New Challenges and Opportunities in Pharmacoepidemiology: An International View

1
New Challenges and Opportunities in
Pharmacoepidemiology An International View

• Songlin Xue, MD, PhD
• Assistant Vice President,
• Global Safety Surveillance and Epidemiology
• Wyeth Research, USA

2
Growing Applications of Pharmacoepidemiology

• In post-marketing setting
• To assess drug safety
• To study drug utilization
• To measure drug effectiveness
• To evaluate risk management program

3
To Assess Drug Safety

• Risk Detection
• - To identify safety signals
• Risk Investigation
• - To rule out alternative explanations (competing
  causes)
• Risk Evaluation
• - To quantitate the risk
• - To find high risk sub-groups of patients
• Risk Minimization/Mitigation
• - To study the impact of any risk
  intervention/prevention

4
Risk Detection

• Conduct analyses of ADR reports for a drug to
  look for trends, patterns, event proportions or
  clusters
• Analyze ADR data for the same class drugs
• Analyze these data in a context of exposure data
• Conduct active surveillance (e.g., using database
  or patient registry)

5
Risk Investigation

• Put observed/reported adverse events into a
  patient population perspective (i.e., comparing
  to background incidence rates in the patient
  population)
• Conduct epidemiologic study to test the risk
  association after controlling known risk factors
  (eg, age, gender, medical Hx, co-morbidity,
  co-medications, smoking)

6
Risk Evaluation

• To conduct safety studies to estimate the
  incidence rate, and to characterize AE onset
  pattern and outcomes
• To identify high risk sub-groups
• Age (e.g., children or elderly)
• Medical History (e.g., previous liver disease)
• Co-morbidity (e.g., CHF, renal disease)
• Co-medication (e.g., P-450 inhibiting drugs)

7
Risk Minimization/Mitigation

• To study the impact of a risk intervention on
• Patients/physicians awareness level
• Drug usage trends/patterns
• Compliance to the drug label
• Actual adverse event incidence

8
To Study Drug Utilization

• Who use the drug?
• Patients characteristics (age, gender, etc.)
• Why do they use it?
• Patient conditions likely to be treated for
  (labeled use and off-labeled use)
• How do they use it?
• Dose, frequency, duration, discontinuation,
  switching
• What other drugs they are taking?
• Concomitant medications
• Who prescribe the drug?
• Physician specialties

9
To Measure Drug Effectiveness

• How well the drug works for the approved
  indication in the real world?
• Assess the changes/differences in disease
  activity, remission rate, mortality rate, etc.
• Compare to usual care
• Compare to other drugs
• Compare to historical experiences

10
Challenges In Pharmacoepidemiology

• Global drug use with more diverse populations
  leads more complicated potential interactions
  (drug-drug, drug-genotype, drug-food,
  drug-disease, etc.)
• Different medical terminologies (ICD-9, ICD-10,
  MedDRA, more....) make it hard to use a consist
  case definition
• Aging populations worldwide (population with
  multiple diseases and are on multiple drugs)

11
Challenges In Pharmacoepidemiology

• How to study very rare but serious adverse events
• How to evaluate a long-term safety (eg, cancer
  risk)
• How to define the risk window and analyze
  various exposure time
• How to handle OTC drugs and herbal medicines
• How to assess the overall risk-benefit of a drug

12
Challenges In Pharmacoepidemiology

• Credibility recent controversies surrounding the
  safety issues related to the home replacement
  therapy and Cox-2 inhibitors have raised new
  questions on how to judge and reconcile the
  findings generated from pharmacoepidemiologic
  studies in the broad spectrum of evidence from
  other scientific investigations including
  randomized controlled clinical trials

13
Opportunities for Pharmacoepidemiology

• Study Design/Methods
• Case crossover design (self-control)
• Propensity matching
• Meta-analysis

14
Opportunities for Pharmacoepidemiology

• Data Sources
• More large healthcare-related databases available
• More linkages among clinical data, prescription
  data, hospital data, lab data, cancer registries,
  mortality data in some countries
• Growing number of electronic medical record (EMR)
  databases
• GPRD (UK), MedPlus (Germany, France), GE Health
  (US)

15
Opportunities for Pharmacoepidemiology

• New technologies
• Genomics and protenomics enable population-based
  studies of different drug effects/responses
• Remote data capture (RDC) for rapid and high
  quality data collection during a study

16
Opportunities for Pharmacoepidemiology

• Growing Research Community
• More talents joined this field in academia,
  government, and pharmaceutical industry
• More research and publications (books and
  journals)
• More organizations and forums
• More training programs

17
New Fronts in Pharmacoepidemiology

• Virtual registry method in large healthcare
  systems to actively assess any emerging adverse
  events associated with the use of new drugs
• Special pharmacoepidemiologic studies being
  carried out to address specific safety concerns
  and also to measure the effectiveness of
  specific risk minimization programs

18
New Fronts in Pharmacoepidemiology

• Population-based pharmacogenomic research could
  help to identify good as well as bad
  responders then leads to individualized
  medicine in order to minimize the risk and
  maximize the benefit of a given drug

19
Pharmacoepidemiology Remains to be A Valuable
Branch of Science

• It offers effective and efficient approaches with
  its unique advantages in large sample size, rapid
  execution, and relatively low cost
• In general, it is a preferable choice when we
  need to study rare events or latent events
• In some circumstances, it is the solely option
  when clinical trials are not feasible or not
  ethical

20
Pharmacoepidemiology Remains to be A Valuable
Branch of Science

• Pharmacoepidemiology will continue to bring
  valuable scientific contributions to our mission
  of promoting and protecting public health
  worldwide
•  

21
Tank You All