Lecture #7 Flashcards
Supply chain - 1987
While the first 70 years of the 20th century brought a number of controls to the safety, efficacy, and labeling of prescription drugs, the supply chain of these products was under regulated. As a result:
1. American consumers could not purchase prescriptions with the certainty of safety or efficacy
2. Distribution methods were insufficient to prevent the sale of potentially substandard, ineffective, or counterfeit drugs
3. A wholesale secondary market made it difficult to ascertain the true source of prescription drugs
4. Health care providers that received medications under market price (samples, for example) were reselling products at a profit that traditional suppliers could not match
Counterfeit Ovulen-21
Hormonal birth control product.
* In 1987, 2 million birth control pills meant to look like this product were
demonstrated to contain little or no estrogen.
* Originated in Spain
* Shipped to Guatemala
* SmuggledacrosstheU.S.border
* Sold in American pharmacies
* This example motivated Congressional action…
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:
* Reimportation
* Preferential Pricing
* Samples and Coupons
* Wholesale Licensure
PDMA - Reimportation
A drug cannot be reimported into the United States 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.
People would buy these drugs in other countries at a significant discount, and reimport into the United States at a profit, often without concern for proper storage and handling of the drugs.
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.*
* Hospitals get different prices than community pharmacies, and for a time were profiting from selling these prescription drugs to pharmacies
*Two entities who have access to the same preferential pricing can sell or trade with one another
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
A drug sample is “a unit of a prescription drug that is not intended to be sold…and intended to promote the sale of a drug.” This definition omits OTC drugs and starter packs, which are both intended for sale
PDMA - Wholesale Licensure and more
States were required to license wholesalers
* Records related to PDMA must be maintained for at least 3 years (Many recordkeeping requirements and documentation requirements were enacted for manufacturers, wholesalers, and distributors, but those were superseded by DSCSA
* Whistleblower awards up to $125,000 enacted for reporting someone violating PDMA
What was the drug supply chain security act (DSCSA)?
In 2013, the DSCSA was passed to further increase supply chain security. It required:
* 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
DSCSA Implementation
The DSCSA was enacted in 2013, but a ten-year lead-in time was granted to allow all parties to successfully adhere to the law.
* The law officially went into effect November 27, 2023
* Due to the complex requirements of the law, the FDA allowed for a
“stabilization period” until November 27, 2024.
* You may see/have seen changes in pharmacy practice because of this law
What is the national drug code (NDC) number?
Universal product identifier for human drugs 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.
Quirks of the NDC
Most NDC numbers only display 10 digits, usually in one of the following ways:
* 4444-4444-22
* 55555-333-22
* 55555-4444-1
* When the number is listed as 10 digits, a leading 0 should be added at the beginning of the section that is short (55555-4444-22):
* 04444-4444-22
* 55555-0333-22
* 55555-4444-01
Drug advertising and promotion
Drugs have stricter requirements than other products when it relates to advertising.
* The FDA regulates prescription drug advertising
* The Federal Trade Commission (FTC) regulates nonprescription drug
advertising
* The FTC is the primary agency responsible for regulating advertisements in the United States
* The FTC works closely with the FDA on nonprescription drug advertisements to ensure that their policies don’t deviate from FDA policies
Advertising to professionals
Many different modalities of advertisement, but always targeted toward 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
Often called direct-to-consumer (DTC) advertising, this practice began in the 1980s.
* For decades, no laws or regulations applied directly to this type of advertising, so ads had to follow the same requirements as advertisements to professionals
* November 21, 2023, the FDA announced a final rule distinguishing requirements for DTC ads. All DTC ads must be compliant to five standards as of November 20, 2024
DTC advertising standards
A major statement must be included highlighting “side effects, warnings, precautions, and contraindications” of the drug. The major statement must be:
1. Presented in consumer-friendly language
2. Presented with appropriate audio (understandable with good pacing)
3. In TV ads, presented using audio and text
4. In TV ads, text must be easily readable
5. Free of audio or visual elements that might interfere with the comprehension of the major statement
DTC advertising to consumers
Previously, the FDA required DTC advertisers to offer consumers an opportunity to view complete labeling information within their advertisements. The new rule does not specify this, but the FDA could still require it moving forward
Before this DTC rule, the FDA had limited regulatory authority to remove advertisements. This language provides that opportunity
Off-label advertising
Off-label use: an indication other than that approved by the FDA, and thus not included in the approved drug labeling
* In the past, advertising on any off-label use was prohibited by the FDA
* In 1997, the Food and Drug Administration Modernization Act permitted manufacturers “to provide written information about off- label uses under certain conditions to healthcare professionals…”
* Any such information must be complete, peer-reviewed journal articles published outside of company influence
To disseminate these journal articles for off-label advertising, 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 and 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)
* Healthplans: Health insurance, government payers (Medicare & Medicaid), Health Maintenance Orgs (HMOs)
* Health care clearing houses: Groups that process PHI on behalf of another entity (PBMs, EHRs, etc.)
HIPPA rules
The law can be broken down into four key pieces:
1. Privacy Rule
2. Security Rule
3. Breach Notification Rule
4. 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
* This information must be able to be used to identify the individual or could reasonably be assumed to identify the individual.
* De-Identified Health information is not Protected Health Information.
HIPAA privacy rule: permitted uses and disclosures
A covered entity must disclose PHI: To individuals requesting access to their own PHI; and to HHS when it is undertaking an investigation or review or enforcement action
* 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
HIPPA privacy rule: permitted uses and disclosures - treatment and payment
Treatment: The provision, coordination, or management of health care and related services for an individual by one or more health care providers.
Payment: Activities of a health plan to obtain premiums, determine or fulfill responsibilities for coverage and benefits, and furnish or obtain reimbursement
HIPPA privacy rule: permitted uses and disclosures - health care operations
Quality assessment and improvement activities
* Competency assurance activities
* Conducting or arranging for medical reviews, audits, or legal services
* Specified insurance functions
* Business planning, development, management, and administration
* Business management and general administrative activities
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 covered entity discovers a breach of unsecured PHI, it is obligated to report that breach.
If a breach affects fewer than 500 individuals:
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.
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.
