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  • Approved Risk Evaluation and Mitigation Strategies
  • Approved Risk Evaluation and Mitigation Strategies Products

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  • Risk Evaluation and Mitigation Strategies
  • FDA Drugs
  • FDA Risk Evaluation
  • FDA Mitigation Strategies

Approved Risk Evaluation and Mitigation Strategies Products Data

The Approved Risk Evaluation and Mitigation Strategies Products dataset includes data on all of the drugs that have ever been part of a REMS program, including information on products that are no longer marketed and/or no longer subject to a Risk Evaluation and Mitigation Strategies (REMS).

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Description

Approved Risk Evaluation and Mitigation Strategies Products dataset lists all drugs related to REMS process.
REMS include a risk mitigation goal, and are comprised of information communicated to and/or required activities to be undertaken by one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication. Together, the goal, communications and/or activities make up the safety strategy.
Each REMS is designed to help one or more of the key participants in a REMS address a specific safety concern.
The most common role(s) of each of the key participants in the Risk Evaluation and Mitigation Strategy (REMS) (e.g., patients, health care providers, pharmacists and health care settings that dispense or administer the drug) are further described below. While these roles may be broadly similar across programs, the specific requirements and key risk messages of each REMS are specific to each medication, the nature of its risks, and the likely setting in which the drug will be or is used.

Patients play an essential role in REMS. The patient role varies and depends on the requirements of the REMS. Patients may receive specific information or counseling about a serious risk associated with the medication, what action they need to take to mitigate a serious risk, and/or what symptoms they need to watch for and/or report to their healthcare provider.
For some medications, patients must sign a form acknowledging that they understand those risks before starting the medication. For other medications, patients need to undergo lab testing. For some REMS, patients must enroll in a registry to ensure monitoring is conducted or to document if a specific adverse event occurs while he or she is taking the medication.
It is important for patients to follow any requirements to ensure that there is no delay or stopping of treatment. For some REMS, patients may not be able to receive the medication until the required documentation is completed.
Patients may also be asked to take surveys about the REMS. The surveys help FDA evaluate the effectiveness of the REMS.
It is important to keep in mind that REMS provide a way for patients to have access to medications with serious risks that would otherwise not be available.

Health care providers with prescribing privileges (e.g., physicians, physician’s assistants, nurse practitioners, or other health care providers) play a key role in ensuring that products with serious risks requiring REMS are prescribed and used safely.
The requirements for health care providers will vary for each REMS. For most REMS, health care providers may receive REMS communications from the manufacturers. Certain REMS may have other requirements for health care providers, such as enrollment in the REMS, completion of training, documentation of counseling of patients, enrollment of patients, monitoring, and/or documentation of compliance with certain safe use conditions.

Pharmacists and other practitioners who dispense medicines play a key role in ensuring that products with serious risks requiring REMS are dispensed and used safely.
The requirements for pharmacists will vary somewhat for each REMS and may vary by setting (e.g., retail pharmacy or inpatient pharmacy). For some REMS, pharmacists and other dispensers will receive REMS communications from the manufacturers.
Certain REMS may also require pharmacies or other healthcare settings to become certified to dispense the REMS medication. Certification generally requires that the pharmacy or the healthcare setting identify an authorized representative to complete the certification process. Generally, the authorized representative enrolls the pharmacy or setting, completes the required training, ensures that policies and procedures put in place to implement the REMS requirements are followed, and ensures staff are trained and comply with the REMS requirements.
Individual pharmacists may be required to complete training, verify safe use conditions (e.g., verifying required laboratory monitoring or that a patient or prescriber is enrolled in the REMS), counsel patients, and/or provide the patient with educational materials or a Medication Guide.

About this Dataset

Data Info

Date Created

2011

Last Modified

2020-10-01

Version

2020-10-01

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Risk Evaluation and Mitigation Strategies, FDA Drugs, FDA Risk Evaluation, FDA Mitigation Strategies

Other Titles

Approved Risk Evaluation and Mitigation Strategies, Approved Risk Evaluation and Mitigation Strategies Products

Data Fields

Name Description Type Constraints
REMS_IdA unique key used to identify each REMS.integerlevel : Nominalrequired : 1
REMS_NameThe name used on the REMS website to refer to the REMS program. Generally, single-product REMS are referred to by the brand name of the product, while shared system REMS are referred to by the name of the molecule or class to which they apply.stringrequired : 1
Established_NameThe official nonproprietary name assigned to the drug. Generally, this is the "generic" name of the drug.stringrequired : 1
Brand_NameThe proprietary or brand name for the drug, where it exists. Many generic products do not have trade names.string-
Dosage_FormThe dosage form of the drug.stringrequired : 1
Application_TypeThe type of marketing approval the drug received. A drug may be marketed under a New Drug Application (NDA), Biologics License Application (BLA), or as a generic drug under an Abbreviated New Drug Application (ANDA).stringenum : Array ( [0] => ANDA [1] => BLA [2] => NDA ) required : 1
Application_NumberThe number assigned by FDA staff to each application. One drug can have more than one application number if it has different dosage forms or routes of administration.integerlevel : Nominalrequired : 1
Added_DateThe date the drug was added to the REMS. For most drugs, this is the same as the date that the REMS was initially put into place, but the dates may be different, if, for instance, a new drug is added to an existing shared system.date-
Approval_DateThe date the drug was initially approved for marketing.date-
Withdrawal_DateThe date published in the Federal Register announcing the drug was withdrawn from the market. If the drug was not withdrawn or the withdrawal was not announced in the Federal Register then this date will be blank.date-
Label_LinkA link to the drug's label on DailyMed. DailyMed is a website hosted by the National Library of Medicine that provides information on the drug's current labeling. The current labeling shown on DailyMed may be different from the version that was initially approved by FDA and displayed at Drugs@FDA.string-
Drugs_at_FDA_LinkA link to regulatory information about a drug at Drugs@FDA. Drugs@FDA is a catalog that provides information about FDA-approved products, including the product's approval history, FDA-approved labeling, therapeutically equivalent products, and consumer information.string-

Data Preview

REMS IdREMS NameEstablished NameBrand NameDosage FormApplication TypeApplication NumberAdded DateApproval DateWithdrawal DateLabel LinkDrugs at FDA Link
237Osmoprepsodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrateOsmopreptabletNDA218922009-10-132006-03-16http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021892
1ActemratocilizumabActemrainjection, solution, concentrateBLA1252762010-01-082010-01-082e5365ff-cb2a-4b16-b2c7-e35c6bf2de13http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125276
17Opioid Analgesic REMSfentanyl transdermal systempatchANDA770622012-07-092007-09-202019-11-18245a75e6-3b45-4dc6-bc58-2e33196faca0http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=077062
37Mycophenolatemycophenolate acid delayed-release tabletstablet, delayed releaseANDA915582012-09-252012-08-21c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091558
58ThalomidthalidomideThalomidcapsuleNDA207852010-08-031998-07-162eda833b-1357-4ed4-a093-194524fcb061http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020785
33Metoclopramide (ANDA 074703)metoclopramidesolutionANDA747032009-09-151997-10-31http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=074703
9Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)buprenorphine and naloxoneZubsolvtabletNDA2042422013-09-042013-07-035f5cfcfe-d52b-49e6-8fe4-550477332dd2http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204242
291Viibrydvilazodone hydrochlorideViibrydtabletNDA225672011-01-212011-01-21http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022567
292VimpatlacosamideVimpattablet, film coatedNDA222532008-10-282008-10-28http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022253
292VimpatlacosamideVimpatinjectionNDA222542008-10-282008-10-28http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022254