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Quality Control of Antibiotics Before the Implementation of an STD Program in Northern Myanmar



Background The ready availability of poor-quality drugs in developing countries leads to treatment failure and, consequently, excess mortality and morbidity. Moreover, the widespread availability of substandard drugs plays a key role in increasing the resistance to antimicrobial drugs.

Goal As a prerequisite to the establishment of a sexually transmitted disease (STD) control program, this study aimed to evaluate the quality of antibiotics recommended for treatment of STDs that were locally available in the capital of a province of Northern Myanmar.

Study Design In addition to the hospital pharmacy, we selected at random 5 of the 41 drug sellers and 5 of the 40 general practitioners who sell antibiotics in the city of Myitkyina. Twenty-one marketing products corresponding to nine different antibiotics used for STD treatment were purchased (benzathine benzylpenicillin, benzylpenicillin, ceftriaxone, chlortetracycline, ciprofloxacin, clotrimazole, co-trimoxazole, doxycycline, and erythromycin). Drugs were sent to France, where they were analyzed according to the WHO guidelines. Drugs were considered to be standard if their dosage remained in the 10% range of the expected value.

Results Among the 21 different specialty products, only three displayed the official “registered” label. Three drugs were expired and the expiration date was not available for six others. One product did not contain the active drug declared (chlortetracycline; Lombisin, Unicorn, China) and did not show any in vitro activity against bacteria. Seven of 21 products (33%) did not contain the stated dosage (1, more than stated dosage; 6, less than stated dosage). The highest deficit observed was 48% in two products (co-trimoxazole, Yong Fong, Myanmar; benzylpenicillin, China [city and manufacturer unknown]). The dosage was not available for five drugs. As a result, only 8 of 21 products (38%) did not contain the stated dosage of active drug.

Conclusion These findings suggest that public health policies based on national treatment guidelines should rigorously include the monitoring of quality control of available antimicrobial products. In the absence of such measures, specific treatment strategies are likely to fail and to generate drug resistance.

A study in Northern Myanmar showed the limited quality of locally available antibiotics recommended for treatments of STDs: 38% did not contain the stated dosage of active drug.

From the *Department of Infectious Diseases, CHR Orléans La Source, Orléans, France; Médecins du Monde, Paris, France; Centre for Population Studies, London School of Hygiene and Tropical Medicine, London, United Kingdom; and §Essential Drug Collaborative Center, Nantes, France

The authors thank Severine Argentier and Alexandra Pillard for their technical assistance.

Reprint requests: Thierry Prazuck, Service de Maladies Infectieuses et Tropicales, CHR Orléans La Source, BP 6709, 45067 Orléans Cedex 2, France.

Received for publication July 24, 2001,

revised January 10, 2002, and accepted January 11, 2002.

PURCHASABLE DRUGS in developing countries are often lacking in quality. According to the WHO, the proportion of total health expenditures on drugs is higher in the least developed countries than anywhere else, and most of the expense is paid out-of-pocket. At the same time, drug control and regulations are lax. In these circumstances the market for counterfeit and substandard drugs becomes a lucrative one. The WHO Essential Drug Program has failed in most countries 1 because of personal financial interests at local, national, and foreign levels or a black market, for example, through intensive cross-border migration. The ready availability of these poor-quality antibiotics leads to treatment failure and consequently to excess mortality and morbidity. 2 Moreover, the widespread availability of substandard drugs plays a key role in increasing the resistance to antimicrobial drugs.

Before conducting an STD control program targeting sex workers as part of an AIDS prevention program, we decided to take steps to control the quality of marketed antibiotics recommended for treatment of STDs that are sold by general practitioners, hospitals, and merchants. The study was part of our evaluation of the long-term sustainability of such a prevention program. By the testing and secondary prescribing of locally available drugs, this program aimed to ensure low cost and sustainable STD treatments.

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This drug quality control program was carried out in October 1997 in Myitkyina, the capital city of the Kachin State (in the northernmost province of Myanmar, bordering China). The drug retailers were identified from the registration list provided by the Township Health Office. This list included the three following types of establishments involved in the sales of drugs: drug stalls, private clinics run by general practitioners (GPs), and the hospital pharmacy. In addition to the hospital's pharmacy, 5 of the 41 drug stores and 5 of the 40 GPs registered were randomly selected from the list. At that time the WHO recommended the nine following antibiotics for the treatment of STDs: benzathine penicillin, benzylpenicillin, ceftriaxone, ciprofloxacin, erythromycin, doxycycline, co-trimoxazole, chlortetracycline, and clotrimazole. From this list, every single brand available in each selected establishment was purchased. Moreover, an open questionnaire on STD prescription behavior was administered informally to the vendors. The medical samples were forwarded for analysis to the Nantes Essential Drugs WHO Collaborative Center (France). Drug quantitative analysis was performed with titrimetry and visible UV spectrophotometry, whereas qualitative analysis used thin-layer chromatography. An antibiotic was considered satisfactory if its dosage did not deviate by more than 10% from the expected value.

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All sellers pretended that they were following the national rules and regulations that forbid nonmedical staff to prescribe medicine. Therefore, they were unwilling to disclose which antibiotics they used for prescriptions for STD syndromes. The sellers were aware of neither expiration dates nor differences in dosage among products.

The commercial features of the 21 purchased items are presented in Table 1. Three of 21 drugs had expired before the date of the purchase. The benzathine benzylpenicillin (Helm Pharmaceutical GMBH, Hamburg, Germany) had expired 2 months previously, the Ciprobid (ciprofloxacin; Cadila Lab, Ahmedabad, India) collected in the hospital had expired 11 months previously, and the Lombisin (chlortetracycline; Unicorn Lab, China) had expired 15 months previously. Of the 6 specialty drugs for which the expiration date could not be established, 4 were sold per tablet and 2 did not have any expiration date on the package. Among the 21 drugs, only 3 had the “registered” label on its packaging: Canesten (clotrimazole; Bayer, Ltd., Thane, India), Oriprim (co-trimoxazole 800 mg; Cadila Lab), and Broadced (ceftriaxone; Kalbe Pharma Lab, unknown origin). The only chlortetracycline available on the market (Lombisin; Unicorn Lab) did not contain the stated active principle. The chemical composition of the drug was not identified. In testing of Lombisin in vitro against common bacterial strains, there was no evidence of bacterial inhibition, unlike the inhibition seen with the tetracycline control.



Seven others of the 21 drugs (33%) that did not contain the expected dosage are presented in Table 2. Although the dosage of four drugs sold by tablets could not be obtained, we inferred that they contained the standard dosage. Three of these four drugs contained acceptable amounts of the active ingredient, i.e., within 10% of the assumed dosage (Plocanmad, Tabellae, and Sulfamethoxazoli), whereas the dosage of the benzylpenicillin from Chuanyao, China (manufacturer unknown), was 550,000 IU (versus the standard of 1,000,000 IU).



In the overall sample of 21 STD drugs, 38% (8 commercial products) did not contain within 10% of the stated dosage of the active ingredient.

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The study highlights the poor quality of antibiotics available in the capital of a province in a developing country. Previous studies in Southeast Asia have shown that the production of counterfeit drugs is common in Myanmar, Thailand, India, and China. 3–5 Because Myanmar is situated at a crossroad between China, India, and Thailand, and because of its poor capacity for drug control, this country is a lucrative market for smuggled drugs and counterfeit drug production. The new pharmaceutical law adopted in China in February 2001 might reduce the production of Chinese counterfeit drugs in the future. 6

According to other studies, patients and village health providers often prefer the fake drugs because of their lower price. 7 In our study, expensive price or luxury marketing or packaging was not a guarantee of the authenticity of the drugs. Although the substandard erythromycin was cheaper than other available erythromycin, the two substandard cotrimoxazole formulations were similar in price to the quality one, and the standard ciprofloxacin was cheaper than its counterfeit. Our study found substandard drugs were sold by any official health care provider, including the State Hospital. As a consequence, the whole Myanmar population is victim to the poor quality of drugs. In addition to decreasing the efficiency of treatments, this circumstance weakens the population's trust in both the public and private health care systems. The low efficiency of antibiotherapies also discredits Western medicine. The lack of quality in locally available drugs raises an ethical issue in infectious disease control programs in developing countries.

The use of imported drugs seriously limits the sustainability of interventions and does not stimulate the local market. To ensure the quality of an intervention that relies on locally available drugs, however, program designers need to guarantee the drugs by regular testing. In addition to excess morbidity, the low dosage of antibiotics and poor compliance with treatment lead to inadequate antibiotic pressure on bacterial ecology. As a consequence, the proportion of multiresistant strains in various bacterial species has rapidly increased in some Asian countries, 8 whereas such strains are still susceptible to common antibiotics in industrialized countries (e.g., Neisseria gonorrhoeae versus quinolones). The dosage of the only available benzylpenicillin was 45% less than the standard dosage.

Our study did not assess toxic substances, which are common in counterfeit drugs. Information collected during the interviews was biased, as sellers immediately identified interviewers as members of an NGO headed by the only foreigner living in town. Although restricted by ethical issues, the use of dummy patients would have been more informative. The low knowledge of drugs and the consequent need to train drug sellers that were revealed in our study should be assessed in depth by an appropriate qualitative study. If the excess of expired medicine on the market pinpoints to the lack of concern shown by medicine sellers about expiration dates, it is unlikely that training of drug sellers alone would be sufficient. In poor settings and in the absence of national control, retailers cannot be expected to care about storage conditions and to discard expired products. Nevertheless, the establishment of an operational national office for the control of medicine must be associated with extensive training programs for medical drug sellers.

Although our study focuses on Myanmar, the production of counterfeit drugs is found throughout developing regions 6,7 and should generate a worldwide public health concern about an increase in bacterial resistance to antibiotics. Moreover, the sustainability of primary health care programs in developing countries depends on the reliability of locally available drugs. In some places, programs should not be considered if thorough, regular evaluations of drug quality cannot be undertaken. In order to ensure the effectiveness of essential drugs, they must be available, affordable, and properly used. The issue of availability of essential drugs needs to be addressed from the perspective of relevant socioeconomic issues and political situations. 9 Advocacy of the establishment of law enforcement and national entities in charge of drug control is essential.

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