1	CONTROLLED SUBSTANCES LAWS AND REGULATIONS RELATED TO VETERINARY MEDICINE Presented by Susan McCann, R.Ph. Administrator, BNDD
2	Topics to be Discussed Prescription Drug Abuse Impairment of Practitioners and Others Controlled Substances Acts Controlled Substance Registration Purchasing and Storing Controlled Substances Record Keeping Requirements Scope of Practice
3	Topics to be Discussed Issuing and Documenting Prescriptions Dispensing Disposing of Unwanted Medications Diversion from Practitioners’ Offices Security Requirements Common Violations Summary
4	Prescription Drug Abuse Culture of drug use in our society 6% of general population abuses substances including those with legitimate need for prescription drugs 1^st time users of prescription drugs for non- medical use 1980s : 0.5 million per year 1998: 1.6 million 2000: > 2 million per year
5	National Household Survey on Drug Abuse Conducted by Substance Abuse and Mental Health Services Administration (SAMHSA) 19.7 million people using pharmaceuticals for non-medical purposes in 2005 (8.1% of the population aged 12 years or older) This figure is an increase from 6.3% in 2000 and 4% in 1999
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8	Drug Abuse/Impairment 10-17% of health care professionals will abuse drugs/alcohol during career Physical/mental stresses Recreational use Knowledgeable about drugs/”immune from harm” 65-85 % of professional discipline is related to controlled substance/alcohol issues
9	Drug Abuse/Impairment Consequences Harm to patients Harm to self Harm to family Harm to career Professional discipline Arrest and criminal prosecution
10	Laws and Regulations State and federal controlled substances acts Closed system of registration, record keeping and security Similarities/differences Not all subjects covered by both
11	Closed System of Distribution Manufacturer Reverse Distributor for Destruction Distributor Practitioner End User Pharmacy
12	Laws and Regulations (cont.) State agencies with controlled substance laws and regulations impacting practitioners include: Board of Pharmacy Board of Veterinary Medicine Department of Agriculture Dept of Health and Senior Services
13	Definitions Administer – To apply or inject a medication to a patient or to provide a dose and observe the patient consuming the medication. Dispense – to provide a supply of medication on behalf of a patient for future use, allowing the patient’s owner to leave your office with the medication in their possession Diversion – Any act that results in a Schedule II-V controlled substance being sold, received, transferred or dispensed in a manner contrary to the law Prescription – A written order or order relayed by other means to a pharmacy to authorize dispensing on behalf of a patient**
14	Schedules of Controlled Substances Criteria for scheduling Potential for abuse Pharmacological effect Current scientific knowledge of substance History of abuse Scope, duration and significance of abuse Risk to public health Potential for psychic or physical dependence Whether an immediate precursor of a current controlled substance
15	Schedules of Controlled Substances Missouri will schedule a substance after the DEA does unless there is an objection Differences between state and federal schedules Codeine cough syrups CIV in Missouri Ephedrine CIV in Missouri Non-prescription strength pseudoephedrine products in solid forms CV in Missouri
16	Department of Health and Senior Services BNDD Organization/staffing Registrations Inspections/investigations Administrative actions Education
17	Registration -- BNDD A registration is required for all legitimate controlled substance activities No registration will be issued if controlled substance conviction or guilty plea: Misdemeanor – 2 years Felony – 7 years
18	Registration Process Applications available by fax, mail or on website: www.dhss.mo.gov/BNDD As a courtesy, applications are mailed out 60 days in advance of expiration Registrations are issued at a practice location only – where patient care occurs and controlled substance activities take place. A different address for mail purposes may also be provided. Applications must have original ink signature and be accompanied by appropriate fee: $90 for a 3 year registration
19	Registration Issues The Bureau must be notified of a change in practice location within 30 days of the change, or the registration automatically terminates Separate registrations are required for separate locations where controlled substances are stored. Locum Tenen (LT) registrations must use the same address as on the professional license. LTs may not stock controlled substances. They may only work at one site 90 days in a row and must keep a log of locations where they have worked
20	Registration – DEA Employee veterinarian may be an agent of a primary veterinarian for administering or dispensing (BNDD is required) Employee veterinarian must register to write prescriptions No facility registration $551 for a 3 year registration
21	Purchasing Controlled Substances You must have both a BNDD and a DEA registration to purchase and stock controlled substances You may delegate the ordering of controlled substances in schedule III-V to an employee, however the registrant is responsible for this activity Schedule II purchases and transfers require a DEA 222 Official Order Form, which may only be signed and executed by the registrant or an individual with the registrant’s power of attorney
22	Controlled Substance Storage
23	Inventory An inventory is a stand-alone document Schedule II inventory separate from inventory for Schedules III-V Required information includes: Registrant name Registrant DEA number Date taken Notation if taken at open (OOB)or close (COB) of business Drug name, strength, dosage form and quantity on hand (exact count for CII and containers of > 1000)
24	Initial and Annual Inventory The first time you receive controlled substances under your registration, you must perform an initial inventory. An annual inventory of controlled substances must performed at least once a year (within 12 months of last inventory). Perpetual controlled substance inventory is recommended, but does not fulfill this requirement.
25	Receipt Records – Schedules III-V You must maintain a record of all controlled substances received Receipt records must contain: Supplier’s name, address and DEA number Receiver’s name, address and DEA number Drug name, strength, dosage form and quantity Date received – If you use invoices as receipt records, you must note the date received (not date shipped) on the invoice.
26	Receipt Records – Schedule II The DEA Official Order Form (222) is the record of receipt for Schedule II controlled substances When Schedule II medications are received, the third copy of the form must be completed with the quantity received and initials of the individual receiving and checking in the medication.
27	Transferring Possession Office stack of controlled substances must be purchased or transferred from another registrant Office stock may not be obtained by issuing a prescription. Prescriptions authorize dispensing on behalf of a patient Records of controlled substances received by transfer from or transferred to another registrant may be stored with records of receipt Transfer records must contain the same information as is required for receipt records. Do not borrow or loan without a record
28	Controlled Substance Records Required information in inventories,transfer and receipt records Name Form Strength Quantity per container Number of containers Date of transaction Name/address of person dispensed to Name/initial of person dispensing Any other type of disposition Goal – records are reconcilable
29	Scope of Practice Veterinary Practice Act Veterinarian/client patient relationship “…has assumed responsibility for making medical judgements” “…sufficient knowledge to initiate… diagnosis” “…has recently seen and is personally acquainted with the keeping and care…examination…or visits”
30	Scope of Practice Veterinary Practice Act (continued) Rules of professional conduct “…shall not dispense or prescribe any controlled substance…except in the professional course of his/her practice and only upon the establishment of a bona fide veterinarian-client-patient relationship
31	Issuing Prescriptions A valid prescription is issued: In good faith In course of professional practice For a legitimate veterinary medical reason In the presence of a legitimate prescriber / client / patient relationship
32	Issuing Prescriptions Prescriptions may be filled only by RPh Format, components for CS prescription: Dated on day signed Name and address of patient Drug name, strength, dosage form Quantity (preferably written out) Complete instructions (preferably not prn) Specify refills
33	Issuing Prescriptions Format, components of a CS prescription May type, preprint or computer generate prescription Must have a written signature No stamp or computer generated signature Must include name and address of prescriber (and preferably telephone number) Must include the prescriber’s DEA registration number
34	Issuing Prescriptions Ensure prescription is legitimate and properly written Pharmacist has a corresponding responsibility with prescriber Changes or additions Many changes are allowed after confirming with prescriber Changes not allowed Patient name Drug name (except generic substitution) Prescriber signature Documentation of changes must be maintained
35	Issuing Prescriptions Expiration No fill or refill of CII – IV beyond 6 months from date prescribed CII Prescriptions Always written, except special circumstances Oral (telephone) emergency Immediate admin necessary, no other drug appropriate, can’t reasonably provide Rx Reduce to writing for filing Quantity limited to emergency period Confirm prescriber if unknown Written follow up Rx within 7 days “authorization for emergency dispensing” Attach to oral
36	Documentation in Patient Charts All controlled substance activities regarding patients must be documented in patient charts: Prescriptions written or issued via telephone Controlled substances administered Controlled substances dispensed Required information includes: Date Drug name, strength, quantity, dosage form Instructions for use Refills authorized on prescriptions issued
37	Dispensing Controlled Substances Must have a V-C-P relationship Dispensing must be in containers approved by the U.S. Food and Drug Administration Child resistant containers must be used
38	Administration and Dispensing Records Documentation of controlled substances dispensed from office stock must be maintained separate from patient charts It is highly recommended that maintenance of documentation of controlled substances administered in the office be kept separate from patient charts Required information includes: Date Patient name and species Owner name and address Drug name, strength, dosage form, quantity and initials of staff administering or dispensing
39	Dispensing Controlled Substances All dispensing laws regarding labeling must be followed. Labels must include: Dispensing practitioner’s name and address Patient and owner name Drug name, strength, dosage form and quantity Directions for use Date dispensed Containers must have a warning sticker or label advising that it is illegal to transfer controlled substances to anyone other than the patient for which prescribed
40	Dispensing for a Herd Identify species of animal (hogs to be cut) Number of animals in the herd (150) Average weight of animals (X pounds/hog) Average dose per animal by wt (one vial/X lbs) Multiply the number of doses times the number of animals in the herd (150 vials) Dispense the quantity necessary to treat the herd DOCUMENT YOUR WORK AND CALCULATIONS Do NOT dispense a supply for “general future use”
41	General Record Keeping Requirements All controlled substance records must be maintained at the registered site All controlled substance records must be maintained for two years All controlled substance records are open for inspection and copying by the Bureau and law enforcement officers All controlled substance records must be readily retrievable: Separate, or Available through electronic or mechanical access, or Visually identifiable Must be provided within three (3) working days
42	Disposing of Unwanted Drugs Drugs and partial doses contaminated by patient contact may be destroyed (wasted) on site Drugs must be destroyed beyond reclamation In administration log, document all required administration information, including the amount wasted and reason for the waste The wastage must be witnessed by a second person and both the person wasting and the witness must sign/initial the administration log Unwanted drugs that are expired and not contaminated must be transferred by to the manufacturer or distributor or to a reverse distributor
43	Drug Diversion from Veterinary Offices Office staff (including practitioner) or family member Steal drugs from stock Order for self Use another’s password to access ADS Telephone false prescriptions Write false prescriptions Steal or sell prescription blanks Theft Opportunistic Planned access Break-ins
44	Drug Diversion from Practitioners’ Offices Methods of diversion (continued) Record falsification Forged, altered prescription Administration records (including ADS) Distribution records Inventory records Receiving records
45	Security Locked storage areas Office, truck, barn Secured at all times when not in use Key control Limit access to persons authorized to administer or dispense Monitor Checks to invoices Inventory records – perform periodic audits Administration and dispensing records compared to patient charts
46	Security Waivers to employ required For person with any conviction re controlled substances, if will have access to controlled substances Misdemeanor -- from BNDD only Felony – from BNDD and DEA For previous denial, revocation or surrender of a controlled substance registration
47	Security Reporting losses Police BNDD Any theft/significant loss Report “upon discovery” Loss report form within 7 days Permission for interim report Summary, name of thief, police report “Insignificant” loss – file with inventory
48	Security Reporting losses to the DEA Call immediately Follow up with form Form may be completed and submitted electronically
49	Performing a Controlled Substance Audit Drugs on hand (from annual inventory) 200 5mg tablets Drugs received since annual inventory 3,200 5mg tablets Total dosage units you’re responsible for 3,400 5mg tablets Drugs administered and dispensed 1,600 5mg tablets Drugs sent to reverse distributor 100 5mg tablets Drugs contaminated/destroyed on site 10 5mg tablets Dosage legitimately disposed 1,710 5mg tablets Drugs that should be on hand the day of the audit: 3,400 – 1,710 = 1,690 5 mg tablets
50	Most Common Violations Practitioner moved and did not notify the Bureau Failure to maintain an annual inventory: No annual inventory maintained Schedule II annual inventory on same document as Schedules III-V Annual inventory not marked as being performed at “opening of business” or “close of business” Failure to document controlled substance prescriptions in patient charts Invoices used for tracking receipt of drugs not maintained or maintained with required info
51	Most Common Violations Failure to secure controlled substance stock Unwanted controlled substances illegally destroyed instead of reversed Controlled substances legitimately wasted not witnessed or documented properly Dispensing in unapproved containers Dispensing without proper labeling Failure to maintain dispensing records separate from patient charts Practice under an employer veterinarian without obtaining a BNDD registration
52	Administrative Action
53	Other Consequences Possible criminal action – arrest and prosecution Misdemeanor -- refusal to make or keep records Felony – theft, false/forged Rx or making a false record DEA Diversion Task Forces are arresting patients and licensed professionals for serious controlled substance violations DEA may also assess civil penalties
54	Summary
55	Where to Get More Information Internet references: Bureau of Narcotics and Dangerous Drugs www.dhss.state.mo.us/BNDD Drug Enforcement Administration www.deadiversion.usdoj.gov Missouri State Boards of Licensure www.pr.mo.gov/ then select profession
56	Resources BNDD P.O. Box 570 Jefferson City, MO 65102-0570 (573) 751-6321 Fax (573) 526-2569 www.dhss.mo.gov/BNDD DEA—St. Louis DEA—Overland Park, KS 317 S. 16^th Street 8600 Farley, Suite 200 St. Louis, MO 63103 Overland Park, KS 66212 (314) 538-4600 (913) 825-4100