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Pharmacoepidemiology in Pharmacy Practice

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Pharmacoepidemiology in Pharmacy Practice This chapter discusses the incorporation of evidence-based medicine into clinical practice. Other areas to which pharmacists ... – PowerPoint PPT presentation

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Title: Pharmacoepidemiology in Pharmacy Practice


1
Pharmacoepidemiology in Pharmacy Practice
2
  • This chapter discusses the incorporation of
    evidence-based medicine into clinical practice.
  • Other areas to which pharmacists apply
    pharmacoepidemiological methods include
  • adverse drug reaction surveillance
  • drug utilization evaluations (DUEs)
  • pharmacoeconomical analyses
  • All of these functions provide pharmacists with
    excellent sources of data to conduct more
    formalized pharmacoepidemiological research.

3
Evidence-Based Medicine
  • The best drug therapy decisions are decisions
    based on sound evidence.
  • Evidence that a drug is safe and effective is
    obtained from pharmacoepidemiological studies and
    disseminated via the medical literature.
  • Medical literature can be classified as
  • primary
  • secondary
  • tertiary

4
Primary medical literature
  • Provides new information to the field of medicine
    and consists of
  • descriptive
  • observational
  • interventional studies.
  • All of these study designs are used to provide
    new information about the use or effect of a
    particular drug in a specific population.
  • These studies are then published in pharmacy and
    medical journals.
  • Hundreds of medical journals are published every
    week.

5
Secondary medical literature
  • Consists of indexing systems.
  • The secondary systems allow practitioners to
    search through the vast array of medical journals
    to find information about a particular subject.
  • Some databases provide access to complete
    article(s), and others provide information only
    on where to locate the article(s).
  • Example The Medline database, (PubMed)
  • most commonly used
  • was created in 1966
  • indexes more than 1600 medical journals

6
Tertiary medical literature
  • Consists of literature reviews, which can be in
    the form of
  • textbooks
  • reference books
  • review articles in medical journals.
  • Before a review is written
  • a literature search is conducted using the
    secondary systems to identify all of the articles
    published on a particular subject.
  • The information is then collated and presented in
    a manner that is easily used by practitioners.
  • Tertiary resources are quick, efficient resources
    that are used to answer questions about the most
    common clinical problems.

7
  • Suppose a patient presents to a clinician
    complaining of tachycardia.
  • The clinician conducts
  • a complete medical history
  • physical examination of the patient.
  • If the clinician suspects the tachycardia is an
    adverse drug reaction associated with a
    particular medication, then he or she attempts to
    find evidence in the literature that supports the
    suspicion.
  • The best clinical decisions are based on sound
    medical evidence, rather than hunches or
    suspicions.

8
  • To obtain medical evidence on a particular topic,
    clinicians
  • first searches the tertiary literature (e.g.,
    textbooks, reference books).
  • If no information is found, a literature search
    using the secondary systems is conducted.
  • A literature search reveals where and when
    information on the topic has been published
  • The clinician must then retrieve and review all
    of the articles.
  • The studies must be critiqued with regard to
    design, methodology, quality of data, and bias.
  • A clinical decision based on sound evidence is
    then made that either supports or negates the
    theory that the tachycardia is associated with
    the use of the drug.

9
Cochrane Database of Systematic Reviews.
  • Archie Cochrane, a physician-epidemiologist,
    realized that conducting exhaustive literature
    searches and medical literature reviews were
    daunting and time-consuming tasks requiring many
    resources.
  • Cochrane believed that clinicians should be able
    to conduct a search on a specific topic and find
    a well-conducted, systematic review that
    identifies and summarizes all of the medical
    literature published on a particular topic.
  • He enlisted a group of international
    collaborators to create and maintain such a
    database it is called the Cochrane Database of
    Systematic Reviews.

10
  • They have included reviews on
  • herbal medicine
  • Homeopathy alternative medicine, treats patients
    with heavily diluted preparations
  • acupuncture
  • massage
  • Cochrane collaborators perform exhaustive
    searches for published and unpublished studies in
    English and other languages.

11
  • Whenever possible, the Cochrane reviews are based
    on
  • randomized clinical trials (the gold standard in
    medical research.)
  • If randomized clinical trials are not available,
    then the strongest observational studiesthe best
    designed and conducted studiesare used in the
    Cochrane reviews.
  • After completion, the reviews undergo rigorous
    peer review.
  • Cochrane reviews are updated on a regular basis
    to include new information.

12
Adverse Drug Reaction Surveillance
  • Adverse drug reaction reporting and monitoring
    plays an important role in the postmarketing
    surveillance of drugs.
  • Pharmacists play an integral part in adverse drug
    reaction reporting.
  • In fact, historically, pharmacists have the
    highest rate of adverse drug reaction reporting
    among health care professionals.

13
  • Typically, pharmacists collect and report adverse
    drug reactions on a regular basis to pharmacy and
    therapeutics committees (PT committees) in their
    individual institution.
  • These reports are most commonly used to monitor
    the safety of drugs within institutions, but
    pharmacists are usually also responsible for
    forwarding serious adverse drug reactions to the
    Food and Drug Administration (FDA).
  • Just as the FDA acts after receiving several
    serious adverse drug reactions associated with a
    particular drug, the PT committees of individual
    institutions react to serious adverse drug
    reactions within the institution by creating
    medication guidelines and restrictions.

14
Drug Utilization Studies
  • The World Health Organization (WHO) defines drug
    utilization as "the marketing, distribution,
    prescription, and use of drugs in a society, with
    special emphasis on the resulting medical,
    social, and economic consequences.''
  • Pharmacists conduct drug utilization studies, or
    DUEs, as part of their routine activities.
  • Like adverse drug reaction monitoring, the Joint
    Commission for the Accreditation of Health Care
    Organizations (JCAHO) requires health care
    institutions to conduct drug utilization studies.

15
  • DUEs are most commonly conducted to monitor
    prescribing patterns.
  • Medications monitored via DUE are chosen
    according to
  • cost
  • frequency of use
  • risk of toxicity.
  • Drugs newly approved by the FDA that have shown
    serious adverse effects in phase III trials are
    typically chosen to be monitored via DUEs.

16
  • Example
  • when alteplase (TPA ) was first approved by the
    FDA, many practitioners were concerned about the
    bleeding side effects that had occurred in phase
    III trials.
  • Consequently, pharmacists chose to conduct DUEs
    to monitor the use of alteplase.
  • Information was collected on both prescribers and
    patients.
  • Data collected on patients included
  • demographic information
  • past medical history
  • Indication
  • Dose
  • duration of therapy
  • specific documentation of unintended bleeding
    effects.
  • The goal of the DUEs was to monitor the use of
    alteplase to ensure that the drug was being used
    as indicated in the proper patients and to
    measure the extent of bleeding associated with
    alteplase.

17
  • Subjects exposed to a particular drug are
    followed for a period to determine the incidence
    of an adverse reaction.
  • These DUEs can easily be expanded to a
    prospective cohort model.

18
Pharmacoepidemiological Research as an Extension
of Daily Clinical Practice
  • Pharmacists in clinical settings monitor the uses
    and effects of drugs on a daily basis.
  • Clinical pharmacists collect information about
    individual patients however, pharmacists can
    also choose to view patients as populations,
    rather than individuals, for the purpose of
    epidemiological research.
  • If information collected about patients is
    systematic and routine, then the routine
    monitoring of individual patients can easily be
    applied to a cohort study design.
  • The data collected can then be analyzed to
    generate new hypotheses or to identify trends of
    drug use.

19
  • For example, a pharmacist conducting rounds in a
    critical care unit will collect information about
    individual patients with regard to demographics,
    past medical history, current medical problems,
    laboratory data, physical findings, and so forth.
  • The pharmacist will monitor each individual
    patient in an effort to optimize pharmaceutical
    care.
  • The data collection may or may not be consistent
    from patient to patient.
  • In this scenario, the information is typically
    used solely for the purpose of caring for the
    patient.

20
  • The pharmacist could instead choose to develop
    data-collection forms to be used on all patients.
  • If data collection is systematic and consistent,
    then the data can be analyzed to determine the
    effects of drugs within populations of patients,
    rather than thinking of patients only as
    individuals.
  • New hypotheses can be generated from the data
    collection and analysis these hypotheses can
    then be tested using more sophisticated
    observational or interventional studies.

21
Professional Organizations and Journals in Epidemiology
Professional organizations  
  American College of Epidemiology
  American Public Health Association
  American Statistical Association, Section on Epidemiology
  Association for Professionals in Infection Control Epidemiology
  Canadian Society for Epidemiology and Biostatistics
  European Society of Clinical Pharmacy
  International Society for Pharmacoepidemiology
  Society for Epidemiologic Research
22
Professional journals  
  American Journal of Epidemiology  
  American Journal of Public Health  
  Annals of Epidemiology  
  Biometrics  
  Drug Safety  
  Emerging Infectious Diseases  
  Epidemiologic Reviews  
  Epidemiology  
  Epidemiology and Infection  
  Journal of Clinical Epidemiology  
  Journal of Epidemiology and Community Health  
  MMWR Morbidity and Mortality Weekly Report  
  Pharmacoepidemiology and Drug Safety  
  Society for Clinical Trials  
  Viral and Health Statistics  
  Weekly Epidemiological Record  
  World Health Statistics Quarterly  
23
E-mail/Web Address Type of Site
  List serves  
E-mail address LISTPROC_at_CC.UMONTREAL.CA. To subscribe, include "subscribe epidemio-1 your first and last names" in the body of the message.   Epidemiology Discussion Group
E-mail address majordomo_at_mailhost.tcs.tulane.edu. To subscribe, include "subscribe epi-info end" in the body of the message.   Epi Info Discussion Group
E-mail address LISTSERV_at_UNIVSCVM.CSD.SC.EDU. To subscribe, include "sub epiworld your first and last names" in the body of the message.   EPIWORLD Discussion Group
Web address http//www.egroups.com/group/pharmacoepidemiology.   Pharmacoepidemiology  Pharmacoeconomics Discussion Group
  Epidemiology directory  
http//www.epibiostat.ucsf.edu/epidem/epidem.html   Virtual Library-Epidemiology
  Downloadable Statistical Software  
http//www.cdc.gov/epiinfo   Epi Info
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