Prescription Only Medicine BETAMETHASONE SODIUM PHOSPHATE 4mg INJECTION (POM) YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES The initial treatment of musculo-skeletal pain in the foot in adult patients Indication Patient Group Direction (PGD) for the Administration of:
Inclusion Criteria
Exclusion criteria
under the care of Holme Valley Podiatric Surgery Unit. Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the administration of the medicine. Adult patients (over 16 years of age) identified with: Soft tissue inflammation in the foot due to acute biomechanical stress (e.g. plantar fasciitis) Pain from peripheral nerve entrapment (e.g. Morton’s neuroma) Acute mono articular or peri articular pain (e.g. capsulitis of 2nd MPJ) Intra operative use (e.g. site of resected neuroma) Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Patients under 16 years of age. Known hypersensitivity to Betamethasone or to any of the components of the injection. History of adverse reaction to steroid injections Presence of local infection. Where infection is suspected not to be used until ruled out or eradicated. Systemic infections unless specific anti-infective therapy is employed Local or general sepsis Prosthetic joint of the joint to be injected Active tuberculosis or past medical history of tuberculosis Pregnancy and/or breast-feeding Peripheral vascular disease at site to be injected Patients on anti-coagulant therapy or with coagulation disorders Recent trauma/injury at site to be injected Hypovolaemia Severe or unstable heart conditions including heart block, congestive cardiac failure and cardiac conduction disturbances. Immunocompromised patients Betamethaone Injection should NOT be injected directly into tendons. Please also see Cautions/Need for further advice section
PGD No 59 v 2 - Betamethasone Sodium Phosphate Injection Approval Date: 24.4.12
Review Date: 31.5.14 Page 1
Cautions/Need for Further Advice
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies. Appropriate precautionary measures should be taken prior to administration. Caution is advised with the use of corticosteroids in patients who have suffered a recent myocardial infarction because of the risk of myocardial rupture. Recent contact with someone who has chickenpox, shingles or measles, or suffered from recent chickenpox, shingles or measles. This medicine may make chickenpox, shingles or measles much worse. Particular care is required when considering use of systemic corticosteroids in patients with the following conditions: Hypertension or congestive heart failure Impaired renal function Impaired hepatic function Cardiac impaired function Porphyria Epilepsy Glaucoma (or family history of glaucoma) Previous corticosteroid-induced myopathy Diabetes meillitus (or a family history of diabetes) Existing or previous history of severe affective disorders (especially previous steroid psychosis). Peptic ulceration Ulcerative colitis Diverticulitis Hypothyroidism Myasthenia Gravis Thromboembolic tendencies Osteoporosis Recent intestinal anastomoses Herpes simplex keratitis Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised Care should be taken for patients receiving cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/potassium loss. Potential drug interactions – always check concurrent medication for interactions before administration under this PGD. Refer to appendix 1 of the current BNF.
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Cautions/Need for Further Advice cont.
Some interactions include: ○ Antidiabetics – corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosterids are initiated, discontinued or changed in dosage. ○ Antihypertensives, including diurectics – corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide is enhanced. ○ Ciclosporin – monitor for evidence of increased toxicity of ciclosporin when the two are used concurrently. ○ Drugs that induce hepatic enzymes, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, ephedrine and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced. ○ Steroids may reduce the effects of anticholinesterases used in the treatment of myasthenia gravis. ○ Drugs such as erythromycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. ○ The risk of hypokalaemia is increased with theophylline, ulcer healing drugs such as carbenoxolone and antifungals such as amphoteracin B. ○ Oestrogens, including oral contraceptives – corticosteroid half-life and concentration may be increased and clearance decreased. ○ NSAIDs – corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDs. ○ Methotrexate – increased risk of haematological toxicity when corticosteroids given with methotrexate. ○ Mifepristone – effect of corticosteroids may be reduced for 3-4 days after mifepristone. ○ During corticosteroid therapy antibody response will be reduced and therefore affect the patient’s response to vaccines. Live vaccines should not be administered. Please refer to current BNF and product SPC for full details If in doubt always refer to an appropriate medical practitioner
PGD No 59 v 2 - Betamethasone Sodium Phosphate Injection Approval Date: 24.4.12
Review Date: 31.5.14 Page 3
Action if Patient Declines or is Excluded
Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record. Give information about risks of infection and benefits of treatment (where appropriate). Give information about how to recognise signs and symptoms of infection (where appropriate). Give information about when the medicine may be given.
DESCRIPTION OF TREATMENT Name, Form & Betamethasone Sodium Phosphate 4mg/ml injection Strength of Medicine Subcutaneous or intra-lesional or intra-articular injection Route/Method Betamethasone Sodium Phosphate injection should not be injected directly into tendons. Adults
Dosage
Dose range between 0.1ml (0.4mg) to 1ml (4mg) as determined by Podiatric Surgeon
Frequency
SINGLE administration per site at any one visit.
Duration of Treatment
SINGLE administration per site at any one visit.
Maximum or Minimum Injection can be repeated on two or three occasions at 4 – 6 week intervals dependant upon patient response. Treatment Period Maximum of 3 joint injections in a 12-month period.
Quantity to Administer Licensing Information
Dependent on dosage The product is licensed for the listed indication.
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Occasional acute inflammatory reaction.
Side Effects
Anaphylaxis is rare but can occur up to 72 hours after injection. Please refer to current BNF and product SPC for full details. Report all serious suspected adverse reactions (ADRs) in adults, and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a health professional or the patient.
Advice to Patient/Carer
Follow Up
It is the responsibility of the health professional identifying the ADR to report it. Explain treatment and course of action Give the patient a copy of the manufacturer’s patient information leaflet and discuss as required. Information on steroid injections to be provided Explain possibility of local symptoms such as post-injection flare, transient pain and irritation. Advise the client to return or seek medical advice if there are unacceptable or serious side effects. If patient develops signs of infection/necrosis at site of injection they should seek further clinical advice If condition worsens or symptoms persist then seek further medical advice. Anaphylaxis is rare but can occur up to 72 hours after injection. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash. Patient to remain within treatment area for 30 minutes postinjection and observed for any immediate post-injection adverse reactions Advise patient to report any adverse effects. Advise patient to seek further medical advice if: The condition worsens or does not improve. They experience any hypersensitivity reaction
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REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements
Referral arrangements (including self-care) to be documented in patients notes. If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct or A&E for further assessment and advice
Records/Audit Trail
The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose supplied and route Site of injection Batch number, expiry date, manufacturer, and brand name. Advice given to patient (including side effects) Date supplied Signature/name of staff who administered the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient’s medical record. Current medication Known allergies Diagnosis Referral arrangements (including self-care)
STAFF CHARACTERISTICS Qualifications
Specialist Competencies or Qualifications
Registered professional who is either a State Registered Podiatrist undergoing a surgical fellowship training programme approved by the College of Podiatrists or a Fellow of The College of Podiatrists (Faculty of Surgery). Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Has undertaken training and is competent in resuscitation skills
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Continuing Training & Education
The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Practitioner should have access to current BNF and updated DH advice where appropriate. Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation. Keeps undated via departmental updates and meetings.
References & Resources
1. Current edition of the British National Formulary (BNF) Number 62, September 2011 2. Summary of Product Characteristics (SPC) available at: www.medicines.org.uk
This PGD is an amended version of PGD No 59, Betamethasone Sodium Phosphate 4mg Injection March 2010. It was updated for use within Locala Community Partnerships by the authors as listed below Name
Position
Date
Linda Fox
Community Services Pharmacy Manager
February 2012
Lucianne Ricketts
Head of Medicines Management
February 2012
Dawn Toothill
Specialist Pharmacy Technician
February 2012
Pam Linton
Nurse Team Leader
January 2012
Stephen Finney
Consultant Podiatric Surgeon
January 2012
Matt Jaggar
Trainee Podiatric Surgeon
January 2012
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Review Date: 31.5.14 Page 7
RECORD OF CHANGES MADE TO PREVIOUS VERSION
SECTION Inclusion criteria
EXPIRED VERSION Informed consent has been given in accordance with current PCT guidelines for the supply of the medicine Adult patients identified with
REVIEWED VERSION Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Adult patients (over 16 years of age) identified with
Exclusion criteria
Informed consent has NOT been given in accordance with current PCT guidelines for the supply of the medicine
Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine.
Cautions / Need for further advice
Deleted - Predisposition to thrombophebitis
Added Thromboembolic tendencies Added - Herpes simplex keratitis Added - Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised Added - Please refer to current BNF and product SPC for full details
Side effects
Deleted - This list is not exhaustive
Licensing information
Added - The product is licensed for the listed indication
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Individual authorisation for the administration of Betamethasone 4mg Injection by appropriately qualified Locala Staff at Holme Valley Podiatric Surgery Unit PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD. In signing this declaration the healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct Name of Professional
Signature
Authorising Manager
Date
Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials.
Authorising Managers For Locala staff this will be the team leader, or relevant clinical manager. Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine. PGD No 59 v 2 - Betamethasone Sodium Phosphate Injection Approval Date: 24.4.12
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Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.
ORGANISATION Director of Clinical and Operational Services
Locala Community Partnerships Name: Christina Quinn
Signature: Head of Medicines Management
Date
Name: Lucianne Ricketts
Signature: Medical Lead
Date:
Name: Dr Stephen Warner
Signature:
Date:
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PCT Authorisation ORGANISATION Governance Lead
NHS Kirklees Name: Sue Cannon
Signature: Senior Medicines Management Adviser
Date
Name: Eric Power
Signature: Medical Director
Date:
Name: Dr Matt Walsh
Signature:
Date:
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