Document Control Title Policy for Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists Author Directorate Author s job title Etended Scope Physiotherapist Department Musculoskeletal Physiotherapy Service (Eastern) Version Date Issued Status Comment / Changes / Approval 0.1 Oct 2016 Draft Initial version for consultation 1.0 16 th Sept 2016 Final Ratified at Drugs and Therapeutics Committee 2016 Main Contact Tel: Direct Dial 01392 208418 Physiotherapy Department, Franklyn House, Eeter Lead Director Physiotherapy Lead Superseded Documents N/A Issue Date Review Date Sept 2016 Sept 2019 Consulted with the following stakeholders: Cluster Pharmacist Document users Physiotherapy injection group Trust NMP lead Head of Profession for Therapy services Clinical manager MSK services Lead Pharmacist, community Approval and Review Process PGD group Injection Therapy Group Review Cycle Three years Local Archive Reference G:\PoliciesProceduralDocuments\PublishedPolicyDatabase\Physiotherapy Filename Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Policy categories for Trust s internal website Tags for Trust s internal website (Bob) (Bob) Physiotherapy Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 1 of 12
1. Contents Document Control... 1 2. Introduction... 3 3. Purpose... 3 4. Definitions... 3 5. Responsibilities... 4 6. Role of Injection Therapy Group... 4 7. Supporting Documents:... 4 8. Mechanisms for authorising medicines:... 5 Patient Group Direction (PGD)... 5 Patient Specific Direction (PSD)... 5 Independent Prescribing... 5 9. Injection Practice... 6 Inclusions... 6 Eclusions... 6 Lidocaine... 7 Doses... 7 Preparation... 8 10. Documentation... 8 11. Aftercare... 8 12. Training and Qualifications required... 9 Additional requirements... 9 13. Monitoring Compliance with and the Effectiveness of the Policy... 10 Standards/ Key Performance Indicators... 10 Process for Implementation and Monitoring Compliance and Effectiveness... 10 14. Equality Impact Assessment... 11 15. References... 11 16. Associated Documentation... 12 Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 2 of 12
2. Introduction 2.1. Since 1995 injection therapy has fallen within the scope of practice for those physiotherapists who have undertaken appropriate, recognised training. Current practice is restricted to the injection of intra-articular and peri-articular conditions. 2.2. The training courses currently recognised as providing best practice are those that result in a Diploma in Injection Therapy. These are either run by the Association of Chartered Physiotherapists in Orthopaedic Medicine or in conjunction with Institutions of Higher Education and are awarded at M level. 3. Purpose 3.1. This policy is intended to inform practitioners who are responsible for performing either intra-articular or peri-articular corticosteroid injections. It will assist professionals who make decisions concerning the appropriate care of musculoskeletal patients. 3.2. It is intended to encourage high standards of practice in injection therapy and to reduce variation in practice in injection therapy. 3.3. The policy applies to all Physiotherapists carrying out injections within the trust 3.4. Implementation of this policy will ensure that: Staff have a clear framework within which to operate when providing injection therapy Risk of complication is reduced Patient safety is optimised 4. Definitions 4.1. CPD- continuing professional development 4.2. MSK Musculoskeletal 4.3. PGD Patient Group Direction 4.4. PSD Patient Specific Direction Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 3 of 12
5. Responsibilities 5.1. Role of Head of therapy services: has overall responsibility for ensuring that this guideline is adhered to by all Physiotherapy staff registered to practice Injection Therapy and that the clinical manager for musculoskeletal (MSK) service checks for evidence of observed practice at appraisal. 5.2. Roles of Chair of Injection Therapy Group: Maintaining and updating a register of practising clinicians and ensuring CPD requirements are fulfilled. Assessing the competency of new employees who join the trust with eisting injection qualifications. Ensuring that the protocol is consulted on by key stakeholders and disseminated. Describing how the document will be monitored for compliance and effectiveness. 5.3. Role of all injecting physiotherapists: all staff are responsible for making themselves aware of trust policies and operating procedures that link to their practice, as detailed in section 4. Staff must have an up to date working knowledge of the medicines that they are administering via PGD and are responsible for reporting any incidences or near misses, as well as being accountable for ensuring that they practice within the bounds of this policy and the constraints of their professional standards. 5.4. Role of clinical manager and team leaders: Ensuring that protocol and associated supporting documents are available in practice. Identifying staff who are operating under PGD and ensuring that they have completed PGD training. 6. Role of Injection Therapy Group 6.1. The Injection Therapy Group is responsible for: Reviewing the Policy for Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists every 3 years. Maintaining and epanding the evidence base for injection therapy practice Ensuring that all members comply with guidance and take part in regular CPD and observed practice. This will be written up and presented to line manager at annual review. Issuing evidence to all staff involved in injections, using meeting minutes and injection resource on a shared drive. 7. Supporting Documents: 7.1. This Document is written to be used in conjunction with: PGDs for Administration of Triamcinalone Acetonide/ Methyl Prednisolone/ Lidocaine by Registered Physiotherapists NDHT Injectable Medicines Policy and standard operating policies and procedures Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 4 of 12
Anaphylais Policy Standards for Independent Physiotherapist Prescribers 8. Mechanisms for authorising medicines: Patient Group Direction (PGD) 8.1. A PGD is a specific written instruction for the supply or administration of a licensed named medicine, including vaccines, to specific groups of patients who may not be identified before prescribing HSC 2000/026 Appendi 1 8.2. A PGD facilitates timely application of injection therapy for the patient and efficient use of staff time and resources. The Health Service circular HSC 2000/026 outlines the requirement of a PGD. 8.3. A PGD can only be used with licensed drugs which include the steroids and local anaesthetic recommended for use with this guideline. A PGD cannot be used for unlicensed drugs which includes the situation where two or more licensed drugs are mied together, creating a new unlicensed product. Patient Specific Direction (PSD) 8.4. This is a written instruction by an independent prescriber, for a named patient whom they have assessed and subsequently formulated a treatment plan which may include the supply or administration of a medication. It provides a clear demarcation of responsibilities, with the prescriber having the responsibility for prescription of the drugs, and the injecting therapist the responsibility of administration of the drugs. It also allows the therapist to mi the LA and steroid prior to delivery. However there are drawbacks to this authority to administer. If the independent prescriber is not immediately available to sign the PSD, the patient is denied immediate treatment and is inconvenienced by having to return for an additional appointment which also contributes to increased clinic waiting times Independent Prescribing 8.5. A qualified independent prescribing physiotherapist can prescribe the drugs contained within this policy, adhering to the Standards for Independent Physiotherapy Prescribers from the Health and Care Professions council (HCPC) and the Chartered Society of Physiotherapy (CSP). Miing of steroid and local anaesthetic prior to administration is permissible using this mechanism. Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 5 of 12
9. Injection Practice Inclusions 9.1. An injection may only be carried out if informed consent is given and in the absence of eclusions. Triamcinolone Acetonide and Methylprednisolone Acetate can be administered via injection for the management of pain, stiffness and inflammation associated peripheral neuro-musculoskeletal lesions. Injections are limited to periarticular and intra-articular lesions of the upper and lower etremities only. Lidocaine may also be administered. Injection is only offered after a full assessment of the patient, including medical history, list of medications/sensitivities, history of presenting problem and discussion of alternative treatment options. It is less common for injection to be offered as a standalone treatment, though this does happen in certain cases (eg De Quervains Tenosynovitis), with its use normally to provide pain relief and facilitate physiotherapy. It may also be used to try and differentiate the source of pain where this is unclear. Eclusions 9.2. Contraindications and cautions are listed in the individual medication PGDs and systemic infection/ septic arthritis must specifically be checked for. 9.3. Where a caution to injection is present, alternative management should be discussed with the patient in addition to the effects and side effects of injection including the possible effects on their medical condition. If necessary, the physiotherapist should consult the patient s medical practitioner to discuss the individual case. If the medical practitioner agrees that it is acceptable to continue with injection therapy, record of this decision should be documented in patient s notes. If the medical practitioner feels it is unsuitable to continue with injection therapy, this too is documented and patient informed of decision and alternative management agreed. 9.4. Corticosteroids provide the following benefits when injected : Suppressing inflammation in joints and connective tissues, Suppressing eacerbations of degenerative joint disease, Disruption of the inflammatory response in low grade re-injury of soft tissue, A possible promotion of articular surface protection. Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 6 of 12
9.5. Drugs to be used are Triamcinolone Acetonide 40mg/ml (Kenalog ), Methylprednisolone Acetate, Methylprednisolone Acetate 40mg/ml (Depo- Medrone ), 40mg with Lidocaine Hydrochloride 10mg/ml(Depo-Medrone with Lidocaine).They may be administered using a PGD, PSD or prescribed by a registered prescriber. Due to the high concentration of these drugs they are ideal for injecting small joints and tendons to prevent distension, which could increase post injection flare. Kenalog is the first line agent with all intra-articular and periarticular injections. If Kenalog is unavailable then Depo-Medrone will be the second line agent used. When Lidocaine is indicated but a premi solution is unavailable then two separate injections of Lidocaine and Steroid will be given. As above Kenalog becomes the first line steroid agent to be used. If Kenalog is unavailable then Depo-Medrone will be the second line steroid agent used. Under these patient group directions miing agents and diluting agents is prohibited. Lidocaine 9.6. Lidocaine can be administered either as a sole agent, in a premi solution with steroid or via separate injections. Local anaesthetic provides the following benefits when injected : Therapeutic inhibition of inflammatory pain immediately, Confirmation of diagnosis on immediate pain relief, Distention of tissues with larger volumes to reduce adhesions. 9.7. Lidocaine can be used as a sole agent when any of the above are required. Pre mied solution can be used as an alternative to steroid alone to provide immediate pain relief post injection and at the choice of the patient. 9.8. Recent changes to the statement of product characteristics for lidocaine for injection state that injection of lidocaine into joints may have a detrimental effect on cartilage. This effect has been shown to be a class effect and to be dosage and contact time dependent. Effects are most strongly seen following continuous infusion post-surgery. Advice to injecting physiotherapists is to use the minimum dose necessary and to consider avoiding in intrarticular injections unless specifically required for diagnostic purposes. Doses 9.9. Maimum dosages are as listed in the relevant PGDs. 9.10. When Lidocaine is administered intrarticularly, this is an unlicensed use of a licensed product. This is common practice, however the patient should be informed of this fact. Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 7 of 12
Preparation 9.11. Skin cleaning prior to injection must be undertaken using a disposable disinfection wipe containing 2% w/v chlorheidine gluconate. According to the Medicines and Healthcare Regulatory Agency alert in October 2012, known sensitivity to chlorheidine gluconate needs to be checked before use. If chlorheidine gluconate wipes are not available or the patient has sensitivities to chlorheadine gluconate then an alcohol wipe must be used. Steroid injection is carried out following a no touch technique and in keeping with trust infection control and hand hygiene policies. 10. Documentation 10.1. The following will be recorded in the patient s clinical records (see Appendi 1 for eample proforma) according to local Trust Guidelines: Record patient consent The diagnosis and treatment The dose administered Batch number and epiry date The route and site of administration The date of administration Time of injection The signature and name of the person administering/supplying the medication 11. Aftercare 11.1. The patient should be asked to remain in the clinic after any injection to observe for potential adverse effects. There is no recommended time limit and should be at the discretion of the treating therapist. 11.2. Review of the patient after injection therapy should be arranged to assess the effect of treatment, to check for side effects and to arrange other treatment as required. Review may be face to face or by telephone, e-mail or letter and is normally within one month. In Etended Scope Practitioner run triage clinics, patients seen for injection have open access and may not be formally reviewed, but will have a telephone number to contact in case of adverse effect. In these cases, follow up will be dictated by symptom response. 11.3. Patients should be warned of possible side effects and be given written information including drug name, dosage and site of injection (Arthritis Research UK, 2014). 11.4. Available evidence suggests that a 48hr period of relative rest can prolong symptom relief and this is therefore advised. Patients are advised to avoid heavy loading of tendons that have been injected around for up to 2 weeks, due to the potential for transient weakening. Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 8 of 12
11.5. The patient s medical practitioner should be informed of the injection procedure that includes date, drug name, dosage and site of administration and should be conveyed within 48hrs (72 in eceptional cases) as stated in the trust non-medical prescribing policy. 12. Training and Qualifications required 12.1. In order to work under this guideline, therapists must be; 12.2. HCPC registered physiotherapists who have specific, appropriate supervised training and have been assessed as competent to administer injections under locally ratified PGDs and PSDs Or 12.3. HCPC registered physiotherapist undertaking the appropriate training and working under the supervision of a physiotherapist qualified in injection therapy. Additional requirements Immediate access to Adrenaline 1 in 1000 for anaphylais Up to date Hepatitis B vaccination Familiarity with the British National Formulary information and Summary of Product Characteristics (SPC) (Data sheets) in all drugs to be administered via a PGD Emergency cardiopulmonary resuscitation and anaphylais training Working knowledge of Trust Medicines Policy and associated Standard Operating Procedure; Injectable Medicines Policy, Anaphylais Policy and Consent policy An up to date risk assessment of the Injectable Medicines in accordance with the National Patient Safety Agency alert 20 Annual update in emergency cardiopulmonary resuscitation (CPR) and anaphylais procedures Evidence of continuing professional development, training and competence in intra-articular and soft tissue injection and the management of musculoskeletal lesions Knowledge of The use of Medicines with injection therapy in physiotherapy services.4th edition by the Chartered society of Physiotherapists (CSP) 6 PGD training 12.4. Physiotherapists training to administer injections will also be epected to comply with this guideline. 12.5. Clinical governance will be ensured by: All staff undertaking 2 peer (qualified member of injection group) observed injections per year, which will be written up and presented at appraisal Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 9 of 12
Record of participation in the injection therapy group and of observed practice being kept on shared drive and overviewed by the group/ chair as a standing item on the agenda to ensure compliance Cascading minutes of meetings to all injecting staff and saving educational materials on a shared drive accessible by all injectors. New staff within the trust undertaking 2 injections prior to practicing, observed by a senior clinician qualified in injection therapy. 13. Monitoring Compliance with and the Effectiveness of the Policy Standards/ Key Performance Indicators 13.1. Key performance indicators comprise: Level of adverse effects 2 peer observed practices per year recorded for all staff Annual Resuscitation training completed Bi-annual Anaphylais training completed Minimum 1 attendance at and participation in the injection group per year Audit of outcomes Process for Implementation and Monitoring Compliance and Effectiveness 13.2. This protocol will be emailed out to all injecting physiotherapists within the trust, as well as being presented at the injection group meeting and physiotherapy team lead meeting. 13.3. Monitoring process: Compliance will be monitored via regular review at the injection group, as a standing agenda item. This will cover attendance at the group, record of satisfactory observed practices, up to date resuscitation and anaphylais training. Group members will be asked to present adverse effects as well as reporting via Dati/ MHRA as appropriate. Injectors will also be asked to show evidence of observed practice at annual appraisal. All injectors will receive the minutes of the injection meeting via email. Non-compliance will be highlighted at the injection group and opportunity to rectify any shortfall given. If this is not achieved, the member of staff involved will be asked to suspend injection practice until it has been. If non-compliance continues after reasonable opportunity to meet the protocol has been given, the line manager and clinical manager of the service will be informed. Outcomes from injection therapy will be audited bi-annually. Observed practice will be used as the primary means of ensuring individual practice follows the protocol. Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 10 of 12
14. Equality Impact Assessment 14.1. The author must include the Equality Impact Assessment Table and identify whether the policy has a positive or negative impact on any of the groups listed. The Author must make comment on how the policy makes this impact. Table 1: Equality impact Assessment Group Age Disability Gender Gender Reassignment Human Rights (rights to privacy, dignity, liberty and non-degrading treatment), marriage and civil partnership Pregnancy Maternity and Breastfeeding Race (ethnic origin) Religion (or belief) Seual Orientation Positive Impact Negative Impact No Impact Comment 15. References Arthritis Research UK (2014). Local Steroid Injections Saunders, S, Longworth, S. Injection Techniques in Orthopaedics and Sports Medicine: A Practical Manual for Doctors and Physiotherapists (2006) 3 rd Edition. Amendments to A Clinical Guideline for the Use of Injection Therapy by Physiotherapists (1999) The Chartered Society of Physiotherapy, July 2010. Seshadri V, Coyle CH, Chu CR. Lidocaine potentiates the chondrotoicity of methylprednisolone. Arthroscopy. 2009 Apr;25(4):337-47 Statement of Product Characteristics Lidocaine for injection. Hameln https://www.medicines.org.uk/emc/medicine/20887. Last accessed 07/09/2016 Health and Care Professions Council (2013). Standards for prescribing. Accessed online: http://www.hcpcuk.org/publications/standards/inde.asp?id=692. Last accessed 07/09/2016 Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 11 of 12
16. Associated Documentation Medicines Policy Injectable Medicines Policy and associated SOPs Anaphylais Policy Infection Control Policy Consent Policy Administration of Steroid and Local Anaesthetic Injections by Registered Physiotherapists v1.0 16Sep16 Page 12 of 12