ADR Final1
ADR Final1
ADR Final1
Definition:
Adverse Drug Reaction (ADR):
Any noxious(harmful, poisonous, or very unpleasant) change which is suspected to be
due to a drug, occurs at doses normally used in man, requires treatment or decrease in dose or
indicates caution in future use of the same drug.
World Health Organization (WHO) defined as Adverse Drug Reaction as: “Any
response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis,
diagnosis or therapy of disease or for the modification of physiological functions.” It excludes
ADRs due to overdose of medicine.
American Society of Health-System Pharmacists (ASHP) defines ADR as:
“Any unexpected, unintended, undesired, or excessive response to a drug that requires
discontinuing the drug (therapeutic or diagnostic), requires changing the drug therapy, requires
modifying the dose (except for minor dosage adjustments), necessitates admission to a hospital,
prolongs stay in a health care facility, necessitates supportive treatment, significantly
complicates diagnosis, negatively affects prognosis, or results in temporary or permanent harm,
disability, or death.”
1. AGE: ADR can occur in any age group but the very young and the very old people are
particularly vulnerable to ADR because they have the ever changing body physiology.
2. GENDER: Females have 1.5 to 1.7 fold greater risk of developing ADR compared to
males due to changing hormonal level during menstruation, pregnancy and lactation.
Classification of ADRs
1. Depending on Onset of event:
a. Acute (<60 minutes)
b. Sub-acute (1-24 hrs) and
c. Latent (>2 days)
2. Depending on Severity:
a. Minor ADRs
These are very simple reactions and here no therapy, antidote or
prolongation of hospitalization is required.
b. Moderate ADRs
This requires change in drug therapy, specific treatment or prolongs
hospital stay by atleast 1 day.
c. Severe ADRs
These are potentially life threatening reactions and cause permanent
damage or require intensive medical treatment.
d. Lethal ADRs
These types of reactions directly or indirectly contribute to death of the
patient.
3. Depending on the Type of reaction: According to Wills and Brown, basically the
ADRs are classified into two groups:-
a. Type A (Augmented)
b. Type B (Bizarre)
Further the ADRs are classified as
c. Type C (Continuous use of medicine)
d. Type D (Delayed type )
e. Type E (End of the treatment)
f. Type F (Failure of therapy)
g. Type G (Genotoxicity)
h. Type H (Hypersensitivity)
i. Type U (Un classified)
Management of ADRs
If it is non-immune ADR, then following steps should be followed for its management:
Step1: Drugs should be modified.
Step2: Alternative drug should be used.
Step3: Prophylactic regimen should be considered
(if seen to be effective).
Step4: Patient/Physician education.
Photosensitivity
Photosensitivity is a skin problem that is triggered when expose to sunlight. It is an
immune system reaction where drugs or its metabolites accumulate in skin. When the skin is
exposed to sunlight there is photochemical reaction between UV light and accumulated drug on
skin that results some allergic reaction including redness of skin, itching, blistering, swelling etc.
The shorter UV light with wavelength 200-300nm cause phototoxicity and the longer UV light
with wavelength 300-400nm cause photoallergy. For example some drugs like Tetracycline,
doxycycline, nalidixic acid, voriconazole, amiodarone etc cause photosensitivity reaction. To
avoid this type of problem it is better not to expose to sunlight during therapy or use some
sunlight blocking creams.
For example when tetracycline is used for bacterial infection but due to over/misuse of this drug
cause reduction in bacterial microflora results superinfection.
Idiosyncrasy
It is the type of ADR that is caused due to genetically determined abnormal reactivity in
recipient when a drug id used. Here drug interacts with some unique features of individuals that
produce uncharacteristic reaction which is not found in majority of people. For example
Chloramphenicol cause aplastic anaemia in some patients, barbiturates cause mental confusion or
excitement in some patients.
Drug Dependence
It is property of some drugs that produces a state in which person believes that
continuous use is necessary for state of well being ( psychic dependence) or to avoid withdrawal
symptoms ( physical dependence.) i.e. these type of drugs form habit in recipients. Here repeated
administration of drug required to maintain physiological behavior. For example Opiods,
Benzodiazepines, Alcohol, Barbiturates produces dependence in recipients.
Drug Allergy/Hypersensitivity
It is an immunologically mediated allergic response occurs when sensitised individuals
are re-exposed to same drug again and again. Here drug acts as antigen and body system acts as
antibody. So there are antigen-antibody reaction results some allergic reaction such as rashes,
itching, blistering, swelling, anaphylactic shock etc. For example penicillin group of medicine
cause drug allergy in some individuals.
Drugs Drug Induced Skin Diseases
Antibiotics(Penicllin) Urticaria
➢ Sulphonamides, barbiturates, lamotrigine and phenyl- Stevens–Johnson syndrom
butazone
Pharmacovigilance
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to
the collection, detection, assessment, monitoring, and prevention of adverse effects of the
medicine. Simply this is ADR monitoring tool.
The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug)
and vigilare (Latin for to keep watch)
According to WHO, Pharmacovigilance (PV) is defined as“the science and activities relating to the
detection, assessment, understanding and prevention of adverse effects or any other drug-related
problem.” WHO established its Programme for International Drug Monitoring in response to the
thalidomide disaster detected in 1961.
Pharmacovigilance In Nepal
Government of Nepal nominated Department of Drug Administration (DDA) in October
2004 as the focal point (National Pharmacovigilance centre) to liaison with WHO collaborating
centre for International Drug Monitoring, Sweden and started collecting adverse drug reactions.
Nepal became a WHO programme full member in July 2007.
At present, there are 13 regional pharmacovigilance centers in Nepal