COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIEN - PowerPoint PPT Presentation

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COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIEN

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Counterfeits harm health, results in economic loss. Meaningful surveillance. Strong DRA ... ACKNOWLEDGEMENTS. DRUG ANALYSIS AND RESEARCH UNIT (DARU) STAFF ... – PowerPoint PPT presentation

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Title: COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIEN


1
COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC
SYSTEMS IN DEVELOPING COUNTRIES THE KENYAN
EXPERIENCE
By Isaac O. Kibwage
2
  • Authors
  • G.N. Thoithi1, K.O. Abuga1, H.K. Chepkwony2 and
    I. O. Kibwage
  • 1Department of Pharmaceutical Chemistry,
    University of Nairobi, Kenya.
  • 2National Quality Control Laboratory (NQCL),
    Nairobi, Kenya

3
Quality of Medicines
  • Quality of medicines
  • Impact of quality on consumers
  • Kenyan mass media reports drug quality concerns
  • Poor quality
  • Expired products
  • Counterfeits
  • Lack of adequate policy
  • Limited market surveillance

4
Daily Nation, Monday May 2, 1988
PSK Symposium1988 Debate on quality of locally
produced medicines stopped by PSK chairman
5
Kenya Times, Tuesday May 3, 1988
6
Africa Health Market Letter, Vol. 6 No. 4, April
1992
VLIR, KUL UON Project for QC of drugs
7
Sunday Standard, Nov. 9, 1997
Sale of non-registered loperamide
sulfadoxine/pyrimethamine in the Kenyan
market. Chief pharmacist admitted dispensing
malpractices and the presence briefcase imports
in the country
8
Sunday Standard, Nov. 9, 1997
Sale of non-registered loperamide
sulfadoxine/pyrimethamine in the Kenyan
market. Chief pharmacist admitted dispensing
malpractices and the presence briefcase imports
in the country
9
Specialties authorized for the Kenyan
market1982-2007
10
Historical Background
DARU Established in 1977 Work started
in1980 VLIR funded KUL-UoN project was a
major boost NQCL Established in
1993 Takeoff slow - inadequate
facilities 2004 Enhanced budgetary allocation
donor funding WHO certification in the
process
11
Sources of Drugs
  • Central Medical Stores
  • Government and Private Hospitals
  • Pharmaceutical industry
  • Pharmacy and Poisons Board
  • Community Pharmacies
  • Doctors, Dentists and patients

12
Sources of Drugs
  • Local Manufacturers
  • Imported
  • India
  • China
  • Israel
  • Far East
  • Western/ Eastern Europe

13
Results for DARUPeriod 1980 - 2007
14
Results for DARUPeriod 1980 - 2007
15
Results for DARUPeriod 1980 - 2007
Therapeutic categories ( Failure)
16
Results for DARUPeriod 1980 - 2007
17
Failure Rate for Analgesics ()
18
Failure Rate for Antibiotics ()
19
Failure Rate for Antimalarial Drugs ()
20
Failure Rate for Antitubercular Drugs ()
21
Failure Rate for Skin Preparations ()
22
Observations
  • 2001-2007 Quality of drugs has improved
  • Failure rate slightly higher in locally
    manufactured drugs
  • Drugs of greatest concern
  • 1980 1990 skin preps (?50 failure)
  • nutritional preps (25-38)
  • antibiotics (about 30).
  • 1996-2007 antimalarials, especially S/P
    (30)

23
Possible Reasons for Improved Quality
  • Improved technology globally
  • Professional advice given to local industry
    following failure of their products.
  • Investment in QC Labs
  • More pharmacists in the industry
  • Greater vigilance by the regulatory authority.

24
Results for NQCLPeriod 1996 - 2007
25
Results for NQCLPeriod 1996 - 2007
26
Failure Rate for Analgesics ()
27
Failure Rate for Antibiotics ()
28
Failure Rate for Antimalarials ()
29
Failure Rate for Antitubercular Drugs
30
Observations
  • 2001-2007 Quality of drugs has improved
  • Failure rate slightly higher in imported
    drugs
  • Drugs of greatest concern by end 2007
  • antibiotics (17.3)
  • anthelmintics (10)
  • antituberculars. (17.4)
  • antimalarials, (13.8)

31
Counterfeit Medicines
32
Counterfeit Medicines
33
Counterfeit Medicines
34
PREDINSOLONE TABLETS COUNTERFEIT (NQCL)
TWO PACKS WITH THE SAME BATCH TABLETS LOOK
DIFFERENT
35
METAKELFIN? TABLETS COUNTERFEIT (NQCL)
Counter feit
Genuine product
36
METAKELFIN? TABLETS COUNTERFEIT (NQCL)
Genuine product
Counter feit
37
DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit product
Genuine product
38
DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
New product bears the hologram FACT
39
DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New genuine pack
40
DOU-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
41
DUO-COTECXIN? TABLETS COUNTERFEIT (DARU)
Counterfeit
Genuine product
New pack
42
The Financial Standard, Tuesday April 20,1999
43
The People Daily, Friday August 6, 2004
44
The Financial Standard May 18,1999
45
Market Surveillance
46
Market Surveillance Reports
47
Market Surveillance
  • Market surveillance is weak in Kenya
  • Concern for quality
  • Availability of substandard products in the
    market
  • Regulatory authority needs to be more stringent

48
Conclusions
  • Counterfeits harm health, results in economic
    loss
  • Meaningful surveillance
  • Strong DRA
  • Well equipped QC facilities
  • Comprehensive policies on handling and
    distribution of drugs

49
ACKNOWLEDGEMENTS
VLIR Equipment Human resource
development Technology transfer DARU
Staff NQCL Staff GoK, PPB Donors GTZ, DANIDA,
WHO
50
ACKNOWLEDGEMENTS
NATIONAL QUALITY CONTROL LABORATORY (NQCL) STAFF
51
ACKNOWLEDGEMENTS
DRUG ANALYSIS AND RESEARCH UNIT (DARU) STAFF
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