Medication Incidents Involving Drug Tapering In Community .

Transcription

ISMP CANADAMedication Incidents Involving DrugTapering in Community Pharmacy:A MULTI-INCIDENT ANALYSIS BY ISMP CANADAAmanda Chen, BSc, BScPhm, ACPR, PharmD CandidateLeslie Dan Faculty of Pharmacy, University of TorontoAnalyst, ISMP CanadaSharon Liang, BSc, PharmD CandidateSchool of Pharmacy, University of WaterlooResearch Assistant, ISMP CanadaCertina Ho, BScPhm, MISt, MEdProject Manager, ISMP CanadaINTRODUCTIONPrescriptions involving a drug tapering processare often complex in nature, involving multiple,sequential doses of medication(s), extensivedirections of use, and complex mathematicalcalculations.1-3 In addition, the lack of standard-ized tapering guidelines may explain the factthat in practice, a wide variety of unique taperingregimens are prescribed that do not follow ahomogenous, consensus-based pattern. As aresult, pharmacists may find it challenging toassess the appropriateness of the prescription,with respect to its efficacy, safety and tolerabilityfor the particular patient.1-3 All of these considerations illustrate the inherent vulnerability of drugtapering to errors that may occur at any stage ofthe medication-use process, including prescribing,order entry, dispensing, administration, and/orpatient monitoring. As such, further investigationof incident reports may be beneficial to helpelucidate a better understanding and appreciationof potential contributing factors that are associated with drug-tapering incidents.TABLE 1 – THEMES AND SUBTHEMESTHEMESUBTHEMELack of standardized taperingguidelinesooPrescribing errorMiscommunicationInadequate patient counselingooCross-taperMulti-medication compliance aidsOperational limitationsooLabeling restrictionsBilling restrictionsComplexity of prescriptionooooCalculation errorTranscribing errorWrong selection of prescription to be filledPrescription preparation errorPAGE 34 FALL 2014 PHARMACY CONNECTION

ISMP CANADADrug tapering is defined asthe gradual discontinuationor reduction of a therapeuticdose of a particular drug over aperiod of time. Conversely, drugtitration refers to the incrementalincrease in drug dosage to alevel that provides a desiredtherapeutic effect. In practice,these terms are sometimes usedinterchangeably to signify gradualdosage change - up or down - toachieve the targeted goal ofeither discontinuation of therapy,lowered maintenance dose, oroptimal therapeutic effect. For thisanalysis, incidents involving drugtapering as well as drug titrationare included, as both are associated with similar challenges andrisks for medication errors.The Community Pharmacy Incident Reporting (CPhIR) Program(available at http://www.cphir.ca) is designed for communitypharmacies to report near missesor medication incidents to ISMPCanada for further analysis anddissemination of shared learningfrom incidents.4 CPhIR has allowedcollection of invaluable information to help identify system-basedvulnerable areas in order toprevent medication incidents.4This article provides an overviewof a multi-incident analysis ofdrug tapering-related incidentsreported to the CPhIR program.MULTI-INCIDENT ANALYSIS OFDRUG-TAPERING INCIDENTS INCOMMUNITY PHARMACY PRACTICEReports of medication incidentsinvolving “taper,” “titrate,” “wean,”“escalate, “de-escalate,” “increasing dose,” or “decreasing dose”were extracted from the CPhIRProgram from 2010 to 2014.In total, 122 incidents met thecriteria and were included in thisqualitative, multi-incident analysis.The majority of the incidentsinvolved corticosteroid therapy(e.g., prednisone, dexamethasone,budesonide), but antidepressants(e.g., SSRIs, SNRIs, TCAs), painmedications (e.g., opioids, methadone), and anti-epileptics (e.g.,gabapentin, pregabalin) were alsocommonly reported.The 122 medication incidentswere independently reviewedby two ISMP Canada Analysts.The incidents were analyzedand categorized into four majorthemes, all of which are potentialcontributing factors for drugtapering incidents in communitypharmacy practice: (1) lack ofstandardized tapering guidelines,(2) inadequate patient counseling,(3) operational limitations, and (4)complexity of prescription. Thefour major themes were furtherdivided into subthemes, as shownin Table 1. Tables 2 to 5 providefurther details and incidentexamples for each subtheme.(Note: The “Incident Examples”provided in Tables 2 to 5 werelimited by what was inputted bypharmacy practitioners to the“Incident Description” field of theCPhIR program.)TABLE 2 – THEME #1 LACK OF STANDARDIZED TAPERING GUIDELINESSUBTHEMEINCIDENT EXAMPLEPrescribing errorThe physician wrote a high dose prednisone prescriptionthat lasted over 14 days, but did not prescribe a taperingregimen thereafter.COMMENTARYThe prednisone prescription had a quantity of 30 days, butthe tapering schedule only lasted for 17 days. The pharmacytechnician filled the prescription assuming it was for thefull 30 days, but later discovered that the prescription wasintended to last only 17 days – 13 extra tablets were thengiven to the patient.Miscommunication The patient brought in a computer generated prescription(i.e. amongst health- for prednisone, with the first line of directions stating ‘takecare professionals)6 tabs by mouth for 5 days.’ The next line stated ‘will weanafter seven days’ with no additional directions or totalquantity given. The patient was not sure about the directions of use either.Standardized, pre-printedorder forms for drugtapering prescriptionsshould be consideredin order to encouragecomplete and accuratecommunication ofinformation betweenphysician, pharmacist,and patient.PHARMACY CONNECTION FALL 2014 PAGE 35

ISMP CANADATABLE 3 – THEME #2 INADEQUATE PATIENT COUNSELINGSUBTHEMEINCIDENT EXAMPLECross-taperPatient brought in a new prescription for venlafaxine 150mg daily, which was to be switched with his old prescription,sertraline 75 mg daily. However, cross-tapering directionswere not specified on the prescription, and the patient wasunclear on the directions of use as well. The physician wascalled to obtain these instructions.Multi-medicationcompliance aidsCOMMENTARYThe patient’s prescriptions were being blister packed forthe first time. Because her prednisone prescription wasbeing tapered, it was not included in the blister pack, but ina separate vial instead. Several days later, the patient calledthe pharmacy to say that she just noticed the additionalprednisone vial in the prescription bag and that she missedher doses for the past couple of days. She thought that allof her medications would have been included in the blisterpack.Providing patients witha tapering scheduletool (i.e. personalizedcalendar or booklet) fortheir reference, maybe beneficial to clarifyconfusing and extensivedirections of use.This should be donein conjunction withadequate face-toface counseling andappropriate follow-up.TABLE 4 – THEME #3 OPERATIONAL LIMITATIONSSUBTHEMEINCIDENT EXAMPLECOMMENTARYLabeling restrictionsThe wrong sig (directions of use) wasentered during order entry because theoriginal instructions were too long forthe space provided. The technician triedto shorten it, but important parts ofthe instruction were being left out. Theprescription label was corrected beforereaching the patient.A helpful feature of the order entry queuewould be an “extended labeling” function,where directions longer than the standardspacing restrictions would automaticallypopulate into this new interface. The fulldirections would then be entered, printed,and affixed to the prescription vial.Billing restrictionsThe prescription was for budesonide9 mg daily x 6 weeks, followed by 3mg taper every 2 weeks, for a totalduration of 10 weeks. Unfortunately,the patient’s drug plan only alloweda month’s supply (i.e., 35 days) perprescription fill, so the full supply wasnot able to be dispensed in one transaction, which added much confusionduring prescription order entry. Thisresulted in a transcribing error on thesecond part of the prescription, whichwas logged.A helpful feature of the order entry queuewould be an interface for “chained” or“linked” prescriptions, where the total drugtapering schedule is entered sequentiallywith start and stop dates automaticallypopulating as directions, durations, andquantities are entered. Another benefitof this feature is that it only allowsprescriptions to be filled in sequential order(i.e., prescription in the middle of the chaincannot be selected to be filled), which isalso helpful in addressing the followingTheme #4 (Complexity of Prescription)– Subtheme #3 (Wrong Selection ofPrescription to be Filled) – see Table 5.PAGE 36 FALL 2014 PHARMACY CONNECTION

ISMP CANADATABLE 5 – THEME #4 COMPLEXITY OF PRESCRIPTIONSUBTHEMEINCIDENT EXAMPLECalculation errorPrescription for lamotrigine involved a gradual dose titrationup before reaching steady maintenance dose. The wrongtotal quantity was calculated – 448 tablets were given, butshould have been 280 tablets.COMMENTARYTranscribing error(e.g., typo, wrongdose, wrongformulation, wrongfrequency, wrongaddition/exclusionof refills)The patient was prescribed a tapering dose of prednisoneand given the correct number of tablets to complete it. Henoticed 2 refills on the vial, so he called the pharmacy forthe repeat prescription. As he was leaving with the medication, he asked if he should start with taking 8 tablets againand wean down. The pharmacist looked up the originalprescription and noted that there were no refills prescribed.The pharmacist took back the medication and explainedthat he had completed his therapy.Wrong selectionof prescription tobe filledThe prescription was written for an increasing dose titrationfor galantamine. On June 28th, the 8 mg strength was filled,while the 16 mg was logged for July, and the 24 mg waslogged for August. When the patient came in for a refill inJuly, the 24 mg prescription was filled in error, skipping the16 mg dose. The patient felt unwell after taking 1 dose, andreturned to pharmacy.Prescriptionpreparation errorPrescription was written for ‘prednisone 50 mg daily x 5days, then taper by 5 mg every 3rd day until discontinued.’Prescription was filled as prednisone 50 mg – take 10tablets once daily for 5 days, then taper by 1 tablet (5 mg)every 3rd day until discontinued. Prescription should havebeen filled with Prednisone 5 mg tablets, not 50 mg tablets.The error was picked up when the pharmacist was checkingthe prescription.THE IMPORTANCE OFDRUG TAPERINGDrug tapering can be a very longand arduous process fraught withconfusion, miscommunication andmedication errors, as demonstrated in the incident examplesfrom Tables 2-5. But there arespecific scenarios that warrantits use. First, drug tapering isimportant to help prevent adversedrug withdrawal reactions thatwould otherwise be very difficultand challenging for patients towithstand.5 Second, the gradualand sequential reduction in doseallows for early detection of returnof condition/symptom(s) beingtreated.5 These symptoms canbe mitigated immediately witha consequent increase in dose,followed by close monitoring.Both of these beneficial effectsof drug tapering ultimately helpto increase patient tolerability andoverall comfort, which is one ofthe key goals to pharmaceuticalcare and patient-centred care.Independent doublechecks should beperformed for eachprescription duringthe order entry anddispensing process.6 Morespecifically, rules andpolicies in the dispensaryshould be implementedto increase awarenessand conscientiousnessduring the prescriptionpreparation process. Forexample, calculationsshould be documentedby both the order entrystaff as well as theindependent doublechecker to enhanceaccuracy.CONCLUSIONErrors associated with drugtapering regimens occur on alllevels of patient care that involvephysicians, pharmacists, patients,and caregivers alike. Learningfrom medication incidents isan imperative step in improving medication-use systems.Future development of a generalframework for drug tapering(e.g. aggressive or conservativeregimens) may be helpful forprescribers in clarifying safePHARMACY CONNECTION FALL 2014 PAGE 37

ISMP CANADAand effective drug taperingmethods. The objective of thismulti-incident analysis was toidentify potential systems-basedcontributing factors and areas ofvulnerability towards medicationincidents involving drug tapering.It is hoped that these insights canpave way for future developmentsin quality improvement initiativesat the local, provincial and nationallevels.ACKNOWLEDGEMENT1. S uttner J, White Lovett A, Vernachio K. Best practicesin tapering methods in patients undergoing opioidtherapy. Advances in Pharmacology and Pharmacy2013; 1(2):42-57.3. A lberta Provincial CNS Tumor Team. Clinical PracticeGuidelines: the use of dexamethasone in patientswith high grade gliomas. Re: dexamethasone tapering.Alberta Health Services, 2013; 5-6.2. A merican College of Rheumatology Ad Hoc WorkingGroup on Steroid-Sparing Criteria in Lupus. Criteriafor steroid-sparing ability of interventions in systemiclupus erythematosus. Consensus meeting summary.Arthritis and Rheumatism 2004; 50(11):3427-3431.4. H o C, Hung P, Lee G, Kadija M. Community pharmacyincident reporting: a new tool for community pharmacies in Canada. Healthc Q 2010; 13:16-24.The authors would like toacknowledge Roger Cheng,Project Leader, ISMP Canada, forhis assistance in conducting theincident analysis of this report.ISMP Canada would like toacknowledge support from theOntario Ministry of Health andLong-Term Care for the development of the Community PharmacyIncident Reporting (CPhIR)Program (http://www.cphir.ca). TheCPhIR Program also contributes tothe Canadian Medication IncidentReporting and Prevention System(CMIRPS) (http://www.ismpcanada.org/cmirps.htm). A goal of CMIRPSis to analyze medication incidentreports and develop recommendations for enhancing medicationsafety in all healthcare settings.The incidents anonymouslyreported by community pharmacypractitioners to CPhIR wereextremely helpful in the preparation of

the pharmacy to say that she just noticed the additional prednisone vial in the prescription bag and that she missed her doses for the past couple of days. She thought that all of her medications would have been included in the blister pack. The wrong sig (directions of use) was entered during order entry because the original instructions were too long for the space provided. The technician .