NORTH WALES NHS TRUST GLAN CLWYD HOSPITAL (CENTRAL AREA)
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1 NORTH WALES NHS TRUST GLAN CLWYD HOSPITAL (CENTRAL AREA) MINUTES OF THE CONWY & DENBIGHSHIRE DRUG & THERAPEUTICS COMMITTEE MEETING HELD IN THE RON & MARGARET SMITH SEMINAR ROOM, NORTH WALES CANCER TREATMENT CENTRE, GLAN CLWYD HOSPITAL ON TUESDAY 10 th FEBRUARY 2009 MEMBERS PRESENT Consultant Nephrologist (Chair) Partnership Pharmacist Consultant Pharmacist (Clinical Services) Principal Pharmacist (Formulary) Medical Director (LHB) Consultant Paediatrician Director of Pharmacy Consultant Microbiologist Head of Pharmacy & Medicines Management (LHB) Cancer Network Pharmacist Consultant Psychiatrist Consultant Gastroenterologist Consultant Anaesthetist Palliative Medicine Consultant APOLOGIES Assistant Director of Finance Head of Pharmacy & Medicines Management (LHB) Clinical Effectiveness Manager Consultant Orthopaedic Surgeon Professor of Cancer Studies IN ATTENDANCE 09/01 PATIENT SAFETY MESSAGE OF THE MONTH FEBRUARY The February Patient Safety Message was on Legible Signature on Notes Name Stamps. It is mandatory that medical staff use names stamps and if not possible must sign and print. A request for zero tolerance has been made to pharmacy that prescriptions are returned if they are not stamped or names legible. 09/02 DECLARATIONS OF INTERESTS The Consultant Pharmacist (Clinical Services) declared an interest in item 09/06(a) The Consultant Nephrologist (Chair) declared an interest in item 09/06(b) 09/03 MINUTES OF THE MEETING HELD ON THE 9 th DECEMBER 2008 The minutes were accepted as a true and accurate record. 1
2 09/04 MATTERS ARISING (a) Health care support workers and the administration/checking of medicines (minute 08/211 refers) Due to time constraints and attendance, an update is to be provided at the next meeting. (b) BuTrans Information Sheet (minute 08/214(d) refers) The Committee had received correspondence from the Pain Management Service advising that they would not be drawing up a Shared Care Agreement but would be developing an Opioid Contract that could be used in both primary and secondary care. The Opioid Contract is an individualised agreement setting out responsibilities for all parties. (c) Rivaroxaban for DVT prophylaxis following total hip replacement, requested by Consultant Orthopaedic Surgeon (minute 08/216(d) refers) Rivaroxaban has not yet been reviewed by NICE but this is due in June. This is an oral preparation with one dose for all patients instead of two as with dabigatran which already has NICE approval. Concern was raised that the application is for Mr s patients only and not all the Orthopaedic Surgeons, which raised issues around risk at having different practices on the ward and the Committee feels that a consistent approach is needed within the division. The Formulary Pharmacist advised that a DVT prophylaxis protocol had been handed to her for discussion at a future meeting. It was agreed that before approval is given that the Orthopaedic Surgeons are asked that they all use this and that rivaroxaban is added into the protocol. (d) Non-medical Prescribing Policy (minute 08/159, 08/171(d) and 08/190(a) refer) The Palliative Medicine Consultant asked the Committee if they would accept that mixing medicines within a syringe driver was classed as off-label rather than an unlicensed. The Committee were advised that mixing drugs in a syringe was best practice and that independent prescribers should be able to continue to do this and that it would allow patients to remain in their homes rather than to treat them within the hospital setting. It was agreed that the Committee would support this as best practice and the Palliative Medicine Consultant would contact the Welsh Legal Department to ensure that the Trust would indemnify these independent prescribers. 09/05 N WALES CANCER NETWORK FORMULARY GROUP The Chair of the N Wales Cancer Network Formulary Group attended the meeting to discuss this item. The Committee advised why this item had not been discussed at earlier meetings and also questioned the reasons for the non-inclusion of items within the formulary. The Committee were advised that the Formulary Group are trying to apply consistent clinical practice across North Wales and also the process for introducing new regimens and also discontinuing those that are not used. It is hoped that this process will be accepted by all three hospitals in North Wales. It was explained that those items not included in the formulary were those that had small numbers; five or less, these would be returned to the Trusts for them to make a decision within the local D&T. The Group will be provided a summary of what has been included/excluded and the reasons why. The Committee were advised that any items that were referred back to the Trusts would be able to seek expert advice from DH, TP or NS. This would also apply for requests the DTC 2
3 Executive were asked to decide upon. It was agreed to approve the changes proposed by the N Wales Cancer Network Formulary Group. 09/06 NEW DRUG APPLICATIONS (a) Clopidogrel for patients undergoing percutaneous coronary angioplasty and stenting (PCI). Requested by Consultant Cardiologist This application has been made for those patients undergoing percutaneous coronary angioplasty and stenting (PCI) within Glan Clwyd Hospital. These patients would previously have received this treatment when they travelled to Liverpool or Manchester for this procedure to be carried out. It was agreed to approve the application. (b) Insulin glulisine (Apidra). Requested by Consultant Diabetologists This application is for a short acting analogue can be used in a pen device, which tends to be more acceptable with patients and aids compliance. This insulin would not replace others that are already on the formulary but gives prescribers more choice for the most suitable insulin for their patient. The DTC in the East has previously approved this insulin. It was agreed to approve the application. 09/07 UNLICENSED DRUG REQUESTS (a) Bio Kult as pro-biotic treatment in a child with Hirschprung Disease. Requested Consultant Paediatrician This application has been made for a patient already using Bio Kult on the recommendation from Alder Hey Children s Hospital and if approved would aid in the logistics of providing it for the child. It was agreed not to approve the application as it has not been approved by Alder Hey Drug & Therapeutics Committee and due to insufficient evidence of effectiveness. (b) Intrathecal diamorphine for elective hip and knee surgery at Abergele Hospital. Requested by Anaesthetic Department. Intrathecal morphine which is currently used at YGC which can cause delayed respiratory depression occurring 6-14 hours after administration, whereas for intrathecal diamorphine respiratory depression occurs 4-6 hours after administration. The use of intrathecal morphine is precluded at Abergele as there is no on-call anaesthetist on site should delayed respiratory depression were to occur. Respiratory depression occurring from diamorphine was more likely to occur when anaesthetists were still on site. It was agreed to use intrathecal diamorphine at Abergele and to also explore the use on the Glan Clwyd site. (c) Pentoxyfylline and tocopherol (vitamin E) and clodronate (Bonefos) to prevent and treat osteoradionecrosis of the jaws. Requested by Consultant Maxillofacial Surgeon. There is currently no existing prevention / treatment of osteoradionecrosis of the jaw other than hyperbaric oxygen and surgery and with the oxygen treatment the wound does not always heal and surgery would still be required. It was agreed to approve the application and that an audit be carried out for twelve months and reported back to the Committee. A decision on whether to continue its use would be agreed after such time. For information of DTC decisions: (d) Plerixafor for Mobilisation of haematopoietic stem cells. Requested 3
4 Consultant Haematologist The Executive approved this application by Dr. (e) GDCVP regimen (gemcitabine, dacarbazine, cyclophosphamide, vincristine and prednisolone) for relapsed Hodgkin s lymphoma. Requested by Consultant Haematologist The Executive approved this application for use in an individual patient. 09/08 FOR RATIFICATION The Committee had received a reminder that any guidelines for approval should not be discussed or approved without confirmation that consultation had taken place with relevant colleagues in the East Division. (a) PGD Cyclopentolate Hydrochloride 1% eye drops for Orthoptists (renewal) It was agreed to approve the renewal. (b) PGD Ceftriaxone and Gentamicin for the treatment of suspected neutropenic pyrexia (new) This PGD has been drawn up as there is a delay with patients receiving the first dose of antibiotics. Concern was raised that this should be a Patient Specific Direction (PSD) rather than PGD as some patients may telephone the Cancer Centre before presenting for treatment. The Committee were advised that triage only took place on Enfys Ward between the hours of 9am and 5pm. Therefore, it was agreed to approve the PGD as long as the Medical Division were happy with their Doctors involvement. (c) Clopidogrel for STEMI Concern was raised that the relevant NICE Guidance had not been referred to within the document, that the Cardiac Network have recently finalised their guidelines which differs to this and also the extension from four weeks to twelve month treatment. It was agreed that the Principal Pharmacist (Formulary) would speak to the author and request that a Cardiologist attends the next meeting. (d) All Wales Anticoagulation Chart An all Wales Group of Pharmacists and Haematologists have been looking at having a standard form across Wales. There has been difficulty in getting agreement from all areas. The all Wales chart is based on a chart which had been drawn up in Glan Clwyd, but this chart has improved greatly since then. The Committee were advised that in practice the initiation protocols are frequently not followed in secondary care. There is also concern that currently the three acute sites in North Wales use different forms and once all merged this would become an issue. If the Trust did not use the all Wales form it will not be able to utilise the e-learning package that is being made to educate staff. Support was given to look at developing a North Wales form based on the all-wales form because of all the progress that has been made in Glan Clwyd Hospital with SPI and also 1,000 Lives Campaign. (e) Guidelines For The Management of Clostridium difficile Associated Diarrhoea The Consultant Microbiologist confirmed that this guideline had been drawn up with consultation of colleagues in the East. Concern had been raised on point 8 by the Gastroenterologists, it was agreed to approve the guideline and that the Consultant 4
5 Microbiologist and Gastroenterologist would work together to reword point 8 appropriately so that this guideline can be used as soon as possible. (f) Inpatient Pain Service Clinical Guidelines (Acute Pain Guidelines) (g) Guidelines For Management of Acutely Disturbed Adults (18 to 65 years) Rapid Tranquilisation The Consultant Psychiatrist advised the Committee that the East had their own guidelines for rapid tranquilisation and feels that these would be more appropriate for Central to use. It was agreed to look at the use of the East Guidelines and localise them for Central use. (h) Therapeutic Drug Substitution Clarithromycin for Erythromycin The Director of Pharmacy advised that this is not a guideline and is a recommendation to switch use of drug. It was agreed to approve the therapeutic substitution. (i) Easyhaler device for the inhaled treatment of Asthma and COPD Information Sheet for Healthcare professionals (j) North Wales Osteoporosis Network update i. Guidelines for the Management of Osteoporosis * ii. Ibandronic Acid (Bondronat ) for the management of Metastatic Bone Disease in Breast Cancer Information Sheet for Healthcare professionals iii. Calcitonin (Salmon) 200 units nasal spray (Miacalcic ) Information Sheet for GPs iv. NWCTC Guidelines for the use of bisphosphonates v. Letter to Dentists Bisphosphonates Related Osteonecrosis of the Jaws (BRONJ) These guidelines (*) have been drawn up on a North Wales basis and has had consultation with all relevant colleagues in the East. It was agreed to approve these guidelines. The other items were not discussed due to time constraints, to be put on the agenda of the next meeting. (k) Stillbirths, Late Miscarriages and Termination of Pregnancy from 20 weeks 09/09 FEEDBACK FROM (a) Safer Medicines Group November 2008 Issues of significance and minutes (b) Mental Health Medicines Management Sub-Committee October 2008 Minutes (c) Mental Health Medicines Management Sub-Committee December 2008 Issues of Significance and minutes (d) Diabetologists re Exenatide and Sitagliptin usage Items not discussed due to time constraints. 09/10 NICE TECHNOLOGY APPRAISALS 5
6 (a) TA 163 Infliximab for acute exacerbations of ulcerative colitis (b) TA 164 Febuxostat for the management of hyperuricaemia in people with gout 09/11 AWMSG MINISTERIAL RATIFICATIONS (a) Atazanavir (Reyataz ) for the treatment of HIV-1 infected adults in combination with other antiretroviral medicinal products: for treatmentexperienced patients (b) Atazanavir (Reyataz ) for the treatment of HIV-1 infected adults in combination with other antiretroviral medical products: for treatment-naïve patients (c) Alemtuzumab (MabCampath ) for the treatment of patients with B-cell chronic lymphocytic leukaemia for whom fludarabine combination chemotherapy is not appropriate (d) Tenofovir disoproxil fumarate (Viread ) for the treatment of hepatitis B Ministerial ratification has been received approving the recommendations by the AWMSG for the use of the above products within the NHS in Wales. 09/12 FOR INFORMATION (a) MHRA Drug Safety Update January 2009 (b) MHRA Drug Safety Update February 2009 (c) N Wales Drug & Therapeutics Committee (East) Minutes December 2008 For information. 09/13 ITEMS OF SIGNIFICANCE FOR EMT (a) 09/06 a & b (b) 09/07 b & c (c) 09/08 a, b, e & h 09/14 ANY OTHER BUSINESS No items raised due to time constraints. 09/15 DATE OF NEXT MEETING Tuesday 10 th March 2009, till 2pm, Board Room, 100 Bowen Court 6
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