Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys

Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance\udis vital to patient safety. Spontaneous reporting of ADRs is one method of\udpharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme\ud(YCS). Yellow Card reports are submitted to the Medicines and Healthcare products\udRegulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically\udrecords and reviews information submitted so that important safety issues can be\uddetected. While previous studies have shown differences between patient and healthcare\udprofessional (HCP) reports for the types of drugs and reactions reported, relatively\udlittle is known about the pharmacovigilance impact of patient reports. There have also\udbeen few studies on the views and experiences of patients/consumers on the reporting of\udsuspected ADRs.\udObjectives: To evaluate the pharmacovigilance impact of patient reporting of ADRs by\udanalysing reports of suspected ADRs from the UK YCS and comparing reports from\udpatients and HCPs. To elicit the views and experiences of patients and the public about\udpatient reporting of ADRs.\udDesign: (1) Literature review and survey of international experiences of consumer reporting\udof ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of\udYellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey\udof patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with\udpatient reporters to the scheme; (7) qualitative analysis of focus groups and usability\udtesting of the patient YCS; and (8) national omnibus telephone survey of public awareness\udof the YCS.\udParticipants: Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports\udfrom October 2005 to September 2007. Respondents to questionnaire survey (n = 1362).\udParticipants at focus groups and usability testing sessions (n = 40). National omnibus\udtelephone survey (n = 2028).\udSetting: The literature review included studies in English from across the world. All other\udcomponents included populations from the UK; the omnibus survey was restricted to\udGreat Britain.\udInterventions: None.\udMain outcome measures: Characteristics of patient reports: types of drug and suspected\udADR reported; seriousness of reports; and content of reports. The relative contributions of\udpatient reports and of HCP reports to signal generation. Views and experiences of patient\udreporters. Views of members of the public about the YCS, including user-friendliness and\udusability of different ways of patient reporting. Public awareness of the YCS. Suggestions\udfor improving patient reporting to the YCS.\udResults: Compared with HCPs, patient reports to the YCS contained a higher median\udnumber of suspected ADRs per report, and described reactions in more detail. The\udproportions of reports categorised as ‘serious’ were similar; the patterns of drugs and\udreactions reported differed. Patient reports were richer in their descriptions of reactions\udthan those from HCPs, and more often noted the effects of ADRs on patients’ lives.\udCombining patient and HCP reports generated more potential signals than HCP reports\udalone; some potential signals in the ‘HCP-only’ data set were lost when combined with\udpatient reports, but fewer than those gained; the addition of patient reports to HCP reports\udidentified 47 new ‘serious’ reactions not previously included in ‘Summaries of Product\udCharacteristics’. Most patient reporters found it fairly easy to make reports, although\udimprovements to the scheme were suggested, including greater publicity and the redesign\udof web- and paper-based reporting systems. Of the public, 8.5% were aware of the YCS\udin 2009.\udConclusions: Patient reporting of suspected ADRs has the potential to add value to\udpharmacovigilance by: reporting different types of drugs and reactions than those reported\udby HCPs; generating new potential signals; and describing suspected ADRs in enough\uddetail to provide useful information on likely causality and impact on patients’ lives. These\udfindings suggest that further promotion of patient reporting to the YCS is justified, along\udwith improvements to existing reporting systems.\udIn order of priority, future work should include further investigation of: (1) the\udpharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum\udapproach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs\udin terms of impact on patients’ lives; (4) the knowledge and attitudes of HCPs towards\udpatient reporting of ADRs; (5) the value of using patient reports of ADRs to help other\udpatients and HCPs who are seeking information on patient experiences of ADRs; and\ud(6) the impact of increasing publicity and/or enhancements to reporting systems on the\udnumbers and types of Yellow Card reports from patients