Abstract
BackgroundThe high incidence of adverse drug reactions (ADRs) in children is of global concern. Enhancing the reporting of ADRs could contribute to making safer medicines available to children.AimTo assess parents’ awareness of reporting ADRs and their knowledge on the reporting procedures in South Africa.SettingSouth African parents with online access.MethodA quantitative descriptive study was conducted based on an anonymous voluntarily web-based self-administered questionnaire that was distributed through Facebook® and LinkedIn™ to parents in South Africa.ResultsThe questionnaire was completed voluntarily by 206 respondents. The majority of participants (70.9%) were aware of the term ADR. Significant associations between not being aware of the term ADR and single marital status, lower education level, not having private medical aid and accessing public clinics for medical services were found. The majority (66.5%) of participants did report an ADR to a healthcare professional whilst only 15% reported it to a product manufacturer. More than half of the participants (58.7%) knew how to report ADRs whilst 72.8% knew what type of ADRs to report. Almost a third (32.5%) did not know where more information on ADR reporting could be found or how ADRs could be reported (31.5%).ConclusionThe majority of the respondents were aware of the term ADR, indicative of a good knowledge basis on which ADRs to report and the importance of reporting ADRs. However, gaps in the respondents’ knowledge were identified which highlighted specific groups of individuals to be targeted to increase ADR awareness and improve the knowledge on the reporting process.
Highlights
The high incidence of adverse drug reactions (ADRs) in children is of global concern
Pharmacovigilance is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’
This study identified opportunities for public health education and awareness to be implemented through various methods such as awareness campaigns through TV, radio, social media, at schools for parents, online parenting forums, education through healthcare professionals, product packaging on ADRs
Summary
The high incidence of adverse drug reactions (ADRs) in children is of global concern. Enhancing the reporting of ADRs could contribute to making safer medicines available to children. Medicines are developed with the intention of helping patients, but they may be harmful to the patient by causing adverse reactions.[1] The monitoring of adverse drug reactions (ADRs) to ensure patient safety is a critical component of pharmacovigilance.[2] Pharmacovigilance is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’.3. Studies conducted throughout the world found that ADRs constitute over 6% of all hospital admissions and are amongst the leading global causes of morbidity and mortality.[4] The WHO defines an ADR as:. Research shows that in some developed countries, up to 20% of their hospital budget is spent on managing ADRs.[7]
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