Guideline template



East Kent Hospitals University NHS

Foundation Trust

Clinical Guideline

Guideline for the Prescribing and Administration of Iloprost in Adult Patients with Raynaud’s Syndrome or Digital Ulceration Secondary to Systemic Sclerosis

Summary: This guideline aims to support doctors, pharmacists and nurses in the prescribing and administration of Iloprost.

|Version: |0.3 |

|Ratified by: | |

|Date ratified: | |

|Name of originator/author: |Dr Parul Shrestha, Consultant Rheumatologist based on protocol from |

| |Mr Scott Mercer, Principal Pharmacist Specialist Medicine – Guy’s & |

| |St Thomas’ NHS Foundation Trust |

|Director responsible for implementation: |Dr D De Lord, Consultant Rheumatologist, UCLTC. |

|Date issued: | |

|Review date: |June 2020 |

|Target audience: |Rheumatolologists, Pharmacists, Nurses and anyone else treating |

| |digital ulcers and Raynaud’s with iloprost. |

Version Control Schedule

|Version |Date |Author |Status |Comment |

|0.1 |23/5/2018 |Michaela Heath/Carol Walker |Draft |Retyping of Guy’s protocol in EKHUFT format |

|0.2 |14/6/2018 |Carol Walker |Draft |Updates following circulation for comment |

|0.3 |18/6/18 |Carol Walker |Draft |Definition and archiving added |

|0.4 |25/6/18 |Carol Walker |Draft following |Addition of NHSE ref, drug interactions added, day 3 added to |

| | | |DTC |treatment protocol. |

|1.0 |30/8/2018 |Carol Walker |Approved |UC<C Quality board 13.7.18 |

| | | | | |

| | | | | |

Consultation and Ratification Schedule

|Name and Title of Individual |Date Consulted |

|Dr Parul Shrestha, Consultant Rheumatologist |2/3/18 |

|A Khan, F Bari, S Sukumaran, D De Lord C Walker via email |2/3/18 |

|Carol Walker- circulation for comment, Rheumatology and Pharmacy |11/6/2018 |

|Drug and Therapeutics Meeting |20/6/2018 |

|UC<C Quality Board |13/7/18 |

| | |

| | |

| | |

|Name of Committee |Date Reviewed |

|Rheumatology Business Meeting |15/5/2018 |

|Drug and Therapeutics Committee |20/6/2018 |

| | |

Contents

|1. Introduction, Background and Purpose 4 | | |

|2. Definitions 4 | | |

|3. Scope 5 | | |

|4. Guidance 5 | | |

|5. Training (for administration) 8 | | |

|6. Consultation and Approval 8 | | |

|7. Review and Revision Arrangements 9 | | |

|8. Document Control including Archiving Arrangements 9 | | |

|9. References and Associated Documents 11 | | |

| | | |

| | | |

| | | |

1. Introduction, Background and Purpose

1. Iloprost is a synthetic prostacyclin analogue with vasodilatory and antiplatelet effects. As a result it is a useful agent in the management of Raynaud’s Syndrome and digital ulceration secondary to systemic sclerosis. It is imported from Spain and is unlicensed in the United Kingdom. It is only available on a named patient basis at the request of a Consultant using the paperwork provided by the pharmaceutical company (see end of document). This completed form should be given to the Pharmacist with the drug chart. As iloprost is unlicensed, consent must be obtained using the standard Trust consent form.

2. Iloprost forms part of the patient pathway in NHS England policy A13/P/b Clinical commissioning Policy for the treatment of Digital Ulceration in Systemic Sclerosis.

2. Definitions

1. Raynaud’s Syndrome: Raynaud's phenomenon is episodic vasospasm of the arteries in the extremities, causing pallor followed by cyanosis and/or redness of the fingers and toes (and in some cases the ears and nose)

2. Systemic Sclerosis: Scleroderma is a connective tissue disease causing fibrosis and commonly affects the skin and internal organs such as the GI tract, lungs, kidney and heart.

3. Scope

1. This guideline describes the standard of care to be provided to EKHUFT adult patients for the treatment of this specific set of conditions with iloprost. It is not designed to restrict or limit professional judgment and decision-making.

2. It is also useful for the clinical pharmacist involved in screening and dispensing of this unlicensed medication to ensure all legalities are complied with as regards prescribing, supply and administration of this medication.

3. Users of this policy must be aware of EKHUFT policy on use of unlicensed medicines

4. Guidance

1. Elective Day Case Attendance for Iloprost Infusions

Patients must be informed in advance if they are required to omit any medication prior to the first infusion. Iloprost can potentiate the effects of antihypertensives, anticoagulants and antiplatelets and at the discretion of the Consultant or SpR, it may be necessary to omit them. See Drug Interactions section.

2. Counselling and Patient Information

Issue the following patient information leaflets:

• Arthritis Research Campaign Drug Information – Iloprost ()

• EKHUFT leaflet: Unlicensed Medicines – a guide for patients (Appendix F )

• Referral to smoking cessation services if appropriate

3. Contra-indications

If any of the following are present, the Consultant must assess the risk/benefit to the patient prior to commencing treatment.

• Pregnancy and breast feeding

• Hypersensitivity to Iloprost or any of the excipients (ethanol, sodium chloride, hydrochloric acid, water for injection)

• Active bleeding or conditions where the antiplatelet effect might increase the risk of haemorrhage (active peptic ulcer disease, trauma, intracranial haemorrhage, coagulopathy)

• Severe coronary heart disease or unstable angina

• Myocardial infarction within the last 6 months

• Acute or chronic congestive heart failure (NYHA II-IV)

• Arrhythmias

• Suspected pulmonary congestion

4. Cautions

If any of the following are present, the Consultant must assess the risk/benefit to the patient prior to commencing treatment.

• Hepatic impairment (see section on hepatic dysfunction)

• Hypotension – see monitoring and drug interactions

• Anticoagulant/antiplatelet therapy – see drug interactions

• Infection

• Recent invasive procedures or surgery where bleeding is still a risk

5. Treatment Details

Days 1, 2 and 3

Prescribe as: Iloprost 30-120 nanograms/kg/hour as tolerated and according to guideline

Initial dose: 30 nanograms / kilogram / hour

Target dose: 120 nanograms / kilogram / hour

Dose escalation: If tolerated (see monitoring below) increase the rate of infusion every 30 minutes until target dose achieved.

Preparations: Dilute one 50 microgram ampoule to a total volume of 25mL with Sodium Chloride 0.9% or Glucose 5% (concentration is 2 micrograms/mL). Avoid contact with the skin (see nurse training).

Administration: Intravenous infusion via syringe driver into a peripheral vein.

Duration: 6 hours each day for 3-5 days

|  |Actual Body Weight (rounded to the nearest 5kg)* |

|  |40 |

|Initial infusion rate 30 nanograms / hour (rounded to one decimal place) |

Days 4 and 5

Start the infusion at the maximum tolerated rate achieved on days 1, 2 and 3 and infuse for 6hours.

6. Monitoring and Adverse Effects

Undertake the following clinical assessments. If any concerns stop the infusion, contact the SpR and/or Consultant.

[pic]

1. Single episode of hypotension and/or tachycardia

Reduce the rate of infusion to the previously tolerated rate. If side effects resolve, continue at this rate until the 6 hour infusion is complete.

7. Persistent hypotension and/or tachycardia

If hypotension and/or tachycardia persist, stop the infusion and request a medical review. Continue to monitor the patient for one hour after the infusion has stopped and symptoms have resolved. If it is clinically appropriate to restart the infusion (following medical review), restart the infusion at half the previously tolerated rate. If the patient remains stable, continue the infusion until the 6 hour infusion is complete.

8. Other adverse effects include:

Headache, nausea, vomiting, facial flushing, malaise, cramp-like abdominal pain, diarrhoea, sweating, a sensation of warmth, weakness, pain in the affected limb, paraesthesia, tiredness, fever, chills, confusion, apathy, sedation, agitation, hypertension. All side effects usually disappear quickly with dose reduction.

Arthralgia and allergic reactions may occur. Isolated cases of dyspnoea and bronchial asthma have been reported and individual cases of acute pulmonary oedema or heart failure have been observed in elderly patients with advanced arteriosclerosis.

Redness and pain at the infusion site. In some cases, cutaneous vasodilation may give rise to streaky erythema above the infusion vein.

Iloprost may provoke angina, especially in patients with coronary heart disease.

9. Hepatic and Renal Dysfunction

10. Hepatic impairment

Reduced elimination therefore, starts the infusion at half the recommended dose.

11. Renal impairment

No dose change required.

12. Infusion Stability

Fresh infusions should be prepared each day and used immediately to prevent microbial contamination.

13. Drug Interactions

1. Anticoagulant/antiplatelet therapy

Iloprost inhibits platelet aggregation therefore patient may be advised to omit anticoagulants (therapeutic dose heparin including LMWH and fondapariux, warfarin and other vitamin K antagonists, DOACs eg apixaban, rivaroxaban), or antiplatelet medication (aspirin, clopidogrel, prasugrel, abciximab, eptifibatide, tirofiban). Avoid fibrinolytics, direct thrombin inhibitors and heparinoids. Consultant or SpR to assess and omit medication as necessary.

Note – prophylactic heparin can usually be continued.

2. Antihypertensive therapy

Iloprost may increase the effects of antihypertensive drugs (β-blockers, calcium antagonists, vasodilators and ACE inhibitors). Check baseline blood pressure. Consultant or SpR to review antihypertensive medication and omit as necessary.

3. NSAIDS and SSRI antidepressants

Increased risk of bleeding. Consultant or SpR to assess and omit medication as necessary.

4.8.4 Other drugs with potential to interact

Other drugs listed in the BNF include protein kinase inhibitors eg imatinib, omega-3-acid ethyl esters, nicotinic acid, some mab anticancer drugs eg trastuzumab, anagrelide.

14. Infusion Stability

Fresh infusions should be prepared each day and used immediately to prevent microbial contamination.

5. Training (for administration)

1. Nurses administering iloprost must have passed the Medicines Management Test and fulfilled the Medicines Management Competencies. In addition to this, mandatory adult life support training must be up to date.

2. Nurses preparing the infusion must wear gloves to avoid contact with the skin. Iloprost may provoke long lasting painless erythema. If contact with the skin occurs, the affected area should be washed immediately with copious amounts of water.

6. Consultation and Approval

Persons consulted: Mr Scott Mercer, Principal Pharmacist, Specialist Medicine, Guy’s and St Thomas’ NHS Foundation Trust for protocol

Consultant Rheumatologists EKHUFT: P Shrestha, A Khan, F Bari, S Sukumaran, D Delord

Pharmacists: Carol Walker, Antonios Hrysafis, Rebecca Morgan, Emma Dodridge

Rheumatology Specialist Nurses: Jacqueline Smith, Carol Maidment

For approval at Rheumatology Business Meeting

For approval at Drug and Therapeutics Committee

7. Review and Revision Arrangements

For review at Rheumatology Business Meeting June 2020

8. Document Control including Archiving Arrangements

Document control and archiving arrangements will be via the current Trust electronic document control system.

9. References and Associated Documents

1. EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research Group (EUSTAR). Kowal-Bielecka O, Landewe R et al. Annals of the Rheumatic Diseases, May 2009, vol./is. 68/5(620-628)

2. GKLT Joint Formulary Approved Prescribing List No 13 February 2012

3. MEDUSA Intravenous Therapy Guide.

4. Technical Information Sheet – Iloprost (Bayer)

5. The Renal Drug Handbook. Third Edition

6. A13/P/b Clinical Commissioning Policy; Sildenafil and Bosentan for the treatment of Digital Ulceration in Systemic Sclerosis. July 2015. NHS England

[pic]

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download