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A.gilsenan_ispe poster b.indd

Evaluation of Current Risk Evaluation and Mitigation Strategies
Alicia Gilsenan, Elizabeth Andrews, Brian Calingaert, Debra Crozier, Abenah Vanderpuije
RTI Health Solutions, RTP, NC, United States BACKGROUND
The role of the United States (US) Food and Drug Administration (FDA) with regard to To review characteristics of active REMS in the US for drugs with signifi cant known risks.
All REMS aimed at preventing birth defects or abuse/diversion included elements to assure safe use. Table 1 Table 2 displays drugs with approved REMS requiring components beyond a medication guide.
The requirement for medication guides and postmarketing drug safety has increased over time (Figure 1).
shows drugs with approved REMS requiring a medication guide only.
other REMS components is becoming relatively common following the FDA Table 1. Approved REMS With Medication Guide as Only REMS
Table 2. Drugs With Approved REMS With Additional Components
Amendments Act of 2007,1 which authorized Figure 1. Drug Safety Timeline: Selected Events
Subpart H
approval and
To Err
For the ISPE abstract, we identifi ed all drugs recognized by the FDA as having an active REMS as of Drug (Generic)
Trade Name
Reason(s) for REMS
Medication Communication
Drug (Generic)
Trade Name
Reason(s) for REMS
to Assure
is Human
REMS are highly targeted to specifi c events guidlines
October 31, 2008. To provide the most up-to-date information in this rapidly changing regulatory Abacavir sulfate, abacavir sulfate Ziagen tablets and oral solution, Parallel
environment, REMS approved through July 31, 2009 are included in the results for the poster. This patterns are emerging. However, details of Preg. Reg.
IOM: The
survey of programs updates a review previously published.2 proposed
of Drug
Authors reviewed publicly available information (e.g.,,3 published articles, and available. The lack of publicly available Irritable bowel syndrome Ischemic colitis; complications product labels) to identify the safety issue prompting the REMS; the original indication for the Aplenzin extended-release tablets Depression information limits the knowledge base upon Treatment
products; the nature of REMS elements, including medication guide, communication programs, elements to assure safe use; and whether the REMS was approved at the time of or following drug gastrointestinal recovery opioids immediately prior to Arthritis, psoriasis, Crohn’s disease, Kefauver
Drug, and
A total of 69 drugs were identifi ed as having an approved REMS (14 “deemed” REMS as listed in Cosmetic Act
to FDC Act
the Federal Register4 and 55 subsequently listed on the FDA website3).
CER = comparative effectiveness research.
Of the 69 REMS, 52% (n = 36) required only medication guides, 28% (n = 19) required Food and Drug Administration (FDA). Food and Drug communication plans, 28% (n = 19) required elements of safe use (13/19 are for drugs deemed to Administration Amendments Act of 2007 (P.L. 110-85). Available at:
Under the FDA Amendments Act of 2007,1 the FDA has enhanced responsibilities and have approved REMS), and 13% (n = 9) required an implementation system. cgi?dbname=110_cong_public_laws&docid=f:publ. 085.110 authority with regard to pre- and postmarketing drug safety, including the authority to The total number of REMS approved so far in 2009 (n = 31) accounts for 45% of all REMS Andrews E, Gilsenan A, Cook S. Therapeutic risk require risk evaluation and mitigation strategies (REMS) for certain drugs in order to approved. Figure 2 shows the trend in REMS components over time since March 2008.
management interventions: feasibility and effectiveness. J ensure that a drug’s benefi ts outweigh its risks. Food and Drug Administration (FDA). Approved risk The FDA considers the following when determining whether to require a REMS for a Figure 2. Trend in REMS 2008 to Present
evaluation and mitigation strategies (REMS). Available at: PostmarketDrugSafetyInformationforPatientsandProviders/ • Estimated size of the population likely to use the drug involved ucm111350.htm. Accessed August 4, 2009.
Department of Health and Human Services Food and Drug • Seriousness of the disease or condition that is to be treated with the drug Administration (FDA). Identifi cation of drug and biological Combination antiretroviral treatment Fatal and nonfatal hepatotoxicity products deemed to have risk evaluation and mitigation • Expected benefi t of the drug with respect to such disease or condition strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Federal Register • Expected or actual duration of treatment with the drug ugs with REMS
• Seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the • Whether the drug is a new molecular entity.
Elements of REMS may include one or more of the following components: tal number of dr
• Communication plan to health care providers, which may include the following: Quarter ending
There are no confl icts of interest.
Sending letters to health care providers
Disseminating information about the elements of the REMS to encourage
implementation by health care providers or to explain certain safety protocols infectious disorders. With ribavirin - birth defects (e.g., medical monitoring by periodic laboratory tests) Figures 3 and 4 show the distribution of REMS by indication and the primary safety concern that prompted Disseminating information to health care providers through professional societies
about any serious risks of the drug and any protocol to assure safe use • Elements to assure safe use, which may include one or more of the following: Figure 3. Distribution of REMS by Primary Indication Category
Figure 4. Distribution of REMS by Primary Safety Concern
Health care providers who prescribe the drug have particular training or experience or
Alicia Gilsenan, PhD
Pharmacies, practitioners, or health care settings that dispense the drug are specially
Drug is dispensed to patients only in certain health care settings (e.g., hospitals)
Drug is dispensed to patients with evidence or other documentation of safe-use
conditions (e.g., laboratory test results) Each patient using the drug is subject to certain monitoring
Each patient using the drug is enrolled in a registry
Presented at: 25th International Conference • Implementation system, which may require the sponsor to complete the following: Monitor and evaluate implementation of elements to assure safe use by health care
providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements Work to improve implementation of these elements by such persons.
MDD = major depressive disorder; MI = myocardial infarction; XR = extended release. CNS = central nervous system; ITP = idiopathic thrombocytopenic purpura; PCA = patient-controlled analgesia.


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