Medicines and Healthcare products Regulatory Agency

the EMC site has many great features in its latest incarnation. But it isn't comprehensive, and is never likely to be. The great strength of the MHRA's data is that they ought to have SPCs for everything. I agree it would be nice if the MHRA data were somehow merged with the EMC to give one comprehensive site, but should the regulator be seen to be getting into bed (even at one remove) with the commercial organisations that it regulates?

the eMC site only contains those SPCs and some PILs from those companies who are part of the ABPI. Members then pay to have there SPC and/or PIL included on the site. It is by defintion NOT comprehensive.

If the MHRA could mandate/legislate/encourage/ensure that at the very least a SPC for every licensed medicine in the UK was on the eMC site that would be ideal. But as the eMC stands it is a good but not excellent site in terms of coverage.

The eMC currently contains 3755 SPCs and 3214 PILs submitted by a wide range of pharmaceutical companies. As of January 2010, a total of 166 companies contributed information to the eMC. These contributors are drawn from a larger group than the ABPI, who currently have 64 members. In 2009, 10 million SPCs were downloaded from the eMC website. During the same period, 6.8 million PILs and X-PILs were downloaded from the eMC.

A measure of the comprehensiveness of the resource can be based on the total number of medicines dispensed. The top 90% of medicines dispensed (by volume) in primary care amount to some 800 products (based on Prescription Cost Analysis data provided by the NHS Information Centre in December 2009).This data has been analysed at both salt and preparation level and the presence on the eMC of the SPC and/or the PIL for each product assessed. 95% of these products are covered in the eMC. In the case of secondary care, 97.8% of the top 200 products by volume (based on data provided by the NHS) are covered by the eMC.

We are constantly seeking ways of increasing the comprehensiveness of the eMC because we recognise that it would be ideal if we had information for ALL medicines dispensed. Datapharm, the publisher of the eMC since its inception in 1997, is a not-for-profit organisation established in 1977 to publish regulated information about medicines. We would be delighted to work with the MHRA to find the best and most economical way of making even more medicines information available to those who need it.

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

The emc database is an excellent resource as is the EPAR system on the EMA site, but they are only as good as the people maintinaing them.

If there was a resource linked directly to the sentinel system whether it be EMC itself or something else this woudl be extremely beneficial to me and the public.

I often get asked about product interactions and contra indications even for products I have no knowledge of so this resource would be excellent for me.

I agree that the task of maintaining a system such as the eMC is non-trivial. While there are currently 6969 SPCs and PILs on the eMC, with 257 new documents having been added to the eMC in the last 3 months, a total of 1157 documents have had to be updated in the same period. That is equivalent to two thirds of the documents on the site having to be updated every year. The bulk of the effort is spent keeping the resource up to date.

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

Pharmacists are required to provide a PIL with every item dispensed. Even with the efforts of companies to provide original packs, this is not always possible nor would we be reimbursed for poviding the nearest pack in every case. The most common are probably antibiotics for 5 day courses. Unfortunately, while many PILs are available on EMC, many are not; even when they are available they are not always in a printer friendly format. Some companies publish PILs and SmPCs for most of their products on line but not all of them.

A resource with access to most PILs, in a printer friendly format, would be very useful.

I would agree with the idea of collaboration with existing sites;

an option would be to offer this as something sites could subscribe to; thus a range of sites could offer this information. What the MHRA could offer is a toolkit to enable this information to be available to whichever site wanted to used/serve this information. This could even generate funds to support the maintaenance of this data source.

It would be useful to access this via pharmacy systems or clinical information systems.

The EMC comment relating to the percentage of prescribed products where an SPC is available is pertinent. However, I use SPCs very frequently for writing PGDs and if this is for a generic product there are sometimes differences between the PGDs from different generics companies. If there isn't an SPC for the particular generic being used then it is necessary to compromise. If a comprehensive source of SPCs were available then this would allow the exact SPC to be used.

Another advantage would be access to PILs for OTC products.

I agree the MHRA should mandate that every PIL and SPC is available on the web went it is granted a marketing authorisation - whether this is through EMC or MHRA web-site is to be decided. If MHRA can add SPCs and PILs onto their web-site as a matter of course then this would be great - this should be perhaps integrated with the BNF?

The argument for eMC covering the majority of the products does not stand up. Taking a random example of ondansetron, DM+D lists 17 different suppliers of ondansetron (excluding PIs and Alliance and AAH)yet the eMC lists SPCs from only 6 of these suppliers. The true benefit of an online data source only comes when it is comprehensive and MHRA is the only organisation that has all the data

As indicated in my previous comment, I would like to see SPCs and PILs for ALL licenced medicines on the eMC, including the generics. That said, for most medical information enquiries, being able to access the full range of generic SPCs is no advantage. Where a professional is seeking information prior to the point of prescribing and dispensing, the brand or generic that will eventually be supplied to the patient is unknown, so having all the generic SPCs is irrelevant. I recognise that there are exceptions, and that on occasions the full range of generic SPCs will be useful, hence my ambition to see a comprehensive set on the eMC where the systems and expertise already exist to maintain such a database. Datapharm supports the creation of a fully comprehensive database and is happy to work with the MHRA to make that happen. Meanwhile, with 6 out of 17 ondansetron manufacturers’ SPCs, the enquirer can answer a very high proportion of ondansetron-related enquiries.

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

I agree - emc.medicines.org.uk is very good but not totally comprehensive. Collaboration with MHRA for a definative website would be good.