Adverse Drug Reactions

Presented to: Mam Fatima Saqib

Presented by: Sameen Rashid
Roll no: 13
Warfarin, Insulin and Digoxin are
the most Dangerous drugs in the
elderly.
Do we believe that?
All Drugs are No Drugs are
Dangerous Dangerous if
used properly
Some drugs
Some drugs have
have a low
a low incidence of
therapeutic
horrendous
ratio
effects
Some drugs are The most
dangerous in dangerous
acute poisoning drugs have the
but not when greatest
GOOD
used BAD potential for
therapeutically benefit

Some adverse Some adverse

effects occur effects can be
after a delay How dangerous a drug is predicted if you
or after depends on the skill of the know the
stopping prescriber pharmacology
(Type A); some
are not (Type B)
 The Risk to Benefit Ratio

When prescribing drugs a doctor must assess

risk to benefit ratio in the individual patient by
•Choosing an appropriate class of drug then an
appropriate individual agent
RISK BENEFIT •Is it effective ?
•What are the chances of adverse effect ?
•Are there features in this patient which
affect choice eg other drugs, organ failure,
aged
•Tailoring the dose
•Considering duration of treatment
Adverse drug reactions

“Any response to a drug which is

noxious, unintended and occurs at doses
used for prophylaxis, diagnosis or
therapy.”
An ADR is any unwanted effect resulting
from a drug’s use in treatment.
 
 
Epidemiology

4% of hospital admissions
1 in 1000 deaths in medical wards
10 to 20 % of in-patients
5% of patients in general practice
More frequent in elderly:
erratic drug taking
multiple pathology
altered pharmacokinetics
increased sensitivity of CNS and
CVS
 Mechanisms

Common mechanisms are:

 Abnormal pharmacokinetics due to

genetic factors

comorbid disease states

 Synergistic effects between either

a drug and a disease

two drugs
Drugs

 Anti-coagulants
 NSAIDs
 Corticosteroids
 Anti-hypertensives
 Anti-biotics
 Diuretics
 Insulin
Occur in circumstances related to
Drug’s pharmacology
Predisposing factors in the patient
Care taken in choosing the drug
The dose.
Location

Local effect

limited to a certain location

Systemic effects

Throughout the systemic circulation

ocular antihypertensives administered locally as

eye drops to the systemic circulation.

 Classification

 Type A: Augmented pharmacologic effects

 Type B: Idiosyncratic
 Type A: Augmented
pharmacologic effects
 dose dependent
 Predictable
 constitute approximately 80% of adverse drug reactions
 Are either due to excessive action at targeted receptor or to action
at a non-target receptor
 Are closely related to amount of drug in the body
 usually a consequence of the drug’s primary pharmacological
effect (e.g. bleeding when using the anticoagulant warfarin) or a
low therapeutic index of the drug (e.g. nausea from digoxin)
 usually mild, although they may be serious or even fatal
 usually due to inappropriate dosage
 Can be avoided with care
 Type B: Idiosyncratic

 This effect is unrelated to established pharmacological

effects
 The effect may be serious organ damage
 There is a poor relationship to dose
 Uncommon
 Difficult to detect in drug development
 Cannot be avoided
 Patient idiosyncrasy is a major factor
Monitoring bodies
WHO Uppsala Monitoring Centre

Pakistan Pharmacovigilance Programme of

Pakistan (PvPP)
European Union European Medicines Agency (EMEA)

United States Food and Drug Administration (FDA)

Canada Marketed Health Products Directorate of

Health Canada

Australia Therapeutic Goods Administration (TGA)

Detecting Adverse Effects

 MRHA (Medicine and Healthcare products

Regulatory Agency) freephone service for reporting
and information about suspected ADRs

 Self reporting by patients and relatives using

Yellow cards available at pharmacies

 Prescription event monitoring

 New drugs – black triangles and yellow cards

 Measuring danger

 MHRA activity
through Yellow
card reporting
and prescription
monitoring
 Huge increase
in reports over
recent years
 Who reports to the MHRA?
•Under-reporting estimated at 94% in hospital practice (Smith et al
1996)
•MRHA activity good at detecting adverse effects
•Not very good at assessing the risk ratio
 Prevention of Adverse Drug
reactions
 Never use any drug unless there is good
indication. If the patient is pregnant do not use
the drug unless the need is imperative.

 Allergy and idiosyncrasy are important causes

of ADRs. Ask if the patient had previous
reactions.

 Ask if the patient is already taking other drugs

including self medication
 Preventing ADRs
 Age, hepatic and renal disease may impair
clearance of drugs so smaller doses may be
needed.
 Genetic factors may also predispose to certain
ADRs
 Prescribe as few drugs as possible and give
clear instructions
 Where possible use familiar drugs. With new
drugs be particularly alert for ADRs and
unexpected event.
 If serious ADRs are liable to occur warn the
patient
Some websites

 Clinical pharmacology and therapeutics by roger walker

 www.yellowcard.gov.uk
 http://medicines.mhra.gov.uk
 www.dsru.org
 http://eis.bris.ac.uk/~pmcjcr/Drug%20Safety.pdf
 www.Wikipedia.com