PURPOSE Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, ...

The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveillance because they are often misused, abused, and diverted. These medications include opioid analgesics, stimulants, sedative-hypnotics, muscle relaxants, anticonvulsants and other drug classes. Their advers...

Post-marketing safety studies are an important tool for understanding and monitoring the safety profiles of drugs in the clinical setting. Their importance has attracted not only the attention of regulators for reinforcing legislation but also led to recent changes in European Union (EU) regulations; these regulations have influenced the practice of Post-Authorization Safety Study (PASS) by mar...