As discussed in the first article in this series (see the February 2007 issue, page 41), lawsuits about medication errors in behavioral healthcare tend to have the same allegations from one case to the next. These allegations fall into the following categories:
There was an inadequate informed consent procedure with insufficient warnings of known risks associated with the medication.
There was a failure to properly monitor the patient because inadequate or no baseline data were collected, an insufficient history was gathered, or testing required with the medication was not conducted.
The prescriber failed to connect documented symptoms of an adverse reaction to the medication with known associated risks.
In the second article (see March 2007, page 52), I provided recommendations for an adequate informed consent procedure and discussed the role of healthcare staff in medication risk management. This article concludes my three-part series on medication errors. It includes recommendations regarding a procedure for determining competence to consent to a medication, as well as a discussion of examples of the type of baseline data and monitoring required for appropriate medication management. The article ends with recommendations for a clinical decision-making checklist to document consideration of the factors required by the standard of care in deciding which medication or treatment to use.
Determining Competence to Consent
Staff need to distinguish between legally declared incompetence and actual incompetence to consent to medication. Only a small percentage of the mentally ill has been declared incompetent as part of legal proceedings to determine if a guardian should be appointed. The fact that a patient has not been legally declared incompetent usually has little to do with whether the patient is competent. For instance, there may simply have been no family member who knew how to begin guardianship proceedings or the process may be too expensive, or the courts could be backlogged.
Furthermore, a patient may be incompetent to consent to medication while being competent to consent to other types of treatment. The decision to take medication requires an understanding of a variety of complex factors. Therefore, it is prudent for the prescriber to determine competence to consent to medication separate from other competency evaluations.
The evaluation is best done by two people. The prescriber can be supported by a nurse or other staff member to interview the patient. The prescriber should conduct a mental status exam and educate the patient about the medication and monitoring procedures. The exam should include evaluations of orientation, memory, intellectual functioning, insight and judgment, mood alterations, and factors indicating impairment of rationality such as delusional thinking and hallucinations.
The support staff can follow up with an interview to test the patient's ability to voluntarily consent to medication and understand the issues. The interview should include questions to evaluate the patient's ability to make a choice, to understand the factual issues, to appreciate the situation and its consequences, and to rationally manipulate information. Table 1 lists some example questions.