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PHRM 301

PHRM 301 Integrated Lab
Introduction to Drug Information

Vicki Killion
Pharmacy, Nursing, and Health Sciences Librarian and Associate Professor of Library Science
RHPH 272
4-1417
vkillion@purdue.edu

INTRODUCTION:
The ability to locate information is an essential skill for all pharmacists. Increasingly more and more questions are directed to the only healthcare professional who is perceived as “knowing” everything about drugs.

At the 1987 annual meeting of the American Association of Colleges of Pharmacy, the Task Force Report of Competency Statements for Pharmacy Practice confirmed that many responsibilities of pharmacists require skills in the performance of drug information, research, application, and communication. Researching the medical and pharmaceutical literature and maintaining access to current drug information are specifically defined as necessary skills for patient care and for provision of drug information to other healthcare professionals.

Individuals who have the ability to find and filter information effectively have a competitive edge in academics and business. The ability to identify your information needs, find appropriate and reliable information, use it to solve problems, and communicate the resulting knowledge to colleagues, faculty, employees, and patients is the basis for this part of PHRM 301.

Gathering information for your class assignments will be an integral part of your academic career. The ability to track the latest drug information and the most up-to-date research will benefit you personally. The information retrieval and evaluation skills you develop over the next few years will be of benefit in your first job, in locating a new job, or even in selecting the best consumer product to enhance your life style.

As pharmacists, you will need to have the most complete skills to provide quality pharmaceutical care. There is a major problem. No one person can be expected to know everything. Drug literature information is vast and complex and the amount of biomedical and scientific literature is doubling approximately every two years. Clinical experience with drugs continues to grow and more questions on safety, efficacy, adverse effects, or non-approved uses are surfacing. Current awareness is critical. Pharmacists must know:

how to identify needed drug data and literature;
how to locate the information;
how to use electronic systems to access the data;
and most importantly, how to evaluate the resources required to keep current and the information contained within them.

During the next few weeks, you will have the opportunity to develop some basic drug information retrieval skills and acquire a degree of proficiency in using the Libraries electronic resources. Attendance at each lab is required.

DRUG DEVELOPMENT AND APPROVAL PROCESS

History
- Federal Food and Drug Act (1906) – prohibited adulterated or misbranded food or drugs from interstate commerce. The act was considered inadequate because:
- False statements made by a manufacturer were held by the courts not to be misbranding.
- The act did not extend to cosmetics.
- The act did not grant the authority to ban unsafe drugs.
- Labels were required to identify the contents.
- Food, Drug and Cosmetic Act (1938) – following sulfanilamide disaster, legislature created requiring adequate tests for safety. “Safe” meant nontoxic when used according to conditions on the label.
- Kefauver-Harris Amendment (1962) – following thalidomide disaster, government required program of accountability from pharmaceutical manufacturers:
- Before marketing any new drug, manufacturers were required to supply proof of effectiveness and proof of safety.
- Good Manufacturing Practices (GMP) were established. If a drug was produced without adhering to these practices, it was considered adulterated.
- Prescription drug advertising was placed under the supervision of the FDA; OTC product advertising remained with the FTC.
- Procedure for new drug applications and investigational drug procedures that required informed consent of the research subjects and required reporting adverse drug reactions were established.
- Waxman-Hatch Amendment (1984) – Drug Price Competition and Patent Restoration Act – consumer oriented and designed to lower drug prices by increasing competition. Drugs shown to be safe and effective and identical to a previously approved drug are given an accelerated approval and applications procedure.
Process: http://www.allp.com/drug_dev.htm
- Preclinical testing – laboratory and animal studies to show biological activity of the compound against a specific diseases; safety tests
- Investigation New Drug Application ( IND) – details the clinical study proposed
- Clinical trials:
  - Phase I: 20-80 healthy volunteers; safe dosage range; ADME; toxicity
  - Phase II: 100-300 volunteer patients with the disease; safety and effectiveness
  - Phase III: 1000-3000 patients in hospitals and clinics; monitored to confirm efficacy and identify adverse events
- New Drug Application (NDA) – contains all data collected during trials; typically 100,000+ pages; FDA has six months to review
- Postmarketing surveillance – following approval, manufacturer required to submit periodic progress reports to FDA, including adverse drug reactions (ADR). Phase IV trial may be required to study long-term effects of the drug.
- Health care professionals report ADR to FDA MedWatch (http://www .fda.gov/medwatch/)

DRUG INFORMATION LITERATURE

I. Providing drug information - a systematic, organized approach is more efficient and effective

A. Assessing drug information needs - what the requester really wants to know

B. Obtain background information - patient demographics, product information, dosage and administration, signs and symptoms, medication history, etc.

C. Systematic search of the literature - develop strategy and conduct search

D. Evaluate results and provide response
E. Conduct follow-up and documentation

II. Systematic search of the literature - requires basic familiarity with the available resources and an organized approach in searching the resources

A. Tertiary resources - condensed, compact format; large amount of information synthesized into a general explanation; sufficiently detailed information source that at times can serve as a reference: textbooks, encyclopedias, reviews

B. Secondary resources - resources that guide or direct one to the primary literature

1. indexing system - bibliographic information indexed by topic and author

2. abstracting service - bibliographic data plus summary; indexed by topic and author

C. Primary resources - specific, original data; usually research studies published in journals or conference proceedings

When do you search the primary literature?

1. If the answer cannot be found in texts or general reference books
2. If the information in the text appears to be out of date
3. If the requester asks for the most current information

III. Tertiary resources – There are many drug information handbooks in the Pharmacy, Nursing, and Health Sciences Library. The titles listed here are the resources frequently found in the pharmacy, hospital library, or in personal libraries. To locate these and many more titles, use the Libraries catalog at http://www.lib.purdue.edu - type in a simple keyword search: drugs and (handbooks or dictionaries or encyclopedias or manuals).

A. General - administrative and dosage information, precautions, adverse drug reactions, drug interactions

1. AHFS Drug Information (PNHS Reserves 615.1 Am35)

Prepared by the editorial staff of the American Society of Health-system Pharmacists
Comparative, unbiased, evaluative monographs on single-entity drugs pharmacokinetics, cautions, dosing, hospital type products
Published annually with some updates
AHFS DI (online) – available from the Libraries home page http://www.lib.purdue.edu – click on “Articles & Databases”

2. Drug Facts and Comparisons ( PNHS Reserves 615.083 F119f)

Virtually every FDA-approved drug currently on the US market
Organized into chapters by therapeutic class; further divided to facilitate comparisons
Three versions:
Loose leaf updated monthly; news section
Annual compilation, includes information through December of previous year
eFacts - available from the Pharmacy, Nursing & Health Sciences Library page (http://www.lib.purdue.edu/pnhs/index.html) - off-campus access requires downloading a program to your desktop (http://www.lib.purdue.edu/eresources/wts/trouble.html).

3. Martindale: The Complete Drug Reference ( PNHS Reserves 615.11 M36e 2002)

British publication with information from 16+ pharmacopoeias from around the world; it is not the legal or official book of standards for the UK
Dosage forms and indications of drugs not available in the US; includes OTC products and herbal/homeopathic products
Published every 3-5 years; available in full-text format on Micromedex Ò, a drug information resource on a public workstation in the PNHS Library.

4. Mosby’s DrugConsult ( PNHS Reserves 615.5805 P569)

Brings together variety of information in one source
Includes costs, equivalencies, FDA approval dates
Published annually
Available online from the Libraries home page http://www.lib.purdue.edu – click on “Articles & Databases”

5. Physicians’ Desk Reference (PDR) (PNHS Reserves 615.05 P56)

Compilation of package inserts supplied by the manufacturer
Top selling drug products in the US
Directories for manufacturers and poison control centers
Color photographs of drugs

6. USP DI ( PNHS Reserves 615.1173. Un3)

Three volumes: first is for the healthcare professional; second is for the patient; third is approved drug products listings from the FDA
Useful appendices: orphan drugs, drug-induced side effects, indications, list of banned drugs in NCAA and USOC, etc.
Published annually with updates
Available online from the Libraries home page http://www.lib.purdue.edu – click on “Articles & Databases”

Drug interactions - both these sources give the mechanism, the clinical significance, and the management of the interaction

1. Drug Interaction Facts (PNHS Reference 615.7045 D841)

Drug-drug and drug-food interactions that have been reasonably well-documented in humans
Updated quarterly
Part of eFacts - - available from the Pharmacy, Nursing & Health Sciences Library page (http://www.lib.purdue.edu/pnhs/index.html) - off-campus access requires downloading a program to your desktop (http://www.lib.purdue.edu/eresources/wts/trouble.html).

2. Evaluations of Drug Interactions ( PNHS Reference 615.7 Am36ev)

Originally prepared by the American Pharmaceutical Association
Most comprehensive information with greater specificity in indexing
Updated bimonthly

C. Drug identification - these questions are frequently asked. The following information should be asked of the requester: exact spelling, if possible; whether it is a generic or brand; why was the drug prescribed; in what country was it purchased; who is the manufacturer; and, what is the source of the information gathered (i.e., physician, pharmacist, package insert, etc.)

1. American Drug Index (PNHS Reference 615.1 W69a)

Nearly comprehensive coverage of single-entity drugs available in the US, also includes OTC and some investigational and discontinued products
Brief information: name, manufacturer, dosage form, strength, uses
Published annually

2. Drug Topics Red Book (“Red Book”) (PNHS Reserves 615.05 D839p)

Ordering of drug products
Useful lists: poison control centers, directories of state and national pharmaceutical associations and state examining boards
Published annually

3. Index Nominum (PNHS Reference 615.1 In2)

European drugs
Very brief information: chemical name, molecular formula, structure, synonyms
Published every few years

4. Merck Index (PNHS Reserves 615.1 M53 2001)

10,000+ chemical compounds
Physical and chemical properties, structure, citations to the literature
Use the index!
Published every 7-10 years
Available from the Libraries home page http://www.lib.purdue.edu – click on “Articles & Databases” - off-campus access requires downloading a program to your desktop (http://www.lib.purdue.edu/eresources/wts/trouble.html).

5. USP Dictionary of USAN and International Drug Names (PNHS Reference 615.1 Un33)

Official names of drugs recognized in the US, cross references to trade names and synonyms
Each entry contains the date of legal designation, official pronunciation, chemical names, structures
Published annually as cumulative (1961 - present)

D. Non-prescription drugs - no one comprehensive source

1. Handbook of Non-prescription Drugs (PNHS Reserves 615.886 H191)

In-depth discussion of information on OTC drugs
Includes information on the disease, symptoms, treatment, product selection guidelines, and patient counseling
Published approximately every three years

2. PDR for Non-prescription Drugs and Dietary Supplements (PNHS Reference 615.58 P569)

Package inserts from the top selling OTC products

E. Pharmacology and therapeutics - more detailed information on the disease state and recommended therapeutics

1. Merck Manual of Diagnosis and Therapy (PNHS Reserves 615.1 M53m 1999)

Information relating to most human disorders and diseases
Intended primarily for physicians
Published every 5-7 years
Available online at http://www.merck.com

2. Conn’s Current Therapy (PNHS Reference 616.05 C93)

Focuses on problems frequently encountered in medical practice
Concise and easy to read

3. The Pharmacological Basis of Therapeutics (“Goodman and Gilman”) (PNHS Reserves 615.7 G62p 2001)

In-depth discussion of mechanism of action; frequently used as pharmacology course textbook
Divided into major sections according to the action of a drug or the system affected
Published every four-five years
Harrison’s Principles of Internal Medicine (PNHS Reference 616.H24p 1998)
Leading textbook of medicine
Available from the Libraries home page http://www.lib.purdue.edu – click on “Articles & Databases”

Herbal or natural products
- Review of Natural Products (PNHS Reference 615.32105 L437)
- Loose-leaf, updated monthly - 300+ referenced monographs
- Based on scientific research
- Botany, history, chemistry, pharmacology, medicinal uses, toxicology, patient information, documented interactions
- Part of eFacts - available from the Pharmacy, Nursing & Health Sciences Library page (http://www.lib.purdue.edu/pnhs/index.html) - off-campus access requires downloading a program to your desktop (http://www.lib.purdue.edu/eresources/wts/trouble.html).
- The American Pharmaceutical Association Practical Guide to Natural Medicines (PNHS Reference 615.321 P353a 1999)
- Referenced monographs written for the lay person
- Ratings (effectiveness and safety) given, description, uses, common dosage

DRUG INFORMATION SOURCES

(Texts and references organized by drug information categories)

Category	Source (listed in order should be consulted)

Adverse Drug Reactions	AHFS DI – MICROMEDEX DrugDex – USP DI
	Martindale: the complete drug reference
	Side effects of drugs annual
	Textbook of adverse drug reactions
	Goodman and Gilman’s: the pharmacological basis of therapeutics

Drug Administration/Doses	Drug Facts and Comparisons
	AHFS DI – MICROMEDEX DrugDex – USP DI
	PDR
	Martindale: the complete drug reference

IV/IM	Handbook on injectable drugs

Pediatric	Pediatric drug handbook
	Harriet Lane handbook

Drug Identification
Marketed	Drug Facts and Comparisons
	MICROMEDEX Identidex
	AHFS DI – MICROMEDEX DrugDex – USP DI
	PDR
	American Drug Index
	Handbook of nonprescription drugs
	Drug topics red book

Investigational	Martindale: the complete drug reference
	MICROMEDEX DrugDex
	USP dictionary of USAN and international drug names
	Merck index

Foreign	Martindale: the complete drug reference
	Index Nominum
	USP dictionary of USAN and international drug names

Drug Interactions
Drug-drug	Drug interactions: analysis and management
	Drug interaction facts
	Evaluation of drug interactions
	AHFS DI – MICROMEDEX DrugDex – USP DI

Side Effects of Drugs
Drug-food	Drug interactions: analysis and management
	USP DI, vol. II: Advice for the patient

Drug-laboratory	Handbook of clinical drug data
	Interpretation of diagnostic tests

Indications	Pharmacotherapy (DiPiro)
	AHFS DI – MICROMEDEX DrugDex – USP DI
	Applied therapeutics: the clinical use of drugs
	Harrison’s principles of internal medicine

Infectious diseases	Mandell’s principles and practice of infectious disease
	Medical letter
	Sanford’s guide to antimicrobial therapy

IV or IM Compatibilities	Handbook on injectable drugs
	Martindale: the complete drug reference

Pharmacokinetics	Applied pharmacokinetics: principles of therapeutic drug monitoring
	Basic clinical pharmacokinetics
	AHFS DI – MICROMEDEX DrugDex – USP DI
	Handbook of clinical drug data
	Goodman and Gilman’s: the pharmacological basis of therapeutics
	Martindale: the complete drug reference

Teratogenicity	Drugs in pregnancy and lactation
	AHFS DI – MICROMEDEX DrugDex – USP DI
	PDR
	Catalog of teratogenic agents

Adapted from: Grant KL. Providing drug information. In: Clinical clerkship manual. Boh LE, ed. Vancouver, WA: Applied Therapeutics, Inc.; 1993:3.7-3.8.