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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. These drugs will no longer be included in the Priority Health Medicare formulary as of Jan. 1, 2012.

Download and print a copy of the CMS High-Risk Medication guide (82KB 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:

Amphetamines Antipsychotics Estrogens and progestins
Analgesics Barbiturates Oral hypoglycemics
Anti-adrenergics Belladona alkaloids Sedative hypnotics
Anti-anxiety Benzodiazepines (long acting) Skeletal muscle relaxants
Anti-emetics Calcium channel blockers Tryclycic antidepressants
Antihistamines Cardiac glycosides Vasodilators
Antiparkinson/antipsychotics Narcotics Other
Amphetamines

Causes CNS stimulation: agitation, insomnia; hypertension, myocardial ischemia; dependence; appetite suppression.

  • amphetamine & dextroamphetamine (ADDERALL/XR)
  • benzphetamine (DIDREX)
  • dexmethylphenidate (FOCALIN/XR)
  • dextroamphetamine (DEXADRINE, DEXTROSTAT)
  • diethylpropion (DURAD, TENUATE, TEPANIL)
  • INTUNIV
  • methamphetamine (DESOXYN)
  • methylphenidate (RITALIN/LA, CONCERTA, DAYTRANA, METADATE CD)
  • phendimetrazine (BONTRIL)
  • phentermine (ADIPEX-P)

Alternatives:

Consider discontinuing.

Analgesics
  • indomethacin (INDOCIN): Can cause GI bleeding/peptic ulcer in high-risk patients. Has more adverse effects than other NSAIDs. Edema may worsen heart failure.
  • ketorolac (TORADOL): Gastrointestinal bleeding risk increased in elderly

Alternatives:

Mild pain:

  • APAP (acetominaphen), not covered
  • ibuprofen, T1
  • naproxen, T1
  • meloxicam, T1

Moderate/severe pain:

  • tramadol, T1
  • morphine sulfate (MS Contin), T1
  • hydrocodone/APAP (VICODIN, etc.), T1
  • oxycodone (OxyIR), T1
  • oxycodone/APAP (PERCOCET), T1
  • fentanyl patch (DURAGESIC), T1
  • OXYCONTIN, T2
  • AVINZA, T3 (ST)
Anti-adrenergics

Can cause orthostatic hypotension, bradycardia, CNS adverse effects.

  • guanabenz
  • guanfacine (TENEX)
  • methyldopa (ALDOMET)
  • methyldopa/HCTZ (ALCOLOR, ALDORIL)

Alternatives:

  • HCTZ, T1
  • lisinopril, T1
  • enalapril, T1
  • losartan, T1
  • metoprolol, T1

Anti-anxiety

Can cause dependence; sedation; depression; confusion; falls; fractures; respiratory depression (especially in COPD).

  • meprobamate (EQUINIL)
  • aspirin/meprobamate (EQUAGESIC)

Alternatives:

  • buspirone (BUSPAR), T1
  • ROZEREM, T3 (ST)

Anti-emetics

Can cause anticholinergic side effects: worsened cognition and behavioral problems (especially in dementia); urinary retention or incontinence; questionable efficacy.

  • trimethobenzamide (TIGAN)
  • promethazine (PHENERGAN)

Alternatives:

  • TRANSDERM-SCOP, T2
  • ondansetron (ZOFRAN), T1 (B/D)
  • granisetron (KYTRIL), T1 (B/D)
  • prochlorperazine (COMPAZINE), T1
  • metoclopramide (REGLAN)*, T1 (B/D)
*Avoid using long-term and/or in Parkinson's disease

Antihistamines

These medications are available under various brand names. Can cause anticholinergic side effects: worsened cognition and behavioral problems (especially in dementia); urinary retention or incontinence; confusion; enhanced sedation.

APAP=acetaminophen, PSE=pseudoephedrine  

  • APAP/dextromethorphan/ diphenhydramine
  • APAP/diphenhydramine/ phenylephrine
  • APAP/diphenhydramine/PSE
  • APAP & diphenhydramine
  • brompheniramine/combination products
  • carbetapentane/diphenhydramine/ phenylephrine
  • carbinoxamine/combination products
  • chlorpheniramine/combination products
  • clemastine
  • codeine/promethazine/phenylephrine
  • codeine & promethazine
  • cyproheptadine
  • dexbrompheniramine-pyrilamine
  • dexchlorpheniramine
  • dexchlorpheniramine/ dextromethorphan/ PSE
  • dexchlorpheniramine/ guaifenesin/PSE
  • dexchlorpheniramine/hydrocodone/ phenylephrine
  • dexchlorpheniramine/ methscopolamine/ PSE
  • dexchlorpheniramine & PSE
  • dextromethorphan & promethazine
  • diphenhydramine
  • diphenhydramine/hydrocodone/ phenylephrine
  • diphenhydramine & phenylephrine
  • diphenhydramine & PSE
  • diphenhydramine & magnesium salicylate
  • doxylamine
  • hydroxyzine hydrochloride
  • hydroxyzine pamoate
  • phenylephrine & promethazine
  • promethazine
  • tripolidine

Alternatives:

  • levocetirizine, T1
  • CLARINEX, T3 (ST)

Antiparkinson/antipsychotic

Can cause delirium, worsen cognitive impairment, worsen constipation, worsen urinary retention; not recommended to prevent antipsychotic-associated extrapyramidal effects; not very effective for Parkinson's disease.

  • benztropine (COGENTIN)
  • trihexyphenidyl

Alternatives:

Consider discontinuing or using atypical antipsychotic.

Antipsychotics

Causes CNS side effects; seizure risk; extrapyramidal effects: tremor, slurred speech, muscular rigidity, dystonia (involuntary muscle contractions), bradykinesia (slowing of movement), akathisia (inability to sit/stand still).

  • thioridazine (MELLARIL)

The following atypical antipsychotics are associated with increased mortality when used to treat behavioral issues in elderly with dementia:

  • risperidone (RISPERDAL), T1
  • ABILIFY, T1
  • FANAPT, T2
  • GEODON, T3 (ST)
  • INVEGA, T3 (ST)
  • SEROQUEL, T2
  • ZYPREXA, T2

Alternatives:

  • haloperidol (Haldol), T1

Barbiturates

Higher risk of side effects: falls; fractures; confusion; cognitive impairment; dependence.

  • butabarbital (BUTISOL)
  • butalbital/combinations (FIORICET, FIORINAL, DOLGIC, ESGIC)
  • mephobarbital (MEBARAL)
  • pentobarbital (NEMBUTAL)
  • phenobarbital (LUMINAL)
  • secobarbital (SECONAl)

Alternative sleep aid:

  • ROZEREM, T2

Belladona alkaloids

Can cause anticholinergic AEs: worsened cognition and behavioral problems (especially in dementia); urine retention; agitation and delirium.

CPM=chlorpheniramine, PE=phenylephrine

  • atropine/hyoscyamine/ phenobarbital/scopolamine (BELLADONNA ALKALOIDS, DONNATAL, ANTISPASMODIC ELIXIR)
  • atropine & edrophonium (ENLON)
  • belladonna
  • belladonna/ergotamine/ phenobarbital (BELLAMINE)
  • butabarbital/hyoscyamine/ phenazopyridine (BELLAMINE)
    (PHENAZOPYRIDEINE PLUS, PHENAZOFORTE PLUS)
  • digestive-enzymes/hyoscyamine/ phenyltoloxamine (DIGEX NF)
  • hyoscyamine (HYOMAX, LEVSIN, LEVSINEX, NULEV, SYMAX)
  • hyoscyamine/methenam/m-blue/ phenyl salicyl (URISED, USEPT)

Alternatives:

Constipation:

  • psyllium fiber (Metamucil), Not covered
  • polyethylene glycol (Miralax), Not covered
  • docusate, Not covered

Diarrhea:

  • loperamide (Imodium), T1
  • Aluminum hydroxide, Not covered
  • atropine & difenoxin (MOTOFEN), T1
  • atropine & diphenoxylate (LOMOTIL, LONOX, LOGEN, LOMANATE), T1

Benzodiazepines (long-acting)

Can cause dependence; depression; prolonged sedation; confusion; falls; fractures; respiratory depression (especially in COPD); accumulation of drug.

  • amitriptyline & chlordiazepoxide (LIMBITROL DS)

Alternatives:

  • buspirone (BUSPAR), T1
  • chlordiazepoxide (LIBRIUM), T1
  • diazepam (VALIUM), T1
  • flurazepam (DALMANE), T1

Calcium channel blockers

Can cause hypotension; constipation.

  • nifedipine (short-acting immediate release only) (ADALAT CC, PROCARDIA)

Alternatives:

  • nifedipine ER (PROCARDIA XL), T1

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

Estrogens and progestins

Increased risk of breast &/or endometrial cancer; NOT cardioprotective.

Oral:

  • ANGELIQ
  • conjugated estrogen (PREMARIN, ESTINYL)
  • conjugated estrogen & medroxyprogesterone (PREMPRO, PREMPHASE)
  • esterified estrogen (MENEST)
  • esterified estrogen & methyltestosterone (COVARYX, ESTRATEST)
  • estropipate (OGEN, ORTHO-EST)
  • estradiol (ESTRACE, GYNODIOL)
  • estradiol/norethindrone (ACTIVELLA, MIMVEY)
  • FEMHRT
  • JEVANTIQUE
  • JINTELI
  • Megestrol (MEGACE/ES)
  • ORTHOPREFEST
  • PREFEST

Transdermal:

  • estradiol patch
  • ALORA patch
  • ESTRASORB
  • ESCLIM patch
  • CLIMARA PRO patch
  • COMBIPATCH
  • VIVELLE-DOT patch
  • MENOSTAR patch
  • DIVIGEL topical gel
  • ELESTRIN topical gel
  • EVAMIST topical spray

Vaginal:

  • FEMTRACE

Alternatives:

Hot flashes (non-drug therapy should be emphasized):

  • venlafaxine (EFFEXOR), T1
  • paroxetine (PAXIL), T1
  • fluoxetine (PROZAC), T1
  • sertraline (ZOLOFT), T1
  • gabapentin, T1

Genitourinary symptoms:

  • Femring, T2
  • Premarin vaginal cream, T2
  • Vagifem, T2

Bone density:

  • calcium, Not covered
  • vitamin D, Not covered
  • alendronate (FOSAMAX), T1
  • ACTONEL, T2
  • Ibandronate (BONIVA), T1
  • EVISTA, T2

Narcotics

Causes enhanced CNS effects: confusion, hallucinations; falls; fractures; seizure risk.

ASA=aspirin, APAP= acetaminophen

  • ASA/caffeine/propoxyphene (DARVON COMPOUND)
  • APAP & pentazocine (TALACEN)
  • APAP & propoxyphene (DARVOCET)
  • belladonna & opium (B&O SUPPRETTES)
  • meperidine (DEMEROL)
  • meperidine & promethazine (MEPROZINE)
  • naloxone & pentazocine (TALWIN NX)
  • pentazocine (TALWIN)
  • propoxyphene hydrochloride (DARVON)
  • propoxyphene napsylate (DARVON)

Alternatives:

Mild pain:

  • APAP, Not covered
  • ibuprofen, T1
  • naproxen, T1
  • meloxicam, T1

Moderate/severe pain:

  • tramadol, T1
  • morphine sulfate (MS Contin), T1
  • hydrocodone/APAP (VICODIN, etc.), T1
  • oxycodone (OXY IR), T1
  • oxycodone/APAP (PERCOSET), T1
  • fentanyl patch (DURAGESIC), T1
  • OXYCONTIN, T2
  • AVINZA, T3 (ST)

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

Sedative hypnotics

Can cause cognitive impairment, delirium, unsteady gait, syncope, falls, accidents, fractures, tolerance, delirium, risk of overdose (narrow therapeutic window - chloral hydrate).

  • chloral hydrate (SOMNOTE)
  • LUNESTA
  • zaleplon (SONATA)
  • zolpidem (AMBIEN/CR, INTERMEZZO, EDLUAR, ZOLPIMIST)

Alternatives:

  • Trazodone, T1
  • ROZEREM, T2

Limit use of sedative hypnotic to short-term use

Skeletal muscle relaxants

Can cause anticholinergic side effects: worsened cognition and behavioral problems (especially in dementia); urinary retention or incontinence; confusion sedation; weakness; questionable efficacy (at lower doses).

ASA=aspirin

  • ASA/ caffeine/ orphenadrine
  • ASA/ carisoprodol/ codeine
  • ASA & carisoprodol
  • ASA & methocarbamol
  • carisoprodol (SOMA)
  • chlorzoxazone (PARAFON FORTE)
  • cyclobenzaprine (FLEXERIL, AMRIX, FEXMID)
  • metaxalone (SKELAXIN)
  • methocarbamol (ROBAXIN)
  • orphenadrine (NORFLEX)

Alternatives:

  • baclofen (LIORESAL), T1
  • tizanidine (ZANAFLAX), T1

Triclycic antidepressants

Can cause anticholinergic effects (e.g., confusion, dry mouth, constipation), cognitive impairment, delirium, sedation, orthostatic hypotension.

  • amitriptyline/combinations (ELAVIL, VANATRIP)
  • clomipramine (ANAFRANIL)
  • doxepin (SINEQUAN, SILENOR)
  • imipramine (TOFRANIL)
  • Trimipramine (SURMONTIL)

Alternatives:

  • nortriptyline, T1
  • desipramine, T1
  • trazodone (low dose), T1

Vasodilators

Can cause orthostatic hypotension; ineffective for stroke prevention; unproven and/or questionable efficacy.

  • dipyridamole (short-acting only) (PERSANTINE)
  • ergot mesyloid (ERGOMAR)
  • isoxsuprine (VASODILAN)

Alternatives:

Stroke prevention:

  • aspirin, Not covered
  • PLAVIX, T2
  • AGGRENOX, T2

Alzheimer's/dementia:

  • galantamine, T1
  • rivastigmine, T1
  • ARICEPT, T2
  • EXELON, T2

OTHER (androgen, anabolic steroid; thyroid drug; urinary anti-infectives, psych, cardiac)

Methyltestosterone can cause cardiac side effects & prostatic enlargement in men. Nitrofurantoin may cause nephrotoxicity (kidney). Thyroid desiccated drugs may cause cardiac AEs.

  • methyltestosterone (ANDROID, TESTRED)
  • nitrofurantoin (FURADANTIN)
  • nitrofurantoin macrocrystals (MACRODANTIN)
  • nitrofurantoin macrocrystals-monohydrate (MACROBID)
  • thyroid desiccated (ARMOUR THYROID)
  • SERENTIL
  • ergoloid (HYDERDINE)
  • reserpine/combinations
  • ticlopidine (TICLID)

Alternatives:

Urinary tract infections:

  • ciprofloxacin, T1
  • trimethoprim-sulfamethoxazole (BACTRIM DS), T1

Thyroid:

  • levothyroxine (SYNTHROID), T1
  • levoxyl, T1

Anti-platelet:

  • clopidogrel, T1


References

  1. Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med. 2003; 163(22): 2716-24.
  2. Simon SR, Chan A, Soumerai SB, Wagner AK, Andrade SE, Feldstein AC, et al. Potentially inappropriate medication use by elderly persons in U.S. health maintenance organizations, 2000-2001. J Am Geriatr Soc. 2005; 53(2): 227-32.
  3. Chang CM, Liu PY, Yang YK, Yang YC, Wu C, Lu F. Use of the beers criteria to predict adverse drug reactions among first-visit elderly outpatients. Pharmacotherapy. 2005; 25(6): 831-38.
  4. PL Detail-Document, Potentially Harmful Drugs in the Elderly: Beers List. Pharmacist’s Letter/Prescriber’s Letter. June 2012.

Specifications from Pharmacy Quality Alliance apply to certain drugs for a calculation of cumulative days supply and average dose:

  1. For nitrofurantoin, a patient is included in the numerator if he/she received at least two prescription fills for the medication and if the cumulative days supply for any nitrofurantoin product is greater than 90 days during the measurement period.
  2. For reserpine, a patient is included in the numerator if he/she received at least two prescription fills for the medication and if the average daily dose is greater than 0.1mg.
  3. For digoxin, a patient is included in the numerator if he/she received at least two prescription fills for the medication and if the average daily dose is greater than 0.125mg.
  4. For doxepin, a patient is included in the numerator if he/she received at least two prescription fills for the medication and if the average daily dose is greater than 6mg.
  5. The cumulative calculation applies to the class of nonbenzodiazepine hypnotics and not for each individual medication. A patient is included in the numerator if he/she received at least two prescription fills for any medication in the class and if the cumulative days supply for any product is greater than 90 days during the measurement period. For example, if a patient received a 30 day supply of zolpidem, a second fill for 30 days supply of zolpidem and then a fill for 35 days supply eszopiclone (all during the measurement period), this would qualify for inclusion in the numerator.
Last modified: 2/7/2014
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