| Formulary Chapter 3: Respiratory system - Full Chapter
|
| Notes: |
*Important*
The NENC ICB Respiratory Network recommends that all inhalers should be prescribed by brand for patient safety, to ensure that the correct device is dispensed to support correct technique and avoid patient confusion and medication errors.
Choice of inhaler device should be based on patient ability to use. Devices should be chosen based on availability for the type of drug to be prescribed and the patient’s ability to use it.
Refer to local guidelines for information on preferred options.
Note: All new patients should be started on the updated formulary choices as per local/national guidelines.
When inhalers are removed from the formulary, existing, stable, patients should continue to receive the non-formulary device. Treatment should not be changed unless a full face to face review has been conducted. |
|
| Chapter Links... |
 BTS/SIGN British Guideline on the Management of Asthma |
| County Durham and Tees Valley COPD Treatment Guide |
| County Durham and Tees Valley Adult Asthma Inhaler Guide |
| County Durham and Tees Valley Paediatric Asthma Inhaler Guide |
 North of Tyne, Gateshead and North Cumbria - Asthma in Children Summary Guideline |
| North of Tyne, Gateshead and North Cumbria - COPD Management Guide |
| North of Tyne, Gateshead and North Cumbria - Paediatric Asthma Inhaler Guidance (Children under 5 years) |
| South Tyneside and Sunderland - Asthma Guidance (RS1) |
| South Tyneside and Sunderland - Guidance for Choice of Inhalers for Asthma (RS2) |
| South Tyneside and Sunderland - Guideline for the treatment of COPD (RS3) |
| South Tyneside and Sunderland - Guideline for the Choice of Inhalers for COPD (RS4) |
| NICE NG80: Asthma: diagnosis, monitoring and chronic asthma management |
| NICE NG115: Chronic obstructive pulmonary disease in over 16s: diagnosis and management |
| MHRA Drug Safety Update (July 2018): Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects |
| NENC Regional ‘At A Glance Carbon Footprint Guidance’ |
| NICE TA10: Asthma inhaler devices (children under 5) |
| NICE TA38: Asthma inhaler devices (older children) |
| North Cumbria - Paediatric doses of inhaled corticosteroids |
| North East and North Cumbria Clinical Network Guide - Supporting Greener Respiratory Care |
| Details... |
| 03.01 |
Bronchodilators |
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|
Magnesium Sulphate
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Formulary
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|
MHRA Drug Safety Update (May 2019): Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy
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| 03.01 |
Asthma |
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| 03.01 |
Chronic obstructive pulmonary disease |
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|
| 03.01 |
Croup |
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|
| 03.01.01 |
Adrenoceptor agonists |
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|
| 03.01.01.01 |
Selective Beta2 agonists |
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|
 |
**The propellants used in pressurised Metered Dose Inhalers (pMDIs) have a high carbon footprint. Dry Powder Inhalers (DPIs) are now first choice for all of the different inhaler classes and should be used wherever this is clinically appropriate** |
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| 03.01.01.01 |
Short-acting beta2 agonists |
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|
Salbutamol
|
Formulary
|
- REFER TO LOCAL GUIDELINES FOR ADVICE ON PREFERRED CHOICE
- Easyhaler® breath actuated dry powder inhaler 100 mcg/puff (DPI)
- Accuhaler® breath actuated dry powder inhaler 200 mcg/puff (DPI)
- 100 mcg/puff CFC-free MDI - Salamol® (pMDI)
- 100 mcg/puff breath actuated CFC-free MDI (pMDI)
- Salamol® Easi-Breathe - alternative for patients hypersensitive to lactose or milk protein
- 2.5mg in 2.5ml & 5mg in 2.5ml nebules (Medicine Supply Notification 028 - Supply issue with salbutamol 2.5mg/2.5ml nebuliser liquid unit dose vials)
- 2mg in 5ml sugar-free oral solution
|
National Patient Safety Alert - Shortage of salbutamol 2.5mg/2.5ml and 5mg/2.5ml nebuliser liquid unit dose vials (26 February 2024)
MHRA Drug Safety Update (Aug 2022): Nebulised asthma rescue therapy in children: home use of nebulisers in paediatric asthma should be initiated and managed only by specialists
|
Salbutamol Injection
|
Formulary
|
- 500 mcg in 1ml & 5mg in 5ml injections
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|
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Terbutaline
|
Formulary
|
- Turbohaler® 500 mcg/puff (DPI)
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|
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Terbutaline Injection
|
Formulary
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|
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Terbutaline Nebules
|
Formulary
|
- 2.5mg/ml nebuliser solution
|
MHRA Drug Safety Update (Aug 2022): Nebulised asthma rescue therapy in children: home use of nebulisers in paediatric asthma should be initiated and managed only by specialists
|
| 03.01.01.01 |
Long-acting beta2 agonists |
|
|
Formoterol
|
Formulary
|
- 6 mcg & 12 mcg/puff breath actuated dry powder inhaler (DPI) - Turbohaler®
|
|
|
Salmeterol
|
|
- 50 mcg/puff breath actuated dry powdered inhaler (DPI) - Accuhaler®
- 25 mcg/puff metered dose inhaler (pMDI)
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|
|
| 03.01.01.02 |
Other adrenoceptor agonists |
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|
| |
**The propellants used in pressurised Metered Dose Inhalers (pMDIs) have a high carbon footprint. Dry Powder Inhalers (DPIs) are now first choice for all of the different inhaler classes and should be used wherever this is clinically appropriate** |
|
Ephedrine Hydrochloride
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Formulary
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| 03.01.02 |
Antimuscarinic bronchodilators |
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|
| |
**The propellants used in pressurised Metered Dose Inhalers (pMDIs) have a high carbon footprint. Dry Powder Inhalers (DPIs) are now first choice for all of the different inhaler classes and should be used wherever this is clinically appropriate** |
|
Tiotropium (Respimat®)
|
Formulary
|
- 2.5mg Respimat® inhaler
- Step 4 of the BTS/SIGN Asthma guidelines. Treatment should be stopped if not effective.
|
MHRA Drug Safety Update (Feb 2015): Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial
|
Umeclidinium (Incruse Ellipta®)
|
Formulary
|
- 55 microgram/dose (equivalent to umeclidinium bromide 65m microgram/dose) dry powder inhaler (DPI)
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Tiotropium (Handihaler®)
|
Formulary
|
- 18 mcg inhalation powder capsule (Handihaler®) (DPI)
- For existing COPD patients only and those unable to use the other LAMA devices. Consideration should be given to switching at next review, providing adequate training / counselling is provided in device use.
|
MHRA Drug Safety Update (Feb 2015): Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial
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Glycopyrronium (Seebri Breezhaler®)
|
Formulary
|
- 44microgram (equivalent to 55 micrograms of glycopyrronium bromide) powder capsule with device (DPI)
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Aclidinium (Eklira Genuair®)
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Formulary
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- 322 microgram/dose (equivalent to aclidinium bromide 375 microgram/dose) inhalation powder (DPI)
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Ipratropium Nebules
|
Formulary
|
- 250 microgram/1ml & 500 microgram/1ml nebuliser liquid
|
MHRA Drug Safety Update (Aug 2022): Nebulised asthma rescue therapy in children: home use of nebulisers in paediatric asthma should be initiated and managed only by specialists
|
| 03.01.02 |
Short Acting Anti-muscarinic Bronchodilators |
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| 03.01.02 |
Long Acting Anti-muscarinic Bronchodilators |
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|
| 03.01.03 |
Theophylline |
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|
| |
Seldom indicated. Modified release formulations must be prescribed by brand name.
Asthma: consider for patients not controlled on LABA plus inhaled corticosteroid (ICS) discontinue if no benefit see national guidelines. |
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Aminophylline Injection
|
Formulary
|
- 250mg/10ml injection
- COPD: intravenous aminophylline of limited benefit.
- Injection used in hospital for acute asthma not responding to steroids and continuous inhaled bronchodilators.
- Plasma levels need to be checked before administration if patient has previously taken theophylline/ aminophylline.
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|
|
Theophylline (Uniphyllin ®)
|
Formulary
|
- 200mg, 300mg and 400mg MR tablet
- Green plus50 mg/5 mL oral solution -
 unlicensed
|
MHRA Drug Safety Update (Dec 2014): Smoking and smoking cessation: clinically significant interactions with commonly used medicines
|
| 03.01.04 |
Compound bronchodilator preparations |
|
|
| |
**The propellants used in Pressurised Metered Dose Inhalers (pMDIs) have a high carbon footprint. Dry Powder Inhalers (DPIs) are now first choice for all of the different inhaler classes and should be used wherever this is clinically appropriate** |
|
Glycopyrronium & formoterol (Bevespi Aerosphere®)
|
Formulary
|
- Glycopyrronium 7.2 microgram/dose & formoterol 5 microgram/dose (equivalent to Glycopyrronium (as Glycopyrronium bromide) 7.2 microgram /dose & formoterol fumarate dihydrate 5 microgram/dose) pressurised metered dose inhaler - (pMDI)
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Glycopyyronium & indacaterol (Ultibro Breezhaler®)
|
Formulary
|
- Glycopyrronium 43 microgram/dose & indacaterol 85 microgram/dose (equivalent to glycopyrronium bromide 54 microgram/dose & indacaterol maleate 85 microgram/dose) inhalation powder capsules (DPI)
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Tiotropium & olodaterol (Spiolto Respimat®)
|
Formulary
|
- Tiotropium 2.5 microgram/dose & olodaterol 2.5 microgram/dose pressurised metered dose inhaler - (pMDI)
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|
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Umeclidinium & vilanterol (Anoro Ellipta®)
|
Formulary
|
- Umeclidinium55 microgram/dose & vilanterol 22 microgram/dose (equivalent to umeclidinium bromide 65 microgram/dose & vilanterol (as vilanterol trifenatate) 22 microgram/dose) dry powder inhaler (DPI)
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|
Aclidinium & formoterol (Duaklir Genuair®)
|
Formulary
|
- Aclidinium 340 microgram/dose & formoterol 12 microgram/dose (equivalent to aclidinium bromide 396 microgram/dose, formoterol fumarate dihydrate 11.8 microgram/dose) inhalation powder (DPI)
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| 03.01.05 |
Peak flow meters, inhaler devices and nebulisers |
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| 03.01.05 |
Peak flow meters |
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| 03.01.05 |
Drug delivery devices |
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AeroChamber Plus®
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Formulary
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AeroChamber® Flow-Vu
|
Formulary
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Space Chamber Plus®
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Formulary
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Volumatic®
|
Formulary
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| 03.01.05 |
Nebulisers |
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| 03.01.05 |
Nebuliser Diluent |
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| 03.02 |
Corticosteroids |
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|
| |
Note: For COPD patients on the LABA/LAMA combinations who require escalating to triple therapy with inhaled corticosteroid (ICS) it is appropriate to leave patients on their existing LABA/LAMA and add in a single agent ICS (off label use).
**The propellants used in pressurised Metered Dose Inhalers (pMDIs) have a high carbon footprint. Dry Powder Inhalers (DPIs) are now first choice for all of the different inhaler classes and should be used wherever this is clinically appropriate** |
|
Budesonide
|
Formulary
|
- 100 microgram/dose dry powder inhaler - Easyhaler® (DPI)
- 100 microgram/dose dry powder inhaler - Turbohaler® (DPI)
- 500 microgram/2ml & 1mg/2ml nebuliser liquid
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Beclometasone (Qvar®)
|
Formulary
|
- QVAR® CFC-free MDI: 50mcg, 100mcg per puff
- QVAR® breath-actuated MDI: 50mcg, 100mcg per puff
- N.B. CFC-free beclometasone must be prescribed by brand name.
- 50mcg QVAR is equivalent to 100mcg for a conventional beclometasone inhaler and 100mcg is equivalent to 250mcg conventional beclometasone.
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Beclometasone dipropionate (Clenil Modulite®)
|
Formulary
|
- 50 / 100 / 200 / 250 microgram/dose pressurised metered dose inhaler (pMDI) - Clenil Modulite®
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Fluticasone propionate (Flixotide®)
|
Formulary
|
- 50mcg/inhalation
- Approved for asthma in children only
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Fluticasone propionate and formoterol (Flutiform®)
|
Formulary
|
- 50/5mcg per puff
- 125/5mcg per puff
- 250/10mcg per puff
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|
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Fluticasone propionate and salmeterol (Combisal®)
|
Formulary
|
- Fluticasone 50microgram & salmeterol 25 microgram; fluticasone 125microgram & salmeterol 25 microgram; & fluticasone 250microgram & salmeterol 25 microgram (pMDI)
- Approved for asthma in children only
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|
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Fluticasone propionate and salmeterol (Sereflo®)
|
Formulary
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Fluticasone propionate and salmeterol (Seretide®)
|
Formulary
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Fluticasone propionate and salmeterol (Sirdupla®)
|
Formulary
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| 03.02.01 |
Long-acting beta2 agonists (ICS/LABA) |
|
|
| 03.02.02 |
long-acting muscarinic antagonist (ICS/LABA/LAMA) |
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Mometasone, Indacaterol & glycopyrronium (Enerzair Breezhaler®)
|
Formulary
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- Mometasone 136 microgram/dose, indacaterol 114 microcram/dose & glycopyrronium 46 microgram/dose inhalation powder capsules (DPI)
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| 03.02.02 |
Low dose |
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| 03.02.02 |
Moderate dose |
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| 03.02.02 |
High dose |
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| 03.02.03 |
Combination products (ICS+LABA) for COPD |
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Budesonide and formoterol (DuoResp Spiromax®)
|
Formulary
|
- Budesonide 160 microgram/dose & formoterol 4.5 microgram/dose (equivalent to budesonide 200 microgram/dose & formoterol fumarate dihydrate 6 microgram/dose) dry powder inhaler (DPI)
- Budesonide 320 microgram/dose & formoterol 9 microgram/dose (equivalent to budesonide 400 microgram/dose & formoterol fumarate dihydrate 12 microgram/dose) dry powder inhaler (DPI)
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|
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Budesonide and formoterol (Fobumix®)
|
Formulary
|
- Budesonide 80 microgram/dose & formoterol 4.5 microgram/dose (equivalent to budesonide 100 microgram/dose & formoterol fumarate dihydrate 6 microgram/dose) dry powder inhaler - Easyhaler (DPI)
- Budesonide 160 microgram/dose & formoterol 4.5 microgram/dose (equivalent to budesonide 200 microgram/dose & formoterol fumarate dihydrate 6 microgram/dose) dry powder inhaler - Easyhaler (DPI)
- Budesonide 320 microgram/dose & formoterol 9 microgram/dose (equivalent to budesonide 400 microgram/dose & formoterol fumarate dihydrate 12 microgram/dose) dry powder inhaler - Easyhaler (DPI)
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|
|
Budesonide and formoterol (Symbicort Turbohaler®)
|
Formulary
|
- Budesonide 200 microgram/dose & formoterol 6 microgram/dose inhalation powder (DPI)
- Budesonide 400 microgram/dose & formoterol 12 microgram/dose inhalation powder (DPI)
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|
|
Mometasone and indacaterol (Atectura®)
|
Formulary
|
- Mometasone furoate 127.5 microgram/dose & indacaterol 125 microcram/dose inhalation powder capsules (DPI)
- Mometasone furoate 260 microgram/dose & indacaterol 125 microcram/dose inhalation powder capsules (DPI)
- Both strengths approved for asthma only
|
|
|
Beclometasone and formoterol (Fostair NEXThaler®)
|
Formulary
|
- Beclomethasone 100 microgram/dose & formoterol 6 microgram/dose dry powder inhaler (DPI)
- Beclomethasone 200 microgram/dose & formoterol 6 microgram/dose dry powder inhaler (DPI)
|
|
|
Beclometasone and formoterol (Fostair®)
|
Formulary
|
- Beclomethasone dipropionate 100 microgram/dose & formoterol 6 microgram/dose pressurised metered dose inhaler (pMDI)
- Beclomethasone dipropionate 200 microgram/dose & formoterol 6 microgram/dose pressurised metered dose inhaler (pMDI)
|
|
|
Beclometasone and formoterol (Luforbec®)
|
Formulary
|
- Beclomethasone dipropionate 100 microgram/dose & formoterol 6 microgram/dose pressurised metered dose inhaler (pMDI)
- Additional treatment option
|
|
|
Fluticasone furoate & vilanterol (Relvar Ellipta®)
|
Formulary
|
- Fluticasone 22 microgram/dose & vilanterol 92 microgram/dose dry powder inhaler (DPI): Licensed for COPD and asthma.
- Fluticasone 22 microgram/dose & vilanterol 184 microgram/dose dry powder inhaler (DPI): Licensed for asthma only.
|
|
|
| 03.02.03 |
Triple Therapy products |
|
|
Beclometasone, formoterol & glycopyrronium (Trimbow®)
|
Formulary
|
- Beclometasone 87 microgram/dose, formoterol 5 microgram/dose & glycopyrronium 9 microgram/dose pressurised metered dose inhaler (pMDI)
- Beclometasone 172 microgram/dose, formoterol 5 microgram/dose & glycopyrronium 9 microgram/dose pressurised metered dose inhaler (pMDI)
|
|
|
Beclomethasone, formoterol & glycopyrronium (Trimbow NEXThaler®)
|
Formulary
|
- Beclomethasone 88 microgram/dose, formoterol 5 microgram/dose & glycopyrronium 9 microgram/dose dry powder inhaler (DPI)
|
|
|
Fluticasone, umeclidinium & vilanterol (Trelegy Ellipta®)
|
Formulary
|
- Fluticasone 92 microgram/dose, umeclinidium 65 microgram/dose & vilanterol 22 microgram/dose dry powder inhaler (DPI)
|
|
|
Budesonide, formoterol & glycopyrronium (Trixeo Aerosphere® )
|
Formulary
|
- Formoterol 5 microgram/dose, glycopyrronium 7.2 microgram/dose & budesonide 160 microgram/dose pressurised metered dose inhaler (pMDI)
|
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| 03.03 |
Cromoglicate, related therapy and leukotriene receptor antagonists |
|
|
| 03.03.01 |
Cromoglicate and related therapy |
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|
| 03.03.01 |
Related therapy |
|
|
| 03.03.02 |
Leukotriene receptor antagonists |
|
|
Montelukast
|
Formulary
|
- Review treatment after 6 weeks of initiation and discontinue if no evidence of improvement. Should typically only be initiated by hospital specialist.
- Montelukast is 2nd line after an inhaled corticosteroid for asthmatic children < 5 years old.
|
MHRA Drug Safety Update (April 2024): Montelukast: reminder of the risk of neuropsychiatric reactions
MHRA Drug Safety Update (Sept 2019): Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
|
| 03.03.03 |
Phosphodiesterase type-4 inhibitors |
|
|
Roflumilast (Daxas®)
|
Formulary
|
- 500microgram film-coated tablets
- Approved for the treatment of chronic obstructive pulmonary disease in line with NICE
|
NICE TA461: Roflumilast for treating chronic obstructive pulmonary disease
|
| 03.04 |
Antihistamines, hyposensitisation, and allergic emergencies |
|
|
| 03.04.01 |
Antihistamines |
|
|
| 03.04.01 |
Non-sedating antihistamines |
|
|
Cetirizine
|
First Choice
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|
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Loratadine
|
First Choice
|
|
|
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Desloratadine
|
Alternatives
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Fexofenadine
|
Alternatives
|
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|
|
| 03.04.01 |
Sedating antihistamines |
|
|
Chlorphenamine
|
First Choice
|
|
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Promethazine
|
Second Choice
|
|
|
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Hydroxyzine
|
Alternatives
|
|
MHRA Drug Safety Update (April 2015): Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes
|
Alimemazine
|
Alternatives
|
- Hospital only for the following indications
- Enteral sedation in paediatric ITU setting
- Use in patients where promethazine has failed
- Existing patients can continue to be prescribed in primary care until a treatment review has taken place
|
|
|
| 03.04.02 |
Allergen Immunotherapy |
|
|
Bee and Wasp Allergen Extracts (Pharmalgen®)
|
Formulary
|
- For use in adults and children by adult and paediatric immunologists only. Only approved for use in accordance with NICE guidance.
|
NICE TA246: Pharmalgen for the treatment of bee and wasp venom allergy
|
Grass and Tree Pollen Extract (Pollinex®)
|
Formulary
|
- For use in adults and children by adult and paediatric immunologists only.
|
|
|
Grass pollen extract (Grazax®)
|
Formulary
|
|
|
|
House dust mite allergen immunotherapy (Acarizax®)
|
Formulary
|
- 12 SQ-HDM oral lyophilisates
- Approved for the treatment of house dust mite allergy.
- Licensed alternative to Oralvac®
|
|
|
Peanut Allergy (Palforzia®)
|
Formulary
|
- 0.5mg, 1mg, 10mg, 20mg and 100mg oral powder in capsules for opening
- 300mg oral powder (sachets)
- Approved for the treatment of peanut allergy in children and young people in line with NICE
|
NICE TA769: Palforzia for treating peanut allergy in children and young people
|
White birch (Betula verrucosa) 12 SQ-Bet* per oral lyophilisate (ITULAZAX® 12 SQ-Bet oral lyophilisate)
|
Formulary
|
- For moderate to severe allergic rhinitis and/or conjunctivitis due to tree pollen (birch homologous group)
|
|
|
Grass and Tree Pollen Extract (Pollinex Quattro®)
|
Formulary
|
- For use in adults and children by adult and paediatric immunologists only.
- Less injections than with conventional Pollinex®
|
|
|
| 03.04.02 |
Monoclonal antibodies |
|
|
Benralizumab (Fasenra®)
|
Formulary
|
- 30mg/1ml solution for injection (pre-filled devices)
- Approved for treating severe eosinophilic asthma in adults in line with NICE and NHS England Commissioning Policy.
|
NICE TA565: Benralizumab for treating severe eosinophilic asthma
|
Dupilumab (Dupixent®)
|
Formulary
|
- 200mg/1.14ml & 300mg/2ml solution for injection
- Approved for or treating severe asthma with type 2 inflammation that is inadequately controlled in people 12 years and over in line with NICE
|
MHRA Drug Safety Update Nov 2022: Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
NICE TA751: Dupilumab for treating severe asthma with type 2 inflammation
|
Mepolizumab (Nucala®)
|
Formulary
|
- 100mg/1ml solution for injection (pre-filled devices)
- Approved for the treatment of severe refractory eosinophilic asthma in line with NICE and NHS England Commissioning Policy.
|
NICE TA671: Mepolizumab for treating severe eosinophilic asthma
|
Omalizumab (Xolair®)
|
Formulary
|
- 75mg/0.5ml & 150mg/1ml solution for injection (pre-filled devices)
- Only approved for use in accordance with NICE guidance.
|
NICE TA278: Omalizumab for treating allergic asthma
NICE TA339: Omalizumab for previously treated chronic spontaneous urticaria
NICE TA678: Omalizumab for treating chronic rhinosinusitis with nasal polyps (terminated appraisal)
|
Reslizumab (Cinquil®)
|
Formulary
|
- 10 mg/mL concentrate for solution for infusion
- Approved for the treatment of severe eosinophilic asthma in line with NICE and NHS England Commissioning Policy
|
NICE TA479 Reslizumab for treating severe eosinophilic asthma
|
Tezepelumab (Tezspire®)
|
Formulary
|
- 210mg/1.91ml solution for injection (pre-filled devices)
- Approved for treating severe asthma in paeople 12 years and over in line with NICE and NHS England Specialised Commissioning Policy (SSC2536)
- Only available from:
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- South Tyneside and Sunderland NHS Foundation Trust
- South Tees Hopsitals NHS Foundation Trust
|
NICE TA880: Tezepelumab for treating severe asthma
|
| 03.04.03 |
Allergic emergencies |
|
|
| 03.04.03 |
Anaphylaxis |
|
|
Adrenaline / Epinephrine (Emerade®)
(500 microgram)
|
Formulary
|
- Approved for use in the emergency treatment of anaphylaxis for patients with a BMI of >40 or who have required more than one auto-injector previously to control symptoms. Specialist immunologist initiation only
 .
- Approved for use by NUTH Community Dental Team in anaphylaxis boxes .
|
MHRA Drug Safety Update (Aug 2017): Adrenaline auto- injectors: updated advice after European review
MHRA Drug Safety Update (June 2023) : Adrenaline auto-injectors (AAIs): new guidance and resources for safe use
MHRA Drug Safety Update (May 2014): always call an ambulance after use of an adrenaline auto-injector
MHRA Drug Safety Update (Nov 2021): Adrenaline auto-injectors: reminder for prescribers to support safe and effective use
|
Adrenaline / Epinephrine (Jext® & Jext Junior®)
|
Formulary
|
|
MHRA Drug Safety Update (Aug 2017): Adrenaline auto-injectors: updated advice after European review
MHRA Drug Safety Update (June 2023) : Adrenaline auto-injectors (AAIs): new guidance and resources for safe use
MHRA Drug Safety Update (May 2014): always call an ambulance after use of an adrenaline auto-injector
MHRA Drug Safety Update (Nov 2021): Adrenaline auto-injectors: reminder for prescribers to support safe and effective use
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| 03.04.03 |
Angioedema |
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Berotralstat (Orladeyo®)
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Formulary
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- 150mg capsule
- Approved for preventing recurrent attacks of hereditary angioedema in people 12 years and older in line with NICE
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NICE TA738: Berotralstat for preventing recurrent attacks of hereditary angioedema
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C1 Esterase Inhibitor
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Formulary
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- Approvded for the treatment and pre-procedure prevention of angioedema attacks in patients with hereditary angioedema (HAE).
- Approvded for the routine prevention of angioedema attacks in adults and adolescents years old with severe and recurrent attacks of HAE.
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Clinical Commissioning Policy: Plasma-derived C1-esterase inhibitor for prophylactic treatment of hereditary angioedema (HAE) types I and II
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Conestat Alfa (Ruconest®)
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Formulary
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- Vials: 2,100 units (as dry powder)
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Icatibant (Firazyr®)
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Formulary
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- For use on the advice of immunologist in the treatment hereditary angioedema associated with C1-esterase inhibitor.
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Lanadelumab (Takhzyro®)
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Formulary
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- 300mg/2mL solution for injection
- Approved for preventing recurrent attacks of hereditary angioedema in line with NICE
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NICE TA606: Lanadelumab for preventing recurrent attacks of hereditary angioedema
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Danazol
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Unlicensed
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- For use on the advice of an immunologist in the prophylaxis, treatment hereditary angioedema associated with C1-esterase inhibitor deficiency.
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Oxandrolone 2.5mg and 10mg capsules
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Unlicensed
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- For use on the advice of an immunologist in the prophylaxis treatment hereditary angioedema associated with C1-esterase inhibitor deficiency when danzol and stanozolol are not available.
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Stanozolol 50mg tablets
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Unlicensed
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- For use on the advice of an immunologist in the prophylaxis treatment hereditary angioedema associated with C1-esterase inhibitor deficiency.
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| 03.04.03 |
Intramuscular adrenaline (epinephrine) |
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| 03.04.03 |
Intravenous adrenaline (epinephrine) |
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| 03.04.03 |
Self-administration of adrenaline (epinephrine) |
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| 03.05 |
Respiratory stimulants and pulmonary surfactants |
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| 03.05.01 |
Respiratory stimulants |
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Doxapram
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Formulary
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Caffeine Citrate
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Unlicensed
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- 50mg in 5ml injection (equivalent to 25mg caffeine base in 5ml).
- 50mg in 5ml oral solution.
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MHRA Drug Safety Update (Dec 2014): Caffeine citrate: 2 products of different strengths now available
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| 03.05.02 |
Pulmonary surfactants |
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Beractant (Survanta®)
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Formulary
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- 25mg/ml suspension for intratracheal administration
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Poractant Alfa
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Formulary
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| 03.06 |
Oxygen |
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| 03.06 |
Long-term oxygen therapy |
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| 03.06 |
Short burst oxygen therpary |
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| 03.06 |
Ambulatory oxygen therapy |
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| 03.06 |
Oxygen therapy equipment |
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| 03.06 |
Arrangements for supplying oxygen |
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| 03.07 |
Mucolytics |
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Acetylcysteine
(Mucolytic)
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Formulary
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- 600mg effervescent tablets.
- Green for licensed indications.
- For use on specialist advice in the treatment of idiopathic pulmonary fibrosis.
- For the prevention of x-ray contrast media induced renal damage .
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Carbocisteine
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Formulary
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- 375mg capsules.
- 750mg/10ml oral solution in sachets: first choice liquid preparation for adult patients.
- 250mg in 5ml syrup.
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Sodium Chloride 0.9%
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Formulary
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Ivacaftor
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Formulary
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- Approved for the treatment of cystic fibrosis in patients who have a faulty mutation in the CFTR gene in line with NHS England Clinical Commissioning Policy.
- Only available from:
- South Tees Hopsitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
MHRA Drug Safety Update (Feb 2022): Ivacaftor, tezacaftor, elexacaftor (Kaftrio▼) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing
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Lumacaftor and Ivacaftor (Orkambi®)
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Formulary
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- Ivacaftor 125mg/lumacaftor 100mg & ivacaftor 200mg/lumacaftor tablets
- Ivacaftor 95mg/lumacaftor 75mg, ivacaftor 125mg/lumacaftor 100mg &
ivacaftor 188mg/lumacaftor 188mg granules in sachet
- Approved for the treatment of cystic fibrosis in patients 1 year and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in line with NHS England Specialised Commissioning Policy (SSC2538)
- Only available from:
- South Tees Hopsitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
NICE TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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Tezacaftor and ivacaftor (Symkevi®)
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Formulary
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- Ivacaftor 75g/tezacaftor 50mg tablet & ivacaftor 100mg/tezacaftor 150mg tablet
- Approved for the treatment of cystic fibrosis in line with NHS England Commissioning Policy
- Only available from:
- South Tees Hopsitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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Tezacaftor with ivacaftor and elexacaftor (Kaftrio®)
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Formulary
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- Ivacaftor 75g/tezacaftor 50mg/elexacaftor 100mg & Ivacaftor 37.5mg/tezacaftor 25mg/elexacaftor 50mg tablet
- Approved for the treatment of cystic fibrosis in line with NHS England Commissioning Policy
- Only available from:
- South Tees Hopsitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
MHRA Drug Safety Update (Feb 2022): Ivacaftor, tezacaftor, elexacaftor (Kaftrio▼) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing
TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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| 03.07 |
Dornase alfa |
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Dornase Alfa
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Formulary
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| 03.07 |
Hypertonic Sodium Chloride |
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Hypertonic sodium chloride 7% (Nebusal®)
(For nebulisation)
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Formulary
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| 03.07 |
Mannitol |
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Mannitol inhalation (Bronchitol ®)
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA266: Cystic fibrosis - mannitol dry powder for inhalation
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Mannitol inhalation
(0mg, 5mg, 10mg, 20mg, 40mg capsules for inhalation)
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Formulary
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- Approved for bronchial provocation testing in patients unable to tolerate the taste of methacholine.
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| 03.08 |
Aromatic inhalations |
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| 03.09 |
Cough preparations |
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| 03.09.01 |
Cough suppressants |
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Codeine
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Formulary
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- Codeine linctus 15mg/5ml
- Approved for cough suppression in palliative care patients unable to take tablets
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MHRA Drug Safety Update (February 2024): Codeine linctus (codeine oral solutions): reclassification to prescription-only medicine
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| 03.09.01 |
Palliative care |
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| 03.09.02 |
Expectorant and demulcent cough preparations |
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Simple Linctus
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Formulary
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- Simple linctus and Paediatric simple linctus.
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| 03.10 |
Systemic nasal decongestants |
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Pseudoephedrine Hydrochloride
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Formulary
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MHRA Drug Safety Update (February 2024): Pseudoephedrine: very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
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| 03.11 |
Antifibrotics |
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Nintedanib (Ofev®)
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Formulary
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- Approved for treating idiopathic pulmonary fibrosis
- Approved for treating progressive fibrosing interstitial lung diseases in line with NICE
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NICE TA379:Nintedanib for treating idiopathic pulmonary fibrosis
NICE TA747: Nintedanib for treating progressive fibrosing interstitial lung diseases
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Pirfenidone
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Formulary
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- Approved for the treatment of idiopathic pulmonary fibrosis in line with NICE and NHS England Commissioning Policy
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MHRA Drug Safety Update Nov 2020: Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
NICE TA504: Idiopathic pulmonary fibrosis - pirfenidone
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| 03.12 |
Miscellaneous |
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Talc (sterilised) BP
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Formulary
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- Pleurodesis. Intrapleural administration via chest drain
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Water
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Formulary
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| Non Formulary Items |
Gefapixant
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Non Formulary
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- Gefapixant for treating refractory or unexplained chronic cough (terminated appraisal)
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NICE TA969: Gefapixant for treating refractory or unexplained chronic cough (terminated appraisal)
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
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