Pharmacists’ perception towards pharmacovigilance and the reporting of adverse drug reactions in South Africa.

Abstract

Pharmacovigilance in South Africa is not being utilised in a desired manner. This study highlights pharmacists’ expectations and limitations towards adverse drug reaction reporting in their pharmaceutical sector. Current and previous experience and education of pharmacists towards adverse drug reaction reporting is also questioned. Pharmacists and regulatory bodies in South Africa should consider the value of pharmacovigilance, especially adverse drug reaction reporting in their daily activities and responsibility towards quality pharmaceutical care. The study was undertaken with two main objectives: A comprehensive literature review included the history and development of pharmacovigilance in South Africa, roles of the pharmacist in adverse drug reaction monitoring and reporting, the challenges regarding reporting locally and internationally and the impact of education on adverse drug reaction reporting. The empirical study consisted of a cross-sectional study that used a structured questionnaire, completed by participants, to obtain data. The study population consisted of 11 732 pharmacists from various pharmaceutical sectors across South Africa. The response rate was 5.6% (n=656). The inclusion criteria for participants were as follow: • Participants had to be under 65 years of age, • Pharmacists still had to be practicing as a pharmacist, and • Be registered with the South African Pharmacy Council (SAPC). The respondents consisted of 70.7% (n = 464) female pharmacists. Most respondents were aged between 37 – 43 years (n = 143, 21.8%). Additional training in ADR reporting was received by 64.4% (n = 421) of the respondents, mostly being in-service training (n = 191, 29.1%). Training in pharmacovigilance was also recieved by 191 (29.1%) pharmacists. Most pharmacists were practicing in the private healthcare sector (n = 350, 58.0%). The highest qualification was a Baccaleurs in Pharmacy degree (BPharm/BSc) (n = 477, 72.7%). The highest average years of experience as a practicing pharmacist (N = 603) was more than twenty years (n = 198, 32.8%). The results of the study relating to pharmacists’ perception toward adverse drug reaction reporting in their current pharmaceutical sector indicated that although pharmacists are willing to report ADRs, they feel the need for training in this specific field in pharmacovigilance should be a priority. Pearson’s chi-square (x2) indicated a statistically significant association between respondents who received additional training and the reporting of well-known ADRs x2(1, N = 488) = 22.6, p<0.001, (Cramér’s V=0.216), ADRs caused by OTC medication x2(1, N = 488) = 9.9, p=0.002, (Cramér’s V=0.143) and ADRs caused by herbal- and traditional medication x2(1, N = 488) = 15.1, p<0.001, (Cramér’s V=0.176). Most respondents (N = 412, n= 383, 92.9%, p<0.000, d½=0.859) reacted positively toward believing that they have the ability to report ADRs, as indicated by the Binomial test. More than half (n = 421, 64.4%) of the pharmacists had not received any additional training in ADR reporting. There were pharmacists who received training in pharmacovigilance (n = 191, 29.1%) and drug-related problems (n = 165, 25.1%), but still half of the pharmacists (n = 296, 52.7%) have never reported an ADR in their careers and 29.0% (n = 163) have reported between one and five ADRs, while working in either the public- (n = 106, 42.5%) or private- (n = 92, 36.9%) healthcare sector or a pharmaceutical company (n = 51, 20.4%) at the time of reporting. Pearson’s chi-square indicated a statistically significant association between practice sector and the reporting of well-known ADRs x2(1, N = 488) = 29.9, p<0.001 (Cramér’s V=0.248) and ADRs caused by over-the-counter (OTC) medication x2(1, N = 488) = 7.6, p=0.022 (Cramér’s V = 0.125). Pharmacists working in the public healthcare sector (n = 107, 78.7%) are more likely to report well-known ADRs and pharmacists in the private healthcare sector (n = 255, 88.5%) are more likely to report ADRs caused by OTC medication. Although, pharmacists are willing to report ADRs, certain barriers still refrain them from reporting these ADRs in their pharmaceutical sector, keeping the reporting statistics in South Africa low. Pharmacists reported that ADR reporting is too time-consuming (57.0%) and that they have a lack of clinical knowledge to detect ADRs (50.0%). Pharmacists are well aware of the term pharmacovigilance, but only 11.9% were able to define the term. Pearson’s chi-square indictaed a statistically significant association between knowledge toward the term pharmacovigilance and whether the pharmacist received additional ADR training (p= 0.000, Cramér’s V= 0.409). The study reflects on the shortcomings in the pharmacovigilance system in South Africa. Pharmacists in South Africa need on-going training in the field of pharmacovigilance and specifically toward ADR reporting. Pharmacists, as the go-to healthcare professionals, do have the willingness and ability to report these reactions.