Who should read this document 2 Key points 2 Background/ Scope 4 What is new in this version 4 Policy/Procedure/Guideline 5

Transcription

1 NEBULISED ANTIBIOTIC THERAPY CHALLENGE ADMINISTRATION AS AN OUTPATIENT OR INPATIENT Classification: Clinical Guideline Lead Author: Helen Pyne Advanced Nurse Practitioner (Respiratory) Additional author(s): Tina Wilding Authors Division: Salford Health and Social Care Unique ID: 189TDC388 Issue number: 8 Expiry Date: August 2018 Contents Section Page Who should read this document 2 Key points 2 Background/ Scope 4 What is new in this version 4 Policy/Procedure/Guideline 5 Standards Explanation of terms/ Definitions 13 References and Supporting Documents 15 Roles and Responsibilities Appendix Document control information (Published as separate document - Please contact the Document Control Administrator john.taylor@srft.nhs.uk) Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Page 1 of 16

2 Who should read this document? Respiratory Specialist Nurses Respiratory Consultant and Registrars Respiratory Physiotherapists The respiratory team are responsible for keeping up-to-date with the current research and best practice and disseminating this information. Key Messages Important notice for health care professionals Before undertaking this procedure, please consider there is a small possibility of allergic reaction from the airborne antibiotic drug particles. If you are known to have a severe allergic reaction to any of the outlined antibiotics please do not undertake this procedure Ensure you have ready the products below before proceeding with a challenge of nebulised Colomycin (Colistimethate Sodium): Ventilated room in chest clinic or ventilated side room on a ward Prescription for all necessary drugs and diluents Air compressor Vent-stream nebuliser unit with mouthpiece and elephant tubing or filter chamber with disposable filters Access to Electronic Patient Records/medical notes (check for drug allergies/intolerances) Spirometer (to test lung function pre and post drug administration unless patient has a tracheostomy or is unable to perform the test due to other indications) Pulsoximeter (to test oxygen saturation and pulse rate pre and post administration) Stop watch to time administration Colomycin vial (powder) for nebulisation 1 or 2 MIU (dependent upon prescription, with removable bung) 2ml syringe to draw up diluents Salbutamol 2.5mg/2.5ml nebule (diluent) 5ml plastic ampoule of sterile water (use only 1.5mls) Salbutamol nebule 2.5mg/2.5ml (stock) for emergency use only Oxygen cylinder or piped oxygen with venturi mask (stock) for emergency use only Patient information booklet with contact details Replacement consumables Contract (for the air compressor to facilitate recall and service of the machine if for outpatient use) Access to emergency team if serious allergic reaction were to occur (all standard therapies available on the resuscitation trolley Sharps bin Page 2 of 16

3 Ensure you have ready the products below before proceeding with a challenge of nebulised Promixin (Colistimethate Sodium) Vented room in chest clinic Prescription for all necessary drugs and diluents I-NEB air compressor (supplied by Phillips Respironics) Trainer for the I-neb system Access to Electronic Patient Records/medical notes/sir (check for drug allergies/intolerances) Spirometer (to test lung function pre and post drug administration) Pulsoximeter (to test oxygen saturation and pulse rate pre and post administration) Stop watch to time administration Promixin vial (powder) for nebulisation 1 MIU (with removable bung) U100 insulin syringe to draw up diluents Salbutamol 2.5mg/2.5ml nebule (use only 1ml as diluent) if indicated for airflow limitation (specialist will prescribe) 5ml plastic ampoule of sterile water (use only 1ml as diluent if not using Salbutamol as diluent) Salbutamol nebule 2.5mg/2.5ml (clinic stock) for emergency use only Oxygen cylinder with venturi mask (clinic stock) for emergency use only Patient information booklet with contact details Access to emergency team if serious allergic reaction were to occur (all standard therapies available on the resuscitation trolley located in the out-patient department) Sharps bin Ensure you have ready the products below before proceeding with a challenge of nebulised Amoxicillin Vented room in chest clinic or ventilated side room on the ward Prescription for all necessary drugs and diluents Access to Electronic Patient Records/medical notes/sir (check for drug allergies/intolerances) Spirometer (to test lung function pre and post drug administration unless patient has a tracheostomy or is unable to perform the test due to other indications) Pulsoximeter (to test oxygen saturation and pulse rate pre and post administration) Stop watch to time administration Air compressor Side-stream nebuliser with mask (for pre-dosing with bronchodilator) Salbutamol 2.5mg/2.5ml nebule (pre-dosing bronchodilator) Vent-stream nebuliser unit with mouthpiece and elephant tubing or filter chamber with disposable filters Amoxicillin 500 vial (powder) for nebulisation U100 insulin syringe to draw up diluents 5ml plastic ampoule of sterile water (use all 5mls as diluent) Salbutamol nebule 2.5mg/2.5ml (stock) for emergency use only Oxygen cylinder or piped oxygen with venturi mask (stock) for emergency use only Patient information booklet with contact details Filter set (replacements for air compressor home use) Contract (for the air compressor to facilitate recall and service of the machine if for outpatient use) Page 3 of 16

4 Replacement consumables Access to emergency team if serious allergic reaction were to occur (all standard therapies available on the resuscitation trolley located in the out-patient department Sharps bin Background & Scope The patient will receive the prescribed medication safely and appropriately by a qualified nurse in accordance with British Thoracic Society nebuliser good practice and bronchiectasis guidelines and Trust Drug Policy available on synapse. This protocol includes the challenge of nebulised antibiotic drug therapy and subsequent administration of nebulised antibiotic drugs and management of the equipment required to nebulise the solution. There are two methods of nebulising the antibiotic drugs suitable for management of bronchiectasis or bronchial sepsis. This protocol provides guidance for each method of nebulisation using both ineb and ventstream systems. The most appropriate system will be identified for the patient and funding sought from the individual patient s General Practitioner. Phillips-Respironics supply the ineb free of charge only when used to administer Promixin for the management of pseudomonas colonisation in Bronchiectasis or Bronchial Sepsis. The service includes provision of the machine, consumables and 24 hour support for the patients. This is new technology that provides the patients with sensory stimulation to feedback correct use of the device, correct breathing technique and on-going data of compliance with treatment. A drug challenge with Promixin via the ineb will include education, advice and written information from an ineb specialist and supervision from a hospital based Respiratory Specialist (nurse or doctor). The ineb specialist may visit the patient at home prior to the outpatient clinic appointment to provide the ineb and educate on the use of the ineb device. The drug challenge will take place in the chest clinic in a well-ventilated room usually by a Respiratory Specialist Nurse. Support and replacement equipment and consumables are provided by Phillips-Respironics and medical management will be led by a Consultant Respiratory Physicians. The procedure for a challenge of nebulised antibiotics via a ventstream nebuliser unit and an air compressor is outlined below. Hands must be washed prior to commencing the procedure to prevent contamination of the disposable unit. Hand washing is the single most important means of reducing hospital-acquired infection. What is new in this version? Nothing apart from taking away the nebulised gentamycin as we no longer use. Page 4 of 16

5 Policy/ Guideline/ Protocol 1. Review electronic patient records and/or medical notes. 2. Prescription for antibiotics, pre-dosing salbutamol and appropriate diluent(s) prepared well in advance 3. Arrange a vented room. 4. Invite the patient into clinic for a challenge of treatment supervised by Respiratory Specialist Nurse, ANP or doctor or arrange on the ward for an inpatient. Liaise with ineb specialist from Phillips Respironics regarding patient being booked into clinic or inpatient. 5. Collect the drug and diluent(s) from pharmacy in advance and store in the locked drug cupboard 6. Ensure all drugs, diluent and equipment required is available as per the list outline for each drug above To determine if the patient has any antibiotic drug allergies or intolerances To allow adequate time for the pharmacist to prepare the drug therapy To minimise exposure To facilitate a safe and effective demonstration and administration of one full dose and ensure any serious allergic response is dealt with promptly by the emergency team. Contacting ineb specialist from Phillips Respironics to ensure he/she is able to attend and bring ineb equipment, or visit patient at home prior to clinic appointment. Agreement has been made with outpatient Pharmacy (Lloyds pharmacy in the Hope building) that these therapies will be stock for dispensing however a few days are required to prepare the treatment pack ready for collection. Collect in advance Pharmacy opens 8am. On the ward, order electronically in advance and collect from pharmacy to ensure there is no delay in commencing the drug challenge. 7. Explain to the patient: What the antibiotic therapy is for. Why the therapy is being administered as a nebulised solution. What the potential side effects are What will happen if a serious allergic reaction occurs What the procedure will be for the challenge of treatment Frequency of observations required (Spirometry, SaO2, resp. rate, pulse) How long the therapy will take to administer To help reduce anxieties and gain informed consent Explain the potential risk of bronchospasm or severe allergic reaction (anaphylaxis). What signs and symptoms they may experience. 80% of anaphylactic reactions have skin or mucosal features as the first reactions. See information at the end of the document regarding patient safety Page 5 of 16

6 Procedure How long the full challenge will take and they are safe to go home Try to answer any questions the patient may have. To comply with the NMC Code of Professional Conduct, Patients Charter and Local Standards of Service. 8. Confirm the patients identity with the patient, the medical notes and check with drug prescription and allergy status To ensure the patient receives the appropriate medication. 9. Check the drug and diluent is correct with the prescription. 10. Administer the bronchodilator via the side-stream nebuliser (Amoxicillin only) To facilitate maximum lung deposition of the nebulised bronchodilator and potentially reduce the potential for bronchospasm with the nebulised amoxicillin antibiotic therapy 11. Undertake Spirometry, SaO2, Respiratory Rate, and Pulse and record pre challenge to establish baseline 12. Demonstrate to the patient, or ward staff how to mix the drug with prescribed diluent(s), draw up and dispense into the nebuliser unit. If in outpatients observe the patient/carer preparing the drug, drawing up and administration of one dose safely. 13. Ensure the patient/staff is aware that they must dispense the solution into the nebuliser pot just prior to administration and not leave it sat in the nebuliser pot for more than 15 minutes before administering 14. When using the Ventstream neb, attach the elephant tubing and place outside through the open window or use a filter set. If using ineb, ensure disc is inserted into machine. To establish baseline from which subsequent post challenge tests will be measured In order to observe the correct administration of the drug as prescribed. If the nebulised antibiotic solution is left standing it will lose potency. Ensuring the drug is ventilated out of the window in the room or filtered to minimise exposure. ineb insertion of disc to allow ineb system to work and deliver correct dosage. Page 6 of 16

7 Procedure 15. Commence nebuliser treatment. Administration of antibiotic therapy made up to 4mls will take approximately 10 minutes at optimum breathing pattern via the vent-stream. When using ineb, Promixin is made up to 1ml and will take 2-3 minutes via ineb 16. Recommend mouth breathing with normal tidal volumes with occasional deep breaths. If using ineb AAD system, recommend normal tidal volumes as demonstrated by the ineb specialist, and hold the ineb unit at 90 degree angle. Support ineb specialist from Phillips Respironics who will educate patient on how to use ineb. To ensure the patient receives optimum dose of the medication Approximately 10% of the aerosol will deposit in the lungs via vent-stream and 50-80% via the ineb. ineb monitors breathing pattern and delivers drug at the correct time to reach deep into the lungs. If ineb unit is not held at 90 degree angle, the unit will bleep to alert the patient. 17. Do not leave the patient unattended during the procedure. To ensure early detection of potential allergic reaction or bronchospasm. Signs and Symptoms are listed below: Chest tightness, wheeze, Breathlessness, difficulty swallowing, hoarseness and stridor Swelling of the throat, tongue, lip, around the eyes and full face (angioedema) Erythema (generalised or patchy rash), uritcaria (welts anywhere on the body), Itching, Flushing, abdominal cramps, vomiting, Light headedness, loss of consciousness, Feeling of impending doom, Tachycardia, hypotension, hypoxia, increased respiratory rate, circulatory problems include pallor and clammy skin 18. Record Spirometry fifteen minutes and thirty minutes post challenge of treatment, if no contraindications 19. Record SaO2, respiratory rate, and pulse 15 and 30 minutes post challenge of treatment For early detection of any deterioration in lung function, indicating bronchospasm. Early detection of an allergic reaction to the therapy (see safety advise below for anaphylactic reactions) Page 7 of 16

8 Procedure 20. Encourage the patient to adopt a comfortable well supported upright position at home for administration of the therapy. 21.The medication should be nebulised until the small amount of drug is left in the chamber and it begins to "spit" and subsequently an aerosol is no longer produced. The ineb will signal sound and symbol displayed on screen when finished NB: there will be a small residual volume left in the nebuliser pot To aid lung expansion and comfort throughout the procedure. To ensure maximum dose delivered to the patient. If administration takes longer than 15 minutes then check the equipment. 22. Observe the patient and promptly report and document any reactions to this therapy. Call 2222 for the emergency team to respond to a severe anaphylactic reaction or cardiac arrest NB Observed deterioration in spirometry, acute breathlessness or severe wheezing post nebulised medication are indications of bronchoconstriction and should be reported to a doctor immediately 23. Explain and demonstrate to the patient/staff that after each dose they must dismantle the nebuliser pot and wash in warm soapy water. ineb parts to be inserted into basket provided and washed in warm soapy water. Rinse under a running tap and allow it to dry naturally in room air on a paper towel. 24. Re-assemble the nebuliser pot when dry and reattach to the tubing. Reassemble the ineb device when ready for the next dose. Cleaning prevents a build of bacteria and blockage of the air jet holes. Drying with a kitchen towel or paper towel can lead to deposits of bacteria or small particles, which can potentially be inhaled. To prevent loss of any of the small components. NB When using the vent-stream kit, do not wash tubing. If condensation is observed in the tubing then disconnect from the nebuliser pot and turn on the air supply to blow away any excess moisture. Page 8 of 16

9 Procedure 25.Once weekly the nebuliser pot (or the ineb parts including the basket) must be boiled to sterilise all the components. Follow the instructions in the manufacturers booklet. 26. If using the Ventstream system, change the air outlet filter on the air compressors once every 4 months. Nebuliser pots are single patient use only. However bacteria can multiply within the residual volume of solution and deposit onto the mouthpiece and chamber. Jet holes (and the platinum mesh within the ineb) can become blocked by crystals, which form from the solutions, if the pot is not washed or boiled weekly. Filters will appear grey/black/discoloured when a change is required. 27. The air compressor machine will be serviced every 18 months by the hospital, if supplied by the trust. If using ineb, Phillips Respironics will supply all equipment. Inefficient air compressors reduce the amount of drug delivered to the patient 28. Record the administration of the drug in the clinical note on the patients EPR on completion of one full dose 29.If drug challenge is done in outpatients ensure the patient has a list of medication, diluent(s), equipment and consumables required to administer the drug and send a letter to their GP for their information. Ensure the GP has a shared care agreement and they have authorised the use of this therapy Ensuring accurate communication of the delivery of one full dose of the therapy and any additional information that may be relevant Providing continuation of treatment by repeat prescription from their GP and supply of equipment by the GP surgery. Treatment Options NB Colistimethate Sodium is available as two products which can be nebulised - Colomycin injection which may be used for nebulisation and Promixin powder for nebuliser solution. Colomycin (Colistimethate Sodium) Colomycin Colomycin 1 MIU OD-BD Colomycin 2 MIU OD-BD Colomycin (Colistimethate Sodium) is a very frothy drug when mixed with diluent and should not be shaken. The drug should be prepared by rolling in the palm of the hands and left to adequately dissolve Page 9 of 16

10 Procedure 2mls sterile 0.9% saline (diluent) 2mls Sterile Water for Injection (diluent) OR with 4mls sterile 0.9% saline Promixin (Colistimethate Sodium) Promixin (via the i-neb) Promixin 1MIU powder for nebulisation OD-BD 1 ml Water for Injection or 1ml Salbutamol nebuliser solution 2.5mg/2.5ml (if indicated for airflow limitation) NB: When administering Colistimethate Sodium via the i-neb lung deposition of the drug is enhanced therefore the dose must be adjusted. Promixin (Colistimethate Sodium) via the i-neb is equivalent of double Colomycin (Colistimethate Sodium) via the vent-stream nebuliser unit i.e. 1MIU of Promixin via ineb = 2MIU Colomycin via ventstream nebuliser Promixin powder for nebulisation is usually mixed with a small amount of Salbutamol unless contraindicated, if so, use sterile water. The chamber of the ineb is specially designed to facilitate this concentration of the drug for fast and efficient administration. Some patients may have airflow limitation necessitating the administration of nebulised bronchodilators. The nebulised bronchodilator can be used as a diluent to reduce the inconvenience to the patient of administering the two therapies separately. Amoxicillin 500mg powder for nebulisation OD-BD 5mls sterile water (diluent) The medicines information centre has undertaken a full literature review on our behalf. No reason was identified why Amoxicillin cannot be delivered via this mode of administration. The only evidence of its use was over thirty years ago. The bronchiectasis team have decided only to use it for patients with repeated infective exacerbations of bronchiectasis or bronchial sepsis, isolating haemophilus influenza that are sensitive or intolerant of all appropriate oral antibiotics. For full review see Helen Pyne. 30. Vent-stream nebuliser, if outpatient, educate the patient to administer the drug in a well ventilated room with the elephant tubing outside the window or using filters where available. 31. Suggest mouth rinsing after each dose. Safety measures for the whole family. To prevent unnecessary exposure. To prevent sore throat or hoarseness Page 10 of 16

11 Procedure 32. Vent-stream nebuliser, if outpatient provide written instructions for management of the air compressor nebuliser unit and filter change. 33. If outpatient, ensure the patient has a contact number so that they can access a member of staff if their condition deteriorates or if they have a problem with their medication or the air compressor / nebuliser units. As a reference for the patient and their family/carer. To ensure safety and confidence of the patient and their family/carer. Advise the patient and carer that if they have any further queries, advice can be sought via the contact details provided not only from the bronchiectasis/respiratory Specialist Nursing team but the respiratory secretary will direct to the most appropriate individual if a member of the bronchiectasis team is not available. If they have a problem with ineb equipment, to contact the helpline number provided by the Phillips Respironics team who can advise and respond to queries. 34. If outpatient, advise the patient that they may experience a delayed reaction to the drug within 12hrs. If they become extremely 'wheezy' or 'breathless' they must attend the accident and emergency department immediately for medical assessment, and inform the staff immediately that they have received nebulisation antibiotic therapy See information safety below regarding patient 35. If outpatient, inform the patient and carer that their condition will be monitored under the care of their Consultant Respiratory Physician/Advanced Nurse Practitioner in the chest clinic. Follow up for the safe and effective administration of the nebulised antibiotic will be approximately two months after the initial challenge via telephone review and further follow up in the bronchiectasis clinic The follow up appointment is designed to address any issues with administration. Effective dose and titration of the dose is also established during the consultation. The drug may be discontinued during this consultation if ineffective or administration problematic or any unacceptable side effects identified Page 11 of 16

12 Procedure SAFETY ADVICE If FEV 1 drops during the procedure If the FEV 1 drops by <15% and <200 ml and the patient does not experience side effects, it is safe to give the nebulised antibiotic but, at follow-up visits, check there are no symptoms of bronchospasm related to the nebulised antibiotic. If the FEV 1 drops by >15% and >200 ml or if symptoms of bronchospasm occur, administer salbutamol by nebuliser or inhaler, repeating spirometry at 15 min intervals until it returns to baseline. If allergic reaction occurs There are three possible outcomes: 1. The signs and symptoms may be mild and fade spontaneously or be quickly ended by administering emergency medication. In this outcome, the symptoms do not subsequently recur from this particular exposure. 2. After initial improvement, the symptoms may recur within 4 to 12 hours (late phase reaction) and require additional treatment and close observation. Recent evidence suggests that a late phase reaction occurs in fewer than 10% of cases. 3. Lastly, the reaction may be persistent and more severe, thus requiring intensive medical treatment. The challenge is undertaken in the hospital out-patient department in order to facilitate timely and effective treatment if required, however this is unlikely. Page 12 of 16

13 Procedure Treatment Treatment depends on the severity of the reaction. Epinephrine is a drug that acts immediately to cause the blood vessels to contract, thereby preventing fluid leakage. It is one of the medications frequently used to treat anaphylaxis. Epinephrine also helps relax the bronchial tubes, thus relieving breathing difficulty. It also lessens stomach cramps and stops itching and hives. More importantly, epinephrine helps prevent the release of more mediators of the allergic reaction. In addition to epinephrine, other medications and IV fluids and oxygen will probably be administered as well. Exposure to nebulised antibiotics The medicines information centre have undertaken an extensive search and further contacted the appropriate pharmacy departments on our behalf to establish if any potential risk involved. The conclusion drawn was that the systemic absorption of these drugs is negligible for patients, therefore presumed so for family, friends, carers and healthcare professionals exposed to these substances. There was no evidence found to suggest that teratogenicity in pregnancy is a risk factor in administration or exposure to nebulised antibiotics. Nonetheless it is recommended that prolonged exposure is avoided during pregnancy for carers, healthcare professionals and friends, if at all concerned. This advice can change over time so please contact the medicines information centre at SRFT pharmacy for the most up to data advice (The full document literature search and references are available upon request from Helen Pyne) NB Conclusions drawn from the evidence are that one off drug challenges and ad hoc exposure by carers and family does not pose a threat to the individual or to a foetus in pregnancy. Page 13 of 16

14 Procedure It is recommended that nobody else be in the room during administration of the nebulised drug therapy where possible. Except when using the ineb. The room must be well vented. Consideration will be given to individuals with learning difficulties, hearing impaired, visually impaired or with language barriers to ensure they receive timely, factual and informative communication about the procedure that will ensure they understand the procedure before consent is gained To comply with Trust policy for diversity and equity Explanation of terms & Definitions I-neb AAD System The I-neb is the third generation AAD (Adaptive Aerosol Delivery) system. It is a small, battery powered, lightweight and virtually silent drug delivery device designed to significantly reduce the inconvenience of conventional nebulizer/compressor therapy while delivering a precise, reproducible dose of drug. The aerosol is created through VMT (vibrating mesh technology), and the dosage of drug is controlled through an AAD Disc and specific metering chambers. The metering chambers can deliver a pre-set volume ranging from 0.25 to 1.4 ml with a residual of about 0.1 ml Page 14 of 16

15 References and Supporting Documents Boe, J. Dennis J. H. and O Driscoll, B. R. et. al. (ERS TASKFORCE) (2000) European Respiratory Society Guidelines on the use of nebulizers. European Respiratory Journal; 18: British Thoracic Society - Nebuliser Treatment Best Practice Guideline documents are available by selecting from the links below (BTS) nebuliser-treatment-best-practice-guideline.aspx British Thoracic Society. BTS guideline for non-cf bronchiectasis. Thorax 2010, 65 (Suppl 1) :i1 British Thoracic Society. BTS guidelines on current best practice for nebuliser treatment. Thorax 1997;52(Suppl 2):S1e106. Cole, P. J. (2001) The role of nebulized antibiotics in treating serious respiratory infections. J. Chemother; 3(4): Conway, S. P. (2005) Nebulized antibiotic therapy: the evidence. Chron Respir Dis.;2(1): Review. Govan, J. (2002) TOBI: reducing the impact of pseudomonal infection. Hosp Med; 63 (7): Review. M C Pasteur, D Bilton, A T Hill (2010) BTS Guideline for non-cf Bronchiectasis, Thorax 2010;65, Supplement 1 Prober-C-G, Walson-P-D, Jones-J. Technical report: precautions regarding the use of aerosolized antibiotics. Committee on Infectious Diseases and Committee on Drugs. Pediatrics, {Pediatrics}, Dec 2000, vol. 106, no. 6, p. E89, 48 refs, ISSN: Profile Pharma Ltd Promixin injection Summary of Product Characteristics. Last updated 13th January 2016 (available from emc website ( accessed 05/08/16. Webb AK, Dodd M, Bush A. Nebulised antibiotics in cystic fibrosis and non-cf bronchiectasis in childrena adults. In: Boe J, O Driscoll R, Dennis J, eds. Practical handbook of nebuliser therapy. London: Martin Dunitz, Roles and responsibilities Staff will be required to be trained and signed off as competent to perform the procedure before proceeding independently. A record of this competence being both achieved and maintained will be kept by Helen Pyne. Page 15 of 16

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