REMS stands for Risk Evaluation and Mitigation Strategy (REMS)
It is to make sure use of the drugs have benefits that outweigh the risks. To make sure that drugs are prescribed and taken correctly.
An example of Mifeprex prescribing ( part of REMS program): prescriber must be certified with pharmaceutical company to prescribe. Once certified, prescriber must follow the medication guide, patient package insert, a communication plan (when to call doctor, when to go 911), etc. (2)
An example of REMS is iPledge program for severe cystic acne Zenatade medication that can cause terotrogenicity birth defects. Therefore, patients, prescribers, pharmacists, and the drug company must all work with this program. Pt with pregnancy potential has to go thru monthly testing. (1)
List of REMS programs: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
References:
(1): https://en.wikipedia.org/wiki/IPLEDGE
(2): http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf
It is to make sure use of the drugs have benefits that outweigh the risks. To make sure that drugs are prescribed and taken correctly.
An example of Mifeprex prescribing ( part of REMS program): prescriber must be certified with pharmaceutical company to prescribe. Once certified, prescriber must follow the medication guide, patient package insert, a communication plan (when to call doctor, when to go 911), etc. (2)
An example of REMS is iPledge program for severe cystic acne Zenatade medication that can cause terotrogenicity birth defects. Therefore, patients, prescribers, pharmacists, and the drug company must all work with this program. Pt with pregnancy potential has to go thru monthly testing. (1)
List of REMS programs: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
References:
(1): https://en.wikipedia.org/wiki/IPLEDGE
(2): http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf
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