Jayne Packham, a medical information, medical affairs and Association of the British Pharmaceutical Industry (ABPI) Code of Practice trainer and consultant, reflects on common pitfalls for medical writers regarding the ABPI Code of Practice.

Recorded 1 March 2017 at a MedComms Networking event in Oxford. Produced by NetworkPharma.tv

= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

ABSTRACT:

The ABPI requires all promotional materials produced by pharmaceutical companies to be fully compliant with its Code of Practice and certified. Because non-promotional materials, such as manuscripts, can end up being proactively distributed by sales staff, such materials are not exempt, and pharma companies will more than likely want to check such materials also to ensure that they are non-promotional.

Among the 29 clauses of the Code, Clause 7 is particularly relevant for medical writers, and is one of the most breached. This clause sets out that information, claims and comparisons have to be accurate, balanced, fair, objective, unambiguous, based on an up-to-date evaluation of all evidence, reflect evidence clearly, and not mislead in any way, and that materials must be sufficiently complete to allow recipients to form their own opinion. Certain words are banned, most notably ‘safe’; a writer cannot say that a drug has ‘no adverse effects’, or that it has ‘demonstrated safety’; instead ‘generally well tolerated’ is often used. Other words to beware of include ‘unique’, and ‘approved by the Medicines & Healthcare products Regulatory Agency (MHRA)’. ‘New’ can be used in promotional materials, but only for 12 months after a product launch. In terms of detail, it is important to define the endpoints of a clinical trial, and put secondary endpoints in the context of primary endpoints so as not to mislead readers. Similarly, writers need to ensure that layout, font size and bold text are considered and used with care, and that graphs do not mislead or distort data.

Written by Penny Gray, Freelance Medical Writer

= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

We are building a library of free webcasts, like this one, for the global MedComms Community and others at http://www.networkpharma.tv and we’d welcome your suggestions for new topics and speakers.

Full details of this MedComms Networking event are at http://medcommsnetworking.com/event86.html

Jayne’s presentation (PDF format) is at http://medcommsnetworking.com/presentations/packham02_010317.pdf

Jayne’s Linkedin page is at https://www.linkedin.com/in/jaynepackham/

More about Jayne Packham Consultancy can be found at http://www.jaynepackham.co.uk

Filming and technical direction by Mario Crispino, Freelance Cameraman & Editor

[For the avoidance of doubt: this video is intended to be freely accessible to all. Please feel free to share and use however you like. Cheers Peter Llewellyn, Director NetworkPharma Ltd and Founder of the MedComms Networking Community activity at http://www.medcommsnetworking.com]