Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting

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1 Impct of Phrmcist Intervention on Dibetes Ptients in n Ambultory Setting Julie Stding, PhrmD, CDE, Jmie Herrmnn, PhrmD, Ryn Wlters, MS, Chris Destche, PhrmD, nd Aln Chock, PhrmD Dibetes is the seventh-leding cuse of deth in the United Sttes, ccording to the Ntionl Center for Helth Sttistics t the Centers for Disese Control nd Prevention. 1 More thn 20 million people in the United Sttes hve dibetes, nd of those > 60 yers of ge, one in five hs the disese. 1 Sixty-five percent of ptients with dibetes die from hert disese or stroke. Thirty percent of those > 40 yers of ge hve impired senstion in their feet; 60% of ll nontrumtic mputtions re ttributed to dibetes. 1 Dibetes is lso the leding cuse of kidney filure, ccounting for 44% of ll new cses in To help prevent long-term complictions nd deths relted to dibetes, the Americn Dibetes Assocition (ADA) publishes n nnul position sttement titled Stndrds of Medicl Cre in Dibetes to provide up-to-dte guidelines for the mngement of dibetes. 2 The cre of dibetes ptients is multifceted nd often requires specil ttention to chieve optimum results. A1C testing is considered the gold stndrd mesurement for dibetes control. Previous studies hve mesured A1C vlues in ptients before nd fter seeing phrmcist. 3 7 The current study ssessed A1C chnges resulting from seeing phrmcist nd then compred them to chnges tht result from usul cre to find out whether phrmcist cre results in ny dditionl benefit. METHODS This study investigted the clinicl phrmcist s impct on type 2 dibetes ptients s mesured by the chnge in A1C over 2-yer period in n outptient clinic t Veterns Administrtion institution. Dibetes cre for the tretment group included the phrmcist, dietitin, nd primry cre provider (Tem), with ptients mnged by the primry cre provider nd dietitin serving s controls (Control). For Tem ptients, clinicl phrmcist met with ptients every 3 months or s needed to help meet ADA gols for therpy. 8 This retrospective medicl record review included four groups. The first two groups were composed of newly dignosed type 2 dibetic ptients receiving their first orl hypoglycemic mediction. One group (Tem; n = 33) included ptients monitored by the clinicl phrmcist to review blood glucose redings nd A1C vlues, optimize mediction dosing, provide dibetes eduction, nd follow up on lbortory testing in ddition to visits with their primry cre provider nd dietitin. The other group (Control; n = 50) were ptients monitored nd hving clinicl follow-up by their primry cre provider nd dietitin without the involvement of phrmcist. The finl two groups included type 2 dibetic ptients strted on insulin therpy (complex ptients) seen by the phrmcist in ddition to the primry cre provider nd dietitin (Tem Complex; n = 33) compred to the primry cre provider nd dietitin without phrmcist (Control Complex; n = 44). The monitoring prmeter compred between the two groups ws the chnge in A1C between the Tem nd the Control nd between the Tem Complex nd the Control Dibetes Spectrum Volume 22, Number 4, 2009 Complex groups. The review of chrt informtion for ech ptient covered 2-yer time spn from receiving the new prescription. Phrmcist visits included minutes of eduction, mediction counseling, monitoring, nd mngement bsed on the ADA guidelines for dibetes ptients. 8 At these visits, ssessments of blood pressure, weight, A1C, serum cretinine, blood ure nitrogen, lipids, microlbumin, foot cre, eye cre, nd diet nd exercise dherence nd review of home glucose redings nd ny chnges in helth sttus or medictions tht might ffect blood glucose were performed under protocol by the phrmcist. Referrls to eye, foot cre, or kidney specilists could be mde if problems were noted. Follow-up lbs were ordered, nd medictions chnges were mde by the phrmcist under protocol. Chnges in drug therpy were done bsed on glycemic control, while considering potentil drug-drug interctions, dverse drug effects, drug-disese stte interctions, nd ptient dherence issues. There were no restrictions on the number of medictions tht could be used to bring down A1C throughout the 2-yer follow-up, so s mny s three orl gents were used in some of the Tem nd Control ptients. Clinicl phrmcists t this site hve doctor of phrmcy degree nd hve completed either generl residency or crdiovsculr fellowship. Inclusion nd Exclusion Criteri Ptient selection for newly dignosed ptients ws procured by identifying electroniclly ptients who were newly dignosed nd hd new 241

2 Tble 1. Bseline Chrcteristics: Ptients on Orl Mediction Tem Control b P n men (SD) Medin n men (SD) medin vlue Age (yers) (10.19) (10.08) A1C c (%) (1.46) (0.69) Blood pressure Systolic (mmhg) (13.80) (19.20) <0.001 Distolic (mmhg) (8.45) (11.52) LDL (mg/dl) (26.04) (24.61) HDL (mg/dl) (6.23) (8.93) Triglycerides (mg/dl) (105.10) (88.87) prescription for n orl dibetes mediction from 1 Jnury 2002 to 1 Jnury Ptients on more thn one dibetes mediction were excluded. The remining ptients were seprted into two groups: those who hd visit with the clinicl phrmcist regrding tretment for dibetes within the 2-yer study period nd those who did not. Those not seen by the clinicl phrmcist becme the control group. Complex ptients were identified from electronic medicl records with new insulin prescription from 1 Jnury 2002 to 1 Jnury Ptients could lso be tking orl medictions. Ptients chnging from one insulin product to nother were excluded. However, ptients who hd initil prescriptions for two insulin products concurrently, such s regulr nd NPH, nd were previously insulin nïve were included. The finl list ws seprted into two n n (%) n n (%) Hypertension (87.9) (90.0) Hyperlipidemi (81.8) (68.0) CAD d (39.4) (30.0) CVD e 33 5 (15.2) 50 4 (8.0) Smoker 33 9 (27.3) 50 6 (12.0) Endocrinologist 33 1 (3.0) 50 1 (2.0) CAD, coronry rtery disese; CVD, cerebrl vsculr disese. Phrmcist, primry cre provider, nd dietitin involved in dibetes cre. b Primry cre provider nd dietitin involved in dibetes cre. c Rnge: Tem = 6.50 ( ); Control = 3.20 ( ). d Documented myocrdil infrction, coronry stent plcement, coronry rtery bypss surgery. e Documented cerebrl vsculr incident, trnsient ischemic ttck, crotid stent plcement. 242 Dibetes Spectrum Volume 22, Number 4, 2009 groups. Those who hd visit with the clinicl phrmcist regrding tretment for dibetes mde up the Tem Complex group of ptients. Those who did not meet with clinicl phrmcist becme the Control Complex group. Any ptients who hd not hd t lest three A1C mesurements in the 2-yer study period were excluded from ll four groups. Ptients tking prednisone, cyclosporine, morphine, phenytoin, pentmidine, or pyriminil were excluded from ll four groups. Ptients with two missed (no-show) visits with the physicin or phrmcist in the 2-yer study period were excluded from ll four groups. There were some limittions to this selection process. Ptients re typiclly referred to the clinicl phrmcist by the primry cre provider. Sometimes the ptients who re referred hve personlities tht re more difficult or behviors suggestive of mediction dherence issues. In ddition, some providers tend to refer more often thn others. The ptients seen by the clinicl phrmcists hd visits every 3 months during the 2-yer study period for most ptients, but some ptients were seen more frequently if mediction chnges were being mde. All of these fctors my hve dded some vribles to the results. Dt Collection nd Anlysis To ssess the effectiveness of the tem pproch, two fctoril nlyses of covrince (ANCOVAs), controlling for the bseline A1C mesurement, were conducted seprtely for newly dignosed ptients strting orl mediction nd for more complex ptients strting on insulin therpy. A1C dt were collected t four eqully spced time points (bseline nd t three follow-up time points)

3 throughout the 2-yer study period. Two seprte fctoril ANCOVAs were employed to ssess for group differences in A1C over the three follow-up time points, controlling for bseline. The first nlysis compred Tem to Control, nd the second compred Tem Complex to Control Complex. A fctoril nlysis will produce three seprte sttisticl tests: two min effects nd n interction effect. The first min effect will ssess for n overll difference in A1C between the two groups (i.e., between-groups min effect), wheres the second min effect provides n overll test of chnge in A1C over the three time points (i.e., within-groups min effect). Finlly, the interction effect will compre whether A1C for the two groups responded differently over the three follow-up mesurement times. For both nlyses (Tem vs. Control nd Tem Complex vs. Control Complex), the interction effect is of primry interest (i.e., did A1C for the two groups respond differently over the three follow-up time points?). A computer simultion indicted power of 0.60 to detect n interction effect for ptients receiving orl mediction nd 0.57 to detect n interction effect for ptients on insulin therpy Bseline chrcteristics within both groups (i.e., Tem vs. Control) of orl mediction nd insulin ptients were compred using bivrite nlyses. Continuous vribles were presented s men, stndrd devition (SD), nd medin nd nlyzed employing independent-smples t-tests or, where distributionl ssumptions were violted, Mnn-Whitney tests. Ctegoricl vribles were presented s frequency nd percent nd nlyzed with Fisher s exct tests. All nlyses were performed using PASW Sttistics v (SPSS Inc., Chicgo, Ill.). RESULTS A sttisticlly significnt result indicted n overll difference in A1C between Tem Complex nd Control Complex ptients inititing insulin therpy (F1, 74 = 5.24; P = 0.025), with phrmcist tem ptients, on verge, displying lower A1C vlues compred to ptients mnged without the phrmcist (men A1C = 7.15 nd 7.67%, respectively). Although the Tem ptients receiving orl mediction were trending fvorbly, decreses in A1C were not sttisticlly different in comprison to Control ptients. Ptients on Orl Mediction Tble 1 contins bseline chrcteristics of the Tem nd Control ptients. Control ptients hd significntly higher systolic blood pressure levels compred to the Tem ptients. All other bseline chrcteristics were comprble. A fctoril ANCOVA ws employed to ssess whether A1C for the two groups of ptients (i.e., Tem vs. Control) responded differently over the three follow-up time points, fter controlling for the bseline Dibetes Spectrum Volume 22, Number 4, 2009 A1C mesurement. Six outliers (one Tem; five Control) were identified nd deleted. After removl, no ssumptions were violted. The Huynh-Feldt correction ws pplied to ll F tests to djust for sphericity violtion. Results indicted no sttisticlly significnt interction effect, indicting A1C responded similrly over the three follow-up time points for Tem nd Control ptients, fter controlling for bseline A1C. Further, neither min effect ws sttisticlly significnt. This indicted there ws no overll difference in A1C between the two groups nd, on verge, A1C vlues remined stble over the three follow-up time points. Adjusted mens, stndrd errors (SEs), nd 95% CIs for ech group re presented in Tble 2. Adjusted mens re plotted in Figure 1. Tble 2. Adjusted Mens by Tretment Group for Ptients on Orl Therpy Tem b (n = 33) Control c (n = 50) Men (SE) 95% CI Men (SE) 95% CI A1C: Time 1 (%) 6.77 (0.16) (0.13) A1C: Time 2 (%) 6.64 (0.15) (0.12) A1C: Time 3 (%) 6.55 (0.17) (0.14) Mens djusted for bseline A1C vlue of 6.83% b Phrmcist, primry cre provider, nd dietitin involved in dibetes cre c Primry cre provider nd dietitin involved in dibetes cre Figure 1. Adjusted mens: tretment group by mesurement time orl. Mens djusted for bseline A1C vlue of 6.83%. 243

4 Insulin Ptients Tble 3 contins bseline dt for the Tem Complex nd Control Complex ptients. Tem Complex ptients hd significntly higher frequency of hyperlipidemi thn Control Complex ptients. All other bseline dt were comprble. Fctoril ANCOVA ws employed. Two outliers (one from ech group) were deleted. After removl, no ssumption violtions were indicted. No violtion of sphericity ws indicted. Results of the fctoril ANCOVA indicted no sttisticlly significnt interction fter djusting for the bseline A1C mesurement. This indicted A1C for the two groups responded similrly over the three follow-up time points. However, there ws sttisticlly significnt between-groups min effect fter djusting for ll other effects, including the covrite (F1, 74 = 5.24; P = 0.025; prtil η2 = 0.07 with 95% confidence limits 16 from 0.00 to 0.19). This indicted n overll difference in A1C between the two groups, with Tem Complex ptients displying lower A1C vlues (men = 7.15; SE = 0.17; 95% CI ) compred to Control Complex ptients (men = 7.67; SE = 0.15; 95% CI ). Finlly, the within-groups min effect ws not sttisticlly significnt, indicting, on verge, A1C remined stble over the three follow-up time points. Adjusted mens, SEs, nd 95% CIs for ech group re presented in Tble 4, nd djusted mens re plotted in Figure 2. DISCUSSION One of the questions often sked of phrmcist is, Are you providing dded benefits to the cre of ptients? This study suggests tht, in complex dibetic ptients, there is indeed dded benefit, s is shown with objective evidence provided by group differences in A1C. Why is this so importnt? In 2000, the U.K. Prospective Dibetes Study (UKPDS) observtionl study of 3,642 dibetic ptients showed tht for ech 1% reduction in A1C, there ws corresponding 21% reduction in ny endpoint relted to dibetes, with 14% reduction for myocrdil infrction nd 37% reduction for microvsculr complictions. 9 Is there other evidence tht phrmcists hve positive impct on ptient cre in the re of dibetes mngement? A prospective study published in 2004 by Cioffi et l. 4 showed reduction in A1C from 10.3 to 6.9% in 70 ptients Tble 3. Bseline Chrcteristics: Ptients on Insulin Tem Complex Control Complex b P vlue n men (SD) medin n men (SD) medin Age (yers) (9.83) (12.27) A1C c (%) (1.44) (1.07) Blood pressure Systolic (mmhg) (20.12) (19.53) Distolic (mmhg) (12.90) (12.13) LDL (mg/dl) (33.66) (30.55) HDL (mg/dl) (8.21) (23.68) Triglycerides (mg/dl) (262.78) (304.07) n n (%) n n (%) Hypertension (97.0) (86.4) Hyperlipidemi (81.8) (54.5) CAD d 33 9 (27.3) (27.3) CVD e 33 2 (6.1) 44 4 (9.1) Smoker 33 7 (21.2) 44 9 (20.5) Endocrinologist 33 3 (9.1) 44 3 (6.8) CAD, coronry rtery disese; CVD, cerebrl vsculr disese; HDL, high-density lipoprotein cholesterol; LDL, low-density lipoprotein cholesterol. Phrmcist, primry cre provider, nd dietitin involved in dibetes cre. b Primry cre provider nd dietitin involved in dibetes cre. c Rnge: Tem = 6.30 ( ); Control = 5.10 ( ). d Documented myocrdil infrction, coronry stent plcement, coronry rtery bypss surgery. e Documented cerebrl vsculr incident, trnsient ischemic ttck, crotid stent plcement. 244 Dibetes Spectrum Volume 22, Number 4, 2009

5 Tble 4. Adjusted Mens by Tretment Group for Ptients on Insulin Therpy Tem Complex b (n = 33) Control Complex c (n = 44) Men (SE) 95% CI Men (SE) 95% CI A1C: Time 1 (%) 7.22 (0.17) (0.15) A1C: Time 2 (%) 7.19 (0.22) (0.19) A1C: Time 3 (%) 7.05 (0.22) (0.19) Mens djusted for men bseline A1C vlue of 6.83%. b Phrmcist, primry cre provider, nd dietitin involved in dibetes cre. c Primry cre provider nd dietitin involved in dibetes cre. Figure 2. Adjusted mens: tretment group by mesurement time insulin. Mens djusted for bseline A1C vlue of 7.50%. in time spn of 9 12 months. the primry cre provider nd crried out by the phrmcist. In this study, ptients met with clinicl phrmcist every 6 8 weeks, In nother study by Irons et l., 5 receiving 30 minutes of eduction, retrospective cohort nlysis of 87 mediction counseling, monitoring, dibetic ptients mnged by phrmcists, the study ptients were more nd mngement. Initil therpy consisted of glyburide or metformin. successful on chieving n A1C 7% If glycemic control ws not chieved, compred to the 85 similr ptients then combintion of these two in the control group who did not were used. Acrbose ws dded if hve clinicl phrmcists involved. Another group postprndil blood glucose vlues 6 ssessed the impct of phrmcist-run dibetes mngement progrm involving direct were not controlled. Rosiglitzone ws lso dded if nother orl gent teching, follow-up phone clls, ws needed or intermedite-cting nd mediction lgorithms in 159 insulin if it ws deemed tht dequte control would not be chieved totl of 139 ptients completed the ptients followed for 6 months. A with nother orl gent. Chnges study, which showed decrese in in the regimen were mde bsed on men A1C of 1.9% in the 6-month drug-drug interctions, dverse drug time period. McCord 3 performed effects, drug-disese stte interctions, ptient dherence issues, nd ptients who hd phrmcist inter- retrospective chrt review of 316 glycemic control. The ddition of vention nd showed men A1C new medictions ws discussed with reduction of 1.4% (P < 0.001). The Dibetes Spectrum Volume 22, Number 4, 2009 number of ptients reching gol A1C < 7% incresed from 14.8 to 43.2% (P < 0.001). One concern tht dministrtors stte consistently is the cost ssocited with the cre of dibetic ptients. The worry is tht, by dding phrmcists to the cre tem for ll dibetic ptients, the overll cost of cre will increse. However, Gerber et l. 7 performed dt nlysis on the totl cost to helth mintennce orgniztion (Kiser Permnente) when phrmcist provided consulttion to dibetic ptients nd found tht overll costs including hospitliztion costs, office visits, nd mediction costs were significntly less compred to the cost of cre for those who did not receive consulttions for their dibetes. This study not only shows no increse in costs to the system s whole, but lso ctul svings. Our study shows tht phrmcist involvement in the cre of dibetic ptients in the outptient setting my provide dditionl benefit to the ptients bove tht of primry cre provider nd dietitin. It contributes to the body of evidence tht suggests tht hving multiple helth cre professionls, including phrmcists, improves dibetic ptients dherence to ADA guidelines for preventive cre nd reduces A1C vlues, which the UKPDS suggests my reduce the incidence of myocrdil infrction, stroke, nd microvsculr complictions. 9 CONCLUSION A1C vlues > 7% hve been ssocited with higher incidence of long-term crdiovsculr nd peripherl vsculr disese, greter incidence of ptients requiring dilysis, nd numerous microvsculr complictions, including problems with vision. 10,17,18 The direct nd indirect costs of these complictions hve been estimted t $132 billion, which hs n enormous impct on helth cre in the United Sttes. 1 The UKPDS suggests tht 1% reduction in A1C results in 21% reduction of mcrovsculr complictions, including myocrdil infrction, stroke, nd mputtion (peripherl vsculr disese). 9 The present study suggests tht using clinicl phrmcist in 245

6 ddition to primry cre provider nd dietitin to monitor, mnge, nd provide eduction to dibetic ptients strting insulin therpy will significntly improve A1C vlues with men reduction in A1C from 7.6 to 7.1%. Acknowledgments This study ws presented s poster t the Americn College of Clinicl Phrmcist s nnul meeting in October It ws supported through n internl reserch grnt from Creighton University. References 1 Ntionl Center for Helth Sttistics: Ntionl dibetes fct sheet, 2007 [rticle online]. Avilble from dibetes/pubs/pdf/ndfs_2007.pdf. Accessed 27 Februry Americn Dibetes Assocition: Stndrds of medicl cre in dibetes Dibetes Cre 32 (Suppl. 1)S13 S61, McCord AD: Clinicl impct of phrmcist-mnged dibetes mellitus drug therpy mngement service. Phrmcotherpy 26: , Cioffi ST, Cron MF, Klus JS, Hill P, Buckley TE: Glycosylted hemoglobin, crdiovsculr nd renl outcomes in phrmcist-mnged clinic. Ann Phrmcother 38: , Irons BK, Lenz RJ, Anderson SL, Whrton BL, Hbeger B, Anderson HG: A retrospective cohort nlysis of the clinicl effectiveness of physicin-phrmcist collbortive drug therpy mngement dibetes clinic. Phrmcotherpy 22: , Rothmn R, Mlone R, Brynt B, Horlen C, Pignone M: Phrmcist led, primry cre-bsed disese mngement improves hemoglobin A1c in high-risk ptients with dibetes. Am J Med Qul 18:51 58, Gerber RA, Liu G, McCombs JS: Impct of phrmcist consulttions provided to ptients with dibetes on helthcre costs in helth mintennce orgniztion. Am J Mng Cre 4: , Americn Dibetes Assocition: Stndrds of medicl cre for ptients with dibetes mellitus. Dibetes Cre 26 (Suppl. 1):S33 S50, U.K. Prospective Dibetes Study Group: Assocition of glycemi with mcrovsculr nd microvsculr complictions of type 2 dibetes (UKPDS 35): prospective observtionl study. BMJ 321: , U.K. Prospective Dibetes Study Group: Intensive blood-glucose control with sulphonylures or insulin compred with conventionl tretment nd risk of compliction in ptients with type 2 dibetes (UKPDS 33). Lncet 352: , ADVANCE Collbortive Group: Intensive blood glucose control nd vsculr outcomes in ptients with type 2 dibetes. N Engl J Med 358: , ACCORD Study Group: Effects of intensive glucose lowering in type 2 dibetes. N Engl J Med 358: , Stevens J: Applied Multivrite Sttistics for the Socil Sciences. 2nd ed. Hillsdle, N.J., Lwrence Erlbum Assocites, Cohen J: Sttisticl Power Anlysis for the Behviorl Sciences. 2nd ed. Hillsdle, N.J., Lwrence Erlbum Assocites, D Amico EJ, Neilnds TB, Zmbrno R: Power nlysis for multivrite nd repeted mesures designs: flexible pproch using the SPSS MANOVA procedure. Behv Res Methods Instrum Comput 33: , Smithson MJ: Confidence Intervls. Belmont, Cilf., Sge, U.K. Prospective Dibetes Study Group: Effect of intensive blood-glucose control with metformin on complictions in overweight ptients with type 2 dibetes (UKPDS 34). Lncet 352: , DCCT Reserch Group: The effect of intensive tretment of dibetes on the development nd progress of long-term complictions in insulin-dependent dibetes. N Engl J Med 329: , 1993 Julie Stding, PhrmD, CDE, is n ssocite professor of phrmcy prctice in the School of Phrmcy t Creighton University in Omh, Nebr., nd clinicl phrmcy specilist t the Veterns Administrtion Nebrsk Western Iow Helth Cre System (NWIHCS VA) in Lincoln, Nebr. Jmie Herrmnn, PhrmD, is first-yer generl phrmcy prctice resident t NWIHCS VA in Grnd Islnd, Nebr. Ryn Wlters, MS, is reserch nlyst in the School of Medicine t Creighton University. Chris Destche, PhrmD, is professor of phrmcy prctice, internl medicine, medicl microbiology, nd immunology t Creighton University. Aln Chock, PhrmD, is n ssistnt professor of phrmcy prctice in the School of Phrmcy t Creighton University nd clinicl phrmcy specilist t NWIHCS VA in Lincoln. 246 Dibetes Spectrum Volume 22, Number 4, 2009

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