2019
Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.
Solotke MT, Ross JS, Shah ND, Karaca-Mandic P, Dhruva SS. Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings. Journal Of Managed Care & Specialty Pharmacy 2019, 25: 1201-1217. PMID: 31663461, PMCID: PMC10397710, DOI: 10.18553/jmcp.2019.25.11.1201.Peer-Reviewed Original ResearchConceptsBlack box warningFDA black box warningBox warningFormulary restrictionsFormulary coverageMean percentageNew black box warningsMain outcome measuresPrecision Health EconomicsNational InstituteOutcomes Research InstituteBlue Cross Blue Shield AssociationHealth care qualityCohort studyBoxed warningUnsafe medicationsDrug therapyStep therapy requirementsMayo ClinicFormulary changeOutcome measuresBlue Shield AssociationJohn Arnold FoundationDrug AdministrationFormulary management
2017
Association between FDA black box warnings and Medicare formulary coverage changes.
Dhruva SS, Karaca-Mandic P, Shah ND, Shaw DL, Ross JS. Association between FDA black box warnings and Medicare formulary coverage changes. The American Journal Of Managed Care 2017, 23: e310-e315. PMID: 29087169.Peer-Reviewed Original ResearchConceptsFDA black box warningBlack box warningNew black box warningsBox warningCardiovascular riskDrug alternativesNew safety informationMajority of drugsFormulary changeRetrospective analysisFormulary coverageFormularyDrugsCapsule formulationSubstantial proportionMedicationsDeathRiskSafety informationFDAYearsMedicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline
Dhruva SS, Desai NR, Karaca-Mandic P, Shah ND, Ross JS. Medicare Formulary Changes After the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline. Journal Of The American College Of Cardiology 2017, 69: 244-246. PMID: 28081832, DOI: 10.1016/j.jacc.2016.10.053.Peer-Reviewed Original Research