Pharm Law lecture 7 Flashcards
Before 1987, what are some issues with supply chain that needed to be regulated
- American consumer could not purchase prescriptions with the certainty of safety or efficacy
- Distribution methods were insufficient to prevent sale of substandard or counterfeit drugs
- A wholesale secondary market made it difficult to ascertain the true source of precription drugs
- Healthcare providers that received meds under market price (samples) were reselling prducts at a profit that traditional suppliers could not match
What motivated congressional action to enact the Prescription drug marketing act (PDMA)? WHat was its goal?
2 million counterfeit birthcontrol pills were demonstrated to contain little to no estrogen
Goal- protect public health and to protect public against drug diversion by establishing standards for distribution of drugs
What are 4 main aspects of the prescription drug marketing act (PDMA)
Reimportation
Preferential pricing
Samples and coupons
Wholesale licensure
What does reimportation in PDMA state
A drug cannot be reimported to the US unless importd by the manufacturer or for emergency use after FDA review.
Bans importation of american made drugs from foreign countries, NOT importation of drugs from a foreigh country.
(people would buy these drugs in other countries at a significant discount nd reimport into the US at a profit
A medication that is manufactured in the US, exported to another country and then imported back into the US by a separate entity without FDA approval would be considered
Adulterated
What does preferential pricing aspect in PDMA do?
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
Can two entities who have access to the same preferential pricing sell or trade to one another
Yes
What does the samples and coupons aspect of the PDMA state? WHat are guidelines related to samples and coupons on the PDMA
Bans the sale, purchase or trade 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 record keeping, storage and handling requirements for drug samples
What is a drug sample
A unit of a prescription drug that is not intended to be sold and intended to promote the sale of the drug
Omits OTC drugs and starter packs (which are both intended for sale)
What happened with wholesale licensure in PDMA
States were required to license wholesalers
Records related to PDMA must be maintained for atleast 3 years.
Whistleblower awards upto 125,000 enacted for reporting someone violating PDMA
What does the drug supply chain security act (DSCSA) require
- Manufacturers and repackagers to add barcodes or QR codes to prescription packages to allow for better tracing and verifying of products (some drugs excluded, includng non prescrition drugs)
- Manufacturers and wholesalers must verify the legitimacy of products in question within 24 hrs of inquiry from a pharmacy
- Any illegitimate products must be brought to the FDA within 24 hrs 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 yrs
When was the DSCSA enacted? When did it officially go into effect?
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 went into effect Nov 27, 2023,
due to the complex requirements of the law, the FDA allowed for a stabilization period until nov 27, 2024
How many numbers in an NDC number? WHat do they stand for?
Series of 11 numbers
- 1st 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 product. Assigned by the manufacturer
- Last two identify package size
Why do some NDCs have 0’s?
When the NDC number is listed as 10 digist, a leading 0 should be added at the beginning ofthe section that is short
Who regulated prescription drug advertising? Who regulated non prescription drug advertising?
FDA regulates prescription drug advertising
Federal trade commission (FTC) regulates nonprescription drug advertising
FTC is the primary agency responsible for regulating advertisments in USA. FTC works closely woth FDA on non prescription drug advertisements
For advertising to professionals, advertisement must include? What would happen if indoration is false or misleading?
Established name of drug
Adverse event information
Contraindication
Effectiveness
Formula of drug
Information cannot be false or misleading, or biased in its discussion of adverse effects as compared to effectiveness (this would be misbranding)
For DTC advertising (direct to consumer), what are the 5 standards that needs to be met
- 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 readible
- Free of audio or visual elements that might interfere with comprehension of the major statements
What must be required for off-label advertising? What alllowed this?
Any off abel advertising must have complete, peer reviewed journal articles published outside of company influence
The 1997 the food and drug administration modernization act permitted manufacturers to provide written information about off label uses
For off label advertising, to disseminate the 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 atleast 60 days before disseminating
for off label advertising, what should the document contain that we submit to the FDA
a) A disclosure noting that the information has not been approved
b) A copy of the official labeling for the product
c) Any other products that have been approved for off label use
d) The funding source for the studies relating to the use
e) A bibliography of publications relating to use
Who are the three covered entities HIPAA applies to?
Health care providers- who electronically transmit any health information (can be individual or group like physician, clinics, hospitals, pharmacies)
Health Plans- Health insurance, government payers (medicare, medicaid)
Health care clearinghouses
- Groups that process PHI on behalf of another entity (PBMs)
What are 4 key pieces of HIPAA
privacy rule
security rule
breach notification rule
enforcement rule
Describe privacy rule for HIPAA
Rule identifies PHI as info including demographics that relateto
- individuals past, present or future physical or mental health condition
- The provision of healthcare to the individual
-The past, present or fiture payment for the provision of healthcare to the individual
Anything that could be used to identify a pt is PHI (not zipcode)
Are de identified health informatipn protected health information
No
Accroding to HIPAA privacy rule (permitted uses and disclosures) When MUST an entity disclose PHI? when MAY it?
MUST
- To individuals requesting access to their own PHI
-To HHS when it is undertaking an investigation or review or enforcement action
May
- To the individual even if they do not request it
-FOr treatment, payemnt and health care operations
- for an opportunity to agree or onject
- for incidental use and disclosure
-For public interest and benefit activities
- for a limited data set
When are we permitted to disclose information in HIPAA
Treatment- Provision, coordination or management of healthcare and related services for an individual
Payment- Activities of a helathcare plan to obtain premiums, determine or fulfill responsibilities for coverage and benefits
Healthcare operations- QUality assessment and improvement activities
What us the HIPAA security rule
Requires covered entities to maintain reasonable and approproate administrative, technical and physical safeguards of electronic PHI
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according to the HIPAA security rule, what are things we must do
- must ensure the confidentiality, integrity and availability of all e-PHI that they create, transmit, maintain or receive
-must identify and protect against reasonably anticipated threats to security
-Must protect against reasonably anticipated impermissable uses or disclosures] - must ensure compliance by their workforce
What is the HIPAA breach notification rule
If covered entity discovers a breach of unsecured PHIm it is obligated to report that breach
If a breach affects fewer than 500 undividuals, what must happen? More than 500?
Fewer- report that breach to the secretary of health and human services within 60 days ofthe end of the calendar year in which the breach was discovered
More- 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
