Kentucky Board of Veterinary Examiners Rules and Regulations Relating to Prescribing and dispensing Drugs

KENTUCKY ADMINISTRATIVE REGULATIONS
201 KAR 16:010. Code of ethical conduct.

Section 7. (1) A veterinarian shall not sell, or offer for sale, prescription medicine or drugs at any place other than:
(a) His office, clinic, or hospital; or
(b) Other place where he is treating patients.
(2) The prescription drugs or medicines sold, or offered for sale, shall be used in the treatment of the patient the veterinarian is treating.
(3) A veterinarian may fill the prescription of another licensed veterinarian who has established a bona fide veterinarian-client-patient relationship in a case.


201 KAR 16:110. Prescription and dispensation of drugs for animal use.
RELATES TO: KRS 321.181(5)(b)
STATUTORY AUTHORITY: KRS 321.235(3), 321.240(5)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.181(5)(b) provides that the practice of veterinary medicine includes the prescribing, administering, or dispensing of drugs and medications for veterinary purposes. KRS 321.235(3) and 321.240(5) authorize the board to promulgate administrative regulations to carry out and enforce the provisions of KRS Chapter 321. This administrative regulation establishes a procedure for the prescription and dispensation of drugs by licensed veterinarians for use in animals and livestock.
Section 1. Definitions. (1) "Legend drug" means veterinary prescription drug.(2) "Prescription" means an order from a veterinarian to a pharmacist or another veterinarian authorizing the dispensing of a veterinary prescription drug to a client for use on or in a patient;
(3) "Veterinary drug" means:
(a) A drug for animal use recognized in the official United States Pharmacopoeia or National Formulary of the United States;
(b) A drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals;
(c) A drug, other than feed, medicated feed, or a growth promoting implant intended to affect the structure or function of the body of an animal; or
(d) A drug intended for use as a component of a drug in paragraph (a), (b), or (c).
(4) "Veterinary prescription drug" means:
(a) A drug that is not safe for animal use without a veterinarian using or ordering the use of the product, and that is required by federal law to bear the following statement: "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian";
(b) A drug that is required by state law to be dispensed only on order or prescription of a licensed veterinarian;
(c) The extra-label use of an over-the-counter animal drug or human drugs; and
(d) A medicament compounded by mixing two (2) or more legally-obtained over-the-counter or prescription drugs.
Section 2. Prescribing and Dispensing. (1) A veterinary prescription shall include all of the following:
(a) The name and address of the veterinarian and, if the prescription is a written order, the signature of the veterinarian;
(b) The name and address of the client;
(c) The species and identity of the patient for which the prescription is issued;
(d) The name, strength, and quantity of the drug prescribed;
(e) The date on which the prescription is issued;
(f) The directions for administering the drug;
(g) If the patient is a food producing animal, the withdrawal time for the veterinary drug;
(h) If the prescription authorizes extra-label use, the manner in which the client may use the drug;
(i) Any cautionary statements required by law; and
(j) Number of refills allowed.
(2) A veterinarian shall not:
(a) Prescribe for or dispense to a client a veterinary prescription drug or a drug for extra-label use without personally examining the patient unless a veterinary-client-patient relationship exists between the prescribing veterinarian, client and patient, and the veterinarian determines that the client has sufficient knowledge to administer the drug properly;
(b) Prescribe or dispense a veterinary prescription drug to a client unless the veterinarian indicates in the appropriate records described in Section 4 of this administrative regulation, within seventy-two (72) hours after the prescription is issued or the drug is dispensed, that the prescription has been issued or that the drug has been dispensed;
(c) Prescribe a drug to a client for extra-label use on a patient unless all of the following apply:
1. A veterinary-client-patient relationship exists between the veterinarian, client and patient and the veterinarian has made a careful medical diagnosis of the condition of the patient within the context of that veterinarian-client-patient relationship;2. The veterinarian determines that there is no drug that is marketed specifically to treat the patient’s diagnosed condition, or determines that all of the drugs that are marketed for that purpose are clinically ineffective;
3. The veterinarian recommends procedures for the client to follow to ensure that the identity of the patient shall be maintained; and
4. If the patient is a food producing animal, the veterinarian prescribes a sufficient time period for drug withdrawal before the food from the patient may be marketed; or
(d) Transmit a prescription electronically unless the client approves the transmission and the prescription is transmitted to a pharmacist or veterinarian designated by the client.
Section 3. Labeling. (1) A veterinarian shall not dispense a drug that has been prepared, mixed, formulated or packaged by the veterinarian unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(2) A veterinarian shall not dispense a veterinary prescription drug that has been prepackaged by its manufacturer for dispensing unless the veterinarian affixes to the container in which the drug is dispensed a label containing all of the information specified in Section 2(1) of this administrative regulation, except the address of the client.
(3) A veterinarian may dispense a veterinary over the counter drug without affixing any information to the container in which the drug is dispensed if a label that has been affixed to the container by its manufacturer provides adequate information for its use.
Section 4. Prescription Records. (1) A veterinarian shall maintain complete records of each veterinary prescription drug that the veterinarian receives, prescribes, dispenses or administers, and of each prescription issued by the veterinarian that authorizes extra-label use.
(2) Records of each veterinary prescription drug shall include the name of each veterinary prescription drug that is received, the name and address of the person from whom the drug is received and the date and quantity received, the name and address of the person to whom the drug is dispensed and the date and quantity dispensed and, if the veterinarian prescribes or administers the drug, the information specified in Section 2(1) of this administrative regulation.
(3) Records of each prescription authorizing extra-label use shall include the information specified in Section 2(1) of this administrative regulation.
(4) A veterinarian shall maintain records of each veterinary prescription drug for not less than five (5) years after the date on which the veterinarian prescribes, dispenses or administers the drug or extra-label use.
Section 5. (1) A veterinarian shall not be required to write a prescription for controlled substances or a prescription for any medication that, in the veterinarian’s medical judgment, is not appropriate for the patient’s medical care.
(2) A veterinarian may refuse to write a prescription if it is not directly requested by a client with whom there is, in the veterinarian’s opinion, a current and existing veterinarian-patient-client relationship.
(3) A prescription shall be construed to include any manner of authorization for filling a prescription, including verbal or electronic communication.(4) The veterinarian may delegate to an office employee the authority to communicate a refill of a legend drug to the pharmacy on behalf of the veterinarian pursuant to written protocol established prior to the delegation of that authority.
Section 6. (1) A veterinarian shall ensure that all federal legend drugs and veterinary prescription drugs are maintained, administered, prescribed, dispensed, and destroyed in compliance with all state and federal laws.
(2) A veterinarian shall not prescribe or dispense a quantity of drug that is greater than that the amount required for six (6) months of treatment for an animal, herd, or flock.
(3) To prescribe, sell, distribute, or dispense any drug requiring a prescription for use in the context of an animal, herd, or flock, a veterinarian shall first do all of the following:
(a) Perform an appropriate history and physical examination;
(b) Make a diagnosis based upon the history, physical examination, and pertinent diagnostic and laboratory tests;
(c) Formulate a therapeutic plan, and discussed it with the animal’s owner, agent, or guardian, along with the basis for it and the risks and benefits of various treatments options, a part of which might be a prescription drug; and
(d) Ensure availability of the veterinarian or the veterinarian’s staff for appropriate follow-up care.
Section 7. (1) A veterinarian may dispense a prescription drug only if the prescribing veterinarian has established a veterinarian-client-patient relationship.
(2) If the dispensing veterinarian does not have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug only under the direct supervision of the licensed veterinarian by who the assistant is employed.
(3) If the dispensing veterinarian does have a veterinarian-client-patient relationship, a veterinary assistant may assist in the delivery of a veterinary drug, legend drug, or veterinary prescription drug under the indirect supervision of the veterinarian by whom the assistant is employed.
(4) If a veterinary assistant acts under the provisions of this section, it shall be the responsibility of the licensed veterinarian to ensure that the requirements of this administrative regulation are met.

Complete act can be viewed here.

Vets face difficult drug shortages in Canada

Shared from Trends Magazine found here:

Vets face difficult drug shortages in Canada 

The situation is worsening for Canadian veterinarians in desperate need of key drugs to treat their patients.

Veterinarians continue to remain in short supply of important drugs including morphine, fentanyl and Phenobarbital after production issues with generic drug manufacturer Sandoz, a subsidiary of Novartis.

A fire at a Sandoz production plant halted production of its 235 products, according to the Montreal Gazette. The fire, which broke out March 4, stopped production for about a week before limited production resumed March 12.

Making matters worse, in 2011 Sandoz began a major production upgrade at its Boucherville plant following warnings from the U.S. Food and Drug Administration (FDA) that it had discovered serious deficiencies in its production methods. The FDA warned the company that it would block its exports to the U.S. unless the deficiencies were corrected.

The upgrade caused a slowdown in production, which affected distribution of drugs to both human and animal doctors.

Suzanne Misisaszek, DVM, of Whitemud Creek Veterinary Clinic in Edmonton, Alberta, said she has had trouble finding the drugs she needs for her practice.

According to Misiaszek, the list of drugs in short supply includes glycopyrrolate, diazepam, midazolam, phenobarbital, meperidine, morphine, fentanyl and hydromorphone.

Misiaszek says that Sandoz has told her that no human drugs will be delivered to veterinary wholesalers before the end of 2012, as the priority is to supply human hospitals first.

For Misiaszek, the Canadian VMA and the American Veterinary Medical Association (AVMA) have been giving her practice the most guidance in how to approach the situation.

"This shortfall came without warning and our provincial and national VMAs have really stepped up to help with recommendations," Misiaszek said.

Misiaszek says her clinic has had to turn to alternatives for anesthesia in order to keep a reserve of anesthetics that are presently in short supply. Sometimes, compounded drugs are the only alternative, forcing veterinarians to spend more and pass on cost increases to clients.

"We are using alternative products for anesthesia in regular patients to ensure we have some of the shorted drugs for special cases," Misiaszek said. "An example of a shortfall concern is epileptic patients that use rectal valium as part of their rescue protocol. This is now unavailable without being compounded. This greatly increases the expense and decreases the shelf life of the product."

Sandoz announced that in mid-February, it introduced an allocation system based on 2011 demand which ensures that each customer receives a fair share of available medicines. Further improvements in output are expected which should increase allocation levels for all products in production to at least 100 percent of forecasted market needs by November 2012, the company announced. However, Sandoz has said it will maintain its allocation system through the first quarter of 2013, in order to avoid unnecessary stockpiling and potential backorders.

Sandoz said it had optimized production output at the plant while correcting its production practices, allowing the company to meet the vast majority of Canadian market needs for its entire injectable portfolio. In May, Sandoz Canada reported that it is now supplying more than 80 percent of market needs for its entire injectable portfolio, and more than 90 percent for the products currently in production.

"Sandoz Canada continues to make strong progress in its efforts to maintain a reliable supply of essential medicines following the temporary slow-down in production announced at its Boucherville plant earlier this year," Sandoz announced May 16, 2012.

Still, the situation is forcing veterinarians into a corner, Misiaszek says.

"We are now using more expensive drugs that we have less experience with," Misiaszek said.

Misiaszek said she is starting to use more alfaxalone, and relying more heavily on dexdomitor and using a butorphanol/buprenorphine combo instead of hydromorphone. Being in short supply of hydromorphone has led her clinic to revamp its anesthetic protocols entirely.

Misiaszek says she has also had a hard time treating seizuring patients without injectable phenobarb or valium. In such instances, she often ends up having to compound.

She recommends that veterinarians keep the shortfall drugs in stock for emergencies, using alternatives whenever possible.

"Try to be as familiar as possible with all products available to veterinarians - you never know when you will have to rely on them," Misiaszek said. "We tend to get stuck in our comfort zone."

However, cost to clients can often rise as a result of using alternative drugs.

Misiaszek also recommends webinars led by a boarded anesthesiologist that address alternative drug options.

Using an adverse event book for any new protocol instituted can also track how patients are doing on certain medication combinations, allowing practitioners to make adjustments in a timely manner, Misiaszek said.

Misiaszek says she has had to take staff time to revamp protocols, restructure ordering and pricing, and train staff on the new procedures.

Unfortunately, Misiaszek says she doesn’t see the shortage problem going away any time soon.

"This is a long term problem for us that will probably get worse as our ‘stock’ supply diminishes," she said. "I think that we will be able to cope with alternatives and compounded medications to ensure we have the proper drugs to treat our patients."

Looking long-term, however, Misiaszek says she hopes the drugs will be back in stock and that Health Canada will not source all of the drugs to only one supplier in the future.

Pennsylvania State Board of Pharmacy Meeting Today to Discuss Compounding Issue

Pennsylvania's Board of Pharmacy Agenda for today, September 18, 2012, indicates that the following will be discussed:

Ther-Rx Corporation – Compounding of hydroxyprogesterone caproate
injection ..

To view the entire agenda click here

The Use of Drugs in Food Animals: Benefits and Risks

The Use of Drugs in Food Animals: Benefits and Risks

Auburn University College of Veterinary Medicine Hosting Veterinary Pharmacy Law Seminar

Pharmacy Law Review

• Veterinary Pharmacy Law
• Continuing Education
• For Veterinarians and Veterinary Technicians
• Sunday, September 23, 2012
• 1 p.m. to 3 p.m.
• Overton Educational Wing
• Auburn University College of Veterinary Medicine

Approved by the Florida and Alabama board for the law/pharmacology continuing education credit.

THIS 2-HOUR COURSE:

• Explains current U.S. Drug Enforcement Administration laws for purchasing, documentation, dispensing, and storage and disposal of outdated controlled substances used in veterinary medical practices.
  
• Describes in detail the current compounding regulations and extra-label use of medications that are laws through the U.S. Food and Drug Administration.
  
• Explains devices, policies, and procedures for documentation of training and guidelines for occupational employee safety are included.

COURSE EXPERTISE

The course is taught by Sue Duran and Starr Miller who have a combined instruction training experience of 60 years in the area of veterinary pharmacy. Dr. Duran and Ms. Miller are diplomates of the International College of Veterinary Pharmacy (ICVP), an international college of experts who teach and dispense at veterinary teaching hospitals.

STATE-OF-THE-ART SETTING

Veterinarians and technicians can receive credit while experiencing the most up-to-date in learning. Veterinary Pharmacy Law takes place in the Overton Educational Wing, the college’s newest addition which features theatre-style lecture rooms and the latest in technology.

REGISTRATION

• Register Online
• The course is limited to 75 participants.

FEES

Veterinarians: $250

• Early Bird Discounted Price:
• $175 (by August 5)
• $200 (by September 7)

TRAVEL INFORMATION

Auburn is serviced by Hartsfield-Jackson Atlanta International Airport. Travel to Auburn is available by rental car (approximately 90 minutes via I-85 South) or by shuttle (Express 85: 888-238-7738. Reservations are required.).
Auburn is in the CENTRAL time zone.
Atlanta is in the EASTERN time zone.
Visit our Web site at vetmed.auburn.edu/ce for directions, maps, and links to area accommodations.

QUESTIONS?

• Contact Kris Robertson Street
• 334-844-2497 or kris.street@auburn.edu 

Task force targets Chinese shipments of meth chemicals

Task force targets Chinese shipments of meth chemicals

Stars and Stripes
September 15, 2012

About 80 percent of the meth in the United States is now made in Mexico mainly using Chinese ingredients shipped across the Pacific, according to the U.S. Drug Enforcement Administration. The DoD task force, which includes ... China has become the top ... 

The CPG applies to all Compounders; Physicians, Veterinarians, and Pharmacists and There is a Great Need to Educated Those Individuals as David Miller Points Out

David G. Miller, RPh, IACP Executive Vice President & CEO recently discussed his presentation about U.S. v. Franck's Lab, Inc. at the annual convention of the American Veterinary Medical Association (AVMA). To read his comments, especially about the need for education, click here.

Recalls, Market Withdrawals, & Safety Alerts Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets

Recalls, Market Withdrawals, & Safety Alerts Qualitest Issues Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Due to the Potential for Oversized Tablets

Indiana Board of Veterinary Examiners Statute and Administrative Rules Regarding Prescrptions

Indiana Board of Veterinary Examiners Statute and Administrative Rules, IC 25-38.1-4-5  Prescriptions,  provides:

     Sec. 5. (a) A licensed veterinarian may write prescriptions. Pharmacists shall give the prescriptions written by a licensed veterinarian the same recognition given the prescriptions of persons holding an unlimited license to practice medicine or osteopathic medicine.
    (b) A valid veterinarian-client-patient relationship must exist before a licensed veterinarian dispenses or prescribes a prescription product.
    (c) Veterinary prescription products, including drugs and immunizing products restricted by state and federal law for use by licensed veterinarians, may not be diverted or transferred to an individual for use on an animal if there is not a current veterinarian-client-patient relationship with the original prescribing veterinarian.
    (d) If a veterinarian prescribes a drug for the client's animal, upon request, the veterinarian shall provide the prescription to the client, unless prohibited by state or federal law or to prevent inappropriate use.
As added by P.L.2-2008, SEC.12. Amended by P.L.58-2008, SEC.40.

To view the entire statute click here.

Rule 5. Standards of Practice

888 IAC 1.1-5-1 Standards of practice

Authority: IC 25-38.1-2-14; IC 25-38.1-2-23

Affected: IC 25-1-9

     Sec. 1. A veterinarian may be found guilty of the incompetent practice of veterinary medicine and may be disciplined under IC 25-1-9 if the veterinarian does any of the following:

          (1) Fails to maintain written animal health records as defined by section 2 of this rule.

          (2) Dispenses or prescribes drugs or therapy unless a veterinarian-client-patient

          relationship has been established.

          (3) Knowingly provides prescription drugs or access to prescription drugs for use other than

          in the proper course of veterinary diagnosis or treatment.

          (4) Performs a treatment or procedure that is beyond the skill or knowledge of the

          practitioner.

          (5) Permits, delegates, or requires an employed veterinarian to:

(A) improperly perform the duties of an accredited veterinarian; or

(B) perform services that would constitute a violation of standards provided by this

section.

(Indiana Board of Veterinary Medical Examiners; 888 IAC 1.1-5-1; filed Apr 26, 1988, 2:10 p.m.: 11 IR 3046; filed Aug 11, 1989, 1:35 p.m.: 13 IR 86; filed Dec 27, 1993, 9:00 a.m.: 17 IR 1003; filed May 2, 2001, 10:05 a.m.: 24 IR 2707; readopted filed Jul 19, 2007, 12:53 p.m.: 20070808-IR-888070070RFA; filed Jul 31, 2009, 8:42 a.m.: 20090826-IR-888080679FRA)

Equine Chronicle » Veterinary Compounding

Equine Chronicle » Veterinary Compounding

Veterinary Compounding

September 15, 2012

By Heather Smith Thomas

Compounding is the manipulation of a drug product to produce a dosage or formulation tailored to meet the needs of a specific patient. This can be done by mixing two drugs together, or creating a more palatable oral product by adding flavoring, creating an oral suspension by crushing tablets and mixing them with fluid, etc. Compounding can be done by a licensed pharmacist on the prescription of a licensed veterinarian, or by the veterinarian.

Scarlet Thomas, director of Pharmacy at Hagyard Equine Medical Institute in Kentucky, says compounding can legally be performed only when there’s no approved drug available in correct dosage, form or concentration to appropriately treat the patient. It is not legal to create something that merely duplicates an already existing product.

“There are a number of instances in which compounding could be beneficial or necessary There are a limited number of drugs commercially available for horses. There are more commercial options for small animals, due to the greater number of cat and dog owners,” explains Thomas.

“When there is not an appropriate commercially available product, or when a certain medication is discontinued or unavailable from pharmaceutical companies, compounding becomes necessary. Some medications get dropped by the manufacturer, perhaps due to profitability issues,” she says.

“When products are pulled off the market, for whatever reason (as long as it’s not a safety issue), this might be an appropriate instance to compound that medication. The owner and veterinarian must have some way to obtain these medications, to continue the therapy,” she explains.

In some instances equine patients are allergic to certain preservatives, dyes, fillers, and carriers that exist in commercially available products, and something else must be used. Some patients require tailored dosage strengths to meet a unique need. “If you’re using a human product or small animal product for a horse, and it’s geared toward a 25 pound dog or a 150 pound human and you are treating a 1300 pound horse, this can be challenging,” says Thomas. Compounding the product to appropriately tailor it for that horse is a logical solution.

“In some instances the horse may not be able ingest the medication in its commercially available form. It may be a human product that is not palatable, or it may not be feasible to give the horse 200 tablets of human medication. In those instances it may be necessary to manipulate the drug into a different formulation or dosage, or add flavoring so it could be given orally.”

Legal compounding requires a valid veterinarian-client-patient relationship. “Veterinarians should limit the use of compounded drugs to specific needs in specific patients, when there is no other method or route of drug delivery that is practical for that patient. If there’s a commercial product available that can be given to that horse, that’s the first choice,” says Thomas.

Compounded medications would be the next option, but require a valid prescription from a veterinarian, and must be patient specific. The veterinarian would have to have seen or know the animal and diagnose the condition to be treated. If there’s nothing commercially available to treat that case or there’s something unique about the patient that makes it impossible for the commercial product to be appropriate, then a compounded product would be considered.

“Talk with your veterinarian if a compounded product is necessary for a certain animal. Ask about the source of that compound, making sure it’s a reputable pharmacy that your veterinarian has confidence in and trusts,” she says. Ask which FDA approved drug(s) will be used to compound the prescribed medication. You want to know that the ingredients and potency of the compounded product are reliable

Commercial products that are already on the market should not be compounded. “If medications are compounded in the same dosage formulation as a patented product, it’s usually not for the health and welfare of the horse, but to offer a less expensive product,” she explains. The horse owner may choose a compounded substitute because it’s cheaper, but may be getting something less effective (or even dangerous) if obtained illegally.

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