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Introduction and history of
pharmacovigilancePresented By:
Dr. Bhargav M.Purohit
Associate Professor
Department of Pharmacology
Government Medical College
Bhavnagar. 364001
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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To undergo treatment you have to be very
healthy, because apart from your sickness you
have to withstand the medicine.- Moliere
210/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Relevant terms
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Pharmacovigilance
Science and activities relating to the detection,
assessment, understanding andprevention of
adverse effects or any other drug related
problem.[WHO]
pharmakon (Greek for drug) and vigilare
(Latin for to keep watch).
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Adverse drug reaction(ADR)
Response to a drug,that is noxious or
unintended,and that occurs at the doses,used in
man for prophylaxis, diagnosis or therapy of
the disease or for modification of immune
function. [WHO]
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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To be precise
Harmful effectsof drugs seen at usual doses.
So.... Poisoning is not included in ADR.
Therapeutic failure is not included in ADR
Prescription errors are not included in ADR.
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Serious ADR
Those which
Result in death
Are life threatening
Require inpatient hospitalization or prolongation of existinghospitalization
Result in persistent or significant disability/incapacity or
Produce a congenital anomaly/birth defect
Is an important medical event or reaction, that mayjeopardize the patient or subject and may require medical
or surgical intervention to prevent one of the outcomes
listed above.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Dechallenge
Stopping of the drug following ADR.
Positive dechallenge: when an adverse event
abates or resolves completely following the
drug's discontinuation.
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Rechallenge
Restarting medication following cessation of
ADR.
Positive rechallenge:when the adverse event
re-occurs after the drug is restarted.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Signal
Reported information on a possible causal
relationship between an adverse event and a
drug, the relationship being unknown or
incompletely documented previously.[WHO]
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Why we encounter so many
ADRs????
Formerly when religion was strong and science was
weak at that time men mistook magic as medicine.
Now science is strong and religion is weak and men
mistake medicine as magic -Thomas szasz, the second sin, 1973
.Perception of medicine as magic is
precisely the reason we have so many ADRs.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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History of Pharmacovigilance
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Before 18thcentury In 1780 BC Babylonian Code of Hammurabi states
If a physician make a large incision with open knife, and kill him, oropen a tumor with the operating knife, and cut out the eye, his hands
shall be cut off.
In 10th century Salerno Medical School was empowered to
punish for adulterated drugs.
Whosoever shall have or sell any poison or noxious drug not useful ornecessary to his art, let him hanged.
In 13th century the Oath of Apothecaries(Switzerland)
states..
Drugs should be of such good quality and of such usefulness that heknows, upon his oath, that it will be good and useful for the confection
what the physician is making.
In 1599 King James VI issued a charter to supervise approval
of sales of drugs in Glasgow.10/10/2013 Dept. of Pharmacology,
Govt. Medical College, Bhavnagar.13
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In 18thcentury. William Withering (1785) :
ADRs seen with digitalis obtained from foxglove.
Wouter van Doeveren ( 1789) :
Hazards of blood letting and perspiration inducing drugs.
Detriments caused by empirical therapy. HgCl2 used for yellow fever produced damage to various oral
structures like teeth, mucous membrane, mandible etc.
Oliver Wendall Holmes (1861) famously stated
If whole Materia Medica as it is used now would be sunk to the bottomof the sea, it would all the better for mankindand all the worse for the
fishes.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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In 19thcentury 1808 :First organized Pharmacovigilance activity for cowpox
vaccine was carried out in Netherland. 1848 : adulterated quinine imported for US army prompted to
pass a statute to control the quality of drugs marketed.
Safety of chloroform anesthesia :
Following a death by chloroform Glasgow Committee wasrecruited by BMA in 1880 which stated safety of ether over
chloroform.
In 1888 First Hyderabad Chloroform Commission :
chloroform can be a safe anesthesia if respiration incarefully monitored
Second Hyderabad Chloroform Commission : confirmed
the findings
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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In 20thcentury 1906 : FDA was established and Pharmacopoeias were
published.
This century witnessed two drug tragedies.
Sulfanilamide disaster [1937] :
Sulfanilamide elixir with ethylene glycol by Harold Watkins.
Death of 105 patient + chemist
1938 Food, Drug, and Cosmetic Act, which increased FDA's authority
to regulate drugs.
Safety testing + effective labelling.
Thalidomide disaster [1961]: Used for morning sickness
Between late 1950s to early 1960s 10000-20000 children affected.
Adverse effects :phocomelia, dysmelia, amelia, bone hypo plasticity,
and other congenital defects affecting the ear, heart, or internal organs.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Digitalis tragedy [1969]:
Due to production error high dose of digitalis was given
claiming 19 lives in Veenendal.
Blood dyscrasias registry was set up by Council on Drugs ofthe AMA[1950] after reports of aplastic anemia because of
chloramphenicol.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Drug Cause of withdrawal
Tegaserod MI and stroke
Phenformin Lactic acidosis
Terfenadine Arrhythmias
Cisapride Arrhythmias
Rofecoxib MIRimonabant Severe depression and suicide
Phenylproponalamine Stroke
Pioglitazone MI and Death
Nimesulide Pediatricformulations
Hepatotoxicity
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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How ADRs harm patient ?
Physical harm
Psychological trauma
May increase hospitalization duration Increase the need of more and more drugs
Raise the cost of therapy
..Therapeutic effects and adverse drug
reactions are two sides of the same coin
1910/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Scope of pharmacovigilance
It includes .
Modern drugs
Herbals
Traditional and
complementary medicines Blood products
Biologicals
Medical devices
Vaccines
Many relevant fields are
Substandard medicines
Medication errors
Lack of efficacy reports
Off label use of drugs
Acute and chronic poisoning
Assessment of drug related
mortality
Abuse and misuse of drugs
D/I with other chemicals and
food
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Aims of Pharmacovigilance..
WHO bulletin 2002 states following aims :
Improve patient care and safety in relation to the use of
medicines and all medical and paramedical interventions.
Improve public health and safety in relation to the use ofmedicines
Contribute to the assessment of benefit, harm, effectiveness
and risks of medicine, encouraging their safe, rational and
more effective (including cost effective) use.
Promote understanding, education and clinical training in
Pharmacovigilance and its effective communication to the
public.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Why ADR monitoring and reporting
is necessary ?
Unreliability of preclinical data
Changing pharmaceutical marketing strategy.
Changing physician and patient preferences
Easy accessibility. You may be the First one..
Try to report ALL the adverse events.
It can be a suspected/confirmed ADR.
May be it will help picking up adverse reaction at an earlystage and warning may be issued.
May be timely detection prevent a catastrophic drug tragedy
because of you.
2210/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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How to do ADR reporting ?
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How to do assessment of ADR?
By Naranjos scale.
By WHO-UMC scale.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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H t h k t bilit f
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How to check preventability of
ADR ??
Modified schumock and thronton preventability
scale
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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How to check severity of ADR?
Modified Hartwig and Siegel criteria 1992.
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Success of Pharmacovigilance
Reporting
Obseration
Knowledge
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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FAQs
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Which information is mandatory ?
For an ADR form to be credible, 4 details are
needed :
1. An identifiable patient
2. An identifiable reporter
3. A suspect drug
4. An adverse event
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What should I report ?
EVERYTHING
noxious/unintended/unintentional.
May or may not be related to drug.
ADRs not because of only drugs because of
devices as well.
3010/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Can I report common ADRs?
Yes
It can be as common as ..
Aspirin induced gastritis Ampicillin induced diarrhoea
Chloroquine induced nausea,vomiting etc.
3110/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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What about patients confidentiality ?
Thepatients identity is held in strict confidence
and protected to the fullest extent..
3210/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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What about MY confidentiality?
It is held in strict confidence.
What ever is written in the form will NOT be
disclosed any where.
Programme staff is not expected to and will
not disclose the reporters identity in response
from the public or authority.
3310/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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Can reporting an ADR
go against me?
Absolutely Not.
Scientific fraternity is Indebted to you.
3410/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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To sum up
ADR reporting is service to the medical fraternity and
patients
Anything gone wrong due to or not due to drug
should be reported Doctor and patients confidentiality is strictly
preserved.
Reporting ADR can not and will not go against you
3510/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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What these kind of CMEs do ?
They highlight What to report ?
Why to report ?
How to report ?
Whom to report ? What happens to reports generated ?
They bring healthcare professionals together and encourage
collaboration between them.
Sometimes they give sleepless nights to last minute speakers
10/10/2013 Dept. of Pharmacology,Govt. Medical College, Bhavnagar.
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10/10/2013 Dept of Pharmacology 37
Thank You
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