Controlled substances: Strict protocols, records crucial to compliance

What state and local health departments are to restaurants, state and federal drug authorities are to veterinary practices.

The parallels are numerous, and run-ins can be just as catastrophic.

A state health department investigation can close down a dining establishment. In an animal hospital, revocation of a Drug Enforcement Administration (DEA) license can be an economic death sentence.

Like food-quality investigators, state drug authorities can show up unannounced. They may interview employees, isolated from one another, seeking to hear inconsistent stories that can move an investigation forward.

So the goals for veterinarians, when addressing controlled-substance compliance, are twofold.

1. Maintain a low profile by doing what is necessary to avoid an on-site investigation.

2. Maintain protocols and records to support a satisfactory finding when DEA or state drug compliance personnel come calling.

Triggering an investigation

Consider the types of activities and events that lead to a drug compliance investigation. Some common initiators include:

• Disgruntled employees: Frustrated and embittered ex-employees, including veterinarians, can leave the practice looking for an "opportunity" to get back at the owner or partners. In the past, the route to such retribution would have been complicated and circuitous, but the Internet changed everything. With modern technology, an employee who feels he has been wronged can figure out how to report true or falsified controlled- substance violations quickly and easily. If the practice in question is weak on regulatory rules and complying with them, a former worker can cause much damage with a single phone call or e-mail.

• Police reports subsequent to a break-in: Years ago when I was a backyard hot-rodder, state governments didn't even want to talk to each other. I could get a speeding ticket in Maryland, yet my New York driver's license remained point-free.

Now, with the availability of sophisticated software, we motorists, and veterinarians, cannot escape the intertwined law-enforcement matrix of local, state and federal authorities.

For example, if a burglar walks out of a veterinary clinic with stolen narcotics or other similar products, the local police might be the first to be notified, but not the last.

If the quantity of drugs pinched is substantial, (like several boxes of ketamine after one of those "special deals"), local law enforcement is likely (if not legally obligated) to notify the DEA and/or state drug enforcement.

• Product orders unusual in size and content: One can only do so much to prevent her practice from being investigated by drug enforcement authorities. Once the investigation is set in motion, the new objective becomes keeping the administrative review limited in its invasiveness and scope. Government investigators usually try to interfere as little as possible with the business during an investigation. Nonetheless, there is no way to entirely avoid apprehension and nervousness among staffers. Here are some tips to keep the experience as hassle-free as possible:

Get prepared

• Record keeping and records availability: Regarding compliance, animal hospitals are advised to follow a few simple guidelines. Record keeping for drug compliance is neither difficult nor time-consuming. It merely needs to be qualitatively accurate and maintained clearly for easy access. Nothing will help nip a federal investigation faster than having a clearly maintained drug record book immediately available for inspection. If these records are ready to be checked at a moment's notice, this is certain to impress an investigation team from DEA or your state's drug control agency.

• Make records compliance friendly: Many practices simply keep a list of controlled substances, document the quantity used, and correlate these with the owner's and patient's name. This is a good policy, but it can be enhanced to ease the workload for the investigator.

• Guard against abuse: Don't forget that prescription abuse is as significant a problem as in-hospital substance violations. In many states, the government has improved its ability to track prescriptions. In New York, for example, all prescriptions are now written on sophisticated sequentially numbered forms available only from the state. I applaud this innovation and recommend that veterinary practices help to implement such new programs in these ways:

1. Tear in half and retain any unused prescription forms in a locked cabinet.

2. Photocopy each prescription form used and maintain these copies for investigators. This will immediately prove that if a fraud was perpetrated using one of these documents, it was not done in your office. I also suggest that you stamp each copy with a red-ink rubber stamp to mark the form "COPY" or "VOID" to prevent any chance of use by an office insider. This is especially true if state prescription forms do not contain anti-copy features.

3. Maintain prescription documents (as well as controlled-substance order invoices) in date order (or, in the case of prescriptions, sequence number if your state has such forms). This will allow an investigator to reach the item needed right away.

• Controlled-substance purchases: Gone are the days when the boss bought all the narcotics and other controlled substances and left record keeping up to the doctors and technicians who administer the products. Unfortunately, substance abuse among professionals is rampant and must not be ignored. Instead, a more carefully controlled medication administration system should be put in place. Some additional suggestions are:

1. Controlled medications should be documented by unit, bottle and vial. Inconsistencies should be clearly delineated at the end of each medication control sheet. For example, if the total administration of a 10 ml vial of a liquid controlled substance adds up to 8 ml at the end of the vial, a clear note should be made on the corresponding form. If it happens more than once, the doctor whose DEA license number was used to purchase the substance needs to be alerted.

2. Smart technicians keep a personal log of instances when they have notified doctors of variations in the drug records. This protects the technician from suspicion and serves to motivate the doctors to be more careful in dispensing.

3. Medication orders need to be correlated with use, and this documentation needs to be accessible to the ordering veterinarian. I instruct technicians (as well as staffers who unpack and inventory shipments) to assign a number to each item of controlled substance when it arrives on the premises. A simple way to do this is with a permanent marker.

For example, if a schedule medication arrives by UPS, each bottle can be marked with an in-house code on the back of the label. If Dr. Allen's DEA number was used to buy eight bottles of euthanasia solution, those bottles can be marked as AEU-001 through AEU-008. A drug log page is assigned to each bottle, by description and by number.

This way, when Dr. Zeitz's girlfriend turns up dead unexpectedly, the autopsy will reveal poisoning from 100-ml of euthanasia solution that presumably originated from bottle ZEU-006, not from the bottles I just ordered.

Chrisopher J. Allen DVM, JD

Dr. Allen is president of the Associates in Veterinary Law P.C., which provides legal and consulting services exclusively to veterinarians. He may be contacted at (607) 754-1510 or info@veterinarylaw.com