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.
South African parents with online access.
A 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.
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%).
The 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.
Medicines are developed with the intention of helping patients, but they may be harmful to the patient by causing adverse reactions.
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.
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ADRs result in longer hospital stays and higher costs incurred for the patient and the healthcare system.
A major concern is the high incidence of ADRs in children. Numerous medicines have not been adequately tested and approved for use in children.
Patient reporting is not actively promoted in many countries because of financial constraints and a lack of resources.
Under-reporting of ADRs has been recognised to be a common shortcoming of pharmacovigilance programmes in South Africa as well as internationally.
Because parents have a typical caring and protective role, they could play an important part in detecting and reporting ADRs in children. Evidence suggests that parental reporting provides several benefits for pharmacovigilance, including increasing the rate of reporting of ADRs and identifying previously unknown ADRs in children.
The aim of the study was to evaluate and assess the awareness and knowledge of parental reporting of suspected ADRs in South Africa.
A quantitative descriptive study was used to conduct a survey, which was based on an anonymous online self-administered questionnaire, amongst voluntary participants to assess their awareness and knowledge of reporting ADRs.
The survey was conducted on parents over the age of 18 years and living in South Africa. Male and female parents as well as parents of adopted children and/or step children were included. Parents who could not read or understand English, those who were minors (under the age of 18 years), and those who were South Africans, but lived abroad, were excluded. Parents of children older than 18 years were also excluded.
This was an all-inclusive convenience sample of parents who responded voluntarily to the online questionnaire.
A web-based self-administered questionnaire was constructed using Google Forms and these were distributed online to parents in South Africa. The link to the questionnaire was distributed on social media platforms, such as Facebook® and LinkedIn™ between July 2018 and August 2018. The questionnaire comprised three sections that covered demographic information, ADR awareness and knowledge, and views on ADR reporting. It consisted of 28 closed-ended questions and four open-ended questions. Thematic analysis was performed on the open-ended questions to identify themes within the data.
The researchers, together with colleagues and subject matter experts were involved in the questionnaire design and development to ensure face and content validity. The questionnaire was based on reviewed literature and questionnaires on the same subject matter.
The data collected was coded and entered into a Microsoft® Office Excel spreadsheet. Data was analysed using Statistical Package for the Social Sciences (SPSS) (IBM® SPSS® Statistical software, version 23). Descriptive statistics were used, and the data was summarised using percentages, frequency tables and bar charts. Associations between categorical variables were determined using the Pearson Chi-square (χ2) test and relationships were considered statistically significant if the
Ethical approval was obtained from the Biomedical Research Ethics Committee of the University of the Western Cape (Reference Number: BM/18/4/5) prior to the online survey distribution. Participants were invited and informed on the social media platforms what the survey was about. If they agreed to take part in the survey, they were requested to click on a specific link which opened the first page of the questionnaire pertaining to the informed consent. If they disagreed with the following statement, the survey was terminated: ‘The study has been explained to me in a language that I understand, and I freely and voluntarily agree to participate’. No email addresses or personal identifiers were requested or captured.
A total of 206 parents completed and submitted the online questionnaire voluntarily during July 2018 – August 2018. The detailed socio-demographics of the respondents are summarised in
Socio-demographic characteristics of participants.
Characteristic | Number of participants | % |
---|---|---|
Male | 50 | 24.3 |
Female | 155 | 75.2 |
18–30 | 33 | 16.0 |
31–40 | 100 | 48.5 |
41–50 | 60 | 29.1 |
> 50 | 13 | 6.3 |
Eastern Cape | 12 | 5.8 |
Free State | 6 | 2.9 |
Gauteng | 141 | 68.4 |
Kwazulu-Natal | 14 | 6.8 |
Limpopo | 5 | 2.4 |
Mpumalanga | 4 | 1.9 |
North West | 4 | 1.9 |
Northern Cape | 3 | 1.5 |
Western Cape | 17 | 8.3 |
Single | 26 | 12.6 |
Married | 152 | 73.8 |
Divorced | 20 | 9.7 |
Separated | 6 | 2.9 |
Widowed | 2 | 1.0 |
1 | 59 | 28.6 |
2 | 94 | 45.6 |
3 | 35 | 17.0 |
4 or more | 18 | 8.7 |
Did not finish school | 6 | 2.9 |
Matric certificate | 41 | 19.9 |
Diploma | 68 | 33.0 |
Degree | 75 | 36.4 |
Other | 15 | 7.3 |
Student | 3 | 1.5 |
Unemployed | 11 | 5.3 |
Automotive industry | 15 | 7.3 |
Education and training | 35 | 17.0 |
Financial services | 35 | 17.0 |
Healthcare | 40 | 19.4 |
Information technology | 10 | 4.9 |
Legal services | 8 | 3.9 |
Wholesale and retail trade | 9 | 4.4 |
Other | 32 | 15.5 |
Yes | 177 | 85.9 |
No | 29 | 14.1 |
Private doctor | 177 | 85.9 |
Private nurse | 1 | 0.5 |
Pharmacy | 15 | 7.3 |
Public clinic | 12 | 5.8 |
, did not fill in on the survey:
, did not fill in on the survey:
Most of the participants indicated that they had a qualification post finishing school (76.6%,
It was established that 70.9% (
Associations between socio-demographic variables and awareness of the term ‘adverse drug reaction’.
Socio-demographic variables | Aware – Yes | % | Not aware – No | % | Pearson Chi-Square (χ2) | |
---|---|---|---|---|---|---|
Married | 113 | 74.3 | 39 | 25.7 | 3.4 | 0.066 |
Unmarried (single; divorced; separated; widowed) | 33 | 61.1 | 21 | 38.9 | ||
Post-school education (diploma; degree; other) | 128 | 81.0 | 30.0 | 19.0 | 32.3 | < 0.001 |
No post-school education (did not finish school; completed secondary school Grade 12) | 18 | 38.3 | 29.0 | 61.7 | ||
Student | 1 | 33.3 | 2 | 66.7 | 2.1 | 0.144 |
Unemployed | 5 | 54.5 | 5 | 45.5 | 1.6 | 0.209 |
Automotive Industry | 7 | 46.7 | 8 | 53.3 | 4.8 | 0.030 |
Education and training | 29 | 82.9 | 6 | 17.1 | 2.8 | 0.094 |
Financial services | 27 | 77.1 | 8 | 22.9 | 0.7 | 0.393 |
Healthcare | 36 | 90.0 | 4 | 10.0 | 8.6 | 0.003 |
Information technology | 7 | 70.0 | 3 | 30.0 | 0.01 | 0.931 |
Legal services | 6 | 75.0 | 2 | 25.0 | 0.1 | 0.809 |
Wholesale and retail trade | 3 | 33.3 | 6 | 66.7 | 6.6 | 0.010 |
Other | 19 | 59.4 | 13 | 40.6 | 2.6 | 0.106 |
Medical aid | 132 | 74.6 | 45 | 25.4 | 8.3 | 0.004 |
No medical aid | 14 | 48.3 | 15 | 51.7 | ||
Private (private doctor; private nurse; pharmacy) | 142 | 73.6 | 51 | 26.4 | 12.9 | 0.001 |
Public (public clinic) | 3 | 25.0 | 9 | 75.0 |
, Adjusted
None of the employment areas, including being a student or unemployed indicated any significant association with being aware of the term ADR.
More specific details about the respondents’ knowledge of ADRs are reflected in
Participants’ knowledge of adverse drug reactions.
Question | Responses | % | |
---|---|---|---|
What type of medication can cause ADRs? |
New medicines | 35 | 17.0 |
OTC medicines | 47 | 22.8 | |
Complementary medicines (traditional, herbal, etc.) | 16 | 7.8 | |
All medicines | 130 | 63.1 | |
Does the collection of information on ADRs contribute to improving patient safety? | Yes | 189 | 91.7 |
No | 14 | 6.8 | |
No response to question | 3 | 1.5 |
ADR, adverse drug reactions; OTC, over-the-counter.
, More than one option could have been indicated.
Reporting of adverse drug reactions to healthcare professionals and product manufacturers.
Participants’ responses regarding the reporting process or steps to be taken.
Question | Responses | % | |
---|---|---|---|
Where can you find more information on ADR reporting? |
From a hospital | 73 | 35.4 |
From a pharmacy | 114 | 55.3 | |
From a doctor’s surgery | 90 | 43.7 | |
From a pharmaceutical company | 83 | 40.3 | |
I do not know | 67 | 32.5 | |
To whom can ADRs be reported? |
Doctors | 154 | 74.8 |
Nurses | 104 | 50.5 | |
Pharmacists | 136 | 66.0 | |
Product manufacturers | 183 | 88.8 | |
NADEMC | 165 | 80.1 | |
No response to question | 3 | 1.5 | |
How can ADRs be reported? | Only by post | 1 | 0.5 |
Only by telephone | 6 | 2.9 | |
Only by email/website | 12 | 5.8 | |
By post, telephone, email/website | 121 | 58.7 | |
I do not know | 65 | 31.6 | |
No response to question | 1 | 0.5 | |
What type of ADRs should be reported? | Serious or life-threatening ADRs | 30 | 14.6 |
Uncommon ADRs | 5 | 2.4 | |
ADRs not indicated on package insert | 17 | 8.3 | |
All suspected ADRs | 150 | 72.8 | |
Reporting is not necessary | 4 | 1.9 |
ADR, adverse drug reactions; NADEMC: National Adverse Drug Event Monitoring Centre.
, More than one option could have been indicated.
Regarding to whom ADRs can be reported, a large number (
The respondents’ views on public reporting are shown in
Participants’ views on public reporting.
Question | Possible responses | Number of participants | % |
---|---|---|---|
How important do you think it is for the public to report ADRs? | Absolutely essential | 152 | 73.8 |
Very important | 49 | 23.8 | |
Moderately important | 3 | 1.5 | |
Not important at all | 1 | 0.5 | |
No response to question | 1 | 0.5 | |
Would you consider reporting suspected ADRs in future? | Definitely | 169 | 82.0 |
Probably | 23 | 11.2 | |
Possibly | 10 | 4.9 | |
Probably not | 2 | 1.0 | |
Definitely not | 1 | 0.5 | |
No response to question | 1 | 0.5 |
ADR, adverse drug reactions.
The respondents were requested to describe in their own words about which factors could motivate or prevent them from reporting ADRs experienced by their children or themselves. The most prominent positive theme that emerged was a social concern (
Almost one third of the participants (32.5%,
Methods indicated by respondents to educate and inform the public about reporting include awareness campaigns through television (TV) and radio (
The concept of reporting ADRs in children is very important to consider. Despite the fact that the impact of ADRs on healthcare professionals’ workload and patients have become more prominent over the last two decades, the reporting of ADRs by healthcare professionals in South Africa remains low.
In this study, as evidenced by the survey responses from these parents, they recognised that ADRs could harm people of all ages, that all types of medicines can cause ADRs and that reporting of ADRs can contribute to improving patient safety. Despite the infrequent reporting of ADRs by parents in this study, respondents had knowledge of where to find more information on ADR reporting and surprisingly, how ADRs can be reported. As reported in prospective paediatric pharmacovigilance study (semi-structured telephonic interviews) in the UK
It is important to note that most of the participants in this study were well educated (76.6% completed post-school education higher than Grade 12) and employed, and the majority had medical aid (85.9%) and received general medical services from the private sector. This is in stark contrast to the results from a General Household Survey conducted from January 2017 to December 2017 which concluded that only 13.9% of South Africans had a post-school education higher than Grade 12 and that only 16.9% of South Africans were beneficiaries of medical aid cover.
Studies conducted in India and Poland revealed that participants who lived in urban areas had more knowledge on ADR reporting compared to those that lived outside of the city.
Primary contributors of ADR reports are healthcare professionals although it is a concern for all.
Two crucial problems affecting ADR reporting were identified in this study. These include patients anticipating a complex process and having insufficient knowledge about the process. Previous studies conducted in the UK showed that after the aim and procedure were explained, parents were supportive of ADR reporting and found that the process was not complicated
In a worldwide survey based on telephone interviews, e-mail discussions and field visits, van Hunsel and coworkers
It is important that all patients including parents be encouraged to report suspected ADRs and interventions should be made to improve the public’s knowledge regarding pharmacovigilance and ADR reporting procedures. 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.
Voluntary responses were received from 206 individuals with different socio-demographic characteristics. By using a web-based survey, a large number of individuals could be reached if willing to respond. Respondents could respond to the questionnaire at their chosen time and own pace. It was a convenient method to gather data with minimal costs. Anonymity was maintained through the online survey tool, which provided an opportunity for honest and unambiguous responses.
This study had several limitations, particularly related to the study population. The questionnaire was only made available in English and therefore participants who could not read or understand English were excluded. The study methodology excluded the voice of the less literate and individuals in poorer communities who did not have access to internet and social media. Self-selection bias may have been introduced because of distribution of the survey on social media, which could have skewed the results of this study. Reliability coefficients for the questionnaire was not conducted. The majority of participants lived in Gauteng. Therefore, the results cannot be generalised to the larger population of parents in South Africa.
Various pharmacovigilance awareness programmes should be conducted to encourage the reporting of ADRs by parents. Strategies to increase patient reporting should focus on frequent and feasible barriers to address. In addition to raising awareness, greater attention should be given to improving the public’s understanding of the reporting procedure, where and how to report and the importance of reporting ADRs.
More extensive research is required to evaluate the awareness, knowledge and views of ADR reporting by parents in all provinces in South Africa, including rural areas. Special efforts should be made to specifically target and educate populations identified as being less aware, to raise awareness of ADRs and the reporting process to individuals who have not finished school, have only completed secondary school, have no private medical aid or who visit public clinics for general medical services.
This study suggests that these parental-respondents were aware and willing to report ADRs. However uncertainty as to who reports ADRs and to whom, difficulties with ADR reporting procedures, and time constraints were found to affect parents’ likelihood to report.
Respondents with a post-school education, having private medical aid and access to private medical services were significantly associated with being more aware of the term ADR contrary to respondents, having secondary or less schooling education, no private medical aid and attending public clinics for health services who were more likely to indicate that they were not aware of the term ADR before completing this survey.
The reporting of ADRs in South Africa may be increased if sufficient knowledge is imparted to parents and if access to relevant pharmacovigilance information is made readily available, thereby contributing to improved patient safety.
Parts of this manuscript are published in a mini-thesis submitted in partial fulfilment of the requirements for the degree of Master of Science (MSc) study: ‘Evaluation of reporting all types of adverse drug reactions by parents of children younger than 18 years in South Africa’.
All authors declared no conflict of interest, had access to the data and participated in the actual writing of the manuscript.
S.P. contributed to the conception and design of study, recorded, analysed and interpreted data. M.V. contributed to the conception and design of study, ethics approval and interpreted data. M.M. contributed to data analysis and interpretation of data. The manuscript has been approved by all authors.
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Raw data were generated online using Google Forms. Derived data supporting the findings of this study are available from the corresponding author M.V., on request.
The views expressed in the submitted article are the views of the authors and not an official position of the institution.