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Abstract ID: 497
Author Name : Siriwat Tiptaradol
Email : [email protected]
Presenter Name : Siriwat Tiptaradol
Authors: Tiptaradol S, Abhigantaphand D , Ungboriboonpisal S
Institution : Department of Medical sciences , Ministry of Public Health , Thailand
Title : QUALITY ASSURANCE OF MEDICINES UNDER UNIVERSAL HEALTH COVERAGE PROGRAM
Abstract:
Problem Statement: Surveillance of drug product quality is currently conducted as part of Universal Health Coverage Program, namely “30-Baht Co-payment Scheme”. This is to ensure
that pharmaceutical products marketed in Thailand meet standard specifications for identity, strength, quality, purity and potency. The study is also the activity of the Department of
Medical Sciences for consumer protection on health products. The present study was performed in co-operation from the Provincial Public Health Officers , the Thai Food and Drug
Administration and government hospitals.
Design : The surveillance study was prospectively designed and performed during October 2002 to September 2003 on 21 selected drugs products.Of these,20 drugs were selected
from the National Essential Drugs List and any registered herbal products which were solid dosage forms.
Method: Selection criteria of studied drugs were based on their importance in term of public health, wide usage, wide range of cost differential among products, previously quality
problem reporting and products with stability problem. Examples of these products are diltiazem tablets, colchicine tablets, amoxicillin + clavulanate potassium dosage form and so on. A
total of 1,063 samples were collected from pharmacy unit in government hospitals and drug stores and analyzed for quality according to the current pharmacopeial requirements, except
for the herbal products which were determined only microbial contamination .
Results : Samples were sent to the Bureau of Drug and Narcotic, as well as Regional Medical Sciences Centers for analysis. The results revealed that most drug products conformed to
the pharmacopeial standards. However, it was found that some products were substandard with respect to the amount of active ingredient, dissolution and content uniformity. Some
herbal products failed to meet the requirements due to microbial contamination. One important finding is that poor quality products are often associated with manufacturers lack of Good
Manufacturing Practices (GMP) regarding humidity control, control of raw materials, packaging and quality control revision of current pharmacopeia.
Conclusion :The information regarding the quality of drug products obtained from this study is helpful for health care providers in making decisions on product selection, as well as
improving drug procurement in a cost-effective manner and particularly in providing a better healthcare service to the patients. Finally, the database created will be a source of information
to the Ministry of Public Health for monitoring and/or planning the necessary action to be taken on the Essential Drugs Program at the national level to improve the national medical care
scheme and for effective regulatory enforcement of GMP measures.
Study Funding : The study was supported by the Department of Medical Sciences , Thailand
INTRODUCTION
The Ministry of Public Health,Thailand, has implemented several reforms such as
drug supply management reform at the provincial levels since 1999. In 2001 the Universal
Health Coverage Program, or so-called “30 Baht Co-payment Scheme” was initiated as
part of the government health policy to provide medical services to all Thai people. The
program has covered all 76 provinces since 2002. In this regard, budgeting and
administrative system has to be adjusted. This has led to drug price competition and
significant cost reduction of hospital drug procurement. As a result, there are rising
concerns whether quality of drug products would be compromised. The Bureau of Drug
and Narcotic, as the national drug quality control laboratory, has been working with
Regional Medical Sciences Centers to ensure that drug products marketed in Thailand
meet standard specifications for identity, strength, quality, purity and potency. Research
on several aspects of drug quality as well as post-marketing surveillance for consumer
protections are regularly conducted. The purpose of this study is to assess the quality of
drug products as well as to generate a database to be used as information for drug
procurement in a more cost-effective manner.
OBJECTIVE
1. To assess the quality of essential drugs
2. To assess the quality of registered herbal products
3. To develop drug quality database
METHODOLOGY
The present study was prospectively designed and performed in cooperation
with the Provincial Public Health Offices, the Thai Food and Drug Administration, and
government hospitals. In early fiscal year 2003, all parties concerned were contacted
and informed about the project, sampling requirements and procedures.
Drug products were selected based on their importance in terms of public
health, wide usage, wide range of cost differential among products, quality problem
reporting and stability problems. Twenty drug products in various dosage forms were
selected from the National Essential Drug List. These products were collected from
government hospitals and drug stores and were evaluated for their quality according to
the current pharmacopeia (as shown in Table1). In addition to these modern
medicines,a number of herbal products registered in Thailand were also collected from
marketplace and determined for microbial contamination. Equipment used in
laboratories such as high-performance liquid chromatographs, analytical
balances,dissolution testers, and so on, have been routinely calibrated according to
ISO/IEC 17025.
RESULTS
A total of 1,063 samples of 24 drug dosage forms and herbal products were
evaluated for their quality. Number of samples tested for each product, analysis results
and corresponding numbers of manufacturers are reported in Table2. Samples failed to
meet pharmacopeial specifications are considered substandard products. In the present
study, nine drug products conformed to pharmacopeial requirements.
However, substandard samples were found in various products tested, ranging
from 1% to 61 %. The most common reason for these products to fail the requirement
was dissolution testing. For herbal products, which are non-official products, 60 % of the
samples tested were found to contain microbial contamination.
DISCUSSION
The results presented indicated the quality of drug products used in hospitals
and obtained from the marketplace. The pharmaceutical qualities of drug products
from different manufacturers were compared. However, there were some limitations
concerning the number of batches received of each brand product. Therefore, each
product in the database do not represented in the same amount of batches from each
manufacturer.
Drug products, namely Amoxycillin capsule, Ampicillin Capsule, Diclofenac
Injection, Glibenclamide Tablet, Glipizide Tablet, Isoniazid Tablet, Metronidazole
Tablet, Paracetamol Injection and Acyclovir Capsule, were all conformed to quality
specifications. However, the results showed that problems regarding dissolution of
tablet or capsule still remained for other drug products. This information is very
important for product development since drugs have to dissolve from solid dosage
forms prior to absorption. Further, content uniformity is another important test item
to demonstrate the uniformity of dosage unit, particularly low-dose drug products.
The analysis results of Colchicine Tablet containing 0.6 mg of Colchicine
demonstrated such a problem of these products tested.
Herbal products are very popular among health consumers and are available
in the marketplace. The results indicate that there are problems regarding microbial
contamination in these products.
The poor quality products may be associated with manufacturers lack of Good
Manufacturing Practices (GMP) regarding humidity control, formulation
development and other quality aspects such as packaging materials. The cooperation
of the Provincial Public Health Offices, the Thai Food and Drug Administration and
government hospitals indicated their recognition of the potential values of this study.
CONCLUSION
The information regarding the quality of drug products obtained from this
study is helpful for health care providers in making decisions on product selection, as
well as improving drug procurement in a cost-effective manner and particularly in
providing a better healthcare service to the patients. Finally, the database created will
be a source of information to the Ministry of Public Health for monitoring and/or
planning the necessary action to be taken on the Essential Drugs Program at the
national level to improve the national medical care scheme and for effective
regulatory enforcement of GMP measures.
ACKNOWLEDGMENT
This study was supported by Department of Medical Sciences and the
parties concerned in Ministry of Public Health, Thailand.
REFERENCE
1.The United states Pharmacopeia 24.The National Formulary 19th,ed.Rockville:
United States Pharmacopeial Convention,Inc. 2000
2.British Pharmacopoeia 2001. London: Her Majesty’s Stationary Office, 2001
3 . B u r e a u o f P o l i c y a n d S t r a t e g y,
Ministry of Public Health.
Thailand Health profile 1999-2000.Bangkok :Express Transportation
Organization,2002
Table 1: List of Drug Products Tested According to Pharmacopeial Requirements
T a b le 1 : L is t o f Dr u g P r o d u c t s T e s t e d
A c c o d in g t o P h a r m a c o p e ia l Re q u ir e m e n t s
No .
1
2
3
4
Dr u g Nam e
A c y c lo v ir
A m in o p h y llin e
A m o x y c illin
A m o x y c illin a n d
C la v u la n a t e P o t a s s iu m
5 A m p ic illin
6 C im e t id in e
7 C o lc h ic in e
8 C o -t r im o x a z o le
9 Dic lo f e n a c S o d iu m Dic lo f e n a c
No .
Dr u g Nam e
1 0 Dilt ia z e m
1 1 G e m f ib r o z il
1 2 G lib e n c la m id e
1 3 G lip iz id e
1 4 In d o m e t h a c i n
1 5 Is o n i a z i d
1 6 M e t r o n id a z o le
1 7 O m e p r a z o le
18 Par ace tam o l
1 9 P y r a z in a m id e
2 0 Rif a m p ic in
21 He r b al Pr o d u c ts
Do s ag e Fo r m
T a b l e t ,C a p s u l e
T a b le t
C a p s u le
T a b le t , Dr y S y r u p
T h e r a p e u t ic C la s s
A n t iv ir a l
A n t ia s t h m a t ic
A n t ib io t ic
A n t ib io t ic
W HO C o d e
DO 6BB03
R03DA 05
J01C A 04
J 01C R02
S e le c t io n C r it e r ia B a s e d O n
W id e Us a g e
S t a b ilit y P r o b le m
W id e Us a g e
S t a b ilit y P r o b le m
C a p s u le
T a b le t
T a b le t
T a b le t
T a b l e t In j e c t i o n
Do s ag e Fo r m
T a b le t
T a b l e t ,C a p s u l e
T a b le t
T a b le t
C a p s u le
T a b le t
T a b le t
C a p s u le
In j e c t i o n
T a b le t
C a p s u le
T a b l e t ,C a p s u l e ,P i l l ,P o w d e r ,
S o lu t io n
A n t ib io t ic
A n t iu lc e r a n t
A n t ig o u t
A n t ib a c t e r ia l
A n a lg e s ic
T h e r a p e u t ic C la s s
C a lc iu m A n t a g o n is t
A n t ih y p e r lip id e m ic
A n t id ia b e t ic A g e n t
A n t id ia b e t ic A g e n t
A n a lg e s ic
A n t it u b e r c u lo s is
A n t iin f e c t iv e
A n t iu lc e r a n t
A n a lg e s ic & A n t ip y r e t ic
A n t it u b e r c u lo s is
A n t it u b e r c u lo s is
-
J01C A 01
A 02BA 01
M 04A C 01
J 0 1 EE0 1
M 01A B05
W HO C o d e
C 08DB01
C 10A B04
A 10BB01
A 10BB07
M 01A B01
J04A C 01
A 01A B17
A 02BC 01
N 0 2 B E0 1
J04A K01
J04A B03
-
S t a b ilit y P r o b le m
W id e Us a g e
Q u a lit y P r o b le m
W id e Us a g e
Q u a lit y P r o b le m
S e le c t io n C r it e r ia B a s e d O n
Q u a lit y P r o b le m
Q u a lit y P r o b le m
W id e Us a g e
S t a b ilit y P r o b le m
Q u a lit y P r o b le m
Q u a lit y S u r v e illa n c e
W id e Us a g e
Q u a lit y S u r v e illa n c e
Q u a lit y P r o b le m
Q u a lit y S u r v e illa n c e
Q u a lit y S u r v e illa n c e
M ic r o b ia l C o n t a m in a t io n
Table 2: Detail of Drug Products Analysis According to Pharmacopeial Requirements
No.
1
2
3
4
5
6
7
8
9
10
11
12
Drug Name
Amoxycillin Capsule
Ampicillin Capsule
Diclofenac Sodium Injection
Glibenclamide Tablet
Glipizide Tablet
Metronidazole Tablet
Paracetamol Injection
Acyclovir Capsule
Acyclovir Tablet
Cimetidine Tablet
Co-trimoxazole Tablet
No.of Samples
Tested
66
27
37
13
52
29
40
55
1
73
56
51
No. of Substandard
Samples (%)*
0
0
0
0
0
0
0
0
0
1 (1%)
1 (2%)
2 (4%)
No. of
Manufacturer
23
11
12
11
12
5
16
11
1
10
21
25
Reason Fail
Dissolution
Dissolution
Dissolution
Table 2: Detail of Drug Products Analysis According to Pharmacopeial Requirements
(Continued)
No.
13
14
15
16
17
18
19
20
21
22
23
24
Drug Name
No.of Samples
Tested
Pyrazinamide Tablet
26
Gemfibrozil Tablet
15
Amoxycillin and Clavulanate Potassium Dry Syrup 12
Aminophylline Tablet
98
Gemfibrozil Capsule
59
Diltiazem Tablet
38
Rifampicin Capsule
25
Amoxycillin and Clavulanate Potassium Tablet
20
Diclofenac Sodium Tablet
46
Omeprazole Capsule
47
Indomethacin Capsule
58
Herbal Products
55
No. of Substandard
Samples (%)*
1 (4%)
1 (7%)
1 (8%)
12 (12%)
7 (12%)
5 (13%)
4 (16%)
4 (20%)
10 (22%)
11 (23%)
29 (50%)
33 (60%)
No. of
Manufacturer
4
5
5
6
18
12
10
5
21
15
19
27
Reason Fail
Dissolution
Dissolution
Assay
Dissolution, Content Uniformity
Dissolution
Dissolution
Assay , Dissolution
Assay , Dissolution, Content Uniformity
Dissolution, Content Uniformity
Assay , Weight Variation, Dissolution
Assay , Dissolution, Content Uniformity
Microbial Limit Test