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

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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.

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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!)

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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

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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

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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.

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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.

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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

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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)

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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.

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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.

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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.

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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.

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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

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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.

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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)

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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

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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

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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

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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

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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)

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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)

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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)

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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)

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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)

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Genuine Counterfeit

Detected Counterfeit in 2008 (Paracetamol & Caffeine Tablets) (Cont’d)

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Genuine Counterfeit

Detected Counterfeit in 2008) Paracetamol & Caffeine Tablets) (Cont’d(

Genuine CounterfeitGenuine Counterfeit

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Genuine Counterfeit

?

Detected Counterfeit in 2008) Paracetamol & Caffeine Tablets) (Cont’d(

Genuine Counterfeit

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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.

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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

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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?

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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.

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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)

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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

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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.

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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.

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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.

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THANK YOU