Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.

1. POST MARKETING
SURVEILLANCE
Submitted to: A.Rekha Devi M.pharm
Submitted by: K.G.Yuvaraj B.pharm
Seven Hills College of pharmacy,
Vekataramapuram,Tirupathi.

2. ◦ Post-marketing surveillance refers to the ongoing monitoring and assessment of a
pharmaceutical product or medical device after it has been approved and introduced to the
market. The primary goal is to identify and evaluate any adverse effects or potential safety
concerns that may not have been apparent during pre-marketing clinical trials.j

3. Phases of Clinical Trials
◦ PHASE 1: Healthy volunteers (20-100) Safety & dosage
◦ PHASE 2: People with disease condition (100-300) Efficacy &side effects.
◦ PHASE 3: People with disease condition (300-3000) Confirm effectiveness and monitoring of
adverse drug reaction.4. PHASE 4(POST MARKETINGSURVEILLANCE): Track adverse events and
monitors effects in real world.
◦ PHASE 4(POST MARKETINGSURVEILLANCE): Track adverse events and monitors effects in real
world.

4. ◦ Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market
after clinical trials
◦ It evaluates drugs taken by individuals under a wide range of circumstances over an extended
period of time.
◦ Such surveillance is much more likely to detect previously unrecognized positive or negative
effects that may be associated with a drug.
◦ The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring
and evaluation.
◦ Other important postmarketing surveillance components include unapproved or off-label drug
use, problems with orphan drugs, and lack of paediatric formulations, as well as issues
concerning international clinical trials in paediatric population.

5. ◦ The process of evaluating and improving the safety of medicines used in paediatric practice is
referred to as paediatric pharmacovigilance.It requires special attention. Childhood diseases and
disorders may be qualitatively and quantitatively different from their adult equivalents.

6. ◦ Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of
nausea in pregnant women.In 1961 in Germany an astute pediatrition (Lenz) expressed concern
about the sudden large increase in the number of children referred to his clinic with limb
deformitis (Phocomelia) and thalidomide tragedy has been identified.The prevention of
unwanted drug effects became matter of worldwide public.

7. ◦ • Post market surveillance not only meets regulatory requirements while monitoring the safety
of consumers, but also ensures continuous consumer acceptance of the products and financial
viability.
◦ Post marketing surveillance is a passive, multifactorial, performance- process for health
professionals, manufacturers, regulators and the monitor the performance during the lifecycle of
a product in the open market.
◦ It is important for manufacturers and regulators to share common safety surveillance keeping
consumers in mind.

8. Types & source of real world data
◦ A.Clinical data: 1)Electronic health records.
◦ 2) Case report forms.
◦ B. Patient generated data :1) Health & treatment history.
◦ 2) Patient reported outcomes.
◦ C. Cost & utilization data Claims datasets.
◦ D. Public health data: Government data source

9. Post marketing surveillance System
◦

10. Process of PMS

11. Methods of PMS

12. Voluntary Reporting
◦ Voluntary reporting by physicians and other health care providers, hospitals, and consumers
may act to alert FDA and pharmaceutical firms to possible adverse effects of drugs.
◦ These surveillance systems enable physicians and pharmacists to report suspected ADRs and
thus act as a tool to identify new ADRs and risk factors predisposing to recognized ADRs
◦ It is acknowledged that only a small proportion of ADRs are actually reported to national
reporting centres and pharmaceutical companies. Insight into reasons for underreporting
should enable national reporting centres to take appropriate measures to increase reporting
rates.

13. Control clinical Study
◦ Controlled clinical trials are used primarily for evaluating drug efficacy, not safety, because they
are carried out on hundreds, or, at the most, a few thousand drug users.
◦ Their use for evaluating drugs already on the market is also limited by their high cost and
logistical problems.
◦ These limitations of controlled clinical trials in evaluating the safety of marketed drugs have led
to relying on cohort and case-control methods for postmarketing studies.

14. Cohort study
◦ Cohort design is a type of nonexperimental or observational study design.
◦ Cohort studies are important in research design.The term "cohort" is derived from the Latin
word "Cohors"-"a group of soldiers.“
◦ *In a cohort study, the participants do not have the outcome of interest to begin with. They are
selected based on the exposure status of the individual.
◦ Thus, some of the participants may have the exposure and others do not have the exposure at
the time of initiation of the study.
◦ They are then followed over time to evaluate for the occurrence of the outcome of interest.

15. PROSPECTIVE
◦ Prospective means looking forward
(into the future).
◦ It is a type of cohort study where the
researchers enrol participants into the
study before they develop the disease.
◦ Involves a group of people who don't have
the disease under study.
RETROSPECTIVE
◦ Retrospective means looking backwards
(into the past)
◦ It is a cohort study that analyzes two group
of people those with disease under study
as well as a very similar group of people
who do not have the disease.
◦ Involves a group of people who already
have the disease under study

17. Case control study
◦ Case-control studies are retrospective.
◦ They clearly define two groups at the start: one with the disease and disease.
◦ They look back to assess whether there is a statistically significant rates of exposure to a defined
risk factor between the groups.

18. Advantage
◦ Cheaper
◦ Quicker
◦ Good for diseases with long latency
periods.
Disadvantage
◦ Retrospective / more prone to bias.
◦ Can only assess one Disease.