Can we be sure the MHRA has the correct SPC?
by nightowl
on February 11, 2010 at 06:26PM
When SPCs are issued by the MHRA to companies following a new Product Licence or a change to an existing SPC there is a high error rate. Companies have to request amendments and corrections to the documents the MHRA has issued. The amendments will be made, but the MHRA is slow to do this -- there are examples of the amendments taking 5 - 6 months to be made. How can MHRA find the resource to ensure that any online provision of information of this type is up to date and correct? Who will bear the liability if there is a prescribing or medication error as the result of an incorrect SPC on the MHRA website. Will originator companies be expected to review the SPCs before or after publication? This would be additional to the resource involved in maintaining the existing electronic Medicines Compendium up to date.
Why the contribution is important
Duplication of effort is a bad use of limited resources.
Current tags
Posted by
IonGal
February 12, 2010 at 09:00AM
The duplication of effort associated with uploading SPC and PIL texts to the emc and chasing for corrections to RAMA and also to an MHRA database results in alot of additional work for everyone -at industry and agency level.
With new variation regulations only the MAH will be aware of all changes to the PIL or SPC that have not required an immediate notification or variation and this cold lead to confusion among users of these resource sites.
I believe it is the responsibility of the MAH to provide current SPC and PIL text to those requesting it, it would be far better to spend time and effort in making this a requirement and tailoring the emc website to do so.
With new variation regulations only the MAH will be aware of all changes to the PIL or SPC that have not required an immediate notification or variation and this cold lead to confusion among users of these resource sites.
I believe it is the responsibility of the MAH to provide current SPC and PIL text to those requesting it, it would be far better to spend time and effort in making this a requirement and tailoring the emc website to do so.
Posted by
marlandh
February 16, 2010 at 10:20PM
I understand nightowl's concern regarding having the correct SPC. I established a website of "South African Electronic Package Inserts" in 1996 (see http://home.intekom.com/pharm/).
This is a private initiative, provided as a service to the SA community. Here a large number of prescriptions are issued without information leaflets.
Unfortunately, the site is not comprehensive; many Companies have refused permission for us to carry their product information.
My greatest challenge, over the years, has been to ensure that the information is kept current; for this full support of the Companies is essential and frequently lacking. As a result we carry a Disclaimer.
While it is easy to post new products the updates require constant monitoring. To this end I consider that the site should be controlled by the regulating authority, posting the SPC and PILs following final approval.
If the Company wishes to delay the launch of a product this may present a problem.
One major benefit of such a site would be that, even though legislation may differ from country to country, the basic information remains the same. This could provide an important source of medicines information in third world countries where the internet may be accessed via mobile phones even in remote rural villages.
This is a private initiative, provided as a service to the SA community. Here a large number of prescriptions are issued without information leaflets.
Unfortunately, the site is not comprehensive; many Companies have refused permission for us to carry their product information.
My greatest challenge, over the years, has been to ensure that the information is kept current; for this full support of the Companies is essential and frequently lacking. As a result we carry a Disclaimer.
While it is easy to post new products the updates require constant monitoring. To this end I consider that the site should be controlled by the regulating authority, posting the SPC and PILs following final approval.
If the Company wishes to delay the launch of a product this may present a problem.
One major benefit of such a site would be that, even though legislation may differ from country to country, the basic information remains the same. This could provide an important source of medicines information in third world countries where the internet may be accessed via mobile phones even in remote rural villages.
Posted by
susanfrade
February 19, 2010 at 05:26PM
In response to WhitePJ's comment.
Outreach to the dialog has been rolled in phases. For the first phase, a relatively small number of people were contacted so that we could actually test out the site and eliminate any glitches, before rolling out to the thousands who subscribe to our e-mail alerts.
Susan Frade, MHRA
Outreach to the dialog has been rolled in phases. For the first phase, a relatively small number of people were contacted so that we could actually test out the site and eliminate any glitches, before rolling out to the thousands who subscribe to our e-mail alerts.
Susan Frade, MHRA
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The MHRA have an excellent and long established history of being completely unable to deliver effective and speedy communication to it's users.
Examples:
This dialog started on Feb 8th. I am subscribed to the MHRA "alerting service". Notification was received on Feb 11th. In the evening.
I *still* get class 1 and class 2 alerts late. Furthermore, the alerts that I do get are badly formatted, and tell me almost nothing. I am required to log-on to the website and download the alert before I know what is going on. The old system at least used to tell me.
There is *still* the 'normal practice' to inform the press before I get wind of what is actually going on. How am I supposed to offer effective, comprehensive and authoritative advice in these circumstances? The debacle following DVT's and Oral Contraceptives has not changed much.
Some much potential. So little hope of delivery. A bit like NPfIT.