LEGAL USE OF POLIDOCANOL AND SODIUM TETRADECYL SULPHATE FOR SCLEROTHERAPY

            Many have asked about use of sclerosants and which are FDA approved. The FDA does not yet approve Polidocanol nor Sodium Tetradecyl Sulfate manufactured by any pharmaceutical company. However use of both are legal as they were granfathered in many years ago. In order that polidocanol or sodium tetradecyl sulphate can be used for sclerotherapy, the following generalities are acceptable.
  1. The State licensed compounding pharmacy that makes up the polidocanol or sodium tetradecyl sulfate and the clinicians who use it must have a working relationship. It is best if a letter establishes this relationship but this is not mandatory.
  2. It is recommended that the compounding pharmacy be located in the state in which the polidocanol or sodium tetradecyl sulfate is to be used. This is desirable but not essential. If the compounded polidocanol or sodium tetradecyl sulfate does not cross state lines, it is not necessarily subject to United States Food and Drug Administration regulation but is subject to state regulation.
  3. Although ideally a prescription should be filed with the compounding pharmacy for each individual who is to receive Polidocanol or sodium tetradecyl sulfate, in fact the compounding is a multi-step event. The last step of the compounding can be the dilution of the agent specifically for the patient in the physician's office as ordered and documented in the patient's chart. Therefore, polidocanol or sodium tetradecyl sulfate for dilution and subsequent use can be supplied without a specific prescription for a particular patient.
  4. The polidocanol or sodium tetradecyl sulfate can be used as liquid or foam, although it is recognized that using the liquid solution as a foam does constitute "off label" use.
  5. The importation of any drug that has not been approved by the United States Food and Drug Administration is illegal.
  6. It is illegal and is a Federal Crime to use any imported drug or substance on a Medicare Patient that has not been approved by the United States Food and Drug Administration.
These statements are based upon recommendations given by Jur Strobos, MD, Esq. legal counsel to the American College of Phlebology, from the firm of Olsson, Frank and Weeda, PC, 1400 16th St. NW - Suite 400, Washington, DC 20036.    
These generalizations were prepared because the United States Food and Drug Administration (FDA) has not approved for importation to the United States the Kreussler Pharmaceuticals, Omega Labs and STD Pharmaceuticals' polidocanol and sodium tetradecyl sulfate. This is true even though these are the major suppliers of these agents. It is felt that adherence to these statements, mostly derived from the FDA website, will minimize the chance for legal action to be taken and that polidocanol or sodium tetradecyl sulfate can be used as desired by physicians who are performing sclerotherapy.

NEW DISCOVERIES

In today's medical climate, there are many new discoveries and procedures that come to the surface every day. It is the duty of the physicians at the Vein Institute of La Jolla to select those procedures which have the most promise and then verify their utility in the experience obtained by others. The physicians at the Vein Institute do not want to be the first with every new procedure but instead wish to be informed as developments progress. Many procedures do not succeed after their first applications and those are to be avoided. Others succeed immediately and can be recognized as truly new, practical developments. Among these are the following:

CASTING LIGHT ON INJECTION TREATMENT

For a long time, it has been recognized that high-pressure veins deeper under the skin are actually feeding skin blemishes, spider veins, and thread veins. These are flat, blue-green veins that are in close relationship to the skin blemishes. Now, very bright Halogen light transmitted through fiber optics can be applied directly to the skin. This bright light shows very clearly the veins under the skin that are the cause of the skin blemishes. The light extends the observation powers of the physician doing the treatment. Using the bright light as a guide, injections can be made directly into the feeding vein, thus providing more effective and even permanent treatment for skin blemishes.
The technique decreases the number of injections necessary and appears to be more durable than current techniques. This new method goes by the tongue-twisting name of transillumination sclerotherapy. Despite the name, the bright light considerably improves the pre-treatment physical examination, makes the diagnosis more accurate, and directs therapy. Naturally, there are no side effects of the transillumination and, in fact, it is interesting for patients to view the underlying veins. Although the veins are usually invisible, they can be seen clearly with the aid of the Halogen light.
This new noninvasive, painless technique may change the old time-honored injection sclerotherapy and make it better.

LASER LIGHT INSTEAD OF SAPHENOUS STRIPPING

Vein stripping continues to be an unpopular term, both for physicians and for patients who have heard of the vein stripping operation. In its most precise term, vein stripping means removal of a vein from the circulation and that can be achieved by various techniques, none of which remove the vein from the body. The radio frequency VNUS Closure® system has proven itself as a practical substitute for saphenous vein stripping (removal). Now, the use of electromagnetic waves in a slightly different spectrum allows destruction of the saphenous vein from within by the use of laser light. It is effective in destroying the saphenous vein and removing it from the circulation. This event is mainly done with large amounts of local anesthetic although it can be done with the patient lightly asleep. The use of laser light delivered by quartz fiber is used as a two part procedure. The second part is closure of the varicose veins with sclerosant foam.

SCLEROSANT FOAM

For nearly half a century, destruction of spider veins and some varicose veins by injection treatment has been standard practice. The technique uses various liquids, all of which cause destruction of the treated veins. Gradually, it has become recognized that making the solution into a foam increases the effectiveness of the treatment. It is possible now to create foam within a syringe and use this in treatment of small varicose veins and spider veins. This technique minimizes the number of repeat injections and makes each treatment much more efficient. This is achieved without increasing discomfort or dangers of the procedure. In proper circumstances, the use of sclerosant foam appears to be a truly new development which is worthy of pursuing.
That statement was written 20 months ago. Now, foam injections, properly monitored with ultrasound have replaced surgery for a very significant number of people. While not every one can be treated with foam, a large number can be. Avoiding surgery yet giving equivalent care is very satisfying.
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This site is a general overview of common venous problems and is not intended as a substitute for professional medical care.