Reading 5 Flashcards
Covers the PPA, patient labeling, and USP.
What was the Poison Prevention Packaging Act (PPPA)?
enacted as a response to child poisonings caused by household substances in the 1970s, it gave the Consumer Product Safety Commission (CPSC) the authority to require that hazardous substances be specially packaged in child-resistant containers (CRCs)
Who is ultimately responsible for making sure something is in child-resistant packaging?
pharmacists
Special packaging (CRC) must meet a set of requirements. One of these is: “at least 85% of children under 5 who have never seen the packaging or had instruction opening cannot open the container in __ minutes”.
5
What products require special packaging (CRC)?
- PO controls
- PO Rx drugs
- OTCs approved after 2002 that were originally Rx
- OTCs intended for PO administration
- samples for medications that generally require special packaging
True or false: a fentanyl patch would require CRC.
false; it is not an oral controlled substance
What does a prescriber waiver for CRCs cover?
singular prescriptions on a case-by-case basis
What does a patient or patient representative waiver for CRCs cover?
it is a blanket waiver for ALL prescriptions
Define “package insert (PI)”.
FDA-approved labeling of a product whose contents are specified by law and reviewed during drug approval
- written for healthcare professionals (AKA prescribing information, monograph)
- can be provided to patients
- must be with the product on the shelf, or else it’s misbranded
Define “patient package insert (PPI)”.
FDA-approved labeling written in patient-friendly language.
- explains uses/risks/precautions
- supplied with the product by the manufacturer
- must be dispensed with the drug when given to a patient
- ONLY REQUIRED FOR ESTROGENS AND PO CONTRACEPTIVES
Define “medication guide (MedGuide)”.
FDA-approved labeling written in patient-friendly language
- explains issues related to drug/drug class
- provided on new and refilled prescriptions in outpatient settings
- required when labeling can prevent serious AEs, drug has serious risks relative to benefits, or adherence is important to use
- required for NSAIDs, opioids, SSRI
What does USP <795> cover?
nonsterile compounding standards
What does USP <797> cover?
sterile compounding standards
What does USP <800> cover?
handling of hazardous substances
When will USP <800> actually be compendial applicable?
when <795> and <797> are updated
Who enforces the PPPA?
Consumer Product Safety Commission (CPSC)
