

PMS is the practice of monitoring the safety of a

pharmaceutical drug or medical device after it

has been
Sincereleased
drugs andon the market
medical and
device are is an on the
approved
important part
basic clinical of science
trials, of pharmacovigilance.
which involve relatively small
numbers of people who have been selected for this
purpose-meaning that they normally do not have other
medical conditions which may exist in the general
population –PMS can further refine, or confirm or deny,
the safety of a drug device after it is used in the general
population by large number of people who have a wide
variety of medical conditions.
 All patients vaccination and health outcome are
immediately and continuously accessible in
automated database allowing optimal detection
and analysis of potential problem in vaccine
safety.
- Not there yet –both major limitationand
opportunities in current health information
systems.
-Both problem and solution to enhance vaccine
safety information and analysis are applicable
to safety initiatives for other medical product.
 The primary objective of post-marketing studies is
to develop information about drug effects under
customary of drug use.

Rare adverse events may not be detected in
pre- licensure studies because even very large
clinical trials have limitations.
 Access to more patient and better data

-Better background rates, comparable

“control” population.
-Increase in “non-clinical” data sources
e.g. pharmacy supermarket.
Thus four type studies are generally used to identify
drugs effects :
1.controled clinical trials,
2.spontaneouse

or

voluntary
recording
3.cohort, studies and
4.case control studies
 To minimize bias through such method
as randomization and “double –
blinding”.
 Directly monitor patients for the duration of

studies.
 For evaluating a drugs efficacy and safety.
 They are often costly.
 By physician and other health provider
& hospital may to alert FDA and
pharmaceutical firms adverse effects of
drugs.
3. Cohort studies
•
study follow a defined group of
patient for a period of time.
• Patient are not randomly assigned, &
there is not blinding.
 4.Case- control
studies
Case control studies identify patient with the
adverse effect to be studied , and compare
them with the sample drawn from the
same cohort that gave rise to cases.
 Expert user groups
Customer surveys
The following may be considered as
sources of information;

Customer complaints and warranty claims

Post CE-market clinical trials.
Literature reviews
The media.
These are some of the type of knowledge and feed
back which can achieved from a PMC system.
 Detection of some manufacturing problems.
 Product quality improvement.
 Confirmation of risk analysis.
 Knowledge of long term.
 Performance/reliability/or chronic

complication.
 Knowledge of performance in different user

population.
 Feedback on indication of use.
 Feedback on instruction for use.
 Feedback on use with other devices.
 Feedback on customer satisfaction .
 Feedback on continuing market viability.
 Procedures related to drug use –results
surveys
 Procedure related to post-marketing clinical
studies
 Standards related to in house inspection
 Procedure related to the outsourcing of
duties in post-marketing surveys, etc.
 Any other procedures necessary for
appropriate and smooth implementation of
post –marketing surveys, etc.