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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 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),
• Diphenoxylate with atropine (Lomotil), Hydrocodone (Hycodan), phenobarbital (except dilantin),
• All forms of euthanasia solution,
• Anabolic steroids such as stanozol (Winstrol-V), testosterone, nandrolone, mibolerone (Cheque Drops), and boldenone (Equipoise).
• Pain medications such as butorphenol (Torbutrol, Torbugesic), oxycodone, buprenorphine (Buprenex), fentanyl (Duragesic).
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.
Security & Staff Access
Controlled substances must be kept in a "securely locked, substantially constructed cabinet or safe." A common myth in the veterinary profession is the requirement for double locks; this is not a bad idea, but it is not a requirement. A substantial container and a significant primary lock are the basic necessities.
The owner of the substances must make a reasonable attempt to keep them secured from unauthorized persons, so the interspersing of controlled drugs among the entire pharmacy so that thieves would be less likely to "tear up" the cabinet is not allowed unless the entire pharmacy area has security adequate to meet the definitions of the Controlled Substances Act. Portable lock boxes must be securely affixed to an immovable object such as a cabinet or wall or locked inside of an immovable safe or cabinet when not in use. Similarly, lightweight filing cabinets or fire safes are inappropriate since they can be easily picked up and removed.
In most cases, a combination-style lock is a better choice than a key style for the "working supply" of controlled substances in a veterinary practice. Locks like the one pictured below are inexpensive (about $60) and can be installed on wood or metal doors. Most styles lock automatically when the door is closed. If a combination lock is used, the combination should be changed on a regular basis and whenever someone with a knowledge of the combination leaves.
On a similar note, when using a cabinet or drawer for controlled drug storage:
• it must be sturdy enough to be a reasonable deterrent;
• the hinges should be internal to the door or at least a style that can't be easily removed; and
• all sides of the cabinet and drawer must be enclosed so that access can not be gained by removing the drawer above or opening the cabinet to the side of the locked one.
In the end, veterinary hospitals must take whatever precautions are necessary to protect controlled drugs from break-ins as well as pilfering by staff or visitors.
Ordering Controlled Substances
In most aspects, ordering controlled substances in Schedules III through V is done much the same way as any other product in our inventory. The supplier will normally ask for a copy of the current DEA registration to keep on file. There are no special paperwork requirements for Schedule III through V drug purchases, but it is highly recommended that a copies of the invoices or packing lists be maintained in a special file so that reconciliation of discrepancies can be done quickly.
Ordering Schedule II substances (morphine, demerol, oxymorphone, fentanyl) does take a little more work. The practice must prepare and send an accurate DEA Form 222 to the supplier. These triplicate forms are supplied by the DEA; replacements can be requested on the DEA's web site or via telephone at (800) 882-9539. The order forms are pre-numbered and should be used sequentially. The original and second copy of the form is sent to the vendor while the third copy is retained by the practice.
When the order is received, the practice's retained copy of the DEA Form 222 must be "closed out" with the quantity and date that the drug is received. Completed forms and all three copies of voided or unusable forms must be retained for at least two years. Completed forms must be maintained separate from all other documents; this usually means in a specific folder of their own and not interspersed in the accounting or non-controlled substances inventory records.
All records related to the purchase and use of controlled drugs must be maintained for at least two years (usually corresponding with the biennial inventory).
Obtaining controlled substances from a local pharmacy by writing a prescription for "in-house" or resale use is usually prohibited because it circumvents the normal accountability process at the DEA. Prescriptions filled at local pharmacies for controlled drugs should only be for specific patients and not to replenish hospital supplies unless the pharmacy possesses a wholesale distributor DEA registration.
Practices with multiple physical locations must be especially cautious of ordering the drugs for one location and transferring them to another. This could be an acceptable practice if meticulous records are kept of each transfer, every location is registered with the DEA, there is adequate security at every location and appropriate usage records (patient-level accountability) are maintained for the drugs transferred.
Additionally, when schedule II drugs are transferred from one location to another, the receiving facility must prepare and submit a completed DEA Form 222 to the issuing facility, just as if the issuing facility were a supply company. The issuing facility must annotate and submit copy 2 of the DEA Form 222 to the DEA field office when the transfer is made. In the end, most practices with multiple locations find it easier and more accurate to order controlled drugs for each location using the different DEA numbers for that respective location.
Many practices help the local humane organization or county impound facility by acting as consultants. Because of the severe problems associated with security and record keeping at these facilities, as well as the liability that is placed on the veterinarian, it's not a good idea for a veterinary practice to order or transfer controlled substances (such as euthanasia solution) to an impound facility for their exclusive use.
In most states, if they qualify as a legitimate impound facility, the DEA will issue controlled drug licenses to these organizations directly so they can procure their own supply of euthanasia solution. If the impound facility is unable to obtain a DEA permit of their own, then the veterinarian could agree to euthanasia (or supervise the euthanasia) of animals with drugs from his or her supply on a case-by-case basis, but it is unlawful to transfer a controlled substances to another facility or person not properly licensed to possess them.
Dispensing & Administering
Each time the practice dispenses or administers a controlled substance, it must be recorded both on the medical record and a "readily retrievable" record. Sometimes this becomes a problem because the recordkeeping system doesn't fit the practice style. For instance, many practices appoint a specific person to log all controlled drugs regardless of who actually performed the transaction. In some practices, staff members must rely on medical record "reviews" to complete logs later in the day. These "second person" formats usually result in less accuracy and more frustration for everyone concerned.
Although there are other methods of compliance and a perpetual log is not specifically mandated by the Controlled Substance Act, it has been shown to be the most convenient, effective method to manage this program in most practices.
The logs should contain:
• the date of the transaction,
• the client and patient's name (other details should be available on the medical record),
• the name of the drug (unless the log is for a specific drug),
• the quantity of the substance administered or dispensed.
• an accurate "balance on hand",
• the name of the prescribing veterinarian if there is more than one in the practice, and
• the initials of the staff member who dispensed or administered the drug.
With this system, it's usually better to have the person performing the transaction make the entry in the log rather than "telling someone else to do it." Somehow, when a person puts their initials on the form, pride and professionalism play a large part in the process and the result is usually better accuracy.
Since a perpetual log has a "balance on hand" component, it's very easy to spot a potential problem when there are only 3 bottles left in the safe and the log says there should be four! Without this perpetual log system, it takes an overt "balancing of the books" to discover problems.
It's also acceptable to have more than one "log book" in the practice. In most instances, a "Central Pharmacy/End User Accountability System" is the most practical for a veterinary practice, but the end result is that each time a controlled drug is administered to a patient or dispensed to a client, it is recorded in some format.
Computerized logs are acceptable and very useful to many practices, if the accuracy of the entries are verified periodically and the computer is able to produce a report that identifies the date, client, patient, drug and amount used or dispensed for every single transaction. The balance on hand portion need not be present on the report, but should be easy to verify.
Also be sure that all controlled drugs that are used are accounted for in every transaction. For instance, it does no good to produce a computer report that gives the names of all patients who were given "injectable anesthesia" when the hospital uses three different drugs for this purpose and different quantities for each patient.
For drugs that are prepared by a formula (e.g., weight of the patient) but given to effect, there are two considerations that must be addressed. First, the accountability of the substance is necessary, so the amount drawn must be indicated. Secondly, the forensic and quality of care issues mandate the demonstration of how much the patient actually received - the term "to effect" is no longer acceptable in most cases. Hence, the easiest way to satisfy both requirements is to use the "drawn/given" method of documentation. The name of the drug is followed by two numbers separated by a slash, e.g., Pentothal 10/8. This indicates that 10 ml were drawn up and allocated to this patient, but only 8 ml were actually injected. The wasted amount is the difference.
Controlled substances dispensed to clients for administration to animals must follow the guidelines for packaging and labeling of prescription drugs discussed earlier.
There are no special record-keeping requirements for issuing prescriptions to be filled by a retail pharmacy other than an entry in the medical record.
The Preferred Recordkeeping System
The most practical controlled drug documentation program for a veterinary practice seems to be the "Central Pharmacy/End User" system. In this system, the bulk supply of drugs are received into a central pharmacy and then "issued" to the various sections of the hospital where they are actually used in operations. What makes the Central Pharmacy/End User system different from the traditional methods is the presence of multiple drug logs which are maintained where the drug is actually used or dispensed instead of one centrally-located log. In this case, the term "user" is not an individual person but the section of the hospital where the activity takes place, such as surgery, outpatient pharmacy, etc.
Here's an explanation of how this type of system works:
• When bottles of a controlled drug are received from the supplier, the unopened bottles are placed in the central pharmacy safe (usually a place with limited access such as a storage room or doctor's office.) The receipt is logged (in full bottle quantities) on the central pharmacy log using the invoice number and supplier in the "client ID" section. The balance on hand is updated to reflect the new quantity and the actual amount of the drug in the safe should match the new balance on hand.
• When drugs are needed for a procedure, a single bottle is taken out of the safe and "transferred" to another area of the practice, such as the surgery department or maybe an ambulatory truck. The central pharmacy log is annotated with the place where the drug is being "issued" (e.g., surgery or truck #1.) The balance on hand is updated and the actual quantity of the drug in the safe is verified to match the balance on hand.
• The bottle is then taken to the appropriate activity center (e.g., surgery) and immediately entered on the "user level" drug log as received from the central pharmacy, only this time the drug is entered in the dispensing quantities (such as ml or tablet.) The balance on hand of the user level log is updated and verified. As the drug is used, each patient's dose is recorded on the user level log. When the bottle is empty, the log's balance on hand should be zero and another bottle is obtained from the central pharmacy.
This process takes place for several activity centers simultaneously. For instance, on a single day, the central pharmacy may issue a bottle of drug to the surgery department, the outpatient pharmacy and the ambulatory unit. Each of those activity centers will keep track of their individual activities on their log. Each activity center's log is balanced individually, but each issue of drug can be verified against the central pharmacy log.
In a perfect system, the central pharmacy and each individual activity center would have separate safes or lock boxes. If this isn't practical, it's best to use a small box, tray or basket in the community safe for each activity center so that supplies for each center can be maintained separately.
If at any time in the process, the balance on hand of any log does not match the actual amount of drug present, either an investigation into the shortage is initiated or an "adjustment" is made to the log. If the shortage is significant, an internal investigation is initiated (see Shortages section), but if the shortage is very small and insignificant, such as happens when using multiple dose vials of injectable medications, an "administrative adjustment" entry is made on the log with the date, initials of the person making the adjustment, and an amount necessary to bring the balance to zero at the end of the bottle.
The layout or format of the log is less important than actually entering the information. In some instances (e.g., an ambulatory unit), a single page log for each bottle of drug is the best way to keep track, and in other instances (e.g., the central pharmacy), a "column style" log with multiple drugs on the same sheet is more practical.
If a shortage of a controlled substance is detected, an investigation into the problem is warranted. The first step in an investigation is ensure that there is not a mathematical or record keeping problem rather than an actual shortage. Check the arithmetic to be sure all the numbers were added or subtracted correctly.
Make sure that all entries are posted to the correct drug and strength (e.g., Rx for phenobarbital 15 mg tablets was incorrectly entered on the phenobarbital 30 mg log). Compare computer or sales records with the logs to determine if a prescription was filled and not entered on the log.
If a record keeping problem is identified, then an entry on the log to correct the balance is the appropriate solution. DO NOT rewrite the log or attempt to alter previous entries; simply make an entry on the next available line in the log using the current date and explaining the correction.
If the shortage can not explain with a mathematical or record keeping error, or if it's obvious that there was a theft, a report to the DEA field office is required. There is no time limit that must be observed (i.e., within xx hours of the discovery,) but once it is determined that the loss is not accidental or administrative, then do not delay - report it immediately. Follow the instructions of the agent when making the report, but most often the matter is handled administratively. The DEA agent will provide a form to complete - this will ask for what's missing and for a possible explanation. If the shortage was pilfered from within or if the practice was burglarized, the local police should also be contacted, but don't rely on them to notify the DEA - it's the practice owner's responsibility!
Reporting shortages or thefts will not automatically cause an audit by the DEA and is normally not "held against" the practice unless there has been a serious, willful violation of the rules by the practice.
In the context of the veterinary-client-patient relationship as it applies to controlled substances, when a prescription order is issued, it is expected that the veterinarian has examined the patient at least some time in the recent past. Although it's not specifically mandated, it is highly recommended that patients on long-term treatment plans including controlled drugs be re-examined prior to issuing a refill prescription order.
Because of their severe potential for addiction, schedule II drugs can not be refilled without the clinician issuing a new prescription (either verbal or in writing) each time a refill is necessary. A veterinarian may authorize Schedule III-V drugs to be refilled up to five times within a 6 month period before a new prescription order is required. At the federal level, this limitation implies that only a 30 day supply of a controlled substance should be dispensed at one time. Some states, such as New York, have formalized this limitation in writing by making it a specific violation to dispense controlled substances in any manner that would allow the client to obtain more drugs than would actually be used for the patient in that six month period.
Therefore, under these guidelines, it is implied that animals on recurring doses of a schedule II drug would be examined at least every month and animals on schedule III through V drugs would be examined at least every 6 months.
As with any other aspect of inventory control, regular physical counts are essential to any control program. The DEA requires at a minimum, an initial inventory must be taken on the day the practice first conducts any controlled substance activity (that's when the first drugs are received NOT when they are first dispensed or administered). This inventory must be in writing and contain the following key elements:
• the name, address & DEA registration number of the veterinarian,
• the date and time the inventory is taken,
• the actual amount of each controlled substance physically on hand,
• the signature of the person conducting the inventory.
The inventory procedure and documentation must be repeated every two years; this is called a biennial inventory. These written inventories must be maintained for at least two years.
Of course, this does not mean that inventories can't be conducted more often. Most consultants and inventory professionals recommend at least monthly inventories for highly sensitive items. Just remember to complete the documentation that the DEA requires at least once every two years.
Some practices find it easier to maintain the system when "end of bottle inventories" are performed along with the scheduled counting ones. An end of bottle inventory is simply comparing the quantity on hand in the log or computer to the actual amounts on the shelf whenever a bottle is empty. By using this method, counting hundreds of pills or estimating liquids isn't required. When each bottle is empty, the remaining full bottles are counted and compared to the log with adjustments made to the log to make it current. Of course, that entry is made assuming the shortages or overages are the result of "shrinkage" (an inventory term related to counting or packaging variances) and not loss related to pilfering or theft.
When an unbound (or loose leaf) inventory system is used, pages should be numbered and the first entry on each page should reflect the "balance forward" or an actual "per inventory" amount that matches the last entry on the previous page.
Disposal of Controlled Substances
The DEA has specific rules that must be followed for disposing of expired or no-longer-needed controlled substances. The correct procedure depends on whether the drug is an unused dose or unused stock. And of course, if there is a state-level requirement governing disposal of drugs, the more stringent procedures would apply.
An unused dose is the amount of controlled substance that was removed from the supply for a particular patient, but was not actually administered or dispensed. Because the product may be contaminated in some way, it is not possible to return the unused portion to the supply system. Unused doses are normally squirted into absorbent material for disposal in the regular trash or even flushed down the drain. If the unused dose was already logged out of the hospital's system using the "drawn/given" method described above, there are no special record keeping rules except to note the wasted amount on the medical record.
Similarly, drugs that may have been dispensed to a client and subsequently returned can not be used again because there is no way to guarantee they have not been adulterated. In most cases where no invoice adjustment is expected, the client should dispose of the drugs by flushing them down the drain or toilet. If the drugs are returned "for credit," an annotation should be made on the patient's medical record explaining the situation but the drugs are not logged back into the practice's controlled drug system. Remember, the DEA doesn't care what or how you charge the client, only that the drugs are accounted for until they are dispensed to the "end user." In these situations, most practices will issue a credit to the client but destroy the remaining drugs as outlined above.
Unused stocks are quantities of controlled drugs that have never been "allocated" to a particular patient and are still "on the books" of the practice.
Very small amounts of schedule III through V substances (such as minute amounts of Telazol® that has been reconstituted and has now expired or Pentothal® that has precipitated) may be disposed of by squirting it in absorbent material for disposal in the regular trash. When this happens, an entry on the log stating date, time, drug, quantity, and method of disposal is sufficient. This method is only for the infrequent disposal of reconstituted drugs, not for the disposal of unreconstituted but expired drugs. Although not required, it would be a good idea to have two persons initial or sign the log as witnessing the destruction.
For the remainder of unused stocks, the first step in disposal should be to contact the original supplier of the drug and inquire about returning it for credit or disposal. Often, drug manufacturers and distributors will replace outdated drugs with fresh supplies as long as the expiration date was in the recent past.
If returning the drugs are not an option, disposal of unused stocks of controlled drugs is usually accomplished using "Reverse Distributors." The DEA will no longer accept drugs for disposal but has licensed private companies to receive controlled substances that are expired or no longer wanted. These companies typically charge a fee for the service, but the administrative aspect of the process is greatly streamlined for the veterinary practice. A current list of reverse distributors is available from any DEA office. We've also compiled a short list of reverse distributors and made it available on our web site. Just click on the Suggested Source Sheets link from our home page (www.safetyvet.com.)
Of course, security and accountability for the drugs should be maintained until they are shipped and confirmation is received from the reverse distributor.