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sadisming
sadismly
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scaged
scager
scages
scaging
scagly
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scantily
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scantilyer
scantilyes
scantilying
scantilyly
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schlonged
schlonger
schlonges
schlonging
schlongly
schlongs
scrog
scroged
scroger
scroges
scroging
scrogly
scrogs
scrot
scrote
scroted
scroteed
scroteer
scrotees
scroteing
scrotely
scroter
scrotes
scroting
scrotly
scrots
scrotum
scrotumed
scrotumer
scrotumes
scrotuming
scrotumly
scrotums
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scruded
scruder
scrudes
scruding
scrudly
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scum
scumed
scumer
scumes
scuming
scumly
scums
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seamaner
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seamaning
seamanly
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seamener
seamenes
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seamenly
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seduceer
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seduceing
seducely
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semened
semener
semenes
semening
semenly
semens
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shamedameer
shamedamees
shamedameing
shamedamely
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shit
shite
shiteater
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shiteaterer
shiteateres
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shiteaterly
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shiteed
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shitees
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shitely
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shites
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shitfacely
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shitheader
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shithousely
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shitly
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shitsly
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shitted
shitteded
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shitteding
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shitterer
shitteres
shittering
shitterly
shitters
shittes
shitting
shittly
shitts
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shittyed
shittyer
shittyes
shittying
shittyly
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shized
shizer
shizes
shizing
shizly
shizs
shooted
shooter
shootes
shooting
shootly
shoots
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sissyed
sissyer
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sissying
sissyly
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skaged
skager
skages
skaging
skagly
skags
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skanked
skanker
skankes
skanking
skankly
skanks
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slaveed
slaveer
slavees
slaveing
slavely
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sluting
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slutses
slutsing
slutsly
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smegmaed
smegmaer
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smuted
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snuffly
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sodomed
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sodomly
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spiced
spicer
spices
spicing
spick
spicked
spicker
spickes
spicking
spickly
spicks
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spics
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spoof
spoofed
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spoofes
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spoofly
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spoogeed
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spoogees
spoogeing
spoogely
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spunked
spunker
spunkes
spunking
spunkly
spunks
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steamyer
steamyes
steamying
steamyly
steamys
stfu
stfued
stfuer
stfues
stfuing
stfuly
stfus
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stiffyed
stiffyer
stiffyes
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stiffyly
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stonedes
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stonedly
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stupider
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stupidly
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suckeder
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suckes
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suckinger
suckinges
suckinging
suckingly
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suckly
sucks
sumofabiatch
sumofabiatched
sumofabiatcher
sumofabiatches
sumofabiatching
sumofabiatchly
sumofabiatchs
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tarded
tarder
tardes
tarding
tardly
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tawdryes
tawdrying
tawdryly
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teabagginged
teabagginger
teabagginges
teabagginging
teabaggingly
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terd
terded
terder
terdes
terding
terdly
terds
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testee
testeed
testeeed
testeeer
testeees
testeeing
testeely
testeer
testees
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testely
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testeser
testeses
testesing
testesly
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testicle
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testiclees
testicleing
testiclely
testicles
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testised
testiser
testises
testising
testisly
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thruster
thrustes
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thrustly
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thuged
thuger
thuges
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thugly
thugs
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tinkleed
tinkleer
tinklees
tinkleing
tinklely
tinkles
tit
tited
titer
tites
titfuck
titfucked
titfucker
titfuckes
titfucking
titfuckly
titfucks
titi
titied
titier
tities
titiing
titily
titing
titis
titly
tits
titsed
titser
titses
titsing
titsly
titss
tittiefucker
tittiefuckered
tittiefuckerer
tittiefuckeres
tittiefuckering
tittiefuckerly
tittiefuckers
titties
tittiesed
tittieser
tittieses
tittiesing
tittiesly
tittiess
titty
tittyed
tittyer
tittyes
tittyfuck
tittyfucked
tittyfucker
tittyfuckered
tittyfuckerer
tittyfuckeres
tittyfuckering
tittyfuckerly
tittyfuckers
tittyfuckes
tittyfucking
tittyfuckly
tittyfucks
tittying
tittyly
tittys
toke
tokeed
tokeer
tokees
tokeing
tokely
tokes
toots
tootsed
tootser
tootses
tootsing
tootsly
tootss
tramp
tramped
tramper
trampes
tramping
tramply
tramps
transsexualed
transsexualer
transsexuales
transsexualing
transsexually
transsexuals
trashy
trashyed
trashyer
trashyes
trashying
trashyly
trashys
tubgirl
tubgirled
tubgirler
tubgirles
tubgirling
tubgirlly
tubgirls
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turded
turder
turdes
turding
turdly
turds
tush
tushed
tusher
tushes
tushing
tushly
tushs
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twated
twater
twates
twating
twatly
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twatser
twatses
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undiesed
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undiesly
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uzied
uzier
uzies
uziing
uzily
uzis
vag
vaged
vager
vages
vaging
vagly
vags
valium
valiumed
valiumer
valiumes
valiuming
valiumly
valiums
venous
virgined
virginer
virgines
virgining
virginly
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vixen
vixened
vixener
vixenes
vixening
vixenly
vixens
vodkaed
vodkaer
vodkaes
vodkaing
vodkaly
vodkas
voyeur
voyeured
voyeurer
voyeures
voyeuring
voyeurly
voyeurs
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vulgared
vulgarer
vulgares
vulgaring
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wang
wanged
wanger
wanges
wanging
wangly
wangs
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wanked
wanker
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wankerer
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wankering
wankerly
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wanking
wankly
wanks
wazoo
wazooed
wazooer
wazooes
wazooing
wazooly
wazoos
wedgie
wedgieed
wedgieer
wedgiees
wedgieing
wedgiely
wedgies
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weeder
weedes
weeding
weedly
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weenie
weenieed
weenieer
weeniees
weenieing
weeniely
weenies
weewee
weeweeed
weeweeer
weeweees
weeweeing
weeweely
weewees
weiner
weinered
weinerer
weineres
weinering
weinerly
weiners
weirdo
weirdoed
weirdoer
weirdoes
weirdoing
weirdoly
weirdos
wench
wenched
wencher
wenches
wenching
wenchly
wenchs
wetback
wetbacked
wetbacker
wetbackes
wetbacking
wetbackly
wetbacks
whitey
whiteyed
whiteyer
whiteyes
whiteying
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whized
whizer
whizes
whizing
whizly
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whoralicioused
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whoraliciousing
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whore
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whorealicioused
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whorealiciously
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whored
whoreded
whoreder
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whoreding
whoredly
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whoreed
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whorees
whoreface
whorefaceed
whorefaceer
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whorefaceing
whorefacely
whorefaces
whorehopper
whorehoppered
whorehopperer
whorehopperes
whorehoppering
whorehopperly
whorehoppers
whorehouse
whorehouseed
whorehouseer
whorehousees
whorehouseing
whorehousely
whorehouses
whoreing
whorely
whores
whoresed
whoreser
whoreses
whoresing
whoresly
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whoring
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whoringer
whoringes
whoringing
whoringly
whorings
wigger
wiggered
wiggerer
wiggeres
wiggering
wiggerly
wiggers
woody
woodyed
woodyer
woodyes
woodying
woodyly
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wop
woped
woper
wopes
woping
woply
wops
wtf
wtfed
wtfer
wtfes
wtfing
wtfly
wtfs
xxx
xxxed
xxxer
xxxes
xxxing
xxxly
xxxs
yeasty
yeastyed
yeastyer
yeastyes
yeastying
yeastyly
yeastys
yobbo
yobboed
yobboer
yobboes
yobboing
yobboly
yobbos
zoophile
zoophileed
zoophileer
zoophilees
zoophileing
zoophilely
zoophiles
anal
ass
ass lick
balls
ballsac
bisexual
bleach
causas
cheap
cost of miracles
cunt
display network stats
fart
fda and death
fda AND warn
fda AND warning
fda AND warns
feom
fuck
gfc
humira AND expensive
illegal
madvocate
masturbation
nuccitelli
overdose
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texarkana
effective for the treatment of a baby
effective for the treatment of a boy
effective for the treatment of a child
effective for the treatment of a female
effective for the treatment of a girl
effective for the treatment of a kid
effective for the treatment of a minor
effective for the treatment of a newborn
effective for the treatment of a teen
effective for the treatment of a teenager
effective for the treatment of a toddler
effective for the treatment of a woman
effective for the treatment of adolescents
effective for the treatment of an adolescent
effective for the treatment of an infant
effective for the treatment of babies
effective for the treatment of baby
effective for the treatment of body building
effective for the treatment of boys
effective for the treatment of breast feeding
effective for the treatment of children
effective for the treatment of females
effective for the treatment of fetus
effective for the treatment of girls
effective for the treatment of infants
effective for the treatment of kids
effective for the treatment of minors
effective for the treatment of newborn
effective for the treatment of pediatric
effective for the treatment of pregnancy
effective for the treatment of pregnant
effective for the treatment of teenagers
effective for the treatment of teens
effective for the treatment of toddlers
effective for the treatment of women
effective for the treatment of youths
for the relief of a baby
for the relief of a boy
for the relief of a child
for the relief of a female
for the relief of a girl
for the relief of a kid
for the relief of a minor
for the relief of a newborn
for the relief of a teen
for the relief of a teenager
for the relief of a toddler
for the relief of a woman
for the relief of adolescents
for the relief of an adolescent
for the relief of an infant
for the relief of babies
for the relief of baby
for the relief of body building
for the relief of boys
for the relief of breast feeding
for the relief of children
for the relief of females
for the relief of fetus
for the relief of girls
for the relief of infants
for the relief of kids
for the relief of minors
for the relief of newborn
for the relief of pediatric
for the relief of pregnancy
for the relief of pregnant
for the relief of teenagers
for the relief of teens
for the relief of toddlers
for the relief of women
for the relief of youths
medicating a baby
medicating a boy
medicating a child
medicating a female
medicating a girl
medicating a kid
medicating a minor
medicating a newborn
medicating a teen
medicating a teenager
medicating a toddler
medicating a woman
medicating adolescents
medicating an adolescent
medicating an infant
medicating babies
medicating baby
medicating body building
medicating boys
medicating breast feeding
medicating children
medicating females
medicating fetus
medicating girls
medicating infants
medicating kids
medicating minors
medicating newborn
medicating pediatric
medicating pregnancy
medicating pregnant
medicating teenagers
medicating teens
medicating toddlers
medicating women
medicating youths
at risk for a baby
at risk for a boy
at risk for a child
at risk for a female
at risk for a girl
at risk for a kid
at risk for a minor
at risk for a newborn
at risk for a teen
at risk for a teenager
at risk for a toddler
at risk for a woman
at risk for adolescents
at risk for an adolescent
at risk for an infant
at risk for babies
at risk for baby
at risk for body building
at risk for boys
at risk for breast feeding
at risk for children
at risk for females
at risk for fetus
at risk for girls
at risk for infants
at risk for kids
at risk for minors
at risk for newborn
at risk for pediatric
at risk for pregnancy
at risk for pregnant
at risk for teenagers
at risk for teens
at risk for toddlers
at risk for women
at risk for youths
treating a baby
treating a boy
treating a child
treating a female
treating a girl
treating a kid
treating a minor
treating a newborn
treating a teen
treating a teenager
treating a toddler
treating a woman
treating adolescents
treating an adolescent
treating an infant
treating babies
treating baby
treating body building
treating boys
treating breast feeding
treating children
treating females
treating fetus
treating girls
treating infants
treating kids
treating minors
treating newborn
treating pediatric
treating pregnancy
treating pregnant
treating teenagers
treating teens
treating toddlers
treating women
treating youths
treatment for a baby
treatment for a boy
treatment for a child
treatment for a female
treatment for a girl
treatment for a kid
treatment for a minor
treatment for a newborn
treatment for a teen
treatment for a teenager
treatment for a toddler
treatment for a woman
treatment for adolescents
treatment for an adolescent
treatment for an infant
treatment for babies
treatment for baby
treatment for body building
treatment for boys
treatment for breast feeding
treatment for children
treatment for females
treatment for fetus
treatment for girls
treatment for infants
treatment for kids
treatment for minors
treatment for newborn
treatment for pediatric
treatment for pregnancy
treatment for pregnant
treatment for teenagers
treatment for teens
treatment for toddlers
treatment for women
treatment for youths
treatments for a baby
treatments for a boy
treatments for a child
treatments for a female
treatments for a girl
treatments for a kid
treatments for a minor
treatments for a newborn
treatments for a teen
treatments for a teenager
treatments for a toddler
treatments for a woman
treatments for adolescents
treatments for an adolescent
treatments for an infant
treatments for babies
treatments for baby
treatments for body building
treatments for boys
treatments for breast feeding
treatments for children
treatments for females
treatments for fetus
treatments for girls
treatments for infants
treatments for kids
treatments for minors
treatments for newborn
treatments for pediatric
treatments for pregnancy
treatments for pregnant
treatments for teenagers
treatments for teens
treatments for toddlers
treatments for women
treatments for youths
diagnosing a baby
diagnosing a boy
diagnosing a child
diagnosing a female
diagnosing a girl
diagnosing a kid
diagnosing a minor
diagnosing a newborn
diagnosing a teen
diagnosing a teenager
diagnosing a toddler
diagnosing a woman
diagnosing adolescents
diagnosing an adolescent
diagnosing an infant
diagnosing babies
diagnosing baby
diagnosing body building
diagnosing boys
diagnosing breast feeding
diagnosing children
diagnosing females
diagnosing fetus
diagnosing girls
diagnosing infants
diagnosing kids
diagnosing minors
diagnosing newborn
diagnosing pediatric
diagnosing pregnancy
diagnosing pregnant
diagnosing teenagers
diagnosing teens
diagnosing toddlers
diagnosing women
diagnosing youths
indicated for a baby
indicated for a boy
indicated for a child
indicated for a female
indicated for a girl
indicated for a kid
indicated for a minor
indicated for a newborn
indicated for a teen
indicated for a teenager
indicated for a toddler
indicated for a woman
indicated for adolescents
indicated for an adolescent
indicated for an infant
indicated for babies
indicated for baby
indicated for body building
indicated for boys
indicated for breast feeding
indicated for children
indicated for females
indicated for fetus
indicated for girls
indicated for infants
indicated for kids
indicated for minors
indicated for newborn
indicated for pediatric
indicated for pregnancy
indicated for pregnant
indicated for teenagers
indicated for teens
indicated for toddlers
indicated for women
indicated for youths
useful for a baby
useful for a boy
useful for a child
useful for a female
useful for a girl
useful for a kid
useful for a minor
useful for a newborn
useful for a teen
useful for a teenager
useful for a toddler
useful for a woman
useful for adolescents
useful for an adolescent
useful for an infant
useful for babies
useful for baby
useful for body building
useful for boys
useful for breast feeding
useful for children
useful for females
useful for fetus
useful for girls
useful for infants
useful for kids
useful for minors
useful for newborn
useful for pediatric
useful for pregnancy
useful for pregnant
useful for teenagers
useful for teens
useful for toddlers
useful for women
useful for youths
effective for a baby
effective for a boy
effective for a child
effective for a female
effective for a girl
effective for a kid
effective for a minor
effective for a newborn
effective for a teen
effective for a teenager
effective for a toddler
effective for a woman
effective for adolescents
effective for an adolescent
effective for an infant
effective for babies
effective for baby
effective for body building
effective for boys
effective for breast feeding
effective for children
effective for females
effective for fetus
effective for girls
effective for infants
effective for kids
effective for minors
effective for newborn
effective for pediatric
effective for pregnancy
effective for pregnant
effective for teenagers
effective for teens
effective for toddlers
effective for women
effective for youths
cures for a baby
cures for a boy
cures for a child
cures for a female
cures for a girl
cures for a kid
cures for a minor
cures for a newborn
cures for a teen
cures for a teenager
cures for a toddler
cures for a woman
cures for adolescents
cures for an adolescent
cures for an infant
cures for babies
cures for baby
cures for body building
cures for boys
cures for breast feeding
cures for children
cures for females
cures for fetus
cures for girls
cures for infants
cures for kids
cures for minors
cures for newborn
cures for pediatric
cures for pregnancy
cures for pregnant
cures for teenagers
cures for teens
cures for toddlers
cures for women
cures for youths
use in a baby
use in a boy
use in a child
use in a female
use in a girl
use in a kid
use in a minor
use in a newborn
use in a teen
use in a teenager
use in a toddler
use in a woman
use in adolescents
use in an adolescent
use in an infant
use in babies
use in baby
use in body building
use in boys
use in breast feeding
use in children
use in females
use in fetus
use in girls
use in infants
use in kids
use in minors
use in newborn
use in pediatric
use in pregnancy
use in pregnant
use in teenagers
use in teens
use in toddlers
use in women
use in youths
use in patients with a baby
use in patients with a boy
use in patients with a child
use in patients with a female
use in patients with a girl
use in patients with a kid
use in patients with a minor
use in patients with a newborn
use in patients with a teen
use in patients with a teenager
use in patients with a toddler
use in patients with a woman
use in patients with adolescents
use in patients with an adolescent
use in patients with an infant
use in patients with babies
use in patients with baby
use in patients with body building
use in patients with boys
use in patients with breast feeding
use in patients with children
use in patients with females
use in patients with fetus
use in patients with girls
use in patients with infants
use in patients with kids
use in patients with minors
use in patients with newborn
use in patients with pediatric
use in patients with pregnancy
use in patients with pregnant
use in patients with teenagers
use in patients with teens
use in patients with toddlers
use in patients with women
use in patients with youths
a baby diagnosis
a boy diagnosis
a child diagnosis
a female diagnosis
a girl diagnosis
a kid diagnosis
a minor diagnosis
a newborn diagnosis
a teen diagnosis
a teenager diagnosis
a toddler diagnosis
a woman diagnosis
adolescents diagnosis
an adolescent diagnosis
an infant diagnosis
babies diagnosis
baby diagnosis
body building diagnosis
boys diagnosis
breast feeding diagnosis
children diagnosis
females diagnosis
fetus diagnosis
girls diagnosis
infants diagnosis
kids diagnosis
minors diagnosis
newborn diagnosis
pediatric diagnosis
pregnancy diagnosis
pregnant diagnosis
teenagers diagnosis
teens diagnosis
toddlers diagnosis
women diagnosis
youths diagnosis
a baby medication
a boy medication
a child medication
a female medication
a girl medication
a kid medication
a minor medication
a newborn medication
a teen medication
a teenager medication
a toddler medication
a woman medication
adolescents medication
an adolescent medication
an infant medication
babies medication
baby medication
body building medication
boys medication
breast feeding medication
children medication
females medication
fetus medication
girls medication
infants medication
kids medication
minors medication
newborn medication
pediatric medication
pregnancy medication
pregnant medication
teenagers medication
teens medication
toddlers medication
women medication
youths medication
a baby therapy
a boy therapy
a child therapy
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New Strategy Led to Modest Decline in Antibiotic Misuse
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Tips on Handling a Negative Patient Review
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“It said something like, ‘Do not see Joe the fake doctor. Joe should have his medical license pulled. He didn’t listen to me. He threw drugs at me and he only talked to me for 5 minutes,’ ” Cari, who practices at the University of Colorado Anschutz Medical Campus, Aurora, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Being early in my practice, that hurt; it was a jab to the heart. I had about 20-30 five-star reviews, but I laser-focused on the bad one.”
When a review questions competence, it can feel personal, he continued, even though it often reflects the reviewer’s emotions or experience. Cari, a former Marine, said that clinicians can mitigate emotional responses to negative reviews by building emotional resilience. He draws inspiration from Stoicism (the school of philosophy that originated during the Hellenistic period), which emphasizes developing inner resilience, managing emotions, “and cultivating virtues such as wisdom, courage, and self-discipline,” he said.
Cari often cites a quote from Marcus Aurelius, the former Roman Emperor and Stoic philosopher: “You have power over your mind — not outside events. Realize this, and you will find strength.” Another quote that changed his perspective comes from the Stoic Epictetus: “We cannot control the external events around us, but we can control our reactions to them.”
On a practical level, Cari shared several ways that clinicians can cultivate emotional resilience when faced with a negative review.
Practice mindfulness. Reading reviews in a nonjudgmental way “allows us to pause, reflect, and respond thoughtfully rather than react emotionally,” he explained. He also recommended setting clear boundaries between work and personal life to prevent burnout and maintain a healthy work–life balance. Realizing he needed time to decompress after a previous job that involved a 1-hour drive, he began listening to audiobooks on his way home. “I set that time aside for myself to listen, relax, and let all my troubles from work melt away,” Cari said.
Develop a support network. This includes both professionals, such as therapists, and personal connections, such as colleagues, mentors, and friends.
Practice self-care. Whether it’s yoga, running, jogging, spending time with loved ones, or playing with your dog, find activities that help you recharge. “Most importantly, get some rest and take a vacation,” Cari advised. “Your body is like a machine. If you do not rest it and take care of it, it will slowly breakdown and burnout.”
Practice equanimity. Cari defined this as mental calmness, composure, and evenness of temper, especially in a difficult situation. “Maintaining a calm and balanced state of mind, regardless of external circumstances, is a core Stoic and military practice,” he said.
According to data he attributed to reviewtrackers, an estimated 60% of reviews are influenced by the reviewer’s personal stress or mood, “so don’t take [bad reviews] personally,” he said. Instead, view criticism as an opportunity for self-improvement and to gain insight into others’ perspectives. Cari recommended practicing indifference to both praise and blame. “Do not seek validation or be disheartened by negative reviews,” he said. “Remain focused on your own standards of excellence.”
Cari has reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Expert Reviews Options for Revitalizing Dystrophic Nails
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
LAS VEGAS —
“With the fingernails, we don’t often see onychomycosis, but with toenails, we certainly do,” Tracey C. Vlahovic, DPM, a professor at the Samuel Merritt University College of Podiatric Medicine, Oakland, California, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “But toenails are subject to a lot of forces beyond just fungal [infections]. We have the wear and tear of wearing shoes, gait, and other physical activity.”
For example, she continued, some runners develop second-toenail dystrophy “because there’s constant repetitive trauma to the toenail, and [poorly fitting] shoes can contribute to that. Biomechanical issues are a unique consideration when you’re dealing with toenail issues.”
Vlahovic highlighted several options that can help improve the appearance of dystrophic nails as they recover or grow back:
Urea nail preparations: To temporarily soften the nail.
Genadur (hydroxypropyl chitosan): This product “is used mainly for psoriatic nails, but I use it for all different kinds of nail dystrophy,” she said.
DermaNail (acetyl mandelic acid solution): This can be used for brittle nails and fingernails. Vlahovic said she recommends it be used on toenails “in addition to the onychomycosis and other nail dystrophy treatments that I’m doing because it really helps to hydrate the nail unit.”
Kerasal Fungal Nail Renewal (ingredients include propylene glycol, urea, glycerin, and lactic acid): This product is used “for smoothing out the appearance of the nail,” she said.
KeryFlex: Applied in an office setting, this resin-based product restores the appearance of an individual’s natural nails. “It comes in two colors [and] absorbs the shock of what is going on mechanically with the feet,” Vlahovic said. “So, if I’m treating a ballet dancer performing en pointe, or a soccer player, it’s something I can use to protect the nail, but also to make it cosmetically more acceptable.”
NECPro: A nail reconstruction method that involves the use of a composite used mainly by podiatrists, it “helps you not only create a barrier, but to create a natural-looking color that matches your own nail color,” she said.
In Vlahovic’s experience, KeryFlex and NECPro last 6-8 weeks. “You can use nail polish on top of them if you’d like, but they’re basically cosmetic barriers to protect the nail unit,” she said.
Vlahovic has disclosed being a consultant and investigator for Ortho Dermatologics and Sagis Diagnostics.
A version of this article appeared on Medscape.com.
FROM SDPA 24
Thrombocytosis and Cancer Risk: Management in Primary Care
This transcript has been edited for clarity.
In this podcast, I’m going to talk about unexplained high platelet counts, or thrombocytosis, and the risk for cancer in primary care. Let’s start with a typical case we all might see in primary care.
Louisa is 47 years old and is the chief financial officer for a tech startup company. She presents to us in primary care feeling tired all the time — a very common presentation in primary care — with associated reduced appetite. Past medical history includes irritable bowel syndrome, and she’s an ex-smoker.
Systemic inquiry is unremarkable. Specifically, there is no history of weight loss. Louisa has not been prescribed any medication and uses over-the-counter remedies for her irritable bowel syndrome. Examination is also unremarkable. Blood tests were checked, which were all reassuring, except for a platelet count of 612 × 109 cells/L (usual normal range, about 150-450).
What do we do next? Do we refer for an urgent chest x-ray to exclude lung cancer? Do we check a quantitative immunohistochemical fecal occult blood test (qFIT) to identify any occult bleeding in her stool? Do we refer for a routine upper gastrointestinal endoscopy or pelvic ultrasound scan to exclude any upper gastrointestinal or endometrial malignancy?
Do we simply repeat the bloods? If so, do we repeat them routinely or urgently, and indeed, which ones should we recheck?
Louisa has an unexplained thrombocytosis. How do we manage this in primary care? Thrombocytosis is generally defined as a raised platelet count over 450. Importantly, thrombocytosis is a common incidental finding in around 2% of those over 40 years of age attending primary care. Reassuringly, 80%-90% of thrombocytosis is reactive, secondary to acute blood loss, infection, or inflammation, and the majority of cases resolve within 3 months.
Why the concern with Louisa then? Although most cases are reactive, clinical guidance (for example, NICE suspected cancer guidance in the UK and Scottish suspected cancer guidance in Scotland) reminds us that unexplained thrombocytosis is a risk marker for some solid-tumor malignancies.
Previous studies have demonstrated that unexplained thrombocytosis is associated with a 1-year cancer incidence of 11.6% in males and 6.2% in females, well exceeding the standard 3% threshold warranting investigation for underlying malignancy. However, thrombocytosis should not be used as a stand-alone diagnostic or screening test for cancer, or indeed to rule out cancer.
Instead, unexplained thrombocytosis should prompt us to think cancer. The Scottish suspected cancer referral guidelines include thrombocytosis in the investigation criteria for what they call the LEGO-C cancers — L for lung, E for endometrial, G for gastric, O for oesophageal, and C for colorectal, which is a useful reminder for us all.
What further history, examination, and investigations might we consider in primary care if we identify an unexplained high platelet count? As always, we should use our clinical judgment and trust our clinical acumen.
We should consider all the possible underlying causes, including infection, inflammation, and blood loss, including menstrual blood loss in women; myeloproliferative disorders such as polycythemia rubra vera, chronic myeloid leukemia, and essential thrombocythemia; and, of course, underlying malignancy. If a likely underlying reversible cause is present (for example, a recent lower respiratory tract infection), simply repeating the full blood count in 4-6 weeks is quite appropriate to see if the thrombocytosis has resolved.
Remember, 80%-90% of cases are reactive thrombocytosis, and most cases resolve within 3 months. If thrombocytosis is unexplained or not resolving, consider checking ferritin levels to exclude iron deficiency. Consider checking C-reactive protein (CRP) levels to exclude any inflammation, and also consider checking a blood film to exclude any hematologic disorders, in addition, of course, to more detailed history-taking and examination to elicit any red flags.
We can also consider a JAK2 gene mutation test, if it is available to you locally, or a hematology referral if we suspect a myeloproliferative disorder. JAK2 is a genetic mutation that may be present in people with essential thrombocythemia and can indicate a diagnosis of polycythemia rubra vera.
Subsequent to this, and again using our clinical judgment, we then need to exclude the LEGO-C cancers. Consider urgent chest x-ray to exclude lung cancer or pelvic ultrasound in women to exclude endometrial cancer. Also, we should consider an upper gastrointestinal endoscopy, particularly in those individuals who have associated upper gastrointestinal symptoms and/or weight loss.
Finally, consider a qFIT to identify any occult bleeding in the stool, again if it’s available to you, or certainly if not, urgent lower gastrointestinal investigations to exclude colorectal cancer.
Alongside these possible investigations, as always, we should safety-net appropriately within agreed timeframes and check for resolution of the thrombocytosis according to the condition being suspected. Remember, most cases resolve within 3 months.
Returning to Louisa, what did I do? After seeing a platelet count of 600, I subsequently telephoned her and reexplored her history, which yielded nil else of note. Specifically, there was no history of unexplained weight loss, no history of upper or lower gastrointestinal symptoms, and certainly nothing significantly different from her usual irritable bowel syndrome symptoms. There were also no respiratory or genitourinary symptoms of note.
I did arrange for Louisa to undergo a chest x-ray over the next few days, though, as she was an ex-smoker. This was subsequently reported as normal. I appreciate chest x-rays have poor sensitivity for detecting lung cancer, as highlighted in a number of recent papers, but it was mutually agreed with Louisa that we would simply repeat her blood test in around 6 weeks. As well as repeating the full blood count, I arranged to check her ferritin, CRP, and a blood film, and then I was planning to reassess her clinically in person.
These bloods and my subsequent clinical review were reassuring. In fact, her platelet count had normalized after that 6 weeks had elapsed. Her thrombocytosis had resolved.
I didn’t arrange any further follow-up for her, but I did give her the usual safety netting advice to re-present to me or one of my colleagues if she does develop any worrying symptoms or signs.
I appreciate these scenarios are not always this straightforward, but I wanted to outline what investigations and referrals we may need to consider in primary care if we encounter an unexplained high platelet count.
There are a couple of quality-improvement activities for us all to consider in primary care. Consider as a team how we would respond to an incidental finding of thrombocytosis on a full blood count. Also consider what are our safety-netting options for those found to have raised platelet counts but no other symptoms or risk factors for underlying malignancy.
Finally, I’ve produced a Medscape UK primary care hack or clinical aide-memoire on managing unexplained thrombocytosis and associated cancer risk in primary care for all healthcare professionals working in primary care. This can be found online. I hope you find this resource helpful.
Dr. Kevin Fernando, General practitioner partner with specialist interests in cardiovascular, renal, and metabolic medicine, North Berwick Group Practice in Scotland, has disclosed relevant financial relationships with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, Sanofi Menarini, and Daiichi Sankyo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
In this podcast, I’m going to talk about unexplained high platelet counts, or thrombocytosis, and the risk for cancer in primary care. Let’s start with a typical case we all might see in primary care.
Louisa is 47 years old and is the chief financial officer for a tech startup company. She presents to us in primary care feeling tired all the time — a very common presentation in primary care — with associated reduced appetite. Past medical history includes irritable bowel syndrome, and she’s an ex-smoker.
Systemic inquiry is unremarkable. Specifically, there is no history of weight loss. Louisa has not been prescribed any medication and uses over-the-counter remedies for her irritable bowel syndrome. Examination is also unremarkable. Blood tests were checked, which were all reassuring, except for a platelet count of 612 × 109 cells/L (usual normal range, about 150-450).
What do we do next? Do we refer for an urgent chest x-ray to exclude lung cancer? Do we check a quantitative immunohistochemical fecal occult blood test (qFIT) to identify any occult bleeding in her stool? Do we refer for a routine upper gastrointestinal endoscopy or pelvic ultrasound scan to exclude any upper gastrointestinal or endometrial malignancy?
Do we simply repeat the bloods? If so, do we repeat them routinely or urgently, and indeed, which ones should we recheck?
Louisa has an unexplained thrombocytosis. How do we manage this in primary care? Thrombocytosis is generally defined as a raised platelet count over 450. Importantly, thrombocytosis is a common incidental finding in around 2% of those over 40 years of age attending primary care. Reassuringly, 80%-90% of thrombocytosis is reactive, secondary to acute blood loss, infection, or inflammation, and the majority of cases resolve within 3 months.
Why the concern with Louisa then? Although most cases are reactive, clinical guidance (for example, NICE suspected cancer guidance in the UK and Scottish suspected cancer guidance in Scotland) reminds us that unexplained thrombocytosis is a risk marker for some solid-tumor malignancies.
Previous studies have demonstrated that unexplained thrombocytosis is associated with a 1-year cancer incidence of 11.6% in males and 6.2% in females, well exceeding the standard 3% threshold warranting investigation for underlying malignancy. However, thrombocytosis should not be used as a stand-alone diagnostic or screening test for cancer, or indeed to rule out cancer.
Instead, unexplained thrombocytosis should prompt us to think cancer. The Scottish suspected cancer referral guidelines include thrombocytosis in the investigation criteria for what they call the LEGO-C cancers — L for lung, E for endometrial, G for gastric, O for oesophageal, and C for colorectal, which is a useful reminder for us all.
What further history, examination, and investigations might we consider in primary care if we identify an unexplained high platelet count? As always, we should use our clinical judgment and trust our clinical acumen.
We should consider all the possible underlying causes, including infection, inflammation, and blood loss, including menstrual blood loss in women; myeloproliferative disorders such as polycythemia rubra vera, chronic myeloid leukemia, and essential thrombocythemia; and, of course, underlying malignancy. If a likely underlying reversible cause is present (for example, a recent lower respiratory tract infection), simply repeating the full blood count in 4-6 weeks is quite appropriate to see if the thrombocytosis has resolved.
Remember, 80%-90% of cases are reactive thrombocytosis, and most cases resolve within 3 months. If thrombocytosis is unexplained or not resolving, consider checking ferritin levels to exclude iron deficiency. Consider checking C-reactive protein (CRP) levels to exclude any inflammation, and also consider checking a blood film to exclude any hematologic disorders, in addition, of course, to more detailed history-taking and examination to elicit any red flags.
We can also consider a JAK2 gene mutation test, if it is available to you locally, or a hematology referral if we suspect a myeloproliferative disorder. JAK2 is a genetic mutation that may be present in people with essential thrombocythemia and can indicate a diagnosis of polycythemia rubra vera.
Subsequent to this, and again using our clinical judgment, we then need to exclude the LEGO-C cancers. Consider urgent chest x-ray to exclude lung cancer or pelvic ultrasound in women to exclude endometrial cancer. Also, we should consider an upper gastrointestinal endoscopy, particularly in those individuals who have associated upper gastrointestinal symptoms and/or weight loss.
Finally, consider a qFIT to identify any occult bleeding in the stool, again if it’s available to you, or certainly if not, urgent lower gastrointestinal investigations to exclude colorectal cancer.
Alongside these possible investigations, as always, we should safety-net appropriately within agreed timeframes and check for resolution of the thrombocytosis according to the condition being suspected. Remember, most cases resolve within 3 months.
Returning to Louisa, what did I do? After seeing a platelet count of 600, I subsequently telephoned her and reexplored her history, which yielded nil else of note. Specifically, there was no history of unexplained weight loss, no history of upper or lower gastrointestinal symptoms, and certainly nothing significantly different from her usual irritable bowel syndrome symptoms. There were also no respiratory or genitourinary symptoms of note.
I did arrange for Louisa to undergo a chest x-ray over the next few days, though, as she was an ex-smoker. This was subsequently reported as normal. I appreciate chest x-rays have poor sensitivity for detecting lung cancer, as highlighted in a number of recent papers, but it was mutually agreed with Louisa that we would simply repeat her blood test in around 6 weeks. As well as repeating the full blood count, I arranged to check her ferritin, CRP, and a blood film, and then I was planning to reassess her clinically in person.
These bloods and my subsequent clinical review were reassuring. In fact, her platelet count had normalized after that 6 weeks had elapsed. Her thrombocytosis had resolved.
I didn’t arrange any further follow-up for her, but I did give her the usual safety netting advice to re-present to me or one of my colleagues if she does develop any worrying symptoms or signs.
I appreciate these scenarios are not always this straightforward, but I wanted to outline what investigations and referrals we may need to consider in primary care if we encounter an unexplained high platelet count.
There are a couple of quality-improvement activities for us all to consider in primary care. Consider as a team how we would respond to an incidental finding of thrombocytosis on a full blood count. Also consider what are our safety-netting options for those found to have raised platelet counts but no other symptoms or risk factors for underlying malignancy.
Finally, I’ve produced a Medscape UK primary care hack or clinical aide-memoire on managing unexplained thrombocytosis and associated cancer risk in primary care for all healthcare professionals working in primary care. This can be found online. I hope you find this resource helpful.
Dr. Kevin Fernando, General practitioner partner with specialist interests in cardiovascular, renal, and metabolic medicine, North Berwick Group Practice in Scotland, has disclosed relevant financial relationships with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, Sanofi Menarini, and Daiichi Sankyo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
In this podcast, I’m going to talk about unexplained high platelet counts, or thrombocytosis, and the risk for cancer in primary care. Let’s start with a typical case we all might see in primary care.
Louisa is 47 years old and is the chief financial officer for a tech startup company. She presents to us in primary care feeling tired all the time — a very common presentation in primary care — with associated reduced appetite. Past medical history includes irritable bowel syndrome, and she’s an ex-smoker.
Systemic inquiry is unremarkable. Specifically, there is no history of weight loss. Louisa has not been prescribed any medication and uses over-the-counter remedies for her irritable bowel syndrome. Examination is also unremarkable. Blood tests were checked, which were all reassuring, except for a platelet count of 612 × 109 cells/L (usual normal range, about 150-450).
What do we do next? Do we refer for an urgent chest x-ray to exclude lung cancer? Do we check a quantitative immunohistochemical fecal occult blood test (qFIT) to identify any occult bleeding in her stool? Do we refer for a routine upper gastrointestinal endoscopy or pelvic ultrasound scan to exclude any upper gastrointestinal or endometrial malignancy?
Do we simply repeat the bloods? If so, do we repeat them routinely or urgently, and indeed, which ones should we recheck?
Louisa has an unexplained thrombocytosis. How do we manage this in primary care? Thrombocytosis is generally defined as a raised platelet count over 450. Importantly, thrombocytosis is a common incidental finding in around 2% of those over 40 years of age attending primary care. Reassuringly, 80%-90% of thrombocytosis is reactive, secondary to acute blood loss, infection, or inflammation, and the majority of cases resolve within 3 months.
Why the concern with Louisa then? Although most cases are reactive, clinical guidance (for example, NICE suspected cancer guidance in the UK and Scottish suspected cancer guidance in Scotland) reminds us that unexplained thrombocytosis is a risk marker for some solid-tumor malignancies.
Previous studies have demonstrated that unexplained thrombocytosis is associated with a 1-year cancer incidence of 11.6% in males and 6.2% in females, well exceeding the standard 3% threshold warranting investigation for underlying malignancy. However, thrombocytosis should not be used as a stand-alone diagnostic or screening test for cancer, or indeed to rule out cancer.
Instead, unexplained thrombocytosis should prompt us to think cancer. The Scottish suspected cancer referral guidelines include thrombocytosis in the investigation criteria for what they call the LEGO-C cancers — L for lung, E for endometrial, G for gastric, O for oesophageal, and C for colorectal, which is a useful reminder for us all.
What further history, examination, and investigations might we consider in primary care if we identify an unexplained high platelet count? As always, we should use our clinical judgment and trust our clinical acumen.
We should consider all the possible underlying causes, including infection, inflammation, and blood loss, including menstrual blood loss in women; myeloproliferative disorders such as polycythemia rubra vera, chronic myeloid leukemia, and essential thrombocythemia; and, of course, underlying malignancy. If a likely underlying reversible cause is present (for example, a recent lower respiratory tract infection), simply repeating the full blood count in 4-6 weeks is quite appropriate to see if the thrombocytosis has resolved.
Remember, 80%-90% of cases are reactive thrombocytosis, and most cases resolve within 3 months. If thrombocytosis is unexplained or not resolving, consider checking ferritin levels to exclude iron deficiency. Consider checking C-reactive protein (CRP) levels to exclude any inflammation, and also consider checking a blood film to exclude any hematologic disorders, in addition, of course, to more detailed history-taking and examination to elicit any red flags.
We can also consider a JAK2 gene mutation test, if it is available to you locally, or a hematology referral if we suspect a myeloproliferative disorder. JAK2 is a genetic mutation that may be present in people with essential thrombocythemia and can indicate a diagnosis of polycythemia rubra vera.
Subsequent to this, and again using our clinical judgment, we then need to exclude the LEGO-C cancers. Consider urgent chest x-ray to exclude lung cancer or pelvic ultrasound in women to exclude endometrial cancer. Also, we should consider an upper gastrointestinal endoscopy, particularly in those individuals who have associated upper gastrointestinal symptoms and/or weight loss.
Finally, consider a qFIT to identify any occult bleeding in the stool, again if it’s available to you, or certainly if not, urgent lower gastrointestinal investigations to exclude colorectal cancer.
Alongside these possible investigations, as always, we should safety-net appropriately within agreed timeframes and check for resolution of the thrombocytosis according to the condition being suspected. Remember, most cases resolve within 3 months.
Returning to Louisa, what did I do? After seeing a platelet count of 600, I subsequently telephoned her and reexplored her history, which yielded nil else of note. Specifically, there was no history of unexplained weight loss, no history of upper or lower gastrointestinal symptoms, and certainly nothing significantly different from her usual irritable bowel syndrome symptoms. There were also no respiratory or genitourinary symptoms of note.
I did arrange for Louisa to undergo a chest x-ray over the next few days, though, as she was an ex-smoker. This was subsequently reported as normal. I appreciate chest x-rays have poor sensitivity for detecting lung cancer, as highlighted in a number of recent papers, but it was mutually agreed with Louisa that we would simply repeat her blood test in around 6 weeks. As well as repeating the full blood count, I arranged to check her ferritin, CRP, and a blood film, and then I was planning to reassess her clinically in person.
These bloods and my subsequent clinical review were reassuring. In fact, her platelet count had normalized after that 6 weeks had elapsed. Her thrombocytosis had resolved.
I didn’t arrange any further follow-up for her, but I did give her the usual safety netting advice to re-present to me or one of my colleagues if she does develop any worrying symptoms or signs.
I appreciate these scenarios are not always this straightforward, but I wanted to outline what investigations and referrals we may need to consider in primary care if we encounter an unexplained high platelet count.
There are a couple of quality-improvement activities for us all to consider in primary care. Consider as a team how we would respond to an incidental finding of thrombocytosis on a full blood count. Also consider what are our safety-netting options for those found to have raised platelet counts but no other symptoms or risk factors for underlying malignancy.
Finally, I’ve produced a Medscape UK primary care hack or clinical aide-memoire on managing unexplained thrombocytosis and associated cancer risk in primary care for all healthcare professionals working in primary care. This can be found online. I hope you find this resource helpful.
Dr. Kevin Fernando, General practitioner partner with specialist interests in cardiovascular, renal, and metabolic medicine, North Berwick Group Practice in Scotland, has disclosed relevant financial relationships with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, Sanofi Menarini, and Daiichi Sankyo.
A version of this article first appeared on Medscape.com.
From Primary Care to Specialization: How PAs Make a Specialty Switch
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.
Physician assistants (PAs) are educated as generalists — with the ability to switch medical specialties during their careers. Andrzej Kozikowski, PhD, senior director of research at the National Commission on Certification of Physician Assistants (NCCPA), said that having that kind of career flexibility is often a motivating factor for students who pursue the PA path.
“If you look at the research literature on physicians, you can see that choosing a specialty can be quite stressful,” he told this news organization. “It’s a lifelong decision. You have to commit to a residency, maybe fellowship training, and if you don’t like it and want to switch your specialty, you have to go back and do it again. It’s a decision that weighs heavily on your [physicians] shoulders.”
The PA profession, however, offers lateral movement. Rachel Porter, PhD, interim director of preclinical education at PA program, Duke University, Durham, North Carolina, said that the didactic portion of a PA’s medical education is very broad to support that kind of flexibility. And most PA students, depending on their program, have the opportunity to go through several clinical rotations to see which specialty might be the best fit.
“That initial medical education is meant to provide a good foundation across all systems, across all age groups, subpopulations, and settings — hospital, ambulatory, or outpatient,” she explained. “Once they are exposed to clinical experiences later, we find that students discover their niche and where they want to be once they start their career.”
Making a Lateral Move
According to the 2022 Statistical Profile of Board-Certified PAs by Specialty, based on a survey conducted by the NCCPA, approximately half of board-certified PAs have switched to a different specialty at least once during their career. Nearly 31% have done so at least twice.
Eric Van Hecke, DMSc, MPAS, PA-C, CAQ-EM, assistant professor and PA program director at Concordia University, St. Paul in St. Paul, Minnesota, works in emergency medicine, thanks to his clinical rotations during PA school, which helped him determine that a surgical specialty was not for him.
“I did some surgical rotations, and I found I hated being in the operating room,” he said. “I didn’t like the way PAs were utilized there. But then, toward the end of my PA program, I had the opportunity to do an emergency department rotation and found it was a much better fit.”
Other PAs, however, may not be as lucky to find the right practice straight out of school. Some may be limited by job availability in a specific geographic area, while others may feel more comfortable starting in a hospital setting. Lyndsey Milcarek, PA-C, MPH, a PA in Buffalo, New York, said she started in a primary care role after school but moved to geriatric home health after a year. Then, 3 years later, she switched specialties again to join an emergency department. She said her decisions to move were largely driven by organizational issues.
“In one case, I saw the organization was headed for a buyout and I wanted to get ahead of it,” she said. “In another, the workload was a lot, and you couldn’t go home at the end of your shift if there were still patients to see. It was a recipe for burnout.”
Amanda Michaud, DMSc, PA-C, in Jacksonville, Florida, said she initially enjoyed the “fast-paced environment” of emergency medicine after graduating from PA school. But when her family was looking at a move out of state, she started to consider a specialty change and ultimately ended up joining an allergy practice.
“I wanted to have a more nine-to-five kind of job. I wanted my weekends. I had missed a lot of holidays with my family,” she said. “But I also was interested in becoming more of an expert in a particular field. In the ER, you become an expert in saving lives and stabilizing patients. But I wanted an opportunity to truly learn the medicine and science behind one area.”
Understand Your Why — and Do the Work
The reasons a PA might choose to make a specialty switch aren’t unlike the reasons a corporate attorney might want to practice family law or a nurse practitioner might want to switch from the ICU to the pediatric ward. People might consider it a change of scenery. Some may be looking to relocate, support a better work-life balance, reduce their stress, expand their skills and knowledge, find a more palatable work environment, or make more money. But those who have made lateral moves said it isn’t as easy as it may look.
“It will take time, not just to learn the new specialty but to understand how your new practice does things,” said Michaud. “You need to expect a huge learning curve ahead when you make a change.”
Milcarek added that PAs who are considering a switch should think long and hard about the kind of environment they want to work in and, as they look at other departments or practices, spend time talking to and shadowing PAs to understand what working there will look like. Just because a particular specialty has a reputation for being low stress (or high paying) doesn’t mean that’s what you’ll find once you come on board. So much depends on your employer — and the people you work with.
“There are a lot of opportunities for PA jobs, but employers aren’t always transparent about workflows and management,” Milcarek said. “You want to have good intel upfront before you make a decision.”
Kozikowski agreed. “It takes a while to adapt to a new environment and to understand how things are done,” he explained. “Research suggests that having a good network, mentors, and good onboarding programs are really important. It’s not just finding continuing medical education, you also need to have the right support system in place.”
Despite the challenges involved with a specialty switch, Milcarek said her moves have made her a stronger overall clinician.
“I have a unique perspective because I’ve worked in so many different areas,” she said. “I’ve learned a lot in each and can apply those things in my new roles. I feel fortunate that I’ve been able to make these switches and continue to learn and grow and become a better PA.”
A version of this article first appeared on Medscape.com.
Weight Loss Treatments Beyond the Reach of Many in Need
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — Weight loss treatments aren’t reaching many of the people who need them most because of coverage barriers, new data suggested.
Findings from three studies presented at The Obesity Society’s Obesity Week 2024 meeting illustrate different aspects of the problem.
One, presented by Alissa S. Chen, MD, MPH, a postdoctoral fellow at Yale University, New Haven, Connecticut, found that people with obesity, particularly those with cardiovascular disease (CVD) and those who are Black and Hispanic, have high rates of cost-related prescription drug rationing. Those findings were simultaneously published as a research letter in JAMA Network Open.
“The implications are that structural barriers impede access to medications for Black and Hispanic adults with obesity, which might worsen if there’s not expanding coverage for GLP-1 RAs [glucagon-like peptide 1 receptor agonists], and it’s possible that broader insurance coverage could ameliorate some of these issues,” Chen said.
She noted that patients don’t always volunteer that information. “In my clinical practice, I always start by saying something like, ‘I have a lot of patients who can’t afford their medications. In the last week, was there a time [you didn’t take your medications due to cost]?’ ”
State Medicaid programs vary widely in the degree to which they cover weight loss treatments. But not a single one covers all modalities — nutrition counseling (NC), intensive behavioral therapy (IBT), obesity medications (OMs), and metabolic and bariatric surgery (MBS) — without restrictions or limitations, and only seven states cover them all with restrictions, according to a dual presentation by Christine Gallagher, MPAff, associate director for research and policy with the STOP Obesity Alliance at George Washington University, Washington, DC, and Tracy Zvenyach, PhD, MS, RN, director of policy strategy and alliances at the Obesity Action Coalition, also in Washington, DC.
Detailed Medicaid coverage data for each state are posted on the STOP Obesity Alliance website. (As of now, Medicare doesn’t cover medications specifically for obesity at all.)
A third presentation, by Treah Haggerty, MD, of the Department of Family Medicine and director of the Pediatric Medical Weight Management program at West Virginia University, Morgantown, was of a qualitative descriptive study exploring the impact on 22 individuals enrolled in a medical weight loss management program whose state employee insurance carrier made a policy decision to stop covering all anti-OMs in March 2024. All had been prescribed GLP-1 agonists for weight loss, and the decision forced most to stop using them.
Those findings were published in the September 2024 issue of Obesity Pillars.
“Patients perceive the discontinuation of anti-obesity medication coverage as stigmatizing and unjust, leading to feelings of hopelessness and fear. With more insurance companies denying coverage for these costly medications, more information is needed to identify best ways to address the loss of coverage with patients. Clinical management of these patients should incorporate evidence-based obesity treatments while navigating insurance constraints,” Haggerty said.
Create a Safe Space to Discuss the Barriers
Asked to comment, Session Moderator John D. Clark, MD, PhD, chief population health officer at Sharp Rees-Stealy Medical Group, San Diego, California, told Medscape Medical News, “Health systems and payers are determining what can and can’t be covered, and at the end of the day, it frequently comes down to finances…I think the big challenge is really identifying patients who may have the greatest need. ... If we have limited resources, how and where should we be directing those resources? I would say the current system hasn’t really answered that question or identified patients for whom we would say that the cost truly is less than either the financial or long-term health benefits.”
But Clark said, “When some of these newer anti-obesity medications are able to go generic and be less expensive, which will happen eventually, I think things will change ... and in the future, there will be more options on the market as well.”
In the meantime, he advised that clinicians “try to have conversations with patients about these barriers, acknowledge that these barriers exist, and create a safe space to discuss those barriers. ... Let’s see where we are right now, and let’s come up with a plan.”
People With Obesity More Susceptible to Drug Rationing
Chen reported on a sample of 51,720 adults who participated in the 2020-2022 National Health Interview Survey who did not have diabetes and who used at least one prescription medication of any type. Of those, 80% were White, 9.7% were Hispanic, and 9.7% were Black, and 33.9% overall had obesity.
Cost-related prescription rationing, defined as any self-reported skipping, taking less, or delaying filling a prescription to save money, was reported by 8.3% of those with obesity vs 5.9% without. After adjustment, rationing among those with obesity was significantly associated with younger age (aged 18-44 years), female sex, lower incomes, lack of health insurance coverage, and CVD.
The adjusted estimated probability of cost-related prescription drug rationing was 7.4% for those with CVD vs 4.4% for those without. By race/ethnicity, the proportions reporting rationing were 7.7%, 9.8%, and 10.7% for White, Black, and Hispanics, respectively.
“Given that few insurance providers cover GLP-1 RAs for obesity, cost-related prescription drug rationing could be exacerbated if patients were prescribed GLP-1 RAs at their current price of more than $1000 a month,” Chen noted, adding that the high prices could worsen health disparities among Black and Hispanic individuals with obesity.
Medicaid Coverage Lacking for All Obesity Treatments
For their project, Gallagher and Zvenyach delved into a database that aggregates Medicaid manuals, fee schedules, statutes, regulations, and preferred drug lists for each US state, both for Medicaid fee for service and top Medicaid managed care plans, in order to determine 2024 levels of coverage for NC, IBT, OMs, and MBS for adults with obesity.
No state provides coverage for all those treatments without either limitations — such as body mass index (BMI) cutoffs, age, or “comorbidity regardless of body mass index (BMI)” for OM and MBS — or outright restrictions, such as “proof of failed attempts.” And only seven states provide coverage for the four modalities “with limitations”: California, Arizona, New Mexico, South Carolina, Delaware, Rhode Island, and Massachusetts.
Twenty-two states don’t cover NC, although just one state doesn’t cover IBT. Overall, 37 states don’t cover OMs, and other states ranged considerably in various restrictions and limitations for OMs and MBS. Only four states fully covered the surgery without limitations or restrictions.
“The vast majority of states have significant barriers and conditions of coverage for obesity care,” Gallagher said.
Zvenyach added, “Most of the applied exclusions, limitations, or restrictions do not align with evidence-based practice standards or guidelines.”
When Coverage Stops, Hopelessness and Anger Emerge
Haggerty and colleagues’ research involved semi-structured interviews of the 22 participants — all of them women — who had lost their obesity medication coverage due to their insurers’ decision. Four themes emerged:
- 1. Feelings of hope replaced by hopelessness upon loss of medication coverage: One person said, “I’m afraid for my mental health. It’s tough to be in a situation where you’re never right. And it doesn’t matter what you do; it’s not going to work, and then to have just a glimmer of hope, a little spark of hey, look, this might help. And for someone else to take that away from you for no reason. I don’t know what am I supposed to do.”
- 2. Anger regarding the perceived injustice of anti-obesity medication coverage termination: For example, “They can pay for heart attacks, they could pay for me to have a stroke, they could pay for me to have diabetes, but they won’t let me have this one medicine that could take all of that away. Makes no sense.”
- 3. Perceptions of past and present stigma within the healthcare system and insurance company: “I’m not trying for vanity. I’m way too old to be a Victoria’s Secret model. I’m not trying to do it to be cute and skinny and hot. I just want to make it through a day of work and not be exhausted.”
- 4. Generational influences on obesity treatment: “I’m married, and my husband, since I’ve started this medicine, he’s been eating better. He’s been eating what I eat, and he’s been losing weight as well.”
- Some participants said they planned to cope in different ways, including trying to obtain compounded versions of the drugs from “spas” or online pharmacies, as well as skipping doses, reducing doses, or sharing medications — in other words, rationing.
Asked by this news organization what clinicians should keep in mind, Haggerty said, “that there are big barriers and that we need to take care of the patients within this system that has their arm tied behind their back.
Chen was funded by a grant from the National Institute on Aging outside the submitted work, and she was funded as a Yale National Clinician Scholar. A coauthor received grants from the Food and Drug Administration, Johnson & Johnson, the National Institutes of Health, the Agency for Healthcare Research and Quality, and Arnold Ventures. Another coauthor reported receiving personal fees from UpToDate and the Centers for Medicare & Medicaid Services. Gallagher has received research funding from Altimmune, Amgen, Boehringer Ingelheim, Currax, Eli Lilly and Company, Found, Novo Nordisk, Pfizer, Structure Therapeutics, and WeightWatchers. Haggerty reported article publishing charge was provided by West Virginia Alliance for Creative Health Solutions. Zvenyach and Clark had no disclosures.
A version of this article first appeared on Medscape.com.
FROM OBESITY WEEK 2024
The Use of Biomarkers for Alzheimer’s Disease in Primary Care
In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.
The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.
Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.
Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.
Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.
Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.
Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.
Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.
Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.
The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.
Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.
Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.
Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.
Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.
Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.
Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.
Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
In our previous case-based review, I teased the opportunity to use biomarkers to increase the accuracy and expediency of the diagnosis of Alzheimer’s disease (AD). These tests are no longer confined to the research setting but are now available to specialists and primary care clinicians alike. Given that most cognitive disorders are first identified in primary care, however, I believe that their greatest impact will be in our clinical space.
The pathologic processes associated with AD can be detected approximately 2 decades before the advent of clinical symptoms, and the symptomatic period of cognitive impairment is estimated to occupy just the final third of the disease course of AD. Using imaging studies, primarily PET, as well as cerebrospinal fluid (CSF) and even blood biomarkers for beta amyloid and tau, the pathologic drivers of AD, clinicians can identify patients with AD pathology before any symptoms are present. Importantly for our present-day interventions, the application of biomarkers can also help to diagnose AD earlier.
Amyloid PET identifies one of the earliest markers of potential AD, but a barrier common to advanced diagnostic imaging has been cost. Medicare has now approved coverage for amyloid PET in cases of suspected cognitive impairment. In a large study of more than 16,000 older adults in the United States, PET scans were positive in 55.3% of cases with mild cognitive impairment (MCI). The PET positivity rate among adults with other dementia was 70.1%. The application of PET resulted in a change in care in more than 60% of patients with MCI and dementia. One quarter of participants had their diagnosis changed from AD to another form of dementia, and 10% were changed from a diagnosis of other dementia to AD.
Liquid biomarkers can involve either CSF or blood samples. To date, CSF testing has yielded more consistent results and has defined protocols for assessment. Still, collection of CSF is more challenging than collection of blood, and patients and their families may object to lumbar puncture. CSF assessment therefore remains generally in the province of specialists and research centers.
Primary care clinicians have been waiting for a reliable blood-based biomarker for AD, and that wait may be about to end. A study published in July 2024 included 1213 adults being evaluated for cognitive symptoms in Sweden. They completed a test measuring the ratio of phosphorylated tau 217 vs nonphosphorylated tau 217, with or without a test for serum amyloid ratios as well. These tests were compared with clinicians’ clinical diagnoses as well as CSF results, which were considered the gold standard.
Using only clinical tools, primary care clinicians’ and specialists’ diagnostic accuracy for MCI and dementia were just 61% and 73%, respectively. These values were substantially weaker vs the performance of either the serum tau or amyloid ratios (both 90% accurate). The authors concluded that serum testing has the potential to improve clinical care of patients with cognitive impairment.
Where does that leave us today? Commercially available blood biomarkers are available now which use different tests and cutoff values. These may be helpful but will probably be difficult to compare and interpret for primary care clinicians. In addition, insurance is less likely to cover these tests. Amyloid PET scans are a very reasonable option to augment clinician judgment of suspected cognitive impairment, but not all geographic areas will have ready access to this imaging study.
Still, it is an exciting time to have more objective tools at our disposal to identify MCI and AD. These tools can only be optimized by clinicians who recognize symptoms and perform the baseline testing necessary to determine pretest probability of MCI or dementia.
Charles P. Vega, Health Sciences Clinical Professor, Family Medicine, University of California, Irvine, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for McNeil Pharmaceuticals.
A version of this article first appeared on Medscape.com.
New UTI Guideline Offers Treatment Clarity, Reveals Gaps in Knowledge
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Sustained Benefits With TransCon PTH in Hypoparathyroidism
TOPLINE:
Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.
METHODOLOGY:
- Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
- This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
- Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
- At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
- For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.
TAKEAWAY:
- At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
- In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
- At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
- TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.
IN PRACTICE:
“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.
SOURCE:
The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.
DISCLOSURES:
The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.
METHODOLOGY:
- Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
- This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
- Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
- At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
- For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.
TAKEAWAY:
- At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
- In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
- At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
- TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.
IN PRACTICE:
“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.
SOURCE:
The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.
DISCLOSURES:
The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Long-term treatment with TransCon parathyroid hormone (PTH), a replacement therapy for hypoparathyroidism, demonstrates sustained efficacy and safety in patients with hypoparathyroidism over 52 weeks, with 95% of participants able to discontinue conventional therapy.
METHODOLOGY:
- Conventional therapy for hypoparathyroidism (active vitamin D and elemental calcium) alleviates symptoms of hypocalcemia, but it does not improve insufficient PTH levels and is linked to long-term complications, such as nephrocalcinosis, nephrolithiasis, and renal dysfunction.
- This phase 3 (PaTHway) trial aimed to investigate the long-term efficacy, safety, and tolerability of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism.
- Overall, 82 patients with chronic hypoparathyroidism (mean age, 48.6 years; 78% women; 93% White) were randomly assigned to receive TransCon PTH or placebo, both coadministered with conventional therapy for 26 weeks.
- At the 26-week visit, patients who completed the blinded treatment (n = 79) were assigned to receive only TransCon PTH with conventional therapy in an ongoing 156-week open-label extension.
- For this analysis at week 52, the main efficacy endpoint was the proportion of patients (n = 78) with normal serum calcium levels (8.3-10.6 mg/dL) and independence from conventional therapy (active vitamin D and therapeutic doses of calcium); safety assessments included serum chemistries, 24-hour urine calcium excretion, and treatment-emergent adverse events.
TAKEAWAY:
- At week 52, the majority of the patients receiving TransCon PTH achieved normal serum calcium levels within the normal range (86%) and independence from conventional therapy (95%). None required active vitamin D.
- In secondary endpoints, patients receiving TransCon PTH showed sustained improvement in Hypoparathyroidism Patient Experience Scale scores, reflecting better symptom management, enhanced functioning, and overall well-being through week 52.
- At week 52, the mean 24-hour urine calcium excretion in patients first randomized to TransCon PTH was 185.1 mg/d, remaining well below the upper limit of normal (≤ 250 mg/d), while the placebo group mean fell to 223.1 mg/d during the open-label extension of TransCon PTH.
- TransCon PTH was well-tolerated, with most treatment-emergent adverse events being mild or moderate and none leading to treatment discontinuation.
IN PRACTICE:
“These results suggest that TransCon PTH may improve outcomes and advance the standard of care for adults living with hypoparathyroidism,” the authors wrote.
SOURCE:
The study was led by Bart L. Clarke, MD, Mayo Clinic, Rochester, Minnesota. It was published online in The Journal of Clinical Endocrinology & Metabolism.
LIMITATIONS:
The study’s limitations included the open-label design during the extension period, which may have introduced bias in patient-reported outcomes. Additionally, the study population was predominantly women and White, which may have limited the generalizability of the findings. Further research is needed to assess the long-term effects of TransCon PTH on renal complications. One patient died of fatal cardiac arrest deemed unrelated to the study drug.
DISCLOSURES:
The study was funded by Ascendis Pharma A/S. Seven authors declared being current or former employees of Ascendis Pharma. The other authors declared receiving grants, research funding, honoraria, serving as consultants, advisory board members, study investigators, and other ties with Ascendis Pharma and multiple other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Abuse of the Safety-Net 340B Drug Pricing Program: Why Should Physicians Care?

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.
What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured?
The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide.
The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.
When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)
Why Should Independent Practice Physicians Care About This?
Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.
It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.
Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.
Areas of Concern
There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.
DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%.
There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program.
Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.
Legal Challenges and Legislation
On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.
Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.
However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”
It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics.
Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.
Who’s Guarding the Hen House?
The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”
HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements.
So essentially, the fox is guarding the hen house?
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.
What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured?
The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide.
The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.
When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)
Why Should Independent Practice Physicians Care About This?
Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.
It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.
Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.
Areas of Concern
There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.
DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%.
There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program.
Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.
Legal Challenges and Legislation
On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.
Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.
However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”
It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics.
Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.
Who’s Guarding the Hen House?
The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”
HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements.
So essentially, the fox is guarding the hen house?
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

The 340B Drug Pricing Program began as a noble endeavor, a lifeline designed to help safety-net providers deliver affordable care to America’s most vulnerable populations. However, over the years, this well-intentioned program has strayed from its original purpose, becoming a lucrative space where profits often outweigh patients. Loopholes, lax oversight, and unchecked expansion have allowed some powerful players, such as certain disproportionate share hospitals and their “child sites” as well as for-profit pharmacies, to exploit the system. What was once a program to uplift underserved communities now risks becoming a case study in how good intentions can go astray without accountability.
What exactly is this “340B program” that has captured headlines and the interest of legislatures around the country? What ensures that pharmaceutical manufacturers continue to participate in this program? How lucrative is it? How have underserved populations benefited and how is that measured?
The 340B Drug Pricing Program was established in 1992 under the Public Health Service Act. Its primary goal is to enable covered entities (such as hospitals and clinics serving low-income and uninsured patients) to purchase outpatient drugs from pharmaceutical manufacturers at significantly reduced prices in order to support their care of the low-income and underserved populations. Drug makers are required to participate in this program as a condition of their participation in Medicaid and Medicare Part B and offer these steep discounts to covered entities if they want their medications to be available to 38% of patients nationwide.
The hospitals that make up 78% of the program’s spending are known as disproportionate share hospitals (DSHs). These hospitals must be nonprofit and have at least an 11.75% “disproportionate” share of low-income Medicare or Medicaid inpatients. The other types of non-hospital entities qualifying for 340B pricing are known as initial “federal grantees.” Some examples include federally qualified health centers (FQHC), Ryan White HIV/AIDS program grantees, and other types of specialized clinics, such as hemophilia treatment centers. It needs to be noted up front that it is not these initial non-hospital federal grantees that need more oversight or reform, since according to the Health Resources and Services Administration (HRSA) 2023 report they make up only 22% of all program spending. It is the large, predominantly DSH health systems that are profiting immensely through exponential growth of their clinics and contract pharmacies. However, these health systems have not been able to show exactly who are their eligible patients and how they have been benefiting them.
When the 340B program was established to offer financial relief to hospitals and clinics taking care of the uninsured, it allowed them to save 20%-50% on drug purchases, which could be reinvested in patient care services. It was hoped that savings from the program could be used to provide free or low-cost medications, free vaccines, and other essential health services, essentially allowing safety-net providers to serve their communities despite financial constraints. The initial grantees are fulfilling that mission, but there are concerns regarding DSHs. (See the Coalition of State Rheumatology Organization’s 340B explanatory statement and policy position for more.)
Why Should Independent Practice Physicians Care About This?
Independent doctors should care about the lack of oversight in the 340B program because it affects healthcare costs, patient assistance, market competition, and access to affordable care for underserved and uninsured patients.
It also plays a strong hand in the healthcare consolidation that continues to threaten private physician practices. These acquisitions threaten the viability of independent practices in a variety of specialties across the United States, including rheumatology. HRSA allows 340B-covered entities to register their off-campus outpatient facilities, or child sites, under their 340B designation. Covered entities can acquire drugs at the 340B price, while imposing markups on the reimbursement they submit to private insurance. The additional revenue these covered entities can pocket provides them with a cash flow advantage that physician practices and outpatient clinics will never be able to actualize. This uneven playing field may make rheumatology practices more susceptible to hospital acquisitions. In fact, between 2016 and 2022, large 340B hospitals were responsible for approximately 80% of hospital acquisitions.
Perhaps the most important reason that we should all be concerned about the trajectory of this well-meaning program is that we have seen patients with hospital debt being sued by DSHs who receive 340B discounts so that they can take care of the low-income patients they are suing. We have seen Medicaid patients be turned away from a DSH clinic after being discharged from that hospital, because the hospital had reached its disproportionate share (11.75%) of inpatient Medicare and Medicaid patients. While not illegal, that type of behavior by covered entities is WRONG! Oversight and reform are needed if the 340B program is going to live up to its purpose and not be just another well-intentioned program not fulfilling its mission.
Areas of Concern
There has been controversy regarding the limited oversight of the 340B program by HRSA, leading to abuse of the program. There are deep concerns regarding a lack of transparency in how savings from the program are being used, and there are concerns about the challenges associated with accurate tracking and reporting of 340B discounts, possibly leading to the duplication of discounts for both Medicaid and 340B. For example, a “duplicate discount” occurs if a manufacturer sells medications to a DSH at the 340B price and later pays a Medicaid rebate on the same drug. The extent of duplicate discounts in the 340B program is unknown. However, an audit of 1,536 cases conducted by HRSA between 2012 and 2019 found 429 instances of noncompliance related to duplicate discounts, which is nearly 30% of cases.
DSHs and their contracted pharmacies have been accused of exploiting the program by increasing the number of contract pharmacies and expanding the number of offsite outpatient clinics to maximize profits. As of mid-2024, the number of 340B contract pharmacies, counted by Drug Channels Institute (DCI), numbered 32,883 unique locations. According to DCI, the top five pharmacies in the program happen also to be among the top pharmacy revenue generators and are “for-profit.” They are CVS, Walgreens, Walmart, Express Scripts, and Optum RX. Additionally, a study in JAMA Health Forum showed that, from 2011 to 2019, contract pharmacies in areas with the lowest income decreased by 5.6% while those in the most affluent neighborhoods grew by 5%.
There also has been tremendous growth in the number of covered entities in the 340B program, which grew from just over 8,100 in 2000 to 50,000 in 2020. Before 2004, DSHs made up less than 10% of these entities, but by 2020, they accounted for over 60%. Another study shows that DSHs are expanding their offsite outpatient clinics (“child clinics”) into the affluent neighborhoods serving commercially insured patients who are not low income, to capture the high commercial reimbursements for medications they acquired at steeply discounted prices. This clearly is diverting care away from the intended beneficiaries of the 340B program.
Furthermore, DSHs have been acquiring specialty practices that prescribe some of the most expensive drugs, in order to take advantage of commercial reimbursement for medications that were acquired at the 340B discount price. Independent oncology practices have complained specifically about this happening in their area, where in some cases the DSHs have “stolen” their patients to profit off of the 340B pricing margins. This has the unintended consequence of increasing government spending, according to a study in the New England Journal of Medicine that showed price markups at 340B eligible hospitals were 6.59 times as high as those in independent physician practices after accounting for drug, patient, and geographic factors.
Legal Challenges and Legislation
On May 21, 2024, the US Court of Appeals for the DC Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing program are permissible. The court’s decision follows a lower court (3rd Circuit) ruling which concluded that the 340B statute does not require manufacturers to deliver 340B drugs to an “unlimited number of contract pharmacies.” We’re still awaiting a decision from the 7th Circuit Court on a similar issue. If the 7th Circuit agrees with the government, creating a split decision, there is an increase in the likelihood that the Supreme Court would take up the case.
Johnson & Johnson has also sued the federal government for blocking their proposed use of a rebate model for DSHs that purchase through 340B two of its medications, Stelara and Xarelto, whose maximum fair price was negotiated through the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. J&J states this would ensure that the claims are actually acquired and dispensed by a covered 340B entity, as well as ensuring there are no duplicate discounts as statutorily required by the IRA. When initially proposed, HRSA threatened to remove J&J’s access to Medicare and Medicaid if it pursued this change. J&J’s suit challenges that decision.
However, seven states (Arkansas, Kansas, Louisiana, Minnesota, Missouri, Mississippi, and West Virginia) have been active on this issue, passing laws to prevent manufacturers from limiting contract pharmacies’ ability to acquire 340B-discounted drugs. The model legislation also bans restrictions on the “number, location, ownership, or type of 340B contract pharmacy.”
It should also be noted that there are states that are looking for ways to encourage certain independent private practice specialties (such as gastroenterology and rheumatology) to see Medicaid patients, as well as increase testing for sexually transmitted diseases, by offering the possibility of obtaining 340B pricing in their clinics.
Shifting our focus to Congress, six bipartisan Senators, known as the Group of 6, are working to modernize the 340B program, which hasn’t been updated since the original law in 1992. In 2024, legislation was introduced (see here and here) to reform a number of the features of the 340B drug discount program, including transparency, contract pharmacy requirements, and federal agency oversight.
Who’s Guarding the Hen House?
The Government Accountability Office and the Office of Inspector General over the last 5-10 years have asked HRSA to better define an “eligible” patient, to have more specifics concerning hospital eligibility criteria, and to have better oversight of the program to avoid duplicate discounts. HRSA has said that it doesn’t have the ability or the funding to achieve some of these goals. Consequently, little has been done on any of these fronts, creating frustration among pharmaceutical manufacturers and those calling for more oversight of the program to ensure that eligible patients are receiving the benefit of 340B pricing. Again, these frustrations are not pointed at the initial federally qualified centers or “grantees.”
HRSA now audits 200 covered entities a year, which is less than 2% of entities participating in the 340B program. HRSA expects the 340B entities themselves to have an oversight committee in place to ensure compliance with program requirements.
So essentially, the fox is guarding the hen house?
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.