21 CFR

 BLOG ON ADVERSE DRUG REACTIONS

 

ADVERSE DRUG REACTIONS are UNWANTED or HARMFUL EFFECTS that occur as a result of taking medication. These reactions can range from mild side effects such as headache or nausea to more severe reactions such as allergic reactions or organ damage. These can be more dangerous to people who are older adults and also those with certain health conditions.

CAUSES:

 1. ADRs may occur when a patient receives a higher or lower dose of medication than this is recommended. 

2. Drug interactions: ADRs may occur when a patient is taking multiple medications that interact with each other.

CLASSIFICATION OF ADVERSE DRUG REACTION:

Classification based on the type of reaction

TYPE A:	AUGMENTED	• It means already known • It’s always dose-dependent • Directly related to the pharmacological property of the drug • Often identified in preclinical or clinical trials • associated with high morbidity and low mortality
TYPE B	BIZZARE	• It means strange • Unpredictable • Can occur in any patient • Is not dose-related • Associated with low morbidity and high mortality
TYPE C	CHRONIC	• Dose-related • Time-related • Occurs with long-term use of the rug
TYPE D	DELAYED	• Usually, dose-related • Occurs after a time lag.
TYPE E	END OF TREATMENT	• Occurs at end of treatment or when the drug is stopped abruptly.
TYPE F	FAILURE OF TREATMENT	• Unexpected reduction in drug’s efficacy or unexpected failure in therapy • Dose-related • Caused by drug interactions.

Diagnosis of ADR:

Diagnosis of ADRs involves identifying the signs and symptoms of the reaction, determining

the causative drug, and assessing the severity of the reaction. This process typically

involves taking a patient's medical history, conducting a physical examination, and

performing any necessary laboratory tests or imaging studies. The healthcare professional

may also use diagnostic tools such as the Naranjo algorithm or the World Health

Organization's causality assessment method to help determine the causality of the ADR and

the appropriate course of action. In some cases, further investigation such as a drug

provocation test may be necessary.

Treatment of ADR:

Treatment of ADRs will depend on the severity of the reaction and the specific medication

that is causing it. In some cases, the medication may need to be discontinued or the dosage

adjusted. In more severe cases, hospitalization may be necessary. Depending on the type of

ADR and underlying condition, supportive care, such as IV fluids and antihistamines, may be

administered.

Drugs used to treat ADR

1. Antacids - used to treat GIT infections

2. Laxatives - used for Constipation

3 Antihistamines - used for allergic reactions

4. Epinephrine - used for anaphylactic shock

5.Diuretic - used for oedema

6. Hydrocortisone creams- used for skin reactions

7. Bronchodilators- used for cough

Prevention from an ADR:

1. Taking proper medication history the risk can be minimized.

2. Checking for Drug interactions.

3. Appropriate selection of medicines.

4. Appropriate usage of drugs.

5. Patient education and counseling.

6. Avoid polypharmacy.

7. Individualization of dose.

Conclusion:

ADRs are unwanted harmful effects that occur as a result of taking medication. The causes are due to drug interactions and when a patient receives a higher or lower dose of a medication than recommended. Diagnosis of ADR involves identifying the signs and symptoms of the reaction. Some drugs are used to treat ADR for example Antacids, Laxatives, and Antihistamines.

Reference:

Nebeker JR, Balrach P, Samore MH (May 2004). "Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting". Annals of Internal Medicine Ritter, J M (2008).  A Textbook of Clinical Pharmacology and Therapeutics. Great Britain. p. 62.

Student Name: Aravind Pasupula

Student ID: 016/012023

Qualification: B. Pharmacy

e-Mail ID: pasupula.aravind.111@gmail.com