Healthcare Providers

Healthcare providers who prescribe Probuphine shall be specially certified. To become certified to prescribe Probuphine, healthcare providers shall:

  1. Review the Prescribing Information for Probuphine including the Instructions for Use
  2. Take the Probuphine REMS Program Live Training: Lecture and Practicum
  3. Successfully complete the Probuphine REMS Program Knowledge Assessment
  4. Enroll in the Probuphine REMS Program by completing and signing the Probuphine REMS Program Healthcare Provider Who Prescribes Enrollment Form (form available on this website and at all live training sessions)

Healthcare providers who perform Probuphine Surgical procedures must be specially certified. To become certified to insert Probuphine in the Probuphine REMS Program, healthcare providers must:

  • Review the Prescribing Information for Probuphine.
  • Attest to performing a surgical procedure in the three months immediately preceding enrollment in the Probuphine REMS Program.
  • Take the Probuphine REMS Program Live Training: Lecture and Practicum, which includes training on the proper removal procedure for Probuphine.
  • Successfully complete the Probuphine REMS Program Knowledge Assessment.
  • Successfully complete the Criteria for Procedural Competency.
  • Enroll in the Probuphine REMS Program by completing the Probuphine REMS Program Healthcare Provider Who Performs Probuphine Surgical Procedures Enrollment Form.
  • Obtain recertification annually to continue functioning as an inserter of Probuphine.

Healthcare providers who prescribe, insert and remove Probuphine surgical procedures in a dual role shall be specially certified. To become certified to prescribe and perform Probuphine surgical procedures, healthcare providers shall:

  • Review the Prescribing Information for Probuphine including the Instructions for Use.
  • Attest to performing a sterile procedure in the three months immediately preceding enrollment in the Probuphine REMS Program.
  • Take the Probuphine REMS Program Live Training: Lecture and Practicum, which includes training on the proper removal procedure for Probuphine.
  • Successfully complete the Probuphine REMS Program Knowledge Assessment.
  • Successfully complete the Criteria for Procedural Competency
  • Enroll in the Probuphine REMS Program by completing the Probuphine REMS Program Healthcare Provider Dual Enrollment Form.
  • Obtain recertification annually to continue functioning as an inserter of Probuphine.
Please fill in the information below to receive an email about the Probuphine REMS
Program Live Training: Lecture and Practicum.
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Fedson Inc. will notify each prescriber and healthcare provider who performs Probuphine surgical procedures at least one month prior to the expiration of certification, and an attestation of having completed either online or live training for annual recertification will be required prior to placement of any additional orders from the healthcare provider. Use the Probuphine REMS Program Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form to begin the recertification process. This form is available here or by clicking on the recertification button above.

Healthcare providers who perform Probuphine surgical procedures may be audited. The audit will, at a minimum, consist of a review of documentation to confirm compliance with the Probuphine REMS Program healthcare provider recertification requirements and if required will include an interview with the healthcare provider to discuss the documentation.

Please see below for the Probuphine REMS Recertification Training Requirements:

VIEW REQUIREMENTS

Materials for Healthcare Providers

Probuphine REMS Program Healthcare Provider Who Prescribes Enrollment Form

Probuphine REMS Program Healthcare Provider Who Performs Probuphine Surgical Procedures Enrollment Form

Probuphine REMS Program Healthcare Provider Dual Enrollment Form

Probuphine REMS Program Live Training: Lecture Slides

Probuphine REMS Program Knowledge Assessment

Probuphine REMS Program Criteria for Procedural Competency

Probuphine REMS Program Insertion/Removal Log

Probuphine REMS Program Procedure Record for Recertification

Probuphine REMS Program Surgical Procedures Recertification Video

Probuphine REMS Program Healthcare Provider Who Performs Probuphine Surgical Procedures Recertification Form

What You Need to Know about Probuphine: A Patient’s Guide

Prescribing Information

Probuphine Medication Guide

Probuphine Instructions for Use

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Your Training Requirements can be found at the intersection of the row and column you select below based upon your personal experience:

I have current operating privileges at hospitals or out-patient surgical centers:

(Select the “yes” or “no” Column below that Applies)

  

If YES

IF NO

  
I must review the Probuphine REMS Program Probuphine Surgical Procedures Recertification Video found on the Probuphine REMS website every year.

Number of Probuphine procedures in the past 12 months

(Select the Row that applies)		  

10 or More

Performed 10 or more successful2 procedures (comprised of at least five insertions and five removals)

I must review the Probuphine REMS Program Surgical Procedures Recertification Video found on the Probuphine REMS website every year.

I understand that I should keep documentation of all successfully completed procedures on the Probuphine REMS Program Procedure Record for Recertification or another record of my choosing - which must be provided to the Probuphine REMS Program if I am audited.

Less than 10

Performed less than 10 successful2 procedures (comprised of at least five implantations and five removals)

I must (annually):

  • attend a Probuphine REMS Program Live Training: Lecture and Practicum session

  • successfully complete the Probuphine REMS Program Knowledge Assessment test

  • meet the Probuphine REMS Program Criteria for Procedural Competency

1 Denotes the minimal requirements. Healthcare Providers should utilize the tools provided for recertification as needed to ensure proper insertion/ removal of Probuphine is conducted in accordance with the Probuphine REMS Program.

2 “Successful” implantation and removal procedures exclude attempted procedures that require assistance of other surgical specialties for completion. Removal procedures assisted by imaging studies prior to completion can be included, provided that the HCP successfully removes all implants identified by imaging without involving additional surgical consultants.