CMS/Medicare high-risk medication list

The Centers for Medicare and Medicaid Services (CMS) has identified the drugs listed here as posing a higher risk to patients, especially to seniors.

Download and print a copy of the CMS High-Risk Medication guide (313KB PDF)

Key:

  • Boldface = higher risk
  • ALL CAPS = brand name
  • lower case = generic
  • Initial caps = OTC
  • NA = not available
  • ST = step therapy required
  • B/D = Medicare Part B/Part D determination needed for prior authorization

Jump down the page to view:

Alpha blockers (central) Antihistamines, first generation Anti-infectives
Anti-platelets Barbiturates Cardiac glycosides
Cardiovascular (other) CNS (other)  Endocrine, desiccated thyroid
Endocrine, estrogens Endocrine, megestrol Gastrointestinal 
Non-benzodiazepine hypnotics  Non-COX selective NSAIDS  Oral hypoglycemics 
Pain medications Parkinson's disease  Skeletal muscle relaxants
Sulfoylureas, long duration  Tertiary trycyclic antidepressants Vasodilators for dementia 
Alpha blockers (central)

High risk of adverse CNS effects: May cause bradycardia and orthostatic hypotension.

  • guanfacine (INTUNIV, TENEX)
  • methyldopa (ALDOMET)
  • reserpine (>0.1 MG/DAY) (Included in CMS's 5-star measure for any beneficiary with two or more fills in a calendar year)

Alternatives

Thiazide-type diuretics, preferred for African-American individuals and heart failure)

  • chlorthalidone, T2 (THALITONE)
  • hydrochlorothiazide, T1 (HYDRODINURIL, MICROZIDE)
  • indapamide, T1 (LOZOL)
  • metolazone, T2 (ZAROXOLYN)

ACE inhibitors, preferred for heart failure, diabetes mellitus and chronic kidney disease

  • benazepril, T1 (LOTENSIN)
  • captopril, T1 (CAPOTEN)
  • enalapril, T1 (VASOTEC)
  • fosinopril, T2 (MONOPRIL)
  • lisinopril, T1 (PRINIVIL, ZESTRIL)
  • moexipril, T2 (UNIVASC)
  • perindopril, T2 (ACEON)
  • quinapril, T2 (ACCUPRIL)
  • ramipril, T2 (ALTACE)
  • trandolapril, T2 (MAVIK)

Angiotensin receptor blockers (ARBs), preferred for heart failure, diabetes mellitus and chronic kidney disease)

  • BENICAR, non-formulary
  • candesartan, T2 (ATACAND)
  • EDARBI, non-formulary
  • eprosartan, T2 (TEVETEN)
  • irbesartan, T2 (AVAPRO)
  • losartan, T1 (COZAAR)
  • telmisartan, T2 (MICARDIS)
  • valsartan, T2 (DIOVAN)

Calcium channel blockers

  • Afeditab CR, T2 (ADALAT CC)
  • amlodipine, T1 (NORVASC)
  • AZOR, T4
  • CARDIZEM LA, T4
  • Dilt-XR, T2 (DILACOR XR)
  • diltiazem, T2 (CARDIZEM)
  • diltiazem CD, T2 (CARDIZEM CD)
  • diltiazem ER, T2 (CARDIZEM LA, TIAZAC)
  • felodipine ER, T2 (PLENDIL)
  • isradipine, T2 (DYNACIRC)
  • nicardipine, T2 (CARDENE)
  • nifedipine ER, T2 (PROCARDIA XL)
  • nisoldipine ER, T2 (SULAR)
  • verapamil, T2 (CALAN)
  • verapamil ER, T2 (CALAN SR, ISOPTIN SR)
  • verapamil SR, T2 (VERELAN)
Antihistamines, first generation

Highly anticholinergic (risk of confusion, dry mouth, constipation, blurred vision, drowsiness, hallucinations, difficulty urinating); clearance reduced with advanced age (risk of toxicity); tolerance develops when used as hypnotic.

  • brompheniramine
  • carbinoxamine
  • chlorpheniramine
  • clemastine
  • cyproheptadine (PERIACTIN)
  • dexbrompheniramine
  • dexchlorpheniramine
  • diphenhydramine (oral) (BENADRYL)
  • doxylamine
  • hydroxyzine (ATARAX, VISTARIL)
  • promethazine (PHENERGAN)
  • triprolidine

Saline:

  • intranasal saline, OTC

Second-generation antihistamines:

  • cetirizine (generic for Zyrtec), OTC1
  • fexofenadine (generic for Allegra), OTC1
  • loratadine (generic for Claritin), OTC1
  • CLARINEX SYRUP, T4
  • desloratadine (generic for Clarinex), T2
  • desloratadine ODT (generic for Clarinex RediTab), T2
  • levocetirizine (generic for Xyzal), T2

Intranasal steroids:

  • BECONASE AQ, T4
  • fluticasone nasal spray (generic for Flonase), T1
  • NASONEX, T4
  • OMNARIS, T4
  • QNASAL, T4
  • triamcinolone acetonide (generic for Nasacort AQ), T2
Anti-infectives

Potential for pulmonary toxicity, hepatoxicity, and peripheral neuropathy, especialy with long-term use.

  • nitrofurantoin (MAROBID, MACRODANTIN) (included in CMS's 5-star measure if beneficiary has two or more fills AND receives 90 or more cumulative days of treatment in a calendar year)

Alternatives:

None recommended by The American Geriatrics Society; however, may consider the following:

  • ciprofloxin (CIPRO)
  • MONUROL
  • trimethoprim (PROLOPRIM)
  • trimethoprim/sulfamethoxozole (BACTRIM)
  • trimethoprim/sulfamethoxozole DS (BACTRIM DS)
Antiplatelets

Immediate release may cause orthostatic hypotension. Safer, effective alternatives available.

  • dipyridamole (PERSANTINE)
  • ticlopidine (TICLID)

Alternatives:

  • clopidogrel (generic for PLAVIX), T2
  • aspirin/dipyridamole (generic for AGGRENOX), T2
Antipsychotics, first generation (conventional)

Increased risk of stroke, cognitive decline, and mortality in persons with dementia. Avoid use for behavioral problems related to dementia or delirium unless there is threat of substantial harm to self or others.

  • thioridazine (MELLARIL)

Alternatives: For schizophrenia, use nonanticholinergic antipsychotics: 

  • aripiprazole, T3 (ABILIFY)
  • haloperidol tablet, T1 (HALDOL)
  • risperidone, T2 (RISPERDAL)
  • risperidone ODT, T2 (RISPERDAL M-Tab) 
  • thiothixene, T2 (NAVANE) 
  • ziprasidone, T2 (GEODON)
Barbiturates

High rate of physical dependence, tolerance to sleep benefits, and a greater risk of overdose at low doses.

  • amobarbital (AMYTAL)
  • butabarbital (BUTISOL)
  • butalbital/combinations (FIORICET, FIORINAL, etc.)
  • pentobarbital (NEMBUTAL)
  • phenobarbital (LUMINAL)
  • secobarbital (SECONAL)

Alternatives for epilepsy:

  • lamotrigine, T2 (LAMICTAL)
  • levetiracetam, T2 (KEPPRA)
  • Other anticonvulsants
Cardiac glycosides

No additional efficacy vs. lower doses; toxicity due to reduced renal clearance.

  • digoxin (LANOXIN, DIGITEK, LANOXICAPS)

Alternatives:

Consider discontinuing or dose reduction (e.g. 0.125mg) with monitoring.

Cardiovascular (other)

Disopyramide is a potent negative inotrope and may induce heart failure in older adults. Strongly anticholinergic (risk of confusion, dry mouth, constipation, blurred vision, drowsiness, hallucinations, difficulty urinating)

  • disopyramide (NORPACE, NORPACE CR)

Alternatives for atrial fibrillation rate control:

  • diltiazem, T2 (CARDIZEM)
  • diltiazem CD, T2 (CARDIZEM CD)
  • diltiazem ER, T2 (CARDIZEM LA, TIAZAC)
  • verapamil, T2 (CALAN, ISOPTIN)
  • verapamil ER, T2 (CALAN SR, ISOPTIN SR)
  • verapamil SR, T2 (VERELAN)

Digoxin is not a first-line drug for use in atrial fibrillation. The risk of death may be higher with digoxin compared to other, more effective, alternatives.

  • digoxin (>0.125 mg/day) (LANOXIN) (Included in CMS 5-star measure only when a beneficiary has 2 or more fills with an average daily dose > 0.125 mg.)

Alternatives for atrial fibrillation rhythm control:

  • flecainide, T2 (TAMBOCOR)
  • propafenone, T2 (RYTHMOL)
  • TIKOSYN, T4

Risk of precipitating myocardial ischemia and possible hypotension.

  • nifedipine (immediate release)

Alternatives:

  • amlodipine, T1 (NORVASC)
  • felodipine ER, T2 (PLENDIL)
  • nifedipine ER, T2 (PROCARDIA XL)
CNS (other)

Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium. Avoid antipsychotics for behavioral problems of dementia or delirium unless nonpharmalogical options (e.g., behavioral interventions) have failed or are not possible and the older adult is threatening substantial harm to self or others. Antipsychotics are associated with greater risk of cerebrovascular accident (stroke) and mortality in persons with dementia. Meprobamate has a high rate of physical dependence and is very sedating.

  • chloral hydrate (SOMNOTE)
  • meprobamate (MILTOWN)

Alternatives:

For anxiety

  • buspirone (BUSPAR), T2

SSRIs

  • citalopram, T1 (CELEXA)
  • escitalopram, T2 (LEXAPRO)
  • fluoxetine, T1 (PROZAC) 1
  • fluoxetine delayed-release, T2 (PROZAC Weekly)
  • sertraline, T1 (ZOLOFT)
  • VIIBRYD, T4

SNRIs

  • DESVENLAFAXINE ER, T4
  • duloxetine, T2 (CYMBALTA)
  • FETZIMA, T4
  • KHEDEZLA, T4
  • PRISTIQ, T4
  • venlafaxine, T2 (EFFEXOR)
  • venlafaxine extended-release, T2 (EFFEXOR XR)
  • venlafaxine ER tablet, T4
  • VENLAFAXINE ER tablet, 225 MG, T4
Endocrine, desiccated thyroid

There are concerns about cardiac effects, and safer alternatives are available.

  • desiccated thyroid (ARMOUR THYROID)

Alternatives:

  • levothyroxine, T1 (LEVOXYL, SYNTHROID)
  • LEVOXYL, T2
  • liothyronine, T2 (CYTOMEL)
  • SYNTHROID, T4
  • THYROLAR, T4
  • TIROSINT, T4
  • UNITHROID, T2
Endocrine, estrogens

There is evidence of potential breast and endometrium cancer. There is also a lack of cardioprotective effect and cognitive protection in older women.

Oral:

  • conjugated estrogen (CENESTIN, ENJUVIA, PREMARIN)
  • conjugated estrogen combinations (DUAVEE, PREMPHASE, PREMPRO)
  • esterified estrogen (MENEST)
  • esterified estrogen & methyltestosterone (COVARYX, COVARYX HS, EEMT, EEMT HS, ESSIAN, ESSIAN HS, ESTRATEST, ESTRATEST HX, SYNTEST DS, SYNTEST HS)
  • estradiol (ESTRACE, GYNODIOL)
  • estradiol/norethindrone (ALORA, CLIMARA, DELESTROGEN, DEPOGYNOGEN, DEPO-ESTRADIOL, DEPOGEN, DIVIGEL, ELESTRIN, ESCLIM, ESTRACE, ESTRADERM, ESTRASORB, ESTRING, ESTROGEL, EVAMIST, FEMPATCH, FEMRING, GYNODIOL, GYNOGEN LA, MENOSTAR, MINIVELLE, VALERGEN, VIVELLE, VIVELLE DOT)
  • estradiol combinations (ACTIVELLA, COMBIPATCH, LOPREEZA, MIMVEY, MIMVEYLO)

Alternatives:

Dyspareunia and vulvovaginitis:

  • ESTRING, T3
  • FEMRING, T3
  • PREMARIN VAGINAL CREAM, T3
  • VAGIFEM, T3

Vasomotor symptoms, SSRIs:

  • citalopram, T1 (CELEXA)
  • escitalopram, T2 (LEXAPRO)
  • fluoxetine, T1 (PROZAC)
  • fluoetine delayed release, T2 (PROZAC Weekly)
  • sertraline, T1 (ZOLOFT)
  • VIIBRYD, T4

Vasomotor symptoms, SNRIs:

  • DESVENLAFAXINE ER, T1
  • duloxetine, T2 (CYMBALTA)
  • FETZIMA, T1
  • KHEDEZLA, T4
  • PRISTIQ, T4
  • venlafaxine, T2 (EFFEXOR)
  • venlafaxine extended release, T2 (EFFEXOR ER)
  • VENLAFAXINE ER tablet, T4
  • VENLAFAXINE ER tablet 225 mg, T4
Endocrine, megestrol

Megestrol has minimal effect on weight and increases risk of thrombotic events, and possibly death, in older adults.

  • megestrol (MEGACE, MEGACE ES)

Alternatives: None recommended by the American Geriatrics Society.

Gastrointestinal

One of the least effective antiemetic drugs; can cause extrapyramidal adverse effects (agitation, abnormal or involuntary movement, and psuedoparkinsonism).

  • trimethobenzamide (TIGAN)

Alternatives: None recommended by the American Geriatrics Society

Nonbenzodiazepine hypnotics

Risk of: delirium, falls, and fractures; increased emergency department visits and hospitalizations; motor vehicle crashes. These drugs produce minimal improvement in sleep latency and duration.

  • eszopiclone (LUNESTA)
  • zaleplon (SONATA)
  • zolpidem (AMBIEN, AMBIEN CR)

Alternatives: None recommended by the American Geriatrics Society. However, may consider:

  • Temazepam2, T1 (RESTORIL) (Not recommended by the American Geriatrics Society because of increased risk for cognitive impairment, delirium, falls, fractures and motor vehicle accidents.)
  • trazodone, T1
  • ROZEREM, T5
Non-COX-selective NSAIDS

Increased risk of gastrointestinal bleeding, peptic ulcer disease and acute kidney injury in older adults compared to other NSAIDs.

  • indomethacin (INDOCIN)
  • ketorolac (SPRIX, TORADOL)

Alternatives:

  • acetaminophen, OTC1 (Tylenol)
  • ibuprofen2, T1 (Motrin)
  • naproxen2, T1 (Naprosyn)
  • salsalate, T2 (DISALCID)
Oral hypoglycemics

Risk of prolonged hypoglycemia; risk of SIADH.

  • chlorpropamide (DIABINESE, INSULASE)
  • glyburide (DIABETA, MICRONASE, GLYCRON, GLYNASE)
  • glyburide/metformin (GLUCOVANCE)

Alternatives:

  • glimepiride (AMARYL), T1
  • glipizide (GLUCOTROL), T1
Pain medications

Not effective as a pain reliever in commonly used doses. May have a higher risk of neurotoxicity, including delirium, compared to other opiods.

meperidine (DEMEROL)

Alternatives:

  • morphine sulfate immediate release, T2 (MSIR)
  • morphine sulfate extended-release 12-hour capsule, T4 (KADIAN)
  • morphine sulfate extended-release tablet, T2 (MS CONTIN)

Causes CNS adverse effects more commonly than other opiod analgesics, including confusion and hallucinations. Also a mixed agonist and antagonist.

  • pentazocine (TALACEN, TALWIN, TALWIN COMPOUND, TALWIN NX)

Alternatives:

  • oxycodone/acetaminophen, T2 (PERCOCET)
  • tramadol, T2 (ULTRAM)

Moderate/severe pain:

  • tramadol, T2
  • morphine sulfate (MS Contin), T2
  • hydrocodone/APAP (VICODIN, etc.), T2
  • oxycodone (OXY IR), T2
  • oxycodone/APAP (PERCOSET), T2
  • fentanyl patch (DURAGESIC), T2
  • OXYCONTIN, T5
  • AVINZA, T5 (ST)
Parkinson's disease

Not recommended for prevention of extrapyramidal symptoms with antipsychotics; more effective agents available for treatment of Parkinson's disease.

  • benztropine (COGENTIN)
  • trihexyphenidyl (ARTANE)

Alternatives:

  • carbidopa/levodopa (generic for SINEMET), T2
  • carbidopa/levodopa ER (generic for SINEMETCR), T2
  • carbidopa/levodopa ODT (generic for PARCOPA), T2
Skeletal muscle relaxants

Most muscle relaxants are poorly tolerated by older adults because some have anticholinergic adverse effects, sedation, and increased risk of fractures. 

  • carisoprodol (SOMA)
  • chlorzoxazone (PARAFON FORTE)
  • cyclobenzaprine (FLEXERIL, AMRIX, FEXMID)
  • metaxalone (SKELAXIN)
  • methocarbamol (ROBAXIN)
  • orphenadrine (NORFLEX)

Alternatives:

  • acetaminophen, OTC1 (Tylenol)
  • ibuprofen*, 2, T1 (Motrin)
  • naproxen*,2, T1 (Naprosyn)
  • salsalate, T2 (Disalsid)

*Use only if no heart failure and estimated GFR > 30mL/min. Use PPI combination if used > 7 days.

May also consider, but not recommended by the American Geriatrics Society:

  • baclofen
  • tizanidine2 (Avoid use in men because of urinary retention.)
Sulfonylureas, long-duration

Chlorpropamide has a prolonged half-life in older adults that can cause prolonged hypoglycemia.

Causes syndrome of inappropriate antidiuretic hormone secretion.

  • chlorpropamide (DIABINESE)

Alternatives:

  • glimepiride, T1 (AMARYL)
  • glipizide, T1 (GLUCOTROL)
  • glipizide extended-release, T2 (GLUCOTROL XL)
  • GLUMETZA, T4
  • metformin, T1 (GLUCOPHAGE)

Glyburide has a higher risk of severe prolonged hypoglycemia in older adults.

  • glyburide (DIABETA, GLYNASE, MICRONASE)
Tertiary triclycic antidepressants

(single agent and combination products)

Highly anticholinergic (risk of confusion, dry mouth, constipation, blurred vision, drowsiness, hallucination, difficulty urinating) and cause orthostatic hypotension.

  • amitriptyline (ELAVIL)
  • amitriptyline/chlordiazepoxide (LIMBITROL)
  • amitriptyline/perhenazine (TRIAVIL)
  • clomipramine (ANAFRANIL)
  • doxepin (<6 mg/day) (Doses higher than 6 mg/day are included in CMS 5-star measure for beneficiaries with two or more fills in a calendar year. Doses less than that are not included because its side effect profile is similar to placebo.) (SINEQUAN)
  • imipramine (TOFRANIL, TOFRANIL-PM)
  • trimipramine (SURMONTIL)

Alternatives:

For depression: bupropion

  • bupropion, T2 (WELLBUTRIN)
  • bupropion SR, T2 (WELBUTRIN SR)
  • bupropion XL, T2 (WELLBUTRIN XL)
  • FORFIVO XL, T4

For depression: SSRIs

  • citalopram, T1 (CELEXA) 
  • escitalopram, T2 (LEXAPRO)
  • fluoxetine, T1 (PROZAC)
  • fluoxetine delayed-release, T2 (PROZAC Weekly)
  • sertraline, T1 (ZOLOFT)
  • VIIBRYD, T4

For depression: SNRIs

  • DESVENLAFAXINE ER, T4
  • duloxetine, T2 (CYMBALTA)
  • FETZIMA, T4
  • KHEDEZLA, T4
  • PRISTIQ, T4
  • venlafaxine, T2 (EFFEXOR)
  • venlafaxine extended-release, T2 (EFFEXOR XR)
  • venlafaxine ER tablet, T4
  • VENLAFAXINE ER tablet, 225 mg, T4

For neuropathic pain

  • DESVENLAFAXINE ER, T4
  • duloxetine, T2 (CYMBALTA)
  • FETZIMA, T4
  • KHEDEZLA, T4
  • PRISTIQ, T4
  • venlafaxine, T2 (EFFEXOR)
  • venlafaxine extended-release, T2 (EFFEXOR XR)
  • venlafaxine ER tablet, T4
  • venlafaxine ER tablet, 225 mg, T4
  • gabapentin, T2
  • capsaicin topical, OTC¹
  • LYRICA, T4
  • lidocaine 5% patch (for diabetic neuropathy only), T4

For epilepsy

  • lamotrigine, T2 (LAMICTAL)
  • levetiracetam, T2 (KEPPRA)
  • Other anticonvulsants
Vasodilators for dementia

Lack of efficacy.

  • ergoloid mesylates (HYDERGINE)
  • isoxsuprine (VASODILAN)

Alternatives:

  • donepezil, T2 (ARICEPT)
  • EXELON PATCH, T3
  • galantamine, T2 (RAZADYNE)
  • rivastigmine, T2 (EXELON)
  • memantine, T2 (NAMENDA)
  • NAMENDA, T3
  • NAMENDA XR, T3

References

  1. Pharmacy Quality Alliance. Use of High-Risk Medications in the Elderly (HRM). Available at: http://pqaalliance.org/images/uploads/files/HRM2015.pdf, last accessed Jan. 5, 2016.
  2. American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. JAGS 2015; 1-20.
  3. Hanlon JT, Semla TP, Schmader KE. Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures. JAGS 2015; 1-11.
  4. Clinical Pharmacology. Elsevier Gold Standard. Available at: https://www.clinicalpharmacology.com/.
3. Hanlon JT, Semla TP, Schmader KE. Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures. JAGS 2015; 1-11. 4. Clinical Pharmacology. Elsevier Gold Standard. Available at: https://www.clinicalpharmacology.com/.

     

    Last modified: 1/29/2016
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