Consumers are more inclined than healthcare professionals (HCPs) to submit adverse drug reaction (ADR) reports, usually because of first-hand experience with an ADR. As consumer ADR reporting has led to important findings in other countries, the Turkish Pharmacovigilance Center (TUFAM) started accepting ADR reports directly from consumers.
The purpose of this study was to, for the first time in Turkey, review and compare ADR reports from consumers and HCPs.
We identified and evaluated all ADR reports that were submitted by TUFAM to VigiBase between 1 January 2014 and 31 December 2016 and fulfilled minimum reporting criteria. Minimum reporting criteria required an identifiable reporter, an identifiable patient, at least one suspected active substance/drug and at least one suspected adverse reaction. We compared ADRs submitted by either consumers or HCPs with respect to the reported sex of patients, the Medical Dictionary for Regulatory Activities preferred terms (PTs) used, designated medical event (DME) terms, the seriousness of the ADRs and the suspect drugs.
We analyzed 9150 spontaneous ADR reports that fulfilled the minimum reporting criteria. Of these, 3141 were submitted by consumers and 6009 were submitted by HCPs. Annual reporting rates (RRs) and the number of consumer ADR reports showed an increasing trend over time. The male:female ratio was 0.85 for consumer reports and 0.76 for HCP reports. In total, 12 of the 20 most frequently used PTs were identical for both consumers and HCPs. For ADRs classified as serious, consumers submitted 33.3% and HCPs submitted 52.2%. Consumers used only ten Designated Medical Event (DME) terms while HCPs used 35 DME terms out of a total of 62 DME terms at least once. Consumers most frequently reported ADRs to nervous system drugs, whereas HCPs most frequently reported ADRs to anti-infective drugs for systemic use. Consumers most frequently reported ADRs linked to gastrointestinal disorders, whereas HCPs most frequently reported ADRs linked to skin and subcutaneous tissue disorders.
This is the first study to compare spontaneous ADR reports from consumers and HCPs in Turkey. Our analysis indicates the reporting of ADRs by both consumers and HCPs is increasing. We found not only similarities in the two groups regarding suspect drugs and classification terms used, but also prominent differences. Consumers and HCPs had 12 of the 20 most frequently used PTs in common, but the remaining eight PTs used by consumers differed from those used by HCPs. This probably reflects the effect an ADR can have on a consumer’s daily life. HCPs also reported more serious ADRs than did consumers. Consumer reports have a secondary contribution to ADR reporting, which might then be used to improve existing pharmacovigilance systems with the consumer’s perspective in mind.
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The authors gratefully acknowledge Ali Alkan and Hakkı Gürsöz for their continuous support, Nergiz Temiz Nemutlu, Filiz Özel, and Hacer Ebru Aydoğan’s for collecting the data, and Onur Can Serinyel for his support on graphic design.
No sources of funding were used to assist in the preparation of this study.
Conflict of ınterest
NDemet Aydınkarahaliloğlu, Emel Aykaç, Özge Atalan, and Nilcan Demir are employed by the Turkish Medicines and Medical Devices Agency. They have no other conflicts of interest. Mutlu Hayran has no conflicts of interest.
Ethical approval was not required for this study.
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Aydınkarahaliloğlu, N.D., Aykaç, E., Atalan, Ö. et al. Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016. Pharm Med 32, 353–364 (2018). https://doi.org/10.1007/s40290-018-0244-8