Browsing by Author "Khoza, Star"

Now showing 1 - 6 of 6
  • Thumbnail Image
    Item
    An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme
    (Wiley-Blackwell, 2020) Khoza, Star; Masuka, Josiah Tatenda
    We aimed to determine the reporting trends and characteristics of Individual Case Safety Reports (ICSRs) from the Zimbabwean national pharmacovigilance system. ICSRs submitted to VigiBaseTM, the World Health Organisation's ICSR database between January 1993 and December 2017 were retrospectively reviewed with respect to the suspected medicine, System Organ Class (SOC), adverse drug reaction (ADR) type and seriousness, Anatomic Therapeutic Chemical (ATC) group, age, and gender. In total, 4071 ICSRs were submitted to VigiBaseTM from targeted spontaneous reporting (n = 2909; 71.5%), vaccine surveillance (n = 679; 16.7%), and passive spontaneous reporting (n = 483; 11.9%), respectively
  • Thumbnail Image
    Item
    Antiasthmatic properties of Lippia javanica and Myrothamnus flabellifolius using an in vitro model
    (University of the Western Cape, 2022) Alnamni, Ayiman; Khoza, Star
    Asthma is a reversible, chronic inflammatory disease that causes obstruction to the airways that causes an increase in airway hyperresponsiveness that leads to recurrent episodes of chest tightness and coughing. Lippia javanica and Myrothamnus flabellifolius are among the most widely used medicinal plants in Southern Africa for asthma management, control, and treatment. The aim of this study was to investigate the potential antiasthmatic properties of L. javanica and M. flabellifolius in a cell culture model.
  • Thumbnail Image
    Item
    Exploring the utility of a spontaneous adverse drug reaction reporting system in identifying drug–drug interactions between antiretrovirals, antitubercular drugs, and cotrimoxazole: a case/non-case analysis
    (Springer Nature, 2020) Khoza, Star; Masuka, Josiah Tatenda; Mosam, Anisa
    Background: Drug–drug interactions (DDIs) cause significant morbidity and mortality, especially in patients with HIV with opportunistic infections such as tuberculosis. However, the literature on quantitative signal detection analyses for DDIs within the national spontaneous reporting systems (SRSs) of countries with high HIV/tuberculosis burdens is lacking. Objective: Our objective was to explore the utility of using post-marketing SRSs in quantitative signal detection analyses of DDIs. Methods: A case/non-case analysis using the Zimbabwean adverse drug reaction (ADR) database obtained from VigiBase® was utilized for quantitative signal detection using 2 × 2 contingency table calculations. Cases were defined as individual case safety reports (ICSRs) with the ADR of interest, and non-cases included the rest of the ICSRs.
  • Thumbnail Image
    Item
    An interesting case of carbamazepine-induced Stevens–Johnson Syndrome
    (Springer, 2018) Masuka, Josiah Tatenda; Muzopambwa, Garikai; Khoza, Star; Chibanda, Dixon
    A 29-year-old Black female patient was admitted to a psychiatric ward with symptoms of major depressive disorder with psychosis. The patient was started on amitriptyline 50 mg/day and haloperidol 10 mg/day. On day 4 post-admission, the preferred first-line antidepressant, fluoxetine, became available and the patient was switched from amitriptyline to fluoxetine 20 mg/day. On the same day, the dose of haloperidol was reduced to 5 mg/day. Thirteen days post-initiation of these medications the patient became talkative, associated with emotional lability, an expansive mood, irritability and restlessness. The working diagnosis was changed to bipolar affective disorder in the manic phase. Fluoxetine was discontinued and carbamazepine 600 mg/day was added to the patient’s treatment regimen. Her manic symptoms started to resolve; however, 14 days post-initiation of carbamazepine, the patient had a fever; itchy, discharging eyes; respiratory distress; generalised symmetrical erythematosus rash; buccal ulceration; and conjunctival injection with difficulty opening her eyes. Carbamazepine was immediately discontinued and the patient received intravenous fluid resuscitation. The patient recovered considerably after 12 days of symptomatic and supportive management, and was transferred back to the psychiatric ward for the continuation of bipolar disorder management. Lithium therapy was instituted and the patient was subsequently discharged. Using the Algorithm of Drug causality for Epidermal Necrolysis (ALDEN) Stevens–Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN) drug causality scoring system, carbamazepine and fluoxetine were evaluated as ‘very probable’ and ‘possible’ causes of SJS, respectively, in this patient. Fluoxetine-induced SJS was considered on account of previous case reports, however no evidence of causality was found in this patient. Consecutive administration with a potential increase in carbamazepine due to inhibition of cytochrome P450 (CYP) 3A4 metabolism by fluoxetine was also not ruled out. A diagnosis of carbamazepine-induced SJS was made and was considered an idiosyncratic adverse drug reaction.
  • Thumbnail Image
    Item
    A retrospective analysis of applications for registration of generic medicines processed by the medicines control authority of Zimbabwe
    (Springer, 2023) Samunda, Brilliant Tinashe; Sithole, Tariro; Khoza, Star
    Many applications for registration of medicines are rejected because applicants fail to submit or resolve critical deficiencies in the quality, efficacy, and safety of the medicines. The study aimed to establish approval rates, processing timelines, and common deficiencies of generic medicines applications processed by the Medicines Authority of Zimbabwe (MCAZ). A retrospective study of applications finalized by MCAZ between 2018 and 2020 was conducted. Data were collected from the assessment reports and verified with copies of letters sent to the applicants. Deficiencies were classified as administrative, quality, efficacy, and safety. Other characteristics collated included time to finalization, dosage form, region of origin, and therapeutic class.
  • Thumbnail Image
    Item
    Situation analysis on the regulation of nanomedicines in Southern Africa
    (Frontiers Media, 2023) Mudyiwenyama, Linda G.; Khoza, Star; Dube, Admire
    Medical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resourcelimited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.