Nebulised Colomycin Pseudomonas aeruginosa lung infections in ...

Shared Care Policy for the prescribing of Nebulised Colomycin in thetreatment of Pseudomonas aeruginosa lung infections in Adult patientswith cystic fibrosis and bronchiectasisIntroduction and purposeShared care has been defined as the mechanism of sharing patient carebetween primary and secondary care providers. This document sets out theseresponsibilities from initial diagnosis to on going support.BackgroundPseudomonas aeruginosa is a pathogen that causes severe lung damage inpatients who become colonised and then chronically infected. Patients withCystic Fibrosis and Bronchiectasis are at risk of significant morbidity andmortality from the damage caused by this pathogen. Nebulisedantipseudomonal antibiotic treatment has been shown to improve lungfunction, slow the rate of respiratory decline and reduce the frequency ofexacerbations of infection in these patients. Nebulised antibiotics are able toachieve high local concentrations with low systemic absorption and toxicity asopposed to intravenous antibiotics, where there is high risk of developingadverse effects from systemic absorption.Drug covered by the policy and it’s place in treatmentColomycin is only licensed for the treatment by inhalation of Pseudomonasaeruginosa lung infections in patients with cystic fibrosis (CF). It is alsolicensed for intravenous administration of the treatment of some seriousinfections, caused by gram negative bacteria.This Shared Care Agreement only refers to the treatment of Pseudomonasaeruginosa lung infections for treatment by INHALATION. It also covers theuse of inhaled colomycin for the treatment of infection in patients withBronchiectasis (this is an unlicensed indication but common practice withinthe hospital)Colomycin. The licensed dose for the treatment by inhalation in patients withcystic fibrosis is 2 mega units (2,000,000 units) twice daily.The usual dose prescribed for treatment by inhalation for patients withBronchiectasis is 1 mega unit (1,000,000 units) twice dailyPage 2 of 5

Secondary Care Clinician Responsibilities• Diagnosis of pseudomonas aeruginosa infection in either CF patients orBronchiectasis patients based on a timely and comprehensiveassessment.• Initiation of prescription of colomycin and ensure the first test dose iscarried out before a continuous prescription is supplied• Supplying the initial 28 days treatment• Provision of nebuliser system, and training of patient/carer in the use of thenebuliser system• Monitoring for response and adverse drug reactions (ADRs) during the firsttest dose and the initiation period• Liaison with the general practitioner (GP) to share the patient’s care whenthe test dose has been carried out and proven benefit has beenestablished• Outlining to GP when therapy may be stopped assuming no improvementis recognised in the patient’s condition. Suggest a review of patientscondition and efficacy of treatment 6 months after discharge fromsecondary care, and then annually thereafter, with consideration at eachreview as to whether treatment needs to continue.• Evaluating ADRs raised by the GP and evaluating any concerns arisingfrom physical checks & reviews undertaken by GP.• Advising GP on related issues such as drug interactions etc.• Advising the GP on supply issues related to the prescribing of nebulisedcolomycinGP Responsibilities• Monitoring the patient’s overall health and well being• Observing patient for evidence of ADRs or any abnormalities and raisingwith secondary care clinician if necessary• Prescription of colomycin after achievement of a stable dose regime bysecondary care• Ensuring advice is sought from the secondary care clinician if there is anysignificant change in the patient’s physical health status• Reducing and stopping treatment in line with secondary care cliniciansoriginal requestContact for support and adviceConsultant Respiratory PharmacistAnna MurphyBronchiectasis Specialist NurseKaren PayneCystic Fibrosis Specialist NurseBerni DonaghyConsultant Respiratory PhysiciansDr S Range Prof I Pavord Dr M SteinerProf P Bradding Prof A Wardlaw Dr N KhanDr R Green Dr G Woltmann Dr C BrightlingDr J Bennett Dr M Morgan Dr S AgarwalDr M PeakePage 3 of 5

Supporting informationIndications for Therapy and DosageNebulised Colistin (Colomycin®) is indicated for chronic pulmonary Pseudomonas Aeruginosainfection in Cystic fibrosis patients and patients diagnosed with bronchiectasis. It is alsoindicated for eradication of first pulmonary colonisation with Pseudomonas Aeruginosa for aperiod of three weeks – three months (initially with high dose ciprofloxacin)Cystic Fibrosis Patients Colomycin 2 million units nebulised twice daily for three months(Eradication)Ciprofloxacin 750mg twice daily is co-administeredBronchiectais Patients Colomycin 1 million units nebulised twice daily for three months(Eradication)Ciprofloxacin 750mg twice daily is co-administeredCystic Fibrosis patients – prophylaxis – Colomycin 2 million units nebulised twice dailyBronchiectass patients – prophylaxis – Colomycin 1 million units nebulised twice dailyContra-indications, Precautions and Warnings• Colomycin injection is contra-indicated in patients with a hypersensitivity to colistimethatesodium (colistin / colomycin) or polymyxin B• Also, contra-indicated in patients with myasthenia gravis• Should be used with extreme caution in patients with porphyria• Colistin (colomycin) crosses the placental barrier and there may be a risk of foetal toxicityif repeated doses are given to pregnant patients. Exposure to pregnant carers duringnebulisation should be minimised. Advising patients and carers is the responsibility of thespecialist service• Colistin (colomycin) is excreted in breast milk. It’s use in pregnant or breast-feedingmothers should only proceed if the benefit to the mother outweighs the potential risk tothe foetus and infantMonitoringRegular monitoring during treatment is essential to detect adverse reactions at an early stageand patients should be counselled about the risk factors and to report all signs and symptomsof toxicity. Through the hospital consultant, regular cough swabs / sputum samples /respiratory function monitoring must take placeDrug interactionsAs transpulmonary absorption of colistin is generally considered to be negligible, there are norecorded drug interactions when using the nebulised routePage 4 of 5

Adverse EffectsTranspulmonary absorption of Colistin is generally considered to be negligible therefore, thereis a low risk of systemic toxicity. Nebulised Colistin causes bronchoconstriction in somepatients which may lead to discontinuation. This may be relieved in some patients by using aninhaled bronchodilator prior to nebulisation.Administration and AvailabilityColistin (colomycin®) 1 million and 2 million units injection may be obtained on prescriptionvia the community pharmacist.Before nebulising a dose of Colistin, the patient should either inhale or nebulise a dose of abronchodilator.Each vial of Colistin (colomycin®) should then be reconstituted with water for injections orsodium chloride 0.9% to an appropriate volume for nebulisation (usually 2-4mls)CostA month’s supply of Colistin 1 million units twice daily is £105.40 (excluding diluent)A month’s supply of Colistin 2 million units twice daily is £193.00 (excluding diluent)References1. Summary of Product Characteristics (SPC) – Colomycin Injection ® (Forest Laboratories UKlimited); eMC, revised January 2006,Additional medicines information is available from:Trent Medicines Information CentreVictoria Building, Leicester Royal Infirmary, LE1 5WWTel: 0116 255 5779 / 0116 258 6491Fax: 0116 258 5680Page 5 of 5