Medication safety and Mental Health

Dr Chris Alderman
University of South Australia
Universitas Airlangga
Australian Medication Safety Services
Medication safety
• When the public interact with medical and treatment systems, they
should be able to feel safe

• Health professionals working to care for people should feel like they
can do this safely and effectively
Mental Health/Mental Illness
• Mental health and mental health care matters for everyone, not just
those people who are diagnosed with a psychiatric illness
• Mental illness and compromised mental health have very widespread
impacts:
• The consumer/patient
• Families – partners, children, parents, siblings, grandkids
• Wider society
• Payers, including tax payers
• Health care providers
• The general public
Impact of Mental Illness
▪ Enormous suffering
▪ Stigma
▪ Social isolation and withdrawal
▪ Occupational disability
▪ Markedly increased health service
utilisation
▪ Comorbid substance use disorders and
sequelae of these
Impact of Mental Illness
▪ Poor physical health
▪ Child abuse and neglect
▪ Relationship and family difficulties
▪ Treatment and hospitalization costs
▪ Self-injurious behaviours (SIB)
▪ Suicide risk
▪ Potential for adverse medication events
Some thoughts about medicines
• Drivers for harm
• Approval mechanisms to allow market access
• Gaps in education related to critical appraisal
• Lack of access to quality information about drugs
• Misrepresentation and promotional tricks
• Rapid uptake of new drugs
Some thoughts about medicines
• Drivers for harm
• Voluntary ADR reporting
• Poor understanding by patients
• Deliberate misuse
• Healthcare systems under extreme pressure,
• Lack of true multi-D engagement
It seemed like a good idea at the time ...
• Malaria caused by the foul air
associated with swampy areas
• Mercury & arsenic for venereal
diseases
• Blood-letting ...
• Insulin coma therapy
• Apothecaries – base metals turned to
gold
Worrying statistics
• South Australian research study analyzed data on
medication-related hospitalizations

• Proportion of all hospital admissions that are medication-related

is between 2% and 3%
• At least 230,000 admissions annually with an associated cost of
at least $1.2 billion

• Millions hurt, harmed and killed

• Billions of dollars
 Statistically speaking
Sweden Denmark Scotland
Singapore France Canada
Germany Italy Taiwan
Spain Switzerland Netherlands
• Physicians in the USA approximately 700,000
• Estimate of accidental deaths caused by physicians per year
is 120,000, accidental deaths per physician approximately
0.171 (US Dept Health & Human Services)
• Gun owners in the U.S. is 80,000,000
• The number of accidental gun deaths per year, all age
groups, estimated at 1,500
• Accidental deaths per gun owner is 0.000188 (FBI)
• Statistically, doctors approximately 9,000
times more dangerous than gun owners.
We are 99.9% confident!

“ We are 99.9% confident that we

can get you into hospital and out of
hospital without causing you a serious
drug-related problem.”
 We are 99.9% confident!
• Two unsafe landings at major airports per
day
• 16,000 pieces of mail lost in the USA per
hour
• 32,000 bank cheques deducted from the
wrong account per hour
Public perceptions
Environment Risk score
Airline travel 5.2
Health care 4.9
Nuclear power 4.2

7 = safe 1 = unsafe
Adverse drug events
• Adverse drug events (ADEs) are the largest single category of
adverse events experienced by hospitalized patients
• Approximately 19 % of all injuries
• ADEs increased with increased morbidity and mortality, prolonged
hospitalizations
• 380,000 - 450,000 preventable ADEs occur annually in US hospitals
at an estimated cost of at least 3.5 billion US dollars per annum
Medication safety & adverse events
• Huge amount of attention in recent era, justified
• Iatrogenic harm
• Variable terminology
• ADR
• Medication-related problem
• Medication error
• Adverse events
• Medication safety issues

• The key issue is that these can cause harm or death

• Direct toxicities
• Sub-optimal outcomes
Relationship between adverse drug events (ADEs), potential ADEs, & medication errors.
 IATROGENIC HARM
Infection

Surgical
Falls Error

Code Black

Administrative

Failed
follow-up Diagnostic
Error
Adverse drug events
• Huge amount of attention in recent era, justified
• Iatrogenic harm
• Variable terminology
• ADR
• Medication-related problem
• Medication error
• Adverse events
• Medication safety issues

• The key issue is that these can cause harm or death

• Direct toxicities
• Sub-optimal outcomes
Thoughts about adverse drug events …
• Can be a mistake at any stage of the medication use
process - result of an injury to a drug-related intervention,
regardless of whether an error has occurred.
• All medical error can be prevented, while ADEs can be
categorized as preventable, nonpreventable, or potential.
• MEs occur at an alarmingly high rate, and some MEs and
ADEs have fatal outcomes for patients
Thoughts about adverse drug events …
• MEs can result from any step of the medication-use
process: selection and procurement, storage, ordering and
transcribing, preparing and dispensing, administration, or
monitoring.
• Can be prevented by determining the actual & potential
root causes in the system and correcting these
Thoughts about adverse drug events …
• QI methods include:
• Identifying the ME/ADE
• Understanding the reasons for the ME/ADE
• Designing and implementing a change to prevent an ADE/ME
• Assessing the outcome of that change.
A just culture & adverse drug events …
• “Just Culture” of medication safety:
• Cultivates trust in the workplace
• Makes reporting easy and safe
• Encourages personal responsibility for complying with safe medication
practices
• No blame
• Equality in the processes
• Anonymous if need be
About cheese & adverse events
James Reason
ADEs – what goes wrong?
• Errors in procurement, supply, storage and distribution of drugs
• Errors in the prescribing process – MRPs
• Errors in the administration of drugs
• Errors in the adherence process
• Adverse drug reactions
• Allergic
• Type II
• Overdose and toxicity
• Drug interactions
• With co-prescribed drugs
• With other medicinal drugs
• With non-medical (illicit) drugs
 EDUCATION AND
MENTORSHIP

INTERACTION WITH
THE OUTSIDE WORLD
Who are the clients of clinical
pharmacy services?
PATIENTS – THE CONSUMER
PLUS
• Hospitals
• Clinics
• Doctors
• Nurses
• Administrators
• Governments
• Courts
• Publishers and journals

38
Drug-related problems *Hepler & Strand

• Indicated drug not charted

• Wrong drug
• Too little drug
• Too much of the drug
• Adverse drug reaction
• Drug interaction
• Not receiving the prescribed drug
• Receiving a drug not indicated
Drug-related problems *Hepler & Strand

DETECT

DOCUMENT

RESOLVE

ANALYSE
PK Drug interactions
• Can manifest at any point in drug disposition process

• Drug absorption
• Drug distribution
• Drug metabolism
• Drug excretion

• The more drugs in the regimen, the greater the risk

Risk factors - medicine-related harm
PATIENT ILLNESS EVIDENCE OF BENEFITS STATUS OF ADRs

ADULT MAN LIFE-THREATENING RECOMMENDED STD TEXTS WELL-KNOWN,

and GUIDELINES NO SERIOUS ADRs

OLDER PERSON SEVERE MULTIPLE HIGH QUALITY SOME ADRs

STUDIES IN GOOD SOURCES (PERHAPS SERIOUS)

FERTILE WOMEN MODERATE SUB-OPTIMAL STUDIES WELL KNOWN SERIOUS

ADRs

CHILD MINOR POOR STUDIES SERIOUS ADRs,

POOR STUDIES

INFANT LIFESTYLE ANECDOTES ONLY SERIOUS ADRs

NO REAL STUDIES

PREGNANCY NOTHING PUBLISHED

Late
Early
Adverse drug events in psychiatry
• Medications are complex and polypharmacy common
• Not all prescribers have strong command of therapeutics
• ADRs and drug interactions
• Adherence issues
• Busy and complex wards
• Substance abuse is common
• Comorbid medical illnesses require management
• Safety culture not always well-developed
Simple steps to reduce adverse
drug events in psychiatry
• Deprescribing
• Monitoring for ADRs and DIs
• Education for prescribers and nurses
• Adherence coaching
• Redesign clinical areas like inpatient units
• Provide advice about management of comorbid medical illnesses
• Enhance safety culture
• Reporting
• Support and education
• Research and QI
• Infrastructure – resources, ?CPOE
Adverse drug events in psychiatry

“We are not here to curse the darkness

but to light the candle that can guide
us through that darkness to a safe and sane future.”
John F Kennedy, 1960
Medication Safety CASES
The curious case of Rocco
➢ 71 year old Italian man with a history of HT, gout, GORD and
bipolar disorder

➢ Medications:
➢ Perindopril/indapamide 5/1.25 mg (Coversyl Plus) daily
➢ Allopurinol 300 mg daily
➢ Pantoprazole 20 mg daily
➢ Atorvastatin 40 mg daily
➢ Valproate 1000 mg twice daily

➢ Presents to ED with nausea, haematuria and severe flank pain

The curious case of Rocco
➢ Renal US ► Multiple renal calculi
➢ Medications added - Metoclopramide 10 mg q6h when
needed, indomethacin 50 mg three times daily
➢ Returns three days later with anuria, headache, swollen
ankles, worsening nausea
➢ Serum creatinine (previously WNL per GP) now 650
micromol/L, urea 22 mmol/L, K+ 6.0 mmol/L
➢ Admitted, medication withheld, stat dose of Resonium®
Jack is bleeding
➢ Jack is an 80 year old man with a history of AF, TIAs, OA
and depression

➢ Medications:
➢ Warfarin – variable dose, recently stable at 6 mg
daily
➢ Clopidogrel 75 mg daily
➢ Paracetamol MR 1330 mg three times daily
➢ Tramadol 100 mg SR twice daily

➢ Commenced fluvoxamine 200 mg daily for a week

Jack’s case
➢ A week later Jack sees his doctor to ask about frank rectal blood loss
after bowel actions – “the bowl was full of blood”

➢ Further history reveals that he has two sustained nosebleeds and

also some haemoptisis

➢ Sent to the ED of the nearby hospital, INR found to be 12, Hb 102

g/dL
➢ Admitted, Vitamin K 5 mg orally, repeat INR, hold amiodarone, seek
TDM
Old Uncle Bert has aches and pains
➢ Uncle Bert is everyone’s favourite at the nursing home,
although his health has been in decline. His medical history
includes IHD, MI with coronary artery stents, type II diabetes
and recurrent depression

➢ Medications:
➢ Isosorbide mononitrate 120 mg daily
➢ Diltiazem 180 mg MR daily
➢ Atenolol 25 mg daily
➢ Perindopril 8 mg daily
➢ Clopidogrel/Aspirin 75/100 mg daily
➢ Metformin 500 mg daily
➢ Simvastatin 80 mg daily
➢ Paracetamol MR 1000 mg four times daily when
required
Old Uncle Bert has aches and pains
➢ Nursing staff at the facility have noticed that Bert is breathless and
has a fruity cough, and in view of previous hospitalizations for
pneumonia have asked for a GP review
➢ On examination he is tachypneic and febrile, and affirms a history of
purulent sputum

➢ His GP prescribes clarithromycin 250 mg twice daily for a week

➢ Several days later Bert is complaining bitterly of aching muscles and

joints, and cannot stand from a chair without assistance – this is not
usual for him: after a discussion between pharmacist and doctor
both the antibiotic and his simvastatin is ceased
➢ A plasma CK concentration is found to be > 1200 u/L
Things are not right with Don…
➢ One would generally not have much trouble knowing where Don was in the facility. A large, loud chap with an American
accent, for some years he has been affected by vascular dementia, as well as CKD, IHD, PVD and glaucoma.
➢ Nearly a year ago, Don started having episodes where he would complain of a black spot in his vision. During these
events he would become dizzy, very confused and unsteady, his GP made a clinical diagnosis of TIAs and commenced
clopidogrel 75 mg daily. The episodes promptly stopped for good, or so it seemed.
Things are not right with Don…
➢ Current medications:
➢ Clopidogrel 75 mg daily
➢ Transdermal GTN 15 mg/24 hours
➢ Atenolol 25 mg daily
➢ Rosuvatatin 5 mg daily

➢ After facility staff noticed some weight-loss accompanied by

occasional vomiting, his concerned GP commenced treatment with
esomeprazole 40 mg daily

➢ About a week later, he suffered several TIAs and eventually was

admitted to hospital for assessment. At that time esomeprazole was
replaced with pantoprazole