Medicines and Healthcare products Regulatory Agency

Whereas the electronic Medicines Compendium is not all-inclusive, it does seem to be a duplication of effort to start afresh with an MHRA site for SPCs and PILs. Has Datapharm been approached to see if they could facilitate the publication of all SPCs and PILs not just those of member companies. The funding/fees would be a complicated issue but could probably be worked out.

There is another tag on the same subject. It has been suggested on that tag that there have been some problems with accessibility since the website has been re-designed but I have encountered no problems to date. It has also been pointed out that not all PILs and SPCs are availble on emc. If the MHRA could require all companies with licensed medicines to make their SPCs and PILs available on that site, being able to access one reference source would save duplication and make one feel confident that the correct information can be accessed.

I agree with pharm1 - making the posting of SPC and PILs on one agreed site would be a far more practical solution than creating another system.

Is it only the question of PILs and SPCs? How about the domain of complete list of medicines registered, marketed or expired?

Just copy the layout of the system set up by the Irish Medicines Board and also use some of the fuctionality of datapharms EMC website.

I do note the EMC does not have every UK licensed product SPC nor their PILS

For many lay poeple and patients they want to find out fast informmation on

1-dose
2-how to use
3-side effects of the product and when not to tkae
4-indications
5-ingredients

I do not think PILs and SPCs from the MHRA would duplicate that available from the eMC. I think that the eMC site only provides information from those companies who subscribe to the eMC. I have found that there is no easy reference source for PILS and SPCs for most generic medicines. Patients should be given one with every dispensed medicine but because pharmacists cannot dispense original packs at the moment we often need extra lealflets. Having a comprehensive source of PILs on the MHRA website would be very useful since I presume it would include all licensed medicines. The PIL provided has to match the product i.e. has to be the PIL provided by the particular manufacturer, hence it would be useful to be able to access and print easily extra PILs for any licensed medicine.

In common with some other views expressed here, I would prefer to see extension of the eMC / Datapharm website than for the MHRA to put together its own site from scratch. Patients can already access a lot of information on their medicines including the eMC and NHS websites and there is a risk that this could further muddy the waters. It could be quite a committment to take on this role now which you (the MHRA) could later come to regret.

A Pharma company perspective...

It's indisputable that as an MAH we have an obligation to make the current SmPCs & PILs available to HCPs and the general public. We therefore invest a significant proportion of resource into ensuring our internal systems are maintained with the correct documents, and have Medical Information & Drug Safety professionals on hand to address queries. All of which is subject to auditing by MHRA during inspection.

Notwithstanding these major efforts, we also endorse a single portal for SmPCs & PILs, which is only partially fulfilled by eMC at the present time.

Let's face it... No one wants a third system to maintain as is currently being proposed. DUPLICATION SHOULD BE AVOIDED AT ALL COSTS! Thus, we should either seek to broaden eMC to encompass all products, or wholeheartedly subscribe to an MHRA solution. If the MHRA get it right (which can't be that difficult - can it??) then this must be favourable.

No wonder DataPharm are trying to rally the troops, they're business is clearly under threat. But are we sympathetic...Not really given the annual eMC costs of £25k and the pressure (scaremongery) they exerted on companies to subscribe to X-PIL which has proved of little value.

The aim of this consultation is, I assume, to address the needs and rights of the patients and the public to have ready access to SPCs and PILs. This is not the case now, given that eMC is limited to only those companies who can afford to publish. And with all of the added extrss, eMC is getting quite tricky to search, especially if you are not familiar with it and don't know what you are looking for.

Also, the most up-to-date information will inevitably be closest to its source- the MHRA who approves each and every document. It is assumed (?) that they have a complete and accurate database of current documents- in which case- over to them! No issues with out of date PILs in carton- the new ones can be available as soon as a change is approved. MHRA- be our guest! (Simplistic, I know, but better to start afresh with new ideas than try to adapt existing systems)