Experiences with Adverse Drug Reaction Reporting by Patients

Hunsel, Florence van; Härmark, Linda; Pal, Shanthi N.; Olsson, Sten; Grootheest, Kees van

doi:10.2165/11594320-000000000-00000

Cited by 126 publications

(129 citation statements)

References 26 publications

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“…Start date of patient reporting in the specific countries was obtained from literature 2 or through personal contacts with the national pharmacovigilance centres. This was to ensure that countries not only formally accepted patient reports but actually did so in practice.…”

Section: Methodsmentioning

confidence: 99%

“…Having patients directly reporting to the national pharmacovigilance centres is relatively new in most areas of the world. In 2012 in the European Union, it became mandatory by law for countries to give patients the opportunity to report possible ADRs directly to the competent authority, although several countries introduced reporting by patients earlier 1, 2. In some countries, such as the USA, patients have already been able to report for decades.…”

Section: Introductionmentioning

confidence: 99%

“…In the USA there has been a relatively constant flow of patient reports over time, while in most European countries the number of patient reports continues to rise 3, 24, 25. Also, in the USA patient reports are mostly received through pharmaceutical companies, while in Europe patients mostly report directly to the national pharmacovigilance centre 2.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

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AimsTo explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug–adverse drug reaction (ADR) associations that led to drug safety signals.MethodsThis was a retrospective comparison of time to reporting selected drug–ADR associations which led to drug safety signals between patients and HCPs. ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug–ADR associations of actual drug safety signals. Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann–Whitney U test.ResultsIn total, 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs. 8.3 years (P < 0.001).ConclusionsPatients contributed a large proportion of reports on drug–ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Rolfes

Hunsel

Caster

et al. 2018

Brit J Clinical Pharma

Self Cite

View full text Add to dashboard Cite

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“…reporting to a health authority (or to a regional pharmacovigilance centre) or indirect via a marketing authorization holder (MAH). The percentage given in Table 1 (the patient reports column) in our paper was, most of the time, direct reporting, except for the USA and Canada, where the majority of ADR reports by patients/consumers are received indirectly via the MAH [4].…”

mentioning

confidence: 84%

Authors’ Reply to Ahmad SR: “Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries”

Margraff

Bertram

2014

Drug Saf

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“…Attempts to introduce pilot consumer drug reaction reporting between 2008 and 2010 were met with modest reporting outcomes, and led to the conclusion that improving public awareness was essential. At the time, the telephone was used as the method for contacting the regulatory agency, and reports were handled separately without much regulatory action or feedback provided [5].…”

Section: Introductionmentioning

confidence: 99%

Empowering Consumers as Contributors for Health Product Safety: Lessons from the Philippines

Hartigan-Go

2015

Drug Saf

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Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by the drug regulatory agency revealed consumers' concerns regarding health product legitimacy, quality and market claims, as well as the lack of available and accessible information. These reports led regulators to take action. Initial insights on consumer behavior are proposed for regulators and industry to consider in greater depth and how this may impact on consumers providing valued information that will promote other aspects of product safety. Key PointsConsumers and patients are important allies in ensuring the safety and efficacy of medicines.Consumer reports may bring to the surface issues and concerns involving drug safety not previously covered in reports by health professionals.Social media is a useful tool in increasing awareness and gathering information about pharmacovigilance.

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Experiences with Adverse Drug Reaction Reporting by Patients

Cited by 126 publications

References 26 publications

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Authors’ Reply to Ahmad SR: “Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries”

Empowering Consumers as Contributors for Health Product Safety: Lessons from the Philippines

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