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25_Policy, Practice, and Regulatory Issues

Terms in this set (236)

Health systems may wish to restrict the use of agents that are deemed high risk, high cost, or as needing special monitoring (e.g., Suboxone®)
Criteria for use may include the following:
☐ Patient inclusion: Patients meeting diagnostic criteria for opioid dependence/use disorder needing opioid agonist therapy
☐ Provider inclusion: Authorized to prescribe Suboxone® by meeting all requirements for a waiver specified by the Drug Addiction Treatment Act (DATA) 2000 as codified at 21 U.S.C. 823(g), who has experience in addiction management. Assurance of the availability of necessary treatment resources must be completed by
the physician before prescribing
☐ Considerations for use:
• Alternative first-line therapies for opioid dependence include methadone, though this agent is not available
for office-based opioid treatment
• Consider the potential for QTc prolongation in unstable cardiac disease or low potassium concentrations
• Consider the potential for drug interactions with CYP3A4 inhibitors or inducers and with central nervous system depressants
• Patients will need monitoring for several hours after administration of induction doses
• Patients should be seen weekly for the first 2 weeks of therapy and then at least monthly for the next 3 months
• Patients should be discontinued from therapy if they are found to misuse, abuse, or divert the medication; to be noncompliant with therapy; or to be unresponsive to therapy
☐ System responsibilities:
• Procedures to verify provider authorization and to restrict use to authorized prescribers must be in place
• Quantity limits may be imposed such that enough medication is dispensed to last only until the next scheduled appointment
The USP General Chapters are as follows: Required (numbered below <1000>), Informational
(numbered <1XXX), or Specific for dietary supplements (numbered <2XXX>); the chapters pertaining to compounding include the following:
(a) USP 795: Pharmaceutical Compounding for Nonsterile Preparations
(b) USP 797 (being revised): Pharmaceutical Compounding for Sterile Preparations (CSPs)
(1) USP 797 standards historically assign risk levels (low, medium, and high) according to
requirements for the types of admixtures and preparation procedures. The proposed revisions
limit the risk categories to category 1 and category 2, depending on a product's
beyond-use dating. Proposed revisions also introduce "in-use time," before which an ingredient used in a CSP must be used after it has been opened or punctured, or before which a
CSP must be used after it has been opened or punctured.
(2) As a result of deaths associated with microorganism contamination, CSPs have been under
scrutiny. In October 2015, CMS issued a revision to its Pharmaceutical Services CoP State
Operations Manual aligning their standards of practice for drug compounding with USP
requirements, particularly for CSPs.
(3) An area of interest for organizations is beyond-use dating and sterility for CSPs. According to USP 797, if sterility testing has been performed, pharmacies can assign a beyond-use
date based on the maximum chemical stability as listed in valid references. If sterility testing
has not been performed, pharmacies must use beyond-use dating according to the level
of risk and storage.
(4) In-use dating: Once opened/punctured, must be used
(c) USP 800: Hazardous Drugs: Handling in Healthcare Settings