Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisati...ons and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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This guide helps pharmacists to understand their role in the hypertension program. From maintaining hypertensive drug stock, to drug dispensing, to recording and reporting, to awareness generation with patients.
This document updates the ARIA sections on the links between rhinitis and asthma. Relevant publications between January 2000 and December 2005 were included. Complementary and alternative medicine is not evaluated in this document since it has been published separately. Likewise, an update on pharma...cological therapy of AR was published separately. Therefore, in the therapeutical component of the current review we decided to focus on aspects related to concomitant rhinitis and asthma.
The aim of this review was to present new evidence related to major ARIA statements, either to support or to refute them, by bringing the most recent information in the context of the previous knowledge on this subject. Additionally, we looked for information that could potentially lead to novel statements.
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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