Drug Shortages Guide - Canadian Pharmacists Association

Drug ShortagesA Guide for Assessment and Patient Management

2 Drug Shortages © Canadian Pharmacists Association 2010

Table of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . 2

Managing Drug Shortages . . . . . . . . . . . . 3

Step 1.Checkingallmedicationsupplyavenues . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Step 2. Determininghowcriticalamedicationisforapatient . . . . . . . . . . . . 4

Step 3. Selectinganalternativemedication . . . . . . . . . . . . . . . . . . . . . . . . . 7

Step 4.Initiatinganewtherapywithanalternativemedicationordiscontinuingtherapytemporarily . . . . . . . . . . . . . . . . . . 9

Communication between Pharmacists, Prescribers and Patients . . . . . . . . . . . . . . 10

References . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Pharmacists, physicians and other prescribers must use their professional judgement in using this guide to meet the needs of their own practice settings and situations, and to comply with applicable policies and regulations.

This document has been revised from a guide on drug shortages first published by the Canadian Pharmacists Association in 1999, and updated in 2001.

IntroductionMedicationtherapyiscriticalintreatingandpreventingdiseaseandisanintegralpartofeverydaylifeformanyCanadians .Thepharmaceuticalsupplychainofmanufacturers,wholesalers,distributorsandpharmacists,aswellasphysiciansandgovernments,acknowledgetheimportanceofhavingacontinuoussupplyofmedications .

However,itispossiblewithintoday’sdrugdistributionsystemforglitchestooccur,suchasshort-termbackordersorlong-termdrugunavailability .Thechallengeforhealthcareprovidersistoprovideseamless,equivalentdrugtherapyatcomparablecosts .Assessmentrequiresacriticalevaluationofthecurrentsituationandpotentialimpactoftheshortageonpatientoutcomes .4

Whenanimportantdrugproductisnotavailable,practitionerswillwanttoknow:•reasonsfortheproduct’sunavailability•whentheproductwillbeavailable•optionsforobtainingthedrugfromalternatesources•alternatetherapiesandtheircostconsequences•relatedinformationneedsofhealthcareprovidersandpatients .

Disruptionsinthesupplyofpharmaceuticalsmayoccurduetoseveralreasons,including:•Unexpectedincreasesinutilizationofadrug,resultinginatemporaryshortageuntilmanufacturingcapacitymeetsdemand .

•Voluntarydiscontinuationorrecallsofaproductbyamanufacturer .Insomesituations,othermanufacturersmarketthesamedrug,butareunawareofthediscontinuation,andthereforedonotadjusttheirmanufacturingcapacityinadvance .

•WithdrawalfromthemarketbyHealthCanada/manufacturer .•Naturaldisasters(e .g .,icestormsandfloods) .•Increaseddemandduetoemergencysituations(e .g .,masscasualties)orinfectiousdiseaseoutbreaks(e .g .,causedbyapandemicinfluenza) .

ItisimportanttoacknowledgetheremaybepublicconcernthatCanadianswillbewithoutessentialmedicines .

Asfrontlinehealthcareproviders,pharmacists,physiciansandotherprescribersareinauniquepositiontodeliverareassuringandconsistentmessagetothepublic,aswellasmanageanychangestodrugregimensrequiredduetoadrugshortage .Italsoprovidesanopportunitytodoafullmedicationassessmentorreviewtodetermineoverallappropriatenessofdrugtherapy .CPhAhasdevelopedthisguidetoassistinmanagingpatientsintheeventofadrugshortage .

Fordrug-specifictherapeuticinformation,pharmacists,physiciansandotherprescribersareencouragedtorefertodrugandtherapeuticreferences(e .g .,Therapeutic Choices5;CPS6;eTherapeutics7),clinicalpracticeguidelines(e .g .,CanadianMedicalAssociation’sCPGInfobaseatwww .cma .ca/cpgs),orcontactaregionaldruginformationcentre .

If,inyourpractice,youareawareofcriticaldrugshortagesthatnecessitatechangestoapatient’sdrugtherapy,andhavedevelopedauniquewayofmanagingthesituation,pleaseshareyourexperiencewithus .Pleasecall1-800-917-9489,oremailusatinfo@pharmacists .ca .

CPhAwillcontinuetomonitordrugsupplyissues .

PurposeIt is well known that drug shortages are not uncommon and, in fact, often occur as a part of the routine day for pharmacists.1,2,3 This guide presents a systematic approach to assess the impact of drug unavailability and subsequent patient management. It can be applied whenever drug shortages are encountered.

Thisguideisaconcise,practicaltoolforphysicians,pharmacistsandotherprescribersthatcanbeusedinanydrugshortagesituation .Theguidewasdesignedto:

• Presentanexplicitsystematicprocesstousewhenfacedwithadrugshortage .

• Highlighttheuniquepositionofpharmacists,physiciansandotherprescribersindeliveringastrong,reassuringandconsistentmessagetothepublicregardingthemanagementofdrugtherapyinthefaceofdrugavailabilitydifficulties .

• Discouragepracticesofstockpilingorhavingmedicationsonhand“just-in-case”,andtoprovidetipsforcommunicatingwithpatients .

© Canadian Pharmacists Association 2010 Drug Shortages 3

Asageneraloverviewofhowdrugshortagesshouldberesolved,analgorithm(Figure1)simplifiesthemanagementofdrugshortagesintoanumberofbasicstepsandquestions .

Pharmacistsmayfindthatthecontentsofthissectionrepresentstepsthattheyhavealreadyinternalizedandpracticeonaday-to-daybasis .

Theshadedboxesrepresentthethreemainstepstoresolveamedicationshortage:

1 .Exhaustingeveryavenuetosupplythemedication

2 .Assessinghowcriticalthedrugisforthepatient

3 .Selectinganalternativemedication,ifrequired .

Managing Drug Shortages

Figure 1. Suggested approach for pharmacists in the management of a drug shortage

Drug shortage encountered

Consult checklist for different supply avenues (Figure 2)

Discuss drug shortage with patient and prescriber*

Discuss drug shortage and alternative drug

with patient and prescriber*

NO YES

* In many provinces, pharmacists are authorized to adapt a prescription or prescribe an alternative dosage form or medication.

Have I exhausted every avenue to supply the drug?

Is this a critical drug? (Figure 3)

NO YES

Select an appropriate alternative on an

individual patient basis (Figures 4 and 5)

Step 1.Checking all medication supply avenuesDrugshortagesareadaytodayrealityforpharmacists .Ifamedicationisunavailable,thepharmacistinvestigatesdifferentsourcesforobtainingthemedication .Usethefollowingchecklisttodoublecheckanddocumenttheprocessforobtainingandsupplyingmedications .

Figure 2. Checklist for medication supply avenues

1. Is the medication interchangeable with any brand name or generic alternatives?

hYeshNo

2. If the medication is available in other dosage strengths, can the dose be made up using other strengths?

hYeshNo

3. If the medication is available in a different formulation, can the drug be supplied in this form? Are there any bioavailability differences which require dosage adjustment?

hYeshNo

4. Can drug supply be obtained through another pharmacy?

hYeshNo

5. Can drug supply be obtained through your regular wholesaler or other wholesalers?

hYeshNo

6. Can drug supply be obtained directly from the manufacturer?

hYeshNo

Notes_________________________________________________________

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Step 2.Determining how critical a medication is for a patientIfamedicationisunobtainableandcannotbesuppliedtoapatient,thepharmacistandprescribermustworktogethertodeterminehowessentialor“critical”thedrugissothattheappropriatecourseofactioncanbedetermined .Thepotentialconsequencesofdrugunavailabilitymustbecarefullyconsideredforeachindividualcase .

Adrugshortagealsoprovidesanopportunitytodoafullmedicationassessmentorreviewtodeterminetheoverallappropriatenessofdrugtherapy .Usethefollowingseriesofquestionstoassesstheimpactofadrugshortageonapatient,andtodocumenttheprocessundertakenwiththepatient .

Table 1: Classification of critical and noncritical drugs and recommended actions

Description

Action 1+

Action 2+

Action 3+

+In many provinces, pharmacists are authorized to adapt a prescription or prescribe an alternative dosage form or medication.

Note: This classification system should be used as a guide only. Professional judgement is required in determining whether the above classification of a particular drug is appropriate for each patient, based on individual patient need and assessment.

Level 1

CRITICAL DRUGDrug should be available for initiation or continuation.

Drug therapy for disease is essential and cannot be interrupted for even one dose or one day.

Drug actions may:•beacutelylifesaving*(e .g .,nitroglycerinforanginaattack)

•reducedebilitatingsymptomsofdiseaseorpatientmorbidity(e .g .,opioidsforcancerpain)

•precipitatedangerousdiseaseeventswithcessation(e .g .,insulinproducts)

*Medications that are not firstline therapies and whose actions are accomplished by alternate therapies are exceptions.

Useinterchangeableproductifmedicationisunavailable .Forsinglesourceproducts,gotoAction2 .

Switchtoanalternativedrugwithinclass,ifclasseffectexists .Consultwithprescriber .

Switchtoalternatedrugclasstoensurecontinuedtherapyfordisease .Discusswithpatient .Consultwithprescriber .

Level 2

CRITICAL DRUGDrug should be available for initiation or continuation.

Drug therapy for disease is important; however therapy may be interrupted for greater than one dose or one day, but should not be interrupted for extendedduration.

Drug actions may:•belife-savingovertime(e .g .,diureticsforhypertension)

•reduceintolerablesymptomsofdiseaseorpatientmorbidity

Useinterchangeableproductifmedicationisunavailable .

Mayconsideraswitchtoanalternativedrugwithinclass,ifclasseffectexists .Consultwithprescriber .

Substitutionwithalternatedrugclassmaynotberequired .Discusswithpatientandconsultprescriber .Contactpatientassoonasmedicationbecomesavailable .

Level 3

NON-CRITICAL DRUGDrug availability is preferred but not crucial.

Drug therapy is valuable, yet may be interrupted for an extended durationof time.

Drug use may:•bebasedonpatientpreferenceonly

•reduceminorsymptomsofdisease(e .g .,H2receptorantagonistsfordyspepsia)•bemostlyadjunctive(e .g .,montelukastinasthma)

•addminimalbenefittomanagementofdisease

•belifestyledrugs(e .g .,finasterideformalepatternbaldness)

Useinterchangeableproductifmedicationisunavailable .

Switchingtoanalternativedrugwithinclassmaynotberequired .Discusswithpatientandprescriber .

Substitutionwithalternatedrugclassisnotrequired .Discusswithpatientandprescriber .Informpatientwhenmedicationbecomesavailable .


Table1andFigure3willassistthehealthcarepractitionerindetermininghowcriticalamedicationis:•Level 1 drugs:criticaldrugsthatcannotbemissedforevenasingledoseorday

•Level 2 drugs:criticaldrugsthatmaybemissedforgreaterthanonedoseorday,butshouldbereinstitutedassoonaspossiblesincetheyreducelong-termcomplicationsofdiseaseandreduceintolerablesymptomsofdisease

•Level 3 drugs: non-criticaldrugsthatcansafelybewithheldforaperiodoftime

1. What is the seriousness of the disease? For what disease/condition is the drug being used? What are the consequences of untreated disease?

h Acutelylife-threatening(e .g .,anginaattack)

h Causesdebilitatingsymptomsleadingtodecreasedqualityoflife(e .g .,cancerrelatedpain)

h Causesbothersomesymptomswithnolong-termconsequences(e .g .,allergicrhinitis)

h Seriouslong-termconsequencesbutnotcurrentlybothersome(e .g .,hypertension)

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2. What is the effect of abrupt withdrawal of the medication on the patient?

On the disease? On other medications being taken by the patient?

h Isthemedicationknowntobeassociatedwithawithdrawalreaction?(e .g .,beta-blockers,SSRIs,anticholinergics)

h Willabruptdrugwithdrawalprecipitateacomplicationofthedisease?(e .g .,nitroglycerinforangina)

h Hadthepatient’smedicationsbeenadjustedtocompensatefordruginteractions?Willabruptwithdrawalresultintheappearanceofanydruginteractions?(e .g .,warfarindruginteractions)

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3. How essential is the medication in the management of the disease and what are its therapeutic benefits?

h Acutelylife-saving(e .g .,nitroglycerininunstableangina)

h Curesdisease(e .g .,antibioticsforcommunityacquiredpneumonia)

h Preventsonset/progressionoflong-termconsequences(e .g .,HMGCoAreductaseinhibitorsforcardiovasculardisease)

h Reduces/controlsbothersomesymptomsofdisease(e .g .,sumatriptan,a5HT1agonistformigraine)

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4. Is the patient currently deriving the benefits of the medication?

h Isthetreatmentworking?Objectivedata(e .g .,lipidprofile)

h Isthetreatmentworking?Subjectivedata .Whatisthepatient’sperceivedefficacyofthemedication?(e .g .,PPIsforGERDsymptoms)

h Isthemedicationmeetingthepatient’sgoals?(e .g .,Analgesicsmayreducebutnotcompletelyeliminatepaininpatientswithcancerpain .Painreductionmaybeanacceptablegoalforthepatientratherthanpainelimination .)

h Isthepatientexperiencinganyadverseeffectsfromtherapy?

h Isthepatientadherentwithdrugtherapy?

h Isthedrugtherapystillrequired?

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Figure 3. Steps to determine how critical a medication is for a patient


5. For how long is the duration of the expected drug shortage? Will the drug be unavailable for:

h oneday

h afewdays

h severalweeks

h unknown

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6. What patient factors may increase or decrease the impact of the drug shortage on the patient?

h Isthepatientanxiousabouttheunavailabilityofhis/hermedication?

h Couldthisencouragepatientnon-adherence?

h Couldthisresultinthepatientperceivingthetherapyasnotimportant?

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7. For what length of time can the medication be missed without serious detriment to the patient? (SeeTable1)

h Notevenasingledoseorday

h Greaterthanonedoseoroneday

h Extendeddurationoftime(severalweeks)

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8. Based on the above considerations, how critical is the medication in this situation? (SeeTable1)

h Level1criticaldrug

h Level2criticaldrug

h Level3non-criticaldrug

Notes___________________________________________________________

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Thefinalstepintheprocessisforthephysician,pharmacistorotherprescribertointegratealltheavailableinformationtoarriveataratingofhowcriticaltheunavailablemedicationistothepatient .Classifyingmedicationsinthismannermakestheprioritizationofmedicationsmoreexplicitandhelpstodeterminewhenasubstitutemedicationmustbechosenforthepatient,orwhenatemporaryshortageofamedicationmaybeacceptable .Table1canbeusedtogradehowcriticalacertaindrugmaybeandsuggestsactionsbasedonthelevelofcriticalness .

Figure 3. Steps to determine how critical a medication is for a patient – continued


Step 3. Selecting an alternative medicationIfadrugiscriticalforaparticularpatient,selectasubstitutethatwillbeeffectiveandtolerabletherapyforthepatient .Figure4describesthefactorsthatshouldbeconsideredinselectingasubstitutemedicationforapatient .


1. Are there acceptable brand name or generic equivalents available?

hYeshNo

Notes___________________________________________________________

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2. Does the medication belong to a drug category that is known to have a class effect?

(e .g .,ACEinhibitors,HMGCoAreductaseinhibitors)

hYeshNo

Notes___________________________________________________________

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3. Are there any alternate drug therapies that may be considered?

(Refertocurrenttherapeuticreferencesforpossiblealternatives)

hYeshNo

Notes___________________________________________________________

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4. How well does each alternate drug therapy work?

h Doesitprovidesimilarefficacyinmanagingsymptoms?(e .g .,PPIsaresuperiortoH2receptorantagonistsforseveresymptomsofGERD .)

h Doesithavesimilarefficacyinimprovingoutcomesofdisease?(e .g .,DigoxindoesnotreduceoverallmortalityofheartfailureasACEinhibitorsdo .)

h Hasthepatienttriedanyofthesealternativesinthepast?

h Howwelldidtheywork?

Notes___________________________________________________________

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5. When can the alternate drug therapy be expected to begin working?

(i .e .,Theidealalternatetherapywouldbegintoworkastheeffectsfromtheoriginaldrugwearoff .)

Notes___________________________________________________________

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Figure 4. Checklist for selecting an alternative medication

6. What side effects or toxicities may be expected?

h Whataretheshort-termandlong-termtoxicities?

h Dothetherapeuticbenefitsofamedicationoutweighitsassociatedtoxicities?

h Ifusedpreviously,didthepatientexperienceanysideeffectsortoxicities?

Notes___________________________________________________________

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7. Does the patient have any other medical conditions, co-morbidities or contraindications to the alternate drug?(e .g .,beta-blockersforasthmatics)

Notes___________________________________________________________

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8. Are there any patient-specific factors that may modify your selection of a substitute drug therapy?

h Doesthepatienthaveanydrugallergies?

h Isthepatientpregnantorbreastfeeding?

h Doestheageofthepatientpredisposehim/hertocertainadversemedicationeffects?

h Isthispatientunabletometabolizeand/oreliminatethisdrug?(e .g .,ACEinhibitorsordigoxininpatientswithreducedrenalfunction)

Notes___________________________________________________________

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9. What other medications is the patient taking?

h Doanyofthesemedicationsinteractwithpotentialalternatetherapies?

h Candosemodificationsbemadetoovercomethesedruginteractions?

Notes___________________________________________________________

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10. Is the alternate drug therapy easily administered?

h Canthismedicationbeeasilyintegratedintothepatient’sroutine?

h Isthepatientcapableofundertakinganewregimen?

Notes___________________________________________________________

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11. Are the alternate drug therapies affordable for the patient?

h Isthemedicationcoveredbythepatient’sdrugplan?

h Duetotheshortage,isthealternatemedicationonspecialauthorization?

h Isitmoreexpensiveforthepatient?

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Figure 4. Checklist for selecting an alternative medication – continued


Step 4. Initiating a new therapy with an alternative medication or discontinuing therapy temporarily

Figure 5. Checklist for initiating a new therapy or discontinuing therapy

1. What considerations need to be addressed when discontinuing the original medication?

h Doesthemedicationneedtobetapereddownward?Ifso,byhowmuchandhowoftenshouldthemedicationbetapered?(e .g .,steroidtapering)

h Whatparametersshouldbemonitoredtoensureminimaladverseeffectsfromdrugtermination?(e .g .,beta-blockerwithdrawal:monitorheartrate,bloodpressure,anginasymptoms,etc .)

h Whatparametersshouldbemonitoredtoensurethatthepatientisnotexperiencinganyunnecessaryilleffectsrelatedtolossofdrugactionondisease?(e .g .,diureticsforheartfailurestopped:monitorweight,edema,shortnessofbreath,etc .)

Notes___________________________________________________________

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2. Should the two therapies be overlapped during the switchover?

h Whenshouldthealternatetherapybeinitiatedtoprovidecontinuousdrugcoverage?

h Howfrequentlyshouldthenewmedicationbegiventoensurecontinuousdrugcoverage?(e .g .,fentanylpatchswitchtooralmorphinetablets)

Notes___________________________________________________________

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3. What considerations need to be addressed when the substitute medication is initiated?

h Doesthesubstitutemedicationneedtobetitratedupward?Ifso,byhowmuchandhowoftenshouldthemedicationbetitrated?(e .g .,carbamazepineinitiation)

h Whatparametersshouldbemonitoredtoassessonsetofdrugactionandadequacyofdrugefficacy?

h Whatparametersshouldbemonitoredtodetectanyadverseeffectsrelatedtothemedicationorfasttitrationofmedication?

h Isthedrugcoveredbythepatient’sdrugplan?Ifnot,isthereaspecialauthorizationprocesstoallowforitsuse?

Notes___________________________________________________________

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4. What are the treatment goals?

h Includepatientindeterminingiftreatmentgoalshavebeenmet .

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5. Does the patient require assistance to undertake a new regimen?

h Whatisthepatient’scomfortlevelwiththenewtherapy?

h Whatfriendorfamilysupportsareneededtoensureasmoothtransitionfromoriginalmedicationtoalternative?

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Figure 6. Choice of therapy when the original medication becomes available again


1. Should the patient remain on the current medication or switch back to the original?

h RefertoFigures3and4toevaluatetheoriginalandalternativemedicationsandidentifywhichmedicationispreferableforthepatient .

h Howdoesthepatientperceivetheeffectsofthecurrentmedication?

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2. If the patient is to return to the original medication, what factors should be considered?

h RefertoFigure5toidentifyfactorsthatmustbeconsideredinswitchingmedications .

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Communication between Pharmacists, Prescribers and Patients

Openlinesofcommunicationbetweenpharmacists,physiciansorotherprescribersandpatientsarenecessarywhendealingwithdrugsupplyshortages,sothatpanicisnotunnecessarilycreatedwhenavailabilityofadrugmaybetemporarilycompromised .Thepublicneedstobereassuredthatstockpilingofmedicationsincaseofashortageoutbreakorothereventisunwarranted .

Ifthereisatemporaryshortageofamedication,pharmacistsshouldavoiddispensinglargequantitiesofdrugstoindividualpatientsandalsostockonlytheinventorythatisneededfortheirdispensary .Overstockingbysomecommunityorhospitalpharmaciesmayresultinshortagesfromthemanufacturerorwholesalerforotherpharmacies .Physiciansandotherprescriberscanalsohelpinsuchsituationsbynotprescribinglargequantitiesorforlongperiods .

Ateamapproachbetweenpharmacists,physiciansandotherprescriberswillensurethatastrongandconsistentmessageisdeliveredtopatients .Effectivecommunicationandcooperationwillbecomeessentialwhendrugshortagesdooccur .Agoodworkingrelationshipwillfacilitateapatient-focused,thoroughassessmentofpotentialconsequencesofdrugunavailabilityanddevelopmentofcontingencyplansthatmeetapatient’sdrugrelatedneeds .

Herearesomesuggestedpointstosharewithyourpatients3,8,9,10:

• Reassurepatientsthattheyshouldbeabletoobtainnormalsuppliesofmedication,astheyrequirethem .

• Intheeventthatapharmacyencountersaparticulardrugshortage,thereareanumberofalternativesourcesofmedicationsupplyinthedrugdistributionsystem .

• Encouragepatientstoreordermedicationswhen5-7daysofsupplyremain(e .g .,don’tletyoursupplyrunout) .

• Advisepatientsnottoleavealltheirmedicationseitherathomeorwork(e .g .,carryafewdoseswithyouincaseyouaredelayed .PharmacistscanprovideanextralabelledRxvialforthispurpose) .

• Whentravelling,takeafewextradayssupplywithyouandcarrythemwithyouonairplanes .

• ReinforcethatstockpilingofmedicationisnotnecessaryandthatobtainingdrugsovertheInternetisnotrecommended .

• Thepharmacysupplychainhasademonstratedrecordofbeingresilientduringmanydifferentsituations,evenemergenciessuchasnaturaldisasters .Mostissuescanbequicklyandefficientlycorrected .


References 1. Woodend AK, Poston J, Weir, K. Drug shortages – risk or reality? Can Pharm J 2005; 138(1): 27-30.

2. Lynas K. Pharmacists in Canada challenged to deal with drug shortages. Can Pharm J 2010; 143(4): 164-164.

3. American Society of Health-System Pharmacists. Drug Shortages. Available: http://www.ashp.org/shortages (accessed September, 2010).

4. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm 2009; 66: 1399-1406.

5. Gray, J, ed. Therapeutic Choices. 5th ed. Ottawa (ON): Canadian Pharmacists Association; 2007.

6. Compendium of Pharmaceuticals and Specialties, 2010 edition. Ottawa (ON): Canadian Pharmacists Association; 2010.

7. eTherapeutics [database]. Ottawa (ON): Canadian Pharmacists Association. Available: www.etherapeutics.ca.

8. Canadian Pharmacists Association. Position Statement on Cross-Border Prescription Drug Trade. Ottawa. February 2004. Available: www.pharmacists.ca/content/.../Crossborderprescriptiondrugtrade.pdf (accessed September 7, 2010).

9. Smith DL. Be prepared: keep your medicines close at hand. Taking Control of Your Medicines 2001; 1(2). Available: http://www.consumer-health.com/services/takingcontrol/tcym_vol1_no2.htm (accessed September 7, 2010).

10. Travelling with Prescription Medications. Ottawa (ON): Canadian Pharmacists Association; 2006.

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Drug Shortages Guide - Canadian Pharmacists Association

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