DRUG l{FoRMlTroN, EvTDENcE-B,rsED MEDtctNE, REsE ncH, aND HIpAA

Dnuc I NronvATroN, EvloENcE-BasEo

MEorctNe, ResEARcH, AND HIPAA

Kevrx M. SowrNsxr, Pxanv.D., FCCP

Punoue Uxrvgnsrrv, ColuecE oF PHARMACy

lxorlNl UNrvERstry Scxoot- op Meorcrxe
lNDraNApoLts rxo Wesr Llayerre, lxorlxr

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I. INTRODUCTION

A. Why Do Phamacists Need to Know About These Topics?

B. As these topics pertain to you:

Amb atory Care Pharmacv Specidli) Examinqtion Content Outline

Domain4: Retrieval, Generation lnterpretation, and Dissemination ofKnowledge (15olo of the examination)

l. Retrieve and interplet biomedical literature with respect to study desigo methodology, statistical
analysis, and significarce and applicabiliry ofreported data and conclusions.
2. Respond to drug information requests fiom patients and health carc professionals,
3. Educate pharmacists, physicians, olher allied health care professionals, students, and residents on the
principles and practicc of evidence-based medicine (EBM).
4. Prcvide health- and medication-related education to heahh care professionals.
5 Conduct researcb as a principal iovestigator or coinvestigatd to geDcrate knowledge appiicablc to
ambulatory carc pharmacy practice
6. Prepare and disseminate results ofinvestigations (e-g , case reports, abskacts, reviews, monographs)
through publications and presentations to local, regional, and national audiences.
7. Document and report adverse drug-related events as appropriate (e.g., adverse reactions, drug
interactions, drug/device/assay defects) to add to the body ofknowlodge.

II. OVf,RVIEW OF DRUG INFORMATION RESOURCES

A. Tertiary Literat[re
L Eslablished knowledge or consensus ofopinion; works that summarize, discuss, criticize, etc.,
ttle primary literature
2. Pros
a. Provides an analysis and summar.y of the primary literature
b. Provides discussion of sludies that ale thought to be well cooceived and significant to the field
c. Usually easy to use; more concise, accessible, and convenient
3. Cons
a. Signincant lag time for lrpdates - PrirDary literature publication outpaces tertiary literature.
b. Interpretalion is dependent on the author's opinion, which may lead to incorrect inte.pretation
ofprimary lit€rature.
c. lncomplere; space limitations may exist
4. Formats
a. Available as paper text, as CD/DVD-ROM, online, or as mobile applications (pDA, tablet,
smartphone)
b. Electronic access online is generally considered the easiest to use, tbe most up to da!e, and the
most accessible format to u-se from multiple locatiods.
c. The contcDt ofinformation in each format is not necessarilythe same,
d. Mobile applicalions are a rapidly expanding area. The content ofinformation for mobile
applications is likely to be different from other formats ofthe same title because ofstorage and
memory limitations,
5. Evaluation oftertiary rcsources
a. Authors' experience/expertise relative to the topic; arc they experts, with appropriate experience?

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b. ls the information limely based on publication date or is this a rapidly changing topic?
c. Is the conclusion ofthe author supponed by the primary literature? And is tbe rvork
properly cited?
d- ls the resource relevant and free ofbias or blatant errors?
e. Quality of references used
6. Selected tertiary drug information resources for the ambulatory care clinical pharmacist
a. References selected are available electronically, are geared toward the health aare professional,
provide drug and altemative trealment monographs, and provide patienForiented informalion.
Many other apprcp ate refercnces are available; this is only a partial list.
b. Clinical Pharmacology (www.clinicalpharmacology.com)
c. DrugFactsandComparisons (www.factsandcomparisons.com)
d. Lexicomp onliDe (wwwlexi.com)
e. MicromedexHealthcareSeries(www.rnicromedex.com)
i. Detailed Drug lnformation for the Consumer
ii. CareNotes System

B. SecondaryLiterature
1. Index or abstract prima.y liierature, and tertiary literature found injournals, with the goal of
directing the user to the primary literature
2. Primary purpose is to provide a rapid method for searching the p mary literature and keeping readers
well informed on primary literature publications.
3, Most secoddary literature is electronic or online databases.
4. Indexing system: Provides biographical citation information (title, author, citation, etc)
5. Absfaciing system: Provides biographical citation inforrnation and an abshact
6. Pros: Provides elhcient and accessible access to the primary literature
7. Cons
a- Different databases use differcnt "vocabulaty" or search strategies,
b. Only abstracts or citations are available; primary lirerature ftom the s€arch must be obtained
from alternative sources and is costly.

C. Primary Literature
I Original articles that have nol been in[erpreted, condensed, or evaluated (except by peer review)
by others
a. Research studies and reports; case studievseries published and unpublished
b, Reyiew a icles or editorials are not primary literature.
2 Pros
a Detailed, original articles
b. Direct access to the research reports and conclusioos
3. Cons
a. The reader must sift through methods, interpret tbe data and conclusions, and make decisions
about tbe author's coDclusiotr.
b. The reader must bave slrong literature evaluation (statistics, clinical study, ac.) skills-
c. Tinre-consumiDg, both inthe searching and inthe evaluating

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Table l. ExaDples ofPrimary, Secondary, and Tertiary Literature

Primary Literature Sccondary Literature Terliary Literature

Original articles
tandomized contolled
clinical trials.
nonrandomized,
prospective, clinical
tr-ials, cohort studies,
case-control studies, case
series, and case reports)
CINAHL
Medline General textbooks (Pharmacotherapy,
EMBASE Applied Therapeutics, Briggs Pregnancy
PubMed and Lactation, Meyler's Side Effects
Google Scholar ofDrugs, etc.)
Iowa Drug Information System General product information (Amencan
0Drs) Hospital Formulary Service, Drug Facts
Journal watch and Comparisons, Physicians' Desk
LexisNexis RefereDce, Drug lnformalion Handbook,
BIOSIS Clinical Pharrnacology, UpToDate. etc )
lnternational Pharmaceutical Revielv articles
Absrracts (IPA) Treatment guidelines
Cochrane Library Electronic textbooks and databases
Current Contents (McGraw-Hill ACCESS Pharmacy,
STAT!Ref, Lippincott Health
Sciences Library)

III. INTERNET SOURCES OT'DRUG INF]ORMATION

A Introduction: Usg oflhe Int€met for Drug IDformation

1. CurrentLy used as a drug information tool by the majority ofU.S. aduhs
2. Increased number in the past decade of U.S. adults who use the Intcmet for drug iDformation
3. Instituk of Medicine: "The Intemet is a bit like the Wild Wes[: It has vast anounts ofuoregulated
territory and oo one in charge "

B. Search Engines
I Basic search engines (Google, Yahoo, Bing, etc.)
a. Search tool that sends the user's search requesl. to a single search engine
b. Exarnples: Google, Yahoo, Bing, ASK com
2. Metasearch enghes
a. A seaich tool that sends the user's scarch request to multiple search engines and/or dalabases
b. Examples: Dogpilc.Metacrawler,Webcrawler
3. Boolean logic: Use ofBoolean opsrators such as g4!, q1, and nq! to help narrow searches
4. Medline MeSII terms
a. Standardized vocabulary used for indexing in MEDLINE
b. Content filters: Specific for a drug or disease being searcbed. Ensules the searcher is looking for
tbe most appropriate contenr (e.g., heart failure)
c Validity filters: Use to narow the search to only the highesr-quality studies (e.g., randomized
controlled trials, double-blind snrdies).

C. Evalualing Information on the lnlemet

L EvalMtioninstrumeots
a. ldedicalion Website Assessme Tool
b. HON (Health on the Net Foundation) Code of Conduct
c. Heallhcare Website Asscssment Tool (TIWAI3.0)

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2. National Institutes of Health tulorial: Tutorial geared toward patieots

Table 2 Questions to Ask W}eo Evaluating Web Sites

Parameter Questions
Source of What and who is responsible for the site and is this information readily available on the site?
informanon What is the puryose of the site? Wlry was rhe Web site created, and what is tbe mission in
providing the in formation?
Cost ofacc€ss Does the site want anything from you in return? Ifso, what and why? Does the site want
yoBr personal information, alld ifso, what will the site do with it? What personal information
is required?
Who is funding the site? ls there a site sponsor? Is the sponsorship readily available on 1he
Web site and openly displayed? Does the sponsor gair any benefit?

Quality of ls the information current? Is the information correct? Has it been \.ritten and/or reviev,'ed by
information appropriateLy trained health care professronals? Is tbe information based on opinion or high-
quality controlled clinical trials? Wlat is the cditorial policy for thc sire?
Usability Does the site provide information such as a site map, conlact information, a mission/purpose
statement, or the best way to usg the sitc?
Does the Web site make unbelievable claims or claim to be the answer to all questions or
problems? Does it claim to be the only one to have truc insigbr into the issues?
Adapled ftom PSAP VlIl; information abstract€d from Nalional Library ofMedicift

TV. EWDENCX"BASED CLINICAL PRACTICE

A Introduction to Eeidence-Based Pharmacy,Medicine (EBM)

l. EBM uscs the scientific method as an important source ofknowledge. In addition to the scienrific
mclhod. other sources ofknowledge are listed below.
a. Reference to tsadition: Accepting certain truths or facts as givens
b. Reference to authority: Placing trust in those who are experts in a given area
c. Trial and error: Making several attempts to solve a problem by chance Used when no other
basis for making a decision is possibl
d. Logical reasoning: Deductive reasoniDg
e Scientific method: Applying a logical process to identiry a problem, collocting data, and
developing a conclusion
2. Definitions
a. "The conscientious, explicil and judicious use ofcurrent best evidence in making decisions
about the care ofindividual patienrs while inkgrating clinioal experience with the best available
evidencc liom a systemic search" (Sackctt 1996)
b. EBM is the inte$ation ofclinical expertise, patient values, and the b€st research evidenca
into the decision-making process for patient care. Clinical expertise refers to the clinician's
cumulated expeiience, education, and clinical skills. The patient brings to the encounter his or
her own personal preferences and unique concams, expectations, and values. The best research
evidence is usually found in clinically relevant rcscarch that has been conducted using sound
nethodology (Sacken 2000).
c Proc€ss of nraking discase managemsnt decisions by evahrating and rating the quality of studies

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d. Criticisns ofEBM
i, "Cookbook" or reduced clinician autonomy
ii. Too difficult to apply to individual pahents
iii. Limited data to suggest that evidence-based guidelines tmnslate to improved care
3. Summary of factors that in.fluence the medical decision
a. Clinical evidence
b. Clinical experience
c. Patient cicumstance
d. Patietrt desires
4. Five-step process ofEBM practice
a. Assess the patient: Start with a question thar comes from the clinical care of a patient_
b. Ask the question: Develop an alswerable questiod that rcflects the clinical dileluma posed.
PICO formatl
i. (P)roblen/patienL/populalion
ii. (I)ntervention
iii. (C)omparison
iv. (O)utcome
c. Acquire the evidence: Gather and assemble the dara needed to make a conclusioo.
d. Appraise the evidenc€: Use literature evaluahon skills to assess the quality, qrurtity,
and applicability ofthe data collected-
e. Apply to the patient: Incorporate the evidence into clinical practice.
f Act on and assess your dccision.
5. EBM approaches
a. Top-down: Describ€s the EBM process, which requires resources and time. This approach is
best-suited lor situatioos in whicb decisions are made about groups ofpahenls
(e 9., evidence-based guidelines).
b. Bottom-up: Describes the EBM process with fewer resources and limited time. This approach
is best-suited for indilidual patient decisions when resources ard time are limited
(e.g., day-to-day decisions that clinicians must make).

T.ble 3. Levels ofEvidence Based on Several Evaluation Scales

Ranking Type of llvidence CEBM Scalc USPSI'F Scale ACC Scale
Ilighest RCT 1" I
Nonrandomized, -l B
prospective, CT
Cohort studies 2' -2 c
Case-control studies 3" -2 c
Case series 4 II-3 c
Lowesl Expert opinion 5 III
"A syslenatic review of these study ryp€s ranks bigherrhaD iodi!idual studies.
ACC = Anlericar College ofCardiolosy; CEBM = Centre for Evid€nce-Based Medicine; CT = clinical trial; RCT =randomrzed controlld triali
USPSTF = United Slates Pre!€nti!€ S€rvices T&sk Force.
PSAP V

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B. Evaluating Clinical Guidelines

1 .
Agency for Healthcare Researcb and Quality
a. NationalGuidelinesClearinghouse(wwvguidelines.gov)
b. Allows a comparison ofguidelines
2. Appraisal ofGuideliues for Research and Evaluation (AGREE)
a. Evaluates the process ofpractice guideline development and the quality ofreporting
b. www. agreetnrst.o€/
3. Bandolier
a. "Evidence-based thinking about healthcarc"
b. lndependent group based in Oxford, United Kingdom
c. *t'w.medicine.ox.ac.uk/bandolier/index.html
C. Sources ofClinical Gr.ridelioes (Note: These are only exarnples, nol a complete list )
L National Libnry ofMedicine (PubMed) (www.pubmed.gov)
2. Agency for I{ealthcare Research and Quality (w\lrr'.ahlq.gov)
3. National Instihte lor Clinical Evidence
a. www.nice.org.u!/
b. UK National Health Service
4. Cochrane Collaboration (www. cochrane. org4
5 Association Web sites
a. American Heart Association (wrrr.heart.org)
b. Amcrican College of Cardiology Foundation (&1r.,'/,acc.org)
c American Society for Clinical Oncotogy 6vww.asco.org)
d. American Academy of Family Physicians (wwwaa&.org)
e. The American Society ofHealth-System Pharmacists (www.ashp.orglbestpractices) provides
links to best practice policies and guidelines_

V. INSTITUTTONAL REVIEW BOARD/IIUMAN SUBJECTS' RESEARCII

A. Definirions
L Research: "Systematic investigation (i.e., research developmenj" testing, alld cvaluation) designed
to develop or contribute to generalizable knowledge"
2. Human subject: "Living individual about whom an investigator obtains data thJough intervention
or interaction with the individual OR identinable private information"
3. Quality improvement versus rcsearch
a. In general, ifthe results of a project are Fesetrted outside an organization (i-e,, contributes to
generalized knowledge), either as a p[blication or a presentatiorL it is defined as research.
b. Ifthe results ofa projectare to be used intemally, aDd not meant to contribute to ge[emlized
knowledge, then the activities will fall under quality improvement. Ideally, the institutional
review board (IRB) makes this decisjon.

ts. History and Developrnent ofResearch Ethics

L Nuremberg Code (1948)
a.
Subjects should give infomed voluntary consent.
b.
The benefits of research must outweigh the risks.

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2. Declaration ofHelsinki (19 )

a. Govems intemational research ethics
b. Defines rules for "research combined with clinical care" and "nontherapeutic research"
c. Basis for good clinical pEctices used today
3 . Tuskegee Syphilis Study ( I 972)

a- The study did not minimize risks to humaD subjects. In fact, it increased their risk.
b. These issues hcightened awareness ofthe need to prot€ct human subjecls and to ensur€ their
informed voluntary consent
4, Belmont Repon ( 1978): Prepared by the National Commrssion for the Protection ollluman Subjects
ofBiomedical and Bebavioral Research. which:
a. Srunmariz€s the basic elhical principles ideorifi€d in its deliberatioos
b. Selaes as a stalement ofbasic ethical principles and guidelines that assist in .esolving tbe etbical
problems that sunormd the conduct ofreseatch with human subjects
5. Code ofFederal Regulations (CFR) (1981): The Deparrmcnr ofHealrh and Human Services (DHHS)
and the U.S. Food and Drug Administration (FDA) issued regulatiors according to the
Belmont Report:
a. DIIHS: CFR Title 45 (public welfare), Pan 46 (protecrion ofhunan subjecrs)
b. FDA: CFR Title 2l (food and drugs), Parts 50 (protedion of buman sublects) and 56 (tRBs)
6 Common Rule ( l99l)
a. Obtaining and documenting informed consent
b. IRB membenhip, fi.mction, operations, review ofresearch, and recordkeeping
c. Additional protections for certain !,ulnerable research subjects: Pr€gnant women, prisone$,
children, individuals with impaired capacity
d. Ensuring compliance by research institutions
i Atl inslitutions that conduct federally sponsored research must provide the federal
govemment an "assurance" that slates the institutioo's principles for protecting the righls
and welfar€ ofhuman subjects.
ji. MPA (multiple project assurance) js the most common approach !o this.
7. IRB review ofstudies: Reviewed at one of three levels, depending on the level of risk to the human
subjects. Thc federal guidelines that define the catcgori€s ofrevieq which are:
a. Exempfon fiom full IRB rcview
i Calegories
(a) Research conducted in established or commonly acccpted educational settings
(b) Research involving the use ofeducational tests (cognitive, diagnostic, aptitude,
achievement), survcy procedures, interview procedrues, ot observation ofpublic behavior
(c) Research involving the collection or study ofexisting data, documents, records,
pathologic specimens, or diagnostic specimens ifthese sor.rrces are publicly available ot
ifthe information is recorded by the investigator in such a marmd that subjects cannot be
identified, dfuectly or through identifiers linked to the subj€cts
(d) Research and demonstrarion projects that are conducGd by or subject to the approval of
department or agcncy heads
ii. Projects arc no! assigned an expiration date.
iii.The IRB makes the final decision on exemption; a stallmember usually revie\.vs the proposal.
iv. Review u-sually takes a few days.
b. Expedited IRB review
i. Minjmal risk to pafticipant
ii. Minor change to previously approved study
iii. Involves minimal risk to subjects

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iv. Chairyerson or designee revie\r,s the proposal.

v. Redew usually takes a few weeks.
c. Full IRB revi€w: More tban minimat risk
i. Review protocol and supponing documents.
ii. Lengthy process, usually moDths
iii. Full IRB reviews the proposal.

Table 4. Examples ofIRB Rcview Categories

Qpe of Review Examples

Exemption from reyiew Epidemiologic study with NHANES data

Study of changes in the number of days

requiring antibiotics using de-ideutifi ed
institutional data
Expedited review Cross-sectional study of pstients with heart
failure measuring a biomarker, requiring a
single blood sample

Case-control study of the relationsbip

between admission to the hospital and
drug use
Full review Raodomized controlled trial of a new drug
or device for heart failure therapy

Cross-sectional study requiring

bronchoscopy after admidstration of
methachol ine
IRn = insljtutio l review boardi NHANES = Nalional Healrh a.od Nulririon ExatDinatioE Surv€y.

8. IRB composition
a- At least 6ve members
i. Chairperso!
ii. Scientific membe r
iii. NoDscientificmember
iv. Lalpersotr uDafEliated with fte instibrtion
v. Practitioner
b. Su{ficient qualifications through the exp€rience, expertisg and diversity of ils lnembers and
back$ormds, including considerations oftheir racial and cultwal bsritrage and their sEnsirivity to
issues such as conmr.mity attihndes, to proDote respect for its advice and couosel in safeguarding
the rights and welfare ofhunan subjects
c. Membership must be able to ensue protection of wherable populations-
d. Membership must come from mote than onc profession.
9. Informed consent
a. Informed consent is a Focess, not a fom. IDformation must be presented to the itdi.I.idual
(or refrrcsetrtative) to edable that person to rDake a voluDtary decision to participate as
a research subje€t.

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b. Components
i. Description of any reasonably foreseeable rjsks or discomforts
ii. Description ofany benefts to the subject or to othcrs that may reasonably be expected
iii. Disclosue of appropriat€ altemative procedues or courses ofuealment, ifany
iv. Stalement describing the extent, ifany, to which confidentiality ofrecords identifying the
subjoct will be maintained
v For research itrvolving more than minimal risk, an explanalion about whether any
compensation and an explanation about whether any medical treatments are available
if injury occurs
vi. Contact information for answers to questioN about the research and research subjects' rights;
whom 10 cootact if the subject has a research-relaled injury
vii. A statement that participation is voluntary; refusal to pafticipate will involve no penalty or
loss ofbenefits, and the subjcct may discontinue participation at any time without penalty
c. Waiver or alteratiotr ofconsent: An IRB may waive/alter informed consenL ifthe following
are met:
i. No more than minimal risk
ii. Will not adversely affccr the rights and welfare ofrhe subjccts
iii. The research could not practicably be carried out wilhoul waiver
iv. Subjects will be provided additional pertinent information aner participation.
d. An IRB may atso waive informed consent in a limited class ofresearch in emergency settings.

vI. HIPAA (TIEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF T996)

A. Health Care Access, Portability, and Renewability (Title I): Ensures that indiyiduals moving ftom one
health plan 10 another or to anolher tjpe ofhealth plao (individual vs. group) will have continuity of
coverage and will not be denied coverage under preexisting condition clauses or othet reasons

B. Prevcnring Health Care Fraud and Abuse; Administrative Simptificatiotr; Medical Liability
Reform (Title II)
1. Privacy rule
2. Transactions arld code set rules: Simplify transactlons
3. Sccurity rule: Administrative, physical, and technical sandards
4. Enforcemcnt rule: Increases the federal govemment's fraud enforcement authority in many meas
5. Unique ldentifiers Rule (National Provider Id€ntifier)

C. Sets a National Stardard for Accassing and Handling Medical Information. Privacy is now the law
latber thao an ethical issue.

D. Covered Entities
L Health care providers who conduct cerlain financial and administrative transactioos (billiog,
fund transfers) elechonically
2. Healrh plans and hcalth care clearioghouses

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E. Protected Health lnformation (PHI): 18 identifiers

I Name
2. All gmgraphic subdivisiors smaller than a srate, including srreot address, city, county, precinct.
and zip code, and their equivalent geocodes, except for the initial thee digits ofa zip code, if
according to the crrrent publicly available data from the Bureau ofthe Census:
a. The geographic unit formed by combinirg all zip codes witb the sarne three initial digits contains
more than 20,000 p€ople, and
b. The initial tfuee digits ofa zip code for all such geographic units containing 20,000 or Gwer
people is changed to 000.
3. All elemeots ofdales (except year) for dates dircctly relared to an individual, including bifth dale,
admission date, discharge date, and date ofdeath; and all ages older than 89 yea$ and sll elements of
dates (includidg year) indicative ofsuch age, except thar such ages and elements nlay be aggegated
into a single category ofage 90 or older
4. Telephone numbers
5. Fax numberc
6. Electronic mail addresses
7. Social Security numbers
8. Medical record numbers
9. Health plan beneficiary nurnbers
10. Account numbers
ll. Certificate and license numbefi
12. Vehicle identifiers and serialnumberq including license plate numbers
I 3 Medical device identifiers and serial numbers
14. IDtemet uniyersal resource locatoN
15. lP (Internet protocol) addresses
16. Biometric identifiers (fingerprints and voiceprints)
17. Full-face photographic images and comparable rmages
1 8. Any other unique identifyiog number, characteristic, or code (may assign a code for de-identified
infonDation to be re-idenrified)

F. Br6iness Associares Agreement

1. PHI belongs to the covered endty, but alother person (noncmployee HCp lhospital heahh care
personnell providing service to the covered entity) is using or disclosing the PHI to pqform a function
or activity on behalfofthe covered entity
2. Provlding services to the covered entity if the Fovision of the service involves tlle disclosure ofPHI
to the service provider

C. Patient Information
1. Patients must be notified if thefu health information is uscd and disclosed, and they mr.st be notified of
their nght to privacy under HIPAA.
2. Usually, by a Notice ofP vacy Plactices (letter or brochure)

H. Responsibilities as a llealth Carc Provider

l. Ifyou use or share health information that is not work-related, you could be subject ro disciplinary
action (loss ofprivileges, dismissal) or civil and,/or crimural pcnalties.
2. You can share patient infoimation for work-related reasons:
a. Treatment: Provide, coordinate, maDage health or rclated services; consultations; referral
b- Pa).rnent: Obtain payment or reimbursement for providing health care services: Determining

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eligibility, adjusting insurance rates, handling billing and claims managemedr, handling
colleciions, handling prcauthorizations, and determining medical necessiry
c. Health care operations-Things that we do to run and that improve ow business
d. Aurhorued by the patient: If patients give permission to use or disclose their pI{I, we can share
the minimum amount of infomation necessary to accomplish orrl prupose
3. Day-to-dayactivities
a. Be mindful ofbulletin boards, white boards, desks. computer monitors \Mithout privacy screeis, etc.
b. Discussions with palientvfamilies: Draw curfain, speak quietly; find an cmpty room or
other p vatc area
c. Do not discuss what you see and hear at work or in places such as hallways or clevators.
d. Use sbredders or place in HlPAA-compliant locked rccycling bins. Do not place in garbage or
unlocked bins.
e. Pdnters and fax machines should be in appropriate locations. Many fax machines and copiers
have hard drives
f. Do not share user accouot when PHI is accessible (or ever).
g. Electronic mail is usually not secure; encrj.ption and password protection varies by oryanization-
h Cloud-based storage looations: Dropbox, Dox, Google, etc, Check with your institulion.
Srnarphones, USB storage drives, laptops, and lablctst Major concems for privacy

L ResearcvQuality Improvement Under HIPAA

L Researcb: Approved by the IRB
a. IIIPAA authorization: Permission ftom individuals to use thefu PHI. Cefiain stateDents are
required on the informed consent. Some starcmenls depend on the requirements oflocal IRBS.
b. De-identified data
c. Limited data sets
2. Ifyou are reviewing a patient record for anything other ftan a need to know the basis for rhe care
ofa patien! then you need to determine whether it is quality improvcment or tesearch and take the
appropnate achon_
3. Quality improvement: Work with intcmal committees. l-or example, a review of adverse drug reactions
Dsually takes place under thc authority of tlle Pharmacy and Therapeutics Committee (a medical staff-
authorized quality imFovement activity).

J. Penalties for Violations

l. Civil penalties: Accidental disclosure:g 100/persor/violatior, up to $25,000 per year

2. Criminal penalties;
a. Knowing misrue of information: $50,000 and I year in jail
b. False pretenses: $100,000 and 5 yean injait
c. Ilarmful intelt, sell intbrmarion: $250,000 and l0 years in jail
K. HITECH (Health Information Tecbnology for Economic and Clinical I{ealrh Act)
L Title XIII oftheAmerican Recovery and ReinvestrncnrAct of2009
2. Purpose is to promote and expand the adoption ofhealth information technology.
3. ADticipates the incre?rse in clectronic ttansactions ofPHI, thus increasing the scope ofprivacy
and security prctections
4. Civil penalties for willful neglect up to $250,000 with repeat or unconected up to $1.5 million
a. Breach notificalion: Notiry parient ofall breaches.
b. Breach notilication: Notiry DFIHS and rhe media ifgeatei than 5OO patients.
5. Ifprovider has an electronic health record system, individuals may obtain their PHI €lecfionically
(cPHl); the iddivrdual can also designate a third party ro rec€ive the ePHI.

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VII. PROFESSIONAL WRITING: THE PUBLICATION PROCESS

A. himary l-iterature
l. Experimeotal studies
2. Observationalshrdies
3. Descriptive reports

B. hrblication Process
l. Joumal selection
a. Topic
b. Joumal quality
i- Impact factor
ii. Immediacy index
c. Open access
2. Prepantion of submissiotr: Paper parts
a. Title page
b. Ab6tract
c. Introduction/background
d. Methods
9. Results
f. Discussion
3- Editorial aqd peer rcview
a, TITES ofreviews
i. Single-blind rcview: The reviewsr's id€drtity is hidden ftom the author, but the reviewer krows
the author.
ii. Double-blind review: Both reviewer and author [e blinded.
iii. Open review: Reviewer and author are known to each other.
iv. Publishcd review: RevieweE' comnenLs are published together with the paper.
b. Role ofreviewer
i. Does the sciEnrific conient have value and odginality?
ii. Is the paper consistent withjoumal guidelines?
iii. Are the methods appropriare?
iv What changes should be nade or additiodal experimetrts conducted?
v Make a rerornmendation (accep! revise, rcject) to rhe editor
4. Revision process
5, Poor-quality researclq why?
a. Academic scieDtists rced to publish.
b. Poor training or investigatorvwrile6
c- Lack ofreviewers with sumcient ktrowledge or tirDe !o review
d. Leest publishable unit: Multiple publications frorn sarne snrdy
e. Other influences
i. Curreot political issues and hot topics
ii. lndustry
(a) Design and tunding of sJudies
(b) Commens during publication stage
(c) Ghost \lritels
(d) homotional activities

ACCD Updates in Therapeuticso uot4' Ambulatory Care Pharmacy Preparatory Review and Recertificaiion CoLrrse

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^No

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ACCP l-Jpdates in Therape'iticso 2ora, Ambulatory Care Pharmacy Preparatory Review and Qecertification Course

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