Compounded Sclerosing Agents: Risks and Consequences

by Kenneth J. McKenna, Esq.

For decades, patients have sought medical treatment for unsightly and sometimes painful varicose and spider veins. One common procedure to treat this type of venous disease is sclerotherapy: the injection of a sterile agent into the affected vein, which in response, collapses and is reabsorbed. Beginning in the mid-20th century, most physicians in the U.S. used FDA-approved Sotradecol® (sodium tetradecyl sulfate) manufactured by Elkins-Sinn, Inc. as a sclerosant to eradicate such veins. When Elkins-Sinn pulled Sotradecol® from the U.S. market in 2000, physicians began to look elsewhere for sclerosing agents, including domestic and foreign compounding pharmacies. Although Sotradecol® once again received FDA approval in 2004 and returned to the market through a joint venture between Bioniche Pharma Group, Ltd. and AngioDynamics, Inc., many physicians continue to purchase non-FDA-approved sodium tetradecyl sulfate and polidocanol from compounding pharmacies. However, there can be grave liability risks and legal consequences associated with physician use of compounded sclerosing agents.

In concept, compounding pharmacies exist to allow pharmacists to combine, mix or alter ingredients to create unique medications that meet the particular needs of individual patients. According to the FDA, it is “. . . a practice that is under FDA scrutiny - mainly because of instances where compounded drugs have endangered public health.”1 Much of the criticism directed at compounding pharmacies has focused on the fact that pharmacy compounding has evolved from a patient specific practice to a global, mass production industry that consciously avoids the scrutiny of government oversight. It is one thing to compound a medication to account for a patient allergy or to provide a safe dose for a child, yet it is something altogether different to mass produce and distribute a product such as sodium tetradecyl sulfate to physicians around the country. The simple fact that compounded products have not been subjected to FDA testing to determine their safety and effectiveness places those physicians who choose to use these products at significant risk of legal liability in the event of an adverse outcome.

It is important to acknowledge that there are certainly legitimate reasons for physicians to utilize compounded agents in their day to day practice. For example, a physician may have a genuine clinical preference for a compounded version of an agent versus the commercially available, FDA-approved alternative. However, it must also be acknowledged that many physicians choose to utilize compounded agents in lieu of FDA-approved agents for a fundamental reason wholly unrelated to product performance or patient safety. That reason is money. All things equal, a compounded agent will generally cost less than its FDA-approved equivalent. As a result, a cost-conscious physician may elect to utilize a compounded agent in an effort to reduce overhead and increase their profit margin.

A physician utilizing an FDA-approved agent can proceed with the comfort of knowing that the product was manufactured according to pharmaceutical grade standards and was subject to FDA’s testing and approval process. To the contrary, a physician utilizing a compounded agent has no such assurances. Because compounding pharmacies are not FDA-regulated, the products they provide are not nearly as consistent or reliable. At worst, compounded products can be contaminated and cause devastating consequences for the patients to whom they are administered. The FDA’s files are replete [A1]with reports of compounding nightmares, ranging from patient deaths due to the use of contaminated compounded solutions during heart surgery, to blindness from contaminated products used during cateract surgery. Even compounded products free from contamination can pose serious danger to the consumer. In many cases the potency or concentration of the drug is inconsistent with product labeling, leading to inappropriate dosing and sometimes serious adverse events. In several well-publicized cases around the country, patients have been injured or killed by improperly mixed agents resulting in toxic doses many times more potent than their labeling indicated.

When a patient experiences an adverse outcome from a medical procedure, there is always a risk the patient will take legal action against the physician or facility that provided the care. In evaluating medical negligence claims an attorney must identify the medical cause of the injury before going forward with a claim against the healthcare provider. If the medical cause of the injury is a commercially available FDA-approved product, the target of the claim will usually shift to the manufacturer of the product. On the other hand, if the medical cause of the injury is a compounded agent, the compounding pharmacy may not have sufficient insurance in place to cover malpractice claims. If this is the case, then the malpractice claim will fall upon the physician and facility that utilized the compounded agent. The patient’s attorney will invariably attempt to determine why the compounded agent was utilized and whether an FDA-approved alternative was available to the healthcare provider.

Accordingly, any physician who is utilizing or is considering utilizing a compounded agent should closely consider the following questions:

1. Why did you utilize a non-FDA-approved product when one is available?
2. Where and when was the agent compounded?
3. What steps did you take to ensure that the compounded agent you used was manufactured in an FDA-registered facility?[A2]
4. Do you purchase the agent in bulk? If so, how is it stored and what steps do you take to ensure dosage consistency?
5. How did you test the compounded agent to ensure that it was safe? Do you test each batch?
6. Have you ever visited the compounding pharmacy?
7. Where does the compounding pharmacy acquire its raw materials? Are they all pharmaceutical grade?
8. Do you use compounded agents to increase profit?

After considering the foregoing questions, most reasonable physicians will conclude that they should utilize FDA-approved agents whenever possible or risk exposure to a malpractice claim from a patient injured by a compounded agent. The decision to reduce office expenses in lieu of patient safety will often prove to be devastating to the physician.

In today’s medical-legal environment, all physicians should strongly consider the potential moral and legal consequences of utilizing compounded agents. At a minimum, a physician committed to the use of compounded agents must be able to medically justify the use of the compounded agent and ensure that the compounding pharmacy complies with all applicable state and FDA regulations[A3].1 “The Special Risks of Pharmacy Compounding”, FDA Consumer Health Information Bulletin, May 31, 2007.[A1]There is no adverse reporting requirement for compounded products, so in fact FDA’s records of adverse events associated with compounding are minimal. We’ve learned of most of the cases through litigation or through the press. Setting up an adverse event reporting requirement at FDA is actually one of our top priorities, so I don’t want to give the wrong impression here.

[A2]Pharmacies are not regulated by FDA at all, so there are no “FDA-registered” compounding pharmacies [A3]Since pharmacies aren’t FDA-regulated, a compounding pharmacy cannot be in compliance with FDA regulations. FDA has issued compliance guidelines for when they will exercise their enforcement discretion against compounders, but technically there are no FDA regulations that cover compounding pharmacies.