Sistematični pregled raziskav vrednotenja koristi klinične farmacije in farmacevtske skrbi Systematic review of studies evaluating benefits of clinical pharmacy and pharmaceutical care services Mitja Kos, Darja Bečan Povzetek: Namen članka je sistematični pregled raziskav, ki so vrednotile koristi klinične farmacije in farmacevtske skrbi. V bibliografski zbirki Medline je bilo zajetih 266 raziskav, ki so bile objavljene do 25.11.2011, in sicer 253 kliničnih raziskav ter 13 metaanaliz. Število raziskav sovpada z uveljavljanjem koncepta farmacevtske skrbi v 90. letih in znaša dobrih 20 raziskav na letni ravni po letu 2009. Največ raziskav so izvedli v ZDA, Kanadi in Avstraliji. V Evropi so se prve raziskave pojavile v zadnjih letih 20. stoletja in sicer v Združenem kraljestvu in na Švedskem. Največ raziskav je obravnavalo storitve, ki so jih farmacevti izvajali v ambulantah na primarni ravni in v lekarni. Raziskave so najpogosteje vrednotile storitve farmacevtov za bolnike s hipertenzijo, astmo, diabetesom, hiperlipidemijo, srčnim popuščanjem, bakterijsko infekcijo in depresijo. Poseben pomen imajo raziskave na področju polifarmakoterapije. Rezultati večine raziskav, ne pa vseh, kažejo na pozitivne izide storitev klinične farmacije in farmacevtske skrbi. Ključne besede: sistematični pregled, koristi, klinična farmacija, farmacevtska skrb Abstract: Aim of the manuscript is a systematic review of studies that evaluated benefits of clinical pharmacy and pharmaceutical care. In Medline 266 studies were captured published before 25.11.2011, 253 clinical studies and 13 metaanalises. The number of studies corresponds to the uptake of pharmaceutical care concept in nineties and amounts 20 studies published on a yearly basis after 2009. The highest number of studies evaluated services in USA, Canada and Australia. In Europe the first studies were published in UK and Sweden in the last years of the 20th century. The highest number of studies evaluated services performed in general physicians' clinics and in community pharmacies. Most often studies evaluated pharmaceutical services for the patients with hypertension, asthma, diabetes, heart failure, bacterial infection and depression. Of particular importance are studies evaluating polypharmacy. Results of the majority of studies, but not all, show positive outcomes of clinical pharmacy and pharmaceutical care. Key words: systematic review, benefits, clinical pharmacy, pharmaceutical care 1 Uvod V procesu zdravljenja z zdravili lahko nastanejo težave povezane z zdravili (ang. Drug Related Problems), ki so posledica neprimerne izbire, izdaje ali uporabe zdravila. V Franciji so poročali o 3 % hospitalizacij zaradi neželenih učinkov zdravil (1), na Švedskem pa je bilo kar 14 % bolnikov na oddelku interne medicine hospitaliziranih zaradi simptomov in znakov, ki so bili povezani z neželenimi učinki zdravil (2). Še več raziskav na to tematiko lahko zasledimo v ZDA, kjer so na primer ugotavljali, da je 11 - 28 % vseh hospitalizacij posledica težav povezanih z zdravili. Stroški, ki so s tem nastali, pa so znašali 30,1 -136,8 milijard $, kar je bilo več kot stroški samih zdravil (3). Ne prav številčne in obširne raziskave na tem področju v Sloveniji pritrjujejo, da je pomembno ustrezno upravljanja tega področja tudi pri nas. Tako je bila v zadnjem času posebej izpostavljena razmeroma številčna skupina, ki ima še posebej veliko tveganje za težave povezane z zdravili glede na to, da gre za starejše od 65 let, ki imajo sočasno predpisanih po osem ali več različnih zdravil (4). Z namenom reševanja problema težav povezanih z zdravili so se tudi med farmacevti razvile številne iniciative, ki se večinoma predstavljajo pod terminoma klinična farmacija in farmacevtska skrb. Klinična farmacija obsega aktivnosti in storitve farmacevta, ki vodijo k racionalni in optimalni uporabi zdravil in so komplementarne aktivnostim ostalih zdravstvenih delavcev (5). Farmacevtska skrb je po drugi strani definirana kot praksa v okviru katere farmacevt za posameznega bolnika na odgovoren način zagotavlja zdravljenje z zdravili, ki vodi k naprej definiranim zdravstvenim izidom in tako izboljša kakovost življenja bolnikov (6). Po svoji vsebini oba koncepta opisujeta enako oz. vsaj zelo podobno področje delovanja. Po mnenju nekaterih teoretikov naj bi bila razlika med farmacevtsko skrbjo in klinično farmacijo v prevzemanju odgovornosti za svoja dejanja, medtem ko drugi med obema koncepta ne vidijo bistvenih razlik. Tako so se npr. do doc. dr. Mitja Kos, mag. farm., Univerza v Ljubljani, Fakulteta za farmacijo, Katedra za socialno farmacijo, Aškerčeva 7, 1000 Ljubljana Darja Bečan, mag. farm., Lekarna Plavž, Cesta Cirila Tavčarja 3, Jesenice tega vprašanja posebej opredelili tudi v Evropskem združenje kliničnih farmacevtov ESCP in v definicijo klinične farmacije zapisali, da klinični farmacevti svoje storitve lahko izvajajo tako v bolnišnicah kot tudi v lekarnah, domovih starejših občanov ter drugih ustanovah, kjer se predpisujejo in uporabljajo zdravila. Kljub številnim aktivnostim na tem področju, pa tako v slovenskem kot tudi mednarodnem prostoru, še vedno zasledimo pomisleke o smiselnosti in ustreznosti farmacevtovega delovanja, ki je vezano na aktivnejšo obravnavo težav povezanih z zdravili ter spremljanje bolnikov pri njihovem zdravljenju z zdravili. Nekateri izmed pomislekov so neosnovani in običajno rezultat nerazumevanja farmacevtovega strokovnega potenciala ter dojemanja njegove dejavnosti kot kompetitivne drugi stroki. Prav tako po drugi strani ni smiselno neracionalno in z dokazi nepodprto umeščanje novih storitev v zdravstveno prakso. Tisti, ki koncept klinične farmacije in farmacevtske skrbi sprejemajo, se predvsem sprašujejo o vsebini in terapevtskem področju storitve, ki bo dejansko pomenila korist za bolnike. 2 Namen Namen raziskave je sistematični pregled raziskav, ki so vrednotile koristi klinične farmacije in farmacevtske skrbi. 3 Metode V podatkovni bazi Medline (bibliografska zbirka podatkov, dostop: www.pubmed.com ) smo zajeli klinične raziskave in metaanalize, ki so obravnavale storitve, aktivnosti in programe s področja klinične farmacije in farmacevtske skrbi. Iskalni profil, ki smo ga v ta namen oblikovali, je bil sledeč: "clinical pharmacy" or "clinical pharmacist" or "pharmaceutical care" or ((pharmacy or pharmacist) and intervention) Limits: Clinical Trial, Meta-Analysis. Vključili smo klinične raziskave ter metaanalize v angleškem jeziku, ki so obravnavale aktivnosti in storitve, ki so jih opravljali farmacevti. Vključili smo tudi raziskave, v katerih je intervencijo izvajal celoten zdravstveni tim (poleg farmacevta še splošni zdravnik, zdravnik specialist in/ali medicinska sestra), pri čemer je bila vloga farmacevta jasno določena oz. razvidna. Izključili smo raziskave, kjer storitev niso opravljali farmacevti, in raziskave, ki so programe klinične farmacije in farmacevtske skrbi le opisovale, niso pa podajale kliničnih, humanističnih ali ekonomskih izidov storitev. 4 Rezultati V bibliografski zbirki podatkov Medline je bilo do 25.11.2011 objavljenih 266 raziskav, ki so ustrezale vključitvenim kriterijem in sicer 253 kliničnih raziskav ter 13 meta analiz. Preglednica, ki prikazuje raziskave glede na terapevtsko področje in mesto izvajanja storitve, je zaradi svoje dolžine v celoti predstavljena na spletni strani te številke Farmacevtskega vestnika (http://www.sfd.si/modules/catalog/products/prodfile/fb_4_2012.pdf). 4.1 Pregled kliničnih raziskav Na slikah od 1 do 4 je prikazan pregled kliničnih raziskav in sicer glede na leto, državo izvajanja storitve, mesto izvajanja storitve in terapevtsko področje. 4.2 Pregled metaanaliz V preglednici 1 (str. 214) je prikazan pregled metaanaliz raziskav, ki so vrednotile koristi klinične farmacije oz. farmacevtske skrbi. ■Il.ll.llll v v s? v v v s? vv s? vv s? vvvvvvvvvvvvv Leto objave Slika 1: Število objav raziskav, ki so vrednotile koristi klinične farmacije in farmacevtske skrbi glede na leto objave (N=253 kliničnih raziskav). Figure 1: Number of publications reporting benefits of clinical pharmacy and pharmaceutical care according to year of publication (N= 253 clinical studies). Slika 2: Število objav glede na državo izvedbe raziskave koristi klinične farmacije oz. farmacevtske skrbi (N=253 kliničnih raziskav). Figure 2: Number of publications according to country in which benefits of clinical pharmacy or pharmaceutical care were evaluated (N= 253 clinical studies). Slika 3: Število objav glede na mesto izvajanja storitve klinične farmacije oz. farmacevtske skrbi (N=253 kliničnih raziskav). Figure 3: Number of publications according to location of clinical pharmacy or pharmaceutical care service (N= 253 clinical studies). Slika 4: Število objav raziskav, ki so vrednotile koristi klinične farmacije in farmacevtske skrbi, glede na terapevtsko področje (N=253 kliničnih raziskav). Figure 4: Number of publications according to therapeutic area of clinical pharmacy or pharmaceutical care service (N= 253 clinical studies). Preglednica I: Število raziskav glede na terapevtsko področje in mesto izvajanja storitve. Table I: Number of publications according to therapeutica area and location of clinical pharmacy or pharmaceutcial care service (N= 253 clinical studies). Terapevtsko področje Mesto izvajanja storitve St. raziskav Vir bolezni dihal 25 alregijski rinitis lekarna 1 I ambulanta na primarni ravni 1 II astma lekarna 16 III, IV, V, VI, VII, VIII, IX, X, XI, XII, XIII, XIV, XV, XVI, XVII, XVIII osnovna šola 1 XIX specialistična ambulanta 2 XX, XXI bolezni dihal - splošno lekarna 3 XXII, XXIII, XXIV KOPB specialistična ambulanta 1 XXV bolezni krvi 1 anemija specialistična ambulanta 1 XXVI bolezni mišično-skeletnega sistema in vezivnega tkiva 2 bolečina ambulanta na primarni ravni 2 XXVII, XXVIII bolezni obtočil 50 ambulanta na primarni ravni 15 XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV, XXXV, XXXVI, XXXVII, XXXVIII, XXXIX, XL, XLI, XLII, XLIII hipertenzija lekarna 6 XLIV, XLV, XLVI, XLVII, XLVIII, XLIX letalonosilka 1 L na domu 1 LI specialistična ambulanta 5 LII, LIII, LIV, LV, LVI koronarna bolezen bolnišnica 1 L.VII lekarna 1 LVIII miokardni infarkt bolnišnica 1 LIX možganska kap bolnišnica in lekarna 1 LX specialistična ambulanta 1 LXI bolnišnica 5 LXII, LXIII, LXIV, LXV, LXVI srčno popuščanje lekarna 3 LXVII, LXVIII, LXIX lekarna in na domu 1 LXX specialistična ambulanta 4 LXXI, LXXII, LXXIII, LXXIV ambulanta na primarni ravni 1 LXXV tromboza bolnišnica 2 LXXVI, LXXVII specialistična ambulanta 1 LXXVIII bolezni prebavil 5 bolezni jeter bolnišnica 1 LXXIX bolezni prebavil - splošno bolnišnica 1 LXXX dispepsija lekarna 1 LXXXI gastritis lekarna 1 LXXXII specialistična ambulanta 1 LXXXIII bolezni sečil 5 bolnišnica 1 LXXXIV ledvična odpoved lekarna 1 LXXXV specialistična ambulanta 3 LXXXVI, LXXXVII, LXXXVIII bolezni živčevja 3 epilepsija, Parkinsonova bolezen DSO 1 LXXXIX glavoboli lekarna 2 XC, XCI duševne in vedenjske motnje 16 ambulanta na primarni ravni 4 XCII, XCIII, XCIV, XCV depresija lekarna 4 XCVI, XCVII, XCVIII, XCIX specialistična ambulanta 2 C, CI ambulanta na primarni ravni 1 CII duševne in vedenjske motnje - bolnišnica 1 CIII splošno DSO 3 CIV, CV, CVI specialistična ambulanta 1 CVII Terapevtsko področje Mesto izvajanja storitve St. raziskav Vir endokrine, prehranske in presnovne motnje 35 ambulanta na primarni ravni 9 CVIII, CIX, CX, CXI, CXII, CXIII, CXIV, CXV, CXVI diabetes bolnišnica 1 CXVII lekarna 3 CXVIII, CXIX, CXX specialistična ambulanta 4 CXXI, CXXII, CXXIII, CXXIV ambulanta na primarni ravni 6 CXXV, CXXVI, CXXVII, CXXVIII, CXXIX, CXXX bolnišnica in na domu 1 CXXXI hiperlipidemija lekarna 7 CXXXII, CXXXIII, CXXXIV, CXXXV, CXXXVI, CXXXVII, CXXXVIII specialistična ambulanta 3 CXXXIX, CXL, CXLI hipovitaminoza ambulanta na primarni ravni 1 CXLII infekcijske bolezni 11 ambulanta na primarni ravni 2 CXLIII, CXLIV bakterijske infekcije bolnišnica 5 CXLV, CXLVI, CXLVII, CXLVIII, CXLIX lekarna 2 CL, CLI zobozdravstvena ordinacija 1 CLII virusne infekcije bolnišnica 1 CLIII kardiovaskularne bolezni - splošno 12 kardiovaskularne bolezni - splošno ambulanta na primarni ravni 10 CLIV, CLV, CLVI, CLVII, CLVIII, CLIX, CLX, CLXI, CLXII, CLXIII lekarna 2 CLXIV, CLXV neoplazme 5 rak-preventiva lekarna 3 CLXVI, CLXVII, CLXVIII rak-slabost bolnišnica 1 CLXIX rak-zdravljenje specialistična ambulanta 1 CLXX polifarmakoterapija 27 ambulanta na primarni ravni 7 CLXXI, CLXXII, CLXXIII, CLXXIV, CLXXV, CLXXVI, CLXXVII ambulanta na primarni ravni in na domu 1 CLXX bolnišnica 5 CLXXIX, CLXXX, CLXXXI, CLXXXII, CLXXXIII polifarmakoterapija DSO 2 CLXXXIV, CLXXXV lekarna 10 CLXXXVI, CLXXXVII, CLXXXVIII, CLXXXIX, CXC, CXCI, CXCII, CXCIII, CXCIV, CXCV lekarna in na domu 1 CXCVI specialistična ambulanta 1 CXCVII več terapevtskih področij 56 ambulanta na primarni ravni 16 CXCVIII, CXCIX, CC, CCI, CCII, CCIII, CCIV, CCV, CCVI, CCVII, CCVIII, CCIX, CCX, CCXI, CCXII, CCXIII več terapevtskih področij bolnišnica 21 CCXIV, CCXV, CCXVI, CCXVII, CCXVIII, CCXIX, CCXX, CCXXI, CCXXII, CCXXIII, CCXXIV, CCXXV, CCXXVI, CCXXVII, CCXXVIII, CCXXIX, CCXXX, CCXXXI, CCXXXII, CCXXXIII, CCXXX, CCXXXIV bolnišnica in na domu 4 CCXXXV, CCXXXVI, CCXXXVII, CCXXXXVIII DSO 2 CCXXXIX, CCXL lekarna 7 CCXLI, CCXLII, CCXLIII, CCXLIV, CCXLV, CCXLVI, CCXLVII na domu 3 CCXLVIII, CCXLIX, CCL specialistična ambulanta 3 CCLI, CCLII, CCLIII Skupaj 253 Preglednica 1: Pregled metaanaliz raziskav, ki so vrednotile koristi klinične farmacije oz. farmacevtske skrbi. Table 1: Review of metaanalises that evaluated benefits of clinical pharmacy and pharmaceutical care. Prvi avtor in leto publikacije Namen Storitev Ključni izidi Santschi 2011 (7) Določiti vpliv farmacevtske skrbi na dejavnike tveganja za razvoj kardiovaskularnih bolezni. Izobraževanje bolnikov o boleznih, zdravilih in namenu zdravljenja, priprava opomnikov za bolnike, ovrednotenje kardiovaskularnih dejavnikov tveganja, priprava priporočil za zdravnike glede optimizacije terapije. KT (19 raziskav): -8,1/-3,8 mm Hg, S. Celokupni holesterol (9 raziskav): -17,4 mg/L, S. LDL-H (7 raziskav): -13,4 mg/L, S. Kajenje (2 raziskavi): zmanjšanje, S. Ryan R 2011 (8) Združiti podatke sistematičnih preglednih člankov o učinkovitosti intervencij, katerih namen je bil izboljšati uporabo zdravil. Izobraževanje bolnikov o njihovih zdravilih in namenu zdravljenja ter o pomembnosti jemanja zdravil skladno z navodili, pogovor z bolniki o morebitnih težavah, pregled zdravil in reševanje težav povezanih z zdravili. Intervencije so v večji ali manjši meri pozitivno vplivale na zdravstvene izide (npr. poenostavljeno odmerjanje in intervencije, ki so neposredno vključevale farmacevta), nekatere so bile večinoma neučinkovite (npr. samo izobraževanje). Nobena od intervencij ni imela pozitivnega vpliv na vseh področjih. Morgado MP 2011 (9) Vpliv farmacevtske intervencije na kontrolo krvnega tlaka in vodljivost bolnikov, ki so na antihipertenzivni terapiji. Predlogi glede optimizacije terapije posredovani zdravniku, izobraževanje bolnikov o boleznih, zdravilih in namenu zdravljenja, redno spremljanje KT, priprava opomnikov za bolnike, izobraževanje in opozarjanje zdravstvenih delavcev na morebitne napake. Izidi zdravljenja: signifikantno izboljšanje 87,5 % rezultatov. Vodljivost bolnikov: signifikantno izboljšanje (43,8 % rezultatov). SKT: -4,9 mm Hg, p<0,001. DKT: -2,6 mm Hg, p<0,001. Rubio-Valera M 2011 (10) Ovrednotiti učinkovitost farmacevtske skrbi na izboljšanje vodljivosti bolnikov, ki so na terapiji z antidepresivi. Izobraževanje in spremljanje bolnikov, identifikacija neželenih učinkov, svetovanje o pomembnosti jemanja zdravil skladno z navodili, optimizacija terapije. Vodljivost bolnikov: OR=1,639, p<0,001. Nkansah N 2010 (11) Oceniti vpliv farmacevtskih storitev na izide pri bolnikih in zdravstvenih delavcih. Izobraževanje bolnikov, reševanje težav povezanih z zdravili, priprava priporočil zdravnikom, izobraževanje zdravnikov. Farmacevtske intervencije namenjene: a) bolnikom: 36 raziskav; b) zdravnikom: 7 raziskav. 1) 1 raziskava: izboljšanje KT. 2) 5 raziskav: storitve farmacevtov so zmanjšale pogostost podvajanja zdravil in celotno število predpisanih zdravil; 29 raziskav: poročanje o kliničnih in humanističnih izidih; rezultat farmacevtske intervencije je bilo izboljšanje kliničnih izidov, te izboljšave pa niso bile vedno signifikantne; 8 raziskav: poročanje o kvaliteti življenja, 3 raziskave so poročale o izboljšanju na vsaj treh področjih. 3) raziskav ni. 4) 2 od 7 raziskav kažeta signifikantno izboljšanje pri predpisovanju zdravil. Carter BL 2009 (12) Določiti učinek intervencij pri kontroli hipertenzije, če pri tem sodeluje zdravstveni tim, ki vključuje tudi farmacevte in medicinske sestre. Izobraževanje bolnikov o zdravilih, svetovanje o načinu življenja, obiski na domu, optimizacija terapije (priporočila zdravnikom). Vpliv izobraževanja o zdravilih: KT: -8,5/-3,60 mm Hg. Vpliv priporočil farmacevtov glede terapije: SKT: -9,30 mm Hg. Intervencije so izvajale medicinske sestre: SKT: -5,84 mm Hg; farmacevti v bolnišnicah: -7,76 mm Hg; farmacevti v lekarnah: -9,31 mm Hg. Machado M 2008 (13) Določiti vpliv farmacevtskih intervencij na izboljšanje kliničnih izidov pri zdravljenju hiperlipidemije. Izobraževanje in spremljanje bolnikov, upravljanje z zdravili. Celokupni holesterol se je signifikantno zmanjšal: v primerjavi z začetno vrednostjo: -34,3 mg/dL, p<0,001; v primerjavi s KS: -22,0 mg/dL, p=0,034). LDL-H se je signifikantno zmanjšal: v primerjavi z začetno vrednostjo: -32,6 mg/dL, p=0,004; v primerjavi s KS: -17,5 mg/dL, NS. TG: NS zmanjšanje. HDL-H: NS spremembe. Možen je vpliv na vodljivost bolnikov ter na kvaliteto življenja. Prvi avtor in leto publikacije Namen Storitev Ključni izidi Williams A 2008 (14) Pregled raziskav, ki vključujejo intervencije, ki naj bi izboljšale vodljivost bolnikov pri sočasni terapiji več kroničnih bolezni. Izobraževanje bolnikov o bolezni, zdravilih in namenu zdravljenja. Identifikacija in reševanje težav povezanih z zdravili. Dokazi za učinkovitost intervencij, s katerimi bi izboljšali vodljivost bolnikov z več kroničnimi boleznimi, so slabi. Tonna AP 2008 (15) Določiti, kakšna je vloga farmacevtov v zdravstvenem timu pri optimizaciji antibiotične terapije ter opisati klinične izide takšnih intervencij. Identifikacija neprimerno predpisanih zdravil, priprava priporočil glede zamenjave zdravil ali sprememb načina aplikacije, razvoj smernic, prisotnost na vizitah, racionalizacija protimikrobnih zdravil. Uporaba zdravil: izboljšano upoštevanje smernic; klinični izidi: krajši čas bivanja v bolnišnicah, zmanjšana potreba po parenteralni FO, nižja umrljivost; finančni izidi: manjša poraba antibiotikov, uporaba cenejših bioekvivalentnih zdravil in posledično manjši stroški. Spremembe niso vse signifikantne. Machado M 2007 (16) Opredeliti in kvantificirati klinične izide, občutljive na farmacevtsko intervencijo. Najbolj pogosto uporabljeni intervenciji sta bili upravljanje z zdravili (82%) in izobraževanje bolnikov na področju hipertenzije (68%). 39 rezultatov (57 % vseh ovrednotenih rezultatov) je potrdilo vpliv farmacevtske intervencije. V 13 raziskavah: SKT: -10,7 mm Hg (IS), -3,2 mm Hg (KS), p=0,047. DKT: razlika med IS in KS: 3,6 mm Hg, NS. Kvaliteta življenja: signifikantna razlika v 1/8 raziskavi. Vodljivost bolnikov: signifikantna razlika v 5/13 raziskav. Machado M 2007 (17) Opredeliti in kvantificirati klinične izide, občutljive na farmacevtsko intervencijo. Najbolj pogosto uporabljeni intervenciji sta bili izobraževanje bolnikov na področju diabetesa (69%) in upravljanje z zdravili (61 %). 51 rezultatov (69 % vseh ovrednotenih rezultatov) je potrdilo vpliv farmacevtske intervencije. V 16 raziskavah: HbA1c: -1,00 % (IS), -0,28 % (KS), p=0,03. Royal S 2006 (18) Identificirati in oceniti raziskave intervencij, ki bi zmanjšale neželene učinke zdravil, ki se izražajo v obolevnosti, hospitalizacijah in umrljivosti. Farmacevtske intervencije (pregled zdravil) in intervencije drugih zdravstvenih delavcev (uporaba protokolov s strani medicinskih sester in izobraževalni programi za zdravnike). 17 raziskav je obravnavalo farmacevtske intervencije. Intervencije, ki jih je vodi farmacevt, zmanjšajo število hospitalizacij (0R=0,64), vendar analize randomiziranih kliničnih raziskav niso pokazale signifikantnih izboljšav. Rezultati na ostalih področjih niso pokazali signifikantnega učinka. Morrison A 2001 (19) Ovrednotenje raziskav, ki obravnavajo učinkovitost storitev klinične farmacije. Izobraževanje in oskrba bolnikov, svetovanje zdravnikom. Farmacevti so delovali kot klinični farmacevti v 24 raziskavah in kot lekarniški farmacevti v 2 raziskavah. Svetovanje bolnikom: statistično signifikantno boljša vodljivost bolnikov (5/6 raziskav). Svetovanje bolnikom in njihovim zdravnikom: rezultati signifikantno boljši v IS (6/7 raziskav). Svetovanje zdravnikom: v IS višji delež receptov, predpisanih v skladu s smernicami (1/2 raziskava). 4 raziskave niso dale dokončnih rezultatov. IS- intervencijske skupina, KS: kontrolna skupina, KT - krvni tlak, SKT - sistolični krvni tlak, DKT - diastolični krvni tlak, LDL-H - LDL-holesterol, HDL-H - HDL-holesterol, TG - trigliceridi, HbA1 c - glikiran hemoglobin, FO - farmacevtska oblika, NS - razlika ni signifikantna, S - razlika je signifikantna, OR - razmerje obetov. 5 Razprava Začetki klinične farmacije segajo v sredino šestdesetih let 20. stoletja, ko so farmacevti začeli svojo strokovnost izpopolnjevati in usmerjati v nove ter k pacientu usmerjene storitve (6). Pojav raziskav v večji meri sovpada z uveljavljanjem koncepta farmacevtske skrbi in sicer v 90. letih. V našem primeru najstarejša raziskava sega v leto 1976. Njihovo število je zelo naraslo predvsem po letu 1999 in znaša dobrih 20 raziskav na letni ravni po letu 2009. Največ raziskav so izvedli v ZDA, kjer lahko zasledimo tudi prve raziskave, tej sledita Kanada in Avstralija. V evropskih državah so se prve raziskave pojavile v zadnjih letih 20. stoletja in sicer v Združenem kraljestvu in na Švedskem. 5.1 Mesto izvajanja intervencije Največ raziskav je obravnavalo intervencije, ki so jih farmacevti izvajali v ambulantah na primarni ravni. Ena od prednosti dela na tem mestu je gotovo ta, da omogoča večjo stopnjo interakcije in sodelovanja farmacevta z zdravnikom in s tem t.i. brezšivno oskrbo. Namenska zaposlitev farmacevta na tem mestu obenem omogoča, da se v večji meri posveti optimizaciji in racionalizaciji zdravljenja z zdravili s tem, ko je razbremenjen aktivnosti vezanih na preskrbo z zdravili. Raziskavam storitev farmacevta v ambulanti na primarni ravni sledijo raziskave storitev v lekarni. Ta predstavlja mesto, ki je neposredno vpeto v verigo preskrbe z zdravili. Zelo pogosto se nahaja blizu zdravstvenega doma oz. ambulante na primarni ravni. Lekarna pomeni tudi tim osebja, katerih strokovnost so zdravila in s tem najboljše možno izhodišče za ustrezno svetovanje o zdravilih. Zaradi svoje dostopnosti (običajno brez posebne najave in čakalnih list) so farmacevti v lekarni zelo pogosto tudi prvi zdravstveni delavci, kamor bolniki pridejo po nasvet v primeru novih zdravstvenih težav. Velik del raziskav je obravnavalo tudi intervencije, ki so jih farmacevti izvajali v bolnišnicah in specialističnih ambulantah. Največja prednost dela na tem področju je vključevanje farmacevta v multidisciplinarne zdravstvene time, ki skrbijo za celovito zdravstveno oskrbo bolnikov. Nekaj raziskav je obravnavalo tudi storitve, ki so jih farmacevti izvajali v domovih starejših občanov. Ker gre v tem primeru za posebej ranljivo populacijo starejših bolnikov, ki se običajno zdravijo za več kroničnimi boleznimi, lahko farmacevti s svojim strokovnim znanjem s področja zdravil pripomorejo k odkrivanju in reševanju težav povezanih z zdravili. Posebej velja omeniti raziskave, ki so vrednotile storitve v kombinaciji lokacij npr. domače oskrbe z oskrbo v lekarni, ambulanti oz. bolnišnici. Takšen način dela seveda nudi najboljše iz posameznih inštitucij, obenem pa se v največji možni meri približa bolnikovemu običajnemu življenju s tem, ko se izvaja oskrba na njegovem domu. 5.2 Terapevtska področja in vpliv na zdravstvene izide Raziskave so vrednotile storitve farmacevtov, ki so obravnavale zelo različna terapevtska področja. Pri tem velja izpostaviti raziskave koristi storitev za bolnike s hipertenzijo, astmo, diabetesom, hiperlipidemijo, srčnim popuščanjem, bakterijsko infekcijo in depresijo. Poseben pomen imajo raziskave na področju polifarmakoterapije. Te so vrednotile storitve, katerih namen je reševanje težav povezanih z zdravili, ki so posledica sočasne uporabe več zdravil hkrati. Storitve so najpogosteje vključevale izobraževanje bolnikov o bolezni, zdravilih in pomenu zdravljenja ter sodelovanje z zdravnikom pri predpisovanju zdravil in optimizaciji terapije. Izobraževanje bolnikov je izboljšalo njihovo vodljivost in posledično klinične izide zdravljenja. Farmacevti so s svojimi aktivnostmi bistveno zmanjšali dejavnike tveganja za razvoj kardiovaskularnih bolezni: izboljšala se je kontrola hipertenzije ter zmanjšala raven glikiranega hemoglobina in lipidov v krvi. Izobraževanje bolnikov je izboljšalo tudi tehniko inhaliranja pri bolnikih z astmo in s tem izboljšalo kontrolo astme. Farmacevt je kot strokovnjak s področja zdravil imel pomembno vlogo pri odkrivanju, reševanju in preprečevanju težav povezanih z zdravili, storitve klinične farmacije in farmacevtske skrbi pa so njihovo število zmanjšale. Posledično so se izboljšali klinični izidi ter zmanjšala uporaba zdravstvenih storitev (npr. zmanjšanje števila hospitalizacij in obiskov urgentnega oddelka). Rezultati raziskav nakazujejo pozitiven vpliv farmacevtskih storitev na kakovost življenja bolnikov ter zadovoljstvo bolnikov z zdravstvenimi storitvami. Izobraževanje zdravnikov o predpisovanju zdravil v skladu s smernicami, svetovanje pri izbiri zdravila ter priporočila glede optimizacije terapije so vodila do ustreznejšega predpisovanja zdravil, možen pa je bil tudi vpliv na zmanjšanje števila predpisanih zdravil. Pri tem je bil zelo pomemben oseben stik oz. komunikacija med farmacevtom in zdravnikom. Storitve opisane v raziskavah so imele pozitiven vpliv na ekonomske izide v bolnišnicah, medtem, ko je raven dokazov o finančnih koristih na drugih mestih izvajanja storitev skromna. 5.3 Metaanalize Rezultati metaanaliz, ki smo jih vključili v sistematičen pregled, nam kažejo, da storitve klinične farmacije in farmacevtske skrbi izboljšajo klinične izide na področju hipertenzije, hiperlipidemije in diabetesa ter na ta način zmanjšajo tveganje za razvoj kardiovaskularnih bolezni. Storitve farmacevtov, ki so vplivale na takšne izide, so bile usmerjene tako na bolnike kot tudi na zdravnike. Farmacevti so bolnike izobraževali o boleznih, zdravilih in pomenu zdravljenja, zdravnikom pa so predvsem posredovali priporočila glede optimizacije terapije. 5 področja vodljivosti bolnikov metaanalize ne dajejo povsem konsistentnih rezultatov. Pozitiven vpliv na vodljivost bolnikov je metaanaliza potrdila na področju zdravljenja depresije, medtem ko ostale metaanalize kažejo na možnost pozitivnega vpliva, ne morejo pa ga z gotovostjo potrditi. Izboljšanje kvalitete življenja in stroškovne učinkovitosti, zmanjšanje števila hospitalizacij ter ustreznejše predpisovanje zdravil je glede na ugotovitve metaanaliz možno, niso pa ti rezultati tako jasni kot v primeru vpliva farmacevtskih storitev na kontrolo krvnega tlaka ter glukoze in lipidov v krvi. 5.4 Pomanjkljivosti pregleda Čeprav smo sistematični pregled skrbno načrtovali, postavljeni iskalni profil ni zajel vseh raziskav, ki so vrednotile storitve klinične farmacije in farmacevtske skrbi. Nekatere raziskave namreč ne omenjajo neposredno klinične farmacije oz. farmacevtske skrbi in so opisovale oz. pojmovale storitve na drugačen način. 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