Pharmacovigilance

The Alert Dr. Santi Ranjan Dasgupta

Prescriber
 Hippocratic Oath
Classical Version (5th Century BC)

I will use treatment to help the sick according to my ability

and judgment, but never with a view to injury and wrong-
doing. Neither will I administer a poison to anybody when
asked to do so, nor will I suggest such a course. Similarly I
will not give to a woman a pessary to cause abortion. But I
will keep pure and holy both my life and my art.…Into
whatsoever houses I enter, I will enter to help the sick, and I
will abstain from all intentional wrong-doing and harm,
especially from abusing the bodies of man or woman, bond
or free.
 Where do we stand now?
❖ We do prescribe women abortive medicines. However,
we are pharmacovigilant now.

❖ But what is pharmacovigilance?

❖ And what duties does it entail for the physician or the

prescribing authority?
Pharmacovigilance: Definition

❖ Pharmacovigilance is defined by the World Health

Organization (WHO) as ’the science and activities
relating to the detection, assessment, understanding
and prevention of adverse effects or any other drug-
related problem’.
How did we arrive here?
 The Thalidomide Disaster
The thalidomide disaster is one of the
darkest episodes in pharmaceutical
research history. The drug was
marketed as a mild sleeping pill safe
even for pregnant women. However, it
caused thousands of babies worldwide
to be born with malformed limbs. The
damage was revealed in 1962. Before
then, every new drug was seen as
beneficial. Now there was suspicion
and rigorous testing.
 Aftermath of the controversy
There was a long criminal trial in Germany and a British newspaper campaign.
They forced Grünenthal and its British licensee, the Distillers Company, to
financially support victims of the drug.

In 1964 a leprosy patient at Jerusalem’s Hadassah University Hospital was

given thalidomide when other tranquilisers and painkillers failed.

Research into thalidomide’s effects on leprosy resulted in a 1967 (WHO)

clinical trial. Positive results saw thalidomide used against leprosy in
many developing countries.

It is also used successfully to control some AIDS-related conditions, and its

effects on various cancers are under investigation

The renewed use of thalidomide remains controversial.

 What does this tell us?
❖ The history of a drug is not singular and universal
❖ It manifests differently with every new health
complication
❖ It manifests differently with the change in genetic
composition and economic conditions of different parts
of the world.
 The Roxid incident
Roxid 150 MG Tablet belongs to a group of medicines called macrolide antibiotics.

It was used to treat respiratory infections from both upper and lower airways, such as
otitis, sinusitis, pharyngitis, tonsillitis, bronchitis and pneumonia.

Till, patients started reporting adverse reactions.

Most common side effects reported were gastrointestinal; diarrhoea, nausea, abdominal
pain and vomiting. Less common side effects include central or peripheral nervous
system events such as headaches, dizziness, vertigo, and also rashes, abnormal liver
function values and alteration in senses of smell and taste.

It got replaced with the Azithral group of drugs.

But even a lot of doctors, knowingly or unknowingly, prescribe the drug and get positive
results in situations where the Azithral group fails.
 What is pharmacovigilance for the
physician?
❖ Is it just identifying and reporting previously unknown
and serious adverse drug reactions related to new
products to pharmaceutical companies and getting that
drug removed from the market
or
❖ Is it following some fundamental norms of safe-
prescribing?
 Some salient
Safe-Prescribing features
Prescribing within limits of
competence
Evidence-based prescribing
Interaction with other drugs
Concordance, not Compliance

In recent years there has been a move away from the term
"compliance", which suggests an element of compulsion, to
"concordance", in which prescriber and patient enter into a partnership
concerning the use of medication.

The cornerstones of concordance include:

The level of information given to patients.
Side-effects.
The costs of medication.
The effect on lifestyle.
 Tolerability

Tolerability refers to the degree to which

overt adverse effects of a drug can be
tolerated by a patient. Tolerability of a
particular drug can be discussed in a
general sense, or it can be a quantifiable
measurement as part of a clinical study
Alerting patients to all adverse
effects of the drugs
Checking dosage
 Keeping up to date and following clinical
guidelines, published in the latest science
journals and drug manuals
 Not relying on drugs overtly, but
adopting a holistic approach to health
 Most importantly, not depending on the medical
sales representatives’ demonstration as the only
information on the drug.
 Hippocratic Oath
Modern Version (1964)

I will apply, for the benefit of the sick, all measures [that] are required,
avoiding those twin traps of over-treatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that
warmth, sympathy, and understanding may outweigh the surgeon's knife or
the chemist's drug.
I will not be ashamed to say "I know not," nor will I fail to call in my
colleagues when the skills of another are needed for a patient's recovery….I
will remember that I do not treat a fever chart, a cancerous growth, but a sick
human being, whose illness may affect the person's family and economic
stability. My responsibility includes these related problems, if I am to care
adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.