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REMS/RMP Requirement and its Consideration in Clinical Studies

05 May 2019

Drugs used in therapeutic treatments have associated potential risks for adverse events (AE). Nevertheless, medical practitioners acknowledge such risk and take appropriate precautions while prescribing the drug. Besides that, there are also higher chances of AEs in patients due to lack of awareness. To minimize the risk, some stringent risk management tools like: boxed warnings, prescribing information, SPc, product monograph and limited distribution have already been implemented. However, until all stakeholders (i.e. prescriber, pharmacist, patients. etc) are not completely aware of such risks/precautions while dealing with certain drugs, the chances of AEs cannot be minimized, and sometimes consequences can be life-threatening and even fatal.

In view of such safety issues, regulatory authorities have come up with requirements for several risk management plans during the past decade such as Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs).

Risk Evaluation and Mitigation Strategies (REMS)

REMS is a strategy to manage and prevent the known or potential serious risks associated with a drug product. This is required by the US Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. Since medicines are very different from each other, REMS for each medicine is also different.

These risk minimization strategies go beyond professional labeling and standard information.

REMS was implemented in 2007 when President George W. Bush signed the amendment to the FDA Act. Consequently, the FDA Amendments Act (FDAA) authorized the FDA for the requirement of REMS during market approval review of medications, to minimize the risk associated with some drugs. Also, FDA can request the companies for REMS even after post-approval, in case any new safety information emerges, to ensure that the benefits of the drug outweigh its risks.

Depending on the nature and risk associated with the drug, the information usually included in REMS are: correct dosing pattern; dosing under supervision; limitation of blood (including its component); semen donation restriction; contraindications; warning; precautions; limitation of intercourse due to drug availability in semen; directions to physician, pharmacist, patients; educational program; patients counseling form and registration; emergency contact number; and distribution of medication guide etc.

When is REMS required?

REMS is usually based on the size of population likely to use the medicine; seriousness of disease; expected duration of treatment; expected benefit of the drug; seriousness of known and potential adverse event; and whether the drug is new.


REMS Plan is usually required when a drug is having below mentioned potential risks:


    • Serious infection: Patient education of initial warning sign of infection prior to prescribing.
    • Severe allergic reaction: Healthcare professional must be certified to administer the product.
    • Liver damage: Liver function monitoring while the patient is taking the drug.
    • Severe birth defect: Negative pregnancy test prior to dispensing each prescription.


The elements of REMS

  • Medication Guide: A patient document highlighting important safety information about the drug
  • Communication Plan: Information to healthcare providers about the risks of the drug
  • Elements to Assure Safe Use (EASU): Enforce the appropriate use of a drug. Examples of EASUs include requirement of physician certificate to prescribe certain drugs.
  • Implementation Plan: Describe how certain EASUs will be implemented.
    Timetable for Submission of Assessments: To meet the predetermined goals and objectives, this element provides the required frequency assessment of REMS implementation. As per minimum requirement of FDA, this assessment should be conducted at 18 months, 3 years and 7 years of REMS implementation.


Risk Management Plans (RMPs):

RMPs are a most recent significant risk management programs required for the European Union Market authorization similar to the REMS in the US.

Both the documents are required to ensure adequate safety of the patients while using the medication as they provide a complete guidance on risk identification, proper monitoring, and patient education and counseling; therefore the goals and objectives of REMS and RMPs are similar.

In the European Union, submission of RMP is necessary during application for the marketing authorization of a medicine.

RMPs include information on:

  • Drug safety profile
  • How the risks will be prevented or minimised in patients
  • Plans for additional studies and activities to generate more data regarding the safety and efficacy of the drugs
  • Risk factors for developing adverse reactions
  • Evaluating the effectiveness of risk-minimisation measures

Key Components comparison of REMS and RMPs


Medication Guide

Patient alert card

Patient information sheet

Patient information leaflet

Container label

SPC special warning and precautions

- Provider communication Plan

- Provider information Sheet

- Highlighted information for prescriber

- Training of healthcare professionals



REMS/RMP in Clinical Studies:

In clinical studies, as humans (patients, healthy volunteers) are involved, it is necessary that the safety is not compromised. Therefore, it should be confirmed as to whether the investigational medicine comes under the REMS program or not.


This can be confirmed through official website of USFDA, i.e.


During protocol development, it should be assured that all the relevant criteria/safety criteria of the REMS are included in the protocol. Moreover, all the pertinent information/precautions are also to be provided to the participants.

A written consent on such information/precaution should also to be taken.

Examples of drugs which comes under REMS program:


Molecule   Risk


This is a thalidomide analogue, which is a known human teratogen that can cause severe birth defects (deformed babies) or death of an
unborn baby.


Bradyarrhythmia and atrioventricular (AV) block at treatment initiation, infections, posterior reversible encephalopathy syndrome (PRES),
macular edema, respiratory effects, liver injury including fetal risk


Birth defects (deformed babies), miscarriage, death of the baby, premature births and serious mental health problems. Isotretinoin iPLEDGE:





Increased risk of meningococcal infections with Soliris; early signs of invasive meningococcal infections


Risk of hepatotoxicity and birth defects

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