Thomas Reinders, Pharm.D. Emeritus Professor VCU School of

Thomas Reinders, Pharm.D.

Emeritus Professor

VCU School of Pharmacy

Disclosure

Thomas Reinders declares no conflicts of

interest, real or apparent, and no financial

interests in any company, product, or service

mentioned in this presentation, including

grants, employment, gifts, stock holdings

and honoraria.

Objectives

▪ Identify the official organizations

responsible for naming U.S.

drugs and dosage forms.

▪ List common rules and

limitations for assigning names

to drugs and dosage forms.

▪ Describe how to decipher drug

action based on generic drug

names.

Objectives

▪ List resources for information

about drug and dosage form

names.

▪ Identify recommendations for

minimizing and reporting

medication errors associated

with drug names and dosage

form nomenclature.

Self-assessment

Which of the following organizations

have legal authority in naming drugs

and/or dosage forms?

a. United States Pharmacopeia

b. Drug Safety Institute

c. Food and Drug Administration

d. a and c

e. All of the above

Self-assessment

Match the following drug names with the

appropriate pharmacological action based

on a USAN stem.

__ 1. Gloximonam a. Angiotensin II receptor antagonist

__2. Losartan b. Antihyperglycemic

__3. Oteracil c. Monobactam antibiotic

__4. Gliflumide d. Uracil type antineoplastic

Self-assessmentPharmacists can minimize medication

errors associated with drug names by

which of the following?

a. Being aware of look-alike, sound-alike

names

b. Reporting medication errors to the FDA

c. Being aware of enhanced lettering for

drug names

d. a and b

e. All of the above

What’s in a Name?

“That which we call a rose

but any other name would

smell as sweet.”

William Shakespeare’s

Romeo and Juliet

Drug Naming Perception

https://www.youtube.com/watch?v=DS-w2dzGsOk

https://www.youtube.com/watch?v=DS-w2dzGsOk

Drug Naming Process

Long and Arduous Path

Organizations Responsible

for Drug Nomenclature

• United States Adopted Names CouncilUSAN

• United States PharmacopeiaUSP• United States Food and Drug

AdministrationFDA• International Nonproprietary Names

Programme (World Health Organization)INN

Standards Setting Harmonization

United States Adopted Names

(USAN)

International Nonproprietary

Name (INN)

Unites States Pharmacopeia (USP) & Other

Pharmacopeias

Drug & Dosage Form NamesType Responsibility

Nonproprietary (Generic)

Note: A generic name is the nonproprietary

name used for an identical FDA approved

proprietary product

USAN / INN

Proprietary (Trade/Brand) FDA

Chemical IUPAC / CAS

NPC Code FDA

UNII Code FDA / USP

Pronunciation USP / USAN

Dosage Forms USP

• Created in 1964, succeeding

the AMA-USP Nomenclature

Committee

• Co-sponsored by the

American Medical

Association, United States

Pharmacopeia & American

Pharmacists Association

• Major role in naming drugs,

especially during their

development

United States Adopted Names Council

USAN

P

U

R

P

O

S

E

To serve the health professions in the U.S. by selecting simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.

Name is requested by sponsor when a drug enters the clinical investigation stage.

Name is chosen with the expectation that it will be suitable for prescription and dispensing purposes and for the designation as the title of a monograph should the article be recognized by the USP

USAN

What is Named Example

Small molecule drugs Pitolisant (Treatment of narcolepsy)

(Not yet marketed in USA)

Biotechnology drugs Durvalumab

(Imfinzi, AstraZeneca)

Gene therapies Voretigene neparvovec

(Luxturna, Spark Therapeutics)

Contact lens materials Samfilcon B

(Ultra, Bausch+Lomb)

Cell Therapies Tisagenlecleucel

(Kymriah, Novartis)

Sunscreen active ingredients Bemotrizinol

(Excalol S, Ashland)

Veterinary products Tulathromycin

(Draxxin, Pfizer)

Selected mixtures & extracts Cannabidiol

(Epidiolex, GW Pharmaceuticals)

Guidelines for Coining

USAN Names

https://www.ama-assn.org/about/apply-usan

General (e.g.)

• The name for the active moiety of a drug should be a single word, preferably of no more than 4 syllables.

• A common, simple word element (a "stem") should be incorporated in names of all members of a group of related drugs when pertinent, common characteristics can be identified (e.g., similarity of pharmacological action).

Specific

(e.g.)

• Cellular & Noncellular Therapies

• Monoclonal Antibodies

Coining a USAN Name -

21 Available Letters

A B C D E F G

H I J K L M N

O P Q R S T U

V W X Y Z

USAN Stems (~ 300)Stem Definition Example

-dipine Phenylpryidine vasodilators (nifedipine type) Felodipine

-erg Ergot alkaloid derivatives Pergolide

-nermin Growth factors - tumor necrosis Sonermin

-gli Antihyperglycemics Gliflumide

-imex Immunostimulants Forfenimex

-monam Monobactam antibiotics Gloximonam

-olol Beta-blockers (propranolol type) Atenolol

-racil Uracil type antineoplastics Oteracil

-sartan Angiotensin II receptor antagonists Losartan

-sporin Immunosuppressants (cyclosporine type) Geclesporin

-tibant Antiasthmatics (bradykinin antagonists) Icatibant

-xaban Anticoagulant (Factor Xa inhibitor) Tamixaban

https://druginfo.nlm.nih.gov/drugportal

USAN Stems (~ 300)Stem Definition Example

-dipine Phenylpryidine vasodilators (nifedipine type) Felodipine

-erg Ergot alkaloid derivatives Pergolide

-nermin Growth factors - tumor necrosis Sonermin

-gli Antihyperglycemics Gliflumide

-imex Immunostimulants Forfenimex

-monam Monobactam antibiotics Gloximonam

-olol Beta-blockers (propranolol type) Atenolol

-racil Uracil type antineoplastics Oteracil

-sartan Angiotensin II receptor antagonists Losartan

-sporin Immunosuppressants (cyclosporine type) Geclesporin

-tibant Antiasthmatics (bradykinin antagonists) Icatibant

-xaban Anticoagulant (Factor Xa inhibitor) Tamixaban

https://druginfo.nlm.nih.gov/drugportal

Stems – Recent Approvals

Coining a USAN Name

Prefix Infix Stem Name

Bevaci zumab Bevacizumab

Coining a USAN Name

Name Infix Stem Stem

Subgroup

Meaning

Levofloxacin

(Levaquin)

-oxacin Antibiotics that are chemical

derivatives of quinolone

Atorvastatin

calcium

(Lipitor)

-stat Enzyme inhibitors

Rosuvastatin

(Crestor)

-stat -stat

-vastatin

Enzyme inhibitor

Inhibitors of HMG-CoA

Bevacizumab

(Avastin)

-ci-

-mab

-zumab

Monoclonal antibodies

Humanized

For circulatory targets

USAN Naming Process

Application filed ($15,000 fee)

Initial review by staff

USAN Committee balloting

Firm reviews USAN

Committee decision

International review by INN

USAN and firm review the INN

decision

Statement of adoption

Publication of name

USAN Council Considerations

Conflict with other drug names

Inappropriate prefix (e.g., reference to company name,

anatomy, implication of benefit)

Appropriate stem

Use of restricted letters (H, J, K. W, Y)

Pronunciation difficulty

▪ F2F meetings are held in January and July

▪ Electronic balloting occurs throughout the year

▪ Approximately 150 names approved annually

▪ Five Voting Members

USAN Balloting Process

Drug Name PronunciationUSAN Council

Pronunciation Guide

General Principles

▪ Retain and build on established precedents.

▪ Keep the USAN stem intact if phonetically

reasonable.

▪ Put the primary accent on the USAN stem, if

reasonable.

▪ Insert a secondary accent to differentiate

among the names with the same USAN stem.

▪ Be consistent with first syllables.

▪ Refer to common dictionaries for common

first syllable usage and consider the influence

of the pronunciations of popular trade names.

Drug Name Pronunciation

Nonproprietary

Name

Pronunciation

Erenumab E ren’ ue mab

Vancomycin

Hydrochloride

Van” koe mye’ sin

Hye” droe klor’ ide

Plazomicin Pla” zoe mye’ sin

Lofexidine

Hydrochloride

Loe fex’ o deen

Hye” droe klor’ ide

Cannabidiol Kan” a bi dye’ol

Epoetin alfa E poe’ e tin al’fa

USP Dictionary

▪ USAN staff propose pronunciation

▪ USP Pronunciation Expert Panel

reporting to the USP Expert Committee

on Nomenclature and Labeling

▪ Balloting process

▪ Consensus and approval

▪ Publication in USAN Dictionary

USP Dictionary

United States Pharmacopeia

▪ Non-profit scientific organization

▪ Founded in 1820

▪ Develops public compendial

quality standards for medicines

and other articles

▪ Food, Drug, and Cosmetic ActIf USP has an applicable monograph,

drug will be deemed misbranded

unless its label bears the “official title”

recognized in the USP-NF.

FDCA 502(e)(3)

▪ Code of Federal Regulations FDCA & PHS Act drugs recognized in

USP are deemed adulterated if they

fail to meet USP standards for identity,

strength, quality or purity.

FDCA 501(b); 21 CFR 299.5

USP Nomenclature and Federal Law

USP Nomenclature and Labeling

Expert Committee Members

USP Official

Members

USP Staff FDA

Liaisons

Total

Pharmacist 6 1 4 11

Nurse 1 1 2

Veterinarian 1 1 2

Physician 1 1

Scientist 4 1 5

Industry 4 4

Total 17 3 5 25

USP Nomenclature Rules

General Chapter <1121>

Nomenclature

General Chapter <1151>

Pharmaceutical Dosage Forms

Nomenclature Guidelines

www.usp.org

USP

What is Named Example

Drug Products (USP

Monograph)Finafloxacin Otic Suspension

Drug Substances

(via USAN)Finafloxacin

Compounded

Preparations

Folic Acid Compounded Oral

Solution

Dietary

SupplementsTangerine Peel Dry Extract

Excipients Amino Methyl Propanol

Biologics Epoetin

Type Amount Named

Drug Products 425

Drug Substances 139

Compounded

Preparations42

Dietary Supplements 62

Excipients 19

Biologics 7

Total 694

Nomenclature ApprovalsDuring 2010-2015 Cycle

USP Monograph Title Format

Route of Administration

Injection

Topical

Inhalation

Dosage Form

Capsule

Cream

Emulsion

Foam

Powder

Release Pattern

Extended

Delayed

[DRUG] [ROUTE OF ADMINISTRATION] [DOSAGE FORM]

Foams

(propellant

vs. manual

plunger)

38

Delayed

Release Orally

Disintegrating

Tablet

Naming Novel Dosage Forms

Naming Novel Dosage Forms

▪ The strength of the product or preparation is

expressed in terms of the active moiety except

when clinically significant (Official May 1, 2013)

▪ Policy should be implemented early in drug

development to avoid strength mismatch

Monograph Naming Policy Example

BEFORE AFTER

• U.S. drugs are regulated

by the FDA pursuant to

the Federal Food, Drug

and Cosmetic Act

• Reviews and approves

proprietary names

• Guidance document for

the industry in submitting

names for evaluation

U.S. Food & Drug Administration

Assessment of Proposed Trade Names

Prescreen IND, NDA, ANDA and BLA applications (e.g., similarity in pronunciation or spelling to other names, absence of USAN stem)

Consider Misleading Nature or Error Potential (e.g., inclusion of dosage form, use of sponsor name, other promotional implications)

Misbranding Review (e.g., suggestion that a drug is safer or more effective or some unique composition when it isn’t supported by evidence)

Look-alike Sound-alike Safety Review (POCA)

POCA Analysis

▪ Phonetic and Orthographic

Computer Analysis (POCA)

initiated by FDA in 2009

▪ Scoring system for look-alike

and sound-alike names

▪ Similarity scores

▪ ≥ 70 % High

▪ ≥ 50% to ≤ 69% Moderate

▪ ≤ 49% LowFederal Register / Vol. 74, No. 30

Branding Consultants

Recently Approved Trade Names

Proprietary Name Trade Name Sponsor

Erenumab-aooe Aimovig™ Amgen

Vancomycin

Hydrochloride for

Oral Solution

Firvanq™ CutisPharma

Plazomicin Aemdri™ Achaogen

Lofexidine Lucemyra™ US WorldMeds

Cannabidiol Epidiolex™ Greenwich Biosciences

Epoetin alfa-epbx Retacrit™ Hospira

▪ INN established in 1953

to name pharmaceutical

substances or active

pharmaceutical ingredients

▪ Drug name is generally

recognized globally but

has no role in U.S. federal

law

▪ Works collaboratively with

USAN

International Nonproprietary

Names Programme (INN)

▪ Distinctive in sound and spelling

▪ Not inconveniently long

▪ Name for a substance belonging to a

group of pharmacologically related

substances should, where appropriate,

show this relationship

▪ Not liable to cause confusion with other

names in common use

▪ Worldwide acceptability

General Principles for Coining Names

Items Not Considered by INN

Mixtures

Herbal substances

Long history of medical use (e.g., morphine)

Trivial chemical names (e.g., acetic acid)

INN Naming Process

I• Application Filed ($12,000 fee)

II• INN Experts Consultation

III• Implementation of Meeting Decisions

IV • Proposed INN List (pINN) Published

V• Recommended INN List (rINN) Published

USAN / INN Negotiation Process

Nomenclature Challenges

21/26 available letters for coining names

Names assigned to chemical entities that

are not always marketed

Harmonization issues nationally and

globally (i.e., names, dosage forms, error

reporting)

Industry’s marketing strategies

Nomenclature Challenges

Naming Biosimilars

Working Toward Alignment

INN

USPUSANFDA

Pharmacist Recommendations

FDA

Industry

Health Professional

Consumer

ISMP

Report

Medication

Errors


FDAISMP

Report

Medication

Errors

https://www.ismp.org/report-medication-error

https://www.fda.gov/Safety/MedWatch/default.htm


Examples of Actions from Reported

Medication Errors

•Amrinone (INN) changed to Inamrinone by

USAN to avoid confusion with Amiodarone

•Brintellix (Vortioxetine) changed to Trinetellix

by FDA to avoid confusion with Brilinta

(Vicagrelor)

•Kapidex (Dexlansoprazole) changed to

Dexilant by FDA to avoid confusion with

Casodex (Bicalutamide) and Kadian (Morphine)


Be Aware of Enhanced

“Tall Man” Lettering for

Selected Drugs


Be Aware of Look-alike Sound-alike Names(e.g., FDA’s list of drug names with enhanced lettering)

https://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm164587.htm

Drug Name with

Enhanced Lettering

Confused with

buPROPion BusPIRone

chlorproMAZINE chlorproPAMide

cycloSERINE cycloSPORINE

DAUNOrubicin DOXOrubicin

DOBUTamine DOPamine

glipiZIDE glyBURIDE

vinCRIStine vinBLAStine


Multiple infixes with -mab

More than 500 -mab drugs

Risk of error potential


Read

the

Label

USAN, USP & INN follow rules and guidelines in naming drugs and dosage forms

USAN stems are useful in determining the pharmacological action of a drug

USP Dictionary is a useful tool for pronouncing drug names

Health professionals need to be aware of look-alike and sound-alike drug names

Medication error reports due to confusing drug nomenclature can have an impact

Self-assessment


have legal authority in naming drugs

and/or dosage forms?




d. a and c

e. All of the above

Self-assessment


have legal authority in naming

generic (nonproprietary) drugs?




d. a and c

e. All of the above

Self-assessment

Match the following USAN names with the

appropriate pharmacological action based

on a USAN stem.

__ 1. Gloximonam a. Angiotensin II receptor antagonist

__2. Losartan b. Antihyperglycemic

__3. Oteracil c. Monobactam antibiotic

__4. Gliflumide d. Uracil type antineoplastic

Self-assessment

Match the following drug names with the

appropriate pharmacological action.

c 1. Gloximonam a. Angiotensin II receptor antagonist

a 2. Losartan b. Antihyperglycemic

d 3. Oteracil c. Monobactam antibiotic

b 4. Gliflumide d. Uracil type antineoplastic





names



drug names

d. a and b

e. All of the above





names



drug names

d. a and b

e. All of the above

Questions / Comments

Documents

Thomas Reinders, Pharm.D. Emeritus Professor VCU School of