Call | Career Development Fellowship (CDF) |
Programme | EDCTP2 |
Start Date | 2021-02-01 |
End Date | 2023-01-31 |
Project Code | TMA2019CDF-2768 |
Status | Active |
Countering the prevalence of substandard and falsified medicines in Malawi (COPSMEDS)
Overall Objective; To investigate the prevalence of SF medicines and its linkage with the pharmaceutical price, logistics and supply, and country of origin Specific Objectives • To quantify the prevalence of SF medicines in the public, CHAM and private sectors in Malawi • To assess temperature variation in various storage sites for medicines and medical supplies • To assess the impact of pharmaceutical storage (temperature, humidity) in the deterioration of pharmaceutical quality in various storage sites for medicines in Malawi • To assess the impact of distribution (pharmaceutical supply chain and logistics) on quality of medicines • To assess the influence of economic incentives (including pricing) has on the proliferation of SF medicines
Institution | Country |
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University of Malawi | Malawi |
Kamuzu University of Health Sciences | Malawi |
For this conceptual framework, analysis of quality of selected medicines will be done to explain the model. This approach for investigation is explanatory and comprises cross-sectional and longitudinal sample collection. These will be followed by laboratory analysis and techniques leading to quantitative data for the study. The quantitative data for this study is both descriptive and analytical. Descriptive because it is describing the pattern of prevalence of poor quality medicines in Malawi, while analytical because it tries to infer the possible contributing factors of poor quality medicines in Malawi by looking at country of origin, storage and logistic factors, and price as predictor of substandard and falsified medicines. Eighteen various medicines have been selected which includes antimalarial, antibiotic, antihypertensive and antidiabetic medicines. The selection of the medicines has been done using: Malawi Standard Treatment Guideline 2015 and Malawi Essential Medicines List 2015; WHO Model Lists of Essential Medicines 2019; WHO Model Lists of Essential Medicines for Children 2019
Type | Name | Title | University | Start Date | End Date |
---|---|---|---|---|---|
Masters in Antimicrobial stewardship | Enock Forster | Assessment of Knowledge, Attitude and Practices of individuals who drink alcohol compared to non-alcohol consuming individuals on Human Immunodeficiency Virus Post Exposure Prophylaxis Medicines in Lilongwe city of Malawi | Kamuzu University of Health Sciences | 2020 | 2022 |
PhD in Pharmacy | Francis K. Chiumia | Assessing the quality and antibiotics and associated clinical outcomes in southern Malawi | Kamuzu University of Health Sciences | 2020 | 2023 |
College of Medicine
Associate Professor of Pharmacy
Type | Name | Title | University | Start Date | End Date |
---|---|---|---|---|---|
Davie Kondowe | University of Malawi | 2020 |
Role | Committee/board | Start Date | End Date |
---|---|---|---|
Vice Chairperson | Board | 2018 | 2020 |
Institution | Degree | Year |
---|---|---|
College of Medicine-University of Malawi, Malawi | PhD | 2019-01-26 |
Pharmacy
Introduction: Antimicrobial resistance (AMR) is a global concern. Currently, the greatest mortality due to AMR is in Africa. A key driver continues to be high levels of dispensing of antibiotics without a prescription.
Areas covered: A need to document current rates of dispensing, their rationale and potential ways forward including antimicrobial stewardship programmes (ASPs). A narrative review was undertaken. The highest rates of antibiotic purchasing were in Eritrea (up to 89.2% of antibiotics dispensed), Ethiopia (up to 87.9%), Nigeria (up to 86.5%), Tanzania (up to 92.3%) and Zambia (up to 100% of pharmacies dispensing without a prescription). However, considerable variation with no dispensing in a minority of countries and situations. Key drivers of self-purchasing included high co-payment levels for physician consultations and antibiotic costs, travel costs, convenience of pharmacies, patient requests, limited knowledge of antibiotics and AMR and weak enforcement. ASPs have been introduced in some African countries along with quality targets to reduce inappropriate dispensing, centering on educating pharmacists and patients.
Expert opinion: ASP activities need accelerating among community pharmacies alongside quality targets, with greater monitoring of pharmacists' activities to reduce inappropriate dispensing. Such activities, alongside educating patients and HCPs, should enhance appropriate dispensing of antibiotics and reduce AMR.
Background: Multiple measures introduced early to restrict COVID-19 have dramatically impacted the teaching of medical and pharmacy students, exacerbated by the lack of infrastructure and experience with e-learning at the start of the pandemic. In addition, the costs and reliability of the Internet across Africa pose challenges alongside undertaking clinical teaching and practical programmes. Consequently, there is a need to understand the many challenges and how these were addressed, given increasingly complex patients, to provide future direction.
Method: An exploratory study was conducted among senior-level medical and pharmacy educators across Africa, addressing four key questions, including the challenges resulting from the pandemic and how these were dealt with.
Results: Staff and student members faced multiple challenges initially, including adapting to online learning. In addition, concerns with the lack of equipment (especially among disadvantaged students), the costs of Internet bundles, and how to conduct practicals and clinical teaching. Multiple activities were undertaken to address these challenges. These included training sessions, developing innovative approaches to teaching, and seeking ways to reduce Internet costs. Robust approaches to practicals, clinical teaching, and assessments have been developed.
Conclusions: Appreciable difficulties to teaching arising from the pandemic are being addressed across Africa. Research is ongoing to improve education and assessments.
Introduction: Treatment-resistant hypertension (RH), defined as uncontrolled blood pressure (≥140/90 mm Hg) despite treatment with ≥3 medications of different classes (including diuretics) at optimal doses, is associated with poor prognosis and an elevated risk of end-organ damage. In areas where HIV is endemic, such as sub-Saharan Africa, the risk of hypertension is high in people living with HIV. It remains unknown if HIV infection further increases the risk of RH. This study seeks to determine the association between HIV and RH as well as investigate other factors associated with RH in hypertensive Malawian adults.
Methods and analysis: A case-control study will be conducted among adult hypertensive patients attending a clinic at a referral hospital in Malawi. The cases will be hypertensive patients with a confirmed diagnosis of RH. For each case, two controls (hypertensive patients without RH), frequency matched for age group and sex, will be selected from among hospital clients attending the same hypertension clinic as the case. In both groups, HIV status will be ascertained. Additionally, information on other potential risk factors of RH, such as chronic kidney disease, obesity, hypercholesteraemia, diabetes, smoking, alcohol use, antiretroviral therapy regimen and duration, will be collected in both cases and controls. For each of the potential risk factors, ORs will be calculated to quantify the strength of their association with RH. In a multivariate analysis, conditional logistic regression will be used to assess the independent association between HIV and RH as well as the influence of the other potential drivers of RH.
Background: Prevalence rates of diabetes mellitus are growing across Africa with an appreciable number likely to be on insulin to manage their condition. This has significant implications on future morbidity and mortality exacerbated by high complication rates. Complication rates in patients requiring insulins are enhanced by hypoglycaemia. Long acting insulin analogues were developed to reduce hypoglycaemia and improve patient compliance. However, they are typically appreciably more expensive than human and other insulins in Africa, and continuing controversies surrounding their benefits limits their listing on national Essential Medicine Lists (EMLs). Biosimilars can reduce the prices long-acting insulin analogues. This needs assessing.
Methods: Mixed methods approach including documentation of insulin utilisation patterns and prices among a range of African countries. In addition, input from senior level government, academic, and healthcare professionals from across Africa on the current situation with long-acting insulin analogues as well as potential changes needed to enhance future funding of long-acting analogue biosimilars.
Results: There is variable listing of long-acting insulin analogues on national EMLs across Africa due to their high prices and issues of affordability. Even when listed, utilisation of long-acting insulin analogues is limited by similar issues including affordability. Appreciably lowering the prices of long-acting insulin analogues via biosimilars should enhance future listing on EMLs and use accompanied by educational and other initiatives. However, this will require increased competition to lower prices.
Conclusion: There are concerns with value and funding of long-acting insulin analogues across Africa including biosimilars. A number of activities have been identified to improve future funding and listing on EMLs.
Antimicrobial resistance (AMR) is a high priority across countries as it increases morbidity, mortality and costs. Concerns with AMR have resulted in multiple initiatives internationally, nationally and regionally to enhance appropriate antibiotic utilization across sectors to reduce AMR, with the overuse of antibiotics exacerbated by the COVID-19 pandemic. Effectively tackling AMR is crucial for all countries. Principally a narrative review of ongoing activities across sectors was undertaken to improve antimicrobial use and address issues with vaccines including COVID-19. Point prevalence surveys have been successful in hospitals to identify areas for quality improvement programs, principally centering on antimicrobial stewardship programs. These include reducing prolonged antibiotic use to prevent surgical site infections. Multiple activities centering on education have been successful in reducing inappropriate prescribing and dispensing of antimicrobials in ambulatory care for essentially viral infections such as acute respiratory infections. It is imperative to develop new quality indicators for ambulatory care given current concerns, and instigate programs with clear public health messaging to reduce misinformation, essential for pandemics. Regular access to effective treatments is needed to reduce resistance to treatments for HIV, malaria and tuberculosis. Key stakeholder groups can instigate multiple initiatives to reduce AMR. These need to be followed up.
Objective: To assess the prevalence and factors associated with substandard and falsified (SF) medicines among antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.
Methods: We conducted a cross-sectional study in 23 public, faith-based and private health facilities in Zomba, Machinga and Nsanje districts. We analyzed oral medicine samples of commonly used medicines among antibiotics, antimalarial, antihypertensive and antidiabetics in accordance with Malawi Essential Medicines List and local treatment guidelines. These medicines were subjected to visual inspection for any defects and screening for the content of active pharmaceutical ingredient and disintegration of dosage units. Samples that failed during screening and at least 10% of those that passed were subjected to pharmacopeia assay and dissolution test for confirmation. We used thin layer chromatography and disintegration test methods provided in the Global Pharma Health Fund minilab® for the screening purposes. We conducted confirmatory test using High-Performance Liquid Chromatography (HPLC) or ultra-violet/visible spectrophotometer and dissolution.
Results: Of the 293 medicine samples collected, 14.3% were SF medicines. Among the SF medicines were 12.5% of Amlodipine (1/8), 19.2% of Amoxicillin (5/26), 72.2% of Atenolol (8/11), 21.2% of Ciprofloxacin (7/33), 14.3% of Enalapril (1/7), 44.4% of Flucloxacillin (4/9), and 35.7% of sulfadoxine/ pyrimethamine (10/28). Medicine quality was associated with therapeutic medicine class, stated origin of manufacturer, primary packaging material and geographical location. Antimalarial and antidiabetic medicines were of better quality as compared to antibiotics, odds ratio OR 4.2 (95% CI 1.7-9.49), p < 0.002 and OR 5.6 (95% CI 1.21-26.09), p < 0.028 respectively. In terms of stated country of origin, the prevalence of SF medicines was 30% (15/50), 33% (9/27), 26.7% (4/15) and 6.6% (8/122) for medicines stated to be manufactured in Malawi, China, Kenya and India respectively.
Conclusion: This study presents the first findings on the assessment of quality of medicines since the establishment of the national pharmacovigilance center in 2019 in Malawi. It is revealed that the problem of SF medicines is not improving and hence the need for further strengthening of quality assurance systems in Malawi.
Objective: We assessed the temperature variations in pharmacies and medicine storage areas in southern Malawi and conducted a knowledge, attitude and practices survey for personnel who manage medicine stores in various health facilities.
Methods: This was a longitudinal study design that used installed Tempmate® thermometers in 27 selected health facilities to record temperatures every 15 min for a period of 9 months. In addition, a questionnaire was used to assess the knowledge, attitude, and practices regarding good pharmaceutical storage. Observations were also made on the storage structures of the facilities and compared with the mean kinetic temperature.
Results: Storage temperature ranged from 13.8°C to 42°C with mean kinetic temperature (MKT) being 25.3°C (95% CI 24.4–26.2°C). Mean temperature for public facilities was lower (23.8°C) than the faith-based facilities (25.2°C) and private facilities (26.6°C). In terms of level of health care, lower temperatures were recorded in facilities offering tertiary level of care as compared to secondary and primary care facilities, p < 0.001. For the type of storage facilities, storage-in-a-box unit (SIAB) presented lower temperatures than ordinary storage areas (non-SIAB), p < 0.001. Majority of health workers (69%) had good knowledge on proper storage conditions. Air conditioners and thermometers were available in 88.4 and 76.9% of the facilities, respectively. However, few facilities utilized the air conditioners due to electricity problems. About 46.15% of the participants were able to correctly record temperatures (at least twice a day) for the storage facilities, 23.07% did not properly record while 30.77% of the personnel did not keep temperature records at all. Limited storage space was among the challenges that facilities encounter to maintain proper storage conditions.
Conclusion: Despite having the necessary knowledge on proper storage conditions, the pharmacy personnel failed to adhere to good pharmaceutical storage practices due to resource limitations. There is a need for stakeholder interventions such as increasing budget allocation to address the challenges faced by the health facilities.
Name | Country | Institution |
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Dr. Felix Khuluza | Malawi | Kamuzu University of Health Sciences (formerly University of Malawi-College of Medicine) |
Name | Country | Institution |
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Dr. Felix Khuluza | Malawi | Kamuzu University of Health Sciences (formerly University of Malawi-College of Medicine) |