Social media and PharmacoVigilance
The use of internet (mainly world wide web) is a rapidly growing medium for communication and transmission of information. Many patients and clinicians used social media platforms to discuss their positive and negative experiences of medications. It became as a source of publicly available information that has the potential to provide insights into medicinal product safety concerns.
Few challenges involved in social media: The use of social media data for pharmacovigilance is considered as secondary to the original intended use of these data. In general, the messages posted in social media can be deliberately altered as it flow across forums and groups and unintended parties too. As a result the same kind of post will be posted in multiple forums which throws challenge to identify the exact details from multiple duplicate posts. It would be possible to receive fradulent or manipulated information from these posts; Validation of information posted from the reported source would be difficult; The privacy and security of information posted in social media may prevent to receive additional details for pharmacovigilance activities. It is almost not possible to have follow-up information for originally posted in social media.
Expectations from Regulatory Authority: MAHs are not expected to search non-company sponsored digital media for potential reports of suspected adverse reactions. However, if a MAH becomes aware of a report of suspected adverse reaction described in any of these sources, the report should be assessed to determine whether it qualifies for submission as ICSR. Depending on the website sponsor (e.g., regulatory authority, pharmaceutical company, advocacy/special interest group, an individual, etc.), the information may be accurate and reliable, based on scientific evidence; alternatively, it may be anecdotal, speculative and personal, or it may be out-of-date.
GVP Module VI Chapter VI.B.1.1.4. Information on suspected adverse reactions from the internet or digital media states as follows: Marketing authorisation holders (MAHs) should regularly screen the internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions.
IMI- WEB-RADR project: EU Innovative Medicines Initiative (IMI) WEB-RADR (Recognising Adverse Drug Reactions) project has explored the value of social media (i.e., information exchanged through the internet, typically via online social networks) for identifying adverse events as well as for safety signal detection. The WEB-RADR project has developed a collaborative English language workspace for visualising and analysing social media data for a number of medicinal products.
Summary of points from WEB-RADR:
The use of internet (mainly world wide web) is a rapidly growing medium for communication and transmission of information. Many patients and clinicians used social media platforms to discuss their positive and negative experiences of medications. It became as a source of publicly available information that has the potential to provide insights into medicinal product safety concerns.
Few challenges involved in social media: The use of social media data for pharmacovigilance is considered as secondary to the original intended use of these data. In general, the messages posted in social media can be deliberately altered as it flow across forums and groups and unintended parties too. As a result the same kind of post will be posted in multiple forums which throws challenge to identify the exact details from multiple duplicate posts. It would be possible to receive fradulent or manipulated information from these posts; Validation of information posted from the reported source would be difficult; The privacy and security of information posted in social media may prevent to receive additional details for pharmacovigilance activities. It is almost not possible to have follow-up information for originally posted in social media.
Expectations from Regulatory Authority: MAHs are not expected to search non-company sponsored digital media for potential reports of suspected adverse reactions. However, if a MAH becomes aware of a report of suspected adverse reaction described in any of these sources, the report should be assessed to determine whether it qualifies for submission as ICSR. Depending on the website sponsor (e.g., regulatory authority, pharmaceutical company, advocacy/special interest group, an individual, etc.), the information may be accurate and reliable, based on scientific evidence; alternatively, it may be anecdotal, speculative and personal, or it may be out-of-date.
GVP Module VI Chapter VI.B.1.1.4. Information on suspected adverse reactions from the internet or digital media states as follows: Marketing authorisation holders (MAHs) should regularly screen the internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions.
IMI- WEB-RADR project: EU Innovative Medicines Initiative (IMI) WEB-RADR (Recognising Adverse Drug Reactions) project has explored the value of social media (i.e., information exchanged through the internet, typically via online social networks) for identifying adverse events as well as for safety signal detection. The WEB-RADR project has developed a collaborative English language workspace for visualising and analysing social media data for a number of medicinal products.
Summary of points from WEB-RADR:
- We can find new information in specific niche areas that are underrepresented in current monitoring systems like
- Exposure during pregnancy
- Abuse
- Misuse
- Low exposure, e.g., orphan drugs
- Aspects on quality of life that are not medically serious however these aspects have a significant impact on quality of life: Insomnia, Stress and Depressed mood.
- Social media should not be used as a source of ICSRs With the exception of posts made by patients, carers and healthcare professionals on pharmaceutical company websites that make explicit mention of adverse events.
- General social media platforms like Facebook and Twitter, are not recommended for broad statistical signal detection.
To conclude, If companies are setting up a safety surveillance system based on social media today, it is more important to first improve and calibrate adverse event recognition than the algorithms for statistical signal detection. Social media is not the channel for providing product information related updates to consumers or healthcare professionals; Labeling is identified as an important channel for providing such product information updates; In addition to the mandatory existing product information documents (like Summary of Product Characteristics and Package leaflet) which is time consuming and resource intense process, there are certain electronic product information documentation procedures are initiated currently.
