Regulations you need to know: Pharmacy (Part 2) (Proceedings)
The whole issue of ordering, storing, dispensing and recording controlled drugs can be of the most confusing in the veterinary practice. Since it's inception in 1970, the Controlled Substance Act has placed specific mandates on those who manufacture, distribute, administer or dispense drugs that are deemed addictive or abusive. The Act established the federal Drug Enforcement Agency (DEA) to formulate and enforce regulations. In addition, many states have enacted supplemental regulations that apply in those jurisdictions.
Penalties for violating those regulations can include written warnings, fines, disciplinary action by the state professional board and even revocation of state and federal controlled substance certification.There are five categories, or schedules, of controlled substances, but in a clinical veterinary practice, schedule I drugs are rarely used. Recognizing a controlled substance and it's schedule is fairly simple; the label contains a large letter "C" with roman numerals depicting the schedule centered within the "C". This list is not all inclusive, but some common controlled substances in veterinary hospitals are:
• Anesthetics such as pentobarbital, sodium thiopental (Pentothal), Telazol, ketamine and diazepam (Valium),
A complete list of controlled substances can be obtained on the DEA's web site at http://www.deadiversion.usdoj.gov/schedules/schedules.htm.
With the increased emphasis by governments to curb America's drug problems, health care providers are enduring the results of more frequent audits and reviews by federal and state regulatory agencies. Even veterinarians who have been "left alone" or who have "never had a problem" are finding themselves in discord with the DEA.
Registering With The DEA
Every veterinarian who orders, dispenses, prescribes or administers a controlled substance must be registered with the federal DEA and in some cases, the state agency that regulates controlled substance activity. In most cases, the registration classification is for a "practitioner."
Recently, the federal DEA has changed the rules to allow, in certain situations, associate veterinarians to act as "an agent" of another veterinarian (or practice) and forego the individual registration requirement. Although this idea has appeal because of the cost savings, it's not really suitable for most veterinary practices. This type of registration was designed for the large medical facility with hundreds of residents, interns or attending physicians. In these instances, the institution would routinely do background checks into each provider and would have a central pharmacist overseeing the entire controlled drug program from ordering to patient administration.
Furthermore, in this type of registration, an "agent" cannot write or phone prescriptions to be filled outside of the practice; only a registered practitioner can execute a prescription.
A technician carrying out the order of the registered veterinarian would not normally be considered an "agent" because he or she is not authorized to order the action. However, it is expected that appropriate internal controls and recordkeeping procedures are instituted to minimize unauthorized access and detect inappropriate activity.
If there is more than one physical location in the practice, at least one veterinarian must be registered at each location where controlled substance activity will take place. For instance, in order for controlled substances to be stored and dispensed from a satellite location, the main hospital and the satellite location must be registered individually.
A veterinarian may be registered at more than one location when necessary or practices with multiple veterinarians can have a different one registered at each location in order to meet this requirement.
Relief veterinarians and mobile practitioners should obtain their own DEA registration at their "base of operations" address. This will allow them to issue verbal and written prescription orders at any location where they are licensed to practice, and to use the supplies of the "host practice." A relief veterinarian who orders controlled substances with their DEA number, would be responsible for the recordkeeping and security of those drugs, regardless of their ultimate place of use.