Supply of Clarithromycin by Community Pharmacists to Patients with an Exacerbation of COPD Protocol No: 300 Version 2

Transcription

1 Supply of Clarithromycin by Community Pharmacists to Patients with an Exacerbation of COPD Protocol No: 300 Version 2 Date protocol prepared: April 2010 Date protocol due for review: April 2012 This patient group direction must be signed by all health care professionals involved in its use. NHS Forth Valley should hold the original signed copy Organisation NHS Forth Valley Job Title Name Signature Date Director of Nursing Angela Wallace Signed Angela Wallace 4/6/2010 Medical Director Iain Wallace Signed Iain Wallace 8/6/2010 Director of Pharmacy Gail Caldwell Signed Gail Caldwell 19/7/2010 This document authorises the supply of clarithromycin by appropriate practitioners to patients who meet the criteria for inclusion under the terms of the document. Practitioners seeking to supply clarithromycin must ensure that they assess all clients to make sure they meet the criteria before supplying the product. The purpose of this Patient Group Direction is to help patients by ensuring that they have ready access to a quality assured service which provides a timely, consistent and appropriate supply of clarithromycin for an infective exacerbation of COPD.

2 Signatures of those developing the Patient Group Direction Job Title Name Signature Date Doctor Dr. D. Morrison Signed D. Morrison 2/6/2010 Pharmacist Clare Colligan Signed Clare Colligan 2/6/2010 Nurse Microbiologist (if appropriate) Paediatrician (if appropriate) NA Dr. I. King Signed I. King 16/6/2010 NA Approval from Relevant* Advisory Committee/Group Committee/Group Chair Signed on behalf of committee Date Patient Group Directions Group Primary Care D&T Committee Glynis Gordon Signed Glynis Gordon 17/7/2010 Primary Care Prescribing Group Primary Care Out of Hours Clinical Governance Committee Wound Management Group Acute Services D&T Committee Antimicrobial Management Team Dr. L. Cruikshank Signed L. Cruickshank 1/6/2010 Dr. A. Wallace Signed A. Wallace 4/6/2010 *Patient Group Directions Group and Primary Care Prescribing Group for services relating to the Primary Care setting Primary Care D&T Committee for services relating to the Care Groups Primary Care Out Of Hours Clinical Governance Committee for services relating to the Primary Care Out Of Hours service Wound Management Group for PGDs relating to wound management Acute Services Drug and Therapeutics Committee for services relating to the Acute Services Signature of one GP on behalf of Practice OR Head of Service OR Employer to indicate that other professionals may undertake the work within the confines of the Patient Group Direction Name Signature Date U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 2 -

3 The following Patient Group Direction for Supply of clarithromycin by Community Pharmacists to patients with an exacerbation of COPD may be used from the following business/practice: Name: Address: YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION Indication To allow Community Pharmacists to supply clarithromycin to patients with an infective exacerbation of Chronic Obstructive Pulmonary Disease (COPD) who have an allergy to penicillin. Inclusion Criteria Exclusion Criteria Definite diagnosis of COPD Infective exacerbation characterised by development or increase in sputum purulence and one or more of the following - increase in shortness of breath - increase in sputum volume Patient has Forth Valley COPD self-management plan agreed with GP which allows for treatment from Community Pharmacist 1. Know allergy to clarithromycin 2. Pregnancy 3. Breast Feeding 4. Patients receiving treatment with cisapride, terfenadine, pimozide, colchicine, quinidine, disopyramide, rifabutin, reboxetine, sertindole, verapamil, ciclosporin, eplerenone, eletriptan, sirolimus, tacrolimus, ritonovir or ergot derivatives. 5. Course of antibiotics within the last month with no resolution of symptoms 6. More than 2 supplies by community pharmacist in any 3 month period. 7. Patient does not have Forth Valley COPD self-management plan at time of presentation Caution/ Need for further advice Warfarin therapy Advise patient to contact GP Practice as soon as practical to arrange to have INR checked Statin therapy advise patients on simvastatin or atorvastatin (>20mg) to stop this while taking clarithromycin Theophylline therapy advise patient to half the dose of theophylline while taking clarithromycin Action if Patient declines or is excluded Refer patient to GP or Out of Hours via Professional to Professional Line U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 3 -

4 DRUG DETAILS Name, form & strength of medicine Legal Status Route/ Method Dosage Frequency Duration of treatment Maximum or minimum treatment period Quantity to Supply/ administer Side Effects Clarithromycin 500mg tablets POM Oral 500mg Twice a day 5 days 10 Clarithromycin is generally well tolerated. Side effects include nausea, dyspepsia, diarrhoea, vomiting, abdominal pain and paraesthesia. Stomatitis, glossitis, oral monilia and tongue discolouration have been reported. Other side-effects include headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis have been reported. There have been reports of Stevens-Johnson syndrome / toxic epidermal necrolysis with orally administered clarithromycin. Reports of alteration of the sense of smell, usually in conjunction with taste perversion have also been received. There have been reports of tooth discolouration in patients treated with clarithromycin. Tooth discolouration is usually reversible with professional dental cleaning. There have been reports of transient central nervous system sideeffects including dizziness, vertigo, anxiety, insomnia, bad dreams, tinnitus, confusion, disorientation, hallucinations, psychosis and depersonalisation.there have been reports of hearing loss with clarithromycin which is usually reversible on withdrawal of therapy. Pseudomembranous colitis has been reported rarely with clarithromycin, and may range in severity from mild to life threatening. There have been rare reports of hypoglycaemia, some of which have occurred in patients on concomitant oral hypoglycaemic agents or insulin. There have been very rare reports of uveitis mainly in patients treated with concomitant rifabutin, most of these were reversible. Isolated cases of leukopenia andthrombocytopenia have been reported. As with other macrolides, hepatic dysfunction (which is usually reversible) including altered liver function tests, hepatitis and cholestasis with or without jaundice, has been reported. Dysfunction may be severe and very rarely fatal hepatic failure has been reported. Cases of increased serum creatinine, interstitial nephritis, renal failure, pancreatitis and convulsions have been reported rarely. U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 4 -

5 As with other macrolides, QT prolongation, ventricular tachycardia and Torsade de Pointes have been rarely reported with clarithromycin. There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients For a full list of side effects refer to Summary of Product Characteristics. A copy of this must be available to the health professional administering medication under this Patient Group Direction This can be accessed at Advise patient to contact GP or Community Pharmacist if they experience any adverse effects. Interactions All adverse reactions should be reported to the MHRA through the Yellow Card Scheme GP will be informed that patient has been given clarithromycin and has agreed in advance that patient in suitable for PGD. Clarithromycin has been shown not to interact with oral contraceptives. As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system (eg., oral anticoagulants (eg warfarin), phenytoin and valproate) may be associated with elevations in serum levels of these other drugs. Clarithromycin may potentiate the effects of carbamazepine due to a reduction in the rate of excretion. Rhabdomyolysis, co-incident with the co- administration of clarithromycin, and HMG-CoA reductase inhibitors, such as lovastatin and simvastatin has been reported. See Exclusion criteria and cautions The administration of clarithromycin to patients who are receiving theophylline has been associated with an increase in serum theophylline levels and potential theophylline toxicity. See Cautions The use of clarithromycin in patients receiving warfarin may result in potentiation of the effects of warfarin. Prothrombin time should be frequently monitored in these patients. See Cautions Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV infected adult patients may result in decreased steady-state zidovudine levels. This can be largely avoided by staggering the doses of Clarithromycin and zidovudine by 1-2 hours. U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 5 -

6 Advice to patient/carer Inform patients of possible side effects and their management. The Drug Manufacturer Patient Information Leaflet should be given. Also- see caution/need for further advice section. Follow up Patients not improving after a few days of starting antibiotic course or if any deterioration should be advised to contact GP or OOH service. STAFF CHARACTERISTICS Qualifications Specialist competencies or Qualifications MRPharmS Attendance at local training sessions on COPD Completion of NES Pharmacy Pack Pharmaceutical Care of people with COPD 2007 or Chronic Respiratory Disorders Continuing Training & Education Up to date knowledge in therapeutic area REFERRAL ARRANGEMENTS & AUDIT TRAIL Referral arrangements Patients who are not improving or feel their condition is getting worse should seek urgent treatment from their GP or through NHS24 out of hours Records/audit trail Record of supply must be made on the PMR and in the patient s self-management card. This should include the date of supply, the dosing instructions and the advice given re side effects and follow up. The record on the PMR should include the name of the pharmacist making the supply and criteria satisfied for supply i.e. presenting symptoms A computer or manual record of all patients receiving clarithromycin through this PGD must be kept for audit purposes. Reference sources and comments The patient s GP must be made aware of the supply within 72 hours of supply being made using the agreed pro-forma. 1. Chronic Obstructive Pulmonary Disease. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax.March 2004 (Volume 59, Supplement 1). 2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management and Prevention of COPD ( 3. BNF Current Edition 4. Summary of product characteristics 5. MHRA. Drug safety update Vol 1. Issue 6. U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 6 -

7 PATIENT GROUP DIRECTION AUTHORISATION DOCUMENT Patient Group Direction for Supply of clarithromycin by Community Pharmacists to Patients with an Exacerbation of COPD Protocol No. 300 version 2 Name of Premises Address of Premises PROFESSIONAL AGREEMENT I have read and confirm that I have understood the above named protocol. I confirm that I have the necessary competency and training. A copy of the protocol is available in the clinical situation in which the supply or administration will occur. Name of Professional Job Title Signature Date The above people have been authorised to use this protocol Signature of CHP Nurse Advisor/ Clinical Nurse Manager/ GP (for Practice Nurses) Professional Lead for PGDs pertaining to other professions Name Signature Date U:\share_data\PGDs\Community Pharmacy\clarithromycin\2010\pgdclarithromycin final.doc - 7 -