Lecture 7 - Supply Chain, Advertising, and HIPAA Flashcards
Goal of the Prescription Drug Marketing Act
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 prescription drug samples
Four main aspects of the Prescription Drug Marketing Act
-Reimportation
-Preferential pricing
-Samples and coupons
-Wholesale licensure
What does the PDMA ban on reimportation?
-Bans the importation of American-made drugs from foreign countries
-Does NOT band importation of drugs from a foreign country
When can a drug be reimported?
-The drug manufacturer can reimport their own drug
-Emergency use after FDA review
What does the PDMA ban on preferential pricing?
Bans the sale, purchase, or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity
What does the PDMA do to samples and coupons?
-Bans the sale, purchase or trade of a drug sample or drug coupon, and bans counterfeiting drug coupons
-Practitioners must ask for drug samples in writing
-Community pharmacies cannot have drug samples at any time
-Established recordkeeping, storage and handling requirements for drug samples
What did the PDMA require for wholesalers?
States are required to license wholesalers
How long must records be maintained for PDMA?
At least 3 years
What is the award for reporting someone violating PDMA?
Up to $125,000
What did the Drug Supply Chain Security Act require?
-Manufacturers and repackagers to add barcodes or QR codes to prescription packages to allow for better tracing and verifying of the products (nonprescription drugs excluded)
-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 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
How to read an NDC
-First 5 numbers identify the manufacturer. This number is assigned by the FDA
-4 numbers in the middle identify the drug, strength, dosage form, and formulation of the product. Assigned by the manufacturer
-Last 2 numbers identify the package size. Assigned by the manufacturer
-Most NDCs only display 10 digits
-A leading zero should be added at the beginning of the section that is short
Who regulates prescription drug advertising?
The FDA
Who regulates nonprescription drug advertising?
The FTC
What must be included in advertisements to professionals?
-Established name of the drug
-Formula of the drug
-Adverse event information
-Contraindications
-Effectiveness
What causes advertisements to professionals to be misbranded?
-False or misleading information
-Biased in its discussion of adverse effects as compared to effectiveness
What did the FDA say the major statement must be in a direct to consumer advertisement?
-Presented in consumer-friendly language
-Presented with appropriate audio (understandable with good pacing)
-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 the comprehension of the major statement
What is off-label use?
An indication other than that approved by the FDA, and thus not included in the approved drug labeling
What is required of off-label advertising?
Any such information must be complete, peer-reviewed journal articles published outside of company influence
What must the company do in order to advertise for an off-label use?
-Have applied for approval for that indication
-Submit a copy of the information and any clinical trial data the company has at least 60 days before disseminating
-Include the following documents
-A disclosure noting that the information has not been approved
-A copy of the official labeling for the product
-Any other products that have been approved for off-label use
-The funding source for the studies relating to the use
-A bibliography of publications relating to the use
What three groups does HIPAA cover?
-Health care providers who electronically transmit any health information
-Health plans
-Health care clearinghouses
Four HIPAA rules
-Privacy rule
-Security rule
-Breach notification rule
-Enforcement rule
What is PHI?
-An individuals past, present, or future physical or mental health or condition
-The provision of health care to the individual, or
-The past, present or future payment for the provision of health care to the individual
What is not regarded as Protected Health Information?
De-identified health information
When must a covered entity disclose PHI?
-Individuals requesting access to their own PHI
-HHS when it is undertaking an investigation or review or enforcement action
