A Study on Adverse Drug Reactions of

Antibiotics in a Secondary Care Hospital

Presentation By-
Jv’n Anta Sharma
Enrollment: JV-P/22/6091
 INDEX

Chapter no. Chapter Name Page no.

1. Introduction
1.1 Adverse Drug Reaction
1.2 Definitions
1.3 Epidemiology
1.4 Classification of ADRs
1.5 Prior disposing factors
1.6 Antibiotics
1.7 Adverse reactions to antibiotics
1.8 How to report a differential drug reaction?
1.9 Actions to avoid adverse drug reactions

2. Review of Literature
3. Aim and Objective
4. Plan of work
5. Materials and methods
6. Reference
INTRODUCTION
 Adverse Drug Reaction
Any adverse drug reaction (ADR) that occurs during clinical use and goes beyond the
drug's intended treatments is defined as follows. ''Any response to a drug which is
unpleasant and undesired, and which occurs at levels commonly employed in man
for prophylaxis, diagnosis, therapy of disease, or for the alteration of physiologic
function'' is how the World Health Organization defines an adverse drug reaction
(ADR) [1]. Therefore, overdoses (deliberate or not), drug misuse, unsuccessful
treatments, and mistakes made when administering medication are not included in
this definition.
 EPIDEMIOLOGY
They represent a significant clinical issue, representing 2–6% of all hospital
admissions. The national health budget is severely burdened financially as a result.
ADRs have a significant role in both hospitalized and out-of-hospital patient mortality
and morbidity. Irrational prescription under diagnosis is the cause of many ADRs.
ADRs may occur from a prescription containing more than four medications. Hospital
admissions may result in ADRs in 8–10% of cases. ADRs are responsible for about a
million significant ADRs reported per year and one lakh deaths.
 CLASSIFICATION OF ADRs
Rawlins &Thompson Classification:

Type-A (Augmented): Most prevalent (up to 70%); dose-dependent; harshness rises with dose; largely avoidable by gradually introducing modest
dosages. The pharmacological mechanisms predict Type A for example, beta-blockers hypotension.

Type-B (Bizarre): uncommon, peculiar, genetically determined, erratic, unknown processes, potentially lethal, and dose-independent. For instance,
halothane-induced hepatitis.

Type-C (Continuous drug usage): This is the outcome of ongoing drug use. It could be unanticipated, surprising, and irreversible. For example,
antipsychotics cause tardive dyskinesias.

Type-D (Delayed): Even after treatment is stopped, delayed onset of adverse drug reactions. As in ophthalmopathy following chloroquine.

Type-E (End of dose): Withdrawal reactions at the end of the dosing. It usually happens when taking depressants. For instance, agitation and
hypertension in an opiate abstainer.

Type-F (therapy failure): The outcome of a poor course of treatment. For instance, accelerated hypertension is brought on by ineffective management,
 PRIOR DISPOSING FACTORS
1. Patient-related factors

a. Age:

Geriatrics: Individuals over 60 have a higher risk of experiencing negative medication reactions, which can even
require hospitalization.
Pediatrics: When aminoglycoside-polymyxin sprays are used topically to young children, the result is irreversible
hearing loss; when hexachlorophene sprays are applied topically to neonates, the result is neurotoxicity linked
to enhanced absorption.

b. Gender:

Research has shown that women experience more adverse medication reactions than males do, both in terms of
occurrence and hospital admissions.
 Continued…
c. Pregnancy:
Drug usage poses unique challenges during pregnancy, resulting in widespread teratogenicity as well as an
extension of the drug's pharmacological effects on the fetus and neonate.

d. Concurrent disease:
Hepatic disease: Any medication whose metabolism depends on the liver's regular function may become
less effective if there is liver failure.

e. Genetics:
It has been demonstrated that certain people are more susceptible to the harmful effects of medications
including succinylcholine, isoniazid, monoamine oxidase inhibitors, hydroxalazine, and procainamide
due to hereditary factors.
Continued…
2. Drug-related Factors

a. Dose:
Overdosing on a medication will result in a stronger pharmacological reaction and a higher chance
of side effects.

b. Formulation:
Drug absorption and consequently the possibility of side effects are influenced by particle size,
tablet disintegration time and rate, degree of purity, and the presence of excipients in the
dosage form.
Continued…
3. External Elements
It has been suggested that ambient temperature increases the risk of negative medication
reactions. Heat strokes have been caused by drugs with strong anticholinergic activity,
such as atropine, antipsychotics, and tricyclic antidepressants, in people who are
subjected to hot, humid weather.

4. Multiple-drug treatment
The incidence of adverse drug reactions (ADRs) rises exponentially when more
medications are prescribed and used, suggesting that a combination of drugs may not
necessarily have safe and synergistic effects .
 Antibiotics
To fight dangerous pathogens, antibiotics are
antimicrobial medications that are derived from other
organisms (such as Molds, fungi, and some soil
bacteria). They aren't extremely effective against
viruses and other specific microorganisms, though.

Applications of Antibiotics

 Killing microorganisms is the goal of microbicidal

therapy.
 Treatment with microbiostatic agents: It stops the
growth of microorganisms.
 Continued…
Antibiotic Types

In essence, the chemical structure of antibiotics determines how they are categorized.
Antibiotics belonging to the same structural class will have comparable toxicity, efficacy,
and allergy potential. They are as follows:

 Penicillin's

 Cephalosporins

 Macrolides

 Fluoroquinolones

 sulfonamides

 tetracyclines

 Aminoglycosides
 Continued…
They can be categorized as follows based on their
effectiveness in halting bacterial infection:

 Bactericidal
They destroy the disease-causing germs that are
already present in the body.
Penicillin and polymyxin are two examples.
 Bacteriostatic
Bacteriostatic medications are those that stop
microorganisms from growing.
For instance: - Chloramphenicol and tetracycline
Continued…
The range of action of antibiotics is used to categorize them as follows:

 Broad-spectrum

It can be classified as drugs that destroy or inhibit the growth of a wide range of gram-positive
and gram-negative bacteria. E.g.: – Amoxicillin

 Narrow spectrum

These types of medicines mainly attack Gram-positive bacteria or Gram-negative bacteria.

E.g.:– Penicillin G

 Limited spectrum
It is effective against a specific kind of organism or disease.
 ADVERSE REACTIONS TO ANTIBIOTICS

Sulphonamide Crystalluria (dose-related), Hypersensitivity (2-5% of patients), Photosensitization, Stevens-Johnson

syndrome, and Kernicterus in newborn.
Cotrimoxazole Folate deficiency (Megaloblastic anemia), Blood dyscrasias, teratogenic effects, bone marrow toxicity
in elderly.
Quinolones GI upset, rashes, headache, vertigo, visual disturbance, and occasional seizures in children.
Fluoroquinolones Skin hypersensitivity, photosensitivity, pruritus, tendonitis, and tendon rupture.
Penicillins Local irritancy and direct toxicity, hypersensitivity, superinfection, and Jarisch-Herxheimer reaction.
Cephalosporins Hypersensitivity reaction, nephrotoxicity, bleeding, neutropenia and thrombocytopenia.
Tetracyclines Irritative effects, Liver damage, kidney damage, phototoxicity, temporary suppression of bone growth
in children, antianabolic effects, diabetes insipidus, and vestibular toxicity.
Chloramphenicol Bone marrow depression, hypersensitivity reaction, gray baby syndrome, superinfections and irritative
effects.
Aminoglycosides Ototoxicity, vestibular and cochlear damage, nephrotoxicity, neuromuscular blockade.
Macrolides Hypersensitivity, Reversible hearing impairment, Occasional diarrhoea.
 ACTIONS TO AVOID ADVERSE DRUG REACTIONS

• Preventing ADRs from happening in predictable circumstances is the best approach to

handling them. On the other hand, therapeutic procedures become imperative if it has
happened. The following are preventive measures:
• Use drugs only when there is a clear indication. Don't use drugs on a pregnant lady
unless necessary.
• Select a different treatment that is reasonably safe and effective. For instance, if the
individual is hypersensitive.
• When feasible, take a medication you know well. Novel medications are especially
sensitive to sudden or unforeseen situations.
• Alert the patient if there is a chance that major adverse events will happen etc.
LITERATURE REVIEW
 Literature review
● Michelle D. et al., (2022). The study shows that allergic contact dermatitis is the most
common reaction to aminoglycosides for which patch testing is a helpful diagnostic step.
● Christina Z. et al., (2021). The study's findings comprised that the cephalosporin group
(42.6%) was identified as the most often injected antibiotic that caused adverse drug reactions
among others.
● Ewa Maria S et al., (2021). The study shows that lactam antibiotics were the most often used
class of antibiotics to cause ADR. The study included β-lactam medicines such as
cephalosporins and amoxicillin, both alone and in combination with clavulanic acid, which
affected 22, 18, and 7 patients, respectively. Finally, among antibiotic-induced skin responses,
β-lactam antibiotics were the most common.
● Aifa F et al., (2021).