Healthcare Professionals´ Attitudes and Spontaneous Adverse Drug Reaction Reporting

JI Marques1,2, MT Herdeiro1,2, JJ Polónia1, A Figueiras3. 1Faculty of Medicine, University of Porto, Porto, Northern Pharmacovigilance Center, 4200-319, Portugal, 2Faculty of Medicine, University of Porto, Porto, Center for Research in Health Technologies and Information Systems (CINTESIS), 4200-319, Portugal, 3University of Santiago de Compostela, Santiago de Compostela, Department of Preventive Medicine and Public Health, 15782, Spain

Introduction: It is recognized worldwide that adverse drug reactions (ADR) are an important cause of morbidity and mortality. A voluntary reporting system of ADR is fundamental to drug safety surveillance. However, under-reporting among healthcare professionals is its major limitation. It is estimated that just about 10% of all serious ADRs are reported to the competent authorities. In this matter, nurses can bring fundamental information, even if, the reasons for the high under-reporting among them are not well-known.

Objectives: Identify the knowledge and attitude-related factors associated with ADR under-reporting by nurses.

Methods: We conducted a case-control study, among nurses working in the Northern Portugal. The 265 cases include nurses who had reported at least one ADR to the drug surveillance center from the year 2000 to 2010. The 1060 controls include nurses who had never reported an ADR, and were stratified by the districts of the Northern Portugal and randomly selected in each district. All interviews were conducted using a self-administered questionnaire sent by mail. Knowledge and attitudes regarding spontaneous ADR reporting were mostly based on Inman´s ´seven deadly sins´. Agreement with the questions was measured using an unnumbered horizontal, continuous visual analogue scale. The answers were read in a range from zero to ten. We used a logistic regression to determine the ADR reporting adjusted odds ratio (ORadj) for a change in exposure corresponding to the interquartile range for each attitude.

Results: A total of 263 valid questionnaires and 39 null were received from the 1325 nurses selected for the sample (response rate 20.5%). Reporting probability proved higher among nurses working in primary versus hospital care (ORadj 14.1; 95%IC 7.3-27.4). Concerning to the attitudes associated with under-reporting, hence, an interquartile decrease in any of the following attitudes increased the probability of reporting: (i) near two times for indifference (“The one case an individual nurse might see could not contribute to medical knowledge”) (1/IqORadj 1.8; 95%IC 1.1-3.0); (ii) three times for Complexity of the system (“I would be more likely to report ADRs if there were an easier method”) (1/IqORadj 1.8; 95%IC 1.1-3.0), and (iii) two times for misunderstanding of the system (“I do not know how the information reported is used by the system) (1/IqORadj 2.3; 95%IC 1.3-3.9).

Conclusion: This study shows that there are certain attitudes of nurses associated with under-reporting. An educational intervention targeted to change these attitudes identified, may minimize under-reporting and contribute for the safety of medicines and improve Public Health. Our study also indicates that we must take into account the working place of nurses and their motivation to report an ADR.