PHARMACY INFORMATICS LEC

PHIN212 LEC

data, and video

 The science and activity of using computers and other
TOPIC 1: INTRODUCTION TO
electronic equipment to store and send information
PHARMACY INFORMATICS Examples of Information Technology
What is Pharmacy Informatics?  Telephone and radio equipment and switches used for voice
communications.
 Deals with the application of pharmacy related health data for a
variety of purposes.  Traditional computer applications that include data storage
and programs to input, process, and output the data.
 According to ASHP, it is “the use and integration of data,
information, knowledge, technology, and automation in the  Software and support for office automation systems such as
medication-use process for the purpose of improving health word processing and spreadsheets, as well as the computer to
outcomes.” run them.
 Deals with the subset of informatics relevant to the practice of  Users' PCs and software.
pharmacy  Server hardware and software used to support applications
 An important subset of medical informatics in which the such as electronic mail/groupware, file and print services,
pharmacists use their knowledge of information systems and database, application/ web servers, storage systems, and
medication-use processes to improve patient care by ensuring other hosting services.
that new technologies lead to safer and more effective  Peripherals directly connected to computer information
medication use (ASHP) systems used to collect or transmit audio, video or graphic
 A scientific field that focuses on medication-related data and information, such as scanners and digitizers.
knowledge within the continuum of healthcare systems -  Voice response systems that interact with a computer
including its acquisition, storage, analysis, use and database or application.
dissemination - in the delivery of optimal medication-related  The state radio communications network.
patient care and health outcomes. (HIMSS October 2006)
 Computers and network systems used by teachers, trainers,
 It is the use of electronic health data to support safe and and students for educational purposes.
effective medication use.  "Open/integrated" computer systems that monitor or
 It can include various aspects of medication management: automate mechanical or chemical processes and also store
o from a drug utilization review, information used by computer applications for analysis and
o to the use of barcoding technology during product decision-making, such as a building management system.
dispensing, What are the other terms related to Pharmacy Informatics?
o to the development of alert systems to improve What is Informatics?
prescribing and dispensing of medications  The study and application of information technology to the
 Pharmacy informatics involves broad collaboration between arts, science and professions, and to its use in organizations
pharmacists, pharmacy technicians, physicians, nurses, and society at large.
information technology personnel, and other health care  The study of the best practices in information accrual,
professionals. handling, dissemination, and comprehension using
What is American Society of Health System appropriate technology/
Pharmacist (ASHP)? How Does Informatics impact Health?
 National professional organization members include  Construct computer health information systems by studying
pharmacists, student pharmacists, and pharmacy technicians the needs of doctors, nurses, patients, and health care
who serve as patient care providers on healthcare teams in organizations
acute and ambulatory settings.  Create health networks that allow doctors and nurses to share
What are the applications of Health Informatics in the knowledge and best practices
Process of Care?  Create new methods of information delivery that motivate
1. Hospital administration, billing and accounting patients to follow treatment recommendations
2. Resource management What is MEDICAL INFORMATICS?
3. Medical documentation  is most simply defined as computer applications in medical
4. Diagnostics and therapy care.
5. Imaging  comprises the theoretical and practical aspects of information
6. Communication processing and communication based on knowledge and
7. Information management experience derived from processes in medicine and health
8. Clinical decision support care
What is Information technology? HEALTH INFORMATICS
 The use of hardware, software, services, and supporting  The development and assessment of methods and systems for
infrastructure to manage and deliver information using voice, the acquisition, processing and interpretation of patient data
with the help of knowledge from scientific research
PHIN 211 – PHARMACY INFORMATICS

 It covers all aspects of the generation, handling, technology and automation

communication, storage, retrieval, management, analysis,  Basic understanding of database design and function
discovery and synthesis of data, information and knowledge in  Ability to think about the “end user”
the entire scope of healthcare. Roles of an Informatics Pharmacist
DATA  Ensure patient safety
 Simply discrete and objective facts about subject or an event  Provide guidance and leadership for all technology initiatives
 Easy to capture and store in media such as databases and files that support medication use
EXAMPLE: Patient laboratory values, drug orders, patient’s weight  Customize and tailor health information systems and
INFORMATION technology to the needs of practice
 Data that has relevance and purpose  Serve as a liaison between pharmacy and other departments
 Has meaning because it is contextualized, categorized, o Information Technology
calculated, corrected, or condensed o Nurses
EXAMPLE: Knowing particular lab result was high or low from o Physicians
reference value o Vendors
KNOWLEDGE  Provide education to healthcare professionals and managers
 Broader, deeper, and richer than data and information  Serve as a resource for hospital staff
ALERT  Provide recommendations regarding vendor selection
 a patient- and context-sensitive warning presented to the AREAS OF RESPONSIBILITY
ordering provider at the time an order is being entered. Used 1. Information management
to inform the provider of a clinical concern relevant to the 2. Knowledge delivery
patient and order being placed. 3. Data analysis
CLINICAL REMINDER 4. Clinical informatics
 A context-sensitive electronic prompt to the provider to 5. Change management
perform an intervention or procedure, based on the patient’s 1. Information Management
specific clinical data as applied to a set of logical conditions.  Informatics Pharmacist must generate and share this
NOTIFICATION information with various healthcare professionals to ensure
 It is a patient- and context-sensitive prompt to the ordering patient safety while also measuring the usage and
provider, attending physician, primary provider, or care team effectiveness of this information throughout the clinical
to alert them of new information (i.e., abnormal lab result) or process.
tasks in need of completion (i.e., unsigned order or note). Using the following technology:
TELEHEALTH
 It is the "delivery of health care services, where patients and
providers are separated by distance.
 It uses technology for the exchange of information for the
diagnosis and treatment of diseases and injuries, research and
evaluation, and for the continuing education of health 2. Knowledge Delivery
professionals.  The informatics pharmacist drive the delivery of medication-
TELEMEDICINE related information and knowledge throughout the clinical
 It refers to the practice of caring for patients remotely when knowledge lifecycle.
the provider and patient are not physically present with each Example:
other.
 It must be compliant based on DPA

TOPIC 2: PHARMACY
INFORMATICS
Who are Informatics Pharmacist?
 Is considered a dual specialist: 3. Data Analysis
o Knowledgeable about both pharmacy practice and
 In order to improve healthcare, data must be reviewed and
informatics
the insights gained from this data must be applied.
o Has the ability to look at both the “big picture” and
4. Clinical Informatics
the individual details and processes.
 It promotes the understanding, integration and application of
Characteristics of an Informatics Pharmacist
information technology in healthcare settings.
 Strong understanding of pharmacy practice
 It focuses on an individual patient.
 Knowledgeable about the medication use process
Example: Smart Pump Optimization
 Knowledgeable about information systems, healthcare
PHIN 211 – PHARMACY INFORMATICS

 The skills needed to implement this knowledge in patient-

centered care include effective literature and Web search
skills, an understanding of databases, and the controlled
vocabularies needed for interoperability between systems and
for optimal searching of some databases.
 Thus, pharmacists need to know how to access computerized
5. Change Management medical information in various databases and to understand
 When dealing with knowledge to guide healthcare delivery, the underpinnings of these databases to use them most
the only constant is change. effectively.
 Treatments come and go, diagnostic tools evolve, clinical  Information and technology skills should help the pharmacist
practice changes. clearly see the complex picture of medication management for
What does an Informatics Pharmacist does? each individual patient and make the best possible decisions
 Maintain databases of medication management systems for his or her care
 Liaison between information technology (IT) and pharmacy What is the History of Pharmacy Informatics?
 Understanding system capabilities and limitations TELEMEDICINE
 Identify solutions to and resolve system problems  ANCIENT TIMES
 Work with interdisciplinary teams to implement new  Uses fire, smoke signals, drums, horns, etc.
technology
 Barcode Medication Administration
LEADERSHIP
 Involvement in committees and professional organizations
Education
What are the importance of Pharmacy Informatics in the
Society? EARLY TELEMEDICINE
1. In health care field,  It was kicked off by the inventions of the electrical telegraph
and the telephone.
 its ability to cater to the needs of the patients from any place
at any given time.  The telegraph and telephone brought long distance
 This is highly beneficial for occupational medicine. communication into the mainstream, where almost anyone
could send a telegraph message or make a phone call.
 Telemedicine helps to formulate an efficient and reliable
healthcare plan
2. In rural area,
 help rural providers deliver better health care by connecting
rural providers and their patients to services at distant sites
and promoting patient-centered health
 Major city hospitals and doctor offices installed telephones.
3. In urban area,
Within a few years, many city residents also had telephones in
 It has made waves in less by bringing providers and experts to
their homes.
patients, which also decreases healthcare and travel costs.
Example:
Pharmacy Informatics on the Improvement of Health
Outcomes
 Information about drugs includes primary literature and
electronic information resources, hospital and pharmacy
information systems, pharmacokinetics, and
pharmacogenomics.
 Patient-related issues include medication safety, electronic
health records, decision support systems, and the practice of
 Late 1800’s – Capital Avenue Drugstore was connected to 21
evidence-based medicine.
different local physicians via the early version of telephone
 April 1924
 The first idea of telemedicine was
introduced
 Depicting the use of television and
microphone for a patient to
communicate with a doctor,
including use of heartbeat and
temperature indicators.
PHIN 211 – PHARMACY INFORMATICS

 1925 TOPIC 3: SOURCES OF DRUG

o The concept INFORMATION (PART 1)
“Teledactyl” was
introduced by Hugo What is DRUG INFORMATION?
Gernsback  A PRINTED information in a particular reference or
 The first uses of telemedicine is to transmit video, images, and VERBALIZED by an individual that pertains to medications
complex medical data occurred in the late 1950s and early  In many cases individuals use this term in different contexts by
1960s. associating it with other words, which include the following:
 1959- used interactive telemedicine o Specialist/practitioner/pharmacist/provider
to transmit neurological o Center/service/practice
examinations, which is widely o Function/skills
considered the first case of a real- Who are considered Drug Information Providers?
time video telemedicine consultation.  Pharmacists
 Doctors
 1968  Nurses
 Medical Researches
 Other health care professionals
Misleading Information
 News Media
 Biased/Wrong Information
 Incomplete Research

 The rise of the Internet in the 1990s also brought with it the
information explosion. The Internet protocols allowed support
for practically all information and traffic needed for
telemedicine.
Some of the affordable measurement devices that are
commonly used with telemedicine include:
 Smartphone cameras
 Digital stethoscopes
 Vital sign monitoring devices

 Wearable biosensors What is the purpose of Drug Information?

 To improve the level of patient care by ensuring SAFE and
EFFECTIVE use of medicines.
What are some relevant terms to Drug Information?
INFORMATION
NEW NORMAL  It is the knowledge obtained from investigation, study, or
ONLINE PHARMACY instruction.
 MedExpress Drugstore  It is to describe it as one or more statements or facts that are
 AideApp received by a human and that have some form of worth to the
 Dima recipient.
 MedGrocer  "knowledge communicated or received concerning a particular
 Mercury Drugstore MEDICATION INFORMATION
 Rose Pharmacy  Used to convey the MANAGEMENT and USE of information on
MEDICATION THERAPY and to signify the broader role that all
pharmacists take in information provision.
POPULATION
 Frequently used to refer to an aggregation or group of
individuals defined by a set of common characteristics.
PHIN 211 – PHARMACY INFORMATICS

DRUG INFORMATICS  Review Articles in journals

 It is used to describe the evolving roles of the medication  Full text computer/ handheld databases
information specialist.  Internet
What is the History of Drug Informatics? Secondary Sources
 Developed in the early 1960s when it was used in conjunction  If the information from the tertiary sources is not recent or
with the words center and specialist. comprehensive enough, it may be employed to direct the
 In 1962, the first drug information center was opened at the reader to review primary articles that might more insight on
University of Kentucky Medical Center. the literature provide topic.
What is Drug Information Center? Example of Secondary Sources:
 To be “a source of selected, comprehensive drug information  Computerized Indexing Systems
for staff physicians and dentists to evaluate and compare  Abstracting Publications
drugs” as well as to provide the drug information needs of Primary Sources
nurses.  Often provides the most recent and in-depth information
 To take an active role in the education of health professional about a topic, and allows the reader to analyze and critique
students including medicine, dentistry, nursing, and pharmacy. the study methodology to determine if the conclusions are
Approaches in Providing Drug Information Services: valid.
 Decentralizing pharmacists in the hospital.  Most specific.
 Offering a clinical consultation service.  Most current.
 Providing services for a geographic area through a regional Example of Primary Sources:
center.  Original Research
DRUG INFORMATION  Case Studies
 It should be stored in the center and retrieved, selected,  Manufacturer’s Monograph
evaluated, and disseminated by the specialist. Other Sources
Drug Information Specialist:  Manufacturers
 The individual responsible for operation of thecenter.  Expert in the field
What are some Medication Information Services?  Internet Websites
 Support for clinical services. What are PRIMARY SOURCES?
 Answering questions.  Original published or unpublished works that introduce new
 Pharmacy and Therapeutics committee activity. knowledge or enhance existing knowledge on a subject.
 Education  Include research results and case reports as well as evaluative
 in services for health professionals, students, consumers. and descriptive studies.
 Medication usage evaluation/medication use evaluation.  These are the foundation for the secondary and tertiary
 Investigational medication control. literature
 Institutional Review Board activities - approve, monitor,  Provide the most accurate information because they contain
and review biomedical and behavioral research involving the original communication of ideas.
humans. ADVANTAGES DISADVANTAGES
 Coordination of reporting programs. e.g. adverse drug Access to detailed information Misleading conclusions based
reactions about a topic and the ability to on only one trial without the
 Poison information personally assess the utility and context of other researches.
 Overseeing clinical trials validity of study results.
What are the Drug Information Resources used in More recent than tertiary or There is a need to have good
Pharmacy? secondary literature. skills in medical literature
evaluation.
Generally, the best method to find information includes a stepwise
approach moving first through: Peer-reviewed Longer time needed to evaluate
TERTIARY SECONDARY PRIMARY the large volume of literature
Tertiary Sources available.
 Provide the practitioner with general information needed to What are SECONDARY SOURCES?
familiarize the reader with the topic.  Refers to references that either index or abstract the primary
 Provide rapid access to information. literature with the goal of directing the user to primary
 General source. literature
 Excellent first-line resources  Indexing
 Rapid access to information  Consists of providing bibliographic citation information (e.g.,
Examples of Tertiary Sources: title, author, and citation of the article)
 Textbooks  Abstracting
 Drug Compendia  Also includes a brief description (or abstract) of the
PHIN 211 – PHARMACY INFORMATICS

information provided by the article or resource cited.  Available in print and also electronically.\
 Frequently used to access the primary literature and usually D. CANCERLIT
consist of bibliographic citations.  National Cancer Institute,
 Most sources identify citation through a computer or “online”  This database is maintained by the National Cancer
searching process, some exist in print form. Institute and indexes from a variety of sources specific to
 Can be used for multiple purposes; one can be to help keep a cancer literature
practitioner of recently published information  This resource is most useful when looking for information
 Find more recent or detailed information on specified about oncology therapies or quality - of life issues
treatment or disease  This resource is updated monthly and is available
 Frequently used to access the primary literature and usually electronically at
consists of bibliographic citations. E. CINAHL
 Available as abstracting services, citations, indexes with or  CINAHL Information Systems,
without full text, and directories.  This is an indexing service that covers literature primarily
 Less current than the primary literature. in the fields of nursing and allied health.
ADVANTAGES DISADVANTAGES  This database is useful when seeking information about
 Saves time Time lag patient care from the perspective of allied health
 Cheaper than journal The time lag for most professionals.
 On-line easy to search secondary sources is now 4-8  It is updated monthly
 Updated information weeks after primary resource F. THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS
can be sent to you publication.  Cochrane Library,
periodically  This database, published quarterly, indexes Cochrane
What are useful secondary resources for common reviews about a variety of medical treatments,
conditions, and alternative therapies.
categories of drug information?
 These evidence - based medicine reviews are based on
TYPE OF REQUEST SECONDARY SOURCE
extensive analysis of current literature and provide
General product MEDLINE, EMBASE, IPA, IDIS treatment recommendations.
information
G. CURRENT CONTENTS
Adverse effects REACTIONS WEEKLY, EMBASE,  Thompson Medical
MEDLINE
 This electronic service offers an overview of very recently
Compounding/Formulations MEDLINE, EMBASE, IPA, IDIS published literature as it relates to scientific
Dietary Supplement MEDLINE, EMBASE, IPA, IDIS information.
 The clinical medicine and life sciences subgroups are
EXAMPLES OF SECONDARY DATABASES AND TYPES OF REQUESTS useful for information about recent drug research and
A. ANTI-INFECTIVES TODAY developments.
 Adis International, H. EMBASE
 This monthly service indexes important new research,  Elsevier, <>
adverse reactions, and pharmacoeconomic data in the  EMBASE is a comprehensive abstracting service covering
area of therapies for infectious disease. biomedical literature worldwide
 Paper as well as electronic formats are available.  This database covers material similar to that covered by
B. BIOLOGIC ABSTRACTING/BIOSIS PREVIEWS MEDLINE®, but with greater coverage of international
 Thompson Medical, publications.
 This is a comprehensive database of biologic information,  Additionally, there is less lag time between publication
covering biologic and biomedical information and inclusion in the database.
 BIOSIS also covers abstracts from conferences relating to  This database is useful when seeking information about
basic sciences. dietary supplements or medications that may be
 This is the most helpful when seeking basic science available in other countries.
information. I. GOOGLE SCHOLAR
 Both print and electronic formats are available and are  Google, <<>>
updated semimonthly  An internet search engine that is designed to target
C. CANCER TODAY scholarly materials available online in a variety of
 Adis International, professional areas including health care.
 This is a monthly indexing and abstracting service  Information from a variety of scholarly journals and
summarizing current literature in the area of cancer publications is able to be searched, however, in some
management. cases, the searcher may not be able to access full-text
 Information from recent trials, case reports, and versions of articles or works due to password restrictions.
international meetings is provided. J. INTERNATIONAL PHARMACEUTICAL ABSTRACTS
PHIN 211 – PHARMACY INFORMATICS

 American Society of Health - System Pharmacists, <> P. PHARMACOECONOMICS AND OUTCOMES NEWS WEEKLY
 Coverage includes drug related information, including  Adis International, <>
drug use and development.  Weekly publication
 This database also abstracts a variety of meeting  Covers recent publications regarding economic use of
presentations. health care resources, as well as information on
 The main focus of this database is pharmacy information, prescribing trends, recent health care news, and
including pharmacy administration and clinical services, regulatory updates.
making it the most comprehensive database for  Focuses on the economic impact of disease states and
pharmacy - specific information. medical intervention.
K. IOWA DRUG INFORMATION SERVICE Q. REACTIONS WEEKLY
 Division of Drug Information Service, University of Iowa,  Adis International, <>
<>  A weekly indexing/abstracting service
 This is an indexing service that allows retrieval of  Summarizes literature involving adverse events, drug
complete articles from a variety of biomedical interactions, drug dependence, and toxicology data.
publications.  Useful when seeking case reports on adverse reactions or
 Indexing is done by database specific term, which at times other information on drug safety
makes searching challenging. What are the advantages and disadvantages of using
 This database is useful for information about standard tertiary sources?
medications. ADVANTAGES
 It is unique in that it provides full articles, in either PDF  Convenient and easy to use
form, or for older articles, microfiche.  Well accepted in medical practice
 There are limited number of journals covered and not all DISADVANTAGES
information from a specific journal issue is covered.  Lag time associated with publication.
L. JOURNAL WATCH
 Medical information changes, may be out of date before it is
 Massachusetts medical Society, <> even published.
 Journal watch is an abstracting service including recent  Incomplete information.
information, summarized by physicians, from a variety
 Errors in transcription
of medical literature.
 Human bias
 A general newsletter covering major medical stories of
 Incorrect information
interest to generalists is published along with additional
 Lack of expertise by authors
newsletters in specific specialty areas.
 Impossible to compile a comprehensive list of tertiary
 This is the most helpful when monitoring for new clinical
resources that are useful in all areas of pharmacy practice.
trials involving specific medications.
M. LEXISNEXIS
What are useful tertiary resources for common categories
 LexisNexis Academic & Library Solutions, <> of drug information?
 This indexing service covers a variety of information TYPE OF REQUEST TERTIARY SOURCE
including medical, legal, and business news. Some General product Handbook of Non-prescription
publications are available full text through this service. information Drugs, Major Compendia
 This resource is helpful when attempting to locate Adverse effects Meylers’s Side Effcet of Drugs, Side
information about recent medical news or research. Effects of Drugs Annual (major
N. MEDLINE® compendia)
 National Library of medicine www.medline.com Availability of dosage form Red Book, American Drug Index
 Coverage includes basic and clinical services as well as (major compendia)
nursing, dentistry, veterinary medicine, and many other Dietary Supplement Natural Medicine Comprehensive
healthcare disciplines. Database, Review of Natural
 Information comes from more than 3990 journals in 40 Product
different languages. EXAMPLES OF TERTIARY SOURCES
 Available in PubMed A. Pharmacology and Drug Information Resources
O. PEDIATRICS TODAY  Goodman and Gillman's Pharmacological Basis of
 Adis International, <> Therapeutics
 This monthly indexing and abstracting service covers o contains general principles of action, absorption,
recent literature regarding then use of drugs in pediatrics distribution and metabolism.
from both biomedical literature and recent clinical o It is a "gold standard" hl
meetings.  Basic & Clinical Pharmacology by Katzung
 Requestors seeking information about pediatric uses of o is a complete and comprehensive general
medications may find this resource helpful. pharmacology text which is utilized nationally as
PHIN 211 – PHARMACY INFORMATICS

primary reference for many pharmacology courses. mechanisms of drug interactions

 American Hospital Formulary Service (AHFS) C. Information on Drug Side Effects
o FDA approved and nonlabeled uses; extensive  Meyler's Side Effects of Drugs
dosage and usage section o Side effects of Drugs Annual
o Published annually with quarterly o lists and discusses side effects associated with drug
 Handbook on Injectable Drugs therapy; comprehensive index referenced by drug
o Covers parenteral infusions, drug stability and and adverse drug reaction
compatibility; o published approximately
o published approximately every two years with an D. Other Information Resources
annual supplement  Remington: The Science and Practice of Pharmacy
 Micromedex o information concerning the practice of pharmacy
o an online pharmacology database which has a vast and pharmaceutical sciences
array of information dealing with pharmacology, o republished approximately every
therapeutics, poison information, etc.
 Clinical Pharmacology
o an online pharmacology database that consists of
extensive, peer-reviewed, current, accurate drug
information for health care providers. Contains full
text information on generic, brand, herbal or
investigational drugs
 Drug Facts and Comparisons
o FDA approved drugs and investigational and orphan
agents; legend and OTC listings;
o good quick-source
 Drug Information Handbook
o alphabetical listing of drugs by generic name; many
charts, algorithms, and tables with information; not
referenced DLR201
o published annually
 Martindale: The Complete Drug Reference
o foreign drug information including selected US
drugs; great resource for obscure information and
for names of drugs in other countries; well
referenced; published by the Royal Pharmaceutical
Society of Great Britain
o published approximately every four years
 Physician's Desk Reference (PDR)
o FDA approved product information; usage and
dosage information only as approved by the FDA.
Not useful for finding critical drug information
o updated annually
 American Drug Index
o listing of products available in US and cross-
referenced by trade, generic, and chemical names;
various pharmacy type information
o updated editions blihdll
B. Drug Interaction Resources
 Drug Interaction Facts
o Mechanism of drug/drug and drug/food interaction
listed as well as clinical significance; well referenced
o updated quarterly for placement binders or available
annually in a text version\
 Hansten and Horn's Drug Interaction Analysis and
Management
o similar to Drug Interaction Facts; an introductory
chapter provides an excellent discussion regarding
PHIN 211 – PHARMACY INFORMATICS

 However, some of these bring to the fore some unrecognized

TOPIC: RESEARCH STUDY diseases and play an important role in advancing medical
DESIGNS science.

What is a Research Study Design?

 A research design study refers to the structured framework
that encompasses the methods and procedures employed to
collect, analyze, and interpret data in order to address a specific
research problem or question. It outlines the systematic
approach and structure for conducting the research, ensuring
clarity in the overall process of investigation.

What are the Classifications of Study Designs?

Cross-sectional Studies
 Involve the collection of information on the presence or level
of one or more variables of interest (health-related
characteristic), whether exposure (e.g., a risk factor) or
outcome (e.g., a disease) as they exist in a defined population
at one particular time.
 If these data are analyzed only to determine the distribution of
DESCRIPTIVE STUDIES one or more variables, these are
 (nonanalytical)  However, often, in a cross-sectional study, the investigator
 Merely try to describe the data on one or more characteristics also assesses the relationship between the presence of an
of a group of individuals. exposure and that of an outcome.
 Do not try to answer questions or establish relationships  Such cross-sectional studies are referred to as “analytical” and
between variables. will be discussed in the next article in this series.
 Examples: case reports, case series, and cross-sectional  Cross-sectional studies can be thought of as providing a
surveys (but may be analytical) “snapshot” of the frequency and characteristics of a disease in
 Sample study: A survey of dietary habits among pregnant a population at a particular point in time.
women or a case series of  These are very good for measuring the prevalence of a disease
Case Reports and Case Series or of a risk factor in a population.
 A case report refers to the description of a patient with an  Thus, these are very helpful in assessing the disease burden
unusual disease or with simultaneous occurrence of more than and healthcare needs.
one condition.  Cross-sectional studies are usually simple to do and
 A case series is similar, except that it is an aggregation of inexpensive.
multiple (often only a few) similar cases.  Usually do not pose much of a challenge from an ethics
 Many case reports and case series are anecdotal and of limited viewpoint.
value.  Carry a risk of bias,
PHIN 211 – PHARMACY INFORMATICS

o i.e., the results of the study may not represent the true subject is recorded.
situation in the population.  The subjects are then followed up over time (longitudinally) to
o This could arise from either selection determine the occurrence of the outcome.
Ecological (correlational) Study Design  Thus, cohort studies are forward- direction studies (moving
 Involves looking for association between an exposure and an from exposure to outcome) and are typically prospective
outcome across populations rather than in individuals. studies (the outcome has not occurred at
 Are convenient to do since the data have often already been
collected and are available from a reliable source.
 Particularly useful when the differences in exposure between
WHAT IS AN ANALYTICAL STUDIES?
 Attempt to test a hypothesis and establish causal relationships
between variables.
 In these studies, the researcher assesses the effect of an
exposure (or intervention) on an outcome.
 Can be observational (if the exposure is naturally determined)
or interventional (if
Observational Studies
 Studies which involve researchers documenting naturally
existing relationship between the exposure and the outcome
they are investigating.
 The researcher does not do any active intervention in any
individual, and the exposure has already been decided
naturally or by some other factor.
 For example, looking at the incidence of lung cancer in
smokers versus nonsmokers, or comparing the antenatal
dietary habits of mothers with normal and low-birth babies.
 In these studies, the investigator did not play any
role in determining the smoking or dietary habit
Interventional Studies
 Are experiments where the researcher actively performs an
intervention in some or all members of a group of participants.
 This intervention could take many forms – for example,
administration of a drug or vaccine, performance of a
Case-control Studies
diagnostic or therapeutic procedure, and introduction of an
 The researcher first enrolls cases (participants with the
educational tool.
outcome) and controls (participants without the outcome) and
then tries to elicit a history of exposure in each group.
 Thus, these are backward-direction studies (looking from
outcome to exposure) and are always retrospective (the
outcome must have occurred when the study starts).
 Typically, cases are identified from hospital records, death
certificates or disease registries.
 Identification of appropriate controls is a key element of the
case-control study design and can influence the estimate of
association between exposure and outcome (selection bias).
 The controls should resemble cases in all respects, except for
the absence of disease.
 Thus, they should be representative of
OBSERVATIONAL STUDIES INTERVENTIONAL (EXPERIMENTAL) STUDIES
Cohort Studies
 In these studies, the researcher actively interferes with nature
 A cohort is defined as a “group of people with a shared – by performing an intervention in some or all study
characteristic.” participants – to determine the effect of exposure to the
 In cohort studies, different groups of people with varying intervention on the natural course of
levels of exposure are followed over time to evaluate the  An example would be a study in which the investigator
occurrence of an outcome. randomly assigns the participants to receive either aspirin or a
 These participants have to be free of the outcome at placebo for a specific duration to determine whether the drug
 The presence or absence of the risk factor (exposure) in each
PHIN 211 – PHARMACY INFORMATICS

has an effect on the future risk of developing cerebrovascular each drug is efficacious but also whether a combination of the
events. two is more efficacious than either of them alone.
o In this example, aspirin (the “intervention”) is the  This design allows the study of two interventions in the same
“exposure,” and trial without unduly increasing the required number of
What are the types of Interventional Studies? participants, as also the study of interaction between the two
1. Randomized controlled trials treatments
2. Nonrandomized controlled clinical trials  Example: Two interventions – A and B. The participants are
3. Interventional studies without concurrent controls randomly allocated to one of four combinations of these
4. Before-after (pre-post) studies interventions – A alone, B alone, both A and B, and neither A
5. Factorial study design nor B (control).
6. Crossover study design  This design allows
7. Cluster randomized trials o (i) comparison of each intervention with the control
Randomized Controlled Trials group,
 •The term “controlled” refers to the presence of a concurrent o (ii) comparison of the two interventions with each other,
control or comparator group and
 These studies have two or more groups – treatment and o (iii) investigation of possible interactions between the
control.
 The control group receives no intervention or another
intervention that resembles the test intervention in some (WEEK 4)
ways but lacks its activity (e.g., placebo or sham procedure, PHARMACY INFORMATICS
referred to also as “placebo-controlled” or “sham-controlled”
trials) or another active treatment (e.g., the current standard What are the TERTIARY Resources used for General Product
of care). Information?
 The outcomes are then compared between the intervention ASHP DRUG INFORMATION (ASHP DI)
and the comparator groups.  American Society of Health - System Pharmacists (ASHP)
Nonrandomized Controlled Trials  [www.ashp.org]
 In this design, participants are assigned to different  Organized by MONOGRAPHS
intervention arms without following a “random” procedure.  Containing information on:
 For instance, this may be based on the investigator's o Food and Drug Administration (FDA) approved
convenience or whether the participant can afford a medications
 Although such a design can suggest a possible relationship o off-label uses of medications.
between the intervention and the outcome, it is susceptible to CLINICAL PHARMACOLOGY
bias – with patients in the two groups being potentially  Gold Standard
dissimilar – and hence  [http://cp.gsm.com/]
Interventional Studies w/o Concurrent Control
 Has monographs of prescription and nonprescription products
 When a new intervention, e.g., a new drug, becomes available, as well as some dietary supplements.
it is possible to a researcher to assign a group of persons to
 This can also screen drug interactions, create comparison
receive it and compare the outcome in them to that in a
tables for prescription drugs, determine intravenous
similar group of persons followed up in the past without this
(IV)compatibility, and search for tablets by description or
treatment (”historical controls”).
imprint codes.
 This is liable to a high risk of bias, e.g., through differences in
 Patient education section is also available
the severity of disease or other factors in the two groups or
DRUGDEX SYSTEM
through improvement over time in the available supportive
 Thompson MICROMEDEX
care.
 [www.thomsonhc.com]
Before-after (pre-post) Studies
 This electronic resource is a database within the
 In this design, a variable of interest is measured before and
MICROMEDEX system.
after an intervention in the same participants.
 Contains:
 Examples include measurement of glycated hemoglobin of a
o FDA-approved indications
group of persons before and after administration of a new
o off-label uses
drug (in a particular dose schedule and at a particular time in
o pharmacokinetic data
relation to it) or number of traffic accident deaths in a city
o safety information
before and after implementation of a policy of mandatory
o pharmacology
helmet use for two-wheeler
DRUG FACTS AND COMPARISONS
Factorial Study Design
 WolterKluwer Health, Inc.
 If two (or more) interventions are available for a particular
disease condition, the relevant question is not only whether  [www.factsandcomparisons.com]
PHIN 211 – PHARMACY INFORMATICS

 Organized by DRUG CLASS  Information from the United States Pharmacopoeia (USP) Drug
 Information is provided about specific agents, including Information (DI) resources is also included in MICROMEDEX
inactive ingredients in commercial preparations. healthcare Series.
DRUG INFORMATION HANDBOOK  VOLUME I:
 Lexi-Comp o Contains information for the health care professional
 [www.lexi.com] o Organized into MONOGRAPHS based on nonproprietary
 Organized in BRIEF PRODUCT MONOGRAPH names.
 Information is presented regarding clinical use, safety , and o Information included:
monitoring for a variety of drugs.  Indications
 Contains:  Pharmacology
o FDA-approved medications  Pharmacokinetics
o off-label use of medications.  VOLUME II:
 There is a limited table identification section as part of the o Contains advice for the lay person
electronic format. o Material intended to supplement counseling by a health
HANDBOOK OF CLINICAL DATA care professional
 Organized into MONOGRAPHS and COMPARATIVE CHARTS.  VOLUME III:
 Contains information on: o Information about therapeutic equivalence and
o Dosing USP/National Formulary (NF) requirements for labeling,
o Dosing adjustments for special populations storing and packaging drugs.
o Adverse events o Information about regulations and statutes impacting
o Pharmacology pharmacy.
o Pharmacokinetic data. o ORANGE BOOK - first portion of this volume and contains
 Serves as a quick reference rather than an in-depth review. the same information that is available through the FDA
HANDBOOK OF NONPRESCRIPTION DRUGS: AN INTERACTIVE USP DICTIONARY OF USAN AND INTERNATIONAL DRUG NAMES
APROACH TO SELF CARE  U.S. Pharmacopoeia
 American Pharmacists Association (APA)  [www.usp.org]
 [www.aphanet.org]  Official resource for determining generic and chemical names
 Organized by BODY SYSTEM of drugs, as well as the international nonproprietary name.
o focusing on those disease states for which self care may  Contains additional information:
be appropriate. o Chemical structure
 Contains information on: o Molecular weight
o Comparative efficacy of various over -the-counter (OTC) o Chemical Abstracts Service (CAS) registry number
agents o Pronunciation guide
o Contraindications for self-treatment ADVERSE EFFECTS
o Drug interactions MEYLER’S SIDE EFFECTS OF DRUGS
o Other safety information  Elsevier Publishing
 Use of treatment algorithms and patient care cases make this  [www.elsevier.com]
resource especially helpful for students and new  Published every 4 years with annual updates
practitioners  Provides a critical review of international literature in the area
PHYSICIAN’S DESK REFERENCE (PDR) of adverse events.
 Thomson Healthcare  Chapters - Organized by DRUG CLASSIFICATION
 [www.thomsonhc.com]  Adverse events - Organized by drug name and then by organ
 Compilation of PRODUCT PACKAGE INSERTS. system within each drug.
 Contains additional information: AVAILABILTY OF DOSAGE FORMS
o Contact information for manufacturers AMERICAN DRUG INDEX
o List of poison control centers  Facts and Comparisons
o Limited tablet identification.  Contains brief entries, indexed by product and generic name
 Available: electronic online package from Thomson and via  Contains information on:
MICROMEDEX, as well as in a PDA format.  Product use
 Specially texts PDR:  Available dosage forms and sizes
o PDR for herbal medicines  Charts are also available, including:
o PDR for Nutritional supplements o Look-alike/sound-alike medications
o PDR for Ophthalmic medicines o Pregnancy categories
o PDR for Nonprescription Drugs and Dietary Supplements. o Normal laboratory values
USP DI VOLUMES I, II, AND III o Common pharmacy calculations
PHIN 211 – PHARMACY INFORMATICS

 Updated annually.  Discussion:

RED BOOK o Compounding techniques
 Thomson Healthcare o Explanations of additives used in compounding
 Contains information on: USP/NF
o Prescription  Available in both text and CD-ROM format
o OTC product availability and pricing  Contains the official substance and product and product
 Include a number of tables listing information such as sugar- standards
free, lactose-free, or alcoholic-free preparations.  Official preparation instructions are given for a limited number
 Additional information: of commonly compounded products.
o National Drug Coded (NDC) numbers  Some journals are especially useful for compounding “recipes”
o Routes of administration (ex. International Journal of Pharmacy Compounding, U.S.
o Dosage form, size, and strength. Pharmacist, or American Druggist)
COMPOUNDING
ALLEN’S COMPOUNDED INFORMATION
 American Pharmacists Association
 [www.aphanet.org]
 A collection of U.S. Pharmacist columns that have been
printed as text.
 Provides method of
o Preparation
o Stability
o Discussion of utility of the dosage form.
EXTEMPORANROUS FORMULATIONS
 American Society of Health-System Pharmacists
 [www.ashp.org]
 Compilation of PUBLISHED RECIPES with STABILITY DATA.
 Most products are ORAL FORMULATIONS to reflect the
unique needs of some pediatric patients.
 Information is also provided about LEGAL and TECHNICAL
ISSUES in compounding practices.
MERCK INDEX
 Provides descriptions of the chemical and pharmacologic
information about a variety of products.
 Contains:
o CAS number
o Chemical structure
o Molecular weight
o Physical data: solubility, which may be especially useful
in compounding.
 Available: print, online and on CD-ROM.
REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY
 Lippincott Williams and Wilkins
 Contains information about all aspects of pharmacy practice.
 Discussion:
o Social issues impacting pharmacy
o Information about the basics of pharmaceutics,
manufacturing, pharmacodynamics, and medicinal
chemistry.
 Information is provided regarding common compounding
techniques and ingredients.
A PRACTICAL GUIDE TO CONTEMPORARY PHARMACY PRACTICE
 Lippincott Williams and Wilkins
 [www.lww.com]
 A text resource with CD-ROM
 Organized in an OUTLINE FORMAT to easily find information.