a systematic review of the clinical and economic effectiveness of

408 Journal of Managed Care Pharmacy JMCP June 2013 Vol. 19, No. 5 www.amcp.org

A Systematic Review of the Clinical and Economic Effectiveness of Clinical Pharmacist Intervention in Secondary Prevention of Cardiovascular Disease

Abdulaziz Altowaijri, MSc; Ceri J. Phillips, PhD; and Deborah Fitzsimmons, PhD

ABSTRACT

BACKGROUND: Cardiovascular disease (CVD) is considered to be the main cause of death and one of the most common diseases affecting health care systems worldwide. Many methods have been used to improve CVD out-comes, one of which is to involve clinical pharmacists in the direct care of patients with CVD.

OBJECTIVE: To perform a systematic review assessing the effectiveness of clinical pharmacist interventions within a multidisciplinary team in the sec-ondary prevention of CVD, using studies conducted on patients with heart failure, coronary heart disease, or those with CVD risk factors.

METHODS: Extensive searches of 13 databases were performed—with no time limitation—to identify randomized controlled trials (RCT) in English that evaluated clinical pharmacist intervention in patients with CVD or with CVD risk factors. Two independent reviewers evaluated 203 citations that were the result of this search. Studies were included if they reported direct care from a clinical pharmacist in CVD or CVD-related therapeutic areas such as disease-led management or in collaboration with other health care workers; if they were RCTs; if they were inpatients, outpatients, or in the community setting; and if they included the following outcomes: CVD con-trol or mortality, CVD risk factor control, patient-related outcomes (knowl-edge, adherence, or quality of life), and cost related to health care systems.

RESULTS: A total of 59 studies were identified: 45 RCT, 6 non-RCT, and 8 economic studies. 68% of the outcomes reported showed that clinical pharmacy services were associated with better improvement in patients’ outcomes compared with the control group.

CONCLUSION: The involvement of a pharmacist demonstrated an ability to improve CVD outcomes through providing educational intervention, medi-cine management intervention, or a combination of both. These interven-tions resulted in improved CVD risk factors, improved patient outcomes, and reduced number of drug-related problems with a direct effect on CVD control. These improvements may lead to an improvement in patient quality of life, better use of health care resources, and a reduced rate of mortality.

J Manag Care Pharm. 2013;19(5):408-16

Copyright © 2013, Academy of Managed Care Pharmacy. All rights reserved.

•Cardiovasculardisease(CVD)isoneofthemaincausesofdeathworldwide and is associatedwithhigh cost impactonnationaleconomies throughdirecthealthcosts,productivity losses, andinformalhealthcarecosts.

•The quality of care of CVD patients has been reported to besuboptimal.

What is already known about this subject

•ClinicalpharmacistinterventionsinthecareofpatientswithCVDorinthecareofthosewithhighriskshavebeenevaluatedinsev-eralstudies.Koshmanetal.(2008)conductedasystematicreviewtomeasuretheclinicalbenefitofaddingaclinicalpharmacisttothecareofpatientswithheartfailureinbothinpatientandoutpa-tient settingsworldwide.This reviewdemonstratedan improve-mentformanyoutcomes,includingmortalityandhospitalization.

•Thecurrentstudyisthefirstsystematicreviewtoevaluatephar-macistinterventionsincoronaryheartdisease(CHD)andheartfailure and to evaluate the effect of pharmacist intervention inthepreventionofCVD risk factorswhether as part of primarypreventionorsecondaryprevention.

•Pharmacist intervention resulted in greater improvements inmanyoutcomesthanusingusualcareonly.

•This review highlights the need for further studies to evaluatepharmacistinterventioninsecondarypreventionofCHDininpa-tientsettingsandforafulleconomicevaluationinvestigatingthecost-effectivenessofhealthcareservicesinthissetting.

What this study adds

Cardiovascular disease (CVD) is considered to be themain cause of death worldwide.1 In 2008, CVD wasresponsible for about 48% of the 36 million deaths

worldwide.1Similarpercentageswerealso found incountrieswithadvancedhealthcaresystems.CVDaccountedfor33.4%of deaths in the United States, 34% in the United Kingdom(UK),andinEurope,thepercentageincreasedtoclosetohalfofalldeaths(48%).2,3CVDisalsoconsideredthemaincauseof premature death in people under 70 worldwide, beingresponsibleforabout39%ofthosereporteddeaths.1Themainforms of CVD are coronary heart disease (CHD) and heartfailure (HF). The National Institute for Health and ClinicalExcellence(NICE)definedCHDas“anarrowing(stenosis)ofthecoronaryarteriesasaresultofdepositionofatheroscleroticplaque, which results in an insufficient supply of oxygen totheheartmuscle.4NICEalsodefinedHFas“acomplexclinicalsyndrome of symptoms and signs that suggest the efficiencyoftheheartasapumpis impaired.It iscausedbystructuralor functional abnormalities of the heart.”5 CHD by itself is

SUBJECT REVIEW

http://www.who.int/nmh/publications/ncd_profiles2011/en/index.html



http://www.nice.org.uk/nicemedia/live/12013/41262/41262.pdf

http://publications.nice.org.uk/chronic-heart-failure-cg108

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ofpatientswithCVD.Thescopeofourreviewfocusedonthe2mainformsofCVD:CHDandHF.Acomprehensive,system-atic reviewwasconductedof studies thatevaluate theeffectsofclinicalpharmacist interventionwithinamultidisciplinaryteam in the secondarypreventionofCVD.Since the second-arypreventionofCHDrequiresmodificationofriskfactorsinadditiontosecondarypreventionmedication,thisreviewwillconsider the impact of clinical pharmacists in both areas, aswellastheirroleinHFtreatment.Sincetheinterventionpro-videdbyclinicalpharmaciststohelpcontrolCVDriskfactorsisthesameinprimaryandsecondarypreventionofCVD,weincludedstudiesevaluatingthepharmacisteffectincontrollingCVDrisk factors inbothprimaryandsecondaryprevention.WeincludedCVDriskfactorsthatnecessitatemedicationpre-scriptioninordertocontrolthem,suchashypertension,highcholesterol,diabetesmellitus(DM),andcigarettesmoking.

■■  MethodsWesearched the followingdatabases inFebruary2011 (withnotimelimitationincluded):CochraneDatabaseofSystematicReviews (CDSR), Database of Abstracts of Reviews ofEffectiveness(DARE),HealthTechnologyAssessmentDatabase(HTA),MEDLINE/PubMed,WebofKnowledge,HMIC(Ovid),Cumulative Index to Nursing and Allied Health Literature(CINAHL)plussearchengine,NationalHealthService(NHS)Evidence,ScienceDirect,PharmacyAbstract,NationalInstitutefor Health’s Clinical Trials.gov database, Trip database, andCurrentControlledTrials(CCT;AppendixA,availableonline).Systematic reviewsandmeta-analyseswereexcludedbecausetheir inclusion and exclusion criteria may not have been inaccordwithourcriteria,althoughtheirbibliographiesandref-erencesweresearchedforadditionalarticlesthatmaynothavebeen captured in our electronic database search. The resultswerelimitedtopublishedstudiesinEnglish.

Inclusion and Exclusion CriteriaWe included studies if they (a) involved participants whoreceiveddirectcarefromaclinicalpharmacistintheCVDther-apeuticareaorforCVDriskfactors;(b)describedpharmacistinterventionasapartofamultidisciplinaryteam,incollabora-tionwithotherhealthcareworkersorindisease-ledmanage-ment in direct patient care; (c) reported 1 of the followingoutcomes:CVDcontrolormortality,CVDriskfactorcontrol,patient-relatedoutcomes(knowledge,adherence,orqualityoflife),orcost related tohealthcaresystems; (d)were random-ized controlled trials (RCT); and (e) conducted in inpatient,outpatient,orcommunitysettings.Nonrandomizedcontrolledtrials(non-RCT)reportingcostsandpatientqualityoflifeweredescribed but not included in the synthesis. The descriptionof these non-RCTs helped explain differences found in thecostorqualityof life.Weexcludedstudiesthathadnophar-macist involvement in service or intervention and that were

responsibleforabout12.7%ofalldeaths,whileitisconsideredtobethemaincauseofdeathintheUK,where46%ofallCVDdeathswereduetoCHD.Ontheotherhand,HFisresponsibleforabout5%ofallhospitaladmissions inEurope,with40%oftheseadmissionsdyingorbeingre-admittedwithin1year,6 andrepresentsalargeproportionoftreatmentcosts.Forexam-ple,aU.S.reportshowedthatHFadmissionsconstituteabout60%of the total treatmentcosts.7CVDalsohasa significanteconomicimpactthroughdirecthealthcarecosts,productivitylosses, and informal health care costs. It has been estimatedthatintheUKCVDcoststhehealthcaresystemapproximately£8.7billionandthat23%of thiscostwasduetomedicationprescribing.8IntheUnitedStates,CVDwasestimatedtocostthehealthcaresystemaround$167billion.3

Newly developed medications are designed to be morepotentwithprecisemechanismofaction.TheserequiremoreattentiontoavoidpotentialinappropriateprescribingthatcanleadtoanincreaseintheCVDtreatmentcost.Thetraditionalmethodofprescribinganddispensinghasprovedinsufficientto prevent costly consequences from improper medicationuse.9Furthermore,despiteeffortsmadetooptimizetherapiesthrough publishedCVD treatment guidelines, the adherencetoguidelinerecommendationsisrelatively low,andthequal-ityofcareprovidedtopatientsisdocumentedtobebelowthetargetlevel.10,11Thepresenceofaclinicalpharmacistcanhelpdecrease these problems and optimize patient therapy so astoachievegreaterbenefits.12TheEuropeanSocietyofClinicalPharmacydefinestheroleofaclinicalpharmacistasonethat“develop[s]andpromote[s]safeandappropriatedrugusewiththegoalofoptimizingpatientcare.”13TheAmericanCollegeofClinicalPharmacydefinesclinicalpharmacyasa“healthsci-encedisciplineinwhichpharmacistsprovidepatientcarethatoptimizesmedication therapyandpromoteshealth,wellness,anddiseaseprevention.”14TheadditionofaclinicalpharmacisttothecareofpatientswithCVDcanleadtoanimprovementinCVDpatientsinmanyareas,includingareductioninCVDrisk rates, optimizing CVD medications, improving patientknowledge and satisfaction, improving patient adherence,andpreventingpotentialdrug-relatedproblems(DRPs).Theseimprovements can lead to increased quality of life for CVDpatients, reduced mortality rates, and decreased number ofhospitalizationsoremergencyroom(ER)/clinicvisits.This,inturn,resultsinadecreaseintotalhealthcarecosts.15,16Clinicalpharmacistsmayparticipateinsuchservicesaspatienteduca-tion,medicinemanagement,orboth.14

PrevioussystematicreviewsconductedtomeasuretheeffectofclinicalpharmacistsonthedirectcareofpatientswithCVDhaveshownapositiveimpactonpatientoutcomes.17-19However,it is unknown if this impactwould be seen in patientswithestablishedCHDorifitwouldresultinadecreaseorincreaseinhealthcarecosts. In this review,weaimedtoevaluate theeffectivenessofincludingclinicalpharmacistsinthetreatment

http://www.bhf.org.uk/research/heart-statistics.aspx

http://www.escpweb.org/cms/Clinical_pharmacy



nonanalyticalor interventional studies, studieswithnocom-parison group present, studies not conducted in the CVDtherapeuticarea,andsystematicreviewsormeta-analyses.

Study SelectionWescreened theelectronicsearchresultsandexcluded irrel-evant studies based on the exclusion criteria. The screeningprocesswas implemented to selectpotential studies includedfortheevaluation.Thisprocesswasperformedby1reviewerandcheckedforaccuracybyanother.Theresultsofthescreen-ingstepwerethenassessedby2reviewerswhoindependentlyevaluatedthestudies’titlesandabstracts.Fullcopiesofstudiesacceptedintheabstractassessmentprocesswerethenretrievedandassessedindependentlyby2reviewers.Anydiscrepancieswereresolvedbydiscussion,orifneeded,athirdreviewerwasconsulted.

Data Extraction and Study Quality Assessment We extracted the studies included in this review by using astandardized data extraction form. The extraction processwasperformedbyoneofourreviewersandcheckedforaccu-racybyanother.QualityassessmenttoolsusedinJadadetal.(1996)20wereused toassessRCTs,while the technique fromDrummondetal.(2005)21wasusedtoassesseconomicstudies.

Data AnalysisQualitative analyseswere conducted to characterize the typeof pharmacist services provided to patients and their effectson patient outcomes. Study outcomes were categorized into4groups: theCVDoutcomesandmortalitygroup(mortality,CHDrisk,andHF);theCVDriskfactorcontrolgroup(control-lingDM,hypertension,lipids,orcigarettesmokingcessation);the patient outcomes group (patient adherence, knowledge,satisfaction,orqualityoflife);andthehealthcaresystemscostoutcomesgroup(DRPs,hospitalization,lengthofhospitalstay,ER/clinic visit, or direct). These outcomesweremeasured ineachtypeofpharmacist-providedservice,whetheritwasmedi-cinemanagement,educational intervention,oracombinationofboth.

■■  ResultsOursearchresultedin2,665studiesafterremovinganydupli-cation,fromwhich2,609studieswerefoundfromtheelectronicsearchand56studiesfromsearchingothersystematicreviewsand meta-analyses’ bibliographies and references. The initialscreeningexcluded2,462studies, leavinga totalof203stud-ies.Titleandabstractassessmentoftheremaining203studiesresultedinthefurtherexclusionof108studies.Intheprocessof retrieving full copies of the studies, 14 studies were notobtainableandthereforenotincluded.Thefull-copyassessmentprocess resulted in the inclusion of 59 studies, of which 51describedclinicalandcostoutcomes,and8werefulleconomicevaluations.Figure1illustratesthestudyselectionprocess.

Clinical StudiesThemajority of clinical studiesmeasuredpharmacist impacton CVD risk factor control. Fifteen studies were conductedtomeasure the impact of a clinical pharmacist in improvingpatients’ DM, 12 in hypertension patients, 10 in hyperlipid-emiapatients,and1RCTinhelpingsmokingpatientstoquit.One RCT and 1 cohort study were included in this reviewbecausetheyconcernedthebenefitofclinicalpharmacists inimprovingDRPsassociatedwithCVDriskfactorcontrol.TheCVD risk factor control andDRP studieswere conducted ininpatient, outpatient, and community settings. (Appendix B,availableonline)

RCTs included in this review reported 116 different out-comes, which included mortality, CHD outcomes, HF out-comes,DMcontrol,hypertensioncontrol,lipidcontrol,smok-ing cessation, patient adherence, patient knowledge, patientsatisfaction, quality of life, DRPs, hospitalization, length ofhospital stay (LOS), ER/clinic visits, and direct costs. The116 outcomes found in this reviewweremeasured as resultofpharmacistsprovidingmedicinemanagement interventiononly (14), providing educational interventions only (44), orprovidingbothtypesofintervention(58).Whentheoutcomes

2,609 identified by electronic search

2,462 studies excluded due to irrelevancy

59 identified by searching systematic

reviews and meta-analysis references

203 potentially relevant titles and abstracts after initial screening

108 abstracts rejected

44 abstracts accepted51 abstracts required full-copy assessment

22 rejected 14 studies not found

59 full copies retrieved and assessed for eligibility

Publications included in the review

RCT (n = 45) Economic studies (n = 8)

FIGURE 1 Study Selection Process

RCT=randomized controlled trial.



were categorized according to the setting, 62 outcomesweremeasured in outpatients settings, 51 in community settings,and3 in inpatient settings.Table1 summarizes thedifferenttypesofoutcomesandtypesofservicesprovidedbythephar-macists.Table2categorizes thereportedoutcomesaccordingtothesettings.

CVD and Mortality. Eight RCTs reported improvement inCVDormortalityas1oftheiroutcomes.Fiveoutof7studiesshowed thatclinicalpharmacistshavea statistical significanteffect,while2studiesshowednosignificantdifferences.The2studiesthatreportednosignificantdifferencesinpatientmor-tality were performed by providing educational interventiononly.22,23Theother5studiesreportedstatisticalsignificantdif-ferences:1studymeasuringimprovementsinmortalityandHFthroughmedicinemanagementonly,241studymeasuringmor-talityaftereducationalinterventiononly,25and3studiesmea-suringimprovementinCHDandHFbyprovidingbothtypesof service.23,26,27All the studies reportingoutcomes related toCHDorHFcontrolshowedstatisticalsignificantimprovement.

Risk Factor Control. Thirty-six RCT were found to reportchangesinCVDriskfactorsas1oftheiroutcomes.IntermsofDMcontrol,10studiesoutof14reportedstatisticallysignificantimprovementswith clinical pharmacist interventions.Of thestudies demonstrating a significant difference, 1 interventionwasmedicinemanagementonly;282studieswereeducationalinterventionsonly;29,30and7studiesconsistedofbothtypesofservices.27,31-36 In termsofmeasuring theeffectofpharmacistinterventiononsmokingcessation,only2studieswerefound

thatreportedsmokingcessationasoneoftheiroutcomes.Onestudyofeducationalinterventionfoundthattherewasasignifi-canteffect,whileanotherstudyofbothtypesofinterventionsreportednosignificantdifferences.31,37Intermsofcontrollingbloodpressure,20studiesoutof23(86.9%)showedstatisticalsignificanteffectsofclinicalpharmacistintervention.Ofthesestudies,1performedmedicinemanagement(50%);386studiesprovidededucationalinterventions(86%);29,30,39-42and13stud-iesprovidedbothtypesofintervention(93%).26,27,31,34-36,43-49 In termsofcontrollingpatients’lipidlevels,13studiesoutof20(65%)showedasignificantpositiveeffectwiththeinclusionofaclinicalpharmacist.27,29,34,42,50-58

Patient Outcomes.Wefound20differentstudiesthatreportedoutcomes relating to patient knowledge, satisfaction, adher-ence, or quality of life. Twenty-two outcomes out of 31(71%) were found to have statistical significant differenceswith clinical pharmacist intervention, while 9 of the out-comes showed no statistical significant difference. In termsofpatientknowledge,4studies(80%)showedpositiveeffectsfor clinical pharmacist intervention,29,50,57,59 while 1 studyshowed no significant differences.48 Educational interven-tion was performed in 3 different studies, and all of themreportedsignificantpositivedifferencesforclinicalpharmacist intervention. One study in which both types of serviceswereprovidedshowedstatisticalsignificantdifferences,whileanotherstudyshowednosignificanteffect.Intermsofpatientsatisfaction, 5 out of 6 studies (83.3%) reported statisticalsignificant positive outcomes with clinical pharmacist ser-vices. In 2 of the studies, pharmacists provided educational

Medicine Management (%)

Educational Intervention (%)

Educational and Medicine Management (%)

Total (%) Total Studies

CVDMortality 1 (100)24 1 (33)22,23,25 - 2 (50)

6 (75%)CHDcontrol - - 2 (100)24,34 2 (100)HFcontrol 1 (100)24 - 1 (100)26 2 (100)

CVDriskfactors

DMcontrol 1 (33)63-65 1 (50)29,30,50,59 7 (100)27,31-36 10 (71.5)

44 (74.6%)Smokingcessation - 1 (100)37 0 (0)31 1 (50)BPcontrol 1 (50)38,63 6 (86)29,30,39-42,66 13 (93)26,27,31,34-36,43-49,67 20 (86.9)Lipidcontrol 1 (50)51,63 7 (78)29,30,41,42,50,52-55 5 (56)27,31,34-36,49,56-58 13 (65)

Patient outcomes

Adherence 1 (100)63 3 (100)22,25,42 2 (66.6)44,48,61 6 (85.7)

22 (70%)Knowledge - 3 (100)29,50,59 1 (50)48,57 4 (80)Satisfaction - 2 (100)25,59 3 (75)43,48,49,60 5 (83.3)Qualityoflife 0 (0)62 2 (33.3)22,23,25,30,55,59 5 (83.3)26,43,44,48,58,61 7 (53.8)

Health care systemscosts

DRPs 1 (100)24 1 (100)29 0 (0)36,60 2 (50)

8 (61.5%)Hospitalization - 1 (33)22,23,25 - 1 (33)LOS - 1 (100)25 - 1 (100)ER/clinicvisit - - 1 (33)36,48,56 1 (33)Cost 0 (0)51,62 1 (100)40 3 (75)47,49,56,61 4 (57.1)Total (%) 7 (50) 30 (68.2) 43 (74.1) 69%

BP = blood pressure; CHD = coronary heart disease; CVD = cardiovascular disease; DM = diabetes mellitus; DRPs = drug-related problems; ER = emergency room; HF = heart failure; LOS = length of stay.

TABLE 1 Positive Reported Outcomes: Clinical Pharmacist Services Categorized According to Service Types



intervention,andintheother3,theyprovidedbothmedicinemanagement and educational intervention.25,43,48,49,59,60Oneofthe studies inwhichboth serviceswereprovidedshowednosignificantdifferences.Intermsofpatientqualityoflife,7outof13(53.8%)studies showedstatistical significanteffects forpharmacist intervention.22,23,25,26,30,43,44,48,55,58,59,61,62 Two studiesused educational intervention, and 5 studies providedmedi-cinemanagementandeducationalintervention.Therewasonly1studyinwhichjustmedicinemanagementinterventionwasused,anditshowednosignificantdifferences.

Health Care Systems Cost.Inourreview,wefound16stud-iesthatreportedatotalof18outcomesrelatedtohealthcarecost.TheseoutcomesincludedDRPs,hospitalization,LOS,ER/clinicvisits,anddirectcosts.DRPswerereportedin4studies,ofwhich1studyusedmedicinemanagementinterventionand1 provided educational intervention; these showed statisti-cal significant effects for clinical pharmacist intervention.24,29 Two studiesusingboth typesof intervention showedno sig-nificant improvement.36,60 In termsofpatienthospitalization,1 study out of 3 that used educational intervention (33.3%)showedastatisticalsignificantimprovement.22,23,25Nostudieswere conducted using medicine management or both typesof intervention. In termsofLOS,we foundonly1studythatusededucationalinterventionandshowedsignificantimprove-ment.25 In terms of the number of ER/clinic visits, 3 studieswerecarriedoutbyprovidingbothtypesofintervention.36,48,56 One study showedpositive effects in the clinical pharmacistgroup;anothershowednosignificantdifferences;and1studyshowedsignificantdifferencesinthecontrolgroup.Instudiesreportingdirect costs asoneof theiroutcomes, therewere4

studies found to have significant effect with clinical phar-macist intervention (1 educational and 3with both types ofinterventionsprovided).40,47,56,61Threestudieswereconductedinoutpatientsettingsand1ininpatientsettings.Twostudiesreported lower costs in the intervention group through sav-ingsinmedicationcosts,while2studiesreportedlowercoststhrough savings in the total health care costs. Two studiesusingmedicinemanagement intervention failed to show anysignificant differences, while 1 study that performed bothtypesofinterventionsshowedstatisticalsignificantdifferencesinthecontrolgroup.49,51,62

Economic StudiesWeidentifiedandincluded8economicstudies inourreview(Appendix C, available online). All of the economic studieswereconductedaspharmacist-ledinterventionsincommunitysettings,except1 thatwasconducted inanoutpatientclinic.Three studiesmeasured the economic impact of pharmacistsinhelpingpatients quit smoking;2 studies involvedpatientswithDM;and1 studyeachaddressedCHD,hyperlipidemia,andhypertensionpatients.Foureconomicstudieswerefoundtobecost-effectivenessanalyses,while therewas1each thataddressed cost-benefit analysis, cost-utility analysis, cost-minimizationanalysis,andcostanalysis.Threestudiesusedaneconomicevaluationmodel,while5studiesdidnot.Intermsofhelpingpatientsquitsmoking,2cost-effectivenessstudies68,69 and 1 cost-utility analysis70 found that using pharmacists toprovide smoking cessation services resulted in a better useof health care resources. The same results were found withpharmacistsprovidinginterventionstoimproveDMcontrol,71

Inpatients Outpatients Community

CVDMortality - 224,25 222,23

CHDcontrol - 127 123

HFcontrol - 224,26 -

CVDriskfactors

DMcontrol - 727,28,31,32,36,59,65 729,30,33-35,50,63

Smokingcessation - 131 137

BPcontrol - 1426,27,31,36,38,40-42,45-48,66,67 929,30,34,35,39,43,44,49,63

Lipidcontrol - 927,31,36,41,42,51,54-56 1129,30,34,35,49,50,52,53,57,58,63

Patient outcomes

Adherence 161 325,42,48 322,44,63

Knowledge - 248,59 329,50,57

Satisfaction - 425,48,59,60 243,49

Qualityoflife 161 525,26,48,55,59 722,23,30,43,44,58,62

Healthcare systemscosts

DRPs - 324,36,60 129

Hospitalization - 125 222,23

LOS - 125 -ER/clinicvisit - 336,48,56 -Cost 161 440,47,51,56 249,62

BP = blood pressure; CHD = coronary heart disease; CVD = cardiovascular disease; DM = diabetes mellitus; DRPs = drug-related problems; HF = heart failure; LOS= length of stay; ER = emergency room.

TABLE 2 Clinical Pharmacist Intervention Outcomes Categorized According to Setting and Type of Outcomes Measured



better improvement in patient clinical outcomes comparedwithhealthcareservices thatdidnot involvepharmacists indirect patient care. Clinical pharmacists have an impact onimprovingCVDcontrol,improvingpatientqualityoflife,andindecreasinghealthcarecosts.

Ahighpercentage (86.8%)of the studiesmeasuringphar-macistimpactonCVDriskfactorsreportedsignificantpositiveoutcomes,whileonly2studiesevaluatedthecorrelationwithCVDcontrol.26,35Cliffordetal. (2005)reportedthatpharma-cists were able to improve blood pressure and DM control,whichwasreflectedinasignificantdecreaseinthetotalCHDrisk.35SimilarresultswerefoundbyVarmaetal.(1999),whofound thatpharmacist interventionhelped todecreasebloodpressure, whichwas associatedwith an improvement inHFcontrol, leading to a better score in patient quality of lifemeasures.26 The relationship between decreasing CVD riskfactorsandtheimprovementinCVDoutcomeshasbeenwellestablished, andpublishedclinical guidelines recommendanaggressivereductionintheserisks.

Pharmacist interventionto improvepatientoutcomessuchaspatientsatisfaction,adherence,andknowledgewere foundto lead to an improvement in CVD and patient qualityof life. These results were found in 6 RCTs that showedimprovedpatientoutcomeswereassociatedwithanimprove-mentinsuchCVDriskfactorsasbloodpressureandlipidcon-trol.42-44,50,61FourRCTsfoundthatthiseffectalsoextendedtoan

hypertension,72 and lipid control.73Only1 study reportedanincreaseintheuseofhealthcareresources,withnochangeinpatientoutcomes.74Thisstudywasacost-minimizationstudyconducted tomeasure improvement in CHD outcomes. Fivestudieslookedatthehealthcaresystem,while2studiesusedasocietalapproach,68,72and1studytookagovernmentperspec-tive.73 Four studies reported pharmacist services providingeducationalintervention;1studyexaminedmedicinemanage-ment; and 3 studies reported on educational and medicinemanagement interventions. None of the studies consideredlonger-termeffects throughusinganeconomicmodel.Figure2describestheprocessrelationshipsofinterventionsbywhichclinical pharmacists canhelp improve clinical and economicoutcomes ofCVDpatient care. It shows thatmedicineman-agementinterventionshaveaninfluenceinCVDmanagementandCVD risk factor control and in reducing the number ofDRPs.ThismayleadtobetterqualityoflifeandlessmortalityandreducethenumberofhospitalizationsorER/clinicvisits,whichwill contribute to reducing health care costs. Furtherimprovementsweregainedthrougheducational interventionsaffecting patient knowledge, satisfaction, and adherence tomedications.

■■  DiscussionThe majority of outcomes reported in our review (68.6%)found that clinical pharmacy services were associated with

Patient’s knowledge and

satisfactionImprove CVD risk

factorsImprove CVD

control

Hospitalization and ER/clinic visit

Health care cost

DRPs

Clinical pharmacist

Adherence Mortality

Patient’s quality of life

FIGURE 2 Pharmacist Effect in Improving Clinical Outcomes and Decreasing Costs

CVD = cardiovascular disease; DRPs = drug-related problems; ER = emergency room.



byimprovingvariousaspectsoftheprocess,includingpatientoutcomes (knowledge, satisfaction, and adherence), CVDrisk factor control, reducing thenumberofDRPs, anddirectimprovement inCVDcontrol.These improvementsmay leadtoanimprovementinpatientqualityoflifeandmortalitythusdecreasing health care resources used. The quantity of thiseffect and its relation to the expected funds required to runsuch services isunknown.Becauseofdeficiencies in currenteconomicstudies,furthereconomicevaluationsarerequiredtoassessthecost-effectivenessofclinicalpharmacistinterventioninpatientswithCVD.

improvement inpatientqualityof life.43,44,50,61 In1 study, theeffect of pharmacist intervention did not achieve significantchanges inpatientoutcomes,and itwasalsoassociatedwithnonsignificantimprovementinpatientqualityoflife.

PharmacistinterventionstoimproveDRPswereassociatedwith an improvement inCVD control andCVD risk factors.Gattisetal.(1999)24foundthatdecreasingthenumberofDRPsinHF patients was associatedwith a decrease inHF eventsandmortality.Fornosetal.(2006)29foundthatareductioninthenumberofDRPswasassociatedwithan improvement inCVDriskfactors.Bothsetsofresultsdemonstratetherelation-shipbetweenDRPsandimprovedcareofpatientswithCVD,regardless of whether this benefit is realized through directeffectsonCVDcontrolandmortalityorthroughbettercontrolof CVD risk factors. Patient quality of life was found to beaffectedbyclinicalpharmacistinterventionthroughimprovingpatientoutcomes,CVDriskfactorcontrol,orboth.

Studies evaluating the relationship between pharmacistintervention and health care costs showed that pharmacistscandecrease totalhealth care costs through improvingCVDrisk factor controls and patient outcomes. Thismay indicatethat a reduction in health care costs by using pharmacistinterventions is achieved from the positive impact they haveinimprovingCVDorCVDriskfactoroutcomes.Italsohigh-lighted that pharmacist services that improve CVD or CVDriskfactorsmayusefewerhealthcareresources.

Considering the potential positive CVD outcomes andhealth care system savings associatedwith pharmacist inter-ventions,itseemsreasonabletoconductafulleconomicstudytoevaluatethecost-effectivenessofinvolvingclinicalpharma-cistsinthedirectcareofpatientswithCVD.

LimitationsThissystematicreviewprovidedevidenceofpharmacistben-efitsinthecareofpatientswithCVD,althoughtherearesev-erallimitationsthataffecttherobustnessofitsconclusion.Thereviewonlyincludespublishedstudiesthataremorelikelytoexist if positive outcomes emerge. It also includeddata fromdifferentsettingsandprovidedbydifferenttypesofinterven-tions, which may increase the level of heterogeneity of theresults.Thereviewonlyincluded1clinicalstudyconductedinaninpatientsetting,whichmakestheestimationofpharmacisteffect in this setting less reliable.Furthermore, the economicstudiesfoundinthisreviewthatintendedtomeasurethecost-effectiveness of clinical pharmacist interventions with CVDpatientshadanumberoflimitations,includingnotprovidinga detailed explanation of pharmacist effect nor consideringlonger-termeffectsusingeconomicmodeling.

■■  ConclusionClinical pharmacist intervention can result in a significantimprovementinCVDpatientoutcomes.Thiscanbeachieved

ABDULAZIZ ALTOWAIJRI, MSc, is Researcher; CERI J. PHILLIPS, PhD, is Professor and Deputy Head; and DEBORAH FITZSIMMONS, PhD, is Reader and Director of Studies–Postgraduate Research, College of Human and Health Sciences, Swansea University, Swansea, Wales, United Kingdom.

AUTHOR CORRESPONDENCE: Abdulaziz Altowaijri, MSc, College of Human and Health Sciences, Vivian Tower, 2nd Fl., Swansea University, Swansea, SA2 8PP Wales, United Kingdom. Tel.: +44 (0) 1792.295729; Fax: +44 (0) 1792.295643; E-mail: [email protected].

Authors

DISClOSuRES

Theauthorsreportnoconflictsofinterestregardingthisstudy.Concept and design were performed by Altowaijri, Phillips, and

Fitzsimmons. Data were collected by Altowaijri and interpretated byAltowaijri,Fitzsimmons,andPhillips.Altowaijriwrotethemanuscriptwiththe help of Phillips and Fitzsimmons, and themanuscript was revised byAltowaijri,Phillips,andFitzsimmons.

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http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=8300

http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=8300

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APPEnDIx A Search Strategy1. Cochrane Database of Systematic Reviews (CDSR)Search terms ➢  Step 1:EnteredthefollowingtermsinSearchfield(title):

(PharmacyORpharmacist*OR“pharmaceuticalservice”OR“pharmaceuticalcare”)

➢  Step 2:EnteredthefollowingtermsinSearchfield(abstract):

(Cost*OReconomic*ORcost-effectivenessORcost-benefitsORcost-savingORinterventionORoutcomesORmortalityORmorbidity)

2. MEDlInE/PubMedSearch terms ➢  Step 1:EnteredthefollowingtermsinSearchfield(titleandabstract):

(Cost*OReconomic*ORcost-effectivenessORcost-benefitsORcost-savingORintervention*ORoutcome*ORmortalit*ORmorbidit*)

Thecombinationtermsusedwereasfollows:

((((((((cost*[Title/Abstract])OReconomic*[Title/Abstract])ORcost-effectiveness[Title/Abstract])ORcost-benefits[Title/Abstract])ORcost-saving[Title/Abstract])ORintervention*[Title/Abstract])ORoutcome*[Title/Abstract])ORmortalit*[Title/Abstract])ORmorbidit*[Title/Abstract]

➢  Step 2:EnteredthefollowingtermsinSearchfield(title):

(PharmacyORpharmacist*OR“pharmaceuticalservices”OR“pharmaceuticalcare”)

Thecombinationtermsusedwereasfollows:

(((pharmacy[Title])ORpharmacist*[Title])OR“pharmaceuticalcare”[Title])OR“pharmaceuticalservice”[Title]

➢  Step 3:EnteredthefollowingtermsinSearchfield,combiningsteps1and2:

(#1)AND(#2)

limits Publicationtypelimits:ClinicalTrial,Meta-Analysis,PracticeGuideline,RandomizedControlledTrial,Review,ComparativeStudy,ControlledClinicalTrial,Guideline,MulticenterStudy,English

3. Web of KnowledgeSearch terms ➢  Step 1:EnteredthefollowingtermsinSearchfield(title):

(PharmacyORpharmacist*ORpharmaceuticalcareORpharmaceuticalservice)

➢  Step 2:EnteredthefollowingtermsinSearchfield(topic):

(Cost*OReconomic*ORcost-effectivenessORcost-benefitsORcost-savingORinterventionORoutcomesORmortalityORmorbidity)

➢  Step 3:EnteredthefollowingterminSearchfield(topic):

(Clinicaltrial)

➢  Step 4:combinedsearch1,2and3

4. HMIC (Ovid)Search terms (PharmacyORpharmacist*ORpharmaceuticalcareORpharmaceuticalserviceinthetitlefield)AND(cost*OReconomic*OR

cost-effectivenessORcost-benefitsORcost-savingORinterventionORoutcomesORmortalityORmorbidityintheabstractfield)

Cumulative Index to nursing and Allied Health literature (CInAHl) Plus Searching EngineSearch terms EnteredthefollowingtermsinSearchfield:

(PharmacyORpharmacist*ORpharmaceuticalinthetitleANDcost*OReconomic*ORcost-effectivenessORcost-benefitsOR cost-savingORinterventionORoutcomesORmortalityORmorbidityintheabstract)

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5. national Health Service (nHS) EvidenceSearch terms EnteredthefollowingtermsinSearchfield:

(PharmacyORpharmacist*)

Duetothehugenatureofdatabasesincludedinthissearch,thefollowingfilterswereused:

1-Areaofinterest-Clinical-Publichealth-Socialcare

2-Typeofinformation-Evidencesummaries-Greyliterature-Ongoingtrial-Systematicreviews

3-Sources-AgencyforHealthResearchandQuality-AHRQ-AssociationofPublicHealthObservatories-APHO-CardiovascularDiseasesSpecialistCollection(NHSEvidence)-CentreforReviewsandDisseminationHealthTechnologyAssessments-CRDHTA-DatabaseofAbstractsofReviewsofEffects-DARE-DiabetesSpecialistCollection(NHSEvidence)-EmergencyCareSpecialistCollection(NHSEvidence)-EuropeanObservatoryonHealthSystemsandPolicies-InfectionsSpecialistCollection(NHSEvidence)-LaterLifeSpecialistCollection(NHSEvidence)-LondonHealthObservatory-NationalLibraryforPublicHealth-NHSEconomicEvaluationDatabase-NHSEED-PatientandPublicInvolvementSpecialistCollection(NHSEvidence)-RespiratorySpecialistCollection(NHSEvidence)-ScreeningSpecialistCollection(NHSEvidence)-SouthWestPublicHealthObservatory-StrokeSpecialistCollection(NHSEvidence)-TheatresandCriticalCareCollection-VascularDiseasesSpecialistCollection(NHSEvidence)-WHOHealthEvidenceNetwork

6. Science DirectSearch terms ➢  Step 1:EnteredthefollowingtermsinSearchfield(title):

(PharmacyORpharmacist*OR“pharmaceuticalservice”OR“pharmaceuticalcare”)

➢  Step 2: Searchedwithintheresultofstep1byusingthefollowingterms:


➢  Step 3:Limitedtheresultofstep2withthefollowingtopics:

“pharmaceuticalcare,healthcare,medicare,ambulatorycare,careservice,patientsatisfaction,pharmacypractice,pharmaceuticaloutcome,pharmaceuticalservice,pharmaceuticaltherapy”

7. Database of Abstracts of Reviews of Effectiveness (DARE)➢  DAREdatabasewassearchedbyusingtheNHSsearchingengine.Thissearchisdiscussedinfurtherdetailinstep5.

8. Health Technology Assessment Database (HTA)➢  HTAdatabasewassearchedbyusingtheNHSsearchingengine.Thissearchdiscussedinfurtherdetailinstep5.

9. Pharmacy Abstract (http://www.pharmacyabstracts.org/index.shtml)

Search terms (pharmacist[TI])AND(economic[AB]OReffectiveness[AB]ORmortality[AB]ORmorbidity[AB])

APPEnDIx A Search Strategy (continued)

http://www.pharmacyabstracts.org/index.shtml

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Thefollowingtrialregistriesweresearchedtoidentifyanyfurthercompletedandpublishedtrials:

1. national Institute for Health’s Clinical Trials.gov database (http://www.clinicaltrials.gov)Search terms EnteredthefollowingterminSearchfield:

(pharmacist*)

2. Trip database (http://www.tripdatabase.com/)Search terms 1.EnteredthefollowingtermsinSearchfield(title:Allofthesewords):

(pharmacist*)

2.EnteredthefollowingtermsinSearchfield(anywhereinthedocument:Anyofthesewords):


3. Current Controlled Trials (CCT) (http://controlled-trials.com/)Search terms EnteredthefollowingtermsinSearchfield:

(pharmacist*)

APPEnDIx A Search Strategy (continued)

http://www.tripdatabase.com/

http://controlled-trials.com/

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Author, Year Country

Description of Pharmacist Intervention

(number of patients)Description of Control (number of patients) Result

Jadad Score Comments

AlMazroui,200927

UnitedArabEmirates

Pharmacistreviewedpatientmedi-calrecordsanddiscussedwiththeirphysiciansregardingdrugtherapy,patientawarenessabouttheirillnessandtheirmedication,includingriskofdiabetescomplications,properdosage,sideeffectsandstorageofmedications,healthylifestyleandmanagementofdiabetesmellitussignsandsymptomsthroughself-monitoring.Printedleafletsaboutdiabetesandotherconditionssuchashypertensionandhyperlipidemiaweregiventothepatients.(120patients)

Patientsreceivedadviceaboutself-monitoringoftheirbloodglucosefrommedicalandnursingstaff.(120patients)

Asignificantreductionwasfoundintheinter-ventiongroupcomparedtothecontrolgroup.Thisincludesbodymassindex(P < 0.001),fastingbloodglucose(P<0.001),HbA1c(P <0.001),systolicbloodpressure(P<0.001),diastolicbloodpressure(P<0.001),totalcholesterol(P <0.001),HDL(P <0.001),LDL(P<0.001),andtri-glycerides(P<0.001).Framinghamriskscoreswerealsoimprovedintheinterventiongroup(P <0.001)andremainedunchangedinthecontrolgroup.

3 Thestudydemon-stratedthatclinicalpharmacistshelptoimprovethehealthcareofdiabeticpatients,butthe sustainabilityof benefitsovertimeneedfurther assessment.

Choe, 200564

UnitedStates

Pharmacistevaluatedtherapeuticregimensbasedonefficacy,safety,adverseeffects,druginteractions,drugcosts,andmonitoring.Anychangesrequiredwerediscussedwithprimarycarephysiciansbeforeimplementation.(41patients)

Patientsreceivedthe usualcarewithoutinvolvementinpharmacist services.(39patients)

PatientsintheinterventiongroupachievedagreaterdecreaseinHbA1cthanthoseinthecontrolgroup(P =0.03).Interventiongrouppatientsalsohadmorefrequentexamina-tionsthanthecontrolgroup.ThisincludedLDL(P =0.02),retinalexamina-tion(P =0.004),andfootexamination(P =0.002).

3 Pharmacistimprovedbothgly-cemiccontrolanddiabeticprocessofcareintheprimarysetting.

Clifford,200259

Australia Patientsattendedappointmentswithaclinicalpharmacistat6weeksintervalsfor6months.Alistofques-tionsrelatedtopharmacotherapyanddiabetesincludinguseofmedi-cationwascoveredineachvisit.(48patients)

Patientsreceivedtheusualcarewithnointer- ventionfromapharmacist. (25patients)

Nosignificantdifferenceswerefoundbetweenthe2groupsintermsofchangesinHbA1cmeasurements(P >0.2).Sameresultswerefoundintermsofqualityoflife(P >0.15).Inpatientsatisfactionsurvey,theinterventiongrouphadgreatersatisfactionwiththeserviceprovidedbytheclinicalpharmacist(P =0.007)andbetterdruginformationsatisfaction(P =0.036).

3 Thestudyconcludedthatthepharmacisthadnoimpactonpatients’glycemiccontrolovershortperiodoftime.

HbA1c = hemoglobin A1c; HDL = high-density lipoprotein; LDL = low-density lipoprotein.

TABLE B1 Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Diabetes Mellitus

APPEnDIx B Clinical Studies Conducted to Measure the Pharmacist Impact in Treating Patients with CHD or CVD Risk Factors

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Taveira, 201031

UnitedStates

Patientsattended4weekly,2-hoursupportgroupsessions.Thesessionwasdividedinto2parts:educationandpharmacologicalandbehav-iouralintervention.Theeduca-tionelementcontained4learningobjectives,andeachobjectivewasdeliveredbydifferenthealthcarestaff.Acutecomplicationsbyaclini-calpharmacist,healthyeatingbyanutritionist,physicalactivitybyaphysicaltherapist,andchroniccomplicationsdeliveredbyanurse.Theclinicalpharmacistdeliveredthesecondelement.(64patients)

Patientsreceivedusualcarewithnoinvolvementinthesupportgroupses-sion.(54patients)

InterventiongrouphadasignificantimprovementinHbA1candsystolicbloodpressurecomparedwiththecontrolgroup(P <0.05).Nosignificantchangeswerefoundbetweenthe2groupsintermsoftobaccouseandlipidreduction.

3 Pharmacistinterven-tionsimprovedCVDriskfactorcontrol.Thehighestbenefitwasachievedincon-trollingbloodpres-sureanddiabetesmellitus.

Sarkadi,200432

Sweden Apharmacistmeasuredpatientbloodglucoseandprovidededuca-tionalinterventionconsistingofapatientinterview,lifestyleadvice,avideoofhowtolivewithdiabetes,anddiabeteseducationbooklets.Thepharmacistwasassistedbyadiabetesspecialistordiabetesnurseduringthefirst2interviews.(39patients)

Patientsreceivedusualcarewithoutinterventionfromthepharmacist. (38patients)

SignificantreductioninHbA1cvaluesweremea-suredintheinterventiongroupafter24months(P =0.05),butnotafter6or12months.

3 Thestudyprovidedinformationabouttheeffectofeduca-tionalprogramonglycemiccontrol.

Kirwin, 201065

UnitedStates

Clinicalstaffcollectedpatientdatabyusingdatacollectionforms.Aclinicalpharmacistthenreviewedthepatientdataandgaverecommen-dationstothepatient’sphysicianinaletter.(171patients)

Patientsreceivedusualcarewithoutinterventionfromthepharmacist. (175patients)

Therewerenosignificantdifferencesbetweenthe2groupsintermsofHbA1cimprovements,lipidprofile,orpneumococ-calvaccination.Theonlysignificantdifferencefoundwastheannualeyeexam(P=0.017)infavorofinter-ventiongroup.

3 Thestudyfoundthatusingarecom-mendationlettertoprovidepharmacistinterventionhadnoeffectindiabeticcare.

CVD = cardiovascular disease; HbA1c = hemoglobin A1c.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist-Led Intervention Model for Patients with Diabetes Mellitus

TABLE B2

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Fornos, 200629

Spain Thepharmacistaimedtoprevent,detect,andsolveDRPs.Thephar-macistprovidedverbalandwritteninformationaboutthecorrectuseofeachdruganditspossibleadversereactionsorinteractions.Thephar-macistalsoprovidededucationalinterventionsaimingtoimprovelifestylesandtoimproveormaintainpatientcompliance. (58patients)

Patientsreceivedusualcarewithoutanyinputfromthepharmacist. (56patients)

Patientsintheinterventiongrouphadmoreimprove-mentinmanyoutcomesthanthoseinthecontrolgroup.TheseincludeDRP(P <0.0001),knowl-edge(P <0.0001),HbA1c(P <0.0001),fastingbloodglucose(P =0.0004),totalcholesterol(P =0.0054),andsystolicbloodpressure(P =0.0006).

3 Communityphar-macistplayedanimportantroleinimprovingdia-beticcarethroughincreasingpatientawarenesstothedis-easeandtreatment.

Jameson,201033

UnitedStates

Thepharmacistprovidededucationregardingdiabetesself-management,includingdiet,exercise,bloodglu-coseleveltesting,medications,andinsulin.Thepharmacistalsousedguidelinesforthemanagementofhyperglycemiaintype2diabetes.(52patients)

Patientsreceivedusualcareprovidedbytheirphysicianswithoutinputfromaclinicalpharma-cist.(52patients)

TheinterventiongrouphadalargerdecreaseinmeanHbA1ccomparedwiththecontrolgroup(P =0.06).Thisimprove-mentwasfoundtobemoresignificantinmale(P =0.3)andwhitepatients(P =0.05).Forpatientswithareductionof1%ormoreinHbA1c,theinterventiongrouphadasignificantnumberofpatientscom-paredwiththecontrolgroup(P =0.02).

3 Thestudyconcludedthatusingaclini-calpharmacistcansignificantlyimprovepatients’glycemiccontrolincommu-nitysetting.

DRP = drug-related problem; HbA1c = hemoglobin A1c.

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist Collaborative Model for Patients with Diabetes Mellitus

TABLE B3

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Phumipamorn,200850

Thailand Patientsmetwithapharmacistat2-monthintervals,whenthepharmacistrefilledprescriptions,discussedtheuseofmedication,checkedpillcounts,andgaveeduca-tionondiabetes,whichincludedappropriatelifestyleandcorrectdiet.(67patients)

Patientsreceivedusualcarefromtheirphysicianswithnoextracounselingfromapharmacist.(68patients)

Resultsshowednosignifi-cantdifferencesbetweenthe2groupsintermsofHbA1c(P =0.56).Theinterventiongrouphadasignificantimprovementintotalcholesterolreduction(P <0.0001),LDLreduction(P =0.002),HDLincrease(P =0.06),andpatientknowledgeofdiabetes(P =0.002).

3 Thisstudyshowedthatclinicalphar-macistcanimprovepatients’qualityoflifethroughincreas-ingpatientknowl-edgeandsatisfac-tion.TheeffectonCVDriskwasonlyobtainedfromlipidcontrol

Scott, 200634

UnitedStates

Apharmacistprovidededucationandpharmacotherapymanagementfordiabeticpatients.(76patients)

Patientsreceivedusualcarewithnoappointmenttoattendapharmacistclinic.(73patients)

Thestudyshowedthatbothgroupshadsig-nificantimprovementinHbA1c(P =0.003)withmoreimprovementintheinterventiongroup(P <0.05).Theinterven-tiongroupalsohadmoreimprovementinLDLlevel(P =0.012)andsystolicbloodpressure(P =0.023).

3 Pharmacistserviceshadmoreeffectonlipid,bloodpres-sure,glycemiccontrol,andpatientqualityoflife,whichhelptoreachthetar-gettreatmentgoal.

Clifford,200535

Australia Apharmacistassessedpatientsatbaselinethenat6-weekintervals.Thisincludeddevelopingapharma-cist-patientrelationship;collecting,analyzing,andinterpretingrelevantinformation;listingandrankingdrug-relatedproblems;establishingpharmacotherapeuticoutcomeswiththepatient;determiningfeasiblepharmacotherapeuticalternatives;selectingthebestpharmacotherapeu-ticsolution;designingatherapeuticmonitoringplan;implementingtheindividualregimenandmonitoringplan;andfollow-up.(99patients)

Patientsreceivedusualcarewithoutanyinputfromapharmacist.(99patients)

Patientsintheinterventiongrouphadmoreimprove-mentinfastingserumglucose(P <0.001),HbA1c(P =0.002),systolicbloodpressure(P =0.024),anddiastolicbloodpressure(P =0.043).Nosignificantdifferenceswerefoundintotalcholesterol(P =0.14),HDL(P =0.07),ortri-glycerides(P =0.09).TheestimatedriskoffirstCHDeventsdecreasedmoreintheinterventiongroup(P =0.002).

2 Thestudyshowedthatclinicalpharma-cisthadaneffectontheglycemiccontrolover12months.

Doucette,200963

UnitedStates

Apharmacistgatheredandevaluatedpatientinformationthenformu-latedandimplementedatreatmentplan.Thepharmacistalsofollowedupwithpatientsandphysicianstoensurebetteroutcomes.(36patients)

Patientsreceivedusualcare.(42patients)

TherewerenosignificantdifferencesfoundbetweentheinterventiongroupandthecontrolgroupintermsofchangesinHbA1c,LDL,orbloodpressure.Thepharmacisthelpedpatientstoincreasetheirengage-mentwithdiet(P =0.001)anddiabeticself-activity(P =0.027).

2 Pharmacisthadaneffectinimprovingpatientself-care,butthisdidnotaffecttheclinicalout-comes.

Krass, 200730

Australia Patientswereprovidedwithbloodglucosemeasuringdevicesandaskedtochecktheirglucoselevelsonadailybasis.Ateachmonthlyvisit,apharmacistdiscussedwithpatientstheirbloodglucoseread-ingsandidentifiedinterventionstosupportpatientcare.Thediscussionconsistedofinterventionrelatedtoadherence,medication,diabetesself-management,andlifestylemodifica-tion.(176patients)

Patientsinthecontrolgrouphad2visitswiththepharmacistanddidnomorethantheusualcareservice.(159patients)

TheinterventiongrouphadsignificantchangesinHbA1c(P <0.01),systolicbloodpressure(P=0.06),andqualityoflife(EQ-5D;utilityscoreP =0.07,healthstatescaleP =0.02).

TherewerenosignificantdifferencesinBMI,dia-stolicbloodpressure,totalcholesterol,and triglycerides.

3 Thisstudyprovidedevidenceofthepharmacisteffectonimprovingclinicaloutcomesofdiabeticpatients.

BMI = body mass index; CHD = coronary heart disease; HbA1c = hemoglobin A1c; HDL = high-density lipoprotein; LDL = low-density lipoprotein.

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Diabetes Mellitus

TABLE B4

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Tobari, 201040

Japan Patientsattendedmonthlysessionsthatincludedpharmacistcounsel-ing,questionsaboutsaltintakeandlifestyle,settingindividualgoals,stressingtheimportanceofachievingthesegoals,andprovidingeducationaboutdrugtherapy.(66patients)

Patientsreceivedpharma-cistcounseling,questionsaboutsaltintakeandlife-styleatbaselineonly.(66patients)

Themeansystolicbloodpressuredecreaseintheinterventiongroupwasnotsignificantlygreaterthaninthecontrolgroupforofficeandeveninghomemeasurements.Thedecreaseindiastolicbloodpressurewassignificantintheinterventiongroupcomparedwiththecontrolgroup(P =0.04)formorn-inghomemeasurements.Patientsintheinterven-tiongroupsignificantlyreducedtheiruseofanti-hypertensivemedication(P <0.0001).Morepatientsinthecontrolgrouprequiredadditionalmedi-cationstocontrolbloodpressurethanintheinter-ventiongroup(P =0.003).

3 Thecollaborationofphysicianandpharmacistshowedanimprovementinpatients`bloodpres-surewithlessmedi-cationused.

Bogden,199845

UnitedStates

Apharmacistinteractedwithphy-sicianstooptimizehypertensionmedicationtherapy.Pharmacistmetwitheachpatientfor30min-utesbeforeseeingthephysician.Pharmacistobtainedmedicationhistory,answeredpatientques-tions,andencouragedcompliance.Residentorinternandpharmacistreviewedlaboratorydatatogether,andpharmacistgaveadvicewithregardtodrugcostsandefficacy.Thenresidentorinternsawpatientsandformulatedtreatmentplansanddiscusseditwithasupervisingphy-sicianandalsodiscussedpharmacistrecommendations,whichwerethenacceptedorrejected.Thephysi-cianalsoconsideredcurrentpatientdiseases,preferences,lifestyle,andcircumstances. (50patients)

Patientsreceivedsamemedicalcareasintheinterventiongroupbutwithouttheinputofapharmacist.(50patients)

Patientsachievingtargetbloodpressurelevelwasmorethandoubleintheinterventiongroupthaninthecontrolgroup(50%vs.20%,P <0.001).Theinterventiongroupalsoshowedbetterimprove-mentintermsofdiastolicbloodpressure(P<0.001)andsystolicbloodpressure(P <0.01).

2 Physician-phar-macistcollabora-tionhadaneffectcontrollingpatients`bloodpressureeveninthosewhowereunabletoreachtheguidelinesrecom-mendations.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Hypertension

TABLE B5

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Weber, 201046

UnitedStates

Apharmacistinterviewedpatientstoinvestigatepatientfactorsthatcouldaffecttargetbloodpressureandtocomparecurrenttreatmentwithclin-icalguidelines.Thepharmacistthendiscussedanychangesrequiredwiththepatient’sphysicianwhodecidedtoacceptorrejecttherecommenda-tions.(101patients)

Patientdidnothaveaninterviewwiththeresearchpharmacist.(78patients

Patientstreatedintheinterventiongrouphadmoresignificantchangesintheirbloodpressurethanthecontrolgroup.Thisincludeddaytimesystolicbloodpressure(P <0.001),nighttimesystolicbloodpressure(P =0.004),over-all24-hoursystolicbloodpressure(P <0.001),atofficesystolicbloodpres-sure(P <0.001),daytimesystolicbloodpressure(P <0.001),overall24-hourdiastolicbloodpres-sure(P <0.001),atofficediastolicbloodpressure(P <0.001).Nosignificantdifferenceswerefoundinnighttimediastolicbloodpressure(P =0.12).

3 Thestudyshowedthatthecollabora-tionofpharmacistandphysicianresultedinmorereductioninbloodpressureandmorepatientswithcon-trolledbloodpres-surelevels.

Hennessy,200666

UnitedStates

Apharmacistconductedaneduca-tionalinterventionfortheselectedhealthcareproviderdescribingrecommendationsforhypertensiontreatmentandpercentageofpatientsontargetbloodpressure.Basedonapprovalfromtheprovider,hyper-tensivepatientsweremailedmoti-vationalandeducationalmaterial.(5,401patients)

Patientsandtheirpro-vidersdidnotreceiveeducationalinterventionfromapharmacist.(5,295patients)

Themeanresultwasmea-suredintermsofpatientsachievingtheirtargetlevelsforbloodpressure,whichshowednostatisticallysignificantdifferencesbetweenthe2groups.

3 Theauthorsofthestudydidnotrecom-mendimplantingtheprogramunlessfurtherevaluationswereperformed.

Borenstein,200347

UnitedStates

Apharmacistdeterminedbloodpressure,assessedpatientadherencetomedication,determinedpotentialsideeffects,tobaccouse,diet,andexercise.Thepharmacistalsopro-videdpatienteducation.Thenthepharmacistcontactedthepatient’sphysicianandrecommendedmodifi-cations.(635patients)

Patientsseenonlybyphysicianwithoutanyinputfromapharmacist.(637patients)

Bothgroupsshowedsig-nificantreductioninbloodpressurewithagreaterdecreaseintheinterven-tiongroup(P <0.01).Morepatientswerefoundtoachievetargetbloodpres-sureintheinterventiongroupthaninthecontrolgroup(P =0.02).Patientsintheinterventiongrouphadaloweraveragevisitcostperpatientthanthecon-trolgroup(P =0.02)andloweraverageprimarycarevisits(P <0.01).

2 Theuseofpharma-cist-physiciancol-laborationimprovedbloodpressurecon-trolanddecreasedaverageclinicvisits.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Hypertension (continued)

TABLE B5

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Carter, 200938

UnitedStates

Apharmacistassessedmedicationsandbloodpressureatbaseline,andat1month,andbytelephoneat3months(morefrequentlyifneces-sary)andmaderecommendations.(568patients)

Clinicalpharmacistsdidnotprovidecareforstudypatientsbutcontinuedtoanswerphysician’sgen-eraltreatmentquestions.(674patients)

Guidelineadherencescoreincreasedintheinterventiongroupmorethaninthecontrolgroup(P =0.09).Themeanbloodpressurewasalsoreducedintheinterventiongroupmorethaninthecontrolgroup(P <0.05)withthesameeffectfoundin24-hourmeasurements.Morepatientsachievedcontrolledbloodpressureintheinterventiongroup(P <0.001).

3 Abettermeanbloodpressurewasachievedbypharma-cist-physiciancollab-oration.Theauthorsrecommendedtoinvestigateteam-basedchronicdis-easemanagementstrategies.

Carter, 200867

UnitedStates

Thepharmacistassessedthepatients,suggestedabloodpressuregoal,andrecommendedanychangesrequiredtoimprovebloodpressurecontrol.Also,apharmacistwasinvolvedinpatienteducationandencouragedadherence.(203patients)

Patientsdidnotreceiveanyinputfromapharma-cist.(243patients)

Thepercentageofhyper-tensionpatientswhohadcontrolledbloodpressurewerehigherintheinter-ventiongroupthaninthecontrolgroup(P <0.001).Thisincludeddiabeticpatients(P =0.002)andnondiabeticpatients(P <0.001).

5 Pharmacist-physiciancollabora-tionimprovedbloodpressurecontrolandincreasedadherencetomedicationswith-outincreasingsideeffects.

Hunt, 200848

UnitedStates

Pharmacistsreviewedsubjectmedi-cationandlifestylehabits,assessedvitalsigns,screenedforadversedrugreactions,identifiedbarrierstoadherence,providededucation,optimizedtheantihypertensiveregimen,andscheduledfollow-upappointmentsasjudgednecessary.(230patients)

Patientsreceivedtheusualcarewithout interventionfrom clinicalpharmacists. (233patients)

Patientsintheinterven-tiongrouphadbetterreductioninbothsystolic(P =0.007)anddiastolicbloodpressure(P =0.002).Thisresultedinmorepatientsachievingtheirtargetbloodpressureintheinterventiongroupthaninthecontrolgroup(P=0.003).Intermofuti-lization,patientsintheinterventiongrouphadahighernumberofofficevisits(P <0.0001)andalowernumberofphysicianvisits(P <0.0001).Therewerenosignificantdif-ferencesfoundbetweenthe2groupsintermsofhypertensionknowledge,medicationadherence,qualityoflife,orpatientsatisfaction.

3 Theinvolvementofpharmacistsinthemanagementofhypertensionpatientsimprovedbloodpressurecon-trolwithoutincreas-ingthecost,com-plexityofthedrugregimen,oralteringpatients’qualityoflife.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Hypertension (continued)

TABLE B5

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McLean,200839

Canada Patientsintheinterventiongroupwereassessedbyapharmacist-nurseteamandreceivedcounseling.Thecounselingprocessincludedreview-ingbloodpressureasariskfactor,discussingthecausesofhighbloodpressure,describingtheimportanceandconsequencesofhighbloodpressure,explainingtheeffectofdiabetesonhighbloodpressure,andfocusingonthelifestylestrate-giesthepatientcouldundertaketoimprovebloodpressure. (115patients)

Patientsdidnotreceivetherapeuticadvicefromapharmacist-nurseteam.(112patients)

Theinterventiongrouphadagreaterreductioninsystolicbloodpressurethanthecontrolgroup(P =0.008).Insubgroupanalysisofpatientswithbloodpressurehigherthan160mmHg,clinicalpharmacistinterventiondemonstratedanincreasedsignificantreductionbyanadjustedmean24.1±1.9(P <0.001).

3 Pharmacistandnursecollaborationresultedinimprove-mentofbloodpres-surecontrolindia-beticpatients,espe-ciallyinthosewithsuboptimalbloodpressurecontrol.

Carter, 199743

UnitedStates

Patientsintheinterventiongroupreceivededucationandmonitoringoftheirbloodpressureevery3-5weeks.Theyalsoreceivedadviceaboutlifestylemodificationandunderstandingoftheircurrentdrugs.Informationabouteachpatientvisitwasrecordedandsenttothephysi-cianforreview.Ifimmediateinter-ventionwasrequired,apharmacistcontactedthephysician.(29patients)

Patientsreceivedusualcarewiththetraditionalcounselingfromacom-munitypharmacist. (26patients)

Patientsintheinterventiongrouphadasignificantreductioninsystolicbloodpressureat2,3,4,5,and6months(P <0.001)comparedwithbaseline.Theyalsohadsignificantreductionindiastolicbloodpressureat2,4,and5months(P<0.05)andatendofstudy(P =0.054)frombaseline.Patientsinthecontrolgroupdidnotshowanysignificantchanges.Patientsintheinterventiongroupalsohadsignificantimprove-mentsinqualityoflifescoresandpatientsatis-factionafter6months,whereasthecontrolgroupdidnothavesignificantchanges.Intermsoftotalmeanchanges,theinter-ventiongroupwashigherthanthecontrolgroup(P =0.006).

3 Patientsmonitoredbycommunityphar-macisthadmoreimprovementinbloodpressurecon-trol,qualityoflife,andpatientsatisfac-tionmeasured.

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist Collaborative Model for Patients with Hypertension

TABLE B6

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Park, 199644

UnitedStates

Pharmacistsassessedpatientmedi-calstatusanddesignedahealthcareplan.Thepatient’sphysicianwascontactedwhentherewereanypharmacologicalchangesrequired.Pharmacistsalsoprovidedpatienteducationandcounseling.(32patients)

Patientsincontrolgroupcontinuedtoreceivetheirusualcare.(32patients)

Thestudyshowedthatpharmacistinterventionsignificantlyimprovedpatientbloodpressure(visit3&4,P <0.05),medicationcompliance(P=0.025and0.037invisit2&3),andqualityoflife(P<0.05).

3 Pharmacistser-vicesincommunityimprovedpatientcomplianceandbloodpressure control.





Bogden,199756

UnitedStates

Pharmacistsroutinelyinteractedwithandgaveadvicetopatientsandphysiciansaboutdrugs,dosage,drugselection,andprovidedmonitoring.Interventiongrouppatientswereinterviewedbyapharmacistforhalfanhourbeforemeetingtheirphysi-cians.Theinterviewincludedtakingpatientmedicationhistory,answer-inganyquestionsandencouragingcompliance.Thenapharmacistreviewedlaboratorymeasureswithaninternorresidentandgaverec-ommendations.Thentheinternorresidentdiscussedrecommendationswithanattendingphysiciananddecidedtoacceptorrejectrecom-mendations.(50patients)

Patientsreceivedthesamemedicalcareastheinterventiongroupbutwithouttheinputofapharmacist.(50patients)

Therateofpatientsachiev-ingtargetLDLlevelintheinterventiongroupwasdoubletherateofthoseinthecontrolgroup(43%vs.21%,P <0.05).Insubgroupanalysis,itwasfoundthatpharmacistinterventionwasmoresignificantinpatientswithCHD(P <0.01)orwith2ormoreriskfactors(P <0.05)whilenosignificancesweredetectedinpatientswith-outCHDorwithlessthan2riskfactors.Inthelastmonthofthestudy,medi-cationchargesdecreasedby$11.40perpatientintheinterventiongroup,whileitincreasedby$3.82inthecontrolgroup,butthedifferencewasnotsta-tisticallysignificant.Moreclinicvisitswerefoundintheinterventiongroupthaninthecontrolgroup(P <0.05).

3 Managinghighriskpatientsbyusingpharmacist-physi-ciancollaborationhadbetteroutcomesthanusingstandardcare alone.

Lee, 200954

China Pharmacistsprovidedpatientcounselingandanassessmentofpatientcomplianceandadversedrugreactions.Pharmacistsalsocontactedthepatientsat4-weekintervalsforafollow-up.(59patients)

Patientsreceivedonlyroutinemedicalcarewithoutadditionalpharmacistintervention.(60patients)

PatientsintheinterventiongrouphadagreaterreductionintheirLDL(P <0.001),totalcholesterol(P <0.001),andtriglycerideslevels(P =0.022).TheyalsohadbetterimprovementintheirHDLlevels(P =0.03).

3 Pharmacist-physiciancollaborationwasaneffectivemethodtoachievetargetcholesterollevel.

CHD = coronary heart disease; HDL = high-density lipoprotein; LDL = low-density lipoprotein.

Randomized Controlled Trial Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Hypertension

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Hypertension

TABLE B7

TABLE B8

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Olson, 200941

UnitedStates

Pharmacistscontactedpatientsbyphonetoreviewtheirannualfulllipidprofiles,bloodpressuremea-surements,andmedicationadher-ence;providedcounselingondietandexerciseregimens;andmademedicationadjustmentstomaintaintreatmentgoals.Apharmacistalsoorderedfollow-uplaboratorytests,mailedpatientstheirresults,andscheduledlipidfollow-ups.(214patients)

Patientsweredischargedfromthepharmacistserviceandcontinuedtoreceivetheusualcare.(207patients)

Studyshowedthatindivid-ualswhoweredischargedfromclinicalpharmacistservicescontinuedtohavecontrolledbloodlipidsandbloodpressurewithnosignificantdifferencesbetweenthe2groups:LDL-Cgoal:<100,P =0.46,and<70mg/dL,P =0.23;bloodpressuregoal:<140/90mmHg,P =0.03and<130/80mmHg,P =0.71.

3 Patientsdischargedfrompharmacistser-vicesaftercontrol-lingtheirlipidsandbloodpressurecancontinueundercon-trolwithminimalfollow-up.

Villa, 200955

Chile Pharmacistseducatedpatientsabouttheirillnessesandprovidedthemwithinformationaboutpharmacologicalandnonpharmacologicalinterventions.(85patients)

Controlgroupdidnotreceiveanyinterventionfrompharmacists. (57patients)

Theinterventiongrouphadsignificantchangesinmanylaboratoryoutcomesincludingtotalcholesterol(P =0.0001),LDL(P=0.0001),HDL(P >0.05),andtriglycerides(P =0.009).Theinterventiongroupalsohadsignificantimprovementsintheirqualityoflifecomparedwiththecontrolgroup(P<0.001).

3 Thestudyshowedthatpharmacistcareprogramimprovedpatients’lipidcontrol,CVDrisk,andqualityoflife.

Ellis, 200075

UnitedStates

Pharmacistsprovidedmedicationassessmentsandappliedanychangeswhenrequired.Theyalsofollowedupwithpatientsandmonitoredresponsesuntildesiredgoalswereachieved.(208patients)

Controlgroupdidnotreceiveanyinterventionfromapharmacist. (229patients)

Patientsintheinterventiongroupwerefoundtohavegreaterfastinglipidprofilesthanthecontrolgroup(P =0.021).Theyalsoshowedmoreimprovementintheirtotalcholesterol(P =0.028)andLDL(P =0.042).Nosignificantdifferenceswerefoundintermsofpatientsreachinggoallipidmeasurementsoroverallcosts.

3 PharmacistcanimproveLDLandtotalcholesterolsignificantlywithoutincreaseofoverallhealthcarecost.

CVD = cardiovascular disease; HDL = high-density lipoprotein; LDL-C = low-density lipoprotein cholesterol; mg/dL = milligram per deciliter; mmHg = millimeter mercury.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist-Led Intervention Model for Patients with Hyperlipidemia

TABLE B9

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Tsuyuki,200252

Canada Pharmacistsinterviewedpatientsandobtainedtheirmedicalhistories,measuredcholesterollevels,andedu-catedthemaboutCVDriskfactors.Then,patientswereencouragedtomakeappointmentswiththeirphysi-ciansforfurtherassessmentwhenrequired.Singlepageformsforeachpatientwerefaxed,containinginfor-mationaboutpatientriskfactors,medication,cholesterol,andbloodpressuremeasurements,alongwithanysuggestions.(344patients)

Patientsreceivedtheirusualcareandwerenotinvolvedinthecommu-nitypharmacistcarepro-gram.(331patients)

Significantdifferenceswerefoundinthisstudyinfavoroftheinterventiongroup(P <0.001)intermsofimprovementofcholes-terolmanagement.Patientsintheinterventiongroupalsohadbetteroutcomesinsubgroupanalysis,whichincludedwomen(P <0.001),men(P <0.001),age<70(P <0.001),age≥70(P <0.001),urbanpharmacypractice(P<0.001),ruralpharmacypractice(P =0.07),dia-beticpatients(P <0.001)andnondiabeticpatients(P <0.001).

3 Pharmacistservicesinthecommu-nitycareprogramachievedmoreimprovementincho-lesterolmanagement

CVD = cardiovascular disease.

Randomized Controlled Trial Conducted in a Community Setting Using a Pharmacist Collaborative Model for Patients with Hyperlipidemia

TABLE B10

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Nola, 200057

UnitedStates

Pharmacistsprovidedacompre-hensiveprogramcomposedofdiet,exerciseevaluation,monitoringofcholesterollevels,monitoringofdrugtherapy,collaborationwithphysi-cians,andpatienteducation. (25patients)

Patientsreceivedusualcarewithoutinvolvementinthecomprehensiveprogram.(26patients)

BothgroupshadanincreaseinpatientHDL(8.3,4.5,P <0.01)andpatientknowledge(5.2,1.8)withadecreaseinserumtriglycerides(4.4,1.6).

3 Thepharmacistcanplayanimportantroleinmanagingpatientswithhyper-lipidemia.

Paulos, 200558

Chile Pharmacistsprovidedpatientswithacomprehensivepharmaceuticalcareservice,whichincludedobtainingtotalcholesterolandtriglyceridelevels,educatingpatientsabouttheroleofcholesterolindiseasesandhealth,andprovidingeducationandcounselingregardingeachpatientmedication.(23patients)

Patientsreceivedusualcarewithnormalcounselingfromapharmacist. (19patients)

Thepharmacistinterventiongrouphadasignificantreductioninaveragebloodcholesterollevels(P =0.0266)andtriglyceridelevels(P =0.0169);inthecontrolgroup,patientshadanonsignificantreductionincholesterollevels(P =0.6624)andslightlyincreasedtriglyceridelevels(P =0.1435).Thedifferenceinpatientqualityoflifewashigherattheendofthestudyinfavorofthepharmacistinterventiongroup(P =0.002).

1 Pharmacistscanimprovepatients’bloodlipidvalues,CVDriskfactors,andqualityoflifeintheshortterm.

Peterson,200453

Australia Pharmacistseducatedpatientsabouttheirmedication,goals,andbenefitsofcholesteroltreatment.Patientsalsoreceivedadviceaboutdietand lifestylemodification.(46patients)

Patientsinthecontrolgroupdidnothavefurthercontactuntilthe6-monthfollow-upappointment. (48patients)

Thepharmacistinterventiongrouphadasignificantreductionintotalcholesterolfrombaseline(P <0.005),whilethecontrolgrouphadnosignificantchanges(0.26).Attheendofthestudy,thenumberofpatientswithacontrolledcholesterollevel(<4.0mmol/L)washigherintheinterventiongroup(P =0.06).

3 PharmacistshadausefulroleinreducingmorbidityandmortalityassociatedwithCHDinthecommunity.Thiseffectmaydoublethebenefitsobtainedfromusualcare.

CHD = coronary heart disease; CVD = cardiovascular disease; HDL = high-density lipoprotein; mmol/L = millimole per liter.

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Hyperlipidemia

TABLE B11

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Maguire,200137

UnitedStates

Smokersreceivedaleafletandaone-on-oneinterview.Thefollow-upadvicewasstructuredatweeklyintervalsfor4weeks,thenmonthlyfor3months.(265patients)

Smokersassignedtothecontrolgroupwerepro-videdwithnormalphar-maceuticalserviceswithnostructuredpharmacistcare.(219patients)

Smokersintheinterven-tiongrouphadasignifi-cantlyhighernumberofindividualswhowereabstinentforupto12months(P <0.001).

3 Thestructuredphar-maceuticalcareforsmokingcessationisaneffectivemodel,butquestionsremainabouttheproportionofpharmacistswill-ingtobeinvolvedinthisservice.

Randomized Controlled Trial Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Smokers





Rothman,200576

UnitedStates

Pharmacistsprovidedpatientswithintensiveeducationalsessions,evidence-basedalgorithms,andpro-activemanagementofclinicalparam-eters.(112patients)

Patientsreceivedtheirusualcarefromtheirprimarycarephysicians.(105patients)

Patientsintheinterventiongrouphadasignificantreductionintheirsystolicbloodpressure(P = 0.007),diastolicbloodpres-sure(P =0.005),HbA1c(P =0.02),anduseofaspi-rin(P<0.0001).Therewerenosignificantchangesfoundintotalcholesterolmeasurements(P =0.35),useofclinicalservices,orpotentialadverseevents.

3 Pharmacist-led diseasemanagementprogramtargetingpatientswithdia-betesmellituswasshowntobeeffectiveinimprovingpatientoutcomes.

HbA1c = hemoglobin A1c.

Randomized Controlled Trial Conducted in an Outpatient Setting Using a Pharmacist-Led Intervention Model for Patients with Coronary Artery Disease





Bond, 200762

UnitedKingdom

Medicalrecordsofpatientsintheinterventiongroupwerereviewedbyapharmacistwhorecommendedchangestothegeneralpractitionerbyusingastudyreferralform.(996patients)

Patientmedicalrecordswerenotreviewedbyapharmacist.(1,018patients)

Theoveralladherencetostandardguidelineswasgoodinbothgroups,withnosignificantdifferencesexceptforantiplateletprescribing(P =0.076).Therewerenodifferencesbetweenthe2groupsintermsofqualityoflifeandcosts,withoutincludingpharmacisttimecostsforallpatients.Whenthepharmacisttimecostswereincluded,asignificantdifferencewasfoundinfavorofthecontrolgroup(P <0.001).

3 Benefitsmeasuredintheinterventiongroupweresmall,anditwaslessthanotherstudiesmeasurement.Thisbenefitwascom-binedwithminimalchangesinprescrib-ing,andthecostofthepharmacistgroupwashigherwithoutmeasuringpharmacisttimecost.

Randomized Controlled Trial Conducted in a Community Setting Using a Pharmacist Collaborative Model for Patients with Coronary Artery Disease

TABLE B12

TABLE B13

TABLE B14

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TheMEDMANStudyGroup200749

UnitedKingdom

Pharmacistsprovidedassessmentsoftherapy,medicationcompliance,life-style(e.g.,smokingcessation,exer-cise,anddiet),andsocialsupportandrecommendationstopatient’sgeneralpractitioner.(980patients)

Patientsreceivedusualcarefromtheir generalpractitioners. (513patients)

Nosignificantdifferenceswerefoundbetweenthe2groupsintermsofaspirinprescribed,lifestylemea-sures,lipidmanagement,bloodpressure,smoking,oralcoholuse.Theinter-ventiongrouphadabetterresultintermsofpatientsatisfaction(P <0.01)withahighertotalNationalHealthServicecost(P <0.0001).

3 Thecommunitypharmacistdidnotsignificantlyimprovetheproportionofpatientsreceivingappropriatemedica-tion,anditwasmoreexpensive.

Randomized Controlled Trial Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Coronary Artery Disease





Sadik, 200561

UnitedArabEmirates

Pharmacistsdiscusseddrugtherapyappropriatenessandsimplificationoftherapyregimenswithphysicians.Pharmacistsalsoeducatedpatientsabouttheirdiseases,medications,symptomcontrol,andprovidedlife-styleadvice.(109patients)

Patientsreceivedusualcarewithoutanyadvicefromresearchpharma-cists.(112patients)

Patientsintheinterventiongrouphadmoreimprove-mentinmanymeasures(P <0.05)thanthecontrolgroup,includingexercisetolerancetest,forcedvitalcapacity,andpatientqual-ityoflife.Interventiongrouppatientsalsoshowedbetteradherencetotheirmedicationsandlifestyleadvice.Interventiongroupsalsohadlowertotalhealthcarecosts(Intervention£32,670vs.Control£56,580).

3 Pharmaceuticalcareimprovedpatients`qualityoflife,exer-cisecapacity,pulmo-naryfunction,bloodpressure,pulse,hospitaladmissionrates,compliancewiththeprescribedheartfailuremedi-cationandlifestyleadvice.

Randomized Controlled Trial Conducted in an Inpatient Setting Using a Pharmacist Collaborative Model for Patients with Heart Failure

TABLE B15

TABLE B16

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Bucci, 200360

Canada Pharmacistsreviewedmedica-tionregimensandrecommendedchanges.Theyalsoofferedpreven-tionandsolutionofdrug-relatedproblems,educatedpatientsandhealthcareprovidersaboutdiseaseandmedicationuse,andensuredcontinuityofcare.(42patiens)

Usualcarewasprovidedtopatientswithoutinputfrompharmacist.However,consultationwithaspecializedcar-diologypharmacistwasavailableforoutstandingquestionsaboutappropri-atenessofdruguse. (38patients)

Nosignificantdifferenceswerefoundbetweenthe2groupsintermsofthemedicationappropriatenessindex.Adirectiveguidancepatients’surveyshowedthattheinterventiongrouphadimprovedsignificantlyinallsurveycomponentscomparedwiththecontrolgroup(P <0.001).

3 Pharmacistcanbebeneficialintheareasofeducationandgoalsetting,butitwasdifficulttoaffecttheappropri-atenessofmedica-tioninshorttimeduetohighlyappro-priatenessmeasuredinthebaseline.

Gattis, 199924

UnitedStates

Pharmacistsdiscussedpatientcasesandverballyprovidedtherapeuticrecommendationsregardingopti-mizationoftherapytotheattendingphysician.(90patients)

Patientsreceivedusualcare,andapharmacistdidnotprovideanyrec-ommendationsregardingdrugtherapy. (91patients)

Patientsintheinterven-tiongrouphadalowerrateofallthecausesofmortalityandheartfailureeventscomparedwiththecontrolgroup(P =0.005).Interventiongrouppatientsalsohadsignificantlyhigherangiotensinenzymeinhibitor(ACEI)dosesthanthoseinthecontrolgroup(P <0.001),withahigheruseofothervasodi-latorsinpatientswithACEIintolerance(P =0.02).

3 Thestudyfoundthattheclinicalpharma-cistisanimportantmemberofthemul-tidisciplinaryheartfailureteamandsig-nificantlyimprovespatientcare.

Varma, 199926

UnitedKingdom

Pharmacistsdiscussedwithphysi-cianstheappropriatenessofdrugtherapyandeducatedpatientsforbetterself-care.(42patients)

Patientsreceivedusualstandardcare. (41patients)

Patientsintheinterven-tiongroupshowedmoreimprovementina2-minutewalkingtest(P =0.03)andbloodpressure(P =0.01).Theinterventiongroupalsohadmoreimprove-mentinsomecomponentsofqualityoflifetests,includingphysicalfunc-tioning(P <0.05),vitality(P <0.05),socialfunction-ing(P <0.05),andmentalhealth(P <0.05).Nosignif-icantdifferencesbetweenthe2groupswerefoundintermofforcedvitalcapac-ityorpulsecontrol.

3 Pharmacistimprovedpatients`drugknowledgewithfewerhospitaladmissionsandimprovedoutcomes.Furtherstudyinalargesampleisrequiredtoprovideadditionalevidence.

Randomized Controlled Trials Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Heart Failure

TABLE B17

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López Cabezas,200625

Spain Apersonalinterviewwasperformedthatincludedinformationonthedisease,dieteducation,andinforma-tionondrugtherapy.Pharmacistsalsoperformedfollow-upphonecallsonaregularbasisandprovidedthepatientswithpharmacistcontactdetailsifanyissuesarose. (70patients)

Patientsinthecontrolgroupreceivedusualcarewithoutanyinterventionfromaclinicalpharma-cist.(64patients)

Patientsintheinterven-tiongrouphadsignificantimprovementinpatientadherenceandrateofhospitalreadmissionandhospitalstayatthe2-and6-monthfollow-upvisitscomparedwiththecon-trolgroup.Theyalsohadalowerdeathrateatthe12-monthfollow-upandbetterpatientsatisfactionatthe2-monthfollow-upvisit.Nosignificantdiffer-enceswerefoundbetweenthe2groupsintermsofqualityoflife.

3 Pharmacistprovid-ingpostdischargeeducationforpatientswithheartfailurereducedhos-pitalre-admissionsandthelengthofhospitalstayandimprovedtreatmentcompliancewithoutincreasinghealthcarecosts.

Randomized Controlled Trial Conducted in an Outpatient Setting Using a Pharmacist-Led Intervention Model for Patients with Heart Failure





Bouvy, 200322

Netherlands Patientswereinterviewedbyacom-munitypharmacistwhodiscusseddruguse,reasonsfornoncompliance,andencouragedcompliance.Thenthepharmacistsentareporttothegeneralpractitionerandcontactedthepatientonamonthlybasisfor6months.(74patients)

Patientsreceivedusualcarewithnointerviewwiththepharmacist.(78patients)

Patientsintheinterventiongrouphadgreatercompli-ancetoprescribeddiuret-ics,butnosignificantdifferenceswerefoundintermsofre-hospitalization,mortality,ordiseasespe-cificqualityoflife.

3 Pharmacist-ledinter-ventioncanhaveapositiveeffectonpatientcomplianceforthosewithmod-eratetosevereheartfailureeveniftheyarerelativelyhighcompliance.

Holland,200723

UnitedKingdom

Pharmacistsarrangedforhomevisitswithin2weeksofdischarge;educatedthepatient/caregiveraboutheartfailureanddrugsandgavebasicexercise,dietary,andsmokingcessationadvice;encouragedcomple-tionofsimplesignandsymptommonitoring;distributeddiarycards;removeddiscontinueddrugs,fedbackrecommendationstothegeneralpractitionerandfedbacktothelocalpharmacistforanyneedofdrugadherenceaids.(169patients)

Usualcarewithnohomevisitsfromapharmacist. (170patients)

Patientsintheinterven-tiongroupdidnothaveasignificantdecreaseinthenumberofadmis-sions(P =0.28)ordeath(P =0.54).Intermsofqualityoflife,Eq-5DshowedabetterresultfortheinterventiongroupwhiletheMinnesotaLivingwithHeartFailureQuestionnaireshowedabetterimprovementinthecontrolgroup.Noneofthesequalityoflifemeasuredifferencesweresignificant.

3 Communityphar-macistinterventionsdidnotimproveheartfailureout-comeandreducere-admissionrates.

Randomized Controlled Trials Conducted in a Community Setting Using a Pharmacist-Led Intervention Model for Patients with Heart Failure

TABLE B18

TABLE B19

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Lee,200642 UnitedStates

Pharmaciesprovidedmedicationeducation,dispensedmedicationbyusingadherencetools,andrequiredfollow-upsat2-monthintervals.Theinterventionwasperformedinphase1ofthestudyandcontinuedforpatientsintherandomizedgroup.(83patients)

Patientswererandom-izedtothecontrolgroupinphase2,whentheyreturnedtoreceivetheprestudyservice(usualcare).(76patients)

Attheendofphase1,patientshadsignificantimprovementsinmedica-tionadherence(P <0.001),systolicbloodpressure(P =0.02),andLDLlevelsfrombaseline(P =0.001).Afterstoppingtheservicesforthecontrolgroup,patientsintheinterventiongrouphadasignificantdifferenceinmedicationadherenceandsystolicbloodpressure.

3 Pharmaceuticalcareimprovedmedica-tionadherence,bloodpressure,andlipidcontrol,whichcontinuedaftertheserviceshadceased.Thestudyresultssuggestedthathealthcareorganisationsshouldpromoteclinicalpharmacyservices.

LDL = low-density lipoprotein.

Randomized Controlled Trial Conducted in an Outpatient Setting Using a Pharmacist-Led Intervention Model to Identify Patients with Drug-Related Problems



(number of patients)Description of Control (number of patients) Result Comments

Outpatientsetting:Anaya, 200877

UnitedStates

Pharmacistswereresponsiblefordiabeteseducation;initiating,chang-ing,andmonitoringmedications;orderingallappropriatelaboratorytests;schedulingandreschedulingpatientvisitswiththepharmacist;andmakingreferralstootherhealthcareprovidersasneeded.

Retrospectivechartreviewwasconductedthatincludedpatientswithlaboratoryresultsofinterest.

Patientsreceivinginterven-tionfromclinicalpharmacistshadsignificantimprovementsinHbA1candbloodglucose(P ≤0.001).Theyalsohadimprovementinthenumberofemergencyroomvisits,whichresultedindecreasedcosts(P =0.015).

Pharmacistinterventionsunderagreedprotocolsignificantlyimproveddiabeticpatientcontrol.Thiswascombinedwithsignificantreductioninhospitalizationandemer-gencyroomvisits.

Communitysetting:Cranor, 200378

UnitedStates

Patientsmetwithapharmacistwhomonitoredtreatmentgoals,provideddiabeteseducation,homeglucosemetertraining,informationaboutadherencetotheirregimensandperformedphysicalandlaboratoryassessments.

Baselinemeasurementsforpatientsincludedinthestudywereusedasacontrol.

PatientswhoreceiveddirectcarefromaclinicalpharmacisthadsignificantimprovementsinHbA1cconcentration,espe-ciallyinthefirst2follow-upvisits(P <0.0001).Asignifi-cantreductionwasalsofoundinLDLlevelsatthesecondfollow-upvisitandHDLatthethirdfollow-upvisit(P =0.05).Totalmeandrugcostswerereducedperpatientperyearfrombaselineby$1,200to$1,872.

Pharmacistinterventionsimproveddiabeticpatientcontrolwithadeclineintotalmedicalcostduringeachyearoffollow-up.PatientswithhighlevelsofHbA1cweremostlikelytohavebenefitsfromtheseinterventions.

HbA1c = hemoglobin A1c; HDL = high-density lipoprotein; LDL = low-density lipoprotein.

Nonrandomized Controlled Trials Conducted by Using a Pharmacist-Led Intervention Model for Patients with Diabetes Mellitus and Reporting Cost

TABLE B20

TABLE B21

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Erickson,199779

UnitedStates

Pharmacistsreviewedpatientmedi-calrecords;obtainedmedicalanddrughistories;assessedpatientspecificdrugissues;assessedcom-plianceandpatientknowledgeabouthypertensionandlifestylemodifica-tion;monitoredpatientdrugtherapy;anddiscussedwithphysiciansdrug-relatedproblemsoranychangesrequired.

Controlgroupreceivedusualcarewithoutanyinterventionfromaphar-macistrelatedtopharma-ceuticalcare.

Patientsintheinterven-tiongrouphadasignificantdecreaseintheirbloodpres-surecomparedwithbaselineinbothsystolic(P =0.001)anddiastolicbloodpressure(P =0.01).Patientsinthecon-trolgroupdidnothaveanysignificantdifferencesintheirbloodpressure.Whenthechangesinthe2groupswerecompared,theonlysignificantdifferencewasfoundinsystolicbloodpressure(P =0.05).Therewerenosignificantdifferencesfoundinqualityoflife(SF-36)exceptinphysicalactivity(P =0.03).

Pharmacistcareser-vicestargetingpatientswithhypertensioncanimprovebloodpressurecontrol.

Nonrandomized Controlled Trial Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Hypertension and Reporting Cost




Hilleman,200480

UnitedStates

Pharmacistssentletterstophysi-ciansregardingpatientcholesterol,whichincludedpharmacistrecom-mendations.Pharmaciststhenmadetelephonefollow-upstoconfirmtheapplicationoftheserecommenda-tionsandachievementoftargetlevels.

Patientsinthecontrolgroupdidnotreceive anypharmacist recommendations.

Patientsintheinterventiongrouphadasignificantlyhigherlevelofstatinuse,clinicvisits,andlaboratorytests,whichwerereflectedinasignificantlyhighernumberofpatientsachievingthetargetLDLlevel.Thetotalcostfortheinterventiongroupwaslowerthanforthecontrolgroup($1,576,898vs.$1,968,674).

Concludesthatphar-macist-maderecom-mendationtophysiciansregardingstatintherapyforpatientswithCHDwasassociatedwithanimprovementinstatinuse,betterLDLlevels,andcostsaving.

CHD = coronary heart disease; LDL = low-density lipoprotein.

Nonrandomized Controlled Trial Conducted in an Outpatient Setting Using a Pharmacist Collaborative Model for Patients with Hyperlipidemia and Reporting Cost

TABLE B22

TABLE B23

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Gandhi,200181

UnitedStates

ClinicalpharmacistsprovidedpatientcareinacoronarycareunitfromJuly1998toMarch1999.

PatientsadmittedfromOctober1997toJune1998didnotreceiveanypharmacistintervention.

Drugcostsperadmissionwerenotreducedsignificantlyininterventionperiod1fromnoninterventionperiod(P >0.1).Ininterventionperiod2,drugcostsdecreasedsignifi-cantlywhencomparedwiththenoninterventionperiod(P =0.002).

Clinicalpharmacistcansignificantlydecreasetheestimatedtotaldrugcostinacoronarycareunit.

Nonrandomized Controlled Trial Conducted in an Inpatient Setting Using a Pharmacist Collaborative Model for Patients with Coronary Artery Disease and Reporting Cost




Munroe,199782

UnitedStates

Pharmacistsassessedpatientadher-enceandeducatedpatientsregard-ingtheircondition,medicationadministration,roleofmedication,nondrugtherapy,self-monitoring,andadverseeffects.Pharmacistsalsoassessedpatientbloodpressure,cholesteroldeterminations,bloodglucose,andpeakflowrate,weight,pulse,andrespiratoryrate.Allinfor-mationobtainedbypharmacistswasdocumentedandregularlysenttopatient’sphysicianbyletterorphone.Anyrecommendationsorreferralsrequiredwereincludedintheletters.

Patientsdidnotreceiveanyinterventionfromapharmacist.

Thestudyshowednosignifi-cantdifferencesbetweenthe2groupsintermsofmonthlyprescriptioncosts,exceptforpatientswithasthma(P =0.03).Foroverallcosts,pharmacistinterventionresultedinsig-nificantdifferencesfromthecontrolgroup(P =0.024).

Pharmacistinterventioncanplayanimportantroleindecreasinghealthcarecost,althoughthisstudyshowedahigheraverageofcostperprescriptionintheinterventiongroupthanthecontrolgroup.Thisdifferencewasnotstatis-ticallysignificantexceptforpatientswithasthma.Theaveragemonthlymedicalcostswerereducedintheinterven-tiongroup,andphar-macistinterventionwasshowntoreduceoverallhealthcarecosts.

Nonrandomized Controlled Trial Conducted in a Community Setting Using Pharmacist-Led Intervention Model for Patients with Drug-Related Problems and Reporting Cost

TABLE B24

TABLE B25

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APPEnDIx C Economic Studies Conducted to Measure the Pharmacist Impact in Treating Patients with CHD or CVD Risk Factors

Author Scott,200774 Simpson,200173 Sinclair,199968 Taylor,200571

Type of economic evaluation Costminimization Costanalysis Cost-effectivenessanalysis Cost-effectivenessanalysisPerspective used Healthcaresystemand

patientsperspectiveGovernmentandpharmacymanagerperspective

Socialperspective Healthcaresectoringeneral

Currency used £Sterling $Canadian £Sterling $AustralianModeling Regressionmodeling Nomodeling Nomodeling NomodelingDescription of pharmacist intervention

Pharmacistconductedinterviewswithpatientsanddeliveredmedicinemanagementservice.Thisincludedmedicationreviewandlifestyleadvice.PatientGPswereadvisedofanyprescriptionchangesandrecommendations.

PharmacistsscreenedandidentifiedCVDriskfactors,providedverbalandwritteneducationonriskfactors,withareferraltofamilyphysiciansandmonitoringofpatientscloselyfor16weeks.

Pharmacistsgavedetailedadvicedependingonthesmokercessationstagewithappropriatefollow-up.

Pharmacistsprovidedmedicationreviewanddocumentedanyrecommendationsmadeforeachpatient.

Description of control Patientsinthecontrolgroupdidnothaveastructuredinterviewwithapharmacist.

PatientsreceivedwrittenmaterialwithgeneralinformationaboutCVDriskfactorswithminimalfollow-up.

Pharmacistsgavestandardadviceandsupportforsmokingcessation.

Patientsreceivedthestandardofcareasnormal.

Source of effectiveness data Singlestudy Singlestudy Singlestudy SinglestudySource of resource use data Singlestudy Singlestudy Singlestudy SinglestudySource of unit cost data Datafromactualsource Combinationofboth Datafromactualsource Datafromactualsourcelink between cost and effectiveness data

Onlycostdatacollected–verydetailed.

Datarelatingtocostandeffectivenesswascollectedprospectivelyandconcurrently.

Prospective,concurrentcollectionofcostsandeffectsdata.

Datarelatingtocostandeffectivenesswascollectedprospectivelyandconcurrently.

Clinical outcomes measured and methods of valuation used

OutcomesmeasuredinanotherstudyintermofmedicinemanagementandimprovingCHDpatients’outcomes(nonsignificant).

OutcomesmeasuredintermsofchangesincardiovascularriskbyusingtheFraminghamriskscore.

Outcomesmeasuredintermofquittersat9months.

ClinicaloutcomesmeasuredintermofchangesinHbA1candglucoselevels.

Comments SuitabilityofCMAquestionable.

Unconvincingstudy:authorshaveundertakena”cost-identification”analysisassumingthatimprovementinriskfactormanagementwouldtranslateintoreductioninCVrisk.Wouldneedanimprovedstudytomakesuchacase.

Arelativelyoldandlimitedstudythathighlightedcontributionsmadebyclinicalpharmacistsinachievingacost-effectivecessationinsmoking.

Wouldhavebenefitedfrompatient-leveldataandprobabilisticsensitivityanalysisandconsiderationoflonger-termscenariosviamodeling.

Authors’ conclusions The1-yearpharmacist-ledmedicinemanagementwasassociatedwithatotalcostincreasewithnochangesinpatientoutcomes.Theuseofhealthcareresourcesisunlikelytobeefficientinthisparticularservice.

Clinicalpharmacyservicesincommunitywereshowntobeeffectiveintermsofimprovingcholesterolmanagement,systolicbloodpressure,andreductionofthe10-yearriskofCVDwithaminimalincreaseintheincrementalcosttothegovernmenthealthcaresystem.

Thestudyprovidedevidenceofthecommunitypharmacistcost-effectivenessindeliveringsmokingcessationadvicetoachievenationaltargets.

ThestudyshowedasignificantreductionofHbA1cinfavoroftheinterventiongroupatacostof$A383.Itislikelytoproduceacostsavingtohealthcareinthelongterm.ThesustainabilityofthereductioninHbA1ciftheservicestoppedafter9monthsisunknown.

Author Thavorn,200869 Boyd,200970 Cote,200372 Lowey,200783

Type of economic evaluation Cost-effectivenessanalysis Cost-utilityanalysis Cost-benefitanalysis Cost-effectivenessanalysisPerspective used Healthcaresystem

perspectiveNHSperspective Societalperspective Hospitalandpatient

perspectivesCurrency used Thaibaht £Sterling $Canadian £SterlingModeling Yes–Markov Decision-analyticmodel None None

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APPEnDIx C Economic Studies Conducted to Measure the Pharmacist Impact in Treating Patients with CHD or CVD Risk Factors (continued)

Description of pharmacist intervention

Structuredcommunitypharmacist-basedprogramforsmokingcessation.

NHSsupportviathegroup-basedservice.

Modifiedfactorsthataffectadherencetoantihypertensivedrugtreatment,reinforcedtheuseofnonpharmacologicaltreatments,optimizedpharmacologicaltreatments.

Pharmacistsmetwithpatientsandprovidededucationandmedicinemanagement.AnychangesmadewererecordedandissuedtopatientGPsaftereachvisit.

Description of control Usualcare Selfquit Participantsnotinvolvedinpharmacistinterventionprogram.

Patientdataatbaselinewasusedascontrol.

Source of effectiveness data Review/synthesis Review/synthesis Singlestudy SinglestudySource of resource use data Review/synthesis Singlestudy Singlestudy SinglestudySource of unit cost data Review/synthesis Review/synthesis Singlestudy Singlestudylink between cost and effectiveness data

Costsderivedprospectively;effectivenessdataderivedfromsystematicreview.

Concurrentandprospective Prospective,concurrentcollectionofcostsandeffectsdata.

Prospectiveandconcurrent

Clinical outcomes measured and methods of valuation used

Probabilityofeventswasusedtoassesstheefficacyofthesmokingcessationprogram.

Outcomesmeasuredintermsofchangesinnumbersofquitters.

Outcomesmeasuredintermsofquittersat9months.

Outcomesmeasuredintermsofbloodpressure,cholesterollevels,CHD10-yearrisk,andCVA10-yearrisk.

Comments Highlightsotherdecisionfactors.

GoodCUA–albeitwithoutPSA.

CBAusingWTP–usefulasapproach.

Verylimitedexplanationanddiscussionofcost-effectiveness.

Authors’ conclusions Pharmacyprogramforsmokingcessationwasfoundtobecostsavingandprovidedagaininlifeyears.

Boththepharmacysmokingcessationprogramandsmokingcessationsupportgroupareconsideredtobeverycosteffective.Along-termstudywillberequiredtoassesslifetimecost-effectiveness.

Pharmacistprogramseemspromisingintermsofimprovingpatientbloodpressure.Thisconclusionwillrequirefurtherresearchinordertobeconfirmed.

ThestudyresultedinasignificantreductionofCVAandCHDriskindiabeticpatientsintheinterventiongroup.

CBA = cost benefits analysis; CHD = coronary heart disease; CMA = cost minimization analysis; CUA = cost utility analysis; CV = cardiovascular; CVA = stroke; CVD = car-diovascular disease; GP = general practitioner; HbA1c = hemoglobin A1c; NHS = National Health Service; PSA = probablistic sensitivity analysis; WTP = willingness to pay; $A = Australian dollar.

a systematic review of the clinical and economic effectiveness of

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