CLINICAL PHARMACY 4TH PHARMD

1. MONITORING OF ADRS
PHARM-D 4TH YEAR
CLINICAL PHARMACY
Dr. Pradeepthi.k
Assistant Professor
Department of Pharmacy Practice

2. MONITORING OF ADR:
 Post Marketing Surveillance Post marketing
surveillance is defined as the practice of safety
monitoring of a pharmaceutical product which in
released in the market. It can be done by the
following methods
 Spontaneous reporting system: Spontaneous
reporting system is a principal method of post
marketing surveillance which encourages the
physicians to report the unassociated reactions of
the drugs. The objective of spontaneous reporting
system is to focus on new drugs and serious ADRs,
generation of new signals on potential drug related
problems and continuous monitoring of all drugs
which are freshly marketed.

3.  Intensive monitoring studies: Intensive monitoring studies
involved collection/recording of data which precipitates an
untoward effect after administration of drugs, these
studies are carried out by special trained healthcare team.
In this study, the collection of data is systematic from a
well- defined groups of patient. Popular example for this
methodology is Boston collaborative drug surveillance
program.
 Anecdotal Reporting: The report of ADRs comes through
anecdotal reports when patients suffered from any kind of
unusual or noxious effect. The anecdotal reporting is
usually done by physicians. It requires future studies on
the particular effect in order to confirm the problem.

4.  Cohort Studies: Cohort studies are performed to
determine the incidence rate of any adverse effects by
identifying the patients and recording the events. The
drawback of cohort study is that they are expensive and
they can only be performed on small sample size.
 Case Cohort Studies: The case cohort study is a hybrid
of prospective cohort study and retrospective case
control study, Patients who present with symptoms or an
illness that could be due to an adverse drug reaction are
screened to see if they have taken the drug. The results
are then compared with the incidence of the symptoms
or illness in a prospective cohort of patients who are
taking the drug.

5. Case Control Studies: Case control study includes screening
of patients by correlating the symptoms and the possible
drug that may produce an event. The prevalence of drug
exposure in one group is compared with the
standard/reference population with no symptoms. However,
case control studies do not detect the new adverse events.
Use of Population Statistics: It is very interesting fact that
ADRs can also be detected from population statistics via
any cancer registers or birth defect registers incase of any
drug induced events are taking place in a very low
frequency.
Meta-Analysis: Meta-analysis is also one of the important
tool for detection of ADRs and providing the drug safety
data by analyzing two or more independent studies

6. THANK YOU