Don't want a $1 million fine? Pay attention to regulated drugs

[Editor's note: In this issue of Same-Day Surgery, we put a special focus on compliance with regulated drugs. We've talked with some of the top pharmacy consultants in the country to find out foolproof systems for avoiding diversion and theft. These stories will help you decide where to focus your time and energy, while avoiding liability.]

A hospital-affiliated clinic and surgery center in Oklahoma have been fined $1 million in a settlement over claims that they failed to comply with federal regulations regarding record-keeping and inventory of regulated drugs, according to a media report.1

The parent company of the clinic and surgery center notified officials at the state and federal levels when they realized there were discrepancies in their inventories following the transfer of narcotics to the surgery center from the clinic, according to the report. Upon identifying inconsistencies, the clinic disclosed the discrepancies to the state Board of Pharmacy and the Drug Enforcement Administration (DEA). Investigators found that St. Anthony had not complied with all of the inventory and documentation requirements of the Federal Comprehensive Drug Abuse Prevention and Control Act.1 No further details were released. Failure to comply with the federal requirements is subject to civil penalties of up to $10,000 per violation.

A spokesperson for the parent company was quoted as saying they are committed to improving their regulatory compliance efforts and that corrective actions have been taken.

"We're facing in this country a terrible epidemic to controlled substances, including substances dispensed at medical facilities," says Sanford Coats, JD, U.S. attorney in the Western District of Oklahoma in Oklahoma City. "Tracking is absolutely critical."

According to Robert Troester, executive assistant to the U.S. attorney in the Western District of Oklahoma, a situation becomes problematic not when there is a "single isolated missing form, but a systemic failure to keep control of documents and inventory."

The incident involving the Oklahoma healthcare providers is not isolated, Coats says. While most healthcare providers probably have good compliance programs in place, "some have been sloppy or haven't given it the due attention it needs," he says.

The federal fine comes at a time of increased focus on narcotics. Michael Jackson's death, blamed on propofol, has raised public concern about that drug, while there has been growing recognition of propofol abuse by medical providers. The DEA is considering designating propofol as a controlled substance. In the meantime, some hospitals and surgery centers already are accounting for items such as propofol as though they were designated as such.

Sheldon S. Sones, RPh, FASCP, president of Sheldon S. Sones and Associates, a safe medication and pharmacy consulting firm in Newington, CT, says, "Although it is important to remain compliant with federal and state requirements, I feel it is equally important to insulate the facility's stakeholders from the pain of controlled drug diversion issues. Thus, orchestrating a system that is both compliant and is structured appropriately is the end goal." Consider these suggestions:

• Have a pharmacist consultant review your policies and practices.

OA Center for Orthopaedics, in Portland, ME, addressed the issue of compliance with a team that included Linda Ruterbories, ANP, director of surgical services and program development, a staff nurse who was a compliance specialist, the PACU supervisor, and an anesthesiologist who subcontracted with the facility. Sones was hired to review the facility.

He told the managers that they needed to change their procedures regarding samples of pregabalin. "Obviously, because they are a controlled substance, they needed to go into the Pyxis system and be dealt with in a different manner than before," Ruterbories says. Also, the staff had not been considering injectable Brevital to be a controlled substance. "Brevital is like propofol in a way, in that you wouldn't expect someone to abuse it or deviate from using it in the manner for which it was intended, but if it's a controlled substance, it needs to be treated as a controlled substance," Ruterbories says.

Traditionally, the staff members would pull narcotics from the Pyxis at the request of the anesthesiologist, who would document how much was used. Staff would waste the remainder. Sones recommended that they give the anesthesiologist a box with all of the anticipated medications for the day and have the anesthesiologist document specific patient use or, alternatively, draw the medications through the Pyxis on a patient-by-patient basis. He said either approach has to ensure thorough documentation of who received what, by whom, and when. Ruterbories points out that medications can be kept in locked anesthesia carts during business hours. Anesthesia staff, as well as others, should be monitored for any behavior changes that might indicate diversion, experts suggest.

• Spot check narcotics waste.

Nurses handle this responsibility at OA Center for Orthopaedics. They look at individual patient records and report any physicians or nurses about whom they have questions, Ruterbories says. "We're looking to establish patterns obviously," she says. (See "Anesthesia Medication Reconciliation 2011 template" with the online issue. For assistance, contact customer service at (800) 688-2421.)

Incorrect narcotic counts and patients who don't receive relief after being given pain meds might be signs of diversion, says Bonnie Brady, RN, CNOR, administrator at Specialty Surgical Center of Sparta, NJ. (For more information on narcotics counts, see story, below.) "I have heard of substituting saline for narcotics," Brady says.

Be alert to odd behavior of your staff, Ruterbories advises. Atypical behaviors might include anxiety, belligerence, sweating, tremors, and compromised medical decisions. Random drug testing is one approach to such behavior, Ruterbories says.

• Consider security measures.

A few years ago at OA Center for Orthopaedics, thieves stole an anesthesia badge that was in an unlocked container and used it to enter the medication room and force open the Pyxis system. "Any system is only as good as the criminal trying to get into it," Ruterbories says. "They took all our narcotics."

The room is now locked down from 7 p.m. to 7 a.m. and is tied to the center's alarm system. Additionally, the administrators installed dead bolt locks that require a key. "It's not 100% foolproof; someone could find the key," Ruterbories says.

Centers also could consider installing a security camera in the medication room, which might deter thefts.

• Review your system of ordering narcotics.

At OA Center for Orthopaedics, the medical director "has to sign the DEA form so he's aware of all the narcotics we're ordering," Ruterbories says. The nurse compliance officer works with him on the ordering and obtaining of narcotics, she says.

Brady says. "Regulated drugs that are delivered should not be lying around when delivered but handed to a dedicated staff member to count and lock up."

At Specialty Surgical Center, any two nurses can count narcotics, Brady says. "That prevents any one nurse from being in total control of the count," she says. "Drugs are counted at the beginning and end of the shift and anytime there is a new staff member coming on at night."


  1. Associated Press. St. Anthony pays $1 million fine over non-compliance with federal drug inventory control rules. July 29, 2011.


  • Sheldon S. Sones, RPh, FASCP, President, Sheldon S. Sones and Associates, 15 Coachmen Lane, Newington, CT 06111. E-mail: Web: Sones is a safe medication and pharmacy consultant to more than 110 ambulatory surgery centers in the Northeast.

Daily counts help avoid diversion

Daily counts of regulated drugs are one step to ensure compliance and to avoid diversion, says Sheldon S. Sones, RPh, FASCP, president of Newington, CT-based Sheldon S. Sones and Associates, a safe medication and pharmacy consulting firm.

"We ensure that daily counts are performed at the location of controlled drug distribution as well as the larger 'safe,' which is counted on dispensing as well as monthly," says Sones, who points out that state requirements might differ.

Additionally, expect anesthesia providers to document clearly in the anesthesia record their controlled drug administration trail, he says. (For more on the narcotics trail, see story, below.) Consider these additional suggestions from Sones:

  • Anesthesia providers should attest to drugs drawn for the work day and returned with another licensed individual.
  • Records of controlled drug received should be retrievable and organized in such a way as to permit review of invoices.
  • All discards of controlled drugs should be in a "real time" manner with witnessed signatures. Furthermore, the discards should be done in a manner that renders them "nonretrievable"
  • Pharmacy consultant oversight should be performed on a monthly or quarterly basis with a review and attestation of compliance and accurate inventory.

Can you trace the narcotics trail?

To avoid diversion, address storage, documentation, and quality assurance, suggests Sheldon S. Sones, RPh, FASCP, president of Newington, CT-based Sheldon S. Sones and Associates, a safe medication and pharmacy consulting firm.

Drugs drawn for the day should have a trail that validates who took what drugs and when. "Likewise, on return to the main storage areas for the day, the same documentation should exist," Sones says. "Daily inventories of all stocks should be validated, and the federally required 'Biennial Controlled Drug Inventory' should be retrievable and in good stead."

The emphasis is on the word "trail," Sones says. He asks, "Can you identify what was delivered through your front door, who used what, and that what remains in stock is a quantitative `match'?"

• Ensure your records are in order.

The anesthesia record and the PACU record should be explicit as to what was administered, by whom, and when, Sones says. "One of the things we do on our routine visits is what I call a 'correlation' where we tag anesthesia records and compare them to controlled drug usage records to ensure the 'match.'" Sones says. "It speaks volumes to the commitment that the facility has to ensure compliance and control."

• Don't try to be solve the crime.

When looking for signs of potential diversion, "abnormal behavior of individuals with access to controlled drugs, casual documentation, illegibility, and even sometimes patient `under-response' to heretofor routine dosing are all reasons for suspect," Sones says.

If an issue is identified, communicate the problem to the administrator, clinical director, medical director, the Drug Enforcement Administration (DEA) registrant, which is the person who holds the DEA license; management company (if there is one), he says. "Basically, go up the leadership chain," Sones says.

Also, contact the legal authorities including state officials and DEA, he advises. "The facility should not take extraordinary detective-type efforts on its own," Sones says. "The facility, however, should aggregate data, information, and have a log of information gathered."