E1 Lecture 4 Flashcards
Prior to 1970, what was thought to be the leading cause of injury for children 5 and under?
unintentional poisonings by medicine and household products
Poison Prevention Packaging Act (PPPA)
1970
required prescription drugs to be packaged in child resistant containers (CRC) –> special packaging
Special Packaging
- targeted at kids under 5 years old
- not difficult for normal adults to access
- most kids under 5 should struggle to open and those that can open it will be preventing from obtaining a toxic amount at reasonable time
Child Resistant
- 20% of children or less can open after 10 minutes
- 90% of adults can open after 10 minutes
What drugs must be in special packaging?
drugs for ORAL administration
- OTC
- Rx
- controlled substances
- samples of oral products
What is one exception to oral drugs within special packaging?
bulk products and unit dose containers are not required to be in special packaging
Special Packaging Exemptions
- non oral dosage forms
- waivers
- CPSC exemptions (23 products)
Waivers
prescription-by-prescription waivers (prescriber or patient)
- waives for the life of single prescription
blanket waivers (patient only)
- waives for all products
Notable CPSC Exemptions
SL NTG
oral contraceptives
steroid dose packs
oral powder formulations
unit-dose potassium
STUDY COMPLETE LIST IN LAW
1 Exception to Packaging Reuse
Glass Container
+
New Cap
Class 1 Recall
drug product may cause serious adverse health consequences including death
- pharmacies notify patients who received drugs
Class 2 Recall
drug may cause temporary or reversible effects but the probability of serious harm is remote
Class 3 Recall
drug product is unlikely to cause serious adverse health consequences
Seizure
FDA:
- physically isolate a drug that is adulterated or misbranded while civil lawsuit is filed
DEA:
- physically isolate a drug that is illegal to possess or distribute while a criminal lawsuit is filed –> only controlled substances
Recall is voluntary
Seizure is mandatory
Federal Anti-Tampering Act of 1983
requires tamper-evident packaging for OTC drug products:
- indicators or barriers to entry to show visible evidence that tampering has occurred
- “distinctive by design” and not able to be duplicated
- two piece hard gelatin capsules must be sealed
- features described on package
Label
any printed, written, or graphic material on the stock bottle
Labelling
all labels and written, printed, or graphic material on the stock bottle, container wrapper, or accompanying the product
Is the label a part of labelling?
Yes
Package Inserts
required as part of labeling of prescription drugs and biological products
- intended for HC professionals but can be given to patients
If a drug on a shelf does not have a PI….
misbranded
3 Sections related to Reproduction
Pregnancy
Lactation
Females & Males of Reproductive Potential
Patient Package Inserts (PPI)
FDA-approved labeling written in patient-friendly language which covers:
- drug uses
- risks
- precautions
If a PPI is not dispensed with drug they correspond to…
misbranded
Which drugs require PPIs?
estrogens
oral contraceptives
Medication Guides (MedGuides)
FDA-approved labeling written in patient-friendly language that explains issues related to drug or drug class
must be provided with new and refill prescriptions for patients in outpatient environment not under direct supervision of HC professional
When are MedGuides required?
- labeling could help prevent serious adverse effects
- serious risks of use exist which patients should be made aware of
- patient adherence to directions is crucial to drug effectiveness
Failure to dispense MedGuide with a required drug …
misbranded
Risk Evaluation and Mitigation Strategy (REMS)
used to address serious risks associated with using a medication or class of medications
- may be required by FDA as part of labeling
4 Types of REMS
Patient-Friendly Labeling
- MedGuides and PPI to provide patients with info
Communication Plans
- information sent directly to HC practitioner informing them about the drug & how to mitigate issues for patients
Elements to Assure Safe Use (ETASU)
- required activities that must be done before prescribing, dispensing, or receiving product
Implementation System
- quality assurance process to ensure that risks are being mitigated successfully
Consumer Medication Information
patient information provided when medication is dispensed by a pharmacy but not classed as PPI, MedGuide, nor regulated by FDA
does not take the place of formal counseling
OTC Drug Facts
Active Ingredient
Inactive Ingredient
Purpose
Use
Warning
Directions
Other Info
OTC Label Requirements
Expiration date –> if none, 3 years after purchase
Lot/Batch #
Name, Address of Manufacturer, packer, or distributor
Net quantity of contents
Description of type of tamper-evidence packaging
MedWatch
FDA voluntary reporting system for adverse events with drug products, biologics, medical devices, nutritional products, cosmetics, and dietary supplements
Types:
- 3500 –> HC professionals
- 3500B –> patients
In 2007, mandatory that pharmacies provide patients with notification of toll-free number to report
