Healthcare Professional Reports Research Articles

THU0184 PREVIOUSLY UNKNOWN GASTRO-INTESTINAL ADVERSE DRUG REACTIONS ATTRIBUTED TO ETANERCEPT

Background:Although an increased risk of inflammatory bowel disease (IBD) during etanercept (ETN) use is included in the product information of ETN, no other gastro-intestinal (GI-)adverse drug reactions (ADRs) are described. This is in contrast with other TNFα-inhibitors such as adalimumab (ADA) and infliximab, as these are associated with various GI-ADRs such as nausea and abdominal pain.Objectives:To identify the proportion and type of patient-reported and health care professional (HCP)-reported ETN associated GI-ADRs and compare these with ADA associated GI-ADRs.Methods:Patient-reported data on ADRs attributed to biologics was collected from the Dutch Biologic Monitor (DBM) from 1 Jan 2017 until 1 Nov 2019. HCP reported data on ADRs attributed to biologics was collected from the Dutch rheumatic arthritis monitoring registry and the Dutch registry for spondyloarthritis from 22 Jun 2004 until 1 Nov 2019.GI-ADRs were defined by MedDRA System Organ Class ‘Gastrointestinal disorders’. All reported GI-ADRs attributed to ETN and ADA for patients with inflammatory rheumatic diseases (IRDs) were selected. Proportion of GI-ADRs for ETN and ADA in patient and HCP reports was defined as the number of patients with at least one GI-ADR per total number of patients using ETN or ADA. Patient-reported burden and actions taken after GI-ADRs were compared between ETN and ADA.Results:We included 755 patients from the DBM using ETN (415) and ADA (358) for IRDs, of which 47 patients reported 60 GI-ADRs. The proportion of patient-reported GI-ADRs was 6.3% for ETN and 5.9% for ADA (Table 1). We included 1343 patients using ETN (804) or ADA (796) from the registries, with 43 HCP-reported GI-ADRs in 38 patients. The proportion of HCP-reported GI-ADRs was 1.6% for ETN, which was significantly lower than 3.4% for ADA (p=0.049). Patients experienced ETN associated GI-ADRs more burdensome than ADA associated GI-ADRs (p=0.05 using Mann-Whitney U) (Table 2). The ADR required action in 34% of patient-reported GI-ADRs attributed to ETN and 41% of GI-ADRs attributed to ADA, including biologic discontinuation. No hospitalisation following a GI-ADR was reported.Table 1.Proportion of patient- and HCP-reported GI-ADRs attributed to ETN and ADA.PatientsProportion for ETNTop 3Proportion for ADATop 3p-value*DBM(n=755; 415 ETN, 358 ADA)6.3%(26 pt)1. Nausea: 62. Diarrhea: 53. Abdominal pain: 55.9%(21 pt)1. Nausea: 82. diarrhea: 33. Oral aphthous ulcer: 20.9Registries(n=1,343; 804 ETN, 796 ADA)1.6%(13 pt)1. diarrhoea: 62. Nausea: 23. Abdominal pain: 23.4%(25 pt)1. Nausea: 72. Abdominal pain: 63. Diarrhoea: 50.049*Differences between ETN and ADA were tested using Fisher’s exactTable 2.Actions following patient-reported GI-ADRs attributed to ETN and ADA in the DBMETN (n=38)ADA (n=22)Mean burden score* ± SD2.9 ± 1.02.5 ± 0.9Contact HCP23 (61%)10 (45%)Specialist doctor10 (43%)3 (30%)General practitioner10 (43%)8 (80%)Nurse6 (26%)2 (20%)Other7 (30%)2 (20%)Action of HCPDiscontinuation1 (4%)1 (10%)Dose adjustment2 (9%)1 (10%)Treatment4 (17%)3 (30%)Referral3 (13%)2 (20%)Mentioned, no action12 (52%)5 (50%)Other3 (13%)2 (20%)*5 point Likert scaleConclusion:Although GI-ADRs other than IBD are not included in the product information of ETN, they are often reported by both patients and HCPs. The type of patient-reported GI-ADRs attributed to ETN and ADA is comparable. However, patients regard GI-ADRs attributed to ETN as more burdensome.Disclosure of Interests:Jette van Lint: None declared, Naomi Jessurun: None declared, Astrid van Tubergen Consultant of: Novartis, Martijn van Doorn Grant/research support from: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Speakers bureau: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Eugène van Puijenbroek: None declared, Phyllis Spuls Grant/research support from: Departmental independent research grant for TREAT NL registry LeoPharma December 2019; Contract support: I am involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis for which we get financial compensation paid to the department/hospital, Consultant of: Consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), Sander Tas: None declared, Bart van den Bemt Grant/research support from: UCB, Pfizer and Abbvie, Consultant of: Delivered consultancy work for UCB, Novartis and Pfizer, Speakers bureau: Pfizer, AbbVie, UCB, Biogen and Sandoz., Michael Nurmohamed Grant/research support from: Not related to this research, Consultant of: Not related to this research, Speakers bureau: Not related to this research, Frank Hoentjen Grant/research support from: Received grants from Dr Falk, Janssen-Cilag, and AbbVie., Consultant of: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Speakers bureau: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Harald Vonkeman: None declared

TP2 TREATMENT PATTERNS IN SPINAL MUSCULAR ATROPHY: INTERVIEWS WITH HEALTHCARE PROFESSIONALS IN THE UNITED KINGDOM

Spinal muscular atrophy (SMA) is a rare genetic disorder characterized by weakness and atrophy in skeletal muscles. Excluding the prenatal onset form (type 0), SMA is classified into 4 phenotypes based on severity, with type 1 being the most severe. Emerging treatments are shifting the treatment paradigm, but little is known about current treatment patterns. The objective is to collect data on treatment patterns in SMA types 1, 2 and 3 in the UK through health care professional (HCP) interviews. HCPs, who had seen at least 2 patients with SMA in the past 12 months, were recruited through contacts in clinical centers in the UK. Informed consent was obtained from all respondents with subsequent telephone interviews. Interviews were conducted with 16 HCPs from 8 UK regions: nine neurologists, three pulmonologists, two physiotherapists, one nurse, and one health visitor. HCPs reported that paths to diagnosis depend on symptom timing, and HCPs involved. Time to diagnosis was estimated at up to 3 months for SMA 1, and up to 12 months for SMA 2 and 3. HCPs agreed on key approaches to management and care coordination. Patients’ geographic proximity to hospital often determines who coordinates care. The existence and characteristics of phases in SMA was divisive, although focus was on ventilation, nutrition, and mobility. Many HCPs are involved in patient care, with community support being essential, however, HCPs were not able to report on palliative care and personal social services. The challenges faced by HCPs in SMA are numerous and include lack of resources and lack of effective treatment. HCP reports underline the complexity of treatment coordination for SMA, between hospitals and communities. Management is focused on ventilation, feeding and mobility, with involvement of a large number of HCPs. A comprehensive SMA care model is needed.

Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016

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.

Adverse Event Reporting Patterns of Marketing Authorization Holders, Healthcare Professionals and Patients in Japan: Lessons Learnt From the Human Papilloma Virus Vaccine

A patient organization was founded in 2013 due to skepticism about the safety of human papilloma virus (HPV) vaccines. To evaluate the impact of “priming” patients with information on adverse events following immunization (AEFI) via mainstream media and its impact on reporting by marketing authorization holders (MAHs), healthcare professionals (HCPs), and patients, and to assess the contribution of a pilot patient reporting system for adverse events in Japan to pharmacovigilance. A summary list of reports of anaphylaxis, vagal reflex, and generalized pain-related AEFI, as presented to the Vaccine Adverse Reactions Review Committee (VARRC) between 2011 and 2016, was analyzed to gain information on MAH and HCP reports. Data on patient AEFI reporting were obtained from a pilot Pharmaceuticals and Medical Devices Agency (PMDA) database designed for this purpose. Data on vaccine shipment volumes were obtained from the VARRC. The leading reporting source transitioned from MAHs (82% of the total AEFI reported in 2010) to HCPs (63% in 2011), and patients (43% in 2015). Sharp peaks were observed for both MAH and HCP reports in 2011. A second peak in pain-related AEFIs reported by HCPs was observed in 2013 when the Ministry of Health, Labour and Welfare suspended the active recommendation of HPV vaccines. Patient reports were continuous and accounted for 21.7% of the total AEFIs reported to the current patient reporting system. In Japan, the characteristics of AEFI reports differed by source for HPV vaccines. MAH and HCP reports identified the major trend in AEFI occurrence during the early post-marketing phase, whereas patient reports in cooperation with HCPs facilitated the detection of weak signals of possible AEFIs throughout the product lifecycle. Patient reporting systems should be encouraged, especially by promoting the communication between patients and local “home” pharmacies in cooperation with patient organizations.

Oncologists', nurses', and social workers' strategies and barriers to identifying suicide risk in cancer patients.

To identify oncologists', nurses', and social workers' strategies and barriers in identifying suicide risk in cancer patients. Sixty-one oncology healthcare professionals (HCPs) at 2 cancer centers were interviewed. We used the grounded theory method (GT) of data collection and analysis. Analysis involved line-by-line coding, and was inductive, with codes and categories emerging from participants' narratives. The majority of oncologists and nurses reported that they had encountered at least 1 patient who had committed suicide during their careers (56% and 55%, respectively) and/or had suicidal ideation (65% and 75%, respectively). Social workers reported having fewer suicides in their practices (22%), but similar rates of suicidal ideation among patients (66%). Strategies to identifying suicide risk included paying attention to patients' verbal indicators, explicit actions, and mental health distress. In addition HCPs reported that mental health disorders and other patient characteristics increased their likelihood to assess suicidality among patients. Reported barriers to identification included patient factors such as patients giving no warning, patients concealing suicidality, and patients failing to come in. HCP barriers to identification included lack of training and awareness, difficulty in differentiating suicidality from mental health distress, lack of time with patients, fear of asking about suicidality, and lack of coping resources to deal with suicidal patients. HCPs reports of their lack of training and awareness on identifying suicide risk is alarming given the higher risk of suicide among cancer patients. Training programs should incorporate the successful strategies used by HCPs and overcome barriers to identifying suicide risk.

Patient Reporting in the EU: Analysis of EudraVigilance Data.

New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received from patients. This descriptive study aims to provide insight into patient reporting for the totality of the EU by querying the EudraVigilance (EV) database for the period of 3years before the new pharmacovigilance legislation became operational and the 3years after as well as comparing patient reports with those from healthcare professionals (HCPs) where feasible. We queried the EV database for the following characteristics of patient and HCP reports: demographics (patient sex and age), seriousness, reported ADR terms, reported indications, number of ADRs per report, time to report an ADR, and most reported substances. Wherever feasible, direct comparisons between patient reports and HCP reports were performed using relative risks. The EV database contained a total of 53,130 patient reports in the 3years preceding the legislation operation period and 113,371 in the 3years after. Member states contributing the most patient reports to the EV database were the Netherlands, the UK, Germany, France and Italy. The results for indications and substances show that patients were more likely than HCPs to report for genitourinary, hormonal and reproductive indications. Patients reported more in general disorders and administration site conditions Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), whereas HCPs reported more Preferred Terms (PTs) belonging in the Investigations SOC. However, 13 of the 20 reactions most frequently reported by patients were also among the top 20 reactions reported by HCPs. Patient reporting complemented reporting by HCPs. Patients were motivated to report ADRs, especially those that affected their quality of life. Sharing these results with NCAs and patient associations can inform training and awareness on patient reporting.

Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method study-study protocol.

Background Monitoring adverse drug reactions (ADRs) through pharmacovigilance are vital to patient safety. Spontaneous ADR reporting is one method of pharmacovigilance, and in Canada all reporter types admitted to report an ADR to the Canadian Vigilance Program at Health Canada. Reports are submitted to Health Canada by post, telephone, or via the internet. The Canada Vigilance Program electronically records submitted information to detect medication safety alerts. Although previous studies have shown differences between patients and healthcare professionals (HCPs) on the types of drugs and reactions reported, relatively little is known about the importance of patient reports to pharmacovigilance activities. This article proposed a multi-method approach to evaluate the importance of patient ADR reporting on pharmacovigilance activities, by systematically review the available literature, comparing patient—versus HCPs-generated ADR reports that were submitted to the Canada Vigilance Program, and exploring patient views and experiences regarding the Canadian ADR reporting system. MethodsGuided by a risk-perception theoretical lens, the proposed multi-methods research study will involve three phases. Phase I is a systematic review of all studies that analyse the factors influence ADR reporting by patients to the pharmacovigilance schemes. Phase II is a descriptive statistical analysis of all ADR reports received by the Canada Vigilance Program database between 1 January 2000 and 31 December 2014 from patients and HCPs to compare ADRs reported by patients with those reported by HCP reports in terms of ADR seriousness, ADR classification by system organ class, and the medication involved based on the anatomical therapeutic class system. In phase III, an interpretative descriptive approach will be used to explore patient’s views and experiences on ADR reporting and usability of the Canadian Vigilance ADR report. Participants will be purposefully selected to ensure diverse backgrounds and experiences. Interviews will be digitally-recorded, transcribed verbatim, and inductively analysed to identify themes. Patients will be interviewed until theoretical saturation is achieved. DiscussionFindings from this research will highlight the role of the patients in directly reporting ADRs, and provide information that may guide streamline and optimizing patient ADR reporting. Policy makers, public health officials, and regulatory agencies will require this critical information in order to improve medication safety in Canada and worldwide.

A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital

Background: No pharmacotherapeutic agent is completely free from noxious and unintended effects and thus adverse drug reactions (ADRs) are inevitable consequences of drug therapy. Incidence of ADRs in Indian population ranges between 1.8% and 25.1%. However, ADR reporting in India is inadequate. Developing awareness inpatients and healthcare professionals (HCPs) will help in reducing the ADRs, its suffering and socioeconomic impact. Hence, the present study of ADR monitoring in the outpatients and inpatients of the medicine department in a tertiary care hospital is undertaken. The main objective of this study was to assess the ADR reporting patterns in outpatient and inpatient of medicine department. The study was also aimed to assess the causality, severity, and preventability of these ADRs and comparison between spontaneous reporting by HCP and patient self-reporting of suspected ADRs. Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine. The study plan included analysis and assessment of the clinical pattern, spectrum of ADRs reported based on causality, severity, preventability factors. The impact of ADRs on emotional, occupational, and social life of patients was evaluated. The assessments were compared between patient reporting and HCP reporting of ADRs. Results: The clinical spectrum of ADRs ranged from the more common mild reactions such as skin rashes, itching, nausea, and vomiting to moderately severe reactions prolonging the hospital stay. The predominant causative drugs were antimicrobials, antiretrovirals, non-steroidal anti-inflammatory drugs and antihypertensives. The majority of ADRs were probable in causality assessment, moderate in severity and probably preventable. Comparison of ADR reporting between patient and HCP revealed that ADRs reported by patient’s been less in incidence, similar in qualitative analysis to HCP with very elaborative narration and highlighted emotional and occupational impact due to ADRs than HCP reports. Conclusion: A wide range of ADRs are possible in medicine department. Adequate awareness of ADR reporting and precautions, while prescribing drugs are essential. Including patients as additional reporters of suspected ADR may add to the benefit of pharmacovigilance.

How Do Patients Contribute to Signal Detection?

In 2005, spontaneous reporting of adverse drug reactions (ADRs) to the UK's Yellow Card Scheme (YCS) was extended to include patient reports. Here, we investigate the potential pharmacovigilance impact of patient reporting. The aim of the study was to investigate the relative contribution of patient reporting to signal detection through disproportionality analysis. Data were analysed from all reports submitted directly to the YCS between October 2005 and September 2007. Three datasets of drug-ADR pairs were created: one for patient reports, one for healthcare professional (HCP) reports and one for all reports combined. The proportional reporting ratio (PRR) method was used to identify signals of disproportionate reporting (SDRs) in each dataset. The number of SDRs identified from patient and HCP reports were compared, as well as the type of ADR and suspect drug involved. A sensitivity analysis was performed to examine how combining the patient and HCP reports may affect the SDRs identified. Data were received for 5,180 patient and 20,949 HCP reports, relating to 16,566 and 28,775 drug-ADR pairs, respectively, with 4,340 (10.6 %) pairs found in both datasets. A significantly higher proportion of the SDRs identified from HCP reports involved reactions classified as serious by the Medicines and Healthcare products Regulatory Agency (MHRA), compared with patient reports (n = 931, 48.0 % vs. n = 185, 28.5 %), or involved newly marketed drugs (n = 596, 30.7 % vs. n = 71, 10.9 %). The proportion of SDRs assessed as not listed on the Summary of Product Characteristics (SPC) was similar in each group (~15 %, based on a random sample). After combining the patient and HCP reports, 278 (~11 %) of the SDRs identified when each group was analysed separately no longer met the SDR criteria, including 12 potentially serious ADRs not listed on the product's SPC. On the other hand, the combined dataset identified an additional 508 SDRs that were not identified when patient or HCP reports were analysed separately. Approximately 10 % (n = 47) of these additional SDRs were assessed as serious ADRs and were not listed on the product's SPC. Although this study is limited to the UK experience, overall, the results suggest that patient reporting may provide a positive complementary contribution to that of HCPs. Patient reporting may make an important contribution to drug safety by identifying different SDRs not identified from HCP reports alone. The combination of reports from patients and HCPs, however, when used for the purposes of signal detection through disproportionality analysis, may result in the loss of some information. One possible strategy is to conduct such analyses using reports from patients and HCPs combined, as well as separately for each group.

First French Experience of ADR Reporting by Patients After a Mass Immunization Campaign with Influenza A (H1N1) Pandemic Vaccines

Background: Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients’ reports with reports from healthcare professionals (HCPs). During the 2009–10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations. For the first time, patients were offered the opportunity to report suspected ADRs to pandemic vaccines directly to regional pharmacovigilance centres. Objective: The aim of the study was to compare the characteristics of patient and HCP ADR reports in order to assess the qualitative and quantitative contribution of patient reporting to the French Pharmacovigilance System. Methods: All spontaneous ADRs registered into the French Pharmacovigilance Database from 21 October 2009 to 15 June 2010, in which either one of the most frequently administered pandemic vaccines (i.e. Panenza® or Pandemrix®) was involved, were analysed. ADRs were classified as ‘serious’, ‘medically serious’ and ‘non-serious’. This study focused on ‘serious’ and ‘medically serious’ ADRs. An ADR was ranked as ‘medically serious’ when it required medical intervention or hospitalization within less than 24 hours. In each level of seriousness, frequency of ‘unlabelled’ ADRs, ADRs of ‘special interest’, imputability scores and category of ADRs according to Medical Dictionary for Regulatory Activitives (MedDRA®) primary System Organ Class were compared between patient and professional reports. Results: Among the 4746 reports received during the study period, 1006 (21.2%) originated from patients. HCPs reported significantly more ‘medically serious’ or ‘serious’ ADRs than patients (15.1% [565/3740] vs 8.4% [85/1006], respectively; p < 0.001). No difference was found in ‘unlabelled, serious’ ADRs between patients and HCPs (56.5% [n= 13] vs 56.7% [n= 136], respectively). Conclusions: In this first French experience of formal patient participation to ADR reporting, patient contribution to the total number of ADRs reached 21.2%. This study revealed no major qualitative difference between patient and HCP reports. ADR profiles reported by patients appeared to be consistent with those from professionals. Further investigations are necessary to assess the intrinsic quality of notification forms coming from non-professional reporters. However, this study is of particular interest in the context of publication of the first governmental decree that will formally integrate patient participation to the current French ADR reporting scheme.

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

The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and health-care professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs. To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs. (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS. Patients (n = 5180) and HCPs (n = 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028). The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain. None. Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS. Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009. Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients. The National Institute for Health Research Health Technology Assessment programme.