Associate Professor
Felix Khuluza
Current Organisation
College of Medicine, University of Malawi
Current Job Title
Associate Professor of Pharmacy
Biography
Publications
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.
BACKGROUND:Despite the increasing frequency of ARV medicines stock-outs in Sub-Saharan Africa, there is little research inquiring into the mitigation strategies devised by frontline health facilities. Many previous studies have focused on 'upstream' or national-level drivers of ARVs stock-outs with less empirical attention devoted 'down-stream' or at the facility-level. The objective of this study was to examine the strategies devised by health facilities in Uganda to respond to the chronic stock-outs of ARVs. METHODS:This was a qualitative research design nested within a larger mixed-methods study. We purposively selected 16 health facilities from across Uganda (to achieve diversity with regard to; level of care (primary/ tertiary), setting (rural/urban) and geographic sub-region (northern/ central/western). We conducted 76 Semi-structured interviews with ART clinic managers, clinicians and pharmacists in the selected health facilities supplemented by on-site observations and documentary reviews. Data were analyzed by coding and thematic analyses. RESULTS:Participants reported that facility-level contributors to stock-outs include untimely orders of drugs from suppliers and inaccurate quantification of ARV medicine needs due to a paucity of ART program data. Internal stock management solutions for mitigating stock-outs which emerged include the substitution of ARV medicines which were out of stock, overstocking selected medicines and the use of recently expired drugs. The external solutions for mitigating stock-outs which were identified include 'borrowing' of ARVs from peer-providers, re-distributing stock across regions and upward referrals of patients. Systemic drivers of stock-outs were identified. These include the supply of drugs with a short shelf life, oversupply and undersupply of ARV medicines and migration pressures on the available ARVs stock at case-study facilities. CONCLUSION:Health facilities devised internal stock management strategies and relied on peer-provider networks for ARV medicines during stock-out events. Our study underscores the importance of devising interventions aimed at improving Uganda's medicines supply chain systems in the quest to reduce the frequency of ARV medicines stock-outs at the front-line level of service delivery. Further research is recommended on the effect of substituting ARV medicines on patient outcomes.
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.
Project Title
Countering the prevalence of substandard and falsified medicines in Malawi (COPSMEDS)
EDCTP Project
TMA2019CDF-2768
EDCTP Program
EDCTP2
EDCTP Project Call
Career Development Fellowship (CDF)
Host Organisation
| Department | Institution | Country |
|---|---|---|
| College of Medicine | University of Malawi | MW |
| Pharmacy Department | Kamuzu University of Health Sciences | MW |
Project Objectives
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
Study Design
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
Project Summary
The burden of Substandard and Falsified (SF) medicines is very rampant, especially in low-middle income countries (LMICs). However, little attention is paid to addressing the problem due to limited resources and weak regulatory frameworks. Malawi is one of the sub-Saharan African countries which is struggling to meet the healthcare needs of the population as evidenced by ongoing shortages of essential medicines and inadequate healthcare workers in public health facilities. Previous studies have reported the availability of both substandard and falsified medicines in Malawi, but the documentation of such is poor and the contributing factors to the problem are not known. COPSMEDS is a 30 month project that is aimed at assessing the prevalence of SF medicines and its linkage to pharmaceutical prices, logistics and supply, and the country of origin. The project is being conducted at the Pharmacy Department of the Kamuzu University of Health Sciences (KUHES), formerly the College of Medicine of the University of Malawi. The research team is led by Dr Felix Khuluza who is also the Head of the Department. Currently, the project has completed its second year of implementation and is expected to end by August 2023. Samples are being collected from across 29 randomly selected health care facilities, which include government, private and CHAM hospitals and health centres in Zomba, Nsanje, and Machinga districts in the southern region of Malawi. Almost 50% of the health centres that are participating in the project are remote, hard-to-reach and with limited resources where the medicines are most likely to be exposed to harsh conditions during both transportation and storage. Medicine samples were collected from the facilities at three-month intervals and tested for various quality aspects, including dissolution and content of active ingredients by performing HPLC and other pharmacopeial assays at the KUHES Pharmacy Department laboratory. Simultaneously, storage conditions were being recorded for the whole duration at a 15-minute interval using automated temperature loggers to establish if the storage conditions are contributing to the deterioration of medicine quality. During the first year, cross-sectional samples of 301 antibiotics, antimalarials, antihypertensives, antidiabetic medicines was done. During year two, 235 samples of medicines were collected and followed up at nine months. Some of the preliminary findings on this follow-up is the deterioration of 11.5% of samples. Locally manufactured (by the same company) samples are more likely to deteriorate than imported products. This is a worrying situation as Malawi is promoting a "buy Malawi campaign" with an aim of equipping the local manufacturers with capital that can be used to improve their production capacity and create job opportunities, thereby having ripple economic benefits and reduction in imported medicines, thus saving forex. In terms of storage conditions, temperature ranged from 13.8oC to 42oC. 48% (n=13) of facilities had Mean Kinetic Temperatures (MKT) of between >20 oC and ≤ 25 oC, while 52% (n= 14) of facilities had MKT >25 oC and ≤ 30 oC. However, almost all facilities recorded maximum temperatures above 30oC during the study period, which is above the recommended normal storage temperatures for pharmaceuticals. October to December 2021 were the months that were consistently having higher than normal temperatures in all the facilities. This puts into question as to whether the facilities actually use the air conditioners installed in health facilities. Currently, analysis is ongoing to establish if there is any link with deterioration of medicines due to the temperature. In conclusion, the COPMEDS project is making a significant impact in Malawi through investigating and reporting of SF medicines, training of pharmacy and other health personnel and capacity building at the Kamuzu University of Health Sciences, which is the largest institution for training health professionals in Malawi. During the 3rd year of the project, we submitted five manuscripts. Three were accepted and published other two are being refined before re-submission. The results of this project increased awareness on important issues that need the attention of health practitioners, authorities and policy makers in Malawi for improvement of pharmaceutical services and overall protection of patients and the general public. For example, we highlighted on how lack of adequate funding allocation to facilities affects the availability of essential medicines; pharmaceutical storage conditions; and adherence to treatment guidelines. Potential consequences to these challenges include penetration of SF medicines in the market, deterioration of products before expiry date and poor clinical outcomes including death. Recommendations were made to provide guidance on the strategies that can be taken to tackle these challenges. Some of these findings are used as reference points for discussions within professional bodies such as the Pharmaceutical Society of Malawi (PHASOM). Increasingly, public hospitals and health centers are aware on the need for routine assessment of quality whenever they received medical supplies. This has resulted in frequent recalls of medicines in the public sector than was previously being done.