Medicolegal Issues

How to monitor medication side effects

Current Psychiatry. 2007 August;6(8):68-76

References

1. Knoll J, Gerbasi J. Psychiatric malpractice case analysis: striving for objectivity. J Am Acad Psychiatry Law 2006;34:215-223.

2. Lewis MH, Gohagan JK, Merensteine DJ. The locality rule and the physician’s dilemma: local medical practices vs the national standard of care. JAMA 2007;297:2633-7.

3. American Psychiatric Association Practice guidelines. Available at: http://www.psych.org/psych_pract/treatg/pg/prac_guide.cfm. Accessed June 27, 2007.

4. Berner M. Informed consent. In: Lifson LE, Simon RI, eds. The mental health practitioner and the law. Cambridge, MA: Harvard University Press 1998:23-43.

5. Toffol GJ, Biller J, Adams HP. Nontraumtic intracerebral hemorrhage in young adults. Arch Neurol 1987;44:483-5.

6. Bakheit AM. Intracerebral haemorrhage in previously healthy young adults. Postgrad Med J 1999;75:499-500.

7. McMillen M. Adderall: a stroke of bad news. The Washington Post. February 15, 2005. Available at: http://www.washingtonpost.com/wp-dyn/articles/A24764-2005Feb14.html. Accessed June 27, 2007.

8. U.S. Food and Drug Administration. Alert for healthcare professionals Adderall and Adderall XT (amphetamines). September 23, 2005. Available at: http://www.fda.gov/cder/drug/infosheets/hcp/adderalhcp.htm. Accessed July 5, 2007.

9. Physicians’ desk reference Montvale, NJ: Thompson PDR; 2007.

10. U.S. Food and Drug Administration. Adderall and Adderall XR (amphetamines) information. February 22, 2007. Available at: http://www.fda.gov/cder/drug/infopage/adderall/default.htm. Accessed June 27, 2007.

11. Charatan F. FDA committee votes for warning labels on stimulant drugs. BMJ 2006;332:380-

12. Lamictal prescribing information. Food and Drug Administration Web site. Available at http://www.fda.gov/cder/foi/label/2006020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf. Accessed July 9, 2007.

13. Overstreet K, Costanza C, Behling C, et al. Fatal progressive hepatic necrosis associated with lamotrigine treatment: a case report and literature review. Dig Dis Sci 2002;47:1921-5.

Cases are selected by Current Psychiatry from Medical Malpractice Verdicts, Settlements & Experts, with permission of its editor, Lewis Laska of Nashville, TN (www.verdictslaska.com). Information may be incomplete in some instances, but these cases represent clinical situations that typically result in litigation.

Clinical Point

In general if dosing is in the FDA-approved range or is based on credible research, the treatment will meet the standard of care

Regardless of the treatment used—even if the medication is “off-label” and not FDA-approved for a particular disorder or the dose is not within the FDA-approved dosing range—you should be able to document your rationale for using a medication and dosing by showing that it is part of good clinical practice.

A clinician’s scientific rationale for medication and dosing choice should be based on the psychiatric evaluation and known risks and benefits of the treatment. In addition, the patient should:

understand pertinent information regarding the medication and its side effects
and freely give consent to treatment.⁴

Then document in the patient’s chart that you had this discussion with the patient and obtained consent.

Monitoring for side effects

In these cases, the court also had to determine whether clinicians’ monitoring for side effects was appropriate. For several years, case reports have raised speculation about a link between strokes and amphetamine/ dextroamphetamine^4,5 In 2005, Adderall XR was taken off the Canadian market because of reports of strokes and sudden deaths.⁷

The FDA’s Adverse Event Reporting System database identified 12 cases of sudden death in pediatric patents treated for ADHD with Adderall or Adderall XR.⁸ lthough the drug has returned to the Canadian market and a clear link between stroke or sudden death and Adderall has not been established, The Physicians’ Desk Reference (PDR)⁹ advises physicians to monitor blood pressure in individuals taking amphetamine/dextroamphetamine, particularly those with hypertension. The FDA has issued new labeling instructions for all stimulants advising prescribing clinicians to monitor blood pressure regularly.¹⁰

Clinical Point

Foreseeability is not the same as predictability and should be understood in the context of what information is available

Adverse side effects are possible with any number of medications. Clinicians might need to change assessments and monitoring practices as new information—such as FDA or pharmaceutical company reporting or new studies in professional journals—becomes available.

Even so, if you fail to monitor blood pressure and a patient has a stroke—such as in the first case—you are not necessarily negligent. Successful malpractice cases need to demonstrate causation. The plaintiff must prove:

The physician’s act or omission was the cause-in-fact of the harm. Without the act, the harm would not have occurred.
The act was the proximate cause of the harm. In a natural, unbroken sequence of events, the act produces a foreseeable result. A physician should not be liable for the far-reaching and improbable consequences of an act or omission.¹

Plaintiffs cannot prove proximate cause if there is:

lack of foreseeability—the consequences of the act were not reasonably foreseeable, or
an intervening event that supersedes all others in causing the injury.¹

Foreseeability

A defendant may be liable only if the consequences of the act or omission were reasonably foreseeable. Foreseeability is a vague legal concept and is not the same as predictability. Foreseeability should be understood in context of what information was available at the time. For example, the FDA black box warnings about the link between stimulants and stroke or sudden death did not appear until 2006.¹¹ What light be considered foreseeable now might not have been before 2006 (it is unclear when the above case was litigated).

Intervening events

An intervening event is one that takes effect after the defendant’s negligence and breaks the chain of causation. In the first case, the patient had a history of TIAs before taking amphetamine/dextroamphetamine. The condition that caused the TIAs, such as atherosclerosis in an artery, may also have caused the stroke independent of the use of stimulants, and therefore could be considered an intervening event.

In the lamotrigine case, elevations of aspartate transaminase and alanine transaminase are infrequent or rare. Several case reports have discussed possible hepatotoxicity associated with the drug.¹³

A reasonably prudent physician should warn patients about and monitor for symptoms of Stevens-Johnson syndrome, a serious disorder of the skin and mucous membranes sometimes seen with lamotrigine that can begin with cough, fever, and sore throat. Although hepatitis is a possible complication of Stevens-Johnson, the first step of treatment is to hospitalize the patient in an intensive care unit, which the physician did. The PDR and FDA guidelines do not recommend monitoring liver function tests as a way to assess for Stevens-Johnson or for liver dysfunction as an independent problem with lamotrigine.^9,12

Given the lack of guidelines and the scant literature on this topic, the psychiatrist in this case would not have been expected to monitor liver function, which would meet either the “average practitioner” or “reasonably prudent physician” standard. Although the literature suggests that liver toxicity might have been foreseeable, the patient had a history of polysubstance abuse, which may be determined to be an intervening event. Substance abuse could have caused liver toxicity, depending on the drugs the patient abused.

How to monitor medication side effects

References

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