Medicines and Healthcare products Regulatory Agency

Good point.
NB We don't really need issues of copyright being raised as to why we can't just reproduce PILs. Pharmacos should readily accept that no one is trying to make a buck from copying PILs but simply trying to provide patients with the correct information.

I have recently learned that in at least one other market(Australia?) the Pharmacies are routinely supplied with updated software with PILs for all of the medicines available on the market. Whenever someone buys a medicine from a pharmacy, the pharmacist prints out the PIl and provides it to the patient. You can also ask a pharmacy to provide you with the copy of a PIL if you need it. How sensible is that?

All sources of PIL's that I curently have access to produce pages and pages of print. It would be useful if you could provide a small type face or modified version that would print as a single page but still provide all the important information that is required on a PIL. Other software producers of PIL's should note that a 5 page dosier on a drug is not only intimidating to a patient it also wastes a lot of paper when we are trying to reduce waste.

I think pharmacists will find the new resource helpful as long as it has an easy interaction interface with intuitive searching.

It would indeed be great if pharmacists could easily print PILs when they dispense. As alanmansfield observes, PILs are currently designed as pack inserts not printable documents. Some come in booklet form, many with text size and diagram layout incompatible with A4. The eMC (http://emc.medicines.org.uk/ ) currently contains 3774 PILs. Our experience suggests that the creation and quality assurance of printable PILs or modified versions providing ‘all the important information that is required on a PIL’ as alanmansfield suggests, is a major undertaking and would require significant investment of time and resources from both pharmaceutical companies and the regulator.

Posted by Lawrence Berry (lberry@medicines.org.uk), Datapharm CEO

It must be noted that variations to products happen regularly e.g. change of tablet colour. In this instance how can the patient/pharmacist be assured that the leaflet they download is specific to the product they have?

It can take 6 months from MHRA variation approval to industry supply to the market of the new lealet, and even then there could be two forms of the same product on shelf if the product has a long shelf life.

Therefore only the Marketing Authorisation Holder can ensure, based on batch numbers, what leaflet is correct for the product with the pharmacist/consumer.

If a consumer downloads a Leaflet stating one colour tablet, when their product is the old colour this could cause no end of worry and confusion and no doubt complaints to the MHRA &/or MAH. The MHRA will hopefully give this careful consideration with appropriate controls.