This document provides information on drug information resources and how to evaluate them. It discusses primary sources like research studies, secondary sources like abstracts and indexes, and tertiary sources like textbooks. Primary sources provide the most current evidence but have a narrow scope, while tertiary sources have a broad scope but are often out of date. The document outlines strategies for selecting the best sources depending on the type of question, and how to critically evaluate clinical studies and other drug information.
2. Drug information is current , critically examined, relevant data about drugs
and drug use in a given patient or situation.
A. Current information uses the most recent, up- to-date sources possible.
B. Critically examined information should meet the following criteria:
1. More than one source should be used when appropriate.
2. The extent of agreement of sources should be determined;
3. The plausibility of information, based on clinical circumstances,.
C. Relevant information must be presented in a manner that applies
directly to the circumstances under consideration (e.g. , patient parameters,
therapeutic objectives, alternative approaches) .
3. Primary Resources
•
•
•
Researcher’s and manufacturer’s information
Patents containing original information regarding the discovery of
drug
Reports containing scientific data before product can be sold ,
supplied or represented
•
Scientific journals
•
Provide original studies or reports
E.g. Clinical trial, case series, case report
•
Scope is narrow
•
Good when topic is new or new data has been published
4. Primary Resources
Advantages:
• Most current evidence
• Provide data on new drugs
• Can personally assess validity of studies
Journal articles provide the most cur rent information about
drugs and, ideally, should be the source for answering therapeutic
questions. Journals enable pharmacists to:
a. Keep up to date with professional news
b. Learn how another clinician handled a particular problem
c. Keep up with new developments in pathophysiology, diagnostic agents,
and therapeutic regimens
d. Distinguish useful from useless or even harmful therapy
e. Enhance communication with other healthcare professionals and
consumers
f . Obtain continuing education credits
g. Share opinions with other healthcare professionals through letters to the editor
h. Prepare for the board certification examination in pharmacotherapy,
nutrition support , oncology, etc.
5. Disadvantages :
• May not lead one to best decision because of limited scope
• Data can be poor or controversial
• Every study has limitations
• Too complex for patients
Al though publication of an article in a well -known, respected
journal enhances the credibility of information contained in
an article, this does not guarantee that the article is accurate.
Many articles possess inadequacies that become apparent as
the ability to evaluate drug information improves.
6. Secondary Resources
• Abstract or index which summarizes the information arising in
primary source
• Indexing and abstracting services are valuable tools for quick
and selective screening of the primary literature for specific
information,data, citation, and articles
• Three types of abstracts:
1) Telegraphic abstract ( only string of words)
2) Indicative abstract ( structured in sentence )
3) Informative abstract
• Bibliographic databases that provide abstracts or full-text of
studies
7. Secondary Resources
Advantages :
•
Can construct searches to find specific information at high
granularity
Disadvantages :
• Often require more expertise to use than primary or tertiary
resources
• Retrieved references must be filtered for quality
• Must track down resources before looking for answers
• Too complex for patients
•
generally interpretations of a study and may be a misinterpretation of
important information. Pharmacists should obtain and evaluate the original
article because abstracts may not include enough information to critically
evaluate the study.
8. Tertiary Resources
Compilations of knowledge in the field
E.g. Textbooks, handbooks, online drug compendia
Good for background questions
Scope is broad
9. Tertiary Resources
Advantages
• Provide comprehensive information
• Information reflects views of multiple experts in field
• Fast, easy to use, and may be good for patients
Disadvantages
• Usually at least 2 years out of date by publication
•
High dependency on interpretation of authors**
**Pharmacists can address this by consulting at least
2 tertiary resources
10. General considerations when
examining and using textbooks
a. The author , publisher , or both: What are the author 's and publisher's areas of
expertise?
b. The year of publication (copyright date) or last revision date?
c. The edition of the text : Is it the most current edition?
d. The presence of a bibliography: I f a bibliography is included, are
important statements accurately referenced? When were the references
published?
e. The scope of the textbook or database: How accessible is the
information?
f . Alternative resources that are available (e.g. , primary and secondary sources,
other relevant texts
)
12. Strategies of selecting drug information sources
Tertiary resources are good when:
•
The answer to a question is basic factual knowledge in the field
•
The question was studied extensively and a conclusion was made
•
Many experts have addressed the question and agree on answer
Secondary and primary resources are good when:
•
A question is new and has never been studied
•
There is no consensus among experts; various opinions abound
•
There is conflicting evidence and the question needs further study
13. Addressing a Drug Information Need
1.
2.
3.
4.
5.
Obtain background info/understand context
Determine ultimate question
Select and search appropriate resources
Evaluate and analyze information found
Draw conclusion and formulate response
14. STRATEGIES FOR EVALUATING INFORMATION REQUESTS.
1. Determine the reason for the inquiry.
2. Clarify the drug's identification and availability. Make sure that the
a. The correct spelling of the drug's name
b. Whether it is a generic or brand name drug
c. What pharmaceutical company manufactures the drug and in what
country the drug is manufactured
d. Whether the drug is prescript ion or nonprescription
e. Whether the drug is still under investigation and, if it is on the market ,
the length of time on the market
f . The dosage form of the drug
g. The purpose of the drug (i .e., what medical condition or symptom the
drug is intended to alleviate; this information helps narrow the search if products
with similar names are found)
15. Internet as drug information source
Benefits :
• Search for recently published or discussed in
the media
• Company specific information
• Issues currently in the news
• Government agencies news
16. Limitations :
• Information may not be peer reviewed or
edited before release
• Information not reliable
• Must have an address ( URL)
18. Strategy for locating drug information literature
A. Determine whether the question at hand is
clinical or research related.
B. Determine the type of information and how
much is needed
C. Ascertain as much information as possible
about the drug being questioned
– 1. What is the indication for the prescribed drug?
– 2. Is the drug's use approved or unapproved?
19. a. Approved uses of drugs can be
checked in:
(1) AHFS Drug Informat ion
(2) Drug Facts and
Comparisons/Facts and Compar
ison 4.0 (online)
(3) PDR
(4) USP Drug Information
(5) Drugdex (Micromedex)
(6) Clinical Pharmacology
(7) Drug Information Handbook/Lexi
-Drugs Online (Lexi -Comp Online)
b. Unapproved uses of drugs can be
found in:
(1) AHFS Drug Information
(2) Drug Facts and Comparisons/Facts
and Comparison 4.0 (online)
(3) Martindale: The Complete Drug
Reference
(4) Medline
(5) Drugdex (Micromedex)
(6) Inpharma
(7) USP Drug Information
(8) Clinical Pharmacology
(9) Drug Information Handbook/Lexi
-Drugs Online (Lexi -Comp Online)
20. -3. What are the age, sex, and weight of the patient in quest ion?
-4. Does the patient have any other medical conditions or renal or hepatic
disease?
-5. Is the patient taking any other medications?
-6. What drugs has the patient taken during the past 6 months, and what
were the dosages?
-7. Did the patient experience any signs or symptoms of a possible adverse
drug reaction? If so:
a. How severe was the react ion?
b. When did the react ion appear?
c. Has the patient (or any member of the patient 's family) experienced
any allergic or adverse react ions to medications in the past?
d. The manufacturer of the drug may be a useful source for missing
information. Most companies request further information regarding a
suspected adverse drug reaction.
21. -8. Did the patient experience any signs or symptoms of a drug interaction?
If so:
a. What were the specific drugs in quest ion?
b. What were the respective dosages of the drugs?
c. What was the duration of therapy?
d. What was the length of the course of administrat ion?
e. What are the details of the events secondary to the suspected
reaction?
22. -9. What is the patient 's current medication status?
-10. Does the patient have any underlying diseases?
-11. How has the patient been managed so far?
-12. What is the stability of the drug? How is compatibility of the drug with
other drugs?
What are the administration techniques? What are appropriate containers
for the product?
Resources available with this information include
a. Trissel's Handbook on Injectable Drugs
b. King's Guide to Parenteral Admixtures
c. Trissel's Stability of Compounded Formulations
23. Available resources
1. For drugs manufactured in the United States, the following resources are
available:
a. The American Drug Index, updated annually
b. Drug Facts and Comparisons, updated monthly and bound
annually/Facts and Comparison 4.0 (online)
c. Drug Topics Red Book, periodically supplemented and updated annually
d. Physician's Desk Reference (PDR) , updated annually
e. American Hospital Formulary Service (AHFS) Drug Information,
supplemented quarterly and updated annually
f . Martindale: The Complete Drug Reference, updated every 3 years
g. Lexi-Drugs Online (Lexi -Comp Online)
h. Clinical Pharmacology
i . Thomson Healthcare Series (Micromedex)
24. 2. For drugs manufactured in foreign countries, the following resources
are available:
a. Martindale: The Complete Drug Reference
b. Index Nominum
c. USP Dictionary of United States Adopted Names (USAN) and
International Drug Names
d. Lexi-Drugs International Online (Lexi -Comp Online)
3. For investigational drugs, the following resources are available:
a. Martindale: The Complete Drug Reference
b. Drug Facts and Comparisons/Facts and Comparison 4.0 (onl ine)
c. The Pink Sheet published by FDC Reports
d. The NDA Pipeline published by FDC Reports
25. 4. For orphan drugs—that is, drugs that are used to prevent or t reat a rare
disease (affects < 200,000 people in the United States, so the cost of
development is not likely to be offset by sales) and for which the U.S. Food
and Drug Administration (FDA) offers assistance and financial incentives to
sponsors under taking the development of the drugs—the following
resources are available:
a. Drug Facts and Comparisons/Facts and Comparison 4.0 (online)
b. The FDA Office of Orphan Products Development (OOPD)
c. The National Institutes of Health (NIH) Office of Rare Diseases
d. National Organization for Rare Disorders
e. Lexi -Drugs Online (Lexi -Comp Online)
26. EVALUATING A CLINICAL STUDY
A. Evaluate the objective of the study. Determine the aim of the
research that was performed.
1. What did the researchers intend to examine?
2. Is this goal stated clearly ( i .e. , is the objective specific)?
3. Was the research limited to a single objective, or were there
multiple drugs or effects being tested?
27. B. Evaluate the subjects of the study. Determine the profile of the study
population by assessing the following information:
1. Were healthy subjects or affected patients used in the study?
2. Were the subjects volunteers?
3. What were the criteria for selecting the subjects?
4. How many subjects were included, and what are the demographics of the
subjects (age, sex, and race)?
5. If a disease was being treated, did any of the subjects have diseases
other than that initially being treated? Were any additional treatments
given? Were there any contraindications to the therapy?
6. What was the patient select ion method and who was excluded from the
study?
7. A patient selection review should be done.
28. C. Evaluate the administration of the drug treatment . For each drug
being investigated, determine the following information:
1. Details of treatment with the agent being studied:
a. Daily dose
b. Frequency of administration
c. Hours of day when administered
d. Route of administration
e. Source of drug (i .e. , the supplier )
f . Dosage form
g. Timing of drug administration in relation to factors affecting drug
absorption
h. Methods of ensuring compliance
i . Total duration of treatment
29. D. Evaluate the setting of the study. Try to determine the environment of
the study and the dates on which the trial began and ended. Assess the
following information:
1. People who made the observations; various professionals who offer
different and unique perspectives based on their backgrounds and interests
(Were the same people making observations throughout the study?)
2. Whether the study was done on an inpatient or outpatient basis
3. Description of physical set ting (e.g. , hospital, clinic, ward)
4. Length of the study ( i .e. , dates on which the trial began and ended)
30. E. Evaluate the methods and design of the study.
The method section of the research paper explains how the
research was conducted.
The study design ( i .e. , retrospective, prospective, blind,
crossover ) and the methods used to complete the study are
important in judging whether the study and the results are
reliable and valid.
31. F. Evaluate the analysis of the study. After assessing
specific areas of the study separately, compile the
information together to determine whether the trial
is acceptable and the conclusions are justified by
determining answers to the following questions