Showing posts with label Society of Veterinary Hospital Pharmacists. Show all posts
Showing posts with label Society of Veterinary Hospital Pharmacists. Show all posts

Monday, June 18, 2012

Do Pharmacists Need Specific Training in Veterinary Medicine?


The following article points out the special knowledge required of a pharmacist when filling a prescription written for an animal.  If a pharmacist is not knowledgeable in this specialized area, an animal can be seriously injured or death can result.  Do colleges need to offer a veterinary pharmacy degree?  If so, should pharmacist with this speciality degree be the only pharmacists who can fill these types of prescriptions? Do state boards of pharmacy need to do a better job of regulating pharmacies that fill prescriptions written for animals?  Should the state boards mandate that a pharmacist have a certain number of credit hours or training in veterinary pharmacology?

Veterinarians say pharmacists change prescriptions without asking

June 18, 2012
By: Edie Lau
For The VIN News Service 

Veterinarians in Oregon have reported to state pharmacy regulators concerns that retail pharmacists are making unauthorized changes to prescriptions written for animal patients, apparently out of ignorance of veterinary pharmacology.

The changes they report involve altering prescribed dosages or switching the medication itself — for example, by substituting one type of insulin for another.

Gary Schnabel, executive director of the Oregon Board of Pharmacy, said for a pharmacist to make such changes without permission from the prescribing doctor is unequivocally wrong.

“It’s a direct violation of the pharmacy practice (act) and pharmacy rules,” he said. “That would be a violation in every state. The pharmacist is supposed to prescribe the drug in conjunction with the prescriber’s instruction. Period.”

Schnabel could not confirm that violations actually are occurring, however; he said he is unaware of a formal complaint being filed in his 18 years with the pharmacy board.

“We have not seen an actual event that we can investigate,” Schabel said. “... We can’t say that this is happening or we know it’s happening. All we can say is that we’re hearing about it from veterinarians. ... I don’t say I don’t believe them,” he added. “I just don’t have it documented.”

Two veterinarians from the Oregon Veterinary Medical Association (OVMA), along with OVMA Executive Director Glenn Kolb, met in May with Schnabel and the pharmacy board’s director of compliance, to discuss the problem. The group agreed to collaborate on educating and raising awareness among pharmacists, and Schnabel underscored the need of veterinarians to formally report suspected violations.


Although fielding questions from pharmacists unaccustomed to dispensing drugs to pets isn’t new for veterinarians, the frequency with which veterinary prescriptions are misunderstood appears to be rising as pet owners shift to retail pharmacies for their pets’ medications, practitioners say. Traditionally, pet owners obtained medications directly from veterinarians.

The issue of misunderstood animal prescriptions is not particular to Oregon. Veterinarians from across the United States — and occasionally from Canada and the United Kingdom — have posted about the subject on message boards of the Veterinary Information Network (VIN), an online community for the profession.

Dr. Sheri Morris, president of the OVMA and owner of Willamette Valley Animal Hospital near Salem, Ore., said the problem is driven by broad market trends.  

“I think it’s because of the aggressiveness of human pharmacies to go after veterinary business, that’s what’s brought it to a head,” Morris said. “It used to be that it happened so infrequently that no one did much about it.”  

In Morris’s hospital earlier this year, one doctor had an experience in which a pharmacist changed the type of insulin prescribed for a diabetic cat. The veterinarian prescribed glargine; the pharmacy provided NPH. The pharmacist “convinced (the cat’s owner) to buy it because it was less expensive,” Morris said.  

“But they are completely not interchangeable, so we sent her back to the pharmacy, telling her, ‘No, you need to get what’s in the prescription,’ ” Morris recounted.  



To read the remainder of this article, click here.

Monday, April 23, 2012

India No Longer Making Cisapride

Cisapride, while banned for use in humans, is a commonly used and valuable drug used for animals.  The country of India previously made Cisapride; however, their government has shut down production for human safety reasons.  Several organizations have petitioned the Indian government to reconsider.  Here is the letter that the Society of Veterinary Hospital Pharmacists wrote to the Indian government petitioning them to reconsider.  Click here.


Special thanks to Gigi S. Davidson for bringing this issue to the author's attention. 

Tuesday, April 17, 2012

Positions taken by Society of Veterinary Hospital Pharmacists and Former FDA Officials in Franck's Appeal


In the amicus brief filed by the Society of Veterinary Hospital Pharmacists (SVHP's), its position is clearly stated:

    Regarding the legality of traditional compounding with bulk chemicals, SVHP has adopted a "Position Statement on Compounding," a complete copy of which is available on SVHP's website. See http:svhp.org/position-statement/.   That statement recognizes that in many circumstances traditional compounding with bulk chemicals is essential to providing high quality pharmaceutical care for sick animal patients.  SVHP supports the ability of veterinary pharmacists, in consultation with veterinarians caring for animal patients in need, to compound medicines from bulk ingredients as follows:   If an FDA approved product is unavailable or not appropriate for treatment, compounding with bulk chemicals (APIs) may become necessary and required for proper treatment. The APIs/bulk ingredients used to compound an appropriate product should be of highest possible chemical grade, and the finished product should be compounded from those bulk ingredients using a formula – preferably a USP formula – with evidence-based documentation of potency and stability.  


     The legal position taken by the United States in this matter, through the Federal Drug Administration (“FDA”), is that any compounding from bulk materials by pharmacists for animals is illegal under the Federal Food Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., and has been since the statute was first enacted in 1938. SVHP respectfully disagrees, and believes that legal position to be incorrect.


In the amicus brief filed by Former FDA officials, they make a very persuasive argument distinguishing between traditional compounding and manufacturing of drugs.  Their summary of argument provides:



     The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) did not criminalize traditional pharmacy compounding, including compounding animal drugs from bulk ingredients. Instead, the FD&C Act was enacted to regulate drug Case: 11-15350 manufacturing, which is categorically distinct from traditional pharmacy compounding. Additionally, none of the amendments to the FD&C Act reflect Congress’ intent to criminalize traditional pharmacy compounding, including compounding animal drugs from bulk substances. 

    In asserting that any compounding of animal drugs from bulk substances is unlawful per se, FDA’s policy guidance fails to adequately distinguish between traditional pharmacy compounding of animal drugs and manufacturing of animal drugs. The key difference between traditional pharmacy compounding of animal drugs on the one hand, and manufacturing of animal drugs on the other, is that the former is conducted in response to a prescription order based on a valid Veterinarian-Client-Patient relationship in the course of professional practice, whereas the latter is not so circumscribed. 

    As FDA acknowledges, its policy guidance on animal drug compounding lacks the force of law. Moreover, in issuing that policy guidance, FDA failed to comply with its own regulations, which require that, prior to issuing such guidance, the Agency must provide notice and an opportunity for interested parties to submit comments. 

    As we understand the factual record in this case, the animal drug compounding that Defendants-Appellees conduct is within the scope of traditional pharmacy practice. The district court’s decision therefore should be affirmed. 

The Former FDA Officials are careful to point out that the "factual record" on appeal did not support manufacturing of drugs.  The FDA failed to present this argument in the district court.  Frank's in his brief argues that this argument is waived on appeal.  Normally, if an issue is not raised in the district court it can be considered waived by the appellate court.  If the 11th Circuit wants to avoid the hard issue of what is traditional compounding and what crosses over into manufacturing then it can do so by applying the waiver doctrine.