Browsing by Author "Bapoo, Rafik"
Now showing 1 - 6 of 6
Results Per Page
Sort Options
Item The availability of persons nominated for adverse drug reporting and associated challenges in Gauteng regional and district public hospitals(University of the Western Cape, 2019) Modau, Tumelo; Van Huyssteen, Mea; Bapoo, RafikBackground and Objectives: The reporting of adverse drug reactions (ADRs) is a major public health necessity. It is estimated that only six to 10 percent of all ADRs are reported worldwide. This number is far less than the actual cases of ADRs which occur in healthcare facilities. There appears to be lack of knowledge, awareness and willingness of healthcare professionals to report ADRs, which prompted some countries to nominate a person for ADR reporting in facilities. The objectives of this study were to ascertain which facilities had a nominated person or committee for ADR reporting, describe the knowledge and training of these individuals, describe the processes followed by the facilities for ADR reporting, determine the most commonly reported ADRs and causative drug classes, and, determine the factors which facilitate or hinder ADR reporting. Method: This was an exploratory, multicenter study. A structured questionnaire with closed and open-ended questions was used for data collection. The study was conducted in Gauteng province, where stratified non-random sampling was used to collect data in the selected regional and district public hospitals. Results: Six regional hospitals and five district hospitals participated in the study. Five (45.5%) of these hospitals had a person nominated for ADR reporting, of which all were pharmacists. All the respondents nominated for ADR reporting stated their knowledge and confidence in identification of ADRs as average and above. One (20%) of the nominated persons for ADR reporting did not have pharmacovigilance training. The reported number of ADRs over the past 12 months ranged between zero and 199. Only two (40%) of the hospitals with a nominated person for ADR reporting received feedback on the submitted reports from a committee. Only one (16.7%) of the six hospitals that did not have a nominated person or committee for ADR reporting had plans to nominate a person for this function. ADR reporting in these hospitals were performed by the pharmacy that collated the identified ADRs into a report and distributed these to the Pharmacy and Therapeutics Committee (PTC) and South African Health Products Regulatory Authority (SAHPRA). Only one hospital out of all the hospitals (n=11) did not use the national ADR reporting form and rather used an incident report. Out of all the participating hospitals, only two (18.2%) of the hospitals had an algorithm in place to assist with the identification of ADRs. The researcher went through the file where ADR reporting forms were kept for the past 12 months, and reported that the most commonly reported ADR type across participating facilities was allergic reactions such as rash and angioedema reported by eight of the facilities, followed by administration errors and quality issues each from three facilities. While the most frequently reported drug class associated with these ADRs included antiretrovirals (ARVs) and angiotensin converting enzyme (ACE) inhibitors reported at eight and six facilities, respectively. The most common challenge to ADR reporting at participating facilities was non-reporting of ADRs, followed by fear of litigation and patient’s unwillingness. Although all the hospitals in this study had facility PTCs, only one hospital had a pharmacovigilance subcommittee and the others included ADRs as an agenda point of the PTC meetings. Conclusion: Less than half of the facilities had a person nominated for ADR reporting. Pharmacists and the pharmacy were synonymous with ADR reporting as all nominated persons were pharmacists and in facilities were there were no nominated person, the responsible pharmacist was identified as the contact person for ADR reporting. Although all hospitals had PTCs, there was rarely a subcommittee dedicated to pharmacovigilance or ADR reporting, which culminated in a lack of feedback to healthcare workers that could promote it in the facility. Underreporting of ADRs by health care workers was the major challenge to effective ADR reporting as this function was considered to be too time consuming.Item FTIR, dissolution and anti-viral activity of nevirapine co-crystals(OMICS International, 2017) Samsodien, Halima; Bapoo, Rafik; Doms, T.I.; Harneker, Z.; Louw, A.S.; Scheepers, I.C.; Sonday, A.B.; Geldenhuys, B.The study uses Fourier Transform Infrared (FTIR) spectroscopy to identify five Nevirapine (NV) co-crystals, determines the dissolution profile of the co-crystals and the antiviral activity comparative to pure NV. Hot stage microscopy measured the purity and integrity of each co-crystal. FTIR analysis was used to identify the co-crystals to make recommendations regarding the future use of the technique to identify the NV co-crystals. Dissolution studies of the NV co-crystals prepared with maleic acid, salicylic acid and glutaric acid (NVMLE, NVSLI and NVGLT, respectively) were completed using the rotating basket method. Assays were conducted using High Performance Liquid Chromatography and compared to pure NV and the five NV: co-former mixtures. The antiviral activity was tested to determine whether the co-crystals had an improved activity against HIV-1 compared to pure NV. All co-crystals, except NVTTA (a NV co-crystal prepared with rac-tartaric acid), were pure and maintained their integrity for approximately one year. NVGLT, NVMLE and NVTTA, 1:1 molar ratio co-crystals were identified by FTIR. The C=O stretching frequency of the carboxylic acid groups of NV and GLT were observed at 1638.15 cm-1 and 1719.23 cm-1 in the NVGLT co-crystal which corresponded with spectra of NVMLE and NVTTA. In NVMLE the C=O stretching frequency of the C=O of NV and MLE were observed at 1640.58 cm-1 and 1694.10 cm-1 and in NVTTA it was at 1637.25 cm-1 and 1708.50 cm-1, suggesting the presence of both parent molecules in the new phase for NVGLT, NVMLE and NVTTA. Dissolution studies suggested that NVGLT was the only co-crystal that yielded better results than both NV and its physical mixture. The antiviral activity of the NVSC (an NV co-crystal prepared with saccharin) and NVSLI cocrystals in DMSO was significantly different to pure NV, demonstrating an improvement in anti-viral activity.Item Knowledge-based integration of Zimbabwean traditional medicines into the National Healthcare System: A case study of prostate cancer(University of the Western Cape, 2017) Chawatama, Brighton Itayi; Bapoo, RafikThis study sought to identify the bottlenecks in the promotion of Zimbabwean Traditional Medicines (ZTMs) towards improving the national healthcare delivery system. The indigenous medicines lost value and recognition to the Conventional Western Medicines introduced by the British colonialist since 1871 and is still dominating the national healthcare delivery system. There are growing challenges to ensure accessibility of affordable drugs especially for primary healthcare. The World Health Organization (WHO) and United Nations (UN) is in support of re-engaging indigenous medical interventions to achieve the Millennium development goals. Indigenous Traditional Medicine Knowledge-Based Systems (ITMKS) form the basis of the main source of health care for about 80% of the population in the developing countries. The implementation of the Zimbabwe Traditional Medicines Policy (ZTMP) has been at a stand-still since inception in 2007. The research used mixed methods involving qualitative and quantitative approaches. Data was collected through desk and field research. Questionnaires and focus group discussions were used to record perceptions and attitudes of key informants. The stakeholders included Traditional Health Practitioners (THPs), Medical Doctors, Pharmacists, Medical Research Council of Zimbabwe (MRCZ) staff, Medicines Control Authority of Zimbabwe (MCAZ), Traditional Medical Practitioner’s Council (TMPC), Zimbabwe National Traditional Healers Association (Zinatha), Ministry of Health and Childcare, WHO, Higher Education Institutions (UZ School of Pharmacy staff and students), Christian Groups, NGOs and Prostate Cancer Patients in Harare CBD. The stakeholders sampling framework was obtained from the list of registered practitioners. The stakeholder mapping involved selection of 5 key informants from each focus group obtained through random selection. The Snowball sampling technique was used to follow the closest 5 key informants in each focus group. The key findings established that 80% of respondents agreed to the integration of ZTM. The major bottlenecks were lack of modern dosage forms and standardization to determine quality, safety and efficacy of the ZTM. The study suggests that in order to fast track the integration process, a bottom up implementation strategy providing ZTM advocacy, capacity building in the institutionalization and training of ZTMPs, pharmacists and CMP need to be engaged for a favorable and quick buy-in. The study also recommends further analysis of the Indigenous Knowledge Systems (IKS) areas of specialization in pharmaceutical practice in order to improve treatment outcomes.Item Pharmaceutical formulation and in-vitro testing of Dioxy MP 14 (stabilised chlorine dioxide) against mycobacteria tuberculosis(University of the Western Cape, 2011) Mavu, Daniel Muleya; Uebel, Reinhard; Bapoo, Rafik; Hayward, DonThis study was based on Dioxy MP 14 (DMP), a brand of stabilized chlorine dioxide (SCD). The active pharmaceutical ingredient (API) of DMP is chlorine dioxide (CD) which is a potent oxidant and biocide. These properties have proved invaluable for various applications. The main goals of this study were: to evaluate the effectiveness of DMP for disinfecting Mycobateria tuberculosis (TB) contaminated medical instruments, devices, floors and surfaces; to investigate the stability of DMP; and to explore possibilities for medical application of DMP. Evaluation of disinfectant activity of DMP on TB was performed using the spectrophotometric method, a modification of the European suspension test, EN 14348. M. bovis BCG was employed as surrogate in this test. Results were as follows: The minimum inhibitory concentration (MIC₉₀) = 12.5 ppm; the minimum bactericidal concentration (MBC) = 15.4 ppm; the Mycobactericidal Effect (ME) = 8.8log reduction; and the minimum inhibitory concentration (MIC₉₀) x minimum exposure time (CT) = 12.5 ppm.s. The long term stability study of DMP was performed by monitoring the rate of degradation of DMP stored in the fridge (2-8 °C), in the oven (40 °C), and under ambient conditions (15-30 °C). Analytical methods of assessing DMP concentration was by Iodometric titration method. The shelf life of DMP stored in a transparent bottle at room temperature was 9.8 weeks, as opposed to 52.7 weeks when stored in an amber colored reagent bottle at the same temperature. Both oven samples had an expiry date of about 20 weeks and the fridge samples about 70 weeks. Foam formulations for a vaginal douche (VGD), mouth rinse (MRF), and foot/sit bubble bath (F/SBB)], were developed in the laboratory. DMP and the formulated concentrate were designed to be mixed just prior to administration. During foam evaluation studies, a mechanical overhead stirrer was used to generate foam. Foamability was assessed by quantifying the amount of foam generated. The stability of foams were assessed by: 1) determining the rate of foam decay and the rate of foam drainage observed concurrently from foam loaded in a measuring cylinder; and 2) determining the life span of single bubbles of each foam system i.e. the bubble breaking time (BBT). The density of each foam system was also determined. Potentiometric acid base titration was used to select suitable adjuster alkali, and to show the benefits of employing a buffer. Concentrate development was initiated by a simple mixture of all the ingredients followed by stirring and observing the deviations from desired quality attributes of the product. The subsequent five processes were improvements designed to circumvent the shortcomings of the initial procedure to arrive at the optimized method E. Prototype formulations were employed to optimize excipient quantities to eventually arrive at an optimized master formula. In foam evaluation, it was found that sodium lauryl sulphate/ammonium lauryl sulphate/cocoamidopropyl betaine/cetostearyl alcohol (SLS/ALS/CAPB/CSA) foam system was the most appropriate to use in the formulation. NaOH was selected as the adjuster solution and KHP as the buffer. The dosage formula (DF) of the VGD and F/SBB was determined to be MDF = 5 ml of 50 ppm DMP + 5 ml concentrate + 40 ml water = 50 ml and that of MRF as MDF = 19 ml diluted concentrate + 1 ml of 50 ppm DMP. In conclusion, DMP was found to be a highly effective disinfectant against Mycobacteria. DMP has reasonable shelf life if stored appropriately. Pharmaceutical formulation from DMP was found to be delicate due to the narrow pH window of DMP stability, but is feasible.Item Pharmacoeconomic evaluation in Egypt and its role in the medicine reimbursement(University of the Western Cape, 2018) Mohamed Khalil; Bapoo, RafikAim: The purpose of this research was to assess the validity of pharmacoeconomic evaluation in Egypt three years after the guideline was issued and analyse challenges and opportunities for improvement. Objectives: To conduct a literature review of pricing, medicine reimbursement, and pharmacoeconomic evaluation. Examine, in conjunction with relevant stakeholders, the progress of the pharmacoeconomic evaluation. To present examples of pharmacoeconomic evaluation deployment. To propose recommendations on how to optimize the pharmacoeconomic implementation. Methods: A literature review and a qualitative research method that was conducted using a semi-structured interview with stakeholders of the reimbursement process in Egypt. In addition, examples were analysed to determine the impact of pharmacoeconomic methods on medicine reimbursement in Egypt. Results: The Egyptian Pharmacoeconomic Evaluation Unit was established in 2013, it supports various reimbursement decisions, especially for new technologies. The unit evaluations depended mainly on the available international data. However, fragmentation of the health care system in Egypt is a major obstacle to progress. The guidelines are still non-compulsory for implementation, and accordingly some reimbursement committees do not consider its evaluation in its decision making. Conclusion and Recommendations: The pharmacoeconomic evaluation has demonstrated a good start in Egypt. To gain the full benefit of pharmacoeconomic evaluation, authorities need to consider reducing the complexity of health care system, setting clear strategies, building capabilities to improve pharmacoeconomic awareness; endorsing risk sharing strategy and building a proper health related information system along with creation of full Health Technology Assessment program. The above-mentioned recommendations could be associated together under the Universal Health Coverage road map that Egypt committed to achieve by 2030.Item Service learning in pharmacy: Opportunities for student learning and service delivery(Academic Journals, 2011) Bheekie, Angeni; Obikeze, Kenechukwu; Bapoo, Rafik; Ebrahim, NaushaadHigh patient load and understaffing in public health care facilities preclude the provision of optimal pharmaceutical services in South Africa. A Service Learning in Pharmacy (SLIP) programme for the University of the Western Cape's final year pharmacy students was implemented in health care facilities to assist in service provision. Students rotated between a pharmacotherapy (patient-oriented) and pharmaceutical formulation (product-oriented) activities to develop skills in prescription analysis, manufacturing and packaging of hospital pharmaceuticals. Structured focus group sessions were held with students and pharmacists to assess the integrated service learning experiences. Student feedback was positive, as the 'real world' experiences enabled them to adapt to intense work pressures, developed a sense of 'personal responsibility' towards patient health and they were sensitized to issues of social injustice. Students became competent in prescription analyses, counseling on medication use, manufacturing and pre-packing procedures. Pharmacists fully supported increased student involvement in the health services. Service learning in pharmacy schools is needed to contextualize learning and to address health care needs in South Africa.