Announcing the change yesterday (August 16), the MHRA explained the decision to reclassify this product follows a review by the Commission on Human Medicines (CHM) and a public consultation.

In its proposal to make Nuromol available as GSL, licence holder Reckitt Benckiser Healthcare (UK) proposed that the medicine would be available in a maximum pack size of 16 tablets, with a maximum recommended daily dose of six tablets.

Sarah Branch, director of vigilance and risk management of medicines at the MHRA, said that the reclassification “will help people to manage their pain where paracetamol or ibuprofen alone have not provided adequate pain relief”.

“Wider availability of medicinal products and improved patient access and choice remain high on the health agenda. The MHRA is committed to improving access to medicinal products for self-care where it is safe to do so,” Dr Branch added.

Nuromol is used for the temporary relief of mild to moderate pain associated with issues such as migraines, backache, period pain and fever when paracetamol or ibuprofen alone have not provided adequate pain relief, MHRA said.

 

RPS “concerned” by announcement

 

The Royal Pharmaceutical Society (RPS) disagreed with the proposal to switch the product to GSL and raised concerns about the safety of the move in its response to the consultation, which ran from May 13 to June 3.

Reacting to yesterday’s announcement, RPS President Claire Anderson told C+D today (August 17) that “by moving this combination product from P to GSL, vital interactions with pharmacists are lost and the patients will not be supported with health and medicines advice tailored to their individual needs.”

Professor Anderson added that the RPS still has concerns about the safety of this switch.

“Ibuprofen is contraindicated in several patients, including those with kidney or liver failure, and there are also many times when it should be used with caution, for example in the first and third trimester of pregnancy,” she said.

“We are also concerned about the potential for people to confuse the product with paracetamol alone and take the standard paracetamol dose of two tablets four times a day. This has the potential to cause patient harm.

“Patients must be able to self-care with the support of the professional expertise and judgment of a pharmacist, and the P category of medicines helps facilitate this interaction. This is especially important when a product contains more than one medicine, such as Nuromol,” Professor Anderson added.

Addressing these concerns in its consultation response, the MHRA said that amendments to the labelling and advice leaflet included in packs of Nuromol were considered adequate by CHM. The regulator also stated that, as the pack size were limited, CHM “considered the risk of overdose is minimised acceptably”.

While the MHRA stressed that Nuromol was intended as a second-line treatment, “it is accepted that users can ignore the warning if they choose but they can also ignore advice given by the pharmacist at point of sale and when the product is available in their homes if they choose. Therefore, this risk is not considered to be any higher than if the product was classified as P.”

 

Mixed response from pharmacists to consultation

 

There was a mixed response from other pharmacists who responded to the public consultation.

A pharmacist who disagreed with the change commented that it would be “confusing for patients; there is a risk it could be taken in addition to both ingredients. I don’t think it can be fully mitigated by labelling”.

However, a semi-retired pharmacist agreed with the proposal, noting the recommendation for second-line use “which is clearly stated on the package”.

Similarly, another pharmacist agreed that “satisfactory reasoning has been provided to change the classification of the product”.