Part 3 Controlled Substances

Part 3 - Federal Regulatory Overview for Veterinary Practices

Sobering Statistics:

  • 2019-2020 More than 87,200 overdose deaths in the past year (CDC data).

  • A profound concern is the increased risk of psychiatric disorders and thoughts of suicide among veterinarians when compared to the general population, highlighting the mental health impacts of the profession.

The Opioid Crisis in Veterinary Medicine

Daily Impact:

  • Daily, approximately 100 Americans die from opioid overdoses, a stark reminder of the nationwide crisis.

  • Easy access to medication

  • Stressors inherent in veterinary practice, such as emotional strain from animal care and client interactions, can exacerbate risks of substance misuse among practitioners.

  • Depression and suicide

Drug Classes with High Abuse Potential

Examples of Controlled Substances:

  • Anabolic Steroids: Methyltestosterone, Testosterone

  • CNS Depressants: Pentobarbital, Alprazolam, Diazepam

  • Hallucinogens: Ketamine

  • Opioids: Fentanyl, Hydrocodone, Morphine

  • Stimulants: Amphetamine, Methamphetamine

Signs of Drug Addiction Among Healthcare Professionals

Behavioral Indicators:

  • Frequent absenteeism and patterns of unexplained absences may suggest underlying issues.

  • Noticeable reductions in work performance and fluctuations in productivity can serve as early warning signs.

  • An increase in excessive time spent near drug supplies and concerns over disorganized record-keeping should raise red flags.

  • Signs of substance abuse may also include a progressive deterioration in personal appearance and hygiene.

  • confusion, memory loss, and difficulty concentrating or recalling details and instruction

If a behavior is being ignored, the DEA will consider you an enabler of there addiction. EAP employee assistance program. Counseling and drug addition assistance.

Client seeking drugs

  • specific requests or combinations of med

  • is it necessary for you to script out controlled drugs

  • document!

  • keep DEA # confidential

  • don’t hand write scripts

  • Uphold laws surrounding controlled substances to protect both clients and the community from drug abuse.

  • Demonstrate vigilance by recognizing and reporting suspicious behaviors among colleagues, contributing to a safer workplace.

Reporting Requirements for Theft or Loss of Controlled Substances

  • Any theft or significant loss of controlled substances must be reported to the police and the DEA within specified timeframes.

  • Use DEA Form 106 to formally document and detail incidents of loss or theft.

The Role of the DEA in Inspections

  • The DEA maintains the authority to inspect any environment where controlled substances are managed, including veterinary practices. No specific reason.

  • It is your right to decline access, but if you do, they will get a warranty, and any issue may become a probable cause.

  • Noncompliance can result in civil or criminal penalties arising from violations, often due to poor record-keeping and inadequate security measures.

DEA inspection

  • two different department

    • Diversion control program

      • First visit, no warrant, just a check-in

    • Enforcement

      • warrant

      • raid

    • civil or criminal penalties

      • letter of admonition

      • monetary fin to licensees and registrant

      • suspension or revocation of a DEA license

      • permanent loss of DVM license

      • Prison sentence

Safety Preparedness

  • Forming a safety committee can effectively manage emergencies and ensure all staff members are well-informed about protocols during hazardous situations.

  • Collaborative training with local police education officers is encouraged to improve practice security and enhance staff safety readiness.

Audit Preparedness

  • Each practice should maintain a DEA audit readiness file that includes essential documents such as registration details, inventories, and staff training records.

  • Proactive approaches to training staff on compliance and regulations can mitigate risks during audits.

Conducting an Audit or Inspection

  • Maintain professionalism and foster open communication with inspection agents to facilitate smoother audits.

  • Be prepared to promptly answer questions and provide pertinent records when requested.

DEA Audit Readiness File

  • Copies of

    • DEA registration : this should also be posted in a visible place in your office

    • State Practitioner License. Check your State Regs: this should also be posted in a visible place in your office

    • Your most recent biennial (or annual) inventory. Check your state regs

    • DEA form 222 records or CSOS for Schedule II substances

    • Your Purchasing Records

      • Invoices for Schedule III, IV, and V substances

  • Receiving and Closed Reconciliation Logs/Records

  • Open Controlled Substance Reconciliation Logs/Records

  • DEA Form 106 records - Report of Theft or Loss of Controlled Substances

  • DEA Form 41 records Registrant Record of Controlled Substances Destroyed : Medical Waste Destruction logs/records

  • Expired/Unwanted Destruction log/records

  • Other records you keep that document accounting of controlled substances

  • Power of Attorney

  • Revocation of Power of Attorney

  • Security System Company Information

  • Copy of the Practice’s Floor Plan

  • Staff Training Manual, DEA’s Practitioner’s Manual and Controlled Substance Policy, etc.

DEA Arrival Protocol

  • Understand your rights during a DEA inspection; be sure to request credentials, clarify the reason for the audit, photo ID, contact info and business card(s)

  • Ask for open conference

  • Sign the notice of inspection DEA form 82

Throughout the inspection

  • Accompany DEA agents throughout their inspection and document their findings thoroughly for future reference.

  • Dont leave them alone with the printer

  • Take copious notes

    • List anything they take and request

  • If they want to take original copies ask for a DEA form 21

  • A person with each agent

  • close end questions and answers

  • Closing conference

Plan of correction

  • Link each correction in your POC to the actual citation/regulation quoted in your Letter of Admonition

  • You must assure that all identified areas are corrected precisely and concisely

  • Meet or beat all required time frames

  • Keep all copies

  • Politely follow-up with the Agent through email and telephone calls

Additional Notes from Lecture:

  • EAP (Employee Assistance Program): This program offers cost-effective support, approximately $2.50 to $5 per person monthly, aiding employees facing addiction concerns.

  • Caution with Clients: It is imperative for practitioners to be vigilant towards clients who request specific controlled substances by name, as this raises the possibility of drug-seeking behavior.

  • Security Practices: Implement strict protocols for access management regarding prescription pads and controlled substances. All staff should be trained in safety protocols regarding potential theft.

  • Education and Prevention: Regular training sessions, along with collaboration with law enforcement and mental health resources, can enhance prevention efforts and promote a safe environment within veterinary practices.

  • Resources:

    • For regulatory help or questions, contact Jan Woods at Ask Jan For Help.

    • Refer to the DEA's regulations for compliance and audits.

    • Explore resources from the CDC and groups like Not One More Vet for additional support related to mental health and addiction issues.

    • Contact Zoetis for insights on purchasing pharmaceuticals or diagnostics to facilitate practice growth.