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The following risk management alert was written by the APA-sponsored Professional Liability Insurance Program's risk management department.
In March 1998 the Food and Drug Administration approved the drug Viagra (sildenafil citrate) for use in the treatment of erectile dysfunction. Since then, consumer response has exceeded even the most ambitious forecasts. As responsible physicians, psychiatrists need to consider how the frenzy surrounding Viagra may increase health risks for their patients and liability risks for themselves.
The tools for minimizing liability risks associated with Viagra are the same as those used to minimize the risks associated with any newly approved drug. Patient referrals, education, and documentation are the keys.
Tip: Refer family members and friends to another qualified health care provider.
Tip: Educate yourself about this new drug. Become more knowledgeable about its indications, contraindications, and complications. In addition to the FDA's and manu-facturer's information, consult with other resources, such as other scientific literature and medical specialists, such as urologists. (See end of article for Viagra information on the Internet.)
Tip: Again, educate yourself and stay informed as new information becomes available. Maintain a file (separate from your patient files) containing any scientific literature and professional information that you rely on to support the use of newly approved medications and off-label use of medications.
Tip: Consider including questions about whether a patient has access to and is using Viagra as part of your standard assessment and evaluation. Advise patients that for you to evaluate and treat them appropriately (including the selection of prescription medication), they must inform you of all other medications and treatments they are using, whether prescription or nonprescription.
Tip: Assess whether the patient who is asking about Viagra, or is already on Viagra, has had the recommended workup, including a thorough medical history and physical exam. This will assist you in determining with whom you should be coordinating treatment and what exams, lab work, referrals, or consultations you should be ordering. Be realistic about your own professional limitations. Consider a professional consultation or a referral to another physician with appropriate training and expertise, when appropriate.
Tip: Follow all the preceding risk management tips when considering stacking treatments. One consumer group, Public Citizen's Health Research Group, has already petitioned the FDA to strengthen Viagra's safety warnings, because men may be taking Viagra to treat erectile dysfunction caused by taking other prescription drugs.
Tip: As always, obtain the patient's informed consent, and document the consent. Your documentation should reflect that the patient was informed about the nature of the treatment; the risks, benefits, and potential side effects of the treatment; any alternatives to the treatment; the risks and benefits of any alternatives; the risks and benefits of doing nothing; and what to do if problems or questions arise. In addition, clarify to the patient whether the proposed treatment is an approved or an off-label use.
Keep copies in the patient's medical record of all written instructions or informational materials provided to the patient.
Remember that informed consent is a continuous process. Record the discussions between yourself and the patient about the medication, the response to the drug, any subsequent actions taken by you, and the basis for your clinical decision-making process.
In conclusion, if your actions regarding Viagra, or any other medication, meet acceptable medical standards, and your records adequately document the medical treatment given, then you should be able to minimize your professional liability exposure.
The following are some information resources about Viagra on the Internet that may be of interest to you and your patients. They are current as of August 6.
| FDA letter | www.fda.gov/medwatch/safety/1998/viagra.htm |
| FDA information | http://www.fda.gov/cder/drug/default.htm |
| FDA postmarketing information | www.fda.gov/cder/consumerinfo/viagra/default.htm |
| PBS Online Newshour Forum | www.pbs.org/newshour/forum/may98/viagra_5-15.html |
| NEJM abstract | www.nejm.org/content/1998/0338/0020/1397.asp |
| Pfizer | www.viagra.com |