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February 20, 2017

SUMMARY

The Drug Enforcement Agency and other agencies are scrutinizing hospitals and healthcare facilities more closely for failure to implement and maintain appropriate drug diversion prevention policies, procedures and programs, and they are holding organizations as well as individuals responsible.  As professionals who manage and administer a large number of controlled substances, anesthesiologists and nurse anesthetists should take the lead in collaborative, multidisciplinary efforts to prevent drug diversion in their institutions.  We present highlights of an effective anesthesiologist-led program developed at Mayo Clinic.
  • An endoscopy nurse drops syringes of fentanyl into a secret pocket in her uniform top and substitutes them with syringes containing saline.
  • A radiology technician with hepatitis C diverts unused fentanyl syringes intended for patients and five patients become infected with the virus.  One of the patients eventually dies from the infection.
  • A night custodian rummages through sharps waste containers and consolidates minuscule remaining fentanyl vials for his own use.

Mayo Clinic discovered these incidents of controlled substance diversion at its facilities, but comparable scenarios are playing out in hospitals and healthcare facilities everywhere.  Drug diversion contributed to a fourfold increase in substance abuse treatment admissions between 1998 and 2008 among individuals aged 12 and older, according to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA).  The Office of the Inspector General reports that a bottle of 30 mg oxycodone tablets is trafficked at a price of $1,100-$2,400, up to 12 times the normal price of a legally filled prescription.

The potential for drug diversion by clinicians, staff, patients, family members and others is a reality at all hospitals, and, as healthcare professionals responsible for managing and administering a large number of controlled substances, anesthesiologists and nurse anesthetists have a major role to play in minimizing this potential. 

The fact that anesthesiologists and nurse anesthetists have an above-average rate of drug addiction, due largely to their occupational proximity to opioids, fuels the need for anesthesia providers to lead initiatives and keep drug diversion prevention in the spotlight in their hospitals, surgical suites and pain clinics. 

“All health facilities should have systems in place to deter controlled substance diversion and to promptly identify diversion and intervene when it is occurring,” anesthesiologist Kenneth H. Berge, MD, asserts in Mayo Clinic Proceedings.  These systems require multidisciplinary planning and coordination by anesthesia, pharmacy, safety and security, nursing, legal counsel, human resources and other areas.  Dr. Berge explains hospitals’ unique susceptibility:

In the outpatient setting, there is an elaborate system of checks and balances for prescription, procurement and dosing of a controlled substances.  However, in the healthcare facility environment, vulnerability to diversion exists when a single provider, out of view of others, is free to engage in drug procurement from central stores, drug preparation, drug administration to patients, and/or disposal of drug waste.  Given that CSs are often titrated to a desired effect in patients who may have widely varying drug requirements (e.g., as a result of baseline individual variability, acquired habituation or other factors), in the absence of sufficient controls, it is relatively easy for a single healthcare worker, without the knowledge or collusion of others, to divert drugs intended for patients.

Anesthesia and Hospital Accountability

The need for anesthesia providers to spearhead policies, procedures and programs for drug diversion prevention at their hospitals is growing.  As regulators tighten prescription requirements and work to change prescribing practices in response to the opioid epidemic, hospitals are becoming bigger targets for diversion, a recent article in Becker’s Hospital Review reports.  And although the Centers for Disease Control and Prevention issued a Guideline for Prescribing Opioids for Chronic Pain almost one year ago to address problems of opioid overuse and abuse, “little has been done to address the potential increase in diversion of prescription medications from hospitals,” the article notes. 

At the same time, the Drug Enforcement Agency (DEA) is heightening its scrutiny of healthcare organizations, giving anesthesia providers another compelling reason to put deterrence strategies front and center.  The DEA’s budget for diversion control rose by nine percent in 2016.

While past DEA investigations have focused on the individual’s role in drug diversion, future activities will zero in on the organization as well as the individual, according to a 2015 report by the Deloitte Center for Regulatory Strategies. Hospitals, nursing homes, pharmacies and other organizations will be held accountable for a lack of oversight and diligence when diversion occurs.

Evidence of this trend came in late 2015, when Massachusetts General Hospital (MGH) agreed to pay the United States $2.3 million in the largest settlement of its kind involving allegations of drug diversion at a hospital.  As reported by AHC Media, the DEA launched an investigation of MGH in 2013 after the hospital disclosed that two of its nurses had stolen approximately 16,000 pills, mostly oxycodone, from automated dispensing machines. 

The DEA investigation found discrepancies of 20,000 pills, missing or incomplete medication inventories, and hundreds of missing drug records.  MGH also disclosed that a pediatric nurse with a 12-year substance abuse problem had injected Dilaudid at work; a physician had prescribed controlled substances without seeing patients or documentation; several nurses diverted drugs for many years without detection; and medical staff failed to properly secure controlled substances in many instances. MGH also agreed to implement a corrective action plan.

Successful Strategies

Providers—anesthesiologists and nurse anesthetists included—would be wise to take preemptive steps to mitigate risks.  Deloitte Development outlined the elements of a successful hospital drug diversion prevention program in a 2016 presentation summarized here.  You might consider whether these elements are already in place at your organizations and work with senior leadership and other departments to make improvements as necessary.

  • Create a drug diversion office position and oversight committee.
  • Develop policies and procedures. Example:  “Nobody leaves the unit at the end of the shift” if drug inventory variances are found.
  • Educate employees to identify, detect and report potential drug diversion.
  • Implement a hotline for reporting suspected violations, with anonymous and confidential communication when needed.
  • Send prescriptions for controlled substances electronically.
  • Secure and reconcile DEA-222 forms used for ordering Class II controlled substances.
  • Reconcile drug orders to drug receipts to drug stocking.
  • Secure the delivery process.  The wholesale vendor should deliver controlled substances directly to the pharmacy, where a pharmacist should sign a receipt and take delivery.
  • Deliver drugs from pharmacy to floors and units in a secured manner.
  • Limit, secure and monitor access to the pharmacy vault in which controlled substances are stored.
  • Investigate and review discrepancies on a regular basis.
  • Establish more frequent and unscheduled inventory counts.  Although DEA regulations require physical inventory of controlled substances every two years, increase the frequency for selected drugs.
  • Train employees on the proper use of automated dispensing units.
  • Track key data produced by the automated dispensing system, including a high frequency of discrepancies by certain individuals or service areas, including pharmacy, and higher than expected wasting.
  • Limit the number of individuals with access to controlled substance automated dispensing unit bins.
  • Limit the number of personnel with “super user” status in the automated dispensing system.  These users have the ability to modify inventory counts and add or delete users.

In an article in Hospitals & Health Networks, Sherry A. Unhoefer, MBA, RPh, of Comprehensive Pharmacy Services, also recommends reducing the number of opioid prescriptions.  “It is important to treat a patient’s pain, but the more traditional methods of escalating narcotic use are not always in the best interest of the patient.  Clinical protocols regarding pain management processes can be expanded to a multimodal approach that includes opioid pain killers when appropriate but may also include anti-inflammatories and muscle relaxants, as well as alternative therapies that help patients relax and relieve their pain.”

According to the Becker’s article, organizations often get lulled into a false sense of security by automated drug dispensing systems and “fail to recognize the importance of culture and access as two key factors contributing to drug diversion.  The human component for a strong diversion prevention plan cannot be underestimated.”

Mayo Clinic recognized the human component and incorporated it into its successful drug diversion deterrence program, described in the Mayo Clinic Proceedings article.  The program, which originated in the anesthesiology department, revolved around the establishment of multidisciplinary drug diversion response teams (DDiRT) at all Mayo Clinic facilities.  Mayo Clinic estimates that 75 percent of suspected diversion investigations at its Rochester location have been brought to closure by a confession on the part of the drug diverter.

Following are lessons learned from this program, discussed by Dr. Berge in a recent Health Leaders article:

  • Implement a zero tolerance policy regarding drug theft of any kind.  Make sure employees know they will lose their jobs and be reported to the appropriate authorities.  Educate employees about the dangers of trying fentanyl even once due to the profound risk of addiction.
  • Work cooperatively with law enforcement, including local police and the DEA, who can process search warrants of employees’ homes and cars to help prove a case.
  • When an employee is caught and terminated, offer treatment, and even extend healthcare benefits that provide coverage.  “We say, ‘You’re fired.  Now how can we help you.’?” Dr. Berge says.
  • Advertise your deterrence prevention program with a slogan, such as “Save Your Co-Worker’s Life.”  Post the slogan on automated drug dispensing machines.
  • Assemble a diversion team that includes a coordinator who is either a pharmacist or a certified pharmacy technician to educate employees and help investigate reports.
  • Employ a waste retrieval system everywhere injectable opioids are used in patient care.  Strictly enforce a policy in which all unused drugs be securely returned to a Class II controlled substances vault in the pharmacy under the watch of cameras, for reconciliation with both the automated drug dispensing unit and anesthesia records.  Randomly test drugs to make sure they are the real drugs.  Start with the surgical suite, recovery room, emergency department, GI endoscopy, interventional radiology and other high-risk areas, and expand from there.
  • Dispel myths about individuals who divert drugs.  These myths include the notion that drug diverters are easily identified by their odd behaviors.  The truth is that drug diverters are highly skilled at hiding their activity.
  • Monitor vulnerable areas throughout the organization, such as the loading dock and the incinerator, and update areas monitored as new diversion schemes are discovered.
  • Report drug diverters to the DEA, as federal law requires, and to the responsible state professional licensing board or hospital licensing agency.  If the diverter is a physician or dentist, report it to the National Practitioner Data Bank.
  • As policies tighten where drugs are stored, be aware that attempts to divert drugs will increase closer to patient care, at the beside and “at the stopcock of the IV.”

In its February 2016 publication, What is a Prescriber’s Role in Preventing the Diversion of Prescription Drugs? the Centers for Medicare and Medicaid Services (CMS) provides the following links for reporting suspected drug diversion:

  • DEA, for reporting theft or loss of controlled substances, click here.
  • HHS-OIG, by calling 1-800-HHS-TIPS (1-800-447-8477) or TTY 1-800-377-4950.

CMS provides the following additional resources:

  • For information on fraud prevention and detection compliance guidance, click here.
  • For more information on drug diversion, click here.
  • For more information and statistics on the prescription drugs of abuse, click here.
  • For more information on strategies to reduce drug diversion in the Medicaid program, click here.

We hope these resources and recommendations help you and your colleagues in developing and maintaining a robust drug diversion deterrence program in your facilities. 

We want to hear from you.  Do you have a topic you would like to suggest for an ABC eAlert?  Please send your suggestions to info@anesthesiallc.com.

With best wishes,

Tony Mira
President and CEO