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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
European Union - Overview
Drug War Facts; Common Sense for Drug Policy
(2019)
C2
Accessed: 28.03.2019
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 initi
...
ative was to improve reporting of adverse events (AEs) 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.
more
Synthetic cannabinoids in Europe
European Monitoring Centre for Drugs and Drug Addiction
(2017)
C2
Perspectives on Drugs
New heroin-assisted treatment - Recent evidence and current practices of supervised injectable heroin treatment in Europe and beyond
J. Strang; T. Groshkova; N. Metrebian
European Monitoring Centre for Drugs and Drug Addiction; Publications Office
(2019)
C2
EMCDDA Insights - 11
Accessed: 14.03.2019
Harm reduction: evidence, impacts and challenges
-10-
Country overview: Kyrgyzstan
European Monitoring Centre for Drugs and Drug Addiction
(2015)
C2
Accessed December 2017
Essential Drug list on page 36!!
This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica
...
tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
more
Guidelines for treatment of drug-susceptible tuberculosis and patient care
2017 update
Guidelines for treatment of drug-susceptible tuberculosis and patient care
Update 2017
Guidelines for treatment of drug-susceptible tuberculosisand patient care
2017 Update
This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
COVID-19 Vaccines: 1 Safety Surveillance 2 Manual
While there is no indication that pregnant women have an increased susceptibility to infection with SARS-CoV-2, there is evidence that pregnancy may increase the risk of severe illness and mortality from COVID-19 disease in comparison with non-pregn
...
ant women of reproductive age. As seen with non-pregnant women, a high proportion of pregnant women have asymptomatic SARS-CoV-2 infection and severe disease is associated with recognized medical (e.g., high body-mass index (BMI), diabetes, pre-existing pulmonary or cardiac conditions) and social (e.g., social deprivation, ethnicity) risk factors. Pregnant women with symptomatic COVID-19 appear to have an increased risk of intensive care unit admission, mechanical ventilation and death in comparison with non-pregnant women of reproductive age, although the absolute risks remain low. COVID-19 may increase the risk of preterm birth, compared with pregnant women without COVID-19, although the evidence is inconclusive.
more
The fight against fake drugs by NAFDAC in Nigeria
The fight against fake drugs by NAFDAC in Nigeria Olike Chinwendu
KIT (Royal Tropical Institute) Development Policy & Practice Vrije Universiteit Amsterdam
(2008)
CC
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
WHO operational handbook on tuberculosis: module 4: treatment: tuberculosis care and support
recommended
The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis,
...
Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
more