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Proposed Changes Offer Protections against Psychotropic Drugs

In July, the Centers for Medicare and Medicaid Services (CMS) proposed multiple rule changes applicable to nursing homes that accept funding from Medicare and Medicaid. Today we address the use of psychotropic drugs in nursing homes and the proposed rule changes to protect against their abuse. Psychotropic drugs include a broad range of drug categories, including anti-psychotic, anti-depressant, anti-anxiety, hypnotics, and opioid analgesic. These drugs have very important uses when prescribed correctly, but they also carry dangerous side effects, especially for people suffering from dementia.

Dementia patients frequently experience behavioral and psychological symptoms of dementia (BPSD) including agitation, aggression, cursing and swearing, anxiety, depression, psychosis, and wandering. As you can probably imagine or might have experienced personally, these symptoms make it more difficult to care for someone, but they can oftentimes be prevented or managed without the use of medication. However, these alternative approaches take time, effort, and patience. As a result, we often see these drugs overused in nursing home cases that we handle at Jehl Law Group.  Particularly, facilities that are under staffed or short staffed may use these drugs in excess as a way to chemically restrain residents.

These drugs carry serious side effects, especially for seniors. In particular, anti-psychotics can be dangerous if not FDA-approved “for the treatment of dementia-related psychosis.” It has been further warned by the FDA that these drugs can place dementia patients at “an increased risk of death.”[1] Not all the side effects are that serious, but most of the drugs carry risk of sedation (which is why they are used as chemical restraints), dizziness, and increased confusion. These side effects greatly increase the likelihood of falls, which oftentimes result in fractures and injuries that can be deadly to seniors. There are numerous other side effects associated with each specific psychotropic drug.

The proposed changes offer some safeguards against the over-prescription of these psychotropic drugs. For example, a new section called “Behavioral Health Services” requires training specifically related to caring for residents with mental illnesses and psychosocial disorders. This training would have to include knowledge of non-pharmacological (not involving drugs) interventions in these cases. The proposed changes to the “Pharmacy Services” section also include protections against psychotropic drugs. Specifically, they would increase the oversight that pharmacists must have when these drugs are prescribed, and they would require monthly reviews and reports when there were irregularities. Furthermore, the proposed changes would restrict the use of psychotropic drugs in patients who had never been prescribed them before, and they would also require gradual dose reductions for these drugs whenever possible. Finally, the proposed changes would limit the use of PRN (as needed) orders for psychotropic drugs. Currently doctors can prescribe these drugs PRN so that nurses can administer these drugs when they feel necessary. The new requirements would limit the amount of time that these PRN orders could be used to 48 hours. The doctor would then have to document their rationale for continuing the use of any psychotropic drug. This added oversight by doctors is designed to reduce unnecessary use of psychotropic drugs.

As we mentioned in our post on arbitration agreements, the Jehl Law Group supports these changes. However, although the proposed changes call for more training, they do not specify who will actually receive this training. Will there be enough staff to support these non-pharmacological interventions? Also, who will hold the pharmacists accountable when they review the use of psychotropic drugs, particularly when the pharmacy is owned by the nursing home?

 

[1]http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107211.htm