Strengthening pharmacovigilance in South Africa

Mehta, Ushma; Dheda, Mukesh; Steel, Gavin; Blockman, Marc; A, Ntilivamunda; Maartens, Gary; Pillay, Yogan; Cohen, Karen

doi:10.7196/samj.7517

Cited by 24 publications

(27 citation statements)

References 7 publications

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“…However, ongoing safety and effectiveness of medicines is ensured by voluntary reporting systems that form part of pharmacovigilance programmes. [15] These programmes aim to detect, assess, manage and prevent drug-related problems. [15,16] The importance of the presence of a clinical pharmacist in a paediatric unit to monitor drug treatment and prevent medication errors is well established in some countries.…”

Section: Researchmentioning

confidence: 99%

“…[15] These programmes aim to detect, assess, manage and prevent drug-related problems. [15,16] The importance of the presence of a clinical pharmacist in a paediatric unit to monitor drug treatment and prevent medication errors is well established in some countries. [7,9,17] Clinical pharmacists monitoring medication orders might prevent more than half (58%) of all errors, including 72% of potentially harmful errors.…”

Section: Researchmentioning

confidence: 99%

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Identifying medication errors in the neonatal intensive care unit and paediatric wards using a medication error checklist at a tertiary academic hospital in Gauteng, South Africa

2017

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Section: Researchmentioning

confidence: 99%

Section: Researchmentioning

confidence: 99%

Identifying medication errors in the neonatal intensive care unit and paediatric wards using a medication error checklist at a tertiary academic hospital in Gauteng, South Africa

2017

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“…1,2 Many adverse effects of the drug, drug interactions, interactions with food and other risk factors like specific toxicities are known years after release of a medicine. Some rare adverse effect (1:100000) manifest only after the exposure of drug to a large population.…”

Section: Introductionmentioning

confidence: 99%

Knowledge, attitude and practice of pharmacovigilance among medical professionals at a tertiary care hospital in Mumbai, Maharashtra, India

Katekhaye¹,

Kadhe

John

et al. 2016

Int J Res Med Sci

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Background: Many adverse drug reactions (ADRs), interactions and specific toxicities are known once drug is exposed to a larger population. Spontaneous reporting adverse events (AEs) are fundamental to a robust pharmacovigilance (PhV). Increasing physician awareness about the pharmacovigilance and ADR reporting can significantly contribute the safety of medicines. Objective of the study was to assess the knowledge, attitude and practices related to PhV among medical professionals at a tertiary care teaching hospital.Methods: Postgraduate students (PGs) and medical teachers at a Medical College and tertiary care hospital were evaluated for their knowledge, attitude and practice of pharmacovigilance with the help of a structured questionnaire. Suggestions for improving the effectiveness of the pharmacovigilance practices were also sought.Results: One-hundred and fifty doctors [91 (60.7%) PGs and 59 (39.3%) medical teachers] participated. Overall, 48.7% were males. 96% believed that PhV is important in medical practice but only 79.3% knew the definition of pharmacovigilance. Only 24.7% were aware of the existing nationwide pharmacovigilance program whereas the international collaborating center was known to 26% of the participants. 96% believed that it is the duty of a treating physician to report an ADR while 36.7% felt that ADR reporting should be the responsibility of a separate team. Surprisingly, 54% felt that financial aid should be provided for ADR reporting. 42.7% have not reported any ADR whilst only 16% have reported more than 10 ADRs in their career. To create an ADR database (79.3%) was the common expectation from the PhV center. 98.7% suggested continued medical education (CME) and trainings to improve the effectiveness of PhV in Indian setting.Conclusions: Regardless of a fair attitude towards PhV, the practice of ADR reporting is poor probably because of lack of sufficient knowledge about PhV. Motivating the physicians through CMEs and trainings so as to improve and strengthen the pharmacovigilance practices is the current need in India.

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“…TSR is an active method of surveillance in a well-defined population group, whereas spontaneous reporting is a passive method of surveillance used within an undefined population [13]. Being an active surveillance method, TSR is more resource-intensive than spontaneous reporting.…”

Section: Targeted Spontaneous Reportingmentioning

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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Strengthening pharmacovigilance in South Africa

Cited by 24 publications

References 7 publications

Identifying medication errors in the neonatal intensive care unit and paediatric wards using a medication error checklist at a tertiary academic hospital in Gauteng, South Africa

Identifying medication errors in the neonatal intensive care unit and paediatric wards using a medication error checklist at a tertiary academic hospital in Gauteng, South Africa

Knowledge, attitude and practice of pharmacovigilance among medical professionals at a tertiary care hospital in Mumbai, Maharashtra, India

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

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