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.

Figure. Medication use system.

Karla M. Miller, PharmD, BCPP, the assistant vice president of pharmacy services and clinical therapeutics for the Hospital Corporation of America Clinical Services Group, in Nashville, Tenn, made a similar entreaty at the meeting. “At the heart of all of these organizations is good patient care and protection of patients,” but each has its own focus and ways of operating, Dr. Miller said in a breakout session on compliance survival strategies. “Be sure you know how to respond to these situations, even the ones that are out of your control.”

In addition to surveys by the relatively familiar accreditation groups and the Centers for Medicare & Medicaid Services (CMS), pharmacy leaders could conceivably find themselves dealing with investigations by the Office of Inspector General, the Drug Enforcement Administration (DEA) or any of the state licensing boards for pharmacy and medicine.

Dr. Miller said that on-site DEA inspections are on the rise. “Make sure executive leadership is aware of [the DEA representatives’] presence, get them a private room and a direct contact to work with” and be prepared to provide the biannual inventory report, inventory records, theft and loss reports, policies for medication diversion prevention, substance abuse in the workplace and controlled substance monitoring, as well as other required documents, she said.

“If you can get those [reports] in front of the DEA, you don’t have much to worry about. It’s when you don’t have these quickly in an orderly manner that they’re going to ask questions,” she said.

CMS has its own areas of recent focus, including its newly implemented reimbursement penalties for excessive hospital readmissions (Pharmacy Practice News, December, page 1). Ms. Kienle advised pharmacy leaders to prepare for CMS scrutiny by taking a deeper, closer look at the agency’s Conditions of Participation (CoP) (​Regulations-and-Guidance/​Guidance/​Manuals/​downloads/​som107ap_a_hospitals.pdf). For the three major health care accrediting groups in the United States—the Joint Commission, the American Osteopathic Association (AOA) and Det Norske Veritas (DNV)—the foundation of their standards is the CoP.

Organizations also need to familiarize themselves with the CoP because “CMS is taking a more global approach to what happens in hospitals,” including looking more closely at how the CoP feeds in to the accreditation process, Ms. Kienle said in an interview. Medication-related sections affecting pharmacists are spread throughout the document, not just in the 17 CoP for Pharmaceutical Services. “It’s up to you to know where they are,” added Ms. Kienle, who has served on the Pharmacotherapy Specialty Council of the Hospital Professional and Technical Advisory Committee of the Joint Commission.

“The first half [of the CoP] is almost all about restraints. The second half is all about the operations of the hospital, and the pharmaceutical services piece is key there,” Ms. Kienle said. “There are other things that directly affect our medication perspective, particularly on the acute care side, that are in other areas [of the CoP] as well. So I would suggest you look at that link and make sure you have it available to you.”

She added, “Our responsibility in our enterprise is a bigger net than what we do in the pharmacy. We need to get that message out loud and clear … and sometimes we need to use some of these federal standards as support for what we want to do in our organizations.”


Storing Medications Is Potential Trouble Spot

Standards in the CoP for storage, for example, have changed from requiring that all drugs be locked to requiring that all drugs and biologics be secured and locked when necessary. That change has “put a big onus on the hospital to define what they think is secure,” Ms. Kienle said. “So these are things that should be in your policies. … Do you have a policy that says who has access to medications in your organization? And it needs to be way bigger than pharmacy and nursing because there are lots of other people who have access to specific carved-out areas of meds.”

Ms. Kienle noted that 5% of hospitals receive a validation survey by CMS following an accreditation survey. “What they want to do from a validation standpoint is to make sure those accrediting organizations are complying with the federal standards,” she said. For that reason, “they don’t survey against [the Joint Commission] or AOA or DNV standards, they survey against the CoP.” The vast majority of accreditation standards overlap with those of CMS, she said, “but there are some subtle differences or different approaches,” and pharmacists need to know what those are.

According to Ms. Kienle, hospital and health-system pharmacists can expect heightened scrutiny in the wake of the recent fungal meningitis outbreak (related article, page 1). “You’ve got to believe when these folks are coming in to survey now and in the near future that this compounding issue is going to come up loud and clear,” she said. “The responsibility from a federal perspective is [to ensure] that patients are safe, as it should be. With the atrocious situation that’s occurring with compounding, I think we’re going to see more and more questions in that area.”

The high level of public trust pharmacists have enjoyed for decades has been tarnished, at least temporarily, by a disaster “that never should have occurred,” she said. In Gallup public opinion surveys, pharmacists have ranked among the top three most trusted groups of professionals for the past nine years. “I’m betting we’re not going to be there this year,” she said.

To prepare for survey questions focused on compounding (sidebar), pharmacists should ensure that the need for a compounded preparation is clinically appropriate, she advised. “Some compounds have been used based on convenience or the lack of standardization of concentrations in some organizations. Now is the time to assess the appropriateness and evidence-based practices. Organizations that have been unable to standardize [based on physician preference] can now approach this issue with a different level of urgency.”

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 (​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.