This presentation give detail overview of pharmacoepidemiology, epidemiological study design, case report, case series, analysis of secular trends, case control studies, cohort studies, statistical interpretation, randomised clinical trials, field trials, community trials, drug utilisation studies.
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This presentation give detail overview of pharmacoepidemiology, epidemiological study design, case report, case series, analysis of secular trends, case control studies, cohort studies, statistical interpretation, randomised clinical trials, field trials, community trials, drug utilisation studies.
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Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-01:
Pharmacoepidemiology
Pharma Learning Forever
At the end of this e-learning session you are able to…
A.Explain pharmacoepidemiology?
B. Discuss different types or design of
epidemiological studies.
Copyright @shaikhabusufiyan2021
Definition and history
•Pharmacoepidemiology
thestudyoftheuseandtheeffectsofdrugsin
largenumbersofpeople.
•Thalidomidetragedy:
•Inthe1960s-->itwasusedtocontrol
nauseainpregnancy
•reportsoflimbabnormalities
•needforpharmacovigilance
Types or design of epidemiological studies
•Randomized clinical trial (experimental study)
•Cohort study
•Case-control study
•Analyses of secular trends
•Case series
•Case reports
1. CASE REPORTS
•Casereports-->simplyreportsofsinglepatients.
•Itdescribes-->asinglepatientexposedtoadrug
experiencesadverseoutcome.
Case:I
•ayoungwoman-->onoralcontraceptivessufferedapulmonary
embolism.
Q&A
Q.1 Give definition of Pharmacoepidemiology?
Q.2 Enlist types or design of epidemiological studies.
Q.3Whatarelimitationsofcasereportstudy?
Copyright @shaikhabusufiyan2021
2. Case series
•Caseseriesarecollectionsofpatients
whohaveasingleexposure&oftenfromasingle
hospital
whoseclinicaloutcomesarethenevaluatedand
described.
2. Case series
•Alternatively,caseseriescanbecollectionsof
patientswithasingleoutcome
CASEI:
•100consecutivewomenundertheageof50
whosufferfromapulmonaryembolism--->
30ofthemhadbeentakingoral
contraceptives.
•After drug marketing --> case series are useful for two
related purposes:
1. to quantify the incidence of an adverse reaction.
CASE II:
•``Phase IV'' post-marketing surveillance study of
prazosinwas conducted --> to quantitate the incidence
of first dose syncope from prazosin.
Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-02:
Pharmacoepidemiology
Pharma Learning Forever
At the end of this e-learning session you are able to…
A.Explain methods of case series studies of
pharmacoepidemiology?
B.Discuss analyses of secular trends design
of pharmacoepidemiological studies.
Copyright @shaikhabusufiyan2021
Method of case series study
•Themanufacturerthroughitssalesrepresentatives
recruitphysicianstoparticipateinthestudy.
Eachparticipatingphysician
enrolledthepatientstowhomthedrugwasprescribed.
Q&A
Q.1 Who is responsible for recruitment of physicians in
case series study?
Q.2 What is limitation of case series study of
pharmacoepidemiology.
Q.3Whatissynonymsofanalysisofseculartrend?
Copyright @shaikhabusufiyan2021
CASE CONTROL STUDIES
•Casecontrolstudiesarestudies
whichcompare:
Caseswithadiseasetocontrols
withoutthedisease.
CASE CONTROL STUDIES
•Eg.onecouldselectcasesofyoungwomen
withvenousthromboembolism.
•andcomparethemtocontrols-->without
venousthromboembolism
•lookingfordifferencesinantecedentoral
contraceptiveuse.
Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-03:
Pharmacoepidemiology
Pharma Learning Forever
At the end of this e-learning session you are able to…
A.Discuss Cohort studies of
pharmacoepidemiology.
B.Explain statistical methods of analyzing
case control and cohort studies.
Copyright @shaikhabusufiyan2021
COHORT STUDIES
•Cohortstudies
identifysubsetsofadefined
population
followthemovertime
observedifferencesintheiroutcome.
Types
•2Types
1. Prospective:
Conductedsimultaneous with
the events under study
2.Retrospective:
Conductedaftertheeventsby
recreatingpasteventsusing
medicalrecords,questionnaires,
orinterviews.
Thedifferencebetweencohortandcasecontrolstudies:
•Itisdependsonthebasisonwhichpatientsarerecruitedintothestudy.
Case control studies
Patients are recruited on
the basis of the
presenceor absenceof
a diseaseand their
antecedentexposuresare
then studied.
Cohort studies
Patientsarerecruited
onthebasisofthe
presenceorabsence
ofanexposureand
theirsubsequent
diseasecourseisthen
studied.
Limitations:
•It require extremely large sample sizes to
study relatively uncommon outcomes.
•In addition, prospective cohort studies
can require a prolonged time periodto
study delayed drug effects.
Q&A
Q.1 What are two types of cohort studies?
Q.2 Give difference between cohort and case control study.
Q.3Whatarelimitationsofcohortstudy?
Copyright @shaikhabusufiyan2021
ANALYSIS OF CASE CONTROL AND COHORT STUDIES
•Bothcasecontrolandcohortstudies
providethesamebasicinformation
•Thedifferenceis-->howthisinformation
iscollected.
Statistical Interpretation of Relative Risk
A.
Relative risk
greater than 1.0
exposed subjects
have a greater
risk of the
disease than
unexposed
subjects
B.
Relative risk
of 1.0
exposed subjects
and unexposed
subjects have the
same risk of
developing the
disease
C.
Relative risk
less than 1.0
exposed subjects
have a lower risk
of the disease
than unexposed
subjects
Problem with Case control study
•Inacasecontrolstudy
onecannotdeterminethesizeofeither
theexposedpopulationorthe
unexposedpopulation.
Therefore,relativeriskscannotbe
calculateddirectlyfromacasecontrol
study.
P VALUE
•Bothrelativerisksandoddsratios
-->canbereportedwithp-values.
Itallowtodeterminewhetherthe
relativeriskisstatistically
significantlydifferentfrom1.0
•Preferably, relative risks and odds ratios can be
reported with confidence intervals.
an indication of the range of relative risks within which
the true relative risk for the entire theoretical
populationis most likely to lie.
•A 95% confidence interval --> we can be 95%
confident that the true relative risk lies in this range.
CONFIDANCE INTERVAL
CASE-I
•Forexample,oralcontraceptivesarestronglyassociatedwiththe
developmentofmyocardialinfractioninyoungwomen.
The risk of myocardial
infarction in non-smoking
women in their 20s is so
low that even a fivefold
increase in that risk
i
v
would still not be of
public health
importance.
Incontrast,womenin
their40sespeciallyif
theyarecigarette
smokers.i
v
higherrisk
i
V
Oralcontraceptives
shouldnotbeused
inthesewomen.
Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-04:
Pharmacoepidemiology
Pharma Learning Forever
At the end of this e-learning session you are able to…
A.Discuss Randomized Clinical trial of
pharmacoepidemiology.
B.Explain different typesof
pharmacoepidemiologicalstudies and its
applications.
Copyright @shaikhabusufiyan2021
Q&A
Q.1 What is randomized clinical trails?
Q.2 What are the problem associated with randomized
clinical trails?
Copyright @shaikhabusufiyan2021
CATEGORIES/ TYPES OF PHARMACOEPIDEMIOLOGICAL STUDIES
1. Observational studies
•Investigator measure the parametersbut
does not intervene during the study
•Case report
•Case series
•Analysis of secular trend (Ecological studies)
•Case control
•Cohort studies
2. Interventional Studies: It Involve active attempt
•to change disease parameters (Ex. Exposure)
•Or Progress of disease (By treatment)
•Ex. Clinical Trial
•Field Trial
•Community Intervention studies
Field trials
•Trialsconducted outside clinical settings
are called as field trials
•It generally involve participantswho are
living
at home in their normal environment, rather
than being ‘captive’ in hospitals or outpatient
clinics.
•Most trials of preventive measures, such as:
•immunizationsor health education, are
‘field’ trials.
•Important differences in fieldand clinical
trials include:
•inclusionand exclusion criteria that may be
less stringent in field trials than criteria
often imposed in clinical trials.
Community Intervention studies
•Community interventiontrials are an
example of the broader class ofstudies
called group-randomized trials (GRTs)
investigators randomize identifiable groups
to conditionsand observe members of those
groupsto assess the effects of an
intervention.
Applications of Pharmacoepidemiology
1. Practitioners:
•Help Physicians, Pharmacist, Nurses and
other health practitioners to make proper
decisionabout the patient treatment.
•Help physician in evaluatingand improvinghis
prescription.
Applications of Pharmacoepidemiology
2. Government agencies and Health
care plans:
•It help such agencies to decide
policies and public health care plan.
5. PE studies of
•New vaccines, devices
•Drug induced birth defect
•Risk management
•Medication errors
6. Study of Drug Utilization and drug
utilization review.
Prof. Shaikh Abusufiyan
Assistant Professor,
AIKTC-School of Pharmacy,
New Panvel-410206
Part-05:
Pharmacoepidemiology
Pharma Learning Forever
At the end of this e-learning session you are able to…
A.Discuss Drug utilization studies.
B.Explain effect of Marketing, Patent and
market structureon utilization of drug.
Copyright @shaikhabusufiyan2021
Scope of Drug utilization studies
•To evaluate the present state and future trends
of drug usage.
•To estimate:
•disease prevalence
•appropriateness of prescriptions
•drug expenditures
•and adherenceto evidence-based
recommendations.
Aspect of drug utilization (Factor affecting drug utilization)
•Quality of drug utilization:
•Audit is conducted --> to compare actual use to
nationaland regional prescription.
•Quality indices consider includes:
•Choiceof drug & Drug cost
•Drug dosage
•Drug interaction & ADR awareness
•Proportion of patients being aware/ unaware
of the cost and benefitof the treatment
•Pattern of use: Following aspects are
studied
•Extentand profilesof drug use
•Trends in drug use
•Cost over the time
Patient characteristics
•Patient characteristics or preferences that
influence the use of drugs are:
•age, educational levels
•perceptionsabout the disease
•generic drug information
•misconceptions
•and negative perceptions regarding some medicines
Disease pattern
•Drug utilization is also depend on
the disease pattern such as
•Acute or chronic disease
•Common or rare disease
•Disease in adult/ Geriatric/
Pediatric/ women’s etc.
Disease pattern: Case study of study conducted in geriatric
patient (AwanishP et al. 2010)
•Medicationrelatedriskfactorsandtheir
effectonhealthoutcomesingeriatric
patients
remainsunclearwhichcanonlybeidentified
byhomevisits.
Reimbursement
•Reimbursementis the amount the insurer pays for thedrug,
whether it's a private insurer, Medicare or Medicaid.
•Typically, depending on the type ofdrug, the insurer pays either
•the physician directly
•thedrugmanufacturer
•or an intermediary, such as a pharmacy benefit manager
Case study on Drug Utilization and Reimbursement
•Prescription Drug Utilization and Reimbursement
Increased Following State Medicaid Expansion in
2014. (Mahendraratnam Net al., 2017).
•Study results suggest that Medicaid expansion
•offers vulnerable patients to increased access
to health care resources
References:
•BrianL.StromandStephenE.Kimmel.TextbookOfPharmacoepidemiology.WileyPublication.2006.Page
No.3,13-21.
•AwanishP,PoonamTripathi,RishabhDP.PrevalenceofDiseasesandObservationofDrugUtilizationPattern
inElderlyPatients:AHomeMedicationReview.IndianJournalofPharmacyPractice,2010;3(1):58-63
•Gautier Duflos, Frank R.Lichtenberg. Does competition stimulate drug utilization? The impact of changes in
market structure on US drug prices, marketing and utilization. International Review of Law and Economics
Volume 32, Issue 1,March 2012, Pages 95-109.
•Mahendraratnam N1,Dusetzina SB2,Farley JF. Prescription Drug Utilization and Reimbursement Increased
Following State Medicaid Expansion in 2014. J Manag Care Spec Pharm.2017 Mar;23(3):355-363.