The document provides an overview of post-marketing surveillance (PMS), highlighting its importance in monitoring the safety and efficacy of drugs after they have been approved for public use. It discusses the historical context of PMS, various sources of information, and methods of surveillance used to detect adverse drug reactions. Ultimately, PMS is essential for ensuring product safety and identifying rare adverse events that may not be evident in pre-licensure studies.

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

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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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