- Approved Risk Evaluation and Mitigation Strategies
- Approved Risk Evaluation and Mitigation Strategies Products
- 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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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
John Snow Labs; U.S. Food and Drug Administration (FDA);
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Risk Evaluation and Mitigation Strategies, FDA Drugs, FDA Risk Evaluation, FDA Mitigation Strategies
Approved Risk Evaluation and Mitigation Strategies, Approved Risk Evaluation and Mitigation Strategies Products
|REMS_Id||A unique key used to identify each REMS.||integer||level : Nominal required : 1|
|REMS_Name||The 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.||string||required : 1|
|Established_Name||The official nonproprietary name assigned to the drug. Generally, this is the "generic" name of the drug.||string||required : 1|
|Brand_Name||The proprietary or brand name for the drug, where it exists. Many generic products do not have trade names.||string||-|
|Dosage_Form||The dosage form of the drug.||string||required : 1|
|Application_Type||The 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).||string||enum : Array required : 1|
|Application_Number||The 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.||integer||level : Nominal required : 1|
|Added_Date||The 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_Date||The date the drug was initially approved for marketing.||date||-|
|Withdrawal_Date||The 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_Link||A 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_Link||A 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 Id||REMS Name||Established Name||Brand Name||Dosage Form||Application Type||Application Number||Added Date||Approval Date||Withdrawal Date||Label Link||Drugs at FDA Link|
|231||Oxycontin||oxycodone hydrochloride||OxyContin||tablet, film coated, extended release||NDA||22272||2010-04-05||2010-04-05||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272|
|37||Mycophenolate||mycophenolate mofetil capsules||capsule||ANDA||90253||2012-09-25||2009-05-04||741e079a-646b-47ec-84ac-8e12574c2aaf||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090253|
|60||Transmucosal Immediate-Release Fentanyl (TIRF) Products||fentanyl citrate||Fentora||tablet||NDA||21947||2011-12-28||2006-09-25||8f549d95-985b-f783-1ebb-ef57bd2ecb05||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021947|
|172||Cimzia||certolizumab pegol||Cimzia||injection, powder, lyophilized, for solution||BLA||125160||2008-04-22||2008-04-22||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125160|
|24||Isotretinoin iPLEDGE||isotretinoin||Zenatane||capsule, gelatin coated||ANDA||202099||2013-03-25||2013-03-25||27b3cf26-f22e-5b70-1c24-009933b7c6ee||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202099|
|17||Opioid Analgesic REMS||oxymorphone hydrochloride||tablet||ANDA||202321||2018-09-18||9281b012-ee14-4992-ba6a-ae91180b6f95|
|17||Opioid Analgesic REMS||hydromorphone hydrochloride||tablet, extended release||ANDA||202144||2014-05-12||2014-05-12||5a717315-250b-4e2d-b315-3ae1b6c337f9||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202144|
|17||Opioid Analgesic REMS||oxycodone hydrochloride and naloxone hydrochloride||Troxyca ER||capsule, extended release||NDA||207621||2016-08-19||2016-08-19||2018-05-02||http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=207621|