NAMING A DRUG

WHY THE FUSS?

READING A SCRIPT

Survey says…

Plendil

Isordil

USE A PDR—PLENDIL OR ISORDIL

WHAT ARE THEY FOR?

RISKS?

On June 23, 1995, Ramon Vasquez received the preceeding prescription from his cardiologist. He began taking the medication given to him by the pharmacist on a Saturday morning. By Sunday night, the medication had affected his heart so much that he had a heart attack. He died several days later.

Another one…

Is it… Avandia Coumadin

WHY THE FUSS? USE A PDR—

Avandia or Coumadin WHAT ARE THEY FOR?

RISKS?

NAMING A DRUG

A marketed drug has three names: a chemical name, a generic name, and a brand name.

Chemical Name The chemical name is the scientific name based on

the compound's chemical structure The chemical name is almost never used when the

drug goes to market The chemical name is usually used by scientists and

other researchers only. N-acetyl-para-aminophenol

NAMING A DRUG

Generic NameThe generic name is granted by the USAN

Council (United States Adopted Names Council) and is commonly used to identify a drug during its useful clinical lifetime

Acetaminophen

NAMING A DRUG

Brand NameThe company that patents the drug creates

the brand name (trademark) This name identifies the drug during the 17

years that the company has exclusive rights to make, sell, and use it under patent law

Tylenol

NAMING A DRUG

The process for naming a marketable drug involves five steps:

1. NCE (new chemical entity) submission and patent application

2. Generic naming3. Brand naming4. FDA review5. Final approval

NAMING A DRUG- the chemical name

A pharmaceutical company submits data on a newly discovered compound to FDA for classification as a new chemical entity to gain permission for animal testing to determine any desirable and undesirable effects.

The chemical name is not pre-approved by any organization, nor is it recognized in any standard manuals, such as USP publications

Taking two years on average

NAMING A DRUG-the generic name

The USAN Council grants generic name to an entity that appears to have potential as a drug

The USAN Council Representative from the Food and Drug

Administration (FDA) Representative from the American Pharmaceutical

Association (APhA), Representative from the American Medical

Association (AMA) Representative from the USP

NAMING A DRUG-the generic name

After approval by the USAN Council, the name is sent to the World Health Organization for final approval. At this point, the company begins animal testing for efficacy and toxicity.

The generic name is usually found in the originating country's pharmacopeia, an official book or list of drugs and medicines and the standards established for their production, dispensation, and use.

NAMING A DRUG-the generic name

USAN Council has several criteria for a generic name appropriate for the drugshort, easy to pronounce, and euphonicsuitable for routine use both in the United

States and internationally. The name cannot be misleading or confusing

or imply efficacy or application to particular anatomical parts.

NAMING A DRUG-the generic name

Generic names are coined using an established stem, or group of letters, that represents a specific drug class.

USAN stems include prefixes like -coxib for arthritis medications -celecoxib, valdecoxib, and rofecoxib are generic names containing the stem. Each belongs to a class of drugs known as the COX-2 inhibitors.

NAMING A DRUG-the generic name

Names that include such stems, chemistry roots, or any other coded information are easier to remember, and give clues about what a drug is used for. These names, however, typically sound or look so much alike that they contribute to medication errors, especially if the products share common dosage forms and other similarities.

NAMING A DRUG-the brand name

The brand name, also called trademark, can be created as soon as a generic name has been established.

According to a report in the January-February 2004 issue of the Journal of the American Pharmacists Association, there are more than 9,000 generic drug names and 33,000 trademarked brand names in use in the United States

NAMING A DRUG-the brand name

To minimize confusion between drug names that look or sound alike, the FDA reviews about 400 brand names a year before they are marketed. About one-third are rejected.

Read the article: “When a Drug Maker Creats a New Pill, Uncle Sam Vets Name”, and describe how the FDA approves the final brand name.

Two Compendia of Drug Informaton and Formulation

http://www.usp.org/aboutUSP/whatsNew.html US Pharmacopia –Dosage, Monographs (Each

monograph includes information on pricing, adverse reactions, contraindications, pharmacokinetics as well as related drug monograph topics: dissolution rates.)

NF--An excipient is an inactive substance used as a carrier for the active ingredients of a medication.

Unofficial Sources of Drug Information

Merck Index:The Merck Index OnlineSM is the online version of the monographs in the printed 13th Edition of The Merck Index (a U.S. publication, Whitehouse Station, N.J., USA), an internationally recognized, one-volume encyclopedia of chemicals, drugs, and biologicals. Each monograph in the encyclopedia (each record in the database) discusses a single chemical entity or a small group of very closely-related compounds. Updates contain material not yet available in print.

PDR:The Physicians' Desk Reference (PDR) is a commercially published compilation of manufacturers' prescribing information (package insert) on prescription drugs, updated annually. While designed to provide physicains with the full legally mandated information relevant to writing prescriptions (just as its name suggests), it is widely available in libraries and bookstores, widely used by other medical specialists, and in significant part valuable to consumers.