Needs Assessment for Pharmacy Program Creation Designed to Serve Minority Francophone Populations in Canada.

OBJECTIVES: Current literature provides little insight into the need for French-language pharmaceutical services in Francophone minority settings in Canada. This study aims to understand the pharmaceutical care and services offered in French in Canada. It also aims to conduct a needs assessment in the context of curriculum development, by validating whether pharmaceutical needs are being met in Francophone minority settings in Canada. METHODS: An online survey was sent to community members and health care professionals. Respondents were asked to identify the perceived importance of pharmaceutical needs and the degree to which they perceive these to be fulfilled in French and English in their communities. RESULTS: A total of 113 community members and 109 health care professionals completed the survey. Most respondents were from Ontario (64.84%), Quebec (10.50%), or Atlantic Provinces (10.05%). In total, > 95% of survey respondents identified that pharmaceutical needs assessed were of very high importance. The rate of pharmaceutical need fulfillment was lower in French than English across all pharmaceutical needs assessed. The greatest difference in rate of pharmaceutical need fulfillment was seen with "Having safe access to required medication". The perception of pharmaceutical needs being met was congruent between community members and health care professionals. CONCLUSION: These results confirm a lack of pharmaceutical needs being met in French in Canadian Francophone minority communities. There is a lack of French-language services that limit the ability to receive care in one's own language. Pharmacy education in French may be an effective approach to improve pharmaceutical care services received in French in Francophone minority communities.

Antimicrobial pharmacokinetics and dosing in critically ill adults receiving prolonged intermittent renal replacement therapy: A systematic review.

Prolonged intermittent renal replacement therapy (PIRRT) is gaining popularity as a renal replacement modality in intensive care units, but there is a relative lack of guidance regarding antimicrobial clearance and dosing when compared with other modalities. The objectives of this systematic review were to: (1) identify and describe the pharmacokinetics (PK) of relevant antimicrobials used in critically ill adults receiving PIRRT, (2) evaluate the quality of evidence supporting these data, and (3) propose dosing recommendations based on the synthesis of these data. A search strategy for multiple databases was designed and executed to identify relevant published evidence describing the PK of antimicrobials used in critically ill adults receiving PIRRT. Quality assessment, evaluation of reporting, and relevant data extraction were conducted in duplicate. Synthesis of PK/pharmacodynamic (PD) outcomes, dosing recommendations from study authors, and physicochemical properties of included antibiotics were assessed by investigators in addition to the quality of evidence to develop dosing recommendations. Thirty-nine studies enrolling 452 patients met criteria for inclusion and provided PK and/or PD data for 20 antimicrobials in critically ill adults receiving PIRRT. Nineteen studies describe both PK and PD outcomes. Vancomycin (12 studies, 171 patients), meropenem (7 studies, 84 patients), and piperacillin/tazobactam (5 studies, 56 patients) were the most frequent antimicrobials encountered. The quality of evidence was deemed strong for 7/20 antimicrobials, and strong dosing recommendations were determined for 9/20 antimicrobials. This systematic review updates and addresses issues of quality in previous systematic reviews on this topic. Despite an overall low quality of evidence, strong recommendations were able to be made for almost half of the identified antimicrobials. Knowledge gaps persist for many antimicrobials, and higher quality studies (i.e., population PK studies with assessment of PD target attainment) are needed to address these gaps.

Clinical utility of overviews on adverse events of pharmacological interventions.

BACKGROUND: Overviews (i.e., systematic reviews of systematic reviews, meta-reviews, umbrella reviews) are a relatively new type of evidence synthesis. Among others, one reason to conduct an overview is to investigate adverse events (AEs) associated with a healthcare intervention. Overviews aim to provide easily accessible information for healthcare decision-makers including clinicians. We aimed to evaluate the clinical utility of overviews investigating AEs. METHODS: We used a sample of 27 overviews exclusively investigating drug-related adverse events published until 2021 identified in a prior project. We defined clinical utility as the extent to which overviews are perceived to be useful in clinical practice. Each included overview was assigned to one of seven pharmacological experts with expertise on the topic of the overview. The clinical utility and value of these overviews were determined using a self-developed assessment tool. This included four open-ended questions and a ranking of three clinical utility statements completed by clinicians. We calculated frequencies for the ranked clinical utility statements and coded the answers to the open-ended questions using an inductive approach. RESULTS: The overall agreement with the provided statements was high. According to the assessments, 67% of the included overviews generated new knowledge. In 93% of the assessments, the overviews were found to add value to the existing literature. The overviews were rated as more useful than the individual included systematic reviews (SRs) in 85% of the assessments. The answers to the open-ended questions revealed two key aspects of clinical utility in the included overviews. Firstly, it was considered useful that they provide a summary of available evidence (e.g., along with additional assessments, or across different populations, or in different settings that have not been evaluated together in the included SRs). Secondly, it was found useful if overviews conducted a new meta-analysis to answer specific research questions that had not been answered previously. CONCLUSIONS: Overviews on drug-related AEs are considered valuable for clinical practice by clinicians. They can make available evidence on AEs more accessible and provide a comprehensive view of available evidence. As the role of overviews evolves, investigations such as this can identify areas of value.

A review found heterogeneous approaches and insufficient reporting in overviews on adverse events.

OBJECTIVES: To investigate reporting and methodological characteristics of overviews on adverse (drug-associated) events (AEs) of pharmacological interventions. STUDY DESIGN AND SETTING: We searched MEDLINE, Embase, Epistemonikos, and the Cochrane Database of Systematic Reviews from inception to May 17, 2021 for overviews exclusively investigating AEs of pharmacological interventions. We extracted general, reporting, and methodological characteristics and analyzed data descriptively. RESULTS: We included 27 overviews, 70% of which were published in 2016 or later. The most common nomenclature in the title was "overview" (56%), followed by "umbrella review" (26%). The median number of included systematic reviews (SRs) in each overview was 15 (interquartile range 7-34). Study selection methods were reported in 52%, methods for data extraction in 67%, and methods for critical appraisal in 63% of overviews. An assessment of methodological quality of included SRs was performed in 70% of overviews. Only 22% of overviews reported strategies for dealing with overlapping SRs. An assessment of the certainty of the evidence was performed in 33% of overviews. CONCLUSION: To ensure methodological rigor, authors of overviews on AEs should follow available guidance for the conduct and reporting of overviews.

Adverse Events Associated with Immune Checkpoint Inhibitors: Overview of Systematic Reviews.

BACKGROUND: Recognition and management of adverse events (AEs) associated with immune checkpoint inhibitor (ICI) use by cancer patients requires expertise from multiple disciplines. Greater awareness of potential AEs may result in earlier recognition, appropriate management, and better patient outcomes. OBJECTIVE: The primary objective of this overview of systematic reviews was to synthesize and consolidate systematic review evidence describing the incidence proportion and severity of AEs associated with various ICI therapies across different cancers. METHODS: A systematic literature search of four databases was conducted to identify systematic reviews that describe the incidence proportion and severity of AEs related to ICI therapy in cancer patients. A systematic review was eligible if it included adults with cancer; on ICI alone or in combination with another ICI, chemotherapy, or targeted therapy; severity (graded according to the Common Terminology Criteria for Adverse Events) and incidence proportion of AEs and whether it reported its eligibility criteria. AEs of interest were identified through an iterative ranking exercise by key stakeholders and knowledge users. Extraction of PICOTTS elements and quality indicators (AMSTAR-2) were used to manage overlap of primary studies across systematic reviews at the outcome level. Cancer subtypes were mapped to drug class and AE severity. RESULTS: Overall, 129 systematic reviews met the inclusion criteria for data mapping. Systematic reviews reported incidence proportions for more than 76 AEs, of which 34 were identified as AEs of interest. After overlap assessment, 65 systematic reviews were chosen for data extraction. The three AEs with the highest median incidence were fatigue (18.3%, interquartile range [IQR] 15.0-28.0%), diarrhea (15.3%, IQR 9.7-29.2%) and rash (14.4%, IQR 10.3-19.2%). The three AEs (high-grade) with the highest median incidence were diarrhea (1.5%, IQR 1.2-6.0%), colitis (1.3%, IQR 0.6-6.1%) and neutropenia (1.2%, IQR 0.4-3.3%). Incidence proportions of high-grade AEs were often considerably lower than all-grade AEs and combination therapy (ICI combinations or combinations of ICI with chemotherapy or targeted therapy) was responsible for some of the highest incidence proportions regardless of AE. Rare AEs and certain cancer subtypes were not well reported. CONCLUSIONS: Early recognition of AEs associated with ICIs requires expertise from diverse specialists, not just oncologists. Greater awareness of potential AEs may result in earlier recognition, appropriate management, and better patient outcomes. PROSPERO REGISTRATION: CRD42021231593.

Identifying and addressing conflicting results across multiple discordant systematic reviews on the same question: protocol for a replication study of the Jadad algorithm.

INTRODUCTION: An increasing growth of systematic reviews (SRs) presents notable challenges for decision-makers seeking to answer clinical questions. In 1997, an algorithm was created by Jadad to assess discordance in results across SRs on the same question. Our study aims to (1) replicate assessments done in a sample of studies using the Jadad algorithm to determine if the same SR would have been chosen, (2) evaluate the Jadad algorithm in terms of utility, efficiency and comprehensiveness, and (3) describe how authors address discordance in results across multiple SRs. METHODS AND ANALYSIS: We will use a database of 1218 overviews (2000-2020) created from a bibliometric study as the basis of our search for studies assessing discordance (called discordant reviews). This bibliometric study searched MEDLINE (Ovid), Epistemonikos and Cochrane Database of Systematic Reviews for overviews. We will include any study using Jadad (1997) or another method to assess discordance. The first 30 studies screened at the full-text stage by two independent reviewers will be included. We will replicate the authors' Jadad assessments. We will compare our outcomes qualitatively and evaluate the differences between our Jadad assessment of discordance and the authors' assessment. ETHICS AND DISSEMINATION: No ethics approval was required as no human subjects were involved. In addition to publishing in an open-access journal, we will disseminate evidence summaries through formal and informal conferences, academic websites, and across social media platforms. This is the first study to comprehensively evaluate and replicate Jadad algorithm assessments of discordance across multiple SRs.

Managing overlap of primary study results across systematic reviews: practical considerations for authors of overviews of reviews.

BACKGROUND: Overviews often identify and synthesise a large number of systematic reviews on the same topic, which is likely to lead to overlap (i.e. duplication) in primary studies across the reviews. Using a primary study result multiple times in the same analysis overstates its sample size and number of events, falsely leading to greater precision in the analysis. This paper aims to: (a) describe types of overlapping data that arise from the same primary studies reported across multiple reviews, (b) describe methods to identify and explain overlap of primary study data, and (c) present six case studies illustrating different approaches to manage overlap. METHODS: We first updated the search in PubMed for methods from the MOoR framework relating to overlap of primary studies. One author screened the studies titles and abstracts, and any full-text articles retrieved, extracted methods data relating to overlap of primary studies and mapped it to the overlap methods from the MOoR framework. We also describe six case studies as examples of overviews that use specific overlap methods across the steps in the conduct of an overview. For each case study, we discuss potential methodological implications in terms of limitations, efficiency, usability, and resource use. RESULTS: Nine methods studies were found and mapped to the methods identified by the MOoR framework to address overlap. Overlap methods were mapped across four steps in the conduct of an overview - the eligibility criteria step, the data extraction step, the assessment of risk of bias step, and the synthesis step. Our overview case studies used multiple methods to reduce overlap at different steps in the conduct of an overview. CONCLUSIONS: Our study underlines that there is currently no standard methodological approach to deal with overlap in primary studies across reviews. The level of complexity when dealing with overlap can vary depending on the yield, trends and patterns of the included literature and the scope of the overview question. Choosing a method might be dependent on the number of included reviews and their primary studies. Gaps in evaluation of methods to address overlap were found and further investigation in this area is needed.

Clinical and pharmacokinetic/dynamic outcomes of prolonged infusions of beta-lactam antimicrobials: An overview of systematic reviews.

OBJECTIVE: This overview of reviews aims to map and compare of objectives, methods, and findings of existing systematic reviews to develop a greater understanding of the information available about prolonged beta-lactam infusions in hospitalized patients with infection. DESIGN: Overview of systematic reviews. DATA SOURCES: Medline, Embase, PROSPERO and the Cochrane Library were systematically searched from January, 1990 to June, 2019 using a peer reviewed search strategy. Grey literature was also searched for relevant reviews. ELIGIBILITY CRITERIA FOR SELECTING REVIEWS: Systematic reviews were sought that compared two or more infusion strategies for intravenous beta-lactam antimicrobials and report clinical cure or mortality. Populations of included reviews were restricted to hospitalized patients with infection, without restrictions on age, infection type, or disease. DATA EXTRACTION AND ANALYSIS: Abstract screening, data extraction, quality and risk of bias assessment were conducted by two independent reviewers. Overlap between reviews was assessed using a modified corrected covered area. Overview findings are reported in accordance with Cochrane's recommendation for overview conduct. Clinical outcomes extracted included survival, clinical cure, treatment failure, microbiological cure, length of stay, adverse events, cost, and emergence of resistance. RESULTS: The search strategy identified 3327 unique citations from which 21 eligible reviews were included. Reviews varied by population, intervention and outcomes studied. Between reviews, overlap of primary studies was generally high, methodologic quality generally low and risk of bias variable. Nine of 14 reviews that quantitatively evaluated mortality and clinical cure identified a benefit with prolonged infusions of beta lactams when compared with intermittent infusions. Evidence of mortality and clinical cure benefit was greater among critically ill patients when compared to less sick patients and lower in randomized controlled trials when compared with observational studies. CONCLUSIONS: Findings from our review demonstrate a consistent and reproducible lack of harm with prolonged infusions of beta-lactam antibiotics with variability in effect size and significance of benefits. Despite 21 systematic reviews addressing prolonged infusions of beta-lactams, this overview supports the continued need for a definitive systematic review given variability in populations, interventions and outcomes in the current systematic reviews. Subsequent systematic reviews should have more rigorous and transparent methods, only include RCTs and evaluate the proposed benefits found in various subgroup-analyses-i.e. high risk of mortality. TRIAL REGISTRATION: Prospero registry, CRD42019117118.

A scoping review of community pharmacists and patients at risk of suicide.

BACKGROUND: Medications are commonly used in suicide attempts. Pharmacists are inextricably linked to medications and may have roles in helping those at risk of suicide. We conducted a scoping review to characterize the existing literature and make recommendations about future research. METHODS: We used a 6-step approach based on an existing scoping review methodological framework, including identifying the research question; identifying relevant studies and other literature; study and literature selection; data charting; collating, summarizing and reporting results; and dissemination of results. We searched electronic databases, various grey literature sources and mobile app stores. RESULTS: Thirty-five articles were included following screening of 1013 database citations. Of 1085 results from grey literature searches, we included 12. Most publications were opinion pieces (n = 22), followed by survey studies (n = 9), primarily assessing pharmacists' knowledge and attitudes. Themes included education and training to impact knowledge and attitudes, gatekeeping of medication supply, collaboration and integration, and role perception. Public perspectives on pharmacists' roles were limited. CONCLUSIONS: Research regarding pharmacists' roles in the care of people at risk for suicide is limited. The areas that have dominated the literature include legal liability, especially with respect to gatekeeping medications, ethical decision making and education and training. Research is needed to determine what methods, outcomes and measures are required to best serve in building the evidence base for policy and practice decisions in this area.

Pictograms for Safer Medication Management by Health Care Workers.

BACKGROUND: Inherent risks are associated with the preparation and administration of medications. As such, a key aspect of medication safety is to ensure safe medication management practices. OBJECTIVE: To identify key medication safety issues and high-alert drug classes that might benefit from implementation of pictograms, for use by health care providers, to enhance medication administration safety. This study was the first step in the development of such pictograms. METHODS: Self-identified medication management experts participated in a modified Delphi process to achieve consensus on situations where safety pictograms are required for labelling to optimize safe medication management. The study was divided into 3 phases: issue generation, issue reduction, and issue selection. Issues achieving at least 80% consensus and deemed most essential were selected for future studies. Retained issues were subjected to semiotic analysis, and preliminary pictograms were developed. RESULTS: Of the 87 health care professionals (pharmacists, pharmacy technicians, nurses, and physicians) invited to participate in the Delphi process, 30 participated in all 3 phases. A total of 55 situations that could potentially benefit from safety pictograms were generated initially. Through the Delphi process, these were narrowed down to 10 situations where medication safety might be increased with the use of safety pictograms. For most of the retained issues, between 3 and 6 pictograms were designed, based on the results of the semiotic analysis. CONCLUSIONS: The pharmacists, pharmacy technicians, nurses, and physicians participating in this study reached consensus and identified 10 medication administration safety issues that might benefit from the development and implementation of safety pictograms. Pictograms were developed for a total of 9 issues. In follow-up studies, these pictograms will be validated for comprehension and evaluated for effectiveness.

CONTEXTE: Il y a des risques inhérents associés à la préparation et à l'administration de médicaments. Pour cette raison, l'un des principaux aspects de la sécurité des médicaments est d'assurer des pratiques de gestion des médicaments sécuritaires. OBJECTIF: Déterminer les principales questions de sécurité des médicaments et les classes de médicaments de niveau d'alerte élevé pour lesquelles l'ajout de pictogrammes, destinés aux fournisseurs de soins de santé, permettrait de rendre l'administration de médicaments plus sécuritaire. La présente étude représentait la première étape dans l'élaboration de ces pictogrammes. MÉTHODES: Des professionnels qui se définissaient comme experts en gestion de médicaments ont participé à un processus Delphi modifié dans le but d'arriver à un consensus à propos des situations où des pictogrammes de sécurité doivent être ajoutés à l'étiquette afin d'optimiser la gestion sécuritaire des médicaments. L'étude a été divisée en trois phases : génération de questions de sécurité, élimination de questions de sécurité et sélection de questions de sécurité. Les questions qui atteignaient un consensus d'au moins 80 % et qui étaient considérées comme les plus essentielles ont été retenues pour des études ultérieures. Les questions de sécurité retenues ont été soumises à une analyse sémiotique, puis des ébauches de pictogrammes ont été créées. RÉSULTATS: Parmi les 87 professionnels de la santé (notamment des pharmaciens, des techniciens en pharmacie, du personnel infirmier et des médecins) invités à participer au processus Delphi, 30 ont pris part aux trois étapes. Au total, 55 situations pour lesquelles il pourrait être avantageux d'utiliser des pictogrammes de sécurité ont été générées au départ. Grâce au processus Delphi, ce nombre a été réduit à 10 situations pour lesquelles la sécurité des médicaments pourrait être accrue à l'aide de pictogrammes de sécurité. Pour la plupart des questions retenues, entre trois et six pictogrammes ont été conçus à l'aide des résultats de l'analyse sémiotique. CONCLUSION: Les pharmaciens, les techniciens en pharmacie, le personnel infirmier et les médecins qui ont participé à l'étude ont atteint un consensus sur dix questions au sujet de l'administration sécuritaire des médicaments pour lesquelles l'élaboration et la mise en place de pictogrammes de sécurité pourraient être avantageuses. Ensuite, des pictogrammes ont été conçus pour neuf questions au total. Dans les études ultérieures, il faudra évaluer l'efficacité des pictogrammes et s'assurer qu'ils sont interprétés correctement.