To avoid legal hassles, keep good records of pharaceuticals

Several legal and consulting matters passed through our offices recently, dealing with administrative record-keeping failures related to controlled substances.

Consequently, it seems an appropriate time to discuss a few legal issues related to pharmaceutical record-keeping and inventory.

Animal hospitals and veterinary practitioners are in a fairly unique position vis-à-vis the pharmacy and medication-dispensing laws of most states.

Most human physicians may dispense samples of some medications, but are not routinely responsible for providing patients with complete courses of medication. Pharmacists are charged with responsibility for possession and distribution of substantial amounts of medication. However, they are not qualified or authorized to prescribe.

Veterinarians, on the other hand, have the responsibility of ordering, possessing, managing, prescribing and distributing medications, including controlled substances and doing so is a routine part of their business. Consequently, we need to be particularly circumspect in our adherence to the regulations controlling our possession and distribution of substances that are not available over the counter.

Our handling of such responsibilities generally can be split between matters related to controlled substances and non-controlled substances. Controlled substances, of course, are those that have been determined by the authorities to have a high potential for abuse or addiction. Both controlled and non-controlled products carry simple but important rules for management and distribution.

Vaccines and non-controlled substances

The ordering and utilization of these products may seem like a mundane part of veterinary practice, but management failures can carry with them substantial costs and liability. Consider the following problems often encountered in veterinary practices, particularly those that do not assign specific individual responsibility for product handling:

1. Outdated and obsolete medication. Some states are quite careful about monitoring veterinary establishments under the public-health laws. In those states, merely carrying outdated drugs or obsolete sterile materials, for example, can result in an administrative citation and fine, even professional discipline.

Additionally, in the event an animal dies of a disease against which a vaccine was administered, or dies of an infection against which antimicrobial therapy was undertaken, serious questions might be raised. Any eventual malpractice litigation is likely to probe into how these medicines were handled from the time they arrived at the facility until they were used.

If no established system exists in the facility for the immediate unpacking and continued refrigeration of vaccines or the rotation of expiring pills and tablets, certain negative conclusions may be drawn by a judge or jury. It may not be necessary for a plaintiff to demonstrate conclusively that an expired or bad product was used in a specific instance. Liability could attach simply through the demonstration of a pattern of negligent pharmaceutical handling.

2. Errors and confusion in filling prescriptions. Generally speaking, medication orders should be filled at the animal hospital by doctors and licensed veterinary technicians only. If a practitioner elects to deviate from this principle, he would be well advised to make certain that only well-experienced lay persons handle non-controlled medications. The potential liability for errors in the handling of antibiotics and other therapeutic chemicals can be tremendous.

Licensed professionals generally are very careful in scanning the medical record for potential drug allergies, a history of vomiting or diarrhea associated with a certain class of medication or other potential complications. If a lay person fills a routine prescription, either because the client "has been getting it for years..." or because the vet authorizes the refill without first examining the record, a recent change in dosage may be overlooked.

Further, the intervening addition or substitution of some additional medication (possibly ordered by an associate, relief veterinarian or during an emergency visit to another practice) may conflict with the product refill being requested by the owner.

If an animal gets sick or dies truly or even apparently due to such an oversight, it is the practitioner, not his or her helper who filled the prescription, who is ultimately liable.

Controlled substances

There are two agencies that veterinarians must deal with mainly in purchasing and handling of controlled substances for distribution. Each state has a drug-controlling agency responsible for policing the behavior of prescribers. At the federal level, the U.S. Drug Enforcement Administration (DEA) has jurisdiction over the use of such substances.

It is wise to follow some general guidelines in ordering and handling controlled substances. If there is a problem, it is much easier to reconstruct what happened if the practice had been showing good faith in handling these products all along.

1. The individual with the DEA number is responsible for his products. It is the policy in some veterinary practices for all of the controlled substances to be ordered under the same DEA number, frequently that belonging to the practice owner. While this practice is common, it places a large burden of responsibility on that one individual, who may not even be one of the persons actually administering the medicine.

The person under whose name controlled substances are ordered should make certain that very careful and specific records on the use of each product is maintained. It should be hospital policy that, if there is any inconsistency between what is ordered from the pharmaceutical company and what is tallied by the staff, the person whose DEA number is used for ordering be notified at once. It is then the duty of that person to conduct an investigation as to why a discrepancy exists.

2. There is no substitute for frequency of inventory. I believe controlled substances should be inventoried en masse every month, particularly in multi-DVM practices. If this is done, it is simple to review medical records to identify the reason why some bottles of injectable anesthesia agent or sedative tablets are short or left with undocumented contents. When months have passed, the task can seem so daunting that the tendency is to ignore the failure and "try to do better on the next order." Rarely does a meaningful change in handling policy result.

3. Trust, but verify. It is almost always a good idea to have controlled-substance inventories double-checked by a second person or to rotate the individual responsible for keeping inventory. It also is important to notify the practice owner or one of the other practitioners if a single doctor comes up with controlled-substance inconsistencies more than once. Substance abuse among health professionals is higher than among many other groups of professionals. The access prescribers have may be an important factor related to these statistics. If a veterinarian's access is being abused and that access is negligently left unchecked, practice management, partners, associates and others may be caught up in a subsequent investigation.

Christopher J. Allen

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.