Controlled Substances Regulation for Veterinary Practices Douglas T

Controlled Substances Regulation for Veterinary Practices Douglas T. Kemp, Pharm. D, DICVP College of Veterinary Medicine University of Georgia Athens, GA 30602 -7391

Drug Abuse … the prevalence of severe drug abuse problems and their consequences has increased since 1985…. The Economic Costs of Alcohol and Drug Abuse in the United States, 1992 National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism

C. Y. A.

GOALS Avoid Enforcement Action Discourage Abuse

Non-Controlled Drugs? Detomidine Xylazine Others? ?

Moving Target

Controlled Substances Laws Harrison Narcotic Act of 1914 Comprehensive Drug Abuse Prevention and Control Act of 1971

Controlled Substances Laws & Regulations Title 21 USC § 801 -971 Title 21 CFR § 1300 et seq Federal Register

Web Access USC, CFR and FR are searchable on the WWW table of contents of FR

Georgia Laws and Rules Title 16, Chapter 13, Article 1 -2 (CSA) Title 26, Chapter 4, Article 1 (PHR) Pharmacy Rules, Chapter 480 -28 Vet Rules, Chapter 700 -8 -. 01(c)

Veterinary Rules - GA • Can not prescribe without examination • Can not dispense or prescribe more than 30 days of C-II • Must reexamine before each C-II prescription • Approved doses, published references or documented clinical need

Florida Laws and Rules Florida Comprehensive Drug Prevention and Control Act Rules, Department of Professional Regulation, Board of Veterinary Medicine

State vs Federal Laws If state and federal laws conflict… conflict the more stringent law holds

Basic Requirements Valid Veterinarian/Client/Patient (V/C/P) Relationship Good Faith

Pharmacists have a corresponding responsibility for controlled substances prescriptions

Expectations You are expected to create and maintain a system that prevents theft and/or diversion

System Components Audit Trails Security/Accountability Valid Uses Common Sense

You are being watched!

System Components DEA will inspect many aspects of your practice Policy and procedure manuals

Scheduling Potential for abuse Approved medical use (in the US) International treaties

Schedule I High potential for abuse No accepted medical use (in the US) (heroin, LSD)

Schedule II High potential for abuse Accepted medical use (in the US) (morphine, oxymorphone, fentanyl)

Schedule III-V Decreasing potential for abuse Accepted medical use (in the US)

Butorphanol, Ketamine Butorphanol C-IV 10/97 Ketamine C-III 8/99

Anabolic Steroids C-III September 1991 Any drug or hormonal substance, chemically or pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) Veterinary implants exempt

Anabolic Steroids HCG ACTH

Chemical Diversion and Trafficking Act of 1988 List I : chemicals that are methamphetamine precursors List II : Chemicals that are use in manufacture, encapsulating and tableting machines 21 CFR 1313

Chemical Diversion and Trafficking Act of 1988 Reduced access to chemicals exported for cocaine production Created a diversion market for finished drug products containing ephedrine and related products used in illicit methamphetamine manufacture

Domestic Chemical Diversion and Control Act of 1993 Added finished ephedrine drug products to List I Created a diversion market for pseudoephedrine

Comprehensive Methamphetamine Control Act of 1996 Added finished pseudoephedrine and phenylpropanolamine drug products to List I Defined record keeping for distributors 21 CFR 1300, 1309, 1310

Ephedrine C-V in Ohio (except exempt drug products) Category III terminal distributor license required to dispense ORC 3917. 41

Registration (old) Every veterinarian who administers, prescribes, distributes or dispenses controlled substances must register with DEA

Registration Agents may function as agents of the registrant Agents may administer or dispense Agents may not prescribe

Registration (old) If a veterinarian dispenses or administers controlled substances at more than one location, then that veterinarian must register at each location

Registration If a veterinarian dispenses or administers controlled substances at more than one location, then that veterinarian should contact DEA for registration advice (relief veterinarians, etc)

Practitioner in Charge (PIC) Individual who holds DEA license for common stock All registrants shall provide effective controls…. .

Pharmacop

Use of Agents Non-practitioners: ordering, administering, inventory control…. Can not dispense but can measure quantities, produce labels, under direct supervision

Criminal Background Check shall not employ as an agent or employee who has access to controlled substances any person who: • has a drug conviction • has been considered for charges • DEA license has been refused • DEA license has been revoked • DEA license has been surrendered 21 CFR 1301. 76

Criminal Background Check shall not employ as an agent or employee who has access to controlled substances any person who: “employ” means “use” background check requirement applies to volunteers DEA Advisement

Employee Screening Questions: Illegal use of drugs? Drug convictions? 21 CFR 1301. 90

Criminal Background Check Local law enforcement DEA 21 CFR 1301. 93

Criminal Background Check Concerns cost turn around time overspray confidentiality liability

Trust Don’t

System Components Audit Trails Vapor Trails

C. Y. A.

Records blank 222 forms executed 222 forms C II invoices C III-V invoices dispensing records “biennial” inventory disposal records loss or theft records

Kentucky records Date of receipt, name and address of source, kind and quantity of drugs received Date of sale, administration, dispensing, disposal, name and address of recipient or client, species, kind and quantity of drug KRS 218 A. 200

222 Form

Prescription “Prescription” means a written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treatment of a particular animal, issued by a licensed health care professional authorized to prescribe drugs OCR 4729. 01

Prescription A prescription shall not be issued for a practitioner to obtain a controlled substance for the purpose of general dispensing to patients KRS 218 A 180, 21 CFR 1306. 04

Receiving records C II invoices separate C III-V invoices separate -ormarked with red “C” 21 CFR 1304. 02, 1304. 04

C II Invoices

C III, IV & V Invoices

Security shall provide effective controls and procedures to guard against theft and diversion 21 CFR 1301. 71 shall be stored in a securely locked, substantially constructed cabinet 21 CFR 1301. 75

Security carfentanil, etorphine and diprenorphine shall be stored in a Class V security container 21 CFR 1301. 75

Disposition Records consolidated audit trail clear readily retrievable 21 CFR 1304. 04

Disposition Records

Serial Number Record

Restocking Cycle Old disposition sheet + empty container New disposition sheet + full container

CDM

CDM

CDM KEYPAD

CDM

CDM - DRAWER

CDM - RETURNS

CDM - ELECTRONICS

CDM - PC

AUTOMATED CHARGING CDM PC HOSPITAL SYSTEM

DISPOSITION RECORD

PRESCRIPTIONS C-III, IV, V C OTHERS C-III, IV, V C OTHERS

PRESCRIPTIONS

Prescription Packaging Child Resistant Amber Tight

Packaging

Labeling Name and address of dispenser Serial number and date of dispensing Name of patient Name of drug and quantity Directions for use Expiration date Precautionary information Federal caution label

Audit Records Detect and correct errors WHILE THEY ARE FRESH!

Audit Records

Audit Records All controlled substances records must be readily retrievable

Biennial Inventory Every 2 years Separate from other inventory records Readily retrievable Perpetual Inventory?

Perpetual Inventory

Medical Records Document administration/dispensing Document medical need

Computerized Records Keep written records Keep printouts Complete information Backup system Continuity of records Continuity of system

Loss or theft Notify local law enforcement Notify DEA and complete form 106 Notify your licensing board

Disposal of Drugs Store out of date or contaminated drugs in a secure place separate from other controlled substances Complete DEA form 41 Contact Pharmaceutical Disposer Registrant

Retention of Records 2 years (state and federal law) 5 years (statute of limitations) Infinity (Kemp)

Inspections Must make records available No warrants needed Certain information exempt

Distribution to another Practitioner Not by prescription Subject to 5%limit

Distribution Records

Practitioner Transfers (D) No licensed terminal distributor of dangerous drugs shall purchase for the purpose of resale dangerous drugs from any person other than a registered wholesale distributor of dangerous drugs, except as follows: . . . . occasional purchases of dangerous drugs for resale from a pharmacist. . licensed terminal distributor of dangerous drugs having more than one establishment or place may transfer or receive dangerous drugs from one establishment. . . ORC 4729. 51

Filling Prescriptions Veterinarian/Client/Patient Relationship Federal Law State Law

Criminal Fine Enforcement Act of 1984 up to $100, 000 for a misdemeanor by a corporation or individual not resulting in death up to $250, 000 for a misdemeanor by an individual resulting in death or for a felony up to $500, 000 for a misdemeanor by a corporation or individual resulting in death or for a felony up to 1 year in prison for a misdemeanor up to 10 years in prison for a felony

Other Penalties Forfeiture of property: Real Estate Cars, boats, airplanes Money, securities, items of value

Other Penalties Within 1000 ft of school, park, playground, youth center, public swimming pool, video arcade (including their parking lots)……. Double penalties……up to life imprisonment…. .

Advisements Get important communications with regulatory agencies IN WRITING!