Coroners Court Neil Petrie October 2018 Recent Coroners Case Methotrexate Chemotherapeutic agent for rheumatoid arthritis Also used for some cancers Also may be used in psoriasis Extremely toxic ID: 917139
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Slide1
Possible Consequences of Errors
Coroners CourtNeil PetrieOctober 2018
Slide2Recent Coroners Case
MethotrexateChemotherapeutic agent for rheumatoid arthritisAlso used for some cancersAlso may be used in psoriasisExtremely toxic
Given weekly
Unless in certain cancers when short courses may be ordered.
Slide3Meet Mrs H – Day 1
Has been taking
Methotrexate 17.5mg once weekly for 3-years
Visit to her GP who was away
Seen by locum doctor
Asked doctor if there was a simpler way to take her medicine
Prescription provided for methotrexate
10mg x 1 weekly2.5mg x 3 weekly
Slide4Mrs H – Day 2
Doctor intended to write
”ad” for as directed
However inadvertently wrote
‘OD” for daily
Community pharmacist
Dispensed with label
Take ONE tablet daily
Slide5Mrs H – Day 2
So Mrs H starts taking her methotrexate daily.
Slide6Mrs H – Day 5
Second GP reviews prescription and notes the error.The paper prescription is changed by hand.The computer record is not corrected with correct dose.
Slide7Mrs H – Day 8
Presents to hospital complaining of feeling generally unwell, lethargic and having a sore throat for past 5-days.
Admitted to ENT ward
Resident doctor prescribes her regular medicines
Slide8Mrs H – Day 9
Nurse identifies that the dose should be 10mg dailyAccording to the medication bottle brought in by Mrs H.
Mrs H confirms she recently started taking 10mg daily.
Nurse administers the 10mg dose.
Slide9Mrs H – Day 10
Medication chart sent to pharmacy for more supplies.At this point the order is still 100mg dailyPharmacist crosses off the orderPharmacist asks nurse to clarify order with doctor
Slide10Mrs H – Day 10
Resident doctor phones GP surgery to check doseReceptionist checks patient historyConfirms dose of 10mg daily.
Resident doctor writes a new order
For 10mg daily.
Slide11Mrs H – Day 11
At this point Mrs H has been seen byAt least 4 doctorsAt least 2 pharmacistsA number of nurses
Still no blood tests have been ordered.
Slide12Mrs H – Day 12
Develops a rashNurse looks up side effects of methotrexateThis suggests that methotrexate could be the causeBlood test results revealCritically low platelets
Low white blood cell count.
Slide13Mrs H – Day 12
Methotrexate ceasedTransferred to haematology teamIn total Mrs H has received11 daily doses of methotrexate5 of which were given in hospital
Slide14Mrs H – Days 13-20
Mrs H continues to deteriorate.
Her family are informed that
her
prognosis is poor.
Slide15Mrs H – Day 21
Mrs H dies.Death certificate shows cause of deathGastrointestinal haemorrhagePancytopaenia
Methotrexate toxicity
Slide16One Simple Mistake
One simple error lead toCatastrophic consequencesMedication errors often involve Numerous people
Multiple opportunities to
Identify
Question
Correctly clarify
These systemic failures resulted in a tragic death
Slide17Link to the NPS Website
http://learn.nps.org.au/
Slide18Medication Errors and
Quality Use of MedicinesNeil Petrie
October 2018
Slide19Cost of Medication Errors
Issue
Statistic
Hospital admissions
2-3%
190,000/
yr
Hospital reported incidentsSecond most commonAdverse reactions20-30%Preventable42%Cost$800 million/yr
Literature Review: Medication Safety in Australia 2013
Slide20Cost of Medication Errors
Harm to patient
20%
Significant harm including death
3%
Result
Loss of trust
Emotional impactMedico-legal
Slide21Pathway of Medicine Use
Prescribing
Evaluate patient
Establish need
Select
Individualise
Prescribe
DispensingReview prescription Prepare & DispenseDeliver
Adminstration
Review prescriptionPrepare medication
Administer
Document
Monitoring
Everyone’s responsibility
Slide22Comparing a 70 year old to a 30 year old
Heart pumps at 60%
Liver function reduced
Weight
Storage of medicines
30% muscle loss
30% fat gain
Kidneys – excretion 70%Body water17% decreasePeople over 65 years have higher rates of adverse effects
Greatest users of medicinesAge related changes and co-morbidity increases this risk
Slide23Guiding Principles
Slide24Why do medication errors occur?
Slide25What Factors
contribute to medication errors?
Average of 4 factors
Queensland Study in Hospital
Patient factors
Familiarity with patient
Patient condition
Communication abilityAcuity of problemEnvironmental factorsStaffing levelsWorkloadDistractions
WorkspaceLightingLong hours
Individual factorsPhysical health
Mental health
Insufficient knowledge/training
Team Factors
Lack of supervision
Poor communication
Task Factors
Access to clinical information
Documentation layout
Resource availability - references
Slide26Careful Checking
Slide27Now think about your care for 20 seconds
Slide28Have I removed your Card?
Do we see want we want to see?
Slide29Potential
problems with Medicines
Unnecessary drug therapy
Wrong drug
Dose too high
Dose too low
Adverse drug reaction
Inappropriate administrationNeeds additional drug therapyCan occur withPrescribingDispensingAdministration
Slide30Transcription Errors
Transfer from previous chartHospital dischargePrevious doctorLack of consistency between GP surgery records and chartsHandwriting
Computerised chart errors
Slide31Slide32Strategies for Improvement
Overview of evidence regarding different strategies for reducing medication errors.http://www.safetyandquality.gov.au/our-work/medication-safety/medication-administration
/
Slide33Standardised Medication Charts
Slide34Strategies to Reduce Interruptions (
Hosp)
Interventions included
Do not interrupt vests
Checklists with the medication administration
process
carried
by nurses;Signs requesting not to interruptQuiet zones for medication preparationAllocating other staff to attend to phone calls etc
Weak evidence
Raban
MZ,
Lehnbom
EC, Westbrook JI
. 2013
) Evidence Briefings on Interventions to Improve Medication Safety;
Interventions to reduce interruptions during medication preparation and administration
.
Australian Commission on Safety & Quality in Healthcare. Volume 1, Issue 1: June
2013
Slide35Electronic
Some evidence for hospitalsReduce dose omissionsImproved medication administration documentation.
Lack of evidence for Residential aged care
Slide36Evaluation of a hybrid paper–electronic medicationmanagement system at a residential aged care facility
Slide37Evaluation of a hybrid paper–electronic medicationmanagement system at a residential aged care facility
88 residents
24 doctors
1230 orders (759 regular & 467 PRN & 4 short term)
125 discrepancies
Slide38Slide39Elliott RA, Lee CY,
Hussainy
SY (2015) Evaluation of a hybrid paper–electronic medication management system at a residential aged care facility.
Australian Health Review.
http://dx.doi.org/10.1071/AH14206
Slide40Bar Code Medication Administration (BCMA)
Also called bar code enabled point of care (BPOC)
Scan
Nurse
Patients wrist band
Medicine
}
Electronic medication record
PreventsWrong patientWrong doseWrong time
Wrong drug
Wrong route
Slide41Bar codes
Requires all medications to be barcodedMay need pharmacy to addAnother source of errorTechnology issues
faulty barcodes and time outs
Time and motion impact
Same or decrease in time administering
Increase in direct patient care
Baysari
MT, Lehnbom EC, Westbrook JI (2013) Evidence Briefings on Interventions to Improve Medication Safety; Bar code medication administration systems. Australian Commission on Safety & Quality in Healthcare. Volume 1, Issue 1: June 2013
Inconsistent evidence
Slide42Double Checking Administration
Pros (Quotes)
Cons (Quotes)
Fail safe if rigorously applied
Resource intensive
Only takes 30 seconds
Inconsistently applied
No expensive electronic equipmentToo busyGlanceman test *
Time consuming
Allows 2 people to make an error*
Glanceman
test -
find a man and he glances at it for you.
Ramasamy
S,
Baysari
MT,
Lehnbom
EC, Westbrook JI (2013) Evidence Briefings on Interventions to Improve Medication Safety; Double-checking medication administration. Australian Commission on Safety & Quality in Healthcare. Volume 1, Issue 1: June
2013
Slide43Common Medication Problems
Slide44Adverse Drug Reactions
Reaction Type
Definition
Adverse drug reaction
Overarching term to describe an undesirable or excessive effect of a drug and may also be referred to as a side effect or intolerance.
Allergy
Allergy is adverse reaction to a drug or substance due to an immunological response.
IntoleranceA lowered threshold to the normal pharmacological actions of a drug/substance. It is a poorly defined term.Side effectAn undesirable response to a drug that occurs when used at normal dosesToxicity
An adverse reaction due to a high dose/exposure or a serious adverse reaction e.g. renal toxicityIdiosyncratic
An unpredictable reaction to a drug/substance that is peculiar to an individual and is not dose related
Slide45Reaction Types
Type A
Type B
Predictable
Unpredictable
Usually dose dependent
Rarely dose dependent
High morbidityLow morbidityLow mortalityHigh mortalityResponds to dose reductionResponds to drug withdrawal
Slide46Incidence Reporting
Rare
0.01%-0.1%
Affects > 1
but <
10 / 10,000
Uncommon
0.1% - 1%Affects >1 but < 10 / 1000Common1% - 10%Affects >1 but < 10 per 100Very common> 10%
Affects > 10 people per 100
Slide47D
r
ug
A
ll
e
r
gySide EffectToxicityPer
indopril (
Coversy
l
)
Angioedema
C
ou
g
h, h
y
po
t
ens
i
on
Hypotension, arrhythmia, vomiting
Opioids
A
naph
y
l
a
x
i
s
C
ons
t
i
pa
t
i
on,
ha
ll
uc
i
na
t
i
o
ns,
Respiratory depression
A
m
i
tr
i
p
t
y
li
ne
(
E
ndep)
R
ash
D
r
y
m
ou
t
h
Arrhythmia, seizures
A
m
o
x
i
c
i
l
li
n
(
A
m
o
x
il)
R
ash
Di
a
rr
hoea
(
m
il
d
–
se
v
e
r
e)
Unlikely
Description
Definition
Symptoms
Angioedema
Small blood vessels leak fluid into the tissues
Often associated with urticaria (hives)
May affect
face, lips, tongue, throat
Itchy, tingling, or burning (or just swelling)
Anaphylaxis
Potentially life threatening, severe allergic reaction and should always be treated as a medical emergency.
Potentially life threatening:
May include
Difficult/noisy breathing; Swelling of tongue
Swelling/tightness in throat; Difficulty talking and/or hoarse voice; Wheeze or persistent cough; Persistent dizziness and/or collapse
Pale and floppy (in young children)
Slide48Identifying an Adverse Drug Reaction
Is it feasibleTimingCause and effectHas it happened more than once
Any objective evidence
Did it improve when
dose decreased or drug ceased
Slide49Age
Environmental Factors
Gender
Race/ethnicity
Disease states
Concomitant Drugs
GENETICS can affect
Rate of metabolism
Slow metaboliserReduced
NormalFast
All drugs are not created equal
Neither are people
PERSONALISED MEDICINE
The future of prescribing
Slide50Pharmacogenomics
Identifies variations in genes that affects drugs responseMay predict whether an individual person
Will respond or not to a drug
Has an increased risk of adverse effects
Costs from $149 to $169 from
mydna.life
Common Medication GroupsAntidepressantsProton pump inhibitorsAntipsychoticsCardiovascular agentsAnti-epilepticsSulfonylureas
Anti-inflammatoriesStatinsAnalgesics
Potential Benefits
Improved health outcomes
Reduced side-effects
Less trial and error
Personalised approach
Lifetime relevance
Slide51Patient Group
N
ot toxic and
Not beneficial
Drug toxic but not beneficial
Drug toxic and beneficial
Drug not toxic but beneficial
Same diagnosis, same prescription
Slide52Clinical Application of Pharmacogenomics
Adapted from Xie
and
Frueh
, Personalized Medicine (2005) 2(4), 325–337
Before:
One-dose-fits-all approach
After:Personalised medicine (from genotype to phenotype)PGx
FAST
NORMAL REDUCED SLOW
100 mg
300 mg
100 mg
10 mg
Slide53Celebrities sign their names all the time
Your
signature is more important
Give it – sign it
Failure to sign:
When something is not signed there is a
real risk
that the medication YOU have ALREADY GIVEN
will be given again
by a second nurse.
CONSEQUENCES of OVERDOSE
:
Insulin:
Palpitations,
vomiting,
headache,
coma
Lactulose:
Diarrhoea,
abdominal cramps,
hypokalemia,
hyponatremia
Morphine:
Stupor,
coma,
bradycardia, hypotension,
respiratory depression,
respiratory arrest
Warfarin:
Bleeding or haemorrhage
Slide54How do you ensure everything is signed for?
Have another staff member check that you have signed everything before leaving
The nurse starting the shift should routinely ask to staff leaving if they have signed everything.
Electronic recording
Slide55Common errors
Wrong residentWrong timeWrong dayWrong drugNot administering
Fatal Errors
Incorrect dose 41%
Wrong drug 16%
Wrong route 16%
Almost half in people > 60 yrs
FDA Review
Slide56Confusion with Generics
Definition
Example
Generic name
Drug name
Active ingredient
Risperidone
Trade nameGiven by manufacturerOriginal brandRisperdalOriginal brandFirst patented brand of a medicineRisperdalGeneric brandOnce a patent expires other companies can develop their own version of the medicine.
Ozidal
Slide57Drug
Risperidone
Brands
Apo-risperidone,
Ozidal
,
Rispa
, Risperdal, Rispericore, Risperidone AMNEALRisperidone AN, Risperidone Actavis , Risperidone Sandoz, Risperidone generichealth, Rispernia, RixadoneStrengths500mcg, 1mg, 2mg, 3mg, 4mg, 25mg injection, 1mg/ml liquidFormsTabletOrally disintegrating tablet (Quicklets)Modified release injectionOral liquid
740 PBS listed drugs1850 different forms3500 different brands
Slide58Error Prone
Abbreviation
What should it be
U
E
QD
1.0mg
Acceptable Abbreviations
Error ProneAbbreviationWhat should it beU
UnitsEEye or EarQD
daily
1.0mg
1mg
Slide59High Risk Medicines
Defined as those with a heightened risk of causing significant or catastrophic harm when used in error. This includes:medicines with a low therapeutic index medicines that present a high risk when administered via the wrong route or when other systems errors occur.
Slide60High Risk Medicines
High Risk Medicines
P
Potassium
IV
I
Insulin
NNarcoticsCChemotherapyHHeparin/WarfarinFollowing have accounted for a large % of events
Digoxin, aspirin, Beta blockers, NSAIDs
http://www.safetyandquality.gov.au/our-work/medication-safety/medication-alerts/
Slide61Medication Incidents
Opportunities for improvement
Identify problem
Debriefing
Education
Systems review
Checking
Open disclosure policydescribes the way clinicians communicate with patients who have experienced harm during health care In this document, ‘patient’ also refers to support persons such as family members and carers.
Slide62Partnership Approach
Meeting resident’s complex medication needsPrescribing doctorDispensing pharmacistAdministering nurse
Management
Medication review Pharmacist
Resident/Resident representative
Slide63DPCS ACT & Regulations
Prescribing, dispensing and administrationAustralian Health Practitioner Regulation Authority Guidelines
Guiding
principles
residential
aged care
facilities
CommunityPrivacy ACTCommonwealth Aged Care ACTMy Health Records ACTLegislation
Slide64High Care Residents
Administration of medication to high care residents must be managed by a Division 1,3 or 4 nurse
They should ensure professional supervision of all administration to high care residents.
The responsibility of administering the medicine may be delegated in accordance with the scope of practice
Slide65Where is clinical judgement needed?
Examples may includeWithholding medicationMedication given with no effectHealth status of resident e.g. vomiting
Missed medication
Slide66Rights of Drug Administration
Right resident
Right medication
Right dose
Right time
Right
route
Slide67Phone orders – what is the Law?
The DPCS Regulation 47“must as soon as practicable”(a) confirm those oral instructions in writing; and(b) include them or provide them for inclusion in the treatment records of the person concerned.
Individual Policy and Procedure may indicate 24 hours
Pharmacists can also only supply on a direct order from a authorised person ie doctor
Slide68When taking emergency telephone orders
Verify the prescriberdetails of the resident
Write the instruction in permanent ink directly onto the person’s medicine record
Confirm the instruction with the prescriber
Name, dose, route, timing & frequency
Guidelines for administration
Sign and date the record
Where possible a second person should confirm the instruction with the prescriber.
Slide69Drugs of Addiction
Unexplained discrepancies in balances must be reported to the Victorian Department of Health
It is good practice that S8 drugs are checked and signed by two people
.
Slide70When Administering Medicine
Must remain with the resident until the medication is seen to be swallowedMust only document that administration has occurred when it has been completed
Must not sign for administration before it has been administered
Medication expiry dates must be checked prior to administration
Slide71Non-administered Medicine
If medicine is not given or refused, this needs documenting and the reason whyMedication chartProgress notes
Slide72Medication charts
Communication toolSafety risk with multiple routes in the same orderNever transcribe medication orders
What about computer generated orders?
Can the nurse add these for the doctor to sign?
Slide73Medication charts must include
Route, strength, dosage, frequencySignature of staff administering or supervising the medicinesRelevant date, month, year
Date of next administration of infrequent drugs
Alternative methods of administering medications
Slide74Altering Solid Oral Dose Forms
Altering (crushing) may make it easier to administerEnsure that process employed does not
Result in reduced effectiveness
Result in greater toxicity
Result in an unacceptable presentation in terms of taste or texture.
Slide75Medication
Expiry dates
Medicated eye
drops
Lubricant eye drops
Insulin
Salbutamol nebules
Medications packed in dosage administration aidsAnginineExpiry Dates
Slide76Expiry Dates
Medication
Expiry dates
Medicated eye
drops
30 days after opening
Lubricant eye drops
Most are 6-months after openingInsulinVial in use 30 days at room temperatureSalbutamol nebules90 days for set of 5 in useMedications packed in dosage administration aidsAustralian Guidelines – 8-weeksFDA – 6-months or 25% of shelf lifeAnginine90 days after opening
Slide77Storage issues
Medicine
Storage Conditions
Mylanta mixture
Refrigerate after opening and expires in 6-months
Pradaxa
Must be
stored in original packOroxine tabletsRefrigerateOnly 14 days out of fridgeValproate tabletsNot packed in DAA out of foil
8
0C
Medicine
Storage Conditions
Mylanta mixture
Pradaxa
Oroxine tablets
Valproate tablets
2
0
C
Slide78Issues with Patch therapy
DocumentingRecording in situ each dayRotating application sites
Is covering appropriate
How does external heat affect absorption
How are used patches disposed of
Inappropriate orders for half a patch.
Slide79Summary
Safe medication administration is achieved The rights of medication administrationThis includes documenting at the correct timeFocusing on the task at hand
Good communication
Correct assessment
Correct supervision
Slide80Summary
Communication or lack there of is the biggest cause of medication errors.Make sure you COMMUNICATE effectively.