PHDispensing02: Laboratory • Lethal

Adverse Drug Reactions Directly or indirectly contributes to death of

ADRs the patient
- unintended, harmful events attributed to the use TYPES OF ADRS (TRADITIONAL)
of medicines Type A
- occur as a cause of and during a significant - “Augmented Reactions”
proportion of unscheduled hospital admissions - dose-dependent and predictable based on the
- unwanted or harmful reaction experienced after pharmacology of the drug
the administration of a drug or combination of - are extension of the drug’s known
drugs under normal conditions of use and pharmacological action and are responsible for
suspected to be related to the drug the majority of ADRs
- any undesirable effect of a drug beyond its Examples:
anticipated therapeutic effects occurring during ➢ Anticoagulant – Bleeding
clinical use ➢ Beta blockers – Bradycardia
“A response to a drug that is noxious and unintended, ➢ Nitrates – Headache
and that occurs at doses normally used in humans for ➢ Prazosin – Postural hypotension
the prophylaxis, diagnosis or therapy of disease or for Type B
the modification of physiological function.” - “Bizarre Reactions”
- WHO - are idiosyncratic and not predictable based on
pharmacology
Adverse - result of the intrinsic properties of the - includes idiosyncratic reactions, immunological or
Drug drug and cannot be prevented allergic reactions and carcinogenic/teratogenic
Reaction - in which a causal association is reactions
(ADR) suspected between the drug and Examples:
the event
➢ Penicillin – Anaphylaxis
- an adverse event with a casual link
➢ Anticonvulsant – Hypersensitivity
to a drug
Adverse - injury resulting from medical
Drug intervention related to a drug and
Event includes ADRs, but also includes
(ADE) preventable reactions including
those caused by human error
- any untoward medical occurrence
presenting during administration of
a drug or treatment, but which do
not necessarily have a causal
relationship with this treatment
- happens in a patient taking drug TYPES OF ADRS
CLASSIFICATION OF ADRS - dose-related
• Acute (less than 60 mins) - more common events that
Onset of tend to be related to the
• Subacute (1-24 hrs)
Event pharmacology of the drug
• Latent (more than 2 days)
• A - have a mechanistic basis
A – Augmented
• B - result in lower mortality
• C - occurs from the known
• D pharmacological action of
Type of a drug given to a patient in
• E
Reaction therapeutic doses
• F
• G - non-dose-related
• H - less common, unpredictable
• U events that are not related
• Minor to the pharmacology of the
No therapy, antidote or prolongation of drug
B – Bizarre
hospitalization required - totally abnormal effects that
• Moderate are unrelated to the known
Requires change in drug therapy, specific therapeutic or
Severity pharmacologic action of
treatment or prolongs hospital stay
• Severe the drug
Potentially life threatening, causes - dose-related and time-
C – Chronic
permanent damage or requires intensive related
medical treatment
Esguerra, fRPh
 - events that are related to COMMON ADRS
cumulative dose received DRUG ADR
over time Acetaminophen Nausea, rash, headache
- dose-related reaction that is Dyspepsia, nausea, abdominal pain,
observed after long term use Naproxen constipation, dizziness, drowsiness,
of a drug rash
- time-related May increase risk of serious and
- usually dose-related but do potentially fatal CV thrombotic
not become apparent until events
significant time has elapsed Celecoxib
D – Delayed
since exposure to the drug Headache, dyspepsia, diarrhea,
- reaction to a drug that is abdominal pain, nausea and
manifested long after drug vomiting, rash, flatulence
exposure Guaifenesin Rash, vomiting, nausea
- withdrawal Dizziness, headache, diarrhea,
- occur soon after the use of nausea and vomiting, anorexia,
the drug Digoxin weakness, bradycardia or
E – End of Use - manifested by symptoms tachycardia, confusion, rash, mental
that result from termination disturbance, apathy
or sudden discontinuation of Rash, pruritus, taste changes,
the drug hypotension, dizziness, fatigue,
- unexpected lack of efficacy Captopril
cough, hyperkalemia, nausea and
- common, dose-related vomiting
events where drug Peripheral edema, headache,
effectiveness is lacking, Amlodipine fatigue, palpitations, dizziness,
often due to drug nausea, flushing
interactions Fatigue, dizziness, diarrhea, pruritus,
F – Failure
- lack or insufficiency of drug Metoprolol rash, depression, dyspnea,
products, antimicrobial bradycardia
resistance, drug instability, Peripheral edema, headache,
patient noncompliance, Nifedipine dizziness, flushing, fatigue/ weakness,
expired or fake drugs and palpitations
drug interactions Fetal/neonatal morbidity/ mortality
SUMMARY Losartan
may occur
SERIOUS ADVERSE DRUG REACTIONS

“Adverse drug reactions (ADRs) remain a challenge in

modern healthcare, particularly given the increasing
complexity of therapeutics, an ageing population and
rising multimorbidity.”
- Coleman J.
A careful medication history can assist a prescriber in
understanding the patient’s previous experiences with
drug treatment, particularly in identifying previous ADRs
that may preclude re-exposure to the drug.
RISK FACTORS
• Age
• Concurrent Medicines
• Duration of Therapy
• Gender
• Comorbid Conditions
• Narrow Therapeutic Index Drugs
• Ethnicity and Genetics

Esguerra, fRPh
 - drugs interact with some unique feature on an
individual, not found in majority subjects and
produces the uncharacteristic reaction
Example:
➢ Barbiturates – excitement and mental confusion

NEXT TOPIC:
PHARMACOVIGILANCE
- is the science and activities relating to the
detection, assessment, understanding, and
prevention of adverse effects or any other
medicine/vaccine related problem

• EDD, Rx
medicine containing any amount of prohibited or
regulated drugs supplied on ordinary prescription forms
with S-2 license number by a licensed PDEA prescribing
physician
• Rx
prescription medicine, supplied on prescription only
• Non-Rx
non-prescription medicine, supplied without need for
prescription

TWO BASIC STEPS TO PREVENT AN ADR FROM OCCURING

• Identify the subgroup of patients who are likely
to be susceptible to the adverse effect and
modify the treatment choice accordingly
• Ensure the treatment plan mitigates any possible
adverse effects
MANAGING ADRS
• Altering a dosage regimen
• Withdrawing a medicine suspected of causing an
ADR
Note:
Both are common methods used in practice, but the
course taken to manage an ADR is likely to vary from
clinician to clinician
SIDE EFFECTS
- unwanted but avoidable, pharmacodynamic
effects that occur at therapeutic doses
- predicted from the pharmacological use of the
drug
- known to occur in a given percentage of drug
recipients
S/Es BASED ON THERAPEUTIC EFFECT
➢ Atropine – dry mouth
➢ Acetazolamide – acidosis
S/Es BASED ON DIFFERENT ACTION
➢ Promethazine – sedation
➢ Estrogen – nausea
IDIOSYNCRASY
- genetically determined abnormal reactivity to a
chemical
- bizarre drug effects due to peculiarities of an
individual for which no definite genotype has
been described

Esguerra, fRPh