The role of justification and radiation protection of patients: IAEA perspective

Ola Holmberg, PhDHead, Radiation Protection of Patients Unit (RPOP)

Division of Radiation, Transport and Waste Safety (NSRW)

Regional Workshop on Imaging Referral Guidelines13-16 December 2015

Cairo, Egypt

Benefits of the use of radiation in medicine

0

1000

2000

3000

4000

5000

6000

7000

1988 2008

130 %122 %

26 %

Number of diagnostic procedures, million

Collective dose,1000 man Sv

World population, million

Global increase in the use of radiation

Diagnostic radiology

3.6 billion procedures annually* (incl. dental)

Nuclear medicine

33.5 million procedures annually*

Radiotherapy5.1 million radiotherapy

treatment courses annually*

* UNSCEAR 2008 Report

Global increase in the use of radiation

More can be done with radiation in medicine

• More equipment• More complex equipment• New technologies and techniques

Single slice CT Multi-Detector CTFilm Computed & Digital RadiographyHybrid imaging, PET-CTImage-guided interventional proceduresTomosynthesisPACS, RIS,IMRT, IGRTetc…

Access vary around the worldIssues vary around the worldTailored approaches needed

The increasing medical exposure

UNSCEAR 1993

Global annual per caput effective dose

The increasing medical exposure

UNSCEAR 2008

Global annual per caput effective dose

The increasing medical exposure

NCRP160 2009

U.S. annual per caput effective dose

“Do more good than harm”

Radiation can cause harmRadiation saves livesShort-term effects

(deterministic)Long-term effects

(stochastic)- Carcinogenesis- Hereditary effects- Effects in the

embryo/foetus

“Primum non nocere”

Patient dose and individual risk vary greatly

0.01mSv 0.1mSv 1mSv 10 mSv

Radiography

CT, NM, Image guided interventional

procedures Skin doses – Image guided interventional

proceduresRadiation therapy,

mainly to the target volume

Annual dose from natural background

Increased risk of cancer

Tissue reactions (skin, eye lens,..)

100 mSv

1 000 mSv

10 000mSv

100 000 mSv

Lethal whole body dose

Radiological procedures

Radiation risk

Medical radiation can cause harm

• Over the last three decades, at least 3000 patients have been reported to be affected by radiotherapy incidents and accidents. This is likely grossly under-reported

• Radiation accidents involving medical uses have accounted for more deaths and early acute health effects than any other type of radiation accident, including accidents at nuclear facilities

• ICRP principles of radiation protectionoDose limits don’t apply to medical exposuresoJustification - net benefit for the patientoOptimization - achieve clinical purpose with appropriate dose

management

Radiation risk

Achieve clinical purpose

A need for radiation protection in medicine

“Primum non nocere”

Justification and optimization in medicine

Medical exposure is overwhelmingly the most significant manmade source of exposure to the population from ionizing radiation

Issues around the optimization (e.g. wide variation in doses reported for the same type of CT-scan)

Issues around the justification (a substantial fraction of radiological examinations may be inappropriate)

Justification of medical exposure

• Evidence that many individual medical procedures are lacking in justification and optimization, giving rise to a very significant unnecessary exposure of the world’s population

• A substantial fraction (20% to 40%) of individual radiological examinations may be unnecessary

ICRP identifies three levels at which justification operates:

Level 1 deals with use of radiation in medicine in general (In practice this is accepted as doing more good than harm, and its

justification is taken for granted)

Level 2 deals with specified procedures with a specified objective (The aim at this level is to judge whether the procedure will improve

diagnosis or provide necessary information about those exposed)

Level 3 deals with the application of the procedure to an individual (The particular application should be judged to do more good than harm for the

individual patient)

Justification of medical exposure

• What are the factors behind these unnecessary exposures?

• Lack of knowledge about the patient from referring physician (non-adequate examination of patient, duplicate examinations)

• Lack of knowledge about the procedure or alternatives (benefits and/or risks)

• Variations in local practice (not based on evidence but on “tradition”)• Evidence not available to relevant healthcare providers• Lack of certainty, confidence or experience (radiologist)• Pressure and expectations from patient• Referring physician is also the provider of the service (self-referral,

economic interest)• Referring as a safeguard against possible malpractice liability (defensive

medicine)• …• End result: High and increasing “unnecessary radiation burden”

experienced by the global population – arising from different basic “drivers”

Addressing radiation risk

Q: Are there radiation risks to take into account?

A: We are uncertain. Uncertainty arises from numerous factors:

Figure from: P.W. Horton: “Dose and risk: the hard facts”. In: PROCEEDINGS OF AN INTERNATIONAL WORKSHOP ON JUSTIFICATION OF MEDICAL EXPOSURE IN DIAGNOSTIC IMAGING”, IAEA IN COOPERATION WITH THE EC, BRUSSELS, 2–4 SEPTEMBER 2009

• Uncertainty in radiation risk estimation

• Natural variation of disease occurrence in populations

• Limited information on exposed populations

• Incomplete understanding of the origins and development of cancer

Addressing radiation risk

Q: So what can we do when we are uncertain of the risks?

A: We can apply the Precautionary Principle

• Act in a balanced way to reduce potential hazards before there is strong proof of harm, taking into account the likely risks and benefits of action and inaction

• In clinical imaging using ionizing radiation:• We are uncertain of the risks from imaging investigations using

ionizing radiation• We know that a significant percentage of imaging investigations

using ionizing radiation are unnecessary• As a scientific community, we owe it to the public to reduce

unnecessary exposures, and to look for the beneficial relatively lower-dose alternatives in imaging, in a balanced way

“To establish or adopt … standards of safety for protection of health and minimization of danger to life … and to provide for the application of these standards”

IAEA statute

Safety Guides

Safety Requirements

Safety Fundamentals

All Safety Standards go through the IAEA Safety Standards Committees and Commission, and receive formal Member State comments

Fundamental safety objectives and principles for protecting people and environmentmoral obligation

Requirements that must be met to ensure protection of people and environment legal obligations, "shall"

Recommended ways of meeting the requirements, “should”

IAEA Safety Standards hierarchy

Review2005 - 2006

Revision2007- 2011

IAEA approval2011

IAEA and other cosponsors:

FAO, ILO, NEA/OECD, PAHO, UNEP, WHO, EC

Cosponsor approval2012

1996

Published July 2014

International BSS

IAEA Member States (162)

Effects of radiation

Recommendations for protection

Essential principles

(moral obligation)

Essential requirements

(legal obligation)

International BSS

• The International BSSo Represent an international consensus on

what must constitute a high level of protection and safety

o Mandatory for Member States receiving technical assistance from IAEA

o Used as a basis for many national regulations

o Jointly sponsored by other international organizations, allowing organizations to provide consistent advice and assistance to the various government agencies of their Member States

International BSS

New BSS - Justification of medical exposures

• Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits that they are expected to yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure.

• Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments.

Who? – Respective roles and issues

• Clinical context, medical history• Defensive medicine

• Knowledge about procedure – benefits, risks, limitations

• Financial conflict of interest

Referral guidelines / criteria of appropriateness

..shall be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, ….

Referring physicians Radiological practitioner

“Request for consultation” versus “order/instruction to perform”

Justification for an individual patient

• What needs to be considered?• Appropriateness of the request• Urgency of the procedure• Characteristics of the exposure• Characteristics of the individual patient• Relevant information from previous radiological procedures

Particular attention to be taken for patients who are pregnant or breast-feeding or are paediatric

“Relevant national or international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure”.

Clinical Imaging Guidelines

Ima

gin

g stud

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Co

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Ionizin

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Is it indica

ted?

Clinical Imaging Guidelines

Guidelines that can be used by a clinician when deciding whether or not a particular imaging study is justified, taking into account risk and benefit, for answering the clinical question about a patient who exhibits a specific set of conditions

Clinical Imaging Guidelines

• Clinical imaging guidelines (CIGs) are consensus statements based on the best available evidence, to help physicians to prioritize patients’ needs.

• CIGs for appropriate use of radiation in medical imaging have been developed by professional bodies in several countries.

• However, they are not available worldwide, particularly in developing countries. Even in those countries where CIGs exist, they are not integrated into daily medical practice.

MBUR6 EVIDENCE TABLE: Chronic back pain with no clinical or serological indicators of infection or neoplasia

MBUR6 Reference:

M04

Clinical/Diagnostic Problem:

Chronic back pain with no clinical or serological indicators of infection or neoplasia

Investigation: MRI

Dose None

Recommendation: Indicated

Grade of recommendation: A-C

[C]

Comment: MRI is the preferred investigation for the diagnosis of most spinal diseases.

Median Delphi Likert score for consensus

Clin. problem Modalities

Grading Comments

6/7 6/7 7/7 6/7

Literature Search Results: No. found; No. used

Found – 138Used – 13

Existing NICE, SIGN & ACR Appropriateness Criteria:

Low Back Painhttp://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonNeurologicImaging/LowBackPainDoc7.aspx

Highest level of evidence:

I

Date of Delphi review:

2006

Composition of Review Panel (not for publication):

Removed

Ref Papers referenced / [Evidence level] / Key references/ Hyperlinks

Royal College of Radiologists (RCR)

American College of Radiology (ACR)

Western Australia

Clinical Imaging Guidelines

• CIG are expensive, time consuming and difficult to produce and maintain

• Several sets of high quality CIG exist and can be adopted and adapted

• Many differences exist between countries-expertise, equipment, disease prevalence, IT infrastructure, financial and other resources, access to care, level of interest

• Is adaptation/adoption of existing CIG preferable to creation?

• What resources are currently available?• What Are the major real and potential obstructions to CIG

deployment and use?

Clinical Imaging Guidelines

BSS on Review and records

• Licensees shall ensure that radiological reviews are performed periodically at medical radiation facilities and that records are maintained.

• Radiological reviews:

• Performed periodically by the radiological medical practitioners at the facility

• Include an investigation and critical review of the current practical application of the radiation protection (justification and optimization)

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