Compounded Drugs, What Does this Mean?

Drug compounding is a process to "produce a medication by combining or altering ingredients for the special needs of a patient". As stated in the AAEP Horse Health Article of June 2009, Your Horse's Life is Not Worth the Risk: What every horse owner should know about drug compounding; "Because there is a scarcity of approved medications for use in horses, there is a legitimate need for compounding in equine veterinary medicine. Some examples of legitimate compounding would include crushing a tablet and creating a paste or gel to aid in the administration to the patient or mixing two anesthetics in the same syringe for use in your horse."

Further this article states the American Association of Equine Practitioners (AAEP) position statement on this topic. "The AAEP acknowledges that reputable pharmacies produce legitimate compounded drugs to improve the health of horses when an FDA-approved option doesn't exist. However, when inappropriately compounded and used, these drugs may pose a serious threat to the health of your horse. Knowing the facts about legitimate and illegitimate compounded drugs will help you and your veterinarian decide on the best treatment option for your horse." For the full article refer to the reprint in the OWEC Newsletter, July 2009 issue or search for it on www.aaep.org.

The topic of compounded drugs often sparks much debate. From near conspiracy-theorists who feel that all drug companies are bad and are out to gouge consumers for profit only, to those who are trying to find cheaper or more palatable or easily administered drug options for their horse and everything in between. Bottom line, our horses depend on us to make the safest and best choices for their health and welfare. If a cheaper alternative does not work or is unsafe, have we saved any money? Have we done our best or even an "OK" job by our horse?

As many will remember, in April of 2009, 21 polo ponies were the tragic victims of inappropriately compounded medication given to them by their trainers or caretakers that resulted in sudden death. Several horses in Louisiana in 2006 suffered a similar fate. These are very dramatic examples of the worst consequence. The problem is, when do we know when a compounded product we have ordered (and sent payment) from a source we thought to be reputable is unsafe or ineffective?

Whenever possible, if an FDA-approved drug is available for medicating our horses, our horses depend on us to use them. The FDA-approval process assures the product is safe and effective for its intended use, but also the methods, facilities and controls used for the production of the drug meet FDA Standards to preserve it's identity, strength, quality, purity, and consistency from batch to batch. The FDA-approval process is a very expensive one and those manufacturers who have complied with this process and been granted approval have invested much time and expense to provide the product. As well, if problems are noted we have someone to go to seek solutions or recompense when adverse effects are noted. Compounders' products are unregulated by the government and not subject to the same standards for consumer protection or accountability.

What's All the Fuss About Polyglan? by Dr. Laura Fontana

Polyglcan is a commercially available patented formulation that is labeled for post-surgical joint lavage and joint fluid replacement. This solution is comprised of 3 fractions: hyaluronic acid, sodium chondroitin sulfate, and N-acetyl-D-glucosamine. These 3 fractions are all naturally occurring components of synovia and are instrumental in maintaining joint health. Before discussing the efficacy of this compound, let's review the specific function and independent use of these 3 constituents. Hyaluronan (hyaluronic acid or HA) is a normal joint fluid and cartilage constituent with anti-inflammatory effects as well as joint lubrication and protection properties (1). In equine practice, intra-articular and intravenous administration of HA (Legend) is commonly employed for the treatment of synovitis and osteoarthritis, and intravenous Legend is also used prophylactically. In fact, Legend is the only FDA-approved joint therapy labeled for both intravenous and intra-articular treatment of non-infectious synovitis. Chondroitin sulfate belongs to a class known as polysulfated glycosaminoglycans (PSGAGs), which are an important element of the extracellular matrix of articular (joint) cartilage. Included in this class is Adequan, which is made from cow lung and trachea extracts primarily containing chondroitin sulfate. Adequan and other drugs in this class have been referred to as chondroprotective, or more recently, as slow-acting disease modifying osteoarthritic drugs (SAMOAD) intended to preclude, slow, or revers the cartilaginous lesion of OA (2). Adequan is used intramuscularly, and like HA (Legend), it is also used intra-articularly in equine practice. Glucosamine is a precursor to the disaccharides (sugars) found in aggregan, a molecule that comprises a substantial portion of the extracellular cartilage matrix. Many equine oral joint supplements contain glucosamine as well as chondroitin. The objective of combining hyaluronic acid, chondroitin sulfate, and glucosamine (as Polyglycan), all of which have long been administered independently by a variety of methods, is to create a safe and efficacious product for intravenous and intra-articular use in horse to promote joint health. But, is this combination effective? Frisbie et al (2009) (3) conducted a study to assess intravenous and intra-articular Polyglycan for the treatment of osteoarthritis in horses. The authors concluded that intra-articular Polyglycan (when given once every 7 days for a total of 4 treatments) significantly improved lameness and disease progression in horses, as evidenced by improved lameness scores, decreased radiographic evidence of osteoarthritis, and improved cartilage. In contrast, the intravenous Polyglycan treated horses (which received a dose every 5th day for a total of 14 treatments) showed no improvement in lameness scores and increased radiographic evidence of osteoarthritis. These findings do not support intravenous use of Polyglycan, and suggest that intravenous use may in fact be counterproductive. At this time, and until more studies are performed, continued use of FDA-approved products labeled for intravenous and intra-articular treatment of osteoarthritis is indicated. (1) Frisbie DD, Kawcak CE, McIlwraith CW, et al. Evaluation of polysulfated glycosaminoglycan or sodium hualuronan administered intra-articularly for treatment of horses with experimentally induced osteoarthritis. Am J Vet Res 2009; 70:203 - 209. (2) Section XII, Musculoskeletal System in Equine Surgery 3rd edition. 2005. Jorg Auer and John Stick eds. WB Saunders. Pp 1055 - 73. (3) Frisbie DD, Kawcak CE, McIlwraith CW, Werpy MW. Assessment of intravenous or intra-articular hyaluronic acid, condroitin sulfate and N-acetyl-D-glucosamine in treatment of osteoarthritis using an equine experimental model. Presented at : 55th Annual AAEP Convention; Decemeber 5 - 9: Las Vegas, NV.

Why do we do Coggins' tests each year?

As of March 2, 2011, an updated regulation will take effect regarding the Coggins' test for Equine Infectious Anemia in Virginia. The Virginia Department of Agriculture and Consumer Services (VDACS) has updated the regulation and specifies that "all horses assembled at a show, fair, race meet or other such function or participating in any activity on properties where horses belonging to different owners may come into contact with each other in Virginia must be accompanied by a report of an official negative test for Equine Infectious Anemia". This update further defines what "when horses are assembled" means. Assembly of horses for a trail ride on public property such as a state park is an example of an activity requiring horse owners to have a valid Coggins report with them.

Starting March 2, rangers in state and national parks may check for Coggins' papers and owners without valid test reports could be charged with a Class I Misdemeanor and asked to leave the park. As is currently the case under existing regulations, owners presenting fraudulent paperwork can be charged with civil penalties as well.

The Coggins' test is laboratory test for the disease Equine Infectious Anemia(EIA). EIA is a very contagious (infectious) and possibly fatal disease that affects any species of equines (horses, donkey, mules, etc). It is caused by a virus, a type classified as a retrovirus. There is no vaccine or treatment for the disease. EIA is a blood-borne infection and can be transmitted from horse to horse by large biting insects (horse flies, deer flies) or from blood-contaminated materials.

There are three clinical forms of the disease: Acute, Chronic, and Inapparent. In the Acute form, if a horse is exposed the the EIA virus, they can develop severe signs (fever) of the disease and die within 2 - 3 weeks. In more mildly affected horses, there may an initial fever that resolves and the horse recovers without further symptoms but if this horse is then interacting with other horses, it may act as a potential source of infection for any horse living in its vicinity. There may be no indication at all of the disease until picked up by a routine annual Coggins' test.

In the Chronic form, the horse survives the acute bout of the disease and may develop recurring bouts of illness. Symptoms of this illness may include moderate to high fevers (105 F), petechial hemorrhages (pin point blood spots on mucous membranes or gums), depression/lethargy, weight loss, edema in limbs or underbody surfaces such as the chest or belly, and anemia.

In the Inapparent form, the horse carries the disease with no signs or symptoms of illness. However, they serve as "resevoirs" of infection. The majority of horses positive for EIA are in this category. These horses are carriers for life and the infection may become chronic or acute when under stress from hard work, transportation stress, or when dealing with another illness. Inapparent carriers have lower concentrations of the EIA virus in the bloodstream than horses with active clinical signs of EIA. It is said that only 1 horse fly out of 6 million is likely to pick up and transmit the virus from such horses.

Prevention of EIA is centered around identifying carriers and affected individuals and removing them from contact with other horses. When an equine has a positive result on an official test for EIA, the animal is placed under quarantine. Confirmation testing is initiated and the quarantine from other horses is in order to prevent further exposure and possible transmission of the disease. All exposed horses within 200 yards of the location of the "positive horse" must also be placed under quarantine. The quarantined area and horses are monitored by federal or state regulatory personnel. For more information on EIA Uniform Methods and Rules to implement and conduct a national control program for EIA formulated by APHIS-VS, go to http://ww.aphis.usda.gov/vs/nahps/equine/eia or contact an area APHIS - VS office.

"Equine Infectious Anemia is a serious disease," said Dr. Richard Wilkes, VDACS State Veterinarian. "It affects all members of the equine species and is found in nearly every country of the world. All infected horses, even those that are asympotmatic, become carriers and are infectious for life. Infected animals must either be destroyed or remain permanently isolated from other equines to prevent transmission. The change in regulation is not drastic, but it is important and horse owners need to take seriously the need for a valid Coggins test each year prior to anny assemblage with other equines."