E1 Lecture 6 Flashcards
Prescription Drug Marketing Act (PDMA)
protect public health and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and samples
4 Main Aspects of PDMA
Reimportation
Preferential Pricing
Samples & Coupons
Wholesale Licensure
Reimportation
a drug cannot be imported into the US unless reimported by the DRUG MANUFACTURER or for EMERGENCY USE after FDA review
- bans importation of American-made drugs from foreign countries, NOT importation of drugs from a foreign country
Preferential Pricing
bans the sale, purchase, or trade of a prescription drug:
- purchased at a reduced price by a hospital or other HC facility
- donated
- supplied by charity
Can two entities who have access to same preferential pricing sell or trade with one another?
Yes
Samples & Coupons
bans the sale, purchase, or trade of a drug sample, or drug coupon & bans counterfeiting drug coupons
- practitioners must ask for drug samples in writing
- community pharmacies cannot have a drug sample at anytime
- established recordkeeping, storage, and handling requirements for drug samples
Drug Sample
unit of prescription drug that is not intended to be sold and intended to promote the sale of a drug
- omits OTC & starter packs
Wholesale Licensure
states were required to license wholesalers & keep records related to PDMA for at least 3 years
whistleblower awards up to 125,000$ enacted for reporting someone violating PDMA
Drug Supply Chain Security Act (DSCSA)
- manufacturers and repackagers add barcodes or QR codes to prescription packages to allow for better tracking and verifying of products (excludes nonprescription)
- manufacturers and wholesalers must verify the legitimacy of products in question within 24 hours of inquiry from a pharmacy
- any illegitimate products must be brought to the FDA within 24 hours of discovery by the manufacturer, repackager, distributor, or dispenser
- pharmacies must track specific lot numbers throughout the filling process
- product tracking must be documented for all parts of the supply chain and maintained for 6 years
National Drug Code (NDC)
universal product identifier for human drugs
11 numbers
- first 5 –> manufacturer assigned by FDA
- second 4 –> drug, strength, dosage form, formulation of product assigned by the manufacturer
- last 2 –> package size assigned by the manufacturer
Who regulates prescription drug advertising?
FDA
Who regulates nonprescription drug advertising?
FTC –> works closely with FDA
5 Standards of Advertisements for HC Professionals
- established name of drug
- formula of drug
- adverse event information
- contraindications
- effectiveness
Advertising is false, misleading, or biased in its discussion of adverse effects compared to effectiveness
Misbranded
Are the DTC advertising the same as health professional advertising?
No, changed in November 2024
5 Standards of Advertisement for DTC
Major statement included discussing side effects, warnings, precautions, and contraindications in:
- consumer-friendly language
- appropriate audio
- in tv ads, presented using audio and text
- in tv ads, text must be easily readable
- free of audio or visual elements that might interfere with comprehension of major statement
Off-Label Use
indication other than that approved by the FDA and thus not included in the approved drug labeling
Off-Label Advertising
FDA Modernization Act allowed manufacturers to provide written information about off-label uses under certain conditions
- must be complete, peer-reviewed journal articles outside of company influence
Requirements for Off-Label Advertising
- have applied for approval for that indication
- submit a copy of information and any clinical trial data at least 60 days before disseminating
- disclosure noting information has not been approved
- copy of the official labeling for the product
- any other products that have been approved for off-label use
- funding source for studies
- bibliography of publications related to use
Health Insurance Portability and Accountability Act (HIPAA)
applies to 3 groups:
- Health care providers –> electronically transmit health information
- Health plans –> health insurance, govt insurance, HMO
- Health care clearinghouses –> groups that process PHI on behalf of other entities (PBM, EHR)
4 Key Components of HIPAA
Privacy Rule
Security Rule
Breach Notification Rule
Enforcement Rule
Protected Health Information
- individuals past, present, or future physical or mental health condition
- provision of healthcare to the individual
- past, present, or future payment for the provision of health care to individual
DEIDENTIFIED IS NOT PHI
Must Disclose PHI
- individuals requesting access to their own PHI
- HHS when it is undertaking an investigation/review or enforcement action
May Disclose PHI
- individual
- treatment, payment, and healthcare operations
- opportunity to agree or object
- incidental use and disclosure
- public interest and benefit activities
- limited data set
Security Rule
requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards of electronic PHI
Breach Notification Rule
if a covered entity discovers a breach of unsecured PHI, they are obligated to report it
Breach Affects < 500 individuals
report to Secretary of Health and Human Services within 60 days of the end of the calendar year in which breach was discovered
Breach Affects > 500 individuals
report to Secretary of Health and Human Services within 60 days from discovery of breach
report to prominent media outlets serving state or jurisdiction
