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Intravenous Pamidronate in the treatment of Hypercalcaemia in the communityIV Therapy Team January 2014

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Policy Number

LCH-20

This document has been reviewed in line with the Policy Alignment Process for Liverpool Community Health NHS Trust Services. It is a valid Mersey Care document, however due to organisational change this FRONT COVER has been added so the reader is aware of any changes to their role or to terminology which has now been superseded. When reading this document please take account of the changes highlighted in Part B and C of this form.Part A – Information about this DocumentPolicy Name Bisphosphonates GuidelinesPolicy Type Board Approved (Trust-wide) ☐ Trust-wide ☐ Divisional / Team / Locality ☒

Action No Change ☐ Minor

Change ☐ MajorChange ☐ New

Policy ☒ No LongerNeeded ☐

Approval

As Mersey Care’s Executive Director / Lead for this document, I confirm that this document:a) complies with the latest statutory / regulatory requirements,b) complies with the latest national guidance,c) has been updated to reflect the requirements of clinicians and officers, andd) has been updated to reflect any local contractual requirements

Signature: Date:Part B – Changes in Terminology (used with ‘Minor Change’, ‘Major Changes’ & ‘New Policy’ only)

Terminology used in this Document New terminology when reading this Document

Part C – Additional Information Added (to be used with ‘Major Changes’ only)Section /

Paragraph NoOutline of the information that has been added to this document – especially where it may

change what staff need to do

Part D – Rationale (to be used with ‘New Policy’ & ‘Policy No Longer Required’ only)Please explain why this new document needs to be adopted or why this document is no longer required

Part E – Oversight Arrangements (to be used with ‘New Policy’ only)Accountable Director

Recommending Committee

Approving Committee

Next Review DateLCH Policy Alignment Process – Form 1


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SUPPORTING STATEMENTS This document should be read in conjunction with the following statements:

SAFEGUARDING IS EVERYBODY’S BUSINESSAll Mersey Care NHS Foundation Trust employees have a statutory duty to safeguard and promote the welfare of children and adults, including: being alert to the possibility of child / adult abuse and neglect through their observation of

abuse, or by professional judgement made as a result of information gathered about the child / adult;

knowing how to deal with a disclosure or allegation of child / adult abuse; undertaking training as appropriate for their role and keeping themselves updated; being aware of and following the local policies and procedures they need to follow if they

have a child / adult concern; ensuring appropriate advice and support is accessed either from managers, Safeguarding

Ambassadors or the trust’s safeguarding team; participating in multi-agency working to safeguard the child or adult (if appropriate to your

role); ensuring contemporaneous records are kept at all times and record keeping is in strict

adherence to Mersey Care NHS Foundation Trust policy and procedures and professional guidelines. Roles, responsibilities and accountabilities, will differ depending on the post you hold within the organisation;

ensuring that all staff and their managers discuss and record any safeguarding issues that arise at each supervision session

EQUALITY AND HUMAN RIGHTSMersey Care NHS Foundation Trust recognises that some sections of society experience prejudice and discrimination. The Equality Act 2010 specifically recognises the protected characteristics of age, disability, gender, race, religion or belief, sexual orientation and transgender. The Equality Act also requires regard to socio-economic factors including pregnancy /maternity and marriage/civil partnership.

The trust is committed to equality of opportunity and anti-discriminatory practice both in the provision of services and in our role as a major employer. The trust believes that all people have the right to be treated with dignity and respect and is committed to the elimination of unfair and unlawful discriminatory practices.

Mersey Care NHS Foundation Trust also is aware of its legal duties under the Human Rights Act 1998. Section 6 of the Human Rights Act requires all public authorities to uphold and promote Human Rights in everything they do. It is unlawful for a public authority to perform any act which contravenes the Human Rights Act.

Mersey Care NHS Foundation Trust is committed to carrying out its functions and service delivery in line the with a Human Rights based approach and the FREDA principles of Fairness, Respect, Equality Dignity, and Autonomy


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Title Guidelines for the Administration of Intravenous Pamidronate in the Community for Patients with Hypercalcaemia of Malignancy

Guideline referencenumber

20

Aim and purpose of guideline

The aim of the guidelines is to ensure the safe administration of Pamidronate in the community by professionally registered clinical staff.

Author IV Therapy Team

Type New Guideline

Reviewed Guideline x

Review date July 2018 - 6 month extension agreed at Clinical Standards Group meeting 24.01.18

Person/groupaccountable for review

IV Therapy Team

Type of evidence base used

C: Evidence which includes published and/or unpublished studies and expert opinion

Issue dateOctober 2017

Authorised by Clinical Standards Group

24th October 2017

Impact Assessment Undertaken

Yes √ date when undertaken

Evidence √collated

No


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Version Number: V4

Ratified by: Clinical Standards Group

Date of Approval: 15th January 2014

Name of originator/author: Alison Smith IVT

Operational/Professional Lead

Approving Body / Committee: Clinical Standards Group

Date issued: October 2017

Review date: July 2018

Target audience: IV Therapy team

Name of Lead Director Director of Nursing

Changes / Alterations Made To Previous Version:

Included ‘recent dental

extractions’ under exclusions

and change of wording re

osteonecrosis of jaw.


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Individuals involved in developing the document:Name DesignationAlison Smith IV Therapy

Operational/Professional Lead

Christine McBride Palliative Care Team Leader

Dr Vinita Mishra

Dr Heino Hugel

Dr Richard

Latten Dr Cathy

Hubbert

Consultant Chemical Pathologist

Specialist Palliative Care

Consultant Specialist Palliative

Care Consultant GP End of Life

Lead

This document was circulated to the following individuals for consultation

Name DesignationAnn Murtha Safer Care Lead

Dr Reilly Consultant Oncologist

This document should be read in conjunction with the

following NHS Liverpool Community Health documents:

• Risk Management Strategy• Waste Management Policy• Infection Control Policies• Anaphylaxis guidelines• Consent policy• Patient Identification policy• Peripheral Cannulation Policy• CINS Guidelines

These can be located via the link below:h t tp://n ww .liv er poolh e a l t h.nhs.uk/


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Contents page

Purpose of Guidelines Page 5

Scope of Guidelines Page 5

Definitions Page 5

Inclusion Criteria Page 5

Exclusion Criteria Page 6

Referral Process Page 6

Hypercalcaemia of Malignancy Page 6/7

Rehydration + Treatment regime /8

Adverse effects associated with Bisphosphonates Page 8/9

Monitoring of Serum Adjusted Calcium Page 9

Monitoring of recurrent Hypercalcaemia Page 9

Equality Impact Assessment Page 9

Consultation Process Page 9

Process for reviewing procedural document Page 10

Distribution list/ dissemination Page 10

References Page 10

Appendix 1 Flow chart Page 11

Appendix 2 Referral Form

Intravenous Pamidronate in the treatment of Hyperc

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alcaemia in the communityIAVppTehnedriaxp3yPTresacmription SheetJanuary 2014

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Page 13


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Purpose of the GuidelineThe purpose of the guidelines is to ensure quality and consistency in the delivery of clinical care to patients receiving Intravenous Pamidronate in the community.

Bisphosphonates have an important role in the prophylaxis and treatment of osteoporosis, malignant bone pain and hypercalcaemia.

These guidelines relate specifically to the treatment of hypercalcaemia in the community and Intravenous Pamidronate is the only IV bisphosphonate being considered for use locally.

Scope of guidelinesThese guidelines apply to all qualified nursing staff within Liverpool Community Health NHS Trust Intravenous Therapy Team (IVT) who feel have competencies to deliver this therapy.

Definitions• Bisphosphonates – Medication which inhibits bone reabsorption• Hypercalcaemia – High serum calcium levels*• IVT – Intravenous Therapy Team• Community – refers to the patient’s own home and also includes

residential and nursing homes and community health centres.• SPCC – Specialist Palliative Care Consultant• SPCT – Specialist Palliative Care Team• Cannulate – To insert a flexible tube/catheter containing a needle into a

blood vessel• Rehydration – Process to administer fluids into a vein tissue in order

to achieve fluid maintenance• EMIS – GP Electronic Computer System• Normocalcaemia – Normal serum adjusted calcium levels*• eGFR – Estimated Glomerular Filtration Rate• IV – Intravenous (refers to into a peripheral vein)• HCM – hypercalcaemia of malignancy

* The normal range for serum corrected calcium or albumin-adjusted calcium is 2.2-2.6 mmol/l

Inclusion Criteria

• On Supportive Care/GSF/Electronic Supportive Care/STARS Template

• Symptomatic hypercalcaemia – not acutely confused

• Satisfactory renal function (e GFR>30)

• Serum Adjusted Calcium above the reference range but <3.5 mmol/L


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• Able to stay at home – adequate care needs

• Known to Specialist Palliative Care Team

• GP and Palliative Care Consultant agree suitable for home treatment

• Absence of Heart Failure

• No recent dental surgery or on-going dental health issues

Exclusion Criteria

• Not on Supportive Care/GSF/Electronic Supportive Care Template

• Acutely confused

• Poor renal function (e GFR <30)

• Serum Urea > 8mmol/L

• Heart Failure

• Unable to stay at home due to care needs

• Not known to SPCT

• GP or Palliative Care Consultant feels not suitable for home treatment

• Recent dental surgery or ongoing dental health issues

• Any contra-indication given in the relevant Summary of Product Characteristics

Referral Process

• Patients will be referred by their GP if they meet the criteria for home treatment.

• GP to discuss patient with Specialist Palliative Care Consultant (SPCC).

• If patients do not meet criteria for home treatment, then GP is to discuss with SPCC and consider admission to Secondary care or Hospice.

• If patients do not want home treatment, then GP to discuss with SPCC and arrange admission to Secondary care or Hospice.

• SPCC to arrange home visit to assess patient.

• GP refers to IVT by telephone 0151 285 4696 and faxes the referral form to 0151 285 4698 – See Appendix 2 & 3

• SPCC to complete bisphosphonates prescription sheet and fax to 0151 285 4698

• IVT receives referral and plans date of next visit for the following day. Patient and family to be informed by telephone.


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• Referrals will be accepted 7 days a week, but treatment will only be initiated between Monday to Thursday

Hypercalcaemia

Symptoms of hypercalcaemia include fatigue, weakness, constipation, nausea, vomiting, polyuria, polydipsia, cardiac arrhythmia, delirium, drowsiness and coma.

Treatment includes rehydration and the use of IV Bisphoshonates.

Rehydration with 0.9% Sodium Chloride should be first line management. It may improve some of the symptoms and reduce calcium levels by 0.4-0.6 mmol/l. The benefits are: replacing lost sodium, increasing glomerular filtration and circulating volume, and promoting urinary calcium excretion. Sodium Chloride 0.9% should be used in preference to glucose because it produces a more effective diuresis.

Hypercalcaemia of Malignancy (HCM)This is the most common life threatening metabolic disorder and occurs in approximately 10-20% of cancer patients. Hypercalcaemia occurs mainly in patients with advanced disease and is associated with a poor prognosis. However the incidence of cancer related hypercalcaemia is falling due to the earlier and prolonged use of Bisphosphonates in cancer patients with metastatic bone disease.

Treatment Regime – Day 1 (Rehydration):

• Before hydration IVT will take re- take bloods for calcium profile, renal function and magnesium.

• Hydration alone may be sufficient for asymptomatic patients with borderline raised serumadjusted calcium.

• 0.9% Sodium Chloride (1.5 litres over 8 hours) rehydration is the usual first step in the treatment of hypercalcaemia

• In presence of congestive cardiac failure, rehydration with 0.9% sodium chloride is not indicated.

• Rehydration corrects volume depletion from calcium-induced diuresis and reduced fluid intake, promotes renal calcium excretion and prevents renal failure.

• The routine use of furosemide in conjunction with rehydration to promote calcium excretion is not recommended, because of the risk of volume and electrolyte depletion.

• A patient information leaflet will be given.

Treatment Regime – Day 2 (Check bloods):

• IVT will check bloods on day 2 for adjusted calcium, phosphate, magnesium and renal function as the dose of Pamidronate varies from 60-


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90mg


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dependent on renal function.• Results will be discussed with GP/SPCC• Patients should have their serum urea & creatinine levels or eGFR

assessed prior to each dose of Pamidronate. This is because renal monitoring is recommended prior to each dose of Pamidronate.

• Pamidronate should not be administered to patients with severe renal impairment (e GFR ≤ 30 mL/min) except in life-threatening hypercalcaemia if the benefit outweighs the risk.

• No dose adjustment is required in mild to moderate renal impairment with eGFR>30

Treatment Regime – Day 3 (Administer Pamidronate):

• The total dose of Pamidronate to be used for a treatment course depends on the patient's initial serum adjusted calcium levels (See Appendix 1 - flow chart).

• Pamidronate should be administered intravenously in 500ml Sodium Chloride over 4 hours.

• Following pamidronate therapy the patient will be advised to continue rehydration with oral fluids (2-3L daily).

• A significant decrease in serum-adjusted calcium is generally observed 24 to 48 hours after administration of Pamidronate, and normalisation is usually achieved within 3 to 7 days. If normocalcaemia is not achieved within this time, a further dose may be given 7 days after the first dose.

• The duration of the response may vary from patient to patient, and treatment can be repeated whenever hypercalcaemia recurs.

Day 8: (Check bloods)

• IVT to check bloods for adjusted calcium, phosphate, magnesium and e GFR. If hypocalcaemia (serum adjusted calcium <2.0 mmol/L) occurs, contact GP or SPCC.

Adverse effects associated with Bisphosphonates (Taken from Summary of Product Characteristics)

(AREDIA POWDER 15MG, 30MG, 90MG: PAMIDRONATE SODIUM, NOVARTIS PHARM ACEUTICALS UK)

WWW.MEDICINES.ORG.UK

• “Flu-like” symptoms: Mild fever, chills, bone pain, arthralgia, and myalgia lasting up to 48 hours may occur with Pamidronate. Mild fever can be prevented by prophylactic use of paracetamol.

• Renal dysfunction: Check serum creatinine/eGFR prior to each dose.


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• Ocular complications: Uveitis, conjunctivitis, episcleritis and scleritis have been reported with bisphosphonates. Patients on bisphosphonates who develop visual loss or ocular pain should be referred to an ophthalmologist.

• Osteonecrosis of the jaw: This complication has been reported in cancer patients receiving intravenous Pamidronate, usually for a number of months. Ideally patients should be rendered dentally fit PRIOR to commencing therapy. The importance of maintaining good dental health (including good oral hygiene) and ongoing dental reviews should be emphasised. If invasive dental procedures are inevitable, primary care dentists may be advised to seek advice from an oral / maxillofacial surgeon.

• Other: Nausea, vomiting, pruritus, chest tightness, hypotension,

headache, anxiety, insomnia, fatigue, somnolence, pancytopenia, allergic

reactions.

• Hypocalcaemia may occur, but is usually asymptomatic.

Bronchoconstriction may develop in asthmatics. Asthma must be well controlled and a salbutamol/blue inhaler must be available for use during infusion.

It has been agreed locally that for treatment in the community a serum adjusted

calcium of >3 or <3 will be used. (See appendix 1)

Management of recurrent hypercalcaemia: It has been agreed locally between Specialist Palliative Care Consultants and a Consultant Biochemist that calcium levels will be rechecked 5 days following administration of bisphosphonates. Levels should then be repeated every 3-4 weeks or when symptoms occur. This will be performed by District Nurses and results reviewed by GP. If further IV Bisphosphonate is required then the patient will need to be re-referred to IVT.

Management of treatment resistant hypercalcaemia: If calcium levels are still raised or if symptoms persist it may be appropriate to consider a further infusion of bisphosphonate. At least 7 days should elapse before a further infusion of bisphosphonate to allow maximal response to the initial dose. Discuss treatment with Palliative Care Consultant.

Management of recurrent hypercalcaemia: If the patient is experiencing recurrent hypercalcaemia treatment should be discussed with Palliative Care Consultant.

Equality Impact AssessmentThis has been undertaken and the supporting evidence is both with the author of this policy and the Equality and Diversity lead of Liverpool Community NHS Trust


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Consultation ProcessThis policy was written in consultation with members of the IV Team, SPCT, SPCT Consultants, Consultant Oncologist, and General Practitioner.

Process for Reviewing a Procedural Document

In the absence of baseline data, it has been agreed by Commissioners that the following will be audited and reported back to Commissioners at six and twelve months. The results will inform any changes that are required to policy and will be actioned as required:

• Patient/carer satisfaction• Contacts• Response Times• Treatment Duration• Outcomes of therapy i.e. Hospital admission avoided, did hydration

alone reduce hypercalcaemia, was the hypercalcaemia corrected with IV Pamidronate and was any further IV Pamidronate required within 7 days.

Trends will be monitored via incident reports (including near miss) and complaints. Lessons will be learnt and actioned accordingly.

Datix relating to infusion errors and near misses will be monitored and actioned accordingly via local governance group.

Distribution list/dissemination method

This policy will be disseminated via the Community Intravenous Therapy Team Leader (Community Intravenous Therapy Team) via local team meetings. Following approval at the Clinical Policies Working Group, update will be highlighted via the LCH Weekly Communications.

References• www.medicines.org.uk

• Kovacs CS, MacDonald SM, Chik CL, Bruera E. Hypercalcaemia of malignancy in the palliative care patient: a treatment strategy. J Pain Symptom Manage 1995;10:224-32.

• Shustik C. Tumour-induced hypercalcaemia. Current Oncol 2001;7:173-9.

• Stewart AF. Hypercalcaemia associated with cancer. N Engl J Med 2005;352:373-9.

• Cancer: Principles and Practice of Oncology (4th ed) 1997 DeVita S,


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Hellman S, Rosenberg S, ed. Vol 2 Section 3 Metabolic Emergencies: Hypercalcemia


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pp 2486.

• Major P, Lortholary A, Hon J et al; Zoledronic acid is superior to Pamidronate in the treatment of hypercalcaemia of malignancy: A pooled analysis of two randomized, controlled clinical trials J Clin Oncol 2001 January, Vol 19 No 2 pp 558-567

• Merseyside and Cheshire Palliative Care Network Audit Group. Standards and Guidelines 4th Edition 2010 p 37-43


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Appendix 1 Flowchart: Pamidronate Treatment Regime


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Appendix 2 – Referral Form


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Appendix 3

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