S02 Drugs and Dosage Forms II Learning Objectives

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What is the United States Pharmacopeia (USP)?

science-based public health organization.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What publication does the USP produce?

The USP-NF.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What does the Greek word "pharmakon" mean?

Drug

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What does the Greek word "poiein" mean?

Make

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What does the term pharmacopeia suggest?

Any recipe, formula, or other standards required to prepare a drug.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

Who originally edited the National Formulary (NF)?

Pharmacists

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

Which act recognized the USP/NF as the official compendia of drug standards in 1938?

The Federal Food, Drug, and Cosmetic Act (FD&C).

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

How frequently is the USP published?

Annually

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What information do the formulas, monographs, and reference books in the USP-NF describe?

Standards that manufacturers and pharmacists should maintain when preparing drug products.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What is a drug formulation or formula?

A recipe for the preparation of a drug product.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What two main components are specified under the name and quantities of ingredients in a drug formula?

Active ingredients and excipients.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What details regarding processing are included in a drug formulation?

The mixing sequence and processing steps.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What is the official compendium of drug standards in the United Kingdom?

The British Pharmacopeia (BP).

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What is the official compendium of drug standards in Europe?

The European Pharmacopeia (EP)

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What is the official compendium of drug standards in Japan?

The Japanese Pharmacopeia (JP).

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What section was added to the FD&C Act by the Food and Drug Administration Modernization Act (FDAMA) of 1997?

Section 503A [Practice of Pharmacy Compounding].

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What exemption regarding new drug applications does Section 503A grant to pharmacy compounded products?

Exemption from FDA approval under NDAs or ANDAs.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What labeling exemption does Section 503A grant to compounded drug products?

Exemption from labeling drugs with adequate directions for use.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What manufacturing exemption does Section 503A grant to compounded drug products?

Exemption from Current Good Manufacturing Practices (cGMP) requirements.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What are Current Good Manufacturing Practices (cGMP)?

General practices observed during manufacturing to ensure products meet appropriate and consistent quality standards.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

For whom must a drug product be compounded to qualify for Section 503A exemptions?

An identified individual patient based on a valid prescription order.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

Who must perform the compounding for a product to meet Section 503A exemptions?

licensed pharmacist.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

Which chapters must pharmacy compounding comply with to receive Section 503A exemptions?

The United States Pharmacopeia (USP) chapters on pharmacy compounding.

Learning Objective 1: Recognize and understand the role of official compendia in setting drug quality standards

What restriction does Section 503A place on compounding commercial drug products?

Pharmacists must not regularly or in inordinate amounts compound products that are essentially copies of commercial drugs.

Learning Objective 2: Summarize the steps involved in the drug approval process

What are the three main stages of the pharmaceutical product approval process?

Early Discovery and Pre-Clinical Development, Clinical Development, and Commercialization/post-marketing surveillance.

In what subjects is pre-clinical drug development performed?

Animals

In what subjects are clinical development studies (Phases I, II, and III) performed?

Humans

What application must be filed before testing a drug in humans for the first time?

New Drug (IND) application

What application is submitted to the FDA to market a new drug after clinical trials?

New Drug Application (NDA).

Who participates in Phase I clinical trials?

A small number of healthy volunteers (20 to 100 people).

What are the primary aims of Phase I clinical trials?

To learn how to administer the drug safely, monitor side effect profiles, and obtain initial dosing information.

Who participates in Phase II clinical trials?

Several hundred people with the target disease.

What is the primary aim of Phase II clinical trials?

To determine patients' responses to the drug through proof-of-concept studies.

What key decision is made at the end of Phase II clinical trials?

Whether a useful therapeutic response exists to warrant Phase III trials.

Who participates in Phase III clinical trials?

large number of participants (several hundreds to thousands).

Why are Phase III clinical trials conducted across multiple study sites?

To confirm drug effectiveness in large, multicenter clinical trials.

What is Phase IV of clinical development?

Post-approval studies or post-marketing surveillance

Why is Phase IV post-marketing surveillance necessary?

To detect rare adverse drug reactions (occurring in <1 in 3000 to 5000 patients) not found in earlier phases.

Where do healthcare professionals report adverse drug events to the FDA?

FAERS or the MedWatch program.

What action may the FDA take if post-marketing trends show severe adverse drug reactions?

Require additional data, mandate new clinical trials, revise drug labeling, issue warnings, or remove the product from the market.

What is the definition of a drug dose?

An amount of drug sufficient to produce a therapeutic response without toxic effects

Learning Objective 3: Differentiate between brand and generic drug products

What is a brand-name drug product?

An innovator's product protected by an exclusive patent.

What type of drug name is officially registered as a trademark by a company?

proprietary (Brand) name.

Which 1984 law allowed companies to copy innovator drugs once their patents expire?

The Hatch-Waxman Act.

What is a generic drug product?

A product chemically identical to the original branded drug marketed after patent expiration.

What type of drug name is standardized and recognized as a common name?

A non-proprietary (Generic) name.

Which two organizations establish standardized non-proprietary drug nomenclature?

The USAN Council and the World Health Organization (WHO).

Which application must be submitted to the FDA for generic drug approval instead of an NDA?

Abbreviated New Drug Application (ANDA).

What requirement must generic drugs satisfy in place of preclinical and clinical safety/efficacy studies?

A bioequivalence study showing equivalent efficacy to the brand counterpart.

What features must be identical between a generic product and its brand counterpart?

The active ingredient(s), strength, and dosage form.

What is an unbranded (ordinary) generic drug?

A generic drug made by a company other than the brand owner and approved via an ANDA.

What is an authorized generic drug?

A drug identical to the brand product in all aspects except that it does not use the brand name.

Under which application is an authorized generic drug marketed?

The original brand drug's NDA

When can an authorized generic be sold relative to patent expiration?

Before drug patent expiration.

When can unbranded and branded generics be sold relative to patent expiration?

After branded drug patent expiration.

What is a branded generic drug?

A generic drug that has been given a proprietary market name and requires an ANDA.

How does the cost of an unbranded generic typically compare to branded or authorized generics?

Unbranded generics are typically cheaper