Risk Management for Medication Error
 Introduction

NOTICE

The following materials are intended to be general and educational.  No statements made should be considered as legal advice and no action should be taken in reliance on the statements contained in these materials.  The model forms should be adapted to your unique local needs and should not be used as is. The forms should be periodically updated to reflect the most current state of the development of scientific research. The law in the area discussed varies from state to state.  Competent local counsel should be consulted prior to taking any action. 

The opinions expressed are solely those of the author and are not necessarily those of the National Council for Community Behavioral Healthcare, Inc., Mental Health Corporations of America, Inc., or the Mental Health Risk Retention Group, Inc.

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MEDICATION ERROR LITIGATION

Analysis of trends in professional liability community mental health center insurance claims reveals an emerging focus of litigation around the prescription and medication management of Zyprexa.  The allegations in these claims are strikingly similar to allegations made in litigation involving other medications.  The most common allegations in behavioral healthcare medication error litigation are as follows:

1

The patient was not warned of known side effects of the drug.
2

The prescriber did not obtain sufficient information for an adequate baseline.
3

The patient was not monitored in accordance with the standard of care once the medication was prescribed.
4

The physician did not take appropriate action when the patient demonstrated an adverse reaction to the medication.
5

The drug should not have been prescribed because the patient had a condition associated with a known risk of the drug.
6

The patient was not capable of informed consent and no competent alternative decision maker, such as a guardian or health care surrogate, was consulted.
7

The patient was not informed about life style changes which could have been made to reduce the risk of the drug.

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RISK MANAGEMENT TECHNIQUES

Suggested risk management techniques to address these allegations are as follows:

1

Obtain adequate informed consent from the patient or from an alternative decision maker.  This includes determining and documenting the patient’s competence to consent to treatment with the drug and providing adequate information to the patient to make an informed decision.  This also includes creating an atmosphere in which the patient’s decision is voluntary.
2

Monitor the patient in accordance with the standard of care and consensus guidelines.  This includes obtaining adequate baseline data.
3

Document a thorough clinical decision making procedure for the decision to prescribe the drug including consideration of the risks and benefits of the drug, alternate treatment, past treatment and no treatment.

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MATERIALS PROVIDED

The enclosed materials are intended as an example of a model to accomplish these risk management techniques and to address the allegations commonly made in medication error litigation.  The forms are specifically addressed to Zyprexa, but can be adapted for other medications. They include the following:

Instructions: Please click on to see the appropriate PDF document:
1

A checklist of procedures to follow when obtaining informed consent to treatment.
2

An informed consent and instructions form for the patient’s signature.
3

Competence interview model questions.
4

A checklist of matters for physician consideration and documentation in the patient’s chart when prescribing Zyprexa.

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CONSENSUS GUIDELINES

These materials should be used in conjunction with current information available in the scientific literature. 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. This article is available on the internet at http://care.diabetesjournals.org/.

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).

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THE AUTHOR

These materials were prepared by Ronald Zimmet, who is general counsel to the Mental Health Risk Retention Group, Inc. Mr. Zimmet is an attorney who maintains a litigation practice. He has lectured on risk management for behavioral health care organizations and is the primary presenter in the Mental Health Risk Retention Group loss prevention program. For additional information, Mr. Zimmet may be contacted at 125 Basin Street, Daytona Beach, Florida 32114, 386-255-4020 or rzimmet@att.net.


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