Trasfusioni e malattie emergenti: la legislazione

Transcript

Relazione
Dr. Giuseppina
Facco
Trasfusioni e malattie emergenti:
la legislazione europea in ambito
trasfusionale
con particolare riferimento a Spagna, Francia e
Regno Unito
Corso E.C.M. Trasfusioni e rischio biologico: le nuove infezioni
Bergamo, 07 giugno 2014
Sommario
•Le infezioni emergenti
– Definizione e caratteristiche
– Principali strategie
•L’Europa
– Popolazione e flussi migratori
– La legislazione in ambito trasfusionale
• Francia, Spagna, Regno Unito: impatto sulla
sicurezza trasfusionale delle infezioni emergenti
Le infezioni emergenti
Definizione e caratteristiche
Principali strategie
“New Tools to Hunt New Viruses”
http://www.nytimes.com/2013/05/28/health/new-tools-to-hunt-newviruses.html
•
•
A new flu, H7N9, has killed 36 people
since it was first found in China two
months ago.
A new virus from SARS family has
killed 22 people since it was found on
the Arabian Pennsula last summer
Peter Daszak, a parasitologist and
president of the EcoHealth Alliance, has
even put a number on it:
5.3 new ones each year,
Number of EID events per decade.
Global trends in emerging infectious diseases
Kate E. Jones, Nikkita G. Patel, Marc A. Levy, Adam Storeygard, Deborah Balk, John L. Gittleman & Peter Daszak
Nature 451, 990-993(21 February 2008) doi:10.1038/nature0653
Global richness map of the geographic origins of EID
events from 1940 to 2004 Global trends in emerging infectious diseases
Kate E. Jones, Nikkita G. Patel, Marc A. Levy, Adam Storeygard, Deborah Balk, John L. Gittleman
& Peter Daszak - Nature 451, 990-993(21 February 2008) doi:10.1038/nature0653
the map is derived
for EID events
caused by all
pathogen types
Global distribution of relative risk of an EID event
Global trends in emerging infectious diseases
Kate E. Jones, Nikkita G. Patel, Marc A. Levy, Adam Storeygard, Deborah Balk, John L. Gittleman &
Peter Daszak
Nature 451, 990-993(21 February 2008) doi:10.1038/nature0653
zoonotic pathogens from wildlife,
zoonotic pathogens from non-wildlife,
drug-resistant
pathogens
Bergamo,
07 giugno
2014
vector-borne pathogens.
http://www.worldmapper.org/display.php?selected=15
The territory size shows the number of international immigrants
that live there (2000)
Testo
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174 million people have moved to a new territory.
The United States receives the highest number of international immigrants (people
born in another territory and no longer resident there),
Andorra has highest proportion of immigrants living within its borders. Four out of every
five people in Andorra are international immigrants.
In the Philippines and Guyana, the lowest immigration, only one person in every 500 is
an international immigrant.
Patogeni/Infezioni emergenti e
riemergenti (EIDs):
definizione generale
EIDs
• Numerose
• Tutte le classi di agenti infettivi (virus, batteri,
protozoi)
• 60-70% sono zoonosi, vettori ed ospiti intermedi
(reservoir)
• Quasi tutte le vie di trasmissione
• Il trasporto ha un ruolo critico
• Non hanno caratteristiche in comune
Patogeni/Infezioni emergenti e riemergenti
(EIDs):
meccanismi con cui emergono.




“de novo” colpiscono la specie umana, con un salto di
specie dall’animale all’uomo (HIV, vCJD)
Diventano endemici per il cambiamento dei flussi migratori
delle popolazioni (T. Cruzi) o dei vettori e ospiti intermedi
(WNV)
Cambiamenti ambientali favoriscono la crescita dell’agente
o del suo vettore (batteri, zanzare come vettori)
Mutazioni dell’agente stesso ne favoriscono la diffusione
dall’animale all’uomo e tra gli uomini
Principali strategie
• Donatori: criteri di selezione mirati per
– Individuare fattori di rischio ( per esempio MST)
– Presenza in zone endemiche (…se hai dormito una
notte d’estate a Ravenna…)
• Donazioni: test mirati per le EID
• Emocomponenti: inattivazione dei patogeni
Principali strategie: ma…
Principali strategie: ma…
• Donatori: criteri di selezione mirati e ristretti:
– meno donatori, rischio di non soddisfare il
fabbisogno di sangue
• Donazioni, test mirati per le EID: aumento dei
costi
– “diretti” : kit diagnostici
– “indiretti”: donazioni inutilizzate
• Emocomponenti: Inattivazione dei patogeni
non ancora disponibile per i globuli rossi (>80%
trasfusioni)
L’Europa
Popolazioni e flussi migratori
Testo
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Testo
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I flussi migratori in Europa:
dati 2012
• 1.7 million immigrants to the EU-27 from countries
outside the EU-27
• 1.7 million people residing in one of the EU Member
States (MS) migrated to another MS.
• In Germany the largest number of immigrants (592 200),
followed by the United Kingdom (498 000), Italy (350 800),
France (327 400) and Spain (304 100).
• Relative to the size of the resident population, Luxembourg
recorded the highest number of immigrants (38 immigrants
per 1 000 persons), followed by Cyprus (20) and Malta (17)
http://epp.eurostat.ec.europa.eu/statistics_explained/index.php
Migration_and_migrant_population_statistics
I flussi migratori in Europa
Main countries of citizenship and birth of the foreign
foreign-born population, 1 January 2013 (in absolute
numbers and as a percentage of the total foreign
foreign-born population)
L’Europa
La legislazione in ambito
trasfusionale
Normativa europea
La normativa europea in materia di attività trasfusionali: 2005‐2007
Sangue ed
emocomponenti
Cellule e tessuti
Prodotti
medicinali
DIRETTIVE “FIGLIE”
Trasposizione Direttiva 2004/23/CE
D.Lgs. 191/2007
Trasposizione Direttiva 2006/17/CE D.Lgs. 16/2010
Norme di qualità e di sicurezza per la donazione, l'approvvigionamento, il controllo, la lavorazione, la conservazione, lo stoccaggio e la distribuzione di tessuti e cellule umani.
Prescrizioni tecniche per la donazione, l’approvvigionamento e il controllo di tessuti e cellule umani, nonché per quanto riguarda le prescrizioni in tema di rintracciabilità, la notifica di reazioni ed eventi avversi gravi e determinate prescrizioni tecniche per la codifica, la lavorazione, la conservazione, lo stoccaggio e la distribuzione di tessuti e cellule umani
CELLULE E TESSUTI
DIRETTIVA “MADRE”
Il quadro normativo europeo che interessa il sistema sangue
D.Lgs. 191/2007
Revisione trasposizione Direttiva 2002/98/CE
D.Lgs. 261/2007
Trasposizione DIRETTIVE “FIGLIE”
Norme di qualità e di sicurezza per la raccolta, il controllo, la lavorazione, la conservazione e la distribuzione del sangue umano e dei suoi componenti
Direttiva 2004/33/CE
DD.MM. 3 Marzo 2005
D.Lgs. 207/2007
Protocolli accertamento idoneità donatori di sangue ed emocomponenti
Caratteristiche e modalità per la donazione del sangue e degli emocomponenti
Prescrizioni in tema di rintracciabilità del sangue e degli emocomponenti destinati a trasfusioni e notifica di effetti indesiderati ed incidenti gravi.
Norme e specifiche
comunitarie relative ad un sistema di qualità per i servizi trasfusionali
SANGUE ED EMOCOMPONENTI
DIRETTIVA “MADRE”
D.M. 24 September 2004
Trasposizione Direttiva 2001/83/CE e succ. mod.
D.Lgs. 219/2006
Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice comunitario concernente i medicinali per uso umano, nonché della direttiva 2003/94/CE
PRODOTTI MEDICINALI - 1
Trasposizione Disposizioni sulle documentazioni da presentare a corredo delle domande di autorizzazione all'immissione
in commercio di medicinali ad uso umano in attuazione della direttiva 2003/63/CE della Commissione del 25 giugno 2003
November 2006 EMEA Guideline on plasma‐
derived medicinal products
February 2009
European Pharmacopoeia 6.2: Human Plasma for Fractionation & others (S/D plasma, etc) EMA Guideline on epidemiological data on blood transmissible infections
July 2008
April 2010
Eu Commission Annex 14 GMPs: Manufacture of medicinal products derived from human blood or plasma Other pertinent European Guidelines and notes for guidance (….)
2000 & 2010
PRODOTTI MEDICINALI - 2
EMEA Guideline on the scientific data requirements for a Plasma Master File (PMF) ‐ Rev1
La legislazione europea
in ambito trasfusionale
Selezione del
donatore
Esclusione permanente per pregressa infezioni HBV,
HCV, HIV, HTLVI-II, Babebsiosi, Leishmaniosi,
Trypanosoma Cruzi
Esclusione temporanea per Sifilide (riammissione ad
un anno dalla guarigione clinica), WNV (28 giorni dopo
aver lasciato una zona con casi di trasmissione della
malattia all'uomo), Malaria
Screening malattie
trasmissibili
HBsAg, Anti-HCV, Anti-HIV 1-2.
Additional tests may be required for
 Specific components
 Specific donors
 Epidemiological situations
La legislazione europea
in ambito trasfusionale
Selezione del
donatore
Esclusione permanente per pregressa infezioni HBV,
HCV, HIV, HTLVI-II, Babebsiosi, Leishmaniosi,
Trypanosoma Cruzi
Esclusione temporanea per Sifilide (riammissione ad
un anno dalla guarigione clinica), WNV (28 giorni dopo
aver lasciato una zona con casi di trasmissione della
malattia all'uomo), Malaria
Screening malattie
trasmissibili
HBsAg, Anti-HCV, Anti-HIV 1-2.
Additional tests may be required for
 Specific components
 Specific donors
 Epidemiological situations
La legislazione europea in ambito
trasfusionale: Malaria
Francia, Spagna, Regno Unito:
impatto sulla sicurezza trasfusionale
delle infezioni emergenti
Spagna, Regno Unito, Francia:
Dal colonialismo ai flussi migratori
Relazione
Dr. ….
Guidelines for the Blood
Transfusion Services in the
United Kingdom
(Red Book)
JPAC - Joint United Kingdom
(UK) Blood Transfusion and
Tissue Transplantation Services
Professional Advisory
Committee
http://www.transfusionguidelines.org.uk/red-book
Transfusion Services in the UK
(Red Book)
Transfusion-transmissible infectious diseases
Every effort is made to prevent transmission of disease by
careful and appropriate selection of donors. This includes
ensuring that
• the donor is provided with clear, understandable and up-todate information
• the donor has understood this information (see Chapter 5).
Donors must be assessed for their exposure to any risk
of acquiring a transfusion-transmissible infection.
http://www.transfusionguidelines.org.uk/dsg
Relazione
Dr. ….
Transfusion Services in the UK
(Red Book)
Travel history
•
Increased and rapid travel of the population may lead to asymptomatic
people donating infectious blood.
• A clear and detailed travel history must be obtained from all donors to
minimise the risk of transmission of
• Malaria,
• Trypanosoma cruzi
and emerging diseases such as
• West Nile
• Chikungunya virus.
• The Blood Services and JPAC links with WHO, ECDC and the UK Health
Protection Agency (HPA) and base the donor deferral criteria on the
advice obtained.
• Any changes to current selection guidelines need to be rapidly
communicated and this will happen through change notifications and the
website www.transfusionguidelines.org.uk
Geographical Disease Risk Index
Travel to, birth/maternal birth or residency in, and in some cases
sexual activity with residents of certain countries, is associated
with an increased risk of exposure to infections such as malaria,
T cruzi, WNV and HIV.
• To assess the risk of an individual carrying such infections,
look up the countries:
• that they have visited
• for which they report sexual contact with a resident or
former resident
• in which they were born
• in which their mother was born
http://www.transfusionguidelines.org.uk/dsg/gdri
Geographical Disease Risk Index
http://www.transfusionguidelines.org.uk/dsg/gdri/preliminaries/general-principles
TDSG: Tissue Donor Selection Guideline
WB-DSG: Whole Blood-Donor Selection Guideline
BM: Bone Marrow, CB: Cord Blood,
Screening per malattie trasmissibili
Infectious agent Minimum requirement
Comments
HIV 1+2
RNA screening in pools of a
maximum of 48 donations;
•
Anti HIV 1+2 or HIV
1+2 (Ag/Ab)
HIV RNA
HCV
•
•
Anti-HCV
HCV RNA
HBV
• HBsAg ,
• HBV DNA
• Anti-HBc(+antiHBs)
Syphilis
• Anti-treponemal Ab
•
,
Additional, due to specifically identifiable risk
Mandatory
Donations that are anti-HBc reactive
and have antiHBs > 100mlU/mL are
considered suitable for release.
HBV DNA and HIV RNA not mandatory but
in most of UK are included as commercial
systems are now tryplex assays
Screening per malattie trasmissibili
Infectious agent Minimum requirement
Comments
HTLV I/II
•
Anti HTLV I/II
Not required for FFP components if
they are sourced independently
from cellular components ;
HCMV
•
Anti-HCMV
Ideally IgG and IgM but IgG is
considered sufficient;
Plasmodium
• Anti-P.
Falciparum/Vivax
West Nile Virus
• WNW RNA
,
maximum of 16 donations
Additional, due to specifically identifiable risk
Mandatory
• The National Blood Service (England and North Wales), now part of NHS Blood
and Transplant (NHSBT), was the first blood service in a nonendemic area to
implement serologic screening of “at-risk” donors for T. cruzi antibody.
• Screening began in 1998 in the National Transfusion Microbiology Reference
Laboratory (NTMRL), which was tasked with developing a national system to
deal with the risk of T. cruzi infection being transmitted through blood transfusion
within England and North Wales.
• Initially, donors identified as “at risk” for T. cruzi infection and who had last
returned from an endemic area at least 6 months previously were prescreened
for presence of T. cruzi antibodies.
• Subsequently, screening was changed from this “donor qualification” approach
to “product release,” allowing donations to be collected from at-risk donors, and
was then extended to include tissue and stem cell donations.
Impossibile v isualizzare l'immagine.
• Since the implementation of screening to March 2011, a total of 38,585 donors
have been tested.
• Furthermore, since 2005, 15,536 donations that would otherwise have been lost
have been collected, of which 15,499 (99.8%) were found to be T. cruzi antibody
negative (Table 3) and were able to be released to inventory.
Dal1492 con la scoperta dell’America, gli stati più sviluppati dell’Europa
occidentale iniziarono il lungo processo di conquista e colonizzazione in tre
parti del mondo : America, Africa e parte dell’Asia.
Mem Inst Oswaldo Cruz, Rio de Janeiro, Vol. 102(Suppl. I): 75-85, 2007 75 Epidemiology of Chagas disease in non-endemic
countries: the role of international migration
Testo
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In Spain, 5125 of 241,866 legal immigrants in 2003 (25 per 1000), could be infected.
Of the 4 500 000 foreigners settled in
Spain in 2007, 35% (1 638 694, ) were of
South American origin. Among 1 638 694
immigrants from the Americas,
Ecuador (25%),
Argentina (8%),
Colombia (16%)
Peru (7%)
Bolivia (14%),
Brazil (6 6%).
• Estimations, based on the prevalence of T. cruzi antibodies found in blood donors
in various Latin American countries , indicate that more than 50 000 T. cruzi infected individuals could currently be living in Spain
• In Spain, there have been four reported cases of donors who transmitted the
disease to five recipients
• the majority of transfusion centres have implemented T. cruzi antibody detection
techniques
• those that do not apply these techniques reject all donors who come from the
aforementioned countries
• The decision to adopt one strategy or another depends on the percentage of Latin
Americans resident in each area.
• Since 2005: Blood donor screening in Spain is not universal, it is applied to
selected donors. Selection criteria include
• being born in an endemic country,
• being the child or grandchild of a mother born in an endemic area,
• having been resident in endemic areas
• having received a blood transfusion in an endemic country (Ministry of Health,
2005).
• the majority of transfusion centres have implemented T. cruzi antibody detection
techniques
• those that do not apply these techniques reject all donors who come from the
aforementioned countries
• The decision to adopt one strategy or another depends on the percentage of Latin
Americans resident in each area.
• Since 2005: Blood donor screening in Spain is not universal, it is applied to
selected donors. Selection criteria include
• being born in an endemic country,
• being the child or grandchild of a mother born in an endemic area,
• having been resident in endemic areas
• having received a blood transfusion in an endemic country (Ministry of Health,
2005).
• La France exclut temporairement un donneur de sang
homologue pendant les 4 premiers mois qui ont suivi son
retour d’une zone d’endémie palustre.
• Entre quatre mois et trois ans après le retour, les dons
sont systématiquement soumis à un screening
sérologique, à la recherche d’anticorps plasmodiaux par
immunofluorescence indirecte.
• Si la sérologie est négative, le don est accepté.
• Si la sérologie est positive, le donneur est exclu
définitivement du don du sang.
http://www.infectiologie.com/site/medias/JN
I/JNI13/posters/2013-JNI-A-04.pdf
• Institut National de Veille Sanitaire shows an increase of cases over the past 10
years in French Guiana.
• A hospital-based study in the Paris area confirmed the existence of Chagas
disease in patients moving from LA to the Paris Area.
• 2005: French authorities to stop blood collection in French Guiana and, ban
donations from all individuals who had traveled or were born in LA, until a
detection policy could be set up.
• 2006, the Institut National de Veille Sanitaire found that 2.11% of blood donors
in the Paris area could have been in contact with T. cruzi and therefore should
be screened for Chagas disease.
• In November 2006, a screening program to detect antibodies against T. cruzi in
the Caribbean French departments.
• In April 2007, screening was started in Continental France
prevalence of T. cruzi carriers among donors from LA was 0.31%, whereas the overall
prevalence in the tested population was 9.7 in 100,000 donors.
Donors from LA, the French Caribbean islands, and North America were more likely to
have indeterminate results. No cross reacting with Leishmania Ag, 313 of them become
negative in a second sample several days or weeks after donation
Central America
South America
Un caso esempio:
HTLV-1
Un caso esempio:
HTLV-1
• Il virus T- linfotropico umano di tipo 1 (HTLV-1) appartiene
alla famiglia dei Retrovirus e si trasmette per via orizzontale
(sessuale, uso di droghe EV), verticale (allattamento) ed
attraverso
la trasfusione di emocomponenti cellulari ,
incorporandosi come forma provirale nel DNA linfocitario dei
soggetti infetti.
• È associato all'insorgenza di un'aggressiva neoplasia dei
linfociti T CD4+ maturi (leucemia-linfoma a cellule T
dell'adulto o ATLL), e di una patologia degenerativa del
sistema nervoso centrale (mielopatia associata ad HTLV1/paraparesi spastica tropicale (HAM/TSP), e di uveite
autoimmune.
Un caso esempio:
HTLV-1
• Il virus è diffuso nel mondo dove aree ad elevata
endemicità coesistono con aree in cui il virus è
quasi assente.
• Ad elevata endemicità sono l’area Sud Ovest del
Giappone e Caraibi, in Sud America la Colombia,
Guyana Francese e parte del Brasile, alcune aree
intertropicali africane ed isolati clusters in
Melanesia, mentre in Europa solo la Romania ha
un’endemicità elevata.
Prevention of the risk due to donors coming from endemic areas. In some countries
universal screening is mandatory
• France, Netherlands and UK : donors coming from endemic areas are not
uncommon, due to a strong relationship with the Caribbean and sub-Saharan Africa,
• The case of Romania is very specific, because is in a high prevalence area1
1Taylor, Graham P.The Epidemiology of HTLV-I in Europe Journal of Acquired Immune Deficiency Syndromes. 13:S8-S14,
1996.

Trasfusioni e malattie emergenti: la legislazione

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