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Pharmaceuticals
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Some veterinarians wary of Novartis’ enticements to carry Sentinel
5/9/2013
Interceptor gone forever, company says
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Vetsulin back with label changes
5/3/2013
Surprising new instructions: ‘shake’ drug to mix
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Panel airs FDA restrictions on livestock antibiotics use
4/25/2013
Achieving greater veterinary oversight not simple
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Changing insulin brands may disrupt diabetics
2/5/2013
Problems in veterinary patients highlight heedless switching
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Veterinary prescription problems aired with regulators
1/12/2013
Pharmacy boards urge veterinarians to file complaints
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Company pursues first lymphoma drug for dogs
1/2/2013
$1.5 million raised to fund effort
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Insiders lift veil off veterinary drug distribution practices
9/25/2012
Upcoming FTC meeting prompts disclosures
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Novartis pleads with veterinarians: ‘Save us a spot’
8/29/2012
Interceptor, Sentinel found online but not in veterinary practices
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Future of Novartis anti-parasitics unfolding
8/23/2012
FDA approves new versions of Interceptor, Sentinel
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Accreditation body questions pharmacies on veterinary drug suppliers
6/28/2012
Vet-VIPPS applications said to be suspended during investigation
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Veterinarians say pharmacists change prescriptions without asking
6/18/2012
Retailers' foray into pet drugs causes rising tensions
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More legal turns in push to restrict antibiotics in livestock
6/12/2012
Disease prevention uses in dispute
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Franck's recall triggered by rash of fungal eye infections
5/29/2012
Pharmacy's ophthalmic drops, parenteral medications included
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Veterinarian opens up about going undercover
5/22/2012
Flea-product diversion adventure twisted, turned
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Merial: PureVax for ferrets coming back this week
4/30/2012
Backorder of distemper vaccine stirred worries
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Judge orders FDA to assess antibiotic safety in livestock
4/2/2012
AVMA responds with support for the judicious use of antimicrobials
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Veterinarians frustrated by Novartis backorders
3/26/2012
Practitioners face supply problems tied to generics-maker Sandoz
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Novartis warns veterinarians of possible Clomicalm tablet mixups
2/1/2012
FDA chastises company, prompts plant shutdown
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Veterinarians confront Internet pharmacy PetMed Express
1/16/2012
Company acknowledges: ‘Some mistakes were made’
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FDA limits cephalosporin use in livestock to curb drug resistance
1/6/2012
AVMA calls new restrictions reasonable
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Novartis temporarily suspends production of Interceptor, Sentinel
12/29/2011
Supply of other, unnamed drugs also impacted by plant improvements
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PetMed Express stumbles
12/8/2011
Competitive pressure up in veterinary-drug sales
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DOJ challenges ruling in veterinary compounding case
11/16/2011
Appeal sought of decision that restricted FDA's authority
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Veterinary compounding out of FDA’s jurisdiction, judge rules
9/13/2011
Franck's wins legal battle against federal regulators
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Immiticide supplies run dry
8/9/2011
New guidance from the American Heartworm Society expected
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Pfizer seeks to unload animal health division
7/8/2011
Sale or spin-off expected
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Gilded Lilly? Bayer challenges Elanco claims
6/24/2011
Bayer challenges Elanco claims about diversion, loyalty to veterinarians
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Researcher promotes awareness of accidental hormone exposure in pets
6/8/2011
VIN tallies more than 100 case reports since 2003
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Scientist fired by Merial alleges Heartgard Plus coverup
6/7/2011
Dr. Kari Blaho-Owens seeks damages, whistleblower protections
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Antibiotics: spinning the data from Denmark
5/27/2011
Antibiotics do little to enhance growth, yet producers still use them
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Antibiotics: precaution vs. proof
5/26/2011
Weighing risk to public health from antibiotics used in livestock
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FDA: Food-animal antibiotic consumption dwarfs human medical use
5/25/2011
New data reveal flaws in figures presented by AVMA, industry
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Scrutiny of livestock antibiotic use pressures veterinary profession
5/24/2011
AVMA negotiates shifting regulatory landscape
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Online veterinary pharmacies exploit cross-border regulatory gaps
4/25/2011
Canine heartworm prevention drugs sold without required prescription
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'Party time’s over’ for flea and tick killer ProMeris
4/21/2011
Pfizer plans to discontinue product in September
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Animal health companies move toward consolidation
4/12/2011
Trend promises to impact veterinary medicine
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Silver lining for veterinary medicine in failed union of pharmaceutical giants
4/11/2011
Competition between drug makers a positive for the profession, experts say
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Shar-Pei owners given affordable access to human drug
4/8/2011
Extreme price hike on colchicine caused stir
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Phenobarbital labeling mix-up results in recall, adverse events
3/10/2011
Veterinarians warned of mislabled Qualitest Pharmaceuticals tablets
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Future of veterinary compounding hangs in balance
2/25/2011
Judge hits federal government with tough questions
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Glycopyrrolate shortage hits human, veterinary medicine
2/24/2011
Atropine suggested as a replacement
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Campaign to defend veterinary compounding may be misdirected
2/18/2011
Lack of specifics from FDA begets confusion
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Vetsulin’s removal from market could be temporary
2/8/2011
Intervet ceases production due to bacterial contamination concerns
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Price soars on popular antibiotic metronidazole
1/13/2011
Limited competition among manufacturers behind increase
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AVMA cautions DEA on plans to raise propofol to controlled status
12/22/2010
Comment period closes Dec. 27
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Target tests market for pet medications
12/22/2010
Trend in retail sales of veterinary drugs accelerating
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Veterinarians scramble for mainstay chemotherapy drug
12/20/2010
Doxorubicin hydrochloride in short supply
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FDA releases government data on antibiotic use in food animals
12/9/2010
Non-therapeutic quantities not specified, leaving key questions unanswered
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Veterinarian struggles to protect her online reputation
12/8/2010
Practitioner suspects Internet extortion is at play
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DEA wants propofol elevated to scheduled status
11/10/2010
Change likely to impact veterinary practices
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PetMed Express reports slip in sales
10/19/2010
Ad costs rise as consumer spending falls with the online pharmacy
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Comments sought on EPA unused-drug disposal recommendations
10/15/2010
Agency skips medical facilities survey, directly drafts guidelines
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Lawsuit raises questions about sale of drugs to non-veterinarian
10/13/2010
Case brought by Bayer against shelter rescheduled for Dec. 2 hearing
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Accidental hormone exposures prompt proposed drug label changes
10/11/2010
Seller of topical hormone Evamist awaiting FDA review
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VIN unveils recall center for veterinarians, consumers
9/27/2010
Site intended to act as information resource
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Scrutiny of secondary topical hormone exposures deepens
9/9/2010
Veterinarians to be surveyed; FDA fields reports involving pets and children
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Supplies of injectable butorphanol tartrate to normalize, veterinary insiders report
9/3/2010
Pfizer Animal Health assures commitment to manufacture Torbugesic
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CEVA buys Summit VetPharm
9/2/2010
Plans to market Vectra parasiticides globally
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Propofol shortage hits veterinary medicine
8/26/2010
Clinics turn to alternatives with production of PropoFlo, Rapinovet stopped
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IV furosemide vanishing from veterinary market
8/12/2010
Medication on back order for months, distributors say
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FDA investigating accidental hormone exposure problem
7/29/2010
Issues safety alert on topical estrogen spray product Evamist
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Hormone replacement skin products affect users’ pets, confound veterinarians
6/10/2010
Symptoms include swollen vulvas, enlarged mammaries, fur loss
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Franck’s Pharmacy negotiates with FDA in Washington on veterinary compounding
5/20/2010
Outcome could have broad effects on industry, some contend
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Bayer wins some, loses some
4/28/2010
New sales policy continues to reverberate
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FDA calls veterinary compounding at Franck’s illegal
4/19/2010
In unprecedented action, agency seeks court injunction against pharmacy
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Heartworm treatment drug remains in short supply
4/15/2010
FDA must approve manufacturing facility, Merial reports
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Brand-name buprenorphine production up
4/14/2010
Extended shortage has had veterinarians scrambling
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Mexiletine hydrochloride is back in 150-mg capsules
4/9/2010
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U.S. EPA confirms problems exist with spot-on flea, tick treatments
3/18/2010
Agency proposes changes in labeling, safety monitoring
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Merial details company stance on product diversion
2/26/2010
Executives speak out after veterinarians question company loyalty
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New feline thyroid drug raises safe-handling questions
2/1/2010
Experts say warnings apply to all forms of methimazole
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Seven labels tied to Teva ketamine recall, FDA says
12/31/2009
Details from FDA could alleviate confusion for practitioners
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Expanded ketamine recall leaves veterinarians with unanswered questions
12/29/2009
Action culminates rocky year for Teva Animal Health
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2009 brought huge consolidations in animal health industry
12/21/2009
Butler and Schein merger latest in a series
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Drug maker sues compounding pharmacy
12/17/2009
Bayer says Wedgewood infringing on patent
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Merial reports Immiticide, Heartgard shortages
12/5/2009
Rationing of Immiticide leaves some veterinarians in a lurch
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Confounding Compounding
11/24/2009
Growth of pharmacy practice fuels worries about quality, future
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Company short on Vetsulin details, veterinarians long on frustration
11/9/2009
Practitioners confused, asking questions about stability concerns following FDA's warning
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BI reportedly stops U.S. sales of Mexitil, sparking concern from veterinarians
10/8/2009
Teva Pharmaceuticals USA might be nation’s only maker of mexiletine hydrochloride
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Dog stuck in crate highlights rare risk of spot-on flea treatment
10/7/2009
Benzyl alcohol acted like glue, sticking pet to plastic
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Virbac recalls Iverhart Plus
8/20/2009
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Propofol recall expanded
8/4/2009
Three additional lots affected
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Teva Animal Health closes shop
8/3/2009
FDA shuts down plant, sparks product availability concerns
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Sanofi makes $4-billion deal with Merck for Merial
7/31/2009
Ultimate plan could create world's largest animal-health company
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Tainted lots of propofol prompt recall
7/15/2009
CDC, FDA urge clinicians to check inventory
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FDA denies Nutro investigation despite reports indicating otherwise
4/27/2009
News outlets retract stories that link pet food to adverse reactions, including death
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Makers of spot-on products summoned for EPA meeting
4/24/2009
Oregon State University is taking adverse reaction reports from veterinarians
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EPA investigates reactions from flea, tick killers
4/17/2009
Agency is scrutinizing products' safety
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HSUS to take Prop 2-like action to Ohio
4/6/2009
Veterinarians gear up for talks to thwart high-stakes conflict with activists
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The flea market
4/6/2009
Exploring the diversion of parasiticides from manufacturers, veterinary offices to Web sites, store shelves
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Economic downturn hits veterinary practices
3/11/2009
New VIN survey results anticipated
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Merck buys Schering-Plough
3/11/2009
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Blockbuster Pfizer-Wyeth deal stirs veterinary medicine
2/9/2009
Merger muddies outlook for Fort Dodge Animal Health
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About-face by Florida regulators eases permit policy for DVMs
1/14/2009
Refunds are on the agenda, FVMA says
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Treatment for Cushing's syndrome to hit market
12/17/2008
FDA approves trilostane for canine patients
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VetCentric Executive Admits Accounts Irk Many
11/23/2008
VetCentric gives veterinarians a hard pill to swallow while altering business model in response to authorities ruling their original business model a kick back for writing prescription.
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Glycopyrrolate shortage?
10/17/2008
It's still in stock, distributors say
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FDA alerts veterinarians to new ivermectin directions
9/10/2008
Merial changes instructions for Eqvalan Liquid for Horses
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EPA survey: How do you dispose of unused pharmaceuticals?
8/29/2008
Agency wants to know why some still dump drugs down the drain
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Theophylline production held up by FDA, manufacturer says
8/11/2008
Drug remains available in 100mg, 200mg tablets
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Veterinarians face atropine shortage?
8/1/2008
Penn Veterinary Supply says it has the drug in stock despite backorder claims
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15 drugs received approval in 2007, FDA reports
7/23/2008
Slentrol, Vetmedin, Cerenia rank among what agency officials characterize as "new therapeutic advances"
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Drug makers agree to ethical code for doctor-company relationships
7/15/2008
Veterinary medicine might be next, insiders say
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FDA approves antimicrobial for aquaculture uses
7/11/2008
Supplemental OK involves Terramycin 200
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UPDATE: FDA bans cephalosporin drugs in food animals
7/3/2008
Federal regulators issue change amid concerns about antimicrobial resistance
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Accreditation body questions pharmacies on veterinary drug suppliers
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June 28, 2012
By: Edie Lau
For The VIN News Service
 Pharmacies that wish to receive or maintain accreditation under the Veterinary-Verified Internet Pharmacy Practice Sites (Vet-VIPPS) program run by the National Association of Boards of Pharmacy are now being asked to divulge their drug supply sources.
The association is taking a look at how pharmacies acquire companion-animal prescription medications, according to NABP Executive Director Carmen Catizone.
While the association has no direct regulatory power over pharmacies, it runs an accreditation program specifically for online pharmacies called Veterinary-Verified Internet Pharmacy Practice Site, or Vet-VIPPS. To achieve Vet-VIPPS accreditation, a pharmacy must demonstrate to the association that it is properly licensed and complies with state and federal laws and regulations — something a number of Web-based pharmacies fail to do.
Vet-VIPPS is modeled after a program called VIPPS established for online pharmacies that sell drugs for human patients. Though voluntary, the programs have significant influence with online advertising. Search engine giant Google requires online pharmacies in the United States wishing to purchase advertising to be accredited by the NABP.
When Vet-VIPPS was established in 2009, applicants were not specifically required to disclose to the association its sources of medications, Catizone said. Now they are. “We ask for sample invoices and randomly select and look at them,” he told the VIN News Service.
In addition, the association is “holding up” accreditation of pharmacies about which they’ve received complaints while its investigators attempt to determine whether any laws are being broken, Catizone said. He declined to identify which pharmacies are affected, saying disclosure at this juncture would be premature.
The association has found the supply question to be convoluted and confounding, he said: “Our heads are spinning here."
It's no wonder. Gray-market diversion, as the activity is called, is a complicated affair in the veterinary world. The situation is this:
- Almost every veterinary pharmaceutical company has a sales policy that products are to be sold only through licensed veterinarians who treat patients.
- An increasing number of retail outlets — online and brick-and-mortar alike — carry veterinary non-prescription and prescription drugs.
- Veterinarians accuse manufacturers of secretly selling products directly to outside pharmacies while trying to appear loyal to and supportive of veterinarians.
- Some veterinarians take part in diverting drugs by ordering more than they need and selling the excess to brokers who supply the retailers. This practice, while not necessarily illegal, is considered by the veterinary profession as unethical.
- Manufacturers’ role in diversion is murky. Some veterinarians who have diverted report instances of at least one leading pharmaceutical company facilitating diversion.
Catizone said the NABP began investigating the issue about six months ago after receiving a number of allegations by veterinarians that some Vet-VIPPS pharmacies were illegally obtaining prescription drugs. The complaints and war of words has escalated since, he said.
“We’re getting calls every hour from veterinarians and veterinary pharmacies on this issue with conflicting reports and accusations,” Catizone said.
His sense is that “people are not following the rules on both sides of the equation.”
He said the association has found nothing in the law that prohibits a veterinary pharmaceutical company from shipping product directly to a pharmacy. Whether that is happening in spite of the companies’ official sales policies is something the group is trying to ascertain.
If the pharmacies are buying from sources other than the pharmaceutical companies — in other words, from the gray market — Catizone said, it’s unclear whether that’s a regulatory problem. The U.S. Food and Drug Administration (FDA) has not provided guidance, he said: “We cannot get a solid answer from the FDA or anyone to say what is OK, what is an authorized channel, what’s acceptable and what’s illegal.”
Complicating matters further is the possibility that regulators could consider veterinarian-exclusive sales policies a violation of antitrust laws, Catizone said. Executives with the veterinary pharmaceutical company Merial have told the VIN News Service in the past that they must take care not to police their sales channels so vigorously that they draw accusations of anti-competitive activities.
In terms of professional pharmacy standards, Catizone said a chief concern regarding diverted drugs is whether they are authentic products that have been safely handled. Medications from unauthorized, undocumented sources are considered to have a higher risk of being counterfeit, diluted or otherwise adulterated.
“Without that chain of custody and that pedigree, knowing it came along a valid source, they’re really playing Russian roulette with patients’ lives,” Catizone said.
He’s concerned that patient welfare, which should be foremost, is being pushed to the sidelines in a tug-of-war over who should control, participate and profit from the sales of prescription drugs.
“The idea here is to have a proper diagnosis, a valid prescription, and the patient receives the right prescription and there’s no question about the integrity of the medication,” Catizone said. “.... If we lose sight of the patient and focus on the money, then we’re going down the wrong path.”
Currently, 18 online pharmacies are accredited as Vet-VIPPS. Among them is PetMed Express, Inc., which bills itself as “America’s Largest Pet Pharmacy.” The company states in its annual report that it purchases product from secondary sources because of manufacturers’ refusal to sell to the pharmacy.
Asked about the potential impact of the NABP’s attention to supply sources, PetMed Express Chief Financial Officer Bruce Rosenbloom said he was not familiar with the inquiry. “We don’t have any issues with our certification, if that’s what you mean,” Rosenbloom said. “We’ve gotten our certification, and we’ve followed all rules and regulations.”
PetMed Express’s Vet-VIPPS listing shows it was accredited on March 3, 2010, and will be up for renewal in 2013.
Executives of two other Vet-VIPPS pharmacies interviewed by the VIN News Service said they welcomed the NABP’s scrutiny of diversion.
Wes Hepker, manager of VetRx Direct, the first pharmacy to achieve Vet-VIPPS accreditation in 2009, said his company deliberately has chosen not to purchase drugs from unauthorized suppliers. “Who’s to say those didn’t sit out in the sun, out of a controlled environment?” Hepker said. “We can’t give customers our 100 percent confidence these drugs are safe.”
As a consequence of its decision not to tap alternative markets, Hepker said, VetRx Direct has gaps in its inventory.
The pharmacy does carry some products manufactured by companies that have veterinarian-exclusive sales policies. Asked how it obtains those drugs, Hepker demurred. “A lot of that information is proprietary information for us,” he said. “I know that sounds like a cop-out. But because of the competitive landscape, we don’t discuss specifically where we get our drugs, except they are United States-licensed wholesale distributors.”
Hepker said his company favors the NABP asking accreditation applicants about their drug suppliers, and that VetRx Direct did discuss its suppliers with the NABP during its original accreditation review.
VetSource, another Vet-VIPPS pharmacy, is able to obtain its medications directly from manufacturers owing to its role as a “central fill” pharmacy, said company president and CEO Kurt Green. The pharmacy is contracted by veterinarians to fill their prescriptions, in essence serving as an extension of those clinics.
“The manufacturers understand our model, and we buy directly from the manufacturers,” Green said. “We had to demonstrate (to them) what the concept of the central fill approach was — the fact that we’re veterinarian-sponsored and supporting the veterinarian in this process.”
Of the 18 Vet-VIPPS pharmacies, Green said he suspects only a few obtain all of their products from authorized sources, while the rest rely on diversion to obtain some portion, if not most, of their products.
During his company's Vet-VIPPS certification process, Green said he suggested to the NABP reviewer that the program consider requiring applicants to prove they acquire products only from authorized channels. He was pleased this week to learn that the organization is checking supply sources now.
Dinah Jordan, chief of pharmacy services and a clinical professor at Mississippi State University College of Veterinary Medicine, said she believes the NABP’s decision to investigate diversion will raise the credibility of Vet-VIPPS within the veterinary community.
“I know there’s been concern about the Vet-VIPPS program because of this very thing: Where are (the accredited pharmacies) getting their drugs?” she said. “If you’re going to have a Veterinary-VIPPS standard of approval, then certainly the stamp should reflect not only the legal but also the ethical standards of the profession.”
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