Dataset Information

Toward Good Read-Across Practice (GRAP) guidance.

ABSTRACT: Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislations such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers its successful application and acceptance by regulatory authorities. Despite a potentially broad user community, expertise is still concentrated across a handful of organizations and individuals. In order to facilitate the effective use of read-across, this document aims to summarize the state-of-the-art, summarizes insights learned from reviewing ECHA published decisions as far as the relative successes/pitfalls surrounding read-across under REACH and compile the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, an analysis of ECHA's published final decisions associated with all levels of compliance checks and testing proposals, the consideration and expression of uncertainty, the use of biological support data and the impact of the ECHA Read-Across Assessment Framework (RAAF) published in 2015.

SUBMITTER: Ball N

PROVIDER: S-EPMC5581000 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Toward Good Read-Across Practice (GRAP) guidance.

Ball Nicholas N Cronin Mark T D MT Shen Jie J Blackburn Karen K Booth Ewan D ED Bouhifd Mounir M Donley Elizabeth E Egnash Laura L Hastings Charles C Juberg Daland R DR Kleensang Andre A Kleinstreuer Nicole N Kroese E Dinant ED Lee Adam C AC Luechtefeld Thomas T Maertens Alexandra A Marty Sue S Naciff Jorge M JM Palmer Jessica J Pamies David D Penman Mike M Richarz Andrea-Nicole AN Russo Daniel P DP Stuard Sharon B SB Patlewicz Grace G van Ravenzwaay Bennard B Wu Shengde S Zhu Hao H Hartung Thomas T

ALTEX 20160211 2

Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislations such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to su ...[more]

PMID: 26863606

Similar Datasets

Project description:BackgroundOver two million adults experience domestic violence and abuse (DVA) in England and Wales each year. Domestic homicide reviews often show that health services have frequent contact with victims and perpetrators, but healthcare professionals (HCPs) do not share information related to DVA across healthcare settings and with other agencies or services.AimWe aimed to analyse and highlight the commonalities, inconsistencies, gaps and ambiguities in English guidance for HCPs around medical confidentiality, information sharing or DVA specifically.SettingThe English National Health Service.Design and methodWe conducted a desk-based review, adopting the READ approach to document analysis. This approach is a method of qualitative health policy research and involves four steps for gathering, and extracting information from, documents. Its four steps are: (1) Ready your materials, (2) Extract data, (3) Analyse data and (4) Distill your findings. Documents were identified by searching websites of national bodies in England that guide and regulate clinical practice and by backwards citation-searching documents we identified initially.ResultsWe found 13 documents that guide practice. The documents provided guidance on (1) sharing information without consent, (2) sharing with or for multiagency risk assessment conferences (MARACs), (3) sharing for formal safeguarding and (4) sharing within the health service. Key findings were that guidance documents for HCPs emphasise that sharing information without consent can happen in only exceptional circumstances; documents are inconsistent, contradictory and ambiguous; and none of the documents, except one safeguarding guide, mention how coercive control can influence patients' free decisions.ConclusionsGuidance for HCPs on sharing information about DVA is numerous, inconsistent, ambiguous and lacking in detail, highlighting a need for coherent recommendations for cross-speciality clinical practice. Recommendations should reflect an understanding of the manifestations, dynamics and effects of DVA, particularly coercive control.

Project description:Objective:This study aims to assess good pharmacy practice (GPP) aspects and compare GPP scores among community pharmacies in Lebanon, using a tool developed jointly by the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO) to improve and maintain standards of pharmacy practice. Methods:Data collection was carried out between July and October 2018 by a team of 10 licensed inspectors who work at the Lebanese Order of Pharmacists (OPL) and visited community pharmacies across Lebanon. The questionnaire was adapted to the Lebanese context and included 109 questions organized under five sections: socio-demographics, Indicator A (data management and data recording), Indicator B (services and health promotion), Indicator C (dispensing, preparation and administration of medicines), and Indicator D (storage and facilities). The value of 75% was considered as the cutoff point for adherence to indicators. Results:Out of 276 pharmacies visited, a total of 250 (90.58%) pharmacists participated in the study with one pharmacist being interviewed in every pharmacy. Results showed that 18.8% of pharmacists were generally adherents to GPP guidelines (scores above the 75% cutoff): 23.3% were adherent to indicator A, 21.6% to indicator B, 14.8% to indicator C and 13.2% to indicator D. Moreover, comparison of GPP scores across geographical regions revealed a higher adherence among community pharmacists working in the Beirut region compared to the North region, the South region, Mount Lebanon, and the Bekaa. Conclusions:Our study shows that community pharmacists in Lebanon do not fulfill GPP criteria set by FIP/WHO, and that this poor adherence is a trend across the country's geographical regions. Therefore, efforts should be made to raise awareness among pharmacists about the necessity to adhere to GPP guidelines and standards, and train them and support them appropriately to reach that goal. This is the first indicator-based comprehensive pilot assessment to evaluate GPP adherence in community pharmacies across Lebanon. Working on the optimization of this assessment tool is also warranted.

Dataset Information

Toward Good Read-Across Practice (GRAP) guidance.

Publications

Toward Good Read-Across Practice (GRAP) guidance.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure