The value of patient reporting to the pharmacovigilance system: a systematic review

Inácio, Pedro; Cavaco, Afonso; Airaksinen, Marja

doi:10.1111/bcp.13098

Cited by 158 publications

(143 citation statements)

References 53 publications

(179 reference statements)

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“…We identified a high proportion (36%) of ADEs not listed in the corresponding summary of product characteristics, which, given the only recent availability of the monitored drugs, are largely based on randomized clinical trial data. This finding appears consistent with the results of other studies which showed that consumer reports have the potential to identify new ADEs that were not previously included in the summary of product characteristics, and that the ADEs are sometimes reported earlier by consumers than by healthcare professionals [28][29][30]. Nevertheless, surprising differences among the monitored glucoselowering drugs were found in the present study, with the highest proportions of unlabelled ADEs being reported by new users of DPP-4 inhibitors alone.…”

Section: Discussionsupporting

confidence: 92%

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Torre

Guerreiro²,

Longo³

et al. 2019

Diabet. Med.

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Aims To determine the frequency and the time‐course profile of adverse drug events associated with new glucose‐lowering drugs in daily practice and to explore factors potentially associated to these events. Methods An inception cohort study was implemented. Adults with type 2 diabetes mellitus initiating a dipeptidyl peptidase‐4 inhibitor, a glucagon‐like peptide‐1 receptor agonist or a sodium‐glucose co‐transporter‐2 inhibitor were eligible for inclusion. Data were collected through baseline and follow‐up telephone questionnaires, administered at 2 weeks, 3 months and 6 months. Kaplan–Meier curves and log‐rank were computed to compare the time to adverse drug event onset. Cox models were used to explore potential factors associated with adverse drug events. Results A total of 1328 participants were recruited to the study. In all, 1118 adverse drug events were reported (of which 36% were not listed in the summary of product characteristics) by 41% of participants. The median latency time of adverse drug events reported in ≥1% of participants ranged from 0 to 2 days. Glucagon‐like peptide‐1 receptor agonist and sodium‐glucose co‐transporter‐2 inhibitor subgroups were associated with an increased likelihood of adverse drug event reporting when compared with the dipeptidyl peptidase‐4 inhibitor subgroup. A total of 328 glucose‐lowering drugs were withdrawn, more than half as a result of an adverse drug event. Conclusions More than two‐fifths of participants reported an adverse drug event; dipeptidyl peptidase‐4 inhibitors led to the highest proportion of unlabelled adverse drug events. Adverse drug event latency time data show that counselling and adverse drug event management should be proactively addressed from treatment initiation. There should be greater focus on prevalent new users of glucose‐lowering drugs, who were more complex participants in this study in terms of type 2 diabetes disease, as they were more likely to report an adverse drug event than the incident new users.

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Section: Discussionsupporting

confidence: 92%

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Torre

Guerreiro²,

Longo³

et al. 2019

Diabet. Med.

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“…More than 90% of reports were declared to involve Other serious (medical important events) , essentially owing to the reporter's appraisal of the AEs consequences on patients' family, work or social life. Impact of social media on reporting trends has been highlighted in several studies, relating in particular that AEs reported by patients provided more insight into impact of AEs in daily life . However, few studies involved active patients' groups.…”

Section: Discussionmentioning

confidence: 99%

“…Impact of social media on reporting trends has been highlighted in several studies, relating in particular that AEs reported by patients provided more insight into impact of AEs in daily life. [26][27][28] However, few studies involved active patients' groups. The most important to date could potentially concern that raised for Levothyrox in France, which was accompanied by a reporting wave of such importance that it modified the results of World Health Organisation analytics.…”

Section: Discussionmentioning

confidence: 99%

Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

Langlade

Gouverneur

Bosco‐Lévy

et al. 2019

Brit J Clinical Pharma

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Aims In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. The aim of this study was to describe the reporting of AEs regarding Mirena in France and to study the impact of media coverage on this reporting. Methods All cases reports involving Mirena recorded in the French national pharmacovigilance database from marketing (21 July 1995) until 04 August 2017 were extracted. To allow studying the influence of mediatisation, reports were described separately for the periods preceding and following the observed media coverage peak (15 May 2017). Results Overall, 3224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time‐to‐report was of 5.5 months (interquartile range: 1.7–18.6), and median number of AEs per report was 1 (range: 1–17). After the peak, 98.6% originated from patients; median time‐to‐report was 21 months (interquartile range: 8.1–45.5), and median number of AEs per report was 6 (range: 1–37). After the peak, most reports mentioned anxio‐depressive disorders (38.8 vs 10.6% before) or sexual disorders (47.3 vs 6.9%). Other emphasised AEs were weight increase (42.3 vs 10.2%) and pain (gastrointestinal, 19.1 vs 3.5%; musculoskeletal, 22.2 vs 4.5%). Conclusion This study highlighted the importance of mediatisation impact on spontaneous reporting with changes concerning amounts of reports, type of reporter, and type of reported AEs. For Mirena, this led to generate signals regarding anxio‐depressive and sexual disorders.

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“…It also identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting [10]. One of these aspects is the quality of clinical information.…”

Section: Introductionmentioning

confidence: 99%

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

et al. 2017

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IntroductionClinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients.ObjectiveThe aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional.MethodsA retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient’s healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test.ResultsA total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126).ConclusionsIn a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

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The value of patient reporting to the pharmacovigilance system: a systematic review

Cited by 158 publications

References 53 publications

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

Adverse events reported for Mirena levonorgestrel‐releasing intrauterine device in France and impact of media coverage

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis

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