Document Details. Patient Group Direction. Triamcinolone Acetonide 40mg/ml Intra-articular / Intradermal (Kenalog ) for use in MSK service

Transcription

1 Title Document Details Patient Group Direction (PGD) for Triamcinolone Acetonide 40mg/ml Intra-articular / Intradermal (Kenalog ) for use in MSK service Trust Ref No Local Ref (optional) Main points the document For the treatment of patients with musculoskeletal covers conditions where a parenteral steroid may facilitate alleviation of pain and/or rehabilitation Who is the document Clinical staff treating patients with musculoskeletal conditions aimed at? Author Richard Fallows Approval process Approved by Quality and Safety Delivery Group (Committee/Director) Approval Date 10 January 2017 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Nursing & Operations Category Policy Sub Category Patient Group Direction Review date 30 January 2019 Distribution Who the policy (PGD) will Clinical areas providing treatment for musculoskeletal be distributed to Method conditions notification of entry onto webpage Document Links Required by CQC Regulation 12 Required by NHLSA yes Other Amendments History No Date Amendment 1 December 2014 Scheduled review : 1. Cautions: update in line with recent PRAC recommendations on the risk of postmenopausal haemorrhage 2. Addition of minimum interval of 6 weeks between injections 2 November 2016 Scheduled review: Exclusions addition of orthopaedically true unstable joint Updated list of interacting medicines Page 1 of 8

2 PATIENT GROUP DIRECTION Triamcinolone Acetonide 40mg/ml Intra-articular / Intramuscular (Kenalog )for use in MSK service Peer review by Richard Fallows Extended Scope Practitioner Clinical Specialist MSK Physiotherapist Dr. Louise Warburton FRCGP DM-SMed Clinical Lead Telford MSK service 19/12/2016 Lead clinician consulted in the development of this PGD Contributors Richard Fallows Extended Scope Practitioner Clinical Specialist MSK Physiotherapist 21/11/2016 Andrew Thomas Head of Nursing and Quality Rachel Mole Clinical Service manager Cath Molineux Consultant Nurse If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Doctor Dr Emily Peer Associate Medical Director 19/12/2016 Pharmacist Rita O Brien Chief Pharmacist 10/01/2017 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Steve Gregory Director of Nursing and Operations 10/01/2017 Page 2 of 8

3 STAFF CHARACTERISTICS Employed or contracted by Shropshire Community Health NHS Trust HPC registered Chartered Physiotherapist with ESP/ Specialist status or HPC registered Podiatrist with MSK Specialist status A diploma in Injection Therapy or MSc module with the same content as part of an MSc degree. The clinical manager has evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in the PGD. Provide evidence of training, annual updates and Continuing Professional Development undertaken The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a Patient Group Direction The clinical manager has assessed the competency (against the NPC framework) of the healthcare professional to work to a Patient Group Direction at least every 2 years Has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation Must have access to all relevant sources of information e.g. information issued by the Department of Health (DH), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD) The practitioner needs to re - enforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s Code of Professional Conduct and Ethics YOU MUST BE AUTHORISED BY NAME BY YOUR MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Page 3 of 8

4 CLINICAL CONDITION Clinical need addressed Inclusion criteria Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF Exclusion under this Patient Group Direction does not necessarily mean contraindicated Caution / need for further advice For the administration of intra-articular and deep intra-muscular injections to patients with musculoskeletal lesions. The aim being to relieve pain and stiffness, suppress inflammation and increase mobility Where the Physiotherapist or Podiatrist is satisfied by subjective and objective examination that one of the diagnostic indications is satisfied: o Arthritis (Rheumatoid and Osteo-arthritis) o Synovitis not associated with infection o Bursitis o Tenosynovitis o Epicondylitis. Informed consent is obtained from the patient. No consent Patients under 18 years orthopaedically true unstable joint Presence of infection systemic/soft tissue/in or near the joint (includes herpes zoster), Adjacent osteomyelitis, Hypersensitivity to corticosteroids, or any of the excipients Prosthetic joint. Presence of steroid arthropathy. Pregnancy and breast feeding mothers Not to be injected into the Achilles or Infrapatella tendons. Poorly controlled diabetes. (NB All patients with diabetes should be made aware of the potential for an adverse effect on blood glucose control. Contact diabetic adviser/nurse/specialist in case of problems.) Chickenpox and measles are of particular concern since these normally minor illnesses may be fatal in immune-compromised patients. Bleeding disorders, Patients taking anticoagulant therapy, Injection into hip joint History of infection in the area to be injected, Renal or hepatic impairment. Recent live vaccine administration (within 2 weeks). Haemarthrosis. Concurrent or long term steroid therapy. Psychogenic/ severely anxious patient. Hypertension Chronic Cardiac Failure Tuberculosis Glaucoma Menstrual irregularities may occur and in postmenopausal women vaginal bleeding has been observed Other potential significant drug interactions with: Aldesleukin, rifamycins, coumarins, carbamazepine, erythromycin, itraconazole, ketoconazole, phenobarbital, phenytoin, primidone, amphotericin, ciclosporin, digoxin, hypoglycaemic agents including insulin, ritonavir, antihypertensives and diuretics Please document any considerations of the above factors. Any Page 4 of 8

5 consultation with Medical Authorities should be documented The decision to continue with the injection of the above drug remains the responsibility of the administering Clinician using the PGD. Management of excluded patients Action for patients not wishing to receive care under this PGD Referral to doctor, independent prescriber or other appropriate service if necessary Document action and advice given Refer to doctor or independent prescriber Page 5 of 8

6 DRUG DETAILS Name form and Triamcinolone Acetonide 40mg/ml Intra-articular / Intramuscular strength of medicine (Kenalog ) Legal classification Prescription Only Medicine (POM) Black triangle warning? No Use within licence? Yes Route / method Intra-articular injection and soft tissue infiltration Dose / Frequency The dose is dependent on the size of the joint/tissue to be treated, severity of pain/condition and response (if appropriate) Intra-Articular Injection: the dose of Kenalog Injection may vary from 5mg to 10mg ( ml) for smaller joints and up to 40mg (1.0ml) for larger joints, depending on the specific disease entity being treated. Maximum total dose 80mg via multiple single injections into several sites. Doses of 5 30mg for intrabursal administration. Periarticular doses eg epicondylitis 5-30mg Doses of 10mg are recommended for smaller tendons and 20mg for the large tendons are recommended. Number of times treatment may be administered Quantity to be supplied or administered Side effects Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at Additional Information The frequency of injection will depend on the clinical response to treatment. The maximum number of injections per annual episode will be three with a recommended gap between injections of 6 weeks. Each vial to be used for single dose only Patients should remain in clinic until the practitioner is confident there are no immediate adverse reactions. The following side effects have been seen please refer to SPC for full details: Anaphylactic reaction or allergic reactions. In a few instances, transient flushing and dizziness have occurred. Local symptoms such as post-injection flare, transient pain, irritation, subcutaneous and cutaneous atrophy sterile abscesses, hyper- or hypo-pigmentation, Charcot-like arthropathy and occasional increase in joint discomfort may occur. Local fat atrophy may occur if the injection is not given into the joint space, but is temporary and disappears within a few weeks to months. Reactions following intra-articular administration have been rare. Storage requirements: Store below 25 0 C The following may be more relevant to an administration of systemic course of steroid: Oestrogens may increase the half-life and concentration of steroid Anti tubercular drugs Isoniazid serum levels may be decreased Hepatic Enzyme Inducers e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglitethimide may increase clearance of Methylprednisolone Acetate (Depo-Medrone ) Ketoconazole may slow steroid clearance therefore increasing effects therefore care when using the higher permitted doses of steroid Antihypertensives including diuretics Corticosteroids antagonise the effects of these. The hypokalaemic effect of diuretics including acetazolamide is enhanced. If clinically significant symptoms of potassium depletion occur then refer to appropriate medical authority Page 6 of 8

7 Non depolarising muscle relaxants may be interfered positively or negatively with corticosteroids NSAID s with corticosteroids may increase GI bleeding and ulceration and decrease salicylate serum levels. Care with hypoprothrombinaemia Anticholinesterases may be antagonised Advice to patient / carer Written information leaflet Information for Patients Receiving Injection Therapy Follow up Referral to doctor or independent prescriber if necessary Error reporting Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix). RECORD KEEPING Documentation needed / treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Patient s name, address, date of birth and GP Manufacturer / brand of product, batch number, expiry date Dose Date of administration, route Advice given to patient / carer Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Reconciliation stock balances should be reconcilable with receipts, administration, records and disposal on a patient by patient basis REFERENCES British National Formulary Last accessed: 822/11/2016 Summary of Product Characteristics Last accessed:22/11/2016 Guidelines and Policy on Injection Therapy for Musculoskeletal Conditions by Extended Scope Practitioners (ESP) Specialist Physiotherapists and Musculoskeletal Specialist Podiatrists in Shropshire Community NHS Trust (SCT) (V2.1) 24/10/12 Page 7 of 8

8 Register of practitioners qualified to administer and / or supply Triamcinolone Acetonide 40mg/ml Intra-articular / Intramuscular (Kenalog ) under this Patient Group Direction Name of clinical team manager Signature of clinical team manager Date: All PGD documentation must be kept for 8 years and for children until the child is 25 years old A copy of this page should be retained by the authorising manager for audit purposes. Please state clinical area where this PGD is in use Healthcare professional individual declaration: I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERANT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional (please print) Signature Authorising Manager (Must sign against each entry) Date of authorisation Page 8 of 8