Governmental regulations that all practices need to know (Proceedings)

Personnel Issues

The Fair Labor Standards Act (FLSA) is the federal law that regulates minimum wage, overtime pay, hourly wage vs. salary, the employment of minors and many other employment-related issues. Although the FLSA contains a provisional exemption for businesses making less than $500,000 per year in gross sales, it also contains a requirement that covers each employee individually if that employee engages in certain activities for the practice. For instance, if the practice's gross income is less than $500,000 per year, but a staff member "engages in interstate commerce," that staff member is covered under the FLSA for that pay period. This sounds like bureaucratic double-talk to some people, but the meaning is clear - veterinary hospitals, by our nature, will be obliged to follow the rules of the FLSA regardless of their annual gross income. Veterinary hospitals routinely conduct activities that have been defined as "engaging in interstate commerce" such as ordering, handling or receiving drugs or supplies from out of state vendors, preparing or executing health certificates for interstate travel, or just communicating with a client who now lives in another state about medical or vaccination histories. Since it is virtually impossible for a veterinary hospital to segregate these functions or even track which employees do which tasks during a given week, it must be assumed that the provisions of the FLSA apply to every veterinary hospital.

Penalties for violating any of the provisions of the FLSA can be very severe. Historically, when a practice is audited or when a staff member complains to the DOL, if the practice is found to be in violation, the practice is usually assessed a fine and made to pay all current and former staff members back wages or compensation for the past two years!

Improperly Classifying an Employee as an Independent Contractor

Generally, people in business for themselves are not employees of the practice but they must meet certain criteria in order for the practice to avoid withholding taxes and paying the employer's share of payroll taxes. However, some veterinary practices have been advised to classify certain staff members as independent contractors to save money on those taxes. If a staff member is wrongly classified as an independent contractor and the business were audited by the IRS or the Department of Labor, the practice would probably be responsible for all back withholding taxes associated with that worker's compensation for at least the past two years. In addition, penalties and interest may be added! In general, the IRS assumes the position that all workers in a business are employees unless proven otherwise and they are very suspicious when evaluating claims that a worker is an independent contractor.

Groomers and associate veterinarians who only perform work at one or two practices on a regular basis are most often classified as employees, regardless of how compensation is measured or paid. Merely paying a groomer or associate veterinarian on a production basis (e.g., percent of monies earned) is usually not sufficient to classify them as independent contractors. On the other hand, groomers who just rent space in a veterinary hospital, but handle all of their own business transactions (e.g., appointments, payments, admissions, dismissals) are in a better position to be classified as independent contractors, especially if they possess a separate business license.

For more information, review IRS Publication 15-A. The IRS will determine whether a worker is an employee or an independent contractor if the practice files a Form SS-8. Their determination will be in writing and that would protect the practice from future rulings as long as the job requirements do not change.

Paying an Employee a Salary Instead of an Hourly Wage

Sometimes it is easier to pay a staff member a salary than it is to keep track of hours and some practices have attempted to use this method as a way of avoiding overtime pay. The Department of Labor has ruled that veterinarians fit into this category nicely, but they have applied a more critical interpretation for other veterinary employees. According to the FLSA, only executive, administrative (meaning supervision of other employees, not just paperwork) or professional workers may be classified as salaried (the correct term is Exempt Employees). Typically, a veterinary technician, office manager or receptionist will be considered an Exempt Employee (therefore salaried instead of hourly wage and overtime) only when more than 75% of their time is spent directly supervising other employees. Simply assigning a person an executive job title does not immediately place them in the exempt category.

Giving Employees Compensatory Time in Lieu of Overtime Pay

There is no limit in the Act on the number of hours employees aged 16 and older may work in any workweek, however, when an hourly (or Non-Exempt) staff member works more than 40 hours in any work week, the hours in excess of 40 must be compensated at the overtime rate of 1.5 times the regular hourly wage. Although the FLSA does not require overtime pay for an employee who works more than eight hours per day, some states such as California have additional rules requiring overtime pay for staff members working more than 8 hours in a given day unless a collective bargaining agreement is in place. The FLSA does not require the payment of overtime wages for employees who work on weekends, holidays or regular rest days, except if those hours are in excess of 40 for that work week.

It's also important to note that each work week stands alone and once the schedule or routine is set, it cannot be changed just to avoid payment of overtime wages. For instance, if the normal work week ends on Friday, but since a staff member has worked 10 hours each day, the practice cannot declare that the work week ends on Thursday for this week, then on Wednesday the following week, and so on. The definition of a work week may be changed if the change is permanent and obviously not designed to elude payment of overtime wages.

Employees must be paid for overtime hours worked and can not "accumulate days off" in lieu of overtime pay. Even though current rules do not allow compensatory time off in lieu of payment, it is certainly acceptable for the practice manager to alter schedules (without changing the defined work week) so that a staff member does not work overtime during that week. Altering a schedule for one week to compensate for overtime hours in the previous week is not allowed.

When overtime pay is due, it must be paid as soon after the regular pay period as possible, but always before the next payday. In other words, the staff member must be paid for the overtime work within the pay period when the work was performed. Withholding overtime pay until a pre-determined date (e.g., all overtime pay is paid at the end of the quarter or year) is not allowed.

Pharmacy Issues

Over-the-counter Sales

Veterinarians are routinely faced with clients requesting medications or drugs without presenting the patient for a diagnosis. Under the requirements of the Food, Drug and Cosmetic Act, only products specifically labeled and packaged for over-the-counter sale may be dispensed in this manner. The same drug substances can be marketed in a number of different dosage forms, intended for use by different routes of administration, and in different species of animals. Thus, these drug products may be prescription drugs in some cases and OTC in others.

Any medication or drug labeled with "Caution: to be dispensed by or on the order of a licensed veterinarian" is considered a prescription (or legend) medication and must be dispensed under those rules. There are no exceptions. Veterinarians who sell prescription medications without a veterinarian-client-patient relationship could face loss of licensure as well as a fine, but retail store owners risk only the fine and discontinuance of the product.

There are no special record keeping requirements for over-the-counter sales, but as a professional matter, it is highly recommended that every drug or product dispensed to a client be entered on the patient's medical record or on the practice computer.

Dispensing Prescription Medications

Veterinarians may only dispense or administer a prescription drug (one that is labeled for use by or on the order of a veterinarian or physician) when he or she has a working knowledge of the conditions and treatment regimes of a particular patient and client. This is known as the veterinarian-client-patient relationship. This relationship is built on a simple foundation: the physical examination. Without the examination, the veterinarian-patient-client relationship does not exist.

In the food animal industry, it is customary to treat patients as groups in certain instances. The same relationship must still exist, but the examination can be of a herd or flock instead of a particular animal. Food animal veterinarians should be especially cautious of dispensing medications to clients who may not have a thorough understanding of the problem and the treatment protocol.

Clear directions including the drug name and quantity dispensed, dosage, route and frequency of administration must be written in the medical record or treatment sheet for all prescription drugs dispensed. The client should be especially cautioned (and it should appear on the prescription label) about the necessity for withholding milk or meat from treated animals in cases where residues of the drug may contaminate the product.

Packaging and Labeling

Prescription medications MUST be dispensed only in child-proof containers, even small quantity prescriptions such as a single tapeworm tablet, unless the client requests otherwise. Envelopes, baggies, or other similar containers can only be used to comply with the client's expressed verbal or written wishes for non-child-proof containers. The client may be asked if he or she would prefer an envelope or non-child-proof container BEFORE it is dispensed. When the client requests or approves of other dispensing containers, a note to that effect should be made on the medical record or treatment sheet. Although this is not mandated, medications that are pre-packaged for dispensing to clients, such as ophthalmic drops and ointments, fit nicely into a plastic pill vial. This practice gives the proper impression to the client (prescription medicine rather than an over-the-counter product) and provides an ideal place to adhere the prescription label.

Every container of prescription medication dispensed from a veterinary practice must comply with the labeling requirements of the Food and Drug Administration (FDA). At a minimum, the following information must be clearly printed or typed on a label affixed to the dispensing container:

• Identification of the hospital - including street address, city, state and phone number,

• Name of the prescribing veterinarian,

• The current date,

• The name of the patient - for veterinary prescriptions, the name of the animal and the last name of the owner are acceptable,

• The name, strength and quantity of the drug,

• Clear directions for use,

• Expiration date if the supply being dispensed will not be used up during the current treatment period e.g., more than a month's supply),

• The number of authorized refills (optional, but printing NO REFILLS on the label is a good method to keep clients from calling back several months later and wanting "more of the stuff we had before"),

• Any special precautions (e.g., keep refrigerated, or shake well before use),

• The phrase "For veterinary use only" is recommended when the drug is one approved for use on animals only (Note: this phrase is routinely printed on all prescription labels from veterinary hospitals because it's easier than trying to decide which ones to label and which ones to omit).

• The phrase "Keep out of the reach of children" is also recommended and routinely used on all veterinary prescriptions.

Most labels are placed directly on the vial and clear tape is placed over the writing to prevent alterations or smudging. For the times when the directions are going to be lengthy (as in the initial steroid therapy) the label can contain all the regular information with a statement saying "See enclosed directions." The specific, detailed directions can then be rolled up and placed on the inside of the vial with the tablets. Directions such as "Give as directed" are very vague and should be avoided.

Compounding Medications

The Federal Food, Drug, and Cosmetic Act (the Act) does not distinguish compounding from manufacturing or other processing of drugs for use in animals. FDA acknowledges the use of compounding within certain areas of veterinary practice. The current state of veterinary medicine requires products to treat many conditions in a number of different species, some of which are known to have unique physiological characteristics. Furthermore, FDA regulations specifically permit the compounding of products from approved animal or human drugs under the conditions set forth in 21 CFR 530.13. This activity is not the subject of this guidance.

However, FDA is greatly concerned about veterinarians and pharmacies that are engaged in manufacturing and distributing unapproved new animal drugs in a manner that is clearly outside the bounds of traditional pharmacy practice and that violates the Act (e.g., compounding that is intended to circumvent the drug approval process and provide for the mass marketing of products that have been produced with little or no quality control or manufacturing standards to ensure the purity, potency, and stability of the product). These activities are the focus of this guidance. Pharmacies and veterinarians who engage in activities analogous to manufacturing and distributing drugs for use in animals may be held to the same provisions of the Act as manufacturers.

With regard to compounding from bulk drug substances, two Federal Appeals Court decisions, United States v. Algon Chemical Inc., 879 F.2d 1154 (3d Cir. 1989) and United States v. 9/1 Kg. Containers, 854 F.2d 173 (7th Cir. 1988), affirmed the FDA position that the Act does not permit veterinarians to compound unapproved finished drug products from bulk drug substances, unless the finished drug is not a new animal drug. The principle established by the court applies equally to compounding by pharmacists.

Neither the Act nor its implementing regulations exempt veterinarians or pharmacists from the approval requirements in the new animal drug provisions of the Food, Drug and Cosmetic Act.

"Compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal and human drugs that are intended for use in animals. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states.

However, when the scope and nature of activities of veterinarians and pharmacists raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new animal drug, adulteration, or misbranding provisions of the Act, FDA has determined that it will seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the veterinarian or pharmacist engages in any of the following acts:

1. Compounding of drugs for use in situations (a) where the health of the animal is not threatened; and (b) where suffering or death of the animal is not likely to result from failure to treat.

2. Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving prescriptions issued within the confines of a valid VCPR.

3. Compounding of drugs that are prohibited for extralabel use in food-producing or nonfood-producing animals, under 21 CFR 530.41(a) and (b) respectively, because the drugs present a risk to the public health.

4. Compounding finished drugs from human or animal drugs that are not the subject of an approved application, or from bulk drug substances, other than those specifically addressed for regulatory discretion by the FDA, Center for Veterinary Medicine, e.g., antidotes. Inquiries about compounding from unapproved drugs or bulk drug substances should be directed to CVM, Division of Compliance, 301-827-1168.

5. Compounding from approved human drugs for which FDA has implemented a restricted distribution system.

6. Using commercial scale manufacturing equipment for compounding drug products.

7. Compounding drugs for third parties who resell to individual patients, or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.

8. Failing to operate in conformance with applicable state law regulating the practice of pharmacy.

9. Compounding of drugs for use in animals where an approved new animal drug or approved new human drug used as labeled or in conformity with 21 CFR Part 530 will, in the available dosage form and concentration, appropriately treat the condition diagnosed.

10. Compounding from a human drug for use in food-producing animals if an approved animal drug can be used for the compounding.

11. Instances where illegal residues occur in meat, milk, eggs, honey, aquaculture, or other food-producing animal products, and such residues were caused by the use of a compounded drug.

12. Labeling a compounded drug with a withdrawal time established by the pharmacist instead of the prescribing veterinarian.

13. Labeling of compounded drugs without sufficient information, such as withdrawal times for drugs for food-producing animals or other categories of information that are described in 21 CFR 530.12.

The foregoing list of factors is not intended to be all inclusive. Other factors may be appropriate for consideration in a particular case.

FDA vs. EPA Dispensing

Germicidal preparations for use on inanimate objects, as well as rodenticides, and most insecticides are subject to the Federal Insecticide, Fungicide, and Rodenticide Act, administered by the Pesticide Regulation Division of the Environmental Protection Agency (EPA), Washington, D.C. 20460. However, some products used to control external pests are intended to act systemically and, therefore, are regulated as drugs by the FDA and not as pesticides by the EPA. For example, topically applied flea control products are usually regulated by EPA, whereas orally administered flea control products generally fall under FDA's jurisdiction. In those situations where violative residues of pesticides are detected in animal-derived human food products, FDA has the responsibility for regulatory enforcement.

EPA has issued a notice to remind retailers of a Dec. 31, 2004, stop-sale date for all outdoor diazinon home, lawn and garden products. It is now unlawful to sell diazinon outdoor non-agricultural use products in the United States. This is part of an agreement between EPA and diazinon registrants to phase out and eliminate all residential uses of the insecticide diazinon.

Internet Pharmacies

With the proliferation of internet pharmacies and chain stores getting into the veterinary pharmaceutical market, the veterinary practice may receive requests from clients for medications to be filled by these "outside pharmacies." If a medication would otherwise be prescribed for a patient, a veterinarian can not force a client to purchase needed medication from any specific source, including the in-house pharmacy. If the client requests a written or verbal prescription for medication, the veterinarian must provide that prescription if he/she would have otherwise dispensed the medication from the in-house pharmacy. This implies that a veterinary-patient-client relationship exists and that the veterinarian assumes the primary medical responsibility for the medical case.

It is certainly allowable for the practice to charge a reasonable fee for the execution of the prescription. Furthermore, attempting to educate the client on the hazards associated with internet drug purchases is certainly acceptable, including matching prices as a client courtesy. However, the prescription can not be withheld simply because the client chooses to have it filled somewhere other than the veterinary practice.

It is also acceptable for a veterinary practice to take refill orders from a client via the telephone, e-mail or other means of communication and ship the medication to the client's home or business as long as the refill would have been approved and dispensed if the client were present in the practice. If the medication to be refilled is a controlled substance, it must be shipped via a secure means with an adult signature obtained to confirm delivery.

There are many states Attorney's General that are trying to regulate the internet pharmacy industry, but that's a different issue...the practice can assist those law enforcement agencies but the veterinarian must still give a prescription to the client if he/she asks for it.

Keeping Controlled Drugs Under Control

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.

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.

Most veterinary practices just do not have the safeguards in place to satisfy the requirements of this type of registration. For instance, each registered practitioner must conduct a background check of any person they authorize to prescribe, dispense or administer controlled drugs as their agent. Few practices are willing go through the effort to accomplish these background checks and the ones that do are sometimes surprised by what they find out!

In these "agent" situations, there is also an expectation that the registered veterinarian would formally review the "agent veterinarian's" actions on a given schedule (comparable to a peer review process.) Given the nature of the average veterinary practice, these requirements would be difficult to meet. Finally, remember that the registered practitioner's license would be at risk if the agent were to misuse or divert controlled substances and the registered practitioner did not have the safeguards in place to recognize or prevent the action.

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.

Multiple Facilities

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.

A controlled substance registration is valid for three years. For new applications, or if the renewal form has not been received at least 45 days prior to a registrant's expiration date, contact the DEA at 1-800-882-9539. Registration forms and an interactive application are also available on the DEA's web site (www.deadiversion.usdoj.gov)

Security and 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.

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.

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.

Dispensing and 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.

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.

Shortages

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.

Refills

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.

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.

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.)

Workplace Safety Issues

The Occupational Safety & Health Administration (OSHA) was created under the Department of Labor to enact and enforce those measures necessary to ensure that every American has a safe and healthy work environment. These "rules" are known as standards and are published in Chapter 29 of the Code of Federal Regulations.

The Federal OSHA does allow a state to operate its own OSHA program; however, the state must set standards that are at least as effective as the federal standards and obtain approval from the federal OSHA. New York's state plan covers only public employees; private sector employees still fall under the Federal rules.

Regardless of whether the OSHA rules are enforced by the federal or state government, there are stiff penalties for non-compliance with the regulations. For example, the recommended fine for failure to display the Workplace Safety & Health Protection poster (OSHA 3165) is $1,000; penalties for willful violations (meaning you were aware of the requirement and the potential dangers, but failed to act on the information) can be up to $70,000 for each infraction!1 According to OSHA statistics, almost all inspection are a result of employee complaints or workers' compensation claims. OSHA generally utilizes two criteria for evaluation of a workplace program: documentation and training. Most veterinary hospitals have a safety plan for the staff to one extent or another, but few have the program down in writing for all to see, and fewer still have taken the time to properly train the staff on safety and emergency issues.

Administrative Requirements

Every employer must maintain or post at a prominent location, certain materials in the workplace. These include:

• Job Safety & Health Protection Poster (OSHA 3165) or state equivalent.

• Summaries of petitions for variances from standards or record keeping procedures. You may ask OSHA for a variance from a standard or regulation if you can prove your facility or method of operation provides employee protection "at least as effective" as that required by OSHA.

• Copies of all OSHA citations for violations of standards.

• Summary of Occupational Injuries and Illnesses (OSHA 300 & 300A) and Supplementary Record of Occupational Injuries and Illnesses (OSHA 301). These are only required if the business has 11 or more employees or if the business is selected to participate in a DOL survey. Worker's Compensation forms may be used in lieu of OSHA 301 if the information is essentially the same.

• Appropriate warning or identification signs. This usually refers to exits, hazardous areas (radiation), or situations (hearing protection required) and will be explained in those sections.

• Emergency Action & Fire Prevention Plans. This is required to be in writing when you have 10 or more employees.

Special Hazards of Note

Food and Beverages — The potential for illness from ingestion of pathogens or harmful chemicals is definitely present in most veterinary hospitals. Although some veterinarians jokingly imply that immunity only comes from exposure, OSHA takes eating and drinking in hazardous areas seriously. Several years ago, a veterinarian was fined for allowing employees to eat lunch on the treatment table. Although not specifically mentioned in OSHA standards, the treatment table is a potential contamination source. Consumption of food and beverages must be limited to areas free of toxic and biologically harmful substances.

This rule also applies to preparation of foods and beverages. Many hospitals have a staff coffee pot and utensil area co-located with the lab. Sometimes the cabinets above a coffee or food area will contain hazardous chemicals or supplies. this is generally an unacceptable situation.

Hospital refrigerators are another area of concern. Staff lunches, drinks, condiments and snacks must be stored in an area free from biological or chemical hazards. Vaccines, drugs and laboratory samples are all potential contamination sources. It is acceptable to store patient food in a refrigerator with human food.

Violence - We have all heard the spectacular news stories of disgruntled former employees going on a shooting rampage in retaliation for whatever perceived injustice they have suffered. This is the image that we most associate with workplace violence. The truth is that most incidents of violence against workers doesn't make the news because it is more common than we like to believe. On the average, two American workers are assaulted, murdered or raped while on duty every minute of every day!

As the veterinary profession adapts to meet the needs of a changing society, we are gradually increasing our risk of a violent act happening in the practice. Perhaps the greatest example of this is today's veterinary emergency clinic. The emergency clinic is open throughout the night and often in dangerous neighborhoods. They are typically staffed with a skeleton crew that is preoccupied with internal cases to be very aware of external threats.

But it's not just emergency clinics that are at risk. The traditional veterinary practice shares many of these same concerns. Although violence in the veterinary profession is not as common as in other industries or fields, it does happen. The accurate prediction and preventing of workplace violence is not exact, but already we see emerging trends. Perhaps the most promising news is that increased awareness and preparation seem to be the best prevention strategies.

Although the leadership is faced with the challenge of balancing the need for security with the rights of privacy for employees and the demand for service from the public, it is reasonable to have an appropriate mix of all three.

Chemotherapy -- The occupational risks associated with cytotoxic drugs (CDs) are a combination of the drugs' inherent toxicity and the extent to which the worker is exposed to the drug on the job. The chance of exposure can occur at many points in the handling process, and in the veterinary practice, the most probable routes of exposure are through inhalation of drug dusts or droplets, dermal absorption, and ingestion through contact with contaminated food or cigarettes.

A Biological Safety Cabinet (BSC), where only CDs are prepared, should be used. Warning signs designating the area as a cytotoxic drug preparation area that should not be entered by unauthorized staff should be clearly posted. Spill clean-up procedures should also be posted nearby for easy referral in an emergency. Additionally, smoking, drinking, applying cosmetics, and eating should never take place in the preparation area, as they greatly increase the chance of exposure.

Labeled sealable plastic or wire tie bags should also be available so that contaminated boxes, gloves, gowns and paper liners can be contained properly. There should be a closable, puncture-resistant, shatter-proof container for disposal of contaminated sharp/breakable materials within the work area. Mixing and preparation of the solutions should be done on a disposable absorbent pad; the pad should be discarded in an appropriate waste container (not general trash) upon completion of the procedure or if it becomes soiled. This will prevent any spilled liquids from evaporating too quickly.

When the time comes to actually administer the medication to the patient, it is imperative to recognize the precautions for both patient and staff safety.

Personal Protective Equipment: Although the specifics of each situation will differ, it is generally recommended that the following personal protective equipment (PPE) be utilized by the person administering the drug as well as the one restraining the patient:

• A disposable gown made of lint-free, low permeability fabric with a closed front, long sleeves, and elastic or knit-closed cuffs. The cuffs should be tucked under the gloves. Gowns and gloves in use should not be worn outside the prep or administration area.

• Disposable surgical latex gloves. Double gloving is appropriate if it will not interfere with the procedure.

• A surgical mask. This is for protection from splashing on the mucous membranes and not from respiratory contact since the mask provides only minimal protection against CD aerosols.

• If the client is allowed to witness the procedure, they should be kept a reasonable distance from the area and informed that the protective equipment in use is necessary for workers to be protected against the directly irritating effects of the drugs their eyes and skin. Presumably, the acute and chronic effects of the drug have already been discussed with them.

Aftercare of the patient receiving CD treatments requires a little discussion. Workers who will change soiled bedding or cage materials should be instructed on the hazards of the patient excreting the drugs in body secretions for up to 48 hours after administration. Any staff member who must clean up blood, vomitus, or excreta from patients who have received CDs in the last 48 hours should follow these procedures :

• Always wear surgical latex gloves and disposable gowns when cleaning up spills involving excretia or blood. The gowns and gloves should be discarded after each use.

• Always use surgical latex gloves and a disposable gown when cleaning cages or runs. Contaminated bedding should be placed in a specially marked laundry bag and the laundry bag placed in a labeled impervious bag. This laundry bag and its contents should be washed twice with normal detergents.

• Disposable materials like cage paper should be placed in a separate plastic bag and immediately sealed. The sealed bag should be disposed of according to the hospital hazardous waste plan.

• When possible, patients receiving CD therapy should be exercised in a separate area from other patients. Feces from patients deposited in exercise areas should be removed promptly following the same precautions.

• Of course, proper personal hygiene practices should be followed after handling any patient. A thorough hand washing using a detergent soap should be performed after completion of these tasks.

Fire Emergencies -- Prior planning for emergencies is essential to workplace safety. Pre-designated duties, routes of egress, notification procedures and personnel accountability are essential elements of an emergency action plan. Fire prevention plans must include a list of the major workplace fire hazards and control methods, the names or job titles of persons responsible for the maintenance of emergency equipment or fuel sources, housekeeping procedures to prevent fire emergencies, training of the staff in fire prevention and the scheduled maintenance of emergency equipment.

Emergency telephone numbers, including fire, police, ambulance (or Emergency Medical Service), and emergency maintenance personnel should be assembled and prominently displayed near each telephone. Don't assume that everyone knows to dial 9-1-1 for an emergency. Since a few seconds could make the difference in an emergency, write down clear instructions and a "script" for the person to read.

All workplaces must have appropriate fire extinguishers available. In general, most veterinary hospitals would be safe to have dry chemical type extinguishers, but check with your local fire marshal to be sure. Normally, the fire extinguishers must be placed strategically throughout the hospital, and less than 75 feet apart.

There must be a program to ensure that fire extinguishers are inspected annually by a qualified technician. A record of the inspection must be maintained. This is usually done by placing a tag directly on the extinguisher. Monthly, a designated individual from the hospital must visually checked each extinguisher to ensure it still properly "charged," and that it hasn't been removed or damaged. This monthly check should be annotated on the reverse side of the inspection tag.

Emergency exits and egress (escape) routes must be identified, properly marked and maintained free from obstructions. If an exit is not clearly visible, the route to the nearest exit must be properly marked. Exit doors must not be locked or fastened in such a way as to prevent free escape from the inside of the building. Normally, this means that exit doors should open outward and be equipped with a push-type latching device ("panic bar"). In no circumstances should a deadbolt or lock requiring a key to exit from the inside be installed on an exit door.

For work areas that are located in basements or other "isolated" places, it is usually required to have two means of egress so arranged as to minimize the possibility that both may be blocked by a fire or other emergency. Exit doors must be marked with a sign bearing the word "EXIT" in plainly legible letters not less than 6 inches high and 3/4 inches wide. Where the direction of travel to reach the nearest exit is not immediately apparent, a sign reading "EXIT" with an arrow indicating the direction must be posted. Exits, signs and egress routes must not be decorated or "hidden" so as to detract from their visibility.

Anesthesia - The NIOSH established limits for occupational exposure to waste anesthetic gasses is less than 2.0 parts per million (ppm) for all halogenated agents (methoxyflourane, halothane, isoflorane). Exposure to the nitrous oxide must also be maintained below 25 ppm. Most hospitals are unaware of the actual concentration levels of waste anesthetic gasses in the workplace, but with a comprehensive WAG management program, the risk of unnecessary exposure can be minimized. A comprehensive WAG management program should consist of the following elements:

• Application of a well designed WAG scavenging system. This is the single most effective means of reducing exposures of WAGs in the workplace. A proper scavenging system will capture the excess gasses directly at the source and transport them to a safe exhaust port, usually outside the building. There are three general methods of WAG removal currently in use: active scavenging, passive exhaust and absorption. Each has a place, but rarely does one method fit all circumstances.

• Routine maintenance and evaluation of anesthesia equipment. Anesthetic machines must be checked for leaks and serviced periodically. Although there is no "set" interval, the machine manufacturer's recommendations should be followed. At a minimum, daily "pre-use checks" for leaks in the hoses or connections should be performed, and examination or calibration by a qualified medical equipment repair technician should be completed every four months.

• Developing or revising work practices that minimize leaks and non-scavenged operations. Detailed training for staff members who operate or clean anesthesia equipment is a must. Training should include all areas of anesthesia agent use, including storage of the liquid agents, refilling of the vaporizers, emergency procedures if a bottle is dropped and broken, as well as general operating instructions for the machine.

• Training of the staff in proper principles of anesthesiology so that only the minimum amounts of anesthetic agents are used. Many hospitals use the "about that much" method of gas anesthesia and can significantly reduce the quantity of anesthetic agents used if flow rates were calculated prior to induction.

• Adequate general ventilation in the work areas. Some procedures , like masking, defy collection of waste gasses. In those instances, make sure the ventilation in the room is good. Exhaust fans for evacuating room air to the outside are recommended. Be conscious of air handling systems that recirculate the air; exposure of others may be the result. Induction chambers can be connected to the scavenging system or absorption canisters to reduce the levels of escaping gasses.

Radiology - This area is sometimes confusing to veterinarians since there is often a state registration and inspection requirement for radiation machines. Veterinarians in states with Atomic Energy Commission approved radiation protection plans would be in compliance with OSHA's requirements if they followed the guidelines of their state regulations. Currently, such approved plans are in effect in Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Kansas, Kentucky, Louisiana, Maryland, Mississippi, Nebraska, New Hampshire, New York, North Carolina, North Dakota, Oregon, South Carolina, Tennessee, Texas and Washington.

In all other states, the regulations enforced by OSHA are independent of those required by the state, and the veterinary hospital must follow the most stringent requirements.

A complete hospital radiation safety program must include the following elements:

• Regular evaluations of equipment and procedures.

• Approved monitoring devices for all personnel exposed to ionizing radiation. At a minimum, notification to workers of their exposure measurements must be made annually. Many consultants suggest this become part of the employee's annual performance review.

• Identification and posting of radiation areas. Signs containing the conventional, three blade, radiation caution symbol (magenta or purple on a yellow background) and the words "CAUTION RADIATION AREA" must be conspicuously posted in all radiation areas.

• Availability of appropriate protective equipment. At a minimum, usable lead gloves and aprons must be available. Thyroid and retinal protection is recommended, but not required.

• Written safety policies, operating instructions, and training programs. Staff members performing radiographic duties must be made aware of the hazards associated with radiation, the hospital's policies for minimizing exposure, the proper operation of equipment, and the provisions of OSHA's Ionizing Radiation Standard. A copy of OSHA's standard, as well as the documented rules and operating procedures must be readily available.

Some very simple practices will greatly enhance the effectiveness of a radiation safety program. Things like collimating to isolate the area of concern (leave a clear border around the film), proper measuring and settings to avoid retakes, and rotating radiographic duties among all qualified staff members will significantly reduce the dangers.

Sharps & Medical Waste - This is an area of double concern. The OSHA recognizes that the handling of sharps (needles, scalpel blades, etc.) is a serious safety hazard in veterinary hospitals, but the Environmental Protection Administration (EPA) is the agency responsible for most of the attention and regulations for disposable of medical wastes. Although sharps could definitely be a regulated medical waste, not all waste from a veterinary hospital is considered harmful to humans or the environment.

The federal guidelines for handling and disposal of medical specific wastes provide some good "common-sense" principles of workplace safety. New York has enacted a medical waste tracking acts which details medical waste disposal.

The practice of reusing syringes requires that someone remove the needle, clean the syringe, package and sterilize, then re-stock the syringes. This places someone at an increased risk of injury and is usually not allowed after an OSHA inspection.

Current recommendations suggest the immediate disposal of the entire needle/syringe unit into a puncture-proof, leak resistant container is the best method of containing sharps. This is sound advice, and already practiced in many facilities. The term 'puncture-proof, leak resistant" is very misunderstood. Ordinary plastic milk containers are not sufficient. Try pushing a 22 gauge needle through one. The containers made for this specific purpose are the most effective and are usually very economical.

The practice of cutting needles prior to disposal increases the potential for aerosolization of the contents and should be discontinued. Likewise, the practice of collecting sharps in a smaller container and transferring them to a larger container for disposal places someone at an increased risk of exposure and is not recommended.

Summary

Just like any other program or procedure, hospital's regulatory compliance program doesn't have to be complicated. It should be practical and understandable. Only by understanding the requirements, instituting clear procedures for the staff to follow and enforcing the rules consistently will the hospital stay out of trouble with the numerous regulatory agencies that exercise jurisdiction over our operations.