Policy for the use of the McKinley T34 Syringe pump for the administration of continuous subcutaneous infusions in symptom management for adult palliative care. Numbered Document: Clin049v12 Author: Jane Dacre Lead Director: David Melia Target audience: All staff Version Number: 12 Date reviewed at JCNC Policy Group: Ratified at: Date of publication on MY Intranet: (Administrative Lead will insert date) Date Due for Revision: April 2019 Post Responsible for Revision: Specialist Palliative Care Team Leader Equality Impact Assessment: Neutral Circulation: All staff via MY Intranet Restrictions: None Total Pages: 33 Page 1 of 34
Contents Section Page 1 Introduction 5 2 Purpose 5 3 Aims and Objectives 5 4 Scope 5-6 5 Equality Impact Assessment 6 6 Mental Capacity Act (2005) 6 7 Training and authorization to use 7 8 Indications for use of a syringe pump 7-8 9 Equipment and resources 8-9 10 Drawing up medication 9 11 Drug compatibilities and stability 10-11 12 Prescribing 11 13 Unlicensed medications (Off label) for use in syringe pump 11-12 14 Information for patients 12 15 Procedure for monitoring syringe pump 13 16 Battery life 14 17 Monitoring effectiveness of therapy 14 18 Incident reporting 14 19 Cleaning the device 15 20 Maintenance and servicing 15 21 Transfer/discharge of patient with T34 in situ 15-16 22 Procedure for initiation of McKinley T34 SD 16 23 Re-siting of cannula 16 24 Procedure for discontinuation 16 25 Implementation 16 26 Outcomes 17 27 Audit and Monitoring 17 28 Accountability 17 Appendix 1 References 18-19 Appendix 2 Procedure for the initiation, safe operation and monitoring of 20-21 the McKinley T34 syringe pump Appendix 3 EIA 22-23 Page 2 of 34
Appendix 4 Troubleshooting/alarm guide 24 Appendix 5 Sources of help and advice 25 Appendix 6 Procedure for drawing up medications/diluents separately for 26-27 T34 Syringe pump Appendix 7 Medical Device Loan Operations Flow Chart 28-29 Appendix 8 Prescription chart for CSCI via a T34 syringe pump 30 Appendix 9 Community Prescription Chart 31-32 Appendix D Checklist for the Review and Approval of Procedural Documents 33-34 Page 3 of 34
Review and Amendment Log Version No Type of Change Date Description of change Version 1.0 Update policy February Update policy date of 2004 production Version 8 Review in line with NHSLA assessment August The policy has been rewritten in accordance with the NHSLA template policy Version 9 Review July 2012 Changes in lead director and ratification process Detailed monitoring added Version 10 Review December 2012 Amended to reflect change in responsibility for managing policy approval and update Version 11 Review and update May 2014 Annual review and update for changes in leadership management arrangements Version 11.1 Review and update June 2014 Changes made to Document Control page Version 11.2 Changes to EIA July 2014 Changes made to protected characteristics on the EIA page Version 11.3 Review and update August 2014 Additions to policy taken from policy management paper submitted to CQC meeting 1 st August 2014 by Celia Weldon Version 12.1 Review and update April 2017 Mid Yorks Logo updated Change to arrangements all communication on policies and submission to be via the Policy inbox Flow charts updated Formatting corrections made Page 4 of 34
1. Introduction A major risk for the Trust is undertaking the use of the McKinley T34 syringe pump without a comprehensive policy for administration, education and management including prescribing, monitoring and cleaning the device. 2. Purpose This policy is for the administration of continuous subcutaneous infusion (CSCI) of medication via the McKinley T34 syringe pump in adult palliative care patients at Mid Yorkshire Hospitals NHS Trust (MY) in the Hospitals and community care setting. The McKinley T34 syringe pump is the only portable syringe pump approved for use in the administration of CSCI to adult palliative care patients at MY across the Hospitals and community care setting. A syringe pump is a portable, battery operated mechanical pump used to deliver drugs at a predetermined rate to provide CSCI of medication for patients in whom oral administration would be problematic. They may be used to control symptoms in the care of adults or children in hospital, home and hospice settings. This policy covers usage in adults only across the MY Hospitals and community care setting. The effective use of the T34 syringe pump can enhance quality of life and enable patients to be treated in their preferred place of care with optimum symptom control. Revision This policy has been adapted from the MY Syringe driver policy for adult palliative care. 3. Aims and objectives 3.1 Aim: To ensure the safe and effective use of the McKinley T34 syringe pump by nurses, doctors and pharmacists within Mid Yorkshire Hospitals NHS Trust, across the MY Hospitals and community care setting. 3.2 Objectives: Correct identification of patients who would benefit from an infusion of medication via this route. The correct assembly of the equipment. Effective use of the correct equipment. The safe preparation and administration of prescribed medication. Optimum symptom management avoiding unnecessary frequent injections. 4. Scope This policy is for the use of the McKinley T34 syringe pump to deliver CSCI for symptom management of adult palliative care patients across the MY Hospitals and community care setting. 4.1 This is the only model of syringe pump approved for this use in this patient group at MY hospitals NHS Trust. In the event of any other type of syringe pump for CSCI being in use when a patient is admitted, this should be discontinued and a McKinley T34 commenced. Page 5 of 34
4.2 Only qualified nurses and medical practitioners who have received training in Theory and Practice may set up, monitor and discontinue a McKinley T34 syringe pump. Further information on training can be obtained from ward managers, District nurse managers or the MY Medical Devices Department. http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys 4.3 This policy applies to all staff within MY who undertake preparation; administration; reloading; and/or monitoring of a T34 syringe pump for administration of medicines via this route. 4.4 T34 syringe pump will not be used for those patients who expressly refuse consent to use of the device to administer medication. 4.5 This policy will outline the safe use of the McKinley T34 device, the equipment required, monitoring of the infusion and documentation, training and audit requirements. 4.6 This policy should be used in conjunction with the following policies and guidelines: http://nww.midyorks.nhs.uk/docs/documents/forms/clinical%20policies.aspx Nursing and Midwifery Council (NMC) Standards for Medicines Management (2008) NMC The Code for nurses and midwives(2015) MY Medical physics department Management of Medical Equipment and Devices Policy (April2015) http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys MY Universal infection precautions MY Hand hygiene policy MY Policy for Consent to Examination or Treatment (2014) MY Medicine management http://nww.midyorks.nhs.uk/departments/meddir/medman/pages/default.aspx MY Incident Management Policy and Guidance MY Palliative Care intranet site To use Hyperlinks hold CTRL and click to follow link for further information 5. Equality Impact Assessment (EIA) This policy is not intended to discriminate against any group or individual. An Equality Impact initial screening assessment has been completed (see Appendix 3). 6. Mental Capacity Act (MCA 2005 Code of Practice) This Act applies to all persons over the age of 16 who are judged to lack capacity to consent or withhold consent to acts which are considered by health and social care professionals to be in the best interests of their welfare and health. The Mental Capacity Act 2005 imposes a legal requirement on health and social care professionals to have regard to relevant guidance within the Code of Practice when acting or making decisions on behalf of someone who lacks capacity to make the decision for themselves. Furthermore, they should be able to explain how they had regard to the Code when acting or making decisions. Detailed guidance is available in the Mental Capacity Act 2005 Code of Practice (http://www.dca.gov.uk/legal-policy/mental-capacity/mca-cp.pdf Page 6 of 34
7. Training and authorisation to use 7.1 All healthcare professionals are personally responsible to ensure that they have received training in the safe use and observation of any medical device they need to use (NPSA2004). 7.2 All qualified nurses are required as part of their mandatory training to attend T34 syringe driver training. A record of the names and training are held by medical physics, and maintained within the medical physics department. 7.3 Undertaking the audit which accompanies this policy will be facilitated by the MY Matrons. 7.4 Competency using the T34 syringe pump must be evidenced.as part of core competencies facilitated by the PDEU 7.5 All qualified nurses authorised to use the T34 syringe pump must have received face to face competency-based training. 7.6 Secondary care staff will need to undertake refresher training every three years. 7.7 Primary care staff will need to undertake refresher training every year. 7.8 Individual members of staff have personal responsibility to ensure their mandatory is up to date and to book via MY medical physics department. 7.9 Any training/update required will be identified at annual appraisal. It is the responsibility of managers to ensure practitioners attend training provided. 7.10 MY medical physics department will record evidence of training on the T34 syringe pump at local level and produce reports as required. 7.11 The equipment libraries will not issue T34 syringe pumps to clinical staff or areas in MY hospitals until authorised staff within the clinical area have been trained. 8. Indications for use of a syringe pump and commencing use 8.1 The main indication to commence a T34 syringe pump is a patient s inability to swallow and/or absorb medications. This may be due to: Intestinal obstruction. Mouth, throat and oesophageal lesions. Persistent nausea and vomiting. Weakness or unconsciousness. Malabsorption. Inability to control symptoms any other way. The decision to administer medication via a T34 syringe pump needs to be taken by the multidisciplinary team, in consultation with the patient and/or carers. 8.2 Commencing use of syringe pump The T34 syringe pump is used to deliver drugs at a predetermined rate (ml/hr) over a 24 hour period. The T34 pumps are set at a default of 24 hours (lock off). Page 7 of 34
If a decision is made to use a T34 syringe pump it must be remembered that it will take time for medication to reach therapeutic levels (up to four hours), therefore administration of immediate release medication at the time of initiation of the CSCI will need to be considered (Twycross et al 2012). Consideration should also be given to the potential misuse of medicines. The McKinley T34 syringe pump must be used with a lockable box which will help to minimize this risk. On receipt of a T34 syringe pump staff are responsible for the safe keeping of the lockable box key. 8.3 Suitable site for insertion. As far as possible involve the patient in the choice of the site of needle insertion (see below). Preferred Sites In an area with as much subcutaneous fat as possible e.g. Anterior chest wall Top of thigh Upper arms (unless regular turning required) Anterior abdominal wall (is sometimes uncomfortable) Contra-indicated Sites Areas of broken skin/recent irradiation sites Areas of tumour involvement Oedematous areas including lymph oedematous limbs Bony prominences/sites near a joint Inflammation or infection to the skin Abdomen if patient has ascites Areas where other medication patches are in place 9. Equipment and resources The MY medical physics department will issue all T34 syringe pumps with a lockable box and key, and battery. Clinical areas are expected to keep sufficient stock of the disposable items. Equipment required as follows: McKinley T34 syringe pump including lockable box. Check that the pump does not display the message Calibration Due send for service when powering on. If message is displayed, contact medical physics equipment library. 9v Duracell alkaline battery, plus spares. Page 8 of 34
Selection of syringes and needles for drawing up medications. Luer lock syringe (20ml, 30ml or 50ml syringe). (The pump has been calibrated to use BD Plastipak syringes Other brands may be used but will require change in setting on syringe pump. Failure to change setting to alternative brand may result in over/under infusion. It is recommended therefore only to use Luer Lock syringes). Yellow BD SafT Intima ref FSP324 (Box 25). Codan 75 cm extension sets ref FSB114. Transparent, adhesive dressing a prescription will be needed from the GP in the community setting. Valid prescription. Prescribed drugs. Appropriate diluents (water/sodium chloride 0.9%) A prescription will be needed from the GP in the community setting. Skin cleaning preparation of Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol. Sharps bin. Additive Label. Documentation. 10. Drawing up medication Best practice, as advised by the Specialist Palliative Care team is that each prescribed medication should be drawn up separately in order to ensure accuracy in measurement of the quantity of medication. The manufacturers that produce the ampoules do not guarantee the total amount of medication in each ampoule, only that the dosage is correct (see appendix 6). 10.1 Syringes Medication must be drawn up into a Luer lock syringe of suitable size. Luer lock syringes are recommended to prevent a giving set and syringe separating or being pulled apart. A 20ml syringe should be used as a minimum for loading onto the T34 syringe pump. Using this or higher volume will reduce irritation to site; reduce risk of crystallization; decrease risk of incompatibility and decrease risk of site rejection compared to using lower volumes, (Dickman, Schneider and Varda, 2011 3 rd ed.) 20 ml, 30 ml, and 50 ml Luer lock syringes are recommended for use with the McKinley T34 syringe pump. Fill capacity varies dependent on syringe type used staff should refer to the McKinley T34 Operational Manual available on each ward area and MY medical devices intranet site. A 50 ml syringe will not fit in the lockable box and should only be used in exceptional circumstances following advice from the specialist palliative care team. 10.2 A yellow adhesive label must be completed and applied to the loaded syringe documenting the contents of syringe and recording patient name, date, time, batch numbers, expiry dates and signature of person who has prepared the syringe. Page 9 of 34
11. Drug compatibilities and stability As there is potential for interaction between drugs in a T34 syringe pump, compatibility of medications to be drawn up must be checked prior to mixing of drugs. The Palliative Care Formulary 4 (Twycross et al 2014) suggests suitable combinations of 2 or 3 medications. Other useful resources can be found online at www.palliativedrugs.com, www.pallcareinfo.com, www.pallmed.net (Palliative Medicine Handbook). 11.1 Pharmacy can be contacted for advice about the order in which drugs should be mixed, compatibility information or any other special instructions. 11.2 Provided there is evidence of compatibility, selected medications can be administered in combinations by subcutaneous infusion using the syringe pump. To reduce the risk of precipitation, incompatibility or instability the number of drugs used in a single syringe should be limited to a maximum of 3. If more than 3 drugs are required then advice should be sought from the ward pharmacist, drug information or specialist palliative care team. 11.3 Absence of cloudiness does not guarantee compatibility or stability. Interactions between drugs can lead to changes in solubility, leading to precipitation. This can result in a blocked cannula, inflammation at the injection site or reduction in stability leading to a loss of symptom control. 11.4 The resulting solution must be checked for any cloudiness or crystallization. Any discoloured, cloudy or opaque solutions must be discarded immediately (do not use) and reported to pharmacy. The giving set must also be discarded (do not use). Advice should be sought from the Doctor/GP, ward/community pharmacist, medicines information or Specialist Palliative Care Team on alternative medication/combinations or whether separate infusions are required. Points to consider when combinations of drugs are to be infused by the syringe pump: All the drugs must be compatible with each other at the concentrations used. All the diluents must be compatible with each other. Diamorphine should be diluted first before mixing with other drugs. Increasing the combinations or concentrations of drugs may result in precipitation. The ph of the drug and concentrations used may also affect compatibility. 11.5 Mixing drugs that are not compatible can result in crystallisation; precipitation; syringe pump not working effectively; and loss of symptom control if one drug is denatured. 11.6 Protect the syringe from heat and light wherever possible. 11.7 Most drugs can be prescribed in water for injection or sodium chloride 0.9% EXCEPT Cyclizine which must only be mixed with water for injection. MY Specialist Palliative Care Team usually advises the use of water for injections for preparing all syringe pumps (see appendix 6). If unsure please discuss with your ward or community pharmacist, Medicines Information or Specialist Palliative Care Team. 11.8 The infusions should be prepared within the clinical areas where they are to be administered. Page 10 of 34
11.9 Prescribers should satisfy themselves that those undertaking the mixing of medicines they have prescribed are professionally competent and will take full professional and clinical responsibility for their decisions and actions (MHRA 2009). 12. Prescribing Practitioners must check that medications have been legally prescribed before administration. If there are any concerns regarding the dose, side effects, or the appropriateness of the prescription, the practitioner must contact the prescriber; ward/community pharmacist; medicines information or specialist palliative care team prior to administration of medication. Practitioners must ensure that any previous oral or transdermal medications have been taken into consideration and any conversions reflected in the prescription for the syringe pump medications. Recognised conversion charts can be used or help from the Specialist Palliative Care Team, contact number 01924 543801. There is an on call consultant out of hours available via switchboard. Remember: it is recommended that any transdermal medication should remain in place when the T34 syringe pump is commenced 12.1 All medication to be given by subcutaneous infusion via the syringe pump must be prescribed on the approved MY T34 prescription chart in the secondary care setting. As required medications should be prescribed on the in-patient drug chart. In the Primary care setting subcutaneous medications must be prescribed on the approved Community Palliative Care Chart (see appendix 9). Examples of as required medications include: Analgesics. Anti-emetics. Anti-secretory agents. Sedatives. 12.2 The prescription for each syringe pump should be reviewed every 24 hours. It is the responsibility of the clinical team (Doctors/GP, nurses and pharmacists) to review the effectiveness and side effects of the prescribed medication and initiate changes accordingly. 13. Unlicensed medications (Off label) for use in syringe pump 13.1 In palliative care licensed medicines are sometimes prescribed and administered outside of the dose, route or indication for which they have a product licence. This is referred to as off label. Many drugs used in palliative care practice have been given safely and effectively via CSCI and there is substantial clinical experience to support this practice. The individual datasheet can be consulted for the most up to date information on each drug. 13.2 An unlicensed medicine is the term used to describe a medicine that has no product licence. Page 11 of 34
13.3 The Medicines Act (1968) specifically safeguards a doctor s clinical freedom to prescribe medicines. In the UK a doctor may: Legally prescribe unlicensed medicines. Override the warnings and precautions given in the licence. Use or advise a licensed medicine for indications, doses or routes of administration outside the licensed recommendations if he/she judges that it is clinically indicated and safe to do so. 13.4 When using a licensed medicine outside its product licence or when using an unlicensed medicine, full responsibility and liability for its use lies with the prescriber and not the manufacturer. 13.5 If the nurse has any concerns regarding the dose, side effects or the appropriateness of the prescription, he or she must contact the prescribing Doctor/GP, the ward/community pharmacist, drug information or the Specialist Palliative Care Team for advice, before administering the medication (Standards for Medicines management NMC, 2008). 14. Information for Patients 14.1 The registered nurse administering the first CSCI should: Explain how the McKinley T34 syringe pump works and why it is the preferred method of drug administration. Ensure informed verbal consent is given. (If the patient is unconscious and the infusion is judged to be in the patient s best interest, verbal consent is not required). Inform the patient and or carer of the need to alert a member of staff if the syringe pump is not working properly, i.e. if the: Light changes from green to red. Alarm sounds. SafT-Intima line becomes dislodged. Site becomes painful. T34 syringe pump is dropped or immersed in water. 14.2 Where appropriate the registered nurse administering the first CSCI should: Ensure the patient is given a copy of the McKinley T34 Syringe Pump Patient Reference Guide which can be found on the medical physics intranet page, follow link. http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys Give information about the type of medication used and its common side effects. Information for patients regarding the use of Medicines beyond licence/off label can be found at the British Pain Society. Document in the patient s notes that the above has taken place. Page 12 of 34
15. Procedure for monitoring the T34 syringe pump during use 15.1 The syringe pump infusion should be checked a minimum of every 4 hours in the MY Hospitals care setting. In the MY community care setting the infusion must be checked at every registered nurse visit. This should include checking: The infusion site for signs of inflammation, swelling, pain or SafT-Intima displacement. The syringe and tubing for kinks, blockage, leakage or blood in the infusion line. The line remains attached to the patient and to the syringe. The medication does not show signs of cloudiness, precipitation, crystallisation or discolouration. The pump display: o To confirm the pump is running at the prescribed rate. o There are no alert messages. The battery should be replaced when the battery low message is displayed or at 40% for community patients.. o Press the INFO key once to check the volume to be infused (VTBI) and the volume infused (VI). o Press the INFO key twice to check the battery life remaining. o The volume of drug remaining in the syringe to ensure that the infusion is running to time. The infusion device has no signs of physical damage. The effect of the medication on the patient in terms of symptom management and side effects. 15.2 Following each check the registered nurse should document these on the MY approved T34 prescription chart. 15.3 If there are any problems identified, the nurse should document these and actions taken in the patient s nursing and medical records. 15.4 Clear and concise patient clinical records must be kept at all times (NMC 2015). Box 1: Examples of time remaining for a syringe T34 pump infusion The following values are based on a 24 hour infusion: For a BD 20ml syringe the maximum infusion volume is 18ml and the near end of infusion alarm will sound 45 minutes before the end of infusion For a BD 30ml syringe the maximum infusion volume is 23.5ml and the near end of infusion alarm will sound 45 minutes before the end of infusion Page 13 of 34
16 Battery life Staff should be aware of the battery life projections when using the McKinley T34. At the start of a new battery, it will power at most, 4 full 24 hour infusions. For each new patient episode a new battery should be used. Every 24 hours, the battery level should be checked and documented. At 30 35%, CME McKinley cannot guarantee it will power a complete 24 hour infusion and therefore advise battery change at this point, or 40% in community patients. 17 Monitoring the effectiveness of therapy 17.1 It is important that the effectiveness of symptom control is closely monitored and recorded. The nurse should reassess the patient at each contact. If breakthrough pain or other symptoms occur the patient should be offered additional medication in a suitable form. Advice can be obtained from the treating team/general Practitioner (GP)/ Specialist Palliative Care Team. 17.2 The prescription for each syringe pump should be reviewed every 24 hours. It is the responsibility of the clinical team (doctors, nurses and pharmacists) to review the side-effects and effectiveness of the prescribed medication and initiate changes accordingly. 17. 3 If more than 2 PRN doses of the same drug are used in 24 hours, the dose of that medication in the syringe pump should be reviewed and an increase considered. This action should not be delayed until the next time the syringe pump is due for changing if it is clear that the patient s symptoms are not controlled. 17.4 Clinicians should liaise with the treating team/gp or Specialist Palliative Care Team as necessary and also refer to the symptom control guidelines which can be found on the SPCT Intranet site/ EPaCCS Electronic Palliative Care Coordination System ( EPaCCS) on SystmOne or at the back of the End of Life Care Plan. 18 Incident reporting If an incident occurs involving a McKinley T34 syringe pump, it must be reported immediately to the most senior practitioner/manager on duty and an incident form must be completed on that same shift. Staff involved should also ensure the pump is sent to Medical Physics for a report on events leading to the incident via the event log. Page 14 of 34
19. Cleaning the device The provision of acceptably clean, well maintained equipment is essential to patient safety and comfort. It is the responsibility of the practitioner who discontinues the use of the syringe pump to ensure that it is cleaned with detergent wipes. See medical physics equipment policy. http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys 20. Maintenance and servicing of the device 20.1 Each McKinley T34 syringe pump must be acceptance tested prior to use and registered within MY Medical Physics department. Individual wards must ensure the T34 pump is immediately returned to Medical Physics equipment library when not in use on the ward or in the community setting. 20.2 The McKinley T34 Syringe Pump will display the message Calibration Due send for service to inform the user that a service is due when the machine is switched on. It should be sent to Medical Physics for servicing and an alternative pump selected for patient use. If the Calibration Due message is displayed during a patient episode, both CME McKinley and Medical Physics advise that it is acceptable to continue to use the pump if an alternative is not readily available. However, the pump should be replaced at the earliest opportunity and sent to Medical Physics for servicing via the equipment library process (see appendix 7). 21. Transfer/discharge of a patient with a McKinley T34 in situ It is important that the organisation can keep track of its own T34 syringe pumps for further information see (Appendix 7) MY medical physics department policy on returning equipment. http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys/pages/equipmentlibrary.aspx 21.1 Transition of patients between settings, hospital, community, care home or hospice should be transferred with the T 34 syringe pump and locked box in situ. A key must not be sent with the patient. The receiving health professional will have access to a supply of keys. 21.2 The nurse responsible for the patient s transfer of setting must contact the named nurse in the receiving service to make arrangements for the MY T34 syringe pump to be received in that setting. 21.3 The transferring setting must keep a record on day of transfer of name, address and telephone number of the named nurse in the receiving service. When no longer required the transferring setting must immediately return all syringe pumps to medical physics in accordance with medical device loan operational flow chart http://nww.midyorks.nhs.uk/departments/imtdirectorate/medphys/pages/equip mentlibrary.aspx (see appendix 7) 21.4 If a syringe pump is not returned and classed as lost a charge of 1,200 may be made by medical physics to the hospital ward/community teams budget. Page 15 of 34
21.5 All patients transferred to the community setting MUST have a completed community prescription chart, including anticipatory medications prescribed. 22. Procedure for the initiation, safe operation and monitoring of the McKinley T34 syringe pump (see Appendix 2). 23. Re-siting of cannula and or giving set If the syringe pumps prescription remains the same there is no requirement to change the infusion line/infusion site for 72 hours. The cannula/giving set would need to be re-sited in the following situations: Adverse reaction to cannula. Any alterations to the prescription. Inflammation or sign of infection at infusion site. If this occurs more than once or within 2 days of siting the SafT-Intima, consider switching to a hypoallergenic alternative. 24. Procedure for discontinuation. 24.1 Assess the effect/side effects and appropriateness of the current regimen. 24.2 If an alternative regimen is required, due to lack of effectiveness or excessive symptoms, discuss options with the patient s medical team/gp and the patient themselves. Contact the Specialist Palliative Care Team or ward/community pharmacist if further advice is needed. 24.3 If an alternative regimen is required due to a reduction in symptoms or improvement in clinical condition consider conversion to alternative route/medication using the WHO analgesic ladder/a guide to symptom management in Palliative Care (2016). 24.4 Continue to monitor the patient for symptoms or side effects and treat accordingly. 24.5 If the syringe pump is no longer required, ensure the SafT-Intima cannula is removed. 24.6 Dispose of any remaining medication/giving sets in accordance with the MY Medicines management. 24.7 Remove battery, clean the syringe pump and attach decontamination certificate. 24.8 McKinley T34 syringe pumps are returned to medical physics via the internal post system for hospital patients. 25. Implementation Following approval, this policy will be disseminated, to senior managers for distribution to staff. It will also be available on the MY intranet. Page 16 of 34
26 Outcomes In adhering to this policy the expected outcomes are: 26.1 Optimum symptom control for the patient is achieved. 26.2 The correct equipment has been assembled in the correct manner for the correct patients. 27. Audit and Monitoring 27.1 Audit of adherence to this policy will be facilitated 3 months after launch by MY Hospital/Community Matrons and at intervals thereafter to be determined by the results of the first audit. 27.2. Further evidence of adherence to this policy will be monitored through incident reporting within MY. 27.3 Attendance at training will be monitored by the MY medical physics department. 27 Accountability Each registered practitioner is reminded of the need to be satisfied with and demonstrate his/her knowledge and competency. The registered practitioner must be satisfied that he/she is prepared to accept personal accountability for the action taken. (NMC2015 The code) Page 17 of 34
Appendix 1: References/Bibliography British Pain Society - Using medicines beyond licence Information for patients [Accessed 28th January 2010]. Available at: http://www.britishpainsociety.org/book_usingdrugs_patient.pdf CME. 2007. McKinley T34 Ambulatory syringe pump manual. Ref: 100-090T34 Dickman A et al. 2011. The Syringe Driver, Continuous Subcutaneous Infusions in Palliative Care. 3rd edition. Oxford: Oxford University Press. Dunne K et al 2000. An Audit of Subcutaneous Syringe Drivers in a Non-Specialist Hospital. International Journal of Palliative Nursing. 6:5 Ellershaw J and Wilkinson S. 2003. Care of the dying: A pathway to excellence. Oxford: Oxford University Press. Leeds Teaching Hospitals 2010 Guidelines for the use of the McKinley T34 syringe pump Leeds Community Health care 2010 Clinical guide lines for the safe use of the T34 syringe pump MY. 2015. Medical Devices and Equipment Management Policy. MY Palliative Care intranet site http://nww.midyorks.nhs.uk/departments/specmed/palliative%20care/pages/default.aspx Baxter K (BNF Director). 2015. British National Formulary. Number 70. London: The British Medical Association and the Royal Pharmaceutical Society of Great Britain. MDA Device Bulletin. 2003. Infusion Systems. MDA DB 2003 (02). [Accessed 26th January 2010] Available at: http://www.mhra.gov.uk/publications/safetyguidance/devicebulletins/con007321 MHRA.2009. Report of the CHM working group on mixing of medicines. Executive Summary & Recommendations. [Accessed 26th January 2010]. Available at: http://www.mhra.gov.uk/home/idcplg?idcservice=get_file&ddocname=con057289&revisions electionmethod=latest Mitton T. 2007. Subcutaneous Drug Infusions: a review of problems and solutions. International Journal of Palliative Nursing. 7:2 Nursing and Midwifery Council (NMC). 2015. Standards for medicines management. London: NMC. [Accessed 21st January 2017]. Available at: http://www.nmc-uk.org/adisplaydocument.aspx?documentid=4585 NMC. 2015. The Code: Standards of conduct, performance and ethics for nurses and midwives. London: NMC. [Accessed 21st January 2017]. Available at: http://www.nmc.org.uk/globalassts/sitedocuments/nmc/publications/nmc-codepdf NMC (2009) Record Keeping: Guidance for Nurses and Midwives (NMC 2015). O Doherty CA et al. 2001. Drugs and Syringe Drivers: a survey of adult specialist palliative care practice in the UK and Eire. Palliative Medicine. 15:149-54. Palliative Care Matters. 2001. SDriver-Drug Compatibility Database. [Assessed 26th January 2010]. Available at http://www.pallcare.info Solihull NHS Primary Care Trust. 2004. Policy for the Use of Subcutaneous Syringe Drivers. Twycross R et al. 2012. Palliative Care Formulary, 4th Edition. Nottingham: Palliativedrugs.com. [Accessed 8 October 2013]. Available at: http://www.palliativedrugs.com Page 18 of 34
Twycross R and Wilcock A. 2006. Symptom Management in Advanced Cancer, 3 rd reprinted. Abingdon: Radcliffe Medical Press. Edition A Guide to Symptom Management in Palliative Care..Yorkshire and Humber Palliative and End of Life Care Groups (2016) www.palliativedrugs.com www.pallcareinfo.com www.pallmed.net. http://book.pallcare.info/index.php?op=plugin&src=sdrivers Page 19 of 34
Appendix 2 Procedure for the initiation, safe operation and monitoring of the McKinley T34 syringe pump. Action Rationale 1. Explain the need for commencing /continuing the use of the syringe pump with the patient/parent/carer as appropriate. 2. Assemble all materials and equipment as per MY McKinley T34 policy, checking expiry dates. Check that the syringe pump is within its service date (via the equipment library and by switching the pump on to check Calibration Due warning does not display) on receipt of device. 3. Select and prepare medication to be administered according to prescription chart. Remember the 5 Rights Right patient Right time Right dose Right route Right drug 4. Ensure that the area in which the medicine is to be prepared is as clean, uncluttered and free from interruption as possible. See MY Medicines management policy 5. Wash hands following MY Hand Hygiene Policy 6. Select the most appropriate Luer lock syringe size (minimum 20ml) and infusion line and draw up each medication separately as per MY McKinley T34 syringe pump policy. 7. Complete syringe pump label documenting patient name, contents of syringe (inc. total volume), date, time and signature. Apply the completed label to the syringe, 8. Attach the infusion line to the syringe and PRIME the line before loading onto the syringe pump. 9. Switch the T34 syringe pump on, ensuring the barrel clamp arm is down and allow pre-loading to complete. Check the battery life. Load the syringe and commence infusion set up according to manufacturer s instructions and MY McKinley T34 syringe pump policy. Refer to steps 1-9 on the front of the pump if necessary. Patient/carers consent is agreed following discussion and is documented in the patient care plan. To ensure all equipment is available before commencing the procedure. To ensure that the patient receives medication as prescribed and in accordance with NMC guidance for the administration of medication. To reduce risk of error To reduce risk of cross infection and adhere to Trust policy. To reduce risk of potential irritation caused by medications. To ensure correct dose of each medication is drawn up. To adhere to MY T34 syringe pump policy To identify contents of the syringe. To ensure the infusion does not finish early. To ensure safe operation of the T34 syringe pump. Page 20 of 34
10. Select most appropriate site to insert the infusion line, ensuring the same site is not used consecutively. 11. Ensure infusion site is cleaned with Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol (Clora prep). Insert infusion SafT-Intima cannula Insert it at an angle to the skin and then lay it flat. 12. Secure line using a sterile, semipermeable, transparent dressing. 13. Start the infusion by pressing YES (step 10 on pump instructions). Check the infusion has commenced ( pump delivering message displayed alternating with syringe size and brand and green LED light flashing every 32 secs) Check battery life again after set up is complete 14. Lock the keypad 15. Ensure patient is comfortable, assisting to replace clothing as necessary. 16. Complete MY syringe pump documentation Record any advice/instruction given to patient/parent/carers as well as any changes to medication as a result of symptom management. 17. Dispose of any remaining materials appropriately and according to MY policies. 18. Commence use of syringe pump monitoring chart. Ensure site and syringe is checked and recorded 4 hourly (hospital only). 19. At each consecutive change of syringe or when the pump is no longer required, switch pump off following the correct procedure, i.e. Unlock the keypad Press the RED stop button Turn off the pump by holding the ON/OFF button down until you hear a beep. Remove the syringe. Replace the barrel arm in the down position N.B. Battery only needs removing if discontinuing use of the pump, NOT at each change of syringe. Battery should only be changed at syringe change if less than 30-35%. 20. Do not leave syringe driver in direct sunlight To ensure optimum delivery of medication whilst facilitating patient comfort and compliance. Rotating the sites helps to prevent discomfort To prevent infection and allow safe delivery of the infusion. To allow observation of the site. To commence delivery of prescribed medication. To ensure battery will last for 24hrs following set up process. To maintain safety of the infusion. To maintain dignity. To promote patient comfort whilst infusion in progress. To ensure accurate documentation of medication infusing. To ensure patient/carers are aware of when/how to alert nursing staff if any difficulties arise To ensure waste is disposed of safely. To record observation of infusion whilst in progress. To ensure the current programme is deleted prior to next programme being entered. As per MHRA 2015 Page 21 of 34
Appendix 3 Equality Impact Assessment Initial Assessment Directorate: Specialist Medicine Area: Specialist Palliative Care Policy/Project Summary: Policy for the use of the McKinley T34 Syringe pump for the administration of continuous subcutaneous infusions in symptom management of adult patients. What are you seeking to achieve with this work? What has prompted this change? What are the intended outcomes of this work? The aim of this policy is to support staff in the safe administration of medication via the McKinley T34 syringe pump and standardised practice across the Trust. Who will be affected by it and why? (e.g. Public, patients, service users, staff, etc.) Staff and patients. Information What information is available about the current situation to assist decision making? (e.g. data, intelligence, research or national guidelines; staff and patient experience) National Guidelines Data Research Impact Analysis Based on the information available, an assessment of the current situation and the changes being proposed is there the possibility of a differential impact (positive or negative) on the groups listed below? (Enter Y/N against each characteristic and a rationale with evidence) Y/N Y/N Disability N Gender Reassignment & Transgender N Gender/Sex N Religion or Belief N Race N Pregnancy and Maternity N Age N Marriage & Civil Partnerships: N Sexual Orientation N Carers N Rationale for Answers Above: (Explain for each characteristic, why it is considered that there may or may not be an impact) Page 22 of 34
Summary of Actions Planned as a Result of the Assessment (Indicate timescales and lead officers for each action) Date: 12 April 2017 Name: Job Title: Jane Dacre End of Life Care Facilitator and Interim Macmillan Specialist Palliative Care Team Leader Page 23 of 34
Appendix 4: Trouble shooting/alarm guide Fault Possible Cause Action The pump will not start There is no battery present. The battery has been inserted incorrectly. The battery depleted/very low. The pump is faulty. Fit a battery. Realign battery terminals. Fit a new battery. Service required. The infusion is going too quickly/has ended early or too slowly/volume remaining in syringe at end of infusion Incorrect rate set Wrong syringe brand confirmed during set up Pump faulty or incorrectly calibrated Check displayed rate against prescription, and change if necessary. Re-train user to prevent repeat of this event. Service/calibration required. McKinley T34 pump alarm conditions When the pump detects a problem 4 things occur: The infusion stops An audible alarm is activated A message appears on the display screen indicating the cause of the alarm The LED indicator turns red The following table indicates the appropriate actions to be taken Alarm Possible Cause Action Occlusion or syringe empty Pt access device blocked, kinked, clamped or occluded. Actuator has reached minimum travel position. Remove occlusion and restart or re-load syringe. Flush or replace access device. Release clamp. Syringe displaced Pump paused too long Syringe has been removed or displaced. Pump left or no key presses detected for 2 minutes. End of program, turn pump OFF. Check & confirm syringe seated correctly and resume. Start infusion, continue programming or switch off. Near end 15 minutes from end of Prepare to change syringe or switch off. Infusion. End program Infusion Complete. Pump will either default to KVO (keep vein open) or it will alarm in which case switch pump off and await nurse to replenish/remove. Low battery Battery is almost Prepare to change battery. depleted (30 minutes left). End battery Battery is depleted. Change battery. Page 24 of 34
Appendix 5: Contact: Contact: Sources of Help and Advice Medical devices Equipment library to obtain a T34 syringe pump. Pharmacy for issues pertaining to drug compatibility On-call Specialist Palliative Care consultant for advice on symptom control and dose conversions Local Hospices advice lines Location Telephone Number Pharmacy Contact ward pharmacist Medicines Information 01924 541394 M Y Specialist palliative care team 01924 543801 MY Pain Team - DDH 01924 512058 MY Pain Team -PGI 01977 747200 Medical Physics PGH 01924 541050 Medical Physics DDH 01924 541050 Wakefield Hospice advice line 01924 331400 Prince of Wales Hospice advice line 01977 708868 Out of Hours/Weekends Pharmacy On call pharmacist available Via MY switchboard Specialist Palliative Medicine Advice (Consultant On-Call) Via MY Switchboard: Hospice advice Via hospice advice lines Page 25 of 34
Appendix 6 Procedure for drawing up medications and diluents for T34 Syringe pump 1. Calculate the volume of each drug and diluent required Diamorphine will require reconstitution with some of the diluent to be used in the syringe (water for injection or sodium chloride 0.9%). Do not use sodium chloride 0.9% if the final syringe contains cyclizine. Strength of reconstituted diamorphine solution (mg/ml) = mg in ampoule / volume diluent used to reconstitute (mls). Volume (mls) of drug required = dose (mg) / concentration (mg per ml). NB: Take care with strengths and concentrations not to muddle up milligrams and micrograms 1mg = 1000microgram Volume diluent required = final volume required minus volume of each drugs. 2. Assemble the correct number of ampoules/vials of medication required including the diluent. Check drug names, strengths and expiries carefully. 3. Assemble equipment required to prepare the product, including syringes (for drawing up drugs as per guidance below and a 20ml or 30ml for the final container), needles (1 per drawing up syringe and 1 extra), alcohol swabs (for disinfecting ampoule necks and vial tops) and sharps bin. For accuracy an appropriate size syringe should be used to draw up doses: volumes 1ml use 1ml syringe (not an insulin syringe). volumes >1ml and 2.5ml use 2ml syringe. volumes >2.5ml and 5ml use 5ml syringe. >5ml use 10ml, 20ml* or 30ml* as appropriate. *This maybe the syringe which will be used as the final container. 4. Swab the neck of ampoules and top of vials with an alcohol swab. 5. Draw up required volumes of drugs and diluents using the guidance above to select appropriate syringe size. The largest volume can be drawn up into the final syringe container provided the volume >`5ml. Do not forget that ampoules containing liquid preparations nearly always contain an overage, so measure the exact amount of liquid drug required using an appropriately sized syringe. 6. Check each syringe drawn up against the ampoules/vials. drug name. dose required. volume drawn up. the strength of the drug. expiry date. number of ampoules/vials used Place the ampoules/vials used to the side for a final check at the end. Page 26 of 34
7. Add each drug into the final syringe (draw the plunger of the syringe back a little way past the final volume mark to allow space for addition of drugs and mixing). Attach sheathed green needle. Invert syringe and agitate contents several times to ensure thorough mixing. Expel air and check volume. 8. Perform a final check against the prescription and the ampoules used to confirm that correct drugs and doses have been drawn up and added. 9. Attach an adhesive label to the syringe documenting the contents of the syringe and recording the patient, name, date, time and signature of the person who has prepared the syringe. Page 27 of 34
Appendix 7 Page 28 of 34
Appendix 7 cont. Page 29 of 34
Appendix 8
COMMUNITY PALLIATIVE CARE CHART Appendix 9 Allergies and Adverse Drug Reactions List the medicines or Substances & the nature of the reaction (write NKDA if none) It is mandatory to complete this section Medicine/Substance Reaction First Name Address: Surname Sign (NAME) Date NHS No: DOB: Allergy status unconfirmed. Authority to administer ceases after 24 hours Sign (NAME) Date Consider the administration of a stat dose when starting a new syringe driver SC SYRINGE DRIVER OVER 24 HOURS Syringe driver Dose *Dose titration (community use) Drug (1) Drug (2) Drug (3) Diluent: Prescriber sig Prescriber name (print) Date Syringe driver Dose *Dose titration (community use) Drug (1) Drug (2) Drug (3) Diluent: Prescriber sig Prescriber name (print) Date Syringe driver Dose *Dose titration (community use) Drug (1) Drug (2) Drug (3) Diluent: Prescriber sig Prescriber name (print) Date Syringe driver Dose *Dose titration (community use) Drug (1) Drug (2) Drug (3) Diluent: Prescriber sig Prescriber name (print) Date *Dose titration (optional) - where medication has been prescribed within a range of doses it is acceptable for nurses to titrate dosages according to patient response and symptom control, and to administer within the prescribed range. (NMC Standards for Medicines Management Apr 2007) For information about syringe driver compatibility refer to current version Palliative Care Formulary
Appendix 9 Allergies & Adverse Drug Reactions: First Name: NHS No: Surname: DOB: WHEN REQUIRED DRUGS Drug ROUTE Prescriber sig Date DIAMORPHINE SC Dose Frequency Indications Pain/dyspnoea Max dose in 24 hours - Drug ROUTE Prescriber sig Date MIDAZOLAM (10mg/2ml) SC Dose 2.5-5mg Frequency Indications Anxiety, dyspnoea, agitation, restlessness Max dose in 24 hours 80mg Drug ROUTE Prescriber sig Date HYOSCINE BUTYLBROMIDE SC Dose 20mg Frequency Indication Respiratory secretions Max dose in 24 hours 120mg Drug ROUTE Prescriber sig Date HYOSCINE BUTYLBROMIDE SC Dose 20mg Frequency Indication Colic Max dose in 24 hours 300mg Drug ROUTE Prescriber sig Date HALOPERIDOL SC Dose 1.5-5mg Frequency Indications Nausea, agitation, hallucinations Max dose in 24 hours 10mg Drug ROUTE Prescriber sig Date SC Dose Frequency Indications Max dose in 24 hours Drug ROUTE Prescriber sig Date SC Dose Frequency Indications Max dose in 24 hours Drug ROUTE Prescriber sig Date SC Dose Frequency Indications Max dose in 24 hours Drug ROUTE Prescriber sig Date SC Dose Frequency Indications Max dose in 24 hours Date Other information Sig Author: FS Pharmacist Date March 2013 Approved: Medicines Management Committee March 2013 File Code: Z:\Op. Services\Trust Presc & docs\community Palliative Care Chart (Comm version).doc