patient group direction for the administration of iodinated contrast … · radiographers working...

NHS Grampian

Patient Group Direction For The Administration Of Iodinated Contrast Agent For Injection Required In Diagnostic Computed Tomography Scans By Registered Radiographers Working Within NHS Grampian

Lead Author: Consultation Group: Approver:

Specialist Radiographer, See relevant page in the Medicine Guidelines and CT Department PGD Policies Group

Signature:

e0S.S

Signature:

(A-4 iiiiaiuk

Identifier; Review Review Date: Date Approved:

NHSG/PGD/ContrastMedia/ July 2019 July 2017 MGPG889

A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn

up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory

committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group

Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way.

Uncontrolled when printed

Version 1

UNCONTROLLED WHEN PRINTED Review Date: July 2019 Identifier: NHSG/PGD/ContrastMedia/MGPG889 - i - PGD For The Administration Of Iodinated Contrast Agent For Injection Required In Diagnostic CT Scans By Registered Radiographers - Version 1

This document is also available in large print and other formats and languages, upon request.

Please call NHS Grampian Corporate Communications on (01224) 551116 or (01224)

552245. Revision History: Date of change

Approval date of PGD that is being superseded

Summary of Changes

Section heading

New PGD Subject: Patient Group Direction Identifier: NHSG/PGD/ContrastMedia_PGD/MGPG889 Replaces: New PGD Keyword(s): PGD Patient Group Direction PGD Patient Group Direction

Iodinated contrast Agent injection CT scans radiographers computed tomography pressure injector

Policy Statement: It is the responsibility of individual registered radiographers and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. The lead author is responsible for the review of this PGD as well as its dissemination. Pharmacy and Medicines Directorate is responsible for ensuring registration of this document. Review date: The review date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised. Document: Drafted: August 2016 Completed: May 2017 Approved: July 2017 (published – August 2017)

UNCONTROLLED WHEN PRINTED Review Date: July 2019 Identifier: NHSG/PGD/ContrastMedia/MGPG889 - 1 - PGD For The Administration Of Iodinated Contrast Agent For Injection Required In Diagnostic CT Scans By Registered Radiographers - Version 1

Patient Group Direction For The Administration Of Iodinated Contrast Agent For Injection Required In Diagnostic Computed Tomography Scans By Registered Radiographers Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition

This Patient Group Direction (PGD) will authorise registered radiographers working in Computed Tomography (CT) to administer iodinated contrast agent to patients requiring injections for diagnostic CT scanning investigations. This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF), Society of Radiographers Code of Professional Conduct and individual Summary of Product Characteristics (SPC).

Inclusion criteria

Patients who may be considered for the administration of Iodinated Contrast Agent • All patients 16 years and over whom require iodinated

contrast agent to show the anatomy of the blood vessels and organs, where non contrast sequences cannot provide full information.

• All patients 16 years and over who have given valid consent to be treated by a radiographer under this PGD and where contrast injection is deemed necessary.

• All patients 16 years and over where their parent, guardian or person of responsibility has given signed consent for treatment by a radiographer under this PGD and where contrast injection is deemed necessary.

• For unconscious/unresponsive patients, consent is to be signed by referring/accompanying clinician or radiologist on behalf of the patient.

Exclusion criteria

Patients who fit the inclusion criteria may be administered iodinated contrast agent under this PGD unless: • They are under 16 years of age. • They are allergic (hypersensitive) to iodine or any of the

excipients. • They have thyrotoxicosis. • They are pregnant.


• They have had a recent examination involving the

administration of contrast media (within the last 4 weeks). • They have deranged urea and creatinine levels, e.g.

outwith the following normal limits; o Urea 2.5-7.8mmol/L o Creatinine 50-100µmol/L

• They have a known eGFR < 45. • No recent eGFR blood result (7 days for patients who have

acute illness or who are known to have renal disease, 4 weeks for in-patients and 3 months for out-patients).

Information relating to local eGFR guidelines can be found with the following link: (http://ari-sp-moss2:25001/depts/Radiology/Pages/eGFR.aspx)

Precautions and special warnings

Precautions • Ensure that a recent (within 3 months) blood test has been

taken and that the results are within normal limits for creatinine, urea and eGFR.

• Ensure the patient is well hydrated (2 litres oral fluid over 12 hours pre and post contrast administration).

• Extravasation of contrast media may on rare occasions give rise to local pain, and oedema, which usually recedes without sequelae. However, inflammation and even tissue necrosis have been seen. Elevating and cooling the affected site is recommended as routine measures.

• Contrast agents are poorly excreted in human breast milk and a minimal amount is absorbed by the intestine. Breast feeding may be continued normally when contrast agent has been administered to the mother.

Special Warnings Care should be taken if the patient currently has or may have had previously any of the conditions listed below due to the increased risk of contrast reaction. However, it should be noted that these conditions do not exclude patients from receiving therapy. Radiographers should exercise their professional judgement with regard to administering contrast agent. If there is any doubt as to the patient’s suitability they should be discussed with a radiologist. • Multiple allergies, with the exception of iodine which is an

exclusion criteria. • Asthma (please ensure all patients are advised to attend

with their reliever inhalers). • Diabetes.

http://ari-sp-moss2:25001/depts/Radiology/Pages/eGFR.aspx


• Any disease or tumour of the brain. • Severe heart disease. • Kidney problems or both liver and kidney problems. • Myasthenia gravis. • Adrenal gland tumour that affects blood pressure

(phaeochromocytoma). • Blood or bone marrow disorders. • Dependence on alcohol or drugs. • Epilepsy. • Pulmonary hypertension. • Hyperthyroidism.

Referral criteria

Patients who fall into the categories detailed in the exclusion criteria will be referred back to referring clinicians. The radiographer should not administer Iodinated Contrast Agent and seek radiologist advice if they feel that it is inappropriate for the patient, e.g. the patient has answered yes to an exclusion criteria question.

Action if excluded from treatment

If a patient is excluded from treatment under this PGD, medical advice should be sought – refer to a radiologist. The reason why the patient was excluded under the PGD will be documented in the patient’s medical notes.

Action if patient declines treatment

Prior to the examination, the patient will be asked a series of questions from a checklist, following which the patient will have to give valid consent for the examination to proceed. The checklist will be scanned into the Radiology Information System as a record following the procedures outlined in the PGD. Advice should be given to the patient about the potential consequences of them declining the examination and this should be documented on the Radiology Information System. Refer to the radiologist for discussion with the patient’s consultant.

Consent

Prior to the administration of Iodinated Contrast Agent, valid consent must be obtained, either by the patient, parent, guardian, person with parental responsibility or referring clinician/radiologist. This consent should be documented in the pre CT questionnaire used locally.


Consent must be in line with current NHSG “Staff Policy of Obtaining Consent for Clinical Procedures and Healthcare Interventions”. See link below. http://ari-sp-moss2:25001/depts/qgru/clinicalgovernance/pages/consent.aspx

Description of treatment available under the PGD Name of medicine

See individual product monographs.

Legal status

Medicines referred to in this PGD are all Prescription-only Medicine (PoM).

Form/Strength


Route/Method of administration

Medicines referred to in the PGD are administered via an intravenous cannula, located in the upper or lower extremity. If access is difficult a preplaced central line may be used. This injection can be administered by intravenous injection or via an injector pump.

Dosage/Total Dose


Duration of treatment

One administration during CT scan.

Storage requirements


Follow-up (if applicable)


Advice to patient (Verbal)

All iodinated contrast media may interfere with tests on thyroid function, thus the iodine binding capacity of the thyroid may be reduced for up to several weeks. Therefore patients should be advised to avoid thyroid function tests for several weeks following CT scan.

http://ari-sp-moss2:25001/depts/qgru/clinicalgovernance/pages/consent.aspx




Patients advised to drink 1 litre of fluid prior to examination and 1 litre post examination over a six hour period.

Advice to patient (Written)

The patient information leaflet contained in the medicine(s) should be made accessible to the patient, parent, guardian, or person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given in a language that they can understand. Copies of Patient Information Leaflets and SPCs for all medicines can be found at http://www.medicines.org.uk

Concurrent Medications/Drug Interactions


Adverse effects and managing possible adverse reactions

See individual product monographs. Both the referring clinician and the radiologist need to be informed of all adverse reactions. The following documents must be completed: • A DATIX incident form. See link below:

http://nhsg-sql-datix.nhsg.grampian.scot.nhs.uk/datix/live/index.php

• Contrast reaction documentation (forms held locally) which should then be scanned into the Radiology Information system.

• For adverse reactions the yellow card documentation must be completed. See link below: https://yellowcard.mhra.gov.uk/

Medical advice in cases of anaphylaxis Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should it occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to the Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals).

http://www.medicines.org.uk/



https://yellowcard.mhra.gov.uk/


Facilities and supplies required

The following should be available at sites where the Iodinated Contrast Agent is to be administered: • Appropriate storage facilities and pharmaceutical warmer. • An acceptable level of privacy to respect patient’s right to

confidentiality and safety. • Resuscitation equipment. • Access to medical support • Approved equipment for the disposal of used materials. • Clean and tidy work areas including access to hand

hygiene facilities. • Copies of the current PGD for the medicine specified in

the PGD. • PGD for the administration of Adrenaline (epinephrine) in

cases of suspected anaphylactic reactions by qualified health professional.

Characteristics of staff authorised to administer medicine under PGD Professional qualifications

Registered Radiographers as recognised by the Health and Care Professions Council (HCPC) and working within the CT department.

Specialist competencies

Be competent to assess the patient’s capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. Has undertaken the appropriate departmental training as set out in the CT training guide to carry out clinical assessment of patients, including IV cannulation course and in-house training on the injector pumps. Be aware of current treatment recommendations and be competent to discuss issues about the drug with the patient. Is competent in the administration of the drug.

Ongoing training and competency

Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session (and annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eKSF, or the AT Learning® tool.


Maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. The practitioner must be familiar with the SPC for all medicines supplied in accordance with this PGD.

Professional managers/Lead Radiographers will be responsible for:

Ensuring that the current PGD is available to staff providing care under this direction. Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. Maintaining a current record of all staff authorised to administer the drug specified in this PGD.

Authorisation of administration

Registered Radiographers working within the CT Department, Radiology can be authorised to administer the drug specified in this PGD by their unit clinical director. All authorised staff are required to read the PGD and sign the Agreement to Administer Medicines Under PGD (Appendix 1). A certificate of authorisation (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual practitioners records, or as agreed locally.

Record of administration/ supply

An electronic or paper record for recording the screening of patients and the subsequent administration of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: • Name and address of patient • Patient CHI No and date of birth • Details of parent/guardian, or person with parental

responsibility where applicable • Consultant/General Practitioner details • Risk group, if appropriate • Findings of physical examination, if appropriate • Exclusion criteria, record why drug not administered • Reason for giving • Consent to the administration (if not obtained elsewhere)


• Drug manufacturer, batch number and expiry date

(Vaccines and injectable medicines) • Site where drug administered, dose and route of

administration • Signature and name in capital letters of practitioner who

administered the drug • Date drug given • Record of any adverse effects (advise patient’s doctor). These records should be retained: For children and young people, retain until the patient's 25th birthday or 26th if the young person was 17 at the conclusion of treatment. For 17 years and over retain for 6 years after last date of entry, for 3 years after death, or in accordance with local policy, where this is greater than above.

Audit

All records of the administration of the drug specified in this PGD will be filed with the normal records of medicines in each practice/service. The superintendent radiographer within the CT department will be responsible for auditing completion of drug forms and collation of data. Each radiographer must complete a bi-yearly audit and is responsible for reporting the results to the radiology clinical director.

References

Society of Radiographers Code of Professional Conduct 2013, accessed 25/04/2016 http://www.sor.org/learning/document-library/code-professional-conduct Medicines and Healthcare Products Regulatory Agency (https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency) Scientific leaflet for Iohexol (Omnipaque® 350 – GE Healthcare Date of revision of text August 2014, accessed 25/04/2016 Summary of Product Characteristics (UK SPC) – For Omnipaque® 350 – GE Healthcare – Current at 15/07/2016

http://www.sor.org/learning/document-library/code-professional-conduct

http://www.sor.org/learning/document-library/code-professional-conduct

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Scientific leaflet for lomeprol (lomeron 400)— Bracco UK Limited. Date of revision of text December 2015, accessed 09/01/2017

Summary of Product Characteristics (UK SPC) — For lomeron® 400— Bracco UK Limited — Current at May 2016

Management and Monitoring of Patient Group Direction

PGD Consultative Group

The consultative group is legally required to include a medical practitioner, a pharmacist and a representative of the of the professional group who will provide care under the direction

Name: Title:

Janet Hasell Lorna Main Alan Riddoch Frances Adamson Suzanne Ross Dr Shonagh Walker Dr Dympna McAteer

Pharmacist: Clinical Pharmacist AR! Specialist Radiographer Radiography Manager Medicines Management Specialist Nurse Lead Author: Specialist Radiographer Medical Professional: Unit Clinical Director Acting Unit Clinical Director

Authorising Managers

Dr Nick Fluck Medical Director, NHS Grampian

Mr David Pfleger

-

Director Director of Pharmacy and Medicines Management, NHS Grampian

Professor Amanda Croft Director of Nursing, Midwifery and AHPs, NHS Grampian

UNCONTROLLED WHEN PRINTED Review Date: July 2019 Identifier NHSG/PGD/ContrastMedia/MGPG8139 - 9 - POD For The Administration Of Iodinated Contrast Agent For Injection Required In Diagnostic CT Scans By Registered Radiographers - Version 1


Appendix 1

Health Care Professional Agreement to Administer Medicines Under Patient Group Direction

I:

(Insert name)

Working within:

Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Iodinated Contrast

Agent For Injection Required In Diagnostic Computed Tomography Scans By Registered Radiographers Working Within NHS Grampian

I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor out with the recommendations of the Patient Group Direction. Signed:

Print Name:

Date:

Professional Registration No:


Appendix 2

Certificate Of Authorisation To Administer Medicines Under Patient Group Direction

This authorises:

Working within:

To administer medicines under the following Patient Group Direction Patient Group Direction For The Administration Of Iodinated Contrast

Agent For Injection Required In Diagnostic Computed Tomography Scans By Registered Radiographers Working Within NHS Grampian

The above named person has satisfied the training requirements and is authorised to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor out with the recommendations of the Patient Group Direction Signed:

Authorising Manager/Doctor

Print Name:

Date:


Appendix 3 Medicine Monographs Drug Name Page No IOHEXOL (OMNIPAQUE® 350) Solution for Injection (ADMINISTER) ..................... 13

IOMEPROL (IOMERON® 400) Solution for Injection (ADMINISTER) ....................... 17


IOHEXOL (OMNIPAQUE® 350) Solution for Injection (ADMINISTER)

Drug Group

X-ray contrast media, iodinated.

Drug Legal Status

PoM

Presentation

Solution for injection

Indication

This medicinal product is for diagnostic use only. It is a contrast medium for use in adults undergoing a CT scan to show the anatomy of the blood vessels and organs, where non-contrast sequences cannot provide full information.

Route/Method of Administration

Slow intravenous injection via a flexible intravenous cannula. Omnipaque® 350 should be inspected visually for particulate matter, discolouration and integrity of the container prior to use. The product should be drawn into the syringe immediately before use. Vials and bottles are intended for single use only. It is desirable that solutions of contrast media for intravascular use should be at body temperature when injected. Any unused product or waste material should be disposed of in accordance with local policy.



Dose/Total Dose

The following are dose guidelines as set out in the Summary of Product Characteristics (SmPC) for Iohexol (Omnipaque®

350): CT enhancement in adults (according to body weight, size and examination being done)

Maximum dose of 150mLs only allowed on this PGD.

Examination Volume of Omnipaque® 350 (25-150mLs)

Head 40mLs Head and Neck Angio 75mLs Dual Neck 120mLs CTPA 75mLs Small Adult Body 70-80mLs Medium Adult Body 80-90mLs Peripheral Angio 100mLs Mesenteric Angio 100mLs CT Urogram 150mLs


Care should be taken if the patient is taking the following medications/treatments: Patients treated with interleukin-2 and interferons less than two weeks previously have been associated with an increased risk for delayed reactions. A specific risk of delayed skin rash is associated with Interleukin-2 therapy. Oncologists should be informed that they should always indicate if the patient is on this drug when referring them for a contrast injection. The concomitant use of certain neuroleptics or tricyclic antidepressants can reduce the seizure threshold and thus increase the risk of contrast medium-induced seizures. Treatment with β-blockers may lower the threshold for hypersensitivity reactions, as well as necessitating higher doses of β-agonists when treating hypersensitivity reactions.



Use of iodinated contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin. There is no need to stop metformin after contrast in patients with serum creatinine within the normal reference range and/or eGFR >60mLs/min/1.73m2. If serum creatinine is above the normal reference range or eGFR is below 60, any decision to stop metformin for 48 hours following contrast medium administration should be made in consultation with the referring clinician.

Potential Adverse Reactions

Common side effects during the intravenous use of Iohexol (Omnipaque® 350) include feeling hot, shortness of breath and the feeling of the need to urinate.

Overdose

Preclinical data indicate a high safety margin for Omnipaque® 350 and no fixed upper dose level has been established for routine intravenous use. Symptomatic overdosing is unlikely in patients with normal renal function unless the patient has received an excess of 2000 mg I/kg body-weight over a limited period of time. The duration of the procedure is important for the renal tolerability of high doses of contrast media. In cases of overdose, any resulting water or electrolyte imbalance must be corrected. Renal function should be monitored for the next 3 days. If needed, haemodialysis may be used for clearance of excessive contrast medium. There is no specific antidote.

Monitoring (If applicable)

Patients must be kept under close observation for 15 minutes following the last injection as the majority of severe reactions occur at this time.

Follow up (If applicable)

The patient should remain in the hospital environment (but not necessarily the radiology department) for one hour from the last injection and should return to the radiology department if any symptoms develop.



Storage

Omnipaque® 350 has a shelf life of 3 years for both glass and polypropylene bottles. The expiry date is indicated on the label. Omnipaque® 350 should be stored at or below 30°C and protected from light.


IOMEPROL (IOMERON® 400) Solution for Injection (ADMINISTER)

Drug Group

X-ray contrast media, iodinated.

Drug Legal Status

PoM

Presentation

Solution for injection

Indication

This medicinal product is for diagnostic use only. It is a contrast medium for use in adults undergoing a CT scan to show the anatomy of the blood vessels and organs, where non-contrast sequences cannot provide full information, in particular cardiac work. This contrast medium is also preferred for use in obese patients with a BMI>30.

Route/Method of Administration

Slow intravenous injection via a flexible intravenous cannula. Bottles containing Iomeprol (Iomeron® 400) are single use only. Before use, examine the product to assure that the container and closure have not been damaged. Do not use the solution if it is discoloured or particulate matter is present. The solution should be drawn into the syringe immediately before use and should be accomplished using aseptic technique with sterile syringes. It is desirable that solutions of contrast media for intravascular use should be at body temperature when injected. Any residue of contrast medium in the syringe must be discarded. Solutions not used in one examination or waste material, such as connecting tubing, should be disposed in accordance with local policy.



Dose/Total Dose

The following are dose guidelines as set out in the Summary of Product Characteristics (SmPC) for Iohexol (Iomeron® 400): CT enhancement in adults (according to body weight, size and examination being done) Examination

Volume of Iomeron® 400 (25-150mLs)

Cardiac test bolus 25-35mLs Cardiac acquisition 75mLs BMI >30 Up to 150mLs

Maximum dose of 150mLs only allowed on this PGD.


Care should be taken if the patient is taking the following medications/treatments: • Use of iodinated contrast media may result in a transient

impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin. There is no need to stop metformin after contrast in patients with serum creatinine within the normal reference range and/or eGFR >60mLs/min/1.73m2. If serum creatinine is above the normal reference range or eGFR is below 60, any decision to stop metformin for 48 hours following contrast medium administration should be made in consultation with the referring clinician.

• Patients treated with interleukin-2 and interferons less than two weeks previously have been associated with an increased risk for delayed reactions. A specific risk of delayed skin rash is associated with Interleukin-2 therapy. Oncologists should be informed that they should always indicate if the patient is on this drug when referring them for a contrast injection.

• Treatment with drugs that lower the seizure threshold such as certain neuroleptics (MAO inhibitors, tricyclic antidepressants), analeptics, and anti-emetics and phenothiazine derivatives should be discontinued 48 hours before the examination. Treatment should not be resumed until 24 hours post-procedure.



• It has been reported that cardiac and/or hypersensitive

patients under treatment with diuretics, ACE-inhibitors, and/or beta blocking agents are at higher risk of adverse reactions when administered Iomeprol (Iomeron® 400).

• Beta-blockers may impair the response to treatment of bronchospasm induced by contrast medium.

Potential Adverse Reactions

Common side effects during the intravenous use of Iomeprol (Iomeron® 400) include feeling hot and the feeling of the need to urinate.

Overdose

The effects of overdose on the pulmonary and cardiovascular systems may become life-threatening. Treatment consists of support of the vital functions and prompt use of symptomatic therapy. Iomeprol does not bind to plasma or serum proteins and is therefore dialyzable.

Monitoring (If applicable)

Patients must be kept under close observation for 15 minutes following the last injection as the majority of severe reactions occur at this time.

Follow up (If applicable)

The patient should remain in the hospital environment (but not necessarily the radiology department) for one hour from the last injection and should return to the radiology department if any symptoms develop.

Storage

Iomeprol (Iomeron® 400) has a shelf life of 5 years. It comes in glass bottles with rubber/aluminium cap and should be stored below 30°C. Protect from light.

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