An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme

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%), respectivel

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

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

An Interesting Case of Carbamazepine-Induced Stevens-Johnson Syndrome.

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

The relationship between CYP2D6 polymorphisms and Tardive Dyskinesia in black Zimbabwean psychotic patients on typical antipsychotics

CYP2D6 polymorphisms have been associated with different drug efficacies and adverse effect profiles including Tardive Dyskinesia (TD). The occurrence of these polymorphisms has also been noted to be different amongst different racial or ethnic groups. In Asians and Caucasians CYP2D6*10 and CYP2D6*3, *4 and *5 have been positively associated with TD respectively. In Africans no clear relationships with the prevalent reduced function CYP2D6 genotypes has been shown. The objective of this study was to determine whether occurrence of TD is associated with the most prevalent reduced function CYP2D6 genotypes in black Zimbabweans – CYP2D6*17 and *29. AIMS scoring and CYP2D6 genotyping was carried out on patients exposed to first generation or typical antipsychotic medications at Parirenyatwa Annexe and Harare Psychiatric units in an unmatched case control study. The main outcome measures were CYP2D6*17 and *29 genotypes. The relationship between TD and mutant CYP2D6*17 homozygote and heterozygote genotypes was not statistically significant with p values of 0.740 and 0.442 in the haloperidol exposed and 0.587 and 0.150 in those exposed to haloperidol, FD and CPZ respectively. No CYP2D6*29 result could be determined due to a failure in genotyping for this SNP. The results presented suggest no association between the major reduced function CYP2D6 allele *17 and TD in black psychotic Zimbabwean patients

Importance of clinico‐pathologic correlation in rare, chronic infectious diseases: Actinomycetoma misdiagnosed as botryomycosis—A case report

Key Clinical Message This case report explores the clinical journey of a patient initially diagnosed with botryomycosis, only to later reveal the underlying and rare condition of actinomycosis. The report highlights the challenges in getting to an accurate diagnosis, emphasizing the importance of considering uncommon pathologies, the utility of multi‐disciplinary teams and clinico‐pathologic correlation in clinical practice