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Patient Group Direction (PGD) for the Supply/Administration of:

Pharmacy Medicine PARACETAMOL TABLETS/CAPLETS 500mg (P) YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Adults attending the Holme Valley Podiatric Surgery Unit, identified by Indications the Podiatric surgeon as needing treatment for actual or anticipated mild to moderate post operative pain.

Inclusion Criteria

Adults identified as needing treatment for actual or anticipated mild to moderate post operative pain. Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply supply/administration of the medicine. The medical and drug history has been taken and there is no reason for exclusion.

Exclusion Criteria

Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) for the supply/administration of the medicine Pregnancy and breastfeeding Patients with a known hypersensitivity to paracetamol or any of the other excipients of the tablets or capsules. Liver or kidney impairment Alcohol dependency Please also see Cautions/Need for Further Advice section.

Cautions/Need for Further Advice

. POTENTIAL DRUG INTERACTIONS: The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone. Absorption may be reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increased risk of bleeding; occasional doses have no significant effect. Advisable to check INR if patient is to continue taking paracetamol for more than 5 days Concurrent medication MUST always be checked for interactions before supply under the PGD.

OTHER CAUTIONS: The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Acute alchohol intake may diminish an individual’s ability to metabolise large doses of Paracetamol, the plasma half- life of which can be prolonged.

PGD No 87 v2 - Paracetamol 500mg Tablets/Caplets Approval Date 16.2.2012 Review Date: 31.5.2014 Page 1


Action if Patient Declines or is Excluded

Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record. Give information about risks of infection and benefits of treatment (where appropriate). Give information about how to recognise signs and symptoms of infection (where appropriate). Give information about when the medicine may be given.

DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine

Paracetamol 500mg Tablets OR Paracetamol 500mg Caplets

Route/Method

Oral

Dosage & Frequency

ONE to TWO tablets (500mg to 1g) every FOUR to SIX hours when required. MAXIMUM: 8 tablets in 24 hours.

Duration of Treatment

As required for symptom relief

Maximum or Minimum Treatment Period Quantity to Supply/Administer

Up to 7 days after surgery if required.

Licensing Information

The product is licensed for the stated indications

1 x 32 supply of tablets/caplets

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Side-effects are rare. Very rarely hypersensitivity and anaphylactic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocystosis, but these were not necessarily casually related to paracetamol.

Side Effects

This list is not exhaustive. Please refer to current BNF and product SPC for full details. Report all serious suspected adverse reactions (ADRs) in adults, and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a nurse, pharmacist, healthcare professional, the patient or a doctor. It is the responsibility of the health professional identifying the ADR to report it.

Additional Facilities Advice to Patient/Carer/ Parent/Guardian

None Explain treatment and course of action Give patient a copy of the manufacturer’s patient information leaflet and any other relevant patient information leaflets where available. Advise patient not to exceed the stated dose as liver and less frequently kidney damage can occur. Advise not to take more than 4 doses in 24 hours. Do not take any other medication that contains paracetamol whilst taking this medication. Immediate medical advice should be sought in the event of an overdose, even if the child seems well because of the risk of delayed, serious liver damage. Advise that regular dosing is better than ‘now and then’. Paracetamol can be taken with Ibuprofen (which is an alternative painkiller as long as this is not contra indicated). If condition worsens or symptoms persist then seek further medical advice. Advise not to drink large amounts of alcohol.

Follow Up Advise patient to seek further medical advice if: The condition worsens or does not improve. They experience any hypersensitivity reaction Patient to be telephoned on the day following surgery. To be reviewed in clinic within 8 days.

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REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

Referral arrangements (including self-care) to be documented in patients notes. If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct or A&E for further assessment and advice.

Records/Audit Trail

The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose supplied and route Batch number, expiry date, Advice given to patient (including side effects) Date supplied Name of staff who supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient’s medical record. Current medication Known allergies Diagnosis

STAFF CHARACTERISTICS Qualifications

Registered general nurse with current registration working within Locala Podiatric surgery unit Registered professional who is either a State Registered Podiatrist undergoing a surgical fellowship training programme approved by the College of Podiatrists or a Fellow of The College of Podiatrists (Faculty of Surgery)

Specialist Training or Qualifications

Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent in working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates Has undertaken training appropriate to this PGD

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Continuing Training & Education

References & Resources

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 their scope of practice. Practitioner should have access to current BNF and updated DH advice where appropriate. Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation. Keeps undated via departmental updates and meetings British National Formulary (BNF) No62, September 2011 Summary of Product Characteristics (SPC) available at: www.medicines.org.uk Patient Information Leaflet (PIL) available at: www.medicines.org.uk

This PGD is an amended version of PGD No 87 Paracetamol 500mg Tablets/Caplets produced in February 2010 It was updated for use within Locala Community Partnerships by the authors as listed below

Name

Position

Date

Dawn Toothill

Specialist Technician, Community Services

February 2012

Linda Fox

Community Pharmacy Services Manager

February 2012

Lucianne Ricketts

Head of Medicines Management

Stephen Finney

Podiatric surgeon

Pam Linton

Nurse Team Leader

February 2012 February 2012 February 2012

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health (if this is applicable) This will result in an unlicensed use of a licensed product following current DH guidance.

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REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 87 SECTION Throughout the PGD

CHANGES MADE All references to Walk in centre staff have been removed as due to their relocation they will be the adopting Mid Yorkshire Hospital Trust PGD following expiration of PGD 87.

Advice to patient

Deleted – Dosage should not be continued for more than three days without consulting your doctor. As 4 days supply is given by unit and patients asked to contact unit with any problems.

Record/audit trail

Deleted - manufacturer and supplier as logging batch number and expiry date are sufficient. All stock received from PMU

Qualification

Added - Registered general nurse with current registration working within Locala Podiatric surgery unit

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Individual Authorisation for the Supply/Administration of Paracetamol 500mg tablets/caplets by: Appropriately qualified staff working in Holme Valley Podiatric Surgery Unit 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 I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the registered health care professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct. Name of Professional Signature Authorising Manager and Date signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Locala staff this will be the team leader, or relevant clinical manager. Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.

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Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.

ORGANISATION Director of Clinical and Operational Services

Locala Community Partnership Name : Christina Quinn

Signature: Head of Medicines Management

Name: Lucianne Ricketts

Signature: Medical Lead

Date

Date:

Name: Dr Stephen Warner

Signature:

PCT Authorisation ORGANISATION Director of Patient Care and professions

NHS Kirklees Name : Sheila Dilks

Signature: Senior Medicines Management Advisor

Date

Name: Eric Power

Signature: Medical Director

Date:

Date:

Name: Jim Lee

Signature:

Date:

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