Under-reporting of ADRs caused by non-prescription medicinal products


During the flu season, as the number of affected people grows, so does the demand for medications ensuring the relief of its symptoms. However, with the number of safety reports containing unexpected side effects caused by prescription drugs constantly increasing, patients are turning more and more to non-prescription, “over the counter” (OTC) drugs.

These medicinal products, especially herbal remedies, are often perceived as a safer option among patients, simply because they are not of the synthetic origin. Although they do fulfil the customary criteria for over-the-counter use with their low toxicity, little to none potential for overdose or addiction, uniform dosage etc., an increased and often incorrect use inevitably results in a higher number of adverse reactions (ADRs).

Despite the efforts to encourage reporting of ADRs, the current pharmacovigilance reporting system still faces challenges, since pharmacovigilance methods mostly depend on the spontaneous reporting system. This represents a problem when it comes to the monitoring of OTC products, since these medicines are available without prescription.

Excluding healthcare professionals (HCPs) and relying only on consumers/patients for reporting ADRs often results in the falsely low number of ADR reports. Causes of under-reporting are numerous and an important factor that significantly contributes to this phenomenon is the labelling issue: over the counter products often contain very concise and abbreviated safety information leading to the trouble of recognizing ADRs by consumers without medical background.

Additional reasons for non-reporting include lack of knowledge about the Authority responsible for receiving ADRs, unavailability of ADR reporting forms, and already known and non-serious ADRs.

However, significant efforts have recently been made in order to popularize ADR reporting and to bring pharmacovigilance closer to common consumers. Along with already available ways of reporting through paper and online application, Croatia was among the first three EU countries to introduce a mobile application for ADR reporting in 2016.

Furthermore, the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) recently organized a campaign in cooperation with the Croatian Pharmaceutical Society (HFD) as part of the European ADR reporting awareness week held from 20 to 24 November 2017 (as part of the EU project by Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action). The campaign was conducted through social networks with special focus on encouraging reporting of ADRs caused by OTC medications.

In order to continue encouraging ADR reporting among patients, several actions can be undertaken. These include developing training modules for HCPs and common consumers, commercial advertisements, instructional videos, and inclusion of informative leaflets as a mandatory component of medication containers.

This is essential for further pharmacovigilance development, since ADR reporting by patients provides a more direct insight into the impact that a certain medication has on a patient’s life, making him/her an active participant in healthcare.

Since the reporting process for OTC products is destined to rely on patient’s awareness, each effort that aims to simplify and make ADR reporting more accessible is highly valuable and expected to be an important topic in years to come.

Tamara Vuk, Msc / Junior Pharmacovigilance Associate

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Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Planinska ulica 13, HR 10000 Zagreb
Office: Planinska ulica 13, HR 10000 Zagreb
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