This guideline is for nursing staff within the Pain Services assisting with the administration of botulinum toxin.

Transcription

1 CLINICAL GUIDELINE FOR THE SAFE ADMINISTRATION OF BOTULINUM NEURO TOIN FOR INJECTION within the PAIN SERVICE. Botox and eomin (trade names) 1. Aim/Purpose of this Guideline This guideline is for nursing staff within the Pain Services assisting with the administration of botulinum toxin. 2. The Guidance This procedure should only be undertaken by health care professionals appropriately trained. 2.1 Indications for use Botulinum toxin is indicated for the symptomatic relief of several conditions. It acts as a muscle relaxant. 2.2 Contraindications Individuals with known hypersensitivity to Clostridium Botulinum type A neurotoxin complex (150/900kD) or to any of the excipients. - Presence of myasthenia gravis or Eaton Lambert Syndrome - Infection at the proposed injection site Anaphylaxis may occur rarely and therefore anti-anaphylactic measures, including adrenaline, should be easily available anywhere Botulinum Toxin is being administered. 2.3 Ordering This should be done in advance of the procedure. The order from pharmacy should include the patients name, hospital number and date of birth. 2.4 Storage Do not store with food. eomin Unopened vials should be stored in a locked drug cupboard (not exceeding 25 c). Botox - Unopened vials should be stored at between 2-8 o C (in a pharmaceutical grade fridge). After reconstitution, immediate use of the solution is recommended. However stability has been demonstrated for 24 hours when stored at 2-8 o C. In this case it should be labelled with the date and time it was re-constituted. This label should also include how it was reconstituted and by who. Page 1 of 7

2 2.5 Spillages The contaminated surface should be wiped up either using absorbent material impregnated with sodium hypochlorite <1% eg. Clinell Clorox. 2.6 Disposal All vials and sharps should be disposed of as clinical waste into a Prescribed Only Medications (purple lidded) sharps bin. All other non-sharp equipment must be disposed of in a yellow waste bag with purple stripe (UN 3291). 2.7 Equipment Dressing pack with plastic lined paper towel Plastic aprons Non-sterile, non-latex gloves Vial of eomin / Botox for injection and sterile Sodium Chloride 0.9 % or levobupivacaine. Prescribed only medications bin (POMS) - Purple lidded sharps bin. Waste bag yellow with purple stripe (UN 3291). 2.8 Procedure PROCEDURE RATIONALE 1 Explain the procedure to the patient To obtain appropriate informed consent. To reduce anxiety 2 Assist to position the patient into the To promote safety and comfort appropriate position. 3 All staff undertaking and assisting with the procedure should wash hands, put on gloves aprons. Universal health and safety precautions. 4 Prepare the botulinum toxin for injection by reconstituting the vial with sterile Sodium Chloride 0.9 % or levobupivacain in accordance with the manufacturers guide. The smaller the volume the less discomfort and spread of toxin in the injected muscle occurs. 5 The practitioner injects the diluent gently into the vial. Discard the vial if a vacuum does not pull the diluent. 6 After the procedure place all sharps immediately in a POMS prescribed only medicines sharps container (purple lidded) and all other equipment into the waste bag as described above. 7 The used vial of eomin/ Botox should be placed in a POMS prescribed only medicines sharps bin (purple lidded) sharps container. eomin /Botox is denatured by bubbling or similar violent agitation. Universal health and safety precautions. Safe disposal in accordance to the generic waste management policy. Safe disposal in accordance to the generic waste management policy. 8 Remove gloves, aprons and goggles. Wash hands universal health and safety precautions 9 The practitioner documents the whole process, including the batch number of the eomin / Botox Effective record keeping Page 2 of 7

3 References Allergan Ltd (2014) Botox information UK Summary of Product Characteristics Full prescribing information (2015) 3. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared The safe practice of handling, storage, administration and disposal of Botulinum Toxin within the Pain Service. Pain Services staff - Kate Fleming The policy above is available in clinic. Whenever the procedure is carried out within clinics. Any deviations from policy will be challenged at time of procedure These will be highlighted with relevant staff and noted at dept or nurse meetings as appropriate. The department managers will be responsible for interrogating the required actions. The designated leads i.e. department managers will forward any change in practice where appropriate to the whole department. 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 3 of 7

4 Appendix 1. Governance Information Document Title Date Issued/Approved: 28 th August 2017 Clinical guideline for the safe administration of botulinum neuro toxin for injection within the Pain Service Date Valid From: 28 th August 2017 Date Valid To: 28 th August 2020 Directorate / Department responsible (author/owner): Pain Services, Kate Fleming Theatres and Anaesthetics Contact details: / Brief summary of contents This policy outlines the safe process for administration of botulinum neuro toxin within the Pain Services Suggested Keywords: Target Audience Executive Director responsible for Policy: Date revised: July 2017 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Pain Service, Botulinum Toxin, Botox, eomin RCHT PCH CFT KCCG Director of Nursing, Midwifery and Allied Health Professionals. Guidelines for the Safe Preparation and Administration of Botulinum Toxin (Botox) for Injection Infection Control, Waste Management Team, Senior pharmacist Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Dr Alison Moore n/a {Original Copy Signed} Internet & Intranet Intranet Only Clinical / Pain/ Botox/ Pain/ Pain Services na na Page 4 of 7

5 Training Need Identified? No Version Control Table Date Versio n No April 2008 V th August 2014 V2.0 Summary of Changes Initial Issue produced by Document had been removed as out of date. Amended and updated for the use of Pain Services. Changes Made by (Name and Job Title) Jan Orr and Di Morris Ward manager ENT Outpatients Kate Fleming lead pain nurse specialist 25 th July 2017 V3.0 Document amended and updated for the use of the Pain service. Jayne Thomas. Lead Pain specialist nurse All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 5 of 7

6 Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy. Clinical guideline for the safe administration of botulinum neuro toxin for injection within the Pain Service Directorate and service area: Pain Services Theatres and Anaesthetics Name of individual completing assessment: Kate Fleming 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? Is this a new or existing Policy? New replacement for removed G18 guideline Telephone: : /2792 To standardise safe handling, storage, administration and disposal of botulinum toxin within the Pain Service for staff and patients. 2. Policy Objectives* Ensure that everyone follows the same procedure Health and Safety of patients and staff Ensure Practice is evidence based 3. Policy intended Outcomes* As above 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. Observation Audit Staff and Patients Yes Yes Infection Control Department Senior Pharmacist Waste Manager Estates Department 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Page 6 of 7

7 Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Procedure carried out following the attainment of patient verbal consent The best interests of the patient are considered at every consultation. Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No no 9. If you are not recommending a Full Impact assessment please explain why. Full statement of commitment to policy of equal opportunities is included in the policy Signature of policy developer / lead manager / director Kate Fleming Date of completion and submission 28/08/2014 Names and signatures of members carrying out the Screening Assessment 1. Kate Fleming 2. Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 7 of 7