Transcript MONITORING ADVERSE DRUG REACTIONS (ADRS)

MONITORING ADVERSE DRUG
REACTIONS (ADRS)
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Dr. Dorothy Aywak
OUTLINE
Definition of ADR
 Burden of ADR
 Reporting of ADR
 ADR encountered in KNH
 Challenges in reporting.

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INTRODUCTION
 Pharmacovigilance
(PV) From Greek words:
pharmakon (drug) vigilare (keep alert)
 Adverse
drug reaction (ADR) - an appreciably
harmful or unpleasant reaction, resulting from
an intervention related to the use of a
medicinal product.
 Adverse
Event (AE)- unpleasant reaction
following use of medicinal product, however no3
causal relationship.
“Drugs are double edged weapons”
They do good but can also kill!
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“Some remedies are worse than the disease”
Publilius Syrus, Roman writer, 1st century BC
Thalidomide disaster 1960’s
Phocomelia Eastern Province
Kenya-2009
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BURDEN OF ADR
In Australia, ADRs account for 2.4-3.6% of all hospital
admissions.
 Leading cause of morbidity and mortality 4-6th largest
in the USA


In Kenya, ADR reporting has increased since setting
up of the Pharmacovigilance department.

In 2011, PPB received 1490 ADR reports
( 79% ART related,5% Antimalarial, 3% Anti-TB)

In 2012, 3945 ADR reports (93% ART related)
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Adverse Drug Reaction (ADRs) can be avoided
at EVERY STAGE
(diagnosis, prescribing, dispensing and
administering)… including very early stages!
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ADR REPORTING IN KNH

PV CME conducted in various departments
within KNH.
Medicine
 Paediatrics
 Pharmacy


PPB ranked KNH among top 10 in reporting
(The Lifesaver, Dec 2012).
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ADR reporting form
Report all suspected
adverse reactions to:
- allopathic (modern)
medicines,
- traditional / alternative
/ herbal medicines,
- x-ray contrast media,
- medical devices and
cosmetics.

-
“Yellow form”
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PATIENT ALERT CARD

Issued based on criteria

Informs clinician of past
ADR experience in
patient

Prevents same or similar
ADR in future

Patient to carry card
at all times!
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KNH CASE REPORT :
PHENYTOIN
Class: anticonvulsant
Uses :
 most types of seizure disorders and status
epilepticus


Antiarrhythmic agent, especially
of dysrhythmias due to digoxin toxicity.
Prevent and treat seizures during and after
neurosurgery and head injury.
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ADR REPORTED
 August
2013, 4 ADR reports received from
surgical ward , following Phenytoin IV
administration.
 Description


of reaction:
Extravasation
Cardiotoxicity (hypotension, cardiac
arrhytmias)
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GENERAL ADVERSE EFFECTS OF
PHENYTOIN




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Depend on the route of administration, duration,
exposure, and dosage.
Hypersensitivity, headache, dizziness, tremor,
insomnia, GI disturbances
Hyperplasia of the gums, acne, hirsutism, coarsening
of the facial features, osteomalacia, local irritation or
phlebitis.
Prolonged use may produce subtle effects on mental
function and cognition, especially in children.
Potentially Fatal: Toxic epidermal necrolysis,
Stevens-Johnson syndrome.
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ADVERSE EFFECTS RELATED TO
ADMINISTRATION
•
•
•
Phenytoin administered intravenously at a rate
higher than 50 mg/min may cause hypotension
and cardiac arrhythmias and impaired cardiac
conduction.
Orally administered phenytoin is
ever, associated with cardiac toxicity.
rarely,
if
Extravasation of the IV solution may cause skin
irritation or phlebitis since the solutions are very
alkaline. E.g. purple glove syndrome
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EXTRAVASATION, PURPLE GLOVE
SYNDROME
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CHALLENGES IN REPORTING ADR
 Staff
constraints
 Fear of victimization
 Lack of awareness
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THANK YOU
“You need not be certain…
Just be suspicious”
Report all suspected ADRs and Poor
Quality Medicines to PPB
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