Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017

Abstract

Background Adverse 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. Methods Spontaneously 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). Results There 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. Conclusions Pharmacists 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.

A Step to Improve Pharmacovigilance System: A Cross Sectional Study among Outpatients Visiting Multi Super Speciality Hospital in Kerala Established with ADR Monitoring Centre

“…over the counter medicines are considered as safe, but they can also cause ADR. This was supported by the study conducted by Bukic J et al 7 More over here irrationally patients were dispensed with antibiotics which is not coming under OTC medications. About 40% participants are taking medicines other than allopathy which include ayurveda, siddha, unani and homeo medicines (Table 1).…”

Safety and efficacy evaluation of Simo decoction and Arecae semen in herbal medicine practice

“…Arecoline, the primary alkaloid, acts as a parasympathomimetic agent, functioning as a muscarinic receptor agonist and, in high doses, as a nicotinic receptor agonist. It exhibits various effects, including acetylcholine-like actions, vasodilation, blood pressure reduction, reflex tachycardia induction, intestinal tension and motility stimulation, secretion stimulation, myopathy, and bladder contraction [ 26 ]. Arecae Semen is often mixed with alkalizing agents like lime or ash, as well as cashews, spices, and flavorings.…”

Teaching Pharmacovigilance to Healthcare Students: Identifying Gaps and Opportunities for Improvement

“…Research shows that pharmacists indeed are most prominent reporters of adverse drug reactions for OTC drugs. However, all healthcare professionals should be aware that OTC drugs could also cause adverse drug reactions [33]. Students identified physicians as most important healthcare professionals for monitoring adverse drug reactions for prescription drugs; however, as pharmacists are the most accessible healthcare workers [34], their role in pharmacovigilance of chronic treatments should not be overlooked.…”