(1) there was an inadequate informed consent procedure with insufficient warnings of known risks associated with the medication;
(2) there was a failure to monitor properly because there was an inadequate or no baseline, insufficient history and insufficient testing required with the medication;
(3) the doctor failed to connect documented symptoms of adverse reaction to the medication with known associated risks.
This article will include recommendations regarding a procedure for determining competence to consent to a medication as well as discussion of examples of the type of baseline data and monitoring required for appropriate medication management. The article will conclude 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
Distinguish between legally declared incompetence and actual incompetence to consent to medication. Only a small percentage of the mentally ill have 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 may have a backlog.
Further 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 competence evaluations.
The evaluation is best done by 2 people. The prescriber can be supported by a nurse or other staff to interview the patient. The prescriber should do a mental status exam and educate the patient about the medication and monitoring procedures. The support staff can follow up with an interview to test the patient’s ability to voluntarily consent and understanding of the issues.
The mental status exam should include evaluation of orientation, memory, intellectual functioning, insight and judgment, mood alterations and factors indicating impairment of rationality such as delusional thinking and hallucinations.
The interview by support staff 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. Here are some example questions.
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
Tell me how you reached the decision to accept or reject this medication? What were the factors that were important to you in reaching the decision?
The interviewer should document a final opinion as to whether the patient is competent to consent. Of course if the patient is not competent, alternative decision makers should be contacted. There may be a guardian, a person who has a power of attorney, a health care surrogate, a government agency, or family member who has the authority to consent. Your state law may authorize a mental health center to seek authority to consent. In any event a prescriber should make reasonable efforts to locate an alternative decision maker when appropriate.
Baseline data and patient monitoring
The baseline data required to be gathered before prescribing a drug and the type of patient monitoring is different for each kind of medication. Moreover the standard of care changes as the pharmaceutical industry and researchers learn more about a specific drug. Clinical trials are conducted with a limited population. The experience with a drug and our understanding of it is far more complete when it is used on the open market by millions rather than thousands of people and new studies are conducted and published.
For example the standard of care for baseline data and monitoring for second generation antipsychotics (SGAs) was conceived differently from 2004 to 2006. In 2004 “Consensus Guidelines” were published in Diabetes Care resulting from a cooperative effort of various associations for diabetes, psychiatry, endocrinology, and obesity. American Diabetes Association (2004b), Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes, Diabetes Care 27: 596-601. In 2005 a report and new guidelines were published based on a conference of psychiatrists, diabetologists and pharmacists from major Belgian hospitals, Belgian consensus on metabolic problems associated with atypical antipsychotics, International Journal of Psychiatry in Clinical Practice, 2005; 9(2): 130-137. In 2006 yet another publication contained different guidelines based on a literature review. Metabolic abnormalities associated with second generation antipsychotics: Fact or fiction? Development of guidelines for screening and monitoring, International Clinical Pscychopharmacology 2006, Vol 21 (suppl 2).
Thus it is essential that each prescriber keep up to date on the latest research literature. Mental health center medical directors can greatly enhance patient quality of care by being sure that the most current information is available and staff training occurs regularly. Staying current on the latest research is not only a foundation for quality care and risk management. It is also an ethical duty.
The 2006 guidelines for atypicals are a good example of the specifics of the kind of information required for a baseline and patient monitoring of a medication. The major associated risks for SGAs are diabetes, dyslipidemia and weight gain. The prescriber should obtain a medical history to include symptoms, lab reports and examinations related to diabetes, fasting blood glucose, oral glucose tolerance tests, family history of diabetes and obesity, eating habits, nutritional status, weight, exercise habits and other medications taken which may affect glucose levels. The prescriber should also consider any risk factors for atherosclerosis such as smoking, hypertension, obesity, dyslipidemia, and tobacco or substance use. An in depth physical examination should be completed to include among other things height, weight, waist circumference, body mass index, and blood pressure. Laboratory tests should include fasting plasma glucose and fasting lipid profile.
Follow up monitoring should occur periodically. The 2006 guidelines contain a recommendation to obtain the patient’s weight weekly for inpatients and monthly in ambulatory care. Depending on weight gain the prescriber should consider making changes to the prescription. Fasting plasma glucose should be assessed “monthly in patients with family history of diabetes/obesity and/or with manifested overweight or obesity, and/or with impaired fasting glucose, after 6 and 12 weeks, then quarterly in patients without risk factors.” Total cholesterol, HDL, LDL and triglycerides should be obtained every 3 months for the first year of treatment and annually thereafter. Blood pressure should be taken every 3 months.
These guidelines are different and more watchful than the earlier guidelines. The SGA guidelines are just an example because each medication will have its own requirements for baseline data and monitoring.
Allegations of failing to connect documented patient symptoms with known risks associated with a medication are often a result of inadequate monitoring.
Clinical decision making checklist
Providing quality care includes consideration of all those factors which a reasonably prudent health care provider would consider in making decisions about which treatment or medication is appropriate. Since we all have imperfect memories it is best to have a checklist of those factors. A form could be included in the patient’s chart to document the unique facts and decision process for each patient.
The decision process should include consideration and documentation of the following factors: the diagnosis, severity of symptoms and overall level of functioning currently, in response to past medications and different doses. Is the patient experiencing side effects currently? Why is this medication appropriate rather than some other medication, no medication or other treatment? If the medication being considered is “off label,” is there research literature to support its use and is there some other medication which would be as effective? Does the patient take other drugs which would interact adversely with this prescription? Does the patient have a preference for or against this or another drug? How does the patient’s history of medication compliance or noncompliance relate to this medication decision? Does the patient have any medical conditions or co-morbidities which affect this decision? Does the chart contain sufficient baseline and monitoring data to support the medication being considered? Is an appropriate formulation available? Is the cost of and access to this medication or an alternate medication a problem for the patient? Is the patient or a family member able to understand, remember and report matters to the prescriber as instructed in a consent and instructions form? Why do the benefits of the drug outweigh its risks?
Model forms prepared by the author are available as follows: a clinical decision making checklist, an informed consent procedure checklist, competence to consent to treatment interview checklist and an example consent and instructions form for the patient’s signature. The forms may be accessed on the Mental Health Corporations of America, Inc. web site at ________.