Research and analysis

PAR: Reclassification of Almerg 180mg film-coated tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine

Published 26 April 2021

Public Assessment Report

Prescription Only Medicine to Pharmacy Reclassification

Almerg 180mg film-coated tablets

Fexofenadine Hydrochloride 180mg

PL 36390/0054 - 0029

CIPLA (EU) 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 the MHRA by both healthcare professionals and members of the public via the Yellow Card Scheme.

1. Introduction

Almerg 180mg film-coated tablets can be used for the relief of symptoms associated with chronic idiopathic urticaria (CIU) in adults and children aged 12 years and over. Urticaria, also known as hives, includes swellings (wheals) that appear as a raised, itchy rash on the skin which are usually pink or red, with an oval or round shape. It is classed as chronic when the rash persists or comes and goes for more than 6 weeks, often over many years.

Each tablet contains 180 milligrams of fexofenadine hydrochloride.

The licence holder, Cipla (EU) Limited, applied to change the legal status of this product from Prescription Only Medicine (POM) to a Pharmacy (P) medicine (see Background for definition). A licence holder or marketing authorisation holder is the company with legal authorisation to make the medicine available to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold as a pharmacy medicine. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

2. Background

Fexofenadine hydrochloride is an antihistamine which works by blocking the effects of a substance called histamine in your body. In urticaria, histamine is released in response to a trigger which can cause symptoms such as red and raised itchy skin.

A Prescription Only Medicine (POM) must be prescribed by a doctor or other authorised health professional and it must be dispensed from a pharmacy or from another specifically licensed place.

Pharmacy (P) medicines can be supplied without prescription only from pharmacies, by or under the supervision of a pharmacist.

General Sales List (GSL) medicines can be sold or supplied in retail outlets other than pharmacies by someone who is not a pharmacist.

In the UK, Fexofenadine is also currently available in the following preparations:

• 30 mg twice daily for the relief of symptoms associated with seasonal allergic rhinitis (SAR) in paediatric patients aged 6 to 11 years. This is available only on prescription.
• 120mg once daily for the relief of symptoms associated with SAR in adults and children aged 12 years and above. This is available on general sale.

3. Proposed Terms of Reclassification

Cipla (EU) Limited proposed to make Almerg 180mg film-coated tablets available through pharmacies with the following terms of reclassification:

a) Pack size: 30 tablets

b) Used for the relief of symptoms associated with chronic idiopathic urticaria in adults and children aged 12 years and over

c) Dose: (Adults and children aged 12 years and over): One tablet daily before a meal

d) Route of administration: Tablet for oral use

e) Strength: Each tablet contains 180mg of fexofenadine hydrochloride

4. Prescription Only Medicine (POM) Criteria

To be reclassified from POM to P, a medicine must:

• be unlikely to be a direct or indirect danger to human health when used without the supervision of a doctor, even if used correctly
• be generally used correctly (i.e. not frequently or to a wide extent used incorrectly)
• not contain substances or preparations of substances where the activity of the product or its side effects require further investigation
• not normally be prescribed by a doctor for injection (parenteral administration)

These criteria are set out in the Human Medicines Regulations 2012, regulation 62(3).

5. Assessment of suitability for Pharmacy availability

The MHRA assessed the application against the POM criteria as stated in section 4 to ascertain whether the product could be supplied without a prescription in a pharmacy setting under the supervision of a pharmacist.

5.1 POM Criteria 1

5.1.1 Direct Danger

‘Direct danger’ means that a danger may be present if the product causes adverse reactions that cannot be managed without a doctor.

The safety profile of Almerg 180mg film-coated tablets is considered to be well established, and there has been extensive use of the medicine for over 20 years. The most common side effects are shared amongst many other non-prescription medicines, and are considered to be self-limiting. In comparison to older antihistamines, fexofenadine is less likely to cause sleepiness or drowsiness and is therefore unlikely to impair the ability to drive or operate machinery.

Fexofenadine is unlikely to cause harmful effects by interacting with other medicines. Indigestion remedies containing aluminium and magnesium may affect the action of fexofenadine and therefore it is recommended to leave 2 hours between the time that an Almerg 180mg film coated tablet and an indigestion remedy is taken.

Furthermore, the elderly, individuals with impaired kidney or liver function, or individuals with a history of heart disease are all advised to seek advice from their doctor before taking this product. This is suitable as currently the POM product is prescribed ‘with care’ to these populations, which implies that some level of healthcare professional input is required.

There is limited data regarding the use of fexofenadine in pregnancy. Women who are pregnant or breastfeeding are also advised to talk to a doctor or pharmacist before taking this product.

There are currently other antihistamines which are available as a pharmacy medicine that are also used to treat the symptoms of CIU.

5.1.2 Indirect Danger

“Indirect dangers” are considered to be when treatment might mask an underlying condition that requires medical attention.

The risk of masking an underlying condition is expected to be low, and there are already other medicines available from pharmacies to treat the symptoms of CIU, therefore the condition is already easily diagnosed and well managed in the pharmacy setting. This demonstrates that the public are already accustomed to recognising and managing their symptoms with medicines that can be bought from pharmacies under the supervision of the pharmacist.

It is likely that the symptoms of CIU would be easily recognised and there are already a number of medicines available as non-prescription medicines to treat this condition.

Any indirect danger associated with the above-mentioned populations (e.g. individuals with a history of heart disease) excluded from taking the product in the pharmacy setting is considered to be low. Pharmacists would be able to advise these individuals that the product can only be taken on the advice of a doctor.

5.2 POM Criteria 2

5.2.1 Incorrect Use

There is no evidence that Almerg 180mg film-coated tablets are frequently and to a very wide extent used incorrectly. The risk of intentional misuse related to the use of fexofenadine is low. There is no evidence to indicate that fexofenadine has any abuse potential, and the increased access to fexofenadine 180mg tablets as a P medicine is unlikely to increase this risk.

There may be a small risk of incorrect use in children under the age of 12 years or to treat the symptoms of SAR. This is due to other antihistamines that are available as P and GSL medicines which can be used in children less than 12 years and to treat both chronic idiopathic urticaria and seasonal allergic rhinitis. However, the presence of the pharmacist to ensure that the product is supplied correctly, and the clear labelling and leaflet of Almerg 180mg film-coated tablets are likely to be sufficient to mitigate this risk.

5.3 POM Criteria 3

5.3.1 Activity and/or adverse reactions require further investigation

Fexofenadine has been available as a POM for over 20 years and therefore its activity and safety profile are well established, and no further investigation of the side effects is required. Fexofenadine was also approved as a GSL medicine (120mg strength) in December 2020 and therefore as this product contains the same active ingredient, this criterion has not been met.

5.4 POM Criteria 4

5.4.1 Is normally prescribed as an injection

This product is for oral use only, so this criterion does not apply.

Overall, the MHRA considered that adequate evidence had been submitted to demonstrate that none of the POM criteria have been met, and therefore this product could suitably be classified as a P medicine.

6. Further details on the application

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 Almerg 180mg film-coated tablets identified the main risks associated with the product and proposed how these would be managed through the presence of the pharmacist and 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.

7. Advice from the Commission on Human Medicines

The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. Their views are sought on reclassifications when more complex or new reclassifications of medicines are being proposed.

The Commission considered that the POM criteria had not been met, and therefore advised that Almerg 180mg film-coated tablets, containing 180mg fexofenadine hydrochloride, could be approved for Pharmacy (P) availability based on the conditions outlined in section 3.

8. Conclusion

The MHRA has taken the decision to approve P legal status for Almerg 180mg-film coated tablets under the following conditions:

a) Pack size: 30 tablets

b) Used for the relief of symptoms associated with chronic idiopathic urticaria in adults and children aged 12 years and over

c) Dose: (Adults and children aged 12 years and over): One tablet daily before a meal

d) Route of administration: Tablet for oral use

e) Strength: Each tablet contains 180mg of fexofenadine hydrochloride

Medicines and Healthcare products Regulatory Agency April 2021