A cross-sectional analysis of falsified, counterfeit and substandard medicines in a low-middle income country.

BACKGROUND: High prevalence of falsified, counterfeit and substandard medicines pose a threat to public health and treatment failure. This study aimed to investigate the quality of selected essential medicines available in Mongolia. METHODS: A cross-sectional study collected essential medicines from pharmacy outlets in Mongolia, during June and July, 2017. These products were then submitted for pharmacopoeial analysis and registration status. RESULTS: A total of 1770 samples from 118 pharmacy entities were purchased from wholesalers in urban and rural areas. Pharmacopoeial analysis found 179 (10.1%) samples or eleven product groups were unacceptable. The prevalence of substandard locally produced medicines (n = 105, 5.9%) was higher than imported equivalents [(n = 74, 4.17%, p = 0.0001)]. Approximately one-third of all unacceptable tests were related to assay (n = 73, 30.8%) and weight variation. Of 1770 samples, 76 (4.3%) were unregistered and the prevalence of unregistered samples was 3.8% in Ulaanbaatar city and 5.8% in rural areas, respectively. CONCLUSIONS: This study has indicated that falsified and substandard medicines are prevalent in Mongolia. Considerable effort is required by regulatory authorities, private manufacturers, as well as importers to increase the quality of essential medicines in Mongolia.

Availability, affordability and costs of pediatric medicines in Mongolia.

BACKGROUND: The Essential Medicines List for Children (EMLc) was developed by the World Health Organization (WHO) to assist member countries to achieve Millennium Development Goals (MDG). The Government of Mongolia has adopted a National Essential Drug List (NEDL) with the seventh update published in 2014. The objective of this study was to determine the accessibility, availability and costs of essential pediatric medicines in Mongolia. METHODS: A standardized methodology developed by the WHO and Health Action International (HAI) was employed to conduct a study on the availability, costs and affordability of pediatric medicines in Mongolia. A data collection tool collected information in regards to retail and wholesale availability and costs of essential pediatric medicines at pharmacy outlets during January and August of 2016. RESULTS: Availability of individual essential pediatric medicines varied across the country. The average availability of medicines was 72.6% in the public sector (9.1-100%). Correspondingly, average availability of all selected medicines in the private sector was 76.7% (26.7-100%). Lowest price medicines were 2.45 times higher than the international reference price (IRP) in the private sector and was 1.95 times higher in the public sector. The lowest cost medicines in the public sector were more affordable for all conditions. The least affordable treatment was estimated to be for respiratory tract infections, or otitis media using amoxicillin clavulanic acid, suspension costing up to 1.03 days wages. CONCLUSION: Procurement, supply and distribution of essential pediatric medicines needs to be regularly investigated in order to identify the availability and costs of pediatric formulations in Mongolia.

Drug pricing and reimbursement decision making systems in Mongolia.

BACKGROUND: It is essential to allocate available resources equitably in order to ensure accessibility and affordability of essential medicines, especially in less fortunate nations with limited health funding. Currently, transparent and evidence based research is required to evaluate decision making regarding drug registration, drug pricing and reimbursement processes in Mongolia. OBJECTIVE: To assess the drug reimbursement system and discuss challenges faced by policy-makers and stakeholders. METHODS: The study has examined Mongolian administrative documents and directives for stakeholders and analysed published statistics. Experts and decision-makers were interviewed about the drug pricing and reimbursement processes in Mongolia. RESULTS: Decisions regarding Mongolian drug registration were based on commonly used criteria of quality, safety, efficacy plus some economic considerations. A total of 11.32 billion Mongolian National Tugrugs (MNT) [5.6 million United States Dollars (USD)] or 12.1% of total health expenditure was spent on patient reimbursement of essential drugs. The highest reimbursed drugs with respect to cost in 2014 were the cardiovascular drug group. Health insurance is compulsory for all citizens; in addition all insured patients have access to reimbursed drugs. However, the decision making process, in particular the level of reimbursement was limited by various barriers, including lack of evidence based data regarding efficacy and comparative cost-effectiveness analysis of drugs and decisions regarding reimbursement. CONCLUSIONS: Drug registration, pricing and reimbursement process in Mongolia show an increasing trend of drug registration and reimbursement rates, along with lack of transparency. Limited available data indicate that more evidence-based research studies are required in Mongolia to evaluate and improve the effectiveness of drug pricing and reimbursement policies.

Prevalence estimates of substandard drugs in Mongolia using a random sample survey.

To determine the prevalence of substandard drugs in urban (Ulaanbaatar) and rural (selected provinces) areas of Mongolia, samples of 9 common, therapeutically important drugs were collected from randomly selected drug outlets in Ulaanbaatar and 4 rural provinces by "mystery shoppers". Samples were analyzed by visual inspection, registration status, and biochemical analysis. Samples failing to meet all Pharmacopeia quality tests were considered substandard. In the rural provinces, 69 out of 388 samples were substandard, giving an estimated prevalence of substandard drugs of 17.8% (95% CI: 14.1-22.0). There were 85 unregistered samples, giving a prevalence estimate of unregistered drugs of 21.9%. (95% CI: 17.9-26.3). In the urban Ulaanbaatar districts, 112 out of 848 samples were substandard, giving an estimated prevalence of substandard drugs of 13.2% (95% CI: 11.0-15.7). There were 150 unregistered samples, giving a prevalence estimate of unregistered drugs of 17.7% (95% CI: 15.2-20.4). In the rural provinces, 35 out of 85 (41.2%) unregistered samples were substandard; whereas 34 out of 303 (11.2%) registered samples were substandard. (p < 0.0001) In the urban districts, 18 out of 150 (12.0%) unregistered samples were substandard, whereas 94 out of 698 registered were substandard. (13.5%) (p = 0.6). The prevalence of substandard and unregistered drugs is higher in rural provinces. There is a significant association between substandard and unregistered drugs in the provinces but not in the urban districts. The underlying causes for substandard drugs need to be further investigated in order to help formulate strategies to improve pharmacovigilance and the drug supply quality in Mongolia.

Artemisioside, a new monoterpene glucoside from the aerial parts of Artemisia ordosica (Asteraceae).

A new monoterpene glucoside, artemisioside, was isolated from the aerial parts of Artemisia ordosica Krasch. (Asteraceae). The chemical structure was elucidated from physicochemical data and by the application of Klyne's rule.