Colistin for Nebulisation SCG: For the treatment of Pseudomonas aeruginosa lung infections AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE The following guidelines are designed to provide information relating to Colistin for nebulisation and to outline the responsibilities of the primary and secondary care teams in the prescribing of Colistin for nebulisation. Summary: Indication Eradication or long term prophylaxis for patients with Pseudomonas aeruginosa lung infection Dose Eradication: 1-2million units (MU) nebulised BD for 3 months Prophylaxis: 1-2 million units (MU) nebulised BD on a continuous or month on month off basis Dose and nebuliser system required will be communicated to GP and patient by secondary care clinician Other Ensure co-prescription of diluents: Water for injection or Sodium Chloride 0.9% volume between 1ml 4ml per dose, dependent on nebuliser system used. Introduction: Indication Treatment of Pseudomonas aeruginosa lung infections in patients with Cystic Fibrosis (CF) and patients with non CF Bronchiectasis. Pseudomonas aeruginosa is a pathogen that causes severe lung damage in patients Who become colonised and then chronically infected. Patients with Cystic Fibrosis and Bronchiectasis are at risk of significant morbidity and mortality from the damage caused by this pathogen. Nebulised antipseudomonal antibiotic treatment has been shown to improve lung function, slow the rate of respiratory decline and reduce the frequency of exacerbations of infection in these patients. Nebulised antibiotics are able to achieve high local concentrations with low systemic absorption and toxicity as opposed to intravenous antibiotics, where there is high risk of developing adverse effects from systemic absorption. EJ29 SHARED CARE GUIDELINE Colistin Page 1 of 6
RESPONSIBILITIES and ROLES Secondary Care Clinician Responsibilities: 1. To diagnose Pseudomonas aeruginosa infection in either CF patients or Bronchiectasis patients based on a timely and comprehensive assessment. 2. To initiate Colistin and ensure the first test dose is carried out before a continuous prescription is requested. 3. To supply the initial 28 days treatment. 4. To provide the nebuliser system and train the patient/carer in the use of the nebuliser and preparation of the medication. 5. To co-ordinate servicing/maintenance of the nebuliser system. 6. To monitor for response and adverse drug reactions (ADRs) during the first test dose and the initiation period. 7. To liaise with the general practitioner (GP) to share the patient s care when the test dose has been carried out and proven benefit has been established. 8. To outline to GP when therapy may be stopped assuming no improvement is recognised in the patient s condition. 9. To review the patients condition and efficacy of treatment 6 months after discharge from secondary care, and then annually thereafter, with consideration at each review as to whether treatment needs to continue. 10. To evaluate ADRs raised by the GP and evaluating any concerns arising from physical checks & reviews undertaken by GP. 11. To advise GP on related issues such as drug interactions etc. 12. To advise the GP on supply issues related to the prescribing of nebulised Colistin 13. In relation to eradication therapy, secondary care will supply the patient with sputum collection pots and advise the patient to send the specimens to their GP for processing in the laboratory. 14. The Consultant Physician will follow up results of the sputum cultures after the three months eradication therapy, and relay any information to the GP. 15. In relation to prophylactic therapy, advise the GP if the patient is on continuous treatment with Colistin or on an alternate month on month off basis. 16. To advise the GP if the patient should be prescribed generic Colistin or the Promixin brand of Colistin if it is deemed necessary to have medicine delivered via the I-neb nebulizer. GP Responsibilities: 1. To monitor the patient s overall health and well being. 2. To observe patient for evidence of ADRs or any abnormalities and raise with the secondary care clinician if necessary. 3. To prescribe Colistin after achievement of a stable dose regime by secondary care 4. To ensure advice is sought from the secondary care clinician if there is any significant change in the patient s physical health status. 5. To reduce and stop treatment in line with secondary care clinicians original request. 6. For eradication therapy, GP should ensure sputum samples from the patient are sent for processing two weeks after patient has completed the three month eradication therapy, and send any further samples for processing if requested to. Patient s role: 1. Report any adverse effects to their GP whilst using Colistin for nebulisation. 2. Ensure they have a clear understanding of their treatment. 3. Correctly store and administer the medicine. EJ29 SHARED CARE GUIDELINE Colistin Page 2 of 6
SPECIAL WARNING/ADVICE TO PATIENT Whilst on treatment, patients should continue with their standard treatments as clinically necessary. Where several different respiratory therapies are used, the following order is recommended: bronchodilator, Dornase alfa (Pulmozyme ) or Sodium Chloride 6% or 7% (Hypertonic Saline), chest physiotherapy, other inhaled medicines, and finally nebulised Colistin. BACK-UP ADVICE AND SUPPORT Papworth Hospital Main Switchboard 01480 830541 Cystic Fibrosis Specialist Nurse ext: 4833 (bleep 446) Lung Defence specialist Nurse ext: 4079/4456 (bleep 685) Dr C Haworth ext: 4656 (bleep 363) Dr. H Barker ext: 4697 (bleep 142) Dr. D Wat ext: 4921 (bleep 864) Pharmacy advice: Pharmacy Medicines Information Service (For Healthcare Professional only) Fax: 01480 364330 01480 364179 (direct line) (Mon-Fri 9am-5pm) Pharmacy Medicines Helpline (answer phone) 01480 364739 (for patients only) (response to queries: Mon-Fri 9am- 5pm) Out of hours, contact the on-call pharmacist via switchboard. Consultant and medical staff are always available to give advice and can be contacted through the main hospital switchboard. SUPPORTING INFORMATION Indications Nebulised Colistin (Colomycin ) is indicated for chronic pulmonary Pseudomonas aeruginosa infection in Cystic fibrosis patients and patients diagnosed with bronchiectasis. It is also indicated for eradication of first pulmonary colonisation with Pseudomonas aeruginosa for a period of three weeks three months (initially with high dose ciprofloxacin). Dosage And Administration Adult Patients Eradication regime Cystic Fibrosis and Bronchiectasis patients: Colistin 1-2 million units nebulised twice daily for three months. Dose should be diluted in Water for injection or Sodium Chloride 0.9% to a volume of between 1ml 4ml dependant on brand and nebuliser system employed. Ciprofloxacin 750mg twice daily is co-administered for three months. EJ29 SHARED CARE GUIDELINE Colistin Page 3 of 6
Adult patients prophylaxis regime Cystic Fibrosis and Bronchiectasis patients: Colistin 1-2 million units nebulised twice daily. Dose should be diluted in Water for injection or Sodium Chloride 0.9% to a volume of between 1ml 4ml dependant on brand and nebuliser system employed. In some patients Colistin is used on an alternate month basis with other nebulised antipseudomal antibiotics eg. nebulised Tobramycin. If this regime is employed it will be communicated to the GP. Nebuliser systems Colistin can be administered through a wide variety of nebuliser systems. Papworth patients on Colomycin branded colistin will usually be using Pari Boy compressors coupled with Pari LC Plus nebuliser systems, or Portaneb compressors with Ventstream nebuliser kits, or Pari e-flow compressor-nebuliser systems. Promixin is exclusively nebulised via an I-neb hand-held nebuliser which is provided by the manufacturer. Ongoing use of the I-neb requires activation discs that are present in each pack of Promixin. Cautions / Contraindications Colistin is contra-indicated in patients with a hypersensitivity to Colistin (colistin / colomycin) or polymyxin B. Contra-indicated in patients with myasthenia gravis. Should be used with extreme caution in patients with porphyria. Colistin crosses the placental barrier and there may be a risk of foetal toxicity if repeated doses are given to pregnant patients. Exposure to pregnant carers during nebulisation should be minimised. Advising patients and carers is the responsibility of the specialist service. Colistin is excreted in breast milk. Use in pregnant or breast-feeding mothers should only proceed if the benefit to the mother outweighs the potential risk to the foetus and infant. Each patient will be individually assessed and informed whether or not to continue treatment. Therapeutic Use Used in the long-term treatment of chronic Ps. aeruginosa infection or also used as part of an eradication regime to treat new Ps. aeruginosa colonisation. Adverse Effects Transpulmonary absorption of Colistin is generally considered to be negligible therefore there is a low risk of systemic toxicity. Nebulised Colistin causes bronchoconstriction in some patients which may lead to discontinuation. This may be relieved in some patients by using an inhaled bronchodilator prior to nebulisation. A full list of undesirable effects, recorded from post-marketing data is available from the Summary of Product Characteristics which can be found at www.medicines.org.uk EJ29 SHARED CARE GUIDELINE Colistin Page 4 of 6
Monitoring Regular monitoring during treatment is essential to detect adverse reactions at an early stage and patients should be counselled about the risk factors and to report all signs and symptoms of toxicity. Through the hospital consultant, regular sputum samples / respiratory function monitoring will take place. Drug Interactions There are no recorded drug interactions when using the nebulised route as transpulmonary absorption of Colistin is generally considered to be negligible. Cost BNF list price (61 st edition) for Colistin (Colomycin ) 2 Million units (2MU) is 3.09 (ex VAT) BNF list price (61 st edition) for Colistin (Promixin ) 1 Million units (1MU) is 4.60 (ex VAT) Therefore: For 3 months of eradication therapy the cost is: 556.20 (ex VAT) (Colomycin ) For Long term prophylaxis taken on a continuous basis for 12 months, the yearly cost for 2 million units twice daily is : 2224.80 (ex VAT) (Colomycin ) (+ 284 414 nebuliser consumables) 3312. (ex VAT) (Promixin ) For 6 months of therapy (when taken in an alternate month basis for long term prophylaxis) the yearly cost is: 1112.40 (ex VAT) (Colistin ) (+ 169 299 nebuliser consumables) 1656 (ex VAT) (Promixin ) Availability Colistin (Colomycin ) 1 million and 2 million unit injections may be obtained on prescription via community pharmacies. Colistin (Promixin ) 1 million units is also available for nebulisation which is delivered exclusively via the I-neb nebuliser device. 1 million units delivered in this way is equivalent to 2 million units of conventional Colistin delivered via other nebulisers. Before nebulising a dose of Colistin, the patient should either inhale or nebulise a dose of a bronchodilator. Each vial of Colistin (Colomycin ) should then be reconstituted with water for injections or sodium chloride 0.9% to an appropriate volume for nebulisation (usually 1 4mls dependent on dose and nebuliser device) References 1. Forest Laboratories UK Ltd Colomycin injection Summary of Product Characteristics. Last updated December 2009 (available from emc website (www.medicines.org.uk) accessed 06/09/11. 2. Profile Pharma Ltd Promixin injection Summary of Product Characteristics. Last updated 15 th June 2011 (available from emc website (www.medicines.org.uk) accessed 21/09/11. EJ29 SHARED CARE GUIDELINE Colistin Page 5 of 6
3. Joint Formulary Committee for the British Medical Association and the Royal Pharmaceutical Society of Great Britain. British National Formulary (BNF). 61st ed. London: BMJ Publishing / RPS Publishing. March 2011. Guidelines: Prepared by: Clare Cox - Cystic Fibrosis Pharmacist and Duncan Grady - Thoracic Directorate Pharmacist in consultation with Dr Haworth 06/2011. Approved by: Thoracic Specialty Management Group: 09/2011 Approved by: Drugs and Therapeutics Committee, Papworth Hospital NHS Foundation Trust, Chairman s action: 03/11/2011. EJ29 SHARED CARE GUIDELINE Colistin Page 6 of 6