Objective Anticoagulants often cause of adverse drug events (ADEs), comprised of medication errors and adverse drug reactions, in patients. Our study objective was to determine the clinical characteristics, types, severity, cause, and outcomes of anticoagulation-associated ADEs from 2015-2020 (a contemporary period following implementation of an electronic health record, infusion device technology, and anticoagulant dosing nomograms) and to compare with a historical period (2004-2009). Methods We reviewed all anticoagulant-associated ADEs reported as part of our hospital-wide safety system. Reviewers classified type, severity, root cause, and outcomes for each ADE according to standard definitions. Reviewers also assessed events for patient harm. Patients were followed up to 30 days after the event. Results Despite implementation of enhanced patient safety technology and procedure, ADEs increased in the contemporary period. In the contemporary period, we found 925 patients who had 984 anticoagulation associated ADEs, including 811 isolated medication errors (82.4%), 13 isolated adverse drug reactions (1.4%) and 160 combined medication errors/adverse drug reactions (16.2%). Unfractionated heparin was the most frequent ADE-related anticoagulant (77.7%, contemporary period vs. 58.3%, historical period). The most frequent anticoagulation associated medication error in the contemporary period were wrong rate or frequency of administration (26.1%, n=253), with the most frequent root cause being prescribing errors (21.3%, n=207). The type, root cause, and harm from ADEs were similar between periods. Conclusion We found that anticoagulation-associated ADEs occurred despite advances in patient safety technologies and practices. Events were common suggesting marginal improvements in anticoagulant safety over time and ample opportunities for improvement. 

Anticoagulation-associated Adverse Drug Events in Hospitalized Patients Across Two Time Periods.

OBJECTIVES
Community-dwelling older adults taking 5 or more medications are at risk for medication-related harm. Managing multiple medications is a challenging task for patients and caregivers. Community-dwelling older adults self-manage their medications with minimal healthcare professional supervision. Although organizations, such as the Food and Drug Administration, often issue guidelines to ensure medication safety, how older adults understand and mitigate the risk of harm from medication use in the home environment is poorly understood.


METHODS
We conducted semistructured interviews with community-dwelling older adults 65 years and older who took 5 or more prescription medications to explore medication safety strategies they use. We also compared 2 organizations' medication safety guidelines for areas of concordance and discordance.


RESULTS
A total of 28 older adults were interviewed. Four overarching themes of medication management strategies emerged: collaborating with prescribers, collaborating with pharmacists, learning about medications, and safe practices at home. Study findings revealed that older adults followed some of the published guidelines by the 2 government organizations, although there were some areas of discord. Some of the strategies used were unintentionally against the recommended guidelines. For example, older adults tried weaning themselves off their medications without notifying their providers.


CONCLUSIONS
Older adults and their caregivers in our study used strategies different from those recommended by government organizations in managing medications to enhance drug safety. Patient-provider collaboration and positive patient outcomes can be improved by understanding and respecting strategies older adults use at home. Future studies must effectively incorporate older adults' perspectives when developing medication safety guidelines.

Medication Management Strategies by Community-Dwelling Older Adults: A Multisite Qualitative Analysis.

Background Our aim was to understand actions by primary care teams to improve medication safety. Methods This was a qualitative study using one-on-one, semistructured interviews with the questions guided by concepts from collaborative care and systems engineering models, and with references to the care of older adults. We interviewed 21 primary care physicians and their team members at four primary care sites serving patients with mostly low socioeconomic status in Southwest US during 2019–2020. We used thematic analysis with a combination of inductive and deductive coding. First, codes capturing safety actions were incrementally developed and revised iteratively by a team of multidisciplinary analysts using the inductive approach. Themes that emerged from the coded safety actions taken by primary care professionals to improve medication safety were then mapped to key principles from the high reliability organisation framework using a deductive approach. Results Primary care teams described their actions in medication safety mainly in making standard-of-care medical decisions, patient-shared decision-making, educating patients and their caregivers, providing asynchronous care separate from office visits and providing clinical infrastructure. Most of the actions required customisation at the individual level, such as limiting the supply of certain medications prescribed and simplifying medication regimens in certain patients. Primary care teams enacted high reliability organisation principles by anticipating and mitigating risks and taking actions to build resilience in patient work systems. The primary care teams’ actions reflected their safety organising efforts as responses to many other agents in multiple settings that they could not control nor easily coordinate. Conclusions Primary care teams take many actions to shape medication safety outcomes in community settings, and these actions demonstrated that primary care teams are a reservoir of resilience for medication safety in the overall healthcare system. To improve medication safety, primary care work systems require different strategies than those often used in more self-contained systems such as hospital inpatient or surgical services. 

Primary care teams’ reported actions to improve medication safety: a qualitative study with insights in high reliability organising

Background Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources. Objective This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety. Methods The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients’ self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits. Results The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024. Conclusions This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. Trial Registration ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368 International Registered Report Identifier (IRRID) DERR1-10.2196/57878

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial

AIM
The aim of this study was to visualize vulnerabilities and explore the dynamics of inter-professional collaboration and organizational adaptability in the context of care transitions for patients with complex care needs.


DESIGN
An ethnographic design using multiple convergent data collection techniques.


METHODS
Data collection involved document review, participant observations and interviews with healthcare and social care professionals (HSCPs). Narrative analysis was employed to construct two illustrative patient scenarios, which were then examined using the Functional Resonance Analysis Method (FRAM). Thematic analysis was subsequently applied to synthesize the findings.


RESULTS
Inconsistencies in timing and precision during care transitions pose risks for patients with complex care needs as they force healthcare systems to prioritize structural constraints over individualized care, especially during unforeseen events outside regular hours. Such systemic inflexibility can compromise patient safety, increase the workload for HSCPs and strain resources. Organizational adaptability is crucial to managing the inherent variability of patient needs. Our proposed 'safe care transition pathway' addresses these issues, providing proactive strategies such as sharing knowledge and increasing patient participation, and strengthening the capacity of professionals to meet dynamic care needs, promoting safer care transitions.


CONCLUSION
To promote patient safety in care transitions, strategies must go beyond inter-professional collaboration, incorporating adaptability and flexible resource planning. The implementation of standardized safe care transition pathways, coupled with the active participation of patients and families, is crucial. These measures aim to create a resilient, person-centred approach that may effectively manage the complexities in care transitions.


IMPLICATIONS
The recommendations of this study span the spectrum from policy-level changes aimed at strategic resource allocation and fostering inter-professional collaboration to practical measures like effective communication, information technology integration, patient participation and family involvement. Together, the recommendations offer a holistic approach to enhance care transitions and, ultimately, patient outcomes.


REPORTING METHOD
Findings are reported per the Consolidated Criteria for Reporting Qualitative research (COREQ).


PATIENT OR PUBLIC CONTRIBUTION
No patient or public contribution.

Entangled in complexity: An ethnographic study of organizational adaptability and safe care transitions for patients with complex care needs.

Objectives Care transitions pose a high risk of adverse drug events (ADEs). We aimed to identify hazards to medication safety for older adults during care transitions using a systems approach. Methods Hospital-based professionals from 4 hospitals were interviewed about ADE risks after hospital discharge among older adults. Concerns were extracted from the interview transcript, and for each concern, hazard for medication-related harms was coded and grouped by its sources according to a human factors and systems engineering model that views postdischarge ADEs as the outcome of professional and patient home work systems. Results Thirty-eight professionals participated (5 hospitalists, 24 nurses, 4 clinical pharmacists, 3 pharmacy technicians, and 2 social workers). Hazards were classified into 6 groups, ranked by frequencies of hazards coded: (1) medication tasks related at home, (2) patient and caregiver related, (3) hospital work system related, (4) home resource related, (5) hospital professional-patient collaborative work related, and (6) external environment related. Medications most frequently cited when describing concerns included anticoagulants, insulins, and diuretics. Top coded hazard types were complex dosing, patient and caregiver knowledge gaps in medication management, errors in discharge medications, unaffordable cost, inadequate understanding about changes in medications, and gaps in access to care or in sharing medication information. Conclusions From the perspective of hospital-based frontline health care professionals, hazards for medication-related harms during care transitions were multifactorial and represented those introduced by the hospital work system as well as defects unrecognized and unaddressed in the home work system.

Understanding Hazards for Adverse Drug Events Among Older Adults After Hospital Discharge: Insights From Frontline Care Professionals

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Understanding Hazards for Adverse Drug Events Among Older Adults After Hospital Discharge: Insights From Frontline Care Professionals