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PRESCRIBING BETTER RISK MANAGEMENT

May 1, 2007
by RONALD ZIMMET
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The final article in a three-part series on avoiding medication error lawsuits

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.


Table 1. Questions asked by staff during the follow-up competency interview

Ability to make a choice

  • Have you decided whether to accept our recommendation about medication? Can you tell me what your decision is?

Factual understanding of the issues

  • Please tell me in your own words your understanding of the nature of your condition, the possible benefits of the medication, the possible risks of the medication, the possible risks and benefits of other treatments, and the possible risks and benefits of no treatment at all.

  • Please tell me some of the things you should tell us about if they happen to you while taking the medication. What might happen if you don't tell us?

  • How likely is it that you might experience one of the side effects of the medication? Why do you think we are giving you information about this medication? What do you think will happen if you decide not to go along with our recommendation to take this medication?

  • What do you think you should do to avoid the possible risks associated with this medication, which we have explained to you? Why do you think it is important to keep your appointments with us so that we can monitor your progress on this medication?

Appreciation of the situation and its consequences

  • Please explain to me what you believe is wrong with your health. Do you believe you need some kind of treatment? Why do you think we recommended this medication?

Rational manipulation of information