Transcript Oral Presentation 1

Quality Assurance of Medicines
under
Universal Health Coverage Program
by
Siriwat Tiptaradol (Presenter)
Duangporn Abhigantaphand
Sooksri Ungboriboonpisal
ICIUM 2004 Mar. 31,2004
Chiangmai, Thailand.
Department of Medical Sciences
Ministry of Public Health
Agenda
• Introduction
• Objective
• Methodology
• Result & Discussion
• Conclusion
• Acknowledgement
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.
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
Objective
• To assess the quality of essential drugs.
• To assess the quality of registered herbal products.
• To develop drug quality database.
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.
Methodology (cont.)
• All parties concerned were contacted and informed
about
- details of the project
- sampling requirements
- procedures.
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.
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.
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 )
List of Drug Products Tested
Wide usage criterion :
• Acyclovir Tab / cap.
• Amoxycillin Tab.
• Cimetidine Tab.
• Co-trimoxazole Tab.
• Glibenclamide Tab.
• Metronidazole Tab.
List of Drug Products Tested (cont.)
Stability problem criterion :
• Aminophylline Tab.
• Amoxycillin and Clavulanate pot. Tab/dry syrup.
• Ampicillin sodium Cap.
• Glipizide Tab.
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)
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
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)
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
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
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.
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 lowdose drug products (eg. Colchicine tab )
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
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.
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.
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.
Acknowledgement
This study was supported by
• Department of Medical Sciences.
• The parties concerned in Ministry of Public Health.