Report of Adverse Events of “grade 0” bet

Afssaps

Description

Blood and blood products - "e - fit" the French Haemovigilance Data Base - Adverse Events associated with inappropriate transfusion of labile blood products but with any measurable biologic or clinical effect at the time of the observation
07/06/2008

Informations

• Publié par: ansm-blood-and-blood-products
• Publié le: 07 juin 2008
• Nombre de lectures: 14
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

“e-fit” the French Haemovigilance Data Base Adverse Events associated with inappropriate transfusion of labile blood products but with any measurable biologic or clinical effect at the time of the observation Report of Adverse Events of “grade 0” between 2003 and 2007 in France X X Xth International congress ISBT Mai-Phuong VO MAI, Cyril CALDANI, Jean-François LEGRAS, Béatrice WILLAERT, June 7 - 12, 2008 Macao, China Imad SANDID, Pierrette ZORZI, on behalf of the French Haemovigilance Network Background  1//60520thf  oCEiD fo 8  evitcer "  e, 06coacncSi20e tra elcinidrot g European Commission, Grade 0" reports will henceforth be - The analysis of Adverse Reaction (AR) since 1994 shows that the  long to the field of Serious Adverse Events (SAE) and not to AR surveillance of data needs an important supplement to cover  anymore. AR data and to avoid the lack of reporting for the transfusion of Figure 1 : French definitions of gravity inappropriate Labile Blood Products (LPB) Figure 1. The gravities   1 to 4, that currently exist, couldn’t capture and report all AR Transfusion of inappropriate LBP t discovered. o Grade 0 In October 2002, France began to experience a new mandatory ehp tout withnt, atie cal effect y anasmeabur  b le oloi cigc roinil notification: AR of “grade 0”. Like the other notifications, no mat - ter the level of gravity, the AR “grade 0” has to be reported by Absence of immediate Grade 1 the haemovigilance correspondents (physicians, pharmacists, or long-term vital threat health care providers...), when it is appropriate. Long-term “morbidity” Grade 2 As for, the AR “grade 0”, part of the AR surveillance system,  is define as: Immediate vital threat Grade 3 All events due to dysfunction after transfusion of inappro - p cl r i i n a i t c e a   l L  e P f B f , e   c a t l   t a h t o  t u h g e h  t  t i h m e e r   e o   f i   s t   h n e o   t o  a b n s y e   rv m a e ti a o s n urable biologic or  Death Grade 4 . Methods and data [  Method  [  Data Quantitative analysis of AE of “grade 0” and comparison of the  Analysis carried out with data from “e-fit”, the French national origins and the causes. network reports system, on the period 2003-2007. results [ 150 AE “Grades 0” per year Most of the incidents take place in HE 71.3%, 6.9% in BC, 17.7%   751 AE “Grades 0” have been notified between January 2003 and  in both HE/BC, and the remaining 4.1% are other or not available December 2007, else an average of 150 per year, standard devia -  (Figure 5). tion of ± 16.4, i.e. 38 AE “Grades 0” per trimester, standard devia - tion of ± 6.7 (Figure 2). Figure 5 : Diagram : Origins of dysfunctions Figure 2 : French Haemovigilance Reports  HE & BC 17.7% HE 71.3% Grade 0 number of reports per trimester Grades 1-4 300 2100 250 2000 AR Grades 1-4 200 1900 “Grades 0” 2003-07 150 1800 100 1700 BC 6.9% 2.1% Others 2.0% NA pital Blood Banks*soH  50 SAE "Grade 0" 1600 The causes of dysfunctions differ according to the type of esta - 0 1 2 2003 3 4 1 2 2004 3 4 1 2 2005 3 4 1 2 2006 3 4 1 2 2007 3 4 1500 blishments : - Concerning the HE, the incidents especially occur by : The evolution is about 7.4% per year. Of these, 77.9% were scree -  failure of patient’s identification • ned on Red Cells (RC), knowing that 77.0% of the components is -  defect/lack of control of the documents • sues are RC.  • non respect of the transfusion protocol (Figure 6) In the relevant context, the LBP are transfused before the mis - Figure 6 : Health Establisments’ AE “Grade 0” causes   takes are discovered, and there is no clinical effect or measura - ble biologic effect, which can be helpful for the staff to discover 45.1 % Patient's identification it. Usually, an AR report points 1 or several signs out (up to more 13.7 % Control documents then 15 signs). 7 5 . . 5 8   % % col LBP i of proto taoinedtnfici pser tceliaF eru By definition, the imputability of AE “Grades 0” should be certain, i.e. 2 3 . .4 7     % % Rce ibatmpCo BP Lptei tset  ytili level 4 (Figure 3). However, the level 4 only reaches 98.0% on the pe - in riod 2003-07, probably because of mistakes on the notifications. 1 1 . . 0 4     % % g sendion ript otar g e n gS     aeidror cserP 19.5 % Other Figure 3 : French definitions of imputability Conc main r sons of incidents deal with: Excluded Imputability  0  nsfusi n protocol •  e assi ent • Unlikely Imputability  1  igure p • Pos ible  Imputability 2  a difficult context: vital emer -How E occu s genc ms. Likely Imputability  3 Figure 7 : Blood Centers’ AE “Grade 0” causes Certain Imputability  4 52.1 % Failure respect of protocol 9.0 % Nominative assignment Storage 9.0 % [ Incidence ratio : 0.06 AE of “grade 0” for 1000 LBP 6 9 . .7 9     % % gn aeidnor piitescr n  Pr atioificatPntie I'sntde The incidence ratio is estimated to be at 0.06 for 1 000 compo- 3.5 % Vital emergency nents issues, standard deviation of ± 0.007 (Figure 4). 3.5 % Computer problems However, the heterogeneity among the areas is variable and re - 6.3 % Other mains strong with a scale going from 0 to 0.33 for 1 000 LBP. To the AR “Grades 1 to 4” incidenc [ Corrective a asures for  c 1 o  0 m 0 p 0 a  L re B , P, standard deviation of ± 0.244. e ratio is about 2.7  Most of the “Gra n d d e   s p   r 0 e ” v r e e n p ti o v r e t   s m h e ave been systematically integra - Figure 4 : Incidence ratio ted into rigorous analysis. So far, the investigating and reporting analysis are included in com - Grade 0 number of reports for 1000 LBP per year Grades 1-4 plementary documents joined with the SAE forms. They provide 0.07 3.1 AR Grades 1-4 a better understanding of the causes of the dysfunction and often 3.0 help to set up corrective measures. Henceforth, the healthcare 0.06 SAE "Grade 0" 2.9 those AE to avoid their recurrence on criti -professionals monitor 2.8 cal or specific points such as: 0.05 2.7 • mistakes due to the act of healthcare (bed side control) 2.6 • incorrect healthcare professional practices or non respect of transfusion good practices 0.04 2.5 • insufficiently informed nurses   2.4 • overcharge of work, incorrect checking of recipient’s documents 0.03 2.3 • incorrect control to receipt 2003 2004 2005 2006 2007• unjustified release requirements of LBP or component inversions The study of decrease noted in 2005 and 2006 for the • distribution of expired blood component... 2 curves is still in progress, the results are not yet known.  Indeed, the healthcare professionals manage and gain masteries of the risks. Besides, methodological support of the Department [ Different causes with different origins “Quality control process” or “Management of the quality and pre- One of the main purposes of AE “grade 0” is to identify the events  vention of the risks” has to be sought-after in order to set up ac - with respect to traceability of blood transfusion, both at the hos -  tions’ pital establishments (HE) and at the Blood Centres (BC). ring, a p r l e a  c n. u   r O r n e g nt o l i y n   g p   r e o f v f i o d r e t d s     a o c n c  t o r r a d i i n n i g n   g t , o    t w h it o h s   e a     a R c e ti g o i n o s n ’  a p l  la m n o s n . ito- conclusion 6 years after their implementation, the AE “Grades 0” still represents a challenge for healthcare professionals, as they remain potenti - ally problems in the blood transfusion chain, even in the absence of manifest transfusion effects : Some dysfunctions, linked to human error or equipment failure - even though well known and foreseeable, still stay recurrent. That is why, this survey tends to strengthen the necessity of this kind of mandatory notification. In fact, this type of SAE would not pro - bably have been brought out if the obligation of notification only lies on AR where effects are biologically or clinically measurable. These incidents involve excellent indicator of alert and contribute to improve the transfusion safety, and in all cases, the interpretation and the conclusion call for caution. Finally, in May 07, 2007, the Afssaps has published a Decision which aim is to redefine the AE of “grade 0” according to the Blood Directive 2002/98/CE and the Commission Directive 2005/61/EC, to increase the effectiveness of the “grade 0” reports. The role of the Afssaps is to assure that the efforts undertaken during the last years should be continued and to drive those failures to the reasonable lowest level achieved, as the zero risk may be unreachable. [e-mail]