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house of commonsApril 20 2016

There have been 95 reclassifications of medicines from prescription to over the counter status over the past 25 years, a parliamentary answer has revealed.

Since 1991, excluding variants and generics, 59 Prescription Only Medicines (POMs) have been made available as Pharmacy (P) medicines. In the same period, 36 P medicines were made available as General Sales List (GSL) medicines.

The names of the products and the indications for OTC usage were given in a parliamentary written answer this week.
Justin Madders, MP for Elllesmere Port and Neston, had submitted a number of questions regarding POM to P and P to GSL switching, and asked whether the health secretary would “make it his policy to adopt a target encouraging the reclassification of medicines.”

In his reponse, health minister George Freeman said: “The Government is committed to the continued reclassification of medicines from prescription only to pharmacy classification and from pharmacy to general sales list classification when it is safe to do so and there is a clear benefit to public health. This is an important part of empowering patients to manage their own care.”

He noted that the medicines regulator, the MHRA, is considered to be “at the forefront of moves to reclassify medicines to non-prescription and is recognised as a leader in Europe in this regard.” Among the legislative changes made to help more reclassification, Mr Freeman said that amendments introduced in 2002 had helped reduce the legislative burden for reclassification. In addition, new guidance in 2012 further streamlined the process, and in 2015 “a United Kingdom platform was set up to maximise stakeholder engagement with the aim of encouraging further reclassification of medicines.”

Mr Madders had also asked for information about prescribing costs associated with the products before and after the switch took place. However, Mr Freeman said: “We are unable to calculate the total difference in cost to the public purse following these medicine reclassifications.”

A list of the POM to P and the P to GSL switches for the past 25 years was also published with the written answer. “The lists represent the first reclassification either from POM to P or P to GSL of the product and further extensions such as wider indications, additional pack sizes or higher strengths have not been included. Not all products listed are currently available, for various reasons, including both commercial and regulatory,” said Mr Freeman. In addition, there are no examples of medicines which have been reclassified from POM straight to GSL.

Links:

Parliament UK written question 33762

Parliament UK written question 33763

Parliament UK written question 33764

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