Protocols

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Browsing Protocols by Subject "Research Subject Categories::PHARMACY"

Now showing 1 - 4 of 4
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    Assessing the impact of training and remodeling of adverse drug reaction reporting systems on the practice of pharmacovigilance in Malawi
    (Kamuzu University of Health Sciences, 2021-06-16) Chimimba, Frider
    Pharmacovigilance (PV) system is essential in every country to ensure patient safety and public health in relation to medication. Strong and effective PV is achievable if there are collective efforts from well trained and informed health care professionals who are able to monitor, detect and report suspected adverse drug reactions (ADRs) using convenient and effective reporting tools. Type of the study This is a cross sectional survey that will use quantitative approach to assess the ADR reporting rates, knowledge, attitudes and practices and qualitative approach to seek opinions of healthcare workers on pharmacovigilance. Problem In Malawi and other low- and middle-income counties (LMICs), PV systems are weak and reporting of adverse drug reactions is still low. Furthermore, the currently used traditional paper-based ADR reporting tools face logistical challenges which result in delays in transmission of information and compromise confidentiality. As a way of continued efforts to counter these challenges, the Malawi Pharmacy and Medicines Regulatory Authority (PMRA) with support from the World Health Organization (WHO) have been conducting PV training among Health Care Professionals (HCPs) on basic principles of PV. They are also in the process of establishing Unstructured Supplementary Service Data (USSD) system for reporting of adverse drug reactions and other medicine related problems. However, the impact of the training and use of USSD reporting system on PV in Malawi is not known. Objectives Our main objective of this study is therefore to assess the impact of the training on knowledge, attitudes and practices (KAP) of Pharmacovigilance and use of USSD reporting system on the ADRs reporting rate. The specific objectives are to:  To assess the KAP of healthcare professionals on Pharmacovigilance after undergoing PV training  To investigate the preferences of healthcare professionals on the reporting tools for ADRs  To evaluate the improvement on ADR reporting rate after introducing USSD system training HCP on PV Methodology We will recruit HCPs who participated in PV trainings conducted by PMRA, from randomly selected districts in Malawi. Quantitative data will be collected using a structured questionnaire from all participants who participated and responded to a similar questionnaire before the training to assess the KAP after the training. Face-to-face interviews will be conducted to conveniently sampled participants using a semi-structured questionnaire to collect qualitative data on the usability of USSD system and preferences of HCPs on ADR reporting tools. Quantitative data will be analyzed using both descriptive and analytical statistics in Statistical Package for Social Sciences (SPSS) while qualitative data will be analyzed manually or using NVivo by content thematic analysis. Expected findings We hope that there will be improved level of knowledge, attitudes and practices among healthcare workers after undergoing training and also an improved rate of ADR reporting after launching USSD system as compared to the paper-based reports. In addition, the opinions and preferences of healthcare workers on PV tools will also be known from the study. Dissemination of results The results of this study will be shared with stakeholders such as WHO, Ministry of Health, Pharmacy and Medicines Regulatory authority, members of the academia and COMREC through conferences, meetings and publications. Key words: Adverse drug reactions, drug safety monitoring, Pharmacovigilance
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    Cross section study on knoweledge about Malawi’s poisonous plants among traditional medicine practitioners and users
    (Kamuzu University of Health Sciences, 2020-06-10) Kandodo, Chifundo; Tembo, Yohane; Dambuleni, Jeremiah
    It is undeniable that plants have an important role in the development of modern medicine. But use of traditional medicine from plants is associated with devastating side effects. Specific plants or combination of plants used as medicine are associated with these effects hence this study will assess if traditional practitioners and users have knowledge about these plants. The main objective is to explore knowledge among traditional practitioners and users on poisonous plants that are used as traditional medicine. This study is a cross sectional qualitative study exploring the knowledge about poisonous plants in Blantyre urban and rural. This study will therefore involve qualitative study method. The participants will be traditional practitioners and users of traditional medicine both above 18 years old. These participants will be those living or doing their business in Blantyre. The sampling method will be purposive and convenient sampling method for the traditional practitioners, but for the users will use convenient method. It is expected that by the end of this research, we will identify the poisonous plants which people know and use. The results of this study will be presented at College of Medicine (CoM) research dissemination presentations which are held for students to present their research findings.
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    The prevalence of drug resistant tuberculosis in clinical isolates in Blantyre and Lilongwe, Malawi
    (Kamuzu University of Health Sciences, 2021-11-11) Sikwese Daston, Tionge
    The type of research study: We will conduct a cross-sectional study on Mycobacterium Tuberculosis (MTB) Positive isolates from the EXACT study (Utility of the Xpert® MTB/RIF Ultra assay with the GeneXpert®Omni System and digital chest radiography for diagnosis of tuberculosis in high HIV prevalence settings) which was conducted at Kamuzu University of Health Sciences in 2020 to 2021 and Isolates from National Tuberculosis Reference Laboratory in Lilongwe. 1.2. The problem to be studied Patients infected with Multidrug Resistance Tuberculosis (MDR –TB) strains are difficult to cure and are more likely to remain sources of infection for a longer period of time than are patients with drug-susceptible strains, as a result it necessary to conduct a prevalence survey on MDR-TB in order to assess the emerging cases of MDR-TB. 1.3. The Research objectives 1.3.1. Broad objective  To investigate the prevalence of drug resistant tuberculosis in clinical isolates existing framework for drug resistance in Blantyre and Lilongwe 1.3.2. Specific objectives • To determine the number of patients presenting with investigate the prevalence of drug resistance TB among patients registering for TB treatment in Blantyre and Lilongwe • To find out the number of patients presenting with investigate the prevalence of Extremely Drug resistance (XDR) TB in Blantyre and Lilongwe using sample pooling method • To describe the association between MDR-TB and Age, Sex and HIV status characteristics of patients with MDR-TB using the following parameter (Age, Sex and HIV)  To describe pathways of care for patients with MDR-TB in Blantyre and Lilongwe 1.4. Methodology We will conduct Line Probe Assay test using GenoType MTBDRplus (version 2.0) on 400 culture isolates for Mycobacterium Tuberculosis which were archived from January 2019 active in COM/MLW TB laboratory in Blantyre and Isolates from National TB reference Laboratory in Lilongwe. From the identified MDR-TB we are going to investigate the prevalence of XDR-TB using the pooling method. 1.5. Expected findings and their dissemination. We hypothesize that there is increasing prevalence of MDR-TB among TB patients registering for treatment in Blantyre and Lilongwe. The results of this trial will also be submitted to College of Medicine Research and Ethics Committee (COMREC) and for publication in open access and medical journals. The results of the trial will also be shared with policy makers at the Ministry of Health in Malawi and the World Health Organization (WHO).
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    Risk assessment of different drugs on the Malawi essential medicine list for drug induced dental caries
    (Kamuzu University of Health Sciences, 2021-06-16) Piliminta, Richard; Kamanga, Mercy
    This is a laboratory based experimental study that is aimed at assessing risks of different drugs from the Malawi Essential Medicines List on drug induced dental caries which is a public concern. This will be achieved through the following specific objectives; to measure the pH and corrosion capability of the orally taken drugs; to quantify the amount of sugars in the widely used oral medicines labelled with sugar materials and to assess the risk of developing dental caries on the patients taking vulnerable medicines. Qualitative and quantitative measures of acidity will be measured using the pH parameter of the medicines in aqueous solutions using pH meter. A qualitative measure of the presence of sugars will also be measured.in-vitro tests will also be measured following incubation of the removed teeth to determine if the acidic and basic or neutral medicines indeed translate to tooth corrosion. This will be followed by risk assessment using appropriate risk assessment models in the literature. It is expected that some drugs will be found to be at risk of causing dental caries due to the presence of high sugar levels, low pH and corrosion of incubated tooth. The results will contribute to the general body of knowledge in the scientific world as well as informing Malawians on the risks of drugs they take on dental caries. These results will therefore be reported in peer reviewed journals as well as in international and national research dissemination conferences. 2.0 INTRODUCTION 2.1 BACKGROUND Dental caries is the most prevalent chronic disease worldwide (1). The Global Burden of Disease Study 2016 estimated that oral diseases affected at least 3.58 billion people worldwide, with caries of the permanent teeth being the most prevalent of all conditions assessed. Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth (2). There is no clear statistics on dental caries in Africa as their published articles were limited. The prevalence of dental caries in Africa is rather low compared to its existence in developed countries (3). This may be due to the low sugar intake in African diet and the inability to access sugary snacks and confectioneries because most Africans live below poverty line. However, an increase in urbanization in African cities and a global escalation in sugar intake has caused sugar-rich diets to be more common, and there is a fear that the frequency of dental caries is likely to rise, especially among children in Africa (3). A national Dental & Oral Health Survey conducted in 2014 showed that 50% of school going children (6-9 years) had tooth decay the sugar into acid which destroys the enamel hence causing dental caries. This study will assess the different drugs for drug induced dental caries. In this study the potential of drugs to induce dental caries depends on the pH of the drug. Drugs that are more acidic are more likely to induce dental caries. Therefore, the longer the drugs stay in contact with the teeth the more the enamel dissolves. Drugs that are sugary also have a high potential to induce dental caries because the sugars present will be converted to acid by the bacteria therefore dissolve the teeth enamel. Drugs that are formulated in solution form are more likely to induce dental caries than drugs formulated in tablets and capsules. This is because drugs in solution form are more likely to make contact and stick to the teeth. Drugs that are in capsule and traditional tablets are less likely to induce dental caries because they do not stay in contact with teeth for a long time. However chewable tablets show a high risk of inducing dental caries because they get stuck between the teeth enamel.