Federal Karl + PharmLaw Flashcards by Sara Baldwin

What is the Food, Drug and Cosmetic Act of 1938?

Approval of drugs based on safety ONLY (not efficacy)

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What is the Durham-Humphrey Act of 1951?

Distinguished RX from OTC
“Rx only” must be labeled

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What is the Kefauver-Harris Amendment (Drug Efficacy Amendment) of 1961?

New Drug Application (NDA) process, proof of efficacy, informed consent in clinical trials
Requirement for manufacturers to adhere to CGMPs
FDA now has authority to inspect

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What is the Drug Quality and Security Act of 2013?

Regulations for compounding and outsourcing facilities
Drug supply chain security

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What does the FDA regulate in regards to pharmacy? (3)

Safety of the medication supply
Drug approval and surveillance
Regulation of the profession

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What are some safety measures the FDA regulates?

Adulteration (CGMP)
Misbranding (labeling, child/tamper-resistant packaging)
REMS (MedGuides, professional communication, assuring safe use)
Unapproved drugs
USP chapters
ADR reporting (MedWatch, manufacturing, outsourcing facilities)

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What are the application types for drug approvals?

NDA - New Drug Application (required clinical trials and ethics)
ANDA - Abbreviated New Drug Application (for generics)
Improved generic applications
sNDA - Supplemental New Drug Application (request to the FDA to make changes to a drug that has already been approved under an NDA)
Orphan drug applications
Drug efficacy studies

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What professional regulations are the FDA in charge of? (7)

Compounding (795, 797, 800)
Outsourcing (503b)
Poison prevention
Plan B
Resale Restrictions
REMS
Supply chain security

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The FDA is part of what branch of the government?

Executive (commissioner is appointed by the president)

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What authority does the FDA have? (5)

Issuing/withdrawing FACILITY licenses
Rule making
Issuing warning letters
Issuing guidance documents (compliance policy guides, not legally binding)
Power to inspect

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What is included in the “official compendia”? (4)

USP
Homeopathic Pharmacopoeia of the US
National Formulary
All supplements

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Define “new drug”

“Not recognized as safe or effective” (yet!)
NOT APPROVED by FDA
It is a crime to commercially distribute new drugs

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What is included in the category of “dietary supplements”?

Vitamins
Minerals
Herbals/botanicals
Amino acids

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T/F: SOME dietary supplements must be regulated by the FDA

NO: no requirement for FDA regulation of supplements
however - must adhere to good manufacturing processes (GMP)

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Define adulteration

Filthy, putrid, decomposed
Packed/stored in insanitary conditions
Is not adherent to CGMP
Inappropriate container
Unsafe color additive
Purity falls below standard

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Define misbranding

Labeling is false or misleading
Incorrect name/address of business and medication quantity on drug labels
Required info not prominently placed on labeling
Drug name, active and inactive ingredients not listed on label
Directions for use not listed
Drug not labeled as it appears in the official compendium
No label of precautions
Imitation of another drug

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What is the difference between labels and labeling?

Label - information on immediate container
Labeling - information that accompanies the produce (ie. Pi’s, MedGuides, brochures)

(Label is a component of labeling)

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What is the specific wording for direction requirements of OTCs and Rx labeling?

OTCs: must have “adequate directions for use”
Rxs: must have “adequate information for use”

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What should be included in package insert labeling?

“Adequate info for use”
Highlight brief summary and boxed warnings
Pregnancy warnings

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What legal ‘tools’ does the FDA have the ability to use?

Injunction (court order to cease and desist)
Criminal proceedings
Seize/confiscate
Warning letters
Recalls (Class 1,2,3)

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If a pharmacy plans to transfer to another location, the information submission should be at least how many days in advance?

14 days

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On the date of the transfer of a business, an inventory of WHAT must be conducted?

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Complete controlled substance inventory must be taken
- serves as the official inventory for the acquiring pharmacy

How many years are drug records/controls records?

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2 years

NOTE: NYS is 5 YEARS

What DEA form must be filled out when transferring CII stock drugs to other pharmacies?

DEA 222

What is the name of the online CII ordering form? (Alternative to DEA222)

Controlled Substance Ordering System (CSOS)

What controls can be ordered through CSOS?

C II - V (all controls)

When a pharmacy receives CIIs, what must the receiving person sign?

The invoice/receipt of the received CIIs must be signed by the receiving person

For what controls/quantity can inventory counts be *estimated*? What control inventory must be actual physical count?

Estimated counts - CIIIs - CVs on open bottles with ≤1,000 tabs EXACT counts - CIIs; CIII - CVs for open bottles with >1,000 tabs

After an initial inventory of controls, how OFTEN should a new inventory be taken?

Every *2 YEARS* a new controls inventory should be taken (Same as NYS)

Emergency Rxs for CIIs must have a follow up within HOW MANY days (federally)?

7 days federally NYS = within 72 hours

What DEA form is used to report significant theft?

DEA 106

Who is allowed to be an authorized collector and what do they do?

Receive controlled substances for **destruction** Usually third-party, DEA-approved collectors Retail pharmacies and hospitals where on-site pharmacies may modify their registrations and become “authorized collectors”

T/F: Central fill pharmacies are only allowed to fill refills, NOT initial prescriptions

False: central fill pharmacies CAN fill initial fills so long as a contract is in place with a common owner between the retail pharmacies and the central pharmacies.

Do both retail and central fill pharmacies need to keep records for all patients?

Yes

Are automated dispensing systems property of the LTC or of the contracted retail pharmacy?

Property of the pharmacy: all drugs in dispensed in the cabinet are part of pharmacy stock

A registered pharmacy may distribute controls (without registering as a distributor) to another pharmacy as long as the total doses distributed does not exceed ____ of the of the total dispensed drugs in the pharmacy.

≤ 5% of all dispensed drugs

Pharmacies may mail controls via USPS IF: (3)

1. Inner packaging containing controls is marked and sealed per the Control Substance Act and placed in a plain outer container 2. Inner packaging must also have the name/address of the pharmacy/prescriber dispensing 3. Outside wrapper must be free of markings indicating its contents

What is the “Combat Methamphetamine Epidemic Act”?

Requires drugs like pseudoephedrine to be *locked* behind the counter, check the ID of the purchaser, maintain a record logbook and LIMIT QUANTITIES (3.6g per single day, 9g per month)

Who gets penalized for filling fraudulent controls Rxs?

The pharmacist

What are controls RED FLAGS?

- Rx looks “too good”, handwriting too neat/legible - Quantities/directions/dosages differ from medical indication - Rx does not comply with acceptable abbreviations - Photocopied Rx - Directions written wo abbreviations - Various handwriting/colored ink - Filling multiple Rxs of strongest formulation - Frequent early refill requests - Doctor from extremely far away - Most controls filled by a single prescriber - Patients traveling in groups - Paying mostly in cash - PMP suggests “doctor shopping”

REMS is focused on ____, _____, and ______ serious health risks through education and reinforced actions

REMS is focused on **preventing, monitoring, and managing** serious health risks through education and reinforced actions

What is VAERS?

A publicly-available national vaccine safety surveillance program that helps detect unusual/unexpected ADRs Healthcare workers and patients may both report

What are the FDA’s 4 approaches to making certain drugs available as quickly as possible?

1. **Fast track** - expedited review for drugs treating serious, medically-unmet conditions 2. **Breakthrough therapy** - expedited development for drugs with substantial improvement over available therapy 3. **Accelerated approval** - for drugs w long-term endpoints difficult to measure via RCTs (mortality, survival) 4. **Priority review** - FDA’ aims to review the application within *6 months*

A patient wants to refill a prescription but was not satisfied with the pharmacy that filled and dispensed the prescription the first time. The patient demands the prescription be returned so they can take it to a different pharmacy to obtain refills. The pharmacist should:

Offer to give a **copy** of the prescription to the *patient*, keep the **original** copy at the *pharmacy*, and recommend the patient request the prescription be *transferred to another pharmacy* if legal

What do the 3 sets of numbers bears in an NDC represent? (12345-1234-12)

First set (4-5 digits): Manufacturer Second set (4 digits): Identity of drug Third set (2 digits): product package size

Per iPLEDGE, how many refills are allowed per script?

ZERO! No refills, only 30 days at a time per script

Female patients who can get pregnant using isotretinoin must use what kind of contraception?

2 separate methods of birth control x **1 month BEFORE/during/1 month AFTER** isotretinoin

Female patients who can get pregnant must take a pregnancy test every ________

Pregnancy test every **month**

Can controlled substances be mailed to patients?

YES, so long as the inner package is labeled with the Rx and appropriate information and a PLAIN outer container

What types of patients are included in a Phase I clinical trial for drug development? What characteristic of the drug does it look at?

Small group of healthy participants without the disease condition Looks at **safety**

What types of patients are included in a Phase II clinical trial for drug development? What characteristic of the drug does it look at?

Larger group of 100 or more with the disease Looks at **efficacy**

What types of patients are included in a Phase III clinical trial for drug development? What characteristic of the drug does it look at?

Larger group of hundreds or thousands with the disease Looks at drug **safety, efficacy,** & **dosing** *Passing Phase III = may be approved by the FDA!*

What is Phase IV of a drug clinical trial?

Conducted AFTER drug is approved Looks at the *safety and efficacy* of the drug **LONG-TERM** AKA post-marketing surveillance

According to the FDA, a drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many people in the U.S.?

Orphan drug = **≤ 200,000** people affected

The scheduling of controlled substances at the federal level is performed by the:

U.S. Attorney General

Federal Karl + PharmLaw Flashcards

(56 cards)