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Home therapy with subcutaneous immunoglobulin (SCIg) Classification: Clinical Guideline Lead Author: Dr Archana Herwadkar Consultant Immunologist Additional author(s): N/A Authors Division: Immunology, Neurology Renal and Tertiary medicine Unique ID: TWCIMM05(13) Issue number: 2 Expiry Date: December 2017 Contents Contents .................................................................................................................... 1 Who should read this document?............................................................................... 3 Key Practice Points .................................................................................................... 3 Background/ Scope/ Definitions ................................................................................. 3 What is new in this version?....................................................................................... 3 Guideline/ Protocol..................................................................................................... 3 Eligibility Criteria for home therapy ......................................................................... 3 Funding for home therapy ....................................................................................... 4 Training of patient /carer/nurse ............................................................................... 4 Stages of training .................................................................................................... 5 STAGE 1: Introduction to home therapy, safety and procedure for infusing SCIG at home ................................................................................................................ 5 STAGE 2: Record keeping, drug preparation, priming the giving set ................... 6 STAGE 3: Drug administration, calculation of rate ............................................... 7 STAGE 4: Removal of needles, disposal of equipment ....................................... 7 STAGE 5: The prevention and management of adverse reactions (ADR) ........... 7 STAGE 6: Obtaining supplies, patient contact with the Service ........................... 8 STAGE 7 (Continuous) Assessments .................................................................. 8 Standards .................................................................................................................. 9 Explanation of terms .................................................................................................. 9 References and Supporting Documents .................................................................... 9 Roles and responsibilities .......................................................................................... 9 Appendices .............................................................................................................. 10 Appendix 1 – Freedom 60 questionnaire for patients............................................... 11 Appendix 2 - Home Therapy Training Sub Cut Immunoglobulin .............................. 13 Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 1 of 17 Appendix 3 - Step-by-step guide for subcutaneous infusions for home therapy training ................................................................................................................................. 15 Document control information (Published as separate document) Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 2 of 17 Who should read this document? Immunology/neurology specialist nurses and medical staff who are involved with the training and delivery of home therapy of subcutaneous immunoglobulin, for patients with primary immunodeficiency and neurological conditions requiring immunoglobulin therapy Medical staff managing patients with primary immunodeficiency and neurological conditions requiring immunoglobulin therapy Salford Pharmacy Homecare team Key Practice Points Criteria for home therapy Funding of home therapy Training of patient/carer Stages of training Assessment Background/ Scope/ Definitions This document is necessary to ensure consistency with both training, assessment and infusion technique for patients with immunodeficiency and neurological conditions receiving subcutaneous immunoglobulin at home. What is new in this version? Patients can now have treatment at home, administered independently or supported by a homecare nurse. Salford Pharmacy Homecare Team now established and work in liaison with nurses and homecare providers Guideline/ Protocol Eligibility Criteria for home therapy Consultant Immunologist/neurologist and patient must agree this is a suitable, safe and beneficial Ig treatment method The patients GP is informed in a clinic letter that home therapy is an option – best practice for suitable patients (UKPIN guidelines) Patient must be motivated and committed to attending the training sessions as required Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 3 of 17 The patient may be trained and when trained infuse alone, however if there is a suitable, trainable infusion partner, we would offer training to them also. Patient must have access to a telephone at the place where infusions will be given Agreement to keep infusion logs and symptom diaries with a record of batch numbers Successful completion of a programme of training with appropriate written assessment Agreement from patient to attend Immunology/neurology outpatient clinic for Consultant review at least annually- on the understanding that Immunoglobulin supply will be withheld if the patient does not attend clinic for 3 consecutive appointments after contact has been made from the Immunology/neurology nurse Agreement from the patient to be reassessed every 12-24 months according to the relevant training manual to ensure correct procedures are being followed Agreement from the patient to be reinstated as a hospital attendee for their infusions if any of the above criteria fail to be met or if deemed necessary by your Immunology/neurology team A home visit prior to commencing is desirable to assess the home environment Patient registered on the Department of Health Immunoglobulin management programme database for patients receiving immunoglobulin and all dashboard requirements are maintained NB If a patient has no infusion partner and is unable to administer the infusion themselves, but meets all other criteria, a homecare nurse can be provided to administer the infusion. The application for funding can be arranged by the immunology specialist nurse. Funding for home therapy When the eligibility criteria have been met, funding is available through NHS England. Consultants should complete a clinician request form on the IVIG database. Pharmacy should be informed. Funding must be confirmed before supplies are arranged with a homecare company. Patients are registered with the homecare company, the patient gives written consent to give details to the homecare company and a copy is sent to Salford Pharmacy Home Care Team [email protected] The immunoglobulin and ancillary items are ordered on the homecare prescription. Delivery of all products and ancillary items are arranged towards the end of training by the homecare provider. Training of patient /carer/nurse Training commences within the hospital environment, either on the medical investigations ward, the haematology day unit or neurology unit. Training is over several weeks until the patient/carer feels confident and proficient. Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 4 of 17 After the delivery of all home items, the first infusion is done with the patient at home or the patient brings their own stocks and ancillary items to the ward for final assessment. All the product ancillary items are checked to ensure correct delivery. If a homecare nurse is provided, ideally the first infusion is done at home with both the homecare nurse and the immunology specialist nurse, to ensure a smooth handover for the patient. If this is not possible then a telephone handover is acceptable. The Immunology patient would take home a home therapy pack with infusion logs, antibiotic guidelines, infection records and product/pump specific information. Neurology patients are provided with an information pack together with all essential contact information for the clinical team and Homecare Company Stages of training 1. Introduction to home therapy, safety and procedure for infusing subcutaneous therapy at home 2. Record keeping, drug preparation, priming the giving set 3. Drug administration 4. Removal of the needles, disposal of equipment 5. The prevention and management of adverse reactions 6. Obtaining supplies, patient contact with the service 7. Assessment STAGE 1: Introduction to home therapy, safety and procedure for infusing SCIG at home Objectives of session 1. Explain the rationale for treatment with SCIg and criteria for home therapy 2. Define ‘aseptic technique’ 3. Identify and name equipment needed to infuse SCIg 4. Discuss the prevention of adverse reactions Objective 1: Rationale for treatment with SCIg Assess existing knowledge Patient’s specific condition Benefits of SCIg therapy Home therapy, what is involved & meeting the criteria The drug, manufacturing process and side effects Dosage, route of administration and frequency Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 5 of 17 Objective 2: Aseptic technique Assess existing knowledge Define and discuss the prevention of sepsis Demonstrate hand washing and drying Demonstrate aseptic technique used in preparing & administering SCIg Objective 3: Identification of equipment Assess existing knowledge Presentation and demonstration of equipment function Objective 4: Prevention of adverse reactions Define using classification list Discuss the client’s experiences of adverse reactions Focus on prevention by 1.screening for infection (immunology patients) STAGE 2: Record keeping, drug preparation, priming the giving set Objectives of session 1. Record keeping 2. Storage of immunoglobulin 3. Preparation of drug 4. Priming the giving set 5. Dealing with potential problems Objective 1: Record keeping Discuss importance of record keeping Demonstrate use of all forms Recording of batch numbers Contact numbers Objective 2: Storage of Immunoglobulin Relate to home environment safety, location, temperature Objective 3: Preparation for drug administration Clean work surface Gather all necessary equipment Safety issues: correct drug, correct dose, expiry date, contamination of equipment Objective 4: Priming the giving set Assess existing knowledge Use of demonstration to teach procedure Objective 5: Potential problems Assess existing knowledge Discuss and demonstrate the correction of Immunoglobulin not infusing Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 6 of 17 STAGE 3: Drug administration, calculation of rate Objectives of session 1. Good knowledge of drug administration 2. Rate Objective 1: Good knowledge of drug administration Repeat discussion on aseptic technique Highlight that changes in body weight may affect dose, dose adjustments maybe advised by the patients clinical team Discuss problems associated with infusion rate and refer to adverse reactions Objective 2: Calculation of rate Explain the importance of infusing the Immunoglobulin at the correct rate Explain how the rate is calculated and how this can be changed STAGE 4: Removal of needles, disposal of equipment Objectives of session 1. Safe removal needle sets 2. Safe disposal of equipment Objective 1: Safe removal of needle sets Discuss importance of a safe technique Ensure patient has a sharps container at hand Demonstrate procedure Ensure patient informs others to stand clear -to prevent needle stick injury Objective 2: Safe disposal of equipment Discuss the safe disposal of sharps and all other equipment Discuss action to take in event of needle stick injuries STAGE 5: The prevention and management of adverse reactions (ADR) Objectives of session 1. Possible reactions to SCIG 2. Knowledge of how to minimalise the risks of ADRs 3. How to manage ADRs Objective 1: Possible reactions to SCIG Discuss patient’s own experiences of ADRs Discuss the ‘classification of reactions’ list Objective 2: Knowledge of how to reduce the risks of ADRs Focus on prevention: screening for infection, monitoring rate Demonstrate how to assess base line observations Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 7 of 17 Objective 3: How to manage ADRs If required, the patient can administer in the presence of someone who is trained how to manage an adverse reaction whilst administering SCIg Progress through the ‘classification of reactions’ chart discussing how to deal with the reactions that may occur Discuss anaphylaxis and response to a patient who has collapsed (when training an infusion buddy or partner) Discuss the importance of a telephone being at hand during the infusion STAGE 6: Obtaining supplies, patient contact with the Service Objectives of session 1. The method of obtaining supplies for the specific Immunoglobulin 2. GP involvement and emergency care 3. Contract/consent Objective 1: The method of obtaining supplies for specific immunoglobulin Delivery process and relevant forms contact numbers and names Objective 2: GP involvement and emergency care Discuss the importance of continued GP involvement Discuss the appropriate use of contacting the service out of hours Discuss the importance of taking their home care folder with them in the event of attending an A&E department Objective 3: Contract/consent Discuss with the patient that by consenting to home therapy they are entering a contract regarding: infusion, maintaining their records and batch numbers, attending for appointments and nurse review of technique. STAGE 7 (Continuous) Assessments Objectives of session 1. To monitor learning 2. To motivate the patient and carer 3. To assess the level of patient and carer achievement 4. To enable the patient and carer to participate in home therapy 5. To measure the effectiveness of teaching Assessment is a continuous process to help the patient achieve the best they can. The majority of patients are taught through the stages of home therapy by a gradual process each time they attend the day unit for their infusion. A small number of patients may have their training over two to three days; these will usually be patients who have been having their regular infusions at their local hospital under shared care. Thus the patient gradually becomes more confident. Active participation is encouraged in the learning process and the patient is encouraged. Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 8 of 17 Patients who attend for regular infusions have a formative assessment with the patient and carer encouraged to reflect on each stage of their learning. All assessment, written assessment and training records are documented / scanned onto EPR Standards UKPIN guidelines for administration of immunoglobulin Department of Health Immunoglobulin Demand Management Programme database Explanation of terms N/A References and Supporting Documents Trust protocol: Administration of immunoglobulin. D14 Trust protocol: Trust Guidelines for use of Human Normal Immunoglobulin – intravenous and subcutaneous TWOG19 Trust protocol: Consent to immunoglobulin therapy TWCIMM02 Patient information leaflets: Immunoglobulin replacement therapy CS4(12), Home therapy with immunoglobulin replacement therapy CS3(12) Product manual Use of Immunoglobulin in neurological conditions Trust policy: Homecare Policy TWCG01 (16) Roles and responsibilities It is the responsibility of the immunology/neurology team, the consultant immunologist/neurologist and specialist nurses, to ensure that the patient is able to make an informed decision as to whether they wish to have subcutaneous immunoglobulin at home. The speciality specialist nurses train and support the patient throughout and provide follow up care/home visits/home assessments as required. It is the Salford Royal Home Care team’s responsibility to liaise with Homecare and NHS England regarding funding /invoices It is the immunology specialist responsibility to provide seamless handover to home care nurses. Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 9 of 17 Appendices The appendix contains copies of Assessment sheets Instructions for patients/nurse Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 10 of 17 Appendix 1 – Freedom 60 questionnaire for patients 1. Name: Date: QUESTION 1 Does a Freedom 60 need any batteries to work? Yes No QUESTION 2 What size syringe do you need to use on the freedom 60? 10 20 50/60 100 QUESTION 3 Do you need special freedom 60 tubing to infuse your immunoglobulin? Yes No If so is every freedom 60 tubing marked with freedom 60 on it? Yes No QUESTION 4 Can the freedom 60 be used with any needles? Yes No QUESTION 5 Should you ever need to put your fingers against the black tab or insert them inside the clear syringe casing? Yes No QUESTION 6 Can you over wind the freedom 60? Yes No QUESTION 7 I s the syringe locked into the freedom 60 pump during infusions? Yes No QUESTION 8 How many simple controls are there on a freedom 60 pump? 1 2 Issue 2 March 2016 3 4 5 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 11 of 17 QUESTION 9 Does the freedom 60 need to be kept in an upright position whilst infusing? Yes No QUESTION 10 If there is a blockage will the pressure build up to dangerous levels. Yes No QUESTION 11 Is the freedom 60 silent during infusion? Yes No If not what should you do? Nothing Call the Suppliers QUESTION 12 Can you clamp the tubing set if you need to? Yes No QUESTION 13 Does the freedom 60 carry bag have a handy viewing window and zipper pocket? Yes No QUESTION 14 Do I simply clean the freedom 60 with a surface disinfectant? Yes No QUESTION 15 After an infusion, do I gently push backwards and upwards on the syringe? Yes No QUESTION 16 Is the large disk on the end of the freedom 60 tubing not only essential for the pump to operate but also prevents contamination? True False Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 12 of 17 Appendix 2 - Home Therapy Training Sub Cut Immunoglobulin QUESTION 1 If the needle is accidentally touched, you should: a. _______ Continue to use the same needle b. _______ Clean it with alcohol swab c. _______ Throw it away d. _______ Use a different needle e. _______ Wash it with soap and water QUESTION 2 If another person is accidentally pricked with your needle, you should? a. _______ Apply ice b. _______ Squeeze area and make it bleed c. _______ Wash the area thoroughly d. _______ Ignore it e. _______ Report it to the Immunology centre QUESTION 3 If you experience a headache and shivering during the infusion, you should: a. _______ Stop the infusion immediately b. _______ Take 2 Aspirin/Paracetamol/Piriton c. _______ Speed up the infusion rate d. _______ Slow down the infusion rate e. _______ Do nothing QUESTION 4 Used needles should be: a. _______ Thrown in a rubbish bag b. _______ Cleaned and reused c. _______ Put in a sharps bin d. _______ Bent with a pair of pliers e. _______ Not sure QUESTION 5 List three things that you should always check about your immunoglobulin a. ________________________________________________________ b. ________________________________________________________ c. ________________________________________________________ Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 13 of 17 QUESTION 6 Place a letter from Column B next to the word that describes it: Column A Column B 1.________ Sterile a. Totally free of bacteria b. Inflammation of the liver c. Fever and itching skin 2.________ Hepatitis QUESTION 7 Answer the following questions in your own words. Why do we need to take blood samples? QUESTION 8 List three ways a needle may be contaminated a. _________________________________________________________________ _ b. _________________________________________________________________ _ c. _________________________________________________________________ _ QUESTION 9 When should you NOT do an infusion? QUESTION 10 Why should equipment be disposed of carefully? QUESTION 11 When would you be most likely to call your GP? Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 14 of 17 QUESTION 12 Why is it important to fill in the details on the Home Therapy infusion records? Appendix 3 - Step-by-step guide for subcutaneous infusions for home therapy training Name NHS Number Reason for immunoglobulin Product Method of administration Needle size/type/number of needles Tubing size Other issues Immunology nurses number Step-by-step guide for subcutaneous infusions for home therapy training. 1. Wash Hands using 7 step technique. SEVEN STAGE TECHNIQUE Roll back sleeves to expose wrists and forearms Wet hands thoroughly under running water before applying soap using the technique described below. 1. Rub palm to palm 2. Right palm over left dorsum & vice versa 3. Palm to palm, fingers interlaced 4. Backs of fingers to palms with fingers interlocked Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 15 of 17 5. Rotational rubbing of right thumb clasped in left hand and vice versa 6. Rotational rubbing of right fingers on left palm and vice versa 7. Finish with hands to wrists, both hands. Rinse hands under running water and pat dry thoroughly. USE THE SAME STEPS WHEN APPLYING ALCOHOL HAND GEL SUBCUTANEOUS INFUSION OF IMMUNOGLOBULIN USING FREEDOM 60 PUMP 1. Clean the surface that is it be used for your infusion with soap and water or surface wipe. Clean infusion tray with soap and water and then an alcohol wipe. Leave to dry 2. Open and check name and expiry dates of product and separate into batches. Place them at the side of infusion tray 3. Gather together all equipment needed- Freedom 60 infusion pump, 50ml syringe (2 if you are infusing more than 50mls), yellow needle(s), tubing set and needled infusion set, cleaning wipes, tape, gloves, packet of gauze or cotton wool, alcohol hand gel, sharps bin, waste bag, infusion log and pen. 4. Clean hands with alcohol hand gel 5. Take caps off products and cleanse tops using a different corner of the cleansing wipe for each bottle. Allow to dry. 6. Open the syringe and attach needle, alternatively one needle free adaptor per vial, taking care not to touch the key parts. Draw up 10 mls of air into syringe(s). Open all other equipment onto the infusion tray keeping key parts protected at all times. 7. Take caps off products and cleanse tops using a different corner of the cleansing wipe for each bottle. 8. Alcohol gel hands and apply a pair of gloves Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 16 of 17 9. Draw up product into syringe by initially putting 4 mls of air into air pocket in vial and then drawing back. Expel any air from syringe 10. Take needle off syringe/unscrew syringe from needle free adaptor and attach to tubing set and then infusion needle set taking care not to touch any key parts 11. Prime the line as you have been taught. 12. Clean areas of skin where infusion is to be sited 13. Site needles and tape in place. Pull back slightly to ensure correct position of needles. 14. Place syringe in pump and start infusion. 15. If infusing more than 50mls draw up remaining product into 50ml syringe and place in infusion tray with covered needle attached to end. To change syringe if more than one syringe used 1. Alcohol gel hands 2. Take syringe out of pump and detach it from tubing set and needle set, take new syringe and attach it to tubing set and needle set taking care not to touch key parts. Place back into Freedom 60 and start infusion To remove needle 1. Ensure you have gauze or cotton wool and tape ready. 2. Loosen tape from skin and remove needle, cover infusion site with gauze and tape. 3. Dispose of all equipment safely, yellow needles, needle set, bottles and syringes in sharps bin and clinical waste in yellow/orange bags. 4. Clean infusion tray with soap and water 5. Don’t forget to document batch numbers of products and sites used (legs, abdomen) Good hand washing technique and protection of ‘key parts’ is an essential part of your infusion preparation. Gloves are worn when drawing up immunoglobulin to lessen the severity of needle stick injury and to prevent your hands from coming into contact with the immunoglobulin which is very sticky. Once you have washed your hands with soap and water alcohol hand gel can be used to decontaminate your hands prior to various steps of the procedure. When wearing gloves your hands may become sweaty and hot, which allows your own bacteria to multiply so we ask you to cleanse your hands with alcohol hand gel once you have removed your gloves. Issue 2 March 2016 Home therapy with subcutaneous immunoglobulin (SCIg) Current Version is held on the Intranet Check with Intranet that this printed copy is the latest issue Page 17 of 17
