In this blog, you’ll explore into:
- The Significance of Social Media Reports in Adverse Event Reporting
- Navigating Regulatory Guidelines for Managing Social Reports
- Examining the Pros and Cons of Handling Social Media Reports in Adverse Event Reporting.
Table of Contents:
- Introduction
- Managing the Surge in AE Reports: Recent Period Challenges
- Consider Using Social Media in Pharmacovigilance
- Regulatory Guidance of Using Social Media in Pharmacovigilance
- Pros and Cons of Using Social Media For Receiving Reports in Pharmacovigilance
- Looking Ahead: Social Media’s Future Influence
- Commonly Utilized Platforms for Pharmacovigilance Reporting
- Conclusion
- References
- FAQ
Introduction
In recent times, social Media plays a vital role in reporting Adverse events. Because of easiness and waiting at the call so many prefer the easiness of doing reporting events.
So in this blog we will discover the extensive growth and how reports are taken in to it and how the reports are considered for processing.
So in this article we are gonna discuss about how social media has influence in pharmaceutical industry in terms of Drug Safety and Pharmacovigilance.
Handling High volume of reports
With a rapidly growing population and an increasing number of people using medications, the reception of Adverse Event reports is also on the rise.
According to Lancet reports on Adverse events, there’s a consistent yearly increase in reports. In this technological era, addressing the needs of a large population is fundamental for ensuring efficiency and ease.
So there is a ton of data are being reported in daily basis including signs, symptoms.
Invite: “Engage in conversations on social media – we invite you to connect with us on our social platforms for a deeper dive into insights and the latest news about our company.”
Consider Using Social Media in Pharmacovigilance
In all from developing and developed countries are emerge in using social media and becomes very popular between the population.
Key considerations for implementing social media in Adverse Event (AE) reporting include:
- Ubiquitous Influence: The exponential growth of social media’s power and popularity across all age groups in recent decades.
- Widespread Mobile Adoption: A notable trend where many individuals may lack other gadgets but are almost invariably equipped with mobile devices.
- Geographical Accessibility: Social media’s ease of access from virtually anywhere, contributing to its extensive reach.
- Instantaneous Connectivity: The ability of social media to provide instant connectivity, facilitating rapid dissemination of information.
- Diverse User Demographics: Social media’s diverse user base, encompassing a wide range of demographics and increasing the potential audience for AE reporting.
- Visual Engagement: The visual nature of many social media platforms, enabling the inclusion of images and enhancing the comprehensibility of AE reports.
- Easy access and quick dissemination and widespread use.
- Fostering open communication between patients, physicians and health authorities is crucial.
Regulatory Guidance of Using Social Media in Pharmacovigilance
Social Media’s Extensive Reach:
Despite its widespread popularity, there are specific limitations when utilizing social media in the bio-pharmaceutical sector.
Compliance Mandate:
Companies operating in this domain must adhere to legislative frameworks to ensure responsible and legal use of social media.
Regulations:
In Europe, PV expectations are governed by:
- Regulation 726/2004 (amended by Regulation 1235/2010)
- Directive 2001/83/EC (amended by Directive 2010/84/EU)
And some important regulations are:
- Operational aspects, outlined in Commission Implementing Regulation 520/2012, are further elaborated in the accompanying GVP guidance.
- UK pharmaceutical firms must also adhere to the “Association of the British Pharmaceutical Industry” (ABPI) Code of Practice and informal digital communication guidelines from the Prescription Medicines Code of Practice Authority (PMCPA).
- According to GVP Module VI, marketing authorization holders (MAHs) are required to routinely monitor the internet and/or digital media for potential reports of suspected adverse reactions.
- When dealing with unsolicited cases from these sources, they should be treated as spontaneous reports.
- The “identifiability” of the reporter in cases from the internet or digital media pertains to the presence of a real person.
- The FDA has released three documents.
- Current guidance from EMA and FDA emphasizes screening company-owned/monitored websites, forums, and social media channels for comprehensive safety reporting. Further specific guidance is needed for validating safety data obtained via social media, ensuring compliance with data privacy norms.
- Protocols are necessary for retrieving, analyzing, and integrating this data with standard PV sources. Additionally, effective utilization of social media for risk management and communication requires attention.
Pros and Cons of Using Social Media in Pharmacovigilance
While the use of Social Media in pharmacovigilance is experiencing rapid growth, it comes with both benefits and potential challenges that should take on consideration:
Advantages:
- Seamless Complaint Submission: Streamlined process for submitting complaints.
- Remote Complaint Filing: Conveniently file a complaint from your remote device, regardless of your location.
- Timely Reporting: Enables prompt reporting without waiting in queues.
- Direct Departmental Reporting: Directly submit reports to the relevant department.
- Enhanced Comfort: Provides a comfortable platform for users.
- Image Upload Capability: Allows users to include images as optional attachments when filing a complaint.
- Convenience and Efficiency: Simplified and accessible, eliminating the need for in-person visits to physicians for filing reports and remembered without the hassle of frequent visits.
Drawbacks:
- Anonymity Concerns: Potential issues with maintaining anonymity.
- Privacy Considerations: Risks associated with the privacy of users.
- Data Loss Possibility: Potential risk of data loss.
- Location Tracking: The platform may have the capability to track your location.
- Credential Storage: Possibility of storing user credentials in the platform’s database.
- Usability Challenges: Some users, particularly those unfamiliar, may face difficulties navigating and using the platform.
- Possible duplication: The identification of duplicate safety information with respect to data originating from digital media.
- Multilingual complexity: Multiple languages and how data collected in different languages maps to standard ADR.
- Misleading Information: Risk of spreading rumors/false safety concerns.
- Laboratory findings and typical signs of hypersensitivity reactions cannot be precisely reported or potentially overlooked.
- Some consumers may find it challenging to effectively report discrepancies in drug labeling, whether it’s for generic or brand-name medications.
With that said, while there should be limitations, monitoring proactively becomes a challenging task in the presence of these constraints.
Looking Ahead: Social Media’s Future Influence
The recent surge in AI has marked its significant presence, and it’s evident that AI implementation is underway across all social media platforms. We cannot overlook the profound influence it will have on our future. While there are both advantages and disadvantages to implementing AI in pharmacovigilance, ensuring robust security is paramount.
AI plays a crucial role in pharmacovigilance due to its automation capabilities, allowing for efficient data corrections and report validation. It’s imperative to familiarize ourselves with and embrace AI practices.
- Increased insights for product benefit-risk evaluation.
- Improved relationship between companies and the community.
- Must develop with enhanced robust communication during reporting can be beneficial.
Emerging Regulatory Needs: Unanswered Questions
Addressing these questions and others is crucial before the industry can confidently embrace the utilization of social data for drug safety surveillance. Some of these questions outlined below.
- Industry Responsibility: Determining the Scope in Collecting and Reviewing Social Media Data.
- Innovations in Data Capture: Exploring New Tools and Methods for Real-time Mining of Spontaneous Reports from Social Media and Mobile Apps.
- Ensuring Identifiability: Addressing Challenges in Confirming the Identity of Reporters and Patients in Social Media-derived Safety Data.
- Privacy Considerations: Establishing Acceptable Practices for Investigating Potential Signals while Respecting Data Privacy.
- Protocols for Big Data: Developing Guidelines for Integration, Analysis, Interpretation, and Reporting of Follow-up Results in Drug Safety Surveillance Using Social Data.
Commonly Utilized Platforms for Pharmacovigilance Reporting
The data mining platforms commonly employed by pharmaceutical companies serve as an initial step in traditional data collection. These include:
- Tumblr
- Instagram (upcoming popular network in reporting)
Additionally, there are dedicated sites that professionally engage in similar activities, potential discussions, offering care and protection to patients:
Conclusion
In conclusion, leveraging social media information not only enhances companies’ ability to build more robust product safety profiles but also offers substantial benefits for Pharmacovigilance (PV). Despite perceived risks, the overall advantages of social media engagement in PV are evident.
The opportune moment has arrived to elevate social media’s role within PV organizations to a strategic level, fostering better outcomes by judiciously incorporating social media within the evolving regulatory framework.
Do you believe social media would be advantageous for the future of drug safety? Share your recommendations below to enhance safety.
References:
FAQ:
In what ways does social media play a significant role in advancing pharmacovigilance?
What regulations specifically oversee the reporting of pharmacovigilance incidents on social media platforms?
2. Directive 2001/83/EC (amended by Directive 2010/84/EU)
Which social media platforms are commonly utilized for pharmacovigilance reporting purposes?
2. Tumblr
3. Facebook
4. Twitter
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