As discussed in the first article in this series in the February issue, lawsuits about medication errors in behavioral healthcare tend to have the same type of 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 monitor the patient properly because there was an inadequate or no baseline assessment, insufficient history gathering, and insufficient testing required with the medication.
The prescriber failed to connect documented symptoms of an adverse reaction to the medication with known associated risks.
This article includes recommendations for an adequate informed consent procedure as well as a discussion of the roles of healthcare staff in medication risk management.
An adequate medication risk management system in the community mental health or hospital setting should start with a commitment to involve the facility's entire treatment staff in the effort to avoid errors. The prescriber alone cannot do everything, if for no other reason than the time he/she spends with the patient is limited.
Other staff members, including nurses, case managers, counselors, residential supervisors, and psychiatric technicians, have substantial contact with patients. Their role in risk management should be considered as important as the prescriber's, and adequate resources should be devoted to their training. These staff members should be able to do the following:
educate patients about the risks and benefits of medication, alternatives to a specific medication, and possible adverse reactions;
monitor charts to be sure that adequate information about baseline data and laboratory testing is documented, and alert the appropriate supervisor if something is missing;
monitor the patient's competence and understanding of both medication risks and how to comply with the prescriber's orders; and
monitor the patient's condition, and take appropriate steps to address adverse reactions to the prescribed medication.
To help staff recognize adverse medication reactions, a checklist should be readily available that describes the most common and most worrisome adverse reactions to medications frequently prescribed to the facility's patients.
Some prescribers believe they know what is best for their psychiatric patients, and that they should not fully disclose the risks of medication because the patient might refuse to take what he/she prescribes. This approach, however, increases the risk of lawsuits.
The decision to take or refuse medication legally belongs to the patient. Our legal principles reflect our cultural value that the individual patient knows what is best. Medication should be seen as a “respectfully negotiated aid to recovery.” The focus should be on the patient's empowerment and “role restoration” of self-determination.1
The process of obtaining informed consent should be considered as simply sharing with the patient what we know about a particular medication. Taking enough time to inform the patient at the beginning increases the likelihood of medication compliance. Thus, the prescriber may end up spending less time on emergencies. Furthermore, obtaining informed consent is an important part of building a quality therapeutic relationship, which is critical to both treatment success and good risk management.
Most states have statutes mandating informed consent to any medical treatment and defining required elements. These laws are the starting place for designing an informed consent procedure. Depending on the state, violation of a statute could be the basis for a separate lawsuit apart from any allegations of negligence. Alternately, a violation could be considered evidence of negligence. Most of the statutes require disclosure of adequate information about the nature of the treatment and the risks and benefits of the treatment, alternative treatments, and no treatment.
The informed consent process should include obtaining a signature to a written, up-to-date, medication-specific risk disclosure and consent form, as well as an oral discussion between the prescriber and patient. At a minimum, the prescriber should document discussion of the patient's diagnosis and the treatment's risks and benefits, as required by the particular state's law, and signs of possible adverse reactions. Material risks should be discussed, but the prescriber need not read the prescribing insert to the patient. Instructions for taking the medication should be discussed, a follow-up appointment scheduled, and the patient told to call if anything unusual happens. In addition to keeping the written consent form on file, the prescriber should give the patient a copy of the form. Of course, consent forms should be signed by those who are legally competent. Guardians or other legal representatives should sign on behalf of children and those so psychiatrically impaired that they do not understand the issues.
The prescriber should not use medical terms during the discussion, and language should be as simple as possible. Because jargon can be used habitually, a facility could give providers the opportunity to practice using simple language with an observer who could point out any “slips.” The patient should be given an opportunity to ask questions, and the provider should ask questions to test the patient's understanding of the issues and reeducate as needed.