Health care providers play an integral role in the Pharmacovigilance program especially the nurses due to their close interaction with the patients. Nurses are often the primary source of possible ADR alerts to the clinicians.
Majority of the respondents in the study were females (92.3%). This finding was similar to previous studies [16, 17]. Generally it is observed that the females opt for nursing career than the males which explains this finding on gender disparity. Majority of the nurses in our study were Diploma holders in Nursing, unlike Hanafi et al. where in, majority were Graduates (BSc degree) . The average age of nurses in our study ranged between 20-45 years, which was similar to the earlier studies among the nurses [16, 17].
In the present study, about half of the respondents were aware that ADRs are an important cause for morbidity and mortality. In contrast, Fadare et al. noted that 93.8% of their study participants were aware of this fact regarding ADRs .
The knowledge scores for more than 50 percent of the nurses were above 65% of the total score. The attitude scores of ADR reporting for about 28% of the participants were above 50%. One of the important finding in the present study was the positive correlation between knowledge and attitudes towards ADR reporting. Thus if the knowledge on ADR reporting is improved then the nurses’ attitude also improves which would be reflected on the ADR reporting schemes in a positive manner. In distinction, Hanafi et al. reported poor knowledge level among the nurses and positive attitude to towards Pharmacovigilance . Palaian et al. noted low scores for both knowledge and attitude components of ADR reporting among the nurses .
The correct definition of the terms ‘pharmacovigilance’ and ‘adverse drug reaction’ was identified by 76(83.5%) of the nurses, similar to an earlier study from Iran . In contradiction, Rajesh R et al. and Hanafi et al. studies reported that 21.3% and 32% of the nurses (pre intervention) identified the correct definition of pharmacovigilance respectively [14, 17] and only 1.6% of nurses in a study from China .
Hajebi G et al. reported that nurses with prior familiarity to ADR center had greater knowledge and positive attitude to towards ADR reporting . However in the present study comparing the scores of nurses who have had previously reported ADR and those not reported, the knowledge and attitude scores were similar suggesting that the previous experience of reporting did not improve their knowledge or attitude towards reporting. The probable reason for this finding could be the lack of continuum in the reporting process; ADR reporting is a continuous process among the health care providers in the hospital.
Considerable number of the nurses (80%) had observed ADRs during their nursing practice, and all of them had reported to the concerned doctors and 8.8% of the nurses had reported ADRs to Pharmacovigilance center in spite of ADR reporting not being mandatory similar to other reports [13, 17, 19, 20]. This shows the nurses concern towards their patients' safety. In contradiction, Fadare et al. noted that about 74% of the nurses had observed ADRs . Soleymani et al., demonstrated the significant role of spontaneous reporting system in the health care system . Soleymani et al. reported that the overall reporting frequency of tramadol induced ADRs reduced drastically over a period of 5 years (2006-2010) which was attributed to the initiatives taken by the National Pharmacovigilance center. High reporting frequency of tramadol induced severe ADRs and poisoning cases (dose dependent) to the Iranian Pharmacovigilance Center by spontaneous reporting lead to the implementation of new guidelines to limit the distribution of tramadol to hospital use only and also changed the potency of available injectable form from100mg to 50 mg . These examples can be presented to understand importance of spontaneous reporting in patient safety.
According to the results, 50% of the participants were aware of the existence of ADR monitoring centers. This finding was comparable to Khalili et al. from Iran . This observation further emphasizes the need for awareness of the ADR reporting system among the nurses.
About 40% of the nurses in the present study felt ADR reporting is a professional obligation. Similar observation was noted by a previous report from Iran (16). Patient safety is the prime responsibility of the nurses and by the active and voluntary participation in the Pharmacovigilance program they contribute towards their patient’s safety and medical ethics.
The major barriers to under-reporting, from the present study were uncertainty of the ADRs, the concern of the report may be wrong and inadequate knowledge of the reporting procedure. These observations were consistent with the earlier reports [13, 18, 20]. These observations reflect the common anxieties among the reporters. An ADR report need not be confirmatory of the relationship between the drug and ADR. When an ADR is suspected, even those not known to the drug it should be reported. In order to address the problem of under-reporting, ADR reporting procedure can be made available as small booklets, posters, electronic flashes at various locations in the hospital to serve as constant reminders. Regular sensitization programs such as continued nursing education and workshops should be carried out among nurses to stress the importance of pharmacovigilance. These training programs clear all misconceptions associated with the ADR reporting.
The strategic approaches suggested by the respondents to enhance reporting included training in ADR reporting and easy accessibility to ADR reporting forms which is in line with Li et al. Training and educational interventions would increase the knowledge and as knowledge is directly related to the attitude, this would in turn motivate nurses to reports the ADRs they encounter. Previous reports have reported significant improvement of knowledge, attitude and perception of healthcare workers about ADR after intervention [20, 22, 23] Educational program can include presentations, workshops, small group discussions, providing information about pharmacovigilance for healthcare workers by mail, newsletters, reminders, advertisement and continuous education of nurses, and involvement of clinical pharmacists in the medical wards . Pharmacovigilance can be included in the nursing curriculum to introduce them to this concept early in their career. Nursing supervisors and administrators can monitor and actively initiate these program and workshops to improve reporting in the hospitals. Regular feed back of the reports and presentations of the reported ADRs can be a motivational force to continue reporting process among the health care professionals.
The limitations of the study include; the results are of a single-centre and small sample size which may be. The study can be further extended to other hospitals in the country to generalize the findings. Another limitation is those inherent to questionnaire-based studies such as subjective response and recall bias.
In conclusion, the results of the study strongly point out the need for interventional program among nurses focusing on the importance of ADR reporting and reporting procedure to encourage their active, voluntary participation in drug safety surveillance.