An innovative approach to pharmacovigilance

Abstract

Pharmacovigilance (PhV) plays an important role in safeguarding patient safety and appropriate use of medicines by monitoring adverse drug reactions (ADRs). The monitoring of ADRs following marketing approval of a drug is crucial for identifying previously undetected, rare, or serious side effects. Underreporting of ADRs remains a barrier for ADR monitoring. The aim of the study was to assess healthcare professionals (HCPs) knowledge, attitude, practice, barriers and need for more education about ADR reporting and to identify tools to empower and motivate them to participate in PhV activities. The study was divided into 4 parts: 1) Review of individual case safety reports (ICSRs) received by the Malta Medicines Authority (MMA) from 2004 until 2019. 2) Setting up of three focus groups with HCPs from different settings (academia, hospital, regulatory). 3) Development, validation and dissemination of a questionnaire disseminated to pharmacists, medical doctors, nurses and dentists to assess knowledge, attitude, practice, barriers and need for more education on ADR reporting. 4) Development, validation, dissemination and evaluation of two educational webinars on Pharmacovigilance in the time of a pandemic crisis – Adverse Drug Reaction reporting Part 1 (Background, ADR reporting system, Case studies) and Part 2 (COVID-19 vaccination - current situation, Case studies, Outcomes of ADR reports, Recognising ADRs in practice). Results: 1) The number of ICSRs sharply increased from 29 (2007) to 194 (2010), and from 118 (2016) to 223 (2018). 2) The focus groups pointed out the need for quantifying the extent and reasons for underreporting. 3) The mean knowledge score deduced from the questionnaire for HCPs (374) was 44/50, pharmacists (44/50); medical doctors (43/50), dentists (42/50), nurses (39/50) (p< 0.001). HCPs on a Likert scale 1 to 5 agreed that reporting an ADR was important for medicinal products’ safety and patient care (4.87) and that ADR reporting was part of their duty as HCPs (4.81) (p<0.001). Out of the HCPs who encountered an ADR (65.8%, n=246), 30.1% (n=74) and 23.6% (n=23.6) almost never or rarely reported the event, respectively, claiming difficulty in understanding whether the ADR has occurred (50.0%; n=187) and ADRs being already known and documented (43.9%; n=164). HCPs agreed that they require more education on ADR reporting (strongly agree: 40.4%, n=151; agree 31.8%, n=119), through continuing professional education seminars (65.8%; n=246). 4) The evaluation forms were completed by 103 out of 132 HCPs (first webinar), and 73 out of 90 HCPs (second webinar). Nurses agreed that the educational webinar made them more aware of the importance of ADR reporting (first webinar 4.85, p=0.039; second webinar 4.71, p=0.031) and that it helped them to overcome barriers toward ADR reporting (first webinar 4.70, p=0.047; second webinar 4.76, p=0.031). Nurses agreed more than other HCPs with the idea of the Safety Representative (4.88; p=0.024). It is postulated that HCPs were knowledgeable and had a positive attitude towards ADR reporting and yet they admitted to not reporting ADRs. The main reason stated for not reporting was difficulty to understand whether an ADR occurred, followed by ADRs being already well known and documented to occur. HCPs agreed to receiving more education and training about ADR reporting. Educational webinars, such as the ones conducted in this study, helped increase and improve awareness on the importance of quality ADR reporting which could lead to better PhV practices which can positively impact patient care and patient quality of life.