Adverse Drug Reactions

ADVERSE
DRUG
REACTIONS
OVERVIEW
STATISTICS
5% of adults are allergic to one or more

medications
6 10% of ADRs result from a drug allergy
3% of hospital admissions are due to ADRs
28% of ADRs are preventable
Drugs associated with ADRs: 29% analgesics, 10%
sedatives, 9% antibiotics, and 7% antipsychotics.
PGH: Antibiotics (35%), anti-TB meds (34%),
anticonvulsants and ASA/NSAIDS (10% each)
ADRs: 4th Leading Cause of

Death
Study: Drug reactions kill an
estimated 100,000 a year
April 14, 1998
What are Adverse Drug

Reactions (ADRs)?
any response to a
drug which is
noxious and
unintended and
which occurs at
doses used in man
for prophylaxis,
diagnosis or
therapy
What is an
adverse drug experience?
An undesirable drug effect, whether

harmless, resulting from medications
administered in a dosage normally
given.
It becomes an adverse drug reaction

when it is reported and subsequently
evaluated to be secondary to the drug
usage.
Key points to remember

ADRs
Common Causes of ADRs
Failing to take the correct dosages at the correct

times
Overdosing
Allergies to chemical components of the medicine
Combining the medicine with alcohol
Taking other drugs or preparations that interact with
the medicine
Taking a medicine that was prescribed for someone
else.
Causes of ADR
Pharmaceutical causes
decreasing particle size or changing

excipients
Pharmacokinetic causes
diazepam
aminoglycosides
Pharmacodynamic causes
increased sensitivity of target organs

in the body to drugs
Factors affecting Adverse Drug

Reactions :
Patient-related factors
Age
Sex
Genetic influences
Concurrent diseases (renal,liver, cardiac)
Previous adverse drug reactions
Compliance with dosing regimen
Total number of medications
Misc. (diet, smoking, environmental
exposure)
Factors affecting Adverse

Drug Reactions :
Drug-related factors:
Dose
Duration
Inherent toxicity of the
agent
Pharmacodynamic
properties
Pharmacokinetic properties
Six Classifications of ADR
Type
Type
Type
Type
Type
Type
A
B
C
D
E
F
(Augmented)
(Bizarre)
(Continuous)
(Delayed)
(Ending of Use)
(Failure of Efficacy)
Type A Reactions or
Augmented
Activity (pharmacological) of a drug
Extension Effects
Adverse Effects
Extension Effects
predictable
dose-related responses
prevention: Adjustment of dosage
regimen
Examples of Extension Effects
Benzodiazepines sedation
Furosemide
water and electrolyte
imbalance
Heparin, warfarin spontaneous bleeding
insulin
hypoglycemia
Adverse Effects
predictable, dose-dependent reactions

unrelated to the goal of therapy
often produced by the same drugreceptor interaction responsible for the
therapeutic effect, differing only in the
tissue/s or organ/s affected
Example of Adverse Effects
INH, Rifampicin, PZA hepatotoxicity

ototoxicity, nephrotoxicit
streptomycin
cough
captopril
rhabdomyolysis
simvastatin
headache
nitrates
bronchial asthma
propranolol
hypoplasia of the tee
tetracycline
Type B Reactions or Bizarre
aBnormal effects
Unrelated from the
drugs known
pharmacological
actions
Characteristics of Bizarre
Reactions
no formal dose-response curve (penicillin

hypersensitivity anaphylaxis)
reaction disappears on discontinuation of the
drug
recognizable as an immunological reaction
undetectable during conventional testing
little or no relation to the usual
pharmacological effects of the drug
delay between exposure to the drug and the
occurrence of the subsequent adverse
reaction
Example of Bizarre Reactions
Hypersensitivity reactions
Stevens-Johnsons Syndrome
Hemolytic anemia
Type C Reactions or Continuous
long term effects are usually related to

the dose and duration of treatment
Examples
ethambutol
NSAIDs
Type D Reactions or Delayed
Carcinogenesis
Teratogenesis
Examples: thalidomide,
vitamin A
Type E Reactions or Ending of

Use
Withdrawal Syndromes
Examples:
benzodiazepines
rebound insomnia,
agitation
clonidine
corticosteroids rebound hypertension
acute adrenal insufficiency
opioids
narcotic withdrawal
Type F Reactions or Failure of

Efficacy
Counterfeit medicines
Underdosing of medications
Drug interactions
Exercises
Example #1
An 8-day old female was diagnosed to

have neonatal tetanus. Diazepam was
used as the anticonvulsant with a dose
of 0.2 mg/kg/dose q 4hrs. With
persistence of spasms, the dose was
increased to 0.5 mg/kg/dose up to the
maximum dose of 1 mg/kg/dose but still
no improvement. Higher doses of the
same brand was also ineffective. The
patient was later started on Midazolam
drip which resulted in decreased
frequency of spasms.
Type
F
Example #2
A patient was maintained on clonidine

150 mcg BID and Aspirin 80 mg tab OD.
Then the patient stopped his
medications due to financial
constraints. The patient suddenly
experienced headache, dizziness and
flushing due to increased blood
pressure.
Type
E
Example #3
A TB patient was started with fixeddose anti-TB drugs for 6 months. After
several days, the patient was noted for
rashes. The patient sought consult and
was advised to stop his anti-TB drugs.
This resulted to remission of the rashes.
Type
Example #4
A patient with chronic stable angina was

given isosorbide dinitrate. After taking
ISDN, the patient experienced dizziness
and headache. The dose of ISDN was
reduced which resulted to improvement
of the patients status.
Adverse Effect
ADR REPORTING
Why report ADRs?
To prevent drug-induced human

suffering
To avoid financial risks associated with

unexpected risks
GOVERNMENT POLICY
ON ADR
June 22, 1963 as amended
on May REPORTING
22, 1987
Republic Act 3720 Food, Drugs and Devices and
Cosmetics Act
Creation of Food and Drug Administration now
Bureau of Food and Drugs
April 20, 1994
BFAD Memorandum Circular No. 5 s. 1994
Submission of ADR reports by pharmaceutical
establishments and parties concerned
June 30, 1994
Department Order No. 345 - I s. 1994
Creation of National Adverse Drug Reaction
Advisory Committee (NADRAC)
ADR Monitoring System

Reports
Reports
from
from
Private
Participating
Practitioners
Hospitals
Report
from
Drug Mfr.
Traders/
Outlets
Reports
on
Clinical
Investigations
Reports
from
Regulatory
Authorities
Reports
from
Intl
ADR
Centers
BFAD ADR UNIT

NADRAC
Director - BFAD
Secretary of
Health - DOH
WHO Collaborating Center
REPORTING SCHEME
CASE
Reporter Fills Out a
Form
Hospital
Therapeutic
Committees
ADRMP Office
(Central Database)
WHO
NADRAC
(Trend Analysis)
WHO
THE PGH ADVERSE

DRUG REACTION
REPORTING
SCHEME
How do we report ADRs?

STEP 1 : Fill out the RED ALERT CARDS
PGH FORM # P 60170
PGH ADVERSE DRUG SURVEILLANCE

ALERT CARD
(Clip this on chart front cover)
Name of patient:___________________________________
Ward & Bed No.:__________________________________
Name of suspect drug:______________________________
Manufacturer:_____________________________________
Lot/ Code No.:__________ (Retain empty vial or container)
Describe the reaction:_______________________________
________________________________________________
________________________________________________
__
Reporter:
_________________________________________
(Please Print)
PLEASE NOTIFY: CENTRAL BLOCK PHARMACY
Loc. 3163 / 3170

STEP 2: Complete the ADR REPORT FORM
The Resident - in - charge of
the patient shall
complete the
necessary report of ADR
circumstances.
STEP 3: Submit the red alert card and

the ADR report form to the Central
Block Pharmacy for proper referral.
STEP 4: The Pharmacy will then compile

the reports for review of the ADR
Subcommittee and submission to the
Bureau of Food and Drugs (BFAD).
Pharmacist
IMPORTANT!!!!
The ADR Report Form should include the following:
brand name of the suspect drug
the manufacturer (if generic)
the lot and batch number.
It should be done in duplicate.

ALL REPORTS ARE CONFIDENTIAL
Examples of Reported
ADRs
Common reports
rash caused by Oxacillin
red face, fever secondary to Vancomycin
Uncommon reports
hair loss due to anti thyroid agents
neuroleptic malignant syndrome with
risperidone
TEN COMMANDMENTS to reduce

ADVERSE DRUG REACTIONS
1. Critically review the
total condition of the
patient. Be particularly
careful when you
prescribe to children,
elderly, seriously ill,
pregnant patients
and those with renal,
cardiac or liver
diseases.

2. Use as few drugs as
possible.
Balance
the
seriousness of possible
reactions against the
beneficial effects of each
drug
that
is
being
considered.

3.
Know well the drugs that

you use. Compare the
efficacy and safety of
each of the available
competitive medications
that appear to be worthy
of consideration for the
patient.

4.
Do not change too readily from one

drug you know to one you do not
know. If you decide to use a new
drug, know that drug.

5. Do not hesitate to use
textbooks
and
other
references
providing
information on drug reaction
and interaction.

6. Be especially careful
when prescribing drugs
known to
exhibit a
large
variety
of
reactions/ interactions.

7. Be aware of interactions
with
certain
foods,
alcohol and even with
household
chemicals.

8. Regularly make an
inventory of the drugs
your patient is receiving.

9. Review your patient
regularly for all the drugs
used and especially those
bought without
prescriptions.

10. If your patient
shows signs and
symptoms not clearly
explained by the
course of illness,
think of adverse
drug reaction.

Adverse Drug Reactions

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What are the common causes of adverse drug reactions?

What are the common causes of adverse drug reactions?

What are the different classifications of adverse drug reactions?

What are the different classifications of adverse drug reactions?

ADVERSE

5% of adults are allergic to one or more

ADRs: 4th Leading Cause of

What are Adverse Drug

An undesirable drug effect, whether

It becomes an adverse drug reaction

Key points to remember

Common Causes of ADRs

Failing to take the correct dosages at the correct

decreasing particle size or changing

increased sensitivity of target organs

Factors affecting Adverse Drug

Factors affecting Adverse

Six Classifications of ADR

Activity (pharmacological) of a drug

Examples of Extension Effects

predictable, dose-dependent reactions

Example of Adverse Effects

INH, Rifampicin, PZA hepatotoxicity

Type B Reactions or Bizarre

no formal dose-response curve (penicillin

Example of Bizarre Reactions

Type C Reactions or Continuous

long term effects are usually related to

Type D Reactions or Delayed

Type E Reactions or Ending of

Type F Reactions or Failure of

An 8-day old female was diagnosed to

A patient was maintained on clonidine

A patient with chronic stable angina was

Why report ADRs?

To prevent drug-induced human

To avoid financial risks associated with

ADR Monitoring System

BFAD ADR UNIT

WHO Collaborating Center

THE PGH ADVERSE

How do we report ADRs?

PGH ADVERSE DRUG SURVEILLANCE

How do we report ADRs?

How do we report ADRs?

STEP 3: Submit the red alert card and

STEP 4: The Pharmacy will then compile

brand name of the suspect drug

the manufacturer (if generic)

the lot and batch number.

It should be done in duplicate.

TEN COMMANDMENTS to reduce

TEN COMMANDMENTS to reduce

TEN COMMANDMENTS to reduce

Know well the drugs that

TEN COMMANDMENTS to reduce

Do not change too readily from one

TEN COMMANDMENTS to reduce

TEN COMMANDMENTS to reduce