1 9m
`
`EDITION
`
`Remington:
`Practice of
`
`ALFONSO R GENNARO
`
`Chairman of the Editorial‘ Board
`and Editor
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`The Science and
`Pharmacy
`
`1995
`
`MACK PUBLISHING COMPANY
`
`Easton, Pennsylvania 18042
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`318
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`Entered according to Act of Congress, -in the year 1885 by Joseph P Remington,
`in the Ofl-‘lee of the Librarian of Congress, at Washington DC
`
`Copyright 1889, 1894, 1905, 1907,19! 7, by Joseph P Remington
`
`Copyright 1926, 1936, by the Joseph P Remington Estate
`
`Copyright 1948, 1951 , by The Philadelphia College of Pharmacy and Science
`
`Copyright 1956, 1960, 1965, 1970, 1975, 1980, 1985, 1990, 1995, by The Philadelphia College of
`Pharmacy and Science
`
`All Rights Reserved
`
`Libraly of Congress Catalog Card No. 60-53334
`
`ISBN 0-912 734-04-3
`
`The use ofstntctatralformulasfrom US/LN and the U.S'PDtctiona'ry ofDrug Names is by
`permission ofT7te USP Convention. The Convemion is not responsibtefor any inaccuracy
`crrntained herein.
`
`No'r1cE—Thz'.s text is not intended to "represent, no?" shall it be interpreted to be, the equivabent
`ofor a substttutefor the qfiicial United States Phaxmuzcagneta (USP) cmdf or the National
`Fomnutary (NF). In the event ofany d1j*'e7'e?1ce or discrepancy between the current oflictat
`USP o'rNFsta.nctara!s ofstrength, quality, purity, packaging and Labelingfoo" drugs and
`1‘ep’resentctt'.i0??S ofthem herein, the context and effect ofthe ofitctat compendtct shall. prevail.
`
`Printed in the Umited States (JfAT1’t£??"iCCt by the Mack Printing Company, Ectston, Pennsylvania
`
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`
`Physical Identified-tion of Capsules and Tabtets
`
`Identidar (Micromedex, Denver, CO) is a system for the identification
`oftablets and capsules. The system is indexed alphabetically and numeri-
`cally by imprint code. Color, description, ingredients and manufacturer
`are provided. The system is updated quarterly and available on micro-
`fiche and CD-ROM.
`
`Other sources useful in physical identification include the
`Red Book, the Blue Book (see Trade Information), and the
`PDR Dmg Identmcation (law (Medical Economics, Oradell
`NJ) which publishes separately the identification information
`from the Physicians ’ Desk Reference (see following section).
`
`Therapeutic and Dosage Information
`
`AHF'.S'Dr-u,g Iizforrnatiorz (McEvoy GK, ed, ASHP, Bethesda, MD) is an
`annual in continuous publication since 1959. Sections are numbered and
`arrangement is by therapeutic category. All monographs follow a stan-
`dard format. Through the index, information on a particular drug can be
`located by trade name, generic name, synonym, acronym or former names.
`At the end of each monograph is a. list of available products with dosage
`form and strength. Updated with quarterly supplements.
`Drag Evalaat-ions Subscription, (AMA, Chicago) has a goal of provid-
`ing health-care professionals with information on the clinical use of dnrgs.
`it is a three-volume product with a separately bound table of contents and
`extensive index and quarterly updates. The organization of the chapters
`is by therapeutic classification. Each chapter includes introductory ma-
`terial followed by individual drug evaluations. Nonapproved usage is
`noted. References to the scientific literature are included at the end of
`each chapter. The index includes generic and trade names, therapeutic
`indications and adverse reactions.
`DrugFacts and Compmismis (Olin BR, ed, Facts and Comparisons, St
`Louis, MO) is a monthly updated loose-leaf service which is organized by
`therapeutic use.
`It claims to be the most complete and up-to-date drug
`compendium and includes both prescription and nonprescription drugs.
`Although monographs are brief and unreferenced, the drug-product com-
`parison tables which follow each monograph are very helpful. A unique
`feature is the relative cost index which provides ratios of wholesale costs
`of comparable though not necessarily equivalent products. The index is
`replaced quarterly and is supplemented monthly. A section called “Keep-
`ing Up" provides brief reports on recent developments and “Temporary
`Listings” provides brief information on new product changes before they
`are incorporated into the main pages.
`Dr-ugdea: (Micromedex, Denver, CO) is a system providing evaluated
`drug information for health-care professionals. Extensive monographs,
`called Drug Evaluations, summarize, in a standardized format, data on
`dosage, pharmacolcinetics, contraindications, clinical applications, etc.
`Monographs are referenced well and updated as new information becomes
`available. Drug Consults are shorter reports, oriented toward answering
`a specific question (eg a nonapproved use of a drug). The index provides
`access by generic name, brand name and disease state. Available in
`microfiche or on CD-ROM, the system is updated quarterly.
`The D-List (Facts and Comparisons, St Louis, MO) is an annual compila-
`tion of products which have been withdrawn from the market during that
`year. Products are listed alphabetically by trade name or by generic
`name when all brands of a particular drug have been withdrawn. Only
`those dosage strengths or forms which have been withdrawn are included.
`The Handbook on Injectabfle Drugs, 7th ed, (Trissel LA, ASHP, Wash-
`ington DC, i992) is organized as a collection of monographs on commer-
`cially available parenteral drugs which include concentration, stability,
`dosage and compatibility information. Monographs cite the primary lit-
`erature and the references are collected at the end of the volume.
`Separate sections cover investigational drugs and intravenous infusion
`solutions. The index includes generic, trade and investigational names.
`The Ifcmdboolc ofNongme.sr.'r‘iption Drugs, 9th ed, (APhA, Washington
`DC, 1990) is much more than the title implies. The most comprehensive
`source available for OTC products, it serves both as a textbook for the
`pharmacy student and as an information source for the practicing
`pharmacist. Chapter arrangement is by product category (eg, foot-care
`products and contact-lens products) and each chapter includes a descrip-
`tion of the conditions for product use. Chapters end with tables listing
`the various products, their manufacturers, active ingredients and inactive
`ingredients. This is a particularly useful source for patient education.
`The main drawback is its infrequency of revision.
`The Physicians’ Desk Reference, (Medical Economics, Montvale NJ),
`commonly referred to as the PDR, is certainly the bestknown Source for
`druginformation. An annual publication whose purpose is to make essen-
`tial information on major pharmaceutical and diagnostic products avail-
`able, lt is intended mainly for practicing physicians. The information
`included is provided by the manufacturers and the information is arranged
`alphabetically by manufacturer. Color-coded indexes provide access by
`
`onus INFORMATION
`
`47
`
`manufacturer, product name, product category and generic and chemical
`name. The product-identification section shows capsules and tablets in
`color and actual size.
`The Physicians ’ DesIcReferenceforNonprescription Drugs, (Medical
`Economics, Montvale NJ‘) provides the same information in the same
`format for OTC products.
`Physicians’ Gen.R.27: The Ofiicial. Drug Reference ofFDA Prescrib-
`ing Information and Therapeutic Equivalents (Data Phannaceutica
`Inc, Smithtown, NY), an annual publication which began in 1991, came
`about as a result of the 1984 Drug Price Competition and Patent Term
`Restoration Act, which requires that the FDA make available to the public a
`list of approved drug products with therapeutic equivalents. The Product
`Information section is organized by generic name and provides complete
`information for making prescribing decisions. Where available, official
`FDA monographs are included. A keyword index provides access by any
`name or therapeufic category.
`The USP DI, (The USP Convention, Rockville, MD, 1992) was devel-
`oped to meet the need for a comprehensive source of clinically relevant
`information on drugs in current use. Monographs are developed using
`parameters established by the USP Drug Information Division Executive
`Committee. All monographs are subject to extensive review prior to
`publication. Volume I is Drug Informationfor the Health Care Profes-
`sional, Volume ll is Advice for the Patient, Drug Information in Lay
`Language.
`In both, arrangement is alphabetical by assigned name or
`family group. Monographs in Volume II, which correspond to those i.r1
`Volume I, are designed to be photocopied and provided to patients.
`Volume II also is published and marketed to consumers by Consumer
`Reports under the title United States Phar-macopeia D'r'u.g Information
`for the Consumer. Volume III is Approved Drug Products and Legal
`Requiremrmts. This incorporates the entire contents ofApproved Drug
`Products with ’l"herapenticEquiva.tenceEvalu.ations (US Dept ofHealth
`and Human Services, FDA, Center for Drug Evaluation and Research,
`Bethesda, MD), USP legal requirements for labeling, etc, and portions of
`the federal Controlled Substances Act and other federal acts. A special
`supplement provides portions of a selected state's pharmacy-practice
`acts. Bimonthly additions are published in the USPDI Update.
`
`Trade Information
`
`TheA'rrie'n'can D'r1.eggistBlireBooIc (Edelstein, E, ed, Hearst, New York)
`a.ndDrug TopicsRedBooIc (Cardinale, VA, ed, Medical Economics, Oradell,
`NJ) are both annual price lists of drug products providing manufacturer,
`package size, strength and wholesale and retail prices. Both also provide
`a manufacturer directory, manufacturer catalog and full~color product-
`identification guide. Each has some additional features:
`controlled sub-
`stances manual and inventory sheets iii the Blue Book; orgariization index
`(including state association information), OTC product interactions guide
`and home health-care products listing in the Red Book.
`
`Other US Sources
`
`There are a number of other sources which will prove useful
`in answering or researching certain specific questions.
`Billups NF, Billups SM, eds: American Drug Index, 32nd ed, Lippin-
`cott, Philadelphia, 1988.
`Drake E, Drake R: Saunders Pharniaceutical Word Book, Saunders,
`Philadelphia, 1992.
`Handbook of Pharvnaceatical Esrciprlents; APIIA, Washington DC,
`1986.
`King RE, ed‘. Di.spe'risi-rig ofMedication, 9th ed, Mack Publ, Easton
`PA, 1984.
`NatiomtlDr'u.g Code Directory, 2 vols and suppl, DHHS, USPHS, FDA,
`Washington DC, 1985.
`Rakel RE, ed: Conn 's Current Therapy, Saunders, Philadelphia,
`1984-.
`Report of the Cmnmittee on Infectious Diseases, 21st ed, Am Acad
`Pediatrics, Elk Grove Village IL, 1988.
`Shinn AF, ed: Evaluations of Drug Interactions, Macmillan, New
`York, 1988/'89.
`Turco S, King RE: Sterile Dosage Forms: Their Preparation and
`C'li'riicaLApplication, 3rd ed, Lea& Febiger, Philadelphia PA, 1987.
`
`Non-US Drug Data
`
`The increase in world travel has led to a greater number of
`foreign prescriptions being presented to US pharmacists.
`Any pharmacy or drug information center is likely to receive
`questions necessitating the identification of foreign drugs
`and] or their components and possible US equivalents. The
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`48
`
`CHAPTER 7
`
`following reference sources are of help in identifying foreign
`drug products.
`
`Drugs Avaitcrbie Ahmad (Schlesser, JL, ed, Gale Research, Detroit,
`199 l) is a guide to identification of drugs approved and in use abroad but
`not generally available in the US. The first edition covers 1000 drugs,
`mainly from developed regions ofthe world. Notably excluded are South
`America, Asia and most ofAfrica. Arrangement is alphabetical by generic
`name with indexes by drug action, clinical indication, manufacturer, coun-
`try and drug name (including trade names).
`Euro;oea'riDrug Index (Muller, NF, ed, Eur Soc Clin Pharm, Noordwijk,
`Netherlands, 1990) is a joint venture between the European Society of
`Clinical Pharmacy and Amsterdam Medical Press to answer the needs of
`clinicians responding to the increasing mobility of their European clients.
`Entries are in alphabetical order by trade name and provide composition,
`strength, dosage form, ATC (Anatomical Therapeutic Chemical) classifica-
`tion (an indicator of therapeutic indication) and a code for the country of
`origin.
`Martindale: The Extra Pharmacopoeia, 29th ed, (Reynolds, JEF,
`ed, Pharmaceutical Press, London, 1 989) long has been considered among
`the best sources for information on drugs in clinical use worldwide. The
`latest edition contains monographs on almost 4000 drugs arranged in
`chapters according to similar action or usage. Monographs, aimed at the
`practicing pharmacist and medical practitioner, include a summary of the
`properties, actions and uses of drugs. Proprietary names and country
`of origin also are noted. Martzindcrle Onttrre can be accessed through
`Datastar and on CD-ROM as part of Mtcromsdex CCIS (see CD-ROM/
`Online Database Searching, page 49).
`Orgamlc-Ckerntcol Drugs and ‘Their Synonyms (Negwer M, ed, VCI-I
`Publ, New York, 1987), commonly referred to as “Negwer", is now i.n its
`6th edition. Although originating in Germany, it is international in scope
`identifying over 9000 drugs with more than 80,000 synonyms. The 6th
`edition is the first in English, further emphasizing its international
`importance. Arrangement is by incremental molecular formula and en-
`tries include CAS registry numbers, synonyms, structures and usage.
`Unlisted Drugs (Pharmaco Med Document, Chatham NJ) published
`monthly is a journal which identifies and describes new drugs. From
`searching the current worldwide scientific literature, approximately 200
`new drugs are added each month. Only those drug names not found or
`common reference sources are included.
`Indexes are cumulated semian-
`nually, annually and biennially. The companion publication, Index-
`Gut'a‘.e/ 7, is a 38-year cumulative index (1 946-1986) which contains over
`200,000 entries including manufacturers addresses. Also available on-
`line.
`
`Other non—US sources which may prove useful:
`Diccionctrrlo tie Especrialtdocies Fa-rmaceuttcos, 33rd ed, Mexicana,
`Ediciones P.L.M., Mexico City, Mexico 1987.
`(The same publisher pro-
`duces several Central and South American editions.)
`Dzicttormatre Vidal, 64th ed, Office de Vulgaisation Pharmaceutique,
`Paris, France, 1988.
`Index Nomimtm 198?‘, 13th ed, Swiss Pharm Soc, Zurich, Switzer-
`land, 1987.
`Moffat AC: Ciarke’s Isolation and Identification offlrugs, 2nd ed,
`Pharmaceutical Press, London, 1 986.
`Rate Lists 1988, Editio Cantor, Aulendorf/Wiirtt, West Germany, 1988.
`Schnell BR, ed: Compendium ofPharmoceuttcats and Specialties
`1987, 22nd ed, Canadian l‘-'harmAssoc, Ottawa, Canada, 1987.
`
`Pharmacopeias and Formularies
`
`Books of standards for drugs and devices, known as pharma-
`copeias and formularies, are referred to collectively as drug
`compendia.
`A pharmacopeia or a formulary is a book containing a list of
`medicinal substances (drugs) and/or articles (devices) with
`descriptions, tests and formulas for preparing the same, se-
`lected by a recognized authority. The recognized authority
`which issues these standards i.n most countries is governmen-
`tal, but in the US both the national pharmacopeia and the
`national forrnulary have been published by private organiza-
`tions although officially recognized by the federal govern-
`ment.
`
`Official drug compendia are those compilations of drugs
`and devices which have been recognized as legal standards of
`purity, quality and strength by a governmental agency of the
`country of origin.
`
`United States QfAme?/‘ica
`
`In the US, legal recognition of drug standards did not occur
`until 1906 when the Congress enacted the first Food and Drug
`Act. Sonnedecker provides a complete account of the origin
`and development of The United States Pharmacopeia. and
`The Natilortctt Formuloryf’ Since 1 974 they have been pub-
`lished jointly by the APhA and the USP Convention as a single
`volume.
`
`The United States Phctrmocopeta, 22nd rev, The Na-
`tional Formulary, 1 7th ed, USP Convention, Rockville MD,
`1 990.
`
`Foreign Phormctcopctos and Formulartes
`
`Pharmacopeias and formularies are generally national in
`origin and scope. Among the foreign English-language com-
`pendia with which the American pharmacist should be familiar
`are
`
`British Nottortal Formula-ry, no 16, Br Med Assoc and Royal Pharrn
`Soc Great Britain, London, 1988.
`_
`British Phannacopoeia 1993, Her Majesty’s Stationery Office, Lon-
`don, 1993.
`European Phannacopoeia, 2nd ed, Council of Europe, Maisonneuve,
`Sainte-Ruffine, France, 1985.
`Intemottonol Pharmacopoeia, 2 vols, 3rd ed, WHO, Geneva, Switzer-
`land, 198 l .
`The Phanmrcopoeta ofJapan, 1 1th ed, The Society of Japanese Phar-
`macopoeia, Tokyo, Japan, 1938.
`
`In-Depth Research
`
`In-depth information needs are met by diiferent means than
`are simple questions.
`It is essential to define the research
`question and plan a strategy since this will influence the selec-
`tion of the most appropriate resources.
`In addition, the in-
`tended use for the material retrieved may indicate the quantity
`and depth of information required and perhaps dictate the
`number and currency of references needed. Unless histori-
`cal information specifically is sought, it is conventional to
`start with the most recent data and work backwards until the
`information need is satisfied. The most effective approach is
`to begin with general sources and work toward more specific
`Ones.
`
`The primary literature, usually in the form of journal at-
`ticles, normally will answer these more comprehensive needs.
`Because of the proliferation of journals and the consequent
`potential scattering of relevant information among a number
`of different journals, it is necessary for the researcher to
`follow a systematic approach to the search. This will ensure
`that the researcher does not miss significant papers published
`injournals whose titles could have suggested only a peripheral
`relationship to the topic. The primary literature can be ac-
`cessed by
`Printed indexes and abstracts
`CD-ROM/Qnline database searching
`Current awareness
`Selective dissemination of information (SDI services)
`Bibliographies
`Journal article bibliographies
`
`Indexes and Abstracts
`
`Iwxllledictts [National Library of Medicine (NLM), Bethesda MD] the
`most comprehensive index to the international medical literature and
`covering over 3000 journals, is the continuation of an index which began
`in 1879. Monthly issues are cumulated annually in Cumuioted Imtea:
`Medians. Citations are arranged alphabetically by first author and by
`subject headings. For effective searching the controlled vocabulary for
`subject headings must be used and is published annually as the Medical
`Subject Headings (MeSH). Review articles, in addition to being indexed
`by author and subject, also are collected in the section of each issue titled
`Bibliography ofMedz'co,l Reviews.
`It is available online as MEDLENE
`(see CD-ROM/ Online Database Seorchrng, below}.
`IPA, Internatfmtal Pkarrrtaceuticol Abstracts (ASHP, Bethesda MD),
`the sole abstracting and indexing service devoted exclusively to the phar-
`
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