These slides will help you to know about post marketing surveillance of drug. What are the major goals. Basic steps involve in post marketing surveillance of a drug. How to design a case stuty etc.

1. MUHAMMADNAFEES
PRESENTED BY :
MUDDASIR QURESHI
MADNI SALEEM SOOMRO

2. Post marketing surveillance (PMS)
 Post marketing surveillance (PMS) is the practice of
monitoring the safety of a pharmaceutical drug or
medical device after it has been released on the
market and is an important part of the science of
pharmacovigilance.

4. Goals of post market surveillance
 Detect adverse events or risks as they arise during real-
world usage of a device or drug.
 Compare new products or treatments with existing
options and the standard of care.
 Update clinical guidelines as certain populations or
groups find more benefit than others.
 Comply with regulatory requirements.

5. Different Aspects which to be
Assessed in (PMS)
 Clinical effectiveness: Use data from real-world clinical
settings to examine the relative effectiveness of a device or
drug in a large, diverse patient group to compare that
product to the standard of care or competition.
 Adverse events and side effects: real-world evidence to
identify risks or adverse reactions that might have been
missed in the initial clinical trial for a device or drug.
 Utilization: Examine how a product is actually used in the
real world, which can be different than what is approved or
marketed.

6. Conduction of (PMS)
These are the steps to conducting post-market
surveillance for medical devices and drugs:
 Data Collection
 Data Analysis
 Data Interpretation

7. Step 1: Data Collection for Post-
Marketing Surveillance
 You need the right data sources and the right technology
to collect real-world data efficiently, securely, and
accurately for post-market surveillance activities.
 These real-world data can come from several sources, such
as:
 Clinical data from electronic health records (EHRs) and
case report forms (CRFs)
 Patient-generated data from patient-reported outcome
(PRO) surveys
 Cost and utilization data from claims and public datasets
 Public health data from various government data sources

8. Step 2: Data Analysis for Post-
Marketing Surveillance
 Once you collect data for a given device or product, the
next step is transforming it into real-world evidence.
This involves combining, blending, validating, and
analyzing various data sources.

9. Step 3: Data Interpretation for
Post-Marketing Surveillance
Once you are finished collecting and analyzing data, you
need a way to interpret the data easily and readily. Here are
a few things to keep in mind:
 To ensure timely and accurate interpretation of data, you
need statistically-adjusted reports that are available in real-
time. This helps you quickly and easily measure and
understand clinical outcomes, determine patient quality of
life, and understand the total financial impact of the
intervention.
 Statistically-adjusted reports should be built using key risk
and reliability adjustment methodologies that are essential
to success in maximizing data value.

11. Case study

12. Assessing the Effects of Non-
steroidal Anti-inflammatory Drugs
on Antihypertensive Drug Therapy
Using Post-Marketing Surveillance
Database
Reference:
 Chieko Ishiguro, Toshiharu Fujita, Takashi Omori, Yosuke Fujii,
Takeshi Mayama, Tosiya Sato
Journal of epidemiology, 0805080012-0805080012,2008

13. Background: Antihypertensive and non-steroidal
anti-inflammatory drugs (NSAIDs) are used to treat
many common diseases. However, it has been
suspected that interactions between these drugs exist.
Here, we assessed the interactions between non-
selective NSAIDs and several classes of
antihypertensive drugs.

14.  Methods: The study design was a cohort study using "The
Antihypertensive Drug Database," which is a collection of
data accumulated from Drug Use Investigations. Subjects
newly starting antihypertensive drug therapy were
identified in the database. We compared the "User" group,
who were co-administered NSAIDs, with the "Non-user"
group, who were not. The outcome measure was the change
in systolic blood pressure from the baseline after 2
months of treatment. We estimated the non-adjusted and
adjusted differences in the change in systolic blood
pressure between the "User" and "Non-user" groups.

15.  Results: Data were collected for a total of 1,204
subjects, of whom 364 were prescribed beta blockers,
60 were prescribed diuretics, 628 were prescribed ACE
inhibitors, and 152 were prescribed calcium channel
blockers. The adjusted difference in the change in
systolic blood pressure between the User (n = 301)
and Non-user (n = 903) groups was 2.88 mmHg (95%
confidence interval: 0.89, 4.87); thus, systolic blood
pressure in the Non-User group decreased further
from the baseline than that in the User group.

16.  Conclusion: The effectiveness of antihypertensive
drugs was attenuated by the co-administration of
NSAIDs. The differences in the effects of NSAIDs
varied with different classes of antihypertensive drugs