IMPACT OF SOCIAL MEDIA ON PHARMACOVIGILANCE
Introduction:
Adverse drug reactions come at a considerable cost on society. ADRs are a significant cause of morbidity and mortality worldwide.The vast majority of ADRs still remain unreported. It has thus been suggested that social media may be a method by which pharmacovigilance could be strengthened given that approximately 72% of internet users search for health information online. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. Social media have already been utilized in different domains illustrating their potential application to pharmacovigilance. The quantity and near-instantaneous nature of social media provides potential opportunities for real-time monitoring of ADRs, greater capture of ADR reports and expedited signal detection if utilised correctly.
The role of social media in pharmacovigilance has been gaining in interest with various social media sources used for detecting ADRs, including general purpose social networking sites such as Twitter and health and support networks including Patients Like Me , Daily Strength and Med Help. The analysis of various pharmacovigilance text sources including biomedical literature, clinical narratives and social media. To complement these existing reviews, we take a broad view to incorporate the technical, industrial, legislative and ethical perspectives of using social media for pharmacovigilance in order to highlight current challenges and potential opportunities.
Companies' social media initiatives for PV can be divided into three categories
• Listening (safety data reporting),
• Engaging (follow-up),
• Broad casting (risk communication)
The Social Media Use a Future of Pharmacovigilance
Social Media is the developing philosophy for pharmaceutical organisations to move from the out-dated pharmacovigilance systems and safety reporting methods in the direction of additional patient-focused models for examining, monitoring and reporting safety information and evidence. These social media can provide a platform for easy and open communication between the patients/consumers and healthcare providers regard to the utilisation of medicinal products, subsequently building open trust. These social platforms have the capability for straight forward and open communications among patients/consumers and health care providers regarding the use of medicinal products, thereby serving mutual trust and transparency. Speculating from the outburst of the social media, it can be predicted that monitoring of social networking sites will turn into a regular utility in the future of pharmacovigilance in a long run.
Advantages of social media are as follows
From social media, there are higher chances of capturing ADRs by mining the information that patients would not really complain about going to their specialist or medical attendant. For example- some simple statement about health conditions following administration by a patient can be mapped into important ADR signals.
Business promoters and sponsors are using social networking websites progressively, for their business purposes, where they plan to fit different diseases and their management, medications, expenses of medicine, their therapy like resistance, ADRs, AEs, their illness or medical condition.
Healthcare experts and patients are embracing the social networking sites in a progressive manner, where they exchange the experiences of their ADRs with the approved medicinal item.
The following are the most important aspects of social media-driven pharmacovigilance:
• Analyze Consumers (medical bodies/professionals and patients) are being studied. Recognize appropriate social media keywords and trends that will aid in getting the message to the proper people. Pay attention, listen, and connect. Keep a close eye on all interactions and product mentions.
SOCIAL MEDIA FOR THE PURPOSE OF SIGNAL DETECTION OR VALIDATION
Early signals associated to rare adverse responses or other aspects such as misuse, abuse, overdose, medication errors, occupational exposure, and the influence of medicines on quality of life can be identified using social media data as one of several sources. This matches the description of signal detection, which is defined as "the process of seeking for and/or detecting signals using data from any source." In addition, social media can be a useful tool for validating signals, such as confirming signals that have been detected by other reporting systems. Conceptual overview of the investigation of the utility of social media in safety signal detection.
TEXT MINING HAS BEEN USESD TO ANALYSE:
pharmacovigilance data from a variety of sources, including biomedical literature, clinical narratives, and web search records. To the best of our knowledge, were the first to use machine learning to social media, studying postings from the social support networking site Daily Strength.
Challenges:
Reporting bias:The population reporting ADRs are a potentially biased sub-population of those experiencing ADRs. It is well established that ADRs are generally under-reported, even in serious cases. Furthermore, it is natural to expect that the reporting medium may affect the reporting rate of a specific event. For instance, a patient suffering from impotence may be less likely to post this on a social media site.
Notoriety bias may occur as a result of publicity or because the drug has recently been introduced onto the market, a notable example being bisphosphonates and osteonecrosis of the jaw. Sertindole is an atypical antipsychotic that was suspended due to such bias. This needs to be accounted for when analyzing signals.
INFORMATION EXTRACTION FROM SOCIAL MEDIA
Large amounts of raw data are generated by social media, making analysis difficult. Big data has its own set of limitations, such as search difficulties, a large volume of irrelevant data, issues with validation, user bias, and so on. They are distinguished by large amounts of diverse data and a rapid rate of new data production. Pierce and colleagues emphasised the inherent heterogeneity in data sources, which can change dramatically over time.
In terms of pharmacovigilance, this means that the degree of uncertainty and bias of each SNS must be considered. To fully realise their benefits and provide meaningful signals, a careful mix of each of these data sources is essential. Social media sources must be addressed independently in this process, and approaches must be adjusted to each channel separately, as each has its own set of obstacles. Duplicate reports are also a possibility due to parallel publishing on various platforms.
THE AUTHENTICITY OF SOCIAL MEDIA
Individuals' perspectives have shifted as a result of web-based social networking sites, and the world has altered on both a local and macro level as a result of enabling long-term and uninterrupted connection. Social media has established itself as a significant extension of any country's physical space. Simultaneously, issues of authenticity (such as author credibility, quality of knowledge given, and media content discontinuity) are developing as one of the difficulties that can be accounted for as a source of concern when sharing data on social media. Validity emerged as one of the important challenges of reliance on social media in the pharmacovigilance framework. Other concerns raised were the report's trustworthiness, content, and source. The problem of the quality of the knowledge gained or information collected through social networking networks has also come up.
REGULATORY GUIDANCE ON USE OF SOCIAL MEDIA IN PV
Most guidance from EMA and FDA is focused around screening of company-owned/monitored websites, forums and other social media channels to enable and ensure maximal safety reporting. Additional specific guidance is required in terms of confirmation of validity of safety data, obtained via social media (within the norms of data privacy), protocols to guide further retrieval, analysis and integration of such data with other standard safety data and also effective use of social media for risk management and communication.
The GVP and CIOMS guidelines, as well as the recently issued FDA guidelines, provide guidance to the pharmaceutical and medical device industries on how to screen internet or digital media under their management or responsibility for potential reports of suspected adverse reactions, post information on social media networks, and correct misinformation posted by others. Companies must also disclose both the benefits and the primary dangers associated with a product, maybe with a hyperlink leading to a more extensive list of concerns, according to FDA instructions. These recommendations are a vital first step in offering organisations with direction on how to build and implement social media strategy for PV.
CONCLUSION
Basics of social media (listening, broadcasting, and interacting) are so well matched with the principles of PV practise, social media may be a revolutionary AE reporting channel as well as a long-term strategy instrument for improving PV results. In recent years, the usage and monitoring of social media sites and channels for safety reporting has grown.
Social media, along with conventional pharmacovigilance measures, can be used to detect signals associated with new black box warnings, labeling changes, or withdrawals. Several challenges remain; however, social media will be useful for signal detection of frequently mentioned drugs in specialized health care social networks and forums. Further studies are required to advance natural language processing and mine real-world data on social media.
REFERENCES
https://publichealth.jmir.org/2021/6/e30137/
https://journals.sagepub.com/doi/10.1177/2042098618778191
https://pubmed.ncbi.nlm.nih.gov/31392837/
Student Name: Kelam Himasri
Student ID:070/042023
Qualification: Pharm.D
e-Mail ID: kelamhimasri77@gmail.com
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