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The Journal of Family Practice is a peer-reviewed and indexed journal that provides its 95,000 family physician readers with timely, practical, and evidence-based information that they can immediately put into practice. Research and applied evidence articles, plus patient-oriented departments like Practice Alert, PURLs, and Clinical Inquiries can be found in print and at jfponline.com. The Web site, which logs an average of 125,000 visitors every month, also offers audiocasts by physician specialists and interactive features like Instant Polls and Photo Rounds Friday—a weekly diagnostic puzzle.
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
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Does concurrent use of clopidogrel and PPIs increase CV risk in patients with ACS?
EVIDENCE SUMMARY
A double-blind, double-dummy, placebo-controlled RCT comparing a combination of clopidogrel, aspirin, and omeprazole with clopidogrel, aspirin, and placebo found no increase in composite CV outcomes with the PPI (TABLE).1 Using a PPI did, however, significantly reduce gastrointestinal (GI) bleeding (hazard ratio [HR] = 0.13; 95% confidence interval [CI], 0.03-0.56).Although several meta-analyses have been conducted, they all rely on this single RCT that directly addresses the question, plus post-hoc analyses of other RCTs.
Four of 5 analyses find little or no difference in CV outcomes with a PPI
Four of 5 posthoc analyses (which weren’t themselves randomized) of RCTs found unclear or no differences in composite CV outcomes with concurrent use of a PPI and antiplatelet therapy, after multivariate adjustment for differences in populations taking or not taking a PPI.
Posthoc analysis of the largest study found worse CV outcomes for both clopidogrel and ticagrelor with concomitant PPI use.2 However, patients on any GI drugs (PPI or non-PPI) had composite outcomes similar to patients on a PPI (PPI vs non-PPI GI treatment: HR = 0.98; 95% CI, 0.79-1.23), and patients not taking GI drugs had fewer composite outcomes compared with patients on a PPI (clopidogrel vs no GI therapy: HR = 1.29; 95% CI, 1.12-1.49; ticagrelor vs no GI therapy: HR = 1.30; 95% CI, 1.14-1.49). Researchers postulated that because the rate of composite outcomes increased equally for patients on any GI drug, the higher rate of CV adverse events with a PPI might have been related to GI disease rather than PPI use.
A similar posthoc analysis found no differences with or without PPI use among patients with ACS undergoing planned percutaneous coronary intervention (PCI) and assigned to clopidogrel or prasugrel.3 Researchers performed multivariate adjustment for differences in age, gender, ethnicity, and initial presence of unstable angina/non-ST-elevation MI.
A smaller study also found no significant differences in composite CV outcomes in patients using PPIs.4 Patients did have higher rates of MI (HR = 0.62; 95% CI, 0.42-0.91), but they were more likely to be older and have a previous diagnosis of non-ST-elevation MI, higher incidence of previous coronary artery bypass graft surgery, and history of peptic ulcer disease.
The fourth posthoc analysis of an RCT found that concomitant PPI use (91% of patients on lansoprazole) didn’t alter outcomes among patients undergoing PCI and receiving dual antiplatelet therapy with clopidogrel and aspirin.5 Researchers used a multivariate adjustment for differences in age, gender, and renal function and found no difference in outcomes during the 6-month or 24-month period. PPI prescription was at physician discretion. Researchers didn’t assess for dose-dependent effects of PPI.
A fifth, flawed study finds more adverse events with PPIs
A posthoc analysis of a smaller, open-label trial found increased major adverse cardiac events with PPI use among patients taking clopidogrel after PCI.6 Researchers didn’t adjust for differences in populations at baseline, however, and patients taking PPIs were more likely to be female or older and have diabetes, GI disease, or higher serum creatinine levels.
Continue to: Editor's takeaway
Editor’s takeaway
The best evidence (a large RCT) found that adding a PPI to antiplatelet therapy didn’t alter CV outcomes in patients with ACS, but it did reduce GI bleeds. Hopefully this will give providers the confidence to use PPIs, if clinically indicated, in patients taking antiplatelet therapy with clopidogrel or prasugrel.
1. Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010;363:1909-1917.
2. Goodman SG, Clare R, Pieper KS, et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012;125:978-986.
3. O’Donoghue ML, Braunwald E, Antman EM, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374:989-997.
4. Nicolau JC, Bhatt DL, Roe MT, et al. Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization: insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial. Am Heart J. 2015;170:683-694.e3.
5. Gargiulo G, Costa F, Ariotti S, et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY trial. Am Heart J. 2016;174:95-102.
6. Burkard T, Kaiser CA, Brunner-La Rocca H, et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med. 2012;271:257-263.
EVIDENCE SUMMARY
A double-blind, double-dummy, placebo-controlled RCT comparing a combination of clopidogrel, aspirin, and omeprazole with clopidogrel, aspirin, and placebo found no increase in composite CV outcomes with the PPI (TABLE).1 Using a PPI did, however, significantly reduce gastrointestinal (GI) bleeding (hazard ratio [HR] = 0.13; 95% confidence interval [CI], 0.03-0.56).Although several meta-analyses have been conducted, they all rely on this single RCT that directly addresses the question, plus post-hoc analyses of other RCTs.
Four of 5 analyses find little or no difference in CV outcomes with a PPI
Four of 5 posthoc analyses (which weren’t themselves randomized) of RCTs found unclear or no differences in composite CV outcomes with concurrent use of a PPI and antiplatelet therapy, after multivariate adjustment for differences in populations taking or not taking a PPI.
Posthoc analysis of the largest study found worse CV outcomes for both clopidogrel and ticagrelor with concomitant PPI use.2 However, patients on any GI drugs (PPI or non-PPI) had composite outcomes similar to patients on a PPI (PPI vs non-PPI GI treatment: HR = 0.98; 95% CI, 0.79-1.23), and patients not taking GI drugs had fewer composite outcomes compared with patients on a PPI (clopidogrel vs no GI therapy: HR = 1.29; 95% CI, 1.12-1.49; ticagrelor vs no GI therapy: HR = 1.30; 95% CI, 1.14-1.49). Researchers postulated that because the rate of composite outcomes increased equally for patients on any GI drug, the higher rate of CV adverse events with a PPI might have been related to GI disease rather than PPI use.
A similar posthoc analysis found no differences with or without PPI use among patients with ACS undergoing planned percutaneous coronary intervention (PCI) and assigned to clopidogrel or prasugrel.3 Researchers performed multivariate adjustment for differences in age, gender, ethnicity, and initial presence of unstable angina/non-ST-elevation MI.
A smaller study also found no significant differences in composite CV outcomes in patients using PPIs.4 Patients did have higher rates of MI (HR = 0.62; 95% CI, 0.42-0.91), but they were more likely to be older and have a previous diagnosis of non-ST-elevation MI, higher incidence of previous coronary artery bypass graft surgery, and history of peptic ulcer disease.
The fourth posthoc analysis of an RCT found that concomitant PPI use (91% of patients on lansoprazole) didn’t alter outcomes among patients undergoing PCI and receiving dual antiplatelet therapy with clopidogrel and aspirin.5 Researchers used a multivariate adjustment for differences in age, gender, and renal function and found no difference in outcomes during the 6-month or 24-month period. PPI prescription was at physician discretion. Researchers didn’t assess for dose-dependent effects of PPI.
A fifth, flawed study finds more adverse events with PPIs
A posthoc analysis of a smaller, open-label trial found increased major adverse cardiac events with PPI use among patients taking clopidogrel after PCI.6 Researchers didn’t adjust for differences in populations at baseline, however, and patients taking PPIs were more likely to be female or older and have diabetes, GI disease, or higher serum creatinine levels.
Continue to: Editor's takeaway
Editor’s takeaway
The best evidence (a large RCT) found that adding a PPI to antiplatelet therapy didn’t alter CV outcomes in patients with ACS, but it did reduce GI bleeds. Hopefully this will give providers the confidence to use PPIs, if clinically indicated, in patients taking antiplatelet therapy with clopidogrel or prasugrel.
EVIDENCE SUMMARY
A double-blind, double-dummy, placebo-controlled RCT comparing a combination of clopidogrel, aspirin, and omeprazole with clopidogrel, aspirin, and placebo found no increase in composite CV outcomes with the PPI (TABLE).1 Using a PPI did, however, significantly reduce gastrointestinal (GI) bleeding (hazard ratio [HR] = 0.13; 95% confidence interval [CI], 0.03-0.56).Although several meta-analyses have been conducted, they all rely on this single RCT that directly addresses the question, plus post-hoc analyses of other RCTs.
Four of 5 analyses find little or no difference in CV outcomes with a PPI
Four of 5 posthoc analyses (which weren’t themselves randomized) of RCTs found unclear or no differences in composite CV outcomes with concurrent use of a PPI and antiplatelet therapy, after multivariate adjustment for differences in populations taking or not taking a PPI.
Posthoc analysis of the largest study found worse CV outcomes for both clopidogrel and ticagrelor with concomitant PPI use.2 However, patients on any GI drugs (PPI or non-PPI) had composite outcomes similar to patients on a PPI (PPI vs non-PPI GI treatment: HR = 0.98; 95% CI, 0.79-1.23), and patients not taking GI drugs had fewer composite outcomes compared with patients on a PPI (clopidogrel vs no GI therapy: HR = 1.29; 95% CI, 1.12-1.49; ticagrelor vs no GI therapy: HR = 1.30; 95% CI, 1.14-1.49). Researchers postulated that because the rate of composite outcomes increased equally for patients on any GI drug, the higher rate of CV adverse events with a PPI might have been related to GI disease rather than PPI use.
A similar posthoc analysis found no differences with or without PPI use among patients with ACS undergoing planned percutaneous coronary intervention (PCI) and assigned to clopidogrel or prasugrel.3 Researchers performed multivariate adjustment for differences in age, gender, ethnicity, and initial presence of unstable angina/non-ST-elevation MI.
A smaller study also found no significant differences in composite CV outcomes in patients using PPIs.4 Patients did have higher rates of MI (HR = 0.62; 95% CI, 0.42-0.91), but they were more likely to be older and have a previous diagnosis of non-ST-elevation MI, higher incidence of previous coronary artery bypass graft surgery, and history of peptic ulcer disease.
The fourth posthoc analysis of an RCT found that concomitant PPI use (91% of patients on lansoprazole) didn’t alter outcomes among patients undergoing PCI and receiving dual antiplatelet therapy with clopidogrel and aspirin.5 Researchers used a multivariate adjustment for differences in age, gender, and renal function and found no difference in outcomes during the 6-month or 24-month period. PPI prescription was at physician discretion. Researchers didn’t assess for dose-dependent effects of PPI.
A fifth, flawed study finds more adverse events with PPIs
A posthoc analysis of a smaller, open-label trial found increased major adverse cardiac events with PPI use among patients taking clopidogrel after PCI.6 Researchers didn’t adjust for differences in populations at baseline, however, and patients taking PPIs were more likely to be female or older and have diabetes, GI disease, or higher serum creatinine levels.
Continue to: Editor's takeaway
Editor’s takeaway
The best evidence (a large RCT) found that adding a PPI to antiplatelet therapy didn’t alter CV outcomes in patients with ACS, but it did reduce GI bleeds. Hopefully this will give providers the confidence to use PPIs, if clinically indicated, in patients taking antiplatelet therapy with clopidogrel or prasugrel.
1. Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010;363:1909-1917.
2. Goodman SG, Clare R, Pieper KS, et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012;125:978-986.
3. O’Donoghue ML, Braunwald E, Antman EM, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374:989-997.
4. Nicolau JC, Bhatt DL, Roe MT, et al. Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization: insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial. Am Heart J. 2015;170:683-694.e3.
5. Gargiulo G, Costa F, Ariotti S, et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY trial. Am Heart J. 2016;174:95-102.
6. Burkard T, Kaiser CA, Brunner-La Rocca H, et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med. 2012;271:257-263.
1. Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010;363:1909-1917.
2. Goodman SG, Clare R, Pieper KS, et al. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. Circulation. 2012;125:978-986.
3. O’Donoghue ML, Braunwald E, Antman EM, et al. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet. 2009;374:989-997.
4. Nicolau JC, Bhatt DL, Roe MT, et al. Concomitant proton-pump inhibitor use, platelet activity, and clinical outcomes in patients with acute coronary syndromes treated with prasugrel versus clopidogrel and managed without revascularization: insights from the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial. Am Heart J. 2015;170:683-694.e3.
5. Gargiulo G, Costa F, Ariotti S, et al. Impact of proton pump inhibitors on clinical outcomes in patients treated with a 6- or 24-month dual-antiplatelet therapy duration: insights from the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY trial. Am Heart J. 2016;174:95-102.
6. Burkard T, Kaiser CA, Brunner-La Rocca H, et al. Combined clopidogrel and proton pump inhibitor therapy is associated with higher cardiovascular event rates after percutaneous coronary intervention: a report from the BASKET trial. J Intern Med. 2012;271:257-263.
EVIDENCE-BASED ANSWER:
No. Adding a proton pump inhibitor (PPI) in patients taking antiplatelet medications such as clopidogrel for acute coronary syndrome (ACS) doesn’t increase the composite risk of cardiovascular (CV) events: CV death, myocardial infarction (MI), and cerebrovascular accident (CVA) (strength of recommendation: B, randomized, controlled trial [RCT] and prepon-derance of posthoc analyses of large RCTs).
Jaw pigmentation
Exam and biopsy led to a diagnosis of erythema dyschromicum perstans. Notably, the punch biopsy was performed as superficially as possible to avoid injuring the marginal mandibular branch of the facial nerve. Histology showed focal vacuolar interface changes, pigmentary incontinence, and prominent dermal melanophages—consistent with erythema dyschromicum perstans.
Erythema dyschromicum perstans is an uncommon dermal macular hyperpigmentation that can affect patients of all ages. It is more often seen in patients with Fitzpatrick skin types III and IV. Some patients have a preceding inflammatory phase with associated erythema.
It is believed that erythema dyschromicum perstans may be a form of pigmented lichen planus with similar histologic changes. Genetic predisposition and medications, such as penicillamine and omeprazole, have been suggested as predisposing risk factors, although these risk factors are not always present. Similarly, cases of erythema dyschromicum perstans associated with human immunodeficiency virus and hepatitis C virus have been reported, but a causal link has not been established. Commonly affected sites include the face and neck, although patches on the trunk and extremities occur, as well.
The differential diagnosis includes lichen planus, discoid lupus, drug-induced hyperpigmentation, Hansen disease, and fixed drug eruption.
Erythema dyschromicum perstans is resistant to most therapies, yet it may clear spontaneously over the years. Therapies that have been successful in case reports include Q-switched ruby laser, topical steroids, UV therapy, isotretinoin, and clofazimine. This patient used desonide cream 0.05% bid for 3 weeks without improvement. She then used camouflage concealer for a year, at which point the area had faded almost completely.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Gutierrez D, Krueger LD, Tan A, et al. Proton pump inhibitor-induced erythema dyschromicum perstans-like pigmentation. JAAD Case Rep. 2019;5:701-703.
Exam and biopsy led to a diagnosis of erythema dyschromicum perstans. Notably, the punch biopsy was performed as superficially as possible to avoid injuring the marginal mandibular branch of the facial nerve. Histology showed focal vacuolar interface changes, pigmentary incontinence, and prominent dermal melanophages—consistent with erythema dyschromicum perstans.
Erythema dyschromicum perstans is an uncommon dermal macular hyperpigmentation that can affect patients of all ages. It is more often seen in patients with Fitzpatrick skin types III and IV. Some patients have a preceding inflammatory phase with associated erythema.
It is believed that erythema dyschromicum perstans may be a form of pigmented lichen planus with similar histologic changes. Genetic predisposition and medications, such as penicillamine and omeprazole, have been suggested as predisposing risk factors, although these risk factors are not always present. Similarly, cases of erythema dyschromicum perstans associated with human immunodeficiency virus and hepatitis C virus have been reported, but a causal link has not been established. Commonly affected sites include the face and neck, although patches on the trunk and extremities occur, as well.
The differential diagnosis includes lichen planus, discoid lupus, drug-induced hyperpigmentation, Hansen disease, and fixed drug eruption.
Erythema dyschromicum perstans is resistant to most therapies, yet it may clear spontaneously over the years. Therapies that have been successful in case reports include Q-switched ruby laser, topical steroids, UV therapy, isotretinoin, and clofazimine. This patient used desonide cream 0.05% bid for 3 weeks without improvement. She then used camouflage concealer for a year, at which point the area had faded almost completely.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Exam and biopsy led to a diagnosis of erythema dyschromicum perstans. Notably, the punch biopsy was performed as superficially as possible to avoid injuring the marginal mandibular branch of the facial nerve. Histology showed focal vacuolar interface changes, pigmentary incontinence, and prominent dermal melanophages—consistent with erythema dyschromicum perstans.
Erythema dyschromicum perstans is an uncommon dermal macular hyperpigmentation that can affect patients of all ages. It is more often seen in patients with Fitzpatrick skin types III and IV. Some patients have a preceding inflammatory phase with associated erythema.
It is believed that erythema dyschromicum perstans may be a form of pigmented lichen planus with similar histologic changes. Genetic predisposition and medications, such as penicillamine and omeprazole, have been suggested as predisposing risk factors, although these risk factors are not always present. Similarly, cases of erythema dyschromicum perstans associated with human immunodeficiency virus and hepatitis C virus have been reported, but a causal link has not been established. Commonly affected sites include the face and neck, although patches on the trunk and extremities occur, as well.
The differential diagnosis includes lichen planus, discoid lupus, drug-induced hyperpigmentation, Hansen disease, and fixed drug eruption.
Erythema dyschromicum perstans is resistant to most therapies, yet it may clear spontaneously over the years. Therapies that have been successful in case reports include Q-switched ruby laser, topical steroids, UV therapy, isotretinoin, and clofazimine. This patient used desonide cream 0.05% bid for 3 weeks without improvement. She then used camouflage concealer for a year, at which point the area had faded almost completely.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Gutierrez D, Krueger LD, Tan A, et al. Proton pump inhibitor-induced erythema dyschromicum perstans-like pigmentation. JAAD Case Rep. 2019;5:701-703.
Gutierrez D, Krueger LD, Tan A, et al. Proton pump inhibitor-induced erythema dyschromicum perstans-like pigmentation. JAAD Case Rep. 2019;5:701-703.
Nail discoloration
The clinical findings and medical history were consistent with drug-induced hyperpigmentation and minocycline was the likely culprit. Other medications commonly implicated in drug-induced hyperpigmentation include heavy metals (eg, gold, iron, silver), anticonvulsants, hydroxychloroquine, and amiodarone.
Common sites for minocycline pigment deposition—besides the fingernails—include the gingiva, dorsal hands, shins, and old scars. The diagnosis of drug-induced hyperpigmentation is clinical and does not require a biopsy.
While the use of antibiotics for chronic disease can lead to antimicrobial resistance (and should be avoided when possible), certain cases of rosacea may require chronic therapy, and tetracyclines most commonly are used. When minocycline is chosen as a chronic therapy, part of the treatment surveillance should include monitoring for drug-induced hyperpigmentation.
When drug-induced hyperpigmentation does occur, treatment involves discontinuing the offending agent. It can take years for pigment to develop and years for it to resolve—if it completely resolves at all.
In this case, the physician was concerned about the pigmentation worsening or spreading to other sites, so he discontinued the minocycline and prescribed a topical agent for the patient’s rosacea. Ultimately, the patient required occasional use of doxycycline for flares.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Nisar MS, Iyer K, Brodell RT, et al. Minocycline-induced hyperpigmentation: comparison of 3 Q-switched lasers to reverse its effects. Clin Cosmet Investig Dermatol. 2013;6:159-162.
The clinical findings and medical history were consistent with drug-induced hyperpigmentation and minocycline was the likely culprit. Other medications commonly implicated in drug-induced hyperpigmentation include heavy metals (eg, gold, iron, silver), anticonvulsants, hydroxychloroquine, and amiodarone.
Common sites for minocycline pigment deposition—besides the fingernails—include the gingiva, dorsal hands, shins, and old scars. The diagnosis of drug-induced hyperpigmentation is clinical and does not require a biopsy.
While the use of antibiotics for chronic disease can lead to antimicrobial resistance (and should be avoided when possible), certain cases of rosacea may require chronic therapy, and tetracyclines most commonly are used. When minocycline is chosen as a chronic therapy, part of the treatment surveillance should include monitoring for drug-induced hyperpigmentation.
When drug-induced hyperpigmentation does occur, treatment involves discontinuing the offending agent. It can take years for pigment to develop and years for it to resolve—if it completely resolves at all.
In this case, the physician was concerned about the pigmentation worsening or spreading to other sites, so he discontinued the minocycline and prescribed a topical agent for the patient’s rosacea. Ultimately, the patient required occasional use of doxycycline for flares.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
The clinical findings and medical history were consistent with drug-induced hyperpigmentation and minocycline was the likely culprit. Other medications commonly implicated in drug-induced hyperpigmentation include heavy metals (eg, gold, iron, silver), anticonvulsants, hydroxychloroquine, and amiodarone.
Common sites for minocycline pigment deposition—besides the fingernails—include the gingiva, dorsal hands, shins, and old scars. The diagnosis of drug-induced hyperpigmentation is clinical and does not require a biopsy.
While the use of antibiotics for chronic disease can lead to antimicrobial resistance (and should be avoided when possible), certain cases of rosacea may require chronic therapy, and tetracyclines most commonly are used. When minocycline is chosen as a chronic therapy, part of the treatment surveillance should include monitoring for drug-induced hyperpigmentation.
When drug-induced hyperpigmentation does occur, treatment involves discontinuing the offending agent. It can take years for pigment to develop and years for it to resolve—if it completely resolves at all.
In this case, the physician was concerned about the pigmentation worsening or spreading to other sites, so he discontinued the minocycline and prescribed a topical agent for the patient’s rosacea. Ultimately, the patient required occasional use of doxycycline for flares.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Nisar MS, Iyer K, Brodell RT, et al. Minocycline-induced hyperpigmentation: comparison of 3 Q-switched lasers to reverse its effects. Clin Cosmet Investig Dermatol. 2013;6:159-162.
Nisar MS, Iyer K, Brodell RT, et al. Minocycline-induced hyperpigmentation: comparison of 3 Q-switched lasers to reverse its effects. Clin Cosmet Investig Dermatol. 2013;6:159-162.
Scaly nose plaque
An annular morphology was appreciated on close inspection and small pustules were seen at the edges—features consistent with tinea faciei, a fungal infection of facial skin. A skin exam did not reveal any scaling or erythema on the scalp, hands, feet, trunk, or nails. The diagnosis was confirmed during the visit with a skin scraping and examination in potassium hydroxide with parker pen blue ink (Swartz-Lamkins stain) which revealed hyphae. The diagnosis was made with the knowledge that a history of eczema increases the risk of fungal, viral, and bacterial infections due to an impaired skin barrier.
Tinea faciei is an uncommon diagnosis that often is misdiagnosed as facial dermatitis, rosacea, or acne. The differential diagnosis also includes discoid lupus and psoriasis. Rarely is the annular presentation as obvious as it was here. Diagnosing tinea faciei in a patient can be made more challenging if the patient is already being treated with steroids. That’s because the steroids may decrease the clinical signs of tinea and allow subtle, slow progression of disease.
The location of fungal disease has implications for treatment. While some cases of tinea faciei may respond to topical antifungals, involvement of the eyebrows and glandular structures of the mid-face are beyond the depth of penetration of topical formulations. In these cases, systemic antifungals such as terbinafine, griseofulvin, or itraconazole are more effective.
Because of eyebrow and glandular involvement, this patient was given oral terbinafine 250 mg/d for 3 weeks and the lesion cleared completely in that time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Amigo M, Milani-Nejad N, Mosser-Goldfarb J. Periocular tinea faciei. J Pediatr. 2020;221:255-256.
An annular morphology was appreciated on close inspection and small pustules were seen at the edges—features consistent with tinea faciei, a fungal infection of facial skin. A skin exam did not reveal any scaling or erythema on the scalp, hands, feet, trunk, or nails. The diagnosis was confirmed during the visit with a skin scraping and examination in potassium hydroxide with parker pen blue ink (Swartz-Lamkins stain) which revealed hyphae. The diagnosis was made with the knowledge that a history of eczema increases the risk of fungal, viral, and bacterial infections due to an impaired skin barrier.
Tinea faciei is an uncommon diagnosis that often is misdiagnosed as facial dermatitis, rosacea, or acne. The differential diagnosis also includes discoid lupus and psoriasis. Rarely is the annular presentation as obvious as it was here. Diagnosing tinea faciei in a patient can be made more challenging if the patient is already being treated with steroids. That’s because the steroids may decrease the clinical signs of tinea and allow subtle, slow progression of disease.
The location of fungal disease has implications for treatment. While some cases of tinea faciei may respond to topical antifungals, involvement of the eyebrows and glandular structures of the mid-face are beyond the depth of penetration of topical formulations. In these cases, systemic antifungals such as terbinafine, griseofulvin, or itraconazole are more effective.
Because of eyebrow and glandular involvement, this patient was given oral terbinafine 250 mg/d for 3 weeks and the lesion cleared completely in that time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
An annular morphology was appreciated on close inspection and small pustules were seen at the edges—features consistent with tinea faciei, a fungal infection of facial skin. A skin exam did not reveal any scaling or erythema on the scalp, hands, feet, trunk, or nails. The diagnosis was confirmed during the visit with a skin scraping and examination in potassium hydroxide with parker pen blue ink (Swartz-Lamkins stain) which revealed hyphae. The diagnosis was made with the knowledge that a history of eczema increases the risk of fungal, viral, and bacterial infections due to an impaired skin barrier.
Tinea faciei is an uncommon diagnosis that often is misdiagnosed as facial dermatitis, rosacea, or acne. The differential diagnosis also includes discoid lupus and psoriasis. Rarely is the annular presentation as obvious as it was here. Diagnosing tinea faciei in a patient can be made more challenging if the patient is already being treated with steroids. That’s because the steroids may decrease the clinical signs of tinea and allow subtle, slow progression of disease.
The location of fungal disease has implications for treatment. While some cases of tinea faciei may respond to topical antifungals, involvement of the eyebrows and glandular structures of the mid-face are beyond the depth of penetration of topical formulations. In these cases, systemic antifungals such as terbinafine, griseofulvin, or itraconazole are more effective.
Because of eyebrow and glandular involvement, this patient was given oral terbinafine 250 mg/d for 3 weeks and the lesion cleared completely in that time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
Amigo M, Milani-Nejad N, Mosser-Goldfarb J. Periocular tinea faciei. J Pediatr. 2020;221:255-256.
Amigo M, Milani-Nejad N, Mosser-Goldfarb J. Periocular tinea faciei. J Pediatr. 2020;221:255-256.
Medication use & COVID-19: Unwarranted concerns, evidence-based approaches
References
- National Institute of Health. COVID-19 treatment guidelines: what’s new in the guidelines? Updated June 25, 2020. www.covid19treatmentguidelines.nih.gov/whats-new/. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Remdesivir for treating hospitalised patients with suspected or confirmed COVID-19. Evidence summary [ES27]. Published June 5, 2020. www.nice.org.uk/advice/es27/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in people with or at risk of COVID-19. Evidence summary [ES24]. Published May 21, 2020. www.nice.org.uk/advice/es24/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19. Evidence summary [ES25]. Published May 21, 2020. www.nice.org.uk/advice/es25/chapter/Key-messages. Accessed June 26, 2020.
- Hernandez AV, Roman YM, Pasupuleti V, et al. Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: a living systematic review. Ann Intern Med. 2020 May 27. doi: 10.7326/M20-2496. Online ahead of print.
References
- National Institute of Health. COVID-19 treatment guidelines: what’s new in the guidelines? Updated June 25, 2020. www.covid19treatmentguidelines.nih.gov/whats-new/. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Remdesivir for treating hospitalised patients with suspected or confirmed COVID-19. Evidence summary [ES27]. Published June 5, 2020. www.nice.org.uk/advice/es27/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in people with or at risk of COVID-19. Evidence summary [ES24]. Published May 21, 2020. www.nice.org.uk/advice/es24/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19. Evidence summary [ES25]. Published May 21, 2020. www.nice.org.uk/advice/es25/chapter/Key-messages. Accessed June 26, 2020.
- Hernandez AV, Roman YM, Pasupuleti V, et al. Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: a living systematic review. Ann Intern Med. 2020 May 27. doi: 10.7326/M20-2496. Online ahead of print.
References
- National Institute of Health. COVID-19 treatment guidelines: what’s new in the guidelines? Updated June 25, 2020. www.covid19treatmentguidelines.nih.gov/whats-new/. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Remdesivir for treating hospitalised patients with suspected or confirmed COVID-19. Evidence summary [ES27]. Published June 5, 2020. www.nice.org.uk/advice/es27/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in people with or at risk of COVID-19. Evidence summary [ES24]. Published May 21, 2020. www.nice.org.uk/advice/es24/chapter/Key-messages. Accessed June 26, 2020.
- National Institute for Health Care and Excellence. COVID-19 rapid evidence summary: Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for people with or at risk of COVID-19. Evidence summary [ES25]. Published May 21, 2020. www.nice.org.uk/advice/es25/chapter/Key-messages. Accessed June 26, 2020.
- Hernandez AV, Roman YM, Pasupuleti V, et al. Hydroxychloroquine or chloroquine for treatment or prophylaxis of COVID-19: a living systematic review. Ann Intern Med. 2020 May 27. doi: 10.7326/M20-2496. Online ahead of print.
Newborn ear lesion
This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.
While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.
Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.
These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Bahrani B, Khachemoune A. Review of accessory tragus with highlights of its associated syndromes. Int J Dermatol. 2014;53:1442-1446.
This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.
While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.
Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.
These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.
While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.
Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.
These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Bahrani B, Khachemoune A. Review of accessory tragus with highlights of its associated syndromes. Int J Dermatol. 2014;53:1442-1446.
Bahrani B, Khachemoune A. Review of accessory tragus with highlights of its associated syndromes. Int J Dermatol. 2014;53:1442-1446.
Ecchymotic patches
This patient’s circular ecchymotic patches were due to cupping. One of the clues that this was iatrogenic was the regular and repeated pattern on the skin.
Cupping is a centuries old treatment for pain relief (among other things) that involves applying glass globes or other hollow materials to the skin to create a vacuum. Traditionally, this vacuum is created by heating the air inside the vessel and then holding the vessel in place as the air cools. Practitioners may also use more modern instruments to induce the vacuum that are similar to those used to assist in vaginal deliveries. The mechanical devices leave these circular ecchymotic marks. The ecchymosis fades over time, and this procedure has been shown to significantly reduce myofascial neck and back pain in small trials.
It is important to recognize geometric patterns that are iatrogenic or due to abuse when evaluating skin findings. If skin findings do not follow dermatomal distributions, typical exanthem, or other classic patterns or presentations, there is the possibility that the pattern may be the result of neglect or abuse. On inspection, consider whether an odd pattern may have been caused from a belt buckle, striking instrument, furniture, medical equipment, or a hand strike.
This patient’s findings were consistent with his history of visiting a physical therapist for cupping. No treatment was required; the patient’s back pain from his car accident was improving, and the cupping marks were not troubling him.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Wang YT, Qi Y, Tang FY, et al. The effect of cupping therapy for low back pain: a meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017;30:1187-1195.
This patient’s circular ecchymotic patches were due to cupping. One of the clues that this was iatrogenic was the regular and repeated pattern on the skin.
Cupping is a centuries old treatment for pain relief (among other things) that involves applying glass globes or other hollow materials to the skin to create a vacuum. Traditionally, this vacuum is created by heating the air inside the vessel and then holding the vessel in place as the air cools. Practitioners may also use more modern instruments to induce the vacuum that are similar to those used to assist in vaginal deliveries. The mechanical devices leave these circular ecchymotic marks. The ecchymosis fades over time, and this procedure has been shown to significantly reduce myofascial neck and back pain in small trials.
It is important to recognize geometric patterns that are iatrogenic or due to abuse when evaluating skin findings. If skin findings do not follow dermatomal distributions, typical exanthem, or other classic patterns or presentations, there is the possibility that the pattern may be the result of neglect or abuse. On inspection, consider whether an odd pattern may have been caused from a belt buckle, striking instrument, furniture, medical equipment, or a hand strike.
This patient’s findings were consistent with his history of visiting a physical therapist for cupping. No treatment was required; the patient’s back pain from his car accident was improving, and the cupping marks were not troubling him.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
This patient’s circular ecchymotic patches were due to cupping. One of the clues that this was iatrogenic was the regular and repeated pattern on the skin.
Cupping is a centuries old treatment for pain relief (among other things) that involves applying glass globes or other hollow materials to the skin to create a vacuum. Traditionally, this vacuum is created by heating the air inside the vessel and then holding the vessel in place as the air cools. Practitioners may also use more modern instruments to induce the vacuum that are similar to those used to assist in vaginal deliveries. The mechanical devices leave these circular ecchymotic marks. The ecchymosis fades over time, and this procedure has been shown to significantly reduce myofascial neck and back pain in small trials.
It is important to recognize geometric patterns that are iatrogenic or due to abuse when evaluating skin findings. If skin findings do not follow dermatomal distributions, typical exanthem, or other classic patterns or presentations, there is the possibility that the pattern may be the result of neglect or abuse. On inspection, consider whether an odd pattern may have been caused from a belt buckle, striking instrument, furniture, medical equipment, or a hand strike.
This patient’s findings were consistent with his history of visiting a physical therapist for cupping. No treatment was required; the patient’s back pain from his car accident was improving, and the cupping marks were not troubling him.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Wang YT, Qi Y, Tang FY, et al. The effect of cupping therapy for low back pain: a meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017;30:1187-1195.
Wang YT, Qi Y, Tang FY, et al. The effect of cupping therapy for low back pain: a meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil. 2017;30:1187-1195.
COVID-19 drives nursing homes to overhaul infection control efforts
The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.
“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.
Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.
“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.
Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:
- Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
- Medical directors who are well qualified and engaged
- A survey/inspection process that is educational and not solely punitive
- More resources and attention to structural reform
“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
Prepandemic experience
When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.
Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”
Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”
Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.
As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.
Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”
“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.
An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).
Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.
The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.
Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.
CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)
However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.
Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”
Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.
“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
Moving forward
IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”
Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.
Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.
“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.
“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.
As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.
The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.
Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.
However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.
Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”
In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.
At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.
Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”
The barriers
Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.
Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.
Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”
Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”
Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.
Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”
Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)
“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”
A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”
For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”
The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.
“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.
Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.
“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.
Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:
- Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
- Medical directors who are well qualified and engaged
- A survey/inspection process that is educational and not solely punitive
- More resources and attention to structural reform
“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
Prepandemic experience
When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.
Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”
Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”
Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.
As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.
Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”
“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.
An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).
Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.
The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.
Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.
CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)
However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.
Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”
Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.
“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
Moving forward
IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”
Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.
Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.
“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.
“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.
As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.
The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.
Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.
However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.
Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”
In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.
At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.
Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”
The barriers
Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.
Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.
Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”
Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”
Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.
Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”
Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)
“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”
A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”
For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”
The toll that COVID-19 has taken on nursing homes and their postacute and long-term care residents has a multilayered backstory involving underresourced organizational structures, inherent susceptibilities, minimally trained infection prevention staff, variable abilities to isolate and quarantine large numbers of patients and residents, and a lack of governmental support.
“Nursing homes have been trying their best to combat this pandemic using the best infection control procedures they have, but blindfolded and with their hands tied behind their backs,” said Joseph G. Ouslander, MD, professor of geriatric medicine at Florida Atlantic University, Boca Raton, which has teaching affiliations with three senior communities.
Nursing home leaders are debating how to best use testing to guide transmission-based precautions and isolation strategies and how to keep residents safe while allowing some socialization after months of conflicting guidance from public health officials (on testing and on sites of care for patients discharged from the hospital, for instance), with a lack of adequate personal protective equipment (PPE) and testing supplies, and with nursing home resident deaths estimated to account for at least one-quarter of the total COVID-19–related mortality in the United States.
“COVID is not going away [over the next couple of years],” said Michael Wasserman, MD, medical director of the Eisenberg Village at the Los Angeles Jewish Home and president of the California Association of Long-Term Care Medicine.
Dr. Wasserman and other experts in both long-term care and infectious disease said in interviews that, through the rest of the pandemic and beyond, nursing homes need the following:
- Full-time, well-trained “infection preventionists” – infection prevention managers, in essence – who can lead improvements in emergency preparedness and infection prevention and control (IPC)
- Medical directors who are well qualified and engaged
- A survey/inspection process that is educational and not solely punitive
- More resources and attention to structural reform
“If this pandemic doesn’t create significant change in the nursing home industry, nothing ever will,” Dr. Wasserman said.
Prepandemic experience
When Ghinwa Dumyati, MD, began working with nursing homes in early March to prevent and contain COVID-19 outbreaks, her focus was on PPE.
Nursing home staff were intimately familiar with standard precautions, and many had used contact precautions to prevent transmission of infections like Clostridioides difficile and Candida auris, as well as droplet precautions for influenza. With the threat of COVID-19, nursing homes “had a brand-new requirement to do both contact and droplet precautions – with a new need for eye protection – and in some situations, respiratory precautions with N95 masks,” said Dr. Dumyati, professor of medicine and director of communicable disease surveillance and prevention at the University of Rochester (N.Y.) Medical Center. “And on top of that, [staff] had to learn to conserve and reuse PPE.”
Staff had not been fit-tested for use of N95 respirators, she noted. “The only time an N95 was used in the nursing home prior to COVID-19,” she said, “was for a suspected tuberculosis patient [before hospital admission].”
Similarly, nursing homes had experience in quarantining units to prevent transmission of illnesses like influenza or norovirus – keeping residents in their rooms with no visitations or social activity, for instance – but never did they have to arrange “massive movements of residents to completely new units or parts of a unit,” said Dr. Dumyati, who also has led hospital and nursing home collaborative programs in Rochester to beat back C. difficile, and is now helping to formulate COVID-19 recommendations and guidance for members of AMDA – The Society for Post-Acute and Long-Term Care.
As the SARS-CoV-2 virus began its spread through the United States, efforts to strengthen IPC programs in nursing homes in Rochester and elsewhere had been focused largely on multidrug resistant organisms (MDROs) and antibiotic stewardship – not on pandemic preparedness.
Reducing antibiotic use had become a national priority, and a 2016 rule by the Centers for Medicare & Medicaid Services required nursing homes to develop, over a 3-year period, an IPC program that included an antibiotic stewardship component and employment of a trained infection preventionist on at least a half-time basis. Emergency preparedness (e.g., having alternate energy sources for a facility) was also included in the rule, but it was only in 2019 when CMS updated its “Requirements for Participation” rule to stipulate that emergency preparedness include planning for “emerging infectious diseases.”
“The 2016 regulations came about because infections were so problematic in nursing homes,” especially urinary tract infections, C. difficile, and drug-resistant infections, said Patricia Stone, PhD, RN, of the Center for Health Policy at the Columbia University School of Nursing, New York, who has published widely on infection prevention and control in nursing homes.
An analysis of IPC practices in 2014 and in 2018 suggests that the IPC-focused rules were helping, mainly with antibiotic stewardship programs but also with respect to some of the practices aimed at outbreak control, such as having policies in place for grouping infected residents together, instructing infected staff to stay home, and quarantining units on which outbreaks occur, Dr. Stone said. Policies for confining residents to rooms were reported by approximately 74% of nursing homes in 2014, and by approximately 87% in 2018, for instance. Overall, nursing homes were “getting better policies in place,” she said. The analysis compared data from two cross-sectional surveys of nursing homes conducted in 2014 and 2018 (945 and 888 facilities, respectively).
Nursing homes “have a long way to go,” however, with respect to the training of infection preventionists, Dr. Stone said. In 2014, her analysis shows, almost 65% of infection preventionists had no specific infection-control training and less than 3% were Certified in Infection Control (CIC) – a credential awarded by the Certification Board of Infection Control & Epidemiology. Of the 35% who had some form of official training, most completed state or local training courses.
The numbers improved slightly in 2018, with 7% of nursing homes reporting their infection preventionists had the highest-level certification, and 44% reporting that their infection preventionists had no specific infection-control training. Research has shown that infection-control training of any kind has a “strong effect” on IPC-related outcomes. While not demonstrated in research thus far, it seems plausible that “facilities with certified [infection preventionists] will have better processes in place,” said Dr. Stone, whose research has documented the need for more monitoring of staff compliance with hand-washing and other IPC procedures.
Infection preventionists in nursing homes typically have been directors of nursing or assistant directors of nursing who fold IPC responsibilities into a multitude of other responsibilities. Before the 2016 rules, some smaller facilities hired off-site consultants to do the job.
CMS upped the ante after several months of COVID-19, recommending in mid-May that nursing homes assign at least one individual with training in infection control “to provide on-site management of the IPC program.” The infection preventionists should be a “full-time role” in facilities that have more than 100 residents, the CMS guidance said. (Prior to the pandemic, CMS issued proposed regulations in 2019 that would modify the time an infection preventionist must devote to a facility from “part time” to “sufficient time.”)
However, neither the 2016 rule nor the most recent guidance on infection preventionists define the length or content of training.
Swati Gaur, MD, chair of the Infection Advisory Committee of AMDA and a certified medical director of two skilled nursing facilities in Gainesville, Ga., said that the pandemic “has really started to crystallize some of the limitations of having a very vague role, not just in terms of what an [infection preventionists] does [in the nursing home] but also the training,”
Fortunately, Dr. Gaur said, when SARS-CoV-2 struck, she had just transitioned her facilities’ designated infection preventionist to work full-time on the role. She had worked closely with her infection preventionist on IPC issues but wishes she had arranged for more rigorous independent training. “The role of the [infection preventionist] is huge and complicated,” now involving employee health, contract tracing, cohorting, isolation, and compliance with precautions and use of PPE, in addition to surveillance, data reporting, and communication with public health officials, she said.
“Facilities are finding out now that [the infection preventionist] cannot be an afterthought. And it won’t end with COVID. We have other respiratory illnesses like flu and other viruses that we struggle with all the time,” said Dr. Gaur, who is working alongside Dr. Dumyati and two other long-term care experts on AMDA’s COVID-19 guidance. The nursing homes that Dr. Gaur directs are part of the Northeast Georgia Health Care System and together include 271 beds.
Moving forward
IPC practices often collide with facilities’ role as a home, especially to those receiving long-term care. “We always have to measure what we do [to prevent and control infections] against patient autonomy and residents’ rights,” said Dr. Gaur. “We have struggled with these issues, prior to the pandemic. If patients are positive for multidrug resistant organisms [for instance], how long can they be isolated in their own rooms? You can’t for days and months put someone in a single room and create isolation. That’s where the science of infection prevention can collide with residents’ rights.”
Over the years, the Centers for Disease Control and Prevention has acknowledged this discordance, leaving it to facilities to decide, for instance, whether to actively screen for colonization with MDROs. In 2019, to help nursing homes prevent the transmission of MDROs from residents who are colonized but not actively infected, the CDC introduced new “enhanced barrier precautions” that require the use of gowns and gloves for specific resident activities identified as having a high risk of MDRO transmission. The new category of precautions is less restrictive than traditional contact precautions, which keep residents in their rooms.
Infection control in nursing homes “isn’t where it needs to be ... but we’re always going to have in nursing homes a situation where there’s a high potential for rapid transmission of infectious disease,” said Christopher Crnich, MD, PhD, an infectious disease specialist at the University of Wisconsin–Madison who chairs the long-term care special interest group of the Society of Healthcare Epidemiology of America and has offered COVID-19 advice to his state’s department of public health.
“Anytime you have a congregative community, particularly one that involves susceptible hosts, there will be an intrinsically susceptible environment ... I’m a bit disturbed by the emphasis on saying, ‘This nursing home had a COVID-19 outbreak, therefore this nursing home did something wrong,’ ” Dr. Crnich said.
“How we mitigate the size of the outbreaks is where we need to focus our attention,” he said. The goal with SARS-CoV-2, he said, is to recognize its introduction “as rapidly as possible” and stop its spread through empiric symptom- and exposure-based isolation, multiple waves of targeted testing, widespread use of contact and droplet precautions, and isolating staff as necessary.
As awareness grew this year among long-term care leaders that relying too heavily on symptom-based strategies may not be effective to prevent introduction and transmission of SARS-CoV-2, a study published in April in the New England Journal of Medicine cemented the need for a testing strategy not limited to symptomatic individuals.
The study documented that more than half of residents in a nursing home who had positive polymerase chain reaction (PCR) test results were asymptomatic at the time of testing, and that most went on to develop symptoms. The study was conducted after one case of COVID-19 had been identified.
Some states issued calls this spring for “universal testing” of all nursing home patients and staff, and the CMS recommendations issued to state and local officials in mid-May for phased nursing home “reopening” call for baseline testing of all residents and staff, followed by retesting all residents weekly until all residents test negative and by retesting all staff continuing every week.
However, the experts contacted for this story said that, without a highly accurate and accessible point-of-care test (and even with one, considering the virus’ incubation period), a universal approach that includes all nursing home residents may have more limited value than is being touted. In many scenarios, they said, it is most meaningful to focus still-limited testing supplies on the staff, many of whom work at more than one facility and are believed to be primary vectors of SARS-CoV-2.
Dr. Ouslander, Dr. Wasserman and other long-term care leaders have been discussing testing at length, trying to reach consensus on best policies. “I don’t think there’s any uniform approach or uniform agreement,” said Dr. Ouslander. “For me, under ideal circumstances what needs to be done to protect older people in nursing homes is to get access to as many accurate viral tests as possible and test staff at least once a week or every 10 days.”
In some facilities, there may be an unspoken barrier to the frequent testing of staff: Fear that staff who test positive will need to be quarantined, with no one to take their place on the front line. Dr. Ouslander said he knows of one county health department that has discouraged nursing homes from testing asymptomatic staff. “It’s insane and truly shocking,” he said.
At the University of Rochester Medical Center, Dr. Dumyati said, staffing agencies are running short of nurse aide substitutes, and staffing issues have become the “biggest challenge” facing a regional multidisciplinary group of medical directors, hospital leaders, and health department officials who are working to troubleshoot COVID-19 issues. “Some of our nursing homes have ended up sending some of their residents to other nursing homes or to the hospital [because of the loss of staff],” she said.
Currently in the state of New York, she noted, COVID-19 patients may not be discharged to nursing homes until they test negative for the virus through PCR testing. “And some people don’t clear by PCR for 4-6 weeks.”
The barriers
Staffing shortages – real in some locales, and anticipated in others as economic reopening grows – are reflective of underlying structural and financial factors that work against optimal IPC, experts said. It’s not uncommon for certified nurse assistants (CNAs) to be assigned to 10-15 residents. And according to AMDA, 30%-46% of CNAs are reported to receive some form of public assistance. Low wages force many CNAs to work other jobs, including shifts at other nursing homes.
Turnover of nursing home leadership also creates problems. Dr. Crnich calls it “one of the biggest barriers” to effective IPC in nursing homes. “Facilities can tolerate some turnover in their front line staff,” he said, “as long as their leadership structure remains relatively stable.” Dr. Stone and her coinvestigators have documented at least yearly turnover in top positions: They found that, in 2018, approximately one-quarter of facilities reported employing three or more infection preventionists, three or more administrators, and three or more directors of nursing during the prior 3 years.
Medical directors, moreover, are not uniformly qualified, engaged with their facilities, or supported by nursing home administrators. “It’s an open secret, I think, that a lot of facilities want a medical director who is a good referral source,” said Dr. Gaur. “A medical director needs to be completely engaged in [quality improvement and] infection control practices.”
Some nursing home chains, she noted, “have realized the value of the medical director, and have changed the way they’re paying them. They’re actually holding them accountable [for quality and outcomes].”
Medical directors such as Dr. Wasserman, who previously oversaw a 74-facility nursing home chain in California as chief medical officer and then chief executive officer and has worked on nursing home quality improvement processes for his state, said there is much that can be done clinically to prevent the spread of infections, such as more frequent use of telemedicine, more attention to “deprescribing” unnecessary medications (which reduces the number of medication passes and, thus, the number of “transmission opportunities”), and the use of continuous remote monitoring. He has been trying to secure Bluetooth-enabled pulse oximetry and temperature monitoring for the Los Angeles Jewish Home and other facilities.
Dr. Wasserman and other long-term care leaders believe that a more educational inspection process would also lead to improvements in IPC. “The punitive nature of the survey process is morally deflating to frontline staff [and] penalties take money away from operations,” Dr. Wasserman said. “It’s not a productive approach to quality improvement.”
Dr. Stone agreed. Infection control is now the primary focus of CMS’s inspection process, and she said that increased regulatory scrutiny of IPC beyond COVID-19 is a “good thing.” Her research has shown that most deficiencies identified by inspectors are infection control deficiencies, and that in 2014 and 2018, approximately one-third of nursing homes had infection control citations. (CMS recently increased penalties and fines for identified deficiencies.)
“But my hope would be that the survey process would be more educational [as it is for hospitals],” she said. “We need to be supporting nursing homes to do a better job.”
A silver lining of the COVID-19 pandemic, as Dr. Stone sees it, is that nursing homes may be more engaged with data reporting and infection surveillance going forward. Nursing homes are now required to report their COVID-19 cases to the CDC through its hospital-dominant National Healthcare Safety Network, and the CDC has made technical changes that now make it “easier [than it was in the past] for nursing homes to join and participate,” she said. “Now that all nursing homes are engaged, will they be engaged post-COVID, too? I hope so. Surveillance [of infections] is a first step toward better outcomes.”
For now, said Dr. Crnich, the intensive prevention and mitigation efforts that are being required of nursing homes to minimize COVID-19’s impact is “a big deal and will tax the resources of most nursing homes and exceed the resources of many” without outside support, Dr. Crnich said. “This has been the most illuminating part of all this, and will probably require us to reconsider how we’re resourcing our nursing homes moving forward into the future.”
Diffuse pustules
The presence of these sterile pustules with an erythematous base led to a diagnosis of acute generalized exanthematous pustulosis (AGEP), also known as a pustular drug eruption. Although pustules are present, AGEP is an allergic response to medications and not an infection.
AGEP can be associated with fever and leukocytosis. Interestingly, antibiotics are a frequent cause—not a treatment—since the pustules are sterile. It also is worth noting, in light of the COVID-19 pandemic, that hydroxychloroquine use has been linked to AGEP, although the number of cases cited in the literature is small.
Treatment is avoidance of the offending medication and symptomatic care. AGEP typically will resolve approximately 2 weeks after discontinuing the medication causing the reaction. Systemic steroids also may be used for treatment in severe cases.
This patient had a history of repeated episodes with his chemotherapy regimen, so he was treated symptomatically with diphenhydramine for the itching. Since chemotherapy was a priority to treat his colon cancer, avoidance of the offending agent was not an option. The Family Medicine Service recommended pretreatment with diphenhydramine 25 to 50 mg orally or intravenously for future rounds of chemotherapy to blunt future responses.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Mercogliano C, Khan M, Lin C, et al. AGEP overlap induced by hydroxychloroquine: a case report and literature review. J Community Hosp Intern Med Perspect. 2018;8:360-362.
The presence of these sterile pustules with an erythematous base led to a diagnosis of acute generalized exanthematous pustulosis (AGEP), also known as a pustular drug eruption. Although pustules are present, AGEP is an allergic response to medications and not an infection.
AGEP can be associated with fever and leukocytosis. Interestingly, antibiotics are a frequent cause—not a treatment—since the pustules are sterile. It also is worth noting, in light of the COVID-19 pandemic, that hydroxychloroquine use has been linked to AGEP, although the number of cases cited in the literature is small.
Treatment is avoidance of the offending medication and symptomatic care. AGEP typically will resolve approximately 2 weeks after discontinuing the medication causing the reaction. Systemic steroids also may be used for treatment in severe cases.
This patient had a history of repeated episodes with his chemotherapy regimen, so he was treated symptomatically with diphenhydramine for the itching. Since chemotherapy was a priority to treat his colon cancer, avoidance of the offending agent was not an option. The Family Medicine Service recommended pretreatment with diphenhydramine 25 to 50 mg orally or intravenously for future rounds of chemotherapy to blunt future responses.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
The presence of these sterile pustules with an erythematous base led to a diagnosis of acute generalized exanthematous pustulosis (AGEP), also known as a pustular drug eruption. Although pustules are present, AGEP is an allergic response to medications and not an infection.
AGEP can be associated with fever and leukocytosis. Interestingly, antibiotics are a frequent cause—not a treatment—since the pustules are sterile. It also is worth noting, in light of the COVID-19 pandemic, that hydroxychloroquine use has been linked to AGEP, although the number of cases cited in the literature is small.
Treatment is avoidance of the offending medication and symptomatic care. AGEP typically will resolve approximately 2 weeks after discontinuing the medication causing the reaction. Systemic steroids also may be used for treatment in severe cases.
This patient had a history of repeated episodes with his chemotherapy regimen, so he was treated symptomatically with diphenhydramine for the itching. Since chemotherapy was a priority to treat his colon cancer, avoidance of the offending agent was not an option. The Family Medicine Service recommended pretreatment with diphenhydramine 25 to 50 mg orally or intravenously for future rounds of chemotherapy to blunt future responses.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.
Mercogliano C, Khan M, Lin C, et al. AGEP overlap induced by hydroxychloroquine: a case report and literature review. J Community Hosp Intern Med Perspect. 2018;8:360-362.
Mercogliano C, Khan M, Lin C, et al. AGEP overlap induced by hydroxychloroquine: a case report and literature review. J Community Hosp Intern Med Perspect. 2018;8:360-362.