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Abstract
BackgroundAdverse drug reaction (ADR) reporting practices by health care professionals remain poor. Over-the-counter (OTC) drugs are perceived as safe; however, they can also cause ADRs. The objective of this study was to analyze ADR reporting for OTC drugs in a 10-year period, in order to evaluate frequency of ADRs, population that ADRs most affect and reporters of ADRs of OTC drugs in Croatia.MethodsSpontaneously reported ADRs of non-analgesic OTC drugs, collected from January 2008 to December 2017 were analyzed. Data was obtained from Agency for Medicinal Products and Medical Devices of Croatia (HALMED).ResultsThere were 547 ADRs of OTC drugs reported in total and an increase in number of reports through the years was observed. Pharmacists reported 45.4% of all ADRs, and were most frequent reporters (p < 0.001). In 2017 majority of reports, 62 (49.2%), were obtained from consumers. ADRs were most frequently observed in patients aged 70 years and older (15% of ADRs). Five percent of all reports were accidental exposures among children.ConclusionsPharmacists most frequently reported ADRs of OTC drugs and consumers’ awareness of ADR reporting has risen. Other health care professionals (e.g., nurses and dentists) must be offered proper education in order to improve reporting practice of ADRs. Health care professionals should address concerns about OTC drug safety in elderly and children.
Highlights
Adverse drug reaction (ADR) reporting practices by health care professionals remain poor
There were 547 ADR reports of OTC drugs reported to HALMED in total, during the examined period
An increase in the number of reports through 2013– 2017 was observed in that almost 80% of ADRs of OTC drugs were reported during that time
Summary
Adverse drug reaction (ADR) reporting practices by health care professionals remain poor. The World Health Organization (WHO) defines selfmedication as “the selection and use of medicines by individuals to treat self-recognized illnesses or symptoms” [1]. There are many benefits of self-medication, for both patients and health professionals, among which include physicians avoiding unnecessary consultations, increased advisory role of pharmacists, and patients becoming responsible for their own health. ADRs influence consumers’ quality of life, whereby ADRs may increase health care costs and are a wellrecognized reason for hospitalization and cause of mortality [5, 6]. In order to improve knowledge about drug safety, spontaneous reporting of suspected ADRs has been encouraged. The spontaneous reporting of ADRs has been one of the most essential methods for monitoring the safety of marketed drugs, and remains one of the most. We are still witnessing under-reporting of ADRs, even those characterized as serious [7, 9,10,11]
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