Adverse Drug Reaction

Biswajit Mondal
B.Optom, M.Optm, M.I.A.C.L.E (Australia)
Asst. Professor: Dept. of Optometry & Vision Science

Adverse Drug Reaction?

The World Health Organization's definition of an ADR is:
"a response to a drug that is noxious and unintended and occurs at doses used in man for the
prophylaxis, diagnosis or therapy of disease, or for modification of physiological function."
Adverse Drug Reaction
This 30 year old definition is highly debated but is commonly understood to mean undesired side effects
of pharmacological agents and interactions with other drugs, including herbal remedies, alcohol, and
food.
Adverse Drug Reaction
The terms "side effect" and "ADR" are often interchanged. Although there is no clear distinction, the
former implies minor effects that have no lasting effect and may not even require discontinuation of the
drug (for example, hypotension in a patient with heart failure who has been treated with an ACE
inhibitor) whereas ADRs are more serious, always require discontinuation (or dose reduction), and may
have lasting effects (for example, a florid skin rash in response to an antibiotic).
Adverse Effects have been classified in many ways. One may divide them into:
Predictable (Type A) reactions
Unpredictable (Type B) reaction
Predictable (Type A) reactions
Usually predictable from the known pharmacological properties of a drug (augmented reaction).
Generally less serious
Example-Dehydration with diuretics; postural hypotension with antihypertensives
Management-Reduce dose or withhold and change drug.
Unpredictable (Type B) reaction
(Uncommon, "bizarre" reaction)
Unpredictable and unrelated to known pharmacological properties of the agent. More likely to have
serious consequences than Type A
Example-Torsades de pointes with terfenadine; agranulocytosis with carbimazole
Management-Stop drug immediately. Avoid all future use.
Severity of ADR has been Graded as:
1. Minor
2. Moderate:

3. Severe
4. Lethal
Minor
No therapy, antidote or prolongation of hospitalization required.
Moderate
Requires change in drug therapy, Specific treatment or prolongs hospital stay by atleast one day.
Severe
Potentially life threatening, causes permanent damage or requires intensive medical treatment
Lethal
Directly or indirectly contributes to death of the patient.
Prevention of adverse effects to drugs
Adverse effects can be minimized but not altogether eliminated by observing the following practices:
1. Avoid all inappropriate use of drugs in the context of patients clinical condition.
2. Use appropriate dose, route and frequency of drug administration based on patients specific
variables.
3. Elicit and take into consideration of previous history of drug reactions.
4. Elicit history of allergic diseases and exercise caution (drug allergy is more common in patients with
allergic diseases).
5. Rule out possibility of drug interactions when more than one drug is prescribed.
Prevention of adverse effects to drugs
6. Adopt correct drug administration technique (e.g. Intravenous injection of aminophylline must be
slow)
7. Carry out appropriate laboratory monitoring (e.g. Prothrombin time with warfarin, serum drug levels
with lithium).
Adverse Drug Reaction
1. Side Effects
2. Secondary effects
3. Toxic effects
4. Intolerance
5. Idiosyncrasy
6. Drug allergy
7. Photosensitivity
8. Drugdependence
9. Drug Withdrawal reactions
10. Teratogenicity
11. Carcinogenicity and mutagenicity

12. Drug induced diseases

Poisoning
Poisoning may result from large doses of drugs because it is the dose which distinguishes a drug from a
poison. Poison is a substance which endangers life by severely affecting one or more vital functions.
Not only drugs but other household and industrial chemicals, insecticides, etc. are frequently involved in
poisonings.
Poisoning
Specific antidotes such as receptor antagonists, chelating agents or specific antibodies are available for
few poisons. General supportive and symptomatic treatment is all that can be done for others and is
also important for poisons which have a selective antagonist.
a. Termination of Exposure
b. To prevent absorption of ingested poisons
c. Maintenance of patient airway
d. Maintenance of blood pressure
e. Hastening elimination