Informed consent and contraception when prescribing valproate to individuals of childbearing potential: a quality improvement project.

PURPOSE: Valproate is an efficacious treatment for several neurologic and psychiatric disorders, but it carries a grave risk of teratogenicity. Despite warnings from regulatory bodies, prescribing guidelines from professional associations, and expert opinion against the practice, the medication continues to be commonly prescribed to persons with childbearing potential for psychiatric indications.

METHODS

A quality improvement focused educational intervention on the conduct and documentation of informed consent and contraceptive counseling when prescribing the teratogen valproate to individuals aged 12-55 who may become pregnant was implemented in the Psychiatry Department of an urban community hospital. Documentation from 3 months before and after the intervention was qualitatively assessed for notation of informed consent, including the patient's expressed understanding of risks as well as specific counseling on teratogenicity and the need for contraception, in acute care and outpatient charts that had a prescription from a psychiatric provider for valproate in that time frame.

RESULTS

While statistically significant improvement was found in the documentation of general informed consent and patients' responses to counseling in outpatient charts, there was no improvement in acute care charts and no significant increase in valproate-specific counseling in charts from either care setting.

CONCLUSION

The minimal impact of an educational initiative on documentation of informed consent in the present study suggests that education alone may not be sufficient to address the crucial safety concern of valproate prescribing practices in psychiatric patients who may become pregnant.