A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee

Păcurariu, Alexandra; Coloma, Preciosa M.; Haren, Anja van; Genov, Georgy; Sturkenboom, Miriam; Straus, Sabine M. J. M.

doi:10.1007/s40264-014-0240-1

Cited by 45 publications

(42 citation statements)

References 14 publications

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“…PI updates in these cases were probably due to accumulation of evidence from different sources over the time. This finding highlights again the importance of continued pharmacovigilance for more mature products …”

Section: Discussionmentioning

confidence: 85%

“…The PRAC is responsible for recommendations following signal assessment. During the first 18 months since its operation, 59% of the signals discussed at the PRAC resulted in regulatory actions, mostly updates of safety‐related information in the PI . Such amendments can include the addition of adverse drug reaction (ADR) or new aspect of current ADR, contraindication, warning and precaution related to the drug safety, etc …”

Section: Introductionmentioning

confidence: 99%

“…During the first 18 months since its operation, 59% of the signals discussed at the PRAC resulted in regulatory actions, mostly updates of safety-related information in the PI. 7 Such amendments can include the addition of adverse drug reaction (ADR) or new aspect of current ADR, contraindication, warning and precaution related to the drug safety, etc. 8 Several signal characteristics have been postulated to help in signal assessment, including strength of evidence, public health impact, and the novelty of drugs and/or safety issues.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Characteristics of drugs safety signals that predict safety related product information update

Insani

Păcurariu

Mantel‐Teeuwisse

et al. 2018

Pharmacoepidemiology and Drug

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PurposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.MethodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.ResultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug‐event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).ConclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

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Section: Discussionmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Characteristics of drugs safety signals that predict safety related product information update

Insani

Păcurariu

Mantel‐Teeuwisse

et al. 2018

Pharmacoepidemiology and Drug

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“…SRSs are sometimes criticized for their methodological shortcomings, Electronic supplementary material The online version of this article (doi:10.1007/s00228-017-2237-z) contains supplementary material, which is available to authorized users. but are still the sole method that identifies most signals which lead to regulatory action both in the USA and in Europe [3,4]. An SRS is dependent on reports from healthcare professionals (HCPs) and patients, without reports a spontaneous reporting system cannot function.…”

Section: Introductionmentioning

confidence: 99%

A global view of undergraduate education in pharmacovigilance

Hartman

Härmark

Puijenbroek

2017

Eur J Clin Pharmacol

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“…For medicines, new pharmacovigilance regulations in the EU have highlighted the relevance of signal management, and the European Medicines Agency’s recently established Pharmacovigilance Risk Assessment Committee (PRAC) has been instructed to supervise all aspects of the use of medicines, including signal management and prioritization [21]. Numerous worldwide initiatives are investigating new methods to facilitate earlier signal detection, mainly through mining of routinely collected data from electronic healthcare records (EHRs) [22].…”

Section: Safety Evaluation: a Life Cycle Approachmentioning

confidence: 99%

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

et al. 2016

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Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit–risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.

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A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee

Cited by 45 publications

References 14 publications

Characteristics of drugs safety signals that predict safety related product information update

Characteristics of drugs safety signals that predict safety related product information update

A global view of undergraduate education in pharmacovigilance

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

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