Risk Management



Managing the Risks of Botox

Paul Weber, JD, OMIC Risk Manager

Digest, Summer, 2002

We have witnessed with LASIK how the combination of media hype and aggressive advertising that now surrounds Botox sets the stage for unrealistic patient expectations and frivolous lawsuits. Due to the sometimes unconventional nature of treatment delivery, ophthalmologists must take care to ensure that cosmetic Botox injections are administered in a manner that manages the potential risks. Similar to its refractive guidelines, OMIC is drafting compliance guidelines for Botox. These guidelines will be ready for dissemination to insureds by the end of 2002 and will address the following risk management issues.

Q  What training and continuing education does OMIC recommend for ophthalmologists who wish to administer Botox injections?

A  Attend an approved course on cosmetic application of Botox, such as the one soon to be offered by Allergan and cosponsored by the American Academy of Ophthalmology and the American Society of Ophthalmic Plastic and Reconstructive Surgery. Be able to demonstrate that you have a thorough understanding of the complicated musculature of the human face, particularly the treatment area of the eyelids, brows, and orbit. Be able to identify physical and anatomical contraindications to Botox, such as excessive atrophy or weakness in the target muscle, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, marked facial asymmetry, and inflammation at the planned injection site. Finally, consider being proctored on your first few cases by another physician experienced in injecting Botox.

Q  How extensive does the pre-treatment history and examination need to be for Botox patients?

To determine if Botox is the most appropriate treatment, you will need to obtain a basic medical history from the patient, including allergies and medications (as well as vitamins and herbal supplements), medical problems pertinent to the use of Botox (pregnancy, neuromuscular disorder, neurological disease, etc.) and, of course, any previous cosmetic procedures. A limited eye and physical examination will reveal any physical/anatomical findings pertinent to the cosmetic use of Botox.

Q  How should I handle charting and documentation for Botox cases?

A  As with any other patient medical record, a medical chart must be generated and kept in compliance with the HIPAA patient privacy regulations that will come into effect April 2003.

Can I inject Botox at home parties, gyms, hotel rooms, spas, and other nonclinical settings?

A  This is a medical procedure and OMIC frowns (pun intended) on injecting Botox unless it is done in a clinical setting, such as a physician’s office. Spas are generally not an appropriate setting since they do not have the medical personnel and equipment necessary to safely observe patients, deal with potential complications, and provide for the proper disposal of medical waste as required by the Occupational Safety and Health Administration. Injecting Botox in someone’s home, a hotel banquet room, or other public place presents additional liability problems since these venues lack sufficient privacy for patients to disclose and discuss private health care information and for the physician to provide and document thorough informed consent (risks, benefits, and alternatives). Finally, it goes without saying that Botox should never be injected in any venue where alcoholic beverages are being served. Not only will there be a challenge to the patient’s competency to consent to the procedure and understand and adhere to post-op instructions, there are also clinical contraindications to injecting Botox in a patient who has consumed alcohol.

Q  How do I minimize my risk when I advertise and let patients know that I offer this service?

A  First, it is important to know your state’s specific regulations regarding physician/professional advertising. For instance, some states, such as Texas and Illinois, ban patient testimonials. All states and the Federal Trade Commission ban advertising containing false, fraudulent, deceptive, or misleading material, or guarantees of success. The Academy’s Code of Ethics provides ethical guidelines regarding advertising in the section “Communications to the Public.” These guidelines also create a standard of care that ophthalmologists need to be aware of and adhere to.

Q  Are there any risks to joining Allergan’s Botox Physicians Network?

A  OMIC has reviewed the participation agreement that physicians are required to sign before joining Allergan’s Botox Network and suggests having your own attorney review the contract prior to signing it to explain your rights, obligations, and remedies as set forth in the agreement.

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