Risk Management

Message from the Chairman discusses FDA and Allergan’s Trivaris drug

I have often used this Message to point out the many services OMIC provides to its policyholders, and indeed our profession, that other professional liability carriers cannot. Here is another very recent example of the prompt, specialty-specific advice OMIC is poised to provide.

Within days of the 18 June 2008 announcement in the American Academy of Ophthalmology’s Academy Express that the FDA had approved an injectable triamcinolone acetonide suspension (TA) for ophthalmic use, OMIC began to revise its consent form and anticipate associated medicolegal issues.

Trivaris,TM manufactured by Allergan Inc., is the second approved drug; it joins Alcon’s Triesence.TM These drug approvals come just 18 months after ophthalmologists received a “Dear Doctor” letter from Bristol-Myers Squibb advising them that KenalogTM was not approved for ocular use. In 2006, OMIC policyholders called our confidential Risk Management Hotline to ask if their policy would cover them if they still administered Kenalog.TM OMIC reassured ophthalmologists and assisted them by preparing and distributing a sample consent form to help patients understand that the use of an approved drug in an “off-label” fashion is a legal and often necessary aspect of the practice of medicine.

As a result of the limited indications for which TriesenceTM and TrivarisTM were approved, much ophthalmic use of these forms of TA will continue to be “off-label.” Moreover, now that there are approved formulations of TA, policy- holders are calling the Hotline again to ask, “Can I still use KenalogTM?” Why would physicians want to use a drug off-label if it was available in an approved, single dose form? Retina specialists whose patients were being successfully treated with bevacizumab (Avastin TM) grappled with this issue when Genentech got approval for another of its own products, ranibizumab (LucentisTM).

The answer then and now is related to the topics addressed elsewhere in this issue of the Digest: the cost of health care and the vagaries of reimbursement. Pharmaceutical companies devote years and considerable capital to research and manufacture new drugs. Thus, it is not surprising that freshly approved drugs are generally more expensive than ones already in use. The dilemma for physicians and patients alike, however, is that these drugs may not now—or ever—be included in the formularies of the patient’s health insurance plan. If an ophthalmologist feels the medication is indicated but learns that the cost won’t be borne by the insurance company or can’t be paid by the patient, what should he or she do?

OMIC’s board and committee members are ophthalmologists; we know it is our ethical and professional responsibility to put the patient’s interests above our own and provide what we feel is the most appropriate care. So our answer to our policyholders remains the same: discuss the situation openly with your patient, use your medical judgment, document your decision-making process, and know that OMIC will support you if your care is challenged. Be sure to call our Hotline to discuss particular concerns, and download

the TA consent form and risk management recommendations at www.omic.com.

Our ability to support your care may, however, be jeopardized if you do not properly evaluate and reduce the risks associated with other health care products, such as Medispas, cosmetic skin care, and forensic consulting. While you may gain needed revenue from this type of professional activity, it may come at too high a cost. Indeed, these services raise a number of questions that are addressed in detail in this Digest. Some legal issues can only be resolved by contacting your medical board, practice attorney, or the requesting party. Some malpractice claims coverage questions have clear cut answers, others will depend upon your relationship with the patient and the specific allegations. This issue of the OMIC Digest will at least help you begin your risk assessment.

Joe R. McFarlane Jr., MD, JD OMIC Chairman of the Board