Women

Medicines and Healthcare products Regulatory Agency focus group

The Medicines and Healthcare products Regulatory Agency (MHRA) invited Epilepsy Action to a focus group. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

At this event I fed back that the standard and quality of patient information leaflets (PIL) need to improve across all brands of anti-epileptic drug. The PIL provides information about possible side-effects of taking a medicine, and possible interactions between that medicine and other medicines. It shouldn’t matter which brand of anti-epileptic drug (AED) you take, the quality of information in the patient information leaflet should be of a high standard.

I also explained that risk information needs to be meaningful by being better explained and put into context. Women taking an anti-epileptic drug (AED) want to know what side-effects might be experienced after taking that drug, and the likelihood of experiencing that side-effect. Women also need to know whether a medicine might interact with contraceptives and hormone replacement therapies.

I explained that women taking an AED need to know what risk that drug poses in pregnancy (for example the risk of malformation in the unborn baby). They also need to know the risks of not taking their AED in pregnancy, to enable them to make an informed choice about their medicine. It is not enough to say that a drug or medicine shouldn’t be taken in pregnancy. That doesn’t enable an informed choice to be made. Furthermore a woman might already be pregnant when she reads the PIL. An absence of meaningful risk information can cause anxiety. This can lead to undue stress while she waits for an appointment with her GP.

Hosting the focus group was a positive step from the MHRA as they seek to better understand the needs of people who take medicines. The MHRA also stressed a desire to work more closely with charities and the general public.