Consequences of Drug Diversion in Hospitals
In healthcare settings, prescription drugs can be diverted at any point along the supply chain as they are moved from manufacturers to distributors to pharmacies to hospitals and other healthcare organizations, and finally to the patient. Hospitals are at high risk for drug diversion, because of the ready access to prescription drugs in these facilities.4 Most diversions of drugs occur in outpatient settings, where the majority of prescription drugs are used. The most common drugs diverted from healthcare facilities are opioids.5
Addiction is the primary cause of controlled substance diversion among healthcare professionals.6 Professions with easy access to controlled substances, such as anesthesiology and nursing, have higher rates of addiction. For example, the American Nurses Association has estimated that one in 10 nurses is struggling with drug or alcohol addiction.7 Methods used by healthcare workers to divert controlled substances include theft of vials or syringes, under-dosing patients, taking waste for personal use, raiding sharps disposal containers, and tampering with patient medications by replacing controlled substances with another product, such as saline.
Hospital workers who divert drugs for personal use are a significant threat to patient safety. Impaired practitioners put patients at risk of harm as a result of diminished judgment and slower reaction time. Diversion can also result in patients receiving lower doses of needed pain medications. Tampering with injectable medications can expose patients to bloodborne pathogens or to other unsafe substances.8 In one case in 2016, 16 patients in two hospitals became infected with hepatitis C after a nurse diverted drugs for personal use and then used the same needles as the patients.9 When a patient is harmed as a result of drug diversion by a hospital worker, a lawsuit may be filed against the hospital, which can result in substantial liability and/or consequences.
Hospitals found to have inadequate controls in place are at risk for both criminal and civil penalties. Several recent cases have resulted in multimillion dollar settlements. In 2015, Massachusetts General Hospital agreed to pay $2.3 million to settle allegations that lax controls enabled hospital employees to divert controlled substances for personal use.10
More recently, a California health system paid $2.42 million to settle claims that three of its facilities violated the Controlled Substances Act. In that case, the system for distributing controlled substances between the three hospitals failed to provide sufficient security controls to prevent diversion.11
Hospital workers who divert drugs risk harming themselves and their professions. Substance abusers may suffer from physical and mental ailments, and their involvement in diversion puts them at risk of addiction, exposure to communicable diseases, overdose, and even death. They risk the loss of their job or their provider license, and may face state or federal prosecution as well as civil malpractice actions. Drug diversion also harms the reputation of the medical profession, especially when patient safety is compromised. Coworkers, meanwhile, may be exposed to uncapped contaminated needles, broken glass vials, and other risks created by the drug abuser.12
All prescription products in the United States are subject to federal and state regulation. Controlled substances are more heavily regulated due to their higher potential for addiction and abuse. Unlawful possession or distribution of drugs can result in criminal prosecution.
Controlled Substances Act
The Controlled Substances Act (CSA) has been the primary federal drug law regulating the manufacture and distribution of controlled substances since 1970. The CSA requires every person who orders, handles, stores or distributes controlled substances to be registered with the DEA in order to perform these functions. Registrants must maintain accurate inventories and records, and must have specific security controls and operating procedures in place to guard against theft and diversion.14 In addition, the CSA requires that all prescriptions for controlled substances be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of medical practice.14 Registrants must have a system in place to identify suspicious orders of controlled substances.15
The CSA categorizes drugs into one of five schedules (I-V), based on each drug’s medical use and its potential for abuse or dependency. The most harmful substances are placed in Schedule I, and the rest appear in descending order accordingly. Examples of drugs included in each schedule are:
- Schedule I: heroin, ecstasy, LSD, marijuana
- Schedule II: morphine, cocaine, methamphetamine
- Schedule III: Vicodin, anabolic steroids
- Schedule IV: Ambien, Soma, Valium
- Schedule V: Lyrica, cough suppressants16
Both the DEA and the Food and Drug Administration (FDA) have authority to add or remove drugs from the different schedules. The CSA’s system of schedules makes it easier for state legislatures to enact criminal drug statutes by referencing the schedules rather than listing all substances subject to the law. It also makes it easier to update drug laws all at once, since individual drugs can be added or removed from the schedules as necessary without the need to amend all other drug laws.
The DEA is the enforcement arm of the CSA. The agency is responsible for ensuring that registrants comply with the recordkeeping, security and storage requirements of the CSA. DEA investigators use recordkeeping systems to help identify suspicious movements of controlled substances. The DEA frequently acts on leads from pharmacists, prescribers, patients and members of the public. It also works closely with the FDA, as well as state and local law enforcement, on task forces to stop drug trafficking and drug violence.
Individuals who violate the CSA may be subject to criminal, civil and administrative penalties. Criminal penalties can include prison sentences and fines. Persons involved in diverting controlled substances may also be subject to civil fines or forfeiture actions on the proceeds obtained from the unlawful sale of the drugs. Administrative penalties may include suspension or revocation of DEA registration.
(4) Gregory Burger and Maureen Burger, Drug Diversion: New Approaches to an Old Problem, Am J Pharm Benefits, 2016; 8(1):30-33, http://www.ajpb.com/journals/ajpb/2016/ajpb_januaryfebruary2016/drug-diversion-new-approaches-to-an-old-problem (accessed January 24, 2018).
(5) Keith Berge, et al., Diversion of Drugs Within Health Care Facilities, A Multiple-Victim Crime: Patterns of
Diversion, Scope, Consequences, Detection, and Prevention, Mayo Clin Proc. 2012 Jul; 87(7); 674-682, July 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538481/ (accessed December 20, 2017).
(6) Barry Abramowitz, Drug Diversion in Healthcare, The Journal of Global Drug Policy and Practice, Vol. 8, Issue IV, Winter 2014, http://www.globaldrugpolicy.org/Issues/Vol%208%20Issue%204/Drug%20Diversion%20in%20Healthcare_Commentary.pdf (accessed December 17, 2017).
(7) Mary Ann B. Copp, “Drug Addiction Among Nurses: Confronting a Quiet Epidemic,” Modern Medicine, April 2009, http://www.modernmedicine.com/modern-medicine/news/modernmedicine/modern-medicine-feature-articles/drug-addiction-among-nurses-con?page=full (accessed January 14, 2018).
(8) U.S. Department of Health and Human Services, Kimberly New, Drug Diversion in Health Care Settings Can Put Patients at Risk for Viral Hepatitis, May 2014, https://www.hhs.gov/hepatitis/blog/2014/05/02/drug-diversion-in-health-care-settings-can-put-patients-at-risk-for-viral-hepatitis.html (accessed December 22, 2017).
(9) Shenefelt, Mark, “Investigators: 16 hepatitis C cases identified at McKay-Dee and Davis Hospitals,” Standard Examiner, April 4, 2016, http://www.standard.net/News/2016/04/04/State-announces-results-of-hepatitis-C-investigation.html, (accessed January 25, 2018).
(10) U.S. Department of Justice, U.S. Attorney’s Office, District of Massachusetts, MGH to Pay $2.3 Million to Resolve Drug Diversion Allegations, September 28, 2015, https://www.justice.gov/usao-ma/pr/mgh-pay-23-million-resolve-drug-diversion-allegations (accessed January 5, 2018).
(11) U.S. Department of Justice, U.S. Attorney’s Office, Eastern District of California, Rideout Health to Pay Civil Monetary Penalties to Resolve Controlled Substances Act Claims, December 6, 2016, https://www.justice.gov/usao-edca/pr/rideout-health-pay-civil-monetary-penalties-resolve-controlled-substance-act-claims (accessed January 5, 2018).
(12) Keith Berge, et al., Diversion of Drugs Within Health Care Facilities, A Multiple-Victim Crime: Patterns of Diversion, Scope, Consequences, Detection, and Prevention, Mayo Clin Proc. 2012 Jul; 87(7); 674-682, July 2012.
(13) 21 CFR 1301.71(a)
(14) 21 CFR 1306.04(a)
(15) 21 CFR 1301.74(b)
(16) U.S. Department of Justice, Drug Enforcement Administration, Drug Scheduling, https://www.dea.gov/druginfo/ds.shtml, (accessed December 29, 2017).