Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Ionsys (fentanyl iontophoretic transdermal system)

NDA #021338

REMS last update: 10/03/2018

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:

Ensuring dispensing to patients in certified hospitals only; and
Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website

Hospitals that dispense Ionsys must

To become certified to dispense	Train all relevant staff involved in dispensing and administration on the REMS Program requirements. Have all relevant staff involved in dispensing and administration successfully complete the Knowledge Assessment and submit it to the authorized represenative. Establish processes and procedures to ensure Ionsys is not dispensed for use outside of a certified hospital. Designate an authorized representative to carry out the certification process on behalf of the hospital. Have the authorized representative review the Safety Brochure: Guide for Nurses and Pharmacists, Instructions for Use and Disposal, and the Medication Guide. Have the authorized representative successfully complete the Knowledge Assessment and submit it to the REMS program. Have the authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form.
After certification, within 3 weeks	Provide relevant staff involved in prescribing, dispensing, and administration with the Dear Healthcare Provider Letters and Dear Hospital Pharmacy Letter.
To maintain certification to dispense, within 4 weeks of designating a new authorized representative	Have the authorized representative review the Safety Brochure: Guide for Nurses and Pharmacists, Instructions for Use and Disposal, and the Medication Guide. Have the authorized representative successfully complete the Knowledge Assessment. Have the authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form.
To maintain certification to dispense, every 3 years from initial enrollment	Designate an authorized representative to carry out the certification process on behalf of the hospital. Have the authorized representative review the Safety Brochure: Guide for Nurses and Pharmacists, Instructions for Use and Disposal, and the Medication Guide. Have the authorized representative successfully complete the Knowledge Assessment. Have the authorized representative enroll in the REMS Program by completing the Hospital Enrollment Form.
At all times	For new staff involved in the dispensing and administration: have successfully complete the Knowledge Assessment and submit it to the authorized representative. Comply with audits carried out by The Medicines Company, FDA, or a third party to ensure that all processes and procedures are in place and are being followed. Maintain appropriate documentation.

Wholesalers that distribute Ionsys must

To be able to distribute	Establish processes and procedures to ensure that the drug is distributed only to certified hospitals. Train all relevant staff involved in distributing on the REMS program requirements.
At all times	Maintain records of distribution. Comply with audits carried out by The Medicines Company, FDA, or a third part to ensure

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Ionsys REMS, see the DailyMed link(s).

Material Name	Material Name Link
Dear Healthcare Provider Letters (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Dear_Healthcare_Provider_Letters.pdf
Dear Hospital Pharmacy Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_Dear_Hospital_Pharmacy_Letter.pdf
Guide for Nurses and Pharmacists (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Guide_for_Nurses_and_Pharmacists.pdf
Hospital Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Hospital_Enrollment_Form.pdf
Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Knowledge_Assessment.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date	Summary of change
10/03/2018	Modified to change the timing of the audits of the certified hospitals.
03/29/2017	Modified to align to labeling approved on December 16, 2016 and make additional minor modifications in the REMS document and materials.
11/12/2015	Modified to: Make editorial changes to the REMS document and the following REMS appended materials:Ionsys REMS Knowledge Assessment, Ionsys REMS Safety Brochure: Guide for Nurses and Pharmacists, and Ionsys REMS Hospital Enrollment Form. Add functionality to the Ionsys REMS website that allows for Authorized Representatives, nurses, and pharmacists to log in and access educational materials and the Ionsys REMS Knowledge Assessment as well as the ability to link user accounts with the corresponding Authorized Representative.
04/30/2015	Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.