Temperature Control of Prehospital Medications: “Who`s Burning

Temperature
Temperature Control
Control of
of
Prehospital
Prehospital Medications:
Medications:
“Who’s
“Who’s Burning
Burning Who??”
Who??”
Raymond
Raymond L.
L. Fowler,
Fowler, M.D.,
M.D., FACEP
FACEP
Assistant
Assistant Professor
Professor of
of Emergency
Emergency Medicine
Medicine
The
The University
University of
of Texas
Texas Southwestern
Southwestern
Associate
Associate EMS
EMS Medical
Medical Director
Director
for
for Operations
Operations
Dallas
Dallas Metro
Metro Area
AreaBioTel
BioTelSystem
System
www.doctorfowler.com
Reality
Reality Check
Check
••
"Instead
"Insteadof
ofgetting
gettingmarried
marriedagain,
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going totofind
findaapartner
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like
and
andjust
justgive
giveher
heraahouse.”
house.” Steven
StevenSeagal
Seagal
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"Theproblem
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it'snot
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getsucked
suckedinto
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ofthe
the
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themoff
offatatthe
thewrong
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JeffFoxworthy
Foxworthy
•• "Why
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haveaaseafood
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restaurant? I'm
I'mhalfway
halfwaythrough
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my
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fishburger
burgerand
andIIrealize,
realize,"Oh,
"Oh,my
myGoodness.
Goodness.. .. .IIcould
couldbe
be
eating
eatingaaslow
slowlearner.
learner."" Lynda
Lynda Montgomery
Montgomery
•• "Relationships
"Relationshipsare
arehard.
hard.It's
It'slike
likeaafull
fulltime
timejob,
job,and
andwe
weshould
should
treat
treatititlike
likeone.
one.IfIf your
yourboyfriend
boyfriendor
orgirlfriend
girlfriendwants
wantstotoleave
leaveyou,
you,
they
theyshould
shouldgive
giveyou
youtwo
twoweeks'
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notice.There
Thereshould
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severancepay,
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andbefore
beforethey
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BobEttinger
Ettinger
•• "My
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PaulaPoundstone
Poundstone
The
The use
use of
of medications
medications in
in the
the
out-of-hospital
out-of-hospital environment
environment
may
may benefit
benefit certain
certain patients:
patients:
Asthma
Asthma
Seizures
Seizures
Hypoglycemia
Hypoglycemia
??Cardiac
??Cardiac Arrest??
Arrest??
??Arrhythmia??
??Arrhythmia??
What
What is
is clear
clear is
is that
that the
the
environment
environment that
that medications
medications are
are
being
being taken
taken into
into is
is different
different
from
from an
an in-house
in-house pharmacy
pharmacy
DOES
DOES
IT
IT
MATTER???
MATTER???
DOES
DOES
DOES
IT
IT
IT
MATTER???
MATTER???
MATTER???
Revisions
Revisions in
in the
the standards
standards
of
of the
the United
United States
States Pharmacopeia
Pharmacopeia (USP)
(USP)
related
related to
to product
product dating,
dating, packaging,
packaging,
and
and temperature
temperature monitoring
monitoring are
are discussed.
discussed.
USP
USP has
has revised
revised product
product dating
dating specifications
specifications
as
as they
they relate
relate to
to pharmacy
pharmacy practice.
practice.
“Revised
“RevisedUSP
USPstandards
standardsfor
forproduct
productdating,
dating,packaging,
packaging,and
andtemperature
temperaturemonitoring.”
monitoring.”
Okeke
CC,
Bailey
L,
Medwick
T,
Grady
LT
Okeke CC, Bailey L, Medwick T, Grady LT
Am
AmJJHealth
HealthSyst
SystPharm
Pharm2000
2000Aug
Aug1;57(15):1441-5
1;57(15):1441-5
“A
“A drug
drug isis deemed
deemed to
to be
beadulterated
adulterated ififthe
themethods
methods
used
used in
in or
or the
the facilities
facilities or
or controls
controls
used
used for
for the
the drug’s
drug’s manufacture,
manufacture, processing,
processing,
packing
packing or
or holding
holding do
do not
not conform
conform to
to
or
or are
are not
not operated
operated or
or administered
administered
in
in conformity
conformity with
with good
good manufacturing
manufacturing practice
practice
to
to assure
assure that
that such
such drug
drug has
has the
the identity
identity and
and
strength,
strength, and
and meets
meets the
the quality
quality and
and purity
purity
characteristics
characteristics which
which such
such drug
drug purports
purports
or
or isis represented
represented to
to possess…”
possess…”
21
21 USCA
USCA 351(a)(2)(b)
351(a)(2)(b)–– 351
351 (c)
(c)
The
The United
United States
States Pharmacopeia
Pharmacopeia and
and
National
National Formulary
Formulary (USP
(USP 24/NF19,2000)
24/NF19,2000)
USP
USP requires
requires that
that the
the pharmacy
pharmacy facility
facility
where
where dispensing
dispensing or
or repackaging
repackaging occurs
occurs
be
be maintained
maintained at
at
controlled
controlled room
room temperature
temperature
such
such that
that the
the calculated
calculated
mean
mean kinetic
kinetic temperature
temperature
does
does not
not exceed
exceed 25
25 degrees
degrees C.
C.
Controlled
Controlled Room
Room Temperature
Temperature–– A
A temperature
temperature
maintained
maintained thermostatically
thermostatically that
that encompasses
encompasses
the
the usual
usual and
and customary
customary working
working environment
environment of
of
20
20 –– 25
25 degrees
degrees CC (68
(68–– 77
77 degrees)
degrees) that
that results
results in
in aa
mean
mean kinetic
kinetic temperature
temperature calculated
calculated to
to be
be not
not more
more
than
than 25
25 degrees,
degrees, and
and that
that allows
allows for
for excursions
excursions
between
between 15
15 and
and 30
30 degrees
degrees CC (59
(59 and
and 86
86 degrees
degrees F)
F)
that
that are
are experienced
experienced in
in pharmacies,
pharmacies, hospitals,
hospitals, and
and
warehouses.
warehouses.
MKT = Tk – 273.2
-- 110,000
0,000
___________________________________________________________________________________
___________________________________________________________________________________
ln
ln (( ee –10,000
–10,000 ++ ee -10,000
-10,000 +…
+… ++ ee –10,000
–10,000 ++ ee–10,000)
–10,000)
----------------------------------------------------------------- ----------------------T1H
T1L
TnH
TnL
T1H
T1L
TnH
TnL
_____________________________________________________________________________________________________________________
_____________________________________________________________________________________________________________________
2n
2n
“Prehospital
“Prehospital storage
storage degrades
degrades
the
the physiological
physiological effects
effects of
of epinephrine
epinephrine
in
in human
human myocardium”
myocardium”
Cairns
CairnsCB,
CB,Cain
CainBS
BSetetalal
Annals
AnnalsofofEmergency
EmergencyMedicine
Medicine
[ACEP
Research
Forum
Abstracts],
[ACEP Research Forum Abstracts],
1999
1999Oct,
Oct,Part
Part2,2,34(4)
34(4)
Constant
Constant (169
(169 total
total hours
hours of
of heat
heat exposure)
exposure)
heating
heating resulted
resulted in
in complete
complete degradation
degradation
of
of both
both compounds
compounds (epinephrine)
(epinephrine)
and
and dark
dark brown
brown discoloration
discoloration
of
of the
the solution.
solution. Cyclical
Cyclical heating
heating
(672
(672 total
total hours
hours of
of heat
heat exposure)
exposure)
resulted
resulted in
in aa 31%
31% reduction
reduction in
in EPI
EPI concentration
concentration
and
and aa 225%
225% increase
increase in
in EPI-SA
EPI-SA concentration
concentration
with
with no
no discoloration
discoloration of
of the
the solution
solution
Am
AmJJEmerg
EmergMed
Med1994
1994May;12(3):306-9
May;12(3):306-9
Thermal
Thermaldegradation
degradationofofinjectable
injectableepinephrine.
epinephrine.
Church
ChurchWH,
WH,Hu
HuSS,
SS,Henry
HenryAJ
AJ
Department
of
Chemistry,
East
Carolina
University,
Department of Chemistry, East Carolina University,Greenville,
Greenville,NC
NC27858.
27858.
Prehospital
Prehospital Stability
Stability of
of
Diazepam
Diazepam and
and Lorazepam
Lorazepam
Gottwald,
Gottwald,PharmD,
PharmD,Akers,
Akers,MS,
MS,and
andLiu,
Liu,MD
MD
American
AmericanJournal
Journalof
ofEmergency
EmergencyMedicine,
Medicine,
Volume
Volume17,
17,#4;
#4;333-337
333-337
Department
DepartmentofofClinical
ClinicalPharmacy,
Pharmacy,University
UniversityofofCalifornia
California
San
SanFrancisco,
Francisco,CA
CA
Prehospital
Prehospital Stability
Stability of
of
Diazepam
Diazepam and
and Lorazepam
Lorazepam
Subjected
Subjectedsamples
samplesof
ofValium
Valiumand
and Ativan
Ativanto
to
temperatures
temperaturesranging
rangingfrom
fromrefrigeration
refrigerationto
to
37
37degrees
degreescentigrade
centigrade(98.6
(98.6farenheit)
farenheit)for
for
periods
periodsup
upto
to210
210days
days
Samples
Sampleswere
wereanalyzed
analyzedatat30
30day
dayintervals
intervals
using
usingHPLC
HPLCanalysis
analysis
The
The degradation
degradation
of
of Valium
Valium is
is
accompanied
accompanied by
by
the
the appearance
appearance of
of aa
yellow
yellow color
color
produced
produced by
by aa
“benzophenone
“benzophenone
derivative”
derivative”
“When
“When the
the ambient
ambient storage
storage
temperature
temperature isis 30
30 degrees
degrees or
or less,
less,
ambulances
ambulances carrying
carrying Ativan
Ativan and
and
Valium
Valium should
should be
be restocked
restocked
every
every 30
30 to
to 60
60 days.
days.
When
When drug
drug storage
storage temperatures
temperatures
exceed
exceed 30
30 degrees
degrees C,
C,
more
more frequent
frequent stocking
stocking
or
or refrigeration
refrigeration isis required.”
required.”
Gottwald
Gottwaldetetalal“Stability
“Stabilityof
ofDiazepan
Diazepan
and
andLorazepam”
Lorazepam”
The
The degradation
degradation
of
of drugs
drugs carried
carried in
in
EMS
EMS drug
drug boxes
boxes
produces
produces breakdown
breakdown products
products
the
the effects
effects of
of which
which cannot
cannot be
be predicted.
predicted.
“The
“The results
results indicate
indicate that
that
drug
drug storage
storage temperatures
temperatures
in
in some
some prehospital
prehospital rescue
rescue vehicles
vehicles
exceed
exceed USP
USP guidelines.
guidelines. Mechanical
Mechanical cooling
cooling
of
of the
the storage
storage compartment
compartment results
results in
in
drug
drug storage
storage temperatures
temperatures within
within the
the
USP
USP guidelines.
guidelines. Mechanical
Mechanical cooling
cooling of
of
drug
drug storage
storage compartments
compartments on
on vehicles
vehicles
isis technologically
technologically and
and financially
financially possible.”
possible.”
JJEmerg
EmergMed
Med2000
2000Apr;18(3):345-8
Apr;18(3):345-8
Drug
Drugstorage
storagetemperatures
temperaturesininrescue
rescuevehicles.
vehicles.
DuBois
WC
DuBois WC
“This
“This study
study demonstrates
demonstrates that
that
out-of-hospital
out-of-hospital medications
medications are
are subject
subject to
to
temperatures
temperatures both
both above
above and
and below
below
recommended
recommended storage
storage temperatures.
temperatures.
Time-temperature
Time-temperature indicator
indicator labels
labels
can
can reliably
reliably monitor
monitor exposure
exposure
to
to elevated
elevated temperatures.”
temperatures.”
Acad
AcadEmerg
EmergMed
Med1999
1999Nov;6(11):1098-103
Nov;6(11):1098-103
Storage
Storagetemperatures
temperaturesofofout-of-hospital
out-of-hospitalmedications.
medications.
Allegra
JR,
Brennan
J,
Lanier
V,
Lavery
R,
Allegra JR, Brennan J, Lanier V, Lavery R,MacKenzie
MacKenzieBB
Metro-Dallas
Metro-Dallas Ambulance
Ambulance
Temperature
Temperature Study,
Study, August
August 2001
2001
100
80
60
8/9/2001
8/13/2001
40
8/17/2001
20
8/21/2001
8/25/2001
0
4 p.m. Vehicle
8/30/2001
8 a.m. Vehicle
8 a.m. Vehicle
8 a.m. Bay
12 noon Vehicle
12 noon Bay
4 p.m. Vehicle
4 p.m. Bay
8 p.m. Vehicle
8 p.m. Bay
Bay Temperatures Showed a Steady Rise
During the Summer Texas Heat
91
90
89
88
87
86
S1
Bay
Vehicle
8 p.m.
Bay
Vehicle
4 p.m.
Bay
Vehicle
12 noon
Bay
Vehicle
8 a.m.
85
Drug box temperatures showed
a more gradual and less extreme rise
91
90
89
88
87
86
S1
Bay
Vehicle
8 p.m.
Bay
Vehicle
4 p.m.
Bay
Vehicle
12 noon
Bay
Vehicle
8 a.m.
85
Comparison shows the greater
temperature change on the Bay
91
90
89
88
87
86
S1
Bay
Vehicle
8 p.m.
Bay
Vehicle
4 p.m.
Bay
Vehicle
12 noon
Bay
Vehicle
8 a.m.
85
At
At all
all times,
times, and
and in
in all
all measurements…
measurements…
100
90
80
Safety Range
70
60
50
40
30
20
8/30/2001
8/27/2001
8/25/2001
8/23/2001
8/21/2001
8/19/2001
8/17/2001
8/15/2001
8/13/2001
8/11/2001
0
8/9/2001
10
S1
…
temperatures exceeded
…temperatures
exceeded recommended
recommended
storage
storage temperatures
temperatures
Average Temperatures Exceeded
the safe range at all times
91
90
89
88
87
86
S1
Bay
Vehicle
8 p.m.
Bay
Vehicle
4 p.m.
Bay
Vehicle
12 noon
Bay
Vehicle
8 a.m.
85
75%
75% degradation
degradation of
of Ativan
Ativan in
in the
the
ambient
ambient temperatures
temperatures of
of Texas
Texas
2.5
2
Refrig
1.5
Ambient
37 degree
Linear (37 degree)
1
0.5
0
0
30
60
90
120
150
180
210
Almost
Almost no
no degradation
degradation of
of Ativan
Ativan
in
in the
the ambient
ambient temps
temps of
of San
San Francisco
Francisco
2.5
2
Refrig
1.5
Ambient
37 degree
Linear (Ambient)
1
0.5
0
0
30
60
90
120
150
180
210
15%
15% degradation
degradation of
of Valium
Valium in
in the
the
ambient
ambient temperatures
temperatures of
of San
San Francisco
Francisco
6
5
4
Refrig
Ambient
37 degree
Linear (Ambient)
3
2
1
0
0
30
60
90
120
150
180
210
25%
25% degradation
degradation of
of Valium
Valium in
in the
the
ambient
ambient temperatures
temperatures of
of Texas
Texas
6
5
4
Refrig
Ambient
37 degree
Linear (37 degree)
3
2
1
0
0
30
60
90
120
150
180
210
The
The Simple
Simple Reality:
Reality:
ItIt has
has been
been shown
shown time
time and
and again
again
that
that EMS
EMS drugs
drugs are
are regularly
regularly subjected
subjected
to
to temperatures
temperatures outside
outside of
of recommended
recommended
storage
storage recommendations.
recommendations.
EMS
EMS Drugs
Drugs are
are adulterated!!
adulterated!!
UNMEASURABLE
UNMEASURABLE OUTCOMES
OUTCOMES
Does
Does itit really
really make
make aa
difference?
difference?
Does
Does receiving
receiving only
only aa half
half milligram
milligram
of
of Ativan,
Ativan, or
or only
only three
three
milligrams
milligrams of
of Valium
Valium make
make aa
potential
potential difference
difference in
in the
the
seizure
seizure patient?
patient?
Does
Does receiving
receiving only
only aa half
half milligram
milligram
or
or even
even aa fourth
fourth of
of aa milligram
milligram
of
of epinephrine
epinephrine instead
instead of
of
aa whole
whole milligram
milligram make
make aa
difference
difference in
in the
the setting
setting of
of
cardiac
cardiac arrest?
arrest?
Does
Does receiving
receiving dosages
dosages of
of
butyrophenones
butyrophenones and
and
epinephrine-sulfonic
epinephrine-sulfonic acid
acid
cause
cause toxic
toxic effects
effects in
in the
the human?
human?
Are
Are we
we not
not administering
administering
unprescribed
unprescribed chemicals
chemicals when
when
we
we give
give drugs
drugs that
that have,
have,
or
or may
may have,
have,
breakdown
breakdown products
products
in
in the
the fluid?
fluid?
Even
Even ifif we
we change
change out
out drug
drug boxes
boxes
once
once aa week
week ––
OR
OR EVEN
EVEN DAILY
DAILY ––
THE
THE MEDICATIONS
MEDICATIONS ARE
ARE
STILL
STILL ADULTERATED!!
ADULTERATED!!
Reality
RealityCheck,
Check,continued
continued
••"The
"Theday
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worryabout
aboutcleaning
cleaningmy
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howChicago
Chicagogot
gotstarted.
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people
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'Gee,I'm
I'menjoying
enjoyingthe
the crime
crimeand
andthe
thepoverty,
poverty,
but
it
just
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cold
enough.
Let's
go
west."
Richard
Jeni
but it just isn't cold enough. Let's go west." Richard Jeni
••"If
"Iflife
lifewas
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fair,Elvis
Elviswould
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aliveand
and
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allthe
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impersonatorswould
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bedead.
dead."" Johnny
JohnnyCarson
Carson
••"Sometimes
"SometimesIIthink
thinkwar
warisisGod's
God'sway
wayofof
••teaching
teachingus
usgeography.
geography."" Paul
Paul Rodriguez
Rodriguez
••"My
"Myparents
parentsdidn't
didn'twant
wanttotomove
movetotoFlorida,
Florida, but
butthey
theyturned
turnedsixty,
sixty,
and
andthat's
that'sthe
thelaw.
law."" Jerry
Jerry Seinfeld
Seinfeld
••"In
"Inelementary
elementaryschool,
school,inincase
caseofoffire
fireyou
youhave
havetotoline
lineup
upquietly
quietly
ininaasingle
file
line
from
smallest
to
tallest.
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is
the
logic?
single file line from smallest to tallest. What is the logic?
Do
Dotall
tallpeople
peopleburn
burnslower?
slower?"" Warren
WarrenHutcherson
Hutcherson
••"Bigamy
"Bigamyisishaving
havingone
onewife/husband
wife/husbandtoo
toomany.
many.
Monogamy
Monogamyisisthe
thesame.
same."" Oscar
OscarWilde
Wilde
NO POSITION
Organized Medicine
in General
NO POSITION
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of59
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degreesFF(15
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C)
in
inambient
ambienttemperatures
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Internalstorage
storagetemperature
temperaturedisplayed
displayedon
ondigital
digitalpanel
panel
MC-2000
MC-2000 has
has FDA
FDA approval
approval to
to market.
market.
(according
(according to
to the
the manufacturer)
manufacturer)
Direct
Direct Quotes
Quotes
from
from National
National Salespersons
Salespersons
American
American Emergency
Emergency Vehicles
Vehicles
Matrix
Matrix
February
February 8,
8, 2002
2002
“No
“No demand”
demand”
“Very
“Very new”
new”
“No
“No orders
orders for
for them”
them”
“One
“One person
person has
has called”
called”
“It
“It was
was too
too big
big for
for the
the unit”
unit”
WHAT
WHAT
REALLY
IS
IS
THE
THE
FUTURE?!?
SSyynnt
thheessiis
s
Can we
resolve this
medications
temperature
problem??
A
QUALIFIED
YES
Immediate
Immediate Issues
Issues
1.
1. Drug
Drug boxes
boxes have
have to
to be
be changed
changed
out
out more
more often
often ifif the
the boxes
boxes are
are not
not
kept
kept refrigerated.
refrigerated. How
How often?
often?
2.
2. Ativan
Ativan needs
needs to
to be
be refrigerated.
refrigerated.
3.
3. Little
Little isis published
published about
about the
the other
other drugs
drugs
4.
4. Epinephrine
Epinephrine isis known
known to
to break
break down
down also,
also,
which
which should
should mean
mean that
that Levophed
Levophed does
does also
also
5.
5. Pills
Pills in
in aa solid
solid matrix
matrix are
are known
known to
to be
be
temperature
temperature stable
stable
“William
“William Moore"
Moore" <[email protected]>
<[email protected]>
Solution
Solution from
from
Carrollton,
Carrollton, Texas
Texas
Backpack
Backpack
Cooler
Cooler
(from
(from Costco,
Costco,
II think)
think)
David
David Lee
Lee <[email protected]>
<[email protected]>
Future
Future Issues
Issues and
and Dilemmas
Dilemmas
1.
1. Future
Future ambulances
ambulances should
should be
be equipped
equipped with
with
chambers
chambers that
that maintain
maintain temperature.
temperature.
2.
2. Problem
Problem is,
is, the
the technology
technology isis
not
not commonplace
commonplace at
at this
this time
time
3.
3. Optional
Optional temperature
temperature control
control devices
devices are
are
available
available from
from ambulance
ambulance makers,
makers, but
but at
at
what
what cost?
cost?
Closing
Closing Question?????
Question?????
Are
Are ambulance
ambulance services
services prepared
prepared to
to spend
spend
costs
costs approaching
approaching $1,500
$1,500 per
per rig
rig
to
to adequately
adequately equip
equip EMS
EMS units
units
-- ANY
ANY VEHICLE
VEHICLE CARRYING
CARRYING MEDS
MEDS -for
for temperature
temperature control
control of
of medications?
medications?
The
The Texas
Texas Department
Department of
of Health
Health
has
has issued
issued aa warning
warning
to
to all
all providers
providers of
of Emergency
Emergency Medical
Medical Services
Services
that
that the
the operators
operators of
of the
the vehicles
vehicles
will
will be
be responsible
responsible for
for the
the
proper
proper storage
storage of
of medications
medications
and
and devices,
devices, or
or face
face possible
possible state
state action
action
against
against their
their
license
license and
and operation.
operation.
$$$???
…thank
…thank you
you for
for your
your kind
kind attention
attention
www.doctorfowler.com
www.doctorfowler.com