According to FDA, stakeholders have "expressed concern that information about REMS
materials, tools, and requirements are not communicated in a clear and consistent manner," and that "REMS
materials and requirements may be difficult to locate.
The FDA took its first steps in responding to industry concerns by issuing draft guidance in February that called for the elimination of medication guides from REMS
in certain cases, including when medications are dispensed in the inpatient setting.
First, the guidance says that a manufacturer may voluntarily submit a proposed REMS
"if the applicant believes an REMS
would be necessary to ensure that the benefits of the drug outweigh its risks.
At a minimum, the FDA mandate should build awareness early in the drug development process of the potential need to formulate a REMS
, in the event it becomes required for product approval or during clinical trials.
A drug industry consortium of 25 companies that manufacture generic and branded opioid medications, which formed after the FDA first required the opioid REMS
, supports the use of a patient guide to go with the medications, as well as prescriber and dispenser education, training, and certification, and prescriber-patient agreements with periodic drug screening and information on how to obtain prescription refills, Dr.
sleep has been objectively identified and quantified in many species including humans (1,9), cats (3,10), monkeys (11) and rats (12).
sleep's biological makeup fosters the mistaken belief that one is awake while dreaming, saps the ability to reflect on the weirdness of dreams as they occur, and makes it difficult to recall dreams after waking up.
This article reviews knowledge about the relationship of sleep to memory, including (a) the effect of sleep on learning and memory, (b) the relationship of sleep deprivation in general to memory, (c) the effect of rapid eye movement (REM
) sleep deprivation on memory, (d) the effect of memory and learning on REM
sleep, (e) the effect of non-REM
sleep deprivation on memory and learning, (f) neuro-anatomic correlates, and (g) implications for nursing practice and research.
Locally based, for-profit companies that seek to own and manage the in rems
On May 3, 2012, FDA released an Issue Paper addressing the need for improvement and standardization of REMS
assessments focusing on the use of surveys to assess healthcare professionals' and patients' knowledge and understanding of medication risks titled, Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.
and Roger Pinsonneault, senior director of product management at RelayHealth, examined the FDA's perspective on how best to communicate to the public the risks and benefits of prescribed medications and to explain the potential impact REMS
will have on all health care providers and their patients.
In 2009, ONS testified and submitted comments to the FDA on the possibility of REMS
for opioid medications (see the July 2009 Capitol Connection column).