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The APA Assembly voted last month to approve establishing guidelines for documenting the prescribing of medications for indications in certain psychiatric illnesses not currently bearing FDA labeling approval. The measure now goes to the APA Board of Trustees for action.
For many patients, the only effective treatment for their illness is a drug that has been approved by the FDA but not for their specific problem. For example, SSRI’s were approved by the FDA for treating depression, but they were widely prescribed for treating obsessive-compulsive disorder even before the FDA approved using the drugs for that indication, according to an action paper from Area 2.
Prescribing off-label drugs, although legal, may make psychiatrists more vulnerable to medical malpractice suits. Therefore, APA needs to establish guidelines for documenting the appropriate use of such "off-label" drugs in patient care, according to the action paper.
Suzane Renaud, M.D., chair of the Assembly Reference Committee on Education: Standards and Research, said that the committee had reviewed the action paper and decided that "appropriate documentation of prescribing off-label drugs is critical in protecting members against" being sued for medical malpractice.
K-Lynn Paul, M.D., representative of the South Dakota Psychiatric Association, opposed the action paper. "All of us prescribe off-label drugs in our practice. We are busy and will forget to document this practice, and then we have painted ourselves into a corner."
Ann Sullivan, M.D., a representative of the New York County District Branch and coauthor of the action paper, commented, "Enough of our members have requested such guidelines from APA that we think this should go forward. A key area is helping psychiatrists document their decisions to prescribe off-label drugs."
The other coauthors who are also representatives from the New York County District Branch are Bruce Ballard, M.D., Marlin Mattson, M.D., Molly Finnerty, M.D., and Robert Mitchell, M.D.
In related news, the Assembly approved another Area 2 action paper intended to make peer-reviewed medications used abroad more readily available in the United States despite lacking FDA approval.
Representatives of APA and other medical specialty societies would collaborate on this effort and meet with the FDA to discuss possible solutions.
The Assembly also approved an Area 2 action paper that would provide APA with a comprehensive position statement on the confidentiality of psychiatric treatment records, in particular electronic medical records and the transmission of medical information in the managed care environment. The paper was referred to the Joint Reference Committee (JRC) to be considered as a position statement or a revision of the current position statement.
APA should update and expand its position statement on recovered memories of childhood sexual abuse, according to an Area 4 action paper also approved by the Assembly. The document was referred to the JRC to coordinate input from several related components.