Lecture 7 Flashcards
Objectives
-Identify the key aspects of the 1987 Prescription Drug Marketing Act
-Interpret a National Drug Code number effectively, and compare two separate products to determine generic equivalency
-Protect patient health information in accordance with the 1996 Health Insurance Portability & Accountability Act (HIPAA) and delineate between the four key pieces of the act.
1987: Prescription Drug Marketing Act (PDMA)
Goal was to “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:
1987: Prescription Drug Marketing Act (PDMA)
Reimportation
A drug cannot be reimported into the United States unless reimported by the drug manufacturer or for emergency use after FDA review
1987: Prescription Drug Marketing Act (PDMA)
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.*
*Two entities who have access to the same preferential pricing can sell or trade with one another
1987: Prescription Drug Marketing Act (PDMA)
Samples and Coupons
Bans the sale, purchase, or trade or of a drug sample or drug coupon, and bans counterfeiting of drug coupons.
-Practitioners must ask for drug samples in writing
-Community pharmacies cannot have drug samples at anytime
-Established Recordkeeping, storage, and handling requirements for drug samples
1987: Prescription Drug Marketing Act (PDMA)
Wholesale Licensure & more
States were required to license wholesalers
Records related to PDMA must be maintained 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 to add barcodes or QR codes to prescription packages to allow for better tracing and verifying of the products (some drugs are excluded, including nonprescription drugs)
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) Number
Series of 11 numbers (55555-4444-22)
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.
If a number is missing always add a LEADING zero to that section
Drug Advertising and Promotion
The FDA regulates prescription drug advertising
The Federal Trade Commission (FTC) regulates nonprescription drug advertising
Advertising to Professionals
Targeted to healthcare professionals
Advertisements must include:
Established name of the drug
Formula of the drug
Adverse event information
Contraindications
Effectiveness
information cannot be false or misleading, or biased in its discussion of adverse effects as compared to effectiveness (this would be MISBRANDING)
Advertising to Consumers
MUST HAVE ALL OF THE FOLLOWING
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
Off-Label Advertising
Off-label use: an indication other than that approved by the FDA, and thus not included in the approved drug labeling
Any such information must be complete, peer-reviewed journal articles published outside of company influence
To disseminate these journal articles, the company must:
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.
1996: Health Insurance Portability & Accountability Act (HIPAA)
Brought on by the transmission of protected health information (PHI) electronically, raising concerns about privacy of health information.
Applies to three groups (called Covered entities):
Health care providers who electronically transmit any health information
- Can be individual or group providers (physicians, clinics, hospitals, pharmacies, employees of any of the preceding)
Health plans
- Health insurance, government payers (Medicare & Medicaid), Health Maintenance Orgs (HMOs)
Health care clearinghouses
- Groups that process PHI on behalf of another entity (PBMs, EHRs, etc.)
HIPAA Rules
While the language involved in HIPAA is extensive, the law can be broken down into four key pieces:
Privacy Rule
Security Rule
Breach Notification Rule
Enforcement Rule
HIPAA Privacy Rule: PHI
This rule identifies PHI as information, including demographics, that relate to
-An individual’s 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
De-Identified Health information is not Protected Health Information.
HIPAA Privacy Rule: Permitted Uses and Disclosures
A covered entity must disclose PHI when…
To individuals requesting access to their own PHI; and
To HHS when it is undertaking an investigation or review or enforcement action
HIPAA Privacy Rule: Permitted Uses and Disclosures
A covered entity may disclose PHI…
To the individual
For treatment, payment, and health care operations
For an opportunity to agree or object
For incidental use and disclosure
For public interest and benefit activities
For a limited data set
HIPAA Security Rule
Requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards of electronic PHI (e-PHI)
Must ensure the confidentiality*, integrity, and availability of all e-PHI they create, receive, maintain or transmit;
Must identify and protect against reasonably anticipated threats to the security or integrity of the information;
Must protect against reasonably anticipated, impermissible uses or disclosures; and
Must ensure compliance by their workforce.
*Means not available or disclosed to unauthorized persons.
HIPAA Breach Notification Rule
If a breach affects fewer than 500 individuals
If a covered entity discovers a breach of unsecured PHI, it is obligated to report that breach.
Report that breach to the Secretary of Health and Human Services within 60 days of the end of the calendar year in which the breach was discovered.
HIPAA Breach Notification Rule
If a breach affects 500 or more individuals
Report that breach to the Secretary of Health and Human Services within 60 days from the discovery of the breach.
Report the breach to the prominent media outlets serving the State or jurisdiction.
A list of these reports is available as the public domain.
