Perceptions and experiences of reporting of adverse drug reactions by public sector pharmacists in a rural district in the Western Cape
Background: Adverse Drug Reactions (ADRs) contribute to potentially expensive hospital admissions and are regarded as a major public health priority. ADRs in South Africa are mainly detected by a spontaneous reporting system but it is plagued by under-reporting. Previous records indicated under-reporting of ADRs in the Cape Winelands District amongst healthcare workers. Pharmacists, in particular, did not report ADRs compared to other healthcare cadres whilst they are generally considered to be the custodians of medicines. Study Aim: This study aimed to explore and describe the perceptions and experiences of rural public sector pharmacists’ reporting of ADRs and to understand why pharmacists in this rural health district under-reported ADRs. Study Design: A qualitative study design was appropriate for this research question as the researcher wanted to gain an in-depth understanding of human behavior related to the phenomena of under-reporting. Study Population and Sampling: The primary study population consisted of 24 public sector pharmacists in the Cape Winelands District. A purposive sampling strategy enabled the selection of 16 pharmacists ranging in gender, age, experience and rank. Eight pharmacists were supervisor pharmacists while the rest were production pharmacists, including a community service pharmacist and an intern pharmacist. Supervisor pharmacists are more involved with managerial tasks and the attendance of meetings compared to production pharmacists that focus on patient care and dispensing of medication. Two key informants involved in the Western Cape Pharmacovigilance System were included in the study. One key stakeholder was a policy specialist pharmacist working at Directorate: Pharmacy Services and primarily involved with the Provincial Pharmacy and Therapeutics Committee. The other key policy stakeholder, at the time of the study, was the manager of the Medicines Information Centre which forms part of the University of Cape Town’s (UCT) Pharmacology Division. Both were highly experienced pharmacists familiar with the pharmacovigilance system. Data Collection: In-depth interviews were conducted using a semi-structured interview guide consisting of open- ended questions. The semi-structured interview guide was tested on a participant outside the primary study population. Interviews were conducted in English and Afrikaans. Interviews were tape-recorded and the interviewers made field notes to supplement the data recorded. Two researchers with experience in qualitative data collection, briefed by the investigator, interviewed the pharmacists who worked in the district and the investigator interviewed the two key stakeholders. Data Analysis: The tape recordings were translated, where applicable, and all were transcribed verbatim by the investigator. The transcribed recordings were analyzed by the investigator by assigning codes to material on an Excel spreadsheet. This approach enabled the identification of themes which aided the understanding of the research phenomena. Ethics: Ethical approval was obtained from the University of the Western Cape Senate Research Committee and permission from the Western Cape Department of Health Research Committee. Written informed consent (See Appendix 1, page 73) was obtained from each participant prior to conducting the interviews and interviewees were assured of confidentiality throughout the research. Key Results and Discussion: Pharmacists in the study strongly acknowledged the importance of ADR reporting which is linked with pharmacists seeing themselves as the custodians of medication. Pharmacists in the study associated the reporting of ADRs with medication safety and felt responsible for ensuring it. In spite of this acknowledgement of the importance of ADR reporting, pharmacists rarely reported an ADR themselves. This finding was in line with previous research conducted and linked with barriers pharmacists faced in practice. The study revealed that pharmacists identified ADR reporting opportunities during their normal clinical work and enabled other health care professionals (HCPs) to confirm the occurrence of an ADR and report it. Pharmacists primarily identified ADRs when they scanned patient folders for clues that could indicate that an ADR had occurred. Other research conducted confirmed that the use of patient records could be used in the identification of ADRs. This finding was important to inform future training workshops to promote reporting of ADRs. Some pharmacists in the study associated an ADR with a therapeutic or clinical intervention. In general, therapeutic interventions usually involved a clinical action more closely associated with medical officers and were viewed by pharmacists in the study as being outside their legal and clinical scope of practice. A clinical intervention could include a change of medication, change of dose, and other prescription changes or might involve the medical officer referring the patient to a higher level of care depending on the severity of the suspected ADR experienced. A clinical intervention could include performing complex diagnostic tests, observations and laboratory investigations. Pharmacists’ association of an ADR experience with a clinical intervention was an important factor limiting their reporting of ADRs. The implication of this belief is that patients were referred from the pharmacy back to medical officers for the clinical intervention. In this way, although pharmacists do not directly report an ADR, their referral to medical officers would help improve reporting of ADRs. An unexpected and contrasting finding compared to previous research was the strong belief of some pharmacists in this study that common ADRs should be reported. Pharmacists believed that by reporting common ADRs en masse, authorities might decide to remove the problematic medication from the approved public sector formulary. This was in contrast to previous research where pharmacists either acknowledged that authorities only want novel or serious ADRs from newly marketed medication or believed that reporting well-known ADRs was a waste of time. Pharmacists reported that they faced several barriers in reporting ADRs. The main barriers that were mentioned were a lack of adequate feedback, heavy workload and time constraints, uncertainty in identifying the cause of an ADR and issues pharmacists had with the reporting process. These barriers were consistent with previous research conducted. Finally, pharmacists suggested various means of facilitating ADR reporting including use of electronic reporting aids, creating increased awareness amongst healthcare professionals, conducting continuous training and making amendments to the reporting form, some of which were in line with previous research conducted. Conclusion: Exploring the perceptions and experiences of pharmacists with respect to the under-reporting of ADRs revealed key knowledge about the spontaneous reporting system that could be applied to strengthen the current reporting system and enable more reporting. Whilst it was clear that pharmacists play an important role as the gatekeepers and drivers of the reporting process enabling other HCPs to report ADRs, more should be done to empower pharmacists in managing ADR reporting opportunities. This could benefit the healthcare system in ensuring that more ADRs are reported, as well as decrease the waiting time of patients and the workload of medical officers. In addition, engaging with pharmacists and HCPs to overcome barriers to reporting would facilitate increased ADR reporting. Recommendations: Several recommendations emerged from the study. Future circulars, training workshops and awareness posters about the ADR reporting process should inform all HCPs to report any medication suspected of being the cause of an ADR and not waste time in trying to identify the medication that caused it. A training workshop should be conducted with pharmacists to improve their skills in terms of identifying ADRs, how and what to report and of the appropriate referral of patients to the medical officers. An annual assessment on the availability of reporting forms in all health facilities should be conducted. In addition, the MIC should conduct a survey on the user-friendliness of the reporting form and enable HCPs to provide recommendations to help improve the reporting form template. Pharmacovigilance should be a standing item on the agendas of sub-district PTC meetings at which supervisor pharmacists should give quarterly updates to sub-district management on ADRs reported. As this study focused primarily on the experiences and perceptions of pharmacists in a rural health district, a follow-up study should explore perceptions and knowledge of medical officers and nurses of ADR reporting, specifically on the availability and complexity of the reporting form. Finally, the MIC should explore the development of a basic ADR causality assessment tool that could assist pharmacists and other HCPs in identifying a possible ADR and improve confidence amongst pharmacists and HCPs in reporting ADRs.