Poison Prevention Packaging Act Study Guide (outline)

Question 1

Poison Prevention Packaging Act

Answer 1

This law protects CHILDREN from ACCIDENTAL poisoning with “household substances”

Question 2

Household substances are:

Answer 2

• Hazardous substances as defined in the federal Hazardous Substances Act (THINK: toxic, corrosive, irritant, strong sensitizer, flammable, combustible, or generates pressure AND that may cause substantial personal injury or substantial illness during or as the result of customary use – including ingestion by children)
• Economic poisons defined under the federal insecticide, fungicide, and rodenticide act
• Household fuels when stored in portable container (kerosene, lighter fluid)
• Food, drug or cosmetic defined under the FDCA

Question 3

This products must be sold

Answer 3

These products MUST be sold in child resistant packaging (THIS IS DIFFERENT FROM TAMPER RESISTANT PACKAGING!!! Think about contaminated Tylenol from the 1980’s vs. keeping toddlers from taking drugs out of medicine cabinet

This is defined as 80% of children less than 5 years old cannot open it, but 90% of adults can

Question 4

ALL PRESCRIPTION DRUGS and CONTROLLED SUBSTANCES MUST

Answer 4

MUST be packaged in child-resistant containers.

Question 5

For prescription containers dispensed by the pharmacy:

Answer 5

Child resistant containers CANNOT be reused- Exception- glass or threaded plastic containers. IF a container is reused, it must be dispensed with new safety closure.

Individual patients may make a BLANKET request that all of their prescriptions be filled in non-child resistant packaging

Prescribers may request that A SINGLE prescription be dispensed in a non-child resistant package, but they CANNOT make a BLANKET request

Question 6

For prescription containers dispensed by the pharmacy:

exempt products:

Answer 6

OTC drugs- one size of an OTC product designed for seniors/elders or handicapped may be in non-compliant packaging

BUT- this packaging must include this statement: “This package for households without young children” OR if label is too small, it may contain “Package not child-resistant”

Drugs dispensed to institutionalized patients- Hospitals, LTC, nursing homes, rehab facilities,

Examples of specific prescription drugs and controlled substances:

Sublingual Nitroglycerine tablets

Oral contraceptives- in memory and dispenser packages

Preparations in aerosol containers intended for inhalation

Methylprednisone tablets containing not more than 84 mg per package (Medrol dosepaks)