Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

People tend to know what behavior is expected of them in specific, familiar settings. A script is a person’s knowledge about the sequence of events expected in a specific setting (Schank & Abelson, 1977). Essentially, scripts are a particular kind of schema, one containing default values for the features within an event. In the restaurant example, the script's features include the props (e.g., tables, menu, food, and money), the roles to be played (e.g., customer and waiter),...

Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...

Social proof is a form of persuasion based on comparison and conformity. People compare their behavior and actions to what others are doing and will change to conform to do what their peers do.

Social traps are negative situations where people get caught in a direction or relationship that later proves to be unpleasant, with no easy way to back out of or avoid. The concept was orignally introduced by John Platt who applied psychology to Garrett Hardin's "Tragedy of the Commons", where in New England herd owners could let their cattle graze in the common ground. This situation seems like a good idea, but an individual could have an advantage. If they owned...

Not all intergroup interactions lead to negative outcomes. Sometimes, being in a group situation can improve performance. Social facilitation occurs when an individual performs better when an audience is watching than when the individual performs the behavior alone. This typically occurs when people are performing a task for which they are skilled.