The document discusses pharmacoepidemiology, which is the study of drug use and effects in large populations. It describes the importance of pharmacoepidemiological studies in evaluating drug safety and effectiveness after approval. The document outlines different types of pharmacoepidemiology studies including experimental and non-experimental designs. It also discusses reasons for conducting pharmacoepidemiology studies such as for regulatory purposes, marketing, clinical research, and legal reasons. The future of pharmacoepidemiology is seen as growing with advances in areas like molecular pharmacoepidemiology and risk management.

1. Pharmacoepidemiology
Course: Pharmacy Practice – I
Section: 01
Faculty : Md. Adit Muktadir Pavel
Senior Lecturer, NSU

2. Group Members
 Stanley Lawrence Palma – 141 0022 046
 Rokibul Islam Hridoy -141 1575 046
 Md. Hasibul Hasan – 151 0164 646
 Ahsan Habib Opu – 142 0879 046
 Hasibur Rahman – 151 2278 046

3. Pharmacoepidemiology
Pharmacoepidemiology is the study of the utilization and
effects of drugs in large numbers of people; it provides an
estimate of the probability of beneficial effects of a drug in
a population and the probability of adverse effects.
 It can be called a bridge science spanning both clinical
pharmacology and epidemiology.

4. Importance of Pharmacoepidemiology
 Pharmacoepidemiology (PE) is an important area that evaluates the
effects of drug use in large populations. Data obtained from
pharmacoepidemiological studies may highlight ways to reduce
certain drug-related problems and provide reliable information on the
safety profile of a drug.
 Traditional Clinical pharmacology directs much of its attention to the
pharmacokinetics and pharmacodynamics of drugs. They are mostly
done before the drug come to the market. So we need
Pharmacoepidemiology studies to determine the after effects of the
drugs after they are marketed.

5. Importance of Pharmacoepidemiology
 They helps us determining the frequency of adverse drug reaction.
 The importance of pharmacoepidemiology is highlighted by variety of
outstanding drug withdrawals in recent years. Each of these
withdrawals was preceded by severe or fatal adverse effects that had
been unrecognized or underappreciated at the time of approval.

6. Types of PE studies
 There are two fundamental types of PE studies
 Experimental studies: In experimental studies,
The investigator assigns treatment to subjects, or patients may be
randomly assigned to treatment in some forms of experimental or
analytical studies
Randomized clinical trails are considered to be the best available
evidence in clinical research
 Nonexperimental studies: In Nonexperimental studies ,
 patients are not assigned to treatments by the investigator
 Most of these studies enroll patients who are receiving care,
including medications, from conventional settings of care such as
clinics and hospitals

7. Potential Contributions of PE
Information which supplements the information available
from premarketing studies—better quantitation of the
incidence of known adverse and beneficial effects
New types of information not available from premarketing
studies - Discovery of previously undetected adverse and
beneficial effects
General contributions of pharmacoepidemiology -
Reassurances about drug safety & Fulfillment of ethical and legal
obligations

8. Study designs available for PE studies

9. Reasons to perform PE studies
 Regulatory
To obtain earlier approval for marketing
As a response to question by regulatory agency
To assist application for marketing elsewhere
 Marketing
To assist market preparation by documenting the safety of the drug
To increase name recognition
To assist in repositioning the drug
Different outcomes, e.g., quality-of-life and economic
 To protect the drug from accusations about adverse effects

10. Reasons to perform PE studies
Legal
In anticipation of future product liability litigation
Clinical
 Hypothesis testing
Problem hypothesized on the basis of drug structure
Problem suspected on the basis of preclinical or premarketing human data
Problem suspected on the basis of spontaneous reports
Need to better quantitate the frequency of adverse reactions

11. Reasons to perform PE studies
 Hypothesis generating—need depends on:
whether it is a new chemical entity
the safety profile of the class
the relative safety of the drug within its class
the formulation
the disease to be treated
 Thus, the decision to conduct a PE study can be viewed as similar to the
regulatory decision about whether to approve a drug for marketing or the clinical
decision about whether to prescribe a drug.
 In both cases, decision making involves weighing the costs and risks of a
therapy against its benefits.

12. Molecular PE
 Why do individuals or groups of individuals respond differently to a
specific drug therapy, both in terms of beneficial and adverse effects?
Molecular Pharmacoepidemiology
 It is the study of manner in which molecular biomarkers alter the
clinical effects of medications in population.
 Genes can affect a drug response via:
alteration of drug pharmacokinetics
Pharmacodynamic effects on drug targets
Gene-drug interactions in the causal pathway of disease

13. Molecular PE
 Population prevalence of SNPs and other genetic variants
 Evaluating how these SNPs alter disease outcomes
 Assessing impact of gene-drug and gene-gene interactions on disease
risk
 Evaluating usefulness and impact of genetic tests in populations exposed,
or to be exposed, to drugs
 The ability of genes and other biomarkers to improve patient care and
outcomes needs to be tested in properly controlled studies, including RCTs

14. Special Applications of PE
 Studies of Drug Utilization
 Evaluating and improving physician prescribing
 Drug Utilization Review
 Special methodologic issues in PE studies of Vaccine Study
 PE studies of Devices
 Studies of Drug-induced birth defects
 PE and Risk management
 Use of PE to study Medication Errors
 Hospital PE

15. Future of PE
 PE can contribute to information about drug safety and
effectiveness that is not available from pre-marketing studies
 The discipline of PE has been growing and will continue to grow
within academia, industry and government
 Methodologic advances in risk management and molecular PE
 Content areas like drug utilization review, hospital PE,
pharmacoeconomic, medication adherence, patient safety and surrogate
markers will grow as interest and need for these foci increase

16. Future of PE
 Both computerized databases and de novo studies will serve as
important complements to each other
 Challenges faced by PE include :-
 limited funding opportunities regulatory restrictions
 privacy concerns surrounding human research
 limited training opportunities
 inadequate personnel resources
 All sectors like academia, industry and government must address the
challenges facing PE and support its continued development so as to
maximize benefit and minimize risks inherent in all medications and
medical devices.

17. REPORT 1-Novel anticoagulants given to 60% of
newly diagnosed AF patients.
 Novel oral anticoagulants introduced since October 2010 have been adopted into clinical
practice rapidly, and within 2.5 years were prescribed for more than 60% of patients with
newly diagnosed atrial fibrillation, according to a report published online May 20 in the
American Journal of Medicine. the new drugs are being prescribed for a different patient
population from that indicated by the clinical trials on which Food and Drug
Administration (FDA) approval was based. Specifically, dabigatran, rivaroxaban, and
apixaban are selectively prescribed for younger, healthier men who have high incomes
and reside in wealthier communities, reported Dr. Nihar R. Desai of the division of
pharmacoepidemiology and pharmacoeconomics, Brigham and Women’s Hospital and
Harvard Medical School, Boston, and his associates. In what they described as the first
study to evaluate real-world use of all novel anticoagulants, researchers found that the
rapid uptake of the drugs as first-line therapy for atrial fibrillation (AF) was
accompanied by a marked decline in the use of warfarin. The difference in total costs
between the generic warfarin and the proprietary dabigatran, rivaroxaban, or apixaban
totaled $900 per patient during the first 6 months alone, which "translates into billions of
dollars at the national level."

18.  The researchers analyzed nationwide medical and prescription claims
data for 6,893 adults covered by Aetna who had newly diagnosed
nonvalvular AF and were prescribed an oral anticoagulant between
October 2010 and June 2013. The direct thrombin inhibitor dabigatran
was approved in October 2010, and the factor Xa inhibitors
rivaroxaban and apixaban were approved in November 2011 and
December 2012During the study period, these patients filled 45,472
prescriptions for oral anticoagulants: 57.7% for warfarin, 32.8% for
dabigatran, 9.3% for rivaroxaban, and 0.1% for apixaban. Within 1
year of appearing on the market, dabigatran was equally likely to be
prescribed as warfarin was for new AF patients. Its use as a first-line
therapy..

19. References
 https://www.hopkinsmedicine.org/gim/research/content/pharmacoepi.html
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3794414/
 https://www.omicsonline.org/pharmacoepidemiology/importance.php
 https://www.slideshare.net/DivjyotKaur/pharmacoepidemiology
 https://www.slideshare.net/AISHASID/pharmacoepidemiology-43620550