Pharmacovigilance in resource-limited countries

Olsson, Sten; Pal, Shanthi N.; Dodoo, Alex

doi:10.1586/17512433.2015.1053391

Cited by 133 publications

(180 citation statements)

References 26 publications

(22 reference statements)

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“…There are a limited number of professionals with knowledge of pharmacovigilance around the world 5. However, the number of health employees with competencies related to drug surveillance in low- and middle-income countries is very low, as there are often limited financial resources available in these countries to support attendance at professional development courses in pharmacovigilance 5.…”

Section: Introductionmentioning

confidence: 99%

“…However, the number of health employees with competencies related to drug surveillance in low- and middle-income countries is very low, as there are often limited financial resources available in these countries to support attendance at professional development courses in pharmacovigilance 5. Consequently, there are a limited number of professionals in developing countries capable of performing drug safety assessments 5-7 and improving risk management.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

Varallo¹,

Planeta²,

Mastroianni³

2017

Clinics

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OBJECTIVES:Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals.METHOD:This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events.RESULTS:One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001) and their knowledge of pharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure.CONCLUSIONS:A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

Varallo¹,

Planeta²,

Mastroianni³

2017

Clinics

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“…In 2015, the VigiBase database had about 11 million ADR reports from 120 countries [6]. The International Society for Pharmacovigilance (ISoP in Figure 1) plays a supportive role in providing educational and administrative advice to many pharmaceutical manufacturers and many countries with PV systems.…”

Section: Contextmentioning

confidence: 99%

“…Pharmacovigilance activities, particularly in low-and middle-income countries (LMIC), are often considered 'nice to have', and take second place to efforts focused primarily on improving access to medicines [6]. Given the variety and complexity of public healthcare programmes around the world, the UMC faces considerable challenges and difficulties in attempting to co-ordinate the IDMP.…”

Section: Lack Of Pv Centres and Insufficient Resourcesmentioning

confidence: 99%

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

Schurer

Bam

Kock

2017

SAJIE

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Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised health programmes. The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory bodies, healthcare workers, etc.), and the significant number of dimensions along which the effectiveness and efficiency could be measured, adds to this complexity. Furthermore, the lack of a standardised reporting protocol across the various PV systems hinders efforts to manage PV coherently on a global scale. This paper proposes the value of a standardised global PV reporting system by evaluating the systemic effects of the lack of such a standardised system. OPSOMMINGFarmakologiese waaksaamheid (PV) is gebaseer op die mediese assessering van nadelige mediese gebeure of dwelmverwante probleme wat deur georganiseerde gesondheidsprogramme versamel word. Die groot aantal verskillende PV-sisteme, die ewe groot aantal belanghebbendes in sulke stelsels (farmaseutiese maatskappye, regerings, nasionale en internasionale kliniese reguleringsliggame, gesondheidswerkers, ens.), en die aansienlike aantal dimensies waarvolgens die effektiwiteit en doeltreffendheid gemeet kan word, dra by tot hierdie kompleksiteit. Verder belemmer die gebrek aan 'n gestandaardiseerde rapporteringsprotokol wat oor die verskillende PV-sisteme strek die pogings om PV op 'n wêreldwye skaal konsekwent te bestuur. Hierdie artikel stel die waarde van 'n gestandaardiseerde globale PV rapporteringsprotokol voor deur die sistematiese gevolge van die gebrek aan so 'n gestandaardiseerde stelsel te evalueer

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“…58 Several efforts have been made in establishing such systems in Africa. This includes the WHO collaborating centers of excellence in pharmacovigilance in some countries such as Ghana 58 and efforts by the INDEPTH Network, a nongovernmental organization made up of research institutions with health and demographic surveillance systems. 59 The key challenge in Phase IV studies is the lack of baseline disease profiles of rare diseases due to inadequate diagnostic tools in many health facilities in sub-Saharan Africa.…”

Section: Preparations For Phase IV Malaria Vaccine Trialsmentioning

confidence: 99%

RTS,S malaria vaccine development: progress and considerations for postapproval introduction

Asante¹,

Adjei²,

Enuameh³

et al. 2016

VDT

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Though the burden of malaria has decreased in the last decade in some sub-Saharan African countries, it is still high in others, and there is no malaria vaccine in use. The development of malaria vaccines in combination with current control programs could be effective in reducing the malaria burden. In this paper, we review and discuss the progress made in the RTS,S malaria vaccine development and considerations for its postapproval process. We conclude that the development of malaria vaccines has been a long process confronted with challenges of funding, difficulty in identifying malaria antigens that correlate with protection, and development of adjuvant systems among others. The scientific approval of the vaccine by the European Medicines Agency in July 2015 and subsequent recommendations for pilot implementation studies by the World Health Organization made history as the first human parasite vaccine. It is also a major public health achievement as the vaccine has the potential to prevent thousands of malaria cases. However, there are implementation challenges such as cold chain systems, community acceptance, and monitoring of adverse events post-licensure that need to be carefully addressed.

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Pharmacovigilance in resource-limited countries

Cited by 133 publications

References 26 publications

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

An Investigation Into the Value of a Standardised Global Pharmacovigilance Reporting System

RTS,S malaria vaccine development: progress and considerations for postapproval introduction

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