Lecture 5 Flashcards
Objectives
-Review the Poison Prevention Packaging Act of 1970 and the Federal Anti-Tampering Act of 1983, and understand the impact they have on medication packaging.
-Identify the different requirements related to packaging products, including the distinctions between package inserts, patient package inserts, and medication guides
-Address Risk Evaluation and Mitigation Strategy requirements and drug advertising and promotion requirements for specific products
1970: Poison Prevention Packaging Act (PPPA)
Required prescription drugs to be packaged in child resistant containers also known as special packaging
Special packaging is
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 be opened will be prevented from obtaining a toxic amount in a reasonable time
Child resistant meaning
- Child resistant means 20% of children or less can open after 10 minutes AND at least 90% can open after 10 minutes
Covered products that require CRC
Drugs for oral administration require special packaging. This includes OTC and prescription drugs, controlled substances, and samples of oral products.
If dispensing these products they must be in appropriate CRCs otherwise they may be misbranded
Special Packaging Exemptions
There are always exemptions to special packaging:
1.Non-oral Dosage Forms
2.Waivers
- 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 packaging for all products
Notable CPSC Exemptions
-Sublingual nitroglycerin
-Sublingual and chewable forms of isosorbide dinitrate 10mg or less
-Erythromyvcin oral suspensions 8 grams or less
-oral contraceptives
-Anhydrous cholestyramine in powder form
-potassium supplements
- sodium fluoride
- betamethasone
- pancrelipase
- prednisone in tablet form
- mebendazole in tablet form
- methylprednisolone in tablet form
- colestipol in powder form
- erythromycin tablets
- conjugated estrogen tablets
- norethindrone acetate tablets
- medroxyprogesterone acetate
- sacrosidase
- hormone replacement therapy
- colesevelam hydrochloride in powder form
- sevelamer carbonate in powder form
Packaging Reuse
Generally just don’t reuse packaging
only can reuse if it is a glass vial and with new cap
Class I recall
Drug products may cause serious adverse health consequences including death
Class II recall
Drugs may cause temporary or reversible effects, but the probability of serious health consequences is remote
Class III Recall
drug product is unlikely to cause serious adverse consequences
Seizure
FDA Seizure: FDA may physically isolate a drug that is adulterated or misbranded while a civil lawsuit is filed.
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.
A DRUG RECALL IS VOLUNTARY AND A SEIZURE IS NOT
Aftermath of Chicago Tylenol Murders
FDA requires Tamper-evident packaging for over-the-counter human drug products:
-must have a barrier to entry product and if breached its visible to consumers that tampering has occured
- product mubt be distinctive by design and not be able to be dublicated
- any tow piece hard gelatin capsules must be sealed using an acceptable tamer evidence technology
- tamer evidence features must be described on the package
Federal Anti-Tampering Act
makes tampering a federal crime in 1983.
Label
Label: any printed, written, or graphic material on the product container.
Labeling
Labeling: all labels and written, printed or graphic material on the container, container wrapper, or accompanying the product.
Label vs Labeling
A label is a part of the labeling but is not the only thing that fits the definition of labeling. labeling includes anything accompanying the product, including advertisements and spoken words by drug prepresentatives
Package inserts PIs
Required as part of the labeling of prescription drugs
Must contain many things in a predefined order, including but not limited to:
Boxed warning, indications, dosages, contraindications, warnings, use in special populations, clinical pharmacology, adverse reactions, and drug interactions
These are intended for healthcare professionals though they can be given to the patient
- IF A DRUG ON A SHELF DOES NOT HAVE A PI IT IS MISBRANDED
pregnancy categories
3 sections related to reproduction
- pregnancy
- lactation
- females and males of reproductive potential
Patient package inserts PPIs
FDA approved labeling written in patient friendly language which covers: drug uses, risks, precautions
-Must be dispensed with the drug they correspond to whenever that product is dispensed. Failure to do this results in misbranding.
-These requirements apply to any person who dispenses medications, including institutions and practitioners
-Currently, the only drugs requiring PPIs are estrogens and oral contraceptives
Medication guides
FDA approved labeling written in patient friendly language that explains issues related to a drug or drug class
- MUST BE PROVIDED WITH NEW AND REFILL PRESCRIPTIONS FOR PATIENTS IN AN OUTPATIENT ENVIRONMENT
MedGuides are required when one or more of the following exists:
-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 a MedGuide when required meand drug is misbranded
Risk Evaluation and Mitigation Strategy (REMS)
Used to address serious risks associated with using a medication class of medications
can be required by the FDA as part of a drugs labeling
Risk Evaluation and Mitigation Strategy (REMS) Types
Patient friendly labeling
Medguide and PPI
Risk Evaluation and Mitigation Strategy (REMS) Types
Communication plans
information sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for patients
Risk Evaluation and Mitigation Strategy (REMS) Types
Elements to assure safe use
required activities that must be done before prescribing, dispensing, or receiving a product.
Risk Evaluation and Mitigation Strategy (REMS) Types
Implementation system
A quality assurance process to ensure that risks are being mititgated successfully
Patient Labeling: OTCs
All over-the-counter products are required to have a Drug Facts section, which includes:
-Active Ingredient(s)
-Purpose(s)
-Use(s)
-Warning(s)
-Directions
-Inactive Ingredients
-Other Information
- experation date - if not experation date assume the drug expires 3 years after purchase
- lot or batch code
- name and address of manufacturer, packers, or distributor
- net quantity of contents
- Description of the type of tamper evident packaging utilized
MedWatch
Voluntary reporting system created by the FDA for adverse events with drug products, biologics, medical devices, nutritional products, cosmetics and dietary supplements
Professionals report to FDA form 3500
Patients report to FDA form 3500B
any adverse events associated with drug
In 2007, a law was passed “mandating that pharmacies provide patients with notification of a toll-free number so they can report adverse events
