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Patient Group Direction (PGD) for the Supply/Administration of: ENOXAPARIN 20mg SUBCUTANEOUS INJECTION

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 Prophylactic anticoagulation for at risk adult patients undergoing Podiatric Indication Surgery at Holme Valley Podiatric Surgery Unit, who are deemed to be at increased risk of post-operative venous thromboembolism as identified by the Podiatric Surgeon.

Inclusion Criteria

Informed consent has been given in accordance with current PCT guidelines for the supply/administration of the medicine. Adult patients requiring prophylactic anticoagulation in accordance with NICE Clinical Guideline 92, Venous Thromboembolism (VTE): Reducing the Risk (issue date, January 2010) and local policy on VTE prevention.

Exclusion Criteria

Informed consent has NOT been given in accordance with current PCT guidelines for the supply of the medicine. Patients aged under 16 years. Hypersensitivity to either enoxaparin, heparin, or its derivatives, including other low molecular weight heparins. Breast feeding Acute bacterial endocarditis Active major bleeding Major bleeding disorders Thrombocytopenia in patients with a positive in-vitro aggregation test in the presence of enoxaparin. Patients with a history of heparin-induced thrombocytopenia with or without thrombosis. Active gastric or duodenal ulceration Recent haemorrhagic stroke Other patients with an increased risk of haemorrhage. Severe hypertension Severe liver disease (including oesophageal varices). Renal failure* Patients receiving heparin or other low molecular weight heparins for treatment. Concurrent use of warfarin or any other oral anticoagulant known to increase the risk of bleeding. * Renal failure refers to an estimated glomerular filtration rate (eGFR) of less 2 than 30ml/min/1.73m (NICE)

Please also see Cautions/Need for Further Advice section

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 1


Cautions/Need for Further Advice

Placement or removal of a catheter should be delayed for 10 - 12 hours after administration of DVT prophylactic doses of enoxaparin sodium. Hyperkalaemia â&#x20AC;&#x201C; inhibition of aldosterone secretion by heparin (including low molecular weight heparins) can result in hyperkalaemia; patients with diabetes mellitus, chronic renal failure, acidosis, raised plasma potassium or those taking potassium-sparing drugs seem to be more susceptible. The risk appears to increase with duration of therapy and the CSM has recommended that plasma-potassium concentration should be measured in patients at risk of hyperkalaemia before starting heparin and monitored regularly thereafter, particularly if heparin is to be continued for longer than 7 days. Heparin-induced thrombocytopenia - clinically important heparin-induced thrombocytopenia is immune-mediated and does not usually develop until after 5â&#x20AC;&#x201C;10 days; it can be complicated by thrombosis. Platelet counts should be measured just before treatment with heparin or low molecular weight heparins, and regular monitoring of platelet counts is recommended if given for longer than 4 days. Signs of heparin-induced thrombocytopenia include a 50% reduction of platelet count, thrombosis, or skin allergy. If heparin-induced thrombocytopenia is strongly suspected or confirmed, enoxaparin treatment must be immediately discontinued and the patient switched to another therapy. Renal Impairment - In patients with renal impairment, there is an increase in enoxaparin exposure which increases the risk of bleeding. Careful clinical monitoring is advised. Enoxaparin injection, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: impaired haemostasis, history of peptic ulcer, recent ischaemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery. In low weight women (< 45kg) and low weight men (< 57kg), an increase in enoxaparin exposure has been observed within the prophylactic dosage ranges (non-weight adjusted), which may lead to a higher risk of bleeding. Therefore careful clinical monitoring is advised in these patients. This drug should not be used in pregnant patients unless no safer alternative is available. Pharmacological VTE prophylaxis should only be offered after assessing the risks and benefits and discussing these with the woman and healthcare professionals who have knowledge of using enoxaparin during pregnancy. Concomitant use of drugs that increase risk of bleeding (see potential drug interactions).

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 2


POTENTIAL DRUG INTERACTIONS This list is not exhaustive. Concurrent medication MUST always be checked for interactions before supply under this PGD It is recommended that agents which affect haemostatis should be discontinued prior to enoxaparin therapy unless their use is essential. Such drugs include: aspirin, NSAIDs (including ketorolac, clopidogrel, systemic glucocorticoids, thrombolytics and warfarin (or other anticoagulants). If the combination cannot be avoided, enoxaparin should be used with careful clinical and laboratory monitoring. Enoxaparin has no specific interaction information listed in the BNF but belongs to Heparins and will have the following interactions: Anticoagulant effect of heparins enhanced by aspirin, dipyridamole, and iloprost (possibly). Increased risk of bleeding when heparins given with clopidogrel or NSAIDs. Increased risk of haemorrhage when heparins given with ketorolac avoid concomitant use. Increased risk of hyperkalaemia when heparins given with ACE inhibitors or aliskiren. Enoxaparin belongs to anticoagulants and will have the following interactions:

Action if Patient Declines or is Excluded

Increased risk of bleeding when anticoagulants given with sibutramine Refer to consultant haematologist. Defer surgery until assessment and management agreed with consultant haematologist. Document findings and action taken in patientâ&#x20AC;&#x2122;s record

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 3


DESCRIPTION OF TREATMENT Enoxaparin 20mg (2000units) in 0.2ml subcutaneous injection Name, Form & Strength of Medicine Subcutaneous injection Route/Method Dosage

Adults 20mg (0.2ml)

Frequency Duration of Treatment Maximum or Minimum Treatment Period Quantity to Supply/Administer Side Effects

ONCE daily. 5 days 5 days 5 syringes â&#x20AC;&#x201C; one dose to be administered on the unit and 4 syringes supplied to take home Potential adverse drug reactions: haemorrhage, skin necrosis, thrombocytopenia, hyperkalaemia, hypersensitivity reactions (including urticaria, angioedema, and anaphylaxis); osteoporosis after prolonged use (and rarely alopecia). 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, the patient or a doctor. It is the responsibility of the health professional identifying the ADR to report it.

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 4


Advice to Patient/Carer

Follow Up

Explain treatment, why treatment is required, and course of action. Verbal or written information should include: ◘ the signs and symptoms of deep vein thrombosis and pulmonary embolism. ◘ The correct and recommended duration of use. ◘ The importance of using and continuing treatment for the recommended duration. ◘ The signs and symptoms of adverse events. ◘ The importance of seeking help and who to contact if they have any problems. ◘ The importance of seeking medical help and who to contact if deep vein thrombosis, pulmonary embolism or another adverse event is suspected. Give the patient a copy of the manufacturer’s patient information leaflet and any other relevant patient information leaflet, discussing as required. Give training on administration of the injection (if self administering), in accordance with Clexane Syringe Patient Information Leaflet. Inform patient of potential side effects The patient should be warned to discontinue treatment immediately and seek medical advice if hypersensitivity reactions occur. If severe drug reaction occurs advise to attend Accident and Emergency. (See side effects). Explain follow up procedures.

Continue by self administration after discharge. Platelet counts recommended for patients receiving enoxaparin for longer than 4 days. STOP IMMEDIATELY if 50% reduction of platelet count or development of thrombocytopenia. Applicable to All Services: 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 Podiatry: • Patient to be telephoned on the day following surgery. To be reviewed in clinic 5 to 8 days post operatively.

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 5


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: Patientâ&#x20AC;&#x2122;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 Site of injection Batch number, expiry date, manufacturer, and brand name. Advice given to patient (including side effects) Date supplied Name of staff who administered/supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patientâ&#x20AC;&#x2122;s medical record. Current medication Known allergies Diagnosis Referral arrangements (including self-care)

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 6


STAFF CHARACTERISTICS Registered professional who is either a State Registered Podiatrist Qualifications

Specialist Competencies or Qualifications

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) 2. Summary of Product Characteristics (SPC) available at: www.medicines.org.uk 3. NICE Clinical Guideline 92, â&#x20AC;&#x2DC;Venous thromboembolism: reducing the riskâ&#x20AC;&#x2122; (January 2010).

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 7


This PGD is an updated version of HVMH Extended Primary Care Service PGD No 9, Enoxaparin Injection 20mg (December 2007), originally produced by the individuals listed below: Name

Position

Date

Specialist Technician – Community and Support Services Senior Medicines Management Adviser – Strategy and Operational Development Nurse Team Leader (HVMH Extended Primary Care Services)

November 2007

Stephen Finney

Consultant Podiatric Surgeon

November 2007

Rebekah Ward

Podiatric Specialist Registrar

November 2007

Linda Fox Lucianne Ricketts Pam Linton

November 2007 November 2007

It was updated for use by the individuals listed below: Name Lisa Meeks Lucianne Ricketts Pam Linton

Position

Date

Specialist Technician – Community and Support Services Senior Medicines Management Adviser – Strategy and Operational Development Nurse Team Leader (HVMH Extended Primary Care Services)

March 2010 March 2010 November 2009

Stephen Finney

Consultant Podiatric Surgeon

November 2009

Rebekah Ward

Podiatric Specialist Registrar

November 2009

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 8


Individual Authorisation for the Supply/Administration of Enoxaparin 20mg Subcutaneous Injection by Registered Podiatric Surgeons Employed by NHS Kirklees 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. 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.

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 9


AUTHORISATION 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

Kirklees Primary Care Trust

Director of Patient Care Name: Sheila Dilks & Professions Signature:

Date:

Assistant Director of Name: Neill McDonald Medicines Management and Prescribing Signature:

Medical Director

Date:

Name: Dr Judith Hooper

Signature:

PEC Chair

Date:

Name: Dr David Anderson

Signature:

Date:

PGD No 99 - Enoxaparin 20mg (2000units) Approval Date: 16/6/2010

Review Date: 16/6/2012 Page 10


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http://www.kirklees.nhs.uk/fileadmin/documents/New/Public_Information/med_mgt/PGDs/updated_March_12/PGD_No_99_Enoxaparin_SC_Injection.pdf

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