INTRODUCTION

1. Abstract ID: 497Author Name : Siriwat Tiptaradol Email : siriwat@dmsc.moph.go.thPresenter Name : Siriwat TiptaradolAuthors: Tiptaradol S, Abhigantaphand D , Ungboriboonpisal SInstitution : Department of Medical sciences , Ministry of Public Health , Thailand Title : QUALITY ASSURANCE OF MEDICINES UNDER UNIVERSAL HEALTH COVERAGE PROGRAMAbstract: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

2. 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.

3. 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.

4. 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 eachmanufacturer.

5. 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.

6. 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.Bureau of Policy and Strategy, Ministry of Public Health. Thailand Health profile 1999-2000.Bangkok :Express Transportation Organization,2002

7. Table 1: List of Drug Products TestedAccording to Pharmacopeial Requirements

8. Table 2: Detail of Drug Products AnalysisAccording to Pharmacopeial Requirements

9. Table 2: Detail of Drug Products AnalysisAccording to Pharmacopeial Requirements (Continued)