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

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Presentation on theme: "Quality Control of Medicines and Organization of Market Surveillance in Kenya Dr. H. K. Chepkwony, PhD Director, National Quality Control Laboratory (NQCL);"— Presentation transcript:

1 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, September a

2 Sampling and testing for Quality Control Laboratories, Nairobi, September |2 | Outline  Quality Control of Medicines in Kenya  Pharmacy and Poisons Board (PPB)  National Quality Control Laboratory (NQCL)  Organization of Market Surveillance in Kenya  Conclusion

3 Sampling and testing for Quality Control Laboratories, Nairobi, September |3 | 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.

4 Sampling and testing for Quality Control Laboratories, Nairobi, September |4 | 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!)

5 Sampling and testing for Quality Control Laboratories, Nairobi, September |5 | Policy Formulation: KNPP 1994, KNPP 2009 (Draft) Quality Control of Medicines in Kenya

6 Sampling and testing for Quality Control Laboratories, Nairobi, September |6 | 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

7 Sampling and testing for Quality Control Laboratories, Nairobi, September |7 | 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.

8 Sampling and testing for Quality Control Laboratories, Nairobi, September |8 | PPB (Cont’d)  Drug registration department set up in  This Department contracted Drug Analysis & Research Unit (DARU); School of Pharmacy; University of Nairobi to carry out quality control of medicines.

9 Sampling and testing for Quality Control Laboratories, Nairobi, September |9 | 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

10 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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)

11 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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.

12 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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.

13 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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.  :GTZ reached an agreement with the Kenyan Government to renovate the facility and equip the laboratory at its present location.

14 Sampling and testing for Quality Control Laboratories, Nairobi, September | NQCL History (Cont’d)  :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.

15 Sampling and testing for Quality Control Laboratories, Nairobi, September | NQCL History (Cont’d)  July 2008:Attained WHO Pre-qualification status.  Listed in the 8 th 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 accreditation

16 Sampling and testing for Quality Control Laboratories, Nairobi, September | NQCL 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.

17 Sampling and testing for Quality Control Laboratories, Nairobi, September | 3.To contribute to the overall Ministry of Medical Services’ mandate of “delivery of quality healthcare services to all Kenyans”. NQCL Mandate (cont’d)

18 Sampling and testing for Quality Control Laboratories, Nairobi, September |  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

19 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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

20 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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

21 Sampling and testing for Quality Control Laboratories, Nairobi, September | NQCL Product Analysis:

22 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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 NaHCO 3 only. Detected Counterfeits in Kenya (cont’d)

23 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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)

24 Sampling and testing for Quality Control Laboratories, Nairobi, September | NQCL Findings:  2005: Paracetamol tablets whose packaging was found to be fake. Tablets presented in a container labeled ‘Panadol’. The label was discovered tobe 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)

25 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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 Source of sample: India. Detected Counterfeits in Kenya (cont’d)

26 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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)

27 Sampling and testing for Quality Control Laboratories, Nairobi, September | Genuine Counterfeit Detected Counterfeit in 2008 (Paracetamol & Caffeine Tablets) (Cont’d)

28 Sampling and testing for Quality Control Laboratories, Nairobi, September | GenuineCounterfeit Detected Counterfeit in 2008 (Paracetamol & Caffeine Tablets) (Cont’d) GenuineCounterfeitGenuineCounterfeit

29 Sampling and testing for Quality Control Laboratories, Nairobi, September | Genuine Counterfeit ? Detected Counterfeit in 2008 (Paracetamol & Caffeine Tablets) (Cont’d) Genuine Counterfeit

30 Sampling and testing for Quality Control Laboratories, Nairobi, September | Substandard 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.

31 Sampling and testing for Quality Control Laboratories, Nairobi, September | Impact 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

32 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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?

33 Sampling and testing for Quality Control Laboratories, Nairobi, September | 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.

34 Sampling and testing for Quality Control Laboratories, Nairobi, September | Kenya’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 ( )

35 Sampling and testing for Quality Control Laboratories, Nairobi, September |  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 Future

36 Sampling and testing for Quality Control Laboratories, Nairobi, September | NPQASF 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.

37 Sampling and testing for Quality Control Laboratories, Nairobi, September | Elements 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.

38 Sampling and testing for Quality Control Laboratories, Nairobi, September | Conclusion 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.

39 Sampling and testing for Quality Control Laboratories, Nairobi, September | THANK YOU


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