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The Veterinary Cooperative’s new partnership brings AI communications to nearly 4000 veterinary practices

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Department of Small Animal Medicine and Surgery 

The FDA is advising pet owners to discontinue use of 6 of Darwin’s Natural Selections raw cat and dog food products, manufactured by Arrow Reliance, Inc. The announcement came after 5 FDA samples of these products tested positive for 

Arrow Reliance was advised by the FDA to recall the 6 affected product lots, according to the announcement.

 However, the company has not recalled these products and may still be distributing them.

According to Darwin's Natural Pet Products, they contacted their clients on the same day of the FDA's announcement to offer detailed information about the situation. "As the Darwin’s community knows, transparency in communication is important to us. It is second only to our top priority: the health and wellbeing of the pets we serve," Gary Tashjian, founder and CEO of Darwin's Natural Pet Products, told 

“As part of our outreach, we specifically communicated with customers who had already received product lots that were included in the FDA’s notice – about 3% of our customers nationwide," continued Tashjian. According to the company, only a small amount of product left their facilities, and they had stopped shipping any potentially affected products earlier this month as soon as the FDA informed them about the testing.

The impacted products include specific lots of Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs. They are sold in frozen 2-pound white and clear plastic packages with 4 separate units. The Darwin’s Natural Selections products for dogs comes in blue packaging. The cat food has a combination of blue and green packaging.

The following are the impacted varieties and lot codes

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats: Lot number 10832 MFG. Date: July 25, 2024.

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats: Lot number 10856 MFG. Date: August 4, 2024.

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats: Lot number 10890 MFG. Date: August 13, 2024.

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs: Lot number 10828 MFG. Date: July 24, 2024.

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs: Lot number 10844 MFG. Date: July 30, 2024.

Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs: Lot number 10887 MFG. Date: August 12, 2024.

Lot codes for these products can be found printed on the lower left corner of the front of the package. The FDA is also recommending that consumers regularly check the lot numbers of Darwin’s Natural Selection Antibiotic & Grain-Free products before feeding them to their pets.

In its announcement, the FDA urged any individual that has any of these 6 products to stop feeding it to their pets and dispose of it in a secure container that is inaccessible to other animals, including wildlife. The FDA also warned against the donation of these products. Moreover, the organization advises that consumers throw the products away if lot codes are illegible or if packaging has been discarded.

Should consumers be in possession of the affected pet food products, they should clean and disinfect all pet supplies and surfaces that came into contact with the food or pet, including refrigerators and freezers.

Veterinarians interested in testing pets for 

 can utilize the Veterinary Laboratory Investigation and Response Network (Vet-LIRN Network) if the pet comes from a household where someone is infected with either of these pathogens.

Darwin's Natural Pet Products maintains that their meals are safe. According to Tashjian, the company hired an independent 3rd party to conduct testing using conventional methods, and found that all lots tested negative for listeria. However, the testing did reveal small trace amounts of salmonella, which is inherent to poultry, Tashjian told 

“The products were flagged under the FDA’s zero-tolerance policy, which is largely designed for human safety, not pets. In fact, under the FDA protocol, the products tested positive for pathogens only following an incubation period," said Tashjian in an email to 

“At Darwin’s, the health and wellbeing of the pets we serve is our absolute top priority, which is why we have rigorous standards for quality and safety in manufacturing and sourcing. These protocols help ensure the safety of our products while maintaining the good bacteria that are crucial to pets’ gut health and immune systems,” he continued.

According to the FDA, animal companions may not always show symptoms when infected with Salmonella, but they could exhibit signs such as vomiting, diarrhea—including bloody diarrhea—fever, loss of appetite, and/or reduced activity levels. However, some animals may be asymptomatic and still shed the bacteria in their feces, contaminating the environment when they have a bowel movement.

 are rare in pets, but they can occur, according to the FDA.

 Symptoms may range from mild to severe diarrhea, anorexia, and fever, in addition to nervous, muscular, and respiratory issues. This infection can also lead to pregnancy loss, depression, shock, and death. Pets can transmit 

to humans even if they do not show symptoms. As with 

, infected pets can shed bacteria in their feces and saliva without appearing ill, potentially infecting their human counterparts.

In its announcement, the FDA expressed concern over about 

in pet food because these bacteria are especially concerning for public health, as they can impact both humans and animals, according to the FDA.

 "Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill," wrote the FDA, in its announcement.

FDA advisory: Do not feed certain lots of Darwin’s Natural Selections pet food due to Salmonella and Listeria monocytogenes. News release. US Food and Drug Administration. September 20, 2024. Accessed September 23, 2024. 

https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-do-not-feed-certain-lots-darwins-natural-selections-pet-food-due-salmonella-and?utm_medium=email&utm_source=govdelivery

Five FDA samples of Darwin’s Natural Selections raw cat and dog food products tested positive for Salmonella, with a 6th showing Listeria monocytogenes

Clinical

FDA announces pet food products contaminated with Salmonella and Listeria

Missed out on Fetch Kansas City 2024? No worries—we’ve got you covered! Fetch On-Demand brings the best sessions, speakers, and CE opportunities straight to you, so you can learn when, where, and how it fits into your busy life. Whether you’re catching up between appointments, learning from the comfort of home, or squeezing in a quick session over coffee, Fetch On-Demand gives you the flexibility you need to earn CE credits your way.

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Peter Weinstein, DVM, MBA, spoke alongside Kelley Detweiler, an expert on Drug Enforcement Administration (DEA) regulatory compliance, about best practices for maintaining controlled substance logbooks during a session at the Fetch dvm360 Conference in Kansas City, Missouri. In addition to general logbook compliance, the presentation covered how to handle and reconcile discrepancies, and the DEA’s position on hub loss and substance waste.

Weinstein and Detweiler began their presentation with a brief section about frequently asked questions (FAQs), addressing some common misconceptions. They explained that, according to Title 21 of the Code of Federal Regulations, logbooks are not required to be bound, but they must be maintained in a manner that does not allow any log sheets to be loose or falling out of order. They also must be secured in consistent chronological order for the current 2-year period, according to Detweiler. Logbooks should also be stored close to where DEA-compliant controlled substances are being used, they are not required to be locked up, and they should never leave the premises.

Perhaps the strongest point of emphasis throughout the pair’s discussion regarding DEA-compliant logbooks was the significance of the entries consistently balancing out to 0. The DEA does not want variances. Similarly, it is their recommendation to never leave blanks in logbooks. If a practice is documenting waste, rather than leaving a field blank as in indication that there was no waste, filling in a "0" as a record that there was no confirmed waste was advised.

“[DEA]-compliant logs should tell the story of the controlled substance usage from the point of acquisition to the point of administration, dispensing, or disposition,” Weinstein said during their session at the Fetch dvm360 conference. “Disposition could be wasting, and/or expiration.”

For more information, Weinstein and Detweiler debunked myths and misconceptions surrounding DEA regulation in a 

According to DEA regulations, a full inventory of all controlled substances must be conducted biennially at a minimum following the date when the initial DEA inventory was conducted. Though, Weinstein compares waiting until the last minute to complete biennial inventory to getting taxes together each year on April 14, knowing they are due on April 15.

The speakers discussed conducting controlled substance reconciliations on logbooks, which is the process of comparing the actual amount of physical inventory "on-hand" against the amount of inventory that should be on-hand according to the logbooks, Detweiler noted. They compared to a checkbook of every drug from a specific category. If a practice is not reconciling their controlled substance logs on a regular basis, there would be no way to identify discrepancies or to identify if their logs are consistent with their inventory. Weinstein recommended that reconciliation logs be conducted by an authorized user and a witness, preferably on camera for an extra layer of security.

“So, the more you do a reconciliation, the more likely you are to balance out,” Weinstein said. “Don’t you hate it at the end of the day, when you’re balancing out the drawer, and there’s a penny off? Well, how about if that penny is 1 cc of fentanyl… what do you do to resolve [that]?”

In their session, the pair also recommended that reconciliations be conducted, at minimum, weekly. Although the DEA does not set forth a specific frequency for conducting reconciliations, the more often you reconcile the better. Frequency should be determined based on the size of the practice and volume of controlled substance use. If it's a large practice with higher controlled substance usage, reconciliations should be conducted daily or, if possible, at the end of each shift. In general, the more controlled substances a practice uses, the more often they should reconcile.

Detweiler stressed the urgency of recognizing discrepancies. “Because remember, if something doesn’t jibe, you have 24 hours to make notification to the DEA,” she said. “And that registrant who’s holding the bag needs to know immediately, because it affects their entire license and livelihood.”

What is an acceptable amount of hub loss?

“So, the DEA recognizes that hub loss exists,” Detweiler said during the session. “However, they do not specify a certain amount of hub loss that is allowed, they do not provide how it should be calculated, and they will check how you are accounting for hub loss for things that do not balance out to 0 in your logs.” She explained that, with different substances, often depending on the viscosity, and with different needle gauges, hub loss will vary. Her advice for determining acceptable hub loss is to establish a consistent formula for calculating it. “The DEA wants to know that you’re not predetermining amounts, and that you have a formula,” she said.

She recommended multiplying the number of pokes by whatever amount was determined for hub loss on a specific container or bottle for liquid controlled substances. If the resulting number from your calculations is within 10% of where it’s supposed to be, in most cases that would be considered typical hub loss. Practices should always determine hub loss amounts according to a specific container, and should be prepared to explain those calculations to the DEA with a well-documented formula for how that calculations was determined.

“So, basically, [number of] pokes [multiplied by predetermined amount],” Detweiler clarified. “[If the result is] within 10%, over or under of where you should be, you’re most likely good. If it’s not within 10%, it should be investigated for potential significant loss.”

Concluding their presentation, Weinstein and Detweiler stressed the importance of documenting waste, even if that means writing “0.” Additionally, Detweiler encouraged the audience to add side comments, because there's no such thing as over-documenting. They also recommended including the date and initials next to any corrections or cross-outs so that everyone knows who to ask if they have questions. Some additional tips for success include:

Properly account for document, and don’t predetermine, hub loss

Ensure proper documentation of any discrepancies and make sure the DEA registrant receives a copy of it as soon as possible

“So, we know that this is not a lot of fun, but it’s really, very important,” Weinstein said, wrapping up the session. “It’s very important for you and your practice, it’s important for your team, it’s important for the profession, and it’s important for the community in which you work.”

Weinstein P., Detweiler K. Oh My Log! Championing Logbook Success. Presented at: Fetch dvm360 Conference; August 23-25, 2024; Kansas City, MO.

Record-keeping for DEA-compliant controlled substances was discussed in a session at the Fetch dvm360 Conference in Kansas City

Conference

Practice Management

Best practices for logbooks

Stokes Pharmacy and Bova Group (Bova) announced an exclusive partnership to offer a United States mad oral treatment for feline infectious peritonitis (FIP). The medication will treat the now once-fatal virus through a compounded preparation supported by Bova’s drug formula that has been used in clinical research studies globally.

“Made possible by our Bova partnership, Stokes Pharmacy will compound and sell the only oral formula identical to the Bova formula used in clinical studies across the globe. Our tablets were tested by Bova to meet their exact specifications. We are thrilled to bring this long-awaited treatment to the US and put FIP treatment back in the hands of the veterinarians," Michael Tursi, Stokes' president, in a news release.

 the drug formula created by Bova is used by Bova Aus and Bova UK, with exports to other countries with import permissions currently in place. There was previously no legal access to FIP oral treatment available in the US for veterinarians, according to the company. Because of this, pet owners have relied on options outside of a pharmacy or FDA-registered manufacturer to get treatment for their sick pets. Recognizing this gap in veterinary medicine, Bova vetted leaders within the industry to find the right partner to help bring their formula to the US market and created this partnership with Stokes Pharmacy.

“The introduction of FIP products to Australia and subsequently to the UK has led us on a transformative path. Collaborating with feline specialists around the world has propelled the progression of knowledge and comprehension of FIP. At Bova, we have been fortunate enough to support multiple clinical trials around the world on our unique formulation. This has helped give veterinarians confidence in using our formula and bringing the treatment of this fatal disease back under their control,” said Nick Bova, Bova’s managing director.

There are so many black-market options available out there and their quality is so varied. We wanted a partner who took quality and science as seriously as we do at Bova. Stokes Pharmacy is an impressive organization that prioritizes quality and science. Now, together, we can finally help save cats' lives across the USA who are impacted by this terrible disease," he continued.

“The FDA’s Center for Veterinary Medicine has alerted veterinarians that, while compounded GS-441524 is not legal, the agency does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in 

Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances

. GS-441524 has been nominated by Stokes Pharmacy to be included on the list of animal drug bulk substances regarding GFI #256 office use and now has a place on the GFI under review list. Because of this, the compounded medication 50 mg tablets are eligible to be sold in hospitals for office sale in every state except Arkansas, Maine, Massachusetts, New Mexico, New York, Oregon, Rhode Island, and West Virginia. However, according to the release, veterinarians who work in a state that does not allow GS-441524 for office use can prescribe the drug in the name of the patient.

The compounded treatment became available by veterinary prescription of individual patients in all states on June 1, 2024

John K. Sessions, DVM

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