A Threat To The Innocent Patients
An Adverse Drug Reaction is an unintended response occurring at normal doses of drugs used in the diagnosis, prevention or cure of diseases affecting the human beings. It is different from an allergy or side effect.
An allergy develops as an immune response showing a skin rash, histamine release, abdominal problem etc. It is also called Drug Hypersensitivity which occurs even with smaller doses and should be informed to the Physician.
A side effect is an unwanted ,but unavoidable effect occurring at the therapeutic dose of a drug which is expected and documented during drug development and initial clinical trials. It is included in the profile of a drug with details of percentage of occurrence. Toxic effects will develop due to over dosage or prolonged use of the drug, if unnoticed.
So, an ADR is an untoward, unintended, possibly causing a harmful event with a causal link to a drug. The matter has to be identified and investigated deeply.
An Adverse Drug Reaction should be documented and reported to the ADR Monitoring Centres(AMCs), for preventing future injuries and will be included in its side effect profile through the National Coordination Centre.
An ADR may be acute (develops within an hour), sub acute( within 24 hours) and latent (within two days). The drug can cause genetic defects and cancer after 10 years of regular use, as seen in the case of some chronic treatments.
The ADRs may be minor, moderate, severe or lethal depending on severity. For minor complaints, only discontinuation of the drug is suggested. No need of an antidote or prolonged hospitalization.
For moderate adverse drug reactions, specific treatment, after further testing and evaluation of the injury is suggested.
Severe reactions include significant life threatening situation or permanent disability, requiring intensive medical treatment to prevent permanent impairment or damage.
Lethal reactions directly or indirectly contributes to the death of the patient.
