Ch. 56 - Veterinary Pharmacy

What are CPGs?

Compliance policy guidelines

What are the 4 main CPGs that provide the boundary for drug use to veterinarians?

Extralabel drug use, human label drug use, use of drugs in food producing animals, and compounding for animals

Which CPG was replaced with the Guidance for Industry #230?

Compounding for animals

What does GFI short for?

Guidance for Industry

What is the title of GFI #230?

Use of Bulk Drug Substances in Compounding for Animals

What is AMDUCA?

Animal Medicinal Drug Use Clarification Act

Which of the following are guidelines to when a chemical is considered a drug?

1. It is an article other than food intended to affect the structure or any function of the body of man or other animals

2. It is an article recognized in one of the official compendia (USP/NF) or the official Homeopathic Pharmacopoeia of the United States or their supplements

3. It is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

4. It is an article that is intended to be used as a component of an item falling into categories 1-3

1, 2, 3, and 4

What are the drugs prohibited for extralabel use in food animals?

Chloramphenicol

Clenbuterol

Diethylstilbestrol (DES)

Dimetridazole

Ipronidazole

Other nitroimidazoles

Furazolidone

Nitrofurazone

Sulfonamides in lactating dairy cows

Fluoroquinolones

Glycopeptides

Phenylbutazone for dairy cattle >20 months old **

What is FARAD?

Food Animal Residue Avoidance Database

ELDU is allowed on any drug regardless of FDA approval.

False, only FDA approved human and animal drugs

What is the minimum amount of time you should keep record of the drugs dispensed for animals under your care as a veterinarian?

2 years

What makes it a prescription drug?

All of these

What must be on any prescription drug from a veterinarian?

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian

What is a legend drug?

Prescription drug

What are the label requirements for drugs prescribed for animals?

Name and address of the prescribing veterinarian

Established drug name

Specified directions for use

Any cautionary statements

Specified withdrawal/withholding/discard time if used in food producing animals

What is included within the specified directions for use?

Class/species

Identity of the animal/herd/flock/pen/lot/other

Dosage frequency

Route of administration

Duration of therapy

When should cautionary statement especially be put on the label?

When the drug is to be used extralabelly

If it is the same drug, it is okay to only label one bottle.

False, each bottle must be labeled

What are the situations in which a valid VCPR is constituted?

1. The veterinarian has assumed the responsibility of making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to the follow the instructions of the veterinarian

2. The veterinarian knows the animal personally, even if they have never examined said animal

3. There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), and or by medically appropriate and timely visits to the premises where the animal9s) are kept

4. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy

5. The practicing veterinarian sees a really sick animal and is leaving for vacation the next day

1, 3, and 4

Jerry is a licensed veterinarian in New Hampshire. Jerry’s best friend Tom lives in Vermont but only trusts Jerry with his soul cats Linda and Pepper. Tom is scared to take Linda and Pepper for such a drive as they get really stressed out in the carriers and car. Jerry is at Tom’s for a boys weekend. Tom mentions that Linda is having persistent coughing with no hairball production. Is Jerry able to prescribe a drug to treat Linda’s cough? Why or why not?

No, Jerry cannot prescribe a drug for Linda. He is not licensed within the state of Vermont and he has not demonstrated a valid VCPR

What does it mean when veterinarians are practicing “pharmacy”?

A veterinarian filling prescriptions for other veterinarian and are therefore subject to action by state regulatory boards

What makes it an over-the-counter (OTC) drug?

Availability for human use in retail outlets

How should OTCs be used?

Exactly as labeled - outside of this is extra label use and guidelines govern it

What is a VFD drug defined as?

A drug intended for use in or on animal feed, which is limited to use under the professional supervision of a licensed veterinarian

How is a VFD drug different from a prescription drug?

It is a written (nonverbal) statement issued by a licensed veterinarian in the course of the vet’s professional practice that authorizes the use

What is another name for controlled substances?

narcotics

When was jurisdiction of controlled substances given to the DEA and what is the name of the law that was passed?

1970; Controlled Substances Act

How many classes of narcotics are there? How are they divided?

5 classes divided by potential for abuse

What are compounded drugs?

Mixtures of approved dosage forms or drugs formulated from bulk chemicals that are not approved by FDA for use as drug in the United States

What are API?

Active pharmaceutical ingredients

When are APIs considered drugs?

When they are used for therapeutic purposes and recognized by the FDA to be essential in the treatment of some companion, nonfood animals

You can use compounded drugs in food animals as long as you observe the withdrawal time.

False, never for use in food animals

What is the definition of compounding?

The alteration of the original drug dosage form for the purposes of ease of administration or because the original dosage form is unsuitable for the purpose intended

What does compounding involve according to the USP?

Preparation, mixing, assembling, packaging, and labeling of a drug or device in accordance with a licensed practitioner’s prescription

In what situations is it not considered compounding a drug?

Reconstitution or mixing that is according to the manufacturer’s instructions on an approved human or veterinary drug product

What would cause a drug to need to be reconsituted?

When they are unstable in the form that they need to be administered in (i.e. aqueous solution)

What is a bulk drug substance?

Active ingredients used in the manufacture of finished dosage forms of the drug

What is another name for APIs?

Bulk drug substances

Current law does not permit compounding of animal drugs from APIs but it is recognized that there are some limited circumstances may be an appropriate treatment option.

True

What is the FDA’s GFI?

Food and Drug Administration’s Guide for Industry

What is GFI #230 now known as?

GFI #256

What does GFI #256 do? **

What are the extenuating circumstances in which compounding for animal drugs might be an approved course of action?

When outsourcing facilities may be allowed in the absence of a prescription for an individual animal in instances of drug shortages or emergent use precludes waiting for a compound to be prepared

What is the most common circumstance for compounding drugs?

Toxicosis/poisoning

Why is compounding so regulated by the FDA?

Concern that some compounding is used to circumvent the drug approval process

What are signs of drug instability in liquid dose forms?

Color change (pink or amber)

Signs of microbial growth

Cloudiness, haze, flocculent, or film formation

Separation of phases (e.g. oil and water, emulsion)

Precipitation, clumping, crystal formation

Droplets or fog forming on inside of container

Gas or odor release

Swelling of container

What are signs of drug instability in solid dose forms?

Odor (sulfur or vinegar)

Excessive powder or crumbling

Cracks or chips in tablets

Swelling of tablets or capsules

Sticking together of capsules or tablets

Tackiness of the covering of tablets or capsules

What should you do in the event of drug instability?

Throw the compound out

What drug was compounded from FDA-approved tablets in an aqueous vehicle that retained strength for 7 days and then degraded and showed color and consistency change?

Doxycycline hyclate

Which drug precipitates (because it contains propylene glycol and alcohols) when diluted in either saline or Lactated Ringer’s solution?

Diazepam

Why is there considerable interest in formulating a wide range of drugs transdermally?

Convenience, ease of administration, and therapeutic success

Which organization sets quality and purity standards?

USP

What does chapter <795> encompass?

Pharmaceutical Compounding - Non-Sterile Preparations

What does chapter <797> encompass?

Pharmaceutical Compounding - Sterile Preparations

What does chapter <800> deal with?

Worker safety

What is typically said if something “falls under USP <800>”?

It presents a significant risk to human healthcare

What is the absolute minimum amount of time that anything relating to controlled substances has to be kept?

2 years

States are allowed to have more stringent record keeping regarding controlled substances but you only have to abide by federal law.

False, if the state has tougher restrictions you have to follow those

What must a veterinarian do in order to administer, dispense, or prescribe controlled substances?

Register with the Drug Enforcement Administration (DEA)

What is your DEA license number tied to?

A physical address

If you practice at multiple clinics (i.e. provide relief work at another) you still only need 1 DEA license.

False, must have one for each physical address (unless mobile clinic)

What does it mean to be readily retrievable?

Organized and arranged in a filing cabinet or similar setup

Law necessitates that there is a dispensing record separate from the patient’s medical record.

False, it only has to be the patients medical record by law but for ease of retrieval a separate dispensing log can be used

If you prescribe a Schedule 2 drug, what are the 3 places you should document that dispense?

Patient chart, practice management software, and the controlled substance record

What form should be filled out in regards to Schedule 2 narcotics?

DEA 222

What must be a part of the written inventory records for schedule 2 narcotics?

Name

Address

DEA registration number

Date and Time

Signature

Indication that in inventory is maintained for 2 years

Indication that the inventory and other records are kept separately than others

What are your options when leaving a clinic where you have schedule 2 narcotics?

Either take them with you or transfer them to another vet at the practice that has a DEA license

Whichever way you choose, keep a copy of what you did AND tell the DEA

All records for drugs, regardless of schedule, can be stored together as long as they are readily retrievable.

False, schedule II must be kept separately and readily retrievable

When should your inventory of ALL controlled substances be taken?

Every 2 years on the anniversary of the practitioner’s initial DEA registration

How long do you have to keep records of controlled/schedule substances according to federal law?

Minimum 2 years

What form would you fill out in regards to stolen controlled substances?

DEA 106

What is the minimum amount of locks that controlled substances must be behind?

Two; clinic front door and a safe

Besides the DEA, who else should you notify of a theft of narcotics?

Police department

What is the legal regulation behind child-resistant containers?

Poison Prevention Packaging Act

When was the Poison Prevention Packaging Act passed?

1970

What should you do if someone asks for non-child resistant packaging?

Document it in the chart and have on the label “Caution: packaging not child resistant” and “keep out of reach of children”

What form would you fill out in order to destroy your own controlled substances within your clinic?

DEA 41

How many people should be present when destroying controlled substances?

At least two to sign DEA 41

What should you do when destroying controlled substances within your own clinic?

Render them unuable

What are options when destroying controlled substances to render them unuable?

All of these are valid options

When was the Mobility Act enacted?

2014

What did the Mobility Act allow that was previously inhibited?

Allowed controlled substances to be taken away from the physical address that they were associated with

Why was the Mobility Act so important?

Allowed for mobile clinics to be able to keep schedule 2 narcotics as well as allowed veterinarians associated with a certain clinic to be able to take them to treat patients at a farm or other large scale place that it is hard to transport from

According to table 56.8, what are the drug dispensing labeling requirements?

Name, address, and phone number of the dispensing facility

Name of client

Animal identification (name and species)

Date dispensed

Full directions for use

Name, strength, and quantity of drug dispensed

Name of prescribing veterinarian

For controlled substances, the label must also contain message “Caution: Federal law prohibits transfer of this drug to any person other than than the patient for whom it was prescribed.”

According to table 56.9, what are the requirements for writing a prescription for noncontrolled substances by federal law?

Printed or stamped name, address, and telephone number of the licensed practitioner

Legal signature of the licensed practitioner

Name and strength of the drug

Directions for use

Full name and address of the client

Animal identification (name and/or species)

Cautionary statements including, if applicable, withdrawal times for food animals

Number of refills, if any

How long is a prescription for non controlled substances good for after it is written?

1 year

According to table 56.10, what are the requirements for writing a prescription for controlled substances?

Printed or stamped name, address, and telephone number of the licensed practitioner

DEA registration number of the licensed practitioner

Legal signature of the licensed practitioner followed by the printed name of the practitioner

Name and strength of the drug

Directions for use

Full name and address of the client

Animal identification (name and/or species)

Cautionary statements including, if applicable, withdrawal times for food animals

Which of the following has a limit of 5 refills or the prescription is only good for 6 months?

Schedule III-V

If a schedule III-V narcotic prescription is past 6 months of being written but there are still 2 refills, can you refill it?

No, the number of refills left isn’t relevant after 6 months have passed. They have to get a new written prescription. (6 months or 5 refills, whichever comes first)

Which of the following is not allowed refills?

Schedule II

How long should you keep record of extra-label prescription and what should be on it?

2 years; why you used it

Define prescription.

A written or other order issued by a practitioner who is licensed in his state to administer and prescribe drugs in the course of his professional practice

What properties of a prescription reduce the “other order” to writing?

Controlled substance, preparation, combination, or mixture thereof