Risk control drives risk assessment and risk review: A cause and effect model of pharmaceutical drug recall on patient safety.

Background: Pharmaceutical drug recall is a relentless issue that is composed of multidimensional criteria. The distinct criteria that contributed to drug recalls have been identified in previous literature; however, there is limited information regarding the causal relationships between each criterion. Highlighting key influential aspects and criteria of pharmaceutical drug recall is critical in addressing this ongoing issue and promoting patient safety. Objective: The objective of this study is as follows: (1) identify critical criteria of pharmaceutical drug recalls for improvements, (2) determine the interrelationships among the criteria, and (3) define the causal relationships of pharmaceutical drug recall and provide theoretical insights and practice recommendations to minimize risks associated with pharmaceutical recalls and maximize patient safety. Design: This study proposes five aspects and 42 criteria to identify the impact of pharmaceutical drug recalls on patient safety by evaluating the interrelationships between the criteria by employing the fuzzy decision-making trial and evaluation laboratory method. Methods: A group of 11 professionals across the pharmaceutical industry, hospitals, ambulatory care, regulatory authority, and community care settings were selected for interviews. Results: Risk control is the influencing aspect of pharmaceutical drug recalls that has the most substantial impact on risk assessment and risk review; it generates medium effects on risk communication and technology. Risk assessment, risk communication, and risk review demonstrated comparative weak interrelationships, while risk communication exhibits a weak unidirectional effect on risk review. Finally, risk assessment exerts a weak influence on technology application and development. Product contamination, product subpotent or superpotent, injury to patients, product not sterile or impure, and system detectability of hazards have the strongest influence in the causal group of pharmaceutical drug recalls. Conclusion: The study shows that risk control drives risk assessment and risk review in the pharmaceutical industry manufacturing process. To achieve patient safety, this study suggests focusing on risk control strategies, as this aspect displays the most substantial effect on influencing other critical risk management aspects such as risk assessment and risk review.

The impact of adverse drug reactions on medication adherence and outpatient treatment outcomes in female breast cancer: A review protocol.

AIM: Discover the impact of adverse drug reactions of hormonal and chemotherapy on medication adherence and outpatient treatment outcomes in the breast cancer patient population. DESIGN: A systematic review following the reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guided by the Joanna Briggs Institute methodology will be conducted. DATA SOURCES: A literature search will be conducted using the following databases: PubMed, CINAHL, Web of Science, Medline and Scopus. REVIEW METHODS: Studies published in English before 2022 that report adverse drug reactions with medication adherence and outpatient treatment outcomes as primary outcome measures, following the initiation of one or more oral hormonal, endocrine and chemotherapy agents in female patients with diagnoses of breast cancer will be identified. Observational studies will be included for review, and two reviewers will independently screen study titles, abstracts and full text for inclusion. The quality assessment will be conducted using the Joanna Briggs Institute tools. A meta-analysis will be conducted where sufficient data are available. RESULTS: This is a systematic review study protocol, and results are not available at the time of the submission. All results will be reported on the completion of this study. DISCUSSION: This systematic review will highlight the impact of medication non-adherence on the breast cancer patient population, support determining strategies to address this issue and identify areas for further research. PATIENT OR PUBLIC CONTRIBUTION: This protocol article will identify the impact of adverse drug reactions on medication non-adherence and treatment outcomes in the female breast cancer patient population. A unique contribution of our study is to support determining strategies to address this ongoing public health issue and identify areas for further research. TRIAL REGISTRATION: This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO) database (registration number CRD 42021291364).

Examining adherence to oral anticancer medications through a human factors engineering framework: Protocol for a scoping review.

BACKGROUND: The number of oral anticancer medications has increased over the past few decades, opening new possibilities in cancer care and improving convenience for patients and caregivers. However, adherence levels continue to be suboptimal, potentially jeopardizing therapeutic benefits. Poor adherence levels may indicate gaps in current strategies and interventions aimed at enhancing medication adherence and the extent to which they address the complex and multi-faceted medication management needs of patients and their caregivers. Beyond commonly understood barriers (e.g., forgetting to take medications), adherence interventions must address systemic barriers that may not be fully appreciated by members of the healthcare system. This scoping review aims to apply a systems framework (human factors engineering framework) to examine system elements targeted by adherence enhancing interventions. METHODS: Studies published in English, reporting adherence interventions for oral anticancer medications with adherence and/or persistence as primary outcome measures will be included in this review. We will search the following electronic databases with no limits on dates: Ovid MEDLINE, Cochrane Library, Web of Science Core Collection, Embase, CINAHL Complete, PsycInfo, and Scopus. Two reviewers will independently screen study titles and abstracts for inclusion with a third reviewer adjudicating conflicts. Full text of included articles will be used to extract information on systemic barriers targeted by adherence interventions as well as information about intervention type, outcomes, and study characteristics. Extracted information will be synthesized to generate a summary of work system factors targeted by adherence interventions. DISCUSSION: Through application of a systems-based approach, this scoping review is expected to shed light on the complex and multifaceted nature of factors influencing adherence to oral anticancer agents. The review may also identify areas that are ripe for further research.