Whether we like it or not, our lives are being swamped by modern technology. Gone are the days of typewriters, dictionaries, and paper notepads. It is hard to imagine how we ever survived without mobile phones, computers, and SatNavs! The Internet is now so advanced and readily available that it can give us the answer to anything we want to know, and it can do so in an instant.
When the Internet started out it was just about websites, but then along came . . . Social Media. The content of social media sites is created and controlled by the users themselves; i.e. all of us. Examples of the sites I am referring to include Facebook, Twitter, Flickr, LinkedIn and YouTube. Social Media networking is the integration of technology and social interaction – it enables us to publish, share, discuss, blog, network and build relationships. It is abundantly clear that social media is not a fad or phase, but is here to stay. You may be wondering how social media is relevant to our jobs. Indeed, many companies block their employees from accessing social media fearing they will be using work time inappropriately. However, it’s not all bad. I am a member of LinkedIn which is undoubtedly useful for networking but also I have found the groups helpful, such as PIPA, for postings, polls, discussions and Q&As.
More recently, I decided to join Twitter, not because I wish to follow Britney Spears, and not because I feel I have anything I wish to tweet to the world, but as a trial to see if it does offer any value to my working day. I have managed to find and follow the MHRA, ABPI, DIA, the FDA and of course Panacea Pharma Projects (@ PanaceaPP).
So far, the best revelation is that I can follow the European Medicines Agency and be notified immediately of any new press releases, the most crucial being when the new pharmacovigilance modules were published. The EMA has no email alerting system so this now saves me having to remember to search their website each day. Another positive is being able to read people’s tweets who are attending conferences and training days, and sometimes speakers will tweet links to their slides. Even politicians are including social media in government plans and this week The Health Secretary, Andrew Lansley, has shown his support for technology saying, “Innovation and technology can revolutionise the health service, and we are looking at how the NHS can use these apps for the benefit of patients, including how GPs could offer them for free.” This quote is taken from the Department of Health’s press release entitled ‘GPs to prescribe apps for patients’. The article summarised an event showcasing the best ideas for new and existing health Smartphone apps. This event followed a call to find the best new ideas and existing Smartphone apps that help patients and doctors better manage care.
The most popular app ideas were to: help manage long-term conditions such as diabetes, to help people deal with post-traumatic stress, track and monitor conditions such as high blood pressure, help people find NHS services on a map, get practical information about keeping fit and eating healthily. Aside from all the fun that can be had via social media there is a serious implication for Marketing Authorisation Holders. Health is the most talked about topic on-line worldwide and for those of us in the pharmaceutical industry that has a huge impact.
There is now total freedom for the public to be able to share any experiences they have had with a drug be it an adverse event or a product complaint. We are all well aware by now that company email addresses and fax machines must be monitored for potential in-coming reports of adverse events and product complaints. But, what must we do about monitoring postings on company websites?
The limited guidance available is complex and conflicting with differing approaches globally. The Regulatory Authorities will expect Marketing Authorisation Holders to demonstrate how they perform searches of company owned (www.company.com), controlled (facebook. com/companypage), sponsored (charity.com/diseaseinfo) and independent (the rest of the internet) websites. Where is the legal basis for these requirements?
Here is a summary:
“MAHs should regularly screen websites under their management or responsibility, for potential reports on adverse reactions. The MAH is not expected to screen external websites for information on adverse reactions. However, if a MAH becomes aware of an adverse reaction on any other website the MAH should review the case and determine whether it should be reported in expedited manner.”
The Purple Guide
“The wealth of information available on the Internet and its widespread accessibility means it is an increasingly popular way to seek and share information. “ Contact Us” pages now frequently display generic company email addresses or website enquiry forms. The MAH must consider the mechanism by which incoming information is monitored to allow the identification and transfer of pharmacovigilance data to the correct person in an appropriate timeframe to meet regulatory reporting requirements”.
“A procedure should be in place to ensure daily screening by a designated person(s) of the website(s) in order to identify potential safety case reports. The working group does not believe it necessary for regulators or companies routinely to “surf” the internet beyond their own sites for individual spontaneous reports”.
ABPI Pharmacovigilance Expert Network
The ABPI PEN issued guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites in June 2011. For more information go to: www.abpi.org.uk/our-work/library/industry/Pages/pharmacovigilance-the-internet.aspx. At the same time, a White Paper was released calling for changes to the current pharmacovigilance legislative framework. For more information go to: www.abpi.org.uk/our-work/news/2011/Pages/130611.aspx
The FDA released draft guidance in December 2011“Responding to requests for off-label information”. For more information go to: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
Prescription Medicines Code of Practice Authority
The PMCPA has issued informal guidance on digital communications. The new guidance highlights relevant Code requirements and
includes questions and answers. For more information go to: http://pmcpa.org.uk/?q=node/920
So what’s next? Well, we will wait to see if the ABPI PEN’s White Paper has any influence and perhaps there will be more robust guidance perhaps there will be more robust guidance
coming out in July.