MHRA

Dutch tapering kits website has not broken law, MHRA concludes

Public health inspectors in the Netherlands and the UK’s drugs safety watchdog have both concluded that the English-language version of a Dutch-based selling tapering kits to patients to help wean them off antidepressants and other psychiatric drugs, does not break the law.

The Medicines and Healthcare products Regulatory Authority (MHRA) confirmed on Tuesday 31 October that it had carried out a review which concluded that the site had not broken any laws.

The Dutch Health Care Inspectorate — the government agency responsible for the safety of its public health system — said it has decided that the site’s procedures meet all its existing laws and regulations and is not illegal.

A spokesperson for the inspectorate confirmed the decision and said the details have been forwarded to the UK’s MHRA which had originally expressed concern about the English-language version website.

The site, launched in July and hosted in the Netherlands, is an English-language version of an established Dutch site. It has been developed in collaboration with Paul Harder, a pharmacist from the Regenboog Apotheek, the Cinderella Therapeutics Foundation and the user research centre at the department of psychiatry and psychology at Maastricht University, all of which are based in the Netherlands.

The MHRA ed the Dutch inspectorate when the site was launched because it was concerned that UK patients might be able to use the site to buy a kit made up of prescription-only medicines from the website, going outside the usual UK drug supply chain. The MHRA said that the strips could be purchased without the need for a UK prescription.

Those behind the site, however, have argued that patients have to fill in an order form signed by their GP with their professional registration details, which then acts as a prescription.

Peter Groot from the User Research Centre at Maastricht University’s department of psychiatry and psychology who has been involved in the website welcomed the Dutch inspectorate’s decision. He said: “It is reassuring for us and for the patients we wish to inform that what we do is in order.”

Citation: The Salvadore DOI: 10.1211/PJ.2017.20203849

Readers' comments (1)

  • Bravo, a sensible decision from the medicines regulatory body. The rights and needs of patients who wish to reduce or stop their psychoactive medications should not be ignored. Why should those who are physically or psychologically dependent on psychiatric medications be left high and dry with little support or guidance when they wish to stop? This is all part of fully informed consent and the availability of Tapering Strips has the potential to ease withdrawal difficulties of patients while helping doctors too. This leads to a reduction in medication burden, in addition to time and cost savings for healthcare providers.

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