Source: Council on Pharmacy Practice

To encourage pharmacists to take a leadership role in their health systems for all aspects of the proper use of medications derived from biologic sources, including preparation, storage, control, distribution, administration procedures, safe handling, and therapeutic applications; further,

To facilitate education of pharmacists about the proper use of medications derived from biologic sources.

(Note: Section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] defines biological product as follows: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine [or any other trivalent organic arsenic compound], applicable to the prevention, treatment, or cure of a disease or condition of human beings.)

This policy supersedes ASHP policy 0316.

Source: Council on Therapeutics

To support the current processes used by the Food and Drug Administration (FDA) to determine bioequivalence of generic drug products, including those with a narrow therapeutic index, and to recognize the authority of the FDA to decide if additional studies are necessary to determine equivalence; further,

To oppose a blanket restriction on generic substitution for any medication or medication class without evidence from well-designed, independent studies that demonstrate inferior efficacy or safety of the generic drug product.

Source: Council on Professional Affairs

To advocate that the prescriber provide or pharmacists have immediate access to the intended therapeutic purpose of prescribed medications in order to ensure safe and effective medication use.

This policy was reviewed in 2007 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To advocate reforms in medication-use systems, including electronic systems, and health care provider education and training that facilitate optimal patient-specific dosing in populations of patients (e.g., pediatrics, geriatrics) with altered pharmacokinetics and pharmacodynamics.

This policy was reviewed in 2006 by the Council on Pharmacy Practice and by the Board of Directors and was found to still be appropriate.

Source: Council on Administrative Affairs

To declare that decisions on the management of a medication formulary system (1) should be based on clinical, ethical, legal, social, philosophical, quality-of-life, safety, and pharmacoeconomic factors that result in optimal patient care, and (2) must include the active and direct involvement of physicians, pharmacists, and other appropriate health care professionals; further,

To declare that decisions on the management of a medication formulary system should not be based solely on economic factors.

This policy was reviewed in 2005 by the Council on Administrative Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Administrative Affairs

To declare that health-system decisions on the selection, use, and management of gene therapy agents should be based on the same principles as a medication formulary system in that (1) decisions are based on clinical, ethical, legal, social, philosophical, quality-of-life, safety, and pharmacoeconomic factors that result in optimal patient care and (2) such decisions must include the active and direct involvement of physicians, pharmacists, and other appropriate health care professionals.

This policy was reviewed in 2005 by the Council on Administrative Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To encourage pharmacists to take a leadership role in the therapeutic applications of pharmacogenomics; further,

To advocate the inclusion of pharmacogenomics and its application to therapeutic decision-making in college of pharmacy curricula.

This policy was reviewed in 2004 by the Council on Professional Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Professional Affairs

To support the principle that business leaders and health professionals must share responsibility and accountability for providing optimal health care services to patients; further,

To support the principle that business leaders should expect practicing pharmacists to formulate policies that affect the prerogative of pharmacists to make optimal care decisions on behalf of patients.

This policy was reviewed in 2003 by the Council on Professional Affairs and by the Board of Directors and was found to still be appropriate.

Source: Council on Administrative Affairs

To support the concept of a standardized medication formulary system among components of integrated health systems when standardization leads to improved patient outcomes; further,

To include in the formulary-standardization process the direct involvement of the health system's physicians, pharmacists, and other appropriate health care professionals.

This policy was reviewed in 2004 by the Council on Administrative Affairs and the Board of Directors and was found to still be appropriate.

Source: Council on Legal and Public Affairs

To support public and private initiatives to clarify and define the relationship among drugs, devices, and new technologies in order to promote safety and effectiveness as well as better delivery of patient care.

This policy was reviewed in 2006 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Source: Council on Legal and Public Affairs

To support the concept of therapeutic interchange of various drug products by pharmacists under arrangements where pharmacists and authorized prescribers interrelate on the behalf of patient care.

This policy was reviewed in 2003 by the Council on Legal and Public Affairs and by the Board of Directors and was found to still be appropriate.