E-marketing (part 1)
Jean Samuel
STEP-IN Management Ltd.
Even in the vibrant, constantly changing world of pharma commercial operations, there are aspects where a transition from an established approach into a more powerful, automated or web-enabled setting can be achieved using common sense, albeit with a bit of effort and some obvious adjustments.
Then there are the topics advanced by dynamic marketeers and their Compliance professionals, such as the challenges of social media. This will be the focus of my article.
A flourishing e-marketing programme thrives on novel activities as well as established activities conducted in novel areas - areas national regulatory codes often do not (yet) specifically address and where ‘case law’ is lacking. Consequently, when looking to embed Compliance into e-marketing, I find it useful to start my thinking from the wider European perspective of the EFPIA Code, adding national specifics, as appropriate. This approach reminds us of the principles and encourages a Compliance build rather than force fitting e-marketing into existing company SOPs.¹
"Can pharma, when hosting a discussion forum or setting up a hash tag Twitter conversation, ever be completely ‘hands off’?"
Although the EFPIA Code scope is based upon promotion to HCPs (rather than patients), it includes ‘...any activity which promotes the... recommendation or consumption of [prescription] medicinal products’ and ‘all methods of promotion including...use of internet and other electronic communications...films.’ It also has a useful Annex B Guidelines for Internet Websites available to HCPs, Patients and the Public in the EU which specifically allows health education information and ‘non-promotional information intended for patients and the general public about specific medicinal products marketed by the company’ .¹
A pharma company may abide by these minimum standards regarding promotion, the guidance for websites accessible to patients and add additional safeguards regarding social media where patients will participate. This may be a defensible base for giving due care to e-marketing activities. Documenting the thinking and decisions is, as always, core to such a defence.
Let’s try this out with some of the issues most frequently raised during debate at e-marketing conferences and on e-marketing blogs and Twitter groups. This month I ask:
Can pharma, when hosting a discussion forum or setting up a hash tag Twitter conversation ever be completely ‘hands off’?
It may be tempting, in terms of engendering public trust, maintaining reasonable costs of maintenance and underpinning the integrity of your information exchange objectives, to decide on a policy of total non-participation. In this case you would, no doubt, publish at the entry point to your hosted forum that you undertake only to observe and never to participate in the discussion.
"To prevent inappropriate responses, however well meant, you will also need a policy on employee/ agent participation in social media"
Although a position of good intent, this may not be possible in practice. Here’s why: the established, legal obligation to report Adverse Events (AEs) and your company’s perceived responsibility to correct disinformation regarding your product.
At the very least, your company participation would amount to reporting observations that are AEs and in regard to disinformation, EFPIA Code states ‘promotion must encourage the rational use of medical products by presenting them objectively...’ and later, you ‘may refer to medicinal products, provided that the discussion is balanced and accurate.’ ¹
So, what if a patient (group) discusses the benefits of or even recommends an off-label, and/or potentially dangerous use of your medicine? Your company may decide it is obliged to respond in such cases and so you would need to define how a decision to respond or not is evaluated, who responds (doubtless a medic), how a response is approved, advice to consult a HCP etc. To document this, you may need only to revise an existing SOP but you will probably need to add processes about how Twitter conversations, discussion fora, blogs etc. are to be monitored, in order to respond. To prevent inappropriate responses, however well meant, you will also need a policy on employee/ agent participation in social media.
Reactive in nature, both these types of participation entail consistent, quality monitoring requiring skilled resource.
Last autumn I witnessed an excellent presentation and debate regarding the methods needed and efforts appropriate to establish whether one is looking at a reportable AE.² Using a fairly innocuous tweet about a lingering headache, two Compliance factors stood out: i) in determining if there is an identifiable person a Twitter tag can sometimes, depending on the tweeter’s choice, be linked to an active e-mail address and ii) if you looked back at the whole Twitter conversation the actual medicine was mentioned. The latter point would have been irrelevant if the tweet was on a brand specific site as the medicine could be assumed.
"I would suggest that a good risk analysis is needed, you decide where your line is drawn and how it reflects due care."
If your policy is to respond to off-label discussion, then note that the EFPIA Code states ‘Quotations from...personal communications must be faithfully reproduced... and the precise sources identified.’ What care would you need to take in following the life of your highly managed, contextual communication once it is set loose in the social media world and thereafter enjoys its half life of Twitter brevity, multiple forwarding, paraphrasing et al.¹ Do you respond to each new occurrence? Correct it or refer back to the original communication? Where does your responsibility stop?
I would suggest that a good risk analysis is needed, you decide where your line is drawn and how it reflects due care. Bear in mind that, if you are already providing resource for monitoring for SAEs, it would be hard to argue that monitoring for disinformation is not practicable. And then, once you know about disinformation on your product, deciding on a policy to do nothing becomes far less rational or defensible. Deciding how much you do, however, is only sensible.
As I stress above, document the thinking and decisions, reflect it in policies and procedures but also monitor and review your position in the light of actual data. The policy and procedures should be adequate and appropriate, not heroic.
References:
1. European Federation of Pharmaceutical Industries and Associations
2. Reportable Adverse Events and the Internet, Daniel Ghinn &, Paul Grant of Creation
Part 2 of this article can be viewed here
About the author:
Jean has worked in the pharmaceutical industry for over 20 years, and is currently an interim manager addressing business compliance and records management with a special interest in e-marketing, Joint Working and the UK Bribery Act.
Former positions include Compliance Director for Schering Plough UK and Head of Clinical Programming and Medical Writing at Pfizer’s UK R&,D. In previous roles Jean had responsibility for the development of GCP SOPs, Training and Clinical Trial process improvement, was Inspection Readiness lead during an MHRA inspection and was part of an EFPIA Task Force addressing the secondary use of Electronic Health Records for clinical trials and the privacy and data standards issues this concept raises.
jean.samuel@step-inmanageemnt.com
Is it time for policies to dictate social media participation?
