Regulatory Rapporteur is the name of a journal (www.topra.org) as well as as an apt moniker for Center for Medicine in the Public Interest Visiting Fellow Dr. Rick Turner.
Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety: An overview of recent FDA guidences and initiatives."
Rick's article can he found here.
His abstract sets the stage:
"Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines."
Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read.
They don't call him "Page" Turner for nothing.
Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety: An overview of recent FDA guidences and initiatives."
Rick's article can he found here.
His abstract sets the stage:
"Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines."
Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read.
They don't call him "Page" Turner for nothing.
