Reporting of adverse drug reactions: an exploratory study among nurses in a teaching hospital, Ajman, United Arab Emirates

Abstract

Background and the purpose of the studyAdverse drug reactions (ADRs) are important public health problem associated with morbidity, mortality and financial burden on the society. Nurses play important role in medication safety surveillance through the spontaneous voluntary reporting of ADRs. Nurses’ knowledge, attitude and practice towards ADR reporting and factors affecting reporting was assessed in the study.MethodsAll nurses working in a tertiary care hospital, Ajman, UAE participated in this cross-sectional survey. A self administered questionnaire of four domains (knowledge, attitude, practice, factors affecting reporting) was distributed among nurses after obtaining informed consent. The knowledge and attitude components were assigned score of one for correct response. Data was analyzed using SPSS (version 19). Mann–Whitney U test was used to compare knowledge and attitude scores between subgroups; Spearman’s correlation for any relationship between knowledge and attitude.ResultsOf the total participants, females constituted 92.3%; average duration of clinical experience 6.5 ± 3.3 years; mean age 28.9 ± 4.1 years. Median score for knowledge components of ADR reporting was 11(total score: 17) and for attitude components was 4(total score: 8). No difference noted in knowledge and attitude scores between gender, age group, educational qualification. A positive correlation between knowledge and attitude components was observed (r = 0.38). ADRs are important cause for morbidity and mortality was reported by (54.9%). 49.5% were aware of Pharmacovigilance centers’. Uncertainty of ADRs (49.5%); concern that the report may be wrong (46.2%) and inadequate knowledge of ADR reporting procedure were the major barriers to reporting. Training in ADR reporting as the key measure to improve reporting was suggested by (86.8%).Major conclusionThe 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.

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

“…However, pharmacists with high level of education with more years of experience were correlated positively with attitude towards pharmacovigilance activities in general and ADRs reporting in particular [21]. Gavaza P et al found that the number of hours worked and practice setting were associated positively with the pharmacists' attitudes towards ADRs reporting [22].…”

A Survey on Knowledge, Attitude and Practice of Pharmacovigilance towards Adverse drug reactions reporting among Doctors and Nurses in a Tertiary Care Hospital in South India

“…This shows the importance of conducting regular pharmacovigilance training programme to ensure that the newer and junior faculties are trained periodically. 16,[26][27][28] The study also emphasizes on the fact that certain factors such as knowledge about the ADR forms and its ease of access, previous exposure to training programs on pharmacovigilance contribution of ADR reporting. …”

Pharmacovigilance: Where Do We Stand?

“…For effective adverse event monitoring, the Indian Pharmaceutical companies are dependent on the experiences shared from these regulated markets, where the drug was already used for many years before coming into Indian market. Because of this reason, Pharmacovigilance system is not that strong in India [6,7,8].…”

“…A healthy database will help the Indian pharmacovigilance system greatly and will play a great role in the safety analysis of the drugs. Clarity regarding the reporting of AEs is needed as the Schedule Y presently is pretty ambiguous in terms of reporting timeframes and needs to be completely overhauled [13,14]. As soon as possible but no later than 7 calendar days after first knowledge followed by a complete a report as possible within 8 additional calendar days.…”