What Is Evidence Based Medicine

Pharmacology SGD 5: Evidence Based Medicine & TDM
~Anvi R.
1. Concept of evidence-based medicine. (KDT pg 83)
• Process of systematically finding, evaluating and

using contemporary research findings as the basis of
clinical decisions.
• Evidence-Based Medicine (EBM) aims for the ideal

that healthcare professionals should make
"conscientious, explicit, and judicious use of current
best evidence" in their everyday practice.
• The key difference between evidence-based

medicine and traditional medicine is not that EBM
considers the evidence while the latter does not. Both
take evidence into account; however, EBM demands
better evidence than has traditionally been used.
• One of the greatest achievements of evidence-
based medicine has been the development of
systematic reviews and meta-analyses, methods by
which researchers identify multiple studies on a topic,
separate the best ones and then critically analyze them
to come up with a summary of the best available
evidence.
• The EBM-oriented clinicians of tomorrow have

three tasks:
o a) to use evidence summaries in clinical practice. o

b) to help develop and update selected systematic
reviews or evidencebased
guidelines in their area of expertise; and
o c) to enroll patients in studies of treatment,

diagnosis and prognosis on which medical practice is
based.
2. Sources of drug information – their importance.

(KDT pg 4)
2
• Resources available: Primary Sources (info
presented by authors w/o any evaluation by a second
party – most current info about drugs. Ex: articles in
journals and thesis), Secondary Sources (Original
source has been evaluated by second party other than
publisher – modified/rearranged form. Ex: Review
articles like Medline), Tertiary Sources (info from
primary and secondary source arranged in. a manner
to represent a composition of the available
information. Ex: BNF, Pharmacopoeias) o
Pharmacopoeias:
 official code containing a selected list of

established drugs and medicinal preparations with
descriptions of their physical properties and tests for
their identity, purity, and potency. Ex: Indian
Pharmacopoeias, British, European, etc. o Formularies:
 produced in booklet form and list indications,

dose, dosage forms, contraindications, precautions,
adverse effects, and storage of selected drugs that are
available for medicinal use in the country. Ex: British
National Formulary (BNF), National Formulary of India
(NFI), etc. o Martindale:
3
 The Complete Drug Reference
(extrapharmacopoeia):
Published every 2-3 years by Royal Pharmaceutical

Society of Great
Britain – includes all new launches, etc. o Physician

Drug Reference
(PDR) and Drug Facts and Comparisons
(both from USA) o
Textbooks in Pharma o Bulletins
and Journals
o Monographs: Discourse on a single topic and gives

details about a single topic or about particular drug. o
Patient Package Insert: Label should comply with the
requirements
• Importance of Drug Information:
4
o The purpose of drug information center is to
provide authentic individualized, accurate, relevant
and unbiased drug information to the consumers and
healthcare professionals regarding medication related
inquiries to the nation for health care and drug safety
aspects
o Drug information center provides in-depth,

unbiased source of crucial drug information to meet
needs of the practicing physicians, pharmacists and
other health care professionals. o Poor drug
regulations and lack of independent, unbiased drug
information's are the main contributing reasons for
irrational drug use in India.
o About 40% of the health care service's budget is

consumed by medicines and with a limited resource
available, it becomes essential to promote rational
drug use
3. What is therapeutic drug monitoring (TDM)? Major

indications. (KDT pg 42)
5
• Therapeutic drug monitoring (TDM) is generally
defined as the clinical laboratory measurement of a
chemical parameter that, with appropriate medical
interpretation, will directly influence drug prescribing
procedures. It involves the use of drug concentration
measurements in body fluids as an aid to the
management of drug therapy for the cure, alleviation
or prevention of disease.
• TDM enables the assessment of the efficacy and

safety of a particular medication in a variety of clinical
settings. • The goal of this process is to individualize
therapeutic regimens for optimal patient benefit.
• INDICATIONS:
o 1. Drugs for which relationship between dose and

plasma concentration is unpredictable, e.g Phenytoin
o 2. Drugs with a narrow therapeutic window: - will

allow dosage alterations to produce optimal
therapeutic effect or to avoid toxic effects. Ex: Lithium,
phenytoin, and digoxin
o 3. Drugs with steep dose response curve: e.g.,

theophylline. o 4.
6
Drugs for which there is difficulty in measuring or
interpreting the clinical evidence of therapeutic or
toxic effects: - Nausea & vomiting occur in both
digitalis toxicity & congestive heart failure.
o 5. Drug with saturable metabolism: Phenytoin
o 6. Drug with poorly defined end point or difficult

to clinically predict the response. Example:
immunosuppressant drugs
o 7. Renal disease: Alter the relationship between

dose & the plasma concentration. Important in case of
digoxin, lithium & aminoglycoside antibiotics.
o 8. Drug interactions: When another drug alters the

relationship between dose & plasma concentration
e.g., plasma concentration of lithium is increased by
thiazide. o 9. Drug with large individual variability at
steady state PDC in any given dose
o 10. For diagnosis of suspected toxicity &

determining drug abuse o 11. To evaluate compliance
of patient o 12. Guiding withdrawal of therapy:
Antiepileptics, Cyclosporine.
7
4. Knowledge about maximum and minimum drug
concentrations.
• Minimum effective concentration (MEC) is the

minimum plasma concentration of a drug needed to
achieve sufficient drug concentration at
the receptors to produce the desired pharmacologic

response, if drug
molecules in plasma are in equilibrium with drug

molecules in the various tissues.
On the other hand, the maximum therapeutic

concentration or minimum

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Pharmacology SGD 5: Evidence Based Medicine & TDM

1. Concept of evidence-based medicine. (KDT pg 83)

• Process of systematically finding, evaluating and

• Evidence-Based Medicine (EBM) aims for the ideal

• The key difference between evidence-based

• The EBM-oriented clinicians of tomorrow have

o a) to use evidence summaries in clinical practice. o

guidelines in their area of expertise; and

o c) to enroll patients in studies of treatment,

2. Sources of drug information – their importance.

 official code containing a selected list of

 produced in booklet form and list indications,

Published every 2-3 years by Royal Pharmaceutical

Britain – includes all new launches, etc. o Physician

(PDR) and Drug Facts and Comparisons

(both from USA) o

Textbooks in Pharma o Bulletins

o Monographs: Discourse on a single topic and gives

• Importance of Drug Information:

o Drug information center provides in-depth,

o About 40% of the health care service's budget is

3. What is therapeutic drug monitoring (TDM)? Major

• TDM enables the assessment of the efficacy and

o 1. Drugs for which relationship between dose and

o 2. Drugs with a narrow therapeutic window: - will

o 3. Drugs with steep dose response curve: e.g.,

o 5. Drug with saturable metabolism: Phenytoin

o 6. Drug with poorly defined end point or difficult

o 7. Renal disease: Alter the relationship between

o 8. Drug interactions: When another drug alters the

o 10. For diagnosis of suspected toxicity &

• Minimum effective concentration (MEC) is the

the receptors to produce the desired pharmacologic

molecules in plasma are in equilibrium with drug

On the other hand, the maximum therapeutic

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