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Class 2 - Pharmacovigilance Overview PDF
Class 2 - Pharmacovigilance Overview PDF
Introduction
Definitions: Drug, PV, AE
Drug Development
Adverse Event
Need for PV‐Clinical Trials and Post marketing
PV in countries
Reporting
Benefits‐ Public and drug manufacturer
Rationale
Recall
1
Drug
• Substance or mixture of substances used for
diagnosis, treatment, mitigation or prevention
of disease or disorders.
• Used for restoring correcting or modifying
organic functions in human beings or animals.
2
Drug development
Preclinical Testing
IND Application
Clinical Testing – Phase I
Clinical Testing – Phase II
Clinical Testing – Phase III
New Drug Application
Clinical Testing–Phase IV
critical importance throughout the drug development process and is
updated with new information as it becomes available.
The purpose of the IB is to compile data relevant to studies of the IP in
human subjects gathered during preclinical and other clinical trials.
An IB is intended to provide the investigator with insights necessary for
management of study conduct and study subjects throughout a clinical
trial.
An IB may introduce key aspects and safety measures of a clinical trial
protocol, such as:
Dose (of the study drug)
Frequency of dosing interval
Methods of administration
Safety monitoring procedures 4
An IB contains a "Summary of Data and Guidance for the Investigator"
section, of which the overall aim is to "provide the investigator with a
clear understanding of the possible risks and adverse reactions, and of
the specific tests, observations, and precautions that may be needed for
a clinical trial.
This understanding should be based on the available physical, chemical,
pharmaceutical, pharmacological, toxicological, and clinical information
on the IP.
Guidance should also be provided to the clinical investigator on the
recognition and treatment of possible overdose and adverse drug
reactions that is based on previous human experience and on the
pharmacology of the investigational product".
5
•ICF- subject voluntarily confirms to participate, made aware of all aspects
•Placebo- A substance containing no medication, given to reinforce a patient's
expectation to get well (an inactive substance or preparation used as a control
to determine the effectiveness of a medicinal drug) GUIDELINES (declaration
of helsinki)
•Blinding/Masking- one or more parties kept unaware of the treatment
assignment
•-Single blinding subjects unaware
•-double blinding subjects, investigators, monitor, data analysts are also
unaware
•Randomized- subjects assigned randomly to treatment or control ( chance to
reduce bias)
•Serious- death, LT, hospitalization, disability, birth defect
•Concomitant medication- medications used by patients in a clinical trial, other
than the investigational drug. ( also to treat AE)
investigational drug.
•Causality- that AE was due to the medicine in question
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Overview of Pharmacovigilance
Introduction
Definitions: Drug, PV, AE
Drug Development
Adverse Event
Need for PV‐Clinical Trails and Post marketing
PV in countries
Reporting
Benefits‐ Public and drug manufacturer
Rationale
Recall
7
Overview: POP QUIZ!
1. When was the Food drug and cosmetic Act passed?
1938
3. In which phase is the likelihood of an adverse event maximum of all the 4 phases?
Trick question!!! All phases of preclinical and clinical.
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Why pharmacovigilance in clinical trials
• After the completing preclinical studies in
animals, first time trial drug will be
administered to the human.
• At this time the drug will act in different
way to the human body.
• Chances of adverse will also persist.
9
Pharmacovigilance in post marketing –
Why?
• At the time of approval, clinical trial data are available
on limited numbers of patients treated for relatively
short periods
• Once a product is marketed, large numbers of patients
may be exposed, including:
– Patients with co‐morbid illnesses
– Patients using concomitant medications
– Patients with chronic exposure
– Genetic diversity in large population
10
Pharmacovigilance – Why?
• After marketing, new safety information may
become available:
– Through use of the product domestically or in
other countries
– Through use of other drugs in the same class
– From preclinical studies
– From pharmacologic studies
– From clinical trials
11
Importance of Pharmacovigilance in every
country
There are differences among countries ( and even within
countries ) in the occurrence of ADRs (Adverse drug reactions)
and other drug related problems
Differences in diseases
Prescribing practices
Genetics
Diet
Traditions/lifestyle of people
Drug manufacturing processes
Drug distribution
The use of drugs ( dose, indications and availability)
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Who reports about adverse events in
Clinical Trials?
Investigator sponsor
13
Who reports about adverse events in clinical Trials
Health
Sponsor authority
14
Who reports in post marketing adverse events
Consumer
Physician Sponsor Health Authority
Healthcare prof
15
SPONTANEOUS REPORTING
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Spontaneous reporting of suspected adverse
drug effects is central to pharmacovigilance—
which is the systematic search for signals of drug
toxicity.
When such a signal is detected it has to be
verified, explored, and understood—realizing that
the drug may be acceptably safe if used by
individuals who are not at especially high risk by
virtue of genetic constitution, metabolism, or other
characteristics that could alter individual risk.
17
Partners in Pharmacovigilance
Government
Pharmaceutical Industry
Hospitals and academia
Medical and pharmaceutical associations
medicines information centers
Health professionals
Patients
Consumers
The media??
World Health Organization 18
POP Quiz
1. Is an Adverse Event always because of the suspected
medication?
A. NO. An ADR is always bcoz of Suspected medication.
2. Who should be ulimately be informed of all Adverse Events?
A. Regulatory Authority.
3. What is Spontaneous reporting?
A. Unsolicited reporting, by the patients, consumers and healthcare
professionals.
4. Is WHO also a partner in PV?
A. YES
5. Is it the law for AEs to be reported?
A. Yes
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What is the role of pharmacovigilance?
The goal of pharmacovigilance is to:
• Monitor the quality of drugs
• Identify the health risks involved in the
administration of certain drugs
• Prevent harm to patients
• Research the efficacy of drugs
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How does pharmacovigilance help the public?
Pharmacovigilance helps save thousands of lives
each year. By monitoring the adverse effects of
drugs right from the lab to the pharmacy and
then on for many years, pharmacovigilance
keeps track of any drastic effects of drugs. This
way, it prevents harm to patients using those
drugs.
21
How does pharmacovigilance help drug
manufacturers?
Pharmaceutical companies spend millions of dollars and a
considerably long‐time in developing new drugs. They again
spend a lot of money in conducting clinical trials before the
drugs are approved and launched in the market. But after all
this, if there are adverse effects to the drugs, the company
again loses millions of dollars in sales and litigations.
Furthermore, the reputation of the company is also severely
damaged. Pharmacovigilance monitors the development of
the drug across various stages and assesses its effectiveness
after its launch for many years. This way it may reduce the
adverse risk from drugs, thereby aiding the drug
manufacturers.
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The Need
• Regulatory agencies are increasingly proactive
in seeking out potential safety issues with
marketed drugs ‐ you must be ready to
respond quickly
• Political and social pressures have increased
along with faster communication channels
• Failure to practice pharmacovigilance can lead
to the suspension or withdrawal of license
23
Rationale for pharmacovigilance
• Prevents Disasters
• Builds up customer confidence
• Ensures Compliance and retention
• Builds brand image
24
Rationale for pharmacovigilance
What to report?
• ADR associated vaccines, diagnostics, drugs
used in traditional medicine, herbal remedies,
cosmetics, medical devices and equipment
• lack of efficacy and suspected pharmaceutical
defects
• overdose (because may cast doubt on safety
of a drug)
25
Rationale for pharmacovigilance
What to report?
Every single problem related to the use of a
drug, because probably nobody else is
collecting such information!
NOTE: When in doubt‐ Always report!!
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DRUG RECALL
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Classified as CLASS I, II and III
•Class I recalls are for dangerous or defective products that
predictably could cause serious health problems or death.
•Examples of products that could fall into this category are a
food found to contain botulinal toxin, food with undeclared
allergens, a label mix‐up on a life saving drug, or a defective
artificial heart valve.
•About 1 million packets of birth control pills are being
recalled in the U.S. by Pfizer because a packaging mishap
could increase the likelihood of pregnancy. Feb 2012
• 2010 pfizer recalls hypertension drug‐ Thelin‐ due to liver
toxicity.
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•Class II recalls are for products that might cause a
temporary health problem, or pose only a slight
threat of a serious nature.
•Example is a drug that is under‐strength but that is
not used to treat life‐threatening situations.
•Tylenol‐ acetaminophen tablets manufactured by
J&J‐ 2009 till date have been recalled‐ contaminated
with pesticides, over/under dosed
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•Class III recalls are for products that are unlikely to
cause any adverse health reaction, but that violate
FDA labeling or manufacturing regulations.
•Examples might be a container defect (plastic
material delaminating or a lid that does not seal); off‐
taste, color, or leaks in a bottled drink, and lack of
English labeling in a retail food.
30