Risk Evaluation and Mitigation Strategies

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8 Terms

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Risk Evaluation and Mitigation Strategies

These requirements were set out in 2007 under the FDA Amendments Act (FDAAA).

Medications with special requirements include:

  • Drugs with potentially very harmful adverse effects.

  • Drugs that increase the risk of fetal harm (teratogenic drugs).

  • Drugs with a high risk of abuse potential.

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Clozapine

An antipsychotic drug that increases the risk of agranulocytosis

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Fentanyl

An opioid analgesic with a high risk of abuse potential

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Buprenorphine

An opioid, again, that carries abuse potential

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Thalidomide

A drug that carries a high risk of deformed babies

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Isotretinoin

A teratogen that also carries a risk of psychiatric disorders

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Pseudoephedrine–containing products

Can be used in the illegal production of methamphetamine

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The functions of iPLEDGE include:

  • Ensure that communication of the release of the drug is consistent across all healthcare professionals – including the prescriber, patient, pharmacy, and the drug wholesaler.

  • To ensure effective communication on the teratogenic effects of isotretinoin and its risk of severe psychiatric effects.

  • Promote the safe and effective prescribing and use of isotretinoin.