2019
Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing
Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS. Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing. JAMA Network Open 2019, 2: e191340. PMID: 30924899, PMCID: PMC6450314, DOI: 10.1001/jamanetworkopen.2019.1340.Peer-Reviewed Original ResearchConceptsMedicare Part D beneficiariesPart D beneficiariesOpioid toleranceClock opioid analgesicsMitigation strategy programAccess programOpioid prescribing trendsPercentage of prescriptionsInterrupted time series analysisREMS implementationBreakthrough painCohort studyPrescribing trendsOpioid analgesicsCancer definitionsMAIN OUTCOMECancer statusPatientsUS FoodDrug AdministrationPrescribingCancerFentanyl drugsPrescriptionMonthly decrease
2018
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonths