Temperature Control of Prehospital Medications: “Who`s Burning
Transcription
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, again,I'm I'mgoing going totofind findaapartner partnerIIreally reallydon't don'tlike like and andjust justgive giveher heraahouse.” house.” Steven StevenSeagal Seagal •• "The "Theproblem problemwith withthe thedesignated designateddriver driverprogram, program,it's it'snot notaadesirable desirablejob. job. 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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' weeks'notice. notice.There Thereshould shouldbe be severance severancepay, pay, and andbefore beforethey theyleave leaveyou, you,they theyshould shouldhave havetotofind findyou youaatemp. temp."" Bob BobEttinger Ettinger •• "My "MyMom Momsaid saidshe shelearned learnedhow howtotoswim swimwhen whensomeone someonetook took her herout outininthe thelake lakeand andthrew threwher heroff offthe theboat. boat.IIsaid, said, 'Mom, 'Mom,they theyweren't weren'ttrying tryingtototeach teachyou youhow howtotoswim. swim. Paula 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 dayIIworry worryabout aboutcleaning cleaningmy myhouse houseisis the theday daySears Searscomes comesout outwith withaariding ridingvacuum vacuumcleaner. cleaner."" Roseanne Roseanne ••"I"Ithink thinkthat's that'show howChicago Chicagogot gotstarted. started.AA bunch bunchof ofpeople people ininNew NewYork Yorksaid, said,'Gee, 'Gee,I'm I'menjoying enjoyingthe the crime crimeand andthe thepoverty, poverty, but it just isn't cold enough. Let's go west." Richard Jeni but it just isn't cold enough. Let's go west." Richard Jeni ••"If "Iflife lifewas wasfair, fair,Elvis Elviswould wouldbe bealive aliveand and all allthe theimpersonators impersonatorswould wouldbe 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. What 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 …CAN YOU CALL BACK AFTER LUNCH?? ? SOLUTIONS?? CFE CFE Medical Medical Products Products Laramie Laramie Wyoming Wyoming fcylvick@drugcase.com fcylvick@drugcase.com $495 $495 -- $715 $715 17 17 xx 16 16 xx 7H 7H 21 21 xx 16 16 xx 16H 16H 21 21 xx 16 16 xx 21H 21H Very Veryreliable reliablesensors sensorsand andelectronics electronicscontrol controlthe the thermoelectric thermoelectricheat heatpump pumpto toassure assure the theMC-2000 MC-2000drug drugcase casewill willkeep keepmedications medications in inthe therecommended recommendedstorage storagetemperature temperaturerange range of of59 59--86 86degrees degreesFF(15 (15--30 30degrees degreesC) C) in inambient ambienttemperatures temperaturesranging rangingfrom from 20 20--120 120degrees degreesFF(-8.7 (-8.7--48.9 48.9degrees degreesC). C). •• •• Solid Solidstate statecontrols controls --no nomoving movingparts parts •• Very Veryquiet quietbrushless brushlessfan fan •• Adjustable Adjustabletemperature temperatureset setpoint point •• Operates Operateswith withany any12 12VDC VDCvehicle vehiclepower power •• or or110 110VAC VACwith withoptional optionalpower poweradapter adapter Internal 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" <wmoore@etmc.org> <wmoore@etmc.org> Solution Solution from from Carrollton, Carrollton, Texas Texas Backpack Backpack Cooler Cooler (from (from Costco, Costco, II think) think) David David Lee Lee <David.Lee@cityofcarrollton.com> <David.Lee@cityofcarrollton.com> 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