Tackling potentially inappropriate prescriptions in older adults: development of deprescribing criteria by consensus from experts in Colombia, Argentina, and Spain.

BACKGROUND: Potentially inappropriate medication use is prevalent among older adults in primary care, leading to increased morbidity, adverse drug reactions, hospitalizations, and mortality. This study aimed to develop and validate a tool for identifying PIMs in older adults within the primary care setting. The tool is composed of a list of criteria and was created based on consensus among experts from three Spanish-speaking countries, including two from Latin America. METHODS: A literature review was conducted to identify existing tools, and prescription patterns were evaluated in a cohort of 36,111 older adults. An electronic Delphi method, consisting of two rounds, was used to reach a formal expert consensus. The panel included 18 experts from Spain, Colombia, and Argentina. The content validity index, validity of each content item, and Kappa Fleiss statistical measure were used to establish reliability. RESULTS: Round one did not yield a consensus, but a definitive consensus was reached in round two. The resulting tool consisted of a list of 5 general recommendations per disease, along with 33 criteria related to potential problems, recommendations, and alternative therapeutic options. The overall content validity of the tool was 0.87, with a Kappa value of 0.69 (95% CI 0.64-0.73; Substantial). CONCLUSIONS: The developed criteria provide a novel list that allows for a comprehensive approach to pharmacotherapy in older adults, intending to reduce inappropriate medication use, ineffective treatments, prophylactic therapies, and treatments with an unfavorable risk-benefit ratio for the given condition. Further studies are necessary to evaluate the impact of these criteria on health outcomes.

From private incentives to public health need: rethinking research and development for pandemic preparedness.

Pandemic preparedness and response have relied primarily on market dynamics to drive development and availability of new health products. Building on calls for transformation, we propose a new value proposition that instead prioritises equity from the research and development (R&D) stage and that strengthens capacity to control outbreaks when and where they occur. Key elements include regional R&D hubs free to adapt well established technology platforms, and independent clinical trials networks working with researchers, regulators, and health authorities to better study questions of comparative benefit and real-world efficacy. Realising these changes requires a shift in emphasis: from pandemic response to outbreak control, from one-size-fits-all economies of scale to R&D and manufacture for local need, from de novo product development to last-mile innovation through adaptation of existing technologies, and from proprietary, competitive R&D to open science and financing for the common good that supports collective management and sharing of technology and know-how.

Development of a stepwise tool to aide primary health care professionals in the process of deprescribing in older persons.

OBJECTIVE: The aim of this study was to develop and validate a stepwise tool to aid primary health care professionals in the process of deprescribing potentially inappropriate medication in older persons. METHODS: We carried out a systematic review to identify previously published tools. A composite proposal of algorithm was made by following the steps from clinical experience to deprescribe medications. A 2-round electronic Delphi method was conducted to establish consensus. Eighteen experts from different countries (Colombia, Spain and Argentina) accepted to be part of the panel representing geriatricians, internists, endocrinologist, general practitioners, pharmacologists, clinical pharmacists, family physicians and nurses. Panel members were asked to mark a Likert Scale from 1 to 9 points (1= strongly disagree, 9= strongly agree). The content validity ratio, item-level content validity, and Fleiss' Kappa statistics was measured to establish reliability. The same voting method was used for round 2. RESULTS: A 7-question algorithm was proposed. Each question was part of a domain and conduct into a decision. In round 1, a consensus was not reached but statements were grouped and organized. In round 2, the tool met consensus. The inter-rater reliability was between substantial and almost perfect for questions with Kappa=0.77 (95% CI 0.60-0.93), for domains with Kappa= 0.73 (95%CI 0.60-0.86) and for decisions with Kappa= 0.97 (95%CI 0.90-1.00). CONCLUSIONS: This is a novel tool that captures and supports healthcare professionals in clinical decision-making for deprescribing potentially inappropriate medication. This includes patient's and caregiver's preferences about medication. This tool will help to standardize care and provide guidance on the prescribing/deprescribing process of older persons' medications. Also, it provides a holistic way to reduce polypharmacy and inappropriate medications in clinical practice.

Algorithm for the evaluation of therapeutic failure reports--proposal and pilot analysis.

PURPOSE: To propose and validate an algorithm to analyze the reports of suspected therapeutic failure (TF) received in pharmacovigilance programs. METHODS: A Delphi consensus method with a group of 12 international experts was used to identify the different causes that prompt TF and to propose an algorithm to analyze reports of suspected lack of efficacy of medicines. A pilot analysis of 50 reports was the basis to evaluate the interrater and intrarater validity of the algorithm. RESULTS: A 10-question algorithm was proposed. The evaluation of 50 reports of suspected TF showed that only 8% could be actually attributed to a manufacturing quality problem, whereas the real reason underlying the alleged TF was the inappropriate use of the prescribed drug in 28%. Minimum information to attribute the cause to a TF was lacking in 31% of these reports. The interrater reliability was "moderate" (kappa coefficient = 0.55), and the intrarater reliability ranged from 0.732 to 0.908 ("substantial" to "almost perfect"). CONCLUSIONS: The proposed TF algorithm is a valid, reliable, and reproducible analysis tool that can help to disentangle the frequent and complex reports of suspected TF.