2009 (Draft)
Quality Control of Medicines in Kenya
Sampling and testing for Quality Control Laboratories, Nairobi, September 20096 |
Quality Control of Medicines in Kenya (Cont’d)Quality Control of Medicines in Kenya (Cont’d)
QA component of the new KNPP outlines four (4) primary objectives, which include strengthening of national institutions for:
Medicines procurement, Supply, Regulation and Quality control
Sampling and testing for Quality Control Laboratories, Nairobi, September 20097 |
Pharmacy and Poisons Board (PPB)Pharmacy and Poisons Board (PPB)
National Drug Regulatory Authority in Kenya. Established in 1957 Through an Act of Parliament; CAP. 244 Laws of Kenya
The PPB’s overall mandate is to regulate and control the pharmaceutical sector.
Initially relied on services of other Govt. agencies (KEBS, Govt Chemist) in evaluation of drug quality.
Sampling and testing for Quality Control Laboratories, Nairobi, September 20098 |
PPB (Cont’d)PPB (Cont’d)
Drug registration department set up in 1982.
This Department contracted Drug Analysis & Research Unit (DARU); School of Pharmacy; University of Nairobi to carry out quality control of medicines.
Sampling and testing for Quality Control Laboratories, Nairobi, September 20099 |
PPB (Cont’d)PPB (Cont’d)
Quality control of medicines overseen through the activities of:
1.Drug Registration Department Committee for Drug Registration (Human) Committee for Drug Registration (Vet.)
2.Inspectorate Department Drug Manufacturers: GMP/QA Inspections Retail & Wholesale Premises Inspections
Sampling and testing for Quality Control Laboratories, Nairobi, September 200910 |
PPB (Cont’d)PPB (Cont’d)
3.Pharmacovigilance Department Focal Point for Complaints on Poor Quality of
Medicinal Products
Investigates Complaints and Collects Medicinal Products through Post-market Surveillance (PMS)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200911 |
National Quality Control Laboratory (NQCL): HistoryNational Quality Control Laboratory (NQCL): History
1978: Originally conceived and temporarily set up as Drug
Analysis & Research Unit (DARU), housed at the
then University of Nairobi, Faculty of
Pharmacy through facilitation of the Ministry
of Health.
1985: MoH decided to incorporate a specific quality
control laboratory as part of theNational Drug
Policy.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200912 |
NQCL History (Cont’d)NQCL History (Cont’d)
1986: A project study was carried out by the German
Government through GTZ on the establishment
of NQCL.
1990: German Government agreed to assist in the
establishment of the NQCL.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200913 |
NQCL History (Cont’d)NQCL History (Cont’d)
1992: The Government of Kenya through an Act of
Parliament; CAP 244 Section 35D (Pharmacy &
Poisons (Amendment) Act, 1992); established
the Laboratory as a legal entity.
1993-1994:GTZ reached an agreement with the Kenyan
Government to renovate the facility and equip the
laboratory at its present location.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200914 |
NQCL History (Cont’d)NQCL History (Cont’d)
1994-1999: NQCL run jointly by GTZ and the Kenyan
Government.
1999: Full operation of the laboratory handed over
to the Kenyan Government.
Mar 2005: Initiated participation in newly established
WHO laboratory pre-qualification
program.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200915 |
NQCL History (Cont’d)NQCL History (Cont’d)
July 2008: Attained WHO Pre-qualification status.
Listed in the 8th Edition of the official WHO List of Pre-qualified Quality Control Laboratories.
Became the first public institution in East, West and Central Africa to be thus recognized.
Currently pursuing ISO 17025 accreditation
Sampling and testing for Quality Control Laboratories, Nairobi, September 200916 |
NQCL MandateNQCL Mandate
1. Check quality of drugs & medicinal substances by
performing physical, chemical, biological and other
pharmaceutical evaluation of drugs and medicinal
substances in circulation within the country.
2. Inform Government through the PPB of the results of such
tests so that appropriate action can be taken if products do
not comply with set specifications for safety and
effectiveness.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200917 |
3. To contribute to the overall Ministry of Medical Services’
mandate of “delivery of quality healthcare services to all
Kenyans”.
NQCL Mandate (cont’d)NQCL Mandate (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200918 |
Administered by Board of Management (BoM) appointed by Registrar, Pharmacy and Poisons Board.
Director, who is appointed by the BoM, is responsible for overall day-to-day operations and performance of the institution.
NQCL ManagementNQCL Management
Sampling and testing for Quality Control Laboratories, Nairobi, September 200919 |
Civil Servants (15):
Pharmacists (11)
Pharmaceutical Technologists
(3)
Driver (1).
Contracted Staff (14):
Analytical Technicians (7)
Executive Secretary (1)
Accounts Assistants (3)
Laboratory Assistants (2)
Messenger (1).
NQCL Work Force
Sampling and testing for Quality Control Laboratories, Nairobi, September 200920 |
NQCL Clients
Government Hospitals
Private Sector
Non-Government
Agencies
Govt Agencies: KEMSA,DOMC, NLTP, NASCOP
NQCL
Pharmacy and Poisons Board
Collaborations:PQ Labs/ ISO cert.
Institutions
Sampling and testing for Quality Control Laboratories, Nairobi, September 200921 |
NQCL Product Analysis: 2002 - 2009
Samples Received & Analysed : 2002 - 2009
490
870
565
413
779
486546544
625561
212
379
765
462523
580
0
250
500
750
1000
2002 2003 2004 2005 2006 2007 2008 2009 (to-date)
Year
Sa
mp
les
Samples Received
Samples Analyzed
Sampling and testing for Quality Control Laboratories, Nairobi, September 200922 |
Drug Analysis & Research Unit (DARU) Findings:
Panadol Jnr tablets that contained Aspirin instead of Paracetamol.
Salbutamol tablets that contained no active ingredient.
Metakelfin tablets containing Sulfamethoxypyridazine in place of Sulfamethoxypyrazine
Hydrocortisone ointment that contained a different ester of Hydrocortisone than claimed on the label
Andrew’s Liver Salt which contained NaHCO3 only.
Detected Counterfeits in Kenya (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200923 |
NQCL Findings:
2003: Zidovudine/ Lamivudine tablets that did not contain Lamivudine
2004: Amoxicillin-Clavulanate tablets that did not contain Clavulanate Potassium as claimed on the label.
Sulfamethoxypyrazine/Pyrimethamine tablets that did not have Sulfamethoxypyrazine as labelled.
Bulk raw materials of Amoxicillin Trihydrate and Ampicillin Trihydrate found to contain no
active ingredients.
Detected Counterfeits in Kenya (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200924 |
NQCL Findings:
2005: Paracetamol tablets whose packaging was found to be fake. Tablets presented in a container labeled ‘Panadol’. The label was discovered to be a poor quality coloured copy of the original. The tablets were found to be circular instead of the normal caplet shape. They were embossed other letters instead of ‘panadol’ as is the case with the original.
Detected Counterfeits in Kenya (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200925 |
NQCL Findings:
2006: Raw material of Caffeine was tested and found not to contain any of the active ingredient.
Amoxicillin Trihydrate 500mg Capsules (‘Amoxil 500 capsule’) presented by
multinational manufacturer found to contain low levels of Amoxicillin Trihydrate compared
with the genuine one. The package was not the genuine one of the
manufacturer, it contained NAFDAC (Nigeria) registration number.04 -2481.
Source of sample: India.
Detected Counterfeits in Kenya (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200926 |
NQCL Findings:
2007: Dissolution profile for amoxicillin trihydrate 500 mg capsules for a local manufacturer
against a market leader brand. It was found that the market leader brand contained low levels of Amoxicillin Trihydrate. Its source was
questionable.
Detected Counterfeits in Kenya (cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200927 |
Genuine Counterfeit
Detected Counterfeit in 2008 (Paracetamol & Caffeine Tablets) (Cont’d)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200928 |
Genuine Counterfeit
Detected Counterfeit in 2008) Paracetamol & Caffeine Tablets) (Cont’d(
Genuine CounterfeitGenuine Counterfeit
Sampling and testing for Quality Control Laboratories, Nairobi, September 200929 |
Genuine Counterfeit
?
Detected Counterfeit in 2008) Paracetamol & Caffeine Tablets) (Cont’d(
Genuine Counterfeit
Sampling and testing for Quality Control Laboratories, Nairobi, September 200930 |
Substandard ProductsSubstandard Products
Poorly packaged and labeled products;
Products with poor physical characteristics e.g. Caking suspensions, friable tablets, spilling capsule contents;
Products having inadequate quantity of active ingredients;
Products exhibiting poor dissolution/ bioavailability profiles.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200931 |
Impact of Counterfeit & Substandard ProductsImpact of Counterfeit & Substandard Products
Therapeutic failure
Harmful ingredients
Erosion of public confidence in healthcare providers
Tarnishing of the reputation and financial standing of manufacturer whose name is being fraudulently used
Sampling and testing for Quality Control Laboratories, Nairobi, September 200932 |
Why Post-Market Surveillance (PMS) of Medicines?Why Post-Market Surveillance (PMS) of Medicines?
For drug registration purposes, comprehensive evaluation of application samples is not always indicative of the expected quality of the products once they’ve been granted marketing authorization
Kenya’s Challenges: Illegal chemists, illegal importation of medicines and hawking of medicines from chemist to chemist by quacks.
Quality of Medicines in the supply chain or market?
Sampling and testing for Quality Control Laboratories, Nairobi, September 200933 |
Why Post-Market Surveillance (PMS) of Medicines? (Cont’d)
Why Post-Market Surveillance (PMS) of Medicines? (Cont’d)
PMS ensures that, even after registration, drugs continue to meet the required standards whilst in the market.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200934 |
Kenya’s Current Situation on PMSKenya’s Current Situation on PMS
Surveys of medicines to evaluate: Range and availability, Registration status with PPB and Quality analysis
Post distribution surveillance of KEMSA procured drugs (2004)
Antimalarials (baseline pre-ACT, QAMSA), ARV, Anti-TB (2004-2009)
Sampling and testing for Quality Control Laboratories, Nairobi, September 200935 |
A National Pharmaceutical Quality Assurance Surveillance Framework (NPQASF).
Overall goal: To ensure quality medicines, medical supplies and services are provided to the various stakeholders according to legal requirements and professional standards, through a system of monitoring and evaluation directed and implemented the office of the PS, MoMS.
Kenya’s Strategy on PMS in FutureKenya’s Strategy on PMS in Future
Sampling and testing for Quality Control Laboratories, Nairobi, September 200936 |
NPQASF Specific ObjectivesNPQASF Specific Objectives
To provide strategic direction for pharmaceutical quality assurance in the Kenyan market.
To co-ordinate, monitor and evaluate the implementation of pharmaceutical quality assurance activities.
To ensure that the institutions involved in pharmaceutical quality assurance provide the outputs of their activities for dissemination to relevant institutions and stakeholders.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200937 |
Elements of the NPQASFElements of the NPQASF
ELEMENTS OF THE FRAMEWORK
KEY FOCUS AREAS
LEGAL FOUNDATIONRelevant/related Acts of Parliament, policies, guidelines, enforcement, licensing
PHARMACEUTICAL PRODUCTS
Manufacture, importation, registration and re- registration, procurement, distribution, storage, market surveillance, disposal, clinical trials, dispensing (OTC & POM)
PHARMACEUTICAL SERVICES
Licensing, professional practice and ethics, consumption, dispensing (OTC & POM)
OVERSIGHTMeasurement, QA system, monitoring and evaluation, feedback.
Sampling and testing for Quality Control Laboratories, Nairobi, September 200938 |
ConclusionConclusion
The Drug Regulatory Body (i.e., PPB) and Procuring Entity (KEMSA) collaborates well with the NQCL on Quality Control of Medicines.
Intensifying Public Awareness on the role of NQCL, taking profit of the WHO Pre-qualification status.
The NPQASF will form a strong foundation upon which to launch a sustainable post market surveillance program that would give an indication of quality of pharmaceutical products available to the public.
Enhance Collaboration between Pre-qualified QCLs and National Drug Regulatory Authorities.