Guidelines for the use of Nebulised Colistemethate Sodium (Colomycin) Injection () in Pseudomonas aeruginosa Lung Infections in Adults

Transcription

1 Index No: MMG41 Guidelines for the use of Nebulised Colistemethate Sodium (Colomycin) Injection () in Pseudomonas Version: 2 Date ratified: November 2017 Ratified by: (Name of Committee) Name of originator/author, job title and department: Director Lead (Trust-wide policies) Associate Medical Director (local Policies) Clinical Management Team / Directorate Applicable to Name of responsible committee for the policy: Medicines Management Committee Aneeka Chavda, Pharmacist, Pharmacy Medical Director Medicine Medicines Management Committee Date issued for publication: November 2017 Review date: August 2020 Expiry date: (Date 3 months following review date) Equality impact assessed by: (name, job title and department) Date impact assessed: CQC Fundamental Standards: November 2020 This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a N/A Regulation 12: Safe Care and Treatment 1

2 CONTRIBUTION LIST Individuals involved in developing the document Name Aneeka Chavda Dr R Reddy Simon Lee Hina Mistry Designation Pharmacist Respiratory consultant Nurse Specialist Pharmacist Advanced Cardio-Respiratory Circulated to the following individuals for consultation Name Designation 2

3 Index No. MMG41 Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this process. Name Job Title Signature Date Local Committee approval (where applicable) Name of Committee Name of Chairperson Date of Approval Medicines Management Committee Mr Robin Lee July 2014 Change History Version Date Author Reason /10/13 Converted from Trust Policy format to Medicines Management Guideline format. Previous reference: MM /4/14 Hina Mistry Guidelines reviewed and converted to meet Medicines Management Guideline format 2 16/10/17 Sue Hussain Guidelines Reviewed Impact Assessment This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a A translation service is available for this guideline. The Interpretation/Translation Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide policies. 3

4 CONTENTS Section Page 1 Scope 5 2 Introduction 5 3 Aim Colomycin injection (Colistin) and its place in treatment Indications Contraindications Cautions and Warnings Responsibilities Possible adverse effects Anaphylaxis 3.7 First dose administration Administration Ventilated patients Patients with tracheostomy masks Drug interactions Precautions for storage 8 4 Training 8 5 Monitoring arrangements for compliance and effectiveness 6 Plan for dissemination and implementation 9 7 References 9 Appendix 1 Information for patients prescribed Colomycin injection for nebulisation

5 1. SCOPE The aim of this guideline is to establish clear guidance for use of nebulised Colomycin injection in the treatment Pseudomonas aeruginosa lung infection in adult patients with chronic lung disease. 2. INTRODUCTION Pseudomonas aeruginosa causes severe lung damage in patients who become colonised and chronically infected. The lung damage caused by this pathogen is a major cause of morbidity and mortality in patients with bronchiectasis. Treatment with nebulised anti-pseudomonal antibiotics has been shown to improve lung function, reduce the frequency of exacerbations of infection and hence avoid hospital admissions for intravenous (IV) antibiotics and slow the rate of respiratory decline in patients. Nebulised antibiotics produce high local concentrations with low levels of systemic absorption and toxicity compared with IV antibiotics. 3. AIM 3.1 Colomycin injection (Colistin) and its place in treatment Colomycin (Colistin) is a polymyxin B antibiotic indicated for the long term management of chronic Pseudomonas aeruginosa infections of the lung. It binds between the protein and phospholipid layers of the cell membrane, affecting the osmotic integrity of the cell. It is bactericidal and active in vitro against many gramnegative bacteria. The aim of these guidelines is to ensure the appropriate administration of Colomycin. Licensed indications: Intravenous use for treatment of serious infections caused by susceptible Gram negative bacteria, including infections of the lower respiratory tract and urinary tract. Inhaled colistemethate sodium is licensed for the treatment of pseudomonas aeruginosa in people with cystic fibrosis. Note: Not licensed in bronchiectasis for non-cystic fibrosis but established and common practice in many hospitals. This guidance refers to the treatment of chronic Pseudomonas aeruginosa lung infections with NEBULISED Colomycin only in adult bronchiectasis patients. Nebulised Colomycin is not recommended for use during acute exacerbations, where intravenous antibiotics are more effective. The use of nebulised antibiotics offers the advantage of delivery of antibiotics to the site of infection, with resultant minimal systemic adverse effects, as well as offering the possibility of treatment at home. 5

6 3.2 Indications Nebulised Colomycin is indicated to delay Pseudomonas aeruginosa progressing to chronic colonisation and for the prevention of clinical deterioration/recurrent exacerbations in patients chronically colonised with Pseudomonas aeruginosa infection. 3.3 Contraindications Known hypersensitivity to Colomycin or polymyxin B Contra-indicated in patients with myasthenia gravis (Colomycin reduces the amount of acetylcholine released from the pre-synaptic neuromuscular junction). 3.4 Cautions and Warnings Bronchospasm may occur on inhalation of antibiotics. This may be prevented or treated with appropriate use of inhaled beta 2 agonists. If troublesome, treatment should be withdrawn. The first dose should be given under medical supervision (Please see first dose administration) Acute respiratory failure may result when reconstituted Colomycin solution is not used promptly. After reconstitution, Colomycin is hydrolysed to form active components including polymyxin E 1 which has been shown to cause localised inflammation of the airway epithelia. Use with caution in renal impairment (Colomycin is renally excreted) Bronchial hyper-reactivity in response to Colomycin may develop over time with continued use. Check pre- and post-dose FEV 1 in patients who report any symptoms suggestive of this. Use with extreme caution in patients with porphyria. 3.5 Responsibilities Treatment can only be initiated by the chest consultants who should also outline the duration of the treatment. This is usually after they have seen them either as an inpatient or outpatient. Dose - for guidance only and should be adjusted according to clinical response. Adults: 1-2 million units twice daily by inhalation 3.6 Possible adverse effects Local irritation such as bronchospasm or coughing Sore throat or mouth has been reported and may be due to Candida albicans infection or hypersensitivity Anaphylaxis Anaphylaxis may occur upon administration of the first dose of all inhaled antibiotics. It is important to monitor the patient when administering the first dose. 6

7 Signs and symptoms of anaphylactic reaction: Swelling of face, lips, eyes and tongue Tightening of the throat Difficulty in breathing and change or loss of voice There may be loss of consciousness 3.7 First dose administration It is recommended that patients should be given an initial test dose in hospital where they can be observed for any adverse effects, in particular the possibility of bronchoconstriction. Any allergies should be noted before first dose administration. Ensure the patient has been written for nebulised salbutamol in case of broncoconstriction. However a nebulised bronchodilator should always be administered before the test dose if this is part of the patient s current regime. All patients should have their FEV 1 and FVC measured before the test dose and then at 15 and 30 minutes after. They should be monitored for post dose wheezing and bronchoconstriction. If the FEV 1 drops by <15% and <200ml and the patient does not experience side effects, it is safe to give the nebulised Colomycin at follow up visits. Checks should be made to ensure there are no symptoms of bronchospasm related to the nebulised Colomycin. If the FEV 1 drops by >15% and >200ml or if symptoms of bronchospam occur, administer salbutamol by nebulizer or inhaler, repeating spirometry at 15min intervals until it returns to baseline. The test dose may be repeated at least 24 hours later if wheezing or bronchoconstriction occurs. In this case, the Colomycin should be dissolved in 2ml water for injections and mixed with 2.5mg salbutamol if this was not prescribed before the initial test dose. If the patient tolerates the test dose, 200micrograms (two puffs) salbutamol inhaler or 2.5mg salbutamol nebulised 10 minutes before subsequent doses should be used. If their FEV 1 drops by >15% and >200ml, refer back to the prescriber who may have to consider an alternative drug. Ensure there is an anaphylactic kit nearby in the case of anaphylaxis. If there are no side effects the patient may be left 30mins after the end of the test dose. 3.8 Administration Colomycin powder is dissolved in 2-4ml of water for injections or 0.9% sodium chloride for use in a nebulizer attached to an air/oxygen supply. Salbutamol 2.5mg/2.5ml has been used to reconstitute Colomycin instead of sodium chloride 0.9% without any problems but there is no stability data to support this. Colomycin should not be mixed or diluted with any other drug or 7

8 fluid. Administer Colomycin inhalation treatment promptly after reconstitution. Colomycin is hydrolysed into two active components, Colistin A (polymyxin E 1 ) and Colistin B (polymyxin E 2 ). Polymyxin E 1 has been shown to cause localised inflammation of the airway epithelia. Colomycin is administered via a normal nebuliser but requires a special VentStream system. This device provides a filter, which is changed with each dose to prevent the drug being inhaled by others in the area as it is exhaled by the patient. This kit is kept on Harrowden A ward. Colomycin should be inhaled over minutes using the VentStream nebuliser. The patient should be encouraged to rinse their mouth with water and spit out after nebulisation, in order to reduce systemic side-effects. If other therapies are due at the same time they should be taken in the following order: Bronchodilator, chest physiotherapy, other inhaled medicines, Colomycin. 3.9 Ventilated patients These patients should receive nebulised Colomycin in the same way as other nebulised drugs. This includes patients with tracheostomies but excludes patients who have been weaned down onto to tracheostomy masks. Since the ventilation circuit is a closed circuit, I.e. the air/oxygen is returned to the wall, any waste nebulised drug will not enter the environment and people in the vicinity of the patient will not be exposed to any Colomycin. No additional filters are required Patients with tracheostomy masks Patients with tracheostomy masks require help to ensure no Colomycin leaks out into the environment. A Pari system can be attached to the tracheostomy and the system manually supported for the duration of the nebule Drug interactions Drug interactions are unlikely to occur with nebulised Colomycin as transpulmonary absorption is generally considered negligible. There are no recorded drug interactions when using the nebulised route Precautions for storage Colomycin vials should be stored at room temperature. Storing prepared Colomycin aqueous solution for longer than 24 hours increases Colomycin concentration and increases the potential for lung toxicity. Therefore Colomycin should be freshly prepared before use and any unused solution should not be stored but disposed of in a safe and appropriate manner. 4. TRAINING No additional training is required. 8

9 5. MONITORING ARRANGEMENTS FOR COMPLIANCE AND EFFECTIVENESS Aspect of compliance or effectiveness being monitored The document is intended to guide clinicians. Adherence is not mandatory and so compliance monitoring is not required. Monitoring method See above Responsibility for monitoring See above Frequency of monitoring See above Responsible committee for monitoring and implementation of required actions See above 6. PLAN FOR DISSEMINATION AND IMPLEMENTATION This guideline will be implemented and disseminated via the following methods: Placed on the hospital intranet sites briefing to relevant clinicians and pharmacy staff 7. REFERENCES 1. Summary of Product Characteristics. Colomycin Injection: TevaUK Ltd, May Guidelines For The Use Of Nebulised Colomycin injection, (Colistin) in Pseudomonas, Chesterfield Royal Hospital NHS Foundation Trust guidelines, Sept Guidelines For The Administration Of Nebulised Antibiotics, Barts and the London NHS trust, August DRUGDEX Evaluations, Colistimethate sodium, May 2010, Last accessed 25/08/ BTS guidelines - Bronchiectasis (non-cf) Guideline Group, Guideline for non-cf Bronchiectasis, July

10 Appendix I Information for patients prescribed Colomycin injection for nebulisation Introduction Colomycin is an antibiotic which is effective against a bacterium called Pseudomonas aeruginosa. It can be given by IV injection or nebulizer route. Colomycin injection for nebulisation is sometimes prescribed by Specialist Hospital Consultants for use in patients with chronic lung conditions ie bronchiectasis who have had pseudomonal chest infections to try and reduce re-current chest infections. Colomycin injection is approved (licensed) to be given by nebulisation although it is not specifically licensed for use in patients with bronchiectasis. Many Respiratory Consultants do use it and your consultant should discuss this with you. If s/he hasn t or you are unsure please ask him/her to explain it again. The nurses on the ward will train you how to use the nebulizer and prepare the Colomycin. Below is a reminder for you to follow at home. Reminder You may need to use your bronchodilator eg salbutamol before using the Colomycin nebulizer. Once at home you will need to get a repeat prescription from your GP for the Colomycin and sodium chloride. Administration 1. Wash hands. 2. Flip off cap, tear and remove metal seal from Colomycin vial. 3. Using a syringe (without a needle): draw up 2ml sodium chloride 0.9% for injection for 1million unit vial or 4ml sodium chloride 0.9% for 2million unit vial. 4. Add sodium chloride to Colomycin vial and wait for powder to dissolve. 5. Pour solution into nebulizer and nebulise until dry. 6. Discard any remaining sodium chloride. 7. Rinse and discard used Colomycin vial. 8. Rinse and dry syringe ready to re-use. 9. Replace nebulizer filter every 24hrs. 10