2. INDEX
Introduction
History
Benefits to a PMS system
Sources of Post-marketing Surveillance
Need of Post-marketing Surveillance (P.M.S)
Vision of Post-marketing Surveillance (P.M.S)
Opportunity
Practical aspects of PMS
PMS procedure
Method of Post-marketing Surveillance
Manufacturer PMS SYSTEM
Possible Achievements
Summary
Reference
3. 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 in the real
clinical setting.
4. 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 informationon the benefit and risk of
the drugs.
5. POST-MARKETING SURVEILLANCE
No fixed duration/Patient population
Starts immediately after marketing
Report all ADRs
Help to detect
Rare ADRs
Drug interaction
Also new uses for drugs[sometimes called
Phase V]
6. 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.
7. 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.
8. 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
9. 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).
10. A manufacturer of intraocular lenses
collected numerous complaints from
users about broken lenses.
The manufacturer assessed the
complaints and deemed them
statistically significant.
11. 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.
Increase in “non-medical‟‟ data sources-
e.g.Pharmacy,supermarket,employer vaccination.
12. 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.
13. 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.
14. 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.
CONT………..
15. 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 and
log.
This information could constitute
feedback received from user .
16. 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.
17. 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.
18. 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.
19. 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 gave rise to cases.
20. 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. CONTD…..
21. 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.
22. 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 . CONTD……..
23. 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,
electronic health records, patient registries and
record linkage between health database.
24. 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.
25. Absence of complete diagnostic
information.
Vaccines and other medical products
have risk that may include rare
serious adverse events not detected.
26. REFERENCE
1. Borden E.K, The upjohn Co., „„POST-
MARKETING SURVEILLANCE OF out patient
drugs using a pharmacy-based registration
system-report of two studies,‟‟ presented at
the drug information association Work shop,
williamsburg va,DECEMBER 1981,10-32.
2. CLARREN S.N.et al, “The evaluabdity
Assessment of the developing experiment in post
marketing surveillance of prescription drugs‟‟,
prepared for the experiment technology incentives
program, National Bureau of standards , 10-22.
27. REFERENCE
2.FOOD AND DRUGS
ADMINISTRATION, „„Supplementary
reports to contracts and grants committee on
Medicaid”, from the division of Drugs
Experience, BUREAU OF DRUGS,1982, 10-32.
3.KAREN MIDTHUN, „„Deputy Director
Centre for biologics Evaluation and
Research”,FDA,ICDRA Pre-conference berne,
SWITZERLAND september 15
