CMS SOM App. A, Tag A-0160

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.

Interpretive Guidelines §482.13(e)(1)(i)(B)

Drugs or medications that are used as part of a patient's standard medical or psychiatric treatment, and

are administered within the standard dosage for the patient’s condition, would not be subject to the

requirements of standard (e). These regulations are not intended to interfere with the clinical treatment

of patients who are suffering from serious mental illness and who need therapeutic doses of medication

to improve their level of functioning so that they can more actively participate in their treatment.

Similarly, these regulations are not intended to interfere with appropriate doses of sleeping medication

prescribed for patients with insomnia, anti-anxiety medication prescribed to calm a patient who is

anxious, or analgesics prescribed for pain management. The regulatory language is intended to provide

flexibility and recognize the variations in patient conditions.

Whether or not an order for a drug or medication is PRN (Latin abbreviation for pro re nata - as needed;

as circumstances require) or a standing-order does not determine whether or not the use of that drug or

medication is considered a restraint. The use of PRN or standing-order drugs or medications is only

prohibited if the drug or medication meets the definition of a drug or medication used as 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 standard 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. 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.

As with any use of restraint or seclusion, staff must conduct a comprehensive patient assessment to

determine the need for other types of interventions before using a drug or medication as a restraint. For

example, a patient may be agitated due to pain, an adverse reaction to an existing drug or medication, or

other unmet care need or concern.

There are situations where the use of a drug or medication is clearly outside the standard for a patient or

a situation, or a medication is not medically necessary but is used for patient discipline or staff

convenience (neither of which is permitted by the regulation).

• EXAMPLE 1: A patient has Sundowner's Syndrome, a syndrome in which a patient's dementia

becomes more apparent at the end of the day rather than at the beginning of the day. The patient

may become agitated, angry, or anxious at sundown. This may lead to wandering, pacing the

floors, or other nervous behaviors. The staff finds the patient’s behavior bothersome, and asks

the physician to order a high dose of a sedative to “knock out” the patient and keep him in bed.

The patient has no medical symptoms or condition that indicates the need for a sedative. In this

case, for this patient, the sedative is being used inappropriately as a restraint for staff

convenience. Such use is not permitted by the regulation.

A drug or medication that is not being used as a standard treatment for the patient’s medical or

psychiatric condition, and that results in restricting the patient’s freedom of movement would be

a drug used as a restraint.

In addition, the regulation does not permit a drug or medication to be used to restrain the patient

for staff convenience, to coerce or discipline the patient, or as a method of retaliation. While

drugs or medications can be a beneficial part of a carefully constructed, individualized treatment

plan for the patient, drug and medication use should be based on the assessed needs of the

individual patient, and the effects of drugs and medications on the patient should be carefully

monitored.

• EXAMPLE 2: A patient is in a detoxification program. The patient becomes violent and

aggressive. Staff administers a PRN medication ordered by the patient’s physician or other LIP

to address these types of outbursts. The use of the medication enables the patient to better

interact with others or function more effectively. In this case, the medication used for this

patient is not considered a “drug used as a restraint.” The availability of a PRN medication to

manage outbursts of specific behaviors, such as aggressive, violent behavior is standard for this

patient’s medical condition (i.e., drug or alcohol withdrawal). Therefore, this patient’s

medication does not meet the definition of “drug used as a restraint” since it is a standard

treatment or dosage for the patient’s medical or psychiatric condition. The use of this medication

for this patient is not affected by standard (e).

If a drug or medication is used as a standard treatment (as previously defined) to address the

assessed symptoms and needs of a patient with a particular medical or psychiatric condition, its

use is not subject to the requirements of this regulation. However, the patient would still need to

receive assessments, monitoring, interventions, and care that are appropriate for that patient’s

needs.

The regulation supports existing State laws that provide more vigorous promotion of the patient’s choice

and rights. Therefore, when a State’s law prohibits the administration of drugs against the wishes of the

patient without a court order, the State law applies.

Survey Procedures §482.13(e)(1)(i)(B)

• Determine whether the hospital’s policies and procedures employ a definition or description of

what constitutes the use of drugs or medications as a restraint that is consistent with the

regulation.

• Interview hospital staff to determine whether they can identify when the use of a drug or

medication is considered a chemical restraint.