PATIENT GROUP DIRECTION (PGD) FOR Amoxicillin … caps.pdf · PATIENT GROUP DIRECTION (PGD) FOR Amoxicillin 500mg Capsules POM Date approved: 29/03/2010 Date of review : 29/03/2011

PATIENT GROUP DIRECTION (PGD) FOR Amoxicillin 500mg Capsules POM

Date approved: 29/03/2010 Date of review : 29/03/2011 Expiry date: 29/03/2012 Ref : AMX_cap_PO_v1.0 Page 1 of 9

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 uncomplicated chest infections (pneumonia and bronchitis)

Treatment of adults and children 12 and over with severe otitis media (systemically unwell)

Inclusion criteria

Adults and Children over 12 years 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 improvement in 48 hours.

Acute exacerbation of COPD – not indicated in the absence of purulent or mucopurulent sputum

Severe otitis media (systemically unwell)

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 Patients who are immunocompromised

Patients on methotrexate – reduced excretion, increasing risk of toxicity

Patients with severe renal impairment i.e. creatinine clearance < 50 mL/minute

Adults presenting with severe signs and symptoms e.g. raised respiratory rate (>=30/min), low blood pressure (systolic <90mgHg +/- diastolic =<60mm Hg), confusion of recent onset.

Patients with underlying chest conditions other than COPD e.g. tuberculosis, acute asthmatic attack, 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

New onset focal neurological signs (suggestive of cerebral abscess)

Signs of raised ICP Cautions/Need for further advice

Generic Cautions with Antibiotic Use.

Patients on Warfarin (advise to see GP at end of course for INR/dose review)

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Patients with renal impairment

Patients whom are pregnant

Patients who are breastfeeding

Patients who are immunocompromised

Specific Advise for Amoxicillin

Patients with cytomegalovirus infection.

Patients with acute or chronic lymphocytic leukaemia

Action if patient declines

or is excluded

Refer to supervising doctor/receiving facility. Document findings and action taken in patient’s record

Drug Details

Name, form & strength of

medicine

Amoxicillin 500mg

Route/Method Oral

Dosage 500mg

Frequency Three times a day

Duration of treatment Pneumonia – 7 days Severe Otitis Media – 5 days

Maximum or minimum

treatment period

Pneumonia – 7 days Severe Otitis Media – 5 days

Quantity to

supply/administer

Pneumonia – 21 Capsules Severe Otitis Media – 21 Capsules (advise patient to discard the extra 6 capsules at end of course)



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

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)

Anticoagulants could cause the prolongation of prothrombin time, careful monitoring is advised. Advise patient that INR may change during treatment.

Probenecid decreases secretion of amoxicillin and could result in prolonged blood levels of amoxicillin

Oral Contraceptive: Reduction in contraceptive effect. Advise patient to use barrier method during and for at least 7 days after treatment has finished

Methotrexate: increased toxicity with amoxicillin 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

Patients taking oral contraceptives or anticoagulants should be given appropriate advice

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 patient to seek further clinical advice.

Where appropriate smokers should be given smoking cessation advice; this includes parents/guardians of children being treated.

Follow up Outcome of any investigation

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



Staff Characteristics

Professional qualifications Ambulance Paramedic with Paramedic Practitioner Qualification

(must have passed minor injury, minor illness and applied

pharmacology module or equivalent qualification).

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

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.

Demonstrates ongoing competency for treating condition indicated for use of each PGD.

Continuing education &

training

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.



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.

Where a new diagnosis of COPD is suspected (“missing millions”

patient – chronic cough, smoker, over 45), liaise with GP.

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)

Document that patient has received the patient advice leaflet

with the medication (where applicable)

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

NICE guidelines COPD (CG12)

http://www.cks.nhs.uk/chest_infections_adult/management/quick_answers/scenario_acute_bronchitis#-295060

http://www.cks.nhs.uk/chest_infections_adult/management/quick_answers/scenario_acute_bronchitis#-295060

http://www.cks.nhs.uk/otitis_media_acute/management/quick_answers/scenario_acute_otitis_media_initial_presentation#-387119





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: Paul Sutton Position: Chief Executive Signature: Date:

Lead Doctor Name: Dr Jane Pateman Position: Medical Director Signature: Date: 25/3/2010

Lead Allied Health Professional

Name: Andy Newton Position: Clinical Director & Consultant Paramedic Signature: Date: 29/3/2010

Lead Pharmacist Name: Ian Bourns Position: Pharmacy Advisor Signature: Date: 29/3/2010

Clinical Governance Lead

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



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

Robert Jennings Paramedic Practitioner September 2009 Sally Hills PP CEM September 2009

Stuart Rutland PP CEM September 2009

Nick Best PP CEM September 2009 Andy Parker PP Coordinator September 2009



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 scope of practice and in accordance with their own Code of Professional

Standards and 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

Documents

PATIENT GROUP DIRECTION (PGD) FOR Amoxicillin … caps.pdf · PATIENT GROUP DIRECTION (PGD) FOR Amoxicillin 500mg Capsules POM Date approved: 29/03/2010 Date of review : 29/03/2011