TL;DR
FDA REMS Programs: Risk Evaluation and Mitigation Strategies for high-risk medications: prescriber certification, registries, restricted distribution.
FDA REMS Programs
Definition
Risk Evaluation and Mitigation Strategies for high-risk medications: prescriber certification, registries, restricted distribution.
Key Values & Ranges
Risk Evaluation and Mitigation Strategies for high-risk medications: prescriber certification, registries, restricted distribution. REMS programs (iPLEDGE, Clozapine, Opioid REMS) tested on PTCB exam.
Related drug class: Beta blockers includes metoprolol, atenolol, propranolol, carvedilol. Mechanism: Block beta-adrenergic receptors, decrease heart rate and contractility.
Exam Focus Areas
On the Ptcb exam(s), questions about fda rems programs typically test:
- Drug interactions and contraindications that affect patient safety
- Mathematical calculations: dosage, days supply, dilutions, and compounding
- Federal and state regulations governing practice
- Drug classification, mechanism of action, and common side effects
Step-by-Step Procedure
Risk Evaluation and Mitigation Strategies for high-risk medications: prescriber certification, registries, restricted distribution. REMS programs (iPLEDGE, Clozapine, Opioid REMS) tested on PTCB exam.
Related drug class: Beta blockers includes metoprolol, atenolol, propranolol, carvedilol. Mechanism: Block beta-adrenergic receptors, decrease heart rate and contractility.
Safety Considerations
Safety standards for fda rems programs in pharmacy practice are governed by Combat Methamphetamine Act: Pseudoephedrine behind counter, photo ID, logbook, daily limit 3.6g, monthly limit 9g
Enforcing agency: DEA. Compliance is mandatory and subject to inspection.
Regulatory Context
Regulatory framework for fda rems programs in pharmacy:
- Schedule I
- No accepted medical use, high abuse potential. Examples: heroin, LSD, peyote, ecstasy, marijuana (federal). Storage: Not dispensed in pharmacies
- Schedule IV
- Low abuse potential relative to III. Examples: benzodiazepines, zolpidem, tramadol. Storage: 5 refills in 6 months
- Schedule II
- High abuse potential with accepted medical use. Examples: oxycodone, fentanyl, morphine, amphetamine, methylphenidate. Storage: Double-locked, perpetual inventory, no refills, written/electronic Rx only
Equipment & Tools
Risk Evaluation and Mitigation Strategies for high-risk medications: prescriber certification, registries, restricted distribution. REMS programs (iPLEDGE, Clozapine, Opioid REMS) tested on PTCB exam.
Related drug class: ACE inhibitors includes lisinopril, enalapril, ramipril. Mechanism: Block angiotensin-converting enzyme, decrease angiotensin II, cause vasodilation and decreased aldosterone.
Why It Matters
REMS programs (iPLEDGE, Clozapine, Opioid REMS) tested on PTCB exam.
Related Terms
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