Organisation of health care for contrast media

Laatst beoordeeld: 24-06-2020

Hospital-based protocols

Develop hospital-based protocols on the safe use of contrast media (CM) describing (preventive) measures, workflow and responsibilities. Protocols should be available about The prevention of adverse reactions.

 

Treatment of adverse reactions.

Safety of gadolinium use.

Contrast media extravasation.

Safe use of catheters using power injectors.

 

A panel of various local experts should establish these protocols. The panel members will depend on the specific protocol (including a nephrologist, a (plastic) surgeon, an internal medicine specialist, a pharmacologist, a cardiologist, an allergology specialist and a radiologist). The referring physician is held responsible for analysing and giving notice of the patient’s kidney function and hypersensitivity reactions to contrast media, instructing about the patient’s medication, and the patient’s after-care. And for taking blood samples for laboratory testing (tryptase levels) in case of moderate to severe hypersensitivity reactions to contrast media and for referring the patient to an allergy specialist in case of moderate to severe hypersensitivity reactions to contrast media. The physician responsible for the procedure should take the decision about contrast administration. Make agreements with the allergy specialist about the procedure for referral and testing for contrast media allergy.

Actions can be delegated to others according to local rules and protocols.

 

Hypersensitivity reactions to contrast media and prevention

Have a description of preventive measures in patients with a previous allergic reaction, for outpatient and clinical patients. Appropriate patient information leaflets should be available, about the procedure and about the preventive measures. Including the instruction about not driving a car/motorcycle for 24 hours after administration of clemastine.

 

Workflow and responsibilities

Responsible person

Action and responsibility

Referring physician

 

Order procedure: contrast-enhanced CT, contrast-enhanced MRI or angiography / intervention

Inform patient about procedure

Assessment hypersensitivity reactions to contrast media

Mention previous hypersensitivity reactions in the order

Instruct patient about preventive measures

Record severe hypersensitivity reactions to contrast media in allergy registry of the patient record

Record all severe drug (including contrast media) adverse reactions at the National Pharmacovigilance Institute LAREB

Physician responsible for the procedure -

Cardiologist/Radiologist/ Nuclear Medicine/ Radiotherapist

Check the order for the imaging examination/procedure

Check previous hypersensitivity reactions to contrast media

Determine examination protocol and the choice of intravascular contrast medium

Determine prophylactic medication

If there is disagreement about the examination order, consult the referring physician

Order contrast medium and prophylaxis medication in patient record

Record and authorize CM safety alerts in patient record

Record all severe drug (including contrast media) adverse reactions at the National Pharmacovigilance Institute LAREB

Physician responsible for the procedure

Before and during examination/procedure:

Check hypersensitivity reactions and prophylactic medication

Check medication and contra-indications

Administration of prophylactic medication

Administration of contrast medium

Recording prophylactic medication and contrast administration in patient record (name, concentration, volume)

Recording presence of any hypersensitivity symptoms

 

Treatment of acute hypersensitivity reactions to contrast media

Have a description of measures in patients with an acute hypersensitivity reaction. Appropriate patient information leaflets should be available, including the instruction about not driving a car/motorcycle for 24 hours after administration of clemastine.

 

Workflow and responsibilities

Responsible person

Action and responsibility

Management of department of the

Physician responsible for the procedure -

Cardiologist/Radiologist/Nuclear Medicine/ Radiotherapist

Drugs (minimum requirement), equipment and protocol available in every room where contrast media are administered

Crash cart in every department where CM are administered

Telephone number rapid response team available

Organisation of regular training of personnel dealing with contrast media in the management of hypersensitivity reactions to contrast media and other emergency situations.

 

Physician responsible for the procedure -

Cardiologist/Radiologist/Nuclear Medicine/ Radiotherapist

Check and stabilize patient

Stop infusing contrast media

Act according to type of reaction

If applicable, call rapid response team

Keep patient for at least 30 minutes after contrast agent injection in a medical environment

After administration of clemastine, instruct the patient that is not possible/safe to drive a car/motorcycle for 24 hours

Determine serum tryptase 1-2h after start of CM administration

Physician responsible for the procedure

Record contrast administration in patient record (name, concentration, volume) – see details below

Record moderate and severe hypersensitivity reactions to contrast media in patient record (in allergy registry)

 

Referring physician

Take blood samples for laboratory testing (tryptase levels) in case of moderate to severe hypersensitivity reactions to contrast media

Refer patient to allergy specialist in case of moderate to severe hypersensitivity reactions to contrast media AND elevated tryptase levels

Record name contrast medium in consult order

Allergy specialist

Test contrast medium given to patient, which caused a hypersensitivity reaction, and alternative contrast media

 

Gadolinium Safety

Have a description of the safety of macrocyclic and linear gadolinium-based contrast agents (GBCA), nephrogenic systemic fibrosis (NSF), signs of gadolinium deposition, preventive measures and when to evaluate kidney function. Use always macrocyclic GBCA. For liver MRI the use of intravenous linear GBCA is allowed, because they are taken up in the liver and meet an important diagnostic need. For MR arthrography the use of intra-articular linear GBCA is also allowed.

 

Workflow and responsibilities

Responsible person

Action and responsibility

Referring physician

 

Order procedure: contrast-enhanced MRI

Check laboratory results for eGFR value or determine eGFR

If eGFR < 30 ml/min, be careful with gadolinium-based contrast agents

Physician responsible for the procedure -

Radiologist

Check order procedure

Check eGFR if available

If eGFR < 30 ml/min consider indication

Re-examine the need for the use of contrast medium with respect to an unenhanced study or other potential imaging modalities

If there is no agreement on indication consult referring physician

Physician responsible for the procedure - Radiologist

Before and during procedure:

Check eGFR

Check contra-indications

Administration of contrast agent

Recording contrast agent administration in patient record (name, volume, concentration)

 

Contrast Media Extravasation

Have a description of measures in patients with extravasation of contrast media. Appropriate patient information leaflets should be available.

 

Workflow and responsibilities

Responsible person

Action and responsibility

Physician responsible for the procedure -

Cardiologist/Radiologist/Nuclear Medicine/ Radiotherapist

Clinical assessment of CM extravasation

Treatment of non-severe extravasation injury

If severe injury, consider a surgical consultation (if needed a plastic surgeon)

Clear instructions to the patient to be aware of alarming symptoms

Record CM extravasation and treatment in patient record

Record contrast extravasation as a complication in the local reporting system

Notify the referring physician

 

Contrast injection via central catheters and ports using power injectors

Have a description of the use of various catheters and ports applicable in the hospital, where use of power injectors for contrast media is permitted.

Workflow and responsibilities

Responsible person

Action and responsibility

Management of department of the

Physician responsible for the procedure -

Cardiologist/Radiologist/Nuclear Medicine/ Radiotherapist

A (digital) protocol should be available in every room where contrast media are administered using power injectors

 

 

 

Exceptions:

Emergency patients/ procedures

In case of a major life-threatening medical condition, requiring rapid decision making including emergency imaging or intervention, determination of the eGFR and assessment of hypersensitivity reactions to contrast media can be postponed. If it is possible to wait a short time without harm to the patient, eGFR should be determined immediately. And assessment of hypersensitivity reactions should be done. When indicated, preventive measures should be taken before the administration of intravascular contrast medium.

 

Recording of hypersensitivity reactions to contrast media

Proper recording of any hypersensitivity reaction to CM is important, but the way of recording is not well standardized and often insufficient (Balfour, 2015; Deng, 2019).

 

It is mandatory that the physician responsible for the administration of the CM accurately records the following:

  • The contrast agent name, dose (volume, concentration), and time of administration in the imaging report and in the electronic patient file.
  • The patient symptoms (blood pressure, pulse, respiration rate, oxygen saturation, skin abnormalities), the treatment given, and the response of the patient to the treatment in the imaging report and in the electronic patient file.
  • Any clinical follow-up and advice on need for future premedication in the imaging report and in the electronic patient file.
  • Any results of consultation with a drug allergy specialist on future CM administration in the electronic patient file.
  • All details of the reaction (blood pressure, pulse, respiration rate, oxygen saturation, skin abnormalities, tryptase levels 1 to 2 hours after start of reaction), in the hospital adverse events register (“complicatie registratie”).
  • The presence of a documented allergy in the electronic patient file allergy registry (“allergie registratie”). This reporting should be based on the name of contrast medium.

 

If the adverse reaction to a contrast medium is severe or unusual, report all details of the reaction to the National Pharmacovigilance Authority (LAREB).

 

Patient information leaflets

Appropriate patient information leaflets on the various radiological examinations with contrast medium should be available. The occurrence of late reactions must be mentioned in these leaflets.

And indicate what patient should do, ask for advice at the hospital or consult their general practitioner.

In addition, appropriate patient information leaflets about preventive measures in patients with a previous allergic reaction, about treatment of acute hypersensitivity reactions to contrast media, and contrast extravasation should be available.

One should consider having these leaflets available in multiple languages.

 

Training of Personnel

It is important that personnel that work in departments where CM are administered to patients are regularly trained in the management of hypersensitivity reactions and other emergency situations. It has been shown that high-fidelity hands-on simulation training programs are more effective than other forms of training, such as didactic lectures or computer-base training (Wang, 2011; Wang, 2014; Parsian, 2018; Ali, 2019). Checklists and visual aids can help personnel in accurate management of hypersensitivity reactions to CM (Gardner, 2018; Parsian, 2018).

Autorisatiedatum en geldigheid

Laatst beoordeeld : 24-06-2020

Laatst geautoriseerd : 24-06-2020

The board of the Radiological Society of the Netherlands will determine at the latest in 2024 if this guideline (per module) is still valid and applicable. If necessary, a new working group will be formed to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be seen as a reason to commence revisions. The Radiological Society of the Netherlands is considered the keeper of this guideline and thus primarily responsible for the actuality of the guideline. The other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Radiologie
Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose
  • Nederlandse Vereniging van Spoedeisende Hulp Artsen
  • Nederlandse Vereniging voor Cardiologie
  • Nederlandse Vereniging voor Dermatologie en Venerologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging van Ziekenhuisapothekers
  • Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
  • Nederlandse Vereniging voor Intensive Care
  • Patiëntenfederatie Nederland
  • Nederlandse Vereniging voor Allergologie en Klinische Immunologie

Algemene gegevens

The guideline development was assisted by the Knowledge Institute of the Federation Medical Specialists and was financed by the Quality Funds for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten: SKMS).

Doel en doelgroep

Goal

The aim of the Part 2 of Safe Use of Contrast Media guidelines is to critically review the present recent evidence with the above trend in mind and tries to formulate new practical guidelines for all hospital physicians to provide the safe use of contrast media in diagnostic and interventional studies. The ultimate goal of this guideline is to increase the quality of care, by providing efficient and expedient healthcare to the specific patient populations that may benefit from this healthcare and simultaneously guard patients from ineffective care. Furthermore, such a guideline should ideally be able to save money and reduce day-hospital waiting lists.

 

Users

This guideline is intended for all hospital physicians that request or perform diagnostic or interventional radiologic or cardiologic studies for their patients in which CM are involved.

Samenstelling werkgroep

A multidisciplinary working group was formed for the development of the guideline in 2016. The working group consisted of representatives from all relevant medical specialization fields that are involved with intravascular contrast administration.

 

All working group members have been officially delegated for participation in the working group by their scientific societies. The working group has developed a guideline in the period from May 2016 until July 2019.

 

The working group is responsible for the complete text of this guideline.

 

Working group

  • A.J. van der Molen, radiologist, Leiden University Medical Centre, Leiden (chairman)
  • R.W.F. Geenen, radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar
  • T. Leiner, radiologist, University Medical Centre Utrecht, Utrecht (until November 2018)
  • H.M. Dekker, radiologist, Radboud University Medical Centre, Nijmegen
  • I.A. Dekkers, clinical epidemiologist and radiologist in training, Leiden University Medical Centre, Leiden
  • K. van der Putten, nephrologist, Tergooi, Hilversum
  • J.G.R. de Monchy, allergologist, DC-Klinieken, Amsterdam
  • H.R.H. de Geus, internist-intensivist, Erasmus Medical Centre, Rotterdam
  • S.W. Zielhuis, hospital pharmacist, Medical Centre Leeuwarden, Leeuwarden
  • O.R.M. Wikkeling, vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten
  • I. Brummer, emergency physician, Treant Healthcare Group, Emmen
  • M. van der Vlugt, cardiologist, Radboud University Medical Centre, Nijmegen (until April 2018)
  • M. Gotte, cardiologist, Free University Medical Centre, Amsterdam (from July 2018)
  • S.H. Kardaun, dermatologist, University Medical Centre Groningen, Groningen (until March, 2018)

 

Methodological support

  • I.M. Mostovaya, senior advisor, Knowledge Institute of the Federation Medical Specialists
  • J. Buddeke, advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)
  • W. Harmsen, advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)

Belangenverklaringen

The working group members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that are related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested at the administrative office of the Knowledge Institute of Medical Specialists and are summarised below.

 

Last name

Function

Other positions

Personal financial interests

Personal relations

Reputation management

Externally financed research

Knowledge valorisation

Other interests

Signed

Van der Putten

Internist nephrologist

None

None

None

None

None

None

None

14-10-2015

Van der Vlugt

Cardiologist

None

None

None

Chairman of the working group Cardiac MRI & CT and Nuclear imaging of the Netherlands Society of Cardiology

None

None

None

03-01-206

Roodheuvel

Emergency physician

Instructor OSG/VvAA for courses on echography – paid position

Member of department for burn treatment – unpaid.

None

None

None

None

None

None

21-12-2015

Geenen

Radiologist

Member of commission prevention of PC-AKI

None

None

None

None

None

Has held several presentation about contrast media on invitation (GE, BAYER)

25-3-2016

Zielhuis

Hospital pharmacist

None

In the past (2013-2015) has participated in an advisory panel on expensive medication for the companies AbbVie and Novartis. Has received an expense allowance for this. Both forms do not produce contrast media that this guideline is about. Currently not active in an advisory panel.

None

None

None

None

None

8-1-2016

De Geus

Internist-Intensivist Erasmus MC Rotterdam

None

None

None

None

None

None

None

Ja, 31-03-2016

Dekkers

Radiologist in training and PhD-candidate

None

None

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Ja, 8-7-2016

Wikkeling

Vascular surgeon

None

None

None

None

None

None

Not applicable

19-7-2016

Dekker

Radiologist

None

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

10-7-2016

Van der Molen

Chairman
Radiologist at LUMC

None

None

None

None

None

Not applicable

One-off royalties Springer Verlag (2014)
Reference work Safety of contrast medicine
One-off payment by Guerbet for (2014)
reference card management of CM reactions (educative material)

Incidental payments for presentations or being day chairman at contrast safety congress (2016 Netherlands + Europe
all firms: GE, Guerbet, Bracco, Bayer

6-9-2016

Kardaun

Dermatologist - researcherUniversitair Medisch Centrum Groningen: unpaid

Replacing dermatologist in clinical practice - unpaid
Member of scientific advisory board of Lareb (Dutch center for pharmacovigilance): unpaid

None

None

None

None

None

None

24-2-2016

Brummer

Emergency physician
Treant zorggroep location Emmen and Stadskanaal

None

None

None

None

None

None

None

23-2-2018

Inbreng patiëntenperspectief

It was challenging to find representation for the patient’s perspective, since the guideline does not discuss a specific group of patients with a disease. The Dutch Kidney Patients Association was invited to participate in an advisory board to the working group, but declined since this subject was not specific enough for them to give adequate input; The Dutch Kidney Patients Association did provide written feedback for specific modules during the commentary phase. The Dutch Kidney Patients Association and the Patient Federation of the Netherlands was invited to participate in the invitational conference in which the framework of the guideline was discussed. Furthermore, the concept guideline has been submitted for feedback during the comment process to the Patient Federation of the Netherlands and the Dutch Kidney Patient Association.

Methode ontwikkeling

Evidence based

Implementatie

In the different phases of guideline development, the implementation of the guideline, and the practical enforceability of the guideline were taken into account. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found with the Related Products. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found with the Related Products.

Werkwijze

AGREE

This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel. This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).

 

Identification of subject matter

During the initial phase of the guideline development, the chairman, working group and the advisor inventory the relevant subject matter for the guideline. Furthermore, an Invitational Conference was organized, where additional relevant subjects were discussed. A report of this meeting can be found in Related Products.

 

Clinical questions and outcomes

During the initial phase of guideline development, the chairman, working group and advisor identified relevant subject matter for the guideline. Furthermore, input was acquired for the outline of the guideline during an Invitational Conference. The working group then formulated definitive clinical questions and defined relevant outcome measures (both beneficial land harmful effects). The working group rated the outcome measures as critical, important and not important. Furthermore, where applicable, the working group defined relevant clinical differences.

 

Strategy for search and selection of literature

For the separate clinical questions, specific search terms were formulated and published scientific articles were sought after in (several) electronic databases. Furthermore, studies were scrutinized by cross-referencing for other included studies. The studies with potentially the highest quality of research were looked for first. The working group members selected literature in pairs (independently of each other) based on title and abstract. A second selection was performed based on full text. The databases, search terms and selection criteria are described in the modules containing the clinical questions.

 

Quality assessment of individual studies

Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search, so that risk of bias could be estimated. This is described in the “risk of bias” tables.

 

Summary of literature

The relevant research findings of all selected articles are shown in evidence tables. The most important findings in literature are described in literature summaries. When there were enough similarities between studies, the study data were pooled.

 

Grading quality of evidence and strength of recommendations

The strength of the conclusions of the scientific publications was determined using the GRADE-method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org/) (Atkins, 2004).

 

GRADE defines four gradations for the quality of scientific evidence: high, moderate, low or very low. These gradations provide information about the amount of certainty about the literature conclusions. (http://www.guidelinedevelopment.org/handbook/).

 

Formulating conclusions

For diagnostic, etiological, prognostic or adverse effect questions, the evidence was summarized in one or more conclusions, and the level of the most relevant evidence was reported. For intervention questions, the conclusion was drawn based on the body of evidence (not one or several articles). The working groups weighed the beneficial and harmful effects of the intervention.

 

Considerations

Aspects such as expertise of working group members, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects were discussed in the paragraph Considerations.

 

Formulating recommendations

The recommendation answers the clinical question and was based on the available scientific evidence and the most relevant considerations.

 

Constraints (Organisation of healthcare)

During the development of the outline of the guideline and the rest of the guideline development process, the Organisation of healthcare was explicitly taken into account. Constraints that were relevant for certain clinical questions were discussed in the Consideration paragraphs of those clinical questions. The comprehensive and additional aspects of the Organisation of healthcare were discussed in a separate chapter.

 

Development of quality indicators

Internal (meant for use by scientific society or its members) quality indicators are developed simultaneously with the guideline. Furthermore, existing indicators on this subject were critically appraised; and the working group produces an advice about such indicators. Additional information on the development of quality indicators is available by contacting the Knowledge Institute for the Federation Medical Specialists. (secretariaat@kennisinstituut.nl).

 

Knowledge Gaps

During the development of the guideline, a systematic literature search was performed the results of which help to answer the clinical questions. For each clinical question the working group determined if additional scientific research on this subject was desirable. An overview of recommendations for further research is available in the appendix Knowledge Gaps.

 

Comment- and authorisation phase

The concept guideline was subjected to commentaries by the involved scientific societies. The commentaries were collected and discussed with the working group. The feedback was used to improve the guideline; afterwards the working group made the guideline definitive. The final version of the guideline was offered for authorization to the involved scientific societies and was authorized.

 

References

Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-E842.

Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwalitieit, 2012. Available at: https://richtlijnendatabase.nl/over_deze_site/richtlijnontwikkeling.html.

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available at: http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10. Erratum published in: BMJ 2008;336(7654).

Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten.