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Dostupnost Antiinfektiv V České Republice

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aktuálně ročník 27 | číslo 5/2017 LÉKY A PRÁVO Dostupnost antiinfektiv v České republice MVDr. Veronika Valdová Arete‑Zoe, LLC Souhrn Valdová V. Dostupnost antiinfektiv v České republice. Remedia 2017; 27: 509–513. na Seznamu nepostradatelných léčiv Světové zdravotnické organizace figuruje 119 antiinfektiv, z nichž v České republice není registrováno 29. Dalších 10 léčiv je registrováno, ale neobchodováno. Dostupnost antibiotik a dalších nezbytných léčiv má přímý dopad na klinickou praxi. Příkladem je aktuali- zovaný postup pro léčbu sepse a septického šoku, který doporučuje deeskalaci a zacílení na identifikovaný patogen ihned po jeho identifikaci z důvodu snížení zátěže pro organismus pacienta. aktualizované léčebné postupy je nutno brát v úvahu při sestavování národních seznamů nepostradatelných léčiv. Z nepostradatelných tuberkulostatik a antivirotik chybějí v ČR některé fixní kombinace určené pro první linii léčby tuberkulózy a HIV/aIDS. Padělky léčivých přípravků a nedoléčené infekce jsou hlavními příčinami vzniku multirezistentních kmenů původce tuberkulózy. Z hyperimunních sér v ČR chybí sérum proti záškrtu. Vakcíny se potýkají s celosvětovým nedostatkem v důsledku délky a náročnosti výroby. Klíčová slova: antiinfektiva – nepostradatelná léčiva – dostupnost léčiv – nedostatek léčiv – tuberkulóza – HIV/aIDS – sepse. Summary Valdova V. Availability of antiinfectives in the Czech Republic. Remedia 2017; 27: 509–513. the World Health Organization (WHO) lists 119 antiinfectives on the list of essential medicines. Of these, 29 are not registered in the Czech Republic, and another 10 are registered but not marketed. availability of antimicrobials and other essential medicines directly affects clinical practice. One such example is the newly revised guidelines for the treatment of sepsis and septic shock, which recommends deescalation of antibiotic treatment and targeting the causative pathogen immediately after its identification to minimize toxicity to the patient’s metabolism. newly compiled national lists of essential medicines shall consider revised treatment guidelines and not just the WHO list. Some fixed combinations of anti-tuberculars and antiretrovirals for first-line treatment of HIV/aIDS are unavailable in the Czech Republic. Counterfeit drugs and undertreated infections are the main drivers of microbial resistence. Diphtheria antitoxin and rabies immunoglobulin are the only immune sera unavailable in the Czech Republic. Shortage of vaccines occurs globally as a result of complexity and length of the manufacturing process. Key words: antiinfectives – essential medicines – availability of medicines – drug shortages – tuberculosis – HIV/aIDS – sepsis. Na Seznamu nepostradatelných léčiv fekce nelze použít. Antibiotika, obzvláště postupy pro léčbu sepse a septického šoku Světové zdravotnické organizace (World pak injekční formy generických přípravků, [5]. Sepse je nově definována jako „život Health Organization, WHO) figuruje jsou na světových trzích často nedostateč‑ ohrožující dysfunkce orgánů způsobená 119 antiinfektiv [1]. V České republice je ným artiklem. Quadri se spolupracovníky dysregulovanou odpovědí hostitele na in‑ registrováno celkem 2 152 léčivých pří‑ studovali případy nedostatku antibiotik fekci“ [6]. Dle nových diagnostických kri‑ pravků z této skupiny, z nichž 331 bylo ve Spojených státech amerických a zjistili, térií qSOFA jde o kombinaci nejméně dvou v posledním čtvrtletí obchodováno. Ze se‑ že téměř polovina ze 148 hlášených přípa‑ ze tří hodnot: Glasgow Coma Scale (GCS) znamu nepostradatelných antiinfektiv jich dů z období 2001–2013 se týkala zlatého 13 nebo méně, systolický tlak nižší než není registrováno 29, dalších 10 léčiv je standardu léčby vysoce rizikových patoge‑ 100 mm Hg a dechová frekvence vyšší než registrováno, ale neobchodováno. Řada nů, jako je Clostridium difficile, dále karba‑ 22 vdechů za minutu. Syndrom systémové dalších léčiv je k dispozici v minimálním penem‑rezistentních kmenů enterobakte‑ zánětlivé odpovědi (systemic inflammato‑ počtu jedné či dvou registrací od jediného rií, meticilin‑rezistentních kmenů zlatého ry response syndrome, SIRS) se význam‑ výrobce (např. chloramfenikol, benzatin‑ stafylokoka (MRSA), Pseudomonas aeru- ně překrývá s příznaky sepse a systémo‑ ‑penicilin a nitrofurantoin), což znamená, ginosa a lepry. Obvyklými příčinami byly vé infekce [7]. Časné rozpoznání sepse je že v případě výpadku mohou být tyto léky zpoždění ve výrobě, nedostatek zdrojových zásadní pro její úspěšnou léčbu. Prvním taktéž nedostupné. Největší počet příprav‑ chemikálií, monopolní výrobce, obchodní krokem je vždy získání mikrobiologických ků je k dispozici pro amoxicilin a inhibitor priority, neschopnost předvídat a zajistit vzorků, včetně kultivace krve. Izolace pa‑ beta‑laktamáz (340 registrováno/23 ob‑ poptávku, potíže regulačního a adminis‑ togena poté umožňuje přesnější zacílení chodováno), flukonazol (251/22), linezolid trativního charakteru, včetně zákazu do‑ léčby a deeskalaci antibiotické léčby, což je (188/11) a klaritromycin (132/22). Počty vozu, a v jednom případě dokonce živelná důležité především u pacientů se sníženou přípravků odpovídají individuální lékové pohroma [2]. Významné nedostatky po‑ orgánovou funkcí [8]. Léčba sestává z po‑ formě (SÚKL ID), a nikoliv počtu regist‑ stihly v USA antibiotika jako cefotaxim, dání infuzí, z hemodynamické stabiliza‑ račních čísel. Podrobnosti lze najít v ta- cefalexin, trimetoprim‑sulfametoxazol, ce a z podání širokospektrých antibiotik bulce 1. azitromycin, klindamycin, gentamicin, ci‑ v infuzi s ohledem na výskyt izolovaných profloxacin a vankomycin [3]. Nedostatek kmenů v oblasti [9]. Opožděné podání a ne‑ Antibakteriální látky antibiotik byl hlášen i z Austrálie, kde jsou vhodná volba antibiotik mají za následek Antibiotika jsou zařazena na seznam potíže s dodávkami vankomycinu, metro‑ vyšší riziko úmrtí [10]. Nejčastěji izolova‑ WHO nejen z důvodu šíře použití, prav‑ nidazolu a řady antivirotik [4]. Dostupnost nými kmeny jsou Staphylococcus aureus, děpodobnosti rezistence a bezpečnostní‑ léčiv má přímý dopad na klinickou praxi. Streptococcus pyogenes, Klebsiella spp., ho profilu, ale taktéž z důvodu prevence Escherichia coli a Pseudomonas aerugino- vzniku rezistence na modernější antibioti‑ Léčba sepse a septického šoku sa. Patogeny vykazují širokou škálu faktorů ka, která mají být ponechána pro případy, V roce 2016 skupina Surviving Sepsis virulence jako endotoxiny, exotoxiny a en‑ kdy antibiotika první volby pro běžné in‑ Campaign (SSC) připravila nové léčebné terotoxiny [11]. Septický šok je definován Dostupnost antiinfektiv v České republice 509 aktuálně LÉKY A PRÁVO ročník 27 | číslo 5/2017 TAB. 1 Přehled léčiv dle ATC klasifikace léčiv s vyznačením zástupců účinných látek ATC Název REG OBCH Nepostradatelná léčiva J01 antibakteriální léčiva pro systémovou aplikaci A Tetracykliny doxycyklin, chlortetracyklin, oxytetracyklin, lymecyklin, 13 8 doxycyklin tetracyklin, minocyklin aj. B Amfenikoly chloramfenikol, triamfenikol 2 1 chloramfenikol C Beta‑laktamová piperacilin, tikarcilin, karbenicilin, propicilin, meticilin, dik‑ 441 66 ampicilin, amoxicilin, benzylpenicilin, antibiotika, loxacilin, oxacilin, flukloxacilin, inhibitory beta‑laktamázy fenoxymetylpenicilin, benzatin‑ peniciliny (sulbaktam a tazobaktam), kombinace (47 celkem) ‑penicilin, prokain‑benzylpenicilin, kloxacilin, amoxicilin a enzymový inhibitor beta‑laktamázy D Jiná Cefalosporiny první, druhé, třetí a čtvrté generace: 380 60 cefalexin, cefazolin, cefotaxim, cefta‑ beta‑laktamová I – cefalexin, cefadroxil, ceftezol; II – cefuroxim, cefaklor, zidim, ceftriaxon, cefixim antibiotika flomoxef; III – cefixim, cefodizim, cefdinir; IV – cefepim, ce‑ fozopran; Monobaktamy: karumonam a aztreonam; Karba‑ penemy: meropenem, doripenem a imipenem a enzymový inhibitor (58 celkem) E Sulfonamidy trimetoprim, iklaprim; Sulfonamidy: krátkodobě, středně‑ 12 9 trimetoprim, sulfadiazin, sulfame‑ a trimetoprim době a dlouhodobě působící – sulfametizol, sulfafurazol, toxazol sulfatiazol (krátce), sulfadiazin, sulfamoxol (středně), sulfa‑ perin, sulfadimetoxin, sulfamazon (dlouho) a kombinace F Makrolidy, Makrolidy: spiramycin, roxitromycin, miokamycin, telitro‑ 221 50 erytromycin, klaritromycin, azitromy‑ linkosamidy mycin, fluritromycin; Linkosamidy: klindamycin, linkomy‑ cin, klindamycin a streptograminy cin; Streptograminy: pristinamycin, quinupristin/dalfo‑ pristin G Aminoglykosidová Streptomyciny: streptomycin, streptoduocin; Aminogly‑ 29 12 streptomycin, gentamicin, kanamycin, antibiotika kosidy: tobramycin, gentamicin, neomycin, amikacin, amikacin dibekacin, arbekacin, isepamicin aj. M Chinolonová Fluorochinolony: ofloxacin, ciprofloxacin, norfloxacin, 172 27 ofloxacin, ciprofloxacin, levofloxacin antibakteriální trovafloxacin, levofloxacin, moxifloxacin, gatifloxacin; léčiva Ostatní chinolony: rosoxacin, kys. nalidixová, cinoxacin, nemonoxacin (aj.) R Kombinace cefuroxim a metronidazol, spiramycin a metronidazol, 0 0 n/a antibakteriálních levofloxacin a ornidazol, cefepim a amikacin, ciprofloxacin léčiv a ornidazol, norfloxacin a tinidazol X Jiná antibakteriální Glykopeptidy: vankomycin, teikoplanin, dalbavancin, ori‑ 253 26 vankomycin, metronidazol, nitrofu‑ léčiva tavancin; Polymyxiny: kolistin, polymyxin B; Steroidní anti‑ rantoin, spektinomycin, linezolid biotika: kys. fusidová; Imidazoly: metronidazol, tinidazol, ornidazol; Nitrofurany: nitrofurantoin, furazidin; Ostatní: fosfomycin, xibornol, spektinomycin, linezolid, daptomycin, bacitracin, tedizolid
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