Abstract
IntroductionNurses play a significant role in ensuring the safety and quality of drugs. Our aim was to assess significant factors in nurses’ participation in ensuring pharmacotherapy safety by reporting adverse drug reactions (ADR) and detecting substandard drugs (SD).Materials and methodsThe study was a cross-sectional, comparative survey, using original questionnaires. Survey questions were grouped to probe the opinions, attitudes and practices of nurses reporting ADRs and SDs. Data were obtained from nurses working in teaching hospitals in Poland (group A) and, for comparison, in the USA (group B). 1200 questionnaires were distributed in Poland (return rate: 55.7%) and 200 questionnaires in the USA (return rate: 73%). Both groups were surveyed during the same period. There were no exclusion criteria. The questionnaires were self-administered. Distribution and collection were anonymous. Participation was voluntary. The Spearman correlation test was used. Both groups’ responses were cross-tabulated and compared using Fisher’s Exact Test for Count Data.ResultsThe study group comprised 669 Polish and 146 American professionally active nurses working in general care and surgical departments. Age range: 18 to 72 years. Median job seniority: 18.3 years (group A) and 20.6 years (group B). Education levels varied. ADR reporting conditions in Poland are unfavorable: shortage of time—83.9% vs 22.6% in the US (p = 0.01); no incentive—58.2% vs 6.1% in the US (p = 0.01); and no equipment—44.7% vs 2.8% in the US (p < 0.01). Both Polish and American nurses indicate they rarely report SDs, with rates of 0.4% and 11% (p < 0.0001) respectively, during the study period.ConclusionsNurses in Poland are insufficiently prepared to ensure drug safety conscientiously and responsibly. Training is required for Polish nurses. Nurses’ employers need to improve conditions to enable reporting of ADRs and SDs.
Highlights
Nurses play a significant role in ensuring the safety and quality of drugs
Nurses ought to be active in pharmacovigilance (PhV) and report adverse drug reactions (ADRs), as the spontaneous reporting of ADRs is a foundation of post-marketing drug safety surveillance [3, 4]
These data do not indicate how many nurses are involved in the reporting, and it is our understanding that most reports originate with physicians [7], though it is known that the rate of ADRs reporting by nurses in Poland is unsatisfactorily low
Summary
Nurses play a significant role in ensuring the safety and quality of drugs. Our aim was to assess significant factors in nurses’ participation in ensuring pharmacotherapy safety by reporting adverse drug reactions (ADR) and detecting substandard drugs (SD). Physicians, pharmacists, nurses and midwives in Poland are obligated to report ADRs, there is a low rate of ADR reporting which is at odds with the high levels of drug consumption [6] This is confirmed by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP) annual reports in Poland: in 2016 there were 19,656 reports, of which, only 2,433 came from health care providers; in 2017 there were 19,996 reports and only 2,857 of these were from health care providers; and in 2018: 21,425 reporst with only 3,270 from health care providers. Nurses’ close contact with patients gives them the privilege of identifying adverse reactions and providing valuable information on drug safety [8, 9]
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