Psychiatrists Can Reduce Liability Risks of Using Drugs Not FDA Approved

Psychiatrists may want to use promising new drugs approved in countries other than the U.S. for treating patients with intractable mental illnesses, but, given the legal and clinical risks, they should consider using the FDA's investigational new drug treatment process. That is the advice of Jackie Melonas, director of risk management for the APA-sponsored professional liability insurance program.

"A psychiatric patient importing a drug from another country to use in the United States may be allowed to do so on one occasion but not another because entry is subject to FDA personnel discretion. This can disrupt a medication supply and cause withdrawal reactions. Moreover, drugs may not be properly labeled, can contain unsafe ingredients, and have inadequate warnings or information about proper use or side effects," Melonas told Psychiatric News.

Any adverse event caused by the use of a nonapproved drug or a disruption in the patient's supply can expose the psychiatrist to a claim for damages, according to Melonas. Most insurance companies do not cover claims relating to alleged criminal or wrongful acts.

To minimize the risk of liability to the psychiatrist, Melonas recommended obtaining access to unapproved drugs through the FDA's Treatment Investigational New Drug (IND) process.

Melonas reported that a few psychiatric drugs have received treatment IND status including one to treat severe OCD in 1994.

To meet the FDA approval criteria, an applicant must show that the drug is intended to treat a serious or immediately life-threatening disease and that there is no comparable or satisfactory alternative drug or therapy available, said Melonas in the Spring issue of Rx for Risk.

In addition, the FDA only grants IND treatment approval to drugs that have completed phase one of clinical testing in human subjects, which examines the dangers of various doses, according to the article.

A psychiatrist who is granted FDA approval and insured through APA's professional liability program should submit to the program manager all related documentation including any treatment protocols and modifications to the approval. "Documentation is critical to determining coverage if a claim arises from prescribing unapproved drugs under a treatment IND," said Melonas.

She also recommended taking the following steps to reduce the risk of professional liability:

• Exhaust all approved treatment modalities first. The patient's history of illness and response to all pharmacological interventions and medical treatments should be clearly documented.



• Consider sending the patient for a second opinion or a consultation with a doctor with appropriate expertise. Inform the patient of this option and document the results.



• Use an informed patient consent process in compliance with FDA regulations.



• Discuss how patient information will be handled, especially confidential information.



• Follow all clinical protocols scrupulously once a patient consents to using a treatment IND.



• Agree with the patient on a treatment plan including actions that will be taken in case of an adverse reaction, and document the plan.

Melonas emphasized the importance of documenting these steps in the patient's medical record to show that the physician met the standard of care in case of a claim.

To obtain information on current clinical trials with INDs, see these web sites: FDA at www.fda.gov, Center Watch, Inc. at www.centerwatch.com and F-D-C Reports at www.fdcreports.com. To request a treatment IND packet, the FDA e-mail address is esands@bangate.fda.gov.