Approved Risk Evaluation and Mitigation Strategies Products Data

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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).

Complexity

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.

Date Created

2011

Last Modified

2020-07-20

Version

2020-07-20

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

NameDescriptionTypeConstraints
REMS_IdA unique key used to identify each REMS.integerlevel : Nominal required : 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 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 : Nominal required : 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-
REMS IdREMS NameEstablished NameBrand NameDosage FormApplication TypeApplication NumberAdded DateApproval DateWithdrawal DateLabel LinkDrugs at FDA Link
231Oxycontinoxycodone hydrochlorideOxyContintablet, film coated, extended releaseNDA222722010-04-052010-04-05http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272
13DarvonpropoxypheneDarvon-NcapsuleNDA168622009-09-251971-09-092014-03-10http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=016862
37Mycophenolatemycophenolate mofetil capsulescapsuleANDA902532012-09-252009-05-04741e079a-646b-47ec-84ac-8e12574c2aafhttp://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090253
60Transmucosal Immediate-Release Fentanyl (TIRF) Productsfentanyl citrateFentoratabletNDA219472011-12-282006-09-258f549d95-985b-f783-1ebb-ef57bd2ecb05http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021947
172Cimziacertolizumab pegolCimziainjection, powder, lyophilized, for solutionBLA1251602008-04-222008-04-22http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125160
24Isotretinoin iPLEDGEisotretinoinZenatanecapsule, gelatin coatedANDA2020992013-03-252013-03-2527b3cf26-f22e-5b70-1c24-009933b7c6eehttp://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202099
17Opioid Analgesic REMSoxymorphone hydrochloridetabletANDA2023212018-09-189281b012-ee14-4992-ba6a-ae91180b6f95
17Opioid Analgesic REMShydromorphone hydrochloridetablet, extended releaseANDA2021442014-05-122014-05-125a717315-250b-4e2d-b315-3ae1b6c337f9http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202144
350AddyiflibanserinAddyitabletNDA225262015-08-182015-08-183819daf3-e935-2c53-c527-e1d57922f394http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022526
17Opioid Analgesic REMSoxycodone hydrochloride and naloxone hydrochlorideTroxyca ERcapsule, extended releaseNDA2076212016-08-192016-08-192018-05-02http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207621