ADMINISTRATION OF APOMORPHINE VIA THE APO-GO PUMP

Transcription

1 STANDARD OPERATING PROCEDURE ADMINISTRATION OF APOMORPHINE VIA THE APO-GO PUMP First Issued Issue Version One 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 2013 Named Responsible Officer:- Approved by Date Parkinson s Disease Specialist Nurse Medicines Governance Pharmacist Section: - Medicines Management MMSOP16 February 2012 Risk and Governance Group 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 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 No Subject Experts Annie Baker / Lisa Knight Document Librarian QGS Groups consulted and peer reviewed with :- Medicines Management Group Quality and Governance Service Date formally approved by 1 st Dec 2011 Risk and Governance Group Infection Control Approved June 2011 Medicines Management November 2011 Team Approved Method of distribution Intranet Archived Date February 2012 Location S Drive QGS Access Via QGS VERSION CONTROL RECORD Version Number Author/s Status Changes / Comments Version 1 L Knight R / TC Changes to strength of A Baker apomorphine ampoule Status New / Revised / Trust Change 2/15

3 Standard Operating Procedure For: Administration of Apomorphine via the Apo-Go Pump Name of Discipline: Community Nursing. Wirral Community Trust 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 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 Apo-morphine competency framework 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 oral dopamine agonists (or the patient is unable to swallow oral Parkinson s medications or has been To ensure only appropriate patients receive treatment 3/15 Community nurse in consultation with the prescriber and the Parkinson s Disease Specialist Nurse (PDSN)

4 declared nil orally and other routes e.g. nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG) Tube are not viable) 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 its malfunctions, contact Genus Pharmaceuticals and complete an incident form. This should be reported to the medical devices agency (MDA). (See page 10). 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 ICP 7 Cleaning and Disinfection Policy. If the pump becomes soiled in any way, refer to HS14 Medical Devices Management Policy 3. Training The pump should only be used by registered community nursing staff that have successfully completed the apo-morphine competency 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 In the event that some staff have not completed the apomorphine competency, staff may attend the All bases are provided with a resource pack 4/15

5 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 name and signature of authorised prescriber date prescribed name of medicine (apomorphine) route (subcutaneous infusion) number of milligrams of apomorphine and the volume required name of the diluents and the volume required length and frequency of infusion For example If 12mg of apomorphine was infused over 12 hours the Patient Medicine Administration Chart would state: Apomorphine 12 mg over 12 hours daily by subcutaneous infusion 1.2ml of apomorphine (from 50mg in 5ml ampoule) diluted with 8.8ml sodium chloride 0.9% It is also now recommended that the patient s NHS number is included on the Patient Medicine Administration Chart 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 20ml APO-GO crn CRONO syringes Battery (lithium 3 volt CR 123 A Photo lithium battery) Spacer (if made up to 10ml dilution) Blue key ring to open battery compartment Syringe pump holder/elastic belt The company also provide a towel and plastic tray to protect the patient s furniture/belongings. Please contact company to obtain. The pump comes with a battery and a spare battery in the box, batteries last approximately six months. Spare batteries can be obtained from Parkinson s Disease Specialist Nurse Instructions for use: APO-GO Pump User Guide provided by Genus Pharmaceuticals with APO-GO infusion pump abbreviated user guide 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 5/15

6 ALERT:- Prefilled syringes Please note: Do not accept patients who are discharged with the Archimedes Momentum Pump, this must be discussed with a senior manager to avoid delay in hospital discharge. (These pumps are pale aqua coloured pumps and operate in a different manner to the Genus pump, although they look the same) Additional Equipment required: Sphygmomanometer Calculator Patient Medicines Administration Chart signed by general practitioner / authorised prescriber Record of treatment Prescribed medicine (Apomorphine 50mg/5mls and diluent 0.9% sodium chloride) Community Nurses must only use Apomorphine ampoules. If a patient is discharged with prefilled syringes a prescription would need to be obtained for Apomorphine ampoules Single use Sterile dressing pack or single use disposable apron and non-sterile gloves Additional pair of disposable non-sterile gloves Syringes 1ml,2ml or 5ml (depending on dose to be drawn up for accuracy) Green needles Alcohol swab Sharps container Suitable transparent occlusive dressing e.g. Tegaderm Adhesive label specifying drug, dose, amount of diluent, date and time. Suitable infusion set 5b. Choice of suitable infusion sets available which include: Neria lines (Neria lines are available on FP10) Or SIMS-Graseby Medical Flo-Safer Infusion Set 100cm with 25g needle The community nursing service will only supply Graseby infusion sets when directly involved with the management of the patient s care. If Neria lines are not suitable for patients use Prefilled syringes are not suitable for Genus pumps and prefilled syringes are drawn up in a totally different method Line manager to approve order Community Nurse 6/15

7 Thalaset or Graseby line 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. 7. Check Patient Medicines Administration Chart Check the Patient Medicines Administration Chart is clear and unambiguous and contains all essential information Check the pharmacy label on the box of apomorphine and diluent, issued by the supplying pharmacist against the Patient Medicines Administration Chart, checking the name of the patient, the name of the medicine, the dose and volume to be drawn up 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 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 To ensure the pharmacy has dispensed the correct medication Apomorphine is known to reduce blood pressure To ensure the pump is set at the appropriate 7/15 Community Nurse Community Nurse/ PDSN

8 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. setting 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. Changing the syringe setting Remove, and then re-insert the battery 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 1ml will be used to prime the line. Therefore divide the remaining 9mls or 19mls by the number of hours (this is usually a 12 hour period). Calculator should be used for calculations. For example for a 10ml solution 9ml (volume remaining) = 0.75ml/hour 12 (hours of infusion) 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 solution Decontaminate hands prior to procedure To ensure pump is set at the correct rate To reduce the risk of transfer of transient micro-organisms on the healthcare workers Community nurse/ PDSN PDSN Community Nurse 8/15

9 Protect the patient s belongings with a towel or protective cover Check the expiry dates of the apomorphine and the diluent. Record batch numbers and expiry dates after completion of the procedure Unscrew the plunger of the syringe antihands Apomorphine stains green To ensure expired medication is not administered Prepare the label for the syringe, the label should also contain:- Full name of patient Made up by (name of nurse) Name of medicine in syringe Amount of medicine Name of diluent Total volume of fluid in syringe Date and time pump commenced Route 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 a clean field and gather equipment, apply apron and gloves Draw up required apomorphine for total infusion time using 1ml, 2ml or 5ml syringes dependent on dose Transfer Apomorphine into a CRN Crono syringe using a clean non-touch technique. Dilute apomorphine with sodium chloride 0 9% up to a total volume of 10ml or 20mls. Note: There must be a minimum of a 50:50 dilution of sodium chloride 0 9% to Apomorphine e.g. For a 10ml total volume, the maximum apomorphine would be 50mg in 5ml diluted with at least 5mls of sodium chloride 0 9% 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 Take off the needle and place on the blue cap provided A dressing pack may be used in a patient s home to achieve a clean technique To reduce irritation and/or nodule formation at the needle site This is important to avoid spillage when attaching to the pump 9/15

10 clockwise and then place the syringe on the pump driver clockwise until it clicks. Syringes cannot be prepared in advance. The apomorphine ampoule contains no anti-microbial preservative 13. Attach prepared Apomorphine to Apo-Go Pump Take off the blue cap and attach to the infusion line using a clean 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 reduce the risk of transfer of transient micro-organisms on the healthcare workers hands Community Nurse 10/15

11 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 Patient may have a personal preference. Community Nurse Once chosen apply single use disposable gloves, the site should be cleansed with an alcohol swab and left to dry To comply with infection control Gently pinch the skin and insert the needle 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 To elevate the subcutaneous tissue enabling easy access To reduce nodule formulation Community nurse Form a loop in the infusion line around the needle site and secure with a transparent dressing (e.g. semi- permeable) 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 N.B. On the rare occasion that Apomorphine is run over 24 hours, this should be prescribed as 2 x12 hour infusions requiring a change of syringe, giving set and infusion site for each infusion Dispose of sharps in a yellow lidded sharps container for incineration On completion of the procedure remove and dispose of Personal Protective Equipment (PPE) to comply with waste management policy Decontaminate hands following removal of PPE This allows observation of the site and maintains correct position of the needle whilst reducing risk of accidental removal of needle Health and Safety of staff and patients and to comply with Trust policy. 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 To prevent cross infection and 11/15 Community nurse

12 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 environmental contamination To comply with health policy records To comply with health policy records If attending a care home Particular care is needed to check the identity of the patient To reduce risk of medication errors as there may be residents within the home with similar names The registered nurse must complete all checks and not rely on care staff. Ensure treatment occurs away from any distractions ideally in a separate treatment room with no other patient/resident in the same room It is essential that nurses also record administration on the care homes Medicines Administration Records (MAR) chart for cross reference To reduce potential for errors To promote dignity and respect and reduce risk of medication error The care home requires a record of all medicines administered to residents 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 point 18. 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 12/15 Community nurse, patient and carers

13 earliest opportunity 16. Taking pump down When the infusion is completed the pump will display END 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 needle in to a yellow lidded sharps container. 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 sharps container On completion of procedure remove and dispose of PPE to comply with waste management policy. 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) Nodule formation at the needle site (see section 12 on preparation of apomorphine and section 15 observation of site) 18. Where to find help Parkinson s Disease Specialist Nurse (PDSN) Based at The White House, Wirral Community NHS Trust, 3 Port Causeway Bromborough Monday to Friday 09:00 to 17:00pm on Telephone To reduce the risk of transfer of transient micro-organisms on the healthcare workers 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 Apomorphine will make patients sick Community nurse or patient or carer Community nurse or patient or carer Community nurse or patient or carer 13/15

14 Genus Pharmaceuticals Ltd have a helpline available 24 hours per day During Office Hours 09:00 17:00 telephone Out of Hours 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 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. 20. 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 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 Community Nurse to contact PDSN or consultant Community Nurse in conjunction with the patient and or carers. 14/15

15 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 Subsequent batteries for use can be obtained from Parkinson s Disease Specialist Nurses To reduce the possibility of pump malfunction Training Specialist competencies or qualifications The pump should only be used by registered community nursing staff who have successfully completed the apo-morphine competency 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 Continuing education & training Risk Assessments Organisation Department (If applicable) Medicines management training every two years Essential Learning training every two years Device failing, contamination, staining, sharps injury Community Nursing STANDARD OPERATING PROCEDURE (SOP) APPROVED BY:- Peer Agreement Formal Approval Medicines Management Group Risk and Governance Group 15/15