Pharmaceutical Sciences

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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.
Evaluating adverse drug reactions associated with antibiotic use in a public sector hospital.
(2016) Moyo, Nokuthemba Sibusiso.; Oosthuizen, Frasia.
Background and Aim Antibiotics are one of the most troublesome classes of drugs contributing to adverse drug reactions. These adverse drug reactions are generally under reported. This study aimed to evaluate the adverse drug reactions associated with antibiotic use in a public sector hospital. Methods A prospective, quantitative study was carried out using adverse drug reaction reports collected from a public sector hospital in South Africa, for the period 01 July 2016 – 30 September 2016. All the adverse drug reaction reports attributed to use of antibiotics were included in the study. The patient’s age, gender, weight, antibiotic prescribed, dose of antibiotic, route of administration of the antibiotic, adverse drug reaction experienced and action taken regarding the adverse drug reaction was extracted from the adverse drug reaction report. A descriptive and inferential analysis was carried out using SPSS (version 24) to determine the strength of the relationships (Pearson Chi Square test) between different variables. Results A total of 10 adverse drug reaction reports were collected during the 3 month period from which 8 were related to antibiotic use (80%). Adverse drug reactions associated with antibiotic use were experienced mostly by female patients (n=6, 75%). Adverse drug reactions were reported for Amphoteracin B (n=3), Amoxicillin (n=1), Cefazolin (n=1), Lopinavir/Ritonavir combination (n=1), Metronidazole (n=1) and Tenofoir/Emtricitrabine/Efavirenz combination (n=1). Of the 8 adverse drug reactions, 7 required intervention to prevent permanent damage/disability. There were 2 serious adverse drug reactions; 1 required hospitalization and the other prolonged hospital stay; the remaining adverse drug reactions were classified as non-serious. Discussion and Conclusion Antibiotic related adverse drug reactions constituted 80% of all adverse drug reactions reported in a single hospital. The impact of adverse drug reactions associated with antibiotic use in the public hospital ranged from treatment to manage the adverse drug reaction to hospitalization and the prolongation of hospital stay. This study provides useful information on the current status of adverse drug reactions related to antibiotic use in the public sector in South Africa, and indicates the need for adverse drug reaction reporting in hospitals to ensure safety of medicines and better treatment outcomes.
Experiences of Implanon NXT® users at public health facilities in South Africa.
(2018) Prosad, Shimona.; Ojewole, Elizabeth Bolanle.
Background and aim: Implanon NXT® was introduced in South Africa (SA) in the public health sector in February 2014. There exist concerns with premature Implanon NXT® user discontinuation in SA however, the true extent remains unknown due to delayed monitoring systems and limited empirical data. This study aimed to evaluate the experiences of Implanon NXT® among users in the public health sector in SA. Methods: A retrospective study was conducted and entailed analysis of secondary data attained from the National Department of Health Pharmacovigilance Centre for Public Health Programmes using reports submitted from 1 April 2015 to 11 September 2017. A total of 3743 cases were extracted and analysed using SPSS®. Tests of association were performed using demographics, adverse drug reactions and discontinuation variables. Chi square test and Mann Whitney U-Test were performed to test differences between Gauteng and KwaZulu-Natal (KZN). Results: The 20-24-year olds were the most frequent Implanon NXT® users (25.70%; 962/3743). Of the 36.57% (1369/3743) cases which reported adverse drug reactions (ADRs), menorrhagia (52.01%;712/1369), headache (20.45%;280/1369) and dizziness (11.18%;153/1369) were the most frequent ADRs. Discontinuation was reported by 63.56% (2379/3743) of case reports and premature discontinuation was reported by 81.1% (1210/1492). The common reasons for discontinuation were menorrhagia (34.27%;728/2124), expiry (29.57%;628/2124) and headache (10.26%;218/2124). Overall, ADRs were found to be the main reason for discontinuation (83.99%; 1784/2124). Pregnancies reported with Implanon NXT® occurred in 4.97% (68/1369) of case reports and efavirenz-based therapy was suspected to be associated with pregnancy in Implanon NXT® users (p<0.001). The common ADRs and reasons for discontinuation of Implanon NXT® reported in Gauteng was consistent with the national data while drug interaction and pregnancy were commonly reported in KZN. Premature discontinuation of Implanon NXT® was higher in Gauteng (82.6%, 252/305) than KZN (76.7%, 23/30). Conclusion: Young women were frequent users of Implanon NXT® . Menorrhagia was the predominantly reported ADR among all the users. A high frequency of discontinuation was identified, and ADRs were mainly responsible for discontinuation. The frequency of failure was small and efavirenz was suspected to be associated. The experiences of Implanon NXT® users differed between KZN and Gauteng which emphasizes tailored strategies need to be considered. Users’ counselling, adverse drug reaction treatment and management, monitoring and evaluation are recommended to address high discontinuation in SA.
Knowledge, attitudes and practices of community pharmacists in Harare regarding the reporting of adverse drug reactions.
(2017) Mafundikwa, Tafadzwa Christine.; Gray, Andrew Lofts.
Adverse drug reactions (ADRs) cause considerable morbidity which contributes significantly to health expenditure. Worldwide, there is under-reporting of ADRs by healthcare workers and Zimbabwe is no exception. In Zimbabwe, ADRs are mainly detected by use of a spontaneous reporting system. There is a greater need for enhanced pharmacovigilance (PCV) in Africa, where weak health systems are likely to contribute to medicine-related harm. The aim of the study was to contribute to the safe use of medicines by strengthening reporting of adverse drug reactions by pharmacists in Harare, by identifying knowledge, attitudes and practices that hinder their involvement at present. The objectives of the study are to determine if pharmacists practicing in private community pharmacies in Harare, Zimbabwe, know how to identify and when to report ADRs and whether they are reporting ADRs to the relevant authorities. In addition, the study seeks to determine their attitudes towards identification and reporting of ADRs and finally, to make recommendations for interventions to improve the knowledge, attitudes and practices of pharmacists in relation to the identification and reporting of ADRs. The study was designed as an observational, cross-sectional, analytical study. This design was used since it offered a cost-effective way of gathering information from many people in a relatively short period. Study Population and sampling: The study took place in Harare, Zimbabwe, where over 44% of the country’s private community pharmacies are located. A census approach was used as little is known about the subject locally. A self-administered questionnaire was designed to establish the socio-demographics of the respondents, their knowledge on ADR reporting and their attitudes and practices regarding ADR reporting. The questionnaires were distributed via electronic mail and at a continuing professional development session to a combined total of 129 community pharmacists. Data were analysed using Statistical Package for the Social Sciences (SPSS) version 16 and Microsoft Excel 2007. The respondents displayed poor knowledge of ADR reporting and hence there is under-reporting of ADRs. Factors such as post-graduate training and years of experience post- graduation have no bearing on the knowledge possessed by the respondents regarding ADR reporting. Although the respondents showed an appreciation of the importance of ADR reporting, there are barriers such as lack of knowledge and fear of legal liability that prevent pharmacists from reporting ADRs. Discussion: Lack of knowledge is the main barrier to reporting of ADRs by community pharmacist in Zimbabwe. To address this gap, interventions such as education for community pharmacists are required for both undergraduate pharmacist students and qualified pharmacists. There is a low level of knowledge and poor attitudes and practices amongst Zimbabwean pharmacists with respect to ADR reporting. Multi-sectoral interventions are required to overcome the barriers that community pharmacists encounter in reporting ADRs.

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Browsing Pharmaceutical Sciences by Subject "Adverse drug reactions."