4 minute read
Global Medical Information and Standard Response Documents
By Charlotte Mason
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Earlier this year, as part of PIPA’s first Global Forum in March, I had the opportunity to co-chair a discussion session on Global Medical Information, with Bev Lilley from Novo Nordisk. The session was designed to be interactive and to foster discussion with peers in a friendly and secure environment. We ran polls throughout to keep attendees actively involved and I certainly felt there was lots of excellent discussion both in the breakout rooms and in the wider group.
I gained a lot from this session, and it definitely proved that even virtually we can engage with, and learn from, each other.
One of our discussion topics was around global standard response documents (SRDs), and I have summarised the key takeaways from this session below.
What is Global Medical Information?
First of all, we broadly defined what Global Medical Information is. A team/function within a company that cascades up-todate, evidence-based information about products and therapy areas. A team responsible for creating standard response documents/letters for use by other medical information teams within the company for regional or local adaptation. Then we explored why having global standard responses documents is beneficial:
Localisation of Standard Response Documents
We set up break out rooms for smaller group discussions on the following: • What do you need to keep in mind when using a Global SRD to create a local version? • How are you notified if there are revisions to the Global SRD? Then we returned to the whole group and discussed ‘Hints and Tips’ for localisation of Global SRDs:
Some key areas to consider are the differences in country-specific pharmaceutical regulations and variations of product labelling between countries e.g. licensed indications and contraindications.
A pertinent example of differences between regulations is the UK ABPI Code of Practice for the Pharmaceutical Industry (2021) requirement to include the inverted black triangle symbol and adverse event reporting statement in responses to/ information intended for members of the public: Clause 26.4 of The ABPI Code of Practice (2021) [1] Any material which relates to a medicine and which is intended for patients taking that medicine must include the statement below or a similar one:
‘Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at [a website address which links directly to the MHRA Yellow Card site]. By reporting side effects, you can help provide more information on the safety of this medicine.’ When the material relates to a medicine which is subject to additional monitoring, an inverted black equilateral triangle must be included on it together with the statement below or a similar one:
‘This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See [a website address which links directly to the MHRA Yellow Card site] for how to report side effects.’ This inclusion of the inverted black triangle symbol is not a specific requirement in most other European countries or the US.
Use of infographics
The use of infographics within response documents generated a lot of healthy debate and engagement. Overall, it was the consensus that as long as the infographics are used in a compliant way, they can really enhance response letters. Complex clinical trial designs and results can be easier to understand when displayed visually as diagrams. Points to consider are whether the infographics appear promotional and not to use brand imagery or colours.
Content Management of Global SRDs
We moved the conversation onto processes and asked the following poll question: • Do you have Standard Operating Procedures (SOPs) or Process Flows for localisation of Global SRDs? The poll results showed that there were only a small number of the attendees who had processes in place. This led us on nicely to present a process flow Bev and myself had put together for the session:
Something else to contemplate here is how to communicate any updates or new versions of the Global SRDs to the other affiliate countries - will you send a monthly email report? Will there be an expectation that the affiliate countries check regularly within the content management system for updates (provided they have access to view the global SRDs)? However you approach this process - once you have it in place - the advantages are: • more efficient ways of working • a reduction in duplication of work • consistency of responses across the business. The concept of the global medical information function varies greatly between companies and is dependent on several factors. Even if you already have a process in place it is always useful to learn how others approach a particular task and this session was a perfect platform for that. I hope this article helps to encourage best practice in relation to the localisation of global SRDs within your organisation.
References
1. ABPI CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY 2021: https://www.pmcpa.org.uk/media/3406/2021-abpi-codeof-practice.pdf
Contact email address: charlotte.mason@jazzpharma.com
Charlotte Mason
Associate Director Medical Information Jazz Pharmaceuticals
