Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Lead Author: Dawn Lavery Dermatology Advanced Nurse Practitioner Additional author(s) N/A Division/ Department:: Dermatology, Clinical Support and Tertiary Medicine Applies to: (Please delete) Salford Royal Care Organisation Approving Committee Dermatology clinical governance committee Salford Royal Date approved: 13 February 2019 Expiry date: February 2022 Contents Contents Section Page Document summary sheet 1 Overview 2 2 Scope & Associated Documents 2 3 Background 3 4 What is new in this version? 3 5 Policy 4 Drugs monitored by nurses 4 Acitretin 7 Alitretinoin Toctino 11 Apremilast 22 Azathioprine 26 Ciclosporin 29 Dapsone 34 Fumaric Acid Esters – Fumaderm and Skilarence 36 Hydroxycarbamide 39 Hydroxychloroquine 43 Methotrexate 50 Mycophenolate moefetil 57 Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 1 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version Standards 67 6 Roles and responsibilities 67 7 Monitoring document effectiveness 67 8 Abbreviations and definitions 68 9 References 68 10 Appendices N/A 11 Document Control Information 71 12 Equality Impact Assessment (EqIA) screening tool 73 Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) 1. Overview (What is this policy about?) The dermatology directorate specialist nurses are responsible for ensuring prescribing and monitoring for patients under their care, is in accordance with this protocol. It is essential that practitioners remember to report (yellow card system) any serious adverse events (SAE) related to the use of systemic therapies. 2. Scope (Where will this document be used?) Dermatology nurse specialists who are responsible for delivering systemic therapy monitoring clinics for patients who are being prescribed: acitretin, azathioprine, ciclosporin, dapsone, fumaric acid esters, hydroxycarbamide, hydroxychloroquine methotrexate, and mycophenolate mofetil, for the treatment of inflammatory dermatoses. This protocol may also be of interest to dermatology medical staff. Associated Documents Prescribing by Non-Medical Personnel Trust Medicines Policy Trust Medicines Formulary Trust Health Records Policy Policy for the Recording of Allergies, Hypersensitivities, Intolerances & ADRs. (“The Allergies Policy”) Methotrexate - Use of Oral Methotrexate Understanding Methotrexate British Association of Dermatologists guidelines for systemic monitoring Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 2 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version 3. Background (Why is this document important?) The use of systemic therapies in dermatology requires the use of guidelines for drug toxicity monitoring, as adverse effects can be significant in some patients. Most specialists recommend regular safety monitoring of these drugs based on clinical experience and the data from published literature, such as Product Specific Characteristics, the British National Formulary (BNF) and publications from various clinical trials in the specialty literature (refer to British Association of Dermatologists (BAD) web site. The adverse effects of systemic therapies as reported in research trials have limitations, as the patient characteristics are likely to be different from those in daily clinical practice. Nurse-led drug monitoring clinics within the dermatology centre at Salford Royal NHS Foundation Trust are an innovative approach to improving care delivery and maintaining both a high standard of quality and efficient service. Nurse led clinics have freed up consultant appointments to enable patients to be seen earlier, thus reducing waiting lists. Areas of practice have been identified to enable dermatology nurses to utilise their skills, knowledge and clinical expertise in order to achieve both improvements in a range of outcomes and comparable clinical outcomes to medical colleagues. The main objective of this protocol is to provide clear information that the responsible specialist nurse can use to ensure systemic therapies may be safely prescribed and monitored. It is expected that the protocol should be viewed with individual drug SPC’s (Summary of Product Characteristics) and together will provide sufficient up-to-date knowledge about the treatments. This protocol provides an evidence-based approach with appropriate references to all recommendations in terms of predicting, assessing and counteracting any toxic effects related to the use of the systemic therapies in dermatology. 4. What is new in this version? Updated protocol to include Skilarence. Updated protocol to include Greater Manchester Medicine Group guidleines / shared care protocols for monitoring systemic therapies in primary care. Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 3 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version 5. Policy 5.1 Subsection Define situation/condition Drug monitoring by a dermatology specialist nurse, for patients who are prescribed the following systemic agents to manage their skin condition: acitretin, alitretinoin apremilast azathioprine ciclosporin dapsone fumaderm and skilarence hydroxycarbamide hydroxychloroquine methotrexate mycophenolate moefetil Criteria for inclusion The following are pre-requisites for patients to be referred to the nurse-led drug monitoring clinic: The patient must: Be aged 18 years or older Have been referred from a dermatologist to the nurse-led drug monitoring clinic by entry in medical notes, electronic patient records or clinic letter Have been prescribed acitretin, alitretinoin, apremilast, azathioprine, ciclosporin, dapsone, fumaderm, hydroxychloroquine, methotrexate or mycophenolate moefetil by a dermatologist to manage their skin condition Have had full explanation from the medical staff of the purpose of treatment, the monitoring procedure required and potential adverse side effects. This should be documented in the medical notes or electronic patient records. Have had a detailed medical history taken and medical examination where necessary performed by the medical staff Have a full list of current medications documented in medical notes or electronic patient records Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 4 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version Have been informed by medical staff of all necessary precautions when taking the prescribed treatment. Have all preliminary investigations relevant to treatment carried out and documented in the medical notes or electronic patient records Have clear documentation of the planned drug dosage regimen and proposed follow up schedule in the medical notes or electronic patient records Have a clear plan for obtaining supplies of medications through the hospital pharmacy or their GP until their next medical review appointment Criteria for exclusion Unanticipated change in skin condition (e.g. severe flare up, infected, erythrodermic or pustular) Significant out of range / abnormal changes to biochemical and haematological blood results Unplanned pregnancy Development of any new health problems which contraindicate treatment Uncertainty on the part of the nurse about any side effects of treatment Patient non-compliance with treatment or follow up arrangements Overdose of medication Action if excluded Refer back to dermatologist Action if patient declines Refer back to dermatologist Characteristics of staff Qualifications required First level nurse, minimum band 6, with at least 1 year dermatological experience Additional requirements Diploma or degree in nursing ( including a portfolio of evidence or working towards qualification) Knowledge of the anatomy and physiology of the skin. Knowledge of common skin conditions for which treatment is prescribed. Knowledge of topical and systemic treatments and side effects Knowledge of psychological effects of living with a Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 5 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version skin disease on the patient’s lifestyle The nurse must have undertaken a minimum of 3 months dermatology clinics where drug monitoring is undertaken under the supervision of a consultant dermatologist or an experienced highly specialist nurse. This will give the nurse the opportunity to gain knowledge about the management of dermatology patients receiving systemic therapies. The nurse will meet a set