PMS Final

POST-MARKETING
SURVEILLANCE
PHASES OF CLINICAL TRIALS
 Phase I :First in man Safety
 Phase II: First in Patient –
dose,dosage forms
 Phase III: Efficacy , ADRs
 Post-marketing Surveillance or
Phase –IV :Evaluation of real
clinical setting.
INTRODUCTION
 To market a drug,the manufacturer must provide evidence
of its efficacy and safety to the U.S.FOOD AND DRUG
 ADMINISTRATION(FDA)
In Premarketing testing,the numbers and type of patient
used to demonstrate a drug`s efficacy and safety are
limited as compared with the numbers and type of patient
who will eventually be prescribed the drugs after it is

marketed.
Although post-marketing surveillance cannot provide
 knowledge of the safety or efficacy of the drug at the time
of there introduction into the market.
Post-marketing surveillance of drug therefore play an
 important role to discover an undesirable effect that might
present at risk.
It provide additional information on the benefit and risk of
the drugs.
POST-MARKETING SURVEILLANCE
 No fixed duration/Patient population
 Starts immediately after marketing
 Report all ADRs
 Help to detect
 Rare ADRs
 Drug interaction
HISTORY
 In the 1960 at least two serious drugs reactions were

observed in many patient. thalidomide causes limb
 deformities(phocomelia).
observed in Japan,was the optic nerve damage(subacute
 myelooptic –neuropathy).
The PMA,senator Edward Kennedy (D-Mass.) suggested
that
 a better system was need for monitoring the use and
effects of prescription drug after they are marketed.
As a result, the joint commissionon Prescription Drugs Use
was established in 1976,funded largely by the drug
 industry, with the mandate to design a post-marketing
surveillance system to detect,quantify,and describe the
anticipated and unanticipated effects of marketed drugs.
The delayed discovery of the practolol`s adverse effects
spurred effects to improve post-marketing surveillance.
SOURCES OF PMS INFORMATION
 The following may be considered as sources
of information, some source are proactive
and some are reactive.
 Expert user groups (“ focus groups‟‟)
 Customer surveys.
 Customer complaints and warranty claims
 Post CE-market clinical trials.
 Literature reviews.
 Device tracking/implant registries.
 User reaction during training programmers.
 The media.
ARE THERE BENEFITS TO A
PMS SYSTEM
 Detection of manufacturing problems;
 improvement of medical device quality;
 verification of risk analysis;
 Intelligence of long-term performance;
 chronic complications;
 performance trends;
 Performance in different user
populations
 mechanisms the device may be misused.
 feedback on indications for
use,instructions for use.
 training required for users; use
with other devices.
 customer satisfaction.
 market performance and sustainability.
 identification of incident reports (and
field safety corrective action reports).
WHY DO WE NEED POST-
MARKETING SURVEILLANCE
 The primary objective of post-marketing surveillance
is to develop information about drug effects under
 customary condition of drug use.
Rare adverse events may not be detected in pre-
licensure studies because in very large clinical trials
 have limitation.
 Access to more patient and given data Given
diversity of data sources, innovative approaches to
retrieval of key data may have great
 potential vs. single unified system.
Better background rates, comparable “control‟‟
 Population.
VISION FOR POST-MARKETING
SURVEILLANCE
 All patient‟s vaccination and health
outcomes are immediately and continuously
Accessible in automated database allowing
optimal detection and analysis of potential
problem in vaccine safety.
 Not there yet –both major limitation and
opportunities in current health information
system.
 Both problems and solution to enhance vaccine
safety information and analysis are applicable to
safety initiatives for other medical products.
POST-MARKETING SURVEILLANCE
OPPORTUNITY
 Access to additional health system
data.
 Access to global
data:regulatory,inspectional,health
system,international surveillance and
pharmacovigilence.
 Better analytical tools and methods.
PRACTICAL ASPECTS OF PMS
 PMS should be proactive.
 Manufacturer should document
compliance.
 Manufacturer`s PMS procedure
should discuss the information that
will be collected and obtained as a
part of system.
ABOUT PMS PROCEDURE
 It should assign departments or
position a responsible for performing
a particular function.
 Manufacturer may find it helpful to a
have report at the end of year, as
well as PMS tracking schedule.
 This information could
constitute feedback received
from user.
 Information obtained from PMS
system should be communicated, at a
minimum, annually during a
management review meeting-which is
top management's examination of the
organization's quality management
system.
METHODS OF SURVEILLANCE
 Thus, four types of studies are generally used to
identify drugs effects:
1. Controlled clinical trials,
2. Spontaneous or voluntary recording
3. Cohort, studies and
4. Case control studies
1. Controlled clinical trials:
 To minimize bias through such method as
randomization and “double-blinding‟‟.
 Directly monitor patients for the duration of studies.
 For evaluating a drug‟s efficacy and safety.
 They are often costly.
2. Spontaneous or voluntary reporting
 By physician and other health provider &
hospital may to alert FDA and
pharmaceutical firms to possible adverse
effects of drugs.
3. Cohort studies :
 Studies follow a defined group of patient for a
period of time.
 Patient are not randomly assigned, & there is
no blinding.
 If adverse reaction occur. A second group of
patient with the same medical condition,
who are not taking the drug and who may be
receiving alternative treatment.
4.Case-control studies :
 Case control studies identify patient with the
adverse effects to be studied, and compare
them with the sample drawn from the same
cohort that give rise to cases.
MANUFACTURER PMS SYSTEM
These are some of the type of knowledge and
feed back which can achieved from a PMS
system.
 Detection of some manufacturing problems.
 Product quality improvement.
 Conformation (or otherwise) of risk analysis.
 Knowledge of long term
performance/reliability and /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.
 Identification oF vigilance report.
 Feedback on continuing market
viability.
SUMMARY
 Postmarketing surveillance (PMS) is the
practice of monitoring the safety of a
pharmaceutical drug .
 Device after it has been released on the
market and is an important part of the science
of pharmacovigilance.
 Since drugs are approved on the clinical
trials
which involve relatively small numbers of
people who have been selected for this
purpose .
 Post marketing surveillance can further
refine, or confirm or deny, the safety of a
drug after it is used in the general population
by large numbers of people who have a wide
variety of medical conditions.
 Postmarketing surveillance uses a number of
approaches to monitor the safety of licensed
drugs, including spontaneous reporting
databases, prescription event monitoring, ele
ctronic health records, patient registries and
record linkage between health database.
 Pre-licesure clinical product,and
manufacturing data are critical
foundation for evaluating safety and
effectiveness.
 However , post-licensure
surveillance
is essential to assure product safety.
 Absence of complete diagnostic
information.
 Vaccines and other medical products
have risk that may include rare
serious adverse events not detected.

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POST-MARKETING

 In the 1960 at least two serious drugs reactions were

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