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3-5a. Quality Control of Medicines and Organization of Market Surveillance in Kenya. Dr. H. K. Chepkwony, PhD Director, National Quality Control Laboratory (NQCL); Kenya.

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3-5a

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


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Outline

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)

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?

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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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)

  • 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)

  • 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)

Quality control of medicines overseen through the activities of:

  • Drug Registration Department

    • Committee for Drug Registration (Human)

    • Committee for Drug Registration (Vet.)

  • Inspectorate Department

    • Drug Manufacturers: GMP/QA Inspections

    • Retail & Wholesale Premises Inspections


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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): 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)

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)

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)

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)

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 Mandate

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.

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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To contribute to the overall Ministry of Medical Services’ mandate of “delivery of quality healthcare services to all Kenyans”.

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 Management


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NQCL Work Force Registrar, Pharmacy and Poisons Board.

Contracted Staff (14):

  • Analytical Technicians (7)

  • Executive Secretary (1)

  • Accounts Assistants (3)

  • Laboratory Assistants (2)

  • Messenger (1).

Civil Servants (15):

  • Pharmacists (11)

  • Pharmaceutical Technologists (3)

  • Driver (1).


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Pharmacy and Poisons Board Registrar, Pharmacy and Poisons Board.

Government Hospitals

Govt Agencies: KEMSA,DOMC, NLTP, NASCOP

NQCL

Non-Government Agencies

Private

Sector

NQCL Clients

Collaborations:

PQ Labs/ ISO cert.

Institutions


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NQCL Product Analysis: 2002 - 2009 Registrar, Pharmacy and Poisons Board.


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Detected Counterfeits in Kenya (cont’d) Registrar, Pharmacy and Poisons Board.

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.


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Detected Counterfeits in Kenya (cont’d) Registrar, Pharmacy and Poisons Board.

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.


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Detected Counterfeits in Kenya (cont’d) Registrar, Pharmacy and Poisons Board.

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.


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Detected Counterfeits in Kenya (cont’d) Registrar, Pharmacy and Poisons Board.

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.


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Detected Counterfeits in Kenya (cont’d) Registrar, Pharmacy and Poisons Board.

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.


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Detected Counterfeit in 2008 Registrar, Pharmacy and Poisons Board.

(Paracetamol & Caffeine Tablets) (Cont’d)

Genuine

Counterfeit


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Detected Counterfeit in 2008 Registrar, Pharmacy and Poisons Board.

(Paracetamol & Caffeine Tablets) (Cont’d)

Genuine

Genuine

Genuine

Counterfeit

Counterfeit

Counterfeit


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Detected Counterfeit in 2008 Registrar, Pharmacy and Poisons Board.

(Paracetamol & Caffeine Tablets) (Cont’d)

?

Counterfeit

Counterfeit

Genuine

Genuine


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Substandard Products Registrar, Pharmacy and Poisons Board.

  • 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 Products Registrar, Pharmacy and Poisons Board.

  • 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? Registrar, Pharmacy and Poisons Board.

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) Registrar, Pharmacy and Poisons Board.

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 PMS Registrar, Pharmacy and Poisons Board.

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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Kenya’s Strategy on PMS in Future Registrar, Pharmacy and Poisons Board.

  • 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.


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NPQASF Specific Objectives Registrar, Pharmacy and Poisons Board.

  • 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 NPQASF Registrar, Pharmacy and Poisons Board.


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Conclusion Registrar, Pharmacy and Poisons Board.

  • 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 Registrar, Pharmacy and Poisons Board.


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