PGD_No_96v2_Codeine_Phosphate_30mg_Tabs

Patient Group Direction (PGD) for the Supply of: CODEINE PHOSPHATE 30mg TABLETS

Prescription Only Medicine (POM)

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 with actual or Indication Inclusion Criteria

Exclusion Criteria

anticipated post operative pain that requires more than just simple analgesia,(Paracetamol or Ibuprofen), as identified by Podiatric Surgeon.

Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine.

Adults (aged 16 or over) who are identified to require more than simple analgesia, (Paracetamol or Ibuprofen), for actual or anticipated post operative pain.

The medical and drug history has been taken and there is no reason for exclusion.

Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine.

Patients aged under 16 years.

A known hypersensitivity/previous allergy to codeine or other opioids.

A known hypersensitivity to any of the excipients of the tablets to be supplied.

Pregnancy Breast-feeding Hepatic impairment Renal impairment Risk of paralytic ileus Head injury or raised intra-cranial pressure Acute respiratory depression Impaired respiratory function (eg. COPD or acute episode of asthma) Patients with known alcohol dependency or intoxication Current or previous opiate dependency Hypothyroidism Adrenocortial insufficiency Concomitant use of any other opioid analgesics.

Patients taking any of the following: (1) Monoamine oxidase inhibitors (MAOIs) (or have taken MAOIs within the previous 14 days).

(2)Sodium oxybate (3)Moclobemide Please also see Cautions/Need for Further Advice section

Approval Date: 24.4.12

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 1

Cautions/Need for Further Advice

Elderly or debilitated patients – a reduced dose is recommended.

Care should be observed in administering codeine to any patient whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.

Asthma – risk of adverse effect on respiratory funtion Hypotension/shock/myasthenia gravis/cardiac arrhythmias/acute abdomen/gallstones/prostatic hypertrophy/obstructive or inflammatory bowel disorders/disorders of the biliary tract/convulsive disorders – increased likelihood of side-effects/adverse reactions

POTENTIAL DRUG INTERACTIONS This list is not exhaustive. Concurrent medication MUST always be checked for interactions before supply under this PGD Cimetidine – metabolism of opioid analgesics inhibited by cimetidine Domperidone/metoclopramide – opioid analgesics antagonise effects of domperidone/metoclopramide Increased sedative and hypotensive effects may be experienced by coadministration of: Alcohol (avoid concurrent administration) Antidepressants, Tricyclic Antihistamines, Sedating Antipsychotics Anxiolytics & hypnotics (avoid concurrent administration where possible)

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.

Approval Date: 24.4.12

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 2

DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine Route/Method

Codeine Phosphate 30mg tablets

Dosage & Frequency

Adults: ONE to TWO Tablets (30mg to 60mg) every FOUR to SIX hours.

Duration of Treatment Maximum or Minimum Treatment Period Quantity to Supply Licensing Information Side Effects

Oral

MAXIMUM:- 8 TABLETS IN 24 HOURS Up to 7 days after surgery Up to 7 days after surgery 28 tablets.

The product is licensed for the stated indications Opioid analgesics share many side effects. The most common sideeffects include nausea and vomiting (particularly in initial stages), constipation, dry mouth, and biliary spasm; larger doses produce muscle rigidity, hypotension, and respiratory depression. Other common side-effects of opioid analgesics include bradycardia, tachycardia, palpitation, oedema, postural hypotension, hallucinations, vertigo, euphoria, dysphoria, mood changes, dependence, dizziness, confusion, drowsiness, sleep disturbances, headache, sexual dysfunction, difficulty with micturition, urinary retention, ureteric spasm, miosis, visual disturbances, sweating, flushing, rash, urticaria, and pruritus.

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 health professional or the patient.

It is the responsibility of the health professional identifying the ADR to report it.

Approval Date: 24.4.12

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 3

Advice to Patient/Carer

Special Considerations /Addition Information Follow Up

Explain treatment and course of action.

Give the patient a copy of the manufacturer’s patient information leaflet and discuss as required.

Advise patient that tablets may cause drowsiness or dizziness. If affected not to drive or operate machinery.

Avoid alcohol The recommended dose should not be exceeded and that regular dosing is better than ‘now and then’.

If condition worsens or symptoms persist then seek further medical advice Do not take other medication that contains codeine at the same time as this medication Inform patient that if codeine is taken with other medicines that have a sedative effect e.g. sleeping tablets, antidepressants, alcohol etc. then drowsiness is likely to increase Regular or prolonged use of codeine can cause constipation.

Elderly or debilitated patients – a reduced dose is recommended Patient telephoned on the day following surgery.

Review in clinic within 8 days Advise patient to seek further medical advice if: The condition worsens, does not improve, or they have not fully complied with treatment.

They experience any hypersensitivity reaction

REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

Records/Audit Trail

Approval Date: 24.4.12

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 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 and expiry date.

Advice given to patient (including side effects) Date supplied Name and signature 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 Referral arrangements (including self-care) PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 4

STAFF CHARACTERISTICS Qualifications

Specialist Competencies or Qualifications

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).

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 and is competent for working under PGDs for the supply and administration of medicines Has undertaken training and is competent in resuscitation skills.

Has undertaken training and is competent in the recognition and treatment of anaphylaxis.

Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD.

Continuing Training & Education

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.

References & Resources

1. Current edition of the British National Formulary (BNF) Number 62, September 2011 2. Summary of Product Characteristics (SPC) available at: www.medicines.org.uk

This PGD is an updated version of PGD No 96, Codeine Phosphate 30mg Tablets, June 2010. It was updated for use within Locala Community Partnerships by the authors as listed below.

Name

Position

Linda Fox

Community Services Pharmacy Manager

March 2012

Lucianne Ricketts

Head of Medicines Management

March 2012

Dawn Toothill

Specialist Pharmacy Technician

March 2012

Pam Linton

Nurse Team Leader (HVMH Extended Primary Care Services)

January 2012

Stephen Finney

Consultant Podiatric Surgeon

January 2012

Matthew Jaggar

Trainee Podiatric Surgeon

January 2012

Approval Date: 24.4.12

Date

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 5

SECTION

RECORD OF CHANGES MADE TO PREVIOUS VERSION EXPIRED VERSION REVIEWED VERSION

Throughout the PGD Side Effects

Licensing Information Records / Audit trail References

Approval Date: 24.4.12

All references to Kirklees PCT

Now say Locala Community Partnership (LCP) Yellow cards may be completed Yellow cards may be completed by a nurse, pharmacist, the by a health professional or the patient or a doctor patient The product is licensed for the stated indications Batch number, expiry date, Batch number and expiry date manufacturer and brand name Reference to LCD PGD for Removed reference Codeine Phosphate 30mg

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 6

Individual authorisation for the supply of Codeine Phosphate 30mg tablets by appropriately qualified Locala Staff at 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 supply this medicine only in accordance with this PGD. In signing this declaration the healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct Name of Professional Signature Authorising Manager Date

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.

Approval Date: 24.4.12

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 7

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:

Name: Dr Stephen Warner

Signature:

Approval Date: 24.4.12

Date

Date:

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 8

PCT Authorisation ORGANISATION Governance Lead

NHS Kirklees Name: Sue Cannon

Signature: Senior Medicines Management Advisor

Name: Eric Power

Signature: Medical Director

Date:

Name: Dr Matt Walsh

Signature:

Approval Date: 24.4.12

Date

Date:

PGD No 96v2 - Codeine Phosphate 30mg Tablets Review date: 31.5.14 Page 9