No news is good news.
Especially for hospitals in the middle of the opioid epidemic.
Recently, the University of Michigan Health System (UMHS) agreed to a civil penalty in the amount of $4.3 million for failing to prevent opioid drug diversion and federal recordkeeping violations as a result of a DEA investigation. The headline from the U.S. Attorney’s Office, Eastern District of Michigan read: “Eastern District of Michigan Announces Record-setting Hospital Drug Diversion Civil Penalty Settlement With the University of Michigan Health System.”
This past May, Effingham Health System (EHS) in Georgia agreed to pay the U.S. government $4.1 million for failing to prevent opioid drug diversion and federal recordkeeping violations as a result of a DEA investigation. The press release read: “Southern District Of Georgia Announces Largest Hospital Drug Diversion Civil Penalty Settlement in U.S. History.”
And in 2015, Massachusetts General Hospital (MGH) agreed to pay the United States $2.3 million to resolve allegations that lax controls enabled MGH employees to divert opioids for personal use as a result of a DEA investigation. The news release read: “MGH to Pay $2.3 Million to Resolve Drug Diversion Allegations.”
Is the DEA targeting hospitals?
No, DEA is responding to drug diversion, usually after some triggering incident. In the UMHS case, DEA was notified after a nurse and a medical resident both overdosed in the hospital on fentanyl that had been intended for patients. The nurse died as a result of her overdose, and the medical resident was subsequently terminated.
Let’s go deeper
In the MGH investigation in Boston, two nurses had been stealing oxycodone tablets (almost 16,000) from automatic drug-dispensing machines (ADMs) over a period of several months. Investigators also found incomplete medication inventories and missing records in violation of federal law.
In the Georgia case involving EHS, the DEA began its investigation after receiving reports that “tens of thousands of oxycodone 30mg tablets were unaccounted for” over a four-year period.
And in the UMHS case, investigators concluded that UMHS deficient recordkeeping negatively impacted UMHS’s ability to guard against the theft and diversion of controlled substances.
What are the recordkeeping rules for hospitals?
The federal recordkeeping requirements for those that handle controlled substances are found in Title 21 Code of Federal Regulations Part 1304. Summary recordkeeping requirements can also be found in the DEA’s Pharmacists Manual and Appendix A which require initial, biennial and closing inventories; receiving, distribution and dispensing records; theft and loss reports and drug destruction records.
By federal law, there should be a record for every form of a controlled substance from manufacture, to a distributor, to a pharmacy, to the prescriber, to the ultimate patient or drug destruction. Congress developed these recordkeeping requirements back in 1971 when they created the Controlled Substances Act.
Just like an accountant can track every dollar from financial records, a hospital must also track and record where every form of a controlled substance goes.
So, how do I prevent my hospital from being in the news and what should I do?
Here are my top 12 musts.
1. Establish a drug diversion team to oversee and investigate drug diversion. At a minimum, the team should have a compliance person, a pharmacist and a supervisory nurse. The Mayo Clinic was one of the first to develop such a program which the MGH settlement agreement mirrored.
2. Implement “rule of two” controlled substance policies whenever possible. This means two people involved in all high-risk diversion-potential operations. The DEA requires this action on all high-risk operations involving money and drug seizures. The “rule of two” is extremely important when “wasting” injectables like fentanyl and other powerful opioids. One of the most common hospital diversion occurrences is the diversion of a patient-intended opioid injectable diverted to a hospital employee which occurred in the UMHS investigation. This type of diversion poses significant risk to hospitals due to the possibility of a hepatitis transmission and has occurred in multiple states including New Hampshire, Florida, Washington and Colorado. This should be a high-focus area of your program.
3. Maintain strong oversight and accounting of automatic drug-dispensing machines (ADMs). This includes keeping access records current and mandating supervisory personnel review of usage records for anomalies. Lax controls and oversight contributed to ADM diversion in both the MGH and UMHS investigations. The MGH settlement agreement also details multiple lax controls which contributed to the hospital’s opioid diversion. This should be another high-focus area of your program.
4. Have one pharmacist responsible for the oversight of all hospital pharmacy operations, security, and recordkeeping requirements. Separate registrations with the DEA are required for all locations where drugs are kept pursuant to Title 21 Code of Federal Regulations Part 1301. Part of the findings in the UMHS investigation identified the failure of the hospital to register 15 off-site ambulatory care centers where drugs were stored.
5. Just like accounting firms conduct quarterly and annual audits of businesses to detect financial fraud, so should hospitals by either hiring outside firms or by their own compliance and audit teams.
6. Use software to track and maintain records of all hospital controlled substances and to identify possible misuse.
7. Train staff annually on drug diversion and prevention and on proper procedures for controlled substance access and wasting.
8. Minimize the number of locations wherever controlled substances are maintained and ensure strong oversight and review by management and pharmacy personnel.
9. Act and investigate when diversion occurs and constantly adjust your policies to prevent future occurrences.
10 Pre-screen all new employees for drug usage and, if possible, conduct random drug testing of all current high-risk employees.
11. Help those medical personnel suffering with opioid use disorder with treatment but ensure they are also reported to the appropriate licensing agency. The non-reporting of medical personnel diversion could put your hospital at risk like reports and lawsuits from Tennessee, Utah, Georgia and Colorado.
12. Create a hotline to receive complaints regarding internal drug diversion and investigate them fully.
The misuse and diversion of hospital controlled substances will probably never be stopped — but good policies and procedures, coupled with a continual focus on high-risk operations will significantly decrease the odds of your hospital from ever making front page news.
Dennis Wichern is a retired DEA agent.
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