Welcome | Information required for SPC changes added to the National electronic Library for Medicines (NeLM).
Previously notifying Medicines Information Pharmacists of changes to Summaries of Product Characteristics via the National electronic Library for Medicines (NeLM) was communicationed by emailing the information to david.erskine@gstt.nhs.uk using a standard form. The eMC now shows information on SPC changes and the NeLM now take their information from this source.
What's changed?
The What's New page on the eMC (electronic Medicines Compendium) now gives detailed information about the exact changes made to updated SPCs. During the SPC submission process, companies complete a free text 'change details' section, which is then displayed on the eMC. This gives all eMC users a clear and succinct summary of what has changed. The eMC 'change details' section is based on the SPC change form that was developed by PIPA and UKMI.
Why?
Datapharm has made these changes at the request of several key groups:
- Medical Information Departments who need to communicate SPC changes (in line with the PIPA standards)
- Medicines Information Pharmacists, medical publishers (e.g. Haymarket who produce MIMS) and patients on long-term therapy, who all need to track changes to ensure medicines continue to be used safely.
How can you help?
PIPA members can really help by making sure that their company's entries are written clearly and concisely. If another department is responsible for updating the eMC, discuss with them how best to present the information. The change details need to be succinct and informative and include what exactly has changed in the SPC. Users don't just want a contact phone number or another copy of the SPC with no changes marked. Providing quality and proactive information should cut down the number of SPC queries to your department. To see the new SPC change information, visit http://www.medicines.org.uk and then click on the eMC link. Click the information icons displayed on the What's New page to view the SPC change information.
The format outlined below, provides information of the data fields required on products when information is added to the SPC changes web page of the NeLM.
Company, Product Name, Generic Name, Type of Change*, Supporting Information*, Legal Category, CSM Black Triangle?*, Date on SPC*, On eMC?
* See glossary below
Type of Change
The reason for submitting an entry usually falls under one of the following seven categories:
New Product:
This applies to new drug entities or existing drug with new indications.
New Supplier:
Applies for existing drugs, now available by another company, i.e. generics
New Presentation:
Applies to existing proprietary drug now available as a new formulation, within a new delivery system or new packaging, where a new SPC is produced.
Revised SPC:
Applies to any changes made to sections 1-10 of an existing SPC. (Excluding section 7)
Admin change:
This applies to circumstances where companies make any of the following changes: -
- Addition of separate SPCs for a product with several presentations
- Addition of a joint SPC covering all presentations of a product
- Change from separate to joint SPCs for a product (or vice versa)
- Change from datasheet to SPCs
Company change:
Applies when a product has been transferred from one company to another (i.e.-change to section 7 of the SPC-marketing authorisation number)
Discontinued:
Applies to products that have been withdrawn from the market.
Supporting Information
This section contains more detailed information relating to the type of change recorded. Examples of what type of detail should be entered for each category is outlined below:
New Product:
Indication for use
New Supplier:
No further details required
New Presentation:
Further details of the new presentation, e.g. new dosage form, formulation of dosage delivery device.
Revised SPC:
Details outlining which sections of SPC have been amended and a summary of the changes made.
Admin Change:
Type of changed made is specified (see above)
Company Change:
Previous and new marketing authorisation holder is outlined. If change only applies to part of a product range then affected presentations are specified.
Discontinued:
Details on date of discontinuation (if known) and which presentation(s) and/or pack sizes are affected.
CSM black triangle
This field indicates whether the product is listed on the CSM's current issue of 'new drugs under intensive surveillance'
Date of SPC:
This is the most recent date recorded in section 10 of the SPC (or section 9, if SPC is new).