Browsing by Author "Bangalee, Varsha."

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Adenosine monophosphate-activated protein kinase as a potential target for synthetic chalco-naringenin analogs and putative therapeutic applications.
(2017) Nyane, Ntsoaki Anna.; Bangalee, Varsha.
Introduction: Diabetes mellitus is a multifactorial chronic metabolic disorder that is characterized by defects in endogenous insulin secretion or action, or both, resulting in chronic hyperglycemia, a clinical hallmark of diabetes. Metformin is currently the first-line drug of choice for the treatment of type 2 diabetes (T2D), being prescribed to at least 120 million people worldwide. It exerts its antidiabetic effects by reducing hepatic glucose production and increased peripheral glucose utilization through activation of AMP-activated protein kinase (AMPK). However, despite significant gains with metformin as a monotherapy in T2D, some patients experience gastrointestinal disturbances and lactic acidosis although the latter is very rare. Moreover, some patients still fail to achieve optimum glycemic control when treated on metformin only. Naringenin, a flavonoid exerts its antidiabetic effects by inhibition of gluconeogenesis through upregulation of AMPK, hence metformin-like effects. Because of these similar pharmacological effects between naringenin and metformin, our laboratory synthesized analogs of chalco-naringenin compounds which could be more permeable to the plasma membrane and hence putatively increased pharmacological effects. Aims: To identify AMPK as a potential target of synthetic chalco-naringenin analogs and putative therapeutic applications. Methods: A novel series of 4-[(cyclopropylcarbonyl)amino] chalco-naringenin analogs, compound 5a to 5k, were synthesized and characterized by IR, 1H-NMR and 13C-NMR. In silico screening of the compounds was conducted to evaluate potential antidiabetic activity of the novel chalco-naringenin series. Compounds 2-chlorophenyl (5b) and 5k (2,3-dimethoxyphenyl) had highest binding affinity to AMPK hence were chosen for a study. C2C12 and Chang cells were cultured in dulbecco's modified eagle medium (DMEM) and eagle's minimum essential medium (EMEM) media, respectively, allowed to grow to 80% confluence, and then exposed to different concentrations. MTT assay was used to determine cell viability and chalcones were subjected for 12, 24 and 48 hours at concentrations (10-750 μM). Cells were exposed to metformin (2-10 mM), naringenin (50-500 μM) and chalcones (10-500 μM) for 48 hours and further subjected to phospho-AMPKα (Thr172) sandwich ELISA Kit to determine phosphorylation of AMPK. To measure the amount of glycogen in cells after exposure to metformin, naringenin and chalcones for 48 hours, cells were harvested (1x106 per mL) and the glycogen assay performed according to Seifter et al. (1950). Results: A chalcone series of eleven compounds were successfully synthesized using the Claisen-Schmidt reaction. The absorbance values and peaks observed on the IR spectra confirmed the different functional groups observed on the compounds. The synthesized compounds were also characterized through 13C-NMR and 1H-NMR spectroscopy. The 13C-NMR spectras indicated the presence of the CH2 group of the cyclopropylcarbonyl amide and there were certain distinct peaks on the spectras that identify carbon atoms found on the compounds. In 1H-NMR, the chemical shift for all the CH2 groups on the cycloalkane resonated around δ 1,16 – 0,80 ppm as multiplets, while the other CH multiplet resonated around δ 1,62 – 1,58 ppm. Docking scores of the chalco-naringenin series suggested a good binding affinity of these compounds to AMPK, with compound 5b showing the highest binding affinity to AMPK. Cell viability as determined by 3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide (MTT) assays were found to be dose-dependent for all compounds and compound 5k exerted reduced cell viability as compared to 5b. Furthermore, compound 5b presented with higher IC50 values compared to 5k. The effects of chalcones on AMPK phosphorylation were potentiated by co-treatment with metformin or naringenin. Metformin, naringenin and chalcone 5b significantly reduced synthesis of glycogen as compared to control (p < 0.05). Conclusions: Chalco-naringenin analogs showed potential in expression of AMPK through computational chemistry, however in the in vitro model the effects of chalcones on AMPK were potentiated by metformin and naringenin. The chalcones could further be explored for their potential on AMPK activity on primary hepatocytes and/ or in vivo studies.
Annual costs incurred on managing adverse drug reactions attributable to fixed-dose combination Highly Active Anti-Retroviral Therapy (HAART) in an outpatient ARV clinic in Gauteng.
(2020) Chikeya, Grace.; Bangalee, Varsha.; Oosthuizen, Frasia.
Objective The aim of the study is to identify adverse drug reactions attributable to tenofovir- and zidovudine-based fixed-dose combinations of highly active anti-retroviral therapy and, subsequently, to determine the annual costs incurred managing these adverse drug reactions and the budget implications of these costs at an outpatient anti-retroviral clinic in Mamelodi, Pretoria. Methods This retrospective cohort study reviewed de-identified clinical data for adverse drug reactions. The study was carried out at Stanza Bopape ARV Clinic in Mamelodi, Pretoria. De-identified medical charts of HIV-positive patients were analysed for clinical information and laboratory data of adult patients who started on HAART between July 2017 and June 2018. Data collection commenced in October 2018. Based on the costs and the incidence rates of adverse drug reactions observed in the analysis, a decision tree model was established to estimate the cost impact of adverse drug reaction management on the clinic¶s budget. Results A total of 469 patient files were analysed (62% female vs 38% male). The mean age at the start of anti-retroviral therapy for the cohort was 36.6yrs (95% CI 35.74-37.45) and the mean baseline CD4 count was 380 (95% CI 343-418). Incidence of adverse drug reactions to tenofovir- or zidovudine-based fixed-dose combinations of anti-retroviral therapy was found to be 24.95%. The ADRs reported with the use of TDF and AZT based HAART regimens were rash (n=45, 27%), decreased glomerular filtration rate (n=34, 21%), trouble sleeping (n=39, 21%), severe diarrhoea (n=19, 12%), nausea and vomitting (n=18, 11%), decreased heamoglobin or anaemia (n=4, 2%), headaches (n=4, 2%), dizziness (n=2, 5.3%). The study revealed that ZAR427.30 was the cost attributed to adverse drug reactions due to tenofovir-based regimens whilst ZAR467.94 was the cost attributed to adverse drug reactions due to zidovudine-based regimens, per patient, annually. Costs attributed to gastro-intestinal related adverse drug reactions were the highest in comparison to other adverse drug reactions. Estimated total cost of adverse drug reactions attributed to zidovudine-based therapy was ZAR8003.98 (US$556.40) and estimated total cost of adverse drug reactions attributed to tenofovir-based anti-retroviral therapy per annum was ZAR33 788, 23 (US$2348.80) for 1221patients initiated on antiretroviral therapy between July 2017 and June 2018. Conclusion Despite our estimated costs to the clinic, due to adverse drug reactions, being lower than similar studies, there remains a notable budget impact on a resource-limited setting.These estimates will allow for cost due to adverse drug reactions caused by tenofovir- and zidovudine-based anti-retroviral therapy to be accounted for in budgets at the antiretroviral clinic.
Attitude and practices about the coronavirus disease and its’ impact on the mental well-being on university students: a cross-sectional study amongst pharmacy students in the University of KwaZulu-Natal.
(2023) Ebrahim, Nabeela.; Bangalee, Varsha.; Moudgil, Khayati.
Student mental health at a tertiary level of education has become a growing concern since the beginning of the COVID-19 pandemic. University students in South Africa face academic challenges as well as a cascade of socio-economic challenges making them more at risk for anxiety and depression. The restrictions, and challenges that COVID-19 brought has intensified these risks. The effect of the COVID-19 pandemic on the psychological well-being of South African university students has a major role to play in analyzing the future implications for the populations’ mental health. The steps that were taken to prevent the spread of COVID-19 including lockdown measures, social distancing and quarantine have introduced significant threats to the mental health of the public at large. The current study aims to determine the attitude, practices impact of COVID-19 on the mental health of Pharmacy students at University of KwaZulu-Natal (UKZN). Method This study was designed to be a cross-sectional quantitative study which was carried out as a survey questionnaire to fulfil the required objectives. Data was collected via a survey questionnaire; hard copies of the survey were distributed to third-and-fourth year pharmacy students at UKZN once on-site learning at the campus resumed after a period of remote learning as a result of COVID-19. The data was entered into Microsoft® Excel® and analyzed using Statistical Package for the Social Science® (SPSS®), version 28. Descriptive and inferential statistics were calculated, the results were discussed, and conclusions were drawn. Results A total of 190 participants completed the survey. There were no exclusions as all the participants were over the age of 18 and were studying in third- or fourth-year pharmacy at UKZN. Majority of the participants (72.5%) perceived the COVID-19 virus as a threat to their community and 83% of students felt scared towards the COVID-19 pandemic. Increased levels of anxiety, loneliness, depression, and substance abuse was also reported. Most students found trouble concentrating (75.9%), which impacts academic and daily functioning and 77.6% found that the lockdown had a negative impact on their academic experience. Conclusion The current study was able to provide a comprehensive assessment of the attitudes and practices about the Coronavirus Disease (COVID-19) and its’ impact on the mental well-being on university students amongst pharmacy students in the University of KwaZulu-Natal. The findings suggest that the Covid-19 outbreak has globally introduced many hurdles for tertiary education institutions and challenges for students’ mental health. A variety of factors that are linked to the pandemic such as financial difficulty, a weakened social circle, trouble sleeping, fear of contracting the virus, trouble concentrating, and loneliness have increased anxiety and stress among university students. The study also reports a thorough analysis of the students and their range of feelings during the pandemic and consequent lockdown to evaluate their energy levels, prepotent feelings and challenges faced as a result. Our findings highlight that most participants displayed negative feelings and experienced many challenges as a result of the lockdown. In light of these findings, it is imperative that proactive measures are implemented to address the mental health concerns of students. Such efforts should not only encompass addressing the immediate challenges posed by the pandemic but also address the pre-existing vulnerabilities that have been exacerbated. By recognizing the multifaceted nature of these challenges and the diverse emotional responses they elicit, institutions and governments can work in tandem to provide comprehensive support systems that aid students in navigating these unprecedented times.
Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia.
(2020) Ndlovu, Garnet.; Oosthuizen, Frasia.; Bangalee, Varsha.
Objective Reporting of adverse drug reactions (ADRs) in Namibian public health facilities is routinely done through safety yellow forms which are forwarded to the Therapeutics Information and Pharmacovigilance Centre (TIPC) for further assessment and possible interventions. This study investigated the awareness and knowledge of healthcare practitioners (HCPs) regarding the ADR reporting system in the country. Methods A cross-sectional study was conducted via a self-administered questionnaire at two state hospitals in Namibia; one located in the Khomas region and the other located in the Hardap region. The questionnaire was distributed to HCPs in current practice dealing directly with medication and it included a combination of open-ended, closed-ended and multiple-choice questions. Questionnaires were distributed in hard copy form during the period of 1 October 2019 up until 15 December 2019. Data was coded and transcribed into Microsoft® Excel® 2016 and analysed with SPSS® for IOS version 24. Results One-hundred and three completed questionnaires were received. Sixty-eight percent of the respondents were nurses, 24.3% were medical doctors and 7.8% were pharmacists. The majority of HCPs (73.8% and 56.3% respectively) were able to define the terms “adverse drug reaction” and “pharmacovigilance” correctly while only 41.7% correctly defined “spontaneous reporting”. The majority of HCPs (60.2%) have identified an ADR in practice; however only 36.9% reported this following the approved process. Only 48.5% of HCPs were aware of the safety yellow form for ADRs and 63.1% of HCPs did not know where to obtain the form. Furthermore only 37.9% of HCPs knew the name of the drug regulatory authority in Namibia. Conclusion Awareness and knowledge of ADR reporting systems by HCPs in Namibia is insufficient. While HCPs deem it necessary to report ADRs, reporting is unacceptably low leading to serious concerns regarding continuous monitoring of drug safety. Pharmacists showed better awareness compared to other HCPs and can, therefore, be best utilised as focal points in pharmacovigilance protraction. Mass awareness programs by the TIPC and other stakeholders need to be established to expand pharmacovigilance among HCPs.
A comparison study between public and private healthcare sector medicine prices in South Africa.
(2020) Thaver, Tarryn.; Padayachee, Neelaveni.; Bangalee, Varsha.
Introduction The adoption of medicine pricing regulations was established to counter the on-going global struggle of high medicine prices. South Africa’s healthcare is divided into the private and public sector and each sector functions utilizing different medicine pricing systems i.e. the tender and single exit price (SEP) system. The National Health Insurance (NHI), in its pilot phase in SA, may declare new system changes and improvements. Therefore, increased data on current medicine pricing systems are necessary particularly to assist the NHI process. Aim The overall aim of this study was to compare the medicine prices procured in the public tender system with the private SEP system. Objectives The objectives of the study were to compare pricing trends, determine price differentials, and equate the average price index of a basket of medicines between the public and private healthcare sectors in South Africa. Methods A pricing list consisting of 32 essential medicines available in both the public and private healthcare systems of South Africa was chosen for this study. The price of medicines for the private sector were obtained from the Medicine Price Registry- Open Up website for the period 2014–2018. Public sector medicine prices were obtained from the Department of Health website for the corresponding period. Observations and pricing trends were identified and analysed using Microsoft Excel version 2016. Key Findings A total of 74 medicine brands were analysed in the study. It was found that the prices across both sectors had increased over time, however, the majority of brands (87%) displayed higher prices in the private sector in comparison to the public sector. The price differential between the private and public sector medicines yielded positive values with the median of 252.30%. Conclusion The study found vast price differences between each pricing system due to the different methodologies practiced. Some of the methods and procedures utilized are known, however, both systems lack complete transparency in the processes applied. Therefore, more transparent medicine pricing systems need to be considered for the future of South Africa’s healthcare system as the country transitions toward universal health coverage.
Development of a tool to assess knowledge, awareness and perception of prostate cancer amongst women in Ghana.
(2020) Wiafe, Ebenezer.; Oosthuizen, Frasia.; Bangalee, Varsha.; Mensah, Kofi Boama.
Background and Objectives: The incidence of prostate cancer in developing countries is less than 30%, yet it has the disease's highest mortality. To address the mortality, strategies to increase awareness of the disease have been proposed, including the recommendation for women's active involvement. This is because women act as family health advocates, advisors, managers, and promoters. Therefore, it is essential to gather evidence on women's awareness of prostate cancer. Also, in Ghana, there is a lack of evidence about women's awareness of prostate cancer. However, there are about 50 indigenous Ghanaian languages, with Akan been the most spoken language. Providing a valid and reliable Akan version of a modified tool for assessing Ghanaian women's awareness of prostate cancer is vital. The study aim was (1) to conduct a mixed-methods systematic review on the awareness of women regarding prostate cancer, and (2) to translate, validate, and conduct a reliability assessment of a questionnaire for studying the knowledge, awareness, and perception of prostate cancer in Ghanaian market women. Methods: The Joanna Briggs Institute manual was employed in the development of a mixed methods systematic review protocol. The protocol was then used to conduct a systematic review of the awareness of women on prostate cancer. MEDLINE (EBSCOhost), CINAHL (EBSCOhost), PsycINFO (EBSCOhost), Web of Science, and EMBASE (Ovid) were searched based on the inclusion criteria for studies conducted between 1999 to 2019. Also, questionnaires on prostate cancer awareness were adopted from other studies, modified, and translated to Akan using the forward and backward translation protocols. The Akan questionnaire was certified, validated, and a reliability assessment was performed by measuring average scores, content validity index, and Cronbach’s alpha, respectively. Study participants for the validation and reliability study were recruited using a simple random sampling technique. Results: A total of 2201 articles were identified from the search, of which seven were included in the review. The selected studies' results indicated moderate knowledge on signs and symptoms; and causes and risk factors of prostate cancer. An inadequate level of knowledge about prostate cancer screening tools was recorded among women. An Akan questionnaire was adequately developed and certified. The average scores for all parameters employed in the face validation were greater than 4. The content validity index was within the range of 0.90 - 0.99 whilst Cronbach’s alpha within the range of 0.7808 - 0.9209. Conclusion: The selected studies indicated moderate awareness about prostate cancer among women. The selected studies for the review were few; hence this hinders the generalizability and transferability of the results. More studies should be conducted on prostate cancer awareness among women to promote their role in disease prevention. The Akan questionnaire for assessing women's awareness of prostate cancer was adequate, reliable, and valid for the Ghanaian or Akan speaking people.
Drug utilization review of analgesics in the management of pain in accordance with the South African Standard Treatment Guidelines at a hospital level in Limpopo, South Africa.
(2022) Rikhotso, Muhluri Alvinah.; Bangalee, Varsha.; Suleman, Fatima.
Background One of the aims of the National Drug Policy (NDP) of South Africa was to promote the rational use of medicines and to achieve this goal, the Essential Medicines Programme (formerly EMP), which included an Essential Medicines List (EML) and Standard Treatment Guidelines (STGs), was developed. The STGs offer guidance on the rational use of medicines for the most common conditions including pain management. A perceived marked increase in the use of tramadol for pain management requires that research be undertaken to confirm if there is use of tramadol outside of prescribed guidelines, and to determine the contributing factors for this. Study aim The overall aim of the research was to review the use of analgesics in the management of pain in terms of compliance with STGs by prescribers and to determine the cost implication of failure to follow STGs in pain management for the district hospital. Prescriber awareness and use of the guidelines for pain management and the associated cost implications of nonadherence to guidelines was also assessed. Finally the study sought to ascertain prescriber experience on the misuse of tramadol when treating patients for pain. Methods This was a quantitative study in which the records of patients admitted and being treated for chronic mild to moderate pain at a district hospital in Limpopo from the 1st of April to the 30th of September 2021 were reviewed to determine whether the Hospital Level Adults STG/EML (2019) was followed when patients commenced with treatment. An Excel spreadsheet was used to record patient demographics; diagnosis; pain medication prescribed; dosage regimen; prescriber post and prescriber compliance with recommended STG. The treatment regimens for pain that were captured included paracetamol; ibuprofen; and tramadol as single prescribed therapies as well as combinations of paracetamol and ibuprofen; paracetamol and tramadol; and a combination of all three, viz. paracetamol, ibuprofen and tramadol. The recorded prescriptions were assessed for compliance in terms of the stepwise process of pain management as outlined in the Hospital Level Adults STG/EML (2019). Descriptive statistics and Excel were used for data analysis. The cost of analgesics was obtained from the Limpopo Province Pharmaceutical Depot (LPPD). A questionnaire was used to determine prescribers’ awareness of STGs, compliance with guidelines for the management of chronic mild to moderate pain, and awareness of the cost implications of non-compliance among prescribers assigned to the general ward for the period of data collection. Full ethical approval was obtained before commencement with the study. Results A total of 224 prescriptions were recorded for the 6-month period. Patients initiated on paracetamol as first-line treatment for pain were 129 (57.5 %). Nineteen patients (8.5%) were initiated on tramadol and 54 patients (24 %) on paracetamol and tramadol. Patients initiated on paracetamol and ibuprofen were 12 (5.4%); those on ibuprofen were 3 (1.3%) and 7 (3%) were switched between pain regimens. The prescription compliance rate in terms of the stepwise process of pain management as outlined in the STGs/EML was 90.6% and 9.4% were noncompliant. The total cost for both compliant and non-compliant prescriptions was R1128,10. Compliance to STGs when prescribing analgesics as reported by prescribers was 33%. Half of the prescribers (50%) stated that they only follow guidelines occasionally. Only 33% followed STGs when prescribing tramadol although 83% stated that they prescribe paracetamol for pain. All prescribers had encountered tramadol misuse by patients but only 50% monitored patients after the medicine was prescribed. The study found that 67% of prescribers had poor knowledge of the cost implication associated with non-compliance to STG. Conclusion This study has identified that there is a prescription compliance rate of 90.6% among prescribers in prescribing analgesics according to the STG/EML. There is however still room for improvement because non-compliance to guidelines has cost implications. In the South African setting where there are resource constraints, compliance is critical for the purpose of efficient use of health care resources. There is also a need for educating prescribers on the importance of compliance to guidelines.
The effect of consignment on the price of pharmaceuticals and liquidity in a private hospital in Mombasa, Kenya.
(2022) Ganiwalla, Shaheed Imtiaz.; Bangalee, Varsha.
Background A well-structured procurement system will enable the acquisition of quality products in the correct quantity, at the right time, and the right cost. There are several procurement methods available for organizations’ to choose from, and each method will alter the organizations financial position in its unique way. Bomu Hospital transitioned from a tenderbased procurement system to a consignment model in 2020. Aim and Objectives This study aims to assess the impact of consignment on the financial health of Bomu Hospital. Specific objectives include: i) to determine the effect of consignment on the cost price of pharmaceuticals, ii) to assess the effect of consignment on the liquidity ratio, iii) to evaluate the effect of combining a tender and consignment system on the cost price of pharmaceuticals, and iv) to compare the mean adjusted cost price of pharmaceuticals with the Management Sciences for Health International Medical Products Price Guide 2015. Methodology The study used a retrospective pre-post observational design. Medicine purchase price data was collected from the 2019 tender document, 2020 consignment supplier invoices, and the 2022 tenders-for-consignment document. Liquidity was assessed by comparing the institution's cash flow statements from 2019 and 2020. Descriptive and inferential statistics were used to determine the effect of the two procurement systems on the purchase price of pharmaceuticals and its effect on the liquidity. Results The dataset included 65 products listed by proprietary name. Quantitative analysis of the purchase price obtained through tenders in 2019 and consignment in 2020 shows that the price increased by a median of 4.78% [IQR = -5.66% - 12.71%] (p=0.48). However, when tenders-for-consignment were introduced, the price reduced by a median of 7.71% [IQR = -11.72% - 1.935%] (p=0.65). Consignment resulted in a direct cash savings of KES 4,427,266.10 in one year. The median price ratio was 4.4319 [IQR = 0.8496-12.6193]. Conclusion Consignment offers substantial savings through reduced capital expenditure. However, eliminating competition results in higher purchase prices that can harm the affordability of medicines. Comparatively, tenders provide the best prices because of competition between suppliers. Combining both results in substantial savings for the institution without negatively impacting the cost of medicines.
Exploring pharmacists views, knowledge and perceptions regarding generic medicines in the Western Cape.
Shaikh, Naseema.; Suleman, Fatima.; Bangalee, Varsha.
BACKROUND In 1996, South Africa adopted a National Drugs Policy. An important objective of this policy focused on promoting the use of generic medicines in the country to ensure that medicines are accessible to the majority of South Africans. Pharmacists play a vital role in influencing patients’ choice of medication, thus highlighting the importance of gaining all health professionals’ support for the quality and utilization of generic medicines. OBJECTIVES This study sought to assess and evaluate the perceptions, views, knowledge and willingness to recommend generic medicines by pharmacists that are located within the Western Cape, as well as to explore pharmacists’ perceptions towards the safety, quality, and efficacy of generic medicines. In addition, the study assessed pharmacists’ views on current policy with respect to substitution of generic medicines as well as to determine if these views vary in the different practice settings. Finally the study assessed pharmacists’ views on the pricing system of generics as well as their opinion on promotion of these medications. METHOD A cross-sectional online survey, which targeted 1730 pharmacists living in the Western Cape, was conducted, using SurveyMonkey, from 7 September to 7 October 2014. Data collected included participant demographics, qualification, experience, education, knowledge and perceptions of generic medication. Survey Monkey was used to produce graphical representations of the data and data was exported onto Microsoft excel in order to make analytical comparisons. RESULTS A total of 321 pharmacists responded to the questionnaire (a response rate of 18,6%). 82% of pharmacists stated there is no difference in safety between original brand and generic medicines. Majority of respondents (74%) believed that generic medicines are therapeutically equivalent to the original medicines. However, 39% of pharmacists stated that original medicines are of a better quality than their generic counterparts. A large number (more than 60%) of pharmacists reported concerns of bioequivalence as their main problem when switching to a generic medicine. CONCLUSION Majority of Pharmacists in the Western Cape had a positive outlook on generic medication and supported and encouraged its use. Concerns were raised however, regarding quality, safety, and effectiveness of generic medicines as well as doubts in the reliability of certain generic manufacturing companies. Pharmacists’ opinions could negatively impact generic usage in South Africa, therefore continuing education and awareness campaigns should be implemented in order to re-confirm pharmacists’ knowledge of generic medicines being bioequivalent and of equal quality to branded medicines. Furthermore, pharmacists should be encouraged to report Adverse Drug Reactions in order to resolve any quality issues.
Investigating the impact of a fixed-dose combination compared to triple therapy on metabolic syndrome in patients on highly active antiretroviral therapy.
(2017) Kazi, Aniessa.; Bangalee, Varsha.
Introduction: Southern Africa is home to one of the largest populations with Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome (HIV/ AIDS). Although morbidity and mortality rates have reduced with the advent of Highly Active Antiretroviral Therapy (HAART), long-term use may lead to metabolic complications such as insulin resistance, lipodystrophy and dyslipidaemia. These adverse-effects are the components of metabolic syndrome (MetS), associated with an increased risk of cardiovascular disease and type 2 diabetes. Continuous efforts are being made to improve the quality of life of HIV/ AIDS patients whilst controlling the disease state. The introduction of a fixed-dose combination (FDC) pill (EFV/FTC/TDF) as first-line treatment ensures a more favourable side-effect profile, decreased pill burden and improved adherence. Aims and Objectives: To investigate the incidence and prevalence of metabolic syndrome in HIV patients on HAART triple therapy compared to a fixed-dose combination. To investigate the impact of a single pill compared to triple therapy on the incidence and prevalence of metabolic syndrome in patients on HAART. Method: Data was collected as a retrospective chart review upon obtaining gatekeeper’s permission from Addington Hospital. Questionnaires were used as a collection tool for demographic and anthropometric data in a total of 350 patients. Patients were divided according to HAART regimens, FDC (A) and triple therapy (B). The joint interim statement by the International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart Lung and Blood Institute, American Heart Association, World Health Organisation, International Atherosclerosis Society and International Association for the Study of Obesity was used to define the metabolic syndrome. Results: Of the patients studied, 62.6% were female and 37.4% male. The overall prevalence of MetS was 16.6%. There was a significant association between HAART regimen and MetS (p = 0.001). There was a higher prevalence of MetS among triple therapy patients (23.4%) compared to FDC (9.7%). When adjusted for age, gender, comorbidities and patient markers, the multivariable logistic regression found HAART viii regimen, glucose, BMI, and the presence of comorbidities to be significant predictors of MetS. Conclusion: Patients on triple therapy had 3 times the odds of developing MetS compared to those on FDC. Increased levels of blood glucose, Low-Density Lipoprotein cholesterol (LDL-c), systolic and diastolic blood pressure were significantly positively associated with triple therapy.
An investigation into the relationship between the number of available generics within a therapeutic class and prices of medicines in South Africa.
(2013) Bangalee, Varsha.; Suleman, Fatima.
Abstract available in PDF file.
Overview of proton pump inhibitor use: a medical scheme perspective.
(2023) Mohanlal, Kajal.; Bangalee, Varsha.; Oosthuizen, Frasia.
Background: Proton pump inhibitors (PPIs) are highly effective and safe drugs for the treatment of acid-related disorders. However, their easy availability over-the-counter (OTC) often results in the misuse of these drugs. Inappropriate prescribing practices also lead to overutilization, leading to potential long-term adverse effects and rising cost implications on medical schemes. This study aims to provide an overview of PPI misuse and the financial implications on medical schemes in South Africa. Method: Retrospectively, all acute and OTC PPI claims from four different medical schemes from January 2021 to December 2021 were extracted from an electronic database of a pharmaceutical benefit management organization. A total of 268 537 claims made by 81 566 patients were included in the study. The data obtained were recorded on Excel® and included patient age, sex, generic entity including strength and quantity claimed, prescriber and provider types, month claimed, benefit applicable and the cost reimbursed by the medical scheme per claim in South African Rands. Descriptive and analytical measures were used to evaluate the frequency and duration of PPI usage, provide an overview of the safe indications for use and determine the overall financial impact of PPI usage on medical schemes. Results: Five different PPI generic entities were analyzed (pantoprazole, omeprazole, lansoprazole, rabeprazole and esomeprazole). PPIs were claimed at an average of 8 times within the twelve-month period per patient. There was a significant correlation between the patient’s age and the duration of therapy (p < 0.001). Omeprazole (34%), pantoprazole (25%) and esomeprazole (24%) were the most frequently utilized generic entities. More than half of the PPIs claimed were prescribed by general practitioners. Lansoprazole 15 mg, omeprazole 10 mg and 20 mg and pantoprazole 20 mg are available for OTC usage. OTC pharmacy claims made up 13.99% of the total PPI claims submitted. The total cost to the medical schemes was R20 715 453,58, of which high-dose esomeprazole accounted for 30.08%. Two of the four medical schemes implemented an annual quantity limitation on PPIs of 90 tablets or capsules per year effective from 2023. Conclusion: Despite clear indications for safe use, PPIs are being overutilized on a long-term basis and for inappropriate indications. De-prescribing of PPIs in the elderly, especially high-dose esomeprazole, should be considered when re-evaluating patients to prevent overutilization. Authorized prescribers and pharmacists play an essential role in reducing PPI expenditure and discouraging PPI misuse by prescribing only according to national guidelines for appropriate indications and treatment duration, encouraging the use of cost-effective generics and alternative therapies, and educating patients on healthy lifestyle measures for the long-term management of acid-related disorders. The cost of PPIs to medical schemes in South Africa is currently very high and increasing steadily each year. The costs to medical schemes can be further reduced by implementing benefit design restrictions on PPI reimbursement.
A price and availability survey of essential medicines in Harare Province, Zimbabwe.
(2015) Marume, Amos.; Bangalee, Varsha.
Access to essential medicines is both a fundamental basic right and necessity for everyone, thus governments should make concerted efforts to ensure that all have access to safe, quality and comparative cost-effective medicines. Efforts aimed at identifying factors hindering full access are key in informing relevant policy makers. Thus in pursuant of making significant contributions to the above, a survey was carried-out in Harare metropolitan province of Zimbabwe to determine prices, price components, pricing policies, source and availability of essential medicines (their innovator and/or generic equivalents) in both private and public retail sectors. Comparisons with 36 other low to middle-income countries in the rest of Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia and Western Pacific were also conducted. A standardized methodology developed by World Health Organization and Health Action International (WHO/HAI) was used to survey a selected basket of 40 medicines. The selection was based on the WHO/HAI core medicines list and the latest version of the essential drug list of Zimbabwe. The survey was conducted in 110 private pharmacies, of which 55 were from the central business district, 33 from the high density and 22 from the low density suburbs. In both private and public sectors, availability of the selected essential medicines (low priced generics) was quite high (>80%). Fewer innovator brands were found for the selected medicines. Median price ratios (MPR) of the lowest priced generics revealed that many people still might be having their accesses to essential medicines compromised by high prices, particularly in the private sector (4.52). The public sector showed significant progress towards procurement efficiency (MPR of 1.5). More than 70% of the surveyed medicines were from manufacturers outside Zimbabwe with more than 60% being produced by Indian generic manufacturers. Zimbabwe still needs to do more on pricing, particularly in the private sector as well as promoting local production among other efforts in its quest to ensure all its people have access to quality, safe and effective medicines.
Price, availability and affordability of antineoplastic medicines in Harare’s public and private institutions: implications for access.
(2020) Mutyavaviri, Sly Ngoni.; Bangalee, Varsha.; Marume, Amos.
Background: Antineoplastic medicines are increasingly becoming more vital in many public health setups. There has been significant progress made in terms of newer molecules since the advent of chemotherapy. Despite the importance of antineoplastic medicines and advent of these molecules, there are still issues of limited availability and affordability in Zimbabwe. Currently the country has no government initiated policies on pricing and accessibility of antineoplastic medicines in public and private institutions, placing health care consumers at risk. A study was therefore designed to assess the price, availability and affordability of antineoplastic medicines in Harare Province, Zimbabwe. Methods: The study was based on the standardised method recommended by the World Health Organisation (WHO) and Health Action International (HAI). A data collection form-based cross-sectional survey was conducted in public and private medicine outlets. A total of 153 facilities were surveyed. The facilities consisted of three (3) public institutions and one hundred and fifty (150) private pharmacies in Harare and surrounding towns. The percentage availability, median price ratio using International Reference Prices, mark-ups, price and affordability of antineoplastic medicines were determined. Affordability was determined by using the wage of the lowest paid government worker which was USD296 per month. Median price ratios were calculated for twenty-two (22) of the antineoplastic medicines that were imported into the country from the import records at the Medicines Control Authority and also appearing on the medicines register for private pharmacies and seven (7) medicines for the public hospital pharmacies. The WHO’s International Reference Prices were used for calculation of median price ratios. Range, mode and average mark-up percentages for the antineoplastic medicines were also determined. Availability and price in the public sector was compared to availability in the private sector. Affordability was calculated as the out-of-pocket day’s wages to buy a monthly cycle of the antineoplastic medicine. Results: The percentage availability of the antineoplastic medicines at the government institutions was 25%, whilst the percentage availability of the antineoplastic medicines in the private sector ranged from 1% to 42.7%. Fifty percent of the twenty-two (22) medicines in the private sector had a median price ratio of lower than 4. The median price ratio in the private sector ranged from 0.60 to 11. Median price ratios were calculated for seven (7) medicines in the public sector. The median price ratio in the public sector ranged from 0.73 to 2.25. Eleven (11) of the medicines in the private sector were affordable with ten (10) days wage and below. Eight of the medicines were slightly affordable with wage days more than 10 days wage but less than 20 days wage. Wage days in private sector ranged from 1 day to 490 days. Affordability of the medicines in the public sector ranged from 1 to 10 days wage. Average percentage mark-up was 51.3% in the private sector and 34% in the public sector for the medicines that were available. Conclusion: Medicines were generally more available in the private sector than in the public sector. The government needs to continue supporting the National Pharmaceutical Company’s procurement of antineoplastic medicines. Generally medicines were more affordable in the public sector than in the private sector. The high percentage mark-ups calculated in the private sector compared to the public sector are as a result of the overhead expenses in private pharmacies which have to be borne from the actual sales of the medicines unlike in the public sector were the services are subsidised by the government. The low availability of antineoplastic medicines coupled with a very high unemployment rate means there is a huge burden on accessibility of antineoplastic medicines in Harare. Most patients cannot afford antineoplastic medicines which can result in increased mortality. There is a need to subsidise the medicines to improve accessibility. This will reduce the out-of-pocket expenses made by patients. There is a need to also ensure that medical insurance in Zimbabwe allow all pharmacies to retail antineoplastic medicines instead of the selective incorporation of pharmacies into their health insurance schemes. The calculated median price ratios range showed that the prices of the medicines are varied and there is need to have medicine procurement and pricing policies that minimise the median price ratio to lower than 5 for all antineoplastic medicines.
The use and safety of antibiotic therapy in pregnant women.
(2020) Naidoo, Sasha.; Oosthuizen, Frasia.; Bangalee, Varsha.; Mensah, Kofi Boama.
Background Antibiotic therapy in pregnant women has significantly increased in the effort to reduce maternal and neonatal deaths. However, antibiotic exposure may negatively affect the developing foetus. Information on the use, safety, and impact of antibiotics on birth outcomes and maternal-foetal health in low and middle-income countries are limited. This study aims to evaluate the use of antibiotics among pregnant women by quantifying antibiotic use and commenting on their safety profile. Furthermore, the risk perception of antibiotics among pregnant women, across all geographic regions, were determined. Method Patient demographics and treatment information were obtained from MediTech®; an electronic patient information database, from January 2019 to July 2019. Descriptive and analytical measures were used to describe both patient demographics and antibiotic treatment variables. A systematic review was conducted to determine the risk perception of antibiotics among pregnant women. A systematic search for studies from January 2000 to December 2019 were performed using four databases, which included: PubMed, Scopus, CINAHL, and Psycinfo. The systematic review involved the categorisation of data into relevant themes and sub-themes; data transformation and outcomes were discussed using narrative and thematic synthesis. Results A total of 416 antibiotic prescriptions, issued to 184 patients, were reviewed. Penicillins (39.7%), macrolides (13.0%), and combination penicillin-and-beta-lactam inhibitors (12.3%) were reported as the most commonly prescribed antibiotics in pregnancy. Most antibiotics were prescribed for diseases of the circulatory system (36.1%). A significant correlation was found between the duration of therapy and the age of the patient (>20, p=0.0009, 20-29, p=0.017, 30-42, p=0.03). The systematic review identified a total of 1539 articles, of which 14 studies met the inclusion criteria. The selected studies included four regions: Europe, America, Asia, and Africa. Limited studies were found in low and middle-income countries, especially among rural communities. Conclusion Penicillins remain as the most common antibiotic used in pregnant women. However, the use of other antibiotic classes apart from the commonly used beta-lactams are also increasing, showing evidence of antibiotic resistance. In addition, the influence of perception significantly affects antibiotic use among pregnant women.