Standardization of key performance indicators and metrics for investigational drug services: Consensus recommendations among IDS specialists.

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.

Evaluating the use of appropriate anticoagulation with lenalidomide and pomalidomide in patients with multiple myeloma.

BACKGROUND: Lenalidomide and pomalidomide are two immunomodulatory medications with the potential to improve outcomes for patients with multiple myeloma; however, a black box warning for venous thromboembolism exists. PURPOSE: The purpose of this study was to assess overall adherence to guideline recommendations for anticoagulation therapy with lenalidomide and pomalidomide in multiple myeloma patients. METHODS: This retrospective study at an ambulatory oncology clinic utilized chart reviews from the calendar years 2013-2016. The primary endpoint was prescription of appropriate anticoagulation upon initiation of therapy based on a list of predetermined risk factors. Secondary endpoints included incidence of deep venous thromboembolism, pulmonary embolism, myocardial infarction, stroke, and major bleed; initial anticoagulant prescribed; and whether or not anticoagulation was prescribed for another disease state. RESULTS: A total of 130 patients met inclusion criteria: 70.8% (n = 92) and 29.2% (n = 38) were prescribed lenalidomide and pomalidomide, respectively. A total risk score of two was most common (n = 54, 41.5%). Aspirin 81 mg oral tablet was prescribed most often (n = 53, 40.8%), followed by no anticoagulation (n = 30, 23.1%). Overall, 27 patients (20.8%) were prescribed anticoagulation in accordance with National Comprehensive Cancer Network guidelines. Incidence of deep venous thromboembolism was the most common adverse event (n = 4, 3.1%), followed by major bleed (n = 1, 0.8%). No reports of pulmonary embolism, myocardial infarction, or stroke were documented. CONCLUSIONS: Overall, a disparity exists between appropriate prescribing of prophylactic anticoagulation and current practice guidelines. However, documentation of thromboembolic events was lower than recorded in previously published literature.