Meeting on “Incident Reporting in Radiotherapy” September 3, 2010

1. Meeting on “Incident Reporting in Radiotherapy”September 3, 2010 Notification and public information on patient events in France in the context of radiotherapy Aurélie ISAMBERT Nuclear Safety Authority Ionizing radiation and health Department FRANCE aurelie.isambert@asn.fr

2. CONTENT Notification system in France Legal obligation Notification criteria Public information on patient events ASN-SFRO scale Communication Some figures

3. CONTENT Notification system in France Legal obligation Notification criteria Public information on patients events ASN-SFRO scale Communication Some figures

4. Legal obligations: Significant events must be notified as specified in the public health code (CSP) : L. 1333-3modified by law n°2009-879 of July 21st, 2009 – art. 106 (V) The licensee and the health professionals involved in the treatment or in the follow up of exposed patients must notify without delay to ASN any accident or incident likely to affect human health through exposure to ionizing radiation R. 1333-109modification expected in that terms: The licensee and the health professionals involved in the treatment or in the follow up of exposed patients have to notify to ASN any events or incidents likely to have consequences for the health of person exposed to ionizing radiation as part of a medical procedure 1. Notification system

5. 1. Notification system Draft guidance for notification of significant events in radiation protection (guidance ASN/DEU/03)with operational criteria (www.asn.fr) published by ASN on June 2007 Experimental guidance => assessment is underway before making it mandatory by a technical decision from ASN, subject to approval by Minister of Health

6. 1. Notification system Criteria 2.1: Patient exposure as part of a therapeutical procedure: Any unexpected situation or any organizational, material or human malfunction occurring during radiation treatment of a patient resulting in: - improper treatment regarding the prescribed dose or - the occurrence of unpredictable deterministic effects given the therapeutic strategy decided with full-inform consent of the patient.

7. 1. Notification system Criteria 2.1: Patient exposure as part of a therapeutical procedure: • The conformity of the dose includes: • for radiotherapy and brachytherapy, compliance with a tolerance of • +/- 5% of the total prescribed dose + compliance with the planned schedule and/or fractionation, taking into account any clinical or technical constraints for the patient treatment; • for internal targeted therapy, compliance with a tolerance of + 10% of the prescribed activity of administered radiopharmaceutical; • non-systematic dose error likely to affect several patients, regardless of the value of the error. • + any incorrect identification of patient must be declared

8. CONTENT Notification system in France Legal obligation Notification criteria Public information on patient events ASN-SFRO scale Communication Some figures

9. INES scale does not cover events concerning persons exposed intentionally in the context of medical procedures (patients) Needed after a severe accident (Epinal accident led to 5 fatalities and acute effects to few tens of patients) to provide the public with accessible information and to facilitate the understanding of the severity of an event 1- Public information • A legal obligation for ASN: the TSN Act recalls and confirms the role of ASN

10. Elaborated in July, 2007 by ASN with SFRO (French society of radiation oncologists) and tested for a 12-month period Evaluated with professionals (SFRO and SFPM, French society of medical physicists) in June, 2008 Final scale was published on ASN website in July, 2008 2. Public information – ASN-SFRO Scale

11. The events are rated on an 8-level severity scale (from 0 to 7, as INES) The scale refers to an international clinical classification and incorporate clinical grading tables already used by practitioners (CTCAE-Cancer Therapy Evaluation Program) Grade 1 (mild effects) Grade 2 (moderate effects) Grade 3 (severe effects) Grade 4 (serious or life-threatening effects) Grade 5 (death) 2. Public information – ASN-SFRO Scale

12. Taking into account the expected effects due to overexposure (overdose or inappropriate volume) For confirmed effects, over-rating will be used to take into account the number of patients concerned 2. Public information – ASN-SFRO Scale

13. if nber of patients > 1, sign + is added to the level 2. Public information – ASN-SFRO Scale

14. 2. Public information – ASN-SFRO Scale Radiotherapy Department Level is proposed by the Radiotherapy Department SFRO ASN ASN consults ASN rates the event on the ASN-SFRO scale and informs the Radiotherapy Department

15. 2. Public information – ASN-SFRO Scale TERMINOLOGY COMMUNICATION ASN Annual report Press Release 7 Incident notice published on ASN website Front page of the ASN website 6 ACCIDENT 5 4 3 INCIDENT 2 1 EVENT Anonymized quarterly report 0

16. 2. Public information – ASN-SFRO Scale

17. The radiotherapy department is responsible for its own communication ASN information gives the rating of the event on the ASN-SFRO scale and is mainly focused on the steps taken by ASN to assess the situation and draw out the necessary safety conclusions The physician must have informed the patient within the maximum legal period of 15 days (L. 1142-4 of the Public Health Code) 2. Public information – ASN-SFRO Scale

18. CONTENT Notification system in France Legal obligation Notification criteria Public information on patients events ASN-SFRO scale Communication Some figures

19. Number of events notified per month since 2007 Number of events 2d half of the year. 2007 : 56 2008 : 199 2009 : 221 Number of Events notified in 2009, rated on ASN-SFRO scale Out of scale Level ≤ 1 Level ≤ 2

20. THANK YOU FOR YOUR ATTENTION