Lecture 5 - Packaging Flashcards
What did the Poison Prevention Packaging Act do?
-Required Prescription drugs (and harmful chemicals) to be packaged in child resistant containers (CRCs), also known as “special packaging”
What is special packaging?
-Targeted at kids under 5 years old
-Not difficult for normal adults to access
-Most kids under age 5 should struggle to open, and those that can open it will be prevented from obtaining a toxic amount in a reasonable time
What does child resistant mean?
-20% of children or less can open after 10 minutes
-At least 90% of adults can open after 10 minutes
What products must be dispensed in a CRC?
-Drugs for oral administration
-Bulk products and unit dose containers are not required to be manufactured in CRCs so they must be dispensed in appropriate CRCs otherwise they are misbranded
What happens if a product is not dispensed in a CRC?
It is misbranded
Exemptions from special packaging
-Non-oral dosage forms
-Waivers
-Consumer Product Safety Commission exemptions (23 products)
What are the waivers that can be signed to be exempted from special packaging?
-Prescription-by-prescription waivers (can be given by prescribers and patients), waives CRC packaging for the life of a single prescription
-Blanket waivers (patient authorization only), waives CRC for all products
Notable CPSC exemptions
-Sublingual nitroglycerin
-Oral contraceptives in mnemonic dispenser packages
-Steroid dose packs
-Some oral powder formulations
-Unit-dose potassium
When can you reuse packaging?
If it is made out of glass and is using a new cap
What is a recall?
The correction or removal, and notification to the company, of a product which is in violation of the law
What is a class 1 recall?
Drug product may cause serious adverse health consequences including death (pharmacies notify patients who received recalled drugs)
What is a class 2 recall?
Drug may cause temporary or reversible effects, but the probability of serious health consequences is remote
What is a class 3 recall?
Drug product is unlikely to cause serious adverse health consequences
Difference between a recall and a seizure
A drug recall is voluntary, a seizure is not
What is a FDA seizure?
FDA may physically isolate a drug that is adulterated or misbranded while a civil lawsuit is filed
What is a DEA seizure?
DEA may physically isolate a drug that is illegal to possess or distribute while a criminal lawsuit is filed, with probable cause and a warrant when necessary
What was the aftermath of the Chicago Tylenol Murders?
-FDA requires Tamper-evident packaging for over-the-counter human drug products
-Federal Anti-Tampering Act is passed in 1983 making tampering a federal crime
What is a label?
Any printed, written, or graphic material on the product container
What is labeling?
-All labels and written, printed or graphic material on the container, container wrapper, or accompanying the product
-A label is a part of the labeling, but is not the only thing that fits the definition of labeling
What is a package insert?
Required as part of the labeling of prescription drugs and biological products, there are sometimes referred to as “prescribing information” or a “drug monograph”
What if a drug on a shelf does not have the package insert?
It is misbranded
What are the three pregnancy categories included in labeling?
-Pregnancy
-Lactation
-Females and males of reproductive potential
What are patient package inserts?
-FDA-approved labeling written in patient-friendly language which covers drug uses, risks, and precautions
-Must be dispensed with the drug they correspond to whenever that product is dispensed
-These requirements apply to any person who dispenses medications, including institutions and practitioners
What happens if PPIs are not included with the corresponding product dispensed?
The drug is misbranded
