TYPES OF ADVERSE DRUG REACTIONS (SEVERITY)

An adverse drug reaction (ADR) is a negative or damaging reaction that occurs after taking a medication or medication combinations under everyday circumstances. Usually, an ADR calls for stopping the medication or lowering the dose.  ADRS is distinct from that of "side effects," which can have both positive and negative consequences. The field of pharmacovigilance is concerned with the analysis of ADRs. 

ADVERSE EVENTS 

Any unanticipated or improper occurrence when taking a drug, whether or not related to the drug's administration, is referred to as an adverse event. An ADR is a particular kind of AE in which a causal connection can be established. 

CLASSIFICATION OF ADVERSE DRUG REACTION;

Type A

AUGMENTED 

Exaggerated pharmacological response  

Pharmacodynamic ( eg bronchospasm, from beta blockers)

Type B

BIZARRE

Non pharmacological ,often allergic response 

  1. Medicine induced disease ( eg. Antibiotic associated colitis)

  2. Allergic reaction (penicillin anaphylaxis )

Type C

CHRONIC

Continuous or long term , time related 

Osteoporosis with oral steroids 

Type D

DELAYED

(Lag time)

They are  seeming some time after the use of medication

Teratogenic effects with anticonvulsants or lisinopril

Type E

END OF TREATMENT 

They are related with withdrawal of the medication 

Withdrawal with benzodiazepines 

Type E

FAILURE OF TREATMENT 

Surprising failure in therapy triggered by drug interactions 

(no response)

Resistance to antimicrobial 



SEVERITY:



  • No antidote treatment is required: 

  •  hospitalization is not prolonged.

  • EXAMPLES ;

  • Antihistamines (roughly)

  • Drowsiness opioid’s;

  • And constipation 


A change in Treatment (e 9., modified dosage, addition of a drug , but not essentially discontinuation  of the drug, is required. hospitalization  can be prolonged, or specific treatment can  be required

EXAMPLES;

hormonal contraceptive’s 

venous thrombosis 

NSAIDS; hypertension and oedema 

An ADR is possibly life threatening and involves disconnections of the drug and detailed treatment of the ADR

EXAMPLES;

ace inhibitors;

angioedema 

phenothiazines;

abnormal heart rhythm 

An ADR directly or indirectly subsidizes To a patient's death.

EXAMPLES;

acetaminophen over dosage

liver failure anticoagulants;

haemorrhage 

Even if there is no adequate substitute, mild or moderate adverse drug responses do not always require people to cease taking a medication. The dose, frequency of use (number of doses per day), and timing of doses, however, are likely to be revaluated (for example, before or after meals; in the morning or at bedtime). To reduce the negative drug effect, other medications may be taken (for example, a stool softener to relieve constipation).

DETAILED DISCRIPTION ABOUT THE SEVERITIES ;(adverse reactions)

MILD ;

that are typically seen as being unimportant include 

  • digestion-related issues (such as nausea, constipation, diarrhoea)

  • Headaches

  • Fatigue

  • Unspecific muscular pain

  • Malaise (a broad sensation of disease or suffering) (a general feeling of illness or discomfort)

  • alterations in sleeping habits

Nonetheless, those who have such experiences may find them to be extremely upsetting. As a result, patients could be less inclined to take their medication exactly as directed, which could prevent the treatment from being successful.

MODERATE;

moderate responses consist of

  • Rashes (particularly if they are severe and chronic) (especially if they are extensive and persistent)

  • Visual alterations (especially in people who wear corrective lenses Muscle  tremor

  • Having trouble urinating (a common effect of many drugs in older men)

  • Any observable change in mood or mental function

  • some alterations in blood components, such as a brief, reversible drop in white blood cell count or alterations in the amounts of specific chemicals, such glucose

  • Additionally, reactions that are generally classified as mild are termed moderate if the individual experiencing them thinks them particularly bothersome, distressing, or intolerable.

SEVERE ;

  • Serious reactions include those that can be fatal (such as liver failure, irregular heartbeats, and specific allergic reactions), that necessitate prolonged hospitalisation or considerable impairment, and those that result in birth abnormalities. 

  • There are hardly many severe responses. Individuals who experience a severe reaction typically need to stop taking the medication and receive treatment but occasionally,  some continue giving high risk medications (for example, chemotherapy to people with cancer). 

LETHAL ;

Drug responses that either directly or indirectly result in death are known as lethal reactions. These responses are frequently serious ones that weren't caught in time or didn't improve with treatment. Certain medications may be taken off the market due to lethal effects (such as troglitazone and terfenadine).Directly or indirectly contribute to the death of the patient .




HOW TO ASSESS SEVERITY OF ADVERSE DRUG REACTION?

the assessment can be done by MODIFIED HARTWIG’S AND SIEGEL ASSESSMENT SCALE .

this scale  categorised ADR severity into seven levels according to clinical consequences , that may include resultant harm and intensity of medical intervention required 

Severity assessment of ADR using Hartwig and Siegel scale. | Download ...

Mild: Level 1: Treatment for the ADR with the alleged medicine doesn't need to be changed.

Level 2: The ADR requires that the supposed drug be withheld, discontinued or otherwise changed. NO cure or other treatment is required, and no prolonged hospitalization.

Moderate:  Level 3: The ADR  involves the suspected drug to be withheld, withdrawn or otherwise changed, and / or an antidote or other treatment is required. There is no rise in length of stay

Level 4 (a): Any level 3 ADR that intensifies prolonged hospitalization  by at least one day

Level 4 (b): The Adverse drug reaction are the  cause for admission.

Severe: Level 5: Any level 4 ADR that needs thorough medical care.

Level 6: The ADR causes enduring harm to the patient

Level 7: The ADR may cause the patient's mortality either directly or indirectly.


REFERENCES:

  1.  https://en.wikipedia.org/wiki/Adverse_drug_reaction

  2. https://www.msdmanuals.com/home/drugs/adverse-drug-reactions/severity...

  3. https://medssafety.com/what-are-the-types-of-adverse-drug-reaction-adr



Student Name: Sheeba Shabnam

Student ID:022/022023 

Qualification: Pharm. D

e-Mail ID: sheebashabnam018@gmail.com


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