Reference Number: BDPGD056
Patient Group Direction for the administration of Hydrocortisone Acetate (Hydrocortistab) Injection 25mg/ml by Physiotherapists revised September 2008
Authorisation: Patient Group Direction approved on behalf of the Trust by:
Name: Dr Mohan
GP/ Clinical Governance Lead on behalf of the Clinical Governance Committee Signature: ________________
Name: Mark Shepperd Director of Provider Services (Executive Nurse Director)
Signature: ________________ Date Direction came into force: 1st September 2008 Date of Review: 1st March 2010 Date Direction expires: 1st September 2010 (Unless change in clinical practice indicates otherwise) Total number of pages: 13 Owner of PGD: Mark Shepperd Tel: 0208 532 6228 Storage: Clock House Barking and Dagenham PCT, General Practice, Clinics
Reference Number: BDPGD056
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1.Rationale
1.1 Direction for the administration of : Intra-articular or periarticular hydrocortisone acetate (Hydrocortistab) 25mg/ml injection by physiotherapists working in Barking and Dagenham PCT. To treat patients within the PCT with specific musculoskeletal disorders requiring corticosteroid treatment To enable chartered physiotherapists, who have received specific training and are competent to undertake the corticosteroid injections.
1.2 Objectives of care this direction will provide:
1.3 Relevant national guidance if applicable:
Chartered Society of Physiotherapy “A clinical guideline for the use of injection therapy by physiotherapists”
2. Staff Characteristics
2.1 Professional qualifications to be held by staff, and work area: Member of the Chartered Society of Physiotherapy. Current registration with the Health Professions Council. Qualified and practicing for at least five years. Working as a senior physiotherapist in/for Barking and Dagenham PCT. Appropriate accredited training course / diploma in injection therapy. Anaphylaxis training (inline with trust guidelines) Basic Life Support Training (inline with trust guidelines) Has worked as a physiotherapist in orthopaedic or rheumatology outpatients for at least 2 years Be able to demonstrate higher levels of diagnostic reasoning and have proof of training in injection therapy
2.2 Specialist qualification, training, experience and competency necessary:
Reference Number: BDPGD056
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2.3 Requirements for continuing training and education:
Maintain competency by carrying out procedure regularly with evidence of CPD. Regular updates in anaphylaxis and basic life support inline with trust guidelines. A register (Appendix I) of all physiotherapists will be held and updated accordingly by the line manager
3. Statement
Chartered Physiotherapists should only undertake this role if they feel competent to take part as outlined in the „Rules of Professional Conduct‟ (CSP 2005) and have prior agreement with their manager.
4. Consent
4.1 All patients for whom treatment with injection is proposed should give their consent to the injection, in accordance with the Barking and Dagenham PCT Consent to Examination and Treatment Policy ( Reference : CL001) 4.2 A written record of consent must be maintained, using NHS consent form 3 (Patient/parental agreement to investigation or treatment).
5. Adverse Drug Reactions
5.1 All adverse drug reactions must be reported immediately to the GP. 5.2 Only serious reactions (e.g. anaphylaxis) should be reported to the Medicines and Healthcare Products Regulation Agency (MHRA) using the Yellow Card System. Yellow Cards are available in the BNF.
6. Facilities
Access to telephone Anaphylaxis guidelines and Epinephrine (Adrenaline) Pocket mask (Laerdel) Facilities for the safe disposal of needles, syringes, clinical waste and unused medicines. Comprehensive arrangements for security, storage and labeling of medicines Access to latest edition of BNF (published March and September each year). Reference Number: BDPGD056
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7. References
1. Review of Prescribing, Supply and administration of Medicines under Group Protocol, DoH (1998) 2. Health Service Circular 2000/026, 9th August 2000 3. Rules of Professional Conduct CSP, 2nd Edition 2002 4. Standards for Medicines Management NMC, 2008 5. BNF no 55, March 2008 6. Guidelines for the use of injection therapy by Physiotherapists B+D PCT. (Poilcy number CL043 7. A clinical guideline for the use of injection therapy by physiotherapists. Chartered society of physiotherapy 1999 8. Patient group direction proforma. Association of Chartered Physiotherapists in Orthopedic Medicine 2002. 9. BDPCT, Guidelines for the management of anaphylaxis (CL042G1) 10. SPC for Hydrocortisone Acetate (Hydrocortistab 25mg/ml) Injection by Sovereign Medical, last updated on emc 29th April 2008 11. Saunders, S Injection techniques in Orthopaedics and Sports Medicine. WB Saunders 2002
8. Clinical Condition
8.1 Definition of condition /situation: To treat patients within the PCT with specific musculoskeletal disorders requiring corticosteroid treatment
8.2 Criteria for confirming condition/situation:
Persons aged 18 years and over The following lesions in the upper or lower limb: arthritis, bursitis, capsulitis, synovitis, tendonitis, tenosynovitis, entrapment neuropathy, ganglia or ligament injury after full examination using clinical reasoning skills to ensure that the condition is appropriate for treatment.
8.3 Patients included in this direction: Clinical criteria that must exist for a patient to be eligible for the administration
Persons aged 18 years and over who have undergone a full clinical examination and: For patients who have joint or soft tissue pain where a steroid injection is considered appropriate
Reference Number: BDPGD056
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of the drug.
And have given consent to the treatment.
8.4 Patients excluded from this direction:
People under 18 years of age. Current febrile illness or acute infection If any of the following apply, the Known hypersensitivity to any of the Patient Group Direction cannot components or to any local anaesthetic of the be used and the Patient must be amide type. referred to the Doctor. Adverse or side effects from previous steroid therapy including steroid related psychoses Local/systemic infection. Previously infected joint as can cause reactivation of infection. Unstable joints Prosthetic joints Recent Trauma Tuberculosis Pregnancy and breast feeding Poor diabetic control Uncontrolled hypertension Spinal conditions Anticoagulant therapy Family history or current episode of psychotic disorder Severe or uncontrolled depression (due to increased risk of psychiatric episode) Patient has declined / refused treatment Lack of comprehension by patient Open wounds in area Known cardiac arrhythmias Taking digoxin, cyclosporin or methotrexate Liver failure or cirrhosis Fresh intestinal anastomoses Predisposition to thrombophlebitis Porphyria Uncontrolled epilepsy Patients with adrenocortical insufficiency Patients currently on corticosteroids Live vaccine in the previous 3 weeks or due to have one in the next 3 weeks Severe Osteoporosis Congestive Heart Failure Glaucoma Renal impairment where serum creatinine level is above 150micromoles/litre. Reference Number: BDPGD056
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Ulcerative Colitis Diverticulitis Myasthenia Gravis Patients on non steroidal anti-inflammatory agents or aspirin/salicylates when used in conjunction with Hypothrombinaemia Due for surgery or dental work in the next 4 weeks or had surgery or dental work within the last four weeks NB: Most of the exclusions listed above are based on the fact that although the injection is not being administered systemically, there is the possibility of systemic effects 8.5 Precautions Patients without a definite history of chickenpox should be advised to avoid close contact with chickenpox or herpes zoster over the next 3 months. If exposed must see a medical practitioner immediately for advice. Patients on aspirin or non steroidal antiinflammatory agents may experience increased gastrointestinal upset and should be advised to see a medical practitioner immediately if symptoms develop. High dose diuretic, theophylline or salbutamol therapy (i.e. doses higher than standard doses that are normally seen in patients on a daily basis) This is included since steroids can cause hypokalaemia which could put a patient at increased risk. Renal function must be monitored to ensure potassium levels do not fall below the required range Current or history of Peptic ulcers, Gp should be asked to prescribe a proton pump inhibitor such as Omeprazole.
8.6 Action if patient declines or is excluded:
Refer to General Practitioner or appropriate consultant Offer alternative treatment if appropriate to those who have declined treatment
Document action in patient’s notes
8.7 Patient Assessment Name DOB Reference Number: BDPGD056
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Sex M/F Address Medical History, past and present Current prescribed medication by all routes including oral contraceptives Any recently purchased over the counter medicines Record any other medication taken prior to arrival to the physiotherapy service eg. analgesics Check for any history of allergies or sensitivities to Lidocaine (Lignocaine) or any ingredient of the injections indicated in the PGD. Any known allergies to any other medicines, ingredients or plasters Document rationale for treatment, with dosages, route, frequency, duration of medication to be taken Ensure patient has been made aware of the contraindications and that none are present that are stated in the Summary of Product Characteristics
9.
Treatment
Hydrocortisone Acetate injection Hydrocortistab Injection 25mg/ml by Sovereign Medical POM Suspension for injection 25mg in 1ml (1 ml ampoules) Store at 15 to 25 C in a locked cupboard Do not freeze and protect from light Store in an upright position The recommendation of the Association of Chartered Physiotherapists in Orthopaedic Medicine (APCOM) state that the lowest effective dose should be used for the minimum period to minimise undesirable side effects. Saunders 2002 recommended dose of Hydrocortisone Acetate for Intra-articular Reference Number: BDPGD056
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9.1 Name of Medicine:
9.2 Legal status: 9.3 Form and strength:
9.4 Storage:
9.5 Dose and route:
injection : Joint→
Large Joints knee, ankle, shoulder
Medium Joints elbow, wrist
Small Joints Thumb joint
Dose for Intraarticular injection
10 -40mg
10 – 20mg
5- 10mg
Treatment area→
Small soft tissue areas e.g ligament s 10 20mg
Intrabursa injection s e.g subdeltoid bursitis 20mg
Tendon sheath e.g. tendinitis
Dose
5- 10mg
9.6 Frequency:
Individual injections of not less than 6 week interval except for hip or knee joints and frozen shoulder Frozen shoulder: 1 week interval if appropriate Hip or knee joints: to be repeated only if effective, at least three months interval Repeat injections must be as infrequently as possible and consistent with adequate patient care with a maximum of: 3 injections per lesion in any one year Clients should be observed for immediate adverse reactions and should be asked to remain on site for 30 minutes following injection The time of onset of anaphylactic reactions following subcutaneous or intramuscular administration of vaccines may be delayed for up to 72 hours. Clients should be advised to seek medical attention if they develop early symptoms such as breathlessness, swelling of lips, face, neck or tongue and rash. Refer to the Immunisation Against Infectious Diseases
9.7 Management of Care:
Reference Number: BDPGD056
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9.8 Advice to be given to the patient or carer before or after the treatment (including written advice)
9.9 Documentation:
1996 and the current edition of British National Formulary for latest information on management of anaphylaxis. Individual counselling Details of advantages and disadvantages for specific conditions. Possible adverse reactions Patient consent form for invasive procedures Patients should also be advised that they may experience mild soreness and swelling at site of injection (can last up to 2 days) May take simple analgesics if needed Patients should be advised to seek medical advice urgently if any of the following are experienced: Difficulty with breathing, unsteadiness/ weakness, swelling of lips, face, neck or tongue Patient to be followed up in three to four weeks (may be done over the telephone) Give Patient injection Information leaflet Appendix II Give Patient Information Leaflet (Pils) if available Consent Date administered and by whom Strength Dose administered Site of injection Route Manufacturer / Brand Batch number and Expiry date Any adverse reactions experienced Advice given All of the above to be documented in patient's notes GP notification letter for all patients Patients should be advised of physiotherapy staff contact numbers during working hours and emergency contact numbers outside working hours Outcome of the follow up of the patient All the documentation should comply with CSP Rules of Professional Conduct, 2005
Reference Number: BDPGD056
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10. Management and monitoring
10.1 This Direction has been prepared under the auspices of: THE PATIENT GROUP DIRECTION DEVELOPMENT GROUP, the membership of which consists of:
Name:
Dr E Saunderson
General practitioner
Signature: _________________
Date:
Name:
Fiona Stock
Physiotherapist
Signature: _________________
Date:
Name:
Kam Takhar
Pharmacist
Signature: _________________
Date:
10.2 Audit The Patient Group Directions will be reviewed every year or sooner if there is significant change in clinical practice. There must be a secure system for recording and monitoring medicine use, from which it should be possible to reconcile incoming stock and outgoings on a patient by patient basis. The Trust have the responsibility to delegate to a named individual the regular audit of the effectiveness of this patient group direction in accordance with Clinical Governance
Reference Number: BDPGD056
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10.3 Ratification 10.3 .1 General Practitioner or professional lead, authorising undernamed physiotherapist as competent to administer medication described in the enclosed Patient Group Direction
Name …………………………
Title ……………….
Signature
Date
…………………… ………………..
10.3.2 I hereby accept and sign that I will accept responsibility to work within this Patient Group Direction
Name ………………………… ………………………… ………………………… ………………………… ………………………… ………………………… …………………………
Title ………………. ………………. ………………. ………………. ………………. ………………. ……………….
Signature
Date
………………… ……………… ………………… ……………… ………………… ……………… ………………… …………….. ………………. …………….. ……………… ……………… ……………... ……………..
Reference Number: BDPGD056
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Appendix I
PATIENT GROUP DIRECTION (PGD) FOR THE ADMINISTRATION OF Hydrocortisone Acetate Injection by physiotherapists within Barking and Dagenham PCT
Name of Physiotherapist
Type of training (Record of training content and competence should be included in the physiotherapist’s personal file*)
Date of Training
Signature of physiotherapist
Signature of service line manager
Date
*A copy should be available for the Physiotherapist’s Personal Portfolio
Reference Number: BDPGD056
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Appendix 2 PATIENT INJECTION INFORMATION
What is a corticosteroid? A medicine which can relieve swelling, stiffness and pain by reducing inflammation Is this the same drug that athletes and bodybuilders take? No. The steroids we inject are completely different and are extremely safe. Why do I need a steroid injection? Because it will help reduce your pain. You can then start rehabilitation sooner, have fewer treatment sessions and return to normal activities more quickly. Why don’t I just take anti-inflammatory pills? You can, but the side effects of these are much more common and can cause stomach upsets and bleeding. These injections bypass the stomach and are directly administered to the problem area. Are there any times I should not have an injection? Yes, if you: Have any infection on your skin or anywhere else in your body or if you are taking anti-biotics Are allergic to local anesthetic or steroid or have suffered from side effects from these medications in the past. Feel unwell Are pregnant Are under 18 Do not want the injection If you have had or are due to have a vaccination in the three weeks before or after your injection. If you have had or are due to have surgery or dental work in the previous or next four weeks. Reference Number: BDPGD056
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Have been diagnosed with any of the following o Tuberculosis o Adrenocortical insufficiency o Liver failure or cirrhosis o Severe osteoporosis o Congestive heat failure o Glaucoma o Ulcerative colitis o Diverticulitis o Myasthenia Gravis
What are the possible side-effects? These are very rare and your Physiotherapist will discuss them with you: Flushing of the face for a few hours Small area of fat loss or a change in colour of the skin around the injection site Menstrual irregularities Diabetic patients may notice a temporary increase in blood sugar levels If you are taking blood thinning drugs, there may be some temporary bruising Infection: if the area becomes hot, swollen and painful for more than 24 hours you should contact your Physiotherapist or Doctor immediately You will be asked to wait for approximately 30 minutes after the injection to ensure there is no allergic reaction to the drug.
How is the injection done? The skin is cleaned with antiseptic. A needle is gently put into the affected part and the solution is injected through the needle. Shortly after, you will be examined again. Is the injection painful? Not particularly, as your Physiotherapist has had intensive training in the technique. Sometimes it can be sore for a few hours, but you will be told what to do about this. How fast does the injection work? If local anesthetic is also used, the pain should be less within a few minutes, though it may return after about an hour, just as when you Reference Number: BDPGD056
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visit the dentist. The steroid usually starts to work within 24-48 hours, but may take longer. How long does the effect last? This varies from person to person and the condition being treated, but the steroid usually continues working for 3 to 6 weeks. How many injections can I have? This depends on the part of the body involved and will be decided by your Physiotherapist and yourself. Usually one injection is sufficient, but if the pain is severe or has been there for a long time, you may need more. What should I do after the injection? If the problem was caused by overuse, you will probably be told to rest the area for about a week; if it is a joint pain you may start early gentle movement.
When will I have to be seen again? Usually your Physiotherapist will want to see you or speak to you about three to four weeks after the injection. You may then be referred for Physiotherapy treatment.
If there is a problem following your injection, during office hours 08.30am – 4.30pm please telephone 020 8276 7001 to speak to the Physiotherapist who carried out your injection. If you need to contact someone outside of these times, please telephone your GP and you will be directed to the contact number for the out of hours primary care service, local walk in centre. In the event of a serious emergency, telephone 999.
Reference Number: BDPGD056
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Physiotherapist intra-articular and soft tissue injection checklist Patient Name: DOB: Date of procedure Infection present at any site? Previously infected joint Unstable joint High dose diuretic, theophylline or salbutamol Uncontrolled hypertension Family or personal history of psychotic disorder Anticoagulant therapy Known cardiac arrhythmias Fresh intestinal anastomoses Porphyria Epilepsy Adrenocortical insufficiency Peptic ulcers Severe osteoporosis Congestive heart failure Glaucoma Ulcerative colitis Diverticulitis Myasthenia Gravis Currently taking NSAID’s / salicylates in conjunction with Hypothrombinaemia. Severe renal impairment Damaged/broken skin? Previous allergic reaction / side effects including psychoses Reference Number: BDPGD056
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Yes
No
Comments
Controlled ?
Serum creatinine level above 150 micromoles/litre
Prosthetic joint? Had in the last 4 weeks or have planned procedure in next 4 weeks e.g. dental treatment / surgery? Anticoagulant therapy? Recent live vaccination? Diabetic patient? Pregnant/Breast feeding Recent trauma / haemarthrosis Steroid therapy? Able to take appropriate rest? MEDICATION Name of Drug Dose / Volume / Strength Manufacturer Batch No Expiry Date INJECTION Location Approach No touch technique
Don’t inject 3 weeks pre or post live injection Warn patients to check levels
Yes No Comments Patients warned about infection Patient given home exercises Patient given advice to rest during first 48 hours Signature of Clinician..…………….....……………… Date……………………
Reference Number: BDPGD056
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