Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research.

Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research. This article discusses the following general pharmacy practice-based considerations relating to IRB processes: strategies for developing research projects, key distinctions between quality improvement and research, practical considerations for submitting IRB applications and documentation, different categories of IRB submission, informed consent and conditions for waivers or alterations of consent, and principal investigator obligations for approved research. Pharmacists should also account for organization-specific IRB processes when designing, submitting, and implementing research projects.

Development of complexity categories for an investigational drug services complexity scoring tool to assess pharmacy effort in clinical trial initiation and maintenance.

PURPOSE: Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort. This project seeks to develop and validate complexity categories based on CST scores. METHODS: Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment. RESULTS: A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance. CONCLUSION: Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation.

Error-avoidance recommendations for tubing misconnections when using Luer-tip connectors: a statement by the USP Safe Medication Use Expert Committee.

Recommendations are provided to assist health care professionals, manufacturers, and consumers in the appropriate handling of tubing with Luer-tip connectors.

Cannabinoids in Pediatrics.

Despite its controversial nature, the use of medical marijuana and cannabis-derived medicinal products grows more popular with each passing year. As of November 2016, over 40 states have passed legislation regarding the use of either medical marijuana or cannabidiol products. Many providers have started encountering patients experimenting with cannabis products for a wide range of conditions. While the debate continues regarding these agents for both medicinal and recreational use in the general population, special consideration needs to be made for pediatric use. This review will deliver the history of marijuana use and legislation in the United States in addition to the currently available medical literature to equip pediatric health care providers with resources to provide patients and their parents the best recommendation for safe and appropriate use of cannabis-containing compounds.

Improving the safety of neuromuscular blocking agents: a statement from the USP Safe Medication Use Expert Committee.

PURPOSE: Recommendations of the interdisciplinary Safe Medication Use Expert Committee of the United States Pharmacopeia (USP) to assist health care professionals, manufacturers, and organizations in handling neuromuscular blocking agents (NMBAs) safely and effectively are discussed. SUMMARY: Review and analysis of the USP Medication Errors Reporting Program and MEDMARX program databases showed a continuing risk of patient harm or death due to errors with NMBAs. Medication errors involving wrong concentrations, wrong doses, wrong drugs, look-alike packaging, and sound-alike names, combined with lack of monitoring and communication, have been associated with the use of NMBAs in health care institutions. Serious adverse events occur when NMBAs are used without adequate safeguards. Recommendations for improving safety were developed through review and discussion of root causes and areas of concern with these medications. CONCLUSION: Medical errors with NMBAs continue to result in patient morbidity and mortality. Increased awareness and action on the part of all parties involved are needed to improve the safety of this class of medications.

Standardizing i.v. infusion concentrations: National survey results.

PURPOSE: The results of a 2008 survey by the U.S. Pharmacopeia (USP) Safe Medication Use Expert Committee assessing the use of standardized i.v. drug concentrations at U.S. health care institutions are presented. METHODS: To evaluate progress toward the goal of standardizing and limiting the number of i.v. infusion concentrations of high-risk medications, particularly those commonly used in pediatric patients, a USP-appointed expert committee surveyed a nationally representative sample of hospital and health-system pharmacy directors; 229 usable survey responses and 174 requested lists of routinely used or "standard" concentrations (i.e., those designed to meet the needs of at least 90% of the target adult, pediatric, and neonatal populations) were received. RESULTS: The survey responses indicated that multiple concentrations of high-risk drugs are still commonly used; in some instances, as many as four standard concentrations of a single medication were reported to be in use for a particular age group. Depending on the drug and target group, the proportion of respondents reporting the use of one standard concentration for a given drug ranged from 15% to 79%. The survey data informed and helped focus the USP expert committee's efforts to develop recommended standard concentrations for 10 high-alert drugs. Also presented in this article are general principles drafted by the USP committee to guide the development of local and national standard concentrations. CONCLUSION: The results of a national USP survey indicate that many institutions do not use standard i.v. infusion concentrations of commonly used high-risk medications in adult, pediatric, or neonatal patient populations.