Associate Professor
Felix Khuluza
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)
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.
Host Organisation
| Department | Institution | Country |
|---|---|---|
| College of Medicine | University of Malawi | MW |
| Pharmacy Department | Kamuzu University of Health Sciences | MW |