Medication Safety: What Nurses Should Know About Black Box Warnings.

"Safety first" has always been a nursing priority-just as medication education has been an essential nursing function. Approximately 79 million individuals of all ages, birth-to-death, were prescribed psychotropic medications in 2013. Nurses of all disciplines and who work in all practice settings must be aware of the potential safety concerns related to medications patients may be taking. Black Box Warnings (BBWs) are the strictest labeling requirements that the U.S. Food and Drug Administration can mandate. Risks of increased suicidality, mortality in older adults, potential for abuse and drug dependence, and life-threatening hepatic failure are among the most significant BBWs attributed to psychotropic medications. As such, nurses must be aware of not only how medications will benefit patients in relieving symptoms of or preventing their disease but also the potential risks, adverse reactions, and BBWs. [Journal of Psychosocial Nursing and Mental Health Services, 55(6), 11-15.].

Nurse-led titration of angiotensin converting enzyme inhibitors, beta-adrenergic blocking agents, and angiotensin receptor blockers for people with heart failure with reduced ejection fraction.

BACKGROUND: Heart failure is associated with high mortality and hospital readmissions. Beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors (ACEIs), and angiotensin receptor blockers (ARBs) can improve survival and reduce hospital readmissions and are recommended as first-line therapy in the treatment of heart failure. Evidence has also shown that there is a dose-dependent relationship of these medications with patient outcomes. Despite this evidence, primary care physicians are reluctant to up-titrate these medications. New strategies aimed at facilitating this up-titration are warranted. Nurse-led titration (NLT) is one such strategy. OBJECTIVES: To assess the effects of NLT of beta-adrenergic blocking agents, ACEIs, and ARBs in patients with heart failure with reduced ejection fraction (HFrEF) in terms of safety and patient outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials in the Cochrane Library (CENTRAL Issue 11 of 12, 19/12/2014), MEDLINE OVID (1946 to November week 3 2014), and EMBASE Classic and EMBASE OVID (1947 to 2014 week 50). We also searched reference lists of relevant primary studies, systematic reviews, clinical trial registries, and unpublished theses sources. We used no language restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing NLT of beta-adrenergic blocking agents, ACEIs, and/or ARBs comparing the optimisation of these medications by a nurse to optimisation by another health professional in patients with HFrEF. DATA COLLECTION AND ANALYSIS: Two review authors (AD & JC) independently assessed studies for eligibility and risk of bias. We contacted primary authors if we required additional information. We examined quality of evidence using the GRADE rating tool for RCTs. We analysed extracted data by risk ratio (RR) with 95% confidence interval (CI) for dichotomous data to measure effect sizes of intervention group compared with usual-care group. Meta-analyses used the fixed-effect Mantel-Haenszel method. We assessed heterogeneity between studies by Chi(2) and I(2). MAIN RESULTS: We included seven studies (1684 participants) in the review. One study enrolled participants from a residential care facility, and the other six studies from primary care and outpatient clinics. All-cause hospital admission data was available in four studies (556 participants). Participants in the NLT group experienced a lower rate of all-cause hospital admissions (RR 0.80, 95% CI 0.72 to 0.88, high-quality evidence) and fewer hospital admissions related to heart failure (RR 0.51, 95% CI 0.36 to 0.72, moderate-quality evidence) compared to the usual-care group. Six studies (902 participants) examined all-cause mortality. All-cause mortality was also lower in the NLT group (RR 0.66, 95% CI 0.48 to 0.92, moderate-quality evidence) compared to usual care. Approximately 27 deaths could be avoided for every 1000 people receiving NLT of beta-adrenergic blocking agents, ACEIs, and ARBs. Only three studies (370 participants) reported outcomes on all-cause and heart failure-related event-free survival. Participants in the NLT group were more likely to remain event free compared to participants in the usual-care group (RR 0.60, 95% CI 0.46 to 0.77, moderate-quality evidence). Five studies (966 participants) reported on the number of participants reaching target dose of beta-adrenergic blocking agents. This was also higher in the NLT group compared to usual care (RR 1.99, 95% CI 1.61 to 2.47, low-quality evidence). However, there was a substantial degree of heterogeneity in this pooled analysis. We rated the risk of bias in these studies as high mainly due to a lack of clarity regarding incomplete outcome data, lack of reporting on adverse events associated with the intervention, and the inability to blind participants and personnel. Participants in the NLT group reached maximal dose of beta-adrenergic blocking agents in half the time compared with participants in usual care. Two studies reported on adverse events; one of these studies stated there were no adverse events, and the other study found one adverse event but did not specify the type or severity of the adverse event. AUTHORS' CONCLUSIONS: Participants in the NLT group experienced fewer hospital admissions for any cause and an increase in survival and number of participants reaching target dose within a shorter time period. However, the quality of evidence regarding the proportion of participants reaching target dose was low and should be interpreted with caution. We found high-quality evidence supporting NLT as one strategy that may improve the optimisation of beta-adrenergic blocking agents resulting in a reduction in hospital admissions. Despite evidence of a dose-dependent relationship of beta-adrenergic blocking agents, ACEIs, and ARBs with improving outcomes in patients with HFrEF, the translation of this evidence into clinical practice is poor. NLT is one strategy that facilitates the implementation of this evidence into practice.

Therapeutic education to cancer patients: experiences of Italian nurses.

INTRODUCTION: Therapeutic patient' education is a complex process requiring a proper level of communication between the patient and the healthcare professional. Nurses play a key role in providing the patients and their families with educational activities. OBJECTIVE: This paper is the report of a study which investigates the experiences of some Italian nurses with regards to their role in therapeutic education to cancer patients. METHODS: Qualitative research. Semi-structured interviews were carried out with 52 nurses working in different Local Health Service Units of two northern Italy regions: Piedmont and Valle d'Aosta. To identify categories and items arising from the data, the researchers used a qualitative content analysis. RESULTS: The interview format was classified into six main categories: a) Patient education as daily care activity; b) Relevance of communication and dialogue for educational purposes; c) Relative usefulness of written information; d) Therapeutic education recording; e) Patients' feedbacks as a tool for assessing therapeutic education; and f) Difficult communication. CONCLUSIONS: The experience of nurses in terms of their professional role in therapeutic education for cancer patients shows the steady presence of educational activities carried out in a non-planned way. This research confirms the need to launch educational interventions for nurses. IMPLICATIONS FOR PRACTICE: It is essential to implement an action plan to promote opportunities of professional training in the field since among the most frequent reasons for project failure in therapeutic education is the lack of expert human resources.

Sedation practice in Nordic and non-Nordic ICUs: a European survey.

BACKGROUND AND AIMS: A trend towards lighter sedation has been evident in many intensive care units (ICUs). The aims of the survey were to describe sedation practice in European ICUs and to compare sedation practice in Nordic and non-Nordic countries. DESIGN AND METHODS: A cross-sectional survey of ICU nurses attending the fourth European federation of Critical Care Nursing associations (EfCCNa) in Denmark, 2011. Data included use of protocols; sedation, pain and delirium assessment tools; collaborative decision-making; sedation and analgesic medications; and educational preparation related to sedation. RESULTS: Response rate was 42% (n = 291) from 22 countries where 53% (n = 148) used sedation protocols. Nordic nurses reported greater use of sedation (91% versus 67%, p < 0·01) and pain (91% versus 69%, p < 0·01) assessment tools than non-Nordic nurses. Decision-making on sedation was more inter-professionally collaborative in Nordic ICUs (83% versus 61%, p < 0·01), units were smaller (10 versus 15 beds, p < 0·01) and nurse-patient ratio was higher (1:1, 75% versus 26%, p < 0·01). Nordic nurses reported greater consistency in maintaining circadian rhythm (66% versus 49%, p < 0·01), less use of physical restraints (14% versus 36%, p < 0·01), less use of neuromuscular blocking agents (3% versus 16%, p < 0·01), and received more sedation education (92% versus 76%, p < 0·01). Delirium assessment was not performed systematically in most settings. CONCLUSIONS: Organizational and contextual factors, such as ICU size, staffing ratio and inter-professional collaboration, are contributing factors to sedation management in European ICUs. The Nordic context might be more germane to the goal of lighter sedation and better pain management. RELEVANCE TO CLINICAL PRACTICE: Our study raises awareness of current sedation practice, paving the way towards optimized ICU sedation management.

A patient with tumor lysis syndrome.

When caring for a patient with TLS, astute nursing care is required for positive patient outcomes. Assessments and monitoring are required for prompt management of complications and patient safety. Because of the skilled nursing care that Mr. B received, along with supportive medications and hydration, his renal function improved, with increased urine output, normalization of electrolytes, and return of his appetite.

Monitoring of international normalized ratios: comparison of community nurses with family physicians.

OBJECTIVE: To determine whether community-based, nurse-led monitoring of the international normalized ratio (INR) in patients requiring long-term warfarin therapy was comparable to traditional physician monitoring. DESIGN: A retrospective cohort analysis of patients taking long-term warfarin therapy. SETTING: The study used data gathered from 3 family medicine clinics in a primary care network in Edmonton, Alta. PARTICIPANTS: Medical records of patients currently taking warfarin were examined. INTERVENTION: Implementation of nurse-led monitoring in a primary care network in place of standard family physician INR monitoring. MAIN OUTCOME MEASURES: The degree of INR control before and after the implementation of nurse-run INR monitoring was assessed. The average proportion of time spent outside of therapeutic INR ranges, as well as the average number of days between successive INR readings, was calculated and compared. The degree of control placed patients into either a good-control group (out of range ≤ 25% of the time) or a moderate-control group (out of range > 25% of the time) and these groups were compared. RESULTS: Before nurse monitoring, INR values were out of range 20.4% of the time; after nurse monitoring they were out of range 19.2% of the time (P = .115); the time between sequential INR readings also did not differ before and after implementation of nurse monitoring (23.9 vs 21.6 days, P = .789). CONCLUSION: Nurse-led monitoring of INR is as effective as traditional physician monitoring. Advantages of nurse-led monitoring might include freeing family physicians to see more patients or to spend less time at work. It might also represent potential cost savings.

Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.

BACKGROUND: Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients. METHODS: This randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per microL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was prespecified as an upper 95% CI for the hazard ratio that was less than 1.40. This study is registered with ClinicalTrials.gov, number NCT00255840. FINDINGS: 408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1.09 (95% CI 0.89-1.33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (ten vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively. INTERPRETATION: Nurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART. FUNDING: National Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.

Anticoagulation monitoring by an anticoagulation service is more cost-effective than routine physician care.

BACKGROUND: Vitamin K antagonists (VKAs) are the mainstay of long-term anticoagulation but require careful monitoring for effectiveness and safety. Physicians manage anticoagulation for most patients, although anticoagulation services are becoming increasingly popular. A new anticoagulation service (AS) run by nurses and overseen by a physician was established and its effectiveness vs usual physician care was independently assessed using costs of emergency department (ED) visits and hospitalizations resulting from failure or complication of anticoagulation. We report the results of this independent analysis of anticoagulation monitoring of patients treated with VKAs. METHODS: The AS-treated patients received VKAs according to a written protocol, whereas physician monitoring was performed according to individual practice. An independent analysis of ED visits and hospitalizations due to complications of anticoagulation in patients receiving long-term VKAs between July 1, 2008, and December 31, 2008, was performed. The average cost of ED visits and hospitalizations was calculated for each patient cohort. The expense of each was amortized for a 12-month period to determine the annual cost of anticoagulation morbidity per 100 patients treated. RESULTS: Long-term VKAs were used to treat 2397 patients. Physicians managed 2266 patients (95%; group I) and the AS monitored 131 patients (5%; group II). In group I, 247 patients (10.9%) visited the ED, with an average cost of $288 per visit; the ED cost per patient treated was $31. In group II, two patients (1.5%) visited the ED, with an average cost of $139 per patient. The ED cost per patient treated was $2, leading to annual savings of $5800 per 100 patients (P = .0006). Complications of anticoagulation required hospitalization in 289 group I patients (12.8%), with an average cost of $15,125 per hospitalization and $1929 per patient treated and in three group II patients (2.3%), with an average cost of $17,794 per hospitalization and an average cost of $401 per patient treated. When the savings from ED visits and hospitalizations were combined, AS-managed anticoagulation led to annual savings of $305,600 (P = .0004). Subtracting the cost of staff services resulted in a yearly net savings of $241,400 per 100 patients (P ≤ .0001) managed by the AS. CONCLUSIONS: Management of long-term VKA therapy by an AS using established protocols appears to reduce anticoagulation morbidity and results in significant cost savings by reducing the number of ED visits and hospitalizations.

Design and Implementation of Hospital Automatic Nursing Management Information System Based on Computer Information Technology.

Clinical nursing work fails to integrate various nursing tasks such as basic care, observation of patients' conditions, medication, treatment, communication, and health guidance to provide continuous and full nursing care for patients. Based on this, this paper uses the Internet of Things (IoT) technology to optimize the infusion process and achieve closed-loop management of medications and improve the efficiency and safety of infusion and medication administration by using a rational and effective outpatient and emergency infusion and medication management system. The system was built by applying wireless network, barcode technology, RFID, infrared tube sensing, and other technologies and was combined with actual nursing work to summarize application techniques and precautions. The application of this system will become a new highlight of medical informatization, improve patient experience, monitor infusion safety, enhance nursing care, reduce emergency medical disputes, improve patient satisfaction, and will create good social and economic benefits for the hospital.

Task Shifting for Initiation and Monitoring of Antiretroviral Therapy for HIV-Infected Adults in Uganda: The SHARE Trial.

BACKGROUND: With countries moving toward the World Health Organization's "Treat All" recommendation, there is a need to initiate more HIV-infected persons into antiretroviral therapy (ART). In resource-limited settings, task shifting is 1 approach that can address clinician shortages. SETTING: Uganda. METHODS: We conducted a randomized controlled trial to test if nurse-initiated and monitored ART (NIMART) is noninferior to clinician-initiated and monitored ART in HIV-infected adults in Uganda. Study participants were HIV-infected, ART-naive, and clinically stable adults. The primary outcome was a composite end point of any of the following: all-cause mortality, virological failure, toxicity, and loss to follow-up at 12 months post-ART initiation. RESULTS: Over half of the study cohort (1,760) was women (54.9%). The mean age was 35.1 years (SD 9.51). Five hundred thirty-three (31.6%) participants experienced the composite end point. At 12 months post-ART initiation, nurse-initiated and monitored ART was noninferior to clinician-initiated and monitored ART. The intention-to-treat site-adjusted risk differences for the composite end point were -4.1 [97.5% confidence interval (CI): = -9.8 to 0.2] with complete case analysis and -3.4 (97.5% CI: = -9.1 to 2.5) with multiple imputation analysis. Per-protocol site-adjusted risk differences were -3.6 (97.5% CI: = -10.5 to 0.6) for complete case analysis and -3.1 (-8.8 to 2.8) for multiple imputation analysis. This difference was within hypothesized margins (6%) for noninferiority. CONCLUSIONS: Nurses were noninferior to clinicians for initiation and monitoring of ART. Task shifting to trained nurses is a viable means to increase access to ART. Future studies should evaluate NIMART for other groups (e.g., children, adolescents, and unstable patients).

Cost-effectiveness of point-of-care testing with task-shifting for HIV care in South Africa: a modelling study.

BACKGROUND: The number of people on antiretroviral therapy (ART) requiring treatment monitoring in low-resource settings is rapidly increasing. Point-of-care (POC) testing for ART monitoring might alleviate burden on centralised laboratories and improve clinical outcomes, but its cost-effectiveness is unknown. METHODS: We used cost and effectiveness data from the STREAM trial in South Africa (February, 2017-October, 2018), which evaluated POC testing for viral load, CD4 count, and creatinine, with task shifting from professional to lower-cadre registered nurses compared with laboratory-based testing without task shifting (standard of care). We parameterised an agent-based network model, EMOD-HIV, to project the impact of implementing this intervention in South Africa over 20 years, simulating approximately 175 000 individuals per run. We assumed POC monitoring increased viral suppression by 9 percentage points, enrolment into community-based ART delivery by 25 percentage points, and switching to second-line ART by 1 percentage point compared with standard of care, as reported in the STREAM trial. We evaluated POC implementation in varying clinic sizes (10-50 patient initiating ART per month). We calculated incremental cost-effectiveness ratios (ICERs) and report the mean and 90% model variability of 250 runs, using a cost-effectiveness threshold of US$500 per disability-adjusted life-year (DALY) averted for our main analysis. FINDINGS: POC testing at 70% coverage of patients on ART was projected to reduce HIV infections by 4·5% (90% model variability 1·6 to 7·6) and HIV-related deaths by 3·9% (2·0 to 6·0). In clinics with 30 ART initiations per month, the intervention had an ICER of $197 (90% model variability -27 to 863) per DALY averted; results remained cost-effective when varying background viral suppression, ART dropout, intervention effectiveness, and reduction in HIV transmissibility. At higher clinic volumes (≥40 ART initiations per month), POC testing was cost-saving and at lower clinic volumes (20 ART initiations per month) the ICER was $734 (93 to 2569). A scenario that assumed POC testing did not increase enrolment into community ART delivery produced ICERs that exceeded the cost-effectiveness threshold for all clinic volumes. INTERPRETATION: POC testing is a promising strategy to cost-effectively improve patient outcomes in moderately sized clinics in South Africa. Results are most sensitive to changes in intervention impact on enrolment into community-based ART delivery. FUNDING: National Institutes of Health.

Peak flow monitoring in pediatric asthma management: a clinical practice column submission.

Peak expiratory flow (PEF) monitoring has long been a mainstay of asthma management, but controversy surrounds its efficacy in the pediatric population, and little published research exists on the subject. PEF is both effort and technique dependent and is not suitable for use in children under the age of 5 or with developmental disabilities. However, PEF is useful for monitoring airway changes if used properly, especially in that segment of the population labeled as "poor perceivers" of worsening symptoms. The authors review existing literature on the subject, including the newly revised National Heart, Lung, and Blood Institute (National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services. (2007). Expert panel report 3: Guidelines for the diagnosis and management of asthma-full report 2007. Retrieved June 17, 2008, from http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm) evidence-based guidelines.

Managing patients receiving sorafenib for advanced hepatocellular carcinoma: a case study.

Despite improvements in cytotoxic chemotherapy agents over the last 50 years, the outlook for patients with many of the most common solid tumours has remained poor. However, in recent years a number of targeted therapies have been licensed in the European Union for use in these cancer types. One such therapy, a tyrosine kinase inhibitor (sorafenib) is now used to treat patients with advanced hepatocellular carcinoma (HCC) and metastatic renal cell carcinoma. This article will explore the role of the oncology nurse in managing patients receiving sorafenib for advanced HCC. A brief overview of sorafenib as a current treatment approved for advanced HCC in the palliative setting is presented. This is followed by a case study-based discussion with particular reference to some of the key care coordination challenges facing the oncology nurse. The management of treatment-related adverse events and the importance of using a multidisciplinary team approach is also reviewed.

Clinical implications of treating depressed older adults with SSRIs: possible risk of hyponatremia.

Depression is a serious mental health problem in older adults. Some of the symptoms of depression include depressed mood, significant change in weight or appetite, changes in sleep patterns, a decrease in concentration and energy, and possible suicide. However, depression is a treatable illness, especially with the newer class of antidepressant agents, the selective serotonin reuptake inhibitors (SSRIs). One side effect of SSRI use includes hyponatremia, which is becoming an increasingly serious complication that may have harmful clinical ramifications. Older adults are especially at risk for hyponatremia and could experience serious consequences if left untreated. The purpose of this article is to use an individual example to demonstrate the clinical importance of detecting hyponatremia in older adults receiving SSRI treatment.

Regulatory components for treating persistent pain in long-term care.

Persistent or chronic pain is frequently reported by older adults and has the potential to dramatically influence quality of life. Estimates indicate that 25% to 50% of community-dwelling older adults experience this kind of pain. This rate is even higher in long-term care facilities, where 50% to 75% of residents have chronic pain syndromes that are untreated or undertreated. To promote optimal pain management and enumerate the responsibilities of skilled nursing facilities to effectively treat and prevent pain, the Centers for Medicare & Medicaid Services released a new pain management surveyor guidance, F-Tag 309, which endorses the presence of an interdisciplinary team approach to pain management that involves the resident. The guidance delineates pain management principles, the need for ongoing professional education in all components of pain management, and emphasizes the important role of appropriate pharmacological treatment in conjunction with nonpharmacological interventions to aggressively manage pain. This directive will help skilled nursing facilities achieve optimal pain management for their residents.

Antithrombosis management in community-dwelling elderly: improving safety.

Thrombus-related conditions are increasing in the elderly population. This article provides an overview of thrombus formation and describes the various pharmacologic options for prevention. Thromboprophylaxis requires an assessment of the risks and benefits of treatment so that catastrophic bleeding does not result. A practice model, the "S.A.F.E. Triad" is proposed to provide a framework for addressing safety concerns, while algorithms assist with decision-making.

Apoptosis: understanding programmed cell death for the CRNA.

Apoptosis, or programmed cell death, is a physiologic mechanism employed by most multicellular organisms to maintain homeostasis of body tissues. In balance with the production of new cells by mitosis, apoptosis provides for the orderly destruction and removal of cells that are no longer needed by the organism. Apoptosis occurs by complex pathways involving multiple biochemical signals and processes. Dysfunctional apoptotic mechanisms are the pathologic basis for many human diseases, including common disorders of the heart, lungs, brain, and endocrine systems. Researchers have demonstrated in animal models that neurodegenerative changes after the administration of anesthetic drugs are related to apoptosis. Anesthesia drugs have been found to induce apoptosis, perhaps through the production of reactive oxygen species. Propofol is a drug used in anesthesia that has unique antioxidant qualities that may be beneficial. The purpose of this article is to review, for nurse anesthesia providers, current information about the process of apoptosis, the role of apoptosis in comorbid diseases, and the implications of the effects of anesthesia drugs on normal apoptotic mechanisms that need to be evaluated as potential sources of risk or benefit to surgical patients.

Successful management of in-hospital hyperglycemia: the pivotal role of nurses in facilitating effective insulin use.

Clinical studies have shown glycemic control improves outcomes for the hospitalized patient with hyperglycemia or diabetes, and insulin use can achieve normoglycemia. The use of nurse-driven protocols for initiating and titrating insulin to improve patient outcomes significantly is described

Development, dissemination and implementation of a sedation and analgesic guideline in a pediatric intensive care unit...it takes creativity and collaboration.

Sedation and analgesia are administered to critically ill children to provide comfort and pain relief, decrease anxiety and to promote patient safety in relation to life-saving treatments. A comprehensive practice guideline focused on ways to implement evidence-based sedation and analgesia practices was developed, disseminated and implemented by an interprofessional team in the pediatric intensive care unit (PICU) at the Children's Hospital of Eastern Ontario (CHEO) in Ottawa, Canada. The goals of this quality of care initiative were to (1) reduce inconsistent practices, (2) improve patient outcomes related to comfort, and (3) enhance collaboration among health care team members caring for critically ill children. An evidence-based sedation and analgesia management (SAM) guideline for critically ill, intubated and ventilated infants and children was developed over a six-month period by a team composed of PICU physicians, pharmacists and nurses. The quality of patient care initiative focused on consistent use of (a) validated sedation and analgesia assessment tools, (b) a goal-directed approach by identifying daily therapeutic target scores and titrating interventions accordingly, and (c) non-pharmacologic, pharmacologic and adjunctive measures. The authors describe their experience in the development, dissemination and implementation of an interprofessional guideline directed at improving sedation and analgesia and patient safety in the PICU. Tools developed to support the practice change, challenges and lessons learned are shared.