Study design and location
This study used a well-structured, pretested, closed-ended questionnaire to collect data from health professionals involved in ADR reporting in the Kpone-Katamanso District in Ghana. The District, made up of five sub-districts, is located along the coastal part of Tema in the Greater Accra region, not far from Accra (Figure 2). The sub-districts are Kpone (the district capital), Zenu, Gbetsile, Oyibi, and Appolonia. Kpone-Katamanso has a huge population of about 109,864 with several health facilities that are equitably distributed across the District [23].
Study population
This study included 268 health professionals within the District, including pharmacists and pharmacy technicians, physicians and physician assistants, nurses, midwives, and disease control officers. These health professionals are directly involved in the diagnosing, dispensing and administration of drugs directly to the patients and are in the position to report any drug-related reactions of the patients. The medical doctors and physician assistants are responsible for the diagnoses and prescription of medications for treatment. The pharmacists and pharmacy technicians are responsible for the dispensing of drugs and provision of drug-related information to the patient. The nurses and midwives are responsible for the administration of prescribed drugs to the patient on the wards. The disease control officer is responsible for the immunization programs at the district level. Considering the responsibilities of these professionals in drug therapies, they receive complaints of and observe some ADR amongst the patients. Thus, they are required to voluntarily report ADR.
Inclusion/exclusion criteria
Health professionals who have practised for not less than a year, directly involved in the supervision, diagnosis, dispensing and administration of drugs to patients and are to detect ADR were eligible for inclusion in the study. Health professionals who declined participation were excluded.
Healthcare service delivery in Ghana
Healthcare service delivery in Ghana is based on the primary health care concept that seeks to promote practical and socially acceptable methods universally accessible to individuals and families in the communities through their full participation. The Ghana Health Service is organized in levels of care, with the lowest level being the Community–based Health Planning Services (CHPS). This is the first point of contact with the formal health care service and manned by community health nurses usually with two years of formal training who provide basic curative and immunization services to clients. Cases that cannot be handled at the CHPS compounds are referred to the health centre, but sometimes they are referred directly to the district hospital.
The Health Centre, the next level of care delivery, is normally staffed with a Physician Assistant (who has had four years of university training in diagnosis and management of diseases) or an experienced nurse-midwife and supported by enrolled and community health nurses. Most Health Centres lack laboratory facilities, and therefore, treatment for most diseases are usually based on signs and symptoms (presumptive treatment). However, in some situations, patients are asked to go to private laboratories for confirmation of diagnosis. Usually, first aid is provided to serious cases reporting to the health centres before they are referred to the district hospital. The health centres also offer preventive services and run outreach programmes such as immunization, antenatal services and health education to their catchment areas. They also conduct outbreak investigations, usually done by disease control officers.
The district hospitals are staffed with one or more qualified medical doctors, nurses and pharmacists. They also have laboratories manned by Biomedical scientists and laboratory technicians, and other support staff. The district hospitals deal with all cases, except specialized care, perform surgical operations and refer serious cases to the regional or tertiary hospitals in the regional capitals. Some district hospitals have specialists who provide specialist care. All district hospitals provide public health services to the towns and villages in their catchment area. The regional and tertiary hospitals provide specialist care and services and specialist diagnostics and provide non-specialized services to communities within their catchment areas.
Within the communities, there is a strong presence of private sector participation in the provision of healthcare services by residents or herbalists, traditional birth attendants and drug peddlers. Community pharmacies and chemical shops licensed by the Pharmacy Council provide medicines prescribed for clients. The Ministry of Health (MOH) provides the overall policy and strategic direction for health service delivery in Ghana. The Ghana Health Service (GHS) is a government body established in 1996 as part of the Health Sector Reform in Ghana under the MOH. The GHS develops appropriate strategies and sets technical guidelines to achieve Ghana's national policy goals and objectives. The GHS also undertakes management and administration of the overall Ghana health resources within the service and promotes healthy mode of living and good health habits by people in Ghana.
The Pharmacovigilance in Ghana
In Ghana, the Food and Drugs Authority (FDA) 's management of drug safety issues is handled under the Public Health Act 851. Thus, the FDA keeps an ADR data repository. The trend of spontaneous reporting has progressively increased since the country joined the International Medicine Safety Monitoring System in 2001 as the 65th Member State and the 1st in sub-Saharan Africa [24]. The Pharmacovigilance system of reporting is such that, at the various health facilities, irrespective of the level of health organization, there should be mandated Institutional Contact Persons (ICP) who are supposed to serve as the link between the FDA and the health professionals [25]. Where a patient experiences an ADR, an ADR reporting form (known as the "blue form"), is filled and submitted through the health facilities to the regional offices of the FDA [25]. At the regional offices, there are designated regional Pharmacovigilance officers who receive the report forms, assess the validity of the report and present the report to the national FDA Central Database [24]. However, health professionals from a health facility can forward an ADR report directly to the FDA Central Database through the online reporting page of the FDA website. The FDA has an online database called the Safety Watch System that is International Conference of Harmonization E2B compliant [25]. The reports received at the headquarters are forwarded as an E2B (xml) file [24].
Pharmaceutical Manufacturing Companies are mandated to report ADR of their pharmaceutical products to the FDA. The companies do this through the Qualified Person for Pharmacovigilance (QPPV). The QPPV is a trained individual responsible for reporting all pharmacovigilance for all medicinal products by pharmaceutical companies holding marketing authorizations.
Sample size determination
The sample size was estimated using the Cochran formula [26], assuming 16% of health professionals have ever reported adverse drug reaction with a 95% confidence interval (CI), 5% precision and 15% non-response rate. The final sample size was 245, representing the minimum number of participants required for this study. However, researchers of this study sampled and enrolled 268 health professionals. These Health professionals are directly involved with the drug administration and consented to be part of the study.
Sampling technique
Health professionals were selected by multistage random sampling. A list of all health facilities in the various sub-districts was obtained from the Kpone Katamanso District Health Directorate. There were 29 medical facilities in the District comprising six health centers, nine clinics, one polyclinic, one maternal home, seven hospitals and four CHPS. Also, there were 38 community pharmacies in the District. At the first stage of sampling, the 29 medical facilities were numbered and 19 were randomly selected. Again, the 34 community pharmacies were numbered and 17 community pharmacies were randomly selected using an online random number generator with permission from the authorities of these facilities; 363 participants who were eligible for this study were randomly sampled. They were asked to pick from an envelope containing shuffled sheets with yes or no written on them. Participants who picked yes and agreed to participate in the study were informed on the rationale, ethical issues, and purpose of the study. They were assured of privacy and confidentiality. Participants were permitted to ask questions. Those who agreed to be part of the study were then enrolled. A total of 268 health professionals were enrolled in the study.
Data collection and management
The data were collected using a closed-ended questionnaire developed after reviewing related studies and previous practice experience. The questionnaire captured the health professionals' demographics, knowledge of health professionals on spontaneous reporting, the attitude of health professionals towards reporting, ADR reporting practice, and the factors that they perceived may influence reporting. Provision was also made for suggestions on possible ways to improve ADR reporting. The dependent variable, Spontaneous reporting of ADR, was measured as a composite variable of the following items: having observed a patient with an adverse reaction, reported adverse drug reaction, stated reporting of ADR to Food and Drugs Authority (FDA), having received feedback from the FDA and documented the observed ADR. A score of 1 was awarded to each correct item. A Health professional was said to have reported an ADR if the respondent had ever witnessed an ADR, reported to FDA and had received feedback from FDA or had documented the ADR. Hence, a score equal to or more than three means the participant had reported ADR before.
The proportion of health professionals who spontaneously reported an ADR was determined by dividing participants who had ever reported ADR by the number of participants assessed. To measure knowledge of participants, 6 items were used and every correct answer was coded as 1, otherwise 0 for a wrong answer. A score of 5 to 6 was considered as very good, 4 to 3 was average, and 2 to 0 was rated as poor knowledge of a participant on adverse drug reporting. The variable, knowledge was measured as an ordinal one. To measure attitude of professionals as poor or good, 12 items were used. A coding of 1 was scored for ticking Yes and 0 for ticking No. Attitude was classified as poor, if the respondent` scored a value greater than or equal to 6 whilst it was classified as good if the respondent scored a value less than 6. The factors affecting ADR reporting among community pharmacists were assessed based on multiple responses to questions like Concern that the ADR report may be wrong, availability of reporting forms, fear of legal consequences, the workload on participants, etc. These factors were coded 1 for Yes and 0 for No. This provided nominal variables, which were used for the univariate analysis. Data collected were checked, cleaned, coded and entered into Stata version 15. The data were verified independently for errors and accuracy.
The researcher of this study encrypted the dataset with password protection and securely stored a copy of the dataset on a study designated pendrive kept in a safe. The paper questionnaires were shredded after the data were locked and securely stored on the pendrive.
Data processing and analysis
Descriptive statistics were used to summarise the socio-demographic characteristics of the study participants. Categorical predictor variables were summarised using frequencies and percentages, while the continuous predictor variables were summarised using means and medians. Mean and standard deviations were used to describe the central tendency for the continuous variables such as age and the years of practice, whereas frequencies and percentages were used for the categorical variables. A simple logistic regression analysis was carried out to determine the association between the dependent variable (spontaneous reporting of ADR) and the independent variables (unadjusted odds ratio). Multiple logistic regression analysis was then used to test the strength of association between variables that showed a significant effect under the Chi-square test and simple logistic regression analysis. The Adjusted Odds Ratio (AOR) was reported for the multiple logistic regression analyses. The results were expressed with their respective 95% Confidence Intervals (CIs) and p-values. A p-value <0.05 was considered statistically significant.
Ethical Considerations
Ethical approval for the study was obtained from the Ghana Health Service Ethics Committee (Reference - GHS-ERC032/01/18). Informed consent was obtained from the participants of the study. The researchers ensured that all health professionals were adequately educated on the purpose of the study, risks and benefits of the conduct of the study and the health professionals were allowed to ask questions before their consent was taken. During the conduct of the study, the confidentiality and privacy of the health professionals were assured during the conduct of the study. The study procedures were carried out in accordance with relevant guidelines and regulations.