ADR

1. Medication error & harm
• Medication Error: Any preventable event that may lead to
inappropriate medication use or cause harm to the patient
while the medication is in control of a health care professional,
patient or consumer.
• HARM: defined as death, or temporary or permanent
impairment of body function/structure requiring intervention.
• Intervention may include monitoring the patient’s condition,
change of therapy, or active medical or surgical treatment.

2. Medication error categories
A. Wrong Drug Error: Drug that was not ordered for a
patient was administered.
B. Extra Dose Error: A patient receives more doses of a
drug than were ordered.
C. Omission Error: A dose of drug was not administered
as ordered but was skipped.
D. Wrong Dose or Wrong Strength Error: Either the
wrong dose of a medicine or the wrong strength is
administered.

3. Medication error categories
E. Wrong Route Error: A patient receives a dose of
a medication by a route that was not ordered
by a physician.
F. Wrong Time Error: A patient does not receive a
dose of medication at the time at which it was
to be administered.
G.Wrong Dosage Form Error: A patient receives a
dose of medicine in a dosage form that was not
intended.

4. ADR VS DI VS ADE
• ADR
- Any response to a drug which is Noxious and
unintended which occurs at doses used in man for
prophylaxis, diagnosis or therapy.
• DI
- Occurs whenever the action of drug is modified in or on
the body by another pharmacologically acting chemical
substance
• ADE
- An injury resulting from the use of a drug

5. MEDICATION ERROR CATEGORIES• Based on severity:
Category Description
A Circumstances or events that have the capacity to
cause error.
B An error occurred but the medication did not reach
the patient.
C An error occurred that reaches the patient
(administered or not), but did not cause harm.
D An error occurred that resulted in the need for
increase patient monitoring, but no patient harm.
E An error occurred that result in need for treatment
or intervention and caused temporary patient harm.
F An error occurred that resulted in initial or
prolonged hospitalization and caused temporary
patient harm.
G An error occurred that result in permanent patient
harm.
H An error occurred that resulted in a near death
event.
I An error occurred that resulted in patient death.

6. Difference of side effect or allergy?
• An allergy is an adverse drug reaction mediated by an
immune response (e.g., rash, hives).
• A side effect is an expected and known effect of a drug that
is not the intended therapeutic outcome.

7. Factors
1. Patient Factors
Adverse Drug Reactions
Patient’s reactions to the drug.
2. Drug Factors
Drug-Drug Interaction
Drug-Food Interaction
Drug-Disease Interactions
Other incompatibilities.

8. SPECIAL POPULATION
A. PEDIATRICS
1. Age Definition (Childhood Stages)
STAGE DURATION
Neonate 0-30 days
Infant 1 month to 1 year
Toddler 1 to 3 years
Pre-schooler 3-5 years
School age 5-11 years
Pre teen 11-12 years
Teen 13 years and above

9. SPECIAL POPULATION
2. Adverse Drug Reactions
Enamel Hypoplasia and permanent discoloration of
teeth with tetracycline.
Growth suppression with long term corticosteroids in
prepubertal children.
Paradoxical hyperreactivity in children treated with
phenobarbital.
Hepatotoxicity associated with the use of valproate.
Increased risk of Reye’s Syndrome with the use of
salicylates in children with mild viral infections.

10. SPECIAL POPULATION
3. Medication Errors
Heterogenous nature of the pediatric population with
corresponding lack of standard dosage.
Calculation errors
Lack of available dosage forms and concentrations appropriate
for administration.
Lack of familiarity with pediatric dosing guidelines.
Confusion between adult and pediatric preparations.
Limited published information.
Administration errors and inappropriate use of measuring
devices.
Ten-fold dosing errors.

11. SPECIAL POPULATION
B. Pregnant Women
Risk of transplacental transmission
Category Interpretation
A Adequate, well-controlled studies in pregnant women have not shown an
increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
B Animal studies have revealed no evidence of harm to the fetus, however, there
are no adequate and well-controlled studies in pregnant women.
No animal studies, but has well controlled studies in pregnant women causing
no harm to the fetus at the first trimester
C Animal studies have shown an adverse effect and there are no adequate and
well-controlled studies in pregnant women.
D Adequate well-controlled or observational studies in pregnant women have
demonstrated a risk to the fetus. However, the benefits of therapy outweigh
the potential risk.
X Adequate well controlled or observational studies in animals or pregnant
woman have demonstrated positive evidence of fetal abnormalities or risks.

12. CAUSES OF ADR
• Pharmaceutical causes
- By altering the quantity of drug available for systemic
absorption
- By influencing release rates
• Pharmacodynamic causes
- Increased sensitivity of target organs in the body to
drugs

13. Predisposing factors to Adverse drug
reactions
•Drug Related Factors
-Pharmaceutical properties
-Pharmacokinetic properties
-Pharmacodynamic properties

14. •Pharmacokinetic causes
- The way drug is handled by the body during
ADME may affect humans in an adverse
manner.

15. Predisposing factors to adverse drug reactions
• Patient-related factors
- Presence of renal, hepatic, and cardiac diseases
- Age
- Previous ADR or drug allergy
- Gender
- Genetic influence
- Miscellaneous (Diet, smoking, alcohol, environmental
exposures, individual variations)

16. CLASSIFICATIONS OF ADR• Adverse Effects
• Atropine – dryness
• Captopril – Cough
• Codeine – constipation
• Fluvastatin – Myopathy
• Nitroglycerin – Headache
• Phenothiazenes – Extrapyramidal symptoms
• Propranolol – Bronchial asthma
• Streptomycin – Ototoxicity
• Tetracycline – hypoplasia of teeth

17. •Adverse Effects
-predictable, dose-dependent reactions unrelated
to the goal of therapy
-Produced by the same drug-receptor interaction
responsible for the therapeutic effect

18. Type A: Augmented
•Refers to ADR related to the pharmacologic
activity of a drug.
types:
•Extension effect – predictable, dose-related
responses arising from an extension of
therapeutic effects; Prevention by Adjustment of
Dosage

19. •Extension Effects
•Benzodiazepenes (Anxiety neurosis) –
sedation and falls/trauma
•Furosemide (Diuresis) – Water and
Electrolyte imbalance
•Heparin (thromboembolic disorders) –
spontaneous bleeding
•Insulin (Diabetes) - hypoglycemia

20. •Management
•Reduced dose or withhold
•Consider effects of concomitant
therapy

21. Type B : Bizarre
• Refers to totally abnormal effects, unrelated from the drug’s
unknown pharmacological actions. Non-dose related High mortality
• Characteristics:
a. No formal dose-response curve and very dose of the drug may
elicit the reaction once allergy or idiosyncracy is established
b. Reaction disappears on discontinuation of the drug
c. Illness is often, recognizable as an reaction
d. Undetectable during conventional testing
e. Little or no relation to the usual pharmacological effects of the
drug
f. Delay between first exposure to the drug and the occurrence of
the subsequent adverse reaction

22. • Idiosyncracy – an example of Type B
• Genetically determine abnormal response to a drug (i.e.
neuroleptic malignant syndrome)
• Altough sometimes dose-dependent , such reactions are
unpredictable in most instances
• Cannot be attributed to drug allergy sometimes (i.e., Steven-
Johnson Syndrome)
• Aspirin, Sulfonamides and Vitamin C – if used in patient with
erythrocyte G6PD-deficiency can cause haemolytic anemia.

23. • Management
• Withold and avoid in the future

24. Type C: Continuous (Chronic)
• Long term effects are usually related to the dose and duration
of treatment. Dose and time related to the cumulative dose.
• Ethambutol – Optic neuropathy
• Adrenal Suppression by corticosteroids
• Rifampicin – Red orange Urine color
• Management – Reduced dose or withhold; withdrawal may
have to be prolonged

25. Type D (Delayed Hypersensitivity Reaction)
• Time-related
• Occurs or becomes apparent some time after the use of the
drug
• Teratogenesis
• Carcinogenesis

26. Type E : End of Use
• Withdrawal
• Alcohol- delirium tremens
• Barbiturates – Restlestness, mental confusion,
convulsions
• Benzodiazepenes – rebound insomnia, agitation,
restlestness
• Clonidine – rebound hypertension
• Corticosteroids – Acute adrenal insufficiency
• Opioids – narcotic withdrawal

27. Type F- Failure of Efficacy/Therapy
• Unexpected failure of therapy
• Can be the result of imperfect or counterfeit
manufacture of drug
• Failure to control infection/apparent antimicrobial
resistance
• Uncontrolled hypertension
• Intractable pain