ACCESSPOINT • VOLUME 5 • ISSUE 10 PAGE 31

The authors

massoud Toussi, mD, PHD, mSC, mbA is Principal, RWE Solutions, IMS HealthMtoussi@fr.imshealth.com

Improving drug benefit-riskassessment leveraging social media

brand teams have been using social media for years toprovide patients with useful, accurate information as they try tobetter understand diseases and treatment options (as allowed by market). While there are risks to be managed,there is also significant new potential for pharmacovigilance.Here we explore the under-tapped safety-related applications.

Siva Nadarajah, bSC is General Manager, Social Media, IMS HealthSnadarajah@us.imshealth.com

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INSIGHTS HEOR, PHARMACOEPIDEMIOLOGY & DRUG SAFETY

Time to hear the patient voiceA significant increase in healthcareinformation gathered through digital media – which includes websites, web pages, blogs,social networking sites, internet forums andhealth portals – reflects growing publicinterest in sharing and discussing health-related issues online. In the USA, a reportedone third of consumers use social media sitessuch as Facebook, Twitter and YouTube toinform decisions about their health, sharesymptoms with others and derive or profferopinions on treatments and physicians;1 in theUK, research has identified Facebook as thefourth most popular source of healthinformation;2 in Europe more broadly, over40% of online consumers have stated theiruse of social media forums for healthpurposes.3 And survey research has foundthat individuals spend 24 times longer onhealthcare consumer community sites than on healthcare company sites.1

Notably, most of the data responsible for this exponentialgrowth is unstructured, and includes tweets, comments andvideos. Such has been the speed of take-up – social mediahas been identified as the fastest growing media platform4

– that the technology for evaluating and managing this typeof information is struggling to keep pace. And the trend isset to continue: by 2020, it is estimated that the amount ofdata recorded on digital media will reach 44 zettabytes;i

9% will be related to healthcare, of which half will be relatedto drugs.5

Challenges for pharmaThe pharmaceutical industry has been more reluctant than most to adopt digital media. Research from the IMS Institute for Healthcare Informatics shows that half ofthe top 50 pharmaceutical companies do not engage withconsumers or patients through social media on healthcare-related topics.6

A recognized need to improve their effectiveness in thisarea has seen more pharmaceutical marketing departmentsstart to leverage these channels to understand patientperceptions about their drugs. However, other functional

areas, such as safety and pharmacovigilance, remainskeptical about the validity of the knowledge extracted.This cautious approach to adopting social media reflects acombination of issues but particularly concerns aroundregulatory compliance, privacy and the validity of theaccumulating data.

Regulatory issuesTraditionally, the identification of adverse drug reactions(ADRs) has relied on individual case reports overseen byphysicians and drug safety groups. The European MedicinesAgency’s (EMA) Good Pharmacovigilance Practices (GVP)define an ADR as a response to a medicinal product which isnoxious and unintended. Such reactions are deemed seriousif they involve death, a life-threatening condition,inpatient hospitalization or prolongation of hospitalization,persistent or significant disability or incapacity, acongenital anomaly or a birth defect. An individual casesafety report (ICSR) describes one or several ADRs thatoccur in a single patient at a specific point in time. An ICSR is considered valid in the presence of:

• At least one identifiable reporter

• A single identifiable patient

• At least one suspect adverse reaction

• At least one suspect medicinal product

Applying these definitions to social media reports of ADRsis challenging. However, the importance of ADR reportingcannot be overstated. Marketing Authorisation Holders(MAHs) are legally responsible for the safety andeffectiveness of medicines on the market. They are requiredto report ADRs to the relevant authorities, operateappropriate pharmacovigilance and risk managementsystems, and ensure that action can be taken whennecessary. Only with a thorough understanding of the ADRscaused by their products can they fulfill theserequirements. Within the EU, MAHs are legally obliged toforward adverse events (AEs) to the EMA. There are alsovoluntary programs to improve ADR reporting such as theFDA Adverse Event Reporting System (FAERS) in the USA,and The Yellow Card Scheme in the UK.

Additionally, MAHs have an onus to regularly screeninternet or digital media under their management orresponsibility for potential reports of suspected ADRs. Anyreports that come to light in a non company-sponsoreddigital medium must also be assessed to determine whetherthey qualify for reporting.

Improving drug benefit-riskassessment leveraging social media

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Opportunities for enhanced drug safetyToday, the growing use of social media by patients as avehicle for sharing their experiences with medicines offers a new and thus far largely underutilized source for ADR reporting.

Web-based patient-reported outcomes can provide anopportunity for MAHs and regulatory bodies to understandthe benefits and risks of medicines in the real world.Information captured from online communities can aidappreciation of how patients perceive their ADRs, improvethe way adverse effects of drugs are managed, and facilitatethe development of strategies for improving treatmentadherence. It can also serve to highlight topics that are ofparticular concern to patients (eg, medication convenienceor packaging) and side-effects that are not discernible inclinical trials. In addition to ADRs, social media data canhelp to assess patient perception of risk.

Although research on tracking ADRs with the help of socialmedia is still nascent, documented evidence of its validity isemerging, along with demonstrations of its value:

• In monitoring pharmaceutical products in Twitter,Freifeld and colleagues identified more than 4,000 poststhat resembled AEs, and demonstrated a significantcorrelation with data from FAERS by System Organ Class(p<0.0001)7

• Analysis of 3,785 items from five social media sites foundthat patients with glaucoma had stronger positivefeelings towards complementary therapies andtreatments with a poor evidence base than towardsmedically proven therapies, suggesting a lack ofawareness about the latter8

• A mixed methods study examined the content related toaromatase inhibitor (AI)-associated side-effects postedby breast cancer survivors on 12 message boards between2002 and 2010. Of the 25,256 posts related to AIs, 18%mentioned at least one side-effect. Close to 13%mentioned discontinuing AIs and 28% switching AIs9

• Analysis of patient narratives on popular social mediawebsites for health-related topics in France before andafter withdrawal of all medicines containing benfluorexfound a drastic change in patient perceptions: prior tothe withdrawal date, most posts concerned efficacy; afterremoval, most discussed cardiovascular side-effects10

Figure 1: IMS Health’s Nexxus™ Application Suite AETracker provides a cloud-based engine for AE monitoring

RxOntology

MeSH(MedicalSubject

Headings)

UnifiedMedicalLanguageSystem

NexxusSocial MediaOntology

PV Analysis

Feedback into theontology

Natural language processingand semantic algorithms

Disease, conversation and side-effect ontologies

Custom syndicatedontologies from client projects

PotentialAdverseEvents

AETrackerUnstructured

Data

Source: ImS Health

PAGE 34 IMS HEALTH REAL-WORLD EVIDENCE SOLUTIONS

INSIGHTS HEOR, PHARMACOEPIDEMIOLOGY & DRUG SAFETY

Technical considerationsThe increasing use of social media by patients to post anddiscuss their experiences with diseases, drugs andtreatments has generated a large volume of unstructuredinformation, specifically concerning reactions to medicinesthat MAHs are required to monitor and act on accordingly.Current tools and techniques for analyzing unstructureddata, especially in pharmacoepidemiology and safety, arelimited. There is thus a need for a solution to both capturethe data and leverage it efficiently for detecting ADR reportsand bringing them to the attention of MAHs for validationand further actions.

Two examples providing insights into the technicalpossibilities of detecting safety signals through the internet are:

• IMS Health’s Nexxus™ Application Suite and its moduleAETracker. This provides a cloud-based engine for AEmonitoring, off-label usage and other legal, regulatoryand reputation risks in company-sponsored digital assetsincluding social media accounts and mobile apps. In realtime, pharmacovigilance experts review and confirm anyfalse positives or alert the client within one hour of an AEbeing reported (Figure 1).

• In the UK, the WEB-RADR initiative, a multi-stakeholderinitiative led by the MHRA, seeks to investigatetechnologies for gathering ADR data through a mobileapp to add to the established safety profiles of medicines,enable earlier detection of new signals, reveal newpatterns or trends in reporting, and even provide a meansfor geo-pharmacovigilance.

ConclusionGrowing public interest in health-related issues coupledwith a surge in the volume of data generated through socialmedia, in particular the sharing of information on ADRs,brings specific challenges for pharma. However, it alsooffers unique opportunities for pharmacoepidemiology totap a rich new source of information and provide insightsfor a more complete benefit-risk evaluation of medicines.

While there is still unmet need for regulatory transparencyaround the tracking of ADRs through social media, alongwith the technology required to assess and analyze the data,steps have been taken by governments and agencies toaddress the gaps. Going forward, there is a role for a multi-stakeholder approach involving the industry, patients,regulators, prescribers and academic groups. For individualmanufacturers, the analysis of social media – even forpurposes other than drug safety – may generate ADRinformation beyond their current processing capabilities.However, with the right management and coordinationbetween functions, this new data source can be effectivelyleveraged to help improve both patient safety and internalcommercial effectiveness.

1 Social media “likes” healthcare: From marketing to social business, PwC Health Research Institute, April 20122 Dawson J. Doctors join patients in going online for health information. New Media Age, 20103 New Study Shows 72 Percent of European Online Consumers are Social Health Users. Available at http://manhattanresearch.com/News-and-Events/Press-Releases/european-social-health-users Accessed 30 Apr 2015

4 Turning buzz into gold: How pioneers create value from social media. McKinsey & Co, May 2012. Available at:http://www.mckinsey.de/sites/mck_files/files/Social_Media_Brochure_Turning_buzz_into_gold.pdf Accessed 30 April, 2015

5 Wikibon Blog. A Comprehensive List of Big Data Statistics (cited 2015 Feb 09). Available at: http://wikibon.org/blog/big-data-statistics/6 IMS Institute for Healthcare Informatics. Engaging patients through social media: Is healthcare ready for empowered and digitally

demanding patients? January, 2014.7 Freifeld CC, Brownstein JS, Menone CM, Bao W, Filice R, Kass-Hout T, et al. Digital drug safety surveillance: Monitoring pharmaceuticalproducts in twitter. Drug Saf, 2014;37(5): 343-50

8 McGregor F, Somner JE, Bourne RR, Munn-Giddings C, Shah P, Cross V. Social media use by patients with glaucoma: what can we learn?Ophthalmic Physiol Opt. 2014;34(1): 46-52

9 Mao JJ, Chung A, Benton A, Hill S, Ungar L, Leonard CE, et al. Online discussion of drug side effects and discontinuation among breast cancersurvivors. Pharmacoepidemiol Drug Saf, 2013; 22(3): 256-62

10 Abou Taam M, Rossard C, Cantaloube L, Bouscaren N, Roche G, Pochard L, et al. Analysis of patients’ narratives posted on social mediawebsites on benfluorex’s (Mediator®) withdrawal in France. J Clin Pharm Ther, 2014; 39(1): 53-5

There are unique opportunities for pharmacoepidemiology to tap a richnew source of information and provide insights for a more completebenefit-risk evaluation of medicines.

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