RESUMEN
PURPOSE: There are currently no consensus guidelines on establishing metrics for investigational drug services (IDS). Because of the complexity of research protocols, it remains difficult for sites to track pharmacy productivity and create a baseline for IDS growth within the institution, as well as to perform benchmarking with peer institutions. The goal of this study was to help establish practical guidance for IDS metrics and site utility as applicable. METHODS: This was a survey-based project conducted by the metrics subgroup of the Hematology/Oncology Pharmacy Association (HOPA) IDS special interest group (SIG), which was formed specifically for this analysis. Three surveys developed by the metrics subgroup were sent to members of the IDS HOPA SIG to gather metrics. The first survey included questions about what metrics IDS sites currently collect. The identified metrics were then condensed into categories. Through a consensus-based approach, standardized definitions were established and applied to future surveys. The 2 subsequent surveys sent to HOPA SIG members helped create a list of top recommended metrics that are recommended for every IDS site to track. RESULTS: A total of 3 surveys were sent to 75 recipients, with the response rate ranging from 24% to 38%. From these surveys and consensus with the metrics subgroup, 5 top recommended metrics were identified: (1) active protocols; (2) dispenses; (3) new clinical trials initiated; (4) patients treated; and (5) clinical interventions. CONCLUSION: These recommended metrics should serve as guidance and allow for standardization to help ensure adequate resources are available for IDS pharmacy staff. These recommendations should serve as a basis for standardization and benchmarking with peer institutions.
Asunto(s)
Benchmarking , Consenso , Drogas en Investigación , Humanos , Drogas en Investigación/normas , Encuestas y Cuestionarios , Servicio de Farmacia en Hospital/normas , Servicio de Farmacia en Hospital/organización & administraciónRESUMEN
OBJECTIVE: This study was developed to evaluate the incidence of off-label prescribing at a pediatric rehabilitation center. Secondary objectives were to describe the medications, patient age groups, and diagnoses most often associated with off-label prescribing. METHODS: This was a prospective observational study conducted at an academic, inpatient children's rehabilitation center from November 11, 2011, to April 1, 2012. Patients younger than 16 years of age who received at least 1 prescription medication were included. Data were collected from the patients' electronic medical records. RESULTS: A total of 240 medications orders were placed during the study, with 57% written off-label. Thirty-five patients (88%) received at least 1 off-label medication. Forty-nine percent of the orders were for patients younger than the approved range, with 48% written for an unapproved indication, 2% for an alternative route of administration, and 1% for an unapproved age and indication. Children 2 to 12 years of age received 40% of the off-label orders, followed by adolescents with 37%. The therapeutic classes most often prescribed off-label were central nervous system agents and anti-infectives. CONCLUSION: Off-label prescribing was found in the majority of children receiving rehabilitative services, a rate as high or higher than that reported in pediatric acute care or clinic settings. The medications prescribed off-label most often were central nervous system agents, reflecting the need to study medications in the chronic rehabilitation population to optimize function in children with brain or spinal cord injury.
RESUMEN
Duloxetine is a serotonin-norepinephrine reuptake inhibitor approved by the US Food and Drug Administration for the treatment of fibromyalgia and painful diabetic neuropathy at doses of 60 mg daily. Duloxetine has been shown to significantly improve the symptoms of chronic pain associated with these disorders, as measured by the Fibromyalgia Impact Questionnaire, Brief Pain Inventory scores, the Clinical Global Impressions Scale, and other various outcome measures in several placebo-controlled, randomized, double-blind, multicenter studies. Symptom improvement generally began within the first few weeks, and continued for the duration of the study. In addition, the efficacy of duloxetine was found to be due to direct effects on pain symptoms rather than secondary to improvements in depression or anxiety. Adverse events including nausea, constipation, dry mouth, and insomnia, were mild and transient and occurred at relatively low rates. In conclusion, duloxetine, a selective inhibitor for the serotonin and norepinephrine transporters, is efficacious in the treatment of chronic pain associated with fibromyalgia or diabetic neuropathy, and has a predictable tolerability profile, with adverse events generally being mild to moderate.