Know What You’re Buying: The Messy World Of Compounding Pharmacies By Natalie Voss Continued on Page 5 From Dec. 28 to Dec 30, 2015, inspectors from Florida’s Department of Health observed business at Ergogenic Labs in Wellington, Fla., where pharmacist Scott Mangini oversaw the compounding of human and animal drugs. The inspectors were not happy with what they found. In a subsequent report dated Jan. 5, 2016, they “noted serious deficiencies of state and federal law,” including “filthy conditions in the pharmacy’s clean room,” mislabeled or unidentified drugs on the shelves, and several substances in bottles labeled “Not intended for humans or animals” and “Not for Drug, Household, or Other Uses.” The floor of the pharmacy was so filthy that one inspector was able to write the initials “DOH” in the dust with an alcohol swab. The pharmacy, the inspectors wrote, was not conducting tests for sterility or for endotoxin contamination of their products. One report from the Florida Department of Health said employees were washing their hands in a bucket in lieu of a working sink. Compounding pharmacies are often used by veterinarians to provide a form of medication that’s commercially unavailable by changing the route of administration (like making an oral paste version of a drug that’s typically injected), adding flavoring, or producing a drug during a manufacturing shortage. Many humans and animals use compounded drugs without incident, but some pharmacies have made headlines in recent years for recurring neglect or making drugs outside the bounds of federal law. In February 2016, the Florida Department of Health filed a report calling for an emergency restriction on Mangini’s license to operate the pharmacy. Their December inspection convinced them that Mangini had failed in his capacity as the pharmacy’s Prescription Department Manager. Not only had he overseen the shoddy conditions, but he was in charge while the pharmacy compounded an illegal omeprazole drug called UlcerRX using ingredients labeled “not for drug, household or other uses.” The department also alleged he failed to keep a proper audit trail of drugs like furosemide, sildenafil, Procrit, Aranesp, among other substances. Weeks later, Mangini, a longtime owner in both the Standardbred and Thoroughbred racing worlds, voluntarily surrendered Ergogenic’s Special P/E license, which allowed sterile compounding at the facility, to avoid further sanctions from the Florida Board of Pharmacy. Among other items in the agreement Mangini signed was a promise that Ergogenic would never reapply for a Special P/E license in Florida, and that Ergogenic “agrees to voluntarily cease operating as a pharmacy immediately upon executing this Voluntary Relinquishment.” During Kentucky Derby week in 2016, Kentucky Horse Racing Commission officials received a report that a non- veterinarian representing Ergogenic was on the backstretch at Churchill Downs, hoping to interest trainers in purchasing a compounded ulcer medication, allegedly without requiring them to obtain a prescription. Despite the filthy conditions described in reports to the Florida Department of Health after the December inspection, Ergogenic Labs remained in operation for months. In March 2020, Mangini was one of 27 people indicted by the Federal Bureau of Investigation connected to an alleged equine doping ring that included trainers Jason Servis and Jorge Navarro. Horsemen may want to consider themselves their own best get on BOARD DES | 859.509.2106 MARK | 859.421.0151 BRIAN | 859.519.6477 THE BREEDERS' FARM PAID BOARDING UP TO 30 DAYS on all new bookings to $15,000-or-under stallions. .COM SPECIAL 2YO SALE March 18, 2020
Transcript
Know What You’re Buying:The Messy World Of Compounding Pharmacies
By Natalie Voss
Continued on Page 5
From Dec. 28 to Dec 30, 2015, inspectors from Florida’s Department of Health observed business at Ergogenic Labs in Wellington, Fla., where pharmacist Scott Mangini oversaw the compounding of human and animal drugs. The inspectors were not happy with what they found.
In a subsequent report dated Jan. 5, 2016, they “noted serious deficiencies of state and federal law,” including “filthy conditions in the pharmacy’s clean room,” mislabeled or unidentified drugs on the shelves, and several substances in bottles labeled “Not intended for humans or animals” and “Not for Drug, Household, or Other Uses.” The floor of the pharmacy was so filthy that one inspector was able to write the initials “DOH” in the dust with an alcohol swab. The pharmacy, the inspectors wrote, was not conducting tests for sterility or for endotoxin contamination of their products. One report from the Florida Department of Health said employees were washing their hands in a bucket in lieu of a working sink.
Compounding pharmacies are often used by veterinarians to provide a form of medication that’s commercially unavailable by changing the route of administration (like making an oral paste version of a drug that’s typically injected), adding flavoring, or producing a drug during a manufacturing shortage. Many humans and animals use compounded drugs without incident, but some pharmacies have made headlines in recent years for recurring neglect or making drugs outside the bounds of federal law.
In February 2016, the Florida Department of Health filed a report calling for an emergency restriction on Mangini’s license to operate the pharmacy. Their December inspection convinced them that Mangini had failed in his capacity as the pharmacy’s Prescription Department Manager. Not only had he overseen the shoddy conditions, but he was in charge while the pharmacy compounded an illegal omeprazole drug called UlcerRX using ingredients labeled “not for drug, household or other uses.” The department also alleged he failed to keep a proper audit trail of drugs like furosemide, sildenafil, Procrit, Aranesp, among other substances.
Weeks later, Mangini, a longtime owner in both the Standardbred and Thoroughbred racing worlds, voluntarily surrendered Ergogenic’s Special P/E license, which allowed sterile compounding at the facility, to avoid further sanctions from the Florida Board of Pharmacy. Among other items in the agreement Mangini signed was a promise that Ergogenic would never reapply for a Special P/E license in Florida, and that Ergogenic “agrees to voluntarily cease operating as a pharmacy immediately upon executing this Voluntary Relinquishment.”
During Kentucky Derby week in 2016, Kentucky Horse Racing Commission officials received a report that a non-veterinarian representing Ergogenic was on the backstretch at Churchill Downs, hoping to interest trainers in purchasing a compounded ulcer medication, allegedly without requiring them to obtain a prescription.
Despite the filthy conditions described in reports to the Florida Department of Health after the December inspection, Ergogenic Labs remained in operation for months.
In March 2020, Mangini was one of 27 people indicted by the Federal Bureau of Investigation connected to an alleged equine doping ring that included trainers Jason Servis and Jorge Navarro.
Horsemen may want to consider themselves their own best
g e t o n B O A R D
DES | 859.509.2106 MARK | 859.421.0151 BRIAN | 859.519.6477
T H E B R E E D E R S ' F A R M
PAID BOARDING UP TO 30 DAYS on all new bookings to $15,000-or-under stallions.
Veterinarians at Rood and Riddle Equine Hospital answer your questions about sales and healthcare of Thoroughbred auction yearlings, weanlings, 2-year-olds and breeding stock.
Email us at [email protected] if you have a question for a veterinarian.
QUESTION: Since some veterinarians and farms use different types of vaccines, is it a problem to buy an individual and start it on another type? DR. KEVIN HYDE: The short answer to this question is no. In this day and age, vaccines from all of the major pharmaceutical companies have a significant amount of research behind them and do a good job of protecting our horses from the diseases they were created against.
Is there one vaccine that is slightly more effective than another? Maybe. But if you feel comfortable with one brand or line of vaccine than another and it has done a good job on your farm, there is no reason you can’t switch a new horse over to the brand you are comfortable with. In an ideal world, we would always get the complete vaccine history from the previous owner and could just continue giving the same vaccine without missing a beat. Unfortunately, more times than not, we don’t get a complete history and there can be questions about how well the horse has actually been vaccinated. In these cases, we should probably treat the horse as if it has never been vaccinated. We should begin vaccinating with the initial series recommended by the manufacturer to ensure that an adequate immune response is initiated to protect our new horse. After that the new horse can be placed on the routine vaccine schedule you have put together with your veterinarian for your particular farm. Even if we know the vaccine history and still decide to switch to a vaccine we are more comfortable with, we should use the recommended initial series for that vaccine. This is to ensure that the levels of protective immunity are reached for that specific vaccine. Because each vaccine works slightly differently to create an immune response, the full recommended series may be needed to get to the levels of immunity to be protective. Sales and long-distance transport can be very stressful for a horse. Stressful events such as this can reduce a horse’s immune response. It’s important to vaccinate
Dr. Hyde
PRS
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early enough to give the horse’s body adequate time to build up protective immunity prior to the sale. If buying a horse from a sale, we need to realize that their protective levels may have been lower during that “stressful” event and treat the new horse accordingly. This includes effective biosecurity measures and herd health practices to protect all of the horses on the farm. Remember, no vaccine is perfect and can’t be guaranteed to prevent 100 percent of infections. But by following the manufacturer’s guidelines, under the direction of our veterinarians, we will have the best chance for success.
Dr. Hyde graduated from the Washington State University School of Veterinary Medicine in 2005. He completed an internship at Rood and Riddle Equine Hospital in 2006 and then became an associate with the practice for five years. Dr. Hyde became a shareholder at Rood and Riddle at the beginning of 2019.
QUESTION: Which horse has taught you the most about life?
CATHERINE PARKE: Heartlight No. One, Burt Bacharach’s champion 3-year-old filly. She had a fractured pelvis when she came from the track and she colicked once a week for her entire life. I literally lived with her for 10 years. She had three surgeries, lots of banamine, and at that point, I realized how much I really loved horses.
She lived to be 18, and she was a wonderful horse, but she would tell me when she was going to colic. I know that
sounds corny, but she’d scream and holler, and I’d rush and get the banamine. I’d rush and give that to her, and then walk her. She taught me more about horses than anybody.
I had a radio sensor from Australia on her, and when she’d lay down for five seconds, I had a beeper and it would beep me, so if it was 3 a.m. and she laid down for that long, it would send this radio signal off and I’d go rushing to the barn. I was 27 years old and I didn’t have a year-round nightwatchman. I couldn’t afford one, so I was the year-round nightwatchman, but it was worth it.
She was a brilliant, brilliant racehorse and a beautiful mare. He pelvis was fractured, so her hind gut was compromised, circulatory-wise, so she colicked a lot. She wouldn’t have lived two years, but I lived with her literally for a very long time, and I don’t regret it at all. I was with her 24/7 pretty much her entire life, and it made me realize that I really love horses and wanted to do this. It never occurred to me I couldn’t do it. PRS
Heartlight No. One
LESSON HORSESCatherine Parke Of Valkyre Stud On Heartlight No. One
By Joe Nevills
KEENELAND LIBRARY THOROUGHBRED TIMES COLLECTION
HEARTLIGHT NO. ONE1980 (Rock Talk x Icantell, by Tell)
A homebred for musician Burt Bacharach, Heartlight No. One raced for one season, but she made it count, winning five of seven starts to clinch champion 3-year-old filly honors in 1983. She notched wins in the G1 Hollywood Oaks and G2 Del Mar Oaks, and beat older competition in the G1 Ruffian Handicap before her career ended due to injury.
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protection against using dangerous compounds on horses. Fortunately, experts say there are a few things consumers can do to determine whether the pharmacy they’re buying from is operating according to acceptable standards.
Many horsemen purchase drugs from compounders in an effort to save money, but Dr. Dionne Benson, former executive director of the Racing Medication and Testing Consortium and now chief veterinary officer at The Stronach Group, said price should be a big “tell”—particularly if the drug you’re buying claims to combine two commonly-used remedies for the same problem, like omeprazole and ranitidine, which both treat gastric ulcers.
“True compounded medications [that are combinations] should cost more than either medication [on its own] because you should be using two FDA-approved medications,” said Benson. “It’s not so concerning with omeprazole and ranitidine, but with some drugs we don’t know how they play together. They could turn into battery acid, they could make one much stronger, they could make one much weaker, they could cancel each other out and you could be doing nothing.”
The reason FDA-approved versions of drugs are more expensive isn’t price gouging; it’s because the testing process for a new animal drug takes years and tens of thousands of dollars. It also requires regular testing for the sterility of the ingredients and the consistency of the resulting product. Without that, Benson said, trainers and horsemen are running the risk of incurring a drug overage or even worse, poisoning their horse with an incorrectly-formulated compound.
A study from the Minnesota Racing Commission found compounded triamcinolone acetate (used for osteoarthritis) that was labeled at a strength of 6 mg/ml but contained only .00828 mg/ml. A study from the University of California-Davis compared compounded formulations of the bronchodilator clenbuterol and found one as high as ten times its labeled concentration, which could be enough to kill a horse.
A close look at the label of a compounded product could also tell a lay person whether the drug has been put together thoughtfully. Authorized medication (including compounds) will have a national identification number (some drugs have NADA numbers, others ADA, NBC, or ANADA) that should correspond to the ingredients inside the drug’s packaging. The FDA also maintains an online “green book” that contains authorized producers of prescription drugs such as phenylbutazone (including generics).
“When you don’t see those, that’s when you should get a little concerned,” said Benson.
Insiders suggest that seals of approval from many private organizations professing to certify a pharmacy’s quality are less meaningful than they were a few years ago. The possible exception to this is Verified Internet Pharmacy Practice Sites (VIPPS), which is an arm of the National Association of Boards of Pharmacy.
A version of this feature was originally published in 2016. Read the full extended version on PaulickReport.com
Second-Crop Sire RoundupSecond Crop Of 2-Year-Olds At OBS March
By Joe Nevills
Stallions whose second crops of 2-year-olds are represented in the Ocala Breeders’ Sales Co. March Sale of 2-Year-Olds In Training, including the number of horses cataloged and the farm where the stallion is currently advertised.
