Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries

Ozawa, Sachiko; Evans, Daniel R.; Bessias, Sophia; Haynie, Deson; Yemeke, Tatenda T.; Laing, Sarah; Herrington, James E.

doi:10.1001/jamanetworkopen.2018.1662

Cited by 242 publications

(293 citation statements)

References 107 publications

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“…Many SSA countries are faced with the challenges of limited financial resources for medicine safety surveillance, inadequate technology, insufficient infrastructure and a lack of HCPs trained in PV. Challenges associated with traditional healing practices [16], the relatively low literacy level among adults, widespread self-medication and counterfeit drugs could also have an impact on AE reporting [17].…”

Section: Introductionmentioning

confidence: 99%

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

et al. 2020

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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV. Objective The objective of this initiative was to improve reporting of adverse events (AEs) by strengthening passive safety surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare facilities (HCFs). Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders, and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representatives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of reports, serious AEs reported and timeliness of recording into VigiFlow. Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (enabling Malawi to become a member of the World Health Organization Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter, event, patient and product, but under 1% were transmitted to the national PV office within 48 h. Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi, but the transmission of reports to the national PV centre requires further improvement. Plain Language Summary When a medicine or vaccine is made available for use, healthcare organisations maintain regular surveillance to confirm that the medicinal product is safe and effective. The efficiency of this surveillance depends mainly on the healthcare system and medical practices in place in each country. An important element is an effective procedure for identifying and reporting any unwanted medical occurrences (adverse events) after taking a medicinal product. In countries where regular safety surveillance has not been maintained, it is important to train and mentor healthcare providers on the need to be aware of adverse events and the importance of adhering to safety reporting procedures. GSK and partners conducted a pilot project in Malawi with the aim of improving adverse event reporting by training and mentoring healthcare providers. Training sessions and continuous mentoring were conducted over 18 months, involving 443 healthcare providers at 61 healthcare facilities. There was a large increase in the number of adverse events reported: from 22 in the 16-year period before the project started to 228 during the 18-month project period. This project showed that the training and mentoring programme for healthcare providers was effective in increasing the number of adverse events reported. This enabled...

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Section: Introductionmentioning

confidence: 99%

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

et al. 2020

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“…Furthermore, most of the burden falls on low‐ and middle‐income countries, such as Lebanon, because of poor pharmaceutical governance, weak technical capacity and poor supply chain management . Circulation of substandard and falsified medicines with little clinical effectiveness also places entire communities at risk of drug resistance, posing a threat to global treatment effectiveness, as well as undermining people's overall trust in the health system and its legitimate healthcare professionals . Solving the problem of substandard medications is important to ensure that patients do not lose faith in the benefits of pharmaceuticals and become non‐adherent with their treatments.…”

Section: Discussionmentioning

confidence: 99%

Patients’ perceptions regarding pharmacists’ healthcare services: the case of Lebanon

Tawil¹,

Sacre²,

Sili

et al. 2020

Pharmacy Practice and Res

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Background: Community pharmacists are involved in a variety of important patient-oriented activities. Patients generally agree that their interaction with pharmacists improves health outcomes. In Lebanon, patients' perceptions regarding the role of community pharmacists remain largely unknown. Aim: This study assessed participants' perceptions of services provided in community pharmacies compared with those provided in primary healthcare centres (dispensaries). Methods: A cross-sectional study was conducted from June until November 2017. In all, 1070 participants completed a self-administered questionnaire. Descriptive statistics were calculated using mean and standard deviation for continuous measures, counts and percentages for categorical variables. Results: Although 85% of participants thought that community pharmacists were responsible for their health security and medication safety, 30% believed that the only role of community pharmacists was to dispense medications and only 33.4% found the services provided by dispensaries trustworthy. Most (65%) participants agreed that the personnel working at the dispensaries do not have appropriate qualifications. When asked about the quality of medications, 68% of respondents trusted the quality of drugs available in community pharmacies, compared with 34.4% for drugs from dispensaries. Conclusions: The results show an acceptable level of satisfaction regarding healthcare services provided in community pharmacies from patients' perspectives compared with services offered by primary healthcare centres. Community pharmacists should interact more with patients and guide them to appropriate medication use, whereas dispensaries should abide by the existing laws and employ a pharmacist to supervise the dispensing of medications.

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“…In spite of the fact that the failure rate was only 2%, it cannot be ignored because presence of substandard drugs in the market at any percentage poses threats to society. These threats are as follows but not limited to drug toxicity, poor treatment outcomes and disease prognosis, drug resistance and death but also in terms of economic implications and effects on global pandemics [43].…”

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 99%

“…This can be explained by the fact that most of ARVs in the market are procured by government agencies with donor funding. The funding agencies impose stringent procurement condition such as requirements for the WHO pre-qualification for all suppliers and so, low failure rates [43]. Of importance is that for all sampled medicines that were deemed to have deficiencies during PIR, the TMDA directed manufacturers to bring requests for amendments for all deficiencies observed.…”

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 99%

Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

Mziray¹,

Maganda

Mwamwitwa³

et al. 2020

Preprint

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Background Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) is still health problem worldwide, particularly in sub-Saharan African countries, such as Tanzania. Anti-retroviral medicines (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Thus, good quality ARVs is amongst the key factors which guarantee successful therapeutic outcomes and prevention of development of drug resistant strains. This study was aimed at monitoring the quality of ARVs circulating on the Tanzania Mainland market.Methodology This was a prospective cross sectional study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All samples were subjected to screening testing using the Global Pharma Health Fund ® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were subjected to confirmatory testing using full pharmacopoeia monographs at the Tanzania Medicines and Medical Devices Authority (TMDA), quality control laboratory prequalified by the World Health Organisation. Samples collected from the medicine distribution outlets were also subjected to product information review.Results A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. All sampled ARV’s that were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. In confirmatory testing using full pharmacopoeia monographs, all samples conformed to the requirements, except of FDC stavudine/lamivudine/nevirapine which failed disintegration 2% (2/100) and assay tests 1% (1/100) respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%).Conclusion The quality of majority of ARVs circulating on the Tanzania Mainland market was good. The existence of number of ARVs circulating on Tanzania Mainland market which do not comply with product information requirements was significant. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.

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Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries

Cited by 242 publications

References 107 publications

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Patients’ perceptions regarding pharmacists’ healthcare services: the case of Lebanon

Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

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