Changed Process for Accessing Phenol, Sodium Hydroxide and Trichloroacetic Acid for Nail Treatment March 2023

Phenol has been registered as a medical device for a considerable period of time.

More recently a member of the public lodged an inquiry about this which forced Medsafe (the independent authority) to review the product. As a result of this review Medsafe have determined that phenol is a medicine as opposed to a medical device.

Medsafe have specifically stated that phenol, sodium hydroxide and trichloroacetic acid on the nail bed is a pharmacological action and so these products are medicines. Because none of these products have been through the medicines applications process they are not allowed to be supplied for therapeutic purposes and therefore Medsafe have notified the Regulatory Board that they may not be used by podiatrists until such time as the applications have been approved.

It is the responsibility of the supplier to make this application.

Proposed Changes Medsafe have proposed a workaround until such time as this application is successful, recognising that in each instance the patient needs to obtain the product prior to the surgery.

This is as follows:

1. The Swab-It phenol product can be purchased by the patient on the prescription of a medical doctor under the exemption provisions in section 29 of the Medicines Act 1981. (Note that standing orders do not apply to the supply of an unapproved medicine and a GP cannot do a standing order for a clinic as standing orders can only be given for approved medicines).

Medsafe is working with the wholesaler that previously supplied this product to enable continued supply under these provisions and we have been informed that a licence has been received by the wholesaler. Phenol may be in short supply for a short period of time whilst this new process gets underway.

IMPACT ON GPS AND PHARMACISTS: Podiatrists will be asking patients to get a prescription from their GP and then get this filled at a pharmacy before bringing it back to podiatry clinic to be used in the treatment.

2. A pharmacist in a pharmacy can manufacture a trichloroacetic acid solution for a named patient, on receipt of a prescription by an authorised prescriber, under the exemption provisions in section 26 of the Medicines Act. (Note that standing orders do not apply to the supply of an unapproved medicine).

3. Patients could ask a pharmacist to prepare a sodium hydroxide solution that they then take to the podiatrist for the podiatrist to use on them under the exemption provisions in section 26 of the Medicines Act. Section 26 does not permit a pharmacist to manufacture a sodium hydroxide solution for sale to podiatrists for use on their patients.

IMPACT ON PHARMACISTS: There may be an increasing number of podiatry patients requesting either sodium hydroxide or trichloroacetic acid solutions.