Approved Risk Evaluation and Mitigation Strategies Materials Data

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

Complexity

Approved Risk Evaluation and Mitigation Strategies Materials (REMS) dataset lists all materials 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

2020-08-05

Version

2020-08-05

Update Frequency

Irregular

Temporal Coverage

2008-2020

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

Drug Safety, Risk Evaluation and Mitigation Strategies, FDA Drugs, FDA Risk Evaluation, FDA Mitigation Strategies, REMS Materials, REMS Process

Other Titles

Approved Risk Evaluation and Mitigation Strategies, Approved Risk Evaluation and Mitigation Strategies Materials

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
Version_IdA unique key used to identify the version of the REMS.integerlevel : Nominal required : 1
Version_DateThe date this version of the REMS was approved. The earliest version_date of the REMS is the date that the REMS was initially approved. For REMS that are no longer in place, the latest version_date indicates the date that the REMS was removed.daterequired : 1
Material_IdA unique key used to identify the REMS material.integerlevel : Nominal required : 1
Material_NameThe name of the material, as specified in the REMS document.string-
Material_LinkA link to download the material from the REMS website.string-
REMS IdREMS NameVersion IdVersion DateMaterial IdMaterial NameMaterial Link
24Isotretinoin iPLEDGE1722010-10-2295Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant
37Mycophenolate1732012-09-25177Obstetrician/Gynecologist Referral Template Letters for Contraception Counseling
49Soliris1172011-09-23250Soliris Patient Safety Card
63Tysabri1432012-01-20329Guidance for Evaluation of New Neurologic Symptoms
149Adempas7402014-06-11398Prescriber Guide for the Adempas REMS Programhttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Adempas_2014-06-11_PRESCRIBER GUIDE FOR THE ADEMPAS REMS PROGRAM .pdf
313Aveed7232014-03-05425AVEED REMS Program Website Screenshothttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Aveed_2014-03-05_REMS WEBSITE.pdf
28Letairis7002014-01-31508Patient Enrollment and Consent Formhttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2014-01-31_PATIENT ENROLLMENT AND CONSENT FORM.pdf
46Revlimid1942013-11-15627Emergency Contraception Brochurehttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Revlimid_2013-11-15_EMERGENCY CONTRACEPTION BROCHURE.pdf
61Tracleer1992013-07-01730Prescriber letter from certified pharmacyhttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Tracleer_2013-07-01_DEAR PRESCRIBER LETTER FROM CERTIFIED PHARMACY.pdf
24Isotretinoin iPLEDGE2082012-04-12842Prescriber Contraception Counseling Guidehttp://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2012-04-12_PRESCRIBER CONTRACEPTION COUNSELING GUIDE.pdf