Drug information : a guide to current resources

This is the long-awaited third edition of the most comprehensive compilation of drug information resources available. A co-publication with the Medical Library Association, it draws on industry expert Bonnie Snow's 30+ years of experience with pharmaceutical information needs and applications. Snow reviews 400+ print and electronic resources.More than a bibliography, this readable guide brings together the best resources plus practical advice on everything from expert search techniques to core collections for libraries. Subject areas covered include: pharmaceutical technology; legal and regulatory issues world-wide; industrial pharmacy; market research; product guides and prescribing information in the global marketplace; drug interactions; drug effects on pregnancy, lactation, and reproduction; pharmacovigilance; and much, much more. Completely revised, reorganized, and updated, the third edition focuses on information sources not covered elsewhere. Absolutely unique in its value as both a desk reference and a text for classroom use or self-study, this edition manages to meet the needs of students, information professionals, health care providers, and pharmacy practitioners.

• List of Figures p. ix
• Preface p. xi
• Chapter 1 Guide to the Guide p. 1
• Prospective Users and Practical Applications p. 1
• Three Different Approaches to Using the Guide's Content p. 2
• Scope p. 4
• Reference Format and Annotation Content p. 4
• Beware: No Single Source Is Comprehensive p. 8
• Chapter 2 Drug Identification: Variations in Drug Nomenclature and Their Impact on Information Retrieval p. 9
• Types of Drug Names p. 11
• Chemical Name p. 11
• Chemical Abstracts Service Registry Number (CAS RN) p. 12
• Laboratory Code, Research Number, or Investigational Drug Number p. 13
• Nonproprietary or Generic Name p. 13
• Brand, Proprietary, Trade, or "Trivial" Name p. 15
• Drug Classification p. 15
• Pharmacological Action p. 16
• Therapeutic/Diagnostic Use p. 16
• Chemical Derivation or Affiliation p. 16
• Less Frequently Used Identifiers p. 18
• Molecular or Empirical Formula p. 18
• Chemical Structure, Structural Formula p. 18
• Enzyme Commission Number p. 19
• National Drug Code p. 19
• Other Nomenclature Issues p. 20
• Synthetic versus "Natural" p. 20
• Prescription versus Over-the-Counter p. 20
• "Ethical" as a Marketing Term p. 21
• "Generic" as a Marketing Term p. 21
• Drug Identification and Nomenclature Sources p. 22
• Official Compendia p. 23
• Commercial Sources p. 28
• Additional Nomenclature Sources Integrated into Online Search Systems p. 33
• Drug Identification from Description or Observation of a Dosage Form p. 35
• FDA Regulation of Imprints p. 36
• Factors to Consider When Evaluating "Physical ID" Resources p. 37
• Physical ID Guides Incorporated into Drug Compendia p. 40
• References p. 42
• Additional Sources of Information p. 42
• Chapter 3 Government Regulations Affecting Drugs and the Pharmaceutical Industry p. 45
• The New Drug Development and Approval Process in the United States p. 46
• Historical Background p. 46
• Preapproval Requirements p. 48
• Access to Regulatory Information Prior to NDA/BLA Approval p. 59
• Sources for Product Approvals and Basis-of-Approval Documents p. 59
• U.S. Regulation of Over-the-Counter Product Introductions p. 63
• The New Drug Registration Process in Europe p. 69
• Historical Background p. 69
• Marketing Authorization Applications for New Drugs and Biologics p. 70
• EU Product Approvals and Basis-of-Approval Documents p. 72
• EU Regulation of Over-the-Counter Product Introductions and Herbal Medications p. 77
• Generic Drugs p. 80
• U.S. Regulation of Generic Drugs p. 81
• Market Exclusivity Provisions in U.S. Law p. 82
• Verifying U.S. Patent Term Extensions and Tracking Applications for "Restoration Days" p. 88
• Regulation of Generic Drugs in the European Union p. 91
• EU Provisions for Market Exclusivity p. 94
• Answering Questions about EU Marketing Exclusivity and Patent or SPC Expiration p. 97
• Verifying Producers of Active Pharmaceutical Ingredients: DMFs and CEPs p. 102
• Regulatory Incentives to Encourage Innovation and Reduce "Drug Lag" p. 103
• Orphan Drug Laws p. 104
• Incentive Programs for Pediatric Drugs p. 108
• Providing Patients Access to Investigational Drugs Prior to Approval p. 111
• Measures to Expedite the Regulatory Review Process p. 114
• International Cooperative Efforts: ICH and the Pharmacopeial Discussion Group p. 123
• Phase IV Postmarketing Studies p. 126
• Government Programs to Ensure Drug Safety p. 129
• Risk Management Strategies p. 131
• Restricted Access Programs: Scheduled Drugs p. 133
• Hazard Communication Standards and MSDS p. 138
• Documents Associated with Quality Assurance and Compliance p. 139
• Regulations p. 140
• Guidelines p. 142
• GMP Compliance Policy Guides and Inspection References p. 143
• Warning Letters p. 146
• Product Recalls, Seizures, or Withdrawals p. 148
• Commercial Regulatory Information Systems, Current Awareness Sources, and Free Web Directories p. 151
• Current Awareness Sources p. 153
• Specialized Web Directories and Pathfinder Sites p. 156
• Laws Governing the Practice of Pharmacy p. 158
• References p. 162
• Additional Sources of Information p. 164
• Chapter 4 Evaluating Drug Information Sources and Developing a Search Protocol p. 165
• Structure and Organization of the Literature: Scaling the Pyramid p. 167
• Source Evaluation Checklist p. 169
• Documentation and Credibility p. 171
• Guides to the Literature p. 172
• Internet Pathfinders p. 177
• References p. 181
• Additional Sources of Information p. 181
• Chapter 5 Pharmacology and Therapeutics Reference Sources p. 183
• Core Collection for Access to U.S. Pharmacotherapeutic Information p. 183
• Alternative Selections and Additional Bibliography p. 190
• Handbooks p. 192
• Encyclopedic Works and Textbooks p. 193
• Free Pharmacotherapeutic Ready-Reference Sources on the Internet p. 195
• Guides to Nonprescription Drugs and Dietary Supplements p. 198
• Reference Sources for Herbal Preparations, Phytopharmaceuticals, and Other "Natural" Drugs p. 201
• Product Guides and Prescribing Information in the Global Marketplace p. 209
• Preparing to Answer Foreign Drug Identification and Equivalency Inquiries p. 210
• Historical and Commercial Trends Influence Resource Selection p. 211
• Veterinary Drugs p. 218
• References p. 223
• Additional Sources of Information p. 224
• Chapter 6 Reference Sources for Adverse Drug Reactions and Interactions p. 227
• Adverse Reactions Information Sources p. 229
• Ready-Reference Sources for Drug Interactions p. 233
• Parenteral Incompatibilities p. 238
• Specialized Adverse Effects Publications p. 240
• Food-Drug Interactions p. 242
• Drug Effects on Pregnancy, Lactation, and Reproduction p. 243
• Pharmacovigilance Systems: Adverse Event Reports Submitted to Regulatory Authorities p. 248
• Online Repositories of Postmarketing Adverse Event Data p. 250
• Hazardous Substance Directories p. 258
• Material Safety Data Sheets p. 261
• References p. 263
• Additional Sources of Information p. 265
• Chapter 7 Drug Analysis, Formulation, and Compounding Reference Sources p. 267
• Official Compendial Standards p. 268
• Complementary Reference Sourcebooks for Drug Analysis p. 272
• Resources to Support Formulation Development p. 274
• Additives and Excipients p. 276
• Sourcebooks in Pharmaceutical Technology p. 282
• Resources to Support Extemporaneous Compounding in the Pharmacy p. 284
• References p. 289
• Additional Sources of Information p. 289
• Chapter 8 Compiling Background Bibliography Using Online Resources p. 291
• Major Biomedical Databases p. 292
• Subject Specialty Indexes to the Bibliography of Pharmacology and Therapeutics p. 302
• Complementary Resources p. 307
• Influential Factors in Database Selection p. 312
• Retrieving References to Routes of Administration p. 313
• Isolating Citations to Specific Subject Populations p. 316
• Searching Drug Categories p. 317
• Finding References to Proprietary Preparations or Brand Name Comparisons p. 321
• Filtering Bibliographies by Author Affiliation or Address p. 325
• Identifying Publication Types p. 327
• Finding References to Conference Papers or Posters p. 328
• Free Web Repositories of Meeting Presentations p. 333
• Tracking Down Clinical Trial Results Published in Journals p. 333
• Databases to Answer Adverse Effects and Interactions Questions p. 336
• Retrieving Bibliography on Interactions p. 338
• Pharmacovigilance: Searches to Comply with Postmarketing Drug Safety Surveillance Regulations p. 339
• Searching for Alternatives to Animal Testing and Related Animal Welfare Bibliography p. 342
• Animal Welfare Search Guides and Database Directories p. 346
• Pharmaceutics, Pharmaceutical Technology, and Biotechnology Bibliography p. 348
• Searches Focused on Drug Delivery p. 350
• Online Indexes of Biotechnology Literature p. 353
• References p. 354
• Additional Sources of Information p. 355
• Chapter 9 Competitive Intelligence Resources: Drugs-in-Development Directories, Protocol Registries, and Clinical Trial Results Repositories p. 357
• Drug Pipeline Databases: Drugs-in-Development Directories p. 357
• Key Differences in Pipeline Directories p. 395
• Resources for Monitoring Clinical Trials p. 397
• The Evolution of Clinical Trial Directories p. 399
• Major Protocol Registries or Portals p. 401
• Results Repositories and "Trial Tracking" Resources Online p. 408
• References p. 420
• Additional Sources of Information p. 422
• Chapter 10 Pharmaceutical Business Intelligence: Companies, Products, and Marketplace Research Sources p. 423
• Tracking Pharmaceutical News Online p. 423
• Subject Specialty Company Directories Online p. 435
• Company Profiles Integrated into Pipeline Search Platforms p. 439
• Sources Designed for Monitoring Company Collaborations and Licensing Opportunities p. 442
• Surveying the Therapeutic Landscape: Product Directories p. 451
• Other Online Sources of Pharmaceutical Market Intelligence p. 453
• Syndicated Market Research and Investment Analyst Reports p. 457
• Statistical Yearbooks p. 461
• References p. 462
• Glossary p. 463
• Key to Abbreviations and Acronyms p. 495
• Index p. 509
• About the Author p. 545