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1 Patient Group Direction 2210 version 1.0 Supply of Dexamethasone for the Prevention of Chemotherapy Induced Nausea and Vomiting by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Date of Introduction: October 2017 Review Date: September 2019 Developed By Name Signature Date Physician Pharmacist Lead Professional Lead Pharmacist for Cancer Services Cancer & Vascular Access Advanced Nurse Practitioner Note: The Lead Professional is responsible for ensuring the co-ordination, composition, consultation, revision and distribution of the PGD to practitioners who will be using the PGD as well as ensuring that the PGD is no longer used if becomes out of date and once it has expired. The Clinical Effectiveness Department will write to the Lead Professional approximately 4 months before the review date as a reminder that a review is required. Ratified on behalf of: TORBAY AND SOUTH DEVON NHS FOUNDATION TRUST Medicines Management Committee Chair Signed: Name: Clinical Director Pharmacy and Prescribing Date: Lead Officer Signed: Name: Medical Director Date: October 2017 September 2019 Page 1 of 8

2 Patient Group Direction 2210 version 1.0 Supply of Dexamethasone for the Prevention of Chemotherapy Induced Nausea and Vomiting by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Objective To enable nurses to efficiently prevent and treat chemotherapy induced nausea and vomiting by dispensing Dexamethasone 2mg to be taken TDS reducing by 2mg daily over 3 days. 1. Clinical Condition Definition of condition/situation Patients who receive Chemotherapy are at risk of chemotherapy induced nausea and vomiting. Facilities required Criteria for inclusion Dexamethasone will be kept in a locked drug cupboard as TTA packs on the Ricky Grant Day Unit and Turner Ward. Patients may be included in the PGD if the patient is receiving chemotherapy. Criteria for exclusion Hypersensitivity to Dexamethasone Possible interactions with - Aldesleukin - Rifamycins - Coumarins - Carbamazepine - Fosphenytoin - Phenobarbital - Phenytoin - Primidone - Amphotericin - Caspofungin - Daclatasvir - Simprevir - Indinavir - Lopinavir - Saquinavir - Telaprevir - Rilpivirine - Netupitant - Live Vaccines Action if excluded If receiving chemotherapy and excluded from PGD, refer to medical team on Turner ward or a nonmedical prescriber for assessment. Action if patient refuses medication Document informed refusal in patient s records and action taken: a) Refer to the medical team on Turner Ward or a non-medical prescriber to review the patient. b) Inform the patient s consultant. October 2017 September 2019 Page 2 of 8

3 2. Characteristics of Staff Qualifications required NMC Registered Nurse who has successfully completed the NMC NURB 292 Care of the Patient Requiring Chemotherapy, NURB 360 Enhanced Care of the Patient Requiring Chemotherapy or equivalent course. Additional requirements Working knowledge of Medicines Policy, Anaphylaxis Policy, Consent Policy and Chemotherapy Services SOP. Evidence of continuing professional development and revalidation. Working knowledge of the NMC Standards for Medicines Management 2007, (updated 2010) and other relevant codes of professional practice. 3. Description of Treatment Name of Medicine Supplied Legal Class Storage Dose to be used (including criteria for use of differing doses) Method or route of administration Total dose and number of times drug to be given. Details of supply (if supply made) Dexamethasone POM (Prescription Only Medicine) Locked drug cupboard in the prep room on RGDU and Turner ward. 2 milligrams Oral 2mg to be taken three times daily for 1 day, then 2mg to be taken twice daily for 1 day, then 2mg to be taken as a single dose. Starting the day after chemotherapy. Supply one TTA pack of 6 tablets. Administered from ward stock of TTA packs. Contra-indications Refer to medical practitioner or non-medical prescriber if appropriate or alternative action as indicated by related protocol and document in patient s records Live vaccines Systemic infection October 2017 September 2019 Page 3 of 8

4 Cautions Congestive heart failure. Diabetes mellitus Diverticulitis Congestive heart failure Epilepsy Glaucoma PMH of steroid myopathy PMH of TB Hypertension Hypothyroidism Infection Myasthenia gravis Ocular herpes simplex Osteoporosis Peptic ulcer Psychiatric reactions Recent intestinal anastomoses Recent MI Severe affective disorders Thromboembolic disorders Ulcerative colitis Interactions If patient is taking any other medications consult BNF Appendix 1 for any potential interactions. October 2017 September 2019 Page 4 of 8

5 Potential side-effects and adverse reactions The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment. Fluid and electrolyte disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalaemic alkalosis, hypertension, increased calcium excretion. Musculoskeletal effects: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (especially in post-menopausal females), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, tendon rupture. Gastro-intestinal: Peptic ulcer with possible perforation and haemorrhage, perforation of the small and large bowel particularly in patients with inflammatory bowel disease, pancreatitis, abdominal distension, ulcerative oesophagitis, dyspepsia, oesophageal candidiasis. Dermatological: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, suppressed reaction to skin tests, other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic oedema. Neurological: Convulsions, vertigo, headache. Increased intracranial pressure with papilloedema (pseudotumour cerebri) may occur usually after treatment. Psychiatric: A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions(including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions have been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Endocrine: Menstrual irregularities, amenorrhoea, development of Cushingoid state, suppression of growth in children and adolescents, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery or illness), decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, hyperglycaemia, increased requirements for insulin or oral hypoglycaemic agents in diabetics, hirsutism. Anti-inflammatory and immunosuppressive effects: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs. Opportunistic infections, recurrence of dormant tuberculosis. Eye disorders: Posterior subcapsular cataracts, increased intra-ocular pressure, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral disease, glaucoma, exophthalmos, chorioretinopathy. Metabolic: Negative nitrogen balance due to protein catabolism. Negative calcium balance. Cardiovascular: Myocardial rupture following recent myocardial infarction. Other: Hypersensitivity, including anaphylaxis has been reported, leucocytosis, thromboembolism, weight gain, increased appetite, nausea, malaise, hiccups. Withdrawal symptoms and signs Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension, and death. In some instances, withdrawal symptoms may simulate a clinical relapse of the disease for which the patient has been undergoing treatment. Management of potential side-effects and adverse reactions Contact the medical team on Turner Ward to review patient. Trust anaphylaxis policy. Unusual or life threatening reactions require immediate medical attention. October 2017 September 2019 Page 5 of 8

6 Advice and information to patient/carer including follow-up Specify method of recording supply /administration including audit trail Unusual or life threatening reactions require immediate medical attention. If symptoms of nausea persist contact the 24 hour chemotherapy telephone triage. The following will be recorded in the patient s records: The diagnosis and treatment The dose and quantity supplied Batch number and expiry date if appropriate The route of administration and site of administration where appropriate The frequency of administration and duration of treatment The time and date of supply/administration The signature and name of the person supplying/administering the medication Document allergies and other adverse drug reactions clearly in patient records and inform the GP and other relevant practitioners/patient/carer for further reporting and action if required. Report any adverse drug reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) through the yellow card reporting system ( 4. Other Information Follow up treatment: Arrangements for medicine supply: Arrangements for medical referral: The patient / carer has access to a 24 hour help line. The patient s level of emesis will be assessed at each chemotherapy appointment. Use ward stock of TTA packs. Junior medical team is available by pager and they are based on Turner Ward. Associate specialist available by pager and is based in Oncology. Consultants can be contacted, or message left, via their secretaries. Lines of accountability: 5. Appendices References used in the development of this PGD: The senior nurse coordinating the shift is accountable. NICE guidance National Institute for Health and Care Excellence, 2013, NICE medicines practice guidelines [MPG2] Patient Group Directions Guidance and guidelines NICE BNF MIMMS Green Book Stockley for Drug Interactions Current SPC (Last Updated on emc 13-July-2017) Department of Health Information Trust Protocols and Documents Local Formularies Audit details Annual snapshot audit of the medical notes October 2017 September 2019 Page 6 of 8

7 Training Clinical condition Chemotherapy induced nausea and vomiting. Medical treatment Management of potential side effects Competency assessment Successful completion of the NMC NURB 292 Care of the Patient Requiring Chemotherapy, NURB 360 Enhanced Care of the Patient Requiring Chemotherapy or equivalent course. Local chemotherapy competency document. Frequency of training / review process Chemotherapy competence to be maintained at yearly intervals by attendance of the CUREP study day. Please refer to the summary of product characteristics for full information This Patient Group Direction is operational from the start of October 2017 and expires end of September 2019 Version History Version Date Brief Summary of Change Owner s Name v 1.0 September New PGD developed by Cancer Services to enable Torbay and South Devon NHS 2017 registered nurses to supply Dexamethasone Foundation Trust For more information on the status of this document, contact: Medicines Governance Team Administrator Pharmacy Department Torbay Hospital tsdft.medicinesgovernance@nhs.net Date of Issue October 2017 Reference PGD 2210 v 1.0 Dexamethasone Path V:medicines governance/pgds/cancer Services/PGD 2210 v1.0 Dexamethasone Oct17-Sept19 October 2017 September 2019 Page 7 of 8

8 Patient Group Direction 2210 version 1.0 Supply of Dexamethasone for the Prevention of Chemotherapy Induced Nausea and Vomiting by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Objective: To enable nurses to efficiently prevent and treat chemotherapy induced nausea and vomiting by dispensing Dexamethasone 2mg to be taken TDS reducing by 2mg daily over 3 days. The individual practitioners named below are authorised to operate within the above PGD, being employees of Torbay and South Devon NHS Foundation Trust CLINICAL AREA LOCATION / DEPARTMENT The following list must be kept with a copy of the PGD in each clinical area using that PGD. Each practitioner will receive and sign for an individual copy of the PGD. Only fully competent, qualified and trained professionals may operate within PGDs. I agree to administer/supply the above preparation in accordance with this Patient Group Direction and I have received an up to date copy of the ratified PGD: NAME (please print) PROFESSIONAL TITLE SIGNATURE AUTHORISING MANAGER (please print) MANAGER S SIGNATURE DATE October 2017 September 2019 Page 8 of 8

9 Document Control Information This is a controlled document and should not be altered in any way without the express permission of the author or their representative. Please note this document is only valid from the date approved below, and checks should be made that it is the most up to date version available. If printed, this document is only valid for the day of printing. Ref No: 2210 Document title: Dexamethasone, Supply of within Cancer Services Purpose of document: Patient Group Direction Date of issue: 6 October 2017 Next review date: 30 September 2019 Version: 1 Last review date: Author: Physician Pharmacist Cancer & Vascular Access Advanced Nurse Practitioner Directorate: Medical Services Equality Impact: The guidance contained in this document is intended to be inclusive for all patients within the clinical group specified, regardless of age, disability, gender, gender identity, sexual orientation, race and ethnicity & religion or belief Committee(s) approving the document: Clinical Director of Pharmacy Trust, Medicines Management Committee Chair Date approved: 28 September 2017 Links or overlaps with other policies: All TSDFT Trust Strategies, policies and procedure documents Does this document have training implications? If yes please state: Please select Yes No Does this document have financial implications? If yes please state: Is this document a direct replacement for another? If yes please state which documents are being replaced: Document Amendment History Date Version no. Amendment summary Ratified by: 6 October New Clinical Director of Pharmacy Trust Medicines Management Committee Chair Collated by Clinical Effectiveness Dexamethasone, Supply of within Cancer Services Document Control Information