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Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. Shared Care Guideline for the use of Pregabalin in treating GAD Development Process This guidance has been produced by Sarah Hudson, Lead Pharmacist following an AMBER classification status of pregabalin by the Barnsley Area Prescribing Committee. This guideline has been subject to consultation and endorsement by the Area Prescribing Committee on 10 December 2014 and the LMC on 10th March 2015 Introduction Indication/Licensing information Pregabalin is licensed for General Anxiety Disorder. Its other indications are Peripheral and Central Neuropathic pain, adjunctive therapy for partial seizures with or without secondary generalisations. Dosage and administration Generalised anxiety disorder, ADULT over 18 years, initially 150 mg daily in 2–3 divided doses, increased if necessary at 7-day intervals in steps of 150 mg daily; max. 600 mg daily in 2–3 divided doses Capsules, pregabalin 25 mg (white), 84-cap pack = £96.60; 50 mg (white), 75 mg (white/orange), 100 mg (orange),150 mg (white),; 200 mg (orange), 225 mg (white/orange), 300 mg (white/orange), Responsibilities of the specialist initiating treatment Summary 1, Initiate and stabilise treatment with Pregabalin (this phase is expected to last at least six months). To initiate therapy, arrange prescription and evaluate over the first 3 months 2. Discuss the benefits and side effects of treatment with the patient. 3. Ask the GP whether he or she is willing to participate in shared care and agree with the GP as to who will discuss the shared care arrangement with the patient. 4. Periodically review the patient’s condition and communicate promptly with the GP when treatment is changed. To review the patient and treatment at least once a year until the patient is discharged from the mental health service where this is possible. 5. Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist. 6. Report serious adverse events to the MHRA and GP. 7. Ensure that clear back-up arrangements exist for GPs to obtain advice and support. Baseline Tests None required Routine Tests None required. Disease monitoring Please refer back to secondary care if patient deteriorates. Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Page 1 of 6 Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. Responsibilities of other prescribers Acceptance of Responsibility by the Primary Care Clinician It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on shared care only if they are willing and able. Summary 1. Reply to the request for shared care as soon as practicable. 2. Prescribe Pregabalin at the dose recommended. 3. Adjust the dose as advised by the specialist. 4. To monitor physical parameters such as weight, fasting blood sugar, BP, smoking status and full lipid screen where necessary (at least annually). 5. To request earlier specialist review or seek specialist advice when necessary. 6. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment. 7. Refer back to specialist if the patient’s condition deteriorates, as advised. 8. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 9. Report serious adverse events to the specialist and MHRA. Clinical Particulars BNF therapeutic class Cautions and Contraindications Adverse Drug Reactions Control of Epilepsy Hypersensitivity to active substance or excipients. Elderly population may experience falls due to side-effects of somnolence and dizziness Caution I use in people with a history of substance misuse The most common side-effects include somnolence and dizziness. Monitoring Other side-effects (less than 10%) include dry mouth, constipation, nausea, vomiting, drowsiness and insomnia. None required Interactions Can potentiate the sedative effects of CNS depressant medications. Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Page 2 of 6 Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. Communication Specialist to GP The specialist will inform the GP when they have initiated drug pregabalin. When the patient is near completing the satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and where possible give an indication as to the expected length of treatment. The Specialist will also send a Shared care request form to support the GP in undertaking shared care. (Appendix A) GP to specialist If the GP has concerns over the prescribing of drug pregabalin, they will contact the specialist as soon as possible. Contact names and details Contact Details Telephone number Email Sarah Hudson Lead Pharmacist 01226 434649 [email protected] Medicines Information 01924 327619 [email protected] References Dr S Chari (North Team) 01226 434171 BNF 64 http://www.medicinescomplete.com/mc/bnf/current/129077.htm SPC capsulesTeam) www.medicines.org.uk Dr GLyrica Kirk (Central 01226 433523 . [email protected] [email protected] Dr A Karan (South Team) 01226 341374 [email protected] Dr H Malik (Dearne Team) 01226 341374 [email protected] Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Page 3 of 6 Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. Appendix A – Shared Care request form (Amber) Specialist to complete when requesting GP to enter a shared care arrangement. GP to return signed copy of form. Both parties should retain a signed copy of the form in the patient’s record. From (Specialist): To (GP): Patient details Name: ID Number: Address: DOB: Diagnosed condition: Amber Drug details Drug name: Dose: Date of initiation: Length of treatment: The patient will be reviewed by the Consultant on: Telephone number(s) for contact: The patient should be reviewed by the GP by: Consultant: Date: Monitoring The following monitoring should be undertaken by the GP: Parameter Date next test due Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Frequency Page 4 of 6 Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. Communication Consultant Telephone number: Fax number: Email address: Specialist Nurse Telephone number: Fax number: Email address: Confirmation of acceptance of shared care Specialist (Doctor/Nurse) name: Specialist (Doctor/Nurse) signature: Date: I, Dr …………………………….., can confirm I : □ accept the request to participate in shared care for the patient named above. □ reject the request to participate in shared care for the patient named above. The reason for this being ……………………………………………………………………………………….. GP signature: Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Date: Page 5 of 6 Shared Care Protocol –remains open to review in light of any new evidence Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care. ALGORITHM FOR PHARMACOLOGICAL THERAPY OF GENERALIZED ANXIETY DISORDER 1st LINE SSRIs (PAROXETINE AND ESCITALOPRAM ARE LICENSED. HOWEVER, OTHER SSRIs ARE ALSO USED) 2nd LINE SNRIs (DULOXETINE AND VENLAFAXINE GENERALISED ANXIETY DISORDER) HAVE LICENCE FOR PLEASE ALSO NOTE THAT SSRIs/ SNRIs MAY TAKE UP TO 3 MONTHS TO HAVE A THERAPEUTIC EFFECT IF ABOVE FAILS/ INTOLERABLE DUE TO SIDE-EFFECTS : 3rd LINE PREGABALIN OR ANY OTHER DRUGS WITH SOME EVIDENCEBASED EFFICACY, SUCH AS BUSPIRONE, IMIPRAMINE ETC. Note: BENZODIAZEPINES NOT RECOMMENDED FOR MORE THAN FOUR WEEKS – AVOID IF POSSIBLE Drug pregabalin Shared care Guideline Date Prepared: December 2014 Review Date: December 2016 Page 6 of 6