Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
How Social Media can Improve the Healthcare System
Social Media offers a lot of potential for the Pharmaceutical industry. Future collaborations on social platforms between consumers, patients, healthcare professionals and medicines regulators could change the nature of treatmeants and the way people interact with their healthcare providers.
Susana Goncalves, Sr. Pharmacovigilance Leader, Drug Safety & Epidemiology at Novartis, enumerated a few of the benefits of such a collaboration at the one of Fleming. conferences.
Benefit #1 Raise awareness of different diseases and treatments
Social Media can be a good opportunity for patients, professionals and regulators to communicate about diseases, treatments, adverse drug reactions (ADRs) and other subjects. Patients can take an active role int the treatment of their own conditions and professionals can improve recruitment and retention within clinical trials
Benefit #2 Listen
Up to 90% of side effects to drug side effects are not being reported, according to the Pharmaceutical Journal. Therefore, Social Media can help companies to put the puzzles together and create a bigger picture.
Is it worth it?
Both the FDA and EMA are open to using Social Media, especially for Pharmacovigilance.
The FDA has sponsored the development of the new MedWatcher platform which associates simplified mechanisms for reporting by consumers and HCPs (Medwatcher reporting), subscription to alerts for products of interest (Watchlist) and a new social media monitoring and analytics platform (MedWatcher for Enterprise).
The EMA and MHRA are leading Web-RADR. Web-RADR is a three-year project jointly funded by IMI and the industry to establish policy and a regulatory framework for Pharmacovigilance surveillance using Social Media and mobile technology. Web- RADR also aims to design and implement a mobile reporting platform by providing applications that enable direct reporting of suspected adverse events to competent national authorities and integrating these data with established workflows & tools (e. g. EudraVigilance). All of this will be used to develop data mining methodologies to scan social media content for emerging, self-reported medical insights such as adverse events associated with medicines and medical devices.
Twitter offers similar informations as the FDA
A small US company, Epidemico, a subsidiary of Booz Allen Hamilton, is developing algorithms to gather accounts of drug side effects from social media as part of the Web-RADR project. Even before becoming engaged in the Web-RADR project, Epidemico tracked mentions of all new medicines in Social Media in a 2014 study funded by the FDA.
And yes, Epidemico found that the use of Social Media is worth it.
Nabarun Dasgupta, co-founder of Epidemico, said for the Pharmaceutical Journal that there is a high concordance between informal adverse reaction reports made on Social Media and those reported in the clinical trials for the FDA.
Publich heath benefits vs. privacy concerns
Susana Goncalves, Sr. Pharmacovigilance Leader, Drug Safety & Epidemiology at Novartis, warns that there are important ethical concerns toghether with these benefits. Before setting off the eventual public heath benefits, regulators must ponder upon any privacy concerns. One of these concerns comes from the absence of a possibility to confirm consent for the collection, processing and databasing of information on adverse events that patients share via SocialMedia, including patient's personal information.
Let's consider adverse events collected from Social Media for Pharmacovigilance purposes and classified as spontaneous reports. The assumption that a patient has voluntarily shared this information through Social Media, and therefore publically, may not be sufficient to justify the processing of personal data, at least under some current data privacy laws. In this scenario, we need to take into consideration the company's legal responsibility to collect and report adverse events and the legal responsibility to preserve the patient's right to refuse to have their posts used for Pharmacovigilance purposes.
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