Download Drugs That Require Gradual Dose Reduction (GDR)

CE Offering/Geriatrics
for a calendar year. Because costs are now
indexed to the increase in average total
drug expenses of Medicare beneficiaries,
out-of-pocket expenses will likely increase
incrementally. The larger issue for prescribers is the multitude of provider organizations (Medicare drug plans), because each
has its own unique formulary.
CMS requires that nursing homes honor
each resident’s right to make an informed
choice of Medicare D plan. This can become
an issue when a nursing home has a contractual agreement with a specific pharmacy
to supply medication for residents. Nursing
homes are now required to work with such
pharmacies to recognize resident choices or
to add additional pharmacies, as necessary.
(See www.cms.hhs.gov/SurveyCertification
GenInfo/downloads/SCLetter06-16.pdf.)
The initial challenge for the patient’s family
and provider is selecting a formulary that
supplies most of the drugs the patient is
taking — or changing drugs to meet the
requirements of a given plan. The latter
choice becomes risky if a patient is stable
on a given drug and dose. Enrollees can
switch health care providers only once each
year, during an open enrollment period.
Due to the rapidly changing medication
needs of frail older adults in LTC, a recent
change in CMS regulations allows these
patients to change plans as frequently as
once a month — if the change is necessary
to maintain continuity of drug use. (This
ability to change becomes effective on the
first of the month that follows the patient’s
initial month of residence.) The ability to
switch coverage plans presents an obvious
challenge to maintaining safe drug use and
preventing adverse drug reactions.13
New Federal Guidelines for Pharmacy
Services. The nurse practitioner in the
skilled nursing setting is further restricted in
medication selection by federal regulations
established by the Nursing Home Reform
Act.14 Contained within this legislation are
Table 5
Drugs That Require Gradual Dose Reduction (GDR)
Sedatives and Hypnotics
GDR required quarterly
• benzodiazepines
• chloral hydrate (Aquachloral)
• eszopiclone (Lunesta)
• zaleplon (Sonata)
• zolpidem (Ambien)
• sedating antihistamines (dipenhydramine
[Benadryl], hydroxyzine [Vistaril])
• ramelteon (Rozerem)
• sedating antidepressants
First-Generation Antipsychotics
GDR required twice in first year, in two separate quarters; wait at least 1 month between attempts
• chlorpromazine (Thorazine)
• perphenazine (Trilafon)
• fluphenazine (Prolixin)
• thioridazine (Mellaril)
• haloperidol (Haldol)
• thiothixene (Navane)
• loxapine (Loxapac)
• trifluoperazine (Stelazine)
• mesoridazine (Serentil)
• triflupromazine (Vesprin)
• molindone (Moban)
Second-Generation Antipsychotics
GDR required twice in first year, in two separate quarters; wait at least 1 month between attempts
• clozapine (Clozaril)
• ziprasidone (Zeldox)
• aripiprazole (Abilify)
• quetiapine (Seroquel)
• olanzapine (Zyprexa)
• risperidone (Risperdal)
Anxiolytics (when used to manage behavior, stabilize mood or treat a psychiatric disorder)
GDR required twice in first year, in two separate quarters; wait at least 1 month between attempts
• benzodiazepines
• antidepressants
• buspirone (Buspar)
• cognitive enhancers
• anticonvulsants
Exempted indications:
Used for neuromuscular syndromes
Long-acting benzodiazepine used to withdraw a resident from a short-acting benzodiazepine
Symptom relief in end-of-life situations
Source: CMS Manual System. Department of Health and Human Services Publication 100-07. Available at http://www.ascp.
com/resources/nhsurvey/#updates
34
September 2007 • ADVANCE FOR NURSE PRACTITIONERS • WWW.ADVANCEWEB.COM/NP
strict prescriptive guidelines for the use of
certain drugs in nursing homes. Guidelines
to interpret the regulations are published
in the State Operations Manual (SOM).
Included in the SOM are interpretive guidelines offering detailed instruction to surveyors. Several revisions have been made since
the original guidelines were published in
1992. To qualify for federal reimbursement
under Medicare and Medicaid, facilities
must comply with these regulations. CMS
has the authority to apply a wide array of
sanctions for noncompliance.
In late 2006, CMS implemented new
guidelines for pharmacy services and
unnecessary medications. The new CMS
guidance document emphasizes the importance of seeking an appropriate dose and
duration for each medication and gradual
dose reduction (GDR) or tapering for specific classes of medication. This applies to all
psychotropic drugs, including antidepressants and mood stabilizers. Guidance documents can be found at www.cms.hhs.gov.
Psychotropic medications that require
a dose reduction unless clinically contraindicated are displayed in Table 5. Federal
regulations define “clinically contraindicated” as documented clinical rationale for
why an attempted dose reduction would be
likely to impair function or cause psychiatric instability by exacerbating an underlying
medical or psychiatric disorder.
Adverse Drug Events
Adverse drug events (ADEs) are defined
by the World Health Organization as
“a response to a drug that is noxious and
unintended and occurs at doses normally
used for prophylaxis, diagnosis or therapy of
a disease, or for the modification of psychological function.”15 Serious ADEs are defined
by the Food and Drug Administration as
events caused by a drug that result in a
patient’s death, hospitalization or disability; that cause a congenital abnormality or
life-threatening event; or that require an
intervention to prevent permanent damage.
ADEs are common, contribute to significant
morbidity and health care costs, and carry
the single greatest risk for harm to patients
in hospitals. ADEs are often ambiguous,
may be mistaken for disease progression or
a side effect, or may go unnoticed.
When an ADE occurs, document it in the
medical record, and include the nature of
the reaction and the evidence supporting it.
Older patients who take multiple medications, patients with a history of ADEs, and
patients with a reduced capacity to eliminate medications are at high risk for ADEs.
Few studies have assessed the incidence