RX 526: Federal Labeling Dispensing Supply Chain

Federal Anti-Tampering Act Applies to what?

CONSUMER products

Federal Anti-Tampering Act: Five criminal act

- tampering

- tainting

- communicating false information

- threatening to tamper

- conspiracy to tamper or taint

Certain OTC medications, cosmetics, devices must be in ___-___ ___.

tamper-evident packaging (CONSUMER products)

Adulteration or misbranding? Violation of tamper-evident packaging

adulteration, misbranding, or BOTH

What is Tamper-evident package

"one having an indicator or barrier to entry, which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred"

Tamper-evident package Labeling must have what?

- Identify all tamper-evident features

- Be prominently placed

- Placed so it is not lost if tamper-evident features removed

Adulteration or misbranding? Failure to manufacture certain OTC products in a tamper-evident package

MISBRANDING could also be adulteration

PDMA

Prescription Drug Marketing Act

Prescription Drug Marketing Act (PDMA)

- Ensure drug products are safe and effective

- Avoid use of counterfeit, adulterated, misbranded, subpotent, expired drugs

PDMA Actions

- Require states to license wholesale distributors of prescription drugs

- Ban sale, trade, or purchase of drug samples

- Mandate storage, handling, recordkeeping requirements for drug samples

- Ban the trafficking in or counterfeiting of drug coupons

- Prohibit resale of prescription drugs purchased by hospitals or healthcare facilities (with some exceptions)

- Ban reimportation of prescription drugs, except by the manufacturer or for emergency use

PDMA: Prescription Drug Samples & Coupons

- Samples and coupons are not meant to be sold

--- Intended to promote sale of the drug

- Coupons are intended to accompany a prescription

- Cannot offer to sell, purchase, or trade these

- Practitioners must request samples in writing

- Sample require recordkeeping, storage, handling

- Retail pharmacies CANNOT receive samples

- Pharmacy in a hospital or healthcare entity may receive samples at the request of a licensed practitioner

PDMA: Preferential Pricing

- Hospitals, healthcare facilities, charities can obtain medications at lower prices than community pharmacies

- Some resold purchases at a markup to brokers, retail pharmacies, wholesalers

--- Adulteration and misbranding issues

--- Also led to unfair competition - Sale, purchase, trade of prescription drugs purchased by hospital, healthcare entity, or charitable organization is prohibited

- Hospitals CAN sell or trade with another qualified hospital (or other entity)

Charitable Institutions & Drug Sample Donations: What drugs may be donated?

Original, unopened packaging with labeling intact, and UNEXPIRED

Charitable Institutions & Drug Sample Donations: What records must be kept?

- Name, address, telephone number of licensed practitioner/donating institution

- Manufacturer, brand name, quantity, lot or control number

- Date of donation

Charitable Institutions & Drug Sample Donations: How long must records be kept (minimum time frame)?

At least 3 years

Reimportation of Prescription Drugs "Gray market"

selling prescription medications outside of a manufacturer's authorized channels

Reimportation of Prescription Drugs is Prohibited by PDMA unless...

- done by the manufacturer for emergency use

--- MUST be reviewed by FDA

Medicare Prescription Drug, Improvement, and Modernization Act (MMA) allows Secretary of DHHS to do what?

promulgate regulations that facilitate the wholesale importation of prescriptions from Canada

MMA

Medicare Prescription Drug, Improvement, and Modernization Act

Importation For Personal Use: Foreign nationals (not U.S. citizens or residents)

- may import up to a 90-day supply

- No controlled substances or biologic products

- Must import "on their person"

Importation For Personal Use: U.S. citizen guidance

- up to 90 days from Canada

- total combined quantity of 50 dosage units of controlled substances that must be transported personally(from any country) per patient

Executive Orders Related to Drug Importation

- July 2020: Facilitating Drug Importation to Lower Prices for American Patients

--- FDA finalized a rule in Sept 2020

----- Allow prescription drug importation from Canada

--- Products must be FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that specific country

--- Native American tribes, pharmacists, wholesalers can submit important program proposals to FDA for review and authorization

--- Patients would get from state-licensed pharmacy

- 2021 Executive Order: Promoting Competition in the American Economy

Executive Orders Related to Drug Importation: Apo-Varenicline

Apotex initiated temporary importation of Apo-Varenicline from Canada - Approval from FDA

DSCSA

Drug Supply Chain and Security Act

DSCSA Applies to what?

trading partners of prescription drugs such as Manufacturers, wholesalers, repackagers, third-party logistics providers, dispensers (pharmacies)

Per DSCSA, trading partners of prescription drugs must have what?

- Must have systems in place to quarantine, investigate, notify FDA of suspect and illegitimate prescription drug products

--- Within 24 hours of making determination

--- Also notify trading partners (wholesaler, manufacturer)

DSCSA Dispensers cannot receive a prescription product unless...

prior owner provides tracing information

DSCSA Dispensers must product tracing to subsequent purchasers EXCEPT for...

patients and exemptions on next slide

DSCSA Dispensers can only accept products containing what?

- the unique product identifier (UPI)

--- UPI includes lot number, expiration date, NDC, serial number

DSCSA Product Tracing Exceptions for Pharmacies

- Transfer from one pharmacy to another to fulfill a patient need (e.g. filling a prescription)

- Distribution in a minimal quantity by a pharmacy to a practitioner for office use

- Distribution pursuant to a sale/merger of pharmacy

- Distribution of drug/device combination products

-Distribution for emergency medical reasons

- Product returns

- Transactions with first responders

GTIN

Global Trade Item Number

UPI

Unique Product Identifier

Unique Product Identifier (UPI)

2-dimensional matrix barcode that includes NDC, unique serial number, lot number, and expiration date in both human-and machine-readable formats.

To do "Generic Substitution...", you want a drug that is ___ ___to the brand drug

THERAPEUTICALLY EQUIVALENT

Pharmaceutical Equivalent

- Products with same active ingredients

- Identical in strength and are of same dosage form

Therapeutic Equivalent

Pharmaceutical equivalents with the same clinical effects and safety

Therapeutic equivalence does NOT mean ___ ___

therapeutic substitution

Therapeutic substitution refers to what?

substituting different therapeutic agents that may be used for the same condition

Therapeutic equivalence is used for ___ substitution

GENERIC

"Orange Book" Two letter rating system

- First letter is A or B - A-rated products can be substituted and are therapeutically equivalent

- B-rated products are more complicated...

--- Actual or potential bioequivalence issues that have not been solved; no equivalence exists

- Second letter varies but provides additional bioequivalence information or dosage information

- Three character code (two letters, one number) occurs when more than one pharmaceutically equivalent reference drug exists

--- AB1, AB2, AB3, etc.(ENTIRE CODE should match to substitute!)

Brand vs Generic Drug "Orange Book" Substitution Notes

- Refer to state law

--- Some states only allow "A" substitution

- Substituting a "B" rated drug product for the drug described does not violate FDCA

--- Orange Book is a guide NOT a regulation or law

--- BUT this could violate state law

----- Some states refer to the Orange Book in their laws

NTI

Narrow Therapeutic Index

NTR

Narrow therapeutic ratio

Narrow Therapeutic Index/Ratio Drugs

Drug with:

--- less than 2-fold different between the median lethal dose and median effective dose

--- OR less than 2-fold difference between minimum toxic concentrations and minimum effective concentrations in the blood

Narrow Therapeutic Index/Ratio Drug Examples

carbamazepine, clonidine, levothyroxine, lithium, minoxidil, phenytoin, theophylline, warfarin

Purple Book

- Used to evaluate biologics

- B = biosimilar

- I = interchangeable with a reference biological product

- If biosimilar is interchangeable, it may be substituted without the intervention of the prescriber

- Refer to state law

"BIG FOUR" Prescribers

- Physicians (MD/DO)

- Dentists (DDS/DMD)

- Podiatrists (DPM)

- Veterinarians (DVM)

"BIG FOUR" Prescribers: Prescriptive authority [is/is not] determined by the federal government

is not

"BIG FOUR" Prescribers: Notes

- Prescriptions from these prescribers licensed in ANY state are valid in Indiana

- Prescription must be valid as written in the state in which the prescriber is practicing

- On correct prescription paper

- Meet requirements of the state

Four practitioners recognized in ALL states as prescribers

- Physicians (MD/DO)

- Dentists (DDS, DMD)

- Veterinarians (DVM)

- Podiatrists (DPM)

Scope of Practice Notes

- What a provider can do based on state-issued license

- Decided by the states

- Prescribing privileges fall within scope of practice

A providers Scope of Practice is Dictated by what for the "big four"?

the practitioner's degree, not specialty for the "big four"

Physicians (MD/DO) Scope of Practice

- Scope of practice includes whole body

- Some states may have limitations for prescribing, but this is very rare

- Controlled substance prescribing can be limited

Dentists (DDS/DMD) Scope of Practice

- Scope of practice: mouth, oral cavity, maxillary area

- Only can prescribe for these areas, related structures, or conditions affected in these areas

- Pharmacists may have to call to verify prescriptions sometimes

Podiatrists (DPM) Scope of Practice

- Scope of practice: feet, ankles, and associated structures

- Some states include hands, but NOT Indiana

- Only can prescribe for these areas, related structures, or conditions affected in these areas

- Pharmacists may have to call to verify prescriptions sometimes

Veterinarians (DVM) Scope of Practice

- Scope of practice: animals ONLY

- May prescribe animal drugs or human drugs for conditions in animals

- Indiana has specific dispensing requirements for veterinarian prescriptions (will discuss later; test 3 material)

Who are Midlevel Practitioners?

Nurse practitioners, physician assistants, optometrists, pharmacists, dietitians, etc.

Midlevel Practitioners Notes

- Very different prescribing scope of practice than the "big four"

--- Varies significantly by state

- Prescribing may be based on specialty of the practitioner they are working under

--- E.g. NP and PA in endocrinology clinic may only be allowed to prescribe for endocrinology-related conditions

- Pharmacists able to prescribe selected items in some states

--- Idaho = example of broad prescriptive authority

Agency

- Individual who does not have the authority on their own, but needs to complete a task

- Individual with authority is the principal; individual to whom authority is delegated is the agent

Example of Agency

a nurse calling in a prescription is an agent; the physician is the principal

Agency Dos and Don'ts: Agent can

- Call in prescriptions (not CII)

- Fax prescriptions

- Prepare prescriptions for prescriber signature

- Clarify prescriptions

Agency Dos and Don'ts: Agent CANNOT

- Determine if patient needs the medication

- Authorize refills (unless state law allows this task to be delegated)

Prescriber (principal) MUST do what to the agent?

specify all elements of prescription or verify the prescription if being prepared for signature