Ovrednotenje implementacije in koristi farmacevtskih kognitivnih storitev, osnovanih na pregledu zdravil v Sloveniji

doktorska disertacija

Urška Nabergoj Makovec (Avtor), Mitja Kos (Mentor)

Povzetek

Razvoj zdravstvene dejavnosti, ki v središče delovanja postavlja pacienta, je prinesel tudi spremembe in razvoj vloge farmacevta pri zdravljenju z zdravili. Storitve, osnovane na pregledu zdravil (ang. medication review, MR), v zadnjih desetletjih predstavljajo osrednjo vlogo farmacevta pri zdravljenju z zdravili in skrbi za pacienta. V mednarodnem prostoru zasledimo različno oblikovane storitve MR na vseh ravneh zdravstvene dejavnosti, ki pozitivno vplivajo na sodelovanje pacientov pri zdravljenju z zdravili, identifikacijo in reševanje težav, povezanih z zdravili (DRP), ter prispevajo k zniževanju stroškov. Obenem pa, tudi zaradi velike heterogenosti v storitvah in pomanjkljivem opisu le-teh, še ni jasnih dokazov o vplivu na število zapletov, hospitalizacij in smrtnost. V Sloveniji lahko zasledimo številne aktivnosti z elementi MR, ki se izvajajo na različnih ravneh zdravstvene dejavnosti. V Zakonu o lekarniški dejavnosti (ZLD 2016) imamo definirani dve storitvi, osnovani na pregledu zdravil, in sicer pregled uporabe zdravil (PUZ) ter farmakoterapijski pregled (FTP). PUZ se osredotoča na pacienta in njegovo uporabo zdravil in se je razvil na podlagi znanja in izkušenj iz programov farmacevtske skrbi. Razvoj FTP, ki predstavlja celovit pregled pacientovih zdravil z namenom njihove optimizacije, pa se je začel v bolnišnicah, leta 2012 pa še na primarni ravni zdravstvenega sistema v okviru pilotnega projekta na pobudo Zavoda za zdravstveno zavarovanje Slovenije (ZZZS). Od leta 2016 je storitev FTP tudi sistemsko umeščena in financirana s strani ZZZS za izvajanje na primarni ravni zdravstvenega sistema. Obenem sta se obe storitvi razvijali in dokončno standardizirali v skupnem konceptu pod okriljem Lekarniške zbornice Slovenije (LZS). Namen doktorske disertacije je bil ovrednotiti implementacijo in koristi farmacevtskih kognitivnih storitev, osnovanih na pregledu zdravil v Sloveniji. V prvem delu naloge smo se osredotočili na opis farmacevtskih kognitivnih storitev v mednarodnem prostoru, s poudarkom na storitvah MR. V drugem delu pa smo vrednotili implementacijo in koristi obeh storitev MR, prisotnih v slovenskem zdravstvenem sistemu. Opise farmacevtskih kognitivnih storitev, posebno storitev MR, smo najprej ovrednotili s krovnim pregledom literature v dveh bibliografskih bazah. Vključili smo 60 različnih sistematičnih pregledov (SP) in 4 krovne preglede, katerih namen je bil opredeliti, kako kakovostno so bili SP narejeni. SP, vključeni v 4 krovne preglede, so bili večinoma srednje kakovosti, saj tretjina teh ni opredelila kakovosti raziskav pred vključitvijo, poleg tega so bili opisi populacij, intervencij in izidov pomanjkljivi. Zaradi velike heterogenosti pogosto ni bilo mogoče izvesti meta analize (MA). Storitve MR na primarnem nivoju sicer pozitivno vplivajo na uravnavanje nivoja glikiranega hemoglobina, krvnega tlaka, holesterola in drugih dejavnikov tveganja za srčno-žilne zaplete ter omogočajo prepoznavanje DRP. Heterogenost otežuje jasne zaključke o vplivu na humanistične in ekonomske izide. Med kliničnimi izidi ni vpliva na smrtnost, potencialni vpliv na število hospitalizacij pa ima klinični pregled zdravil (tip 3). Rotta in sodelavci so v okviru krovnega pregleda preučili 273 primarnih raziskav in na podlagi identificiranih elementov razvili orodje DEPICT, ki bi lahko pripomoglo k bolj standardiziranemu poročanju elementov storitev in lažjemu kvantificiranju izidov. Nadalje smo v mednarodni presečni raziskavi PRACTISE z uporabo spletnega vprašalnika opredelili dostop, raven implementacije in načine financiranja (remuneracija) farmacevtskih kognitivnih storitev v Evropi, s poudarkom na storitvah MR na primarnem nivoju zdravstvene dejavnosti. V večini sodelujočih držav (n = 34) najdemo osnovne storitve, kot so podajanje informacij o zdravilih, generična zamenjava itd. Nivo implementacije storitev sicer močno variira, polovica držav pa je poročala, da je najpogostejši model financiranja »fee-for-service«. Med naprednimi storitvami se v 55,9 % držav izvaja vsaj ena storitev MR, v sedmih državah imajo le-te tudi visoko raven implementacije. V zunanjih lekarnah se najpogosteje izvajata tip 1 (n = 13) in tip 2a (n = 14), tip 3 pa se izvaja v šestih državah, med njimi v dveh v okviru zdravstvenih domov, saj storitev zahteva dostop do celotne medicinske dokumentacije pacienta. Večina storitev MR tipa 2 in 3 ima sicer postavljene vključitvene kriterije, vendar so ti precej ohlapni (npr. starejši od 65 let). Pri vseh tipih storitev so končne klinične odločitve v rokah zdravnikov. Implementacijo storitve PUZ v slovensko lekarniško prakso smo preverjali v dveh ločenih raziskavah. Najprej smo v fokusni skupini s 7 farmacevti razpravljali, kakšne so izkušnje prvih izvajalcev storitve pri pridobivanju kompetenc in umeščanju storitve v prakso. Po njihovem mnenju so magistri farmacije najbolj kompetentni zdravstveni delavci za izvajanje storitve, ki se osredotoča na izboljšanje pacientovega sodelovanja in razumevanja zdravljenja z zdravili. Prepoznavnost storitve med različnimi deležniki (pacienti, sodelavci in vodstvom, zdravniki ter plačniki) je nizka, zato je bila prepoznana potreba po celostnem pristopu k trženju storitve. Kljub temu da so pacienti po PUZ izražali zadovoljstvo in izkazovali večjo samozavest pri zdravljenju z zdravili, je prav pridobitev in vključitev pacienta predstavljala največji izziv. Velik izziv pa z vidika upravljanja PUZ predstavlja ustrezna organizacija dela v lekarni, ki bi nudila več časa za izvajanje storitve. Koristi storitve PUZ smo ovrednotili v randomizirani kontrolirani raziskavi. Vključeni pacienti so bili randomizirani v kontrolno (K) ali testno (PUZ) skupino, ki je na prvem srečanju prejela PUZ. Po 12 tednih sta obe skupini prišli na ponovno ocenjevanje preiskovanih parametrov. Primarni izid raziskave je bil ovrednotenje sodelovanja z uporabo programske opreme ©Morisky Widget MMAS-8 Software. Uporabili smo generično različico vprašalnika, pri čemer so bili pacienti, glede na doseženo število točk (0–8), opredeljeni kot slabo (do < 6), srednje (od 6 do < 8) ali dobro (8) sodelujoči. Poleg celokupnega smo ovrednotili tudi namerno in nenamerno sodelovanje. Vpliv PUZ smo opredelili kot razliko med PUZ in K po 12 tednih in razvili multivariabilni linearni regresijski model, da smo ocenili učinek PUZ glede na izhodiščno kategorijo sodelovanja, in sicer smo primerjali slabo sodelujoče z združeno kategorijo srednje in dobro sodelujočih. Analizirali smo podatke 153 pacientov s srečanja 1 in 140 pacientov s srečanja 2. Na prvem srečanju je slabo, srednje in dobro sodelovalo 17,6 %, 48,4 % in 34,0 % pacientov. Učinkovitost PUZ se je pokazala pri slabo sodelujočih pacientih, ki so sodelovanje izboljšali za 1,20 točke (95 % CI = 0,16–2,25) v primerjavi s kontrolno skupino (p = 0,025). 0,84 točke je prispevalo izboljšanje namernega sodelovanja (95 % CI = 0,05–1,63; p = 0,038); 0,36 točke pa izboljšanje nenamernega (95 % CI = -0,23–0,95; p = 0,226). Poleg tega so farmacevti v testni skupini prepoznali visok delež dejanskih DRP (41-%), pri čemer sta bili dve tretjini povezani z varnostjo. PUZ je v testni skupini statistično značilno zmanjšal delež dejanskih težav (p = 0,001), delež pacientov z dejanskimi težavami (p < 0,001) ter ogroženost pacientov zaradi dejanskih DRP (p < 0,001). Poleg tega se je značilno zmanjšala zaskrbljenost pacientov glede dolgoročnega jemanja zdravil (p = 0,029). Storitev FTP smo ovrednotili v okviru opazovalne prospektivne raziskave v Zdravstvenem domu Ljubljana (ZD LJ). Namen raziskave je bil pridobiti pogled zdravnikov na implementacijo in koristi storitve FTP s kvalitativnim pristopom (intervjuji). V 38 intervjujih je sodelovalo 24 zdravnikov. Vsebinsko smo rezultate opredelili z Donabedianovim modelom kakovostne zdravstvene oskrbe: struktura, proces, izidi. Ključna farmacevtova kompetenca je poglobljeno in vedno aktualno znanje o zdravilih in farmakoterapiji, kar omogoča pogled na terapijo z druge perspektive. Poleg tega je bilo prepoznano, da pacienti kliničnemu farmacevtu bolj resnicoljubno poročajo o jemanju zdravil, kar je verjetno tudi posledica večje količine časa, ki ga ima klinični farmacevt na voljo za pogovor s pacientom. Ostala temelja strukture sta dober dostop do kliničnega farmacevta in komplementarnost dveh zdravstvenih strok. Med razlogi napotitve je prednjačila polifarmakoterapija, v večji meri zaradi pacientove želje, izražene zdravniku ali referenčni sestri, po manjšem številu zdravil. Razlogi ob napotitvi na zdravnikovo pobudo so bili navadno bolj specifični, npr. fiziološke funkcije. Glavni izziv v procesu FTP predstavljata pomanjkanje časa za prepoznavo primernih pacientov in dodatne obremenitve, ki jih prinaša implementacija ukrepov. Zdravniki se zavedajo, da je treba povečati število napotitev, pri čemer so predlagali na primer definiranje kriterijev za »avtomatske« napotitve, napotovanje pacientov s strani referenčnih sester ipd. Obenem so poudarili, da je FTP novost, ki potrebuje svoj čas, da se uveljavi. Priporočila kliničnega farmacevta so sprejeta v visoki meri (62 %), vendar čas izvedbe priporočil v praksi močno variira. Ko priporočilo zadeva zdravilo, ki je bilo predpisano s strani specialista, zdravniki posredujejo izvid FTP in odločitev o implementaciji priporočila prepustijo specialistom. Opolnomočenje pacienta pri uporabi zdravil je bilo navedeno kot glavna korist za paciente, kar posledično podpira in izboljšuje kakovost zdravstvene oskrbe pacienta s strani zdravnika. Poleg tega je narava številnih priporočil takšna, da so prenosljiva na podobne primere. Družinski zdravniki tako prepoznavajo številne koristi storitve, so z izvajanjem zadovoljni in menijo, da so zelo zadovoljni tudi pacienti. Z obstoječimi raziskavami smo potrdili, da so farmacevtske kognitivne storitve, posebno storitve MR, sicer zelo raznolike, vendar predstavljajo pomembno orodje za kakovostnejšo zdravstveno oskrbo pacientov. Za visokokakovostne dokaze o vplivu storitev na zdravstvene izide potrebujemo kakovostno izvedene raziskave s tarčnimi populacijami pacientov in izidov, ki bodo jasno opisovale potek in elemente intervencij. Z uporabo obstoječih orodij in smernic (npr. DEPICT) je treba še bolj prispevati k že opaznemu trendu kakovostnejšega poročanja. Umeščenost dveh storitev MR uvršča Slovenijo med uspešnejše evropske države na tem področju, vendar je treba izboljšati raven njune implementacije in zagotoviti ustrezne finančne spodbude, predvsem v primeru storitve PUZ. Potrebna je jasnejša opredelitev, katere težave je smiselno naslavljati v okviru posamezne storitve, in na tej podlagi oblikovati ustrezne kazalnike kakovosti, ki bodo omogočali dolgoročno spremljanje učinkovitosti storitev MR tako v Sloveniji kot tudi v mednarodnem prostoru.

Ključne besede

bolnišnice;vloga farmacevtov;zdravljenje z zdravili;farmacevtske kognitivne storitve;uporaba zdravil;meta analiza;kontrolirane preiskave;

Podatki

Jezik:	Slovenski jezik
Leto izida:	2020
Tipologija:	2.08 - Doktorska disertacija
Organizacija:	UL FFA - Fakulteta za farmacijo
Založnik:	[U. Nabergoj Makovec]
UDK:	615.15(047.31)(043.3)
COBISS:	25927427
Št. ogledov:	131
Št. prenosov:	0
Ocena:	0 (0 glasov)
Metapodatki:

Ostali podatki

Sekundarni jezik:	Angleški jezik
Sekundarni naslov:	Assessment of implementation and benefits of pharmaceutical cognitive services based on medication review in Slovenia
Sekundarni povzetek:	Developments in patient-oriented healthcare brought changes to the role of the pharmacist in medication treatment. In the last decade, pharmacist-led medication review (MR) services, represent one of the key elements in medication management and patient-centred care. Different MR services on different levels of healthcare are present, with positive impact on adherence, identification of drug-related problems (DRPs) and decreased costs are observed. On the other hand, due to high heterogeneity in services and superficial description of its elements, the evidence regarding health complications, hospitalisation and mortality is inconclusive. Several MR activities are present at different levels of the Slovenian healthcare system. Two services are defined in the Pharmacy Act (2016) – Medicines Use Review service (MUR) and Clinical Medication Review service (CMR). MUR focuses on adherence and proper medicines use, and harmonised previous experiences from pharmaceutical care programmes. CMR is the most comprehensive review with the aim to optimise individual patient’s medicines. Under the initiative of the Health Insurance Institute of Slovenia (HIS), the CMR started as a pilot project in 2012, and was officially implemented as a regular, reimbursed service in primary care in 2016. Concurrently, both services were developed and standardised under the same concept within Slovene Chamber of Pharmacies. The aim of this doctoral thesis was to evaluate the implementation and benefits of MR services in Slovenia. Firstly, we focused on the description of the pharmaceutical cognitive services in international literature, especially MR services. Secondly, we evaluated implementation and benefits of both services performed in Slovenian healthcare. An umbrella review was performed in two bibliographic databases, to analyse descriptions of MR services in international literature. We included 60 systematic reviews and four umbrella reviews which also aimed to assess how well the included systematic reviews were performed. Overall, the systematic reviews (included in the 4 umbrella reviews) were of medium quality, as one third of systematic reviews haven't assessed the quality of primary studies and the description of population, interventions and outcomes was deficient. High heterogeneity was the main reason why meta-analysis was not performed. MR service in primary healthcare positively impacts the levels of glycated haemoglobin, blood pressure, cholesterol and other cardiovascular risk factors as well as enabling identification of DRPs. There is high variation in evidence regarding MR impact on humanistic and economic outcomes. MR does not impact mortality rates, while CMR has a potential to affect hospitalisation rates. After performing an umbrella review, Rotta et al., extracted and evaluated the 273 primary studies for elements of the services. Based on the identified elements they developed the DEPICT toll - a tool to standardise the reporting of pharmaceutical cognitive services and facilitate quantification of outcomes. A cross-sectional study, PRACTISE, was conducted using an online survey to gather data regarding availability, the rate of implementation and the existence of remuneration of pharmacist-led cognitive services in Europe, with a special focus on MR services in primary care. Provision of medicines’ information (94.1%), generic substitution (85.3%), etc are the core services reported as the most widely disseminated. There is wide variation in the implementation level of services, and half of the participating countries mentioned models of remuneration predominantly based on a fee-for-service. MR was the most disseminated among advanced services, with at least one type of MR present in 55.9% countries, and seven countries reporting high implementation levels. Type 1 (n=13) and 2a (n=14) MR services seem to be more feasible to implement in the community pharmacy than type 3 (n=6). In two countries type 3 is performed at the general practitioners (GP) clinics to assure access to clinical data as the essential element of MR type 3. Inclusion criteria are set in the majority of reported type 2 and 3 MR services, however the criteria are very broad (e.g. patients over 65 years). Physicians are the key stakeholders when it comes to clinical decision making in all types of MR services. Implementation of MUR in Slovenian pharmacy practice was evaluated in two separate studies. Firstly, a focus group with 7 pharmacists was performed to gain an in-depth understanding of initial providers experiences with the MUR educational programme to ensure competency for service provision and implementation of MUR into daily practice. Pharmacists’ broad knowledge in pharmacotherapy was emphasised as the basis of quality provision and main advantage in performing MUR in comparison with other healthcare professions. Recognisability of MUR among different stakeholders (patients, co-workers and pharmacy management, physicians, payer) should be improved with a comprehensive approach in marketing of the service. Positive patient feedback was reported, however persuading them to attend MUR presented a challenge. Better management of the service, especially in terms of work organization, would facilitate MUR provision. Secondly, a randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the control or test group, where patients received MUR at visit 1. After 12 weeks all investigated parameters were re-assessed. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software. The questionnaire was adapted for generic use across all prescription medications for regular use. Patients’ scores were classified as follows: < 6 indicates low adherence, 6 to <8 indicates medium adherence, and = 8 indicates high adherence. Furthermore, two aspects of adherence were analysed separately: intentional and unintentional non-adherence. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, medium and high in 17.6%, 48.4% and 34.0% patients respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI=0.16-2.25) increase in total ©MMAS-8 score (p=0.025) compared to control group patients. A 0.84 point (95% CI = 0.05-1.63) increase was due to intentional non-adherence (p=0.038), and a 0.36 point (95% CI = -0.23-0.95) was due to unintentional non-adherence (p=0.226). In addition, high share (41%) of manifested DRPs were recognized in the test group, among them two thirds related to safety. Statistically significant decreases in the proportion of manifested DRPs (p=0.001), patients with manifested DRPs (p<0.001), and risk due to manifested DRP (p<0.001) were shown. Moreover, patients were less concerned regarding chronic medicines use (p=0.029). A prospective observational study was conducted in Community Health Centre Ljubljana to assess the implementation of the Clinical Medication Review (CMR). A qualitative approach (interviews) was used to gain an in-depth insight into implementation and benefits of the service from the perspective of GPs. Thirty-eight interviews were performed with 24 different GPs. The emerging themes were nested under three main domains representing Donabedian model of quality healthcare – structure, process, outcomes. The service structure is built on broad and current pharmacotherapy knowledge as the main clinical pharmacist (CP) competency, which enables the fresh perspective on patient’s medication. It was recognised that patients are more truthful with the CP regarding medicines as the CP has the advantage of more time for the conversation. Good accessibility of the CP and complementarity of two healthcare professions were also reported as pillars of the service structure. Patients are mainly referred to the CMR due to polypharmacotherapy, especially when patients expressed their wish to the GP or nurse to decrease the number of medicines. When the initiative for referral is given by the GP, the reasons are usually more specific, e.g. physiological functions. Lack of time to recognise eligible patients and additional workload to study and implement the recommendations, were identified as major challenges in the service process. GPs recognised the need to improve the low number of referrals and suggested to redefine and narrow inclusion criteria, to include nurses in the referral process etc. It was emphasised that CMR is a new service and some time is needed for it to become routine. The majority of CPs recommendations are accepted (62%), although the implementation time varies. When a recommendation addresses medicines prescribed by a clinical specialist, the CMR report is forwarded to them for decision regarding implementation of recommendation. Participating GPs emphasised the empowerment of the patients in medicines use as the major benefit of the CMR, which consequently supports and enhances the quality of GP’s patient care. In addition, transferability of recommendations to similar cases was mentioned. Overall, GPs recognise several benefits of the CMR service and report high levels of satisfaction of GPs and patients, with the service. In conclusion, pharmaceutical cognitive services, especially MR services, represent an important tool for quality patient healthcare despite the acknowledged high heterogeneity. High quality of evidence regarding MR impact on health outcomes can be gathered by planning and performing high quality studies with the target population and core outcomes sets with a clearly described process and elements of interventions. Further improvements in the quality of reporting by using existing guidelines and tools (e.g. DEPICT) is needed to continue the already noticed trend in the international literature. With two MR services provided in practice, Slovenia is among the more successful European countries. Nevertheless, challenges such as the increase of implementation levels and assuring reimbursement in the case of MUR service need to be overcome. The future of both services should encompass a consensus as to which types of DRPs should be addressed. Furthermore, quality indicators, to assure long-term quality and sustainability of the services, should be developed for national as well as international use.
Sekundarne ključne besede:	Farmacevti;Raziskovalne naloge;
Vrsta dela (COBISS):	Doktorska disertacija
Komentar na gradivo:	Univ. v Ljubljani, Fak. za farmacijo
Strani:	232 str.
ID:	15504135