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Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 1
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
I. PURPOSE
To outline and define a uniformed Inventory of Controlled Substances at OC Animal
Care.
II. POLICY
All controlled substances shall be inventoried and audited on a regular basis according to
Drug Enforcement Administration (DEA) and state requirements. Disposition of drugs,
audits of inventories and logs, and accuracy of records is the responsibility of the
veterinarian(s).
III. SCOPE
Applicable to all staff who handle controlled substances in the course of their job duties
at OC Animal Care.
IV. FORMS
Controlled Substances Inventory Audit Form
Central Supply – Inventory Controlled Drug Log Check In/Out Record
Controlled Drug Disposition Record
Chameleon Controlled Substance Report - Surgery
Chameleon Controlled Substance Report – Non-Surgery
Chameleon EUTH Solution Report
Field Chemical Capture – Drug Check In/Out Record
Field Euthanasia – Drug Check In/Out Record
Field Telazol Disposition Record
Field Euthanasia Report Log
DEA Form 222
V. REFERENCES
1. Drug Enforcement Administration, Office of Diversion Control, United States
Department of Justice. Practitioner’s Manual: An Informational Outline of the
Controlled Substances Act. 2006 Edition
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 2
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
2. California Veterinary Medical Association. DEA at a Glance – Updated 2005.
DEA Controlled (Scheduled) Drug Log Information. Pharmaceutical Waste.
Controlled Drugs & Employee Screening Clarification. DEA Guidelines for
Registration of Animal Shelters. www.cvma.net.
3. Seibert, Philip. Governmental regulations that all practices need to know. CVC
Proceedings. DVM 360. Aug 1, 2008.
4. Seibert, Philip. Keeping Controlled Drugs Under Control. Veterinary Information
Network. Copyright 2009, ACVC.
5. Controlling Your Controlled Substances. PULSE. Southern California Veterinary
Association. March 2010.
6. Rhoades, Rebecca H., DVM. The Humane Society of the United States
Euthanasia Training Manual. 2002.
7. Kemp, Doug Pharm. D., DICVP. Pharmaceutical Regulatory Review. Veterinary
Information Network. April 2, 2009.
VI. DEFINITIONS
1. DEA – Drug Enforcement Administration.
2. Controlled substance – a drug or chemical substance whose possession and use
are regulated under the Controlled Substances Act because of their potential for
abuse or addiction.
3. Schedule I (C1) – includes those substances that have no accepted medical use in
the United States and have a high abuse potential. Examples include heroin, LSD,
and marihuana.
4. Schedule II (CII) – have a high abuse potential with severe psychic or physical
dependence liability. These drugs do have medical applications and include
pentobarbital (euthanasia solution), morphine, codeine, hydromorphone,
oxycodone, and fentanyl.
5. Schedule III-V (CIII-V) – have decreasing abuse potentials. Examples include
Telazol, Ketamine, Buprenorphine, Butorphanol, and Diazepam (Valium).
6. Fatal-Plus aka Sodium Pentobarbital aka Euthanasia solution – CII drug
administered to animals to humanely cause death.
7. Disposition Log (Drug Log) – record to keep track of each transaction when a
scheduled drug is administered.
8. Hubbage – small amount of drug normally lost when drawn up into a syringe,
often calculated as 0.05ml per dose.
9. Chemical capture – the use of a controlled substance (usually Telazol) to sedate
an animal in order to facilitate confinement or restraint of the animal.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 3
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
10. CURES (Controlled Substance Utilization Review and Evaluation System) -
California’s prescription drug monitoring program which includes a statewide
database and requirement for reporting all controlled substances dispensed in
California.
VII. PROCEDURE
A. Registration
Every veterinarian who orders, dispenses, prescribes, or administers a controlled
substance must be registered with the DEA.
1. All veterinarians employed by OC Animal Care should have their own
DEA license. In addition, one veterinarian is to be designated as the DEA
registered veterinarian responsible for ordering all controlled substances
and is responsible for the recordkeeping and security of those drugs.
2. All drugs must be stored at the registered location (OC Animal Care
Clinic).
3. The DEA Certificate of Registration (DEA Form 223) must be maintained
at the registered location in a readily retrievable manner and kept available
for official inspection.
4. The controlled substance registration must be renewed every three years.
5. If the physical address/location of the shelter/clinic where controlled
substances are registered and stored changes, a modification of registration
must be requested though the DEA.
6. If there are multiple facilities (clinics/shelters), a separate registration is
required for each location.
B. Security
All registrants are required to provide effective controls and procedures to guard
against theft and diversion of controlled substances.
1. Scheduled drugs must be stored in a “securely locked, substantially
constructed cabinet or safe”. The central supply of OC Animal Care’s
controlled substances is stored in two safes in the Clinic Storage Room.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 4
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
2. A camera positioned to view the safe door provides surveillance. This
safe is to remain closed and locked at all times except when veterinarians
are checking drugs in and out and taking inventory.
3. A small supply of controlled substances (one opened bottle of each drug)
is kept in the small cabinet safe within the clinic cabinet for daily use. A
small supply of controlled drugs for surgery are kept in the Surgery Room
only when in use and returned to the cabinet safe in the clinic when
surgeries for the day have concluded.
4. Controlled drugs must be kept locked in the cabinet or safe at all times
except when actually in use.
5. Animal control officers that are authorized to use controlled substances in
the field, each have their own individual lockbox for storing a small
amount of Telazol and Fatal-Plus. The lockbox is stored in a cargo
compartment of their truck when they are on duty. When the officer is not
on duty, the lockbox is stored in the chemical capture storage closet.
6. DEA requires due diligence on the part of all DEA registrants when
considering if an employee may have access to controlled drugs. The
Code of Federal Regulations, Section 1301.76 states that registrants
should not employ as an agent or employee who has access to controlled
substance:
a. Any person who has been convicted of a felony offense related to
controlled substances.
b. Any person who has been denied a DEA registration.
c. Any person who has had a DEA registration revoked.
d. Any person who has surrendered a DEA registration for cause.
6 If there is a theft of scheduled products or significant loss is noticed, the
DEA must be notified upon discovery. The DEA will provide instructions
and the proper forms that must be completed. Regulations also require the
loss be reported to the local police agency, however do not rely on the
local police to notify the DEA – it is the practitioner’s responsibility.
C. Recordkeeping
Appropriate internal controls and recordkeeping procedures are required to
minimize unauthorized access and detect inappropriate activity. OC Animal Care
and its veterinarians must ensure that the controlled drugs are used solely for the
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 5
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
purposes intended and only by individuals authorized by the California Veterinary
Medical Board.
Inventories and disposition logs for controlled substances are kept in notebooks
located in the closet in the doctor’s office. Schedule II drug records must be kept
separate from the others. Notebooks are labeled accordingly. All records related
to controlled substances must be maintained and be available for inspection for a
minimum of two years.
1. Inventory
All DEA registrants are required to conduct a complete new inventory of
controlled substances at minimum every 2 years. In addition, all new
registrants must conduct an initial complete inventory of all controlled
substances at the time of initiation or transfer of DEA registration.
a. The inventory record must be written, typewritten, or printed. It
must be signed, dated, and maintained at the registered location for
at least two years from the date the inventory was conducted.
b. OC Animal Care veterinarians should use OC Animal Care’s
Controlled Drug Inventory forms to conduct inventory monthly.
c. Veterinarians shall “balance the books” at least monthly by using
an Controlled Drug Short Audit form to ensure that the difference
between calculated and actual drug usages for all controlled drugs
are within an acceptable range. Large discrepancies shall be
investigated. If a significant discrepancy cannot be accounted for
by hubbage, normal bottle volume variation, or mathematical or
record keeping error (check for errors in Chameleon reports), it
must be reported to the supervising administrative manager and the
DEA.
2. Disposition Logs
A record must be kept for each transaction when scheduled drugs are
administered.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 6
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
a. OC Animal Care keeps separate sets of records for each controlled
substance differentiated by dividers in the appropriately labeled
notebooks stored in the doctor’s closet.
b. Controlled drug bottles shall be individually and sequentially
numbered and placed in the Central Supply safe upon arrival to OC
Animal Care.
c. An entry shall be made for the received drugs on the corresponding
drug’s Central Supply – Inventory Controlled Drug Log Check
In/Out Record form with the date, bottle number(s), amount
received, balance on hand, and signature.
d. Individual bottles are logged out of the central supply safe for use
by making an entry on the Central Supply – Inventory Controlled
Drug Log Check In/Out Record and indicating the location the
bottle was moved to (i.e. Clinic, Field, Surgery).
e. Bottles that are designated for daily clinic or surgery use are
logged into the corresponding drug’s Controlled Drug Disposition
Record for the clinic by making an entry that adds the amount
“opened” (ml in the bottle) to the running balance on hand for the
clinic cabinet safe supply. Only as much as is required for
anticipated daily needs should be stored in the clinic cabinet safe at
any one time.
f. Most controlled drugs for clinic and surgery use are included in
Chameleon-generated Controlled Substance Reports. Currently,
there are three Controlled Substance Reports – Controlled
Substance Report – Surgery, Controlled Substance Report – Non
Surgery, and EUTH Solution Report. These reports must be
printed daily at the end of each business day after all controlled
drug administrations have been completed.
g. The total amount of each controlled drug used for the current date
shall be calculated from all logs and entered as one entry on the
corresponding drug’s Controlled Drug Disposition Record.
h. A visual estimation of the amount of actual drug present in the
opened bottle(s) should be entered on the Controlled Drug
Disposition Record in the Actual On Hand box and compared to
the Calculated On Hand box. Major discrepancies shall be
investigated. See section VII. d. Shortages. Appropriate wastage
may be entered in the Wastage box.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 7
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
i. The printed daily Chameleon-generated Controlled Substance
Reports shall be placed in the appropriate notebook containing
the Controlled Drug Disposition Record.
j. For drugs that are not included in the Chameleon-generated
Controlled Substance Reports, the veterinarian must manually
enter every dose administered individually throughout the day on
the Controlled Drug Disposition Record for that drug.
2. Field Services
Telazol and Fatal-Plus may be dispensed to authorized animal control
officers for chemical capture and field euthanasia. A list of authorized
officers and the field disposition logs are kept in a labeled notebook in the
doctor’s closet.
a. Individual bottles checked out to an animal control officer must be
logged out of the central supply safe by making an entry on the
Central Supply-Inventory Controlled Drug Log Check In/Out
Record indicating the bottle was moved to Field and the officer’s
name.
b. The bottle must then be checked into the animal control officer’s
log by finding the divider with officer’s name in the Field Services
Controlled Drug Log notebook and making an entry on the
officer’s Field Chemical Capture – Drug Check In/Out Record or
Field Euthanasia – Drug Check In/Out Record depending on the
controlled substance. The officer and the veterinarian dispensing
the bottle must sign the log.
c. When an officer is dispensed a bottle of Telazol or Fatal-Plus, they
are provided a Field Telazol Disposition Record or Field
Euthanasia Report Log to be completed as they administer the drug
to individual animals. Audits need to be performed weekly and
recorded on the Controlled Drug Short Audit Form. These logs
must be completed and returned when the bottle is returned.
d. An officer is to return all empty bottles of controlled drugs. An
officer is to return any partially used bottles of Telazol
immediately after use or reconstitution. Each individual officer is
not to have more than two bottles of Telazol or one bottle of Fatal-
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 8
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
Plus logged out to them at one time unless approved by the
veterinarian for an extenuating circumstance.
e. When a bottle is returned, the previous entry for that bottle on the
officer’s Field Chemical Capture - Drug Check In/Out Record or
Field Euthanasia – Drug Check In/Out Record is completed with
the date and amount returned, location returned to, whether the
bottle’s log was returned, and the initials of the individual the
bottle was returned to.
f. The actual amount of drug remaining in the returned bottle shall
be verified by the veterinarian, and the Field Telazol Disposition
Record or Field Euthanasia Report Log must be reviewed,
verified, signed by the officer and veterinarian, and filed under the
officer’s name in the Field Services Controlled Drug Log
notebook.
g. Any unexpired drug remaining in the returned bottle, shall be
logged back into the Central Supply – Inventory Controlled Drug
Log Check In/Out Record (noting that it was received from Field
and the officer’s name) and placed in the central supply safe.
Telazol bottles shall be labeled for EUTH ONLY. All unexpired
drugs returning from Field Services should be used for euthanasia
only.
h. Unexpired controlled drugs returned from Field Services and
intended for euthanasia are logged into and out of controlled drug
logs the same as other drugs with the exception that their quantity
is always indicated in terms of milliliters (ml).
i. Controlled drugs that are expired or otherwise unsuitable for use
should be disposed of as directed under VII. f. Disposal. Animal
control officers are required to return controlled drugs prior to their
expiration.
j. All authorized officers shall be provided with (3) 3 cc syringes
with 20 gauge needles attached, (6) additional 20 gauge needles,
(4) 22 gauge needles, (1) 6 cc syringe and (1) 12 cc syringe. It is
the responsibility of the officer in possession of a drug lockbox to
ensure that he/she has the appropriate supplies to humanely and
effectively perform 905X. If needles or syringes need to be
replaced, officers are directed to see the Chief Veterinarian, a
Clinic Veterinarian, the Supervising RVT or Shelter Manager for
replacements. No replacements will be given unless the used
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 9
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
products are returned. In other words, if (6) 20 gauge needles are
in need of replacement, (6) used needles will also need to be turned
in to the supervisor at the time of replacement.
k. The Field Services Controlled Drug Log notebook and its records
shall be periodically reviewed and audited for compliance and
accuracy.
l. Unannounced audits of the Animal Control Officer’s drug lockbox,
Field Telazol Disposition Record and Field Euthanasia Report Log
shall be conducted on an annual basis.
D. Shortages
If a shortage of a controlled substance is detected, the problem shall be
investigated.
1. The first step is to ensure that there is not a mathematical or record
keeping error rather than an actual shortage. Check the arithmetic to be
sure all the numbers were added or subtracted correctly. Make sure all
entries are posted correctly.
2. If a record keeping problem is identified, then an entry on the log to
correct the balance is the appropriate solution. DO NOT rewrite the log or
attempt to alter previous entries; simply make an entry on the next
available line in the log using the current date and explaining the
correction.
3. If the shortage cannot be explained with a mathematical or record
keeping error, or if there was a theft, the administrative manager should be
notified, and it should be reported immediately to the DEA field office. If
the shortage was pilfered from within or if there was a burglary, the local
police should also be contacted.
E. Ordering
The registered veterinarian will be responsible for maintaining the controlled drug
inventory and requesting orders as needed through OC Animal Care’s purchasing
agent.
1. The average monthly use for each drug should be used to help establish a
reorder level and reorder quantity.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 10
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
2. The registered veterinarian will submit their request for ordering
controlled drugs via email to the purchasing agent (cc to the supervising
administrative manager) with the name, amount, and concentration of the
drug requested.
3. For Schedule III-V drugs no special paperwork is required for ordering
other than providing the supply company with a copy of the current DEA
registration to keep on file.
a. Copies of the invoices or packing lists are maintained in a special
file in the clinic so that reconciliation of discrepancies can be done
quickly.
4. When ordering Schedule II substances (i.e. Fatal-Plus – sodium
pentobarbital, hydromorphone), a DEA Form 222 must be prepared and
sent to the supplier.
a. These triplicate forms are supplied by the DEA; replacements can
be requested on the DEA’s website.
b. The unused forms shall be locked and stored securely.
c. The order forms are pre-numbered and must be used sequentially.
d. Be sure to indicate the number of lines used and cross out the other
lines to prevent alteration.
e. The original and second copy of the form is sent to the vendor
while the third (blue) copy is retained by the practitioner.
f. When a shipment of Schedule II substances is received, the
retained third copy of the DEA Form 222 must be annotated with
the quantity and date that the drug is received.
g. All three copies of voided or unusable forms must be retained.
h. All completed forms must be maintained in a file separate from all
other documents – they should not be filed with accounting
paperwork.
5. All records of purchases must be maintained for two years.
F. Disposal
Scheduled drugs should not be thrown out in the regular trash, sewer system, or
medical or hazardous waste stream. Scheduled drugs must be handled in a
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 11
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
manner that allows for accurate tracking. The DEA has specific rules that must
be followed for disposing of expired and no-longer needed controlled substances.
The correct procedure depends on whether the drug is an unused dose or unused
stock.
1. Unused dose is the amount of controlled substance that was removed from
the supply for a particular patient, but was not actually administered or
dispensed. Because the product may be contaminated in some way, it is
not possible to return the unused portion to the supply system.
a. Small unused doses can be squirted into undesirable absorbent
material (i.e kitty litter, coffee grounds) and disposed of in regular
garbage. If the unused dose is already logged out of the clinic’s
system, there are no special record keeping rules except to note the
wasted amount on the medical record.
b. Very small amounts (e.g. < 10% of a full bottle) of Schedule III-V
substances (such as minute amounts of reconstituted Telazol) may
be disposed of by squirting it in undesirable absorbent material for
disposal in the regular trash. When this happens, an entry on the
log stating date, time, drug, quantity, and method of disposal is
sufficient. This method is only for the infrequent disposal of
reconstituted drugs, not for the disposal of unreconstituted but
expired drugs. Two persons should initial or sign the log as
witnessing the destruction. This method of disposal is not
suitable for Schedule II drugs.
2. Unused stocks require the use of “Reverse Distributers”. These are private
companies authorized to receive controlled substances that are no longer
wanted or expired.
a. A list of reverse distributers can be obtained by contacting the
nearest DEA field office.
b. Sometimes the original supplier of the drug may allow return for
credit or disposal if the expiration date was in the recent past.
c. CII substances require transfer via DEA Form 222.
d. CIII-V can be transferred via invoice.
e. Drugs should be secured and accounted for as usual until they are
shipped and confirmation is received from the reverse distributer.
Number: 700.24
SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 12
Date: 6/7/12
Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15
f. The veterinarian should maintain copies of the records
documenting transfer and disposal of controlled substances for a
period of two years.
g. The veterinarian should arrange for transfer of unused stocks
through OC Animal Care’s purchasing agent.
G. Prescribing/Dispensing
Controlled substances should not be prescribed or dispensed from OC Animal
Care. OC Animal Care does not currently participate in the level of reporting this
requires (CURES), and currently there is no indication for OC Animal Care to
dispense controlled substances.

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Manage controlled substances inventory

  • 1. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 1 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 I. PURPOSE To outline and define a uniformed Inventory of Controlled Substances at OC Animal Care. II. POLICY All controlled substances shall be inventoried and audited on a regular basis according to Drug Enforcement Administration (DEA) and state requirements. Disposition of drugs, audits of inventories and logs, and accuracy of records is the responsibility of the veterinarian(s). III. SCOPE Applicable to all staff who handle controlled substances in the course of their job duties at OC Animal Care. IV. FORMS Controlled Substances Inventory Audit Form Central Supply – Inventory Controlled Drug Log Check In/Out Record Controlled Drug Disposition Record Chameleon Controlled Substance Report - Surgery Chameleon Controlled Substance Report – Non-Surgery Chameleon EUTH Solution Report Field Chemical Capture – Drug Check In/Out Record Field Euthanasia – Drug Check In/Out Record Field Telazol Disposition Record Field Euthanasia Report Log DEA Form 222 V. REFERENCES 1. Drug Enforcement Administration, Office of Diversion Control, United States Department of Justice. Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. 2006 Edition
  • 2. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 2 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 2. California Veterinary Medical Association. DEA at a Glance – Updated 2005. DEA Controlled (Scheduled) Drug Log Information. Pharmaceutical Waste. Controlled Drugs & Employee Screening Clarification. DEA Guidelines for Registration of Animal Shelters. www.cvma.net. 3. Seibert, Philip. Governmental regulations that all practices need to know. CVC Proceedings. DVM 360. Aug 1, 2008. 4. Seibert, Philip. Keeping Controlled Drugs Under Control. Veterinary Information Network. Copyright 2009, ACVC. 5. Controlling Your Controlled Substances. PULSE. Southern California Veterinary Association. March 2010. 6. Rhoades, Rebecca H., DVM. The Humane Society of the United States Euthanasia Training Manual. 2002. 7. Kemp, Doug Pharm. D., DICVP. Pharmaceutical Regulatory Review. Veterinary Information Network. April 2, 2009. VI. DEFINITIONS 1. DEA – Drug Enforcement Administration. 2. Controlled substance – a drug or chemical substance whose possession and use are regulated under the Controlled Substances Act because of their potential for abuse or addiction. 3. Schedule I (C1) – includes those substances that have no accepted medical use in the United States and have a high abuse potential. Examples include heroin, LSD, and marihuana. 4. Schedule II (CII) – have a high abuse potential with severe psychic or physical dependence liability. These drugs do have medical applications and include pentobarbital (euthanasia solution), morphine, codeine, hydromorphone, oxycodone, and fentanyl. 5. Schedule III-V (CIII-V) – have decreasing abuse potentials. Examples include Telazol, Ketamine, Buprenorphine, Butorphanol, and Diazepam (Valium). 6. Fatal-Plus aka Sodium Pentobarbital aka Euthanasia solution – CII drug administered to animals to humanely cause death. 7. Disposition Log (Drug Log) – record to keep track of each transaction when a scheduled drug is administered. 8. Hubbage – small amount of drug normally lost when drawn up into a syringe, often calculated as 0.05ml per dose. 9. Chemical capture – the use of a controlled substance (usually Telazol) to sedate an animal in order to facilitate confinement or restraint of the animal.
  • 3. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 3 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 10. CURES (Controlled Substance Utilization Review and Evaluation System) - California’s prescription drug monitoring program which includes a statewide database and requirement for reporting all controlled substances dispensed in California. VII. PROCEDURE A. Registration Every veterinarian who orders, dispenses, prescribes, or administers a controlled substance must be registered with the DEA. 1. All veterinarians employed by OC Animal Care should have their own DEA license. In addition, one veterinarian is to be designated as the DEA registered veterinarian responsible for ordering all controlled substances and is responsible for the recordkeeping and security of those drugs. 2. All drugs must be stored at the registered location (OC Animal Care Clinic). 3. The DEA Certificate of Registration (DEA Form 223) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection. 4. The controlled substance registration must be renewed every three years. 5. If the physical address/location of the shelter/clinic where controlled substances are registered and stored changes, a modification of registration must be requested though the DEA. 6. If there are multiple facilities (clinics/shelters), a separate registration is required for each location. B. Security All registrants are required to provide effective controls and procedures to guard against theft and diversion of controlled substances. 1. Scheduled drugs must be stored in a “securely locked, substantially constructed cabinet or safe”. The central supply of OC Animal Care’s controlled substances is stored in two safes in the Clinic Storage Room.
  • 4. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 4 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 2. A camera positioned to view the safe door provides surveillance. This safe is to remain closed and locked at all times except when veterinarians are checking drugs in and out and taking inventory. 3. A small supply of controlled substances (one opened bottle of each drug) is kept in the small cabinet safe within the clinic cabinet for daily use. A small supply of controlled drugs for surgery are kept in the Surgery Room only when in use and returned to the cabinet safe in the clinic when surgeries for the day have concluded. 4. Controlled drugs must be kept locked in the cabinet or safe at all times except when actually in use. 5. Animal control officers that are authorized to use controlled substances in the field, each have their own individual lockbox for storing a small amount of Telazol and Fatal-Plus. The lockbox is stored in a cargo compartment of their truck when they are on duty. When the officer is not on duty, the lockbox is stored in the chemical capture storage closet. 6. DEA requires due diligence on the part of all DEA registrants when considering if an employee may have access to controlled drugs. The Code of Federal Regulations, Section 1301.76 states that registrants should not employ as an agent or employee who has access to controlled substance: a. Any person who has been convicted of a felony offense related to controlled substances. b. Any person who has been denied a DEA registration. c. Any person who has had a DEA registration revoked. d. Any person who has surrendered a DEA registration for cause. 6 If there is a theft of scheduled products or significant loss is noticed, the DEA must be notified upon discovery. The DEA will provide instructions and the proper forms that must be completed. Regulations also require the loss be reported to the local police agency, however do not rely on the local police to notify the DEA – it is the practitioner’s responsibility. C. Recordkeeping Appropriate internal controls and recordkeeping procedures are required to minimize unauthorized access and detect inappropriate activity. OC Animal Care and its veterinarians must ensure that the controlled drugs are used solely for the
  • 5. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 5 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 purposes intended and only by individuals authorized by the California Veterinary Medical Board. Inventories and disposition logs for controlled substances are kept in notebooks located in the closet in the doctor’s office. Schedule II drug records must be kept separate from the others. Notebooks are labeled accordingly. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years. 1. Inventory All DEA registrants are required to conduct a complete new inventory of controlled substances at minimum every 2 years. In addition, all new registrants must conduct an initial complete inventory of all controlled substances at the time of initiation or transfer of DEA registration. a. The inventory record must be written, typewritten, or printed. It must be signed, dated, and maintained at the registered location for at least two years from the date the inventory was conducted. b. OC Animal Care veterinarians should use OC Animal Care’s Controlled Drug Inventory forms to conduct inventory monthly. c. Veterinarians shall “balance the books” at least monthly by using an Controlled Drug Short Audit form to ensure that the difference between calculated and actual drug usages for all controlled drugs are within an acceptable range. Large discrepancies shall be investigated. If a significant discrepancy cannot be accounted for by hubbage, normal bottle volume variation, or mathematical or record keeping error (check for errors in Chameleon reports), it must be reported to the supervising administrative manager and the DEA. 2. Disposition Logs A record must be kept for each transaction when scheduled drugs are administered.
  • 6. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 6 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 a. OC Animal Care keeps separate sets of records for each controlled substance differentiated by dividers in the appropriately labeled notebooks stored in the doctor’s closet. b. Controlled drug bottles shall be individually and sequentially numbered and placed in the Central Supply safe upon arrival to OC Animal Care. c. An entry shall be made for the received drugs on the corresponding drug’s Central Supply – Inventory Controlled Drug Log Check In/Out Record form with the date, bottle number(s), amount received, balance on hand, and signature. d. Individual bottles are logged out of the central supply safe for use by making an entry on the Central Supply – Inventory Controlled Drug Log Check In/Out Record and indicating the location the bottle was moved to (i.e. Clinic, Field, Surgery). e. Bottles that are designated for daily clinic or surgery use are logged into the corresponding drug’s Controlled Drug Disposition Record for the clinic by making an entry that adds the amount “opened” (ml in the bottle) to the running balance on hand for the clinic cabinet safe supply. Only as much as is required for anticipated daily needs should be stored in the clinic cabinet safe at any one time. f. Most controlled drugs for clinic and surgery use are included in Chameleon-generated Controlled Substance Reports. Currently, there are three Controlled Substance Reports – Controlled Substance Report – Surgery, Controlled Substance Report – Non Surgery, and EUTH Solution Report. These reports must be printed daily at the end of each business day after all controlled drug administrations have been completed. g. The total amount of each controlled drug used for the current date shall be calculated from all logs and entered as one entry on the corresponding drug’s Controlled Drug Disposition Record. h. A visual estimation of the amount of actual drug present in the opened bottle(s) should be entered on the Controlled Drug Disposition Record in the Actual On Hand box and compared to the Calculated On Hand box. Major discrepancies shall be investigated. See section VII. d. Shortages. Appropriate wastage may be entered in the Wastage box.
  • 7. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 7 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 i. The printed daily Chameleon-generated Controlled Substance Reports shall be placed in the appropriate notebook containing the Controlled Drug Disposition Record. j. For drugs that are not included in the Chameleon-generated Controlled Substance Reports, the veterinarian must manually enter every dose administered individually throughout the day on the Controlled Drug Disposition Record for that drug. 2. Field Services Telazol and Fatal-Plus may be dispensed to authorized animal control officers for chemical capture and field euthanasia. A list of authorized officers and the field disposition logs are kept in a labeled notebook in the doctor’s closet. a. Individual bottles checked out to an animal control officer must be logged out of the central supply safe by making an entry on the Central Supply-Inventory Controlled Drug Log Check In/Out Record indicating the bottle was moved to Field and the officer’s name. b. The bottle must then be checked into the animal control officer’s log by finding the divider with officer’s name in the Field Services Controlled Drug Log notebook and making an entry on the officer’s Field Chemical Capture – Drug Check In/Out Record or Field Euthanasia – Drug Check In/Out Record depending on the controlled substance. The officer and the veterinarian dispensing the bottle must sign the log. c. When an officer is dispensed a bottle of Telazol or Fatal-Plus, they are provided a Field Telazol Disposition Record or Field Euthanasia Report Log to be completed as they administer the drug to individual animals. Audits need to be performed weekly and recorded on the Controlled Drug Short Audit Form. These logs must be completed and returned when the bottle is returned. d. An officer is to return all empty bottles of controlled drugs. An officer is to return any partially used bottles of Telazol immediately after use or reconstitution. Each individual officer is not to have more than two bottles of Telazol or one bottle of Fatal-
  • 8. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 8 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 Plus logged out to them at one time unless approved by the veterinarian for an extenuating circumstance. e. When a bottle is returned, the previous entry for that bottle on the officer’s Field Chemical Capture - Drug Check In/Out Record or Field Euthanasia – Drug Check In/Out Record is completed with the date and amount returned, location returned to, whether the bottle’s log was returned, and the initials of the individual the bottle was returned to. f. The actual amount of drug remaining in the returned bottle shall be verified by the veterinarian, and the Field Telazol Disposition Record or Field Euthanasia Report Log must be reviewed, verified, signed by the officer and veterinarian, and filed under the officer’s name in the Field Services Controlled Drug Log notebook. g. Any unexpired drug remaining in the returned bottle, shall be logged back into the Central Supply – Inventory Controlled Drug Log Check In/Out Record (noting that it was received from Field and the officer’s name) and placed in the central supply safe. Telazol bottles shall be labeled for EUTH ONLY. All unexpired drugs returning from Field Services should be used for euthanasia only. h. Unexpired controlled drugs returned from Field Services and intended for euthanasia are logged into and out of controlled drug logs the same as other drugs with the exception that their quantity is always indicated in terms of milliliters (ml). i. Controlled drugs that are expired or otherwise unsuitable for use should be disposed of as directed under VII. f. Disposal. Animal control officers are required to return controlled drugs prior to their expiration. j. All authorized officers shall be provided with (3) 3 cc syringes with 20 gauge needles attached, (6) additional 20 gauge needles, (4) 22 gauge needles, (1) 6 cc syringe and (1) 12 cc syringe. It is the responsibility of the officer in possession of a drug lockbox to ensure that he/she has the appropriate supplies to humanely and effectively perform 905X. If needles or syringes need to be replaced, officers are directed to see the Chief Veterinarian, a Clinic Veterinarian, the Supervising RVT or Shelter Manager for replacements. No replacements will be given unless the used
  • 9. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 9 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 products are returned. In other words, if (6) 20 gauge needles are in need of replacement, (6) used needles will also need to be turned in to the supervisor at the time of replacement. k. The Field Services Controlled Drug Log notebook and its records shall be periodically reviewed and audited for compliance and accuracy. l. Unannounced audits of the Animal Control Officer’s drug lockbox, Field Telazol Disposition Record and Field Euthanasia Report Log shall be conducted on an annual basis. D. Shortages If a shortage of a controlled substance is detected, the problem shall be investigated. 1. The first step is to ensure that there is not a mathematical or record keeping error rather than an actual shortage. Check the arithmetic to be sure all the numbers were added or subtracted correctly. Make sure all entries are posted correctly. 2. If a record keeping problem is identified, then an entry on the log to correct the balance is the appropriate solution. DO NOT rewrite the log or attempt to alter previous entries; simply make an entry on the next available line in the log using the current date and explaining the correction. 3. If the shortage cannot be explained with a mathematical or record keeping error, or if there was a theft, the administrative manager should be notified, and it should be reported immediately to the DEA field office. If the shortage was pilfered from within or if there was a burglary, the local police should also be contacted. E. Ordering The registered veterinarian will be responsible for maintaining the controlled drug inventory and requesting orders as needed through OC Animal Care’s purchasing agent. 1. The average monthly use for each drug should be used to help establish a reorder level and reorder quantity.
  • 10. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 10 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 2. The registered veterinarian will submit their request for ordering controlled drugs via email to the purchasing agent (cc to the supervising administrative manager) with the name, amount, and concentration of the drug requested. 3. For Schedule III-V drugs no special paperwork is required for ordering other than providing the supply company with a copy of the current DEA registration to keep on file. a. Copies of the invoices or packing lists are maintained in a special file in the clinic so that reconciliation of discrepancies can be done quickly. 4. When ordering Schedule II substances (i.e. Fatal-Plus – sodium pentobarbital, hydromorphone), a DEA Form 222 must be prepared and sent to the supplier. a. These triplicate forms are supplied by the DEA; replacements can be requested on the DEA’s website. b. The unused forms shall be locked and stored securely. c. The order forms are pre-numbered and must be used sequentially. d. Be sure to indicate the number of lines used and cross out the other lines to prevent alteration. e. The original and second copy of the form is sent to the vendor while the third (blue) copy is retained by the practitioner. f. When a shipment of Schedule II substances is received, the retained third copy of the DEA Form 222 must be annotated with the quantity and date that the drug is received. g. All three copies of voided or unusable forms must be retained. h. All completed forms must be maintained in a file separate from all other documents – they should not be filed with accounting paperwork. 5. All records of purchases must be maintained for two years. F. Disposal Scheduled drugs should not be thrown out in the regular trash, sewer system, or medical or hazardous waste stream. Scheduled drugs must be handled in a
  • 11. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 11 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 manner that allows for accurate tracking. The DEA has specific rules that must be followed for disposing of expired and no-longer needed controlled substances. The correct procedure depends on whether the drug is an unused dose or unused stock. 1. Unused dose is the amount of controlled substance that was removed from the supply for a particular patient, but was not actually administered or dispensed. Because the product may be contaminated in some way, it is not possible to return the unused portion to the supply system. a. Small unused doses can be squirted into undesirable absorbent material (i.e kitty litter, coffee grounds) and disposed of in regular garbage. If the unused dose is already logged out of the clinic’s system, there are no special record keeping rules except to note the wasted amount on the medical record. b. Very small amounts (e.g. < 10% of a full bottle) of Schedule III-V substances (such as minute amounts of reconstituted Telazol) may be disposed of by squirting it in undesirable absorbent material for disposal in the regular trash. When this happens, an entry on the log stating date, time, drug, quantity, and method of disposal is sufficient. This method is only for the infrequent disposal of reconstituted drugs, not for the disposal of unreconstituted but expired drugs. Two persons should initial or sign the log as witnessing the destruction. This method of disposal is not suitable for Schedule II drugs. 2. Unused stocks require the use of “Reverse Distributers”. These are private companies authorized to receive controlled substances that are no longer wanted or expired. a. A list of reverse distributers can be obtained by contacting the nearest DEA field office. b. Sometimes the original supplier of the drug may allow return for credit or disposal if the expiration date was in the recent past. c. CII substances require transfer via DEA Form 222. d. CIII-V can be transferred via invoice. e. Drugs should be secured and accounted for as usual until they are shipped and confirmation is received from the reverse distributer.
  • 12. Number: 700.24 SUBJECT: INVENTORY OF CONTROLLED SUBSTANCES Page: 12 Date: 6/7/12 Approved: Jennifer Hawkins DVM, Interim Director Revised: 1/15/15 f. The veterinarian should maintain copies of the records documenting transfer and disposal of controlled substances for a period of two years. g. The veterinarian should arrange for transfer of unused stocks through OC Animal Care’s purchasing agent. G. Prescribing/Dispensing Controlled substances should not be prescribed or dispensed from OC Animal Care. OC Animal Care does not currently participate in the level of reporting this requires (CURES), and currently there is no indication for OC Animal Care to dispense controlled substances.