@article{10188,
  author = {Nicole Ansani and Carl A. Sirio and Thomas Smitherman and Bethany Fedutes-Henderson and Susan Skledar and Robert J. Weber and Nathalie Zgheib and Robert Branch},
  title = {Designing a strategy to promote safe, innovative off-label use of medications.},
  abstract = {<p>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. This strategy has been implemented through institutional staff structure. The review process balances benefits/risks for biologically plausible therapy that lacks rigorous data support. The authors' strategy illustrates collaboration that enables a priori consideration for innovative off-label medication use while providing safety surveillance and outcomes monitoring.</p>},
  year = {2006},
  journal = {Am J Med Qual},
  volume = {21},
  pages = {255-261},
  month = {12/2006},
  issn = {1062-8606},
  language = {eng},
}