THE BUSINESS OF PRACTICE: MANAGING PRACTICE CHALLENGES AND OPPORTUNITIES


in the Enforcement division. If a practice is visited by the Diversion division, and any false information is given, or they have reason to believe that full cooperation is not being given, the Enforcement di- vision will be called. The CSA, 21 Unites States Code (USC) 801-890,


and the DEA regulations, Title 21, Code of Federal Regulations (CFR), Parts 1300 to 1316 can be ac- cessed online.2 They provide for five schedules of CSs. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment and their relative abuse potential and likelihood of causing depen- dence when abused. All drugs listed in Schedule I have no accepted medical use in treatment and therefore may not be prescribed, administered, or dispensed for medical use. Schedule II substances have a high potential for abuse with severe psycho- logical or physical dependence. Examples of Sched- ule II substances include morphine, codeine, hydromorphone, meperidine, oxycodone, fentanyl, and pentobarbital. Schedule III substances have less potential for abuse, and include ketamine and anabolic steroids, as well as some combination prod- ucts containing small amounts of the narcotics hy- drocodone and codeine. Substances in Schedule IV and V have a lower potential for abuse relative to substances in other schedules, and include such sub- stances as diazepam, midazolam, and preparations containing limited quantities of certain narcotic and stimulant drugs generally used for antitussive, an- tidiarrheal, and analgesic purposes. The comprehensive document of DEA regula-


tions, Title 21, CFR, Parts 1300 to 1316 outlines the expectations for handling of CS by manufac- turers, distributors, practitioners, pharmacies, and researchers.


3. The Importance of Compliance


In enforcing the CSA, it is the DEA’s responsibility to ensure drugs are not diverted for illicit purposes. This effort can result in significant financial penal- ties if registrants have not complied with regula- tions. The DEA regulations provide for up to $10,000 penalty per violation and/or loss of the DEA licensure. Because each improperly documented invoice for a delivery of CSs would be considered one violation, there is high potential for fines to be sig- nificant. These penalties could financially cripple your veterinary business or cause you to lose your DEA license. In addition, as a practitioner, your role in the proper prescribing, administering, and dispensing of CSs is critical not only to patients’ health but also in safeguarding society against the diversion of CSs. It is more important now than ever to be vigilant in preventing the diversion and abuse of CSs. The United States is experiencing an alarming


drug abuse problem: more than 6 million Ameri- cans are abusing prescription drugs—more than the number of Americans abusing cocaine, heroin, hal-


102 2019  Vol. 65  AAEP PROCEEDINGS


lucinogens, and inhalants, combined. Every day, more than 130 people in the United States die after overdosing on opioids.3 The misuse of and addic- tion to opioids, including prescription pain medica- tions, heroin and synthetic opioids such as fentanyl, is a national crisis that affects public health as well as social and economic welfare. The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid mis- use alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involve- ment. Researchers report that opioid prescription painkillers now cause more drug overdose deaths than cocaine and heroin combined. Around 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid. In 2017, the number of over- dose deaths involving opioids (including prescription opioids and illegal opioids like heroin and illicitly manufactured fentanyl) was 6 times higher than in 1999.4


Compliance with all DEA regulations is your best defense against unnecessary business risk and helps to ensure that you are not contributing to the na- tional opioid crisis.


4. Most Important Areas of Noncompliance for Veterinary Practices and Best Practices for Meeting Compliance Requirements


DEA Registration


DEA regulations require that each registration must maintain separate records, storage, and ac- countability of CSs. Many practices have each vet- erinarian maintain individual DEA registration, and some states required this. However, this can be expensive and unnecessary in some states, and can cause administrative challenges. These diffi- culties arise because multiple DEA registrations re- quire multiple recordkeeping sites with strict attention to preventing the commingling of CSs or CS records. To avoid this, one option is to have a “clinic” reg- istration. All veterinarians are then listed and ref- erenced under the clinic registration as -1, -2, etc. However, a clinic registration requires the employ- ment of a fulltime pharmacist, so this is not work- able for the vast majority of veterinary practices. The simplest option is to have only one registrant who acts as the primary registrant with subordinate agents. If state requirements include DEA regis- tration for all veterinarians, or the practice prefers that, CS should still be ordered through only one primary registrant, with other registrants acting as agents. This avoids the specter of duplicate safes, filing cabinets, and accountability exercises. The primary registrant then has responsibility to super- vise his agents, as he or she is personally and fully responsible for their conduct. This can be risky if CS protocols are not in place and followed carefully, especially reconciliation. However, if CS are or-


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