Lecture 7

Question 1

Supply chains in 1987 (underregulation of products)

Answer 1

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 which received medications under market price (ex. samples) were reselling products at a profit that traditional supplies could not match

Question 2

Counterfeit Ovulen-21

Answer 2

2 million birth control pills meant to look like Ovulent-21 had little to no estrogen

Question 3

Goal of the Prescription Drug Marketing Act (PDMA)

Answer 3

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

Question 4

Four main aspects of the PDMA

Answer 4

Reimportation, preferential pricing, samples and coupons, and wholesale licensure

Question 5

Reimportation of PDMA

Answer 5

A drug cannot be reimported into the US unless reimported by the drug manufacturer or for emergency use after FDA review

Question 6

Importation banned by PDMA

Answer 6

Bans importation of American-made drugs from foreign countries not importation of drugs from a foreign country

Question 7

Status of a drug that is illegally reimported

Answer 7

Adulterated

Question 8

Preferential pricing of PDMA

Answer 8

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

Question 9

Can two entities who have access to the same preferential pricing sell or trade with one another?

Answer 9

yes

Question 10

Samples and coupons of the PDMA

Answer 10

Bans the sale, purchase, or trade of a drug sample or drug coupon, bans counterfeiting of drug coupons, and established recordkeeping, storage, and handling requirements for drug samples

Question 11

How must practitioners ask for drug samples?

Answer 11

in Writing

Question 12

Who cannot have drug samples at anytime?

Answer 12

community pharmacies

Question 13

drug sample

Answer 13

Unit of a prescription drug that is not intended to be sold and intended to promote the sale of a drug (not OTC or starter packs since these are intended for sale)

Question 14

Wholesale licensure of PDMA

Answer 14

States are required to license wholesalers

Question 15

Recordkeeping requirements of PDMA

Answer 15

Records related to PDMA must be maintained for at least 3 years

Question 16

Max award amount for reporting someone violating PDMA

Answer 16

$125,000

Question 17

Purpose of the Drug Supply Chain Security Act (DSCSA)

Answer 17

Increase supply chain security

Question 18

DSCSA requirement for prescription packages

Answer 18

Required manufacturers and repackagers to add barcodes or QR codes to prescription packages to allow for better tracing and verifying of the products (excludes nonprescription drugs)

Question 19

How quickly must manufacturers and wholesalers verify legitimacy of products?

Answer 19

Within 24 hours of inquiry from a pharmacy

Question 20

How quickly must illegitimate products be brought to the FDA?

Answer 20

Within 24 hours of discovery by the manufacturer, repackager, distributor, or dispenser

Question 21

DSCSA on filling process

Answer 21

Pharmacies must track specific lot numbers throughout the filling process

Question 22

Product tracking and DSCSA

Answer 22

Product tracking must be documented for all parts of the supply chain and maintained for 6 years

Question 23

National drug code (NDC)

Answer 23

Universal product identifier for human drugs that contains 11 numbers

Question 24

First 5 numbers of NDC

Answer 24

Identifies the manufacturer and is assigned by the FDA

Question 25

Middle 4 numbers of NDC

Answer 25

Identifies the drug, strength, dosage form, and formulation of the product and is assigned by the manufacturer

Question 26

Last two number of the NDC

Answer 26

Identifies the package size and is assigned by the manufacturer

Question 27

Who regulates prescription drug advertising?

Answer 27

FDA

Question 28

Who regulates nonprescription drug advertising?

Answer 28

Federal Trade Commission (FTC)

Question 29

Who should advertisements to professionals target?

Answer 29

Healthcare professionals

Question 30

What do drug advertisements to professionals have to include?

Answer 30

Established name of the drug, formula of the drug, adverse event information, contraindications, and effectiveness

Question 31

How would advertising to professionals become misbranded?

Answer 31

Information is false or misleading, or information is biased in its discussion of adverse effects as compared to effectiveness

Question 32

Requirements of the major statement in direct-to-consumers advertising

Answer 32

A major statement must highlight side effects, warnings, precautions, and contraindications of the drug, and be: 1. Presented in consumer-friendly language 2. Presented with appropriate audio (understandable and with good pacing) 3. Presented with audio and text in TV ads 4. Text must be easily readable in TV ads 5. Free of audio or visual elements that might interfere with the comprehension of the major statement

Question 33

Off-Label Use

Answer 33

Indication other than that approved by the FDA, and thus not included in the approved drug labeling

Question 34

Where must information about off-label uses for a drug be obtained?

Answer 34

From a complete, peer-reviewed journal article published outside of company influence

Question 35

Requirements if a company disseminates journal articles about off-label use

Answer 35

1. Apply for approval for that indication 2. Submit a copy of the information and any clinical trial data the company has at least 60 days before disseminating 3. Include the following documents: (1) a disclosure noting that the information has not been approved; (2) a copy of the official lableing for the product; (3) any other products that have been approved for off-label use; (4) the funding source for the studies relating to the use; (5) a bibliography of publications relating to the use

Question 36

Covered entities under HIPAA

Answer 36

Individual or group providers (physicians, clinics, hospitals, pharmacies, employees) who electronically transmit any health information

Question 37

Health Plans in HIPAA

Answer 37

Health insurance, government payers (Medicare and Medicaid), and Health Maintenance Orgs (HMOs)

Question 38

Health care clearinghouses in HIPAA

Answer 38

Groups that process PHI on behalf of another entity (PBMs, EHRs)

Question 39

Key rules of HIPAA

Answer 39

Privacy, security, breach notification, and enforcement rule

Question 40

Protected health information (PHI) under the privacy rule

Answer 40

Information that relates to an individual's past, present, or future physicial 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

Question 41

Is de-identified health information classified as protected health information?

Answer 41

NO

Question 42

When must a covered entity disclose PHI

Answer 42

To individuals requesting access to their own PHI and to HHS when it is undertaking an investigation or review or enforcement action

Question 43

When may a covered entity disclose PHI

Answer 43

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; or for a limited data set

Question 44

Treatment under HIPAA

Answer 44

Provision, coordination, or management of health care and related services for an individual by one or more health care providers

Question 45

Payment under HIPAA

Answer 45

Activities of a health plan to obtain premiums, determine or fulfill responsibilities for coverage and benefits, and furnish or obtain reimbursement

Question 46

Health care operations under HIPAA

Answer 46

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, and business management and general administration activities

Question 47

HIPAA Security Rule

Answer 47

Requires covered entities to maintain reasonable and appropriate administration, technical, and physical safeguards of electronic PHI

Question 48

Are covered entities obligated to report a breach of unsecured PHI?

Answer 48

YEs

Question 49

Reporting a breach that affects <500 individuals

Answer 49

Report that breach to the Security of Health and Human Services within 60 days of the end of the calendar year in which the breach was discovered

Question 50

Reporting a breach that affects 500+ individuals

Answer 50

Report that breach to the Secretary of Health and Human Services within 60 days from the discovery of the breach, as well as to the prominent media outlets serving the State or jurisdiction (list of these reports is available as the public domain)