Checked
Condition applies under the item instruction.
Manual page N-4DiraChart MDS item reference
This item is referenced against CMS MDS source materials. Verify coding against the current CMS RAI Manual, item set instructions, and facility documentation before submission.
Use the item-specific response choices below when structured codes apply.
Condition applies under the item instruction.
Manual page N-4Condition does not apply under the item instruction.
Manual page N-4Review what the item asks, how to choose the response, and what should be verified before submission.
1. Review the resident’s medical record for documentation
that any of these medications were received by the resident
and for the indication of their use during the 7-day look-
back period (or since admission/entry or reentry if less than
7 days).
2. Review documentation from other health care settings
where the resident may have received any of these
medications while a resident of the nursing home (e.g.,
valium given in the emergency room).
•
Code all high-risk drug class medications according to
their pharmacological classification, not how they are
being used.
o Column 1: Check if the resident is taking any
medications by pharmacological classification
during the 7-day observation period (or since
admission/entry or reentry if less than 7 days).
o Column 2: If Column 1 is checked, check if there is an indication noted for all
medications in the drug class.
DEFINITIONS
INDICATION
The identified, documented
clinical rationale for
administering a medication
that is based upon a
physician’s (or prescriber’s)
assessment of the resident’s
condition and therapeutic
goals.
DOSE
The total amount/strength/
concentration of a medication
given at one time or over a
period of time. The individual
dose is the amount/strength/
concentration received at
each administration. The
amount received over a 24-
hour period may be referred
to as the “daily dose.”
MONITORING
The ongoing collection and
analysis of information (such
as observations and
diagnostic test results) and
comparison to baseline and
current data in order to
ascertain the individual's
response to treatment and
care, including progress or
lack of progress toward a
goal. Monitoring can detect
any improvements,
complications, or adverse
consequences of the
condition or the treatments
and support decisions about
adding, modifying,
continuing, or discontinuing
any interventions.
N0415: High-Risk Drug Classes: Use and Indication (cont.)
•
N0415A1. Antipsychotic: Check if an antipsychotic medication was taken by the
resident at any time during the 7-day look-back period (or since admission/entry or
reentry if less than 7 days).
•
N0415A2. Antipsychotic: Check if there is an indication noted for all antipsychotic
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415B1. Antianxiety: Check if an anxiolytic medication was taken by the resident
at any time during the 7-day look-back period (or since admission/entry or reentry if less
than 7 days).
•
N0415B2. Antianxiety: Check if there is an indication noted for all anxiolytic
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415C1. Antidepressant: Check if an antidepressant medication was taken by the
resident at any time during the 7-day look-back period (or since admission/entry or
reentry if less than 7 days).
•
N0415C2. Antidepressant: Check if there is an indication noted for all
antidepressant medications taken by the resident any time during the observation period
(or since admission/entry or reentry if less than 7 days).
•
N0415D1. Hypnotic: Check if a hypnotic medication was taken by the resident at any
time during the 7-day look-back period (or since admission/entry or reentry if less than 7
days).
•
N0415D2. Hypnotic: Check if there is an indication noted for all hypnotic
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415E1. Anticoagulant (e.g., warfarin, heparin, or low-molecular
weight heparin): Check if an anticoagulant medication was taken by the resident at
any time during the 7-day look-back period (or since admission/entry or reentry if less
than 7 days).
•
N0415E2. Anticoagulant: Check if there is an indication noted for all anticoagulant
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415F1. Antibiotic: Check if an antibiotic medication was taken by the resident at
any time during the 7-day look-back period (or since admission/entry or reentry if less
than 7 days).
•
N0415F2. Antibiotic: Check if there is an indication noted for all antibiotic
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415G1. Diuretic: Check if a diuretic medication was taken by the resident at any
time during the 7-day look-back period (or since admission/entry or reentry if less than 7
days).
N0415: High-Risk Drug Classes: Use and Indication (cont.)
•
N0415G2. Diuretic: Check if there is an indication noted for all diuretic medications
received by the resident any time during the observation period (or since admission/entry
or reentry if less than 7 days).
•
N0415H1. Opioid: Check if an opioid medication was taken by the resident at any
time during the 7-day look-back period (or since admission/entry or reentry if less than 7
days).
•
N0415H2. Opioid: Check if there is an indication noted for all opioid medications
taken by the resident any time during the observation period (or since admission/entry or
reentry if less than 7 days).
•
N0415I1. Antiplatelet: Check if an antiplatelet medication (e.g., aspirin/extended
release, dipyridamole, clopidogrel) was taken by the resident at any time during the 7-day
observation period (or since admission/entry or reentry if less than 7 days).
•
N0415I2. Antiplatelet: Check if there is an indication noted for all antiplatelet
medications taken by the resident any time during the observation period (or since
admission/entry or reentry if less than 7 days).
•
N0415J1. Hypoglycemic (including insulin): Check if a hypoglycemic
medication was taken by the resident at any time during the 7-day observation period (or
since admission/entry or reentry if less than 7 days).
•
N0415J2. Hypoglycemic (including insulin): Check if there is an indication
noted for all hypoglycemic medications taken by the resident any time during the
observation period (or since admission/entry or reentry if less than 7 days).
•
N0415K1. Anticonvulsant: Check if an anticonvulsant medication was taken by the
resident at any time during the 7-day observation period (or since admission/entry or
reentry if less than 7 days).
•
N0415K2. Anticonvulsant: Check if there is an indication noted for all
anticonvulsant medications taken by the resident any time during the observation period
(or since admission/entry or reentry if less than 7 days).
•
N0415Z1. None of the above: Check if none of the medications above were taken
by the resident at any time during the observation period (or since admission/entry or
reentry if less than 7 days).
and Special Populations
•
Code medications in Item N0415 according to the medication’s therapeutic category
and/or pharmacological classification, not how it is used. For example, although
oxazepam may be prescribed for use as a hypnotic, it is categorized as an antianxiety
medication. Therefore, in this section, it would be coded as an antianxiety medication and
not as a hypnotic.
N0415: High-Risk Drug Classes: Use and Indication (cont.)
•
Facilities may wish to identify a resource that their staff consistently use to identify
pharmacological classification as assessors should be able to identify the source(s) used
to support coding the MDS 3.0.
•
Assessors should consult the manufacturer’s package insert, which may contain the
medication’s pharmacological classification. They can also work with the resident’s
pharmacist to confirm the medication classification(s) for a resident’s medication(s).
•
Medications that have more than one therapeutic category and/or pharmacological
classification should be coded in all categories/classifications assigned to the medication,
regardless of how it is being used. For example, prochlorperazine is dually classified as
an antipsychotic and an antiemetic. Therefore, in this section, it would be coded as an
antipsychotic, regardless of how it is used.
•
Include any of these medications given to the resident by any route in any setting (e.g., at
the nursing home, in a hospital emergency room) while a resident of the nursing home.
•
Do not code antiplatelet medications such as aspirin/extended release, dipyridamole, or
clopidogrel as N0415E, Anticoagulant.
•
Anticoagulants such as Target Specific Oral Anticoagulants (TSOACs), which may or
may not require laboratory monitoring, should be coded in N0415E, Anticoagulant.
•
Do not code flushes to keep an IV access patent in N0415E, Anticoagulant.
•
Code a medication even if it was given only once during the look-back period.
•
Count long-acting medications, such as fluphenazine decanoate or haloperidol decanoate,
that are given every few weeks or monthly only if they are given during the 7-day look-
back period (or since admission/entry or reentry if less than 7 days).
•
Transdermal patches are generally worn for and release medication over a period of
several days. To code N0415, only capture the medication if the transdermal patch was
applied to the resident’s skin during the observation period. For example, if, during the 7-
day look-back period, a fentanyl patch was applied on days 1, 4, and 7, N0415H Opioid
would be checked, because the application occurred during the look-back period.
•
Combination medications should be coded in all categories/pharmacologic classes that
constitute the combination. For example, if the resident receives a single tablet that
combines an antipsychotic and an antidepressant, then both antipsychotic and
antidepressant categories should be coded.
•
Over-the-counter sleeping medications are not coded as hypnotics, as they are not
categorized as hypnotic medications.
N0415: High-Risk Drug Classes: Use and Indication (cont.)
•
Herbal and alternative medicine products are considered to be dietary supplements by the
Food and Drug Administration (FDA). These products are not regulated by the FDA
(e.g., they are not reviewed for safety and effectiveness like medications) and their
composition is not standardized (e.g., the composition varies among manufacturers).
Therefore, they should not be counted as medications (e.g., melatonin, chamomile,
valerian root). Keep in mind that, for clinical purposes, it is important to document a
resident’s intake of such herbal and alternative medicine products elsewhere in the
medical record and to monitor their potential effects as they can interact with medications
the resident is currently taking. For more information consult the FDA website
https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-
supplements.
•
Opioid medications can be an effective intervention in a resident’s pain management
plan, but also carry risks such as overuse and constipation. A thorough assessment and
root-cause analysis of the resident’s pain should be conducted prior to initiation of an
opioid medication and re-evaluation of the resident’s pain, side effects, and medication
use and plan should be ongoing.
•
Residents who are on antidepressants should be closely monitored for worsening of
depression and/or suicidal ideation/behavior, especially during initiation or change of
dosage in therapy. Stopping antidepressants abruptly puts one at higher risk of suicidal
ideation and behavior.
•
When residents are having difficulty sleeping, nursing
home staff should explore non-pharmacological
interventions (e.g., sleep hygiene approaches that
individualize the sleep and wake times to accommodate
the person’s wishes and prior customary routine) to try
to improve sleep prior to initiating pharmacologic
interventions. If residents are currently on sleep-
enhancing medications, nursing home staff can try non-
pharmacologic interventions to help reduce the need for these medications or eliminate
them.
•
Many psychoactive medications increase confusion, sedation, and falls. For those
residents who are already at risk for these conditions, nursing home staff should develop
plans of care that address these risks.
•
Doses of psychoactive medications differ in acute and long-term treatment. Doses should
always be the lowest possible to achieve the desired therapeutic effects and be deemed
necessary to maintain or improve the resident’s function, well-being, safety, and quality
of life. Duration of treatment should also be in accordance with pertinent literature,
including clinical practice guidelines.
•
Since medication issues continue to evolve and new medications are being approved
regularly, it is important to refer to a current authoritative source for detailed medication
information, such as indications and precautions, dosage, monitoring, or adverse
consequences.
DEFINITION
SLEEP HYGIENE
Practices, habits and
environmental factors that
promote and/or improve
sleep patterns.
N0415: High-Risk Drug Classes: Use and Indication (cont.)
•
Anticoagulants must be monitored with dosage
frequency determined by clinical circumstances and
duration of use. Certain anticoagulants require
monitoring via laboratory results (e.g., Prothrombin
Time [PT]/International Normalization Ratio [INR]).
— Multiple medication interactions exist with use of
anticoagulants (information on common
medication-medication interactions can be found in
the State Operations Manual, Appendix PP,
Guidance to Surveyors for Long Term Care
Facilities at https://www.cms.gov/regulations-and-
guidance/guidance/manuals/internet-only-manuals-
ioms-items/cms1201984, which may
○ significantly increase PT/INR results to levels
associated with life-threatening bleeding, or
○ decrease PT/INR results to ineffective levels, or
increase or decrease the serum concentration of
the interacting medication.
Example
1. The Medication Administration Record for Resident P reflects the following during the 7-day
observation period:
•
Risperidone 0.5 mg PO BID PRN: Received once a day on Monday, Wednesday, and
Thursday for bipolar disorder.
•
Lorazepam 1 mg PO QAM: Received every day for bipolar disorder.
•
Temazepam 15 mg PO QHS PRN: Received at bedtime on Tuesday and Wednesday only.
Coding: Medications in N0415, would be coded as follows: N0415A1 and
N0415A2. Antipsychotic = checked; risperidone is an antipsychotic
medication and indication of use for bipolar disorder noted. N0415B1 and
N0415B2. Antianxiety = checked; lorazepam is an antianxiety medication and
indication of use for bipolar disorder noted. N0415D1. Hypnotic = checked;
temazepam is a hypnotic medication. N0415D2. Hypnotic = not checked;
indication for use of temazepam was not noted.
Please note: if a resident is receiving medications in all three of these high-risk drug
classes simultaneously there must be a c
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