PTCB Pharmacy Law PTCB Test Prep

Risk Evaluation and Mitigation Strategies!

Jul 7th, 2020
risk evaluation and mitigation strategies

What is REMS?

Under Federal Requirements, one of the core subjects of the 2020 PTCB syllabus to know is REMS – risk evaluation and mitigation strategies. Here, we review the key details that pharmacy technicians are expected to know.

Not all medicines are equal in risk.

Some drugs pose a greater risk to the public than other drugs. These drugs must be dispensed with special requirements – and these requirements are set out in the risk evaluation and mitigation strategies (REMS).

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.

Drugs with REMS Program

The FDA may request that before a medicine is available to the public, that it contains a Risk Evaluation and Mitigation Strategy program.

Drugs in this list include:

  • Clozapine – an antipsychotic drug that increases the risk of agranulocytosis.
  • Fentanyl – an opioid analgesic with a high risk of abuse potential.
  • Buprenorphine – an opioid, again, that carries abuse potential.
  • Thalidomide – a drug that carries a high risk of deformed babies.
  • Isotretinoin – a teratogen that also carries a risk of psychiatric disorders.
  • Pseudoephedrinecontaining products – because pseudoephedrine can be used in the illegal production of methamphetamine.

Some drugs have their own REMS program.

For example: in the case of isotretinoin, the REMS program is called the iPLEDGE.

Case Study – Isotretinoin

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.

For instance, such is the serious nature of isotretinoin, that patients are expected to sign a consent form accepting the known risks of adverse effects. Furthermore, it is incumbent upon healthcare professionals to robustly counsel patients on the effects of the medicine and how to correctly take the medicine.

In addition, patients are required to have scored negative on two separate pregnancy tests before the drug is prescribed, as well as having taken two forms of birth control for at least one month before they are permitted to take isotretinoin.

Prescriptions must be in written form and cannot be electronically sent or phoned in to the pharmacy.

Risk evaluation and mitigation strategies – as the name suggests – is about implementing strategies that reduce the risk of potential harm to either the patient or, in the case of isotretinoin too, the developing fetus.

Conclusion

As a pharmacy technician, you are expected to know:

  • Definition of REMS – risk evaluation and mitigation strategies.
  • Function of REMS – to limit adverse effects and risk with a select group of medicines which carry higher risks.
  • Example REMS drugs – which include opioid medicines, pseudoephedrine-containing drugs, drugs that harm the fetus – such as thalidomide and isotretinoin.

With this knowledge to hand, you should be more than capable of answering any REMS questions under the Federal Requirements part of the 2020 PTCB syllabus.

Check back to PTCB Test Prep soon for more study guides, practice test questions, and more on the life and skills needed to become an effective pharmacy technician.

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