1. Introduction and History of Pharmacovigilance

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Introduction and history of

pharmacovigilancePresented By:

Dr. Bhargav M.Purohit

Associate Professor

Department of Pharmacology

Government Medical College

Bhavnagar. 364001

[email protected]

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

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Relevant terms


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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).


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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]


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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.


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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.


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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]


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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.


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History of Pharmacovigilance


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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.


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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


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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.


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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.


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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


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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



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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


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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.


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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.



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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.


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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


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How to check severity of ADR?

Modified Hartwig and Siegel criteria 1992.


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Success of Pharmacovigilance

Reporting

Obseration

Knowledge


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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.



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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.



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What about patients confidentiality ?

Thepatients identity is held in strict confidence

and protected to the fullest extent..



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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.



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Can reporting an ADR

go against me?

Absolutely Not.

Scientific fraternity is Indebted to you.



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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



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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


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10/10/2013 Dept of Pharmacology 37

Thank You
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1. Introduction and History of Pharmacovigilance

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