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TM Safely Save Money on Horse Drugs Not all horse medicines are created equally. W hen your horse becomes sick, the bills begin to pile up. The veterinary fees are bad enough, but you understand that there’s equipment to pay for and support staff to be paid. But what about the drugs? What if your horse must take a drug for the rest of his life? Is there a way to save money? And can you use “old drugs”? Old Drugs I’ve had clients hand me a dusty old bottle of medicine and ask, “Is this any good?” Here’s the thing: An expired product might be ineffective, or worse, could be unsafe. Be wary of anything contaminated by hair, dirt or even your hand. Drugs and chemicals can become toxic with time, so if you’re not sure, ask your veterinarian and provide specific information as the name of the drug, how you stored it and its expiration date. Products not stored according to label instructions, such as “Store between 20° and 25° C (68° to 77° F). Protect from excessive moisture.” That means, if you’ve kept in your unheated tack room all winter long, you’ve probably ruined the medication. See story on shelf life of barn products, too. Generic Drugs A generic drug is the same chemical produced under the same rigorous FDA standards as the original drug. Generics are safe, and they can save you money. A prime example is bute. There are hundreds of manufacturers, but all of the bute tablets are the same. We found prices ranging from $15.99 to $22.99 for 100 tablets. However, not all drugs, i.e. Adequan, have generics. The patent remains in place long enough to allow the original manufacturer to recoup the costs of researching and marketing the original drug. That’s one of the reasons you see advertising telling you, “There is no generic Adequan.” There is no FDA-approved generic Adequan. (Adequan is a Horse Journal recommended drug because it works. It may even save you money over oral nutraceuticals.) Compounded Drugs Compounded drugs lack FDA approval and aren’t necessarily made under the same rigorous standards set forth for new and generic drugs. Mixing two injectable drugs is compounding. Creating an oral liquid from crushed tablets is compounding. Even adding apple flavoring to a commercially available drug is compounding. Usually, this is done to meet the needs of a particular patient, such as making a specific concentration to meet an individual animal’s needs. Because the regulations regarding compounding drugs allow for quite a bit of latitude, people assert that their use is dangerous. Our chart shows you the risks associated with compounded medications vs. FDA-approved drugs. One of the biggest issues is that you can’t be certain that the drug you’re What You Can Do To Protect Your Horse Until the FDA can regulate compounding pharmacies, here are some questions you can use to help ensure your horse’s safety: Ask Your Veterinarian: 1. Is this a new, generic or compounded drug? 2. If it’s compounded, which pharmacy made it? (An Internet You may surprise your vet with these quessearch can tell you about the tions, but they’re well worth asking. pharmacy.) 3. What is the expiration date of the drug? (You may be shocked at how many drugs are expired when a veterinarian hands them to you.) 4. Are there any new or generic drug options? Ask The Compounding Pharmacy: 1. Is this drug compounded from FDA-approved commercial drugs or is it compounded from bulk ingredients? (Bulk ingredients are often from developing countries and packaged and transported with little adherence to standards; ask where they came from.) 2. How are your expiration dates determined? (Expiration dates are obtained from compounded-drug stability data when available or are calculated using criteria from U.S. Pharmacopoeia.) Signs of Compounded Drug Instability Liquid-Dose Forms Color change (pink or amber) Signs of microbial growth Cloudiness, haze, flocculent or film formation Separation of phases, e.g. oil and water emulsion Precipitation, clumping, crystal formation Droplets of fog forming on inside of container Gas or odor release Swelling of container Solid-Dose Forms Odor (sulfur or vinegar odor) Excessive powder or crumbling Cracks or chips in tablets Swelling of tablets or capsules Sticking together of capsules or tablets Tacky-feel of covering of tablets or capsules Article from Horse Journal Online - www. horse-journal.com - Copyright ©2014 TM giving has in it what the label indicates. Current federal law does allow compounding pharmacies to mix drugs, but only under certain circumstances, such as: • There must be no other FDAapproved commercially available drug that is made to specifically treat the problem at hand. • The compounded drug must be made from FDA-approved ingredient drugs. • It must be safe and effective. • All labeling must conform to federal regulations. Be aware that, by adding other chemicals or flavorings or by interfering with protective coatings of tablets, a compounder may interfere with the drug stability, thereby decreasing its potency. This in turn compromises the drug’s ability to be absorbed into the body, which consequently reduces its efficacy. For example, research found compounded oral omeprazole (aka GastroGard and UlcerGard) wasn’t as effective for treating equine ulcers as the commercially available FDA-approved form of the drug from Pfizer. The study showed the systemic absorption of the compounded formulation was lower than for the real (FDA-approved) product. BOTTOM LINE. Work with your veterinarian on drug costs. If you can find the same drug elsewhere, your veterinarian will likely give you the prescription you need. Article by Contributing Veterinary Editor Grant Miller DVM. Regulations: New and Generic Drugs vs. Compounded Drugs Requirement Benefit to the consumer FDA-Approved New or Generic Drug Compounded Drug FDA Approval Independent FDA verification of manufacturers drug claims YES NO Tested in target animal species in both laboratory and field trials Scientific demonstration of the drug’s safety and efficacy YES NO Manufactured according to current Good Manufacturing Practices (cGMPs) Ensures that each drug unit is manufactured within specification for therapeutic consistency YES NO Ongoing stability testing of drugs Ensures that drug shelf life matches labeled expiration date YES NO Labels approved by the FDA Means that everything written on the label is scientifically substantiated YES NO Advertising/ Promotional material reviewed by the FDA Means nothing is false or misleading about the drug advertisements YES NO Adverse effects / Lack of efficacy reported to FDA Permits unanticipated yet significant post-marketing experiences to be communicated back to the veterinarian/ FDA authority YES NO Analytical testing of product prior to release for: Strength Identity Purity Ensures that the drug contains what is represented on the label YES YES YES NO NO NO Patient-specific dosing on manufacturer label Provides a greater chance that the patient will get the correct dose each time NO YES Modified dosage form, concentration or route of administration Provides more versatile use of the medication NO YES Flavor added Provides a greater chance that the animal will ingest the medication NO YES Article from Horse Journal Online - www. horse-journal.com - Copyright ©2014
