Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial.

OBJECTIVES: To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home. DESIGN: Randomised, parallel design. SETTING: Medical wards at six hospital sites in southern Ontario, Canada. PARTICIPANTS: Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks. INTERVENTIONS: Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care. OUTCOMES MEASURES: Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation. RESULTS: Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)). CONCLUSION: This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial. TRIAL REGISTRATION NUMBER: NCT02777047.

Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol.

BACKGROUND: Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group. METHODS: The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets; completes consult, including priorities for improving prescribing negotiated with the patient; starts the care plan; ensures a detailed discharge medication reconciliation and circle-of-care communication; and sees the patient at least twice after hospital discharge via virtual visits to consolidate the care plan in the community. Control group receives usual care. Primary outcomes are feasibility - recruitment, retention, costs, and clinical - number of drug therapy problems improved, with secondary outcomes examining coordination of transitions in care, quality of life, and healthcare utilization and costs. Follow-up is to 3-month posthospital discharge. DISCUSSION: If results support feasibility of ramp-up and promising clinical outcomes, a follow-up definitive trial will be organized using a developing national platform and medication appropriateness network. Since the intervention allows a very scarce medical specialty expertise to be offered via virtual care, there is potential to improve the safety, outcomes, and cost of care widely. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04077281.

Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD): protocol for a pilot randomised controlled trial.

BACKGROUND: Oral anticoagulants (OACs) are commonly prescribed, have well-documented benefits for important clinical outcomes but have serious harms as well. Rates of OAC-related adverse events including thromboembolic and hemorrhagic events are especially high shortly after hospital discharge. Expert OAC management involving virtual care is a research priority given its potential to reach remote communities in a more feasible, timely, and less costly way than in-person care. Our objective is to test whether a focused, expert medication management intervention using a mix of in-person consultation and virtual care follow-up, is feasible and effective in preventing anticoagulation-related adverse events, for patients transitioning from hospital to home. METHODS AND ANALYSIS: A randomized, parallel, multicenter design enrolling consenting adult patients or the caregivers of cognitively impaired patients about to be discharged from medical wards with a discharge prescription for an OAC. The interdisciplinary multimodal intervention is led by a clinical pharmacologist and includes a detailed discharge medication reconciliation and management plan focused on oral anticoagulants at hospital discharge; a circle of care handover and coordination with patient, hospital team and community providers; and early post-discharge follow-up virtual medication check-up visits at 24 h, 1 week, and 1 month. The control group will receive usual care plus encouragement to use the Thrombosis Canada website. The primary feasibility outcomes include recruitment rate, participant retention rates, trial resources management, and the secondary clinical outcomes include adverse anticoagulant safety events composite (AASE), coordination and continuity of care, medication-related problems, quality of life, and healthcare resource utilization. Follow-up is 3 months. DISCUSSION: This pilot RCT tests whether there is sufficient feasibility and merit in coordinating oral anticoagulant care early post-hospital discharge to warrant a full sized RCT. TRIAL REGISTRATION: NCT02777047.

Multidisciplinary care for opioid dose reduction in patients with chronic non-cancer pain: A systematic realist review.

CONTEXT: Opioid related deaths are at epidemic levels in many developed nations globally. Concerns about the contribution of prescribed opioids, and particularly high-dose opioids, continue to mount as do initiatives to reduce prescribing. Evidence around opioid tapering, which can be challenging and potentially hazardous, is not well developed. A recent national guideline has recognized this and recommended referral to multidisciplinary care for challenging cases of opioid tapering. However, multidisciplinary care for opioid tapering is not well understood or defined. OBJECTIVE: Identify the existing literature on any multidisciplinary care programs that evaluate impact on opioid use, synthesize how these programs work and clarify whom they benefit. STUDY DESIGN: Systematic rapid realist review. DATASET: Bibliographic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Library), grey literature, reference hand search and formal expert consultation. RESULTS: 95 studies were identified. 75% of the programs were from the United States and the majority (n = 62) were published after 2000. A minority (n = 23) of programs reported on >12 month opioid use outcomes. There were three necessary but insufficient mechanisms common to all programs: pain relief, behavior change and active medication management. Programs that did not include a combination of all three mechanisms did not result in opioid dose reductions. A concerning 20-40% of subjects resumed opioid use within one year of program completion. CONCLUSIONS: Providing alternative analgesia is insufficient for reducing opioid doses. Even high quality primary care multidisciplinary care programs do not reduce prescribed opioid use unless there is active medication management accomplished by changing the primary opioid prescriber. Rates of return to use of opioids from these programs are very concerning in the current context of a highly potent and lethal street drug supply. This contextual factor may be powerful enough to undermine the modest benefits of opioid dose reduction via multidisciplinary care.

Empowering Patients to Start a Conversation: 5 Questions to Ask about Your Medications.

This quality improvement initiative to help prevent known medication-related failures during transitions of care was co-led by Patients for Patient Safety Canada, the Institute for Safe Medication Practices Canada, the Canadian Patient Safety Institute, the Canadian Pharmacists Association, and the Canadian Society for Hospital Pharmacists. Initially, the intervention was to develop, test, evaluate and disseminate a medication safety "checklist" for patients and healthcare providers. Through small tests of change, the checklist was redesigned as the "5 Questions to Ask about Your Medications." Collective results demonstrate a shared commitment among more than 200 organizations to empower patients with questions to ask about their medications.

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.

Vasopressor stewardship: a case report and lesson shared.

A case report, focused on vasopressor use and presented in this article, is likely to resonate with many critical care nurses. In this article the authors describe opportunities to enhance safety with vasopressor therapy. Specifically, the goal of improving communication among physicians, nurses, and pharmacists around desired endpoints for vasopressor therapy, triggers for reassessment of the therapeutic strategy and cause of the patient's shock was identified as an area for improvement. A form piloted within an organization for use during multidisciplinary rounds and key findings is shared. Vasopressors constitute the mainstay of therapy for nearly every hemodynamically unstable patient in critical care. It is hoped that the lessons and information shared help empower critical care nurses to facilitate vasopressor stewardship within their facilities and, ultimately, enhance patient safety.

Review article: improving drug safety for patients undergoing anesthesia and surgery.

PURPOSE: This article presents a summary of recent advances, including tools and interventions, that are designed to improve drug safety for patients in critical care settings, particularly those undergoing anesthesia and surgery. PRINCIPAL FINDINGS: Medication error remains a leading cause of adverse events among patients undergoing anesthesia. Misidentification of ampoules, vials, and syringes is a common source of error. Systems are now being engineered to reduce the likelihood of medication misidentification through approaches such as revision of standards for labelling of drug ampoules and vials and the development of bar code systems that allow "double checking" or drug verification in the operating room. Also, efforts are being made to improve medication reconciliation, a process for accurately communicating a patient's medication information during transitions from one healthcare setting to another. Finally, the opportunity exists for anesthesiologists to increase awareness about the rising problem of opioid addiction in patients for whom typical doses are initially prescribed for appropriate indications such as postoperative pain. CONCLUSIONS: There is a need to improve drug delivery systems in complex critical care environments, particularly the operating room. Anesthesiologists must continue to play a leading role in promoting drug safety in these environments.

Drug name alert: potential for confusion between pradax and plavix.

In this article, the authors highlight an incident that involved a mix-up between the oral anticoagulant medication Pradax (dabigatran etexilate) and the antiplatelet medication Plavix (clopidogrel). Because critical care nurses may admit or care for patients who are receiving (or have received) one of these medications, it is important that they be aware of the potential for confusion between these two drug names throughout the medication-use process.

ALERT: mix-ups between conventional and lipid formulations of amphotericin B can be extremely dangerous.

In this column, the authors review Amphotericin B incidents reported Although amphotericin B may be less commonly used today because to ISMP Canada. In particular, we focus on incidents reported to have of alternative antifungal agents available, incident reports suggest resulted in patient harm due to mix-ups between the conventional there continues to be a need to alert practitioners to the different (non-lipid)formulation and lipid formulations of amphotericin B. formulations, and to implement system safety strategies.

Hospitals report on medication safety in Canada.

Measurement of safety can be difficult. Given that incident reporting systems rely primarily on voluntary reporting and some types of medication incidents may occur rarely, lack of reports about a particular type of incident cannot be interpreted as evidence that the underlying causes are resolved. Proxy measurements, such as the level of implementation of evidence-based practices known to reduce the risk of a particular incident, may provide an indication of progress toward safer systems. This article includes an overview of some proxy measurements influencing medication use systems in patient care areas, including critical care, as reported in the biennial Hospital Pharmacy in Canada survey.

Checking it twice: an evaluation of checklists for detecting medication errors at the bedside using a chemotherapy model.

OBJECTIVE: To determine what components of a checklist contribute to effective detection of medication errors at the bedside. DESIGN: High-fidelity simulation study of outpatient chemotherapy administration. SETTING: Usability laboratory. PARTICIPANTS: Nurses from an outpatient chemotherapy unit, who used two different checklists to identify four categories of medication administration errors. MAIN OUTCOME MEASURES: Rates of specified types of errors related to medication administration. RESULTS: As few as 0% and as many as 90% of each type of error were detected. Error detection varied as a function of error type and checklist used. Specific step-by-step instructions were more effective than abstract general reminders in helping nurses to detect errors. Adding a specific instruction to check the patient's identification improved error detection in this category by 65 percentage points. Matching the sequence of items on the checklist with nurses' workflow had a positive impact on the ease of use and efficiency of the checklist. CONCLUSIONS: Checklists designed with explicit step-by-step instructions are useful for detecting specific errors when a care provider is required to perform a long series of mechanistic tasks under a high cognitive load. Further research is needed to determine how best to assist clinicians in switching between mechanistic tasks and abstract clinical problem solving.

Pharmaceutical bar coding: moving forward in Canada.

The purpose of this article is to provide an update on the status of automated identification (e.g., bar coding) of pharmaceutical products manufactured for distribution within Canada.

ALERT: Revatio is another brand name for sildenafil.

In this column, the authors highlight a medication incident that occurred with Revatio (sildenafil), along with the learnings and recommendations from a previously published ISMP Canada Safety Bulletin. It is well-known to health care practitioners that use of nitroglycerin therapy is contraindicated in patients taking sildenafil (commonly known as Viagra). Many health care practitioners may be unaware that sildenafil is also marketed under the brand name Revatio for treatment of primary pulmonary hypertension or pulmonary hypertension secondary to connective tissue disease. The following incident signals the need to heighten the awareness that Revatio is a brand name for sildenafil.

A near miss involving cyclophosphamide.

Reports of near miss incidents offer valuable learning opportunities. In this article, the authors highlight a near miss incident that occurred in an intensive care unit with the cytotoxic medication cyclophosphamide, for a non-oncology indication. The learning from this incident, including recommendations, is shared.

Desmopressin (dDAVP) incident signals the need for enhanced monitoring protocols.

In this article, the authors highlight the circumstances surrounding the death of a young adult neurosurgical patient, recently reported to ISMP Canada. The incident signals the need for enhanced safeguards for patients receiving desmopressin (also known as dDAVP) and intravenous therapy. The authors present information from a recent ISMP Canada Safety Bulletin relevant to critical care, including an outline of potential contributing factors and suggested recommendations.