CMS revises guidance for pharmaceutical services and compounding medications

Patient Safety Monitor Insider

November 11, 2015

The Centers for Medicare & Medicaid Services (CMS) last week released revised hospital guidance for pharmaceutical services and expanded guidance related to compounding medications. The update to the State Operations Manual Appendix A covers the following:

  • Revisions were made to portions of the pharmaceutical services Conditions of Participation to bring them into alignment with current accepted standards of practice. The revised guidance addresses accepted professional pharmacy principles including United States Pharmacopeia standards, compounding of medication, determining beyond-use dates, safe medication storage, and high-alert medications and minimizing drug errors.
  • A new standard-level tag was added to allow surveyors to cite to the regulatory language found in the CMS Automated Survey Processing Environment software.
  • CMS is updating its guidance for the nursing service regulatory requirements concerning medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those limited instance when compounded sterile preparation may be prepared outside the pharmacy.

The changes were prompted by a January 2015 report issued by the Office of Inspector General (OIG) about the use of compounding pharmacies by hospitals. The OIG investigated the issue after a nationwide meningitis outbreak in 2012 was caused by injections of contaminated compounded medications produced by a compounding pharmacy.

Read the CMS guidance.