An Exploratory Bibliometric Analysis of African Pharmacovigilance Research Output Using SCOPUS.

Most global pharmacovigilance (PV) data is derived from developed countries. However, the determinants of the differences in PV research output between developing and developed countries contributing to this discrepancy still need to be explored. The objective of the current study is to describe the publication trends and characteristics of pharmacovigilance-related research stemming out of Africa in comparison to that emanating from developed countries. A bibliometric analysis was carried out using the SCOPUS literature index for published global pharmacovigilance-related articles or documents pre-COVID-19. Data on annual publication trends, citations, author affiliations, and other study characteristics such as study funding were extracted and descriptively analyzed. Author co-citation and keyword co-occurrence analyses were also conducted and presented using VOSviewer software program version 1.6.15 (CWTS, Universiteit Leiden, Netherlands). During the period under review, a total of 27,516 documents were retrieved globally. Out of these, 588 (2.1 %), 9,438 (34.3 %), and 17,829 (64.8 %) were from Africa, Europe, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) founder member countries respectively. Annual publications have steadily increased, but at a slower rate in Africa compared to Europe. The mean annual publications and number of citations are significantly lower in Africa compared to Europe, p < 0.0001 for both parameters. The top 10 funders of African PV activities are European and American organizations. In conclusion, improved PV activity driven by international funders has been notable on the African continent. However, there is an increased need for local funding, government involvement, and legislation to improve PV activities on the African continent.

The Prevalence of Clinically Undiagnosed Depression in Patients With Autoimmune Bullous Diseases Seen at Inkosi Albert Luthuli Central Hospital, Durban, South Africa.

Background Chronic autoimmune bullous diseases have been associated with major depression in previous studies. This has been attributed to inflammatory cytokines, chronic pain, and the chronicity and debilitating nature of the disease. As no similar studies have been conducted in our setting, we aimed to determine the prevalence and severity of clinically undiagnosed depression in patients with autoimmune bullous diseases. Methodology We performed a cross-sectional study among outpatients managed in a bullous disease clinic at Inkosi Albert Luthuli Central Hospital, a quaternary provincial hospital in Durban, South Africa. Results A total of 44 participants were recruited and included in this study. The majority of the participants were females (29, 65.9%). The most common autoimmune bullous diseases were pemphigus vulgaris (19, 43.2%), bullous pemphigoid (18, 40.9%), and pemphigus foliaceus (5, 11.4%). The overall prevalence of at least mild and at least moderate depression in patients with autoimmune bullous diseases in our clinic was 52.3% and 20.5%, respectively. Pemphigus vulgaris showed the highest median Patient Health Questionnaire-9 score compared to other bullous dermatoses. Statistically significant differences were observed between females and males for the duration with the bullous disease (p = 0.014) and between intraepidermal and subepidermal disease for both the mean age (p = 0.038) and age at onset (p = 0.015). Conclusions Clinically undiagnosed depression is common in patients with autoimmune bullous disease. Its frequency and severity may differ depending on the underlying autoimmune bullous disease and possibly other factors. Dermatologists should always be alert to this fact and prompt psychiatric consultation as required to comprehensively manage these patients.

Microbiologic characterisation of bacterial infections in children with atopic dermatitis.

Background: Patients with atopic dermatitis (AD), the commonest chronic inflammatory skin disease are often colonised and infected by Staphylococcus aureus. In this study, we aimed to determine the type and antibacterial sensitivities of the bacteria infecting eczematous lesions in children with AD and to recommend first-line antibiotic therapy. Methods: A prospective study was conducted from June 2020 to June 2021 in children with AD presenting with a cutaneous infection at the King Edward hospital VIII outpatient dermatology clinic. Swabs were collected for microbial culture, confirming infections and assessing antibiotic sensitivity for infected sites. Results: Ninety six children were recruited during the study period with a mean age of 4.3 ± 3.4 years. The commonest cause of bacterial infection was Staphylococcus aureus seen in 74 (77.1%) cases, followed by Staphylococcus aureus and Group A ß-haemolytic streptococcus (GAS) co-infection in 22 (22.9%) cases. The majority of these infections were observed on the lower limbs in 50 (52.08%) cases and in moderate 37 (38.5%) cases and severe eczema cases of 38 (39.6%) in AD. There was no gender predilection. Staphylococcus aureus was sensitive to amoxicillin-clavulanic acid in 57 (77.0%) cases, cloxacillin in 53 (71.6%) cases and clindamycin in 24 (32.4%) cases, whereas GAS was mostly sensitive to ampicillin in 10 (45.5%) cases. No swabs retained a resistant strain. Conclusion: Staphylococcus aureus is the commonest bacterial cause of cutaneous infection in children with AD in our setting. Amoxicillin-clavulanic acid and cloxacillin remain the most sensitive therapeutic options for this infection, however, a larger study is required to explore resistance strains, if any, in our setting.

Selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor associated cutaneous adverse drug reactions: A systematic review of case reports and case series.

Anecdotal evidence suggests that selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) cause cutaneous adverse drug reactions (CADRs). However, there is limited information on the factors associated with these occurrences. In this study, we aimed to describe the demographic, clinical and pharmacological characteristics associated with CADRs encountered by patients administered SSRIs and/or SNRIs for psychiatric diagnoses and to compare the differences in these factors between severe and non-severe CADRs. A protocol was developed a priori (PROSPERO: CRD42020204830) in line with the PRISMA guidelines. We searched PubMed/Medline, PsycINFO and SCOPUS from inception to October 2020 to identify case reports and/or case series of SSRI and SNRI associated CADRs. Additional cases were obtained from the retrieved articles' bibliography. A total of 141 articles were included in the study, documenting 173 CADRs. Females accounted for 128 (74.0%) of the analysed CADRs. The median age of the cases was 42 IQR (27; 53) with no statistically significant differences in age between males and females (P = 0.542). A total of 157 (90.8%) of the reported CADRs were associated with SSRIs, particularly fluoxetine 68 (39.5%), sertraline 30 (17.4%) and paroxetine 25 (14.5%). Non-severe CADRs and severe CADRs accounted for 23 (13.4%) and 149 (86.6%) reports respectively. No statistically significant differences were observed for gender (P = 0.616), age at onset (P = 0.493) and time to onset (P = 0.105) between non-severe CADRs and SCARs. In conclusion, CADRs following SSRIs and SNRIs disproportionately affect females in the reproductive age group compared to males and are mostly associated with SSRIs.

Concurrent pulmonary tuberculosis and lepromatous leprosy in a newly diagnosed HIV positive patient: a case report.

BACKGROUND: The leprosy-tuberculosis (TB) co-infection is rarely reported in recent times. However, this dual comorbidity is associated with high mortality and major morbidity. Unrecognised leprosy-TB co-infection may predispose affected patients to rifampicin monotherapy and subsequent drug resistance. CASE PRESENTATION: A 35 year old migrant, human immunodeficiency virus (HIV) positive male worker presented with 6 month history of symmetric infiltrative nodular plaques of the face and distal, upper extremities. A few days after initial dermatology presentation, a sputum positive pulmonary tuberculosis diagnosis was made at his base hospital. Subsequent dermatology investigations revealed histology confirmed lepromatous leprosy and a weakly reactive rapid plasma reagin test. The presenting clinical features and laboratory results were suggestive of lepromatous leprosy coexisting with pulmonary tuberculosis in an HIV positive patient. CONCLUSIONS: This case illustrates the occurrence of leprosy with pulmonary tuberculosis in an HIV infected patient and the difficulties in interpreting non-treponemal syphilis tests in these patients. This case also highlights the need for a high index of suspicion for co-infection and the need to exclude PTB prior to initiation of rifampicin containing multi-drug therapy (MDT). Interdisciplinary management and social support are crucial in these patients.

Osteomyelitis complicating secondarily infected atopic eczema: two case reports and a narrative literature review.

BACKGROUND: Atopic eczema is a relapsing, itchy chronic cutaneous inflammatory disease that commonly affects children. The disease is often complicated by cutaneous infections such as eczema herpeticum, eczema vaccinatum and a varied number of bacterial infections - impetigo, cellulitis and erysipelas. However, rare case reports of infective endocarditis, otitis media and osteo-articular infections have been associated with atopic eczema. These associations possibly represent the extracutaneous infectious complications of atopic eczema. CASE PRESENTATION: Here we present two cases of osteomyelitis in HIV negative children with habitual scratching of poorly managed and/or uncontrolled atopic eczema respectively. Both cases presented to the orthopaedic surgeons and were admitted as acute phalangeal osteomyelitis and acute - on - chronic tibial osteomyelitis respectively. The first case was an 8 year old girl who had moderate-severe poorly-controlled atopic eczema and contiguously spread phalangeal osteomyelitis. The second case was an 11 year old pre-pubertal boy who had untreated atopic eczema and tibial osteomyelitis possibly from haematogenously spread Staphylococcus aureus infection. Both were successfully discharged from hospital and currently have well controlled eczema. The 11 year old patient is also being reviewed monthly by the orthopaedic surgeons and is chronic suppressive antibiotics. He may require sequestrectomy, should it be needed. CONCLUSIONS: Invasive staphylococcal and streptococcal osteo-articular (OA) infection can arise as an extra-cutaneous infectious complication of poorly controlled atopic eczema. It is more common in the 3 to 15 year age group and especially in boys with a septic arthritis to osteomyelitis ratio of around 29:5. Clinicians should maintain a high index of suspicion in patients with moderate-severe atopic eczema and they ought to promptly manage these OA infections with intravenous antibiotics to avoid further complications.

A Comparison of Adverse Drug Reaction Profiles in Patients on Antiretroviral and Antitubercular Treatment in Zimbabwe.

INTRODUCTION: Few studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries. OBJECTIVES: To describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART). METHODS: We analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016. All reports considered certain, probable or possible were included in the analysis. RESULTS: A total of 1076 ICSRs were included in the analysis. Most of the reports were from the HAART only group (n = 882; 82.0%), followed by patients on HHART (n = 132; 12.3%), and ATTHAART (n = 62; 5.7%). The ATTHAART (35.5%) and HHAART (34.1%) had a higher frequency of hepatic disorders than the HAART group (5.0%) (p < 0.0001). A higher frequency of rash was reported in the HHAART (35.6%) and HAART groups (29.4%) than the ATTHAART group (14.5%) (p = 0.011). Peripheral neuropathy occurred more frequently in the ATTHAART group (19.3%) than other groups (p = 0.001) while Stevens-Johnson syndrome (14.7%; p < 0.001), gynaecomastia (18.2%; p < 0.001), and lipodystrophy (4.5%; p = 0.012) occurred more frequently in the HAART group. The HHAART group was associated with a higher frequency of psychosis (4.5%; p = 0.002). CONCLUSION: Antiretroviral therapy was associated with a higher frequency of Stevens-Johnson syndrome, gynaecomastia, and lipodystrophy. Co-administration of antiretroviral and antitubercular medicines was associated with a higher frequency of drug-induced liver injury and peripheral neuropathy. Similarly, co-administration of isoniazid preventive therapy and antiretroviral drugs was associated with a higher risk for psychosis. There is a need to carefully manage TB/HIV co-infected patients, due to the higher risk of adverse drug reactions which may lead to poor treatment adherence and outcomes.