Treatment ban: More pain for toenail sufferers
An important chemical used in the treatment of ingrown toenails has been taken off shelves by Medsafe, the country’s medicines regulator.
A regulatory oversight classifying a commonly used podiatric chemical phenol as a medical device rather than a medicine by Medsafe, has rendered the treatment of ingrown toenails nearly impossible for the time being.
Andrew Jones the lead podiatrist at Hamilton based Waikato Podiatry Clinic, says that the immediate ban on the use of phenol to inhibit nail growth could see 13,000-14,000 treatments affected annually.
‘‘The nuts and bolts of the situation is
Medsafe have had a query from a member of the public about the accessibility of phenol to podiatry, that has triggered an internal investigation that has found that the classification of phenol has been inappropriate and needs to be reclassified as a medicine rather than a medical appliance.’’
Phenol, Jones explains, is the best evidence-based treatment for the matrixectomy of toenails and features as the ‘‘gold standard’’ procedure in the medical treatment database, the Cochrane library. The alternatives sodium hydroxide and trichloracteic acid have also been banned for use.
Jones says while he understands the agency has a job to do, the way the order to remove the chemical from the list of podiatric medical appliances has been executed was done in a ‘‘cumbersome way’’.
‘‘Medsafe will provide an exemption for podiatrists to continue to use phenol.
‘‘Unfortunately, that could take six to 12 months. So a short term measure they have proposed is that if a podiatrist wants to do a phenol matrixectomy they have to refer the patient back to the GP requesting a script for phenol, the patient then has to fulfil the script and bring the phenol in with them to the treatment at the podiatrist.’’
With GPs already stretched thin, Jones says this ‘‘bureaucratic’’ response to phenol treatments will leave nobody better off.
‘‘This implementation is only going to increase wait times, pressure on GPs and cost of the treatment for the end user.’’
Jones’ Australian colleagues he says are paid better and have the right to prescribe some podiatric treatments, something Kiwi podiatrists don’t.
Those factors could lure New Zealand clinicians to Australia, he says. Inflaming the podiatrist shortage in New Zealand.
A Ministry of Health spokesperson said in a statement that while the regulatory status of phenol hasn’t changed, the status of the chemical as a medical device has.
‘‘If a product has a therapeutic purpose, then it could be a medicine or a medical device.
The key difference is the way the product affects the body. If a product acts by pharmacological, immunological or metabolic means, it is a medicine.
If it doesn’t, it is a medical device. For example, removing the nail by physical or chemical means would be the action of a medical device.
However, in this case, the action of putting phenol on the nail bed has a pharmacological effect, and so these products are medicines.
This was recently raised with Medsafe, and it agreed that under the Medicines Act 1981, phenol, sodium hydroxide and trichloracteic acid are medicines rather than medical devices.
Medsafe has been providing advice to the Podiatrists Board and Podiatry NZ regarding options to access a suitable product for their use while meeting legal requirements, and we have received positive feedback.’’
‘‘The nuts and bolts of the situation is Medsafe have had a query from a member of the public about the