For the first time, people aged 16 years and over will be able to buy Colourstart Test 65mcg cutaneous patches without a prescription or under the supervision of a pharmacist, to see if they are allergic to paraphenylenediamine (PPD), which is commonly found in hair dyes.

The Medicines and Healthcare products Regulatory Agency (MHRA) announced yesterday (August 1) that it had decided to reclassify the product from a POM to a general sale list (GSL) product to help “make it easier for people to screen for allergy to hair colourant”.

The move to make the Colourstart Test more widely accessible will help people avoid suffering skin reactions if they are allergic to PPD, the MHRA added.

The Colourstart Test Patch was licensed as a POM in 2012. The self-adhesive plaster consists of two patches: one containing 65mcgs of PPD, the active patch; and the other a control patch with no PPD. The test patch is applied to the top of the arm and if there is a reaction, hair dyes should not be used, the MHRA explained.

NPA, RPS and CCA respond

The decision to reclassify the product was made following a “robust assessment” of the safety of the Colourstart Test, consideration by the Commission on Human Medicines (CHM) – which advises the government on the safety, efficacy and quality of medicinal products – and a public consultation, which ran from October-November 2018, the MHRA said.

Five professional bodies responded to the consultation, including the National Pharmacy Association (NPA), Royal Pharmaceutical Society (RPS) and the Company Chemists’ Association (CCA).

Of the five responses, only the RPS and CCA were in favour of switching the Colourstart Test Patch from POM to GSL, with the NPA arguing that the product should in fact be reclassified as a pharmacy (P) medicine.

“Community pharmacists are well positioned to provide the advice and support to the customer, including side effects and potential interactions with medicines, such as corticosteroids or immunosuppressants,” the NPA said in its response.

“The community pharmacist would also be able to advise in the case of a false positive result, as well as instances when the positive reaction may persist.”

The CCA and RPS both welcomed the proposal to reclassify the Colourstart Test, to improve public access to it. However, the RPS suggested pharmacies should be included in the list of retailers to supply the product, as “pharmacists are well placed to provide additional advice to a person with any questions about the product or if a reaction occurs”.

The MHRA said the issues raised during consultation were further considered by the CHM, before it issued its final advice to reclassify the product.

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