Are the MHRA NOT complying with EU guidance?

It seems the MHRA are failing to follow the guidance of the European Union (EU) regarding patient information leaflets in the UK. Ironic really as I have been banging the drum quite loudly in the direction of the MHRA to change the Seroxat Patient Information Leaflet. Well, it now appears that they are not only ignoring me (a concerned patient) but the EU guidelines too!

After they investigated (Ahem!) GSK they told us they could bring no prosecutions due to EU Law. I'm now using the EU excuse at them!

Question: Why are the MHRA failing to follow the EU guidelines regarding the adequacy of Patient Information Leaflets on Adverse Effects?

I will explain.

It appears that anecdotal evidence suggests that most leaflets give little indication of the likelihood of adverse effects. The MHRA suggests using a combination of words and numbers to convey this information.

The EU guideline on this matter is clear, they suggest using five verbal descriptors on a scale from common to rare leads to lead to gross overestimation of the risk of adverse effects.

A recent assessment (Authors: Carrigan, Neil1; Raynor, D.K.1; Knapp, Peter1) showed that 40% of 50 Patient Information Leaflets studied gave no indication of the likelihood of adverse effects occurring.

More worrying was that only 12% of the 50 Patient Information Leaflets studied used the recommended EU terms and a further 40% used a wide range of other verbal descriptors.

Only four leaflets (8%) provided any form of numerical indication of risk!

The conclusion of this assessment can be read in abstract form here.

Conclusions: Patient need is not being met in terms of the provision of usable information about the likelihood of adverse effects. Most patients receive no information, whereas some are given verbal descriptors, both of which lead to overestimation of the risk. Very few of the patient information leaflets assessed used currently described best practice, i.e. to present verbal descriptions alongside numerical information in the form of natural frequencies, e.g. `rare (affects less than 1 in 1000 people)'.

I have wrote to the MHRA with a simple question, a copy was also sent to my MP, Gisela Stuart and the CEO of the MHRA, Kent Woods.

Why are the MHRA failing to follow the EU guidelines regarding the adequacy of Patient Information Leaflets on Adverse Effects?

The MHRA proudly boast on their website:

"We enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks."

Their answer should prove interesting.

Fid


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