Post Marketing Drug Safety & Pharmacovigilance

TRAINER: MD. ZAKARIA FARUKI
Orion Pharma Limited
Dhaka, Bangladesh Slide 1 of 32
TRAINING ON
Post Marketing Drug Safety &
Pharmacovigilance Study for
Global Regulatory
ORION

Introduction
 To market a drug, the manufacturer must provide
evidence of its efficacy and safety to the 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.
 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.
ORION
Training on Post Marketing Drug Safety Conducted by Md. Zakaria Faruki Slide 2 of 32

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 commission on 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.
ORION
Slide 3 of 32Training on Post Marketing Drug Safety Conducted by Md. Zakaria Faruki

Definitions
• Post-marketing drug safety surveillance refers to the monitoring
of drugs once they reach the market after clinical trials through a
process which evaluates drugs taken by individuals under a wide
range of circumstances over an extended period.
– Post-marketing surveillance has traditionally been carried out by
systematic manual review of spontaneous reports of adverse drug
reactions.
• Pharmacovigilance is the science and activities
relating to the detection, assessment, understanding,
and prevention of adverse effects or any other
drug-related problems.
*Section 505(0)(3) authorizes FDA to require certain post marketing
studies and clinical trials for prescription drugs approved under section
505(b) and biological product approved under section 351.
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Training on Post Marketing Drug Safety Conducted by Md. Zakaria Faruki

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Types of Post-Marketing
Surveillance

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Pharmaceutical Post-marketing
Surveillance System

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Routine Post-marketing
Pharmacovigilance

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FDA Adverse Event Reporting
System (FAERS)
• FAERS contains adverse drug
reaction reports FDA has received
from manufacturers as required by
regulation
• Single or multiple Individual
Case Safety Reports (ICSRs)
comprises of FAERS
• The MedWatch site provides
information about voluntary and
mandatory reporting of FAERS

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Individual Case Safety Reports
(ICSRs)

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Limitations of FDA Adverse Event
Reporting System (FAERS)

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Regulatory Actions

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Regulatory Actions
• Product information changes –
Warnings, Precautions, Adverse
Reactions
• Pharmacovigilance activities -
enhanced surveillance (e.g.,
expedited reporting), registry,
epidemiology studies
• Risk Evaluation and Mitigation
Strategy (REMS) Communication
plan, restricted use
• Drug Safety Communication (DSC)
• Market withdrawal

Conclusion
• Post marketing surveillance is defined
broadly as any information-gathering
activity that is performed after product
approval.
• Post marketing surveillance (PMS) is the
practice of monitoring the safety of a
pharmaceutical drug which is on the
market.
• Vaccines and other medical products have
risk that may include rare serious adverse
events not detected
• Post marketing surveillance uses a number
of approaches to monitor the safety of
licensed drugs, including spontaneous
reporting databases, prescription event
monitoring patient registries and record
linkage between health database.
Slide 28 of 32
ORION

Acronyms
• HCP – Health Care Provider
• SE – Safety Evaluator
• PMC – Post marketing Commitment
• PMR – Post marketing Requirement
• CFR – Code of Federal Regulations
• DSC – Drug Safety Communication
• EMA – European Medicines Agency
• FDA – Food & Drug Administration
• FDAAA – Food & Drug Administration Amendment Act
• FAERS – FDA Adverse Events Reporting System
• REMS – Risk Evaluation & Mitigation Strategy
• CDER – Center for Drugs Evaluation & Research
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ORION

References
1. 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.
2. Introduction to Postmarketing Drug Safety Surveillance: LT
Andrew Fine, Pharm.D., BCPS
3. Pharmaceutical Regulations in Japan: chapter-4
4. LARREN 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.
5. Postmarket Drug Safety Information for Patients and Providers
(FDAAA 915):
https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfor
mationforPatientsandProviders/default.htm
https://www.fda.gov/Safety/MedWatch/default.htm
6. Arthur N et al. The Importance of Pharmacovigilance – Safety
Monitoring of Medicinal Products. WHO2002.
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ORION
Slide 32 of 32Training on Post Marketing Drug Safety Conducted by Md. Zakaria Faruki

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