Chicago—Pharmacy leaders should plan ahead to ready their departments for an audit or survey by any of the several state and federal agencies that could come knocking on the door, recommended compliance experts at the 2012 leadership conference of the American Society of Health-System Pharmacists.
“Being familiar with these organizations and understanding what your role is in the different types of audits and surveys is a requirement for pharmacy leadership,” said Patricia C. Kienle, MPA, BS Pharm, FASHP, the director of accreditation and medication safety for Cardinal Health Pharmacy Solutions, in Laflin, Pa
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Tips for Boosting Compounding Safety

Adhering to a few core strategies can go a long way toward improving the safety of your hospital’s partnerships with outside sterile compounders and in the process avoid compliance issues during site surveys, according to Patricia C. Kienle, MPA, BS Pharm, FASHP, the director of accreditation and medication safety for Cardinal Health Pharmacy Solutions, in Laflin, Pa.. She said that the following approaches could be particularly useful:
  • Ensure that any source used for the provision of medications meets your health system’s standards. “This isn’t limited to compounding pharmacies; any purchases outside of your known, acceptable vendors need to be vetted.”
  • Review the contract you have with any compounding pharmacy (both sterile and nonsterile).
  • Read the ASHP Guidelines on Outsourcing Sterile Compounding Services (www.ashp.org/​DocLibrary/​Bestpractices/​Mgmt​Gdl​Outsourcing​SterileComp.aspx).
  • Assess your internal compliance with United States Pharmacopeia (USP) Chapter <797>. Accreditation organizations often ask for the most recent gap analysis if a facility is not USP <797> compliant. Complete a new gap analysis if needed (both for nonhazardous as well as hazardous sterile compounding), and share the results with hospital leadership.
As with many partnerships or alliances, it is crucial to review the documentation for any compounding pharmacy, Ms. Kienle noted. The following records can be particularly revealing and should be on your quality control checklist:
  • Pharmacy license in the state where the outsourced pharmacy is located.
  • DEA registration, if controlled substances are provided.
  • Registration with the FDA, as applicable and/or accreditation by the Pharmacy Compounding Accreditation Board for sterile compounding (does not apply to radiopharmaceuticals).
  • Wholesaler or distributor license in the state where the outsourced pharmacy is located, if required.
  • If the outsourced pharmacy is located in another state, out-of-state wholesaler or distributor license, if required by your state.
  • If the outsourced pharmacy is located in another state, any special license required by your state (e.g., controlled substances, sterile compounding), as applicable.
  • Licensure of pharmacists employed by the outsourced pharmacy.
  • Registration/certification of pharmacy technicians employed by the outsourced pharmacy, if applicable.
  • Written training program that meets USP <797> requirements and any state requirements, if applicable.
  • Summary of results of personnel competence.
  • Quality monitoring, including sterility testing of each batch and pyrogen testing if nonsterile ingredients are used.
  • Sources of ingredients.
  • Product recall procedures and records.
  • Proof of liability insurance.
  • Records of regulatory inspections.
—S.B.