OBJECTIVE: To generate patient-centered, evidence-based decision support tools and compile resources that will assist pharmacists in prescription drug product substitution activities and related communication, and to present the resulting tools and resources. DATA SOURCES: Food and Drug Administration (FDA) publications, data, and communication; peer-reviewed literature; interviews with pharmacists; structured discussions with members of the project Advisory Board; and author's own knowledge and records of events. SUMMARY: A decision whether to substitute an alternative product for a prescribed medication is a clinically based process that must be grounded in appropriate medical evidence, therapeutic equivalence information, financial factors, and consideration of how the substitution will impact the patient. Product substitution decisions are influenced by therapeutic issues, legal matters, patient-centered concerns, and pharmacy practice factors, including work flow, supply issues, access to current resources, and misperceptions about database information. While generic substitution is clearly defined in many cases, some medication categories require special consideration, i.e., critical dose and narrow therapeutic index drugs, products with special release mechanisms, bioengineered protein products, many hormonal products, older drugs marketed before 1938 that were not subject to FDA approval, and others with limited bioequivalence data. In response to reports of the challenges pharmacists face when determining the appropriateness of product substitution and in support of their interdisciplinary efforts to improve medication use, the American Pharmacists Association (APhA) convened an advisory board to create the decision support tool featured in this article. CONCLUSION: The U.S. health care system and patients rely on pharmacists as medication use experts to ensure that prescription drug product substitutions are appropriate. Pharmacists must be able to efficiently determine therapeutic equivalence, identify situations where further research is required, have access to timely resources for gathering information, and effectively communicate with patients and physicians about substitution issues. The prescription drug product substitution tool and related resources presented are intended to assist pharmacists in making and communicating clinically sound product substitution decisions that are patient centered, evidence based, consistent with state and federal laws and regulations, and reflective of the realities of health care today.
OBJECTIVE: To generate patient-centered, evidence-based decision support tools and compile resources that will assist pharmacists in prescription drug product substitution activities and related communication, and to present the resulting tools and resources. DATA SOURCES: Food and Drug Administration (FDA) publications, data, and communication; peer-reviewed literature; interviews with pharmacists; structured discussions with members of the project Advisory Board; and author's own knowledge and records of events. SUMMARY: A decision whether to substitute an alternative product for a prescribed medication is a clinically based process that must be grounded in appropriate medical evidence, therapeutic equivalence information, financial factors, and consideration of how the substitution will impact the patient. Product substitution decisions are influenced by therapeutic issues, legal matters, patient-centered concerns, and pharmacy practice factors, including work flow, supply issues, access to current resources, and misperceptions about database information. While generic substitution is clearly defined in many cases, some medication categories require special consideration, i.e., critical dose and narrow therapeutic index drugs, products with special release mechanisms, bioengineered protein products, many hormonal products, older drugs marketed before 1938 that were not subject to FDA approval, and others with limited bioequivalence data. In response to reports of the challenges pharmacists face when determining the appropriateness of product substitution and in support of their interdisciplinary efforts to improve medication use, the American Pharmacists Association (APhA) convened an advisory board to create the decision support tool featured in this article. CONCLUSION: The U.S. health care system and patients rely on pharmacists as medication use experts to ensure that prescription drug product substitutions are appropriate. Pharmacists must be able to efficiently determine therapeutic equivalence, identify situations where further research is required, have access to timely resources for gathering information, and effectively communicate with patients and physicians about substitution issues. The prescription drug product substitution tool and related resources presented are intended to assist pharmacists in making and communicating clinically sound product substitution decisions that are patient centered, evidence based, consistent with state and federal laws and regulations, and reflective of the realities of health care today.