PROPOSAL:



PROPOSAL:Off-Label Use of MedicationSUBMITTED BY: Board of DirectorsDATE: October 4, 2017 SITUATION: 1.CSHP Professional Policy #2015-04 directs CSHP to adopt ASHP policies and other guidance documents as CSHP Professional Policy2.To adopt as CSHP policy all ASHP Policy Positions, Guidelines, Bulletins, and all official Statements in the current edition of the Best Practices for Health-System Pharmacy of the ASHP, except when such policies differ substantially from CSHP policy.3.To endorse the use of ASHP Position Statements, Guidelines, and Technical Assistance Bulletins by its members in their practice settings.4.CSHP will review all ASHP Policy Positions by 2020 for possible adoption as CSHP Professional Policy.5.CSHP has policy 2014-51 Off-Label Use of Medication#2014-51: Off-Label Use of Medication The California Society of Health-System Pharmacists: 1.Supports the practice of prescribing medications for off-label uses that are documented in the medical literature in a system that: a) Maintains patient access to pharmacist review of all medications. b) Protects the pharmacist’s right of refusal of an off-label use of a medication. c) Preserves the patient-pharmacist-prescriber relationship. d) Provides adequate patient counseling and education, particularly to patients taking medications for off-label use. e) Recognizes the prescriber’s responsibility in assuring the appropriate and safe use of all medications; and f) Encourages evidence-based decision making and prescribing. 2.Opposes efforts to restrict the off-label use of medication when the usage is medically appropriate, evidence-based and in the patient’s best interest 3.Recognizes the authority of the Food and Drug Administration to regulate and restrict the promotion and dissemination of information about off-label uses of medications by manufacturers.4.Supports that such promotion and dissemination of off-label use by a manufacturer be permitted if manufacturers submit a supplemental new drug application for new use within a reasonable time after initial dissemination of information about off- label uses.6.The 2016 ASHP House of Delegates replaced ASHP policy 1120 Regulation of Off-Label Promotion and Marketing with new policy 1620 with a new title, the addition of medication-containing devices and manufacturer representatives, and a revision to the paragraph on the promotion of off-label uses:1620PROMOTION OF OFF-LABEL USESTo advocate for authority for the Food and Drug Administration (FDA) to regulate the promotion and dissemination of information about off-label uses of medications and medication-containing devices by manufacturers and their representatives; further, To advocate that such off-label promotion and marketing be limited to the FDA-regulated dissemination of unbiased, truthful, and scientifically accurate information based on peer-reviewed literature not included in the New Drug Approval process.Rationale Congress is considering significant changes in the way drugs are developed, approved, and marketed in the United States. A provision in the House-passed 21st Century Cures bill (H.R. 6) would allow pharmaceutical manufacturers to promote off-label uses of their products to clinicians. This change has raised concerns about the accuracy and sources of such information. Sources of such information, if unreliable, could put patient safety at risk. Despite these concerns about promotion of off-label uses by manufacturers, ASHP has suggested an amendment that would require Food and Drug Administration (FDA) oversight of such promotion and require promotional materials to be unbiased, truthful, scientifically accurate, and based upon peer-reviewed literature not included in the approved labeling of the drug. Materials would therefore require approval by the proper authority (FDA), meet certain requirements, and be truthful and scientifically accurate.7.Status Update of H.R. 6H.R. 6 passed through the House and was sent to the Senate Committee on Health, Education, Labor, and Pensions on July 13, 2015 where it remains.TARGET:1.CSHP provides resources to its members, their patients, and the public per the 2017-2021 Strategic Priorities and Goals.2.CSHP develops professional policy in congruence with other professional organizations, but adopts policy as an independent professional society.3.CSHP has an updated professional policy that addresses off-label use of medication, which includes modifications to include text within ASHP Policy 1620. PROPOSAL: 1.Update CSHP policy 2014-51 to harmonize paragraph 4 with ASHP Policy 1620 on promotion of off-label use of medication while retaining paragraphs 1-3 in CSHP policy 2014-51.2.Adopt the following as CSHP Professional Policy:#2014-51: Off-Label Use of Medication The California Society of Health-System Pharmacists: 1.supports the practice of prescribing medications for off-label uses that are documented in the medical literature in a system that: maintains patient access to pharmacist review of all medications. protects the pharmacist’s right of refusal of an off-label use of a medication. preserves the patient-pharmacist-prescriber relationship. provides adequate patient counseling and education, particularly to patients taking medications for off-label use. recognizes the prescriber’s responsibility in assuring the appropriate and safe use of all medications; and encourages evidence-based decision making and prescribing. 2.opposes efforts to restrict the off-label use of medication when the usage is medically appropriate, evidence-based and in the patient’s best interest 3.supports the authority of the Food and Drug Administration (FDA) to regulate the promotion and dissemination of information about off-label uses of medications and medication-containing devices by manufacturers and their representatives.4. supports that such off label promotion and marketing be limited to the FDA-regulated dissemination of unbiased, truthful, and scientifically accurate information based on peer-reviewed literature not included in the New Drug Approval process. RESOURCES REQUIRED FOR PROPOSED ACTION(S) Financial: Minimal CEO time: MinimalStaff time: MinimalCSHP BOARD ACTION: The CSHP Board of Directors approved this proposal on October 3, 2017 for consideration by the 2017 House of DelegatesACTION:? Bylaws update? Rules and Procedures of the House of Delegates? Update Administrative Policy catalog ? Update Professional Policy catalog ? Staff Procedural manual? CCTF’s volunteer hand book? Minutes only? Any other (please state)HOD ACTION: Approved as written. ................
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