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What is the TIRF?

TIRF (transmucosal immediate-release ) medicines contain , a prescription opioid pain reliever. TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain.

What is REMS program in pharmacy?

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

When did REMS start?

R.E.M. was an American rock band from Athens, Georgia, formed in 1980 by drummer Bill Berry, guitarist Peter Buck, bassist Mike Mills, and lead vocalist Michael Stipe, who were students at the University of Georgia.

What is the TIRF REMS program?

The Transmucosal Immediate Release (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Program is an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines.

What is the purpose of REMS?

The purpose of the REMS is to ensure that the drug is administered only in certified health care facilities that can observe patients for at least three hours and provide the medical care necessary in case of an adverse event.

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What is a TIRF medication?

TIRF (transmucosal immediate-release ) medicines contain , a prescription opioid pain reliever. TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain.

What are REMS requirements?

Types of REMS Requirements 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.

What is a REMS document?

A REMS is a required risk management strategy that can include one or more. 49. elements to ensure that the benefits of a drug outweigh its risks.

Is REMS mandatory?

While completion of REMS-compliant accredited CE is not mandatory, all healthcare providers who provide care to patients and their caregivers, including pharmacists and nurses, are STRONGLY encouraged to successfully complete a REMS-compliant activity from an accredited provider of CE.

What does REMS stand for?

A Risk Evaluation and Mitigation Strategy (REMS) is a formal plan required by the FDA for certain \u201criskier\u201d drugs to ensure that the benefits of these drugs outweigh their risks.

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