A nationwide study on generic medicines substitution practices of Australian community pharmacists and patient acceptance

A nationwide study on generic medicines substitution practices of Australian community pharmacists and patient acceptance
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  This article appeared in a journal published by Elsevier. The attachedcopy is furnished to the author for internal non-commercial researchand education use, including for instruction at the authors institutionand sharing with colleagues.Other uses, including reproduction and distribution, or selling orlicensing copies, or posting to personal, institutional or third partywebsites are prohibited.In most cases authors are permitted to post their version of thearticle (e.g. in Word or Tex form) to their personal website orinstitutional repository. Authors requiring further informationregarding Elsevier’s archiving and manuscript policies areencouraged to visit:  Author's personal copy Health Policy 99 (2011) 139–148 Contents lists available at ScienceDirect HealthPolicy  journal homepage: A nationwide study on generic medicines substitution practices of Australian community pharmacists and patient acceptance Chee Ping Chong a , b , ∗ , Geoff March b , Alice Clark b , Andrew Gilbert b ,Mohamed Azmi Hassali c , Mohd Baidi Bahari a a Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia b Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA 5000, Australia c Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia a r t i c l e i n f o Keywords: Generic medicinesGeneric substitutionCommunity pharmacistsPatientsCost-saving a b s t r a c t Objectives:  This study evaluated Australian community pharmacists’ rate of genericmedicinesubstitution,patientacceptanceofgenericsubstitutionandcost-savingsachievedfor patients from substitution. Method:  A national stratified sample of 500 Australian pharmacies was randomly selectedfrom different geographical areas. The data of the first 25 srcinal PBS prescription itemsdispensed on one working day eligible for generic substitution were collected from eachpharmacy. Results:  Responses were received from 82 pharmacies with a response rate of 16.4%. Thepharmacistsrecommendedgenericsfor96.4%(1461/1515)oftheprescriptionitemswhichwere eligible for substitution. The generic substitution recommendation rate in urban(98.7%) and rural areas (98.0%) was significantly higher than remote areas (91.6%). Con-versely, patients’ acceptance in remote areas (84.5%) was significantly higher than rural(78.6%) and urban areas (73.2%). Patients with chronic diseases demonstrated significantlyloweracceptability(72.4%)thanpatientswithacuteconditions(81.6%).Throughacceptanceof substitution, the patients’ medicines expenditure reduced by around 21%. Conclusion:  Australian community pharmacists demonstrated a high rate of recommend-ing generic substitution. However, to optimize the generic medicines utilization, patients’acceptance requires further improvement. © 2010 Elsevier Ireland Ltd. All rights reserved. 1. Introduction A key element in any health system is to ensure timelyaccess to safe and efficacious medicines at affordable costsfor consumers [1]. The Australian health system aimsto achieve this through the establishment of a nationalsubsidized medicines scheme (Pharmaceutical Benefits ∗ Corresponding author at: Discipline of Clinical Pharmacy, Schoolof Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden,Penang, Malaysia. Tel.: +60 12 5342685; fax: +60 4 6570017. E-mail address: (C.P. Chong). Scheme, PBS) where taxpayers pay for the larger por-tion and the patients sharing a small proportional of thecosts [2]. As of 1 August 2008, when purchasing a PBSprescription medicine, the maximum a general patientand a concessional patient (low-income citizens and wel-fare recipients) pays is the co-payment of AUD$31.30and AUD$5.00 respectively and the balance is subsi-dized by the scheme [3]. Also, to assist with affordability,there is a Safety Net provision where the cost of themedicine is reduced for people who are high users of medicines. Once a family has spent a certain amount onPBS subsidized medicines in a calendar year, the gen-eral co-payment is reduced to AUD$5.00 per PBS script 0168-8510/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.healthpol.2010.08.002  Author's personal copy 140  C.P. Chong et al. / Health Policy 99 (2011) 139–148 while the concessional co-payment is reduced to zero[3].Recently, rises in pharmaceutical costs are threateningthe sustainability of the PBS [4–6]. Consequently, generic medicines policy was introduced as one mechanism toreduce the growth rate of PBS expenditure [7,8]. Compe- tition between srcinators and generic medicines began in1990 with the introduction of the Brand Premium Policy(a reference-pricing system) where the Government sub-sidizedonlyuptothepriceofthelowest-pricedbrandandthe patient paid the brand premium (balance above thebaseprice)ontopofthebasicPBSco-payment[7].Thecon- sumer achieved cost-savings when a brand product withbrand premium was substituted by premium free genericproduct. Price competition was generated and resulted ina small price differential between srcinators and genericmedicines[7].TheGovernment’scost-savingoccurredasa resultofpricecompetitionbetweenbrandswhichreducedthe negotiated purchase price for the Government.TheAustralianGovernmentfurtherencouragedtheuti-lization of generic medicines when it introduced a genericsubstitution policy in 1994, which allowed communitypharmacists to voluntarily substitute specified PBS-listedbrand name medicines with equivalent generics, providedconsent was obtained from both the prescriber and thepatient [7,8]. The Australian approach is the opposite to the mandatory generic substitution policy in certainEuropean countries like Denmark, Finland and Sweden,which obligates pharmacists to substitute generics unlessrestricted[9–11].Apreviousstudyrevealedthatprofitsand concernsaboutPBSexpenditureandlongtermsustainabil-ity were major factors which encouraged the Australianpharmacists to actively offer generics [12]. Studies fromother countries show that profits, patient and physiciandemand were among the factors that influenced pharma-cists’ generic substitution practices [13–15].In November 2006, a PBS reform occurred with thepassage of National Health Amendment (Pharmaceuti-cal Benefits Scheme) Act 2007 [16,17]. The unnecessarilyhighGovernmentpurchasecostforgenericmedicineswasmajor reason for the reform [17,18]. Previously, generic pharmaceutical companies encouraged pharmacists topromote their products by supplying them through bulkdiscounts at below PBS purchase prices [18]. As the phar- macists received the same profit margin on PBS purchaseprices of generic and brand name medicines [3,19], thediscounts from generic companies was a driving factorfor generic substitution [18]. The PBS reform disallowed the discount system and required pharmaceutical compa-nies to disclose to the Government the real prices sold topharmacists. The Government then set a price that betterreflected the discounted price previously given to phar-macists. To alleviate the pharmacists’ lost income, theGovernment provided an incentive of AUD$1.50 to thepharmacy owner each time a substitutable, premium freegeneric medicine was dispensed [16]. Additionally, thePBS drug mark-up and dispensing fee were increased [16].However, some pharmacists were unsure whether theseincentives would be an adequate compensation for theprofitslostandwerehesitantinsupportingthereform[20].This situation indicated that research designed to evaluatethe pharmacists’ generic substitution practices under thisPBS reform was required.Patientwillingnesstoacceptagenericmedicineisacorerequirementoffacilitatingtheuptakeofgenericmedicines[21,22].However,nostudyhadbeenconductedtoevaluateAustralianpatientacceptanceofgenericsubstitutionbasedon aggregated data on PBS prescriptions. There was nodocumentationonthecost-savingsachievedforAustralianpatients from substitution. As the generic price was signif-icantly reduced with the PBS reform, the level of patientresistance might influence a lower price. The aims of thisstudy were to evaluate the Australian community phar-macists’ generic substitution rate, patient acceptance of genericsubstitutionandcost-savingsachievedforpatientsfrom substitution. 2. Methods A cross-sectional national descriptive study using aself-completed anonymous data form was conducted withAustraliancommunitypharmacists.Thesurveyinstrumentwas tested for face and content validity by three academicexperts and five community pharmacists before being dis-tributed to the study population.This study required the identification of instances of possible generic substitution. The inclusion criteria werethefirst25originalPBSprescriptionitemsencounteredonone working day where the drug was prescribed using itsbrandnameandforwhichanequivalentgenericbrandwasavailable. Further, the brand name medicine had to carrya brand premium in which generic substitution resultedin a cost-saving for the patient. Prescriptions for whichbrand substitution was not permitted by the prescriberwere also included in the study. The first 25 prescriptionitems were included based on a pharmacists’ approximatedaily workload so that the process was not onerous forthe pharmacists. Prior consultation with a few communitypharmacists, the number of prescription items for them tointervene should not be more than 25 in order for them tovoluntarily participate in this study. The exclusion criteriaweretherepeatprescriptionsandmedicationswhichcouldnot be substituted under the PBS. The repeat prescriptionis excluded because based on the PBS brand substitutionguidelines, brand switching is discouraged in repeat pre-scription in order to avoid patient confusion [23]. Eachpharmacy was provided with 25 data forms and one formwastobecompletedforeachitemwhichfulfilledtheinclu-sioncriteria.Thepharmacistswererequestedtorecordthedetailsofthebrandproductrequestedandthesubstitution,including the product name, strength, dose and an indica-tion of the patient’s willingness to accept the substitutedbrand.  2.1. Study participants, sampling method and datacollection The study population was Australian registered com-munity pharmacists. The sampling unit was communitypharmacy and the sampling frame was list of communitypharmacies obtained from the Pharmacy Board in eachstate of Australia, the Pharmacy Guild of Australia and the  Author's personal copy C.P. Chong et al. / Health Policy 99 (2011) 139–148 141  Table 1 Numbers of pharmacy outlets, response rate and distribution of respondents according to area.Area Pharmacy population, a n  (%) Minimum response required,  n  (%) Original sample,  n  (%) Response,  n  (%) Response rate (%)Urban 4726(81.6) 94(40.2) 200(40.0) 24(29.3) 12.0Rural 451(15.5) 79(33.8) 165(33.0) 34(41.4) 20.6Remote 165(2.9) 61(26.0) 135(27.0) 24(29.3) 17.8Total 5342(100.0) 234(100.0) 500(100.0) 82(100.0) 16.4 a Actual pharmacy number at time of survey. Yellow Pages of Australia. There were 5342 communitypharmacies in the sampling frame.Stratified random sampling was used to obtain a repre-sentative numbers of urban, rural and remote pharmaciesin Australia, with an assumption that pharmacists indifferent area would have different generic substitutionrates. The PhARIA (Pharmacy Access/Remoteness Indexof Australia) system, which provides a pharmacy spe-cificmeasurementofremotenessforover13,000localitiesaround Australia, was used as a guide to the sampling pro-cess [24]. The system classifies pharmacies into six groupsbasedonitsaccessibility,whicharePhARIA1:Highlyacces-sible;PhARIA2:Accessible(group1);PhARIA3:Accessible(group 2); PhARIA 4: Moderately accessible; PhARIA 5:Remote;andPhARIA6:Veryremote.Thecommunityphar-maciesinthesamplingframewerematchedtotherelevantPhARIA. The sample size was calculated by using Statcalc2.0 ® Program.Assuminga60%genericsubstitutionrateoneligible medicines, a minimum number of 234 pharmacieswouldprovidearepresentativesampleofpharmacieswith95% confidence interval. With an estimation of a responserate of around 47%, systematic random sampling methodwasusedtoobtainasampleof500communitypharmacies,to give a total of 234 respondents (Table 1). Subsequently,pharmacies located in PhARIA 1 and 2 were merged toform one “Urban” group (4726 pharmacies), PhARIA 3 and4 were merged to form one “Rural” group (451 pharma-cies)whilePhARIA5and6weremergedintoone“Remote”groupwhichcomprisedof165pharmaciesasaresultoftherelatively small numbers in these remote zones.This study was granted approval by the Universityof South Australia’s Human Research Ethics Committeeand endorsed by the Pharmacy Guild of Australia. Thesurvey data forms were distributed via mail. The Dill-man Protocol which involves four follow-up mailings wasused to improve the response rate [25]. The participantswere offered a summary report upon completion of theresearch. The participation was strictly voluntary and nofindingwhichcouldidentifyanyindividualrespondentwasreported. The data was collected from 1 July 2008 to 31August 2008.  2.2. Data analysis The collected data were entered into SPSS ® version11.5 for analysis. Chi-square test was used to determineanysignificantdifferencesinthepharmacists’genericsub-stitution recommendation rate and patients’ acceptancerate across different geographical areas, type of pharma-cies, employment positions, type of patients and diseasetypes. There were two steps in the chi-square analysis.The first step was to look for differences within the sub-groupsofeachindependentvariable.A  p -valueoflessthan0.05 was set to demonstrate statistical significance. If theresulting chi-square value was significant and the vari-able had more than two sub-groups, follow-up pair-wisecomparison tests were conducted to determine where thedifferences lie. The Holm’s Sequential Bonferroni methodwas used for controlling Type I Error across the multi-ple pair-wise comparisons tests [26]. Odds ratios werecalculated for sub-groups which demonstrated significantdifferences based on chi-square analysis. The second stepinvolvedcross-tabulationanalysisforvariableswhichhavedemonstrated significant differences in the first step anal-ysis. This was to determine the effects of one variabletowards the other variables on the pharmacists’ decisionto offer generic medicines and the patients’ acceptability.  2.3. Cost-saving  The actual patients’ cost-savings achieved through theacceptanceofgenericsubstitutionwascalculated.Thecost-savings were determined based on the dispensed pricesto the patient for brand name medicines and relevantgeneric substitute listed on the Schedule of PBS [3]. As thisscheduleisupdatedmonthly,twoversionsoftheschedule(July and August 2008) which were relevant to the studyperiodwereusedinthedeterminationofcost-savings.Thecost-savings determined in this study is only the directcost-savings rather than the indirect cost-savings, whichoccur if generic substitution facilitates the price competi-tion between pharmaceutical companies. 3. Results Uponcompletionofthestudy,responseswerereceivedfrom 82 pharmacies for a response rate of 16.4%. Theresponse rate in the rural area (20.6%) was higher than theremote (17.8%) and urban area (12.0%) (Table 1).  3.1. Demographic and practice characteristics A total of 97 pharmacists responded to this survey.The majority (83.5%) of respondents worked as full timepharmacists and around half were proprietors of thepharmacies.Therespondentsmostlypracticedinindepen-dentlyownedpharmacies(51.1%),while33.0%practicedinpharmacies operating under a marketing banner group inwhich common promotional support and advice on busi-ness practices are supplied to their members (Table 2).  Author's personal copy 142  C.P. Chong et al. / Health Policy 99 (2011) 139–148  Table 2 Demographic and practice characteristics of survey respondents.Characteristic  n  (%) a Characteristic  n  (%) a Gender b  Type of pharmacy where practicing  Male 42(46.2) Independently owned 50(55.6)Female 49(53.8) Banner group 32(35.6)Missing data  n =6 Company (Chain pharmacy) 8(8.8)Missing data  n =7  Age group, year c Number of prescriptions dispensed per day  <30 22(24.2) 40–100 24(27.9)30–34 16(17.6) 101–200 43(50.0)35–44 16(17.6) 201–300 12(14.0)45–54 23(25.3) 301–500 7(8.1) ≥ 55 13(15.4) Missing data  n =11Missing data  n =6  Working condition State where practising  d Part time 9(10.0) New South Wales (NSW) 25(25.8)Full time 81(90.0) South Australia (SA) 24(24.7)Missing data  n =7 Victoria (VIC) 19(19.6)Queensland (QLD) 16(16.5) Employment position  Western Australia (WA) 6(6.2)Sole or partner proprietor 47(51.6) Tasmania (TAS) 3(3.1)Manager 18(19.8) Australian Capital Territory (ACT) 2(2.1)Employee 25(27.5) Northern Territory (NT) 2(2.1)Locum 1(1.1)Missing data  n =6 a Valid percentage (the missing data is excluded from the calculation of percentage).National data [40,41]: b Male: 44.0%; female: 56.0%. c <35 years of age: >40.0%; ≥ 55 years of age: 17.0%. d NSW: 31.5%; VIC: 26.9%; QLD: 19.2%; WA: 9.9%; SA: 7.5%; TAS: 2.6%; ACT: 1.7%; NT: 0.6%.  3.2. Brand name medicines requests A total of 1551 data forms were collected from therespondents. Some of the pharmacies ( n =30, 36.6%)returned less than 25 completed data forms. Most of these pharmacies were located in rural or remote areas( n =22, 73.3%) which did not received 25 prescriptionitems to fulfill the inclusion criteria. Brand substitu-tion was not permitted by the prescribers in 36 cases(2.3%) and involved therapeutic classes of cardiovascularsystem (27.8%), nervous system (25.0%), systemic antiin-fectives (22.2%) and others (25.0%). The remaining 1515cases (each case involved one item) were eligible forgeneric substitution and the details of these cases aregiven in Table 3. Most of the cases were from rural area(43.1%)andjustoverhalf(55.0%)werefromindependentlyownedpharmacies.Aroundtwo-thirdofthecasesinvolvedacute diseases while the balance involved chronic dis-easeswhichneededlongtermtreatment.Thecasesmostlyinvolved therapeutic classes such as antiinfectives for sys-temic use (27.9%) and nervous system medicines (25.5%)(Table 4).  3.3. Generic substitution recommendation rate Therespondingpharmacistsofferedgenericsubstitutesfor 96.4% (1461/1515) of the brand name medicines pre-scribed by medical practitioners which were eligible forgeneric substitution (Table 3). The generic substitutionrecommendation rate in remote areas (91.6%) was sig-nificantly lower than the urban (98.7%) and rural areas(98.0%). The recommendation rates among pharmacistswhopracticedunderdifferenttypesofpharmacy(indepen-dently owned, banner group and company) were around95.0–98.0%andthedifferenceswerenotsignificant.Ofthepharmacists in different employment positions, managersdemonstrated a significantly higher recommendation ratethan proprietors (98.6% versus 94.8%). The pharmacistsdemonstratedasignificanthighertendencytooffergenericsubstitution to concessional patients compared to generalpatients (97.4% versus 94.4%). Nevertheless, both the dif-ferences in recommendation rate based on pharmacists’employmentpositionsandtypeofpatientswereexplainedbydifferencesinthedistributionofgeographicalareas.Therecommendation rate did not differ significantly betweenpatientswithacute(96.2%)orchronicdiseases(97.0%).Thegeneric offering rates were more than 90% for most of thetherapeutic classes involved (Table 4).  3.4. Patient acceptance Overall, 78.5% of the generic substitution recommen-dation cases were accepted by patient (Table 3). Patientsin remote areas (84.5%) were significantly more willingto accept generics compared to those in urban (73.2%)and rural area (78.6%). The patients who visited dif-ferent types of pharmacy demonstrated no significantdifferences in their acceptability. The substitution rec-ommendations performed by managers were significantlymore accepted by the patients than those who recom-mendedbytheproprietors(98.6%versus94.8%).However,this difference in patients’ acceptability was because of 
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