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Understanding Drug and Dosage

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Understanding Drug and Dosage 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-assessment Pharmacists 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 Drug Naming Process Long and Arduous Path Organizations Responsible for Drug Nomenclature USAN • United States Adopted Names Council USP • United States Pharmacopeia • United States Food and Drug FDA Administration • International Nonproprietary Names INN Programme (World Health Organization) Standards Setting Harmonization United States Adopted Names (USAN) International Unites States Nonproprietary Pharmacopeia Name (INN) (USP) & Other Pharmacopeias Drug & Dosage Form Names Type Responsibility Nonproprietary (Generic) USAN / INN Note: A generic name is the nonproprietary name used for an identical FDA approved proprietary product Proprietary (Trade/Brand) FDA Chemical IUPAC / CAS NPC Code FDA UNII Code FDA / USP Pronunciation USP / USAN Dosage Forms USP United States Adopted Names Council • 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 USAN To serve the health professions in the U.S. by P selecting simple, informative and unique nonproprietary names for drugs by establishing U logical nomenclature classifications based on pharmacological and/or chemical relationships. R Name is requested by sponsor when a drug P enters the clinical investigation stage. O Name is chosen with the expectation that it will S be suitable for prescription and dispensing purposes and for the designation as the title of E 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 • The name for the active moiety of a drug should be a single word, preferably of no more than 4 syllables. General • A common, simple word element (a "stem") should (e.g.) 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 • Cellular & Noncellular Therapies (e.g.) • Monoclonal Antibodies https://www.ama-assn.org/about/apply-usan 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 Beva ci zumab Bevacizumab Coining a USAN Name Name Infix Stem Stem Meaning Subgroup Levofloxacin -oxacin Antibiotics that are chemical (Levaquin) derivatives of quinolone Atorvastatin -stat Enzyme inhibitors calcium (Lipitor) Rosuvastatin -stat -stat Enzyme inhibitor (Crestor) -vastatin Inhibitors of HMG-CoA Bevacizumab -mab Monoclonal antibodies (Avastin) -zumab Humanized -ci- For circulatory targets USAN Naming Process USAN and firm Application filed Statement of review the INN ($15,000 fee) adoption decision Initial review International Publication of by staff review by INN name Firm reviews USAN USAN Committee Committee balloting decision 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 USAN Balloting Process ▪ F2F meetings are held in January and July ▪ Electronic balloting occurs throughout the year ▪ Approximately 150 names approved annually ▪ Five Voting Members Drug Name Pronunciation USAN 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 Pronunciation Name Erenumab E ren’ ue mab Vancomycin Van” koe mye’ sin Hydrochloride Hye” droe klor’ ide Plazomicin Pla” zoe mye’ sin Lofexidine Loe fex’ o deen Hydrochloride 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 USP Nomenclature and Federal Law ▪ Food, Drug, and Cosmetic Act If 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 Labeling Expert Committee Members USP Official USP Staff FDA Total Members Liaisons 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 Finafloxacin Otic Suspension Monograph) Drug Substances Finafloxacin (via USAN) Compounded Folic Acid Compounded Oral Preparations Solution Dietary Tangerine Peel Dry Extract Supplements Excipients Amino Methyl Propanol Biologics Epoetin Nomenclature Approvals During 2010-2015 Cycle Type Amount Named Drug Products 425 Drug Substances 139 Compounded 42 Preparations Dietary Supplements 62 Excipients 19 Biologics 7 Total 694 USP Monograph Title Format [DRUG] [ROUTE OF ADMINISTRATION] [DOSAGE FORM] Route of Administration Dosage Form Injection Release Pattern Topical Capsule Inhalation Cream Extended Emulsion Delayed Foam Powder Naming Novel Dosage Forms Foams (propellant
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