Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People's Democratic Republic.

INTRODUCTION: The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR). METHODS: All unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h. The patients or their relatives were interviewed to complete the study questionnaire. MUIs suspected of being involved in ADR(s) were identified through comparison of visual characteristics of tablets/capsules with that of reference medicines (photograph tool), and by proton nuclear magnetic resonance and mass spectrometry analyses. Factors associated with ADRs were identified by multivariate logistic regression. RESULTS: The frequency of hospitalizations related to an ADR was 5.1% (23/453, 95% confidence interval [CI] 3.1-7.1). Forty-eight (12.8%) patients used MUI(s) in the last 2 weeks preceding hospitalization. They were more likely to be hospitalized because of an ADR (adjusted odds ratio 4.5, 95% CI 1.7-11.5) than patients using medicines of known identity. MUIs were mainly involved in bleeding gastroduodenal ulcers. The photograph tool led to the misidentifications because of look-alike pharmaceutical units in the medicines photograph collection. CONCLUSION: According to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients' care in developing countries with limited capacities for drug analysis.

Population awareness of risks related to medicinal product use in Vientiane Capital, Lao PDR: a cross-sectional study for public health improvement in low and middle income countries.

BACKGROUND: While essential medicines have been made more available in all but the most remote areas in low and middle income countries (L/MICs) over the past years, inappropriate and incorrect use of good quality medicines remains a key impediment for public health. In addition, as medicines have a potential to cause harm (medicine risks), adequate awareness by medicine users of the risks of adverse reactions is essential, especially as self-medication is common in L/MICs. This study aimed to investigate the awareness of Lao residents regarding medicine risks in Vientiane Capital, Lao People's Democratic Republic. METHODS: Face-to-face interviews using structured questionnaires of 144 residents older than 16 years were carried out in 12 randomly selected villages out of the 146 villages of Vientiane Capital with at least one health facility. RESULTS: The respondents were mainly (85.0 %) the heads of households or their husband/spouse . The majority of the respondents were unaware (61.8 %) of medicine risks. Compared to residents living in the urban district of Xaysetha, living in peri-urban and even more in rural areas were identified as factors associated with being unaware of medicine risks [adjusted odds ratio (aOR) =3.3, 95 % Confidence Interval (CI) = 1.1-9.4]) and aOR =7.5 (95 % CI = 2.3-24.2), respectively]. In addition, more than half of the respondents had never heard of poor quality medicines, with a higher rate in rural/peri-urban compared to urban districts (55.6 % vs 38.9 %, respectively, p = 0.02). Finally, approximately one third of all respondents thought that traditional medicines could not cause harm. CONCLUSIONS: Overall, these results suggest a lack of awareness about medicinal product risks. Differences according to the place of residence are apparent and could be partly explained by a lower level of training of healthcare providers in contact with the population in the rural districts in particular. Communication on medicinal product risks to patients through well-trained healthcare providers could probably make a valuable contribution towards the appropriate use of medicines in L/MICs.

Provider performance in treating poor patients--factors influencing prescribing practices in lao PDR: a cross-sectional study.

BACKGROUND: Out-of-pocket payments make up about 80% of medical care spending at hospitals in Laos, thereby putting poor households at risk of catastrophic health expenditure. Social security schemes in the form of community-based health insurance and health equity funds have been introduced in some parts of the country. Drug and Therapeutics Committees (DTCs) have been established to ensure rational use of drugs and improve quality of care. The objective was to assess the appropriateness and expenditure for treatment for poor patients by health care providers at hospitals in three selected provinces of Laos and to explore associated factors. METHODS: Cross-sectional study using four tracer conditions. Structured interviews with 828 in-patients at twelve provincial and district hospitals on the subject of insurance protection, income and expenditures for treatment, including informal payment. Evaluation of each patient's medical record for appropriateness of drug use using a checklist of treatment guidelines (maximum score=10). RESULTS: No significant difference in appropriateness of care for patients at different income levels, but higher expenditures for patients with the highest income level. The score for appropriate drug use in insured patients was significantly higher than uninsured patients (5.9 vs. 4.9), and the length of stay in days significantly shorter (2.7 vs. 3.7). Insured patients paid significantly less than uninsured patients, both for medicines (USD 14.8 vs. 43.9) and diagnostic tests (USD 5.9 vs. 9.2). On the contrary the score for appropriateness of drug use in patients making informal payments was significantly lower than patients not making informal payments (3.5 vs. 5.1), and the length of stay significantly longer (6.8 vs. 3.2), while expenditures were significantly higher both for medicines (USD 124.5 vs. 28.8) and diagnostic tests (USD 14.1 vs. 7.7). CONCLUSIONS: The lower expenditure for insured patients can help reduce the number of households experiencing catastrophic health expenditure. The positive effects of insurance schemes on expenditure and appropriate use of medicines may be associated with the long-term effects of promoting rational use of drugs, including support to active DTC work.

Community perceptions and treatment-seeking behaviour regarding reproductive tract infections including sexually transmitted infections in Lao PDR: a qualitative study.

Creating community awareness of reproductive tract infections (RTI), including sexually transmitted infections (STI), and how to prevent them is essential to minimize their spread. Data on people's views about RTI/STI are entirely lacking in Laos. The aim of this study was thus to explore people's perceptions, treatment-seeking behaviour and understanding of information about RTI/STI, in urban and rural communities in two provinces in Laos. Fourteen focus group discussions and 20 in-depth interviews were held with 76 women and 56 men, selected purposively to provide diversity of socio-demographic backgrounds. Qualitative content analysis was employed for the data analysis. The major finding was that both male and female participants had a variety of misconceptions about the causes and symptoms of RTI/STI and their cure, and a reluctance to seek health care, which could cause delay in appropriate diagnosis and treatment. The most common treatment-seeking behaviour was self-medication through private pharmacies, following advice mostly given by friends and drug sellers. The main reasons for not going to health facilities were fear of social discrimination or shyness of genital examination. Complaints were also made about clinicians' negative attitudes towards 'dirty disease'. Although condom use was mentioned as a way to prevent RTI/STI, an unwillingness to use condoms was commonly expressed. The main media sources of RTI/STI information were radio and television, and access to health information was more difficult in rural areas. The health messages provided were mostly understood, except for some technical terms. The findings indicate that strengthening health education and promotion through interventions at the community level is recommended to improve quality of RTI/STI management. Health education messages should be more accessible in rural areas. There is also an urgent need to improve communication between RTI/STI patients and clinicians.

A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance.

BACKGROUND: Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines) in the Lao PDR (Laos). METHODS: In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC), mass spectrometry (MS), X-ray diffractometry and pollen analysis. RESULTS: Of 180 outlets sampled, 25 (13.9%) sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68-97%) sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8%) fakes contained detectable amounts of artemisinin (0.26-115.7 mg/tablet). CONCLUSION: This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT) in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention.

Health providers' competence in the management of reproductive tract infections in Vientiane, Lao People's Democratic Republic.

This cross-sectional study aimed to assess health providers' reported knowledge and practice competence regarding management of reproductive tract infections (RTIs) including sexually transmitted infections (STIs) in Vientiane, Laos. All 272 health providers (medical doctors/assistants, midwives/nurses and drug sellers) working with RTI/STI patients in one urban and one rural district were invited to fill in a self-completed questionnaire including four written simulated case scenarios, and 93% participated in the study. Of 252 respondents, 34% scored below 50% regarding both the case scenarios and reported knowledge, and 87% gave inadequate advice regarding health education. Only 34% gave correct advice on contact tracing, 38% on counselling, 52% regarding compliance and 59% on condom promotion. Drug sellers scored lowest in all aspects of RTI/STI management. Urban respondents were more likely to report adequate knowledge. Continuous training in syndromic approach and supervision are recommended to improve the quality of RTI/STI management, particularly at private pharmacies and in rural areas.

Reproductive tract infections among women attending a gynecology outpatient department in Vientiane, Lao PDR.

OBJECTIVES AND GOAL: To clinically and microbiologically identify reproductive tract infections (RTI), including sexually transmitted infections (STI), and to monitor the antibiotic susceptibility of Neisseria gonorrhoeae among women attending a gynecology outpatient department in Vientiane, Laos. STUDY DESIGN: Clinical and laboratory-based cross-sectional study. Women aged 15 to 49 years underwent a pelvic examination, and specimens were taken for laboratory testing. RESULTS: Of 1125 study participants, 82% clinically presented with an RTI syndrome. However, only 64% had an etiologically diagnosed RTI, including 11% with an STI. Endogenous infections were most prevalent (candidiasis 40%; bacterial vaginosis 25%), followed by STI [Chlamydia trachomatis 4.1%; N. gonorrhoeae (NG) and Trichomonas vaginalis, both 3.7%]. The 41 NG isolates showed 20% resistance to ciprofloxacin, 98% to penicillin, and complete to tetracycline. CONCLUSIONS: High RTI/STI level combined with high NG resistance emphasizes that concurrent with syndromic case management, periodic evaluations of etiological diagnosis should be available to ensure adequacy of treatment algorithms and prescribed medications.

Rational use of drugs: prescribing and dispensing practices at public health facilities in Lao PDR.

PURPOSE: To evaluate the rational use of drug (RUD) patterns with a focus on prescribing and dispensing practices for providing information to the policy makers for further planning and identifying intervention strategies. METHOD: A cross-sectional study conducted by interviewing 370 presenting outpatients, checking records of 900 out- patients with any cases and 798 outpatients with tracer diseases such as simple diarrhea, pneumonia and non-pneumonia (Flu) within 30 public health facilities (HFs) of five geographical areas with different socio-economic statuses grouped into high, middle and low. The WHO Operational Package for Monitoring and Assessing Country Pharmaceutical Situations indicators were used for data collection. RESULTS: Among the 3 items of drugs prescribed per average encounter, 97% were dispensed from HFs, of which 67% were adequately labeled, 84% were on the national essential drug (ED) list, and 78% were prescribed by generic name. Seventy-four percent of patients knew how to take the drugs they received, 47% of them received antibiotics (ABs), and 18% received injections. Forty-seven percent of under-five children with simple diarrhea received ABs, 77% received Oral Rehydration Salts (ORS) and 5% received anti-diarrhea drugs, and 91% of such under-five children with mid/moderate pneumonia received one of first line ABs, 15% received more than one ABs, and 41% of non-pneumonia (flu) patients of any age received ABs. CONCLUSION: The use of drugs in Laos was not fully appropriate in terms of rationally prescribing and dispensing practices. Since prescriptions for AB, injections, non-ED, and non-generics are still high, information on drug use provided is insufficient. Therefore, continuous health education programs among both health staff and public are needed.

Knowledge and perceptions of drug quality among drug sellers and consumers in Lao PDR.

In most developing countries, including the Lao People's Democratic Republic (PDR), high prevalence of low quality drugs has been reported. The aim of this study was to explore knowledge and perceptions regarding drug quality among drug sellers and consumers, in Savannakhet province, Lao PDR. Quantitative and qualitative methods were used. Fifty-nine drug sellers and 278 exit customers were interviewed. Eight focus group discussions with drug sellers and community members were conducted. There was inadequate scientific drug knowledge among drug sellers. Only a few customers were aware of the existence of low quality drugs. Only one drug seller knew what constitutes a good quality drug according to the given criteria, and only two drug sellers knew the correct temperature for drug storage. Forty-four per cent had correct knowledge on drug labelling and 73% could read the expiry date. Fifty-eight per cent stated that they bought some drugs from unauthorized sources. Both drug sellers and consumers also elaborated on a local definition of drug quality. They determined drug quality by its perceived efficacy in the sense that a drug is good if it takes the disease away. They also trusted the responsible authorities not to provide them with low quality drugs. A majority of the consumers (73%) did not worry about the quality of the drugs, their greatest problem being financial constraints. People living in urban districts had significantly more knowledge on aspects of drug quality than those living in rural and remote areas. The limitations in scientific knowledge among drug sellers and the low awareness among consumers may contribute to the continued existence of low quality drugs. Government interventions through training of drug sellers and drug information for lay people are suggested.

The quality of drugs in private pharmacies in Lao PDR: a repeat study in 1997 and 1999.

OBJECTIVE: To present a repeated test of the quality of ampicillin, tetracycline, chloroquine and ASA from private pharmacies in Laos in 1997 and 1999, and to discuss the quality in relation to the National Drug Policy Programme. METHOD: A total of 115 of 214 licensed private pharmacies were selected in Savannakhet province, a pilot province in the Lao National Drug Policy Programme. The four drugs, if available, were collected at each pharmacy. Thirty tablets of each drug were taken from a selected container. In 1997, 366 samples were analysed and three hundred in 1999. Identity, assay (content of active component) and measurement of weight variation tests were performed. Drug quality was compared mainly according to the standards of the British and United States' pharmacopoeias. RESULTS: The percentage of substandard drugs decreased significantly from 46% to 22% between 1997 and 1999 (P< 0.001). Substandard ampicillin and tetracycline were reduced significantly from 67% to 9% and from 38% to 12%, respectively (P < 0.001). In total, 3% vs 1% contained no active ingredient, 12% vs 4% had too little or too much active ingredient, and 35% vs 14% had weight variation outside pharmacopoeial limits. CONCLUSION: Drug quality was improved. However, the prevalence of substandard drugs was still unacceptably high, which may result in adverse clinical effect or treatment failure for individual patients.