Addressing innovative off-label medication use at an academic medical center.

Purpose: A large hospital's systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described.

Summary: In 2003 the University of Pittsburgh Medical Center (UPMC)-Presbyterian implemented a policy that created a formal process for the systematic evaluation of formulary requests and drug-utilization patterns indicating or suggesting off-label use. Explicit criteria were developed for differentiating "innovative off-label use" (i.

Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease.

Background: Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels.

Methods: We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 g/dL.

Poor 1-year outcomes after percutaneous coronary interventions in systemic lupus erythematosus: report from the National Heart, Lung, and Blood Institute Dynamic Registry.

Background: Women with systemic lupus erythematosus (SLE) have premature and accelerated atherosclerosis. Although percutaneous coronary intervention (PCI) is used frequently to treat coronary artery disease in SLE, little is known regarding PCI outcomes immediately after PCI and after discharge.

Methods And Results: Baseline demographic, procedure-related, and adverse outcome data on consecutive patients undergoing PCI during 5 recruitment "waves" of the National Heart, Lung, and Blood Institute Dynamic Registry across 23 clinical centers were collected.

Designing a strategy to promote safe, innovative off-label use of medications.

Innovative off-label medication use (defined as prescribing with reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns, yet is not clinical research) is common practice and provides challenges to ensuring high-quality health care and patient safety. This article describes a strategy to promote policy and standardization of innovative off-label medication use, ensure oversight of patient safety, and prospectively assess efficacy. A multidisciplinary group developed a policy and process to regulate innovative off-label medication use that standardizes formulary review, maximizes peer expertise input, and minimizes institution liability by evaluating the effectiveness of use, promoting evidence-based practices, and ensuring ethical obligations to patients and society.

United States medical practice summary: innovative off-label medication use.

Data are limited regarding how academic medical centers (AMCs) deal with medication use that represents a departure from product labeling; has reasonable rationale for use, but insufficient evidence to allay safety, efficacy, and cost-effectiveness concerns; yet is not clinical research (defined as innovative off-label medication use). This report describes national trends in management of innovative off-label medication use. A cross-sectional survey of US AMCs was conducted.

The value and throughput of rest Thallium-201/stress Technetium -99m sestamibi dual-isotope myocardial SPECT.

Myocardial perfusion scintigraphy is an established method in cardiology for the diagnosis and evaluation of coronary artery disease (CAD). Thallium-201 and Tc-99m sestamibi myocardial perfusion imaging has been widely accepted as non-invasive diagnostic procedure for detection of CAD, risk stratification and myocardial viability assessment. But, standard Tl-201 redistribution and same day or 2-day rest/stress Tc-99m sestamibi protocols are time-consuming.