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 Formulary Chapter 3: Respiratory system - Full Chapter
03.01  Bronchodilators
03.01  Asthma and COPD
 note 

Asthma

  • Initial treatment of acute severe asthma should usually include oxygen, corticosteroid and high dose beta2 agonist via nebuliser or spacer.
  • Nebulised ipratropium bromide (Atrovent) should not be routinely added to the beta2 agonist. It is appropriate where life-threatening features are present or in those with poor response to initial therapy, when it may provide additional bronchodilator effect.
  • Although first line choice drugs have been indicated where possible, for any inhaled treatment choosing the most suitable device for the patient is an important factor for ensuring effective treatment.
  • Beta-blockers (including eye drops) are contra-indicated in patients with asthma.

COPD

  • Smoking cessation will reduce decline in lung function in COPD
03.01  Chronic obstructive pulmonary disease
03.01.01  Adrenoceptor agonists
03.01.01.01  Selective Beta2 agonists to top
03.01.01.01  Short-acting beta2 agonists
 note 
  • Inhaled short-acting selective beta2 agonists are the treatment of choice for the relief of acute symptoms. Both salbutamol and terbutaline act within 3-5 minutes of inhalation. Oral therapy is rarely indicated and is no longer routinely recommended.
  • Successful inhalation therapy depends on selection of an appropriate device and good adherence (compliance). Current BTS/SIGN guidelines recommend a metered-dose inhaler (MDI) as first choice, but a significant number of patients find these difficult to use properly.  Many modern dry powder inhalers provide a cost effective and convenient alternative and are much easier to use.  If an MDI is prescribed it is essential to ensure that MDI technique is satisfactory and if not optimal a spacer must be used.
  • Spacer devices are an effective way of improving the delivery of drug from an MDI. The size of the spacer is important. The large volume spacers with a one-way valve (e.g. Volumatic) are the most effective but are often inconvenient for patients to carry. They also require  monthly washing  and “drip-drying”. Ensure that the MDI is compatible with the spacer device.
  • In acute severe asthma or exacerbation of chronic obstructive pulmonary disease administration of normal doses of beta2 agonist by MDI may not be adequate. High dose therapy should ideally be inhaled via a spacer (10-20 puffs taken separately) or nebuliser but can be given by injection if necessary (side effects are more likely).
  • Home nebuliser therapy is rarely indicated as MDI and spacer are equally effective. Only use when shown to be clearly beneficial by objective testing. Local Nebuliser guidance available via link below.
  • Methotrexate use for severe refractory asthma is classified as RED on the traffic light system for use by respiratory specialists only
Salbutamol (Easyhaler®)
View adult BNF View SPC online  Track Changes
First Choice
Green
Salbutamol Easyhaler (DPI) should be used in patients on other DPIs 
Salbutamol (MDI)
View adult BNF View SPC online  Track Changes
First Choice
Green
Salbutamol MDI should be used in patients on other MDIs 
Salbutamol (Salbutamol Easibreathe® )
View adult BNF View childrens BNF  Track Changes
Second Choice
Green

For people who cannot co-ordinate actuating and inhaling correctly with a MDI and a spacer device is not an option.

 
   
Terbutaline Sulphate (Turbohaler®)
View adult BNF View SPC online  Track Changes
Second Choice
Green

Second choice, for those who cannot tolerate salbutamol. Similar efficacy to salbutamol but a more expensive option.

 
   
03.01.01.01  Long-acting beta2 agonists
 note 
  • In asthma long acting beta2 agonists (LABA) can be used for long term use to improve symptom control in patients who remain poorly controlled on inhaled steroids (Step 3 of the BTS Guideline) They should be used in addition to inhaled steroid therapy and not replace it. 
  • Formoterol has a more rapid onset of action than salmeterol and is also licensed for short-term symptom relief.
  • Formoterol MDI may be considered in those patients who are already using an MDI effectively and in whom adding an Easyhaler would compromise compliance. This is a more costly option.
  • Some generic salmeterol inhalers are not suitable for patients with soya or peanut allergies.  It would be prudent to switch to the formulary choice, formoterol, in those patients.    
Formoterol (Easyhaler®)
View adult BNF View SPC online  Track Changes
First Choice
Green
Dry Powder Inhaler (DPI)
In asthmatics, formoterol should only be prescribed as part of a combination device (ICS/LABA), and a formoterol single agent inhaler should only be used in the few patients who require ciclesonide as an ICS.
For COPD patients, formoterol can be used as a single agent as long as there is no co-existing asthma. 
Formoterol (Turbohaler®)
View adult BNF View SPC online  Track Changes
Second Choice
Green
Dry Powder Inhaler (DPI)
Alternative device but more costly. 
   
03.01.02  Antimuscarinic bronchodilators
 note 
  • Ipratropium is especially useful in chronic obstructive pulmonary disease.
  • Do not prescribe tiotropium with short acting antimuscarinic bronchodilators
  • Ipratropium nebuliser solution is relatively expensive. It should not be given routinely to hospital inpatients with acute asthma but may be added to treatment if a short-acting beta2 agonist alone proves insufficient. If used, review frequently and discontinue as soon as possible.
  • Nebulised ipratropium must only be administered via a mouthpiece and NOT a facial mask due to the risk of precipitating glaucoma.
Aclidinium / Formoterol  (Duaklir Genuair®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
Dry Powder Inhaler (DPI)
COPD. LAMA /LABA combination for use in line with local guidance only  
Link  Leicestershire Evaluation: Aclidinium Formoterol (Duaklir®) inCOPD
   
Tiotropium / Oldaterol  (Spiolto Respimat®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
Metered Dose Inhaler (MDI)
COPD. LAMA /LABA combination for use in line with local guidance only  
Link  Leicestershire Evaluation: Spiolto Respimat® in COPD
   
03.01.02  Short Acting Anti-muscarinic Bronchodilators
Ipratropium Bromide (MDI)
View adult BNF View SPC online  Track Changes
Formulary
Green
 
   
03.01.02  Long Acting Anti-muscarinic Bronchodilators to top
Tiotropium (Respimat®)
View adult BNF View SPC online  Track Changes
Formulary Metered Dose Inhaler (MDI)

Amber Traffic Light Simple amber for Asthma

Green Traffic Light For COPD patients in line with Leicestershire prescribing aid
 
Link  Leicestershire Evaluation: Tiotropium Respimat® in Asthma
Link  Leicestershire Guidance: LAMA Prescribing Aid For COPD
   
Tiotropium (Braltus Zonda®)
View adult BNF View SPC online  Track Changes
Formulary
Green

For COPD patients in line with Leicestershire prescribing aid. Not licensed for use in asthma. Please note saftey advice regarding placement of capsules in the device

 
Link  Leicestershire Guidance: LAMA Prescribing Aid For COPD
Link  MHRA Advice: Braltus (tiotropium): risk of inhalation of capsule if incorrectly placed
   
Aclidinium Bromide  (Eklira Genuair®)
View adult BNF View SPC online  Track Changes
Formulary
Green
Dry Powder inhaler (DPI)
For patients who cannot manage the tiotropium device and in patients with renal impairment (as per Leicestershire Guidance )  
Link  Leicestershire Evaluation: Aclidinium bromide in COPD
Link  Leicestershire Guidance: LAMA Prescribing Aid For COPD
   
Tiotropium (Handihaler®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
For COPD patients.
Restricted ItemIn UHL restricted to initiation by respiratory physicians.
 
   
03.01.03  Theophylline
 note 
  • Different brands of oral theophylline/aminophylline may not be bioequivalent. Patients should not change brands once stabilised unless plasma level monitoring is carried out. The brand name should always appear on prescriptions and in correspondence.
  • Theophylline and its salt aminophylline can produce bronchodilatation additional to that of the beta2 agonists. Slow release preparations of theophylline are better tolerated than standard formulations. They are effective for up to 12 hours and can be useful for nocturnal symptoms if given in adequate dosage.
  • Theophylline interacts with a number of other drugs with a risk of toxicity if co-prescribed with drugs inhibiting metabolism e.g. erythromycin, ciprofloxacin. Metabolism may be affected by cigarette smoking in some patients.
  • Monitoring of plasma levels of theophylline is not routinely necessary in stable patients but may be warranted in certain circumstances e.g. change in clinical status, where toxicity is suspected or during concomitant use of interacting drugs. Seek advice if unsure.
Theophylline (Uniphyllin Continus®)
View adult BNF View SPC online  Track Changes
First Choice
Green
Oral slow release tablets. 
Aminophylline
View adult BNF View SPC online  Track Changes
First Choice
Red
Intravenous use for severe bronchospasm, which has not responded to nebulised salbutamol in asthma or chronic obstructive pulmonary disease (COPD).
IV Monograph available through 'Injectable Medicines Guide' link on front page of INsite. 
Theophylline (Slo-Phyllin®)
View adult BNF View SPC online  Track Changes
Second Choice
Green
Oral slow release capsules. 
Link  Toxicology and Therapeutic Dose Monitoring
   
03.01.05  Peak flow meters, inhaler devices and nebulisers
 note  Selecting an inhaler device:
  • Inhalers should only be prescribed after patients have received training in use of the device and have demonstrated satisfactory technique. Metered-dose inhalers (MDIs) are an appropriate first choice but great attention is required to ensure the patient can use them correctly.
  • Spacer devices can help some patients who experience difficulty using an MDI; they also reduce adverse effects from inhaled corticosteroids. Less portable.
  • Breath-actuated devices (including dry powder inhalers) are an alternative to an MDI with a spacer.
  • Patients should be asked to demonstrate their inhaler technique at every opportunity. Hospital and community pharmacists can demonstrate inhaler devices and check inhaler technique if required.
  • CFC- Free Inhalers

  • Chlorofluorocarbon (CFC) containing beclometasone inhalers are being phased out during 2008. Patients should be switched to CFC alternatives now. Advice for prescribers on how to do this and product choices available via link below.
03.01.05  Spacers & Drug delivery devices
03.02  Corticosteroids
 note 
  • Inhaled corticosteroids act to reduce inflammation and consequent airway oedema and mucus secretion. They are therefore more effective in asthma than COPD.
  • Use a spacer device (e.g. Volumatic) for all patients on an MDI. This improves delivery of drug to the airways and reduces deposition in the oropharynx. Also reduces the need for co-ordinated inhaler technique and may help to reduce the incidence of candidiasis.
  • Nebulised steroids are inappropriate.
  • In the few patients requiring more than 800microg daily of beclometasone (400microg daily of Qvar®) budesonide is preferred due to less potential for systemic side effects (first pass metabolism of swallowed portion).
  • See also supporting information on Asthma, COPD and Combination inhalers.
  • Ciclesonide is occasionally used by specialists second line to other steroid inhalers in patients unable to tolerate due to thrush despite mouth rinsing and use of a spacer device. In UHL this has been restricted to Respiratory Medicine only.
  • Fluticasone inhalers are occasionally used by specialists in difficult to treat asthma. In UHL this has been restricted to Respiratory Medicine only. 

Beclometasone Dipropionate (Qvar®)
View adult BNF View SPC online  Track Changes
First Choice
Green
For asthma in over 12 year olds (Use Clenil in children). Markedly better lung deposition and dose is equivalent to approximately twice the dose of CFC–containing inhalers or Clenil. Prescribe by brand. 
Budesonide (Budesonide Easyhaler® or Pulmicort Turbohaler®)
View adult BNF View SPC online  Track Changes
First Choice
Green
Easyhaler® 1st choice as per adult asthma guidelines due to cost.
Pulmicort® 2nd choice, alternative device as per adult asthma guidelines due to cost.  
Beclometasone Dipropionate (Clenil Modulite®)
View adult BNF View SPC online  Track Changes
First Choice
Green
CFC-free first choice for children (5-12). For use with Volumatic spacer device 
Ciclesonide (Alvesco®)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted Restricted to use by Respiratory medicine. For use in patients unable to tolerate other steroid inhalers due to oral thrush 
   
Budesonide (Pulmicort Turbohaler®, Easyhaler®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green

unlicensed unlicensed - For the treatment of COVID-19 commenced in primary care in eligible adults (65s and over or 50-64 with a comorbidity consistent with a long-term health condition from the flu list). Patients should be treated with inhaled budesonide 800micrograms twice daily for up to 14 days (or until the device runs out).  

 The devices included by this statement are:-

1. Pulmicort Turbohaler 400 micrograms & 200 micrograms

2. Easyhaler Budesonide 400 micrograms & 200 micrograms

 

Further information is available in the CAS alert

 
Link  DoHSC: Interim Position Statement: Inhaled budesonide for adults (50 years and over) with COVID-19
   
03.02.02  Compound Corticosteroid/ Long acting beta-agonist inhalers to top
Budesonide and Formeterol (Fobumix Easyhaler®)
(Dry Powder )
View adult BNF View SPC online  Track Changes
First Choice
Green

First choice for patients aged 18 years and older.

 
Budesonide and Formoterol  (DuoResp Spiromax®)
View adult BNF View SPC online  Track Changes
Formulary
Green

For patients aged 18 years and older.
Prescribe by brand as devices are not interchangeable
To be used only in new patients or after a review by a healthcare professional and counselling of patient to ensure appropriate use of the device.
There is no MART/SMART® equivalent with DuoResp.

 
   
Budesonide and formoterol (Symbicort®)
View adult BNF View SPC online  Track Changes
Formulary
Green
Licensed from 6 years for maintenance therapy (SMART programme from 12). First choice in children 6-18 or in over 12s requiring the SMART programme.


Symbicort SMART® programme for flexibly adjusting dose – see supporting information (link below) Licensed for this in those 12 years and over.

Prescribe by brand as generic preparations available are a different device and are not interchangeable
 
Link  Supporting information
   
Formoterol and beclometasone (Fostair®)
View adult BNF View SPC online  Track Changes
Formulary
Green
ASTHMA: Treament option where a combination is appropriate in patients 18 and over who can’t utilise the Symbicort Turbohaler® or where there is a preference for an MDI.
COPD: Alternative choice where MDI is required
Fostair® is licensed for use with the AeroChamber Plus spacer device. It is stored in the refrigerator until dispensed after which it is given a 5 month expiry date.
Fostair® MART programme for flexibly adjusting dose is available with 100/6 inhaler
 
Link  Leicestershire Evaluation: Fostair in Asthma
Link  Leicestershire Evaluation: Fostair in COPD
   
Formoterol and beclometasone (Fostair NEXThaler®)
View adult BNF View SPC online  Track Changes
Formulary
Green
Dry powder inhaler, available as 200/6 and 100/6.
Asthma:To be used in line with Adult asthma guidance and combination inhaler step down guidance.
COPD: 200/6 is not licensed for use in COPD. To be used in line with COPD guidance and step down ICS guideline  
   
Fluticasone and salmeterol (Seretide®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
ASTHMA: First choice in patients aged 5-12 years, where an ICS/LABA MDI is required. Over 12 years, follow adult guidelines.
Compared to other combination products there is less flexibility in dosage adjustment.

COPD: Non Formulary for this indication  
   
03.02.03  Triple Therapy products for COPD
Glycopyrronium, Beclometasone and Formoterol (Trimbow®)
View adult BNF View SPC online  Track Changes
Formulary
Green

For maintenance of COPD

Use in line with COPD guidelines

 
   
03.03  Cromoglicate, related therapy and leukotriene receptor antagonists
03.03.01  Cromoglicate and related therapy
 note 

Sodium cromoglicate was discontinued however is now available again, although its use is restricted.

03.03.02  Leukotriene receptor antagonists
 note 
  • Montelukast has not been shown to be more effective than a standard dose of inhaled corticosteroid but the two drugs appear to have an additive effect.
  • Leukotriene receptor antagonists may be of benefit in exercise-induced asthma and in those with concomitant rhinitis but they are less effective in those with severe asthma who are also receiving high doses of other drugs.
  • A one-month trial of montelukast will be sufficient to assess effectiveness for most patients. If there is not a measurable improvement in objective outcomes after this time the treatment should be stopped.
  • The Committee on Safety of Medicines (CSM) has advised that leukotriene receptor antagonists should not be used to relieve an attack of acute severe asthma and that their use does not necessarily allow a reduction in existing corticosteroid treatment.
Montelukast
View adult BNF View SPC online  Track Changes
First Choice
Green

10mg OD as initial add-on along side a low dose inhaled corticosteroid and a short acting beta agonist. Review after 4 weeks and stop if ineffective as per NICE 2017. If escalating treatment continue on LTRA

 
03.03.03  Phosphodiesterase type-4 inhibitors to top
Roflumilast (Daxas®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple
For use in COPD in line with NICE TA 461 only 
Link  NICE TA 461: Roflumilast for treating chronic obstructive pulmonary disease
   
03.04  Antihistamines, hyposensitisation, and allergic emergencies
03.04.01  Antihistamines
 note 
  • Antihistamines are used in the treatment of allergic disorders although they may not relieve all symptoms satisfactorily. They are more effective in the early phase (sneezing, ocular itching and rhinorrhea) than in the late phase (nasal congestion).
  • Antihistamines enhance the effects of topical corticosteroids on the nasal mucosa in seasonal allergic rhinitis. They are more effective if taken as a regular dose rather than as 'rescue' medication
  • Cetirizine and loratadine are relatively non-sedating agents, which are preferred for long-term or outpatient use e.g. in allergic rhinoconjunctivitis. They are less likely than chlorphenamine to interfere with driving in adults or learning in children. Nevertheless patients should be advised that sedation can occur and that it may affect performance of skilled tasks (e.g. driving); excess alcohol should be avoided.
  • Cetirizine may be slightly more effective than loratadine. It is renally excreted to a greater extent and is appropriate where drug interactions may render loratadine unsuitable.
  • Corticosteroid nasal sprays are appropriate as first-line treatment for allergic rhinitis.
  • Cumulative anticholinergic medication use  has been shown to be associated with an increased risk for dementia. The long-term impact of prescribing these drugs should be considered when initiating them as the untoward effects may not be reversed by withdrawing them later down the line.
  • The British Society for Allergy & Clinical Immunology (BSACI) guidelines (in line with international guidelines) on urticaria recommend that the first- line treatment for urticaria should be new generation, non-sedating H1-antihistamines. If standard dosing is not effective then the dosage should be increased incrementally up to four times the standard licensed dose in adults and four times the standard licensed age-specific dose in children.

 

Cetirizine Hydrochloride
View adult BNF View SPC online  Track Changes
First Choice
Green
Non sedating 
Loratadine
View adult BNF View SPC online  Track Changes
First Choice
Green
Non sedating 
Chlorphenamine Maleate
View adult BNF View SPC online  Track Changes
Second Choice
Green
Short-term treatment of acute allergic reactions such as drug rash, insect bites and urticaria. Less effective in rhinitis. Use limited by sedation and psychomotor impairment making it unsuitable as a long-term treatment or in daytime activities such as driving. 
   
Chlorphenamine injection
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
Useful as an adjunct to adrenaline in the emergency treatment of anaphylaxis 
   
Fexofenadine hydrochloride
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
For those patients who experience sedation on high doses of other recommended choices only. 
   
Ketotifen (Zaditen®)
View adult BNF View SPC online  Track Changes
Formulary
Amber Simple

For the treatment of Mast Cell Activation Syndrome (MCAS). 

 
   
03.04.02  Allergen Immunotherapy
Benralizumab (Fasenra®)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

For use in line with NICE TA 565 for the treatment of severe eosinophilic asthma only.

Blueteq prior approval required before initiation

Date of entry of decision to Formulary: May 2019 

 
Link  NICE TA 565: Benralizumab for treating severe eosinophilic asthma
   
Dermatophagoides pteronyssinus allergen extract (Acarizax®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red

For use in Allergy Clinic.
Immunotherapy treatment for house dust mite and allergic rhinitis. 

 
   
Dupilumab (Dupixent)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

Type 2 inflammation in asthma, inadequately controlled by high dose inhaled corticosteroids.

 
   
Grass pollen extract sublingual (Grazax®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber SCA
Restricted to initiation by specialist allergist / respiratory clinicians in line with criteria below.
Patients should be assessed at the end of each season to ensure adequate response before continuation  
Link  Assessing Patient Suitability for Immunotherapy With Grazax
Link  SCA: Grazax
   
Mepolizumab (Nucala®)
View adult BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

Asthma. For use by specialist respiratory clinician in line with NICE TA671 to treat severe eosinophilic asthma only. This supersedes 

Date of entry of decision to Formulary: March 2021

 
Link  NICE TA671: Mepolizumab for treating severe eosinophilic asthma
   
Reslizumab (Cinqaero®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
For use in line with NICE TA 479 for the treatment of severe eosinophilic asthma only.

Date of entry of decision to Formulary: January 2018 
Link  NICE TA 479: Reslizumab for treating severe eosinophilic asthma
   
Grass pollen extract subcutaneous  (Pollinex®)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Restricted to initiation by specialist allergist / respiratory clinicians in line with criteria below 
Link  Assessing Patient Suitability for Immunotherapy With Grazax
   
03.04.02  Omalizumab
Omalizumab (Xolair®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

Asthma. For use by specialist respiratory clinicians only for patients attending difficult asthma clinic. Prescribing only in line with NICE TA 278.
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: April 2013

 
Link  NICE TA 278: Omalizumab in asthma
   
Omalizumab (Xolair®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
Chronic spontaneous urticaria in line with NICE TA 339 only. AT UHL prescribing is through the allergy clinic at Glenfield
Date of entry of decision to formulary: September 2015



 
Link  NICE TA 339: Omalizumab in chronic spontaneous urticaria
   
03.04.03  Allergic emergencies to top
03.04.03  Anaphylaxis
 note  Anaphylaxis may be caused by allergic reaction to blood products, vaccines, drugs, insect stings, foods (e.g. nuts) etc. Prompt treatment of symptoms such as laryngeal oedema, hypotension and bronchospasm is essential.
Initial treatment:
  • Secure airway, if patient is hypotensive lay them flat and raise feet, give oxygen where available.
  • Administer adrenaline (epinephrine) 0.5mg (i.e. 0.5mL adrenaline 1:1000) by intramuscular* injection. Repeat after 5 minutes if no improvement, then give chlorphenamine IM (10-20mg).
  • If severe/recurrent reactions or history of asthma give hydrocortisone (100-500mg). If shock is unresponsive to drugs also give intravenous fluids 20mL/kg body weight (crystalloid preferred).
  • Note: use inhaled salbutamol if bronchospasm is present and does not respond to treatment.
  • *Adrenaline given subcutaneously is absorbed erratically - avoid this route.
  • Intravenous adrenaline should be given very cautiously (only when patient is profoundly shocked). It must be diluted 1 in 10 with 0.9% sodium chloride (to make a 1 in 10,000 dilution), given into a large vein at a maximum rate of 1mL per minute with ECG monitoring. Stop when response obtained (risk of serious arrhythmias).
03.04.03  Angioedema
C1-Esterase Inhibitor  (Berinert®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
BlueTeq

High cost drug excluded to tariff. NHSE commissioned

Blueteq prior approval required before initiation

Please Note: Regarding the current shortage, in line with NHS England guidance, there is no requirement to review and switch current patients

 
   
03.04.03  Self-administration of adrenaline (epinephrine)
 note 
  • Auto-injectors are available for self use by patients who are at risk of an anaphylactic reaction.
  • They should be prescribed on an individual basis by a specialist in allergy. 
  • The preferred choice in Leicestershire is Jext. Epipen is available on request.
  • Emerade is non formulary for patient use but a care plan is in place for safety reasons.  It may be used in emergency boxes at UHL for use by professional staff or in the event of stock shortages. 
  • The BNF notes that Injection technique is device specific.
  • To ensure patients receive the auto-injector device that they have been trained to use, prescribers should specify the brand to be dispensed. 
  • Patients should carry two pens with them at all times for emergency "on the spot" use in line with MHRA advice.

November 2019 - MHRA Alert 

July 2018

  • We have been notified that there is a long term supply problem with Jext, Emerade and Epipen adrenaline auto-injector pens.
  • Until the situation is resolved, patients may need to switch brands including using the non-formulary Emerade auto-injector depending on the availability at the time. Please view the CAS alert from the department of health
  • There is also a protocol from NHS England to follow when dispensing and Pharmacy and Dispensing Practice Q and A detailing steps that must be taken when prescribing adrenaline 150mcg autoinjectors.” 
03.05.02  Pulmonary surfactants
Poractant Alfa
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
Specialist prescribing only
High cost drug excluded to tariff commissioned by NHSE 
   
03.06  Oxygen to top
03.07  Mucolytics
 note 

Mucolytics have limited value in COPD. May reduce exacerbations in some patients with chronic obstructive pulmonary disease and a chronic productive cough. Therapy should be stopped if there is no benefit after a 4-week trial. Please see carbocisteine guidance below.

Acetylcysteine (NACSYS®)
View adult BNF View SPC online  Track Changes
First Choice
Green

Effervescent tablets. For use in COPD, reduction of sputum viscosity.

Please note - due to the price difference, the capsules are not to be prescribed, only effervescent tablets.  

 
Carbocisteine
View adult BNF View SPC online  Track Changes
Second Choice
Green

Carbocisteine should be used in patients who can not tolerate the salt content of acetylcysteine. Please see carbocisteine guidance below. 

 
Link  Leicestershire Guidance: Mucolytic Prescribing
   
Dornase Alfa (Pulmozyme®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple
NHS England

Classified Simple Amber in Leicestershire Traffic Lights
For cystic fibrosis.
High cost drug excluded to tariff. NHSE commissioned

 
Link  NHSE Commissioning Policy: Cystic Fibrosis Inhaled Therapies
   
Mannitol
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England

High cost drug excluded to tariff. NHSE commissioned

Date of entry of decision to Formulary: February 2013

 
Link  NHSE Commissioning Policy: Cystic Fibrosis Inhaled Therapies
   
Ivacaftor
(Kalydeco®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England

High cost drug excluded to tariff. NHSE commissioned

 
Link  NHSE Policy: Ivacaftor in Cystic Fibrosis
   
Ivacaftor, Tezacaftor, Elexacaftor (Kaftrio®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England

For the treatment of cystic fibrosis. High cost drug excluded to tariff.  For specialist use in cystic fibrosis as per NHS England commissioning statement 

 
   
Lumacaftor/ Ivacaftor  (Orkambi®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England

High cost drug excluded to tariff. For specialist use in cystic fibrosis as per NHS England commissioning statement 

Date decision added to formulary: November 2019

 
Link  NHSE Commissioning Statement: Cystic Fibrosis Modulator Therapies
   
Tezacaftor/ Ivacaftor (Symkevi®)
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England

High cost drug excluded to tariff. For specialist use in cystic fibrosis as per NHS England commissioning statement 

Date decision added to formulary: November 2019

 
Link  NHSE Commissioning Statement: Cystic Fibrosis Modulator Therapies
   
03.09  Cough preparations
 note 
  • Cough mixtures are considered Drugs of Limited Clinical Value
  • Few patients will need specific treatment for a cough. Many over-the-counter preparations contain several ingredients, some of which are likely to be ineffective or unnecessary.
  • There is no objective evidence that expectorants promote sputum clearance. Inhalation of steam is more likely to facilitate expectoration by keeping the patient’s airway well hydrated.

 

 

03.09.01  Cough suppressants
03.09.01  Palliative care
03.10  Systemic nasal decongestants to top
 note  Considered Drugs of Limited Clinical Value.

Inhalation of steam is an inexpensive alternative that may be beneficial. Addition of an aromatic product e.g. compound benzoin tincture may make this a more attractive therapy to use.

03.11  Antifibrotics
Pirfenidone
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

For treatment of idiopathic pulmonary fibrosis in line with NICE TA 504 only.
For use by specialist respiratory physicians only
High Cost Therapy excluded to tariff commissioned by NHSE
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: July 2013 (Updated April 2018)


November 14: Not supported by TAS for patients with FVC 80-90%

 
Link  NICE TA 504: Pirfenidone for treating Idiopathic Pulmonary Fibrosis (REPLACES NICE TA 282)
Link  Leicestershire Evaluation: Pirfenidone FVC 80% in Pulmonary Fibrosis
Link  MHRA Advice: Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
   
Nintedanib
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Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

In line with NICE TA 379 only by specialist Respiratory Consultants.

Date of entry of decision to Formulary: April 2016

 
Link  Leicestershire Evaluation: Nintedanib in Pulmonary Fibrosis
Link  NICE TA 379: Nintedanib for treating idiopathic pulmonary fibrosis
   
 ....
 Non Formulary Items
Alimemazine

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Non Formulary
Black

Current patients should be discussed with the prescribing specialist and not have treatment stopped abruptly without appropriate review. Patients already prescribed alimemazine should continue until reviewed in secondary care. Please see LMSG page for further information

 
Alutard Wasp venom

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Non Formulary
Black

Preventative treatment for wasp sting allergy. Not yet reviewed

 
 
Desloratidine

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Non Formulary
 
Erdosteine

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Non Formulary
Black
 
Fformoterol/ glycopyrronium/ budesonide  (Trixeo Aerosphere®)

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Non Formulary
Black

Not reviewed for use in LLR

 
Fluticasone and Formoterol  (Flutiform®)

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Non Formulary Not supported by LLR Respiratory Prescribing Group
 
Fluticasone/ umeclidinium/ vilanterol  (Trelegy Ellipta®)

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Non Formulary
Black

Reviewed by local specialists, not for use in LLR

 
Glycopyrronium Bromide

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Non Formulary
Black
Not supported by TAS
Link  Leicestershire Evaluation: Glycopyrronium in COPD
 
Glycopyrronium/ Formoterol  (Bevespi Aerosphere®)

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Non Formulary
Black

Not reviewed in LLR 

 
Indacaterol

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Non Formulary
Black
Link  Leicestershire Evaluation: Indacaterol in COPD
 
Indacaterol / glycopyrronium / mometasone  (Enerzair Breezhaler®)

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Non Formulary
Black

Maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid.

Not yet reviewed in LLR

 
Levocetirizine

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Non Formulary
Link  Leicestershire Evaluation: Levocetirizine in Allergy
 
Mometasone Furoate  (Asmanex®)

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Non Formulary Twisthaler.
 
Pseudoephedrine

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Non Formulary As per LMSG cough, cold and sore throat remedy guidance
Link  LMSG: Low Priority Prescribing
 
Rupatadine Fumarate

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Non Formulary
 
Salmeterol and Fluticasone inhalation powder  (Fixkoh®)

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Non Formulary
Black

Not reviewed in LLR

 
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Black

Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

Red

Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

Amber SCA

Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

Amber Simple

Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.   

Green

Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

Grey

Drugs not yet reviewed  

Green Conditional

Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence. See comments under individual entries  

netFormulary