Situation analysis on the regulation of nanomedicines in Southern Africa.

Background: 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.

A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe.

Background: 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).

Method: A retrospective study of applications finalized by MCAZ between 2018 and 2020 was conducted.

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 VigiBase , 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 VigiBase from targeted spontaneous reporting (n = 2909; 71.

Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase® from 1997 to 2017.

Background: Vaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system.

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.

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.

Wound Healing Properties of Selected Plants Used in Ethnoveterinary Medicine.

Plants have arrays of phytoconstituents that have wide ranging biological effects like antioxidant, anti-inflammatory and antimicrobial properties key in wound management. wound healing properties of ointments made of crude methanolic extracts (10% extract w/w in white soft paraffin) of three plant species, L. (whole aerial plant parts), Klotzsch (whole aerial plant parts) and Lam.

Comparative Hepatotoxicity of Fluconazole, Ketoconazole, Itraconazole, Terbinafine, and Griseofulvin in Rats.

Oral ketoconazole was recently the subject of regulatory safety warnings because of its association with increased risk of inducing hepatic injury. However, the relative hepatotoxicity of antifungal agents has not been clearly established. The aim of this study was to compare the hepatotoxicity induced by five commonly prescribed oral antifungal agents.

Pattern and Epidemiology of Poisoning in the East African Region: A Literature Review.

The establishment and strengthening of poisons centres was identified as a regional priority at the first African regional meeting on the Strategic Approach to International Chemicals Management (SAICM) in June 2006. At this meeting, the possibility of a subregional poisons centre, that is, a centre in one country serving multiple countries, was suggested. The WHO Headquarters following consultation with counterparts at the WHO Regional Office for Africa (AFRO) and the SAICM Africa Regional Focal Point successfully submitted a proposal to the SAICM Quick Start Programme (QSP) Trust Fund Committee for a feasibility study into a subregional poisons centre in the Eastern Africa subregion.

Cost effectiveness of adding nucleic acid testing to hepatitis B, hepatitis C, and human immunodeficiency virus screening of blood donations in Zimbabwe.

Background: The aim of this study was to assess the cost effectiveness of introducing individual-donation nucleic acid testing (ID-NAT), in addition to serologic tests, compared with the exclusive use of serologic tests for the identification of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) I and II among blood donors in Zimbabwe.

Study Design And Methods: The costs, health consequences, and cost effectiveness of adding ID-NAT to serologic tests, compared with serologic testing alone, were estimated from a health care perspective using a decision-analytic model.

Results: The introduction of ID-NAT in addition to serologic tests would lower the risk of HBV, HCV, and HIV transmission to 46.

The costs of producing a unit of blood in Zimbabwe.

Background: There is lack of published data on the costs of blood and blood transfusion in sub-Saharan Africa. This study aimed to assess the unit costs of producing blood in Zimbabwe using an activity-based costing (ABC) method.

Study Design And Methods: A management accounting approach, based on the ABC method, was used to develop a cost model for blood.

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey.

Introduction: Cohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice.

Profiles of blood and blood component transfusion recipients in Zimbabwe.

Background: There are limited published data on the characteristics of blood transfusion recipients in sub-Saharan Africa. This study describes the demographic characteristics of blood transfusion recipients and patterns of blood and blood component use in Zimbabwe.

Materials And Methods: Data on the characteristics of the blood transfusion recipients (age, sex, blood group), blood components received (type, quantity), discharge diagnoses and outcomes following transfusion (discharge status, duration of stay in hospital), were retrospectively collected from four major hospitals for the period from January 1, 2012 to December 31, 2012.

Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: a retrospective analysis.

Background: Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe.

Materials And Methods: A retrospective review of the transfusion-event records of the National Blood Service Zimbabwe was conducted covering the period from 1 January 1999 to 31 December 2011.

The state of health economic research in South Africa: a systematic review.

Background: Economic factors are a limiting factor toward the implementation of many health programmes and interventions. Economic evaluation has a great potential to contribute toward cost-effective healthcare delivery in South Africa. Little is known about the characteristics and quality of health economic (including pharmacoeconomic) research in South Africa.

The impact of herbal drug use on adverse drug reaction profiles of patients on antiretroviral therapy in zimbabwe.

Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology.

Use of antidepressants and the risk of type 2 diabetes mellitus: a nested case-control study.

Background: Recent evidence from case reports, observational studies, and randomized trials suggests that long-term use of antidepressants increases the risk of developing diabetes. However, the nature of the relationship between antidepressants and diabetes remains unclear.

Objective: To determine whether there is an association between antidepressant use and the risk of developing type 2 diabetes mellitus.

ADHD medication use, adherence, persistence and cost among Texas Medicaid children.

Objectives: (1) Describe ADHD medication use, adherence and persistence. (2) Determine factors (e.g.

Glucose dysregulation associated with antidepressant agents: an analysis of 17 published case reports.

Aim Of The Review: Although there are several case reports in literature linking use of antidepressants and disturbances in glucose control, it is difficult to identify risk factors for serious adverse drug events from individual case reports. The aim of this review is to provide a descriptive analysis of the demographic and clinical characteristics of published glucose dysregulation case reports following initiation of antidepressant agents.

Methods: Published case reports of glucose dysregulation associated with antidepressants were accessed through PubMed (Medline), PsycINFO, and Web of Science (WOS) between January 1, 1970 and April 30, 2010.

Texas pharmacists' opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study.

Objective: Pharmacists in the United States (U.S.) are encouraged to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA) through MedWatch.

The state of health economic evaluation research in Nigeria: a systematic review.

This study assessed the state of health economic evaluation (including pharmacoeconomic) research in Nigeria. A literature search was conducted to identify health economic articles pertaining to Nigeria. Two reviewers independently scored each article in the final sample using a data collection form designed for the study.