A patient comes into your hospital’s Emergency Department (ED). He is acutely psychotic and hears voices telling him that people want to hurt him. Staff approach the patient and he strikes out at them. The ED physician orders Zyprexa 10mg IM STAT. The patient receives the medication and subsequently is calmer and no longer exhibiting aggressive behavior. Did your hospital just chemically restrain the patient?

The answer lies in the definition of what constitutes chemical restraint – or as CMS states – what does not constitute chemical restraint. According to CMS, chemical restraint is "a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition". The key is that the use of a medication that controls behavior and is a standard treatment or dosage for the patient’s condition is not a restraint.

Criteria used to determine whether the use of a drug or medication, or combination of drugs or medications, is a standard treatment or dosage for the patient's condition includes all of the following:

• The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters;
• The use of the drug or medication follows national practice standards established or recognized by the medical community, or professional medical associations or organizations; and,
• The use of the drug or medication to treat a specific patient’s clinical condition is based on that patient's symptoms, overall clinical situation, and on the physician's or other licensed independent practitioner’s (LIP) knowledge of that patient's expected and actual response to the medication.

Another component of standard treatment or dosage for a drug or medication is the expectation that the use of a drug or medication to treat the patient's condition enables the patient to more effectively or appropriately function in the world around them than would be possible without the use of the drug or medication.

However, if the overall effect of a drug or medication, or combination of drugs or medications, is to reduce the patient's ability to effectively or appropriately interact with the world around the patient, then the drug or medication is not being used as a standard treatment or dosage for the patient's condition, and it would be chemical restraint.

Unfortunately, surveyors (both accreditors and from CMS) often get confused on this issue. The biggest error made is to automatically label a medication as being a chemical restraint simply because of its ordered purpose. Giving an agitated patient Ativan in a normative dose to calm them is not a chemical restraint. Yet we still see surveyors in the field wrongly citing hospitals. Your challenge is to convince a surveyor that your use of a medication does not constitute a chemical restraint. Using the following decision tree will help.

Question	Yes	No	Comments
Is the drug or medication used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters?
Does the use of the drug or medication follows national practice standards established or recognized by the medical community, or professional medical associations or organizations?
Is the use of the drug or medication to treat a specific patient's clinical condition based on that patient's symptoms, overall clinical situation, and on the physician's or other licensed independent practitioner's (LIP) knowledge of that patient's expected and actual response to the medication?
Is the overall effect of a drug or medication, or combination of drugs or medications, intended to reduce the patient's movement and/or ability to effectively or appropriately interact with the world around the patient?

If the answer to any question lands in a shaded box, then the use of the medication would be considered a chemical restraint.

If the answer to all questions lands in the unshaded boxes, then the use of the medication does not constitute chemical restraint.

Traci's past positions include Chief Quality Officer for a multi-hospital community based health system where she was responsible for accreditation and regulatory compliance. Prior to joining CIHQ, Traci served as the Executive Director of Quality for a large regional medical center, providing executive management oversight in the areas of quality, risk, medical staff credentialing, and patient relations.

Traci received her degree in education from Pima in Tucson Arizona. She is nationally certified in healthcare accreditation, and serves on the Board of Examiners for the Healthcare Accreditation Certification Program.