Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Social Media Screening for ADR-monitoring – Like it or not!
Posted on December 16th, 2015 by Joyce de Langen in Pharmacovigilance
Limitations of clinical trials and traditional post-marketing sources of safety information.
Due to limitations of pre-marketing clinical trials, there isn’t much information available once a medicinal product is authorized for marketing. Rare adverse drug reactions (ADRs) may not be detected due to the limited amount of patients participating in such trials and the relatively short period of time these trials cover. Furthermore, hypersensitivity reactions- or other patient-specific reactions can be still unknown at the moment a medicinal product is marketed, due to exclusion of certain groups of patients from the pre-marketing clinical trials. Women, children, elderly and high-risk patients are usually excluded from pre-marketing testing phase1.
With ADRs being reported to be the fifth-highest cause of death among hospital deaths, being responsible for 5% of the medical hospital admissions and causing a substantial number of health care visits, continuous monitoring of ADRs after a medicinal product is authorized for marketing is of great importance for patient’s well-being and public health2,3.
Traditionally, post-marketing surveillance or pharmacovigilance activities depend highly on spontaneous reporting systems (SRSs) for ADRs reported by health care professionals to the regulatory authorities. However, information obtained from analyzing SRSs is also limited due several reasons such as under-reporting by health care professionals, lack of sufficient clinical data, reporting bias and longtime latency.
Consequently, in recent years it became clear that additional sources and data-mining techniques have been proven useful to retrieve safety information, and therefore may contribute to reducing the impact of ADRs on patient well-being. In one of the previous Elsevier’s blog posts on Pharma R & D Today about the role of scientific literature in pharmacovigilance, the relevance of literature monitoring in detecting ADRs and in monitoring the benefit-risk profile of a medicinal product after authorization was already discussed4. In addition to the role of scientific literature as source for safety information, interest is growing for the use of other sources of safety information such as the use of electronic health records5 or social media6.
Social life of health related information
As said, internet and online sources are increasingly being used by patients and their caregivers to discuss personal health-related topics, such as diseases and medical treatment. The social life of health related topics is robust and depends on two pillars:
- The increasing availability of social media and online tools
- Patient’s motivation to engage with other patient’s, especially in case of patient’s living with chronic/life-long disease or conditions.
A telephone survey by the Pew Research Center showed that the internet has changed patient’s relationship with information.
The survey demonstrated that medical healthcare professionals such as doctors, nurses and other professionals are still the first choice of people to discuss health related issues; however the findings from the telephone survey also showed that online sources are considered a major source of health related information.
Of all adult internet users 80% has looked online for health related information. Of all adult internet users 24 searched the internet for information about drug safety or recalls of medicinal products, while 4% of the internet users actually posted their own experiences with a certain drugs online7.
As health related media platforms are growingly being used by patients and their caregivers to discuss health related topics including adverse drug reactions, these platforms are potentially an interesting source of health related data. Consequently social media networks are getting more and more attention from both the regulatory authorities and the pharmaceutical industry.
Benefit-risk Balance of Social Media for ADR monitoring
Various advantages and challenges of using social media for ADR monitoring have been described in literature. Monitoring large amounts of social media data may potentially reveal new safety information about the use of medicinal products in daily practice. Especially, it might be a useful source for detecting safety information that is very rare and might not be detected before during the clinical trials. Furthermore, internet-based patient-data might be used to identify information about off-label use, use of the product by specific population-groups or certain age-groups such as pregnant women, children or elderly.
However, there are also some challenges when monitoring social media platforms for ADRs:
- The quality of patient-data may be less reliable
- Identifying a specific, single, traceable patient might be difficult for privacy reasons. However, various other resources are available to perform demographic analysis of social media data.
- Data might be less salient then data from other traditional sources, for example due to the limited number of characteristics that can be used (eg.Twitter)9.
In addition, only a small percentage of the medicine-related data from social media actually includes safety information which might be complicating identifying the ADRs. And furthermore, it might be challenging to retrieve the information from social media using text-recognizing techniques, as patients make misspellings and use non-medical, descriptive terms to discuss their health issues and ADRS. This might complicate the system’s capacity to automatically extract information.
According to GVP Module VI, marketing authorisation holders should:
‘Regularly screen internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions. In this aspect, digital media is considered to be company sponsored if it is owned, paid for and/or controlled by the marketing authorisation holder.The frequency of the screening should allow for potential valid ICSRs to be reported to the competent authorities within the appropriate reporting timeframe based on the date the information was posted on the internet site/digital medium.
Marketing authorisation holders may also consider utilising their websites to facilitate the collection of reports of suspected adverse reactions. If a marketing authorisation holder becomes aware of a report of suspected adverse reaction described in any non-company sponsored digital medium, the report should be assessed to determine whether it qualifies for reporting. Unsolicited cases of suspected adverse reactions from the internet or digital media should be handled as spontaneous reports. The same reporting time frames as for spontaneous reports should be applied.
In relation to cases from the internet or digital media, the traceability of the reporter refers to the existence of a real person, that is, it is possible to verify the contact details of the reporter (e.g., an email address under a valid format has been provided). If the country of the primary source is missing, the country where the information was received, or where the review took place, should be used as the primary source country’11.
Social media and pharmaceutical industry
Legislation does not describe that pharmaceutical companies are required to monitor the whole internet or social media for safety information related to their product. So far, pharmaceutical industry is using social media mainly for marketing and sales activities, meaning for distribution of information about medicines, diseases and the treatment of disease, company matters including announcements and to listen to patients and professionals talking about marketed products. A smaller group of pharmaceutical companies is also monitoring social media for patient engagement and patient recruitment and retention within clinical trials11.
The pharmaceutical industry is reaching out to patients through social media platforms mainly to provide product information and promotional materials. Nearly all pharmaceutical companies have guidelines and procedures describing social media policy. These guidelines include for example rules for discussing company activities on personal websites, guidelines of use of social media by personnel, social media advisory board-specific practices, guidelines for posting online videos, directives describing one-way communication between companies and patients in clinical trials, restrictions etc11.
In the past, the large amount of data that need to be processed and lack of regulatory requirement to do so for non-company sponsored media, were the most important reasons for to pharmaceutical companies not to screen non-sponsored social media for ADRs. However, more recent data published last year by Visible Technologies demonstrated that only 3,2% of the posts tracked in a 30-day period actually discussed terms relating to adverse events. And finally it was found that of these posts only 3,27% were actually discussing adverse events12.
Therefore, next to monitoring social media for promotional purposes, pharmaceutical companies should also be using social media to better understand patients’ needs and experiences, and to provide additional education, particularly to those with chronic illnesses.
And as only 3,2% of the post contain terms that relate to adverse events, the number of ADRs is not likely to exceed the amount of data that pharmaceutical companies can handle.
So from that perspective pharmaceutical companies and regulatory authorities will need to cope with handling ADRs from social media and online sources in the upcoming years. Do you like it or not? Please let us know by joining the discussion at Pharma R&D Blog.
- Harpaz R et al. Novel datamining methodologies for adverse drug event discovery and analysis. Clin Pharmacol Ther 2012; 91(3):1010-21
- Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329:15–19.
- Lazarou J et al. Incidence in hospitalized patients. JAMA 1998; 279 (15): 1200-1205
- Pontes H et al.Safety Signal Detection: The relevance of literature review. Drug Safety 2014; 37: 471-479
- Trifiro G et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiology and Drug Safety 2009; 18: 1176-1184.
- Sarker A et al. Utilizing social media data for pharmacovigilance: a review. Journal of Biomedical Informatics 2015; 54: 202-212
- Abbassi A et al. Social media analytics for smart health. Intell Syst 2014:60-80.
R&D Solutions for Pharma & Life SciencesWe're happy to discuss your needs and show you how Elsevier's Solution can help.
Joyce de Langen
Senior Solution Manager Pharmacovigilance
- The Liabilities of Pharmacovigilance Activities
- What Are Best Practices in Literature Monitoring for Top-performing Pharma Companies?
- FDA Regulations Reform? Risks and Benefit for the Approval Process of New Drugs
- Shouldn’t pharmacovigilance be less painful?
- Predicting Adverse Event Risks and Gaining Insights from Disparate Data