Quality Assurance of Medicines under Universal Health Coverage Program

1
Quality Assurance of Medicines underUniversal
Health Coverage Program

• by
• Siriwat Tiptaradol (Presenter)
• Duangporn Abhigantaphand
• Sooksri Ungboriboonpisal
• ICIUM 2004 Mar. 31,2004
  Department of Medical Sciences
• Chiangmai, Thailand.
  Ministry of Public Health

2
Agenda

• Introduction
• Objective
• Methodology
• Result Discussion
• Conclusion
• Acknowledgement

3
Introduction

• Year 2001 - The Universal Health Coverage
  Program so called
• 30 Baht Co-payment Scheme was
  initiated.
• Year 2002 - The program has covered all 76
  provinces to all Thai
• people.
• - Budgeting and administrative
  system has to be adjusted.
  
• - Drug price competition and
  significant cost reduction
• to hospital drug procurement.
• - There are rising concerns whether quality
  of drug
• products would be compromised.

4
Drug Quality Control Surveillance Network

• The parties concerned were
• Department of Medical Sciences
  ( as the National Drug Quality
  Control Lab.)
• Provincial Public Health Officers
• Thai FDA
• Government hospitals

5
Objective

• To assess the quality of essential drugs.
• To assess the quality of registered herbal
  products.
• To develop drug quality database.

6
Methodology

• The surveillance study was prospectively designed
• performed during Oct. 2002 to Sep. 2003
• 20 drug products (24 dosage forms) were selected
  from the National Essential Drug List.
• any registered herbal products which were solid
  dosage form.
• The analysis were performed according to USP 24
  and BP 2001.

7
Methodology (cont.)

• All parties concerned were contacted and informed
  about
• - details of the project
• - sampling requirements
• - procedures.

8
Methodology (cont.)

• Drug products were selected based on
• Their importance in terms of public health
• Wide usage
• Wide cost differential among products(Innovator
  and local manufacturers)
• Quality problem reporting products
• Stability problems.

9
Sampling requirements

• 20 drug products in various dosage forms were
  collected from pharmacy unit in government
  hospitals and drug stores.
• Registered herbal products were collected from
  marketplace.
• Samples were sent to the Bureau of Drug and
  Narcotic, as well as Regional Medical Sciences
  Center , Department of Medical Sciences ,for
  analysis.

10
Quality Control and Specification

• Method and Standard Specification (USP 24, BP
  2001)
• Identity
• Assay
• Dissolution
• Related substances
• Content uniformity
• Microbial contamination ( for any herbal products
  )

11
List of Drug Products Tested

• Wide usage criterion
• Acyclovir Tab / cap.
• Amoxycillin Tab.
• Cimetidine Tab.
• Co-trimoxazole Tab.
• Glibenclamide Tab.
• Metronidazole Tab.

12
List of Drug Products Tested (cont.)

• Stability problem criterion
• Aminophylline Tab.
• Amoxycillin and Clavulanate pot. Tab/dry syrup.
• Ampicillin sodium Cap.
• Glipizide Tab.

13
List of Drug Products Tested. (cont.)

• Quality Problem Criterion
• Colchicine 0.6 mg/tab. (Low dose)
• Diclofenac sodium tab/inj (Dissolution/LAL Test)
• Diltiazem tab. (Dissolution revision in current
  pharmacopeia)
• Gemfibrozil tab/cap. (Dissolution)
• Indomethacin cap. (Dissolution)
• Paracetamol inj (LAL Test)

14
Analysis results

• A Total of 1,063 Samples of 24 dosage forms and
  herbal products were evaluated.
• - 9 dosage forms of 320 samples were
  conformed to the standard requirements
• -Amoxycillin cap -Acyclovir
  cap (only 1 sample)
• -Ampicillin cap -Diclofenac
  sodium Inj
• -Glibenclamide tab -Glipizide
  tab
• -Isoniazid tab
  -Metronidazole tab
• -Paracetamol inj

15
Analysis results (cont.)

• For dissolution problem
• Indomethacin Cap. (50 Failed, 29 out of 58
  samples)(due to less water soluble of active
  ingredient)
• Omeprazole Cap. (23 Failed, 11 out of 47
  samples)(due to enteric coated and instability
  of granules)
• Diclofenac sod.Tab. (22 Failed, 10 out of 46
  samples)(due to enteric coated of tablet)
• Diltiazem Tab. (13 Failed, 5 out of 38
  samples)(due to revision of dissolution
  specification in current pharmacopoeia)

16
Analysis results (cont.)

• For uniformity of content problems
• Colchicine 0.6 mg tab (61 Failed, 39 out of 64
  samples, due to low dose and control of raw
  material )
• Aminophylline Tab (12 Failed, 12 out of 98
  samples, also due to dissolution and stability
  problems )
• All details are presented in Table 2

17
Analysis results (cont.)
About Manufacturers

• Diltiazem Tab.
• - 2 out of 7 importers failed
• - 2 out of 5 local manufacturers failed
• Omeprazole Cap.
• - all 2 importers failed
• - 2 out of 13 local manufacturers failed
• Amoxycillin and Clavulanate Dry Syrup
• - 1 out of 4 importers failed
  

18
Discussion

• There are some limitation concerning the number
  of batches received of each brand product for
  analysis.
• Some products are released only 1 batch/year.
• Each product in the database does not represent
  the same amount of batches from each
  manufacturer.
• The pharmaceutical qualities of drug products
  from different manufacturers were compared for in
  vitro test in term of pass or fail to meet the
  standard specification.

19
Discussion (cont.)

• The results showed that problems regarding
  dissolution of tab or cap still remained for many
  drug products.
• The information is very important for product
  development of both imported and local
  manufacturers.
• Content uniformity is another important test item
  to demonstrate the uniformity of dosage unit,
  particularly low-dose drug products (eg.
  Colchicine tab )

20
Discussion (cont.)

• For Herbal products
• which are very popular among health consumers
  and available in the marketplace.
• The results showed that there are problems
  regarding microbial contamination about
  
• 60 Failed, 33 out of 55 samples

21
Discussion (cont.)

• The poor quality products may be associated with
• manufacturers lack of GMP regarding
• Humidity control
• Formulation development
• Stability study
• Control of raw material
• storage condition
• packaging material etc.

22
Conclusion

• The information of this study is helpful for
• Health care providers in making decision on
  product selection.
• Improving drug procurement in a cost - effective
  manner.
• Particularly in providing a better healthcare
  service to the patients.

23
Conclusion (cont.)

• The database created will be a source of
  information to all parties concerned in Ministry
  of Public Health for
• monitoring and/or planning the necessary action
  to be taken on the Essential Drug Program at the
  national level.
• improving the national medical care scheme.
• to effective regulatory enforcement of GMP
  measure.

24
Acknowledgement

• This study was supported by
• Department of Medical Sciences.
• The parties concerned in Ministry of Public
  Health.

25
THANK YOU