Pharmacist Resources - PS-Pomalidomide REMS

Key Points for Pharmacists

The pharmacy certifies with PS-Pomalidomide REMS
The certified pharmacy must obtain a confirmation number from PS-Pomalidomide REMS before dispensing
The certified pharmacy counsels the patient, and completes the Education and Counseling Checklist
The certified pharmacy dispenses pomalidomide to patient along with a Medication Guide

PS-Pomalidomide REMS information for certified pharmacies

Pomalidomide is only dispensed from PS-Pomalidomide REMS certified pharmacies.

As a PS-Pomalidomide REMS certified pharmacy, you must follow the requirements of PS-Pomalidomide REMS. You may download a guide to the program, a checklist for counseling patients, and the prescribing information below.

Pharmacy Guide to
PS-Pomalidomide REMS Prescribing Information Education and Counseling
Checklist for Pharmacies Lista de verificación de educación
y asesoramiento para farmacias

The PS-Pomalidomide REMS Pharmacy Portal

In addition to calling PS-Pomalidomide REMS to obtain a confirmation number for a prescription, eligible pharmacies can obtain confirmation numbers using the PS-Pomalidomide REMS Pharmacy Portal at BMS REMS Patient Safety. Contact PS-Pomalidomide REMS to see if your pharmacy is eligible.

PS-Pomalidomide REMS
Pharmacy Portal

REPORTING TO PS-Pomalidomide REMS

Please report any suspected pregnancy occurring during the treatment with pomalidomide to PS-Pomalidomide REMS using any of the following methods:

Email:

Worldwide.safety@bms.com

Toll-free:

1-888-423-5436 (REMS Call Center)

REPORTING TO THE FDA

Adverse drug experiences that are suspected to be associated with the use of pomalidomide and any suspected pregnancy occurring during the treatment with pomalidomide may also be reported to the FDA MedWatch Reporting System using any of the following methods:

Online:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Telephone:

1-800-FDA-1088

Mail to:

MedWatch
5600 Fishers Lane
Rockville, MD 20852-9787