Amorolfine

Amorolfine 5% medicated nail lacquer is a topical antimycotic (antifungal) agent that has a fungicidal effect.

Amorolfine is a broad-spectrum antimycotic with activity against a wide range of organisms including dermatophytes (trichophyton, microsporum, and epidermophyton species), yeasts (Candida, Cryptococcus, and Malassezia species) and moulds.

Amorolfine works by inhibiting sterol biosynthesis and thereby disrupts the fungal cell membrane, leading to cell death. 

When amorolfine nail lacquer is applied to the nail surface, the solvent evaporates to leave a highly concentrated deposit of amorolfine in an occlusive film on the nail. Amorolfine then diffuses through the nail plate over the next seven days and is delivered to the nail bed. 

More information on the mode of action can be found in the relevant product SPC and patient information leaflet (PIL) under further information.

Decision-making process for supply

You’ll need to use your professional judgement when dealing with requests (see our professional judgement guide). 

It’s important to share information about the process of supply with the person requesting. Explain that you’ll need to ask some questions to make sure the medicine is suitable for them, and that you may need to refer them to a prescriber if you identify contraindications or if investigations are required. 

Use the following questions to support with diagnosis, prescreening, education and supply. Explore the person’s situation by considering and asking the following: 

• Who is requesting a supply? Is it the person who needs the medicine or a representative?
  • Supply to the person needing the medicine – is the person needing the medicine 18 years of age or older.
  • Ensure you are supplying the medicine within the marketing authorisation.
  • Supply to the person’s representative - see the section on supply to the person’s representative.
• Does the person have signs and symptoms of a mild fungal infection (see the section on onychomycosis) and how long have they had them?
  • Are there any other symptoms that may indicate differential diagnosis or require referral for further investigation? (e.g.) signs of nail dystrophy and destroyed nail plate, see the section on when to refer within the summary of product information.
  • How many nails are affected? Treatment is limited to a maximum of two infected nails at one time.
• Is the person hypersensitive to any of the active ingredients or excipients in amorolfine nail lacquer?
  • It is contraindicated if there is hypersensitivity to the active substance or any excipients listed.
• Do they have any health or medical conditions and are they taking any medicines?
  • Check for contraindications, interactions, and any reason for referral under summary of product information (e.g.) peripheral circulatory disorders, diabetes mellitus, immunocompromised, pregnant, or breastfeeding).
• Are they aware of all the other options available to them? See the section on practical advice.
• Have they already been supplied amorolfine OTC?
  • Check if they experienced any side/adverse effects that would require referral to the prescriber and see the quantity to supply and repeat requests section.
• Have they requested amorolfine in the past and been refused, or had to stop treatment for any reason?
  • Find out why and use your professional judgement to decide if it is a reason for referral. 
• Have they already been prescribed amorolfine?
  • Amorolfine can be purchased from a pharmacy as a P medicine if more practical (e.g., they are unable to get a suitable appointment with their prescriber). However, consider if an emergency supply of the person’s prescribed medicine is more appropriate (e.g.), if they are being prescribed off-licence or under 18 years of age, (etc.) see our guide on emergency supply. 
• Use your professional judgement to decide on suitable action: 
  • If you feel the supply is suitable and the person requesting the medicine is happy to continue, provide counselling and relevant information using the summary of product information section.
  • If you feel the supply is not suitable, if in doubt of suitability, or if medical attention, investigations, or a referral is required, then refer to a prescriber.

Decision-making flowchart for supplying amorolfine 5% medicated nail lacquer

Use our short and easy-to-read flowchart. This can help you with questions and you may consider it appropriate to assess suitability of supply.

The flowchart is designed to be used with the following sections in this guide to help you develop your own consultation skills:

• Decision-making process for supply – for further information and questions
• Summary of product information
• Confidence in consultation skills
• Counselling

Please note: the relevant product SPC and PIL can be found under further information. 

Quantity to supply and repeat requests

Use your professional judgement on a case-by-case basis to decide if multiple packs or a repeat supply to the same person is appropriate.

Remember:

• A review of the treatment is recommended approximately every three months.
• The treatment course depends on the intensity and localisation of the infection. Generally:
  • Fingernails – six months 
  • Toenails – nine to 12 months
• You’ll need to ensure you are satisfied the medicine is still clinically appropriate and suitable on each occasion and check if anything has changed since the last supply. This will determine if a repeat supply is suitable.
• Referral is recommended if:
  • Symptoms worsen or are not improved at three months review.
  • The infection has not cleared after:
    • Fingernails – six months
    • Toenails – 12 months
  • You feel the supply is no longer suitable or in doubt of suitability.
  • Medical attention, investigations, or referral is required.
• If you feel the supply is suitable then provide counselling.

These questions can help you assess continued suitability:

• Have there been any changes in their health or medical conditions or medicines (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational, alcohol, and tobacco) since their last supply?
• Have they experienced any side effects or signs and symptoms of adverse effects – (e.g. serious side/adverse effects may require immediate withdrawal and referral to the prescriber)?
• Have there been any changes in their symptoms that concern them? Refer if symptoms have worsened, or not improved, or if any new onset contraindications.
• Do they have any concerns or issues using the product?

See the relevant product SPC and PIL under further information. 

Supply to the person’s representative 

Amorolfine nail lacquer can be supplied to a representative. However, only supply the product: 

• Within the marketing authorisation. 
• If you’re satisfied it’s a genuine request. 
• If the treatment is clinically appropriate for the person. 

You’ll need to use your professional judgement with requests from representatives. 

Consider the following: 

• Who is requesting on the person’s behalf and why? 
• How will you ensure you’re satisfied that the treatment is clinically appropriate for the person needing the medicine?  (e.g.) check contraindications, referrals, previous medical history, and existing medicines.
• How can you get in touch with the person to assess suitability and determine whether the request is appropriate and genuine? (e.g.) by telephone.
• Be careful not to disclose to the representative what was previously discussed, unless you have consent from the person needing the medicine.
• Are you supplying the medicine within the marketing authorisation? (e.g.) ensure that the person is aged 18 or over and it’s used for the treatment of mild fungal infection.

Summary of  product information

Indication	– Treatment of mild cases of fungal nail infections beneath the tips and sides of nails (distal and lateral subungual onychomycoses) caused by dermatophytes, yeasts, and moulds. – Treatment is limited to a maximum of two infected nails at one time. – For use in adults over 18 years of age.
Contraindications	– People under the age of 18 years. – Pregnant women and breastfeeding women. – Hypersensitivity or allergies to amorolfine or any of the other ingredients.
Dose	– Apply topically to the affected fingernails or toenails once weekly. – For cutaneous use
Administration	Before the first application: – Using a nail file, thoroughly file down the affected areas of nail (particularly the nail surfaces). – Using an alcohol cleaning pad, clean and degrease the surface of the nail. – Using one of the applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. – For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck. – After use, clean the applicator with the same cleaning pad used before for nail cleaning. Repeat applications: – File down the affected nails as required. – Cleanse with a cleaning pad to remove any remaining lacquer. – Treatment should be continued regularly, without interruption, until all of the affected nail tissue has grown out. The nail is then regenerated and the affected areas are cured.  Note: nail files used for affected nails must not be used for healthy nails to help prevent spread of infection. The required frequency and duration of treatment depends on the intensity and localisation of the infection. Generally, it is six months for fingernails and nine to 12 months for toenails.
Side/adverse effects:	Adverse drug reactions are rare. The following may occur but can also be linked to the onychomycosis itself. Rare: – Nail disorders – Nail discolouration – Broken nails – Brittle nails Very rare and unknown frequency: – Skin burning sensation – Hypersensitivity – Erythema – Pruritus – Contact dermatitis – Urticaria – Blisters Report any suspected side effects via the Yellow Card scheme as appropriate.
Interactions	– The SPC for amorolfine currently states no interaction studies have been performed. – However, it would be best practice to use your professional judgement to regularly check interactions with peoples concurrent medicines (including prescribed, OTC, herbal, complementary, vitamins, dietary supplements and other topical products etc.) in case they are of clinical relevance, and need referral to a prescriber. – It’s best to avoid using nail varnish or artificial nails during treatment. However, if you do use nail varnish, wait ten minutes before applying nail varnish. Nail varnish needs to be removed again before reapplying amorolfine.
Pregnancy and breastfeeding	– Cannot be used while breastfeeding. – Cannot be used in pregnancy.
Age	– For use in adults aged over 18 years.
When to refer	– If the person has a contraindication. – If the person experiences any side effects. – If the person is pregnant or breastfeeding. – If the person is taking or using medicine(s) which has a clinically significant interaction with amorolfine. – If there is any doubt a person is suitable for supply. – If the person has nail dystrophy and destroyed nail plates. – If the person has more than two infected nails at the one time. – If the person has underlying conditions predisposing to fungal nail infections including: – Peripheral circulatory disorders – Diabetes mellitus – Immunosuppression After starting treatment, refer people if:  – Symptoms worsen or not improve at three months review. – Symptoms have not cleared after six months for fingernails and 12 months for toenails.
Storage	– Store below 30°C. – Keep the bottle tightly closed and upright. – Flammable: keep away from fire and flames and heat.

Onychomycosis

Onychomycosis is a fungal infection that can affect both fingernails and toenails.

Symptoms of onychomycosis include:

• Brittle and/or broken parts of the nail.
• Changes to the nail spreading along the length of the nail towards the nail base.
• Debris accumulating under the nail, causing scaling and distortion of the nail.
• Thickening of the nail.
• Turning yellow/white in colour at the nail tip.

Differential diagnosis

There are a variety of other conditions that could cause nail changes, resembling fungal nail infections, such as: 

• Eczema
• Lichen planus
• Nail trauma
• Psoriasis
• Tumour of the nail bed
• Yellow nail syndrome

Ideally, suspected onychomycosis should be confirmed by microscopy. However, given that treatment is unlikely to cause harm, OTC medicines can be given without a positive diagnosis.

For further information on amorolfine and onychomycosis see the National Institute for Health and Care Excellence’s (NICE) Clinical Knowledge Summaries (CKS) resource as well as the NHS.UK website.

Practical advice

• Avoid contact of the lacquer with eyes, ears, and mucous membranes.
• When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves to protect the amorolfine nail lacquer on the nails.
• Coexistent athlete’s foot should be treated with an appropriate antimycotic cream.
• Maintain good foot hygiene
• Keep nails short and filed down.
• Avoid sharing nail clippers and nail files with other people.
• Avoid or minimise exposure to situations which predispose to, or aggravate fungal nail infections (e.g.):
  • Prolonged or frequent exposure to warm damp conditions.
  • Wearing occlusive footwear.
  • Damaging the nail.

Confidence in consultation skills

Discussing fungal nail infections symptoms may be uncomfortable for some people and they may feel nervous approaching the pharmacy team. To ensure comfort and confidence, the pharmacy team should always be discreet, non-judgemental, and put the person at ease. 

Pharmacists can supply P medicines or supervise their supply. If the request needs to be referred by counter staff to the pharmacist, then the pharmacy team will also need suitable training to handle such circumstances, since they’re usually the first point of contact. Referral should also be covered in the standard operating procedure.

To support these conversations, good communication between yourself and the patient is essential. We have a pharmacy guide with practical tips and information that could be used to help develop your confidence in consultation skills.

Counselling

Advise the person to read the patient information leaflet and packaging – as a reminder of key safety messages.

Discuss the following:

• The medicine – what it is, how it works, and how to use it.
• Importance of adherence – make sure the person is aware the course of treatment is generally six months (fingernails) and nine to 12 months (toenails). 
• Side/adverse effects and risks – make sure the person is aware what signs and symptoms to look out for and when to seek medical attention and advice.
• Referrals – make sure the person is aware when to see a prescriber.
• Offer practical advice – see section on practical advice.
• Interactions – make sure the person is aware to check interactions with a pharmacist before starting any new medicines.
• Health promotion – provide lifestyle and well-being advice where appropriate including diet, exercise, smoking cessation, weight and blood pressure management. 
• Further supplies – person is aware how to obtain further supplies.

You may also find our pharmacy guide on counselling people on the use of medicines useful.

Other considerations:

• Record-keeping – see section on record-keeping.
• Quantity to supply – see section on quantity to supply and repeat requests.
• Online purchases – highlight the risks of purchasing medicines online.
  • If buying from unregulated resources the medicines may not tested for safety or effectiveness.
  • Advise the person to check that the medicine is being supplied from a reputable provider before purchasing – see guidance from the General Pharmaceutical Council (GPhC) on providing services online.
• Storage and disposal – advise the person to return any unused medicines to a pharmacy for disposal. See section on storage.
• Online pharmacies – will need to meet GPhC regulatory standards for providing services at a distance. For further information see GPhC guidance on providing pharmacy service at distance, including on the internet and premises standards.
• Delivering and posting medicines – there are some additional points for consideration in the Medicine, Ethics and Practice page under delivering and posting medicines to patients.

Record-keeping

There is no legal requirement to make a record of the supply of a P medicine.

However, professionally, you may decide to make a record of the following for audit purposes:

• Referrals
• Discussions
• Reasons for the advice that you gave
• Advice you gave in terms of when and how to seek help if needed (i.e.) safety netting
• Repeat sales
• If someone has asked you to contact their prescriber
• Interaction checks

If you decide to make a record, you need to ensure you have gained consent to do so. See GPhC guidance on confidentiality and GPhC guidance on consent.

You may also find our pharmacy guide on clinical documentation useful.

Further information

Product information

• electronic medicines compendium

Clinical

• NHS

Consultation skills

• Centre for Pharmacy Postgraduate Education
• Health Education & Improvement Wales
• NHS Education for Scotland
• RCPharm counselling people on the use of medicines