Reading 5

Question 1

What was the Poison Prevention Packaging Act (PPPA)?

Answer 1

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)

Question 2

Who is ultimately responsible for making sure something is in child-resistant packaging?

Answer 2

pharmacists

Question 3

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”.

Answer 3

5

Question 4

What products require special packaging (CRC)?

Answer 4

• 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

Question 5

True or false: a fentanyl patch would require CRC.

Answer 5

false; it is not an oral controlled substance

Question 6

What does a prescriber waiver for CRCs cover?

Answer 6

singular prescriptions on a case-by-case basis

Question 7

What does a patient or patient representative waiver for CRCs cover?

Answer 7

it is a blanket waiver for ALL prescriptions

Question 8

Define “package insert (PI)”.

Answer 8

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

Question 9

Define “patient package insert (PPI)”.

Answer 9

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

Question 10

Define “medication guide (MedGuide)”.

Answer 10

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

Question 11

What does USP <795> cover?

Answer 11

nonsterile compounding standards

Question 12

What does USP <797> cover?

Answer 12

sterile compounding standards

Question 13

What does USP <800> cover?

Answer 13

handling of hazardous substances

Question 14

When will USP <800> actually be compendial applicable?

Answer 14

when <795> and <797> are updated

Question 15

Who enforces the PPPA?

Answer 15

Consumer Product Safety Commission (CPSC)