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Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

ABSTRACT: Substandard and falsified medicines represent a serious threat for public health and patient safety. Especially in low and middle-income countries, the prevalence of substandard and falsified medicines is reportedly high. However, reliable information on the prevalence of poor-quality medicines is scarce. In this study, 12 essential medicines, including antibiotics, antidiabetics, cardiac drugs and antiasthmatic drugs, were collected from six informal vendors and six licensed pharmacies in the southern part of Togo (regions Maritime and Plateaux). A mystery shopper approach was used in both types of outlets. In total, 64 samples were collected from licensed pharmacies and 30 from informal vendors. Both availability of medicines and prices of medicines were higher in licensed pharmacies than in informal vendors. 92 medicine samples were analyzed by visual examination, followed by chemical analysis for the content and for the dissolution of the active pharmaceutical ingredients according to the respective monographs of the United States Pharmacopoeia. 7 samples (8%) did not comply with the pharmacopoeial specifications, and one sample (1%) showed even extreme deviations. None of the samples was obviously falsified. However, one sample of amoxicillin capsules contained only 47% of the declared content of the active pharmaceutical ingredient, indicating that it may represent amoxicillin capsules 250 mg, rather than 500mg as declared on the label. Medicines stated to originate from Asia (i.e. mainly from India and China) showed a significantly higher proportion (24%) of non-compliant samples than those from Africa and Europe (4%, p = 0.007). High failure rates were observed in medicines both from informal vendors (13%) and from licensed pharmacies (5%), but the difference between both groups was not statistically significant (p = 0.152). The observed high prevalence of substandard medicines requires action from regulatory authorities and health care providers. Testing of selected samples for related substances indicated that inappropriate transport and storage conditions may have been an important cause for substandard quality.

SUBMITTER: Schafermann S

PROVIDER: S-EPMC6264819 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

Schäfermann Simon S Wemakor Emmanuel E Hauk Cathrin C Heide Lutz L

PloS one 20181129 11

Substandard and falsified medicines represent a serious threat for public health and patient safety. Especially in low and middle-income countries, the prevalence of substandard and falsified medicines is reportedly high. However, reliable information on the prevalence of poor-quality medicines is scarce. In this study, 12 essential medicines, including antibiotics, antidiabetics, cardiac drugs and antiasthmatic drugs, were collected from six informal vendors and six licensed pharmacies in the s ...[more]

PMID: 30496234

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Project description:Access to safe, effective and affordable medicines of good quality is included into the Sustainable Development Goals of the United Nations. Furthermore, WHO has developed a Global Action Plan with the aim to raise access to essential medicines against non-communicable diseases (NCDs) to 80%, and to improve their affordability. In order to contribute to the monitoring of progress towards these goals, the present study investigated the availability and affordability of seven antibiotics and six medicines against non-communicable diseases in the northeast of the Democratic Republic of Congo and the west of the Republic of Cameroon. Data on availability and prices of these medicines were collected in 60 different sites (34 in the DR Congo, 26 in Cameroon), including government health facilities, church health facilities, private pharmacies and informal vendors, as part of a study on medicine quality. The data were analyzed using a standardized procedure developed by WHO and Health Action International (HAI). Average availability of the investigated antibiotics ranged from 62% to 98% in the different types of facilities in both countries, including the informal vendors. Average availability for medicines against NCDs in the different types of facilities showed a higher variation in both countries, ranging from 11% up to 87%. The average availability of medicines against NCDs in government health facilities was only 33% in Cameroon, and as low as 11% in the DR Congo. In contrast, availability of medicines against NCDs in church health facilities in Cameroon was 70%, not far from the 80% availability goal set by WHO. Medicine prices were clearly higher in Cameroon than in the DR Congo, with median price ratios to an international reference price of 5.69 and 2.17, respectively (p < 0.001). In relation to the daily minimum wages in both countries, treatment courses with five of the seven investigated antibiotics could be considered as affordable, while in each country only one out of the five investigated medicines against NCDs could be considered as affordable. Especially generic medicines provided by government and church health facilities showed reasonable affordability in most cases, while originator medicines offered by private pharmacies were clearly unaffordable to a major part of the population. Despite some encouraging findings on the availability of antibiotics in both countries, the availability and affordability of medicines against NCDs urgently requires further improvements.

Project description:BackgroundNon-communicable diseases (NCDs) are the leading cause of death worldwide. Inadequate and inequitable access to essential NCD medicines is a major concern, particularly in low- and middle-income countries. National Essential Medicines Lists (EMLs) are important policy tools that indicate which medicines are prioritized as essential within a country's health system. This study sought to analyze a wide range of national essential medicines lists (EMLs) for their inclusion of priority non communicable disease (NCD) interventions recommended by the World Health Organization (WHO).MethodsThree lists of WHO endorsed priority NCD interventions were included. A database with 137 national EMLs and the WHO EML was created from the WHO Repository and these EMLs were compared for listing of priority NCD interventions.ResultsAcross 137 countries with national EMLs, the median percentage of 20 Best Buys interventions listed was 90% (IQR 80-95) and 31 Package of essential noncommunicable disease interventions (PEN) interventions listed was 94% (IQR 90-97), of 9 HEARTS interventions was 100% (IQR 89-100), and of the 43 unique interventions across the three priority lists was 88% (IQR 84-93). Less than 80% of the 43 interventions were listed by 22 (16%) countries and less than half of the interventions were listed by 2 countries: Angola (35%) and Cambodia (23%). Interventions listed on the fewest number of national EMLs were: influenza vaccine, HPV vaccine, hepatitis B vaccine, cervical cancer chemotherapy, codeine, promethazine, senna, and oxygen.ConclusionMost NCD interventions have been prioritized in national policy in most cases. The majority of priority medicines for NCDs described within key WHO NCD technical packages are listed on nearly all national EMLs across 137 countries of all income levels. Most NCD interventions have been prioritized in national policy in most cases, but in some countries and for select interventions such as the HPV vaccine, prioritization may be reviewed.

Project description:In Kenya, noncommunicable diseases (NCDs) account for 27% of all deaths. Adult Kenyans have an 18% chance of dying prematurely from cancers, diabetes, cardiovascular diseases or chronic respiratory diseases. A Novartis Access Initiative is making medicines available to treat cardiovascular diseases, diabetes, chronic respiratory diseases, and breast cancer in 30 countries, including Kenya. Little is known about patients' perceptions of access to medicines for NCDs in Kenya. The study objective was to understand patients' perceptions of access to medicines; as well as barriers and facilitators at the household, community, and healthcare system level. A baseline qualitative study was conducted in eight of 47 counties as part of an evaluation of the Novartis Access Initiative in Kenya. The 84 patients interviewed through a household survey had been diagnosed and treated for an NCD. Although medicines at government facilities were free or cheaper than those sold in private pharmacies, the availability of medicines presented a constant challenge. Patients often resorted to private pharmacies, where NCD medicines cost more than at public facilities. Participants with an NCD took their health seriously and strove to get the medicines, even under difficult circumstances. Buying NCD medicines put a strain on the household budget, especially for the lower-income participants. Some actions to overcome affordability barriers included: borrowing money, selling assets, seeking help from relatives, taking on extra work, buying partial dosages, leaving without the medicines, or resorting to non-medical alternatives. In conclusion, access to NCD medicines is a major challenge for most adults in Kenya. As a result, they engage in complex interactions between public, private facilities and pharmacies to overcome the barriers. The government should ensure well-stocked public sector pharmacies and subsidize prices of medicines for lower-income patients. Integration of industry-led access to medicine programs may help governments to obtain low cost supplies.

Project description:IntroductionThe aim of this study was to investigate the simultaneous presence of risk factors for non-communicable diseases and the association of these risk factors with demographic and economic factors among adolescents from southern Brazil.MethodsThe study included 916 students (14-19 years old) enrolled in the 2014 school year at state schools in São José, Santa Catarina, Brazil. Risk factors related to lifestyle (i.e., physical inactivity, excessive alcohol consumption, smoking, sedentary behaviour and unhealthy diet), demographic variables (sex, age and skin colour) and economic variables (school shift and economic level) were assessed through a questionnaire. Simultaneous behaviours were assessed by the ratio between observed and expected prevalences of risk factors for non-communicable diseases. The clustering of risk factors was analysed by multinomial logistic regression. The clusters of risk factors that showed a higher prevalence were analysed by binary logistic regression.ResultsThe clustering of two, three, four, and five risk factors were found in 22.2%, 49.3%, 21.7% and 3.1% of adolescents, respectively. Subgroups that were more likely to have both behaviours of physical inactivity and unhealthy diet simultaneously were mostly composed of girls (OR = 3.03, 95% CI = 1.57-5.85) and those with lower socioeconomic status (OR = 1.83, 95% CI = 1.05-3.21); simultaneous physical inactivity, excessive alcohol consumption, sedentary behaviour and unhealthy diet were mainly observed among older adolescents (OR = 1.49, 95% CI = 1.05-2.12). Subgroups less likely to have both behaviours of sedentary behaviour and unhealthy diet were mostly composed of girls (OR = 0.58, 95% CI = 0.38-0.89); simultaneous physical inactivity, sedentary behaviour and unhealthy diet were mainly observed among older individuals (OR = 0.66, 95% CI = 0.49-0.87) and those of the night shift (OR = 0.59, 95% CI = 0.43-0.82).ConclusionAdolescents had a high prevalence of simultaneous risk factors for NCDs. Demographic (gender and age) and economic (school shift) variables were associated with the most prevalent simultaneous behaviours among adolescents.

Project description:Using poor-quality antibiotics leads to increased risk of the development of microorganism-resistant strains, treatment failure, loss of confidence in health systems, and associated socio-economic impacts. The prevalence of poor-quality antibiotics has been found to be high in some of the Low and Middle-Income Countries (LMICs), but no data were available on the situation in Rwanda. This study was conducted to obtain data and inform health professionals on the quality of the 12 most-used selected antibiotics from private retail pharmacies in Rwanda. The investigation was conducted on 232 batches collected from randomly selected private retail pharmacies in all provinces of Rwanda, and concerned only with visual inspection and assay tests. Visual inspection was performed using a tool adopted by the International Pharmaceutical Federation (FIP) to identify manufacturing defects. An assay test quantified the Active Pharmaceutical Ingredient (API) in each collected batch using high-performance liquid chromatography (HPLC) coupled with an ultraviolet-visible (UV) detector, and the results were reported as the percentage content of the amount of APIs stated on the label. A total of 232 batches were analyzed, manufactured in 10 countries; the main country of manufacture was Kenya, with almost half of the batches (49.6%). The results of the visual inspection did not show the presence of counterfeit/ falsified antibiotics on the Rwandan market in this study but revealed weaknesses in labeling: more than 90% of the analyzed batches of the 12 antibiotics did not present the dosage statement on their label, and the complete list of excipients was missing in more than 20% of the analyzed batches. The assay test using HPLC confirmed the presence of APIs in 100% of the analyzed batches. However, moderate deviations from acceptable ranges of the API content defined by M. M. Nasr & C. M. Stanley in 2006 for erythromycin and the United States Pharmacopoeia 2018 for the other 11 molecules were found. The failure rate to meet the quality requirements in terms of the percentage content of active pharmaceutical ingredients declared on the labels was estimated at 8.2% in total, with 3.9% and 4.3% containing more and less than the amount of APIs stated on the labels respectively. The most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.

Project description:BackgroundAccess to medicines is a universal right. Low availability and low affordability of medicines are issues that deny this right to a significant proportion of the world population. The objective of this study was to determine the availability, price and affordability of essential medicines prescribed to treat non communicable diseases in Sri Lanka.MethodsMethodology was based on the 2nd edition of the World Health Organization Health Action International Manual. A country survey was conducted and facilities representing both public and private pharmacies were selected. A total of 109 facilities was surveyed. At each facility data on the availability and prices of 50 essential medicines for non communicable diseases were collected. Percentage availability, median price of originator brand and lowest priced generic, median price ratio to the International Reference Price were calculated for surveyed medicines. Affordability was determined using the daily incomes of the lowest--paid unskilled government worker.ResultsSemi government community pharmacies had the highest (>80%) availability while outdoor pharmacies of public health care facilities, private pharmacies and outdoor pharmacies of private hospital showed a fairly high availability (50 - 80%) of surveyed medicines.Unit price of 76% of selected individual medicines was less than ten Sri Lankan rupees. Out of these 28% of medicines cost less than one Sri Lanka rupee. For 21 of the surveyed medicines the median price ratio to the international reference price was less than one. The prices of originator brands for 14 surveyed medicines were more than five times that of the lowest price generics.Less than a single day's wages was adequate to purchase a month's supply of the lowest priced generic of more than 67% of surveyed medicines.ConclusionsThe availability of selected essential medicines was fairly high in both public and private sectors in Sri Lanka. Most medicines are affordable to the lowest income earners in the community. There were many generic brands and generics available for most of the medicines in private and semi government community pharmacies increasing both availability and affordability.

Dataset Information

Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

Publications

Quality of medicines in southern Togo: Investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors.

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