Antibiotic Oral (tablet/capsule/suspension) PATIENT GROUP DIRECTION (PGD) FOR YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Caution: This drug is also available in a different presentation or dose. Please ensure this is the correct PGD prior to administration Clinical Condition Indication Treatment of children between 5 years and 11 years 11 months with uncomplicated chest infections. Treatment of children between 5 years and 11 years 11 months with severe otitis media (systemically unwell) Inclusion criteria Children between 5 years and 11 years 11 months of age presenting with signs and symptoms of: Community-acquired pneumonia start antibiotics immediately. Advise to call GP for advice or attend local A&E if no response in 48 hours. Acute exacerbation of COPD not indicated in the absence of purulent or mucoprurulent sputum Severe otitis media, associated with pyrexia. Inclusion must also be in accordance with local or national guidance for the diagnosis and treatment of chest infections requiring an oral antibiotic. This should also include local resistance patterns and prescribing policies in consultation with a microbiologist. Exclusion criteria Any convulsion, regardless of suspected aetiology. Cautions/Need for further advice Patients who are immunocompromised Patients on methotrexate reduced excretion, increasing risk of toxicity Patients with renal impairment. Children presenting with severe signs and symptoms e.g. raised respiratory rate (infants > 70 breaths /min and older children >50 breaths/min), intermittent apnoea, not feeding. Patients with underlying chest conditions e.g. tuberculosis, asthma, lung cancer, bronchiectasis Known hypersensitivity to penicillin or other beta-lactam antibiotics e.g. cephalosporins such as rashes and/or anaphylaxis Known previous penicillin-induced cholestatic jaundice or hepatitis Patients with suspected glandular fever increased risk of erythematous rash Children on anticoagulants or cytotoxic agents (for congential heart disease or cancers) Generic Cautions with Antibiotic Use. Patients on Warfarin (advise to see GP at end of course for INR/dose review) Ref : AMX_susp_PO_v1.0 Page 1 of 9
Patients with renal impairment Patients who are immunocompromised Action if patient declines or is excluded Drug Details Name, form & strength of medicine Route/Method Dosage Frequency Duration of treatment Maximum or minimum treatment period Quantity to supply/administer Specific Advise for Amoxicillin Patients with cytomegalovirus infection. Patients with acute or chronic lymphocytic leukaemia Refer to supervising doctor/receiving facility. Document findings and action taken in patient s record Oral Children between 5 years and 11 year 11 months 500mg TDS (2 x 5ml spoonfuls three times a day) Three times a day 7 days 7 days Sufficient bottles to complete the course of treatment Ref : AMX_susp_PO_v1.0 Page 2 of 9
Side effects Side effects are uncommon and are mainly mild and transitory: If hypersensitivity reaction occurs, discontinue treatment Rash (usually 7 10 days after first dose), pruritis and urticaria have been reported occasionally Superficial tooth discolouration has been reported with the suspension. It can be removed by brushing. Diarrhoea, vomiting and diarrhoea may occur Dizziness, convulsions and hyperkinesias have rarely been reported Potential drug interactions: (some centres may wish to exclude such patients from care under PGD for local decision) Probenecid decreases secretion of amoxicillin and could result in prolonged blood levels of amoxicillin Oral Contraceptive: Reduction in contraceptive effect. Avise patient to use barrier method dueing and for at least 7 days after treatment has finished Potential adverse drug reactions: Antibiotic associated colitis Interstitial nephritis Hypersensitivity reactions including urticarial and maculopapular rashes, angioedema and anaphylaxis Please refer to SPC or current BNF full details. Use the Yellow Card System to report adverse drug reactions directly to the CSM. Guidance on its use is available at the back of the BNF or can be accessed via the CSM website Advice to patient/carer Explain treatment and course of action. Give the patient a copy of the manufacturer s patient information leaflet and discuss as required. Advise to take at regular intervals and to complete the course If patient develops an adverse drug reaction (see above) they should stop treatment immediately and seek further medical advice. If patient experiences mucosal Candida infections (thrush) during or after treatment. Advise patient to see their pharmacist or GP Advise rest and to drink several glasses of water a day during treatment to prevent crystalluria, unless they have been told otherwise. Paracetamol can be taken together with amoxicillin to control fever. If symptoms do not improve or get worse over 48 hours, advise Ref : AMX_susp_PO_v1.0 Page 3 of 9
patient to seek further clinical advice. Where appropriate smokers within the family of the child should be given smoking cessation advice; this includes parents/guardians of children being treated. Follow up For at risk patients, it may be an appropriate time to consider vaccination against influenza and pneumococcus patient may require follow up by local health centre or GP Ref : AMX_susp_PO_v1.0 Page 4 of 9
Staff Characteristics Professional qualifications Ambulance Paramedic with Paramedic Practitioner Qualification (must have passed minor injury, minor illness and applied pharmacology module) Registered Nurse with current Nursing and Midwifery Council (NMC) registration and on SECAmb paramedic practitioner pathway (must have passed minor injury, minor illness and applied pharmacology module). Specialist competencies or qualifications Continuing education & training Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD Has undertaken appropriate training for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD e.g. understanding concepts of antimicrobial resistance and appropriate use of antimicrobials The practitioner should be aware of any change to the recommendations for 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 of practice. Consider discussing with your PP CEM or GP mentor if you have concerns over your ongoing competency. Ref : AMX_susp_PO_v1.0 Page 5 of 9
Referral Arrangements and Audit Trail Referral arrangements Instruct patient and/or carer to seek advice in the event of condition worsening. For COPD patients, ensure that the patients GP and/or Respiratory Team are notified. Records/audit trail Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis or working diagnosis Dose and form supplied Batch and expiry details Duration of antibiotic treatment given Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Referral arrangements (including self-care) References/Resources and comments British National Formulary 57 Clinical Knowledge Summaries http://www.cks.nhs.uk/chest_infections_adult/management/ quick_answers/scenario_acute_bronchitis#-295060 Clinical Knowledge Summaries http://www.cks.nhs.uk/otitis_media_acute/management/qui ck_answers/scenario_acute_otitis_media_initial_presentation #-387119 Clinical Knowledge Summaries http://www.cks.nhs.uk/cough_acute_with_chest_signs_in_ch ildren/management/quick_answers/scenario_community_ac quired_pneumonia#293675006 NICE guidelines COPD (CG12) Ref : AMX_susp_PO_v1.0 Page 6 of 9
This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting Organisation South East Coast Ambulance Service NHS Trust Ambulance Headquarters The Horseshoe Banstead, Surrey, SM7 2AS Authorisation Organisational authorisation by Name: Position: Paul Sutton Chief Executive Signature: Lead Doctor Name: Dr Jane Pateman Position: Medical Director Date: Lead Allied Health Professional Signature: Date: 25/3/2010 Name: Andy Newton Position: Clinical Director & Consultant Paramedic Signature: Date: 29/3/2010 Lead Pharmacist Name: Ian Bourns Position: Pharmacy Advisor Clinical Governance Lead Signature: Date: 29/3/2010 Name: Nicola Brooks Position: Assistant Clinical Director (Governance) Signature: Date: 25/3/2010 PGD Authored by Name: Andy Collen Position: Head of Programmes & Planning Signature: Date: 25/3/2010 Ref : AMX_susp_PO_v1.0 Page 7 of 9
Patient Group Direction Peer Reviewed by Name Position Date Andy Collen Head of Programmes and Planning August 2009 Andy Newton Clinical Director August 2009 Jane Pateman Medical Director August 2009 Nicola Brookes Assistant Clinical Director August 2009 Kalvinder Gahir Trust Pharmacist August 2009 Ref : AMX_susp_PO_v1.0 Page 8 of 9
Individual Authorisation PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Authorising Manager Date Ref : AMX_susp_PO_v1.0 Page 9 of 9