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European Pharmaceutical Contractor

Keep Talking

Pharmacovigilance (PV) has evolved significantly over the years, and has become more complex due to higher data volumes, changing regulations, and the rise of social media and innovative technical advances. Digital media is used by biopharmaceutical companies to create patient awareness about diseases and treatments, clinical trial enrolments and patient support programmes. However, unlike other areas in healthcare, the use of the internet and social media has progressed slower in product safety/product vigilance. This presents the industry with opportunities to utilise social media for detection, assessment, understanding and prevention of adverse effects and other drug-related issues.

Social media offers new opportunities for companies to move away from traditional safety reporting systems and methods towards a more patient-centric model that affords swift and open communication between companies, healthcare providers, consumers and patients. Social media monitoring will likely become a standard practice in PV in the future. But, before that can happen, careful evaluation of the use of social media as a PV tool needs to be conducted – both in terms of meaningfulness and impact on outcomes. Furthermore, an assessment of regulations required for effective use, practicality of the use of big data obtained via social media channels, and overall cost-benefit analysis is needed.

Current Guidance

Companies functioning in the social media space are responsible for documenting and following up on potential adverse events communicated through these forums. In Europe, two pieces of legislation underpin PV expectations: Regulation 726/2004 (amended by Regulation 1235/2010) and Directive 2001/83/EC (amended by Directive 2010/84/EU) (1).

Good Pharmacovigilance Practices (GVP) Module 6 (Section VI.B.1.1.4) states that marketing authorisation holders (MAH) should regularly screen the internet and/ or digital media, under their management and responsibility, for potential reports of suspected adverse reactions (2). In this aspect, digital media is considered to be company-sponsored if it is owned, paid for and/or controlled by the MAH. The frequency of screening needs to allow potential valid individual case safety reports (ICSRs) to be reported to competent authorities within appropriate timeframes, based on the date the information was posted on the digital medium (as mentioned in Section VI.C.2.2.1).

The US FDA’s guidance on product promotion on social media and the internet by biopharma and medical device companies addresses the following different aspects, among others:
  • How to respond to off-label enquiries (3)
  • How to provide benefit-risk information on digital platforms with character space limitations, such as Twitter (4)
  • How to address misinformation about company products on digital websites (5)
  • How to fulfil company post-marketing regulatory requirements for submission of “interactive promotional media” for their FDA-approved products (6)
These documents serve as an important first step towards providing guidance for companies to develop and implement their social media strategies for PV.

Safety Data Reporting

Biopharma companies are proactively creating social media platforms that solicit, capture, monitor and report adverse event (AE) activities. There are multiple sites and applications for safety reporting, such as MedWatcher – a free tool that allows patients and doctors to submit AE reports to the FDA via smartphone or tablet.

Using social media for safety reporting has distinct advantages; these reports are faster, closer to real time data and potentially richer data sources than those filtered through healthcare professionals (HCPs). Social media channels have the capacity to act as significant sources of treatment-emergent AEs, including their off-label use and impact of treatments on quality of life. One of the key areas of influence is, therefore, to establish social media as a safety reporting channel by expanding its existing use and unlocking its potential as an added value for companies' PV strategies.

As per the FDA draft guidance for AE reporting and GVP Module VI (2), only valid ICSRs consisting of four criteria qualify for reporting; these are: identifiable patient; identifiable reporter; suspect product; and AE/reaction. Further, GVP Module 6 (Section VI.B.2) states: “When collecting reports of suspected adverse reactions via the Internet or digital media, the term ‘identifiable’ refers to the possibility of verification of the existence of a reporter and a patient (VI.B.1.1.4).”

Patients are likely to be reporters themselves in the social media setting, meaning credibility and origin of these self-generated reports are key issues. Data may be inadequate, inconsistent or require additional follow-up. Another concern is that social media safety data contains personal information related to both patient and reporter.

Confirmation of ‘identifiability’ of both patient and reporter, as well as validation of incoming safety data obtained via social media channels, becomes critical. Businesses need to focus on company-managed social websites to decrease chances of incomplete or duplicate AE reports emerging from different online reporting channels, to maintain reliability of incoming data. Allowing posts/shares on company-monitored websites only after the user has registered and recorded basic user information can help PV teams verify reported data to confirm case validity, and follow up with any additional questions on the report.

Furthermore, processing personal data for PV needs to be compliant with applicable data protection laws supported by transparent, robust processes. Data protection notice is required on company-sponsored sites, explaining the collection of user-generated information deemed to be an AE or product complaint by companies to meet legal obligations with rationale for how such information is beneficial for the protection of public health. Regular training in data protection requirements is recommended for all company staff involved in PV activities (8).

Analytics Challenges

Social media is a promising source for safety data; however, these are unstructured, without governing data quality standards and specific business area orientation. Retrieval and analysis of this amount of data entails extra workload and additional resources, given the sheer size and rapidly changing nature of social media. Consequently, companies may struggle to integrate social media safety reports with those obtained from more standard sources like email correspondence and healthcare hotlines.

Another concern with digital media is the potential bias introduced due to the reporter population. Of the many social media users, only 1% actually report AEs, while most others are occasional contributors or simply observers. What is more, many elderly individuals, who constitute a large demographic user of prescription medications, do not use social media and this creates a strong user bias for PV. Additional technical challenges include duplicate safety information, mapping multilingual data to standard ADRs, effective data cleaning to mitigate the risk of spreading false safety concerns, and global diversity challenges relating to social structures, practices and intangibles (9).

Digital Initiatives


The industry and regulators now recognise the benefits of automation tools for big data analytics. Google Insights for Search is a tool that allows one to look at public safety concerns, measured by web traffic. However, the tool currently lacks precision, has limited use in deriving possible associations between AEs and companies' products, and does not help businesses prioritise amongst an influx of incoming social media signals (8). The FDA is currently exploring such social media-based tools and strategies.

The Web Adverse Events (WEBAE) project aims to form a public-private consortium between the European Federation of Pharmaceutical Industries and Associations and the Applicant Consortium to undertake the development of policy and technology solutions in PV, with the aim of strengthening the protection of public health (10). This will enable mining of publicly available web and social media content and help adopt methodologies and data mining algorithms for social media content to find emerging, self-reported medical insights, such as AEs associated with medicines and medical devices.

Risk Management and Communication

Another area in which social media can be used as an effective digital tool is for risk management and communication. This involves switching to a proactive company mindset, focusing on listening, educating, building trust, increasing safety awareness and improving health outcomes.

PV teams within companies can directly connect and engage with patients, consumers and HCPs to improve awareness about product safety, leading to improved health literacy for consumers and patients.

New Addition

The fundamentals of social media, including listening, broadcasting and engaging, are well-aligned with the principles of PV practice. Therefore, social media offers a potentially transformative AE reporting channel and an overall strategic tool to drive better PV outcomes in the future. Appropriate engagement of consumers and HCPs through social media by PV teams holds the promise of improved safety outcomes for patients and companies alike.

Traditional PV methods will prevail, yet social media has the potential to become an added new age tool to monitor data in real time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging this additional data.

Overall, the benefits of social media engagement for PV seem to significantly outweigh perceived risks. The time is right to elevate its importance at a more strategic level to drive enhanced PV outcomes through appropriate and effective use of social media within the evolving regulatory framework.

References
1. European Medicines Agency, The EU pharmacovigilance system, 2013. Visit: www.ec.europa.eu/health/humanuse/pharmacovigilance/index_en.htm
2. European Medicines Agency, Good Pharmacovigilance Practices, Module 6, Section VI.B.1.1.4, 2013.
3. FDA draft guidance, Guidance for industry responding to unsolicited requests for off-label information about prescription drugs and medical devices, December 2011
4. FDA draft guidance, Guidance for industry internet/social media platforms with character space limitations – Presenting risk and benefit information for prescription drugs and medical devices, June 2014
5. FDA draft guidance, Guidance for industry internet/social media platforms: Correcting independent third-party misinformation about prescription drugs and medical devices, June 2014
6. FDA draft guidance, Guidance for industry fulfilling regulatory requirements for post-marketing submissions of interactive promotional media for prescription human and animal drugs and biologics, January 2014
7. ABPI Guidance, Guidance on UK data protection in post-marketing pharmacovigilance, 2013
8. Edwards R and Lindquist M, Social media and networks in pharmacovigilance: Boon or bane? I. Uppsala Monitoring Centre, Uppsala, Sweden, 2011
9. WEBAE, Leveraging emerging technology for pharmacovigilance. Visit: www.imi.europa.eu/webfm_send/912


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Supriya Desai is a Clinical Research and PV Executive with over 16 years of experience in clinical practice and in various leadership roles within the healthcare industry, including clinical research, drug safety and PV. In her current role as Medical Director and Practice Head at Sciformix, she provides scientific and operational leadership to a global medical team and is involved in medical review activities across pharmacovigilance, safety writing, signal management and allied safety surveillance activities, spanning diverse therapeutic areas.
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