Adverse Drug Reaction reports for cardiometabolic drugs from sub‐Saharan Africa: a study in VigiBase

Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G/Michael; Dheda, Mukesh; Haaijer‐Ruskamp, Flora; Taxis, Katja; Mol, Peter G. M.

doi:10.1111/tmi.12481

Cited by 13 publications

(17 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For established products, data are primarily derived from high-income countries with well-established PV systems [7][8][9]. This is also problematic because the safety profile of certain products may differ between settings due to a variety of factors, including environmental and genetic influences [10][11][12]. It is therefore important that appropriate safety monitoring practices are in place in SSA for both established and newly launched products.…”

Section: Introductionmentioning

confidence: 99%

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

et al. 2020

View full text Add to dashboard Cite

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 (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 representatives. 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 (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. Plain Language Summary When a medicine or vaccine is made available for use, healthcare organisations maintain regular surveillance to confirm that the medicinal product is safe and effective. The efficiency of this surveillance depends mainly on the healthcare system and medical practices in place in each country. An important element is an effective procedure for identifying and reporting any unwanted medical occurrences (adverse events) after taking a medicinal product. In countries where regular safety surveillance has not been maintained, it is important to train and mentor healthcare providers on the need to be aware of adverse events and the importance of adhering to safety reporting procedures. GSK and partners conducted a pilot project in Malawi with the aim of improving adverse event reporting by training and mentoring healthcare providers. Training sessions and continuous mentoring were conducted over 18 months, involving 443 healthcare providers at 61 healthcare facilities. There was a large increase in the number of adverse events reported: from 22 in the 16-year period before the project started to 228 during the 18-month project period. This project showed that the training and mentoring programme for healthcare providers was effective in increasing the number of adverse events reported. This enabled...

show abstract

Section: Introductionmentioning

confidence: 99%

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Our study suggests that the harmful aspects of medication use receive little attention, even in research. In line with this, adverse drug reaction reporting from sub-Saharan Africa is the lowest in the world [93,94].…”

Section: Medication Benefit Versus Harm Aspectmentioning

confidence: 76%

Healthcare professionals' level of medication knowledge in Africa: a systematic review

Berhe

Taxis

Haaijer‐Ruskamp

et al. 2018

Brit J Clinical Pharma

Self Cite

View full text Add to dashboard Cite

AimsUnderstanding how much healthcare professionals (HCPs) know about medication can help in devising strategies to improve rational medication use. This study aimed to synthesize information on the level of medication knowledge of HCPs in Africa.MethodWe performed a systematic literature study in Embase and PubMed. We included original studies quantifying HCPs' medication knowledge, published between 2012 and 2016. We extracted disease focus, country, number and type of HCPs included and all medication‐related knowledge questions and scored the quality of papers. The outcome measure was the percentage of HCPs who correctly answered medication knowledge questions.ResultsWe identified 64 studies from 12 African countries, comprising 13 911 HCPs, mostly nurses/midwifes and physicians. We extracted 306 medication‐related knowledge questions, and only 52% (SD 28) of HCPs correctly answered them. Knowledge questions were mainly about medication prescribed for communicable diseases (70%), followed by non‐communicable diseases (11%), and family planning/gynaecology (10%). Most papers concluded that there was a considerable medication knowledge gap among HCPs.ConclusionWe found a low level of medication knowledge across different disease areas, countries and HCPs. This underlines the continuous need to strengthen the undergraduate and postgraduate education in (clinical) pharmacology and therapeutics in Africa.

show abstract

“…Fourthly, late adverse drug reaction to the ACEIs can occur up to thirteen years of medicine use. Frequent side effects associated with the use of ACEIs family of anti-hypertensive medicines are intractable non-productive cough and the conspicuous labial-facial angio-edema or Quincke’s edema [3, 7]. When any of these occur, the drug and related medicines are immediately stopped and black listed for the patient.…”

Section: Discussionmentioning

confidence: 99%

“…Also, a 74 year old man had to take over thirty medicines including steroid injections daily, cumulated from various consultations from many physicians until he developed iatrogenic Cushing syndrome and multiple organ damage. When switching to another medicine in the elderly, we should ensure that the old and/or frequently used medicines are discarded to reduce the risk of drug intoxication or drug-drug interaction [3]. Also, we should limit our prescription to the most needed medicines, and choose from the once daily intake or the most simple drug regimens [10].…”

Section: Discussionmentioning

confidence: 99%

“…Also, they sometimes have some degree of social problems as they might often live alone, and thereby cater for their daily activities including the intake of medicines with minimal assistance [2]. Multiple drug use combined with their fragile health predisposes them to adverse drug reactions, drug-drug interactions, and direct drug toxicity from potential overdosing [3]. They may even sustain physical injuries with eventual poor outcomes as a result of medicine use [4–6].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A case management of hypertension in the elderlyin sub-Sahara Africa: lessons from Granny

2017

View full text Add to dashboard Cite

Management of chronic disease conditions in the elderly is challenging. They usually have many co-morbidities requiring multiple drug regimens, and memory or cognitive problems that can interfere with management. Also, they sometimes have a degree of social problems as they might often live alone, and thereby cater for their daily activities with minimal assistance. Multiple drug use combined with their fragile health predispose them to adverse drug reactions, drug-drug interactions, and direct drug toxicity from overdosing. We report and discuss the lessons learnt from the case of an elderly woman in an urban setting in sub-Saharan Africa who presented with problems of drug dosing, adverse drug effect, and drug-drug interaction that might prove useful in the future management of hypertension with angiotensin converting enzyme inhibitors.

show abstract

Adverse Drug Reaction reports for cardiometabolic drugs from sub‐Saharan Africa: a study in VigiBase

Cited by 13 publications

References 28 publications

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi

Healthcare professionals' level of medication knowledge in Africa: a systematic review

A case management of hypertension in the elderlyin sub-Sahara Africa: lessons from Granny

Contact Info

Product

Resources

About