PH 125: Public Health Pharmacy w/ Pharmacoepidemiology pt. 2

• APPLICATIONS OF PHARMACOEPIDEMIOLOGY

  • Estimation of risk of ___ ___
  • Use in __ ___
  • Formulation of public health ___ decision
  • Formulation of ___ ___ and discovery of new indications
  • Facilitation of ____evaluation
  • drug use
  • patient counseling
  • policy
  • therapeutic guidelines
  • pharmacoeconomic
• POTENTIAL CONTRIBUTIONS OF PHARMACOEPIDEMIOLOGY

  A . Information which supplements the information available from pre-marketing studies – better quantitation of the incidence of known adverse and beneficial effects. T or F?

  T
• POTENTIAL CONTRIBUTIONS OF PHARMACOEPIDEMIOLOGY

  
  

  A . Information which supplements the information available from pre-marketing studies – better quantitation of the incidence of known adverse and beneficial effects

  • Higher __
  • In patients __ studied prior marketing (elderly, children, pregnant women)
  • As modified by other __ and other illnesses
  • Relative to other drugs used for the __ medication
  • precision
  • not
  • drugs
  • same
• POTENTIAL CONTRIBUTIONS OF PHARMACOEPIDEMIOLOGY

  
  

  B. New types of information not available from pre-marketing studies. T or F?

  T
• POTENTIAL CONTRIBUTIONS OF PHARMACOEPIDEMIOLOGY

  
  

  B. New types of information not available from pre-marketing studies

  1. Discovery of previously undetected adverse and beneficial effects
  2. ___ effects
  3. ___ effects
  4. Patterns of Drug Utilization
  5. The effects of drug overdoses
  6. The economic implications of drug use

  • Uncommon
  • Delayed
• POTENTIAL CONTRIBUTIONS OF PHARMACOEPIDEMIOLOGY

  C. General contribution of pharmacoepidemiology

  1. Reassurance about __ ___
  2. Fulfillment of __and __obligations
  3. drug safety
  4. ethical, legal
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Identification of potential markets through study of disease distribution and medicines utilization

  Drug Discovery
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Estimation of potential market size, unmet medical needs, demonstration of efficacy and safety, demonstrating significant benefit

  Drug Development
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Estimation of prevalence of disease, providing information on other treatments, demonstration of efficacy and safety, demonstrating significant benefit

  Orphan Drugs
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Information on the disease to be treated, existing therapies, safety profile of alternative therapies, demographics of toxicities associated with the medicine. Planning of safety monitoring post-licensing and risk minimization strategies

  Licensing
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • An aid to all steps in the pharmacovigilance process: signal detection and evaluation, benefit/risk assessment, measurement of the health effects of action taken to reduce risk

  Post-licensing pharmacovigilance
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Evaluation of benefits and risks in new indications, re-evaluation of benefits and risks when new data are available regarding an established indication. Estimation of market size and use of existing therapies when considering a move to use without prescription

  Variation, renewal, reclassification
• SCOPE OF PHARMACOEPIDEMIOLOGY IN DRUG REGULATIONS

  • Estimation of costs of therapy and benefits in economic terms to support reimbursement or inclusion in formularies

  Pharmacoeconomics
• PHARMACOEPIDEMIOLOGY IN PRACTICE

  • The basic idea of pharmacoepidemiology is to measure the __, __, __, and __ of drugs in a population and to determine the frequency and distribution of drug use outcomes in that population

  source, diffusion, use, effects
• PHARMACOEPIDEMIOLOGY IN PRACTICE

  FOCUS QUESTIONS (3) WHW

  1. What is being used?
  2. How is it being used?
  3. Why it is being used
• PHARMACOEPIDEMIOLOGY IN PRACTICE

  FOCUS QUESTIONS

  • An assessment of specific drugs being used in certain situations

  What is being used?
• PHARMACOEPIDEMIOLOGY IN PRACTICE

  FOCUS QUESTIONS

  • An assessment of the patterns of use, including how much, where and when, and by whom

  How is it being used?
• PHARMACOEPIDEMIOLOGY IN PRACTICE

  FOCUS QUESTIONS

  • An assessment of the reasons for drug-taking behaviors and the functions that drugs serve in society)

  Why it is being used
• • Focuses its pharmacoepidemiologic efforts on ensuring the quality, safety, and efficacy of drugs and their use in specific populations

  WORLD HEALTH ORGANIZATION
• Studies are performed to:

  1. Describe the current patterns of drug use in specific patient populations
  2. Determine changes in drug use over time

  T or F?

  T
• Studies are performed to:

  3. Measure the effects of information, education, promotional activities, media accounts, and price on drug use

  4. . Detect inappropriate drug use and associated problems

  T or F?

  T
• Studies are performed to:

  5. Estimate drug needs in terms of disease patterns and outbreaks

  6. . Plan the selection, supply, and distribution of drugs

  T or F?

  T
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS (4) 4C

  1. Cross-sectional study
  2. Case-control study
  3. Cohort study
  4. Clinical trials
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  • a prevalence survey of health and illness in the population at one point in time

  Cross-sectional study
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  • a retrospective analysis comparing subjects with the condition (cases) to those without it (controls) with respect to possible risk or causative factors

  Case-control study
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  • Ex. One researcher studies rare cancer or the kaposi sarcoma

  Case-control study
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  • an incidence study that follows a population free of health problems over time, examining subsequent development of problems and factors associated with them

  Cohort study
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  Ex. Psoriasis and Depression, study of HIV

  Cohort study
• RESEARCH METHODS USED BY PHARMACOEPIDEMIOLOGISTS

  • an experimental approach that tests the value of a new treatment or intervention compared with a standard treatment or a placebo, are also considered to be an epidemiological method

  Clinical trials
• SOURCES OF DATA ON DRUG USE (5) INS FE

  1. Institutional record systems and databases
  2. System wide databases
  3. National databases
  4. Field data
  5. Experimental data
• SOURCES OF DATA ON DRUG USE

  • Drug utilization studies
  • Hospital-based medical audits (inpatient)

  Institutional record systems and databases
• SOURCES OF DATA ON DRUG USE

  • Institutionally based reviews (outpatient)
  • Health insurance groups and third-party payers

  System wide databases
• SOURCES OF DATA ON DRUG USE

  • Pharmaceutical organization
  • Commercial vendors of marketing studies and sales data

  System wide databases
• SOURCES OF DATA ON DRUG USE

  • Government-sponsored studies
  • Essential drug lists and inventory data

  National databases
• SOURCES OF DATA ON DRUG USE

  • Pharmacoepidemiological surveillance systems

  National databases
• SOURCES OF DATA ON DRUG USE

  • Records of drug dispensers, sellers, and distributors

  Field data
• SOURCES OF DATA ON DRUG USE

  • Drug-taking behaviors of individuals and small groups

  Field data
• SOURCES OF DATA ON DRUG USE

  • Clinical trial results

  Experimental data
• PROBLEM-SOLVING WITH PHARMACOEPIDEMIOLOGY

  • Beneficial effects of drug therapy

  Medical drug use
• PROBLEM-SOLVING WITH PHARMACOEPIDEMIOLOGY

  • Risks (e.g., adverse reactions, side effects) of drug therapy

  Medical drug use