Two new PRN (as-needed) medication requirements go into effect on Nov. 28, 2017. These requirements “address the concern that PRN orders for psychotropic and antipsychotic medications may remain in place for an extended period without being reviewed by the resident’s physician, and ensure that benefits and side effects of these medications are evaluated between required physician visits,” said officials with the Centers for Medicare & Medicaid Services (CMS) during a Sept. 7 National Provider Call. “These requirements are not intended to discourage use of these medications when they are needed for the resident’s benefit.” Note: Access the call slides, as well as the transcript and audio recording when available, here.
Nevertheless, implementing these PRN rules may require directors of nursing services to make some system tweaks, for example, to ensure that a resident is evaluated timely when required or to ensure that documentation supports PRN decision-making. However, making system adjustments requires knowing the rules:
What’s a psychotropic?
Psychotropic drugs are a new medication category in the regulations, expanding the types of medications to which the requirements at §483.45(e) apply beyond just antipsychotics. The newly revised interpretive guidance at F757 (Drug Regiment Is Free From Unnecessary Drugs) and F758 (Free From Unnecessary Psychotropic Drugs/PRN Use) in the advance copy of Appendix PP of the State Operations Manual states:
“Psychotropic drug” is defined in the regulations at §483.45(c)(3), as “any drug that affects brain activities associated with mental processes and behavior.” Psychotropic drugs include, but are not limited to the following categories: anti-psychotics, anti-depressants, anti-anxiety, and hypnotics.
“Other drugs which may affect brain activity include: central nervous system agents, mood stabilizers, anticonvulsants, muscle relaxants, anticholinergic medications, antihistamines, NMDA receptor modulators, and over-the-counter natural and herbal products,” said CMS officials during the CMS surveyor training video Pharmacy Services. “As with all medications, the facility should monitor for adverse consequences related to these medications as increased confusion or over-sedation could occur.”
With this new medication category, the requirements that apply to antipsychotic medications in the current survey process will apply to psychotropic medications effective Nov. 28. “These requirements are that psychotropic medications are only given if medically necessary to treat a specific diagnosed and documented condition; gradual dose reductions or GDRs must be implemented unless clinically contraindicated; and facilities must apply nonpharmacological approaches,” said officials. “Keep in mind that GDRs may not be appropriate for specific, enduring, progressive, or terminal conditions, such as chronic depression, Parkinson’s disease psychosis, or recurrent seizures.”
The basic PRN requirements
In general, “residents must not receive psychotropic medication on a PRN basis unless the medication is needed to treat a specific diagnosed and documented condition,” said officials. However, if there are PRN orders for psychotropic medications, providers must meet two separate requirements:
· One for antipsychotic medications only; and
· One for psychotropic medications excluding antipsychotic medications (including but not limited to antidepressants, antianxiety medications, and hypnotics). Note: To differentiate, CMS refers to them as antipsychotics and psychotropics even though antipsychotics are a type of psychotropic medication per the definition.
The F757/F758 interpretive guidance includes a table that shows the differences between the requirements for PRN orders for psychotropic medications and PRN orders for antipsychotic medications:
“As you can see from the table, PRN orders for psychotropic medications are limited to 14 days, but the order may be extended beyond 14 days if the attending physician or prescribing practitioner believes it is appropriate to extend the order. The rationale for extending the order should be documented in the medical record,” said officials.
In response to a caller question about this extension for PRN psychotropic medications, CMS officials on an earlier call also noted that “we don’t have a maximum extension either in the regulations or in the guidance. But we expect it to be reasonable and that the rationale fits the situation for that resident.”
For PRN orders for antipsychotic medications, there is no exception to the 14-day limit, said officials. “If the physician or practitioner believes a resident still needs a PRN order for the antipsychotic medication, a new order must be written, but the resident must first be evaluated to determine if the new order is appropriate,” they explained. “For PRN orders for antipsychotics, there are no exceptions with regard to medical conditions or specific medications.”
In response to a follow-up caller question, officials also noted that the PRN requirement does apply to residents who are on hospice. “The requirement applies to all residents,” officials affirmed. “So if [a hospice resident] has a PRN order for an antipsychotic, it cannot be renewed or a new order cannot be put in for the same medication without an evaluation because of the concerns about the side effects of those medications.”
What exactly is an evaluation?
What the evaluation of a resident prior to writing a new order for a PRN antipsychotic medication entails is explained in the new F757/F758 interpretive guidance in Appendix PP, said officials.
“The attending physician or prescribing practitioner must directly examine the resident and assess the resident’s current condition and progress to determine if the PRN antipsychotic medication is still needed,” they explained. “The evaluation and documentation should address [at a minimum] whether the antipsychotic is still needed on a PRN basis, what the benefit of the medication is to the resident, and whether the resident’s expressions or indications of distress have improved as a result of the medication.”
Given that the evaluation must be a direct examination performed by the attending physician or prescribing practitioner, “staff reporting on the resident’s condition to the attending physician or practitioner does not meet the intent of the regulation,” they stressed. “Lastly, the regulation and guidance do not preclude the use of telemedicine by the attending physician or prescribing practitioner to examine a resident.”
In addition, when surveyors investigate concerns around the use of psychotropic and antipsychotic medications, they should “determine whether the medication may have been used for purposes of discipline or convenience rather than to treat medical symptoms,” said officials. “If there is evidence that the medication is being used to sedate, subdue, or restrict a resident’s movement or cognition, surveyors should assess compliance with … F605 for the right to be free from chemical restraints. …”
Psychotropic and antipsychotic medications PRN checklist
In the new survey process, surveyors will use the Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review Critical Element Pathway to investigate a resident who has potentially unnecessary medications, is prescribed psychotropic (including antipsychotic medications), or has the potential for an adverse outcome to determine whether facility practices are in place to identify, evaluate, and intervene for potential or actual unnecessary medications; and to evaluate the medication regimen review (MRR) process.
Surveyors conducting investigations related to psychotropic and antipsychotic medications will check to see if the facility:
¨ Demonstrates adherence to requirements for as needed (PRN) psychotropic and antipsychotic medications.
· Residents do not receive PRN psychotropic medications unless necessary to treat a diagnosed specific condition which must be documented in the record.
· PRN orders for psychotropic medications which are not antipsychotic medications are limited to 14 days. The attending physician/prescriber may extend the order beyond 14 days if he or she believes it is appropriate. If the attending physician extends the PRN for the psychotropic medication, the medical record must contain a documented rationale and determined duration.
· PRN orders for psychotropic medications which are antipsychotic medications are limited to 14 days. A PRN order for an antipsychotic cannot be renewed unless the attending physician/prescriber evaluates the resident to determine if it is appropriate to write a new PRN order for the antipsychotic medication. The evaluation entails direct evaluation of the resident and assessment of the resident’s current conditions and progress to determine if the PRN antipsychotic medication is still needed. Attending physician/prescribing practitioner documentation of the evaluation should address:
o Whether the antipsychotic medication is still needed on a PRN basis?
o What is the benefit of the medication to the resident?
o Have the resident’s expressions or indications of distress improved as a result of the PRN antipsychotic medication?
Surveyor interviews with staff (Nursing Aides, Nurse, Director of Nursing, Social Services) will include this question related to PRN orders for these medications:
¨ If the resident is receiving PRN psychotropic or antipsychotic medication(s): How is this medication monitored and how does the IDT determine if the PRN medication is clinically indicated and ensure the PRN orders are consistent with PRN requirements for psychotropic and antipsychotic medications?
Surveyor interviews with pharmacists will include this question related to PRN orders for these medications:
¨ How do you evaluate PRN medications, specifically PRN psychotropic and antipsychotic medications?
Source: Unnecessary Medications, Psychotropic Medications, and Medication Regimen Review Critical Element Pathway (form CMS-20082). Access all Critical Element Pathways here.
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