Why psychotropics lead to survey deficiencies.

An OBRA consultant explains how "good" practices shade into "substandard" practices in prescribing these commonly used medications

As someone who writes the psychotropic drug use guidelines for surveyors of nursing facilities, I try to convey the importance of looking at the entire picture, rather than just a dosage or diagnosis. Drug therapy is a balance, and it can be very easy to tip the scales in the wrong direction.

The regulations with respect to unnecessary psychotropic drug use in the nursing home seem clear enough on face value: excessive dose and/or duration of therapy, adverse consequences from drug use, absence of adequate indications for drug use, failure to monitor for efficacy and side effects - any one of these can result in a deficiency.

Below the surface, however, things get a bit more complicated.

For example, while a brief, low-dose course of an antipsychotic agent may help to manage symptoms of non-cognitive origin (delusions, hallucinations), in residents with cognitive impairments, such as dementia, the very same drugs can worsen symptoms. There may, or may not, be a deficiency.

Sorting all this out requires, of course, that the prescribing clinician and the nursing staff know which type of impairment they are dealing with. Determining whether this is in fact the case involves gathering information from the clinical records, staff interviews and interviews with and observations of residents.

This can be a rather complex process and, to help facilitate it, I tend to think of psychotropic drug use in terms of a scale - inappropriate use on one end, appropriate use on the other. Each piece of information about a particular situation (resident age, drug type, dose and duration, indications for use, adverse effects, monitoring) becomes a factor that tips the scale in one or the other direction with respect to OBRA guidelines. In short, it is the "sum of the parts," rather than any one piece of information, that determines whether a particular case of drug use is appropriate or questionable by survey standards.

The following examples - all actual case histories from nursing home surveys - illustrate this.

Case 1. (Antipsychotic Agent)

* 72-year-old woman

* Haldol 0.5 mg BID x 2 weeks

* No documented reason for Haldol use

* No maladaptive behaviors in clinical records/MDS or per staff interviews

* Daughter states mother has lost mental alertness and is more sedated

* No agitated behavior noted by surveyor

* Initial care plan did not address Haldol therapy

Discussion

On the acceptable end of the scale is the 1 mg/day dosage - which is below the usual dosage of 3mg/day - and the brief duration of drug use.

On the questionable end of the scale is the resident's advanced age, the absence of a documented indication for the use of an antipsychotic (ie, schizophrenia: delusions hallucinations, maladaptive behaviors), the absence of agitated behaviors, as observed by the staff and the surveyor, and the daughter's observations of the resident's lost mental alertness and increased sedation, which suggest harm. Also of concern is the fact that the initial care plan didn't address the use of the drug.

Determination

While this isn't a particularly egregious case, there is no apparent reason for the use of the drug. Nonetheless, because of the very small dose and brief duration of therapy, a deficiency probably wouldn't be written - unless, of course, use of the drug was extended beyond the two-week order.

Case 2. (Antipsychotic Agent)

* 60-year-old man

* Mellaril 100 mg QID x 2 years

* Diagnosis of schizophrenia

* Transferred from state hospital

* Persistent delusion that staff is trying to kill him, with documented kicking and striking behavior

* No observable signs of tardive dyskinesia or parkinsonism

Discussion

On the acceptable side of the scale is the resident's age (relatively young) and the diagnosis of schizophrenia. Because the resident was transferred from the state hospital, we can be fairly certain that the diagnosis is a good one. Because, however, we sometimes see nursing home residents who are given diagnoses to justify drug use, I ask our surveyors to look beyond the diagnosis, to the symptoms. The resident's full-blown, persistent delusion and his documented kicking and striking out provide evidence the drug is indicated.

Though both dosage and duration of therapy are far above those recommended for an elderly individual with dementia, neither is excessive for a 60-year-old with schizophrenia. While the dose and duration place this resident at risk for drug-induced parkinsonism and dyskinesia, no sign of either has been observed.

Determination

From the regulatory perspective, the scale tips strongly on the side of appropriate use. From a strictly clinical perspective, the fact that the resident is still kicking and striking out, despite the high dosage, raises the possibility that the wrong drug was selected two years ago. On the other hand some might argue that, without the Mellaril, the resident's behaviors would have been completely unmanageable. A very gradual dose reduction would be the only way to decide this.

Case 3. (Antipsychotic Agent)

* 72-year-old man

* Mellaril 400 mg/day x 1 year

* No reason given for drug use

* Transferred from another facility with this order

* Bedfast, unable to walk, talk or feed himself

* Very uncooperative. Yells at nurses

* No documented evidence of harmful behavior

Discussion

The dose is far above the usual daily dose of 75 mg. Also of concern is the duration of treatment. After 6 months, residents should be reevaluated for a possible dose reduction and for any signs of side effects such as tardive dyskinesia.

The fact that the resident was transferred from another facility with this order is cause for concern, since there is no indication that the order was reevaluated upon admission and no documentation of harmful behavior, i.e., indication for use.

Determination

The drug use was deemed inappropriate. Interestingly, a gradual dose reduction was initiated after the survey and the resident became able to walk with a walker and to feed himself and, in general, became more cooperative.

Case 4. (Antianxiety Agent)

* 75-year-old man

* Organic mental syndrome (delirium)

* Ativan 1 mg QID as needed (for pulling at urinary catheter)

* Medication administration record (MAR) shows order was used 10 times in last two weeks and was effective

* Recent admission after prostate surgery

Discussion

In this elderly man with delirium the recent prostate surgery is a telling piece of information, since general anesthesia often causes transient delirium, and this is an indication for use. The drug is a relatively short-acting benzodiazepine and was used only as needed, rather than simply as ordered.

Determination

Drug use in this case is both appropriate and wise: a short-acting drug used only as needed and discontinued after symptoms clear. It's important to note that continued use of the Ativan, as ordered, after the delirium had cleared could have created a dementia-like syndrome of confusion, memory loss and falls.

Case 5. (Antianxiety Agent)

* 70-year-old man

* Organic mental syndrome (dementia)

* Librium 10 mg QID as needed for anxiety

* MAR shows use QID as needed for anxiety

* Has had several falls

* Declining cognition as measured by most recent MDS 

Discussion

Of concern in this case is the use of an especially long-acting drug, as ordered, in an elderly individual. The falls and declining cognition are evidence of harm.

Determination

The drug use is clearly inappropriate and, as a surveyor, I would be obliged to do something about this. Because all the benzodiazepines are known for causing falls (as has already happened in this case), if one of these drugs is needed, a short-acting agent, such as Ativan, should be used.

"Shades of Grey"

From these examples it should be clear that there are no precise boundaries between what is considered appropriate and inappropriate drug use. Much depends on clinical circumstance. The same is true concerning whether a deficiency is rendered. For example, drug utilization in Case 1 is inappropriate but not egregious, so my decision to give a deficiency would depend greatly on how the DON and charge nurse respond to my concerns.

If, for example, the response is along the lines of, "You're right about the side effects and the lack of benefits - but the drug was prescribed by Dr. Jones and he writes Haldol orders for everyone who's admitted," a deficiency would definitely be written if this were confirmed as a pattern. If, however, the DON said it was an order that was transferred with the patient from the hospital and it will be discontinued as soon as possible, it is clear that the DON is aware of the issues involved, and a deficiency would probably serve no purpose.

Focusing on the facts at-hand and the staff's response to them helps me, as a surveyor, to change or reinforce behavior, rather than simply cite and fine. That is the ultimate purpose of the OBRA survey.

Samuel Kidder, PharmD, MPH, is a Pharmacy Consultant for the Health Care Financing Administration.