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“Its easier to start than to stop”
Managing medicines risk in the elderly
patient with polypharmacy and chronic
disease
Setting the scene
May 2016
The impact of chronic disease in
the NZ aging population is the
most challenging issue
facing the health sector
How are we to manage this
challenge?
Mrs T, 79 yrs
• IHD
• CHF
• Atrial fibrillation
• Systolic hypertension
• Type II Diabetes
• Glaucoma
• Osteoarthritis
• Gout
• Chronic renal failure
• Falls risk
2
Medications (13)
Frusemide 20 mg mane
Candesartan 16mg mane
Metoprolol CR 95 mg nocte
Doxazocin 8 mg mane
GTN spray PRN.
Diltiazem CR 120 mg mane.
Codalgin prn
Aspirin 100 mg mane
Simvastatin 10 mg nocte
Allopurinol 300 mg daily
Zopiclone 7.5 mg nocte
Xalatan (Latanoprost) eye drops
Cosopt (Dorsolamide + Timolol) eye drops.
What is Mrs T’s
cumulative medicines
risk?
+
Age and co-morbidities,
Psycho-social & environmental risk factors
Multiple clinical interventions
(multiple prescribers)
How do we manage cumulative medicines risks in patients with chronic disease and
complex medicines regimens?
1. Shift the focus of multi-disciplinary chronic disease management from the hospitals to the community.
(Brand C et al. Int Med J 2007,37: 653. Scott I. Int Med J2008,38:427)
2. Focus on prescribing apropriateness
3. Medication Management Planning (MMP)
‘OPTIMED’ - Goal
Design and implement a sustainable service to
optimise complex drug treatment
Target
Patients taking 6 or > daily medicines
Sth Wairarapa: 680
Masterton area: >2000
Referral criteria
• 6 or more daily medications (Steinman M et al JAGS 2006, 54: 1516).
• Living at home.
• Managing own medicines.
• No age limit.
Optimed service model
• “A patient focused, documented, shared
decision-making process, to identify and
manage treatment risks in the context of
aging and coexistent morbidity – future
proofing against cumulative medicines
risk”.
OPTIMED service components
• Patient consent.
• Medicines reconciliation (community pharmacy).
• Specialist assessment + practice-based MDT
• Risk management recommendations (RMRs).
• GP/Patient shared decision-making
• Medicines management plan (MMP)
• Communication - OPTIMED electronic template)
• Synchronised dispensing (community pharmacy).
• OPTIMED education programme (GPs and practice
staff).
Medicines risk variables – scored electronic template
• Comorbidities
• ADR/allergy
• Medication complexity
• Drug intolerance
• Medication adherence
• Pt’s understanding of
treatment
• Drug + drug
• Drug + disease
interactions
• High risk drugs
• High risk life-style
factors
High Risk Medicines
Insulin, Sotalol, Opiates, Warfarin, Clozapine,
Statins, Digoxin, Antihistamines,
Antipsychotics, Anticholinergics,
Antidepressants, Alpha blockers, Diltiazem,
Nitrates, Tramadol, BDZs, NSAIDs, K sparing
diuretics, Cyclosporin, Methotrexate,
Azathioprine, Phenytoin, Carbamazepine,
Colchicine, Steroids, Azole antifungals,
Glibenclamide, HIV Protease Is, Lithium,
Perhexiline, ACE-Is, ARBs, Timoptol eye
drops, Clopidogrel, Amiodarone, LMW Heparin,
High risk life style factors
• 6 or more medications
• Age >70
• Living alone
• Unsteadiness – (walking aids)
• Deafness
• Vertigo
• Visual impairment
• Orthostatic symptoms
• Incontinence
• Constipation
• Complex social circs.
• Ethanol excess
• Falls (3 months)
Audit
62 patients, taking 6 or more medicines daily,
– 3 Wairarapa Medical Centres,
– 3 non-attenders
– 59 (25 M, 24 F).
– Mean age 65 yrs
• Retrospective audit of risk management
recommendations
– baseline (OPTIMED review), 6 months (uptake of
RMRs), 2 years (% sustainabilty of RMRs)
Audit end points
1. Uptake (6months) and sustainability (mean 25
months) of Risk Management Recommendations
(RMRs), post OPTIMED review.
2. Change in medication complexity.
3. Non-OPTIMED dispensing during the audit period.
4. Frequency of clinical interventions pre and post
OPTIMED review.
Cumulative medicines risk -
component scores.
Mean (SD)
Medicines History 1.8 (1.4) (tolerability, allergies/ADRs, adherence, awareness)
High risk medicines 4.2 (1.5)
Drug/drug interaction 1.0 (1.1)
Drug/disease interaction 0.6 (0,9)
High risk life style factors 6.9 (2.4)
Medicines complexity 13.9 (4.4)
(Mean, SD)
Baseline Endpoint
Medications (n) 10.0
(3.1)
10
(3.2)
Doses 13.1
(4.9)
13.8
(5.5)
Frequency 4.7
(2.1)
5.2
(2.5)
Complexity
score
14.7
(4.3)
15.2
(4.9)
Medicines complexity
Daily medications range 6 - 23
Medication Baseline Endpoint
ACE-I / ARB 50 45
Statin 40 38
Insulin 15 15
Alpha blocker 16 9*
Nitrates 11 11
BDZs 12 13
Warfarin 10 9
Diltiazem 12 5*
Other 72 65
TOTAL 251 224 (P <0.05)
Change in high-risk medications prescribed
during the audit period
0
10
20
30
40
50
60
0 10 20 30 40 50 60 70
Risk score
Patients
Baseline
Endpoint
Mean score = 29
Total cumulative medicines risk scores
RMRs implemented for whole audit period
RMR
categories
Specialist
RMRs
Mean
RMRs per
patient
Implementation
at 6 months
(%)
Implementation
at 2 yrs
(%)
Stop 79 1.2 59.6 58.4
Modify 67 1.1 52.2 49.3
New Medicine 46 0.6 52.1 50 .8
Total 192 2.8 (range 0 –7)
P > 0.05
Paired t tests
Non-
OPTIMED
changes
Mean
New 183 3.0
Stopped 184 3.0
Modified 98 1.6
Non-OPTIMED medication changes
during audit period
Total medication changes 657
OPTIMED RMRs 192
(n = 62)
Pre-assmt.
weekly drug
costs
($)
Change in
weekly cost post
assmt.
3 months
($)
Change in weekly
cost post assmt.
6 months
($)
% cost
reduction
6 months
Mean (range)
18.34 - 5.4
(+17.5 - 37.4)
- 6.97
(+12.3 - 35.9)
- 38%
NOTE: The change in weekly cost = OPTIMED changes + all other
medicines changes
Impact of RMRs on weekly
medicines costs (NZ$)
Conclusion
The OPTIMED service can provide safe and
sustainable medication management for high risk
patients, in the community:
– 38% weekly medicines cost reduction within 6 months
– 54% OPTIMED RMRs actioned within 6 months
– > 90% OPTIMED RMR sustainability over 2 years.
The challenge is to promote DHB
commitment to sustain such services in the
longer term.
Acknowledgements
Practice Staff at the Carterton, Martinborough,
Featherston & Greytown Medical Centres.
Dr A Lincoln Dr L Cherry
Dr I McArthur Dr M Berry
Dr C Cherry Dr Pathmanathan
Dr D Heard Dr S Phillips
James Mitchell (OUW summer student)
Prof M Weatherall (OUW)
David Holt & David Mitchell (Community Pharmacy Partners)
OPTIMED learning points
1. Medication management plan
Four parts:
1. Clinical and therapeutic assessment - risk management recommendations.
2. Medication management plan – shared decision-making
3. Community Pharmacy assessment and support - Pharmacy LTC service
4. Implementation of risk management recommendations
Optimed learning points –
2. medicines review
1. Identify medical conditions, diagnostic certainty, life
expectancy.
2. Identify therapeutic objectives & priorities, including preventive treatment targets.
3. Medicines reconciliation
4. Review medicines appropriateness, in clinical context.
5. Identify patient specific risk factors: ADRs/allergies, medicines complexity, high risk medicines content and life-style factors.
6. Determine medicines to be started, discontinued or doses altered
7. Document and communicate
OPTIMED learning points –
3. Ongoing safe medicines management
• Regular medicines review
• Safe medication withdrawal.
• Strategies for high risk medicines management in the community.
• Managing ‘uncertainty’ - prioritisation of long term complex therapeutic objectives.
• Targeted education of practice staff.
• Patient education
OPTIMED – learning points
4. Spin-off for chronic disease management:
• Sustained improvement in prescribing
appropriateness.
• Specialist out-reach clinics for high risk
patients.
• Improved GP/community pharmacy
communication.
Five key issues in the
management of polypharmacy?
Drug-drug interactions
• Diltiazem/ Verapamil + Statins (+ CRF)
• Alpha blockers + Nitrates (+ age)
• ACE-I + K-sparing diuretics
• Combinations of CNS depressants (opiates,
BDZs, TCADs, SSRIs)
• NSAID + ACE-I
• Clopidogrel + Omeprazole
• Tramadol + Warfarin
Patient - GP consultations per year
during the audit period
Definitions!
Treatment Burden
Cumulative Medicines Risk
Treatment Burden - components
• Multiple co-morbidities.
• Cumulative medicines risk
• Multiple clinics for different conditions.
• Hospital admissions (acute problem focused).
• Lab tests, Drs visits, medicines to collect and
manage.
• Patient’s personal social and environmental risk
factors (insomnia, visual impairment, falls risk)
• The work of communication and information
management.
Cumulative medicines risk components
• Chronic disease risk: - cumulative actual risk of chronic disease (increases with age and co-morbidities).
• Treatment Risk: [chronic disease risk - medication benefit] + medication risk.
• Cumulative Medicines Risk: total treatment risk over time (increases with number of medicines and the number of co-morbidities).
• Work of Treatment
Types of Adverse Reactions
• Type 1: ADR as a result of the intended drug effect: eg Clonidine and dry mouth.
– Predictable (dose dependent)
– Individually variable.
• Type 2: Unexpected, rarer & may not have been reported before: eg Phenytoin and gum hypertrophy.
– Unpredictable
– Idiosyncratic (includes allergies and foetal malformations)
Drug “Side Effects”
“Side effects” are often minimised and patients are poorly informed“
– Frequently occur with the therapeutic effect - generally dose dependent ,
– e.g: nausea, drowsiness, abd discomfort, tireness, dry mouth etc.
• Always ask - think in terms of tolerability
• Beware of new symptoms!
Patient risk factors for ADRs (Onder et al. Arch Int Med. 2010;170:1142-1148)
Variable Weighting
≥4 co-morbid conditions 1
Heart failure 1
Liver disease 1
e-GFR < 60 mls/min 1
Medications:
≤ 5 0
5 - 7 1
≥ 8 4
Prev. ADR 2
Benefit vs Risk –
how much to tell the patient?
• Always inform the patient of the risks
– Type 1 effects – always (most common ones)
– Type 2 effects - “what is reasonable” (HDC).
• Avoid information overload - beware the ‘internet patient’.
• Read the Data Sheet, but drug companies don’t tell all of the story.
Benefit vs Risk
• Difficult !
– singular benefit – but multiple risks, with
variable weighting.
– new drugs – limited knowledge of ADRs.
• Prescriber’s perception of ADR risk
– influenced by personal experience, severity
and frequency.
• Patient’s expectations ?
• Shared decision-making
Medicines treatment ‘complexity’
Daily medicines (DM) 9.5 (2.9)
Daily doses (DD) 13.1 (5.4)
DD/DM 1.37
Medicines complexity 13.9 (4.4)
(mean+/- SD, n= 59))
Advice consensus of 3 C&C specialist physicians)
• Reduce Lipex dose immediately
• Switch Metoprolol to low dose conventional formulation
27.5 mg BD and titrate to control ventricular rate.
• Stop Diltiazem (+ renal impairment = Lipex toxicity)
• Stop Doxazocin (+ GTN + hypotension and falls)
• Stop Paradex (ineffective paracetamol dose + addictive)
• Stop Codalgin (ineffective codeine dose)
• Regular Paracetamol; consider opiate
• Reduce Allopurinol dose (renal impairment)
• Stop Timolol eye drops; non-betablocker alternative.
• Stop Frusemide; trial of Bendrofluazide
• Dont stop Zopiclone
Language!
1. “Treatment burden” - cumulative
potential risk of complex medication
regimens in chronic disease (TB).
– imposed on the patient as result of:
fractured care, multiple co-morbidities,
specific disease Guidelines, etc.
• “Chronic disease burden” - cumulative
actual risk of chronic disease (CDB)
– increases with age and co-morbidities
Treatment burden
(Chronic Disease risk - medication risk/benefit) +
medication risk = treated risk
Treated risk + number of meds = treatment burden
• Medication risk increases with number of medicines.
• Chronic disease risk increases with the number of co-
morbidities.
• Since the benefits and risks of multiple medications
cannot be readily quantified, the sum of the
comorbidities + medicines may be used as a surrogate
for Treatment burden.
Treatment Burden
• Multiple co-morbidities.
• Medicines risk factors
+
• Multiple clinics for different conditions.
• Hospital admissions (acute problem focused).
• Lab tests, Drs visits, medicines to collect and
manage.
• Patient’s personal social and environmental risk
factors (insomnia, visual impairment, falls risk)
The work of communication and information
management.
Why stop the medicine?
• Patient intolerance.
• Risk of adverse drug event doubles for >5 meds.
• Treatment burden - unacceptable cumulative medicines risk.
• Functional incapacity - increasing falls risk.
• Changing disease status – depression, cognitive impairment.
• Non-adherence with medication.
• Medical error.
Patient’s perspective
• Stopping / changing “essential” treatment
– a threat to wellbeing.
– psychological dependence
• Rational process for starting treatment
– “So why stop it” !
• Constant reinforcement to adhere to treatment
– “So why stop it - when nothing has changed”?
Challenge to the Dr / patient relationship
Prescriber’s perspective
• Multiple co-morbidities + multiple medical interventions = multiple treatments:
– Who has control?
• Mixed messages from multiple specialists
– What are the right choices?
• Guidelines for specific diseases
– multiple co-morbidities are not acknowledged as management problems
• Communication breakdown of specialist / GP interface
– role of the Community pharmacy?
Community Pharmacist’s
perspective
• Patient support for stopping /changing treatment
– Part of the treatment team
– Pharmacist has the actual dispensing data
– Medicines Use Review complements process of change in treatment
Communication between Patient’s GP
and Pharmacist is crucial – how can you facilitate this?
Stopping / changing meds - process
• Patient consent - involved and supported
– Pharmacist should be informed
• When stopping think of withdrawal syndromes
– advise and support accordingly
• One step at a time - but
– Stopping one medicine may require revision of multiple medicines
• Communicate the changes to all involved
– Dont forget relatives
Drug withdrawal syndromes
Withdrawal syndromes - principles
• Most withdrawal syndromes are self inflicted.
• The test of a withdrawal effect is it’s alleviation when treatment is restarted.
• Mechanisms are complex – reflecting multiple homeostatic processes activated during chronic drug treatment.
• Drugs causing rebound effects on the cardiovascular system are most dangerous when the system is already compromised.
• High index of suspicion when new symptoms develop during chronic treatment.
Withdrawal syndromes
1) TCADs / SSRIs
• Likely after only 6 weeks of treatment
• Shorter half life drugs.
• Onset within days of stopping
• Insomnia, flu-like symptoms, nausea, imbalance, hyper-arousal and sensory disturbance.
• Gradual tapering over at least a month
• Discontinuation syndromes occur in approx 20% of patients on ‘stable’ chronic treatment.
Withdrawal syndromes
2) Benzodiazepines
• Onset within days.
• More common with shorter half life BDZs.
• Increased risk of convulsions in elderly.
• Adrenergic symptoms, insomnia, weight
loss, anxiety, agitation, cognitive
impairment.
• Gradual tapering may require switch to
Diazepam.
• Psychological dependence is very strong
and develops early in treatment
Withdrawal syndromes
3) Beta blockers
• Hyper-adrenergic symptoms and signs within 1-2 days, maximal in 4-8 days.
• Duration 10-14 days.
• Risk increased with pre-existing IHD.
• Most risky with symptomatic IHD in ambulatory patients and in those with Felodipine / Nifedipine co-treatment.
• Withdraw gradually over 2-3 weeks but avoid high risk scenarios.
Other withdrawal syndromes
• Calcium channel blockers – Rebound angina
• Statins – Ischaemic stroke
• Proton pump inhibitors – Rebound hyperacidity
• Diuretics – Oedema, bloating - often cyclical
• Steroids – Mood swings, mostly in children
• Nitrates – Rebound angina
• Clonidine & methyldopa – Adrenergic crisis
OPTIMED Team
• GP (lead carer)
• Visiting specialist
• Practice nurse
• Community pharmacist
• (PHO clinical pharmacist)
• (Nurse practitioner)
Reflection !
• Was this prescribing justifiable?
• Why should it be changed?
• Why do prescribers differ in their choice of
medicine?
• It is possible to stop or change medication,
but it is much simpler to start it !
‘We Need Minimally Disruptive Medicine’ (May et al. BMJ, 2009, 339:485-7)
“Clinicians lack the tools to detect patients
overwhelmed by the burdens of treatment,
and they lack strategies to lift these
burdens”.
How might we manage Mrs T’s
long term treatment risk ?
‘Shift the focus for Chronic Disease
Management from the specialist
hospital setting to multi-disciplinary
management in the community’.
(Brand C et al. Int Med J 2007,37: 653.
Scott I. Int Med J2008,38:427)
Challenge: manage Mrs T’s
medicines risk ?
‘Shift the focus for Chronic Disease management
from the specialist hospital setting to multi-disciplinary management in the community’.
(Brand C et al. Int Med J 2007,37: 653. Scott I. Int Med J2008,38:427)
OPTIMED
A community based service innovation to manage
cumulative medicines risk in patients with chronic disease
and complex medicines regimens.
“Medication Management Plans’
Individual cumulative medicines
risk scores
0
10
20
30
40
50
60
0 10 20 30 40 50 60 70
patients
score
Mean 28.6, SD 7.6.
Community Pharmacy / GP
communication
• Patient prescription tracker:
– Patient owned, web based,
– Confidential communication between patient, GP and community pharmacy,
– Automatic medicines reconciliation,
– Graphical presentation of changes in prescribing,
– Linked to structured pharmacy care programme
Prescribing in the elderly: key steps
• Prioritise therapeutic objectives – Determine efficacy for elderly
– Determine life expectancy
– Determine preventative targets
• Take a medicines Hx – Identify critical social and environmental risk factors
– Hx of allergy & ADRs
– Drug tolerability
– Adherence
• Complete a medicines reconciliation
• Discuss harm:benefit issues (patient’s/Dr’s expectations)
• Determine starting dose (start low – go slow)
• Monitor function and QOL (as well as primary disease outcomes)
Prescribing in the Elderly:
Principles
Check renal function (e-GFR<60 ml/min)
“Start low – go slow”
Simplest possible regimen
Regular medication review
“Its easier to start than to stop”
Therapeutic Traps in the Elderly
• Higher risk of drug/drug interactions.
• Higher risk of drug/disease interactions.
• Higher risk of ADRs & ADEs
• Higher risk of non-adherence with drug treatment
• Multiple co-morbidities blur the therapeutic
objective.
• Increased sensitivity to drug effect.
• Decreased organ functional reserve
Inappropriate prescribing
- “the selected drug is not clinically effective, or the benefit is outweighed by the risk; or the dose, route, or frequency of dosing are inappropriate”.
- Diltiazem + high dose Simvastatin
- ACE-Is as monotherapy (when a thiazide diuretic should be
added)
- Alpha blockers + Metoprolol
- Amiodarone without a monitoring strategy
- BDZs in sleep apnoeoa
- Verapamil or Diltiazem in heart failure
- Opiates in renal failure
- Hypoglycaemic agents in alcoholics or elderly malnutrition
- Dypyridamole as monotherapy
High risk in the Elderly with
Renal Impairment
• Morphine
• Diazepam
• Digoxin
• Aminoglycosides
• Lithium
• Metformin
• Tramadol
• ACE I
NSAIDs in the Elderly –
beware !
• Check renal function.
• CNS effects are prominent (confusion,
unsteadiness).
• GI bleeding risk increased.
• Multiple drug interactions: ACE-Is,
Diuretics, Lithium, Digoxin, Warfarin.
• Watch for fluid retention in Heart Failure.
• Regular review of need - avoid long term if
possible.
Chronic Pain Management
in the Elderly
• Options (as of July 2010)
– Paracetamol (regular use, NOT ‘prn’)
– Codeine
– DHC Continus ?
– Tramadol (& SR) ?
– Oxycodone (& SR) ?
– Morphine (& SR)
– NSAIDs (Voltaren) / Cox 2 inhibitors
(Celecoxib)
Codeine (3-methyl morphine)
• Analgesic effect due to CYP 2D6 metabolism to morphine. Limited benefit in 10% population.
• Dose 60 mg 4h - avoid compound OTC formulations (inadequate amounts for any effect)
• Effective for ~ 4h.
• Constipation ++
• “ A very inefficient way of giving morphine”
Tramadol
• Same analgesic level as paracetamol.
• Dose-dependent respiratory depression.
• Nausea, agitation, confusion, sweating,
seizures – espec. elderly.
• Halve dose in renal impairment.
• TCADs, SSRIs, neuroleptics increase the
risk of seizures and serotonergic
syndrome.
• Not subsidised – very expensive.
Medicines risk management
categories
1. Modify (drug dose/route/frequency).
2. Stop (stat. or gradual withdrawal)
3. New medicine (new indication, or
substitute for same indication)
4. GP review (GP decision after OPTIMED
review)
5. Potential drug/drug interaction
6. Potential drug/disease interaction
7. Adherence review (community pharmacy)
8. Patient understanding
Other High Risk Medicines
in the Elderly
• Alpha blockers (Terazosin, Doxazosin)
• Anticholinergics TCAD, antihistamines,
Benztropine)
• Warfarin (increased sensitivity)
• Digoxin (increased falls risk)
• Colchicine (poisoning in renal impairment)
• Opiates (increased sensitivity & decreased
renal elimination)
What is your role, as the patient’s Nurse,
in managing this patient’s medication to
optimise their health gain?
• Patient’s understanding
• Communication of issues to medical staff
• Detection & reporting of ADRs/ADEs
• Supporting and facilitating the shared-
decision prescribing/treatment process.
GP prescription changes 6 months after
OPTIMED review
RMR
Total
prescription
changes
GP compliance
at 6 months (%)
Stop 79 59.6
Modify 67 52.2
(GP review) 54 28.1
New Medicine 46 52.1
Total 192* 53.6%
*Total prescription changes exclude 54 ‘GP review’ decisions
made after the OPTIMED review – to stop, modify, or add a new drug.
Mrs T’s cumulative medicines risk
• Medicines complexity (number, frequency, etc.
• Medicines reactions/interactions,
• ‘High risk’ medicines content (CardizemDiltiazem, Doxazosin, BDZs, etc).
+
• Age and co-morbidities,
• Life style & environmental risk factors
• Multiple clinical interventions (multiple prescribers)
“Treatment burden”
0
5
10
15
20
25
30-39 40-49 50-59 60-69 70-79 80-89 90-99
No. of patients
Age
Osteoarthritis Hypertension Diabetes Heart disease Kidney disease Gout Glaucoma
Diet
Exercise
Smoking
Alcohol
Age
+
1 - 2
3 - 4
1 - 3
1 - 2 NZ dep.
index
+
9 – 17 daily medications
1 - 3
Polypharmacy in the elderly is
inevitable !
1
1 - 2
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