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Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

ABSTRACT: Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.

SUBMITTER: Peters T

PROVIDER: S-EPMC7813705 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

Peters Tanja T Soanes Nigel N Abbas Maya M Ahmad Jabeen J Delumeau Jean-Christophe JC Herrero-Martinez Esteban E Paramananda Mélanie M Piper Johanna J Smail-Aoudia Fairouz F van der Spuij Willemijn W Veizovic Tina T Winstanley Gillian G

Drug safety 20201208 1

Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation an ...[more]

PMID: 33289904

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Project description:Recent studies have highlighted a group of 4-repeat (4R) tauopathies that are characterised neuropathologically by widespread, globular glial inclusions (GGIs). Tau immunohistochemistry reveals 4R immunoreactive globular oligodendroglial and astrocytic inclusions and the latter are predominantly negative for Gallyas silver staining. These cases are associated with a range of clinical presentations, which correlate with the severity and distribution of underlying tau pathology and neurodegeneration. Their heterogeneous clinicopathological features combined with their rarity and under-recognition have led to cases characterised by GGIs being described in the literature using various and redundant terminologies. In this report, a group of neuropathologists form a consensus on the terminology and classification of cases with GGIs. After studying microscopic images from previously reported cases with suspected GGIs (n = 22), this panel of neuropathologists with extensive experience in the diagnosis of neurodegenerative diseases and a documented record of previous experience with at least one case with GGIs, agreed that (1) GGIs were present in all the cases reviewed; (2) the morphology of globular astrocytic inclusions was different to tufted astrocytes and finally that (3) the cases represented a number of different neuropathological subtypes. They also agreed that the different morphological subtypes are likely to be part of a spectrum of a distinct disease entity, for which they recommend that the overarching term globular glial tauopathy (GGT) should be used. Type I cases typically present with frontotemporal dementia, which correlates with the fronto-temporal distribution of pathology. Type II cases are characterised by pyramidal features reflecting motor cortex involvement and corticospinal tract degeneration. Type III cases can present with a combination of frontotemporal dementia and motor neuron disease with fronto-temporal cortex, motor cortex and corticospinal tract being severely affected. Extrapyramidal features can be present in Type II and III cases and significant degeneration of the white matter is a feature of all GGT subtypes. Improved detection and classification will be necessary for the establishment of neuropathological and clinical diagnostic research criteria in the future.

Project description:BackgroundEvaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement.MethodsThis study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran.ResultsIran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed.ConclusionA robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators' status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.

Project description:BackgroundChemotherapy Induced Peripheral Neuropathy (CIPN) is the most common presenting side effect of chemotherapy. As a sensory based neuropathy, this condition can persist for a long time after cessation of chemotherapy and impact the quality of life of cancer survivors. Podiatrists in Australia have been managing people with CIPN related lower limb complications, however guidelines on management of CIPN do not exist. The aim of this study was to achieve consensus and agreement of Australian podiatrists on strategies to best manage people presenting with symptoms of CIPN.MethodsAn online three-round modified Delphi survey of Australian podiatrists with expertise in CIPN was conducted in line with recommendations for conducting and reporting of Delphi studies (CREDES). Panellists responded to open-ended questions in Round 1, whereupon their responses were themed into statements and analysed for existing consensus. Statements not reaching consensus were returned during Round 2 to seek agreement from responders using a five-point Likert scale and to allow responders to make further comments. For a statement to reach consensus or agreement, 70% or more of panellists needed to make the same comment or agree or strongly agree with the same themed statement. Statements reaching 50 to 69% consensus or agreement were returned to panellists in Round 3 for them to consider their responses in the light of group outcomes.ResultsRound one resulted in 229 comments from 21 of 26 podiatrists who agreed to participate. These comments were themed into 53 statements with 11 consensus statements accepted. Round 2 resulted in 22 statements reaching agreement, and 15 new statements being generated from 18 comments made by 17 respondents. Round 3 resulted in 11 statements reaching agreement. Outcomes were developed into a set of clinical recommendations for diagnosis and management of people presenting with CIPN. These recommendations provide guidance on 1) identifying common signs and symptoms of CIPN including sensory, motor and autonomic symptoms; 2) diagnosis and assessment of CIPN including neurological, motor and dermatological assessment modalities; and 3) best clinical practice and management strategies for CIPN identified by podiatrists including both podiatry and non-podiatry specific care.ConclusionsThis is the first study in podiatry literature to develop expert-informed consensus-based recommendations for clinical presentation, diagnosis and assessment and management of people with CIPN. These recommendations aim to help guide podiatrists in the consistent care of people with CIPN.

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Dataset Information

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

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Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

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