Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

Version Control This PGD has been  FCMS agreed by the following  PDS Medical organisations  Doncaster CCG  East Lancashire CCG Change history 28/08/17 V02 Review. Adjusted dose and duration to match local guidance. Minor editing changes. 18/09/17 V02 Adjust inclusion criteria to match local guidance. 21/09/17 V02 Adjustments to treatment duration to match local guidance. 29/05/2019 V03 Revalidated

30/05/2019 Page 1 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

CLINICAL CONTENT OF PATIENT GROUP DIRECTION

Staff Characteristics Qualifications Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Specialist competencies  Received training to undertake administration and supply of medicines or qualifications under PGD.  Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. Continuing training and The practitioner should be aware of any change to the recommendations for education the medicine listed. It is the responsibility of the individual to keep up to date with continued professional development and to work within the limitations of individual scope or practice.

Clinical Details Indication  Treatment of skin, soft tissue or wound infections, acute bronchitis, community acquired pneumonia or exacerbations of COPD.  Antibiotic alternative for patients hypersensitive to penicillins or cephalosporins or where these are unsuitable. Inclusion criteria Patients with skin, soft tissue or wound infections:  Consider whether wound infections are clinically necessary to treat.

Patients with acute bronchitis:  Antibiotics are not routinely indicated in people who are otherwise well.  Symptom resolution can take 3 weeks.  Offer immediate antibiotics for: o People with features of pneumonia.  Consider immediate antibiotics for people: o At high risk of serious complications because of pre-existing comorbidity. This includes patients with significant heart, lung, renal, liver or neuromuscular disease, or cystic fibrosis. o Older than 65 years with acute cough and two or more of the following, or older than 80 years with acute cough and one or more of the following: . Hospitalisation in previous year. . Type 1 or type 2 diabetes. . History of congestive heart failure. . Current use of oral glucocorticoids.

Patients with community acquired pneumonia:  Offer immediate antibiotic treatment and consider whether can be managed safely in primary care (use CRB-65 score to guide). 30/05/2019 Page 2 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

Patients with infective exacerbations of COPD/ asthma:  Treat exacerbations promptly with antibiotics if purulent sputum and increased shortness of breath and/or increased sputum volume, or  Clinical signs of pneumonia.  Check previous results of sputum culture contact microbiologist if failure to respond / resistant pathogens. Exclusion criteria  Hypersensitivity to clarithromycin, macrolide antibiotics or any component of the product (see packaging).  Pregnancy or breast feeding.  Patients with myasthenia gravis.  Patients known to have a prolonged QT interval, history of ventricular cardiac arrhythmia or bradycardia <50 beats per minute.  Patients taking any of the following drugs: alprazolam, aminoglycosides e.g. gentamicin, aminophylline, amlodipine and other non- dihydropyridine calcium channel blockers, artemether with lumafantrine, astemizole, atazanavir, avanafil, axitinib, bosutinib, cabazitaxel, carbamazepine, cilostazol, cisapride, colchicine, ciclosporin, crizotinib, dabigatran, dapoxetine, digoxin, dihydroergotamine, diltiazem, disopyramide, domperidone, dronedarone, droperidol, efavirenz, eletriptan, eplerenone, ergot alkaloids, ergotamine, etravirine, everolimus, fesoterodine, fidaxomicin, fluconazole, itraconazole, ivabradine, ivacaftor, lenalidomide, lomitapide, maraviroc, methylprednisolone, midazolam, mirabegron, mizolastine, nevirapine, nilotinib, omeprazole, pazopanib, phenobarbital, phenytoin, pimozide, piperaquine with artenimol, quetiapine, quinidine, ranolazine, reboxetine, rifabutin, rifampicin, rifapentine, rilpivirine, ritonavir, ruxolitinib, saquinavir, sirolimus, St John’s wort, tacrolimus, telaprevir, terfenadine, theophylline, ticagrelor, tipranivir, tolterodine, trazodone, triazolam, ulipristal, valproate, verapamil, vinblastine, vinorelbine, zidovudine.  Patients with known electrolyte disturbances, e.g. hypokalaemia.  Patients with severe cardiac disease.  Patients with severe hepatic impairment.  Patients with severe renal impairment (chronic kidney disease stages 4 or 5, or creatinine clearance / eGFR <30 ml/minute).  Patients with porphyria.  Systemically unwell.  Those with signs of serious complications.

Additional exclusions for skin, soft tissue or wound infections:  Children under the age of 1 year.

30/05/2019 Page 3 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

Additional exclusions for acute bronchitis, community acquired pneumonia and exacerbations of COPD:  Children under the age of 16 years.

PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions  Patients taking hypoglycaemic drugs, e.g. insulins, sulphonylureas, meglitinides: risk of hypoglycaemia.  Patients taking atorvastatin, pravastatin, lovastatin, simvastatin: risk of myopathy – withhold statin during treatment.  Patients taking sildenafil, tadalafil, vardenafil: increased levels – withhold during use of clarithromycin.  Patients on coumarin anticoagulants, e.g. warfarin, will need an INR check within 7 days.  Patients on bromocriptine or cabergoline: increased levels – monitor for any adverse effects.  Recent administration of oral typhoid vaccine (vaccine may be inactivated and become ineffective). Management of  Discuss with GP or Clinical Lead or refer. excluded patients Action for patients not  Make patient aware of risks and potential consequences of not taking wishing / unable to medicine. receive care under this  Discuss alternative options with GP or Clinical Lead. PGD  Discuss with the patient any alternatives if available.  Document discussion with patient.

Description of Treatment Name of medicine Clarithromycin Formulation and route Tablets 250mg and 500mg Oral suspension 125mg/5ml or 250mg/5ml Strength See above Dosage Adults:  250mg twice daily increased to 500mg twice daily in pneumonias or severe infections  Select dose consistent with local antimicrobial guidelines

Children:  Children under 12 years, dose by bodyweight: o Under 8kg = 7.5mg/kg twice daily o 8kg to 11kg = 62.5mg twice daily (2.5ml of 125mg/5ml) o 12kg to 19kg = 125mg twice daily (5ml of 125mg/5ml) o 20kg to 29kg = 187.5mg twice daily (7.5ml of 125mg/5ml) o 30kg to 40kg= 250mg twice daily (5ml of 250mg/5ml) 30/05/2019 Page 4 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

 Children 12 years and over: as adults above  Select dose consistent with local antimicrobial guidelines

Repeated dose See above instructions Duration of treatment Skin, soft tissue or wound infections: 7-14 days

Acute bronchitis: 5 days treatment. Acute exacerbation of COPD/asthma: 5 days. Community acquired pneumonia (CRB-65=0): initially 5 days (review at day 3 and consider extending to 7-10 days if poor response). Community acquired pneumonia (CRB-65=1-2 and being managed at home): 7-10 days (also issue with amoxicillin or doxycycline as per local guidance). Quantity to supply Tablets prepacked box of 14 sufficient to meet needs of course (10, 14, 20 or 28 tablets). Oral suspension in multiples of 70/100ml as needed to complete course. Legal status POM Special precautions Explain indications, contraindications and cautions (refer BNF) Adverse effects  Nausea, vomiting, abdominal discomfort, diarrhoea, rashes, tooth and tongue discolouration, smell and taste disturbance, stomatitis, glossitis, headache.  Less common arthralgia and myalgia.

This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary  Provide the patient with the manufacturer’s Patient Information Leaflet.  Advise on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance.  Advise on storage or expiry details and to dispose of any unused medicines appropriately.  Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate), such as. For sinusitis:  Topical nasal decongestants may help if congestion is problematic, but maximum 3 – 5 days use to avoid rebound symptoms.  Nasal irrigation with saline solution.  Warm face packs. For exacerbations of COPD:  Increase the use of short-acting bronchodilators.  Review the need for oral corticosteroids.  Adequate fluids and rest.  Make patient aware of potential adverse effects and the action to take if 30/05/2019 Page 5 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

they occur.  Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur.  Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors.  Provide any advice relevant to the patient from the Precautions section above.  Complete the prescribed course. Prescribing guidance  Doncaster & Bassetlaw antimicrobial guidelines.  Relevant NICE guidelines and advice from Clinical Knowledge Summaries.  Public Health England guidance on primary care management of infection.

Records and Follow Up Referral arrangements  Inform GP as soon as possible.  Advise if worsening or no improvement to seek further medical advice. Records to be kept  Patient’s name, address, date of birth and consent given.  Contact details of GP (if registered).  Diagnosis.  Dose and form administered.  Batch and expiry details.  Advice given to patient (including side effects).  Signature / name of staff who administered or supplied the medication.  If relevant, signature / name of staff who removed / discontinued the treatment.  Details of any adverse drug reaction and actions taken, including documentation in the patient’s medical record.  Referral arrangements (including self-care).  Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF. Follow up  Advise follow up with GP/ Practice nurse.

Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction.

30/05/2019 Page 6 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION

Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW

Patient Group Direction Authorisation Clinical Governance GP

Dr Andrew Oakford Lead Pharmacist

Magnus Hird Lead Practitioner

Andrew Shakesby Organisational Authorisation for FCMS

Tracey Edwards Organisational Authorisation for East Lancashire CCG

Patient Group Direction Peer Review Reviewed by

Wendy Lambert, Nurse Practitioner 30/05/2019 Page 7 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

30/05/2019 Page 8 of 9

Patient Group Direction for CLARITHROMYCIN (Version 03) Valid From 1 October 2019 – 30 September 2021

Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date

30/05/2019 Page 9 of 9