ADMINISTRATION OF APOMORPHINE VIA THE APO-GO PUMP USING PREFILLED SYRINGES

Transcription

1 STANDARD OPERATING PROCEDURE ADMINISTRATION OF APOMORPHINE VIA THE APO-GO PUMP USING PREFILLED SYRINGES First Issued Feb 2012 Issue Version Two Purpose of Issue/Description of Change To promote safe and effective administration of subcutaneous apomorphine via the Apo-go pump to adults with complex Parkinson s Disease. Planned Review Date 2015 Named Responsible Officer:- Approved by Date Parkinson s Disease Specialist Nurse Medicines Governance Pharmacist Section: - Medicines Management MMSOP16 B Risk and Governance Group April 2013 Target Audience Community Nursing UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM THE TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION

2 CONTROL RECORD Title Purpose Author SOP Administration of Apomorphine via The Apo-Go Pump using Prefilled Syringes To promote safe and effective administration of Subcutaneous Apomorphine via the Apo-go Pump Quality and Governance Service (QGS) Impact Assessment Completed Yes No Actions Required Yes Subject Experts Annie Baker / Lisa Knight / Nuala Browning Document Librarian QGS Groups consulted and peer Specialist Nursing reviewed with :- Quality and Governance Service Date formally approved by April 2013 Quality Patient Experience and Risk Group Infection Control Approved 23 rd April 2013 Method of distribution Intranet Archived Date Location Access Via QGS No VERSION CONTROL RECORD Version Number Author/s Status Changes / Comments Version 1 L Knight R / TC Changes to strength of A Baker apomorphine ampoule Version 2 A Baker L Knight N Browning R To change procedure to use prefilled syringes Status New / Revised / Trust Change 2/18

3 Standard Operating Procedure For: Administration of Apomorphine via the Apo-Go Pump Name of Discipline: Community Nursing, OBJECTIVES SCOPE TARGET GROUP (STAFF WHO ARE AUTHORISED TO FOLLOW STANDARD OPERATING PROCEDURE) CROSS REFERENCE RELATED POLICIES EVIDENCE TO SUPPORT PROCEDURE To promote safe and effective administration of subcutaneous apomorphine via the Apo-go Pump to adults with complex Parkinson s Disease using prefilled syringes To cover patient selection, training requirements, prescription requirements, equipment needed, preparation of apomorphine, setting up of pump, site selection, taking down pump and the management of common problems in patients being administered apomorphine via the Apo-go Pump All registered community nurses employed by the Trust are required to undertake this role and have successfully completed the Apomorphine competency framework (that specifies the use of prefilled syringes) within the last two years. Health Records Policy Safe Handling and Administration of Medicines Policy Infection Control Policies Medical Devices Policy Incident Reporting Policy Consent Policy Record Keeping for Community Nursing NMC (2010) Standards for Medicine Management SOP for Medicine Administration Procedure for Administration of Medication by Injection via the intramuscular and subcutaneous route Blood Pressure Monitoring Procedure National Patient Safety Agency ( NPSA) Alert No 20 Promoting Safer Use of Injectables March 2007 Summary of product Characteristics for Apo-go ampoules available at NMC (2008) Code of professional conduct: standards for conduct, performance and ethics PROCEDURE Activity Rationale Responsibility 1.Patient Selection For community nurses to administer subcutaneous apomorphine via the Apo-go Pump the following criteria have to be fully met: The patient has disabling motor fluctuations that are inadequately controlled by levodopa or other To ensure only appropriate patients receive treatment 3/18 Community nurse in consultation with the prescriber and the Parkinson s Disease Specialist

4 oral dopamine agonists (or the patient is unable to swallow oral Parkinson s medications or has been declared nil orally and other routes e.g. nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG) Tube are not viable) Nurse (PDSN) The use of the Apo-Go Pump is deemed necessary by the consultant The apomorphine has been prescribed on the Patient Medicines Administration Chart with full details The patient has already received a test dose of apomorphine usually in hospital or clinic environment 2. Maintenance and Decontamination If any problems are encountered with a pump or it malfunctions, contact Genus Pharmaceuticals and complete an incident form. This should be reported to the medical devices agency (MDA). A new pump should be delivered within 3 working days or the next day in the case of an emergency. Delivery is by courier service. Advice should be sought from the Parkinson s Disease Specialist Nurse (PDSN) with regard to patient management during this time. Clean pump in line with Trust policy and manufacturer s instructions 3. Training The pump should only be used by registered community nursing staff that have successfully completed the Apomorphine competency (that specifies the use of prefilled syringes) Staff need to update their competency every two years by completing a self-assessment competency A copy of the completed competency will be kept in their personal file and held by Line Manager/Team Leader To meet the patient s clinical needs To reduce the possibility of a serious side effect occurring in a community setting Genus pharmaceuticals are responsible for the maintenance and repair of the pumps Reporting the incident to the MDA complies with Trust Incident Reporting Policy Decontamination of medical equipment is essential to the effective delivery of patient care Nurses will complete a competency assessed initially by a Parkinson s Disease Nurse Community nurse Parkinson s Disease Specialist Nurse 4/18

5 In the event that some staff have not completed the apomorphine competency, staff may attend the discharging hospital to observe the procedure to avoid delaying patient discharge 4. Essential information to be included on the Patient Medicines Administration Chart: Name of patient and date of birth and NHS number if available Name and signature of authorised prescriber Date prescribed Number of milligrams of apomorphine to be infused per hour and length of infusion e.g. 12 or 15 hours Name and strength of medicine (apomorphine 50mg in 10ml prefilled syringe) Route (subcutaneous infusion) Frequency of infusion e.g. daily For example Apomorphine 2mg per hour infused over 12hrs via subcutaneous infusion daily. Apo-go 50mg in 10ml Solution for Infusion in Prefilled Syringe (PFS) 5a. Equipment The following equipment is required before setting up the grey Apo-go pump Equipment supplied by Genus Pharmaceuticals: Crono APO-GO infusion pump 1 Penta Ferte Apo go plastic syringe 1 Rigid connector Battery (lithium 3 volt CR 123 A Photo lithium battery) Spacer (for a 10ml setting) Blue key ring to open battery compartment Syringe pump holder/elastic belt Preparation tray and towel. Please contact Genus Pharmaceuticals to obtain. The pump comes with a battery and a spare battery in the box, batteries last approximately six months. Patients need to purchase their own spare batteries. Instructions for use: APO-GO Pump User Guide provided by Genus Pharmaceuticals with APO-GO infusion pump abbreviated user guide for apomorphine 50mg/10ml prefilled syringes All bases are provided with a resource pack from Genus Pharmeuticals To comply with legal requirements and NPSA Alert No 20 and to ensure the information is clear and unambiguous To ensure all equipment is available To support appropriate usage of equipment Authorised prescriber Community nurse 5/18

6 Additional equipment required: Sphygmomanometer Patient Medicines Administration Chart signed by general practitioner / authorised prescriber Record of treatment Prescribed medicine (Apomorphine 50mg/10mls in pre-filled syringes) Single use sterile dressing pack or single use disposable apron and single use disposable non-sterile gloves Additional pair of single use disposable non-sterile gloves Alcohol swab Sharps container Suitable transparent occlusive dressing e.g. Tegaderm Adhesive label specifying drug, dose, date and time. Suitable infusion set Trust approved cleaning wipe 5b. Choice of suitable infusion sets available which include: Neria lines (Neria lines are available on FP10) Or Thalaset lines (For patients who are receiving care from the community nursing service) 6. Check Patient details Verbally check the identity of the patient against the current Patient Medicines Administration Chart and the pharmacy label on the medicine with the patient, confirming patient s name and date of birth. If not possible-check details with family or carers. Establish if the patient has any known allergies Establish the patient has given appropriate consent; refer to the Trust consent policy for further details if required. Thalaset lines meet the patient needs better than Saf-T Intima lines for patients who are mobile To confirm that the patient is the correct recipient of the medication To ensure the patient is not allergic to apomorphine and to ensure appropriate selection of giving set and occlusive dressing Community Nurse Community Nurse 6/18

7 7. Check Patient Medicines Administration Chart Check the Patient Medicines Administration Chart is clear and unambiguous and contains all essential information Community Nurse Check the pharmacy label on the box of apomorphine, issued by the supplying pharmacist against the Patient Medicines Administration Chart, checking the name of the patient, that the pharmacist has supplied apomorphine 50mg in 10ml prefilled syringes, the number of milligrams of apomorphine to be administered per hour and the length of infusion. To ensure the pharmacy has dispensed the correct medication Check the name and strength of the medicines on the manufacturer s packaging corresponds to the Patient Medicines Administration Chart and the pharmacy label 8. Blood pressure monitoring A baseline blood pressure should be recorded at the patient s initial visit. Be aware that low blood pressure and postural hypotension can be a side effect of Apomorphine. Parkinson s Disease (PD) patients can often have very low blood pressure, but are usually asymptomatic. However, if the patient becomes symptomatic, then blood pressure should be recorded on a daily basis sitting and standing and reported to the GP in the same span of duty and the PDSN as soon as possible. (Typical symptoms include, feeling faint or dizzy, falls, fainting/blackouts) 9. Setting up of Pump For a 10ml setting (spacer is essential) Make sure pump is set for 10ml setting If set for 10ml a small 10 is visible in the top left hand corner of the screen. If a 10ml setting is used then the spacer will need to be applied to the pump plunger. For a 20ml setting Make sure pump is set for 20ml setting If set for 20ml a small 20 is visible in the top left hand corner of the screen. Apomorphine is known to reduce blood pressure To ensure the pump is set at the appropriate setting Community Nurse Community Nurse/ PDSN Changing the syringe setting Remove, and then re-insert the battery 7/18

8 The syringe setting will flash Press the grey button(-) to set it at a 10ml setting or the red (+) button to set it at a 20ml setting (ensure the button is pressed firmly). 10. Calculating the flow rate setting Whether using a 10ml or 20ml solution, approximately 0.5mg/1ml will be used to prime the line. Community nurse/ PDSN To calculate the flow rate see chart in Appendix 1 It is essential that the correct syringes are used After the prescribed infusion period, for example 12 or 15 hours, the pump needs to be taken down. If considering delegating this task to a carer or patient, a risk assessment must be undertaken and a care plan provided for the carer / patient with any necessary support put in place 11. Setting the Flow rate Switch the pump on by pressing the red button (+) for 5 seconds, Once switched on, the pump will display the bolus rate (d) and flow rate (f), it will then go to a time setting. If the flow rate (f) requires changing then this can be done as follows:- Leave the pump switched on Press the grey (-) button until it starts to flash Then either press the grey (-) button to lower the rate or red button (+) to raise the rate Do this until you reach the right rate setting The pump will then be programmed and settings will be retained. Switch the pump off (red) button until infusion is ready to be administered. 12. Preparation of the prefilled syringe using rigid connector Decontaminate hands prior to procedure Protect the patient s belongings with a towel or protective cover To ensure pump is set at the correct rate Using the incorrect syringe will affect the amount of apomorphine delivered If the pump is not taken down after the prescribed infusion period the patient will continue to receive the apomorphine infusion To reduce the risk of transfer of transient micro-organisms on the healthcare worker s hands Community nurse/ PDSN or delegated to a patient/carer. PDSN Community Nurse 8/18

9 Check the expiry dates of the apomorphine syringe. Record batch numbers and expiry dates after completion of the procedure Prepare the label for the syringe, the label should contain:- Full name of patient Made up by (name of nurse) Name of medicine and amount of medicine in prefilled syringe (e.g. apomorphine 50mg in 10ml) Total volume of fluid in syringe 10ml or 20ml Date and time pump commenced Route i.e. subcutaneous If the Apomorphine shows any signs of green discolouration or cloudiness Do Not Use Open single use sterile dressing pack (if required) to create an aseptic field and gather equipment, apply apron and gloves Use an Aseptic Non Touch Technique throughout the procedure FILLING 10ml PLASTIC SYRINGE USING RIGID CONNECTOR Equipment: One Apo-go (apomorphine) 50mg/10ml solution in prefilled syringe required and the spacer device. As per manufacturer s instructions 1. Using an Aseptic Non Touch Technique (ANTT), take the Penta Ferte APO-go syringe (hereafter referred to as the plastic syringe and its blue cap out of the packaging. Dispose of the needle and its casing into the yellow lidded container for incineration. Retain the blue cap in a safe place as this will be required when transfer of solution is complete. 2. Ensure that there is free play of the bung inside the barrel of the plastic syringe by moving the stem up and down the barrel. Push on the stem of the plastic syringe ensuring the bung is located as far down the barrel of the syringe as possible. 3. Unscrew the stem from the bung in the plastic syringe. 4. Ensure the spacer device is attached to the Apo-go Pump. 5. Place the plastic syringe onto the Apo-go For safe disposal of sharps 9/18

10 Pump and twist to engage the syringe s wings. 6. Take the connector and detach one of the caps. Screw open end onto the plastic syringe. Now remove the second cap. Insert the Apo-go pump into the preparation Tray. 7. Holding the pre-filled syringe (PFS) vertically, remove its rubber cap. Place remaining open end of connector onto the PFS and invert the connected syringes to allow bubble to rise to the black bung of the PFS. 8. Continue to hold the connected syringes vertically, push down on the stem of the PFS. (There may be a small amount of resistance at this stage but once overcome the solution will transfer easily). 9. Ensure that sufficient solution is transferred to seat bung fully on the spacer device. There should be no gap between the bung and the spacer device. 10. Tap the plastic syringe to release any trapped bubbles. Depress stem of PFS until any large bubbles are dispelled from the plastic syringe. (Small residual bubbles may remain, these are not a concern). 11. Holding the connector between thumb and forefinger of one hand, unscrew the connector and the PFS from the plastic syringe with the other hand. Screw the retained blue cap onto the plastic syringe. 12. Discard the connector and the empty PFS in the yellow lidded container for incineration. 13. Unscrew the blue cap, attach the giving set to the plastic syringe and turn the Apo-go Pump on ready to prime the line. For the appropriate disposal of equipment contaminated with medication FILLING 20ML PLASTIC SYRINGE USING RIGID CONNECTOR Equipment: Two Apo-go (apomorphine) 50mg/10ml solution for infusion in prefilled syringes required 1. Follow steps 1-3 as per 10ml fill. 4. Place the plastic syringe onto the Apo-go Pump and twist to engage the syringe s wings. 5. Take the connector and detach one of the 10/18

11 caps. Screw open end onto the plastic syringe. Now remove the second cap. Insert the Apo-go Pump into the preparation tray. 6. Take the first PFS and holding it vertically remove its rubber cap. Keeping the PFS vertical, place open end of connector into the PFS and then invert the connected syringes to allow bubble to rise to the black bung of the PFS. 7. Continue to hold the connected syringes vertically, push down on the stem of the PFS. (There may be a small amount of resistance at this stage but once overcome the solution will transfer easily). 8. Ensure all solution is transferred to the plastic syringe. 9. Tap the plastic syringe to release any trapped bubbles. 10. Holding the connector between thumb and forefinger of one hand, unscrew the PFS with the other, leaving the plastic syringe and connector attached to one another. Discard the empty PFS into the yellow lidded container for incineration 11. Take the second PFS and holding it vertically remove the rubber cap. Keeping the PFS vertical, place open end of connector onto the PFS and then invert to allow bubble rise to the black bung of the PFS. 12. Continue to hold the connected syringes vertically, push down on the stem of the PFS, (There may be a small amount of resistance at this stage but once overcome the solution will transfer easily). 13. Ensure the sufficient solution is transferred to seat bung fully on the pusher of the Apogo Pump. There should be no gap between the bung and the pusher. 14. Tap the plastic syringe to release any trapped bubbles. Depress stem of PFS until any large bubbles are dispelled from the plastic syringe. (Small residual bubbles may remain, these are not a concern). 15. Holding the connector between thumb and forefinger in one hand, unscrew the connector and the PFS from the plastic syringe with the other. Discard the connector and the empty PFS in the yellow lidded container for incineration 16. Screw the retained blue cap onto the plastic For the appropriate disposal of equipment contaminated with medication 11/18

12 syringe. 17. Unscrew the blue cap, attach the giving set to the plastic syringe and turn the Apo-go Pump on ready to prime the line. Attach the label to the syringe so that the contents and volume of the syringe is clearly visible. The labeled syringe should then be placed in the pump immediately Pump rate will be set over 24 hours, take down pump after prescribed length of treatment (12 or 15 hours) 13 Prime the line Take off the blue cap and attach to the infusion line using an Aseptic Non Touch Technique. Switch on the pump by pressing the red (+) button for 5 seconds. The settings will now flash and then the screen will display the time length of infusion. Press the blue (d) button to prime the line. This will need to be pressed several times (waiting each time for the LCD display to return to time). Repeat the process until the solution is seen at the tip of the butterfly needle. Remove gloves and decontaminate hands To remove any accumulation of transient and resident skin flora that may have built up under gloves and possible contamination following removal of Personal Protective Equipment (PPE) Community Nurse 12/18

13 14. Site Selection Choose an appropriate site for infusion to be placed in consultation with patient The best sites for needle placement are the anterior abdominal wall below the umbilicus and the upper outer aspects of the thighs. Less commonly, the shoulder and upper outer arm is used Once chosen apply single use disposable gloves. The site should be cleansed with an alcohol swab and left to dry Gently pinch the skin and insert the cannula of the infusion line at an approximate angle of 45 with the bevel downwards It is important to rotate the injection site daily to minimize possible localised irritation Secure the cannula with a transparent dressing Leave the dressing undisturbed unless moisture is seen underneath. The infusion set will remain in place as prescribed, but will require removal at the end of infusion On completion of the procedure remove and dispose of PPE to comply with waste management policy Decontaminate hands following removal of PPE Patient may have a personal preference. To protect hands from contamination with organic matter and transfer of microorganisms To reduce the risk of transfer of any transient and resident microorganisms from skin to subcutaneous tissues To elevate the subcutaneous tissue enabling easy access To reduce nodule formulation This allows observation of the site and maintains correct position of the needle whilst reducing risk of accidental removal of needle To prevent cross infection and environmental contamination To remove any accumulation of transient and resident skin flora that may have built up under gloves and possible contamination following removal of PPE Community Nurse Community nurse Community nurse 13/18

14 Document procedure, ensure batch number, expiry date, dose, site of infusion are recorded including, name, signature and designation of nurse Record all patient s medication on Record of Treatment at the end of the process To comply with health policy records To comply with health policy records 15. Observation of site and Apo-pump Observe for any moisture underneath transparent dressing (for any leakage) Observe the pump, ensuring infusion time is decreasing (a whirling noise from the pump can be heard if the pump is infusing) Observation of the syringe can also be made to ensure it is infusing. Patients and carers should also be advised to observe the syringe during the course of the day. Refer to appendix 2 The patient or carer should also observe for any swelling or redness or leaking from the needle site. Nodule formation is a common side effect of Apomorphine treatment. These can be felt easily under the skin and is sometimes associated with skin discolouration and scarring. This should be reported to the Specialist Consultant or Parkinson s Disease Specialist Nurse caring for the patient at the To ensure safe delivery of infusion contents To highlight early signs of inflammation Community nurse, patient and carers 14/18

15 earliest opportunity 16. Taking pump down When the infusion time is completed e.g. 12 hours, switch off the pump by pressing the red button. The infusion will need to be taken down and the medication destroyed. To retract the pusher at the end of the infusion or at any other time, turn off the pump by pressing the red / + (on/off) button. Decontaminate hands prior to procedure Apply single use disposable apron Apply single use disposable non sterile gloves Detach the infusion line from the patient leaving the syringe attached to the driver. Dispose of line and cannula into a yellow lidded container for incineration. Press the grey and blue buttons together for approximately five seconds. It may take a few more seconds for the pusher to start retracting The pump will then switch itself off Detach the syringe and dispose in an appropriate yellow lidded container for incineration On completion of procedure remove and dispose of PPE to comply with waste management policy. Document the volume of apomorphine solution left in the pump after the infusion period To reduce the risk of transfer of transient micro-organisms on the healthcare worker s hands To protect clothing or uniform from contamination and potential transfer of micro-organisms To protect hands from contamination with organic matter and transfer of micro organisms To prevent cross infection and environmental contamination This will provide an audit trail to enable calculation of the approximate amount of medication infused Community nurse or patient or carer 17. Common problems All patients will initially require domperidone taken orally. In some cases domperidone can be eventually stopped (this is at the discretion of the Specialising Consultant or PDSN). Apomorphine reduces blood pressure (see section 8 on blood pressure monitoring) Apomorphine will make patients sick 15/18 Community nurse or patient or carer

16 Nodule formation at the needle site (see section 12 on preparation of apomorphine and section 15 observation of site) 18. Boost Button The boost button on the APO-GO infusion pump is used to prime the infusion line when preparing the infusion. For any other purpose, the boost button should only be used on instruction from the specialist nurse If breakthrough signs or symptoms of Parkinson s disease are observed then the nurse should contact the Parkinson s Disease Nurse Specialist or consultant in charge for advice on use of boost button. The boost button should not be used unless advised. 19. Advise to Patients and Carers Apomorphine should be stored at room temp, below 25 C and protected from light and kept in the box issued by the supplying pharmacist. Store ampoules in a safe place away from children Observe syringe to monitor contents are infusing Observe for redness, pain, swelling or leaking from needle site Give contact details in the event of queries or problems The Apo-go Pump remains the property of Genus Pharmaceuticals Ltd and should be returned to the PDSN if no longer required Advice re: position and care of an APO-GO Pump Do not get wet Do not expose to direct sunlight Avoid extremes of temperatures Do not open Do not clean with strong household detergents or solvents Recommend suitable means of carrying to try to prevent pump from being dropped A reassessment of the patient s condition is required by both the nursing and medical staff in order to determine the clinical nature and change in the patient s condition. To comply with manufacturer s storage requirements To ensure pump is working To reduce the possibility of pump malfunction Community Nurse to contact PDSN or consultant Community Nurse in conjunction with the patient and or carers. 16/18

17 Training Specialist competencies or qualifications Continuing education & training Organisation Department (If applicable) The pump should only be used by registered community nursing staff who have successfully completed the apomorphine competency (using prefilled syringes) or have been shown how to use the pump by the referring hospital. (The competency will still need to be completed, within one month of patient being admitted to the caseload) Initial assessment of competency is co-ordinated by the PDSN; subsequent assessments are self assessments every two years. A copy of the completed competency will be kept in personal file kept by Line Manager /Team Leader 1. Staff must comply with the Trust s Training Matrix which specifies mandatory training requirements. 2.In addition staff must comply with their service level training matrix for training and competencies as required for role 3. All staff to have an annual appraisal Community Nursing Appendix 1 Milligrams per hour Flow rate value to set on pump mls per hour Number of Milligrams of apomorphine over 12 hours infusion /18

18 Appendix 2 Where to find help Parkinson s Disease Specialist Nurse (PDSN) Based at The White House,, 3 Port Causeway Bromborough Monday to Friday 09:00 to 17:00pm on Telephone Genus Pharmaceuticals Ltd have a helpline available 24 hours per day telephone Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, United Kingdom IF THE PATIENT IS UNDER THE CARE OF THE WALTON CENTRE THEN ADVICE SHOULD BE SOUGHT FROM:- Specialist Nurse for Movement Disorders Walton Centre/Liverpool Telephone extension 5646 Alternatively contact your line manager for advice, or the Trust duty manager for out of hours via reception at Wirral University Teaching Hospital Foundation Trust /18