ADVERSE DRUG REACTION

ADVERSE EVENT - Any injury caused by medical treatment

● Not yet well established, only possibilities
● Any AE associated with use of drugs in humans including:
o AE in course of a drug in professional practice
o AE in course of a drug abuse (Narcotics) causes Toxicity
o AE in course of a drug withdrawal (Requires Drug tapering)
● Any significant failure of expected pharmacologic action
ADVERSE DRUG REACTION
· Very concrete, well established, clinically significant
· Any response to a drug that is noxious and unintended occurring at normal doses
SIDE EFFECT
· Any unintended effect of a pharmaceutical product occurring at normal doses related
to the pharmacology of the drug
· Glutathione-Detoxifying liver
· (SE: Whitening of the skin-Related to the pharmacology of Gluta)
MEDICATION ERROR
· Any preventable event that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the patient or HCP
·
PHARMACOVIGILANCE
· Science and activities relating to detection, assessment, understanding, and prevention
of AE and medication-related problems
· Main fx: Study ADR
· Continuous Activity
NEAR MISS
· “close calls”
· Potential AE
· Almost Happened but prevented
SIGNAL
· Reported information or a possible causal relationship between AE and a medicine-
related being previously unknown or incompatibility documented
ONSETS
· Acute
o Within 24 hours
· Subacute
o Within one to two days
· Late
o More than two days
RISK FACTORS FOR ADRS
■ Age
● (Neonates and Geriatrics have higher risk) (Ex. Chloramphenicol induced grey baby
syndrome. Geriatrics have overused organs)
■ Gender
 ● Female-Have more hormones
■ Comorbidities
● DM: Diabetes Melitus
■ Concurrent medications (Concomitant Drug Therapy)
● Drug-drug interaction
■ Duration of therapy
● Steroids-Dose tapering
● Drug abuse
■ Narrow Therapeutic Index (TI)
● Requires monitoring
■ Ethnicity and genetics (e.g. G6PD, fast acetylators)

CLASSIFICATION OF ADRS (ACCORDING TO SEVERITY)

■ MILD
– No antidote/treatment required
– Hospitalization not prolonged
– Example (Cause):
■ Drowsiness (H1 blockers - Allergic rhinitis, Antihistamines 1st Gen)
■ Constipation (Opioid laxatives)
■ MODERATE
– Change in treatment required but not discontinued
– Hospitalization may be prolonged or specific treatment required
– Example (Cause):
■ GI problems, HTN (NSAIDs) (Give h2 antagonist or B1 blocker)
■ Venous thrombosis (OCPs)

■ SEVERE
· Potentially life-threatening
· Immediate treatment required
· Example (Cause):
o Angioedema (ACEIs)
o Abnormal heart rhythm (Phenothiazines)
■ LETHAL
– Directly or indirectly contributes to patient’s death
– Example (Cause):
■ Bleeding (Anticoagulants)

CLASSIFICATION OF ADRs
(According to Documentation)

Unlikely 🡪Possible 🡪Suspected 🡪Probable 🡪Established

ADR CAUSALITY CATEGORIES (WHO)
1. Certain (Established)
a. cannot be explained by the underlying condition of the patient
b. Anticoagulants-Bleeding (Studies showed that anticoagulant common side effect
is bleeding)
2. Probable/Likely
a. Time frame of the drug is inside the administration of the ADR
b. Reasonable time related to drug administration on ADR
c. No possibility that the ADR is not the drug
3. Suspected
a. There is an evidence that the ADR is caused by the drug itself
4. Possible
a. Clinical event or laboratory test abnormality occurs with reasonable time with the
drug administration
b. Cause might be disease, chemical or drug
5. Unlikely
a. There are clinical event or laboratory test Abnormality along with the time of
drug administration that makes the ADR experienced by the patient possibly
related to the drugs
b. It is not impossible that the drug is the cause of ADR
c. The cause may be not a drug or caused by an underlying disease
6. Conditional/Unclassified
a. There is a clinical event or laboratory test abnormality reported ADR but more
data is needed for proper assessment
b. Additional data should be examined
7. Unassessable/Unclassifiable
a. ADR cannot be assessed/classify because there is insufficient/contradictory
information/data
b. Data cannot be supplemented or verified
c. Reports suggest ADR

Determines ADR classification by documentation