PRESENTER;Maganga M.Gabriel(Pharmacist)
Pharmacy Department
(drug inf &Emer)
Presentation outline
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Definition of medication error
Pharmacovigilance overview
The different types of medication errors
Factors that can contribute(cause) to
medication errors
The suggested ways of reducing
medication errors
Definitions
A Medication error (ME) is any
preventable event that may cause or
lead to inappropriate medication use or
patient harm while the medication is in
the control of health professional,
patient or consumer.
(US National Coordinating Council for
Medication Error Reporting and Prevention)
 Definition of Medication Error
 An error in prescribing, dispensing or
administering of a drug, irrespective of
whether such errors lead to adverse
consequences or not
Pharmacovigilance overview
Why do we need pharmacovigilance?
Will PV prevent these?
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What is Pharmacovigilance?
 The science and activities relating to the
detection, evaluation, understanding and
prevention of adverse drug reactions
(ADR) or any other drug-related
problems (WHO, 2002)
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 Pharmacovigilance (PV or PhV), also
known as Drug Safety, is the
pharmacological science relating to the
collection, detection, assessment,
monitoring, and prevention of adverse
effects with pharmaceutical
products.(wikipedia)
pharmakon (Greek for drug),and vigilare
(Latin for to keep watch).
The Goal of Pharmacovigilance and
Medicines Safety
The goal of Pharmacovigilance is to
safeguard public health and improve
rational medicines use .
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Aims of Pharmacovigilance
 A.To identify/quantify
 New adverse drug reactions (ADRs)
 Risk factors/populations at risk
 Increase in frequency of known ADRs
 B.Detect Drug interactions with other
drugs administered concomitantly
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Aims of Pharmacovigilance cont..
• C.To monitor
• ADR profile of medicines within
therapeutic class
• the safety profile of medicines during
their whole life cycle
• To contribute to good clinical practice in
pharmacotherapy
• To prevent patients from unnecessary
harm.
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Pharmacovigilance From Historical
Perspective
 Drugs’ potential for harm has been
recognized very early.
 In 1937 a sulfonamide elixir containing
over 70% of diethylene glycol (DEG) was
given to over 300 patients in US.
→ 105 deaths (34 children) due to renal
failure.
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 Growing awareness of the importance of
ADRs in pharmacotherapy since the
Thalidomide tragedy
 1961
phocomelia in babies born to
mothers treated with thalidomide while
pregnant (>470 babies in one year in
Germany alone).
 In 1970 Inman discovered the causal
relationship between thromboembolic
disease and high dose oestrogen oral
contraceptives.
16th World Health Assembly 1963
 Assembly Resolution 16.36 - Clinical and
Pharmacological Evaluation of Drugs
INVITES Member States to arrange for a
systematic collection of information on
serious adverse drug reactions observed
during the development of a drug and, in
particular, after its release for general use.
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Pharmacovigilance History...
International community response
 1968 the WHO International ADR
monitoring programme was founded.
 In 1971, WHO international ADR
database was established
 Tanzania joined the program in 1993
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WHO Collaborating Centre for
Drug Monitoring
Pharmaceutical industry
DRUG SAFETY MONITORING
BY THE TFDA
Muhimbili
MNH
PATIENT
Mbeya
MRH
Bugando
BMC
Kilimanjaro
KCMC
HEALTH PROFESSIONNALS
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Medication Errors…
 ME may be related to professional
practice, products, procedures,
working environment or systems.
 They may occur at any stage during
:
 Prescribing (doctor)
 Dispensing (pharm)
 Administration of medicines.
(Nurse etc)
 Use of medicines by patients.
Prescribing Errors cont…
 Prescribing errors may be described as
incorrect medicine selection (not
indicated or contraindicated), wrong dose
or quantity for a patient.
Prescribing Errors cont..
Example:
 Prescribing adult dose to a child
 Prescribing medication for a prolonged
duration
 Prescribing antimicrobials for viral
diseases
 Prescribing contraindicated medicines eg.
Prescribing zidovudine to anaemic patients
Dispensing Errors
 May occur at any stage of dispensing process,
from the receipt of the prescription to issuing
medicine to the patient.
The errors may include:
 Selection of the wrong strength or product. For
example Amiloride 5mg instead of
Amlodipine 5 mg tablets.
 Dispensing wrong dose
 Dispensing medicines to wrong patient.
Administration Errors:
 May occur when there is difference
between the medicine or dose
received by the patient and what was
prescribed.
Examples
 Medicine given to the wrong patient
Administration Errors cont…
 Wrong medicine or IV fluid administered
 Wrong dose or strength given-Overdosing
or underdosing
 Wrong dosage form given
 Medicine given for wrong duration
Administration Errors cont…
 Wrong preparation of a dose (e.g.
Incorrect dilution)
 Incorrect administration technique (e.g.,
unsterile injection)
Administration Errors:
 Medicine given to a patient with known
allergy
 Wrong route of administration use
 Wrong time or frequency of
administration
 Wrong administration duration
Medication Error at Patient Level
 This may occur when a patient fails to
follow treatment instructions.
 Lack of adherence
 Overdose
What are causes of Med errors?
What are causes of Med errors?
 Too many telephone calls
 ? Overload/ unusually busy day
 ? Too many customers
 ? Lack of concentration
 ? No one available to double check
 ? Staff shortage
 ? Similar drug names
 ? No time to counsel
 ? Illegible prescription
 ? Misinterpreted prescription
Possible Causes classified….
Human
Factors
Workplace
factors
Errors in interpreting prescriptions(abbreviations etc),
Illegible handwriting, lack of experience, lack of
training, poor handwriting, verbal orders, heavy staff
workload and fatigue ,(errors in calculations?)
Poor lighting, Interruptions, Excessive workload
Pharmaceut , confusion of medicine names, packaging, or
ical factors labeling,, complexity of calculations needed to
prescribe, dispense, or administer a medicine,
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Problem: Look alikes medicines from same company
(falls under which factor?)
Example: Poor handwriting
(falls under which factor?)
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Easy to read…
Difficult to read
Difficult to read
Difficult to read..
handwriting
Fluid not understood ….
What is that insulin type ?
Required to apply indomethacin?
Piroxicam frequency?
……………………?
Meloxicam ,…..?
Extremely…..
………………?
Same drug family
Medication Errors - Implications
 What are the consequences of medication
errors?
Medication Errors - Implications
 1.Therapeutic failure
– Increased Morbidity
– Prolonged hospital stay
– Mortality
Medication Errors - Implications
 2.Economic consequences
– Wasted resources
– Increased cost of care , prolonged
hospital stay
– Loss of man hours/ absenteeism
 3.Adverse Drug Reactions
Ways of reducing medication errors
Supervise , develop SOP,
guidelines(seniors to
supervise Juniors
Enhance
communication(landl
ines, mobiles
Adhere to quality
improment
programs
Other
ways………?
Let us
Report
ADR,s
Take Home Messages
 Medication errors are one of the most preventable causes of
patient injury although the incidence of such errors varies
widely.
 The majority of medication errors occur as a result of poor
prescribing, emphasizing the need to improve prescribing skills.
 A non-punitive approach should be adopted to improve the rate
of reporting of medication errors, allowing further investigation
of these important causes of preventable patient harm
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