Evaluation of reporting all types of adverse drug reactions by parents of children younger than 18 years in South Africa

>Magister Scientiae - MScIntroduction: Medicines are created with the intention of helping patients but may be harmful to the patient by causing adverse reactions. The effect of adverse drug reactions (ADRs) on patients has become more evident over the last two decades and reporting of ADRs in South Africa is low. This results in many patients, particularly children, potentially being exposed to medicinal products with an uncertain safety profile. Due to parents’ typical caring and protective role, they could play a part in detecting and reporting ADRs in children, thereby contributing to making safer medicines available to children. Aim: This research study evaluated the awareness and knowledge in South Africa of parental reporting of suspected ADRs in their children. Method: A quantitative descriptive study was conducted based on an anonymous web-based self-administered questionnaire that was distributed through Facebook® and LinkedIn™ to parents in South Africa. The questionnaire, which was distributed between July 2018 and August 2018, was standardized for all participants and consisted of closed (n=28) and open-ended (n=4) questions. The questions were coded, data was analysed using descriptive statistics (percentage and frequency counts). Associations between categorical demographic variables were determined using the Pearson Chi-square test. Results: The questionnaire was voluntarily completed by 206 participants. Majority of the respondents were female (n=155, 75.2%) and the most relevant age category for all respondents was 31-40 years (n=100, 48.5%). The majority of participants (n=146, 70.9%) were aware of the term ADR and significant associations between awareness of ADRs and ethnicity, marital status, education level, medical aid and access to general medical services were found. Being white (p<0.001), having a degree (p=0.001) and having private medical aid (p=0.004) were independently associated with being significantly more aware of the term ADR compared to being black (p<0.001), coloured (p=0.004), a single parent (p=0.003), not finishing school (p<0.001), having matriculated (p<0.001), having no private medical aid (p=0.004) and receiving general medical services from public clinics (p = 0.003)

Parental reporting of adverse drug reactions in South Africa: An online survey

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.To assess parents’ awareness of reporting ADRs and their knowledge on the reporting procedures in South Africa.The 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%