Key Topic 4: Obligatory Information

Requirements in terms of obligatory information vary between countries so it is very important to establish which regulations and codes apply to each asset. Here is a list of items which may be obligatory for certain materials – click on each to find out more:

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  • Prescribing Information
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    Prescribing Information (PI)

    The elements that must be included in the prescribing information vary from country to country. However, in general all promotional material should include PI. (There are a few exceptions – again see your local regulations for detail on this).

    The nominated signatory must ensure that the PI is the correct version, up to date and easy to read. The UK Code has specific requirements in terms of layout and font size. Check your local regulations for details on these aspects.

  • Unique identifying number
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    Unique identifying number for each asset

    Each asset has a unique identifying number that should appear on the asset itself. This number is used to identify the material and its supporting documentation. Different layouts of the same material (for example different sized advertisements for different journals with the same content) should have individual asset numbers.

  • Date of preparation and expiry
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    Date of preparation and expiry

    The date of preparation must appear on all promotional material. In addition for global materials an expiry date is required (usually 12 months after the date of preparation).

  • Adverse event reporting
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    Adverse event reporting

    All promotional material requires a statement informing the reader that they should report adverse events to AstraZeneca and to the relevant regulatory authority, and providing them with details on how to do this. Generally a company telephone number would be provided. Global materials may direct the reader to their country specific contact details.

    In addition the ABPI Code requires a similar statement on materials for the general public.

  • Declaration of AZ involvement
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    Declaration of AZ involvement

    It is important that the involvement of AstraZeneca with respect to certain assets and activities is declared. Such declarations must be very clear about the extent of involvement of the company, and be prominent to ensure that readers are aware of it from the start (i.e. not in a tiny footnote or at the end of a booklet).

    For example, the invitation and agenda for an AZ sponsored meeting must include a prominent declaration of sponsorship.

Consider these examples

GSK

GSK sponsored a supplement entitled “ProState of the Nation Report. A call to action: delivering more effective care for BPH [benign prostatic hyperplasia] patients in the UK” which was delivered to health professionals along with the journal ‘Health Service’. GlaxoSmithKline’s corporate logo appeared on the bottom left hand corner of the front page above the statement

‘GSK has sponsored the production of this supplement; for details please see the back cover page of the report’.

 

The corporate logo also appeared on the lower left hand corner of the back outside cover alongside the statement ‘GSK sponsorship has included payment for a medical writer, honoraria to the editorial board and payment to a public relations agency in respect of project management support’.

Would you approve this as an appropriate declaration of sponsorship?

Yes No

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Ruling

This was the subject of a complaint in the UK and was found not to be in breach. The Panel considered that GlaxoSmithKline’s role in the production of the supplement had been made clear. Sufficient details appeared prominently on the front page with further explanation on the outside back cover.

Article

An article entitled ‘Best practice in childhood fever – the comfort cycle’ was the subject of a complaint in the UK.

The article referred to Nurofen for children (ibuprofen suspension) which was marketed by Reckitt Benckiser Healthcare.

Reckitt Benckiser Healthcare had commissioned the article and provided relevant information for inclusion.

The company was able to comment on the final article and had paid for it to be included as a bound insert in the journal ‘The Practitioner’

 

The following declaration
‘Supported with an unrestricted educational grant from Reckitt Benckiser Healthcare’
appeared on the front of the article. Would you approve this?

Yes No

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Ruling

This was ruled to be in breach because the declaration of sponsorship misleadingly implied that it was an independently written educational piece. It was also deemed to be disguised promotion.