Title: Patient Group Direction for the administration of local corticosteroid injections and/or lidocaine by physiotherapists and radiographers working within NHS Grampian
Identifier: NHSG/PGD/SteroidInj/MGPG633 Replaces: NHSG/PGD/SteroidInj/MGPG507 Across NHS Boards Organisation Wide
Directorate Clinical Service Sub
Department Area
Yes
This controlled document shall not be copied in part or whole without the express permission of the author or the author’s representative.
Senior Physiotherapist
Author:
Patient Group Direction
Subject
PGD patient group direction methylprednisolone
Depo-Medrone triamcinolone Kenalog hydrocortisone Hydrocortistab lidocaine physiotherapist radiographer
Key word(s):
NHS Grampian
Policy application:
This Patient Group Direction (PGD) authorises appropriately qualified and trained Senior Physiotherapists and
Radiographers to administer local corticosteroid injections and/or lidocaine to individuals without the requirement for a patient specific prescription written by a medical practitioner.
Purpose:
Responsibilities for implementation:
Chief Executive and Management Teams
Organisational:
Senior Managers
Corporate:
Heads of Service/Clinical Leads
Departmental:
Line Managers
Area:
Assistant General Managers and Group Clinical Directors
Hospital/Interface services:
Unit Operational Managers
Operational
Management Unit:
It is the responsibility of individualphysiotherapists and 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.
Policy statement:
This policy will be reviewed at least every two years or sooner if current treatment recommendations change.
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.
Responsible for review of this document:
Senior Physiotherapist, Senior Radiographer
Responsible for ensuring registration of this document on the NHS Grampian Information/Document Silo:
Pharmacy and Medicines Directorate
Physical location of the original of this document:
Medicines Information Office, Aberdeen Royal Infirmary
Job/group title of those who have control over this document:
Senior Physiotherapist
Responsible for disseminating document as per distribution list:
Senior Physiotherapist, Senior Radiographer
Revision History: Date of change Approval date of PGD that is being superseded
Summary of Changes Section
heading
March 2014 March 2012 2 yearly update into new template all
March 2014 March 2012 Additional conditions to be treated 2.1
March 2014 March 2012 Radiographers added multiple
April 2014 March 2012 Reduction in maximum triamcinolone dose to
40mg from 80mg
3.2
April 2014 March 2012 Addition of information on newer anticoagulants
plus addition of ticagrelor to antiplatelets
3.3
Patient Group Direction for the administration of local corticosteroid injections and/or lidocaine by physiotherapists and radiographers working within NHS Grampian
Contents
Part A –Specific Drug Information Page No
1 Introduction 2
2 Clinical Decision Making 2
2.1 Patients who may be considered for the administration of local corticosteroid injections and/or lidocaine
2 2.2 Patients who may receive the administration of local corticosteroid
injections and/or lidocaine
3
2.3 Contraindications 3
2.4 Precautions 4
2.5 Action to be taken when a patient is excluded from treatment under this PGD
4 2.6 Action to be taken when a patient does not wish to receive treatment
under this PGD
4
3 Description Of Treatment Available Under This PGD 4
3.1 Drug details 5
3.2 Dose, route and frequency 6
3.3 Concurrent medication 7
3.4 Adverse effects 8
3.5 Advice to patient 9
3.6 Follow up treatment 9
Part B – PGD General Information
4 Designated Staff Authorised To Administer Under This PGD 10
5 Documentation 11
5.1 Authorisation of administration 11
5.2 Record of administration 11
5.3 Consent 11
6 Further Points 12
7 Facilities And Supplies To Be Available At Sites For The Administration Of The Drug Specified In The PGD
12
8 Audit 12
Part C – PGD Specific Information
9 Management And Monitoring Of Patient Group Direction 13
9.1 Consultative group 13
9.2 Professional advisory group approving PGD 13
9.3 Authorising managers 13
10 References 13
Appendix 1 - Health Care Professional Agreement To Administer Medicines Under Patient Group Direction
15 Appendix 2 - Certificate Of Authorisation To Administer Medicines
Under Patient Group Direction
Patient Group Direction For The Administration Of Local
Corticosteroid Injections And/Or Lidocaine By Physiotherapists and
Radiographers Working Within NHS Grampian
Part A
1. IntroductionThis patient group direction (PGD) will authorise physiotherapists and radiographers to administer local corticosteroid injections and/or lidocaine to individuals aged 18 years and over.
This PGD is designed to guide authorised physiotherapists and radiographers on the intra-articular and peri-articular administration of corticosteroid injections
(methylprednisolone acetate, triamcinolone acetonide and hydrocortisone acetate) and/or the local anaesthetic injection (lidocaine hydrochloride).
Injection therapy with corticosteroids and/or local anaesthetic would be considered for patients presenting with musculoskeletal conditions that are not responding to conservative treatment such as physiotherapy and/or simple oral analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs). Physiotherapists and radiographers are ideally placed to carry out this treatment to facilitate the patient’s continued
rehabilitation without the need for referral to a doctor.
This PGD will authorise appropriately qualified physiotherapists and radiographers to undertake these injections leading to a reduced workload for GPs and Hospital doctors.
This PGD should be used in conjunction with the recommendations in the current British National Formulary and individual Summary of Product Characteristics.
2. Clinical Decision Making
2.1. Patients who may be considered for the administration of local corticosteroid injections and/or lidocaine
Patients, aged 18 years or over, who present with the following conditions: (i) Soft tissue or osteoarthritic conditions around the shoulder.
(ii) Acromio-clavicular joint sprain or capsulitis. (iii) Soft tissue conditions around the elbow. (iv) Thumb joint capsulitis or arthritis.
(v) Soft tissue conditions around the hand. (vi) Soft tissue conditions around the hip.
(vii) Soft tissue or osteoarthritic conditions around the knee. (viii) Plantar fasciitis.
Diagnosis must be made by a senior physiotherapist with post graduate training and experience in the management of the conditions as listed above. Radiographers will use ultrasound to diagnose the lesion prior to injection. These physiotherapists and radiographers must have attended the local specialist musculoskeletal (MSK) training and worked in MSK service for more than a year. The final diagnosis and decision to inject must be made by the injection therapist. The physiotherapist or radiographer trained to undertake the injection therapy must fully assess the patient’s condition and determine that injection therapy is the most appropriate management.
2.2. Patients who may receive the administration of local corticosteroid injections and/or lidocaine
All patients in 2.1 above, who do not want specifically to consult with a doctor and are willing to have treatment from the physiotherapist or radiographer.
2.3. Contraindications
Patients may receive local corticosteroid injection and/or lidocaine unless: (i) the patient is under 18 years of age.
(ii) they have signs of current, local infection within the joint or site to be injected. (iii) there is local or general sepsis such as chest infection or UTI or unexplained fever.
(iv) there are any skin lesions such as abrasions, ulcers, infected ingrown toenails (source of bacteraemia at time of injection).
(v) the patient has known hypersensitivity to any of the medicines or ingredients within the formulations.
(vi) they have had significant local or general allergic reaction to a previous
administration of methylprednisolone, triamcinolone, hydrocortisone or lidocaine - a doctor should be consulted.
(vii) there is adjacent osteomyelitis. (viii) the joint is prosthetic or unstable.
(ix) there is active tuberculosis or past medical history of tuberculosis within the last 10 years.
(x) the patient is pregnant or breast-feeding.
(xi) there is peripheral vascular disease at the site to be injected. (xii) there is recent trauma/injury at site to be injected.
(xiv) the patient has a severe or unstable heart condition including heart block, congestive cardiac failure and cardiac conduction disturbances.
(xv) the patient has had previous steroid induced myopathy. (xvi) the patient is immunocompromised.
(xvii) no consent has been obtained.
2.4. Precautions
Patients with diabetes should be warned that they may be prone to hyperglycaemia over the hours following corticosteroid injection and they should regularly monitor their blood glucose levels. See section 3.3.
Patients with known bleeding disorders should be discussed with medical staff before proceeding. See section 3.3.
2.5. Action to be taken when a patient is excluded from treatment under this PGD
If a patient is excluded from treatment under this PGD, medical advice should be sought. Alternative treatments should be discussed with the patient as appropriate. Action taken should be recorded in the patient’s medical notes.
2.6. Action to be taken when a patient does not wish the treatment to be received under this PGD
Alternative treatments should be discussed with the patient as appropriate. Action taken should be recorded in the patient’s medical notes.
3. Description Of Treatment Available Under This Direction
Triamcinolone acetonide is preferred for intra-articular injection; methylprednisolone acetate is preferred for injection of soft tissue or tendon sheath.
Hydrocortisone acetate would be chosen for the management of the thumb and where there is concern about fat atrophy.
Hydrocortisone acetate because of its greater aqueous solubility is less likely to cause local fat atrophy. The risk of fat atrophy is greatest with the poorly soluble triamcinolone acetonide.
Lidocaine may be used for diagnostic purposes prior to the administration of
corticosteroid. If there is no beneficial effect from the lidocaine then no subsequent corticosteroid would be given. Corticosteroid injection may be given without
3.1. Drug Details
Methylprednisolone (Depo-Medrone®)
Methylprednisolone (Depo-Medrone®) is presented as a sterile aqueous suspension for injection containing methylprednisolone acetate BP 40mg/mL. It is available in 1mL (40mg), 2mL (80mg) and 3mL (120mg) vials.
Store in a locked drug cupboard. Protect from freezing.
Methylprednisolone (Depo-Medrone®) is a Prescription-only Medicine (PoM). Depo-Medrone® with Lidocaine
Depo-Medrone® with Lidocaine is presented as a white sterile aqueous suspension for injection containing methylprednisolone BP 4% and lidocaine hydrochloride BP 1%.
Each 1mL vial contains methylprednisolone 40mg and lidocaine hydrochloride BP 10mg.
Each 2mL vial contains methylprednisolone 80mg and lidocaine hydrochloride BP 20mg.
Store in a locked drug cupboard at room temperature and protect from freezing. Depo-Medrone® with Lidocaine is a Prescription-only Medicine (PoM).
Triamcinolone (Kenalog®)
Triamcinolone (Kenalog®) is presented as a sterile aqueous suspension for injection containing triamcinolone acetonide 40mg/mL. It is available in 1mL (40mg) vials (boxes of 5).
Store in a locked drug cupboard below 25°C. Protect from freezing. Triamcinolone (Kenalog®) is a Prescription-only Medicine (PoM). Hydrocortisone (Hydrocortistab®)
Hydrocortisone (Hydrocortistab®) is presented as a sterile aqueous suspension for injection containing hydrocortisone acetate Ph Eur (25mg/mL). It is available in 1mL (25mg) glass ampoules (boxes of 10).
Store at 15-25°C. Do not freeze. Protect from light.
Lidocaine Hydrochloride Injection BP 1% w/v
Lidocaine hydrochloride BP 1% w/v is presented as a clear, colourless, sterile injection containing 10mg/mL of lidocaine hydrochloride. It is available in ampoules of 2mL (20mg), 5mL (50mg), 10mL (100mg) and 20mL (200mg).
Lidocaine hydrochloride is available from a number of different manufacturers. Excipients may vary between brands. Always read the information provided on the outer carton and the leaflet(s) provided.
Store in a locked drug cupboard below 25°C and protect from light. Lidocaine hydrochloride is a Prescription-only Medicine (PoM). 3.2. Dose, route and frequency
The dose of corticosteroid and/or lidocaine depends on the size of the joint/bursa/tendon sheath/enthesis and the severity of the condition.
The route of administration is intra-articular, periarticular, intrabursal injection or injection into the tendon sheath. Strict aseptic technique must be employed. The patient must be advised that lidocaine injection is not licensed to be given via the intra-articular route. It is however an accepted clinical practice to administer lidocaine intra-articularly. It is important to document that this has been explained to the patient.
Repeated injections may be given at intervals but no more than 3 injections may be given in any one episode of care depending on the degree of relief obtained from the initial injection. For the purposes of this PGD an episode of care is defined as the period from referral/diagnosis through to the completion of the last encounter related to that problem. For weight bearing joints such as the knee, a minimum of three months is needed between intra-articular injections. No more than 3 injections should be given in any one site in one year.
Where local corticosteroid and lidocaine are both to be administered, they must not be mixed in the same syringe as this would result in an unlicensed product. Lidocaine may be given first, followed by injection of steroid.
If the required doses and choice of agent are appropriate, the pre-mixed methylprednisolone with lidocaine preparation may be used.
The dosage range for methylprednisolone acetate or triamcinolone acetonide injectionis:
• Large joints/bursae/periarticular lesions: methylprednisolone 20 to 80mg, triamcinolone 10 to 40mg.
• Medium joint/bursae/periarticular lesions: 10 to 40mg.
The dosage for hydrocortisone acetate injection is:
• Tendon enthesis at the medial and lateral epicondyle: 25mg.
• Trapezio-metacarpal joint: 25mg.
The maximum dose of lidocaine hydrochloride 1% is: • Large joints/bursae/periarticular lesions: 40mg (4mL).
• Medium joint/bursae/periarticular lesions: 20mg (2mL).
• Small joints/bursae/periarticular lesions: 10mg (1mL). In most acute cases, repeat injections are not needed.
Maximum dose per injection
• 80mg of methylprednisolone acetate.
• 40mg of triamcinolone acetonide.
• 25mg of hydrocortisone acetate.
• 40mg (4mL) of lidocaine hydrochloride 1% w/v.
Maximum daily doses (if giving multiple joint or soft tissue injections) • 80mg of triamcinolone acetonide or methylprednisolone acetate.
• 50mg of hydrocortisone acetate.
• 100mg (10mL) of lidocaine hydrochloride 1% w/v.
A total of 120mg of administered corticosteroid should not be exceeded in any 3 week period. An area should not be re-injected within 6 weeks of injection. 3.3. Concurrent medication
Diabetic patients on insulin or oral hypoglycaemic agents should be treated with caution due to the risk of poor glycaemic control in the hours following corticosteroid injection. If the patient’s diabetes is unstable then medical advice should be sought. Antibiotic therapy would generally exclude a patient due to infection (see 2.3). The injection should be delayed until any risk of infection has passed. Patients may be on antibiotics for long term prophylaxis of infection. Injection should not be
performed if there is any sign of current infection. Seek medical advice. Patients on warfarin may only receive an intra-articular injection if their INR is satisfactory and only on the advice of medical staff. An up to date INR must be available (within 1 week). The INR must be checked with the medical staff in charge of the patient prior to proceeding with any intervention.
Where patients are on the newer oral anticoagulants, e.g. dabigatran etexilate (Pradaxa®), rivaroxaban (Xarelto®) and apibaxan (Eliquis®), intra-articular injections should be used with caution. Refer to a doctor.
Caution should be taken in patients taking antiplatelet medicines such as aspirin, ticagrelor, clopidogrel or dipyridamole as there will be an increased risk of bleeding in these patients.
If in any doubt about a patient’s concurrent medication, seek advice from a pharmacist or doctor.
3.4. Adverse effects
Potential adverse effects of local corticosteroid injection: Local Effects:
Joint sepsis, soft tissue infections, subcutaneous atrophy/skin depigmentation, post injection pain at injection site, tendon rupture, steroid arthropathy.
Systemic Effects:
Facial flushing, alteration in glycaemic control (diabetic patients), menstrual irregularities, syncope. Osteoporosis can occur with the systemic use of
corticosteroids. Systemic effects do not ordinarily occur with intra-articular injections when the proper techniques of administration and the recommended dosage
regimens are observed. However care should be taken to avoid steroid loading in patients with existing osteoporosis.
Potential Adverse Effects of Lidocaine Hydrochloride:
Light headedness, confusion, convulsions, anaphylactic shock.
Report all serious suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA), Commission on Human Medicines using a Yellow Card or on-line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF or in the Summary of Product Characteristics (product data sheet). Yellow Cards may be completed by a nurse, pharmacist, the patient or a doctor. Serious reactions are those that are fatal, life threatening, disabling, incapacitating, or which result in, or prolong, hospitalisation and/or are medically significant. Adverse reactions should be recorded in the medical notes and reported to the referring practitioner.
Medical advice in cases of anaphylaxis
Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an
anaphylactic reaction should this 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 Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals).
Overdose
Medical advice should be sought immediately.
3.5. Advice to patient
Patients should be safe to drive unless they have a hypersensitivity reaction to the injection or feel light headed in which case they must be advised against driving. The patients should remain on the premises for at least 10–15 minutes following the injection.
If they are feeling at all unwell they should speak to the physiotherapist /radiographer/nurse/doctor before they leave.
If the patient develops any problems later they should be advised to contact their GP or the physiotherapist/radiographer.
Patients are advised to rest the injected area for the first few days. They may then begin increased use and rehabilitation usually under the instruction of a
physiotherapist. Often this rehabilitation should start 2-3 weeks after the injection to give it time to take effect.
The patient information leaflet from the packaging should be given to the patient. Where this is unavailable, or unsuitable, sufficient information should be given to the patient/parent/guardian in a language that they can understand.
3.6. Follow up treatment
Patients should not leave if they are feeling at all unwell without speaking to the physiotherapist/radiographer first. If necessary a doctor or the patient’s GP should be contacted for advice.
Follow up with physiotherapy management should be arranged and a review
arranged with the injecting therapist/referring clinician if necessary. Patients who do not respond to the injection will need to be followed up appropriately by liaison between the physiotherapist/radiographer and medical staff.
Part B
4. Designated Staff Authorised To Administer Under This PGDThe following staff are authorised to administer the drugs specified in this PGD without an individual medical prescription providing the patient falls into one of the categories listed in 2.2 of this PGD. Staff must be employed either directly by NHS Grampian, or contracted to provide NHS services, or providing services in partnership with NHS Grampian under the direction of this authorised PGD.
State registered Physiotherapists and Radiographers as recognised by the Health Professions Council (HPC) with additional post graduate training and certification of competence in injection therapy. The level of training will be determined and approved by each individual professional body.
It is important to note that the above professionals may only administer medicines under a PGD as named individuals.
In addition the following requirements are necessary. Staff must:
(i) agree to be professionally accountable for their work (Appendix 1).
(ii) 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. (iii) be aware of current treatment recommendations and be competent to discuss issues about the drugs with the patient.
(iv) have been trained and assessed as being competent in the administration of the drugs. All staff will have access to the current PGD.
(v) have undertaken an NHS e-anaphylaxis training session which includes basic life support (with annual updates) and covers all aspects of the identification and
management of anaphylaxis.
(vi) have immediate access to the appropriate equipment and drugs to treat
anaphylaxis and have access to the current PGD for the management and treatment of anaphylaxis should this occur.
(vii) maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct.
(viii) agree to work within the terms of the NHS Grampian PGD. Professional Managers will be responsible for:
(i) Ensuring that the current PGD is available to staff providing care under this direction. (ii) Ensuring that the staff have access to all relevant Scottish Government Health
(iii) Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above.
(iv) Maintaining a current record of all staff authorised to administer the drugs specified in this PGD.
5. Documentation
5.1. Authorisation of administration
Physiotherapists and Radiographers working within NHS Grampian can be authorised to administer the drugs specified in this PGD by the
Physiotherapy/Radiography Manager in their sector.
A certificate of authorisation (Appendix 2) signed by the authorising manager should be supplied. This should be held in the individual physiotherapists and radiographers records or as agreed locally.
5.2. Record of administration
An electronic or paper record for recording the screening of patients and the subsequent administration of the drugs specified in this PGD must be completed in order to allow audit of practice. This should include:
(i) Name and address of patient, CHI No (ii) Date of birth
(iii) Consultant/General Practitioner details (iv) Risk group, if appropriate
(v) Physical examination required, if appropriate
(vi) Exclusion criteria, record why drug not administered (vii) Reason for giving
(viii) Consent to the administration (if not obtained elsewhere) (ix) Drug manufacturer, batch number, expiry date
(x) Site where drug administered, dose and route of administration
(xi) Signature and name in capital letters of practitioner who administered the drug (xii) Date drug given
(xiii) Record of adverse effects (advise patient’s doctor).
These records should be retained for 6 years after last date of entry or for 3 years after death, or in accordance with local policy, where this is greater than above.
5.3. Consent
Prior to the administration of the drug, consent must be obtained, preferably written, either from the patient and documented either in the patient’s medical records/notes or on an administration form (see section 5.2). Consent must be in line with current NHSG “Staff Policy for Obtaining Consent for Clinical Procedures and Healthcare
Interventions”. See link below.
6. Further Points
The manufacturers leaflet inside boxes of drug should be read and advice from them taken into consideration.
7. Facilities And Supplies To Be Available At Sites For The Administration Of The Drugs Specified In The PGD
The following should be available at sites where the drugs are to be administered: (i) Resuscitation equipment.
(ii) Access to medical support (this may be via telephone). (iii) Safe storage areas for medicines and equipment. (iv) Approved equipment for the disposal of used materials. (v) Clean and tidy work areas.
(vi) Copies of the current PGD for the drugs specified in the PGD
(vii) PGD for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals.
8. Audit
All records of administration of the drugs specified in this PGD will be filed with the normal records of medicines administration in each practice/service. A designated person within each CHP/practice/service will be responsible for auditing completion of drug forms and collation of data.
Hydrocortisone (Hydrocortistab®) - Date of revision of text May 2013, accessed 23/01/14
Lidocaine hydrochloride injection BP 1% w/v (Hameln Brand) - Date of revision of text 5th November 2009, accessed 23/01/14.
3. British National Formulary, September 2013 no 66 –The Pharmaceutical Press. 4. Saunders,S.(2002) Injection Techniques in Orthopaedics and Sports Medicine 2nd Edition, Bailliere Tindall London.
Document: Drafted: April 2009
Completed: March 2010
Approved: March 2012, March 2014 (published – May 2014)
Review date: At least every 2 years or sooner if current treatment recommendations change.
Appendix 1 Health Care Professional Agreement To Administer Medicines Under Patient
Group Direction
I: (Insert name)
Working within: e.g. CHP, Practice
Agree to administer medicines under the direction contained within the following Patient Group Direction
Patient Group Direction for the administration of local corticosteroid
injections and/or lidocaine by physiotherapists and 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 outwith the recommendations of the Patient Group Direction.
Signed:
Print Name: Date:
Appendix 2
Certificate Of Authorisation To Administer Medicines Under Patient Group Direction
This authorises:
Working within: e.g. CHP, Practice
To administer medicines under the following Patient Group Direction
Patient Group Direction for the administration of local corticosteroid
injections and/or lidocaine by physiotherapists and radiographers
working within NHS Grampian
The above named person has satisfied the training requirements and is competent to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction
Signed: Authorising Manager/Doctor
Print Name: Date:
