Rural Veterinary Experience, Teaching, and Service 
An Introduction to Controlled Substance Paperwork

Please do not view this as an end all for information on handling your controlled substances.   I am simply presenting to you how I handle our controlled substance logging and tracking.  It is as good a place as any to start.

I am under the impression that the DEA has a lot of freedom/leeway when they audit you.

Butler Pharmaceuticals has had a controlled substance class.  It lasts about two hours and covers the basics.

The system components
  • Internal 
  • Audit
  • InvoicesTransfers
  • Background check forms
  • Copies of veterinary licenses
  • Disposition Logs
  • Usage logs
  • Filing system
  • Numbering System


Filing System

  • The DEA requires that All controlled substance records must be kept for 2 years.    SOME STATES REQUIRE THAT THEY BE KEPT FOR THREE YEARS (CALIFORNIA FOR EXAMPLE).  CHECK YOUR STATE LAWS. 
  • Our filing system consists of binders.  Every year has its own binder(s)
  • If you are using Class 2 controlled substances, you must maintain a separate system for these.  DO NOT INCLUDE THEM IN A FILE OR BINDER THAT CONTAINS ANY NON-CLASS 2 CONTROLLED SUBSTANCES.

Numbering System

  • Your clinic must have some way of tracking the controlled substances that it uses.  Numbering the bottles helps you keep on top of this.  
  • For large clinics processing lots of controlled substances color coding can make things easier.  This is probably a waste of effort in small clinics.  I print all disposition and usage logs on colored paper, and bottle numbers on color coded stickers (when possible).   It makes them really easy to find and hard to confuse
Buprenorphine = Blue
Euthanasia = Red
Valium =Violet
Ketamine = Yellow
Tealazol = Teal
Torbugesic = Fluorescent Green

Numbering System

There are three components to our numbering system

  • A letter that represents the drug 

B=Buprenorphine
D=Diazepam
E=Euthanasia
K=Ketamine
T=Torbugesic
TZ=Telazol

  • A number that represents the year in which it was purchased

10 = 2010
11 = 2011
12 = 2012    

  • The number assigned to the individual bottle.  I start with
 
001 if I am likely to use more than 100 bottles
01 if I am likely to use more than 10 but less than 99 bottles
1 if I am likely to use 9 bottles or less

So: 

D10-075 is the 75th bottle of diazepam purchased/numbered in 2010
K09-150 is the 150th bottle of ketamine purchased/numbered in 2009

I use stickers to number my bottles.
  
  • If processing large orders it is easy to start writing numbers more than once or to skip them.  The stickers eliminate this.
  • I place two stickers on each bottle, one on the cap and one on the body.
  • The sticker system doesn’t save me any time overall, but it saves me time on the day that the order is received, as I prepare them in advance
  • My stickers are color coded (as are my disposition logs and usage logs).
  • You can pull the stickers off the cap or the bottle and place them on your log if you choose to.
  • Care must be taken once the bottle is in use to not remove all numbers from it.

Processing Your Order/Invoices

  • Your controlled substance order must be processed the day you receive it.
  • Your order will come with an invoice.   On the invoice you will record:
  1.   The date the shipment was received.
  2.   For each type of controlled substance you received you will record the 
a.   Number of bottles
b.   Lot number
c.   Expiration date
d.   Number assigned to the bottles
e.   “20 bottles diazepam, D10-001 to D10-020,  Lot  71-215-01-EV Exp 11-2010”
  • The invoice is then filed, I have a section in my binder marked “invoices”
  • The bottles are recorded in order on a disposition log
  • Your first Biennial audit is performed if this is your first order  
  • The controlled substances are locked in your safe/lock box

Disposition Logs

The disposition log tells you where all bottles of controlled substances in your practice are located at any time.  It includes the following information:
  • When they were received
  • Who they were received from (we don’t use that many suppliers, so I just use initials)
  • Volume in each bottle
  • Lot number
  • Expiration date
  • When a bottle is moved from the safe to a room in the clinic or to a clinician’s bag the date and new location are recorded.  The person responsible for the movement of the bottle initials the “by” column.  
  • All subsequent moves, if any, are recorded. 
  • When the bottle is finished a final entry is made in the disposition log stating the date the bottle was emptied.
  • If more space is needed for a given bottle it is carried to the back page.  This page does not contain the drug, volume, supplier, lot number, or expiration date as it is all recorded on the front page.
Internal Audits

  • You are required to do an audit of your stock: 
1.   On the first day that you receive controlled substances.
2.   Biennially after that (once every two years).   
  • The audit must be performed during hours when no one will access the practices controlled substances, (on a day when the clinic is closed, or during off hours.)
  • This is easier if you allow your stock to run down a little before you do it. (Don’t place a big order and then decide to audit your stock).

NOTE:  There are companies that employ retired DEA officers to consult with veterinary clinics.  According to one such company (2nd hand information) if the DEA audits you they tend to only go back as far as your last internal audit.  For this reason I do an audit every year.  I do it on the first of the year and keep my records for each year completely separate.  I do a balance forward on a new usage log for any open bottles from the previous year.  I make a balance forward entry on my disposition log, and have a new disposition log that covers exactly a one year period. 
  • Under bottle numbers you can list a series, as long as the lot numbers and expiration dates are all the same for the entire series.
  • D10-001 to D10-020,  Lot  71-215-01-EV, Exp 11-2010

Background Check Forms and Veterinary License Copies

  • Any person who will be handling controlled substances in your clinic must sign a background check form.  (There is no requirement that you complete the background check unless you have an Institutional license for your facility), but you must have the form signed.  There are specific requirements for what must be included in this form.  They must include the following points:

Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial.)       YES    NO

If the answer is yes, furnish details of conviction, offense, location, date and sentence on the back of this form.
In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician?  YES            NO

If the answer is yes, furnish details on the back of this form. 

I hereby authorize inquiries to be made of courts and law enforcement agencies for possible pending charges or convictions  
I understand that any false information or omission of information will jeopardize my position with respect to employment/volunteer opportunities. 

I understand that information furnished or recovered as a result of any inquiry will not necessarily preclude employment/volunteer opportunities, but will be considered as part of an overall evaluation of my qualifications.  

I understand that the results of such inquiries will be treated as confidential by the employer/volunteer organization and will in no way compromise the maintenance of fair employment practices, or the protection of my right of privacy.

I have read, understand, and agree to the terms of this document.
SIGNATURE_____________________________________   DATE_____________________________   

PRINT NAME____________________________________

  • All Veterinarians working under your license/with your controlled substances must supply you with a copy of their current veterinary license.

Transfers

  • All controlled substance transfers (DVM to DVM) must have an accompanying signed transfer form.
  • Both DVMs need to sign the form and file a copy in their records.
  • This form must include the following information from both parties
1.   DEA license number 
2.   Expiration date 
3.   Address of record 
4.   Date
5.   Signature
  • The form must also include all pertinent information regarding the controlled substances being transferred.
1.   Drug
2.   Bottle Number (if applicable)
3.   Lot number
4.   Expiration date
5.   Total volume of each drug being transferred

Usage Logs

  • Your usage logs will be your biggest source of frustration. They must include:

1.     The controlled substance type
2.     Bottle number
3.     Lot number
4.     Expiration date
5.     Beginning balance 
6.     Balance forward on: 
 a.   The end of every completed page
 b.   The beginning of every new page
7.     Remaining balance after each draw
 a.   I find that a minimum of 30% of these entries are incorrect
b.   I require an adding machine tape be attached to all completed logs
8.     Date bottle placed into use
9.     Page number
10.   For each draw
a.   Date
b.   Patient 
c.   Person who made the draw
d.   If working in a clinic with multiple clinicians, the clinician who ordered the draw
11.   A total drawn for each page
12.   All errors/corrections require
 a.   A single line out (no scribbling over) 
 b.   Accompanying initials of the person recording the correction
  • Remember, these are legal documents!!
  • I have two types of logs.
1.   Multiple small draws to a single bottle type
2.   Multiple bottles per page for diazepam (5 bottles per page) or ketamine (5 bottles per page) use in horses.

This is not a required training module.  It is simply information that some might find useful.
To download a copy of any of these forms, return to the Volunteer Training page
Check out the Donkey Welfare Symposium website and visit us at the symposium for a great educational opportunity, CE credits available

http://donkeywelfaresymposium.homestead.com/

https://ce.vetmed.ucdavis.edu/content/donkey-welfare-symposium