CONTROLLED SUBSTANCES PAPERWORK BASICS Please d nt view this as an end all fr infrmatin n handling yur cntrlled substances. I am simply presenting t yu hw I handle ur cntrlled substance lgging and tracking. It is as gd a place as any t start. I am under the impressin that the DEA has a lt f freedm/leeway when they audit yu. Butler Pharmaceuticals has had a cntrlled substance class. Lasts abut tw hurs and cvers the basics. The system cmpnents: Internal Audits Invices Transfers Backgrund check frms Cpies f veterinary licenses Dispsitin Lgs Usage lgs Filing system Numbering System Filing System The DEA requires that yur cntrlled substance recrds be kept fr tw years. SOME STATES REQUIRE THEY BE HELD FOR THREE YEARS (CALIFORNIA FOR EXAMPLE). CHECK YOUR STATE LAWS. Our filing system cnsists f binders. Every year has its wn binder(s). If yu are using Class 2 cntrlled substances, yu must maintain a separate system fr these. DO NOT INCLUDE THEM IN A FILE OR BINDER THAT CONTAINS ANY NON-CLASS 2 CONTROLLED SUBSTANCES. Numbering System Yur clinic must have sme way f tracking the cntrlled substances that it uses. Numbering the bttles helps yu keep n tp f this. Fr large clinics prcessing lts f cntrlled substances clr cding can make things easier. This is prbably a waste f effrt in small clinics. I print all dispsitin and usage lgs n clred paper, and bttle numbers n clr cded stickers (when pssible). It makes them really easy t find and hard t cnfuse. Buprenrphine = Blue Euthanasia = Red Valium =Vilet Ketamine = Yellw Tealazl = Teal Trbugesic = Flurescent Green Numbering System There are three cmpnents t ur numbering system A letter that represents the drug B=Buprenrphine D=Diazepam E=Euthanasia K=Ketamine T=Trbugesic TZ=Telazl
A number that represents the year in which it was purchased 10 = 2010 11 = 2011 12 = 2012 The number assigned t the individual bttle. I start with S: 001 if I am likely t use mre than 100 bttles 01 if I am likely t use mre than 10 but less than 99 bttles 1 if I am likely t use 9 bttles r less D10-075 is the 75 th bttle f diazepam purchased/numbered in 2010 K09-150 is the 150 th bttle f ketamine purchased/numbered in 2009 I use stickers t number my bttles. If prcessing large rders it is easy t start writing numbers mre than nce r t skip them. The stickers eliminate this. I place tw stickers n each bttle, ne n the cap and ne n the bdy. The sticker system desn t save me any time verall, but it saves me time n the day that the rder is received, as I prepare them in advance. My stickers are clr cded (as are my dispsitin lgs and usage lgs). Yu can pull the stickers ff the cap r the bttle and place them n yur lg if yu chse t. Care must be taken nce the bttle is in use t nt remve all numbers frm it. Prcessing Yur Order/Invices Yur cntrlled substance rder must be prcessed the day yu receive it. Yur rder will cme with an invice. On the invice yu will recrd: The date the shipment was received. Fr each type f cntrlled substance yu received yu will recrd the: Number f bttles Lt number Expiratin date Number assigned t the bttles 20 bttles diazepam, D10-001 t D10-020, Lt 71-215-01-EV Exp 11-2010 The invice is then filed, I have a sectin in my binder marked invices. The bttles are recrded in rder n a dispsitin lg. Yur first Biennial audit is perfrmed if this is yur first rder. The cntrlled substances are lcked in yur safe/lck bx. Dispsitin Lgs The dispsitin lg tells yu where all bttles f cntrlled substances in yur practice are lcated at any time. It includes the fllwing infrmatin:
When they were received Wh they were received frm (we dn t use that many suppliers, s I just use initials) Vlume in each bttle Lt number Expiratin date When a bttle is mved frm the safe t a rm in the clinic r t a clinician s bag the date and new lcatin are recrded. The persn respnsible fr the mvement f the bttle initials the by clumn. All subsequent mves, if any, are recrded. When the bttle is finished a final entry is made in the dispsitin lg stating the date the bttle was emptied. If mre space is needed fr a given bttle it is carried t the back page. This page des nt cntain the drug, vlume, supplier, lt number, r expiratin date as it is all recrded n the frnt page. Internal Audits Yu are required t d an audit f yur stck: a. On the first day that yu receive cntrlled substances. b. Biennially after that (nce every tw years). The audit must be perfrmed during hurs when n ne will access the practices cntrlled substances, (n a day when the clinic is clsed, r during ff hurs.) This is easier if yu allw yur stck t run dwn a little befre yu d it. (Dn t place a big rder and then decide t audit yur stck). NOTE: There are cmpanies that emply retired DEA fficers t cnsult with veterinary clinics. Accrding t ne such cmpany (2 nd hand infrmatin) if the DEA audits yu they tend t nly g back as far as yur last internal audit. Fr this reasn I d an audit every year. I d it n the first f the year and keep my recrds fr each year cmpletely separate. I d a balance frward n a new usage lg fr any pen bttles frm the previus year. I make a balance frward entry n my dispsitin lg, and have a new dispsitin lg that cvers exactly a ne year perid. Under bttle numbers yu can list a series, as lng as the lt numbers and expiratin dates are all the same fr the entire series.
D10-001 t D10-020, Lt 71-215-01-EV, Exp 11-2010 Backgrund Check Frms and Veterinary License Cpies Any persn wh will be handling cntrlled substances in yur clinic must sign a backgrund check frm. (There is n requirement that yu cmplete the backgrund check unless yu have an Institutinal license fr yur facility), but yu must have the frm signed. There are specific requirements fr what must be included in this frm. They must include the fllwing pints: All Veterinarians wrking under yur license/with yur cntrlled substances must supply yu with a cpy f their current veterinary license. Transfers All cntrlled substance transfers (DVM t DVM) must have an accmpanying signed transfer frm. Bth DVMs need t sign the frm and file a cpy in their recrds. This frm must include the fllwing infrmatin frm bth parties DEA license number Expiratin date Address f recrd Date Signature The frm must als include all pertinent infrmatin regarding the cntrlled substances being transferred. Drug Bttle Number (if applicable) Lt number Expiratin date Ttal vlume f each drug being transferred
Usage Lgs Yur usage lgs will be yur biggest surce f frustratin. They must include: The cntrlled substance type Bttle number Lt number Expiratin date Beginning balance Balance frward n: The end f every cmpleted page The beginning f every new page Remaining balance after each draw I find that a minimum f 30% f these entries are incrrect I require an adding machine tape be attached t all cmpleted lgs Date bttle placed int use Page number Fr each draw Date Patient Persn wh made the draw If wrking in a clinic with multiple clinicians, the clinician wh rdered the draw A ttal drawn fr each page All errrs/crrectins require A single line ut (n scribbling ver) Accmpanying initials f the persn recrding the crrectin
Remember, these are legal dcuments!! I have tw types f lgs. Multiple small draws t a single bttle type Multiple bttles per page fr diazepam(5 bttles per page) r ketamine(5 bttles per page) use in hrses