Transcript DEA Supplement, PowerPoint Presentation

DEA REGULATIONS
FOR THE VETERINARIAN
Frances Cullen, PC
197 14th Street, NW
Suite 250
Atlanta, Georgia 30318
www.francullen.com
(404) 806-6771
OVERVIEW
1. Regulation of Controlled Substances – State of
Georgia – Drug Enforcement Agency (“DEA”) and
Georgia Drugs & Narcotics (“GDNA”)
2. Purchasing Controlled Substances
3. Power of Attorney
4. Required Recordkeeping
5. Initial Inventory
6. Inventory Control
OVERVIEW (Cont’d)
7. Administration
8. Prescriptions
9. Labeling
10. Waste disposal
11. Documentation
12. Security
13. Audits
14. Addressing Loss or Theft
15. Transportation of Controlled Substances
16. Diversion drug dependence by all professionals
DEA REGULATIONS
YOU NEED TO KNOW
• 42 CFR section 1301.12(a) - Requirement for
Separate DEA for Different Locations
• 42 CFR 1301.76 Other Security Measures
• 42 CFR 1304.03,1304.04, 1304.21, 1304.22, –
General Recordkeeping
• 42 CFR 1304.5 – DEA Order Forms for Schedule II
drugs Requirements
• 42 CFR 1304.11 – Inventory Requirements-must
denote open or close-every 2 years
DEA REGULATIONS
YOU NEED TO KNOW (Cont’d)
• 42 CFR 1304.22(d) – Requirement for
Separate Records
• 42 CFR 1305 – Power of Attorney
• 42 CFR 1305.13 – DEA Form 222
• 42 CFR 1307.21 – Drug Disposal
PURCHASING CONTROLLED
SUBSTANCES
• Each provider must have a Valid DEA number
• For Schedule II controlled substances, you must use
DEA Form 222 Order forms signed by the
practitioner or another person authorized to order
controlled substances through a valid Power of
Attorney
• Controlled Substances may be purchased only from:
– Another Registrant, Distributor, or Pharmacy
PURCHASING CONTROLLED
SUBSTANCES (Cont’d)
• Purchases and transfers for controlled substances in
Schedules III—V only require a transfer form. A copy
of the transfer form must be maintained by both the
supplier and the receiver.
POWER OF ATTORNEY
• A Registrant can authorize one or more
individuals to issue orders for Schedule II
controlled substances on the registrant’s behalf
by executing a Power of Attorney (“POA”)
• The POA must be maintained in the files with
executed DEA Form 222
• The POA must be available for inspection.
REQUIRED RECORD KEEPING
• Documentation is required every time a controlled substance
changes hands. You must have a paper trail.
• The trail is from the manufacturer, to the distributor, to the
pharmacy and/or the practitioner, and to the end user.
• State and Federal controlled substance laws require
maintenance of controlled substance records for period of 2
years from the date of each inventory. The GA Board of
Veterinary Practice requires maintaining records for 3 years.
The Statute of Limitations under FDA law is 5 years, so a 5
year retention policy may be advisable.
RECORD KEEPING
• Records must be maintained at the registered practice location
and must be readily retrievable and open to inspection and
copying.
• A registrant must maintain a file of receipt records for their
receipt of all controlled substances.
• Keep records for the receipt of Schedule III-IV drugs separate
from Schedule II DEA Form 222 Official Order Forms.
• Keep your logbooks for 5 years, the Federal FDA Statute of
Limitations.
RECORD KEEPING (Cont’d)
• Keep accessible all DEA Form 222’s for
Schedule II controlled substances
• Keep accessible your invoices for Schedule
III-V controlled substances.
KEY DETAILS FOR RECORD
KEEPING
• Registrants MUST maintain the following information for all
controlled substances received:
1.
Date of receipt
2.
Drug Description
a. Name
c. Dose
b. Drug strength
d. Quantity received
3.
Name, address and DEA number of the supplier
4.
Name, address and DEA number of the recipient
5.
Name or initials of employees verifying receipt of
the drugs
DETAILED RECORD KEEPING
(Cont’d)
• Receipt records may be kept in a handwritten
or typed log, or may be maintained
electronically.
• The third copies of all DEA Form 222 Order
Forms must be signed and dated to verify
receipt of the Schedule II drugs.
INITIAL INVENTORY
• On the date of receipt and stocking of any controlled substance,
you must perform an initial inventory of the controlled
substances on hand.
• The following information must be documented:
1. Date
2. Documentation of whether the inventory was taken at
Opening or Close of business, or if the practice location is
open 24 hours a day, the time of the inventory
3. Drug name
4. Drug strength
5. Dosage form
6. Quantity of dosage units on hand
INITIAL INVENTORY (Cont’d)
• The initial inventory of Schedule II drugs must
be maintained on a separate form and
document then the initial inventory of
Schedule III—V drugs.
• Do not perform an inventory that combines
Schedule II drug counts with drugs in
Schedule III—V, and do not include any noncontrolled drugs on inventory documents.
ANNUAL INVENTORY
• An initial inventory is taken on the first day you start stocking
controlled substances.
• An annual inventory must be taken on any date that is within
one year of initial stocking and, from then on, on any date
within one year of the previous annual inventory date.
• The same information must be maintained in the annual
inventory as is required for an initial inventory.
CHECKLIST!
All of the six areas of information listed for your
initial inventory must be documented.
• Schedule II drugs should be documented on a separate form.
• Do not combine non-controlled drugs on the annual controlled
substance inventory.
• For tax purposes, and to save time and work, you may
coincide your annual inventory date with the date of your
business inventory at the end of the year.
COUNT, COUNT, COUNT!
• Include all controlled substance dosage units in your
inventory regardless of whether they are in stock
bottles, have been set aside for destruction, are
samples, or are outdated.
• You must have an exact count for Schedule II
controlled substances
• When Schedule II controlled substances are counted,
they must be hand-counted every time. No estimates!
COUNTING (Cont’d)
• Counting Schedules III—V controlled substances:
-You may open a bottle and estimate the number of units if
the stock bottle is labeled to contain less than 1,000 dosage
units.
-If the stock bottle is labeled to contain 1,000 units or more,
then an individual hand count must be performed to
provide an exact count.
• If you stock all schedules, you must have two annual
inventory documents; one for Schedule II and one for
Schedules III—V.
• You may choose to perform them on the same date.
LOG YOUR INVENTORY!
• Many practitioners choose to maintain an ongoing log of all
drugs administered or dispensed. This provides an ongoing
count every day of what they have used and what they still
have on hand.
• Perpetual logs are useful and encouraged, and deter theft and
diversion, but do not replace the requirement to have a specific
annual inventory document. They are also not required by
law.
• Annual inventories must always be separate documents that
stand-alone and are maintained separately.
PRESCRIPTIONS
• Prescriptions are written orders provided only to patients.
• Prescriptions may not be written to obtain stock for
administering and dispensing in a clinic.
• A practitioner must establish a legitimate need to prescribe
controlled substances through an assessment utilizing pertinent
diagnostic tools and the determination that there is a valid need
for the drug(s) prescribed.
• A patient chart must be maintained!
PRESCRIPTIONS (Cont’d)
• All prescriptions for controlled substances must contain the
following information:
1. The date in the upper right hand corner must be the date
the prescription was written and signed.
2. Name and address of the patient/pet owner
3. The species of the animal.
4. Drug name, dosage form, drug strength, quantity, and
directions for administration.
5. Original ink signature of the veterinarian.
6. Veterinarian’s DEA number.
7. Name and address of the veterinarian
GA BOARD OF PHARMACY LAW
• Effective October 2011, the Georgia Board of Pharmacy now
requires that all Schedule II prescription drugs be sequentially
numbered and written on approved security paper.
• Keep a separate file of copies of your Schedule II
prescriptions.
ADMINISTRATION/DISPENSING
• Maintain a Controlled Substance Dispensing or Administration
Log that contains the following:
1. Date of administration at facility or dispensing to patient
2. Patient name/owner
3. Patient address/owner
4. Drug name
5. Drug strength
6. Dosage form
7. Quantity
8. Whether it was Administered (A) or Dispensed (D)
9. Name or initials of employee performing the
administering/dispensing
ADMINISTRATION/DISPENSING
(Cont’d)
• This administration/dispensing log should be maintained and
filed separately from patient charts.
• This document should account for the use and disposition of
all controlled substances utilized in the practice.
WHAT’S IN A LABEL?
Labeling:
All controlled substances must be dispensed in child proof
containers with required labels and stickers.
Required labeling:
1.
Date of dispensing
2.
Name and address of dispensing practitioner
3.
Patient’s name
4.
Drug name, drug strength, dosage form and
quantity
5.
Directions for administration
WHAT’S IN A LABEL? (Cont’d)
Warning labels:
All controlled substances dispensed must bear a warning
sticker that informs the owner that it is illegal to transfer
controlled substances to anyone other than the patient for
whom it was dispensed. These stickers are available through
drug companies or pharmacies.
Packaging:
Controlled substance samples in FDA approved pre-packaged
containers are not required to be repackaged.
Controlled substances cannot be dispensed in envelopes,
plastic bags or other unapproved containers.
DOCUMENT PATIENT CHARTS
• All use of controlled substances must be documented in the
patient’s chart.
• Each prescription, administration and dispensing chart note
must contain:
1. Date
2. Activity
3. Drug Name
4. Strength
5. Dosage Form
6. Quantity
DOCUMENT PATIENT CHARTS
(Cont’d)
• If you do not stock controlled drugs and you only prescribe,
then controlled substance prescriptions must only be
documented in the patients’ charts.
• If you administer and dispense controlled substances, you
must document this information both in the
administration/dispensing log and then again in the patient
chart.
WASTE YOUR CONTROLLED
• Controlled substances are wasted or destroyed for two reasons
1. The drugs are outdated, expired or unwanted; or
2. They have been contaminated by patient contact.
• Only controlled substances contaminated by patient contact may
be destroyed onsite by a practitioner.
• When a drug has been contaminated by patient contact it should
be destroyed beyond reclamation by two people and the required
documentation should be completed.
• Outdated/expired controlled substances may not be destroyed on
site by a practitioner without prior approval from the United
States Drug Enforcement Administration.
WASTE YOUR CONTROLLED
(Cont’d)
• When a drug has not been contaminated and is expired,
outdated, recalled or unwanted, it must be sent to a reverse
distributor.
• The DEA Website maintains a current list of reverse
distributors.
• The reverse distributor will inventory the drugs you wish to
have destroyed, and they will remove and destroy the drugs for
you.
• They will provide you with a receipt to show that
you transferred the controlled drugs to them.
• This document must be maintained for 2 years.
TRANSFER OF CONTROLLED
SUBSTANCES
• You must maintain transfer records for transfers
to a reverse distributor or if you sell controlled
substances to another practitioner.
• There is a pre-printed Transfer of Controlled
Substances Form on the DEA website.
• All transfers of Schedule II drugs must be
documented on a DEA Form 222.
TRANSFER OF CONTROLLED
SUBSTANCES (Cont’d)
• Schedule III—V drugs may be transferred on a
form containing all required documentation:
1. Name, address and DEA number of the supplier
2. Name, address and DEA number of the receiver
3. Date of the transfer
4. Name, strength, dosage form and quantity of the
drug(s) transferred
• If both parties have a copy of these documents, it
can serve as a transfer document for the supplier,
and also a receipt record for the receiver.
DOCUMENT YOUR WASTE!
• Any unused portion of a syringe must be documented as
“wastage”.
• “Wastages” may be documented on an administration/
dispensing log or on a separate document in the same file for
the documentation of waste.
• When drugs are wasted or destroyed, they must be destroyed
beyond reclamation.
• Always have a witness to your “wasting.”
DOCUMENT YOUR WASTE
(Cont’d)
When controlled substances are wasted because of contamination
by patient contact, the following documentation must occur:
1. Log must have registrant’s name and address
2. Date of wastage
3. Time of destruction/wastage
4. Patient’s name
5. Drug name, drug strength, and quantity destroyed
6. The reason for the wastage
7. Signature or initials of the person performing the destruction
8. Signature or initials of the second person witnessing the
destruction.
SECURITY!!!
• All registrants are required to have adequate controls in place
to detect and prevent the diversion of controlled substances.
• Some security measures are physical, such as alarms, safes,
and locks.
• Other security measures include the implementation of good
practice and office policies, and maintaining required records.
SECURITY AND STORAGE
STORAGE:
1. All controlled substances must be stored in a securely locked
and substantially built safe or cabinet.
2. The security provided must be commensurate with the
quantity and types of controlled substances stocked.
3. Controlled substances may not be left out unattended and/or
where unauthorized persons would have access to them.
4. Prescription pads should be secured in a locked drawer or
cabinet.
EMPLOYEE SECURITY
BACKGROUND CHECKS:
• Obtain a criminal history or a Georgia Crime Information
Center (GCIC) Report on all employees or potential
employees.
• Employees with a criminal history of a conviction or plea to a
drug crime may not have access to controlled substances
unless the DEA grants a rule waiver for that person.
BEST PRACTICES FOR SECURITY
1.
2.
3.
4.
5.
6.
Routinely review controlled substance laws and regulations so
you are familiar with requirements.
Contact DEA authorities when you have questions or
concerns.
Implement a written policy to ensure compliance with the
DEA and to ensure that employees know how controlled
substances are to be handled in your office.
Conduct periodic training with your staff.
Conduct periodic reviews and self inspections of your own
practice.
Periodically audit and reconcile your drug counts against your
record keeping to ensure that all drugs are accounted for, no
drugs are missing, and there are no record keeping errors.
BEST PRACTICES FOR SECURITY
7. Review your invoices from drug companies to ensure you
authorized the drug purchase.
8. When possible, have all controlled drug activities performed by
two people, not one.
9. The person who orders and purchases the drugs should be a
different person than the person who receives, checks them in,
and adds them to inventory. Ideally, a third person should pay
the bills.
10. Separate the duties of ordering, receiving and paying so there
are checks and balances.
BEST PRACTICES FOR
SECURITY (Cont’d)
11. The person who receives controlled substance shipments and
checks them in should have a second person verify what was
received and that the drugs are accurately being added to the
perpetual inventory logs.
12. Although not required, perpetual inventory logs are
encouraged to provide an ongoing record of what you have
dispensed and what you have remaining in supply.
13. Do not allow patients and visitors access to drug supplies!
This means if drugs are missing, it is an employee who is
responsible.
POLICIES AND PROCEDURES
1. Policies and procedures that require oversight and witnesses
protect both you, your practice, and your employees because if
there is a discrepancy in the drug count, consistent compliance
with policies will protect you and your practice from theft and
potential liability, and protect employees from false
accusations.
2. Restrict the number of people who have access to your drugs.
3. Have a policy in place requiring random drug testing for
employees. Even if you do not want to conduct random drug
testing on a regular basis, you should be able to demand a drug
test during the course of an internal investigation should drugs
be missing.
POLICIES AND PROCEDURES
(Cont’d)
4. Periodically you should personally review your administration
and dispensing logs to make sure that an employee has not
removed drugs and made up the name of a fictitious patient
you don’t remember treating.
5. Set up a calendar or reminder system so you know when it is
time for an annual inventory for the renewal of licenses and
registrations.
HOW TO HANDLE LOSS/THEFT
• There may be small losses in compounding or in using a syringe.
These are considered insignificant losses occurring in the course
of normal practice. You should document these so that your
records will always balance.
• A significant loss occurs anytime you are missing a controlled
substance, you do not know where it went, and cannot account
for it. These significant losses, which may indicate theft and
diversion of controlled substances, must be reported to the DEA
immediately upon discovery.
CALL THE DEA & GDNA
1. When a significant loss or theft is discovered, immediately
call, fax, or email the DEA 1(800)-882-9539. You should also
report the loss by using DEA Form 106. The DEA form may
be submitted electronically from their website at
www.deadiversion.usodj.gov within one business day.
2. You may also want to call the GA Drugs and Narcotics Agency
at (404) 656-5100.
TRANSPORTATION OF
CONTROLLED SUBSTANCES
• Everyone who orders, dispenses, prescribes or administers a
controlled substance must be registered with the DEA.
• Mobile practitioners should be registered at their “base” of
operations – storage must occur at the base.
• Your drugs must be stored and accounted for in accordance
with DEA regulations.
• Non-profit status does not exclude any practitioner from DEA
requirements.
TRANSPORTATION OF
CONTROLLED SUBSTANCES
• Drugs should be removed from the vehicle when not doing
ambulatory calls – remember hot summer weather and cold
winter weather can affect drugs.
• You must have a locked tool box in your vehicle for such use.
EUTHANASIA
• Animal protection laws, along with Federal and State
law govern euthanasia - O.C.G.A. § 4-11-5.1 et seq.
• DEA Rules and Regulations
• Georgia Board of Pharmacy Law and Rules
• Georgia Board of Veterinary Medicine Law & Rules
• Georgia Department of Agriculture Law & Rules
DEA RULES & REGULATIONS
• A veterinarian regularly working in an impound facility must
have a DEA number attached to the facility.
• Controlled substances can be stored at the impound facility.
• Veterinarian can issue a Power of Attorney for someone at the
facility to receive and log in controlled substances.
• Facility must have secure double locked storage for controlled
substances.
DEA RULES & REGULATIONS
(Cont’d)
• For euthanasia performed part time at an impound facility or
on-site, the veterinarian must follow DEA recordkeeping and
security rules for the transport of controlled substances.
• In transporting controlled substances, take only the amount
you anticipate using.
• Have written procedures in place for the transportation of
controlled substances.
GEORGIA BOARD OF
VETERINARY MEDICINE
• Board Rule No. 700-14-.03 permits Indirect
Supervision for certain tasks meaning:
– The licensed veterinarian is not on the premises but has
given either written or oral instructions for the treatment of
the animal patient
GEORGIA DEPARTMENT OF
AGRICULTURE RULES
• GA CODE 4-11-5.1(b)(e):
“Euthanasia shall be performed by a licensed
veterinarian or physician or a lay person who is
properly trained in the proper and humane use of a
method of euthanasia. Such lay person shall perform
euthanasia under the supervision of a licensed
veterinarian or physician. This shall not be construed
so as to require that a veterinarian or physician be
present at the time the euthanasia is performed.”
STAY WITH YOUR SCOPE OF
PRACTICE
• Your veterinary license limits your practice to
animals.
• Treatment of humans is outside the scope of your
practice.
• Beware! Controlled substance activities outside
your scope of your practice is illegal drug
distribution - a felony crime.
• Ensure safe practices for the protection of you,
your employees, your patients and the public!
Keep Current on GA Laws and Rules
• GA Veterinary Laws & Rules can be found at:
• http://sos.georgia.gov/plb/veterinary/
• GA Veterinary Medical Association can be
found at: www.gvma.net
• Check periodically! The GA Board and
GVMA will update you on issues pertinent to
your practice.
FRANCES CULLEN
• Frances E. Cullen is a former assistant attorney general and
former criminal prosecutor with specialized knowledge in
representing licensed professionals subject to Licensing Board
review and criminal actions related to professional practices.
• Also relevant to Veterinary practice, Ms. Cullen has a strong
knowledge of Drug Enforcement Agency (DEA), Georgia
Drugs and Narcotics, and Georgia Board of Veterinary
Medicine laws and rules.
• For more information, please visit www.francullen.com or call
us at (404) 806-6771.