Clozapine clinical toolkit optimizes inpatient clozapine monitoring.

Introduction: Clozapine is the most effective antipsychotic in the management of treatment-resistant schizophrenia; however, its use is challenging due to the risk of severe adverse effects. Despite the risks associated with clozapine, there is no mandatory monitoring in Canada beyond hematologic testing for agranulocytosis surveillance. This study focuses on the development, implementation, and evaluation of a clozapine clinical toolkit (CTK) targeted at optimizing inpatient clozapine use. Methods: A comprehensive literature review was conducted to identify clozapine best practices, experts were consulted, and a comprehensive clozapine CTK was developed and implemented at a large Canadian tertiary hospital in December 2018. To evaluate the CTK, a retrospective chart review was conducted to assess for change in guideline-concordant monitoring pre- and post- CTK implementation. Patients were included if they were > 18 years of age and received clozapine during inpatient admission. Results were analyzed using descriptive and inferential statistics. Results: Among the charts reviewed, 185 and 113 admissions met the pre- and post-CTK inclusion criteria, respectively. Staff used the CTK in the care of 96% of clozapine patients post implementation, and its use resulted in improvements in guideline-concordant monitoring for agranulocytosis and myocarditis. Discussion: Implementation of the clozapine CTK increased the concordance of clozapine monitoring with best practice recommendations. Future research is necessary to assess the impact of the CTK on clinical outcomes and patient satisfaction.

Valproic Acid-Associated Hyperammonemia: A Systematic Review.

BACKGROUND: Hyperammonemia is an adverse effect that poses clinical uncertainty around valproic acid (VPA) use. The prevalence of symptomatic and asymptomatic hyperammonemia and its relationship to VPA concentration is not well established. There is also no clear guidance regarding its management. This results in variability in the monitoring and treatment of VPA-induced hyperammonemia. To inform clinical practice, this systematic review aims to summarize evidence available around VPA-associated hyperammonemia and its prevalence, clinical outcomes, and management. METHODS: An electronic search was performed through Ovid MEDLINE, Ovid Embase, Web of Science, and PsycINFO using search terms that identified hyperammonemia in patients receiving VPA. Two reviewers independently performed primary title and abstract screening with a third reviewer resolving conflicting screening results. This process was repeated during the full-text review process. RESULTS: A total of 240 articles were included. Prevalence of asymptomatic hyperammonemia (5%-73%) was higher than symptomatic hyperammonemia (0.7%-22.2%) and occurred within the therapeutic range of VPA serum concentration. Various risk factors were identified, including concomitant medications, liver injury, and defects in carnitine metabolism. With VPA discontinued, most symptomatic patients returned to baseline mental status with normalized ammonia level. There was insufficient data to support routine monitoring of ammonia level for VPA-associated hyperammonemia. CONCLUSIONS: Valproic acid-associated hyperammonemia is a common adverse effect that may occur within therapeutic range of VPA. Further studies are required to determine the benefit of routine ammonia level monitoring and to guide the management of VPA-associated hyperammonemia.

Improving opioid stewardship programs through shared decision-making.

Opioid stewardship has emerged as an innovative systems-level approach designed to reduce inappropriate opioid prescriptions and improve patient safety in acute care settings. Modeled on the successes of antimicrobial stewardship programs, key distinctions exist; in particular, the inherent subjectivity of managing acute pain is an important consideration of opioid stewardship that differentiates it with the more objective features of antibiotic selection. Shared decision-making, with pharmacists playing a central role, is regarded as an integral part of patient care and plays a vital role in managing pain. We describe important attributes of opioid stewardship and highlight the value of incorporating shared decision-making into these novel programs.

Moving Away From a "One Size Fits All" Model: Ensuring Opioid Stewardship Includes People Who Use Drugs.

The opioid-driven overdose crisis has had devastating effects across North America, resulting from a complex interplay between individual, social-structural, and environmental factors. Changing approaches to pain management, increased heroin use, and potent synthetic opioids infiltrating the drug supply are compounded by both lack of access to opioid use disorder treatment and surrounding stigma. Inappropriate opioid prescribing practices in healthcare settings have played a central role, and in recent years, there has been increasing interest in implementing hospital-based opioid stewardship programs aimed at improving safety and monitoring opioid prescribing. There is a range of approaches taken by these programs, ranging from audit and feedback to consult services; however, a significant focus of many of these programs is on medication restriction. Such measures stand to negatively impact the care of people with complex healthcare needs, including those currently on long-term opioid therapy, and those with increased opioid tolerance. In this commentary, we emphasize the importance of creating opioid stewardship programs focused on appropriate pain treatment rather than solely on medication restriction to both appropriately prescribe to and manage pain in people who use illicit drugs. This population faces many barriers to care, such as unique dose requirements and high interpatient variability that "one size fits all" stewardship cannot appropriately address. Additionally, opioid stewardship programs that use patient-centered strategies such as multi-disciplinary consult services have been shown to lead to positive health outcomes and have significant potential to address the current shortcomings in pain management for people who use illicit drugs.

Evaluating a Pharmacist-Led Opioid Stewardship Initiative at an Urban Teaching Hospital.

BACKGROUND: Deaths due to overdose from illicit drugs have risen in Canada, despite various community-led harm reduction programs. There have been limited pharmacist-led inpatient initiatives aimed at reducing opioid harm. The authors' group recently developed and implemented the Medication and Risk Factor Review, Optimize, Refer at Risk Patients, Educate and Plan (MORE) tool, a systematic checklist designed to help pharmacists follow and enhance the safety of in-hospital opioid prescribing. OBJECTIVES: To evaluate the impact of a pharmacist-led opioid stewardship program utilizing the MORE tool in the care of patients at one tertiary teaching hospital. METHODS: This study involved a review of health care records for patients admitted to general surgery and internal medicine clinical teaching units at a tertiary hospital between September 10 and December 31, 2018, for whom opioids were prescribed during the hospital stay. A descriptive data analysis was performed for patients who underwent assessment with the MORE tool. RESULTS: Of the 210 patients who met the initial eligibility criteria, including in-hospital opioid therapy for at least 3 days, 50 were assessed by a pharmacist using the MORE tool. For 40 (80%) of these patients, the pharmacist recommended an intervention, and 35 (87.5%) of these interventions were accepted by the prescriber. Among all 50 patients, the most common pharmacist interventions were adding or optimizing non-opioid pain medications (23 patients [46%]), decreasing opioid dose or frequency (15 patients [30%]), and adding a bowel regimen (9 patients [18%]). CONCLUSIONS: Most patients who underwent assessment by a pharmacist had risk factors for adverse events from opioid prescriptions and/or suboptimal orders and drug combinations. The MORE tool provided a guided approach for pharmacists to make targeted interventions aimed at improving opioid safety. A dedicated opioid stewardship pharmacist might be able to provide additional benefit.

CONTEXTE: Les décès provoqués par les surdoses de drogues illégales ont augmenté au Canada, malgré les divers programmes communautaires axés sur la réduction des risques. Le nombre d'initiatives menées par les pharmaciens auprès des patients hospitalisés visant à réduire les dommages causés par les opioïdes est limité. Le groupe d'auteurs de cette étude a récemment élaboré et mis en place l'outil Medication and Risk Factor Review, Optimize, Refer at Risk Patients, Educate and Plan (MORE): une liste de contrôle systématique conçue pour aider les pharmaciens à respecter et à renforcer la sécurité de la prescription d'opioïdes en milieu hospitalier. OBJECTIFS: Évaluer l'impact d'un programme de gestion des opioïdes dirigé par des pharmaciens à l'aide de l'outil MORE pour les soins des patients résidant dans un hôpital d'enseignement tertiaire. MÉTHODES: Cette étude impliquait l'examen des dossiers de santé des patients admis dans les unités d'enseignement clinique de chirurgie générale et de médecine interne d'un hôpital tertiaire entre le 10 septembre et le 31 décembre 2018. Des opioïdes ont été prescrits à ces patients lors de leur séjour hospitalier. Une analyse descriptive des données a été menée auprès des patients ayant fait l'objet d'une évaluation à l'aide de l'outil MORE. RÉSULTATS: Sur les 210 patients qui répondaient aux critères d'admissibilité initiaux, notamment à celui d'un traitement aux opioïdes à l'hôpital pendant au moins trois jours, 50 ont fait l'objet d'une évaluation à l'aide de l'outil MORE. Le pharmacien a recommandé une intervention auprès de 40 de ces patients (80 %), et le prescripteur a accepté 35 de ces interventions (87,5 %). Les interventions des pharmaciens les plus répandues réalisées auprès des 50 patients consistaient en l'ajout ou en l'optimisation des analgésiques sans opioïdes (23 patients [46 %]); en la diminution de la dose d'opioïdes ou de leur fréquence (15 patients [30 %]); et en l'ajout d'un régime d'hygiène intestinale (9 patients [18 %]). CONCLUSIONS: La plupart des patients ayant fait l'objet d'une évaluation menée par un pharmacien présentaient des facteurs de risque d'effets indésirables découlant des prescriptions d'opioïdes et/ou d'ordonnances et de combinaisons médicamenteuses sous-optimales. L'outil MORE a permis aux pharmaciens d'adopter une approche guidée pour qu'ils puissent effectuer des interventions ciblées visant à améliorer l'innocuité des opioïdes. Un pharmacien affecté spécifiquement à la gestion des opioïdes pourrait offrir des avantages supplémentaires.

Designing a Pharmacist Opioid Safety and Intervention Tool.

BACKGROUND: Despite the recent increase in opioid overdoses across Canada, few pharmacy-led initiatives have been implemented to address issues related to opioid prescribing in the hospital setting. OBJECTIVES: The primary objective of this study was to develop a clinical tool, intended for use by hospital pharmacists and informed by best practices from the literature, that would provide a structured approach to enhancing the safety of opioid prescribing. The secondary objective was to collect pharmacists' opinions about the feasibility and utility of this tool. METHODS: A comprehensive literature search and pharmacist focus group analysis provided content for development of a candidate clinical tool. This tool was then piloted by clinical pharmacists working on general medical and surgical units in a single hospital. Pharmacists participating in the pilot were invited to complete an online survey concerning their perceptions of the tool. Descriptive statistics were used to analyze the survey results. RESULTS: The literature search and focus group analysis led to development of a candidate clinical tool that focused on Medication review, Optimization, Reassessment, and Education (MORE). It included key risk factors relating to opioid safety, along with suggested mitigating strategies. The MORE tool was piloted for 3 weeks by 14 clinical pharmacists, 9 of whom responded to the subsequent survey. Five respondents indicated that the clinical tool increased their ability to identify risk factors. Five respondents also noted an increase in their ability to identify possible interventions. Most respondents felt that the tool was useful and that it would be feasible to integrate it into their practice; however, they noted that a more streamlined version could improve ease of use. CONCLUSIONS: The MORE tool was well received by clinical pharmacists. Implementation of the tool into routine practice requires additional changes to improve ease of use. Suggestions for modifying and streamlining the tool will be incorporated into future versions.

CONTEXTE: Malgré l'augmentation récente des surdoses d'opioïdes au Canada, peu d'initiatives menées sous la houlette de pharmacies ont été mises en place sur les enjeux potentiels liés à la prescription d'opiacés en milieu hospitalier. OBJECTIFS: L'objectif principal de cette étude visait à élaborer un outil destiné aux pharmaciens d'hôpitaux, s'inspirant des meilleures pratiques rapportées dans la documentation, qui fournirait une approche structurée pour améliorer la sécurité de la prescription d'opioïdes. L'objectif secondaire consistait à recueillir les opinions des pharmaciens sur la faisabilité et l'utilité d'un tel outil. MÉTHODE: Des recherches bibliographiques étendues ainsi qu'une analyse de groupes de discussion de pharmaciens ont fourni le contenu nécessaire à l'élaboration d'un outil clinique expérimental. Ensuite, cet outil a été testé par des pharmaciens cliniciens travaillant dans des unités médicales générales et chirurgicales au sein d'un seul hôpital. Les pharmaciens participant au projet pilote ont été invités à répondre à une enquête en ligne sur leur perception de l'outil. Des statistiques descriptives ont permis d'analyser les résultats de l'enquête. RÉSULTATS: Les recherches bibliographiques et l'analyse des groupes de discussion ont débouché sur le développement d'un outil clinique nommé MORE [pour Medication review, Optimization, Reassessment, and Education, ou Examen, optimisation, réévaluation et éducation aux médicaments]. Il comprenait des facteurs de risque liés à la sécurité des opioïdes ainsi que des suggestions de stratégies d'atténuation. Quatorze pharmaciens cliniciens, dont neuf ont répondu à l'enquête qui a suivi, ont testé le MORE pendant trois semaines. Cinq répondants ont indiqué que l'outil clinique augmentait leur capacité à déterminer les facteurs de risque. Cinq ont également noté une meilleure capacité à déterminer les interventions possibles. La plupart des répondants ont estimé que l'outil était utile et qu'il serait possible de l'intégrer dans leur pratique; cependant, ils ont aussi noté qu'une version simplifiée pourrait faciliter son utilisation. CONCLUSIONS: Les pharmaciens cliniciens ont bien accueilli l'outil MORE. Sa mise en oeuvre dans la pratique courante exige cependant des changements supplémentaires pour faciliter son utilisation. Les versions à venir tiendront compte des propositions visant à le modifier et à le simplifier.

Incidence and Management of Clozapine-Induced Myocarditis in a Large Tertiary Hospital.

OBJECTIVE: Clozapine, an antipsychotic reserved for management of treatment-resistant schizophrenia, is associated with severe adverse effects, including myocarditis. This study aims to determine the incidence of clozapine-induced myocarditis at a large tertiary hospital compared to what is reported in the literature. METHODS: Medical records of adult patients admitted to psychiatry units receiving clozapine between January 1, 2010, and July 31, 2016, were retrospectively reviewed. Cases of clozapine-induced myocarditis were defined as having elevated C-reactive protein (CRP) or detectable troponin and at least 1 sign or symptom of myocarditis, in the absence of alternative plausible aetiologies. The primary outcome was incidence of clozapine-induced myocarditis during the study period. Secondary outcomes included rate and description of the management of clozapine-induced myocarditis. RESULTS: In total, 316 patients were screened; 10 patients met the case definition for clozapine-induced myocarditis. The incidence of this adverse drug reaction over the study period was 3.16%. Reduced left ventricular ejection fraction was observed in 60% of cases, and electrocardiography changes were noted in 60% of cases. Clozapine was discontinued in all cases. Rechallenge was performed in 2 patients; recurrent CRP elevation resulted in discontinuation in each case. Medications for management of myocarditis were used in 50% of cases. Although 2 patients required transfer to critical care, the in-hospital mortality rate was 0%. CONCLUSIONS: The incidence of clozapine-induced myocarditis at the study hospital was consistent with the higher range reported in the literature. Further research is necessary to elucidate risk factors, definitive diagnostic criteria, and effective management of clozapine-induced myocarditis.

Characterizing the inpatient care of young adults experiencing early psychosis: A medical record review.

AIM: To characterize the inpatient care received by individuals experiencing early psychotic episodes in an inner city hospital. METHOD: Medical records of patients admitted between April 01, 2013, and March 31, 2015, to a psychiatric ward at an inner city hospital were retrospectively examined. Included in the study are patients who were 25 years of age or younger and were hospitalized for psychotic symptoms. Demographics and health service use were summarized using descriptive statistics. RESULTS: A total of 73 inpatients (mean age = 22; males =78%; Caucasian = 41%) met the study inclusion criteria with a combined total of 102 care episodes and an average length of stay of 32.6 days. Monitoring of vital signs (VS) and mental status examinations (MSE) were performed in most care episodes although these were not performed regularly (daily VS checks-31%; MSE every nursing shift-18.6%). In 49% of the care episodes, patients were discharged on long-acting injectable antipsychotics. Even when indicated, not all care episodes had follow-up appointments (82.8%) in the community. The use of seclusion was higher in the wards (32%) than in the emergency department (21%), whereas the use of restraints was higher in the emergency department (16%) than in the wards (<1%). CONCLUSIONS: There is wide variation in the rate at which various clinical care processes are performed and in the provision of inpatient care to younger adults experiencing episodes of early psychosis. Consistent standards of care are needed to reduce variations and improve treatment outcomes and experiences.

Levofloxacin Use in the Neonate: A Case Series.

We report 6 cases of intravenous levofloxacin use to treat multidrug-resistant nosocomial respiratory infections in neonates with a postmenstrual age ranging from 27 to 42 weeks. Because of a lack of neonatal-specific information for levofloxacin, the usual pediatric dosage (10 mg/kg per dose every 12 hours) was used in these patients. Clinical cure occurred in 5 of the 6 patients. Only minimal short-term adverse effects were noted.

The Therapeutic Effects of Camel Milk: A Systematic Review of Animal and Human Trials.

The clinical effectiveness and value of camel milk as a therapeutic agent is currently unclear. MEDLINE (1946 to March 2016), EMBASE (1974 to March 2016), and Google Scholar were searched using the following terms: milk, bodily secretions, camels, camelus, camelini, camelidae, dromedary, bactrian camel, body fluid, and bodily secretions. Articles identified were reviewed if the study was investigating the use of camel milk for the potential treatment of diseases affecting humans. Of 430 studies, 24 were included after assessment. Identified studies highlighted treatment with camel milk of diseases, including diabetes, autism, cancer, various infections, heavy metal toxicity, colitis, and alcohol-induced toxicity. Although most studies using both the human and animal model do show a clinical benefit with an intervention and camel milk, limitations of these studies must be taken into consideration before widespread use. Based on the evidence, camel milk should not replace standard therapies for any indication in humans.

Incentives in Rheumatology: the Potential Contribution of Physician Responses to Financial Incentives, Public Reporting, and Treatment Guidelines to Health Care Sustainability.

Concerns about the sustainability of current health care expenditure are focusing attention on the cost, quality and value of health care provision. Financial incentives, for example pay-for-performance (P4P), seek to reward quality and value in health care provision. There has long been an expectation that P4P schemes are coming to rheumatology. We review the available evidence about the use of incentives in this setting and provide two emerging examples of P4P schemes which may shape the future of service provision in rheumatology. Currently, there is limited and equivocal evidence in rheumatology about the impact of incentive schemes. However, reporting variation in the quality and provision of rheumatology services has highlighted examples of inefficiencies in the delivery of care. If financial incentives can improve the delivery of timely and appropriate care for rheumatology patients, then they may have an important role to play in the sustainability of health care provision.