PP89 The Investigation And Development Of A National Formulary Monitoring System Across Wales

IntroductionThe New Treatment Fund (NTF), launched in January 2017, aims to support the faster introduction of new medicines recommended by the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG). The NTF requires seven health boards and one trust to make recommended medicines available within 60 days of any positive recommendation decision. The project goal was to develop a system for demonstrating how monitoring the NTF improves medicines access for the people of Wales.MethodsThe process was derived via a series of task and finish group meetings with relevant stakeholders. The monitoring criteria were agreed through a collaborative expert approach using a nominal group technique. This determined a minimal dataset of formulary status, which included time to formulary addition. Pre-NTF medicines data (n = 59) were available for a six-month period.ResultsBy the three-year milestone of the NTF, the average time taken for newly recommended medicines (n = 219) to become available to patients across Wales had decreased by eighty-five percent from 90 to 13 days (p < 0.01).ConclusionsAn innovative and robust system has been created for accurately monitoring the formulary addition of medicines within the NTF, supporting the rapid and comprehensive uptake of medicines deemed clinically and cost effective by NICE and the AWMSG.

Fall-Risk-Increasing Drugs

This chapter provides a summary of current evidence on fall-risk increasing drugs from the literature (recent systematic reviews) and expert opinion on this topic (statement paper of EuGMS Task & Finish group on FRIDs and results of Delphi study of the group). Furthermore, deprescribing of FRIDs is being discussed.

Why article-level metadata is important to monitor agreements

The Knowledge Exchange (KE) Monitoring Open Access (OA) task and finish group has undertaken research on agreements with OA elements (e.g. agreements with APC discounts, offsetting agreements, read and publish agreements) set between consortia from KE countries and major publishers between 2016 and early 2019. It assessed agreements with OA elements to investigate what OA article-level metadata consortia request from publishers and what metadata publishers deliver to consortia. With more academic publishing agreements including OA elements, publishers must account for the articles published OA. For example, article processing charges may be paid directly by authors, institutions or research funders and the paying entity has the right to know what research it has funded. Another example includes agreements with a cap on the number of articles that can be published OA. In these cases, consortia and institutions must monitor how many articles are being published OA and they can only do so if publishers deliver OA article-level metadata reports on a regular basis. With Plan S research funders requiring a full transition to OA by 2021, the delivery of OA metadata becomes critical to monitor publishers’ compliance with Plan S requirements for transformative arrangements. In its research, the KE Monitoring OA group used recommendations issued by KE and the Efficiency and Standards for Article Charges (ESAC) initiative to develop a list of OA article-level metadata to evaluate if consortia requested OA metadata and if publishers delivered it. The research findings showed that not all consortia agreements requested the OA metadata as recommended by KE and ESAC. Most importantly, none of the publishers provided all the metadata that the consortia requested. Publishers also did not deliver exactly the same OA metadata across countries and this may be due lack of consistency in their practices. The research findings can be used as a benchmark to monitor how major publishers were performing in KE countries until early 2019 and prior to Plan S comes into effect in 2021. To assist in the process OA metadata collection, the KE Monitoring OA task and finish group created a template based on the KE and ESAC recommendations that consortia can use as a guideline for what OA metadata to request from publishers and that publishers can use as a reporting tool.

Uncertainty in measurement and total error: different roads to the same quality destination?

The debate comparing the benefits of measurement uncertainty (uncertainty in measurement, MU) with total error (TE) for the assessment of laboratory performance continues. The summary recently provided in this journal by members of the Task and Finish Group on Total Error (TFG-TE) of the EFLM put the arguments into clear perspective. Even though there is generally strong support for TE in many laboratories, some of the arguments proposed for its on-going support require further comment. In a recent opinion which focused directly on the TFG-TE summary, several potentially confusing statements regarding ISO15189 and the Evaluation of measurement data – Guide to the expression of uncertainty in measurement (GUM) were again promulgated to promote TE methods for assessing uncertainty in laboratory measurement. In this opinion, we present an alternative view of the key issues and outline our views with regard to the relationship between ISO15189, uncertainty in measurement and the GUM.

Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference

This paper, prepared by the EFLM Task and Finish Group on Allocation of laboratory tests to different models for performance specifications (TFG-DM), is dealing with criteria for allocating measurands to the different models for analytical performance specifications (APS) recognized in the 1st EFLM Strategic Conference Consensus Statement. Model 1, based on the effect of APS on clinical outcome, is the model of choice for measurands that have a central role in the decision-making of a specific disease or clinical situation and where cut-off/decision limits are established for either diagnosing, screening or monitoring. Total cholesterol, glucose, HbA

Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical phases”

The improving quality of laboratory testing requires a deep understanding of the many vulnerable steps involved in the total examination process (TEP), along with the identification of a hierarchy of risks and challenges that need to be addressed. From this perspective, the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is focusing its activity on implementation of an efficient tool for obtaining meaningful information on the risk of errors developing throughout the TEP, and for establishing reliable information about error frequencies and their distribution. More recently, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created the Task and Finish Group “Performance specifications for the extra-analytical phases” (TFG-PSEP) for defining performance specifications for extra-analytical phases. Both the IFCC and EFLM groups are working to provide laboratories with a system to evaluate their performances and recognize the critical aspects where improvement actions are needed. A Consensus Conference was organized in Padova, Italy, in 2016 in order to bring together all the experts and interested parties to achieve a consensus for effective harmonization of quality indicators (QIs). A general agreement was achieved and the main outcomes have been the release of a new version of model of quality indicators (MQI), the approval of a criterion for establishing performance specifications and the definition of the type of information that should be provided within the report to the clinical laboratories participating to the QIs project.