Research and analysis

PAR: Reclassification of Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension from Pharmacy (P) medicine to General Sales List

Published 26 May 2021

Public Assessment Report

Pharmacy to General Sales List Reclassification

Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension

Triamcinolone Acetonide

PL 04425/0605 - 0068

AVENTIS PHARMA LIMITED

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK Government agency responsible for regulating medicines and medical devices. We continually review the safety of medicines and vaccines in the UK, and inform healthcare professionals and the public of the latest updates through several means, including public reclassification reports. Suspected side effects to any drug or vaccine can be reported to MHRA by both healthcare professionals and members of the public via the Yellow Card scheme.

Alternative format versions of this report are available on request from [email protected].

1. Introduction

Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension (hereafter referred to as Nasacort Allergy) can be used for the relief of symptoms associated with seasonal allergic rhinitis (SAR) in adults aged 18 years and over. These symptoms include sneezing, itchy and runny nose, itchy, red or watery eyes, nasal congestion or associated sinus discomfort.

Allergic rhinitis is inflammation of the inside of the nose caused by an allergen. An allergen is a substance that causes an allergic response. ‘Seasonal’ allergic rhinitis is when symptoms occur at the same time each year in response to a seasonal allergen, for example grass and tree pollen allergens. It is also known as hay fever.

Each spray contains 55 micrograms of triamcinolone acetonide.

The licence holder , Aventis Pharma Limited, applied to change the legal status of this product from a Pharmacy (P) medicine to a General Sales List (GSL) medicine. (see Background for definition).

The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

2. Background

Triamcinolone acetonide is a steroid (specifically a corticosteroid) that acts to reduce inflammation which is a sign of allergic rhinitis including hay fever.

Pharmacy medicines can be supplied without prescription only from pharmacies, by or under the supervision of a pharmacist. General Sales List medicines can be sold or supplied in other retail outlets other than pharmacies by someone who is not a pharmacist.

Triamcinolone acetonide was first approved in the United Kingdom (UK) as a prescription medicine in 1997. In 2001, the nasal spray was approved with a P legal status with a maximum pack size of 30 sprays to treat the symptoms of seasonal allergic rhinitis in adults aged 18 years and over and has been marketed in the UK since 2009.

3. Proposed Terms of Reclassification

Aventis Pharma Limited proposed to make Nasacort Allergy available through general retail outlets with the following terms of reclassification:

a) Pack size: 30 sprays

b) Used for the treatment of the symptoms of seasonal allergic rhinitis, including hay fever. It relieves such symptoms of seasonal allergic rhinitis as sneezing, itchy and runny nose, itchy, red or watery eyes, nasal congestion or associated sinus discomfort.

c) Dose: (Adults aged 18 years and over): 2 sprays into each nostril once daily. Once symptoms are controlled, 1 spray in each nostril once daily. The maximum daily dose should not exceed 2 sprays into each nostril.

d) Route of administration: Intranasal (use only in the nose)

e) Strength: Each spray contains 55 micrograms of triamcinolone acetonide.

f) Duration of treatment: Treatment should be stopped, or the advice of a doctor sought if an improvement is not seen within 7 days.

4. General Sales List Criterion

Under the provisions of The Human Medicines Regulations 2012, regulation 62(5), General Sales List is appropriate for medicines that can, with reasonable safety, be sold or supplied by someone other than a pharmacist.

The term “with reasonable safety” has been defined as: “where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser.”

5. Assessment of suitability for General Sales List availability

The MHRA assessed the application against the General Sales List criterion, as stated in section 4.

5.1 Hazard to health

It is considered that Nasacort Allergy is already well established in the pharmacy setting, and the GSL availability of the product is unlikely to increase the risk of a hazard to health.

There has been a low reporting rate of adverse events since Nasacort Allergy has been available as a P medicine, in particular, there have been 45 adverse events reported, some of which are common amongst other nasal steroid sprays. The increased availability of Nasacort Allergy is unlikely to increase the risk of adverse events as the product is for short-term use only.

When used at the maximum daily dose, Nasacort Allergy would provide just over 7 days of treatment. The product information has been updated to advise users to stop treatment or to seek the advice of a doctor if any improvement is not seen within 7 days. There are currently other nasal steroid sprays which are available as GSL medicines with pack sizes that provide a greater number of days of treatment when used at the maximum dose. Therefore, this pack size is considered to be appropriate as it minimises the risk of prolonged use and ensures that users are signposted (via appropriate labelling) to seek medical advice after this time period if symptoms have not improved.

Furthermore, the public are already accustomed to managing the symptoms of hay fever by similar medicines which can be bought without the presence of a pharmacist. Therefore, the availability of Nasacort Allergy as a GSL medicine is unlikely to increase the hazard to health as hayfever is already a well-established condition for self-care.

5.2 Risk of Misuse

There is no evidence to suggest that Nasacort Allergy is used incorrectly. Hay fever is readily self-diagnosed, and the proposed product information clearly identifies this and the conditions of its use.

Due to the low amount of medicine being absorbed from the nasal spray, the risk of abuse and the risk of dependence are expected to be very low. There is no indication of significant misuse of this product since it has been marketed in the UK.

5.3 Special Precautions in Handling

There are no special precautions required in handling Nasacort Allergy.

5.4 Wider sale would be a convenience

The MHRA accepts that the availability of this product as a GSL medicine will allow people that have used Nasacort in the past to access the product more readily and from a wider range of outlets.

Furthermore, it is considered that the GSL availability of Nasacort Allergy increases the treatment options available for the treatment of SAR, and therefore the increased availability of another nasal steroid spray would be useful to individuals that benefit from treatment with Nasacort.

5.5 Risk Management Plan

The application contained a risk management plan (RMP). RMPs are documents that contain information on a medicine’s safety profile and one or more of the following:

• how any risks identified in the safety profile will be prevented or minimised in patients
• plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine
• risk factors for side effects
• measuring the effectiveness of measures taken to prevent or minimise risks.

The RMP for Nasacort Allergy identified the main risks associated with the product and proposed how these would be managed through routine pharmacovigilance (monitoring and reporting of adverse events for a medicine, for which there are no special safety concerns) and via the product information (Summary of Product Characteristics, labelling and patient information leaflet). No additional risk minimisation measures were proposed for the product.

6. Reasons for not seeking advice from the Commission on Human Medicines

No major issues have been identified in the assessment of this application. The availability of Nasacort Allergy as a General Sales List medicine would result in minimal changes based on the following reasons:

1. The proposed use of the medicine, dosing regimen, route of administration, strength, and pack size are the same as those for the currently approved P product.

2. There are approved GSL nasal steroid sprays for the same indication in larger pack sizes.

3. The pack size allows use for one week if used at the maximum daily dose. There is also clear information which advises not to use continuously for more than one month.

4. The use of the medicine (hayfever) is well established and the public are already accustomed to managing symptoms of hayfever without the presence of a pharmacist with similar medicines.

7. Conclusion

The MHRA has taken the decision to approve General Sales List legal status for Nasacort Allergy under the following conditions:

a) Pack size: 30 sprays

b) Used for the treatment of the symptoms of seasonal allergic rhinitis, including hay fever. It relieves such symptoms of seasonal allergic rhinitis as sneezing, itchy and runny nose, itchy, red or watery eyes, nasal congestion or associated sinus discomfort.

c) Dose: (Adults aged 18 years and over): 2 sprays into each nostril once daily. Once symptoms are controlled, 1 spray in each nostril once daily. The maximum daily dose should not exceed 2 sprays into each nostril.

d) Route of administration: Intranasal (use only in the nose)

e) Strength: Each spray contains 55 micrograms of triamcinolone acetonide.

f) Duration of treatment: Treatment should be stopped, or the advice of a doctor sought if an improvement is not seen within 7 days.

Medicines and Healthcare products Regulatory Agency May 2021