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Klinick sk anie liekov Spr vna klinick prax a Liekov politika

ttna liekov politika (NATIONAL DRUG POLICY). Shrn a prepojenie legislatvnych, odbornch a technickch opatren, ktorch cielom je kvalitn, cinn a bezpecn liek pre individulneho pacientaZkladn predpoklady: - koncepcia LP deklarcia - zkon o lieku legislatvagarant LP vl

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Klinick sk anie liekov Spr vna klinick prax a Liekov politika

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    1. Klinick skanie liekov Sprvna klinick prax a Liekov politika

    2. ttna liekov politika (NATIONAL DRUG POLICY) Shrn a prepojenie legislatvnych, odbornch a technickch opatren, ktorch cielom je kvalitn, cinn a bezpecn liek pre individulneho pacienta Zkladn predpoklady: - koncepcia LP deklarcia - zkon o lieku legislatva garant LP vlda (Guidelines for developing drug policies, WHO, 1988)

    3. Sprvna klinick prax (Good Clinical Practice) Sprvna klinick prax (SKP) - sbor medzinrodne uznvanch, etickch a vedeckch poiadaviek kvality, ktor zabezpecuj, e klinick skanie sa uskutocnuje v slade s poiadavkami na ochranu a zachovanie prv osb zcastnujcich sa na klinickom skan, ktor je potrebn dodriavat pri prprave, vykonvan, evidovan a oznamovan klinickch pokusov, ktor sa vykonvaj na ludoch.

    5. Klinick farmakolgia Vznik 60-te roky 20. stor. cinnost, ale aj bezpecnost lieku Thalidomid (Contergan) - prevencia rannej nauzey - pokladan za relatvne bezpecn pre experimentlne zvierat a lud r. 1960 prv sprva o fokomlii postihnutch 20% det matiek, uvajcich thalidomid pocet prpadov: Nemecko - 3 000 Anglicko - 450 Nov Zland - 25

    6. Histria ICH - GCP Guidelines Defincia Medzinrodn konferencia o harmonizcii technickch poiadaviek pre registrciu farmaceutickch prpravkov urcench pre lud angl. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; GCP = Good Clinical Practice

    7. Histria ICH - GCP Guidelines KEDY ? 1989 eurpsky nvrh - efektvnej postup ako bilaterlne stretnutia 1991/1993/1995/1997 ICH 1 4 Konferencia public progress reports Budcnost Prebiehajci proces harmonizcie Eurpska komisia Nvrh smernice o sprvnej klinickej praxi (angl. GCP Directive) III/5778/96 konecn = COM(97)369 konecn 3. 9. 1997 prebran Eurpskou komisiou a podan na schvlenie do Eurpskeho parlamentu Smernica 2001/20/EC = Directive 2001/20/EC prijat 4. 4. 2001 Eurpskym parlamentom a Radou Eurpy

    8. Directive 2001/20/EC of the European Parliament and of the Council of April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Smernica 2001/20/EC Eurpskeho parlamentu a Rady zo 4. aprla 2001 o aproximcii zkonov, nariaden a sprvnych ustanoven clenskch ttov tkajcich sa uplatnovania sprvnej klinickej praxe pri klinickom skan medicnskych produktov urcench na humnne pouitie

    9. Smernica 2001/20/EC Preambula - ods. (1) - (19) Cl. 1 Rozsah Cl. 2 Defincie Cl. 3 Ochrana subjektov klinickho skania Cl. 4 Klinick skanie u maloletch Cl. 5 Klinick skanie u inkompe- tentnch dospelch, ktor nie s schopn udelit prvoplatn informovan shlas Cl. 6 Etick komisia Cl. 7 Jednotn stanovisko Cl. 8 Podrobn smernice Cl. 9 Zacatie klinickho skania Cl. 10 Vykonvanie klinickho skania Cl. 11Vmena informci Cl. 12 Pozastavenie klinickho skania alebo priestupky

    14. ODBORN ODPORCANIA

    15. tandardn postupy Odborn odporcania ODBORN ODPORCANIA dg/th postupy liecebno-preventvny proces (nvody, guidelines) liekov politika (racionlna farmakoterapia) ttne orgny zdravotn poistovne zdravotn politika financn politika (priority, zdravotn (systmov hrady, programy, ...) zdravotn plny,...)

    16. 45 zkona c. 576/2004 Z. z. o zdravotnej starostlivosti Ministerstvo zdravotnctva... b) odborne usmernuje poskytovanie zdravotnej starostlivosti c) vydva tandardn diagnostick a tandardn terapeutick postupy (cinnost od 1. 1. 2005)

    17. Odborn odporcania Clinical (Practice) Guidelines Konkrtny postup je vyjadrenm konsenzu, ktor zodpoved definovanm kritrim, repektujcim scasn stav poznania - roven kritri (EBM, dkaz, sksenost) - individulne odchlky - farmakoekonomick aspekty

    18. EBM (EVIDENCE - BASED MEDICINE) Use of current best evidence in making decisions about the care of individual patient. = ICE (INDIVIDUAL CLINICAL EXPERTISE) The proficiency and judgement that individual clinicians acquire thorugh clinical experience and clinical practice. + ECE (EXTERNAL CLINICAL EVIDENCE) Clinically relevant research, often from the basic, but especially from the patient centered clinical research into the accuracy and precision of diagnostic tests, the power of prognostic markers and the efficacy and safety of therapeutic regimens.

    20. Farmakoekonomick aspekty tvorby tandardov

    21. Ciastka 112 Zbierka zkonov c. 322/2006 322 N A R I A D E N I E V L D Y Slovenskej republiky z 3. mja 2006 o spsobe dalieho vzdelvania zdravotnckych pracovnkov, sstave pecializacnch odborov a sstave certifikovanch pracovnch cinnost

    22. Ciastka 112 Zbierka zkonov c. 322/2006

    23. Pocet absolventov SKP I. a SKP II. na UFKF SZU

    24. Certifikacn skka Klinick skanie (produktov a) liekov na UFKF SZU

    25. Sustainable healthcare in Europe ensuring value for money in healthcare PROTECTING EQUITY WHILE IMPROVING EFFICIENCY patient empowerment and efficient health outcomes sustainability of health financing in South & East Europe Equity in Health (Care) EQUAL TREATMENT TO EQUAL NEED social justice, which is extrinsic to preferences Demand and Expectations of Public

    29. N A R I A D E N I A V L D Y Slovenskej republiky c. 742/2004 z 15. decembra 2004 a c. 324/2006 z 3. mja 2006, ktorm sa men a doplna nariadenie vldy Slovenskej republiky c. 742/2004 Z. z. o odbornej spsobilosti na vkon zdravotnckeho povolania

    30. Organizacn forma tdia CPC Klinick skanie liekov (Koordincia stav farmakolgie, klinickej a experimentlnej farmakolgie LF SZU) - povinn cast na koliacich miestach a predpsanch kurzoch v problematike klinickho skania liekov (SKP I., SKP II.), - samotdium - cast na spracovan najmenej dvoch klinickch tdi hodnoten (jednho v zariaden ambulantnej a jednho v zariaden lkovej zdravotnej starostlivosti) - cast na vedecko-odbornch podujatiach - odporca sa cast na vedecko-odbornch podujatiach venovanch problematike Sprvnej klinickej praxe

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