An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring

Geissbühler, Yvonne; Rezaallah, Bita; Moore, Alan

doi:10.1016/j.reprotox.2020.03.004

Cited by 5 publications

(4 citation statements)

References 13 publications

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“…20 For example, in acknowledgement of the obstacles posed by this traditional approach, the EU recently explored using alternative methods for monitoring drug safety in pregnancy. In some cases, the EMA has accepted the use of an industry safety database called PRegnancy outcomes Intensive Monitoring (PRIM) 21 as an alternative to pregnancy registries.…”

Section: Discussionmentioning

confidence: 99%

Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies

Alexe,

Eisele,

Fernandes

et al. 2023

Brit J Clinical Pharma

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Globally, more than 200 million women become pregnant each year, most of whom receive medications despite limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine exclusion of this population from clinical trials due to scientific, ethical, regulatory and legal concerns. Consequently, at the time of initial drug approval, there may be scant safety data to inform the drug benefit‐risk balance to the mother, foetus, or infant. Although momentum is growing to include this underrepresented population in clinical trials, most information on drug exposure outcomes comes from data collected in the post‐marketing setting.Regulatory guidance and legislation on medication use in pregnancy and breastfeeding were reviewed globally by TransCelerate IGR PV Pregnancy and Breastfeeding Team. ICH standards and CIOMS guidelines served as benchmarks for national safety regulations and guidance. The landscape assessment identified a lack of harmonisation of global regulations on research in pregnant and breastfeeding women and lack of specific regulations on this topic in the majority of the territories included in the assessment.This articlefocuses on the ambiguities and lack of harmonisation in global regulations on post‐marketing pregnancy and breastfeeding safety studies. There is currently no ICH standard to guide these types of safety studies and, in most regions reviewed, there are no clear regulations or guidance on when and how to conduct them.While a challenging undertaking, greater clarity and harmonisation would facilitate more timely completion of post‐marketing pregnancy safety studies that would ultimately generate the critical data needed to optimize benefit‐risk decisions for women who may conceive. pregnant and breastfeeding women.

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Section: Discussionmentioning

confidence: 99%

Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies

Alexe,

Eisele,

Fernandes

et al. 2023

Brit J Clinical Pharma

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“…The following data sources each provided 30 randomly selected, full case reports: spontaneous reports and case reports from the literature from the Dutch national spontaneous reporting database (the Netherlands Pharmacovigilance Centre Lareb) [ 11 ]; TIS reports from both the Swiss TIS centre and the UK TIS centre [ 4 ]; pregnancy registry reports from The Dutch Pregnancy Drug Register (Lareb) [ 6 ] and the Gilenya (fingolimod) Pregnancy Registry (Novartis) [ 12 ]; and enhanced pharmacovigilance programme reports from the global Argus Safety database (Novartis) [ 5 ]. All information available in each report was extracted, except personal details or other details that could not be shared because of privacy reasons.…”

Section: Methodsmentioning

confidence: 99%

Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

van Rijt-Weetink,

Egberts,

van Hunsel

et al. 2024

Drug Saf

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Background To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and used in a new tool to assess the quality of information. However, the extent in which the presence or absence of these predefined information elements is associated with the overall clinical quality of these cases, as evaluated by pharmacovigilance experts, remains uncertain. Objective We aimed to validate a novel method to assess the clinical quality of information in real-world pregnancy pharmacovigilance case reports. Methods The clinical quality of case reports regarding medicinal product exposure and pregnancy-related outcomes was appraised from spontaneous reports, literature, Teratology Information Services (UK and Switzerland), The Dutch Pregnancy Drug Register, the Gilenya pregnancy registry and the Enhanced PV programme of Novartis. Assessment was done by means of the novel standardised tool based on the presence and relevance of information, and by expert judgement. The novel tool was validated compared to the expert assessment as the gold standard expressed as the area under the receiver operating characteristic curves, after which the sensitivity and specificity were calculated using cross-tabulations. Inter-rater variability was determined by means of weighted Cohen’s kappa. Results One hundred and eighty-six case reports were included. The clinical quality score as assessed by the novel method was divided into three categories with cut-off values of 45% (poor to intermediate) and 65% (intermediate to excellent). Sensitivity was 0.93 and 0.96 for poor to intermediate and intermediate to excellent, respectively. Specificity was respectively 0.52 and 0.73. Inter-rater variability was 0.65 (95% confidence interval 0.53–0.78) for the newly developed approach, and 0.40 (95% confidence interval 0.28–0.52) for the gold standard assessment. Conclusions The tool described in this study using the presence and relevance of elements of information is the first designed, validated and standardised method for the assessment of the quality of information of case reports in pregnancy pharmacovigilance data. This method confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01389-y.

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“…Organisations with a leading role in the collection, interpretation, and reporting of PregPV data were identified through expert working group discussion (all authors). These included international networks of teratology information services (European Network of Teratology Information Services [ENTIS]) [ 35 ] and specialists (Organization of Teratology Information Specialists [OTIS]) [ 36 ], an international disease-specific pregnancy registry (International Registry of Antiepileptic Drugs and Pregnancy [EURAP]) [ 37 ], national post-marketing surveillance systems (Vaccines and Medications in Pregnancy Surveillance System [VAMPSS]) [ 38 ], an international enhanced pregPV monitoring system (PRegnancy outcomes Intensive Monitoring [PRIM]) [ 39 ], a single medicinal product pregnancy registry (Gilenya ® /fingolimod) operated by a pharmaceutical company (Novartis) [ 40 ], and direct-to-patient online data collection systems (Best Use of Medicines in Pregnancy [BUMPs] [ 41 ], the Dutch Pregnancy Drug Register [ 42 ], and IMI PROTECT [ 43 ]). Details of the guidelines, data dictionaries, and/or data collection materials were either collected from publicly available sources or requested from each of these organisations to provide an overview of the most commonly collected data elements in PregPV research.…”

Section: Methodsmentioning

confidence: 99%

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

et al. 2023

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Introduction and ObjectiveThe risks and benefits of medication use in pregnancy are typically established through postmarketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities. Methods This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk-benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems. ResultsThe finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website (http:// www. entis-org. eu/ cde). Discussion With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.

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An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring

Cited by 5 publications

References 13 publications

Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies

Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies

Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

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