Drug Shortages - PDF document

Drug Shortages A Guide for Assessment and Patient Management Drug Shortages © Canadian Pharmacists Association 2010 Table of Contents Introduction ������������������������ 2 Managing Drug Shortages ����������� 3 Step 1� �������������������������� 3 Step 2� Determining ����������� 4 Step 3� alternative ������������������������ 7 Step 4� alternative ����������������� 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 �rst published by the Canadian Pharmacists Association in 1999, and updated in 2001� Introduction treatingpreventing partofeveryday pharmaceuticalofmanufacturers,wholesalers, distributorspharmacists, governments,importanceof of However,today’s occur,short-termorderslong-term careproviders provide requiresofcurrent ofshortage importantproductpractitioners reasonsproduct’s product fromalternatesources alternate relatedinformationofcareproviders ofpharmaceuticals reasons, increasesofresulting temporaryshortage Voluntaryrecallsofproduct manufacturermanufacturers areunawareof therefore fromCanada/manufacturer disastersstorms Increasedemergency outbreaks importantthereconcern frontcareproviders,pharmacists, prescribersarereassuring regimensrequiredshortage providesopportunity reviewdetermineappropriatenessof ofshortage information,pharmacists, prescribersarerefer references Therapeutic Choices eTherapeutics Association’sCPG regionalinformationcentre If,areawareofshortages patient’stherapy, ofshare info@pharmacists It is well known that drug shortages are not uncommon and, in fact, often occur as a part of the routine day for pharmacists� 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� Thisguideisconcise,practicaltoolforphysicians,pharmacistsandother prescribersshortageguide Presentprocess shortage ofpharmacists, prescribersstrong,reassuring regardingofof of in-case”,provide © Canadian Pharmacists Association 2010 Drug Shortages overviewofshortagesresolved, (Figureof shortagesof Pharmacistsofrepresent alreadyinternalized boxesrepresentthreeresolve shortage: every alternativerequired Managing Drug Shortages Figure 1� Suggested approach for pharmacists in the management of a drug shortage Drug shortage encountered for different supply avenues (Figure 2) shortage with patient and prescriber* Discuss drug shortage and alternative drug with patient and prescriber* In many provinces, pharmacists are authorized to adapt a prescription or prescribe an alternative dosage form or Have I exhausted every avenue to supply the drug? (Figure 3) Select an appropriate alternative on an individual patient basis (Figures 4 and 5) Step 1� Checking all medication supply avenues shortagesarerealitypharmacists pharmacistdifferent sources process Figure 2� Checklist for medication supply avenues Is the medication interchangeable with any brand name or generic alternatives?  Yes  If the medication is available in other dosage strengths, can the dose be made up using other strengths?  Yes  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?  Yes  Can drug supply be obtained through another pharmacy?  Yes  Can drug supply be obtained through your regular wholesaler or other wholesalers?  Yes  Can drug supply be obtained directly from the manufacturer?  Yes  Step 2� Determining how critical a medication is for a patient pharmacistprescriberdetermine “critical”appropriatecourse ofdeterminedof carefullyconsidered shortageprovidesopportunity reviewdetermine appropriatenessofof ofshortage processundertaken Table 1: Classi�cation of critical and noncritical drugs and recommended actions Description In many provinces, pharmacists are authorized to adapt a prescription or prescribe an alternative dosage form or medication� Note: This classi�cation system should be used as a guide only� Professional judgement is required in determining whether the above classi�cation of a particular drug is appropriate for each patient, based on individual patient need and assessment� Level 1 Drug should be available for Drug therapy for disease interrupted for even one dose or one day� Drug actions may: nitroglycerin reduceof precipitatedangerous products) *Medications that are not �rstline therapies and whose actions are accomplished by alternate therapies are exceptions� interchangeableproduct sourceproducts, alternative prescriber alternateensure prescriber Level 2 Drug should be available for 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 extended Drug actions may: diureticshypertension) reduceof interchangeableproduct alternative prescriber alternate required prescriber Level 3 Drug availability is preferred but not crucial� Drug therapy is valuable, yet may be interrupted for an extended duration of time� Drug use may: preference reduce of receptor of pattern interchangeableproduct alternative required prescriber alternate required prescriber Inform Drug Shortages © Canadian Pharmacists Association 2010 TableFigurecare determining Level 1 drugs: Level 2 drugs: greater day,reinstituted reducelong-termof reduceof Level 3 drugs: of What is the seriousness of the disease? For what disease/condition is the drug being used? What are the consequences of untreated disease?  life-threatening  decreased ofrelated  bothersomelong-term allergic  long-termcurrently bothersomehypertension) What is the effect of abrupt withdrawal of the medication on the patient? On other medications being taken by the patient?  reaction?beta-blockers,anticholinergics)  precipitateof nitroglycerin  patient’s result ofwarfarin How essential is the medication in the management of the disease and what are its therapeutic bene�ts?  nitroglycerin  Curesacquired  Preventsonset/progressionoflong-term reductaseinhibitorscardiovascular  Reduces/controlsbothersomeof Is the patient currently deriving the bene�ts of the  treatmentpro�le)  treatment patient’sperceivedof  patient’s reduce Painreduction  adversefrom therapy?  adherenttherapy?  required? Figure 3� Steps to determine how critical a medication is for a patient © Canadian Pharmacists Association 2010 Drug Shortages For how long is the duration of the expected drug shortage? Will the drug be unavailable for:     What patient factors may increase or decrease the impact of the drug shortage on the patient?  of  non-adherence?  resultperceiving important? For what length of time can the medication be missed without serious detriment to the patient? Table   Greater  of Based on the above considerations, how critical is the Table    processpharmacistprescriberinformation ofClassifyingof moredeterminetemporary shortageofTablecertain of Figure 3� Steps to determine how critical a medication is for a patient – continued Drug Shortages © Canadian Pharmacists Association 2010 Step 3� Selecting an alternative medication particularFigure factorsconsidered © Canadian Pharmacists Association 2010 Drug Shortages Are there acceptable brand name or generic equivalents available?  Yes  Does the medication belong to a drug category that is known to have a class effect? ACEinhibitors,reductaseinhibitors)  Yes  Are there any alternate drug therapies that may be considered? currentreferences alternatives)  Yes  How well does each alternate drug therapy work?  provide are receptorsevere of  improvingof Digoxinreducemortalityof heartfailureACEinhibitors  ofalternativespast?  When can the alternate drug therapy be expected to begin working? alternate fromoff Figure 4� Checklist for selecting an alternative medication What side effects or toxicities may be expected?  areshort-termlong-termtoxicities?  of toxicities?  previously, toxicities? Does the patient have any other medical conditions, morbidities or contraindications to the alternate drug? beta-blockers Are there any patient-speci�c factors that may modify your selection of a substitute drug therapy?  allergies?  pregnantbreastfeeding?  ofpredisposecertain adverse  ACEinhibitorsdigoxin reducedrenal What other medications is the patient taking?  of alternate  overcome 10� Is the alternate drug therapy easily administered?  patient’s routine?  ofundertakingregimen? Are the alternate drug therapies affordable for the patient?  coveredpatient’s  shortage,alternate  morepatient? Figure 4� Checklist for selecting an alternative medication – continued Drug Shortages © Canadian Pharmacists Association 2010 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 What considerations need to be addressed when discontinuing the original medication?  tapereddownward? often tapered?steroid  parametersmonitoredensure adversefromtermination? heartpressure,  parametersmonitoredensure unnecessary relatedofdiuretics heartfailureshortnessof breath, Should the two therapies be overlapped during the switchover?  alternateprovide  frequently ensure What considerations need to be addressed when the substitute medication is initiated?  upward? often  parametersmonitoredof ofef�cacy?  parametersmonitored adverserelatedof  coveredpatient’s thereprocess What are the treatment goals?  determiningtreatment Does the patient require assistance to undertake a new regimen?  patient’scomforttherapy?  supportsareensure fromalternative? © Canadian Pharmacists Association 2010 Drug Shortages Figure 6� Choice of therapy when the original medication becomes available again Drug Shortages © Canadian Pharmacists Association 2010 Should the patient remain on the current medication or switch back to the original?  Figures alternativeidentify preferable  perceiveofcurrent If the patient is to return to the original medication, what factors should be considered?  Figureidentifyfactorsconsidered Communication between Pharmacists, Prescribers and Patients ofpharmacists, prescribersarenecessary shortages,created ofcompromised reassuredof ofshortageoutbreak theretemporaryshortageofpharmacists largeof inventory dispensaryOverstocking pharmaciesresultshortagesfrommanufacturer pharmaciesprescribers prescribinglarge approachpharmacists, prescribersensurestrong delivered shortages relationshippatient-focused,thorough ofof ofpatient’srelated Hereareshare Reassurenormal ofrequire pharmacyencountersparticular shortage,thereareofalternativesourcesof reorderof remain carryare Pharmacistsprovide carry Reinforceofnecessary Internetrecommended pharmacyrecord ofresilientdifferent emergenciesdisasters corrected © Canadian Pharmacists Association 2010 Drug Shortages References Woodend AK, Poston J, Weir, K� Drug shortages – risk or reality? Can Pharm J Lynas K� Pharmacists in Canada challenged to deal with drug shortages� Can Pharm J American Society of Health-System Pharmacists� Drug Shortages� Available: http://www�ashp�org/shortages September, 2010)� ASHP guidelines on managing drug product shortages in hospitals and health systems� Am J Health-Syst Pharm Gray, J, ed� Therapeutic Choices ed� Ottawa (ON): Canadian Pharmacists Association; 2007� Compendium of Pharmaceuticals and Specialties , 2010 edition� Ottawa (ON): Canadian Pharmacists Association; 2010� eTherapeutics [database]� Ottawa (ON): Canadian Pharmacists Association� Available: www�etherapeutics�ca 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)� Smith DL� Be prepared: keep your medicines close at hand� Taking Control of Your Medicines Available: http://www�consumer-health�com/services/takingcontrol/tcym_vol1_no2�htm (accessed September 7, 2010)� Travelling with Prescription Medications � Ottawa (ON): Canadian Pharmacists Association; 2006� 1785, prom� Alta Vista Drive, Ottawa, ON K1G 3Y6 Telelphone Fax info@pharmacists�ca www�pharmacists�ca