One comprehensive repository is required

Reponse on behalf of UKMi Executive:

A comprehensive collection of all SPCs and PILs is needed. In the modern culture of "openness", it is a curious anomaly that this doesn’t already exist, and we would encourage and support the MHRA to address the issue. Lack of information is a key factor inherent in medication errors, and a key tenet of the NPSA’s safety alert about injections was that there is no single place where professionals can go to get administration information about all UK licensed injections.

NHS pharmacists, especially those working for UKMi, spend a lot of time chasing companies for such info - it is needed for patient safety, therapeutic decision-making, and formulary work. Online access would save considerable time and enable patient-centred problems to be resolved more quickly. Some generic companies are loathe or very slow to provide copies of SPCs.

The eMC is an extremely valuable and reliable resource, and we would like to see any development building on their success, rather than have an additional place to look for SPCs and PILs. The eMC is easy to use, well-presented, has been responsive to the needs of users, and offers a rigorous audit process. The new search facilities are especially commendable.

There is also perhaps the opportunity to present further new information, such as pictures of each product. This would allow pharmacists to see how products are presented and labelled, which often has important risk implications. It would be particularly welcome if the package inserts for injectable medicines were made available at the same time because these often include information not contained in the SPC which health professionals rely upon for administering injections safely.

We would welcome an opportunity to work with the MHRA and eMC, if our input could help to make this comprehensive database possible.

Why the contribution is important

It will reduce medication errors, save health professionals' time, and make the eMC comprehensive. It fits with the prevailing culture of "openness" and offers an opportunity perhaps for eMC, MHRA and UKMi to work together.

Current rating

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Average score : 5.0 Based on : 20 votes

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eMC
Posted by eMC February 26, 2010 at 07:26PM
Datapharm, the publisher of the eMC, fully supports the views of the UKMi Executive and is committed to working in partnership with the MHRA and UKMi on this very important objective.

Posted by Lawrence Berry (lberry@medicines.org.uk), Datapharm CEO
martinrx
Posted by martinrx March 01, 2010 at 01:46PM
I would like to second all that UKMI have said and just add that finding SPCs for generic drugs which no longer exist as brands has occasionally been problematical.
nhpmplew
Posted by nhpmplew March 01, 2010 at 02:23PM
I support the views expressed by UKMi. SPCs and PILs for all licensed products should be available in one easily accessible and quality assured repository. Finding SPCs for generic products is especially challenging.
Pam681
Posted by Pam681 March 01, 2010 at 03:05PM
I concur with the comments above. Increasingly, obscure generic/distribution firms are being awarded NHS contracts, an universal site for SPC/PIls run along the lines of the eMC would be very useful and contribution to the same should be a condition of being considered for NHS pharmaceutical contracts.
sammyj
Posted by sammyj March 02, 2010 at 11:02AM
I concur with the UKMI views and would also like to add that in my opinion SPCs and PILs being available online should be a legal requirement for all licensed products and this should preferably be presented in a single location. This is particularly essential for community pharmacists working outside normal working hours who are often restricted in the websites they can access by the company they are working for. They need to be able to access this information to provide a professional service to the public and when the information is not avaiable online and the manufacturers are not available to contact by phone there is nothing they can do to provide this essential information.
rhollingsbee
Posted by rhollingsbee March 02, 2010 at 02:19PM
As a Medicines Information pharmacist, I agree that all the SPCs and PILs should be in one place. A site similar to the eMC would be excellent but, failing that, anything which included all products would be a huge help.
lisaforey
Posted by lisaforey March 03, 2010 at 09:24AM
As a Medicines Information Pharmacist, I fully support this statement by the UKMi executive and believe that this development would be a key step in helping to improve patient safety with regards to medication usage. By allowing access to all SPCs and PILs in one central place, this will help to greatly reduce the time that is spent chasing generics companies for this vital information.
drees
Posted by drees March 03, 2010 at 02:07PM
I agree with the comments posted above. We require information from companies regarding their products on a regular basis within the Medicines Information department. Without access to SPCs and PILs we must contact each company directly. This causes an increase in workload and can cause a delay in answering enquiries. The company’s Medical Information department is not always open or able to answer the query directly.
scrawford
Posted by scrawford March 03, 2010 at 02:23PM
I would also like to add my support for this idea. With the increasing numbers of generic products available it is often difficult to obtain information regarding a specific formulation of a drug. Working within Medicines Information I have frequently encountered situations where enquiries have been prolonged by the need to contact a company directly for an SPC/PIL and in some cases await a response if they are closed or their Medical Information dept is unavailable.
GerryShapiro
Posted by GerryShapiro March 03, 2010 at 05:43PM
From a patient standpoint, I agree with the previous comments. There are a proliferation of unconfirmed generic and commercial information which tends to obfuscate rather than inform the end-user. If we are to provide informed consent to the acceptance of alternative medication, we require access to transparent information subject to appropriately authorized governance.
rishichopra
Posted by rishichopra March 04, 2010 at 04:20PM
I am not too sure if the MHRA database of SPCs and PILs would add any value……the electronic medicines compendium already does this (and pretty well) – so why duplicate? Why not just link from the MHRA site to the eMC site? If anything the eMC should just increase its range of information and perhaps the MHRA could work with them to help with this (as suggested above).
MHRA site still needs a little work in places before increasing the complexity of the site….e.g. Serious adverse report analysis is not available unless you type it into the search field.
BenRehman
Posted by BenRehman March 05, 2010 at 02:54PM
I am also a medicines information pharmacist and agree with the views expressed above.
Hameeda
Posted by Hameeda March 05, 2010 at 03:08PM
I also agree with the views expressed by the UKMI executive. This seems a good idea all around!
Emme
Posted by Emme March 05, 2010 at 06:02PM
This would be brilliant. The number of times an SPC hasn't been added to the EMC and I waste a vast mount of time trying to locate it from the manufacturer is ridiculous. This is a very sensible idea and the sooner the better frankly, I can't actully fathom why it isn't standard practice already.
rmcartney
Posted by rmcartney March 08, 2010 at 01:16PM
As a Medicines Information pharmacist I support the comments made by colleagues as above. It would be extremely useful to have all this information available in a single place.
juliewilson
Posted by juliewilson March 08, 2010 at 02:51PM
As a Medicines Inforamtion Manager I fully support UKMi's comments. It would be extremely useful and much less time consuming to have all this information in one place.
juliewilson
Posted by juliewilson March 08, 2010 at 02:51PM
As a Medicines Inforamtion Manager I fully support UKMi's comments. It would be extremely useful and much less time consuming to have all this information in one place.
KennyMole
Posted by KennyMole March 08, 2010 at 04:36PM
As somebody who has worked in the area of Medicines Information and medicines safety for several years, and as the primary author of the University College London Hospitals Injectable Medicines Administration Guide, I fully support the sentiment of the UKMI statement above. Access to the SPC is paramount when making key decisions about patient care. A central repository would be very useful and save valuble time in trying to acquire this information.

If this central database was created, it would be a good opportunity to standardise SPCs to ensure consistency, and to ensure terminology between SPCs is similar. For example, the terms 'intravenous bolus' and 'intravenous infusion' are not used consistently between SPCs.
KennyMole
Posted by KennyMole March 08, 2010 at 04:36PM
As somebody who has worked in the area of Medicines Information and medicines safety for several years, and as the primary author of the University College London Hospitals Injectable Medicines Administration Guide, I fully support the sentiment of the UKMI statement above. Access to the SPC is paramount when making key decisions about patient care. A central repository would be very useful and save valuble time in trying to acquire this information.

If this central database was created, it would be a good opportunity to standardise SPCs to ensure consistency, and to ensure terminology between SPCs is similar. For example, the terms 'intravenous bolus' and 'intravenous infusion' are not used consistently between SPCs.
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