Prepared By Pavan Kumar RR College of Pharmacy , Bangalore. TOPIC COVERED= Post-marketing survillance Special Thanks to Pawan Dhamala

1. 26-03-2022 © R R INSTITUTIONS , BANGALORE 1
REGULATORY AFFAIRS
POST-MARKETING SURVEILLIANCE
RR COLLEGE OF PHARMACY
SUBMITTED BY: SUBMITTED TO:
PAVAN KUMAR ASSOCIATE PROF. SRILATHA KS
1ST SEM , M.PHARM

2. © R R INSTITUTIONS , BANGALORE
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CONTENTS:
1. INTRODUCTION
2. POST-MARKETING SURVILLANCE
3. HISTORY OF PMS
4. SOURCES OF PMS INFORMATION
5. WHY DO WE NEED PMS?
6. PMS OPPORTUNITY
7. METHOD OF SURVILLANCE
8. SUMMMARY

3. INTRODUCTION
A new medicine must pass three hurdles before its approval by the
national drug regulatory authority. Sufficient evidence is required to
show the new drug to be
• of good quality,
• effective, and
• safe for the purpose or purposes for which it is proposed.
To market a drug, the manufacture must provide evidence of its
efficacy & safety to the USFDA.
 Although post marketing survelliance cannot provide knowledge of
the safety or efficacy of the drug at the time of there introduction into
the market.
It play an important role to discover an undesirable effects that might
present at risk.
It provide additional information that benefit and risk of the drugs.
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4. 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)
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POST MARKETING SURVEILLANCE

5. History of PMS
In the 1960 at least two serious drugs reactions were observed in
many patients i.e: thalidomide causes limb deformation(phocomelia).
Observed in japan, was the optic nerve damage(subacute myeloptic-
neuropathy).
The PMA, senator Edward Kennedy suggested that a better system
was need for monitoring the use & effects of prescription drug after
they are marketed.
As a result, the joint commission prescription drud 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 anticipate and unanticipated effects of
marketed drugs.
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6. The following may be considered as sources of information,
some sources are proactive and some are reactive.
Expert user groups (“focus groups”)
Customer surveys
Customer complaints & warranty claims
Post CE- market clinical trials
Literature reviews
Device tracking/implant registries
User reaction during training programmers
The media. © R R INSTITUTIONS , BANGALORE 6
SOURCES OF PMS INFORMATION

7. The primary objective of PMS 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 vary large clinical trials have limitation.
Access to more patient & given data.
Better background rates,comparable “control” population.
Increase in “non-medical” data sources- e.g. Pharmacy, supermarket,
employer vaccination.
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WHY DO WE NEED POST-MARKETING
SURVEILLANCE?

8. POST-MARKETING SURVELLIANCE
OPPORTUNITY
Access to additional health system data.
Access to global data: regulatory, inspectional,
health system, international surveillance &
pharmacovigilance.
Better analytical tool & methods.
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9.  Thus, 4 types of studies are generally used to
identify drugs effects:
1. Controlled clinical trials
2. Spontaneous or voluntary recording
3. Cohort studies &
4. Case controlled studies
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METHODS OF SURVEILLANCE

10. 1. Controlled clinical trials
To minimize bias through such methods as
randomization and “double-blinding”.
Directly monitor patients for the duration of
studies.
For evaluation a drugs’s efficacy and safety.
They are often costly.
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11. 2. Spontaneous or voluntary reporting:
By physician & other health provider & hospital may to alert
FDA & 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.
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12. 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 case.
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13. 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.
PMS can further refine, or confirm or deny , the safety of a drug after
it is used in the general population by the large numbers of people who
have a wide variety if medical conditions.
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SUMMARY

14. Post marketing 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.
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 & other medical products have risk that may include rare serious
adverse events not detected.
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15. REFERENCES:
1)Biopharmaceutics and Pharmacokinetics by D.M. BRAHMANKAR
(Msc. Phd.)
2)www.goggle.com
3)http://en.wikipedia.org/wiki/Post-marketing surveillance
4)https://www.sciencedirect.com/topics/medicine-and-
dentistry/surveillance
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