Načela izrade ISKRA hrvatskih nacionalnih smjernica. Arjana Tambić Andrašević Klinika za infektivne bolesti Dr. Fran Mihaljević
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1 Načela izrade ISKRA hrvatskih nacionalnih smjernica Arjana Tambić Andrašević Klinika za infektivne bolesti Dr. Fran Mihaljević
2 Sadržaj Problem otpornosti bakterija na antibiotike ISKRA MATRA projekt AGREE Instrument
3 It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionaly happened in the body... Moral: If you use penicillin, use enough Fleming A. Penicillin. Nobel lecture. December 11, 1945
4 Antibiotic therapy: use it and lose it
5 Moderna medicina nije održiva bez učinkovitih antibiotika Hip replacement Organ transplants Cancer chemotherapy Intensive care Care of preterm babies
6 Kako zaustaviti rezistenciju na antibiotike? Razumna uporaba antibiotika (samo kad su potrebni, točna doza i duljina primjene) Razvoj novih antibiotika Kontrola infekcija (higijena ruku, traženje kliconoša, izolacija) 6
7 Outpatient antibiotic use in 25 European countries in 2003* Greece France Luxembourg Portugal Slovakia Italy Belgium Croatia Poland Spain Ireland Iceland Israel Finland Slovenia Hungary Czech Rep. Norway UK Sweden Germany Denmark Austria Estonia Netherlands Others Sulfonamides (J01E) Tetracyclines (J01A) Quinolones (J01M) Macrolides (J01F) Cephalosporins (J01D) Penicillins (J01C) * For Iceland total data are use; for Poland 2002 data are used DDD / 1000 inabitants / day
8 Seasonal variation of outpatient antibiotic use in 11 European countries with quarterly data for Greece DDD / 1000 inhabitants / day Portugal Belgium Ireland Finland Iceland Slovenia UK Sweden Denmark Netherlands
9 Seasonal variation of outpatient antibiotic use in 10 European countries not able to deliver quarterly data for , but at least for one year in this period 35 Slovakia DDD / 1000 inhabitants / day Italy Poland Croatia Spain Hungary Czech Rep. Austria 5 Estonia Germany
10 MRSA in 2007
11 Burden of multidrug resistant (MDR) bacteria in the EU, Iceland and Norway Human burden Infections (6 most frequent MDR bacteria, 4 main types of infection) approx. 400,000 / year Attributable deaths approx. 25,000 / year Extra hospital days approx. 2.5 million / year Economic burden WHO / GENEVA Nearly 5,000 people have reportedly died from swine flu since it emerged this year and developed into a global epidemic Extra in hospital costs Productivity losses approx. 900 million / year approx. 600 million / year Limitation: these are underestimates. Source: ECDC, In: ECDC/EMEA Joint Technical Report, 2009.
12 Matra Project MAT 05/hr/9/2 Strengthening Surveillance of Antimicrobial Resistance in Croatia The Netherlands Ministry of Foreign Affairs contributes to the accession of Croatia to the European Union through the Matra Pre-Accession Programme (MPAP) Aim of the project is to assist Croatia in implementing EUdirectives and recommendations in the field of antimicrobial resistance containment International consultants available for assistance in achieving: 1. An Intersectoral Co-ordination mechanism (ICM) in the field of antimicrobial resistance established and functional 2. Surveillance systems for antibiotic resistance and consumption established, functional and analysed through a coordinated action 3. Guidelines for prudent use of antibiotics formulated and implemented
13 Intersectoral Co-ordination mechanism (ICM) Interdisciplinarna sekcija za kontrolu rezistencije na antibiotike (ISKRA) Zadaci: Poticanje aktivnosti vezanih za sljedeće: Praćenje otpornosti na antibiotike i potrošnje antibioitika Edukacija i smjernice o racionalnoj uporabi antibiotika Kontrola infekcija Koordinacija gore navedenih aktivnosti Informiranje MZSS Savjetovanje MZSS o potrebi organiziranja aktivnosti usmjerenih na kontrolu otpornosti na antibiotike u skaldu s europskim i internacionalnim inicijativama
14 Hrvatska strategija za kontrolu otpornosti bakterija na antibiotike Ministarstvo zdravstva i socijalne skrbi Republike Hrvatske Ciljevi Zaustaviti širenje rezistencije na antibiotike Očuvati učinkovitost postojećih antibiotika i smanjiti morbiditet i mortalitet uslijed infekcija uzrokovanih rezistentnim bakterijama Poticati racionalnu uporabu antibiotika i podići kvalitetu zdravstvene skrbi Uspostaviti suradnju između humane i veterinarske medicine na području rezistencije bakterija na antibiotike Uspostaviti suradnju s Europskom komisijom i zemljama članicama Europske unije u skladu s preporukama Vijeća Europske unije (Council Recommendation, 2002/77/EC)
15 Hrvatska strategija za kontrolu otpornosti bakterija na antibiotike Ministarstvo zdravstva i socijalne skrbi Republike Hrvatske Zadatci Intersectoral Co-ordination mechanism (ICM) Praćenje Rezistencije bakterija na antibiotike Potrošnje antibiotika Racionalna uporaba antibiotika Edukacija Smjernice o primjeni antibiotika Kontrola širenja infekcija Informatizacija Istraživanja
16 MATRA workshop Zadar, September, 2006 CRO guidelines reviewed, introduction to AGREE methodology, topics selected, WGs set up Uroinfekcije grlobolja MRSA kirurška profilaksa
17 Zagreb sastanak RADNIH GRUPA November, 2006 METODOLOGIJA, pregled internacionalnih smjernica
18 AGREE Instrument Kriteriji za procjenu kvalitete smjernica za kliničku praksu Smjernice za kliničku praksu su sistematski razvijene izjave koje pomažu praktičarima i pacijentima u donošenju odluka o odgovarajućoj zdravstvenoj skrbi u specifičnim kliničkim situacijama
19 AGREE Instrument Moguća pristranost u donošenju smjernica adekvatno opisana Primjenjivost u praksi Kvaliteta izražavanja Vrijednost smjernica tj. koja je vjerojatnost da će one postići svoju namjenu Učinak smjernica na ishod liječenja nije predmet procjenjivanja
20 AGREE Instrument 23 kriterija: I. Cilj i namjena II. Uključenost svih zainteresiranih III. Metodologija prikupljanja podataka i formuliranja preporuka IV. Jasnoća izražavanja V. Primjenjivost u praksi VI. Izdavačka samostalnost
21 MATRA workshop on gudelines GP meeting Zagreb, November, 2006 mreža predstavnika 47 Domova zdravlja Zašto smjernice Značaj mreže: Pilotiranje smjernica Implementacija smjernica
22 Zagreb sastanak RADNIH GRUPA March, 2007 GUIDELINES first draft versions
23 Razvoj smjernica srpanj 2007 Konačna draft verzija Dogovoreno pilotiranje Postignut konsenzus Politika publiciranja 1. listopad 15. studeni 2007 draft verzija na otvorena za komentare Faza pilotiranja
24 Zagreb sastanak RADNIH GRUPA November, 2007 GUIDELINES comments and implementation
25 ISKRA SMJERNICE ZA GRLOBOLJU: DIJAGNOSTIČKI I TERAPIJSKI PRISTUP HRVATSKE NACIONALNE SMJERNICE ISKRA GUIDELINES ON SORE THROAT: DIAGNOSTIC AND THERAPEUTIC APPROACH CROATIAN NATIONAL GUIDELINES ARJANA TAMBIĆ ANDRAŠEVIĆ, TOMISLAV BAUDOIN, DALIBOR VUKELIĆ, SUZANA MIMICA MATANOVIĆ, DANIJELA BEJUK, DIANA PUŽEVSKI, MAJA ABRAM, GORAN TEŠOVIĆ, ZDRAVKO GRGUREV, GORDANA TOMAC, IRINA PRISTAŠ ISKRA SMJERNICE ANTIMIKROBNOG LIJEČENJA I PROFILAKSE INFEKCIJA MOKRAĆNOG SUSTAVA HRVATSKE NACIONALNE SMJERNICE ISKRA GUIDELINES ON ANTIMICROBIAL TREATMENT AND PROPHYLAXIS OF URINARY TRACT INFECTIONS CROATIAN NATIONAL GUIDELINES VIŠNJA ŠKERK, ARJANA TAMBIĆ ANDRAŠEVIĆ, SAŠA ANDRAŠEVIĆ, EDITA SUŠIĆ, ANA MLINARIĆ DŽEPINA, VESNA MAĐARIĆ, SLOBODAN MILUTINOVIĆ, IVAN KRHEN, LJILJANA PERIĆ, JUGOSLAV BAGATIN, MARIO ĆORIĆ, DANIEL FERLIN, IRINA CAZIN, GORDANA TOMAC ISKRA SMJERNICE ZA PREVENCIJU, KONTROLU I LIJEČENJE INFEKCIJA KOJE UZROKUJE METICILIN- REZISTENTNI STAPHYLOCOCCUS AUREUS (MRSA) SMILJA KALENIĆ, MARINA PAYERL PAL, VERA VLAHOVIĆ PALČEVSKI, JASMINKA HORVATIĆ, TOMISLAV MEŠTROVIĆ, BRUNO BARŠIĆ, VALERIJA STAMENIĆ, BORISLAV ALERAJ, MIROSLAV BULJAN, NIKOLA GRŽALJA, IVAN BURCAR, ANĐELKO KORUŠIĆ, MARINKO VUČIĆ, ROK ČIVLJAK, MARIN STANČIĆ, ANA BUDIMIR
26 Cilj i namjena Kako prekomjerna uporaba antibiotika ima neželjene posljedice i za pojedinca i za zajednicu, svrha ovih smjernica je pomoći u razlučivanju kliničke slike teške streptokokne infekcije, pri kojoj je primjena antibiotika opravdana, od brojnih drugih grlobolja gdje primjena antibiotika neće imati bitan utjecaj na tijek bolesti, ali će doprinijeti razvoju rezistencije bakterija na antibiotike. Preporuke su namijenjene liječnicima koji zbrinjavaju bolesnike s grloboljom koji ne zahtijevaju hospitalizaciju. Indikacija za hospitalizaciju je nemogućnost... Preporuke se odnose na akutnu grlobolju koja ne traje dulje od 14 dana i ne obuhvaćaju smjernice za grlobolju uzrokovanu traumom, stranim tijelom, alergijom ili tumorom.
27 Uključenost svih zainteresiranih Članovi Radne grupe za grlobolju (po abecednom redu): T. Baudoin, voditelj radne grupe, Hrvatsko društvo za otorinolaringologiju i kirurgiju glave i vrata M. Abram, Odbor za praćenje rezistencije bakterija na antibiotike u RH Akademije medicinskih znanosti Hrvatske D. Bejuk, Hrvatsko društvo za medicinsku mikrobiologiju Z. Grgurev, Hrvatsko društvo za obiteljsku medicinu S. Mimica Matanović, Hrvatsko društvo za kliničku farmakologiju D. Puževski, Hrvatsko društvo za pedijatriju A. Tambić Andrašević, Referentni centar za praćenje rezistencije bakterija na antibiotike G. Tešović, Hrvatsko društvo za infektivne bolesti D. Vukelić, Hrvatsko društvo za kemoterapiju
28 Metodologija prikupljanja podataka i formuliranja preporuka 2.3. Pregled literature, snaga dokaza i stupnjevi preporuka Pregled literature Dokazi koji potkrepljuju ove smjernice temelje se na sistematskom pregledu literature. Za početno pretraživanje dokaza RG je koristila škotske (18), američke (10, 20), finske (19) te nizozemske (17) smjernice za dijagnozu i terapiju grlobolje uzrokovanu BHSA. Također su pretražene sljedeće baze podataka časopisa na engleskom jeziku, bez vremenskog ograničenja publiciranja: Medline, Evidence Based Medicine Reviews, Cochrane Database of Systematic Reviews. Kod pretraživanja literature korištene su sljedeće ključne riječi: grlobolja, streptokok grupe A, dijagnostika, liječenje. Lokalni podaci o osjetljivosti bakterija u Hrvatskoj dobiveni su od Odbora za praćenje rezistencije bakterija na antibiotike Akademije medicinskih znanosti Hrvatske (22).
29 Snaga dokaza
30 Stupanj preporuke
31 Jasnoća izražavanja
32
33 Primjenjivost u praksi Pokusna primjena smjernica Tijekom pokusne primjene od dva mjeseca, smjernice je u svakodnevnoj praksi koristilo pet do deset specijalista pedijatra, infektologa, otorinolaringologa i 47 liječnika obiteljske medicine. Liječnici koji su koristili smjernice u pokusnom razdoblju, bilježili su svoja zapažanja u posebno izrađeni upitnik o primjenjivosti smjernica. Članovi radne grupe su razmotrili dobivene prijedloge i komentare te ih uzeli u obzir prilikom objavljivanja završne verzije smjerica.
34 Izdavačka samostalnost Sukob interesa Nije bilo sukoba interesa.
35 Simpozij o ISKRA smjernicama Osijek, June 2008 Dubrovnik, May GP /80 participants registered / 33 questionnairs answered Pula, September, GP /103 participants registered / 37 questionnairs answered Varaždin, November, GP / 180 participants registered / 54 questionnairs answered Čakovec, December, 2009 HLZ sastanak Gospić, svibanj, 2009 Pedijatrijska škola Split, studeni, 2009 Simpozij o uporabi antibiotika Rijeka, studeni, 2009
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