THEOPHYLLINE WITH INHALED CORTICOSTEROIDS (TWICS) TRIAL SELF MANAGMENT / ACTION PLANS GENUAIR INHALERS: POTENTIAL SAFETY ISSUE

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1 I S S U E 4 M A R C H / A R P I L Endorsed December 2014 I N S I D E T H I S I S S U E : Theophylline with Inhaled Corticosteroids (TWICS) Trial Genuair Inhaler: Potential Safety Issue 1 Self Management / Action Plans Changes to Fife Formulary - Respiratory Discontinuation of Pulvinal DPI Prednisolone Amendment 4 Asthma Roadshows 5 Just in Case Boxes THEOPHYLLINE WITH INHALED CORTICOSTEROIDS (TWICS) TRIAL Fife Respiratory MCN were made aware of a trial being undertaken within Secondary Care on Theophylline with Inhaled CorticoSteroids (TWICS). This is a randomised placebo-controlled trial of Aminophylline (oral) alongside ICS in COPD patients who exacerbate two or more times per year. Patients taking part in the trial will be recruited from the respiratory ward and clinic. The trial will run from 1st March 2016 to 31st August GPs will be notified as and when patients are recruited to the trial. There is no need for General Practices to do anything except be mindful of the trial should patients on the trial present to the Practice. GENUAIR INHALERS: POTENTIAL SAFETY ISSUE A note of caution is advised regarding possible patient confusion when reading the dose counter on the Genuair device: Unlike many inhalers, the dose for Duaklir (aclindinium/formoterol) and Eklira (aclidinium) Genuair products reduce in intervals of 10 inhalations: 60, 50, 40, 30, 20, 10, 0. Successful inhalation of the dose is indicated by a change of colour in the control window of the inhaler, not by the dose counter reducing. Please ensure that patients are counselled appropriately to prevent inadvertent overdose. This information is courtesy of NHS Greater Glasgow and Clyde; please visit: for the full note of caution. SELF MANAGMENT / ACTION PLANS Self Management Action Plans allow patients to take control and self manage should they experience an exacerbation. The Fife Respiratory MCN encourages GPs and Practice Nurses to issue self management / action plans to patients at their annual reviews. Fife Respiratory MCN have developed local plans for COPD and bronchiectasis - both are available for download from the Respiratory MCN website or by clicking the links above. Chest Heart & Stroke Scotland have developed a Traffic Lights for COPD self management plan. Hard copies are available, free of charge, by contacting CHSS Head Office on or publications@chss.org.uk Asthma UK have downloadable action plans for both children and adults. The National Review of Asthma Deaths found that only 23% (44 out of 195) of the people who died from asthma were known to have a personal asthma action plan. Page 1

2 Following a review of Chapter 3 (Respiratory) of the Fife Formulary in September 2015, a number of changes were proposed and later accepted by the Area Drugs and Therapeutics Committee (ADTC). Key changes Removal of tiotropium as first choice LAMA Addition of umeclidinium as once daily LAMA with the associated LABA/LAMA combination device Layout change to page 2 of Appendix 3F: Guidance on Management of COPD Inhaled Therapy Changes to Chapter 3 General CHANGES TO FIFE FORMULARY - RESPIRATORY Section Change Rationale Short-acting beta agonists 1) Recommendation for combination inhalers preferable to two separate devices to aid compliance 2) Recommendation that all inhalers are prescribed by brand due to device variability - with the exception of salbutamol MDI No change Long-acting beta agonists Change from salmeterol to formoterol as preferred MDI single preparation combination preparations 1) Removal of tiotropium (handihaler) as first choice LAMA 2) Removal of first and second choices 3) Addition of umeclidinium (Incruse Ellipta) as once daily LAMA N.B Aclidinium (Eklira Genuair) remains on formulary as twice daily device. Addition of umeclidinium / vilanterol (Anoro Ellipta) N.B Aclidinium / formoterol (Duaklir Genuair) remains on formulary as twice daily combination device To ensure consistency between MDI and DPI In line with Lothian and Tayside formularies, other devices easier to use, and combination products available Selection of LAMA now dependent on patient / clinician preference for once or twice daily dosing Combination once daily LABA/LAMA device asthma indication Theophylline Combination bronchodilators Spacer devices Addition of tiotropium (Spiriva Respimat). Prescribing note added regarding tiotropium in asthma Prescribing point added Theophylline only considered if montelukast and tiotropium ineffective / unsuitable Removal of this section Compatible devices list: Atimose added Serevent, Ventolin and Flixotide removed Should only be considered when montelukast ineffective or considered inappropriate Safety issue due to interactions and narrow therapeutic index Ipratropium / salbutamol removed from the formulary and LABA/LAMA combinations included in LAMA section Updated to reflect formulary choices Page 2

3 Changes to Chapter 3 (cont) Nebulisers Asthma CHANGES TO FIFE FORMULARY - cont. Section Change Rationale Nebulisers should only be initiated by specialists Add short term course of oral steroids rather than doubling the dose of inhaled corticosteroid Spacer device and high dose inhaler preferred initially Evidence based Combination device table Split into COPD and asthma In order to place prescribing points adjacent to devices Asthma combination table Leukotrine receptor antagonist Antihistamines Removed first and second choice DPI Selection of ICS/LABA now dependent on patient / clinician preference for once or twice daily dosing Montelukast considered in patients with uncontrolled rhinitis Promethazine restricted to psychiatry Mucolytics Saline changed to sodium chloride Appendices Change Rationale 3A - Guidance on step-wise management of asthma Step 4: addition of tiotropium in adult asthma 3B - Asthma treatment in adults 3C - Asthma treatment in adolescents 3D - Asthma treatment in children 5-12 years old 3E - Asthma treatment in children less than 5 years old 3F - Guidance on management of COPD inhaled therapy Tiotropium added at Step 4 1st and 2nd line choice ICS/LABA removed 1st and 2nd line choice ICS/LABA removed Significant changes to layout of second page Reflects emphasis to differentiate between treating symptoms or exacerbations and includes all updated formulary choices Page 3

4 DISCONTINUATION OF PULVINAL DPI At the end of December a communication was circulated to all Practices advising of the discontinuation of Pulvinal dry powder inhalers. The following dry powder inhalers will no longer be available in the UK: Pulvinal (beclometasone dipropionate) 100mcg, 200mcg, 400mcg, and Pulvinal (salbutamol) 200mcg The Natinal Respiratory Prescribing Strategy, Fife Formulary and Fife Respiratory MCN stress the importance of good inhaler technique to ensure that patients receive their inhaled medication as intended. It is best for patients if all inhalers are of a similar type, either dry powder inhaler (DPI) or metered dose inhaler (MDI). Therefore, the MCN recommends that if patients have good inhaler technique with a DPI that they are changed to a similar one, but if inhaler technique is better with an MDI that this is considered. Pulvinal is non-formulary within NHS Fife, and the MCN would recommend that patients prescribed this are changed to the following dry powder inhalers (DPI) in line with the NHS Fife Formulary choices: Pulvinal inhaler Alternative DPI and recommended dose Alternative MDI and recommended dose Pulvinal salbutamol 200mcg / dose 100 dose inhaler 100mcg/dose 100 dose inhaler 200mcg/dose 100 dose inhaler 400mcg/dose 100 dose inhaler Easyhaler salbutamol Easyhaler budesonide 100mcg/dose 200dose inhaler. Easyhaler beclometasone Easyhaler budesonide 400mcg/dose 100 dose inhaler. Same dosage Salbutamol 100mcg/dose 200 dose inhaler. Inhale two puffs when required. Clenil (beclometasone) 100mcg/dose 200 dose inhaler. Clenil (beclometasone) Closest equivalent is Clenil (beclometasone) 250mcg/dose 200 dose inhaler. Inhale two puffs twice. Note 1: Greater number of doses within device, therefore quantity on prescription should be reduced to one. Recommendation Practices should identify patients prescribed Pulvinal inhalers and change to those inhalers recommended above. Please note that numbers of patients per practice will vary, dependent on current formulary compliance, and that some practices may not have any patients affected. Your Practice Pharmacist / Technician can provide guidance on the number of anticipated patients. PREDNISOLONE: amendment to previous article In the previous issue of the Respiratory MCN Newsletter (Issue 3, October 2015) we published some incorrect information regarding the cost of the 25mg Pevanti (pack size 56). The cost was incorrectly reported as 75 per 56 pack, the correct price of 25mg Pevanti pack size 56 is 40. Page 4

5 ASTHMA ROADSHOWS Gill Dennes, Joint Lead Clinical - Respiratory MCN, and Anne McKean, Paediatric Asthma Nurse Specialist, have been taking their asthma education presentation out on the road! Since October 2015, six Practices across Fife have taken up the offer of the education - and feedback received has been extremely positive. These interactive sessions allowed open discussion about both adult and children, and Practices were given the opportunity to prioritise the areas of discussion prior to the session: Child scenario; including discussion of paediatric asthma management Adult scenario; including 1 st and 2 nd line treatments BTS stepwise approach Fife Formulary Benefits of stepping up and down treatment Adrenal suppression Asthma review Positive feedback from these sessions has been received; including what was the most useful thing covered ; Highlighting the at risk asthmatics in our Practice Emergency rescue best practice Highlighting the NRAD [National Review of Asthma Deaths] issues Going over the drugs relating to the step-wise approach A full evaluation report of the sessions will be available on the intranet in due course. JUST IN CASE BOXES The Standard Operating Procedure for the issuing of Just in Case (JIC) boxes was updated in December There are no significant changes to the SOP, however, the update does clarify that: JIC should be prescribed in advance of the patient deteriorating, NOT at the point where a syringe pump is being considered. It also clarifies how the JIC box should be used once a syringe pump has been set up. Just in Case anticipates symptom management needs of palliative care patients who may deteriorate but are not yet at the stage where they may require more intensive input e.g., syringe driver. This may be days, weeks or months in advance of the JIC box. The JIC boxes are situated in the patient s home / place of care and assists in implementing continuity of care and preventing unwanted hospital admissions. The JIC box ensures availability of medicines likely to be needed urgently. There are four core drugs in the JIC box for: pain; respiratory tract secretions; breathlessness, terminal restlessness & agitation; and nausea & vomiting. For further information or to arrange training on JIC for your Practice or team, or have any queries regarding the system, please telephone Pharmacy Services on The SOP and accompanying information are available on the Respiratory MCN intranet. CONTACT US Lorraine Cooper-King, MCN Coordinator, Management Office Admin Block, Lynebank Hospital, Halbeath Road, Dunfermline, KY11 4UW Fife-uhb.respmcn@nhs.net Page 5