A new tool that could provide a useful framework for deciding what medicines to include in drug formularies is presented in this week's PLoS Medicine by the experts from Harvard Medical School and the University of Illinois at Chicago who developed it.
The experts, led by Gordon Schiff, say: "Formularies and committees that oversee them are present in some form in virtually every US hospital and outpatient drug plan and are highly visible components of public drug benefits in many countries. Thus decisions made by these committees directly or indirectly impact every prescriber, pharmacist, and patient."
Although considerable attention has been devoted to their role in cost containment, the authors argue that "formularies' role in guiding rational drug use remains underdeveloped and could be improved by a more standardized critical evaluation of drugs proposed for formulary placement."
So in a joint project, the authors developed a tool consisting of checklist of 48 questions for evaluating drugs to be considered for inclusion in the formulary related to the evidence of need, efficacy, medication safety, misuse potential, cost issues, and decision-making process.
The authors say: "The checklist can facilitate more standardized and critical scrutiny of the evidence and therapeutic alternatives. It can educate new committee members, guide discussions of drugs proposed for formulary addition, and be used to evaluate the quality of committee decision making."
The authors conclude: "we offer the tool for a broader audience to use and test. We hope that it will prove useful in improving the quality of formulary decision making and stimulating debate related to critical questions that need to be asked, highlighting essential data needed to more safely prescribe drugs."
Funding: This work originated from the Formulary Leveraged Improved Prescribing (FLIP) project, which was funded by the Attorney General Consumer and Prescriber Education Grant Program, and was supported by the Agency for Healthcare Research and Quality grant U18HS016973 funding the UIC Center for Education and Research on Therapeutics (CERT) program. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: WG received grant funding from Abbott Labs- 2% FTE this year, Consulting with Walgreens (member of P&T Committee, ~$5,000). JD had a summer student internship with Abbott Laboratories in Regulatory Affairs 2009-2010 7 k (2009) 8 k (2010). SW consulted for Abbott, Genentech, Primus. MK is a Consultant Pharmacist, Pharmacy and Therapeutics Committee, Catalyst Health Solutions, Inc, Rockville, MD. DT received unrestricted grant funding for research from Medco Health Solutions. BL consulted in last 3 years: Abbott (drug name confusion), Transcept. Stock ownership: Pharm I.R., Inc. (my own company, specializing in preventing and detecting drug name confusion errors). Expert witness testimony: Hernandez v. Schering (for Hernandez), Mason v. General Electric Company, et al. (for Mason). Grants received: Abbott (readability of MedGuides), Novartis (development of pharmacoepidemiologic methods), Ortho McNeil (safety of warfarin post orthopedic surgery), AHRQ (Tools for Optimizing Prescribing). Patents received: BLL Consulting, Inc. (related to preventing drug name confusions) Other: Board of Directors (unpaid) for Med-Errs, Inc. (drug name confusion).
Citation: Schiff GD, Galanter WL, Duhig J, Koronkowski MJ, Lodolce AE, et al. (2012) A Prescription for Improving Drug Formulary Decision Making. PLoS Med 9(5): e1001220. doi:10.1371/journal.pmed.1001220
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Brigham and Woman's Hospital
Harvard Medical School
United States of America