DrugDrug AbuseAbuse

… … the prevalence of severe the prevalence of severe drug abuse problems and drug abuse problems and their consequences has their consequences has increased since 1985….increased since 1985….

The Economic Costs of Alcohol and Drug Abuse in the United States, 1992

National Institute on Drug AbuseNational Institute on Alcohol Abuse and Alcoholism

GOALSGOALS

Avoid Enforcement ActionAvoid Enforcement Action

Discourage AbuseDiscourage Abuse

Controlled Substances LawsControlled Substances Laws

Harrison Narcotic Act of 1914Harrison Narcotic Act of 1914

Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Act of Prevention and Control Act of 19711971

Georgia Laws and RulesGeorgia Laws and Rules

Title 16, Chapter 13, Article Title 16, Chapter 13, Article 1-2 1-2 (CSA)(CSA)

Title 26, Chapter 4, Article 1 Title 26, Chapter 4, Article 1 (PHR)(PHR)

Pharmacy Rules, Chapter Pharmacy Rules, Chapter 480-28480-28

Vet Rules, Chapter 700-Vet Rules, Chapter 700-8-.01(c)8-.01(c)

Veterinary Rules - GAVeterinary Rules - GA

•Can not prescribe without Can not prescribe without examinationexamination•Can not dispense or prescribe Can not dispense or prescribe more than 30 days of C-IImore than 30 days of C-II

•Approved doses, published Approved doses, published references or documented clinical references or documented clinical needneed

•Must reexamine before each Must reexamine before each C-II prescriptionC-II prescription

State vs Federal LawsState vs Federal Laws

If state and federal laws If state and federal laws conflictconflict…

the more stringent law the more stringent law holdsholds

Basic RequirementsBasic Requirements

Valid Valid Veterinarian/Client/Patient Veterinarian/Client/Patient

(V/C/P) Relationship(V/C/P) Relationship

Good FaithGood Faith

System ComponentsSystem Components

Audit TrailsAudit Trails

Security/AccountabilitySecurity/Accountability

Valid UsesValid Uses

Common SenseCommon Sense

System ComponentsSystem Components

DEA will inspect many DEA will inspect many aspects of your aspects of your

practicepractice

Policy and procedure Policy and procedure manualsmanuals

Schedule ISchedule I

High potential for abuseHigh potential for abuse

No accepted medical use (in the US)No accepted medical use (in the US)

(heroin, LSD)(heroin, LSD)

Schedule IISchedule II

High potential for abuseHigh potential for abuse

Accepted medical use (in the US)Accepted medical use (in the US)

(morphine, oxymorphone, fentanyl)(morphine, oxymorphone, fentanyl)

Schedule III-VSchedule III-V

Decreasing potential for abuseDecreasing potential for abuse

Accepted medical use (in the US)Accepted medical use (in the US)

Chemical Diversion and Trafficking Chemical Diversion and Trafficking Act of 1988Act of 1988

List I : chemicals that are methamphetamineList I : chemicals that are methamphetamineprecursorsprecursors

List II : Chemicals that are use in manufacture,List II : Chemicals that are use in manufacture,encapsulating and tableting machinesencapsulating and tableting machines

21CFR131321CFR1313

Chemical Diversion and Trafficking Chemical Diversion and Trafficking Act of 1988Act of 1988

Reduced access to chemicals exported Reduced access to chemicals exported for cocaine production for cocaine production

Created a diversion market for finished Created a diversion market for finished drug products containing ephedrine and drug products containing ephedrine and related products used in illicitrelated products used in illicitmethamphetamine manufacturemethamphetamine manufacture

Domestic Chemical Diversion and Domestic Chemical Diversion and Control Act of 1993Control Act of 1993

Added finished ephedrine drug Added finished ephedrine drug products to List Iproducts to List I

Created a diversion market for Created a diversion market for pseudoephedrinepseudoephedrine

Comprehensive Methamphetamine Comprehensive Methamphetamine Control Act of 1996Control Act of 1996

Added finished pseudoephedrine and Added finished pseudoephedrine and phenylpropanolamine drug products phenylpropanolamine drug products to List Ito List I

Defined record keeping for Defined record keeping for distributorsdistributors

21CFR1300, 1309, 131021CFR1300, 1309, 1310

RegistrationRegistration

Agents may function as agents of the registrantAgents may function as agents of the registrant

Agents may administer or dispenseAgents may administer or dispense

Agents may not prescribeAgents may not prescribe

RegistrationRegistration

If a veterinarian dispenses or administers If a veterinarian dispenses or administers controlled substances at more than one controlled substances at more than one

location, then that veterinarian must registerlocation, then that veterinarian must registerat each locationat each location

(old)(old)

RegistrationRegistration

If a veterinarian dispenses or administers If a veterinarian dispenses or administers controlled substances at more than one controlled substances at more than one location, then that veterinarian should location, then that veterinarian should

contact DEA for registration advicecontact DEA for registration advice

(relief veterinarians, etc)(relief veterinarians, etc)

Non-practitioners: ordering, Non-practitioners: ordering, administering, inventory control….administering, inventory control….

Can not dispense but can measure Can not dispense but can measure quantities, produce labels, under quantities, produce labels, under direct supervisiondirect supervision

Use of AgentsUse of Agents

shall not employ as an agent or employee shall not employ as an agent or employee who has access to controlled substances who has access to controlled substances any person who:any person who:

Criminal Background CheckCriminal Background Check

•has a drug convictionhas a drug conviction

•has been considered for chargeshas been considered for charges

•DEA license has been revokedDEA license has been revoked

•DEA license has been refusedDEA license has been refused

•DEA license has been surrenderedDEA license has been surrendered21CFR1301.7621CFR1301.76

Questions:Questions:

Employee ScreeningEmployee Screening

Illegal use of drugs?Illegal use of drugs?

21CFR1301.9021CFR1301.90

Drug convictions?Drug convictions?

blank 222 formsblank 222 forms

RecordsRecords

executed 222 formsexecuted 222 forms

C II invoicesC II invoices

C III-V invoicesC III-V invoices

dispensing recordsdispensing records

disposal recordsdisposal records““biennial” inventorybiennial” inventory

loss or theft recordsloss or theft records

A prescription shall not be issued A prescription shall not be issued for a practitioner to obtain a for a practitioner to obtain a controlled substance for the controlled substance for the

purpose of general dispensing to purpose of general dispensing to patientspatients

PrescriptionPrescription

KRS218A180, 21CFR 1306.04

C II invoices C II invoices separateseparate

Receiving recordsReceiving records

21CFR 1304.02, 1304.04

C III-V invoices separateC III-V invoices separate-or--or-

marked with red “C”marked with red “C”

PRESCRIPTIONSPRESCRIPTIONS

C-IIC-II C-IIC-II C-IIC-IIC-III, IV, V C-III, IV, V CC

C-III, IV, C-III, IV, VV

OTHERSOTHERS OTHERSOTHERS

C-III, IV, V C-III, IV, V CCOTHERSOTHERS

Prescription PackagingPrescription Packaging

Child ResistantChild Resistant

AmberAmber

TightTight

LabelingLabeling

Serial number and date of dispensingSerial number and date of dispensing

Name of patientName of patient

Name of drug and quantityName of drug and quantity

Name and address of dispenserName and address of dispenser

Directions for useDirections for use

Precautionary informationPrecautionary information

Expiration dateExpiration date

Federal caution labelFederal caution label

Audit RecordsAudit Records

Detect and correct errorsDetect and correct errors

WHILE THEY ARE FRESH!WHILE THEY ARE FRESH!

Audit RecordsAudit Records

All controlled substancesAll controlled substancesrecords must be records must be readily retrievablereadily retrievable

Biennial InventoryBiennial Inventory

Every 2 yearsEvery 2 years

Separate from other inventory Separate from other inventory recordsrecords

Readily retrievableReadily retrievable

Perpetual Inventory?Perpetual Inventory?

Medical RecordsMedical Records

Document administration/dispensingDocument administration/dispensing

Document medical needDocument medical need

Computerized RecordsComputerized Records

Keep written recordsKeep written records

Continuity of recordsContinuity of records

Complete informationComplete information

Backup systemBackup system

Keep printoutsKeep printouts

Continuity of systemContinuity of system

Loss or theftLoss or theft

Notify local law enforcementNotify local law enforcement

Notify your licensing boardNotify your licensing board

Notify DEA and complete form 106Notify DEA and complete form 106

Disposal of DrugsDisposal of Drugs

Store out of date or Store out of date or contaminated drugs in a secure contaminated drugs in a secure

place separate from other place separate from other controlled substancescontrolled substances

Contact Pharmaceutical Disposer RegistrantContact Pharmaceutical Disposer Registrant

Complete DEA form 41Complete DEA form 41

Retention of RecordsRetention of Records

2 years (state and federal law)2 years (state and federal law)

Infinity (Kemp)Infinity (Kemp)

5 years (statute of limitations)5 years (statute of limitations)

InspectionsInspections

Must make records availableMust make records available

Certain information exemptCertain information exempt

No warrants neededNo warrants needed

Distribution to another Distribution to another PractitionerPractitioner

Not by Not by prescriptionprescription

Subject to 5%limitSubject to 5%limit

Practitioner TransfersPractitioner Transfers

(D) No licensed terminal distributor of (D) No licensed terminal distributor of dangerous drugs shall purchase for the purpose dangerous drugs shall purchase for the purpose of resale dangerous drugs from any person of resale dangerous drugs from any person other than a registered wholesale distributor of other than a registered wholesale distributor of dangerous drugs, except as follows:dangerous drugs, except as follows:

.......occasional purchases of dangerous drugs .......occasional purchases of dangerous drugs for resale from a pharmacist.....for resale from a pharmacist.....

.... licensed terminal distributor of dangerous .... licensed terminal distributor of dangerous drugs having more than one establishment or drugs having more than one establishment or place may transfer or receive dangerous drugs place may transfer or receive dangerous drugs from one establishment.....from one establishment.....

ORC 4729.51ORC 4729.51

Criminal Fine EnforcementCriminal Fine EnforcementAct of 1984Act of 1984

up to $100,000 for a misdemeanor by a corporation or up to $100,000 for a misdemeanor by a corporation or individual not resulting in deathindividual not resulting in death

up to $500,000 for a misdemeanor by a corporation or up to $500,000 for a misdemeanor by a corporation or individual resulting in death or for a felonyindividual resulting in death or for a felony

up to 1 year in prison for a misdemeanorup to 1 year in prison for a misdemeanor

up to $250,000 for a misdemeanor by an individual up to $250,000 for a misdemeanor by an individual resulting in death or for a felonyresulting in death or for a felony

up to 10 years in prison for a felonyup to 10 years in prison for a felony

Other PenaltiesOther Penalties

Forfeiture of Forfeiture of property:property:

Real Real EstateEstate

Cars, boats, Cars, boats, airplanesairplanes

Money, securities, items of Money, securities, items of valuevalue

Other PenaltiesOther Penalties

Within 1000 ft of school, park, Within 1000 ft of school, park, playground, youth center, public playground, youth center, public swimming pool, video arcade swimming pool, video arcade (including their parking lots)…….(including their parking lots)…….

Double penalties……up to life Double penalties……up to life imprisonment…..imprisonment…..

AdvisementsAdvisements

Get important communications with Get important communications with regulatory agencies regulatory agencies IN WRITING!IN WRITING!