Quality Assurance of Medicines

under Universal Health CoverageProgramby

Siriwat Tiptaradol (Presenter) Duangporn Abhigantaphand

Sooksri Ungboriboonpisal

2004 312004ICIUM Mar. , Departmeee ee eeeeeee eeeeeeee

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Agenda

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

Introduction - 2001Year The Universal Health Coverage Program so call ed

“ - 3 0 Baht Co payment Scheme” was initiated. - 2002 76Year The program has covered all provinces to

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- Budgeting and administrative system has to be adjuste d.

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to hospital drug procurement. - eeeee eee eeeeee eeeeeeee e eeeeee eeeeeee ee eeee

productswoul d be compr omi sed.

Drug Quality Control Surveillance Network

The parties concerned were :• Department of Medical Sciences ( as the Nation

al Drug Quality Control Lab.)• Provincial Public Health Officers• Thai FDA• Government hospitals

Objective• To assess the quality of ess

ential drugs.• To assess the quality of regi

stered herbal products.• To develop drug quality dat

abase.

Methodology• The surveillance study was prospectively d

esigned• performed during Oct. 2002 to Sep. 2003• 20 drug products (24 dosage forms) were s

elected from the National Essential Drug List.

• any registered herbal products which were solid dosage form.

• The analysis were performed according to 24 2001USP and BP .

Methodology (cont.)

• All parties concerned were c ontacted and informed abou

t- 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 form

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edical Sciences Center , Department o f Medical Sciences ,for analysis.

Quality Control andSpecification

Method and Standard Specification ( USP2 4 , BP2 0 0 1 )

•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 Te sted (cont.)

Stability problem criterion :• Aminophylline Tab.• Amoxycillin and Clavulan

ate pot. Tab/dry syrup.• Ampicillin sodium Cap.• Glipizide Tab.

Quality Problem Criterion :• 06Colchicine . mg/tab. (Low dose)• eeeeeee ee eeee/ (

/ )• Diltiazem tab. (Dissolution revis

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List of Drug Products Te sted. (cont.)

Analysis results 1063 24A Total of , Samples of dosage eeeee eee eeeeee eeeeeeee eeee eeeeeeeed.

- 9 dosage forms of 3 2 0 samples were eeeeeeeee ee eee eeeeeeee eeeeeeeeeees:

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- - Glibenclamide tab Glipizide tab - - Isoniazid tab Metronidazole tab -e eeeeeeee ee eee

Analysis results (cont.) For dissolution problem :• Indomethacin Cap . (5 0 % Failed, 2 9 out of 5 8 samples)

(due to less water soluble of active ingredient)• Omeprazole Cap 23 11 47. ( % Failed, out of samples)

(due to enteric coated and instability of granules)• Diclofenac sod.Tab 22 10 46. ( % Failed, out ofsamples)

(due to enteric coated of tablet)• Diltiazem Tab 13 5 38. ( % Failed, out of samples)eeee ee eeeeeeee ee eeeeeeeeeee eeeeee eeeeeee ee eeeee

nt pharmacopoeia)

Analysis results (cont.) For uniformity of content problems:

• Colchicine 0 .6 mg tab (6 1 % Fai 39 64led, out of samples, due to l

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1 2 outof 9 8 samples, also due to dissolution and stability problems )

2Alldetai l s are presentedi nTabl e

Analysis results (cont.) About Manufacturers

• Diltiazem Tab. - 2 outof7 importers failed - ee e eeeee e eeeeeee25

urers failed• Omeprazole Cap. - 2all importers failed - 2 13out of local manuf

acturers failed• e e eeeeeeeee eee e eeeeee

nate Dry Syrup - 1 4out of importers faile

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Discussion

• There are some limitation concerning the numberof batches received of each brand product foranalysis.

• Some products are released only 1 batch/year.• Each product in the database does not represen

t the same amountofbatches from each manufacturer.

• The pharmaceutical qualities of drug products from di fferent manufacturers were compared for in vitro test

intermof pass or fai l tomeet the standardspeci fication.

Discussion (cont.)

• The results showed that problems regar ding dissolution of tab or cap still remain

ed for many drug products.• The information is very important for pr

oduct development of both imported an d local manufacturers.

• Content uniformity is another important test item to demonstrate the uniformity

- of dosage unit, particularly low dose dru g products (eg. Colchicine tab )

Discussion (cont.)

For Herbal products :• which are very popular among health con

sumers and available in the marketplace.• The resul ts showedthat there are pro

bl ems regardi ngmi crobi al contami nat i onabout

6 0 % Failed, 3 3 out of 5 5 samples

Discussion (cont.) The poor quality products may be ass

ociated with• manufacturers lack of GMPregarding

– Humidity control– Formulation development– Stability study– Control of rawmaterial

• storage condition• packaging material etc.

Conclusion

The information of this study is h elpful for :

– Health care providers in making d ecision on product selection.

– Improving drug procurement in a - cost effective manner.

– Particularly in providing a better h ealthcare service to the patients.

Conclusion (cont.)

The database created will be a source of inf ormation to all parties concerned in Minis

try of Public Health for :– monitoring and/or planning the necessa

ry action to be taken on the Essential Dr ug 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 Minist ry ofPublic Health.