Men –the forgotten one’s
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Transcript Men –the forgotten one’s
End Falls this Fall
Pharmacy Update
Medications and Falls Risk
Medication reviews to identify falls risks
Recommendations for caregivers, prescribers
Managing the risks
Medications that have a high risk for falls
Decreasing doses, decreasing the overall number of medications
(polypharmacy), identifying side effects
Sedatives; benzodiazepines, “Z drugs” like zopiclone
Antidepressants
Anticholinergic agents (oxybutynin/Ditropan®)
Antihypertensives, anticonvulsants (including gabapentin, pregabalin)
Opioids
Increasing client safety
Decrease the medication related risks for falling
Decrease the risk for fracturing
Decreasing Falls & Fractures
–Where could we improve?
Reducing Polypharmacy, since multiple
medications contribute to risk of falls
Reducing the use of medications that are
associated with a high risk for falls
Identifying men at risk for osteoporosis and
fractures
Recognizing disease states that increase risk
for falls and fractures
Prescribing Cascade
Develops when an adverse drug reaction or side effect is
mistaken as a new medical condition and further drug therapy is
added to manage this new “condition”
For example: a movement disorder develops from use of an
antipsychotic medication like olanzapine (Zyprexa®) and this is
misinterpreted as Parkinson’s disease and treated with levodopa
Prescribing Cascade
Another example occurs when an older person is put on an
NSAID such as Naproxen for arthritis pain,
• The next visit to health care provider, blood pressure is
elevated and ankle edema is present so…….
antihypertensive diuretic hydrochlorothiazide started…
•Then electrolytes are low and a potassium supplement is
started….
• Then heart burn develops so omeprazole is started
Avoiding Prescribing Cascades
Side effects/Adverse Drug Reactions (ADR) are
most likely to be experienced soon after a new
medication is started or after the dose increased
90% of patients with an ADR report it within 4
months of starting the new drug
75% of these patients have the ADR within the first month
of treatment
For every new condition or symptom, first ask,
Is it an adverse effect of existing drug therapy?
Don’t just add another medication !
Consider Reducing
Medications in the Elderly
We are pretty good at adding medications but not so great at reevaluating and stopping them
Avoiding certain possibly “more risky” drugs is only part of the
picture
eg. Beers list drugs, anticholinergic drugs
The patient on 13 non Beer’s list meds may still be at risk for
harm, especially if dose/duration inappropriate
Minimizing anticholinergic medications is helpful
Decreasing the use of anticholinergic agents (eg
amitriptyline, tolterodine, paroxetine) which can cause
cognitive decline, confusion,hallucination, urinary
retention, constipation and increased mortality is helpful
but may only be part of the picture in for example,
someone also on high doses of glyburide with poor renal
function
Is there a need for
Deprescribing?
A study that looked at emergency hospital admissions related to adverse
drug reactions, for those age 65 or older found
6.6% admissions were associated with Beers List meds
67 % admissions occurred with non Beers list meds (warfarin,
insulin, oral antiplatelet drugs, oral hypoglycemic drugs)
Starting to hear the term “Deprescribing”
Or related terms like discontinuation, prescription pruning, and
pharmacolysis
Budnitz DS, Emergency hospitalizations for adverse drug events in older Americans N Engl J Med
2011;365:2002
Is there a need for
Deprescribing ?
•
Challenging to manage a complex older adult with multiple
co-morbidities when each set of disease specific clinical practice
guidelines recommends treatments
• For example, someone with COPD, DM Type II, HTN, OP and OA
ends up on a minimum of 12 meds
•
Often guidelines are based on research done in younger persons
without multiple diseases
• Some treatment goals may be overly aggressive in managing an
older person ie diabetes or hypertension
•
A systematic approach is needed for reevaluating and
streamlining a person’s medication list & making it appropriate for
their needs and goals
•
With the understanding that polypharmacy (≥ 4 or 5 Rx)
Increases risk for drug interactions, ADRs, risk for hip fractures
The thought process for
Rational Deprescribing
• Begin with a regular & thorough review of current drug therapy – have
•
them bring all their prescription bottles, vitamins, eye drops , natural
health products, Over-the-counter meds
Tailor medication regimen according to individual’s conditions and their
goals & goals for care
What are the treatment goals?
• Prevention (consider time lines), optimize cognition, pain
management, comfort
Has the individual changed?
• Eg. decreased weight, declining renal function
Does each drug have a reason for use?
• Eg match diagnosis list to drug list
Does the reason for use still exist?
• Eg post op anemia 1 year ago, still getting iron tx
Rational Deprescribing
Does the dose need decreasing ?
•
Does a medication need to be added?
2 or more drugs in the same category eg 2 NSAIDs
Are there new symptoms?
Eg adding a bisphosphonate after a fracture
Are there duplicate therapies?
Eg drug is necessary but side effects experienced
*Could they be an adverse reaction to meds?
Are there non pharmacologic therapies?
Eg sleep hygiene and relaxation techniques for insomnia
instead of benzodiazepines
Some Tools for Deprescribing
Screening Tool of Older Person’s Prescriptions (STOPP)
considers identification of drug interactions, duplicate
therapies
Identified significantly more patients with ER visit due to medication
related effect than the Beers list (2003)
Hamilton HJ, Gallagher PF, O’Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatrics
2009; 9:5.
Screening Tool to Alert doctors to the Right Treatment (START)
Helps to detect sub-optimal treatment or omissions in elderly
patients therapy
Barry PJ et al. START (Screening Tool to Alert doctors to the Right Treatment)—an evidence-based
screening tool to detect prescribing omissions in elderly patients. Age Ageing. 2007;36:632-638.
One approach to
Deprescribing
Educate client and family about this therapy approach
Identify polypharmacy, adverse drug reactions or side effects,
falls, effectiveness (or lack of), treatment goals
Wean one medication at a time, gradually
Begin with a medication thought to be responsible for undesired
side effect or a fall etc
For beta blockers, benzodiazepines, opioids, long term systemic
corticosteroids and levodopa wean down over weeks & perhaps
months
Monitor patient and reassess frequently for withdrawal
syndromes, reappearance of illness,
cognition, falls, quality of life, etc
*Deprescribing,LeCouteur D, Banks E, AustPrescr 2011;34:182-5
Can Medications be
Withdrawn?
Many medications can be safely withdrawn slowly,
gradually & with medical supervision
Although not a lot of data
there are both potential risks and benefits in stopping
Some medications can’t be stopped suddenly:
especially :
benzodiazepines (withdrawal, confusion, seizures etc)
beta blockers (sudden stopping can result in rebound
hypertension and tachycardia )
clonidine (sudden stopping can cause rebound hypertension),
levodopa needs to be tapered very slowly or serious withdrawal
& neuroleptic malignant syndrome can occur with muscle
stiffness,decreased consciousness
Don’t abruptly stop these
either:
Systemic corticosteroids if taken for several
weeks need to be tapered gradually
SSRI’s eg paroxetine, should be tapered
gradually to avoid discontinuation syndrome
Proton Pump inhibitors- stopping suddenly
can result in hypersecretion of acid
Does Deprescribing Work?
• A similar systematic approach was developed into an *algorithm
and used in a Feasibility study
• Evaluated the need to continue or discontinue meds for 70 elderly
community living people with multiple co-morbidities taking a
mean number of 7.7 medications
• stopped 58% of medications, only 2% required restarting
due to recurrence of the original indication
• successful discontinuation achieved in 81% of those
patients
Garfinkel,D;Mangin,D; Feasibility Study of a Systematic Approach for
Discontinuation of Multiple Medications in Older Adults. Arch Intern Med.
2010;170(18):1648-1654
*see Resources slides
Does Deprescribing Work?
88% of those elderly patients reported global
improvement in health!!!
LESS is MORE !
Garfinkel,D;Mangin,D; Feasibility Study of a Systematic Approach for Discontinuation
of Multiple Medications in Older Adults. Arch Intern Med. 2010;170(18):1648-1654
Future Study
The Ontario Ministry of Health and Long-Term Care recently funded Bruyère
Research Institute scientist and Universities of Ottawa and Waterloo assistant
professor, Barbara Farrell, PharmD, approximately $430,000 to study the
development and implementation of deprescribing guidelines aimed to minimize
medications that are causing side effects or are no longer needed. “Reducing
medication use can be a challenging process, but with the introduction of
guidelines and attention to implementation, there will be better consistency in
reducing the number of medications prescribed to older adults with the goal of
improving quality-of-life,” says Dr. Farrell.
For example, a Bruyère Geriatric Day Hospital patient, says he is well on
his way to restoring his active lifestyle, thanks in part to the slow tapering
of some of his medications.
from The Ottawa Citizen, July 3 2013
Decreasing Falls & Fractures
–Where could we improve?
Reducing Polypharmacy as multiple
medications contribute to risk of falls
Recognizing disease states that increase risk
for falls and fractures
Identifying men at risk for osteoporosis and
fractures
Reducing the use of medications that
are associated with a high risk for falls
Selective Serotonin Reuptake
Inhibitors (SSRIs) and Falls
Up to 10% of seniors are affected by
depression and SSRIs are first-line treatment
Depression itself is not associated with fractures
A large prospective study looked at daily
SSRI use in adults in the community
SSRIs Increase Fracture Risk
Daily SSRI use in those 50 yrs or more can
•Increase the risk for fragility fracture by 2 x
•Increase the risk for falling by 2 x
•Lower BMD of the hip
May be due to changes in bone and on risk of
falling, possibly increased risk for hypotension &
syncope
Serotonin receptors found on cells that build and
remodel bone suggesting possible decreased bone
quality
SSRI and Increased Fracture
Risk
Similar studies have found the risk for O/P fractures associated
with corticosteroid use was 1.66 for persons 50 or older versus
risk for fracture of 2.1 with SSRI use, so similar increased risk for
fracture with an SSRI as with corticosteroids
Since elderly are already at increased risk for osteoporosis these
risks should be weighed against the benefits in treating
depression
Consider lowest effective dose, shortest duration
** Effect of selective Serotonin Reuptake Inhibitors on the Risk of Fracture,
Richards,J, Papaioannou, A et al, Arch Intern Med/Vol 167, Jan 22 2007, 188194
Other Potential effects of
SSRIs
Hyponatremia
increased risk with elderly
usually occurs within 2 weeks of starting
can present with confusion, drowsiness, fatigue, delirium
and hallucinations, urinary incontinence, hypotension or
vomiting
Possibility of Serotonin syndrome symptoms
can present with symptoms of tremor, agitation,
myoclonus, muscle rigidity or confusion.
Decreasing Falls & Fractures –
Where could we improve?
Reducing Polypharmacy, since multiple
medications contribute to risk of falls
Identifying men at risk for osteoporosis and
fractures
Recognizing disease states that increase risk
for falls and fractures
Reducing the use of medications that are
associated with a high risk for falls
2010 Osteoporosis Canada
Guidelines
Women and men over age 50 should be
assessed for risk factors for osteoporosis and
fracture
To identify those at high risk for fracture
Those who have had a fragility fracture
Fragility Fracture: Definition
A fracture occurring
spontaneously or
following minor trauma
such as a fall from
standing height or less1,2
Excluding craniofacial,
hand, ankle and foot
fractures
1. Kanis JA, et al. Osteoporos Int 2001; 12(5):417-427.
2. Bessette L, et al. Osteoporos Int 2008; 19:79-86.
Care Gap
90 % men with clinical fragility fracture were untreated
for osteoporosis
Only 10% men with a clinical fracture reported being
diagnosed with osteoporosis
About 20% women with fragility fracture receive
treatment to prevent further fractures
If men are diagnosed with osteoporosis, they are more
likely to be treated
67% with osteoporosis diagnosis received
bisphosphonate and 87% were on calcium and/or
Vitamin D
* The osteoporosis care gap in men with fragility fractures: the Canadian Multicentre
Osteoporosis Study, Osteoporosis International April 2008, Vol 19, Issue 4, p 581-587.
Therapeutic Care Gap: Most Men Do Not
Receive Treatment for Osteoporosis after
Fracture
% of men with fragility fracture
who do not receive therapy
100%
99.5%
94.2%
94.0%
91.6%
92.6%
90.5%
Baseline
Year 1
Year 2
Year 3
Year 4
Year 5
80%
60%
40%
20%
0%
Papaioannou A, et al. Osteoporos Int 2008; 19(4):581-587.
Care Gap
Men have 1/3 of all hip fractures and are less
likely to survive afterwards
One year mortality
31 to 38% men vs 12 to 28% women
2 x more likely to be
institutionalized after
a hip fracture
Why did we forget them ?
Bone loss occurs later in men, after the age
of 70
Women are more likely to fracture than men
until age 80, then similar risk
Men have higher peak bone mass and larger
bones have less risk of fracture
Men have lower rates of bone loss
W.H.O. Fracture Risk Factors in
Men
Previous fragility fracture over 40 yo
Especially vertebral compression #’s
(height loss of ≥ 6 cm or kyphosis)
Glucocorticoid therapy equivalent to ≥ 7.5 mg
prednisone/day x 3 months or more
Advanced age (> 65 yr)
More Factors that Increase Male
Fracture Risk from W.H.O.
Condition associated with bone loss
DM Type I, untreated hyperthyroidism, chronic malnutrition
Family history O/P, parental #
High alcohol intake > 2 units/day
Hypogonadism, delayed puberty
Low BMI < 20 kg/m²
Smoking (past or present)
Anti-androgen therapy treatment for prostate cancer
(ie Casodex®/bicalutamide, flutamide)
2010 Osteoporosis Canada
Guidelines
Which men should be treated?
Deciding to give treatment should be based on
preventing fractures
Those identified at high risk for a major osteoporotic
fracture ( > 20% risk for a fracture over 10 years)
should be offered treatment
If > 50 yo + fragility fracture (hip/vertebra) or
>1 fragility fracture
= high risk for future fractures
should be offered medications
2010 Osteoporosis Canada
Guidelines
State to treat male or female at high risk
for future fracture
The key is identifying men at high risk for
future fractures – that is where improvement
is needed
Two tools integrate the key risk factors for
fracture with (and without) BMD at femoral
neck
CAROC and FRAX
Integrated Approach
Moderate risk
(10-year fracture risk 10%-20%)
Lateral thoracolumbar radiography (T4-L4) or vertebral
fracture assessment may aid in decision-making by identifying
vertebral fractures
Factors warranting consideration of
pharmacologic therapy:
Repeat BMD in
1-3 yr and
reassess risk
• Additional vertebral fracture(s) (by vertebral fracture assessment or
lateral spine radiograph)
• Previous wrist fracture in individuals aged > 65 or those with
T-score < -2.5
• Lumbar spine T-score much lower than femoral neck T-score
• Rapid bone loss
• Men undergoing androgen-deprivation therapy for prostate cancer
• Women undergoing aromatase inhibitor therapy for breast cancer
• Long-term or repeated use of systemic glucocorticoids (oral or
parenteral) not meeting conventional criteria for recent prolonged use
• Recurrent falls (> 2 in the past 12 mo)
• Other disorders strongly associated with osteoporosis, rapid bone
loss or fractures
Good
evidence of
benefit
from
pharmacotherapy
Which Treatments for Men ?
Most osteoporosis meds were tested in women
Some smaller trials with men & osteoporosis,
- Alendronate 10 mg daily (CaCo3 500 mg and Vit D 400
units daily) x 24 months increased BMD
- Risedronate 5 mg daily decreased vertebral fractures by 60%
in men within 12 months
Risedronate and Alendronate effective in prevention
and treatment of glucocorticoid induced O/P in men
and women
What Osteoporosis Canada
Says
For men needing osteoporosis treatment
Alendronate, risedronate and zoledronic acid
can be used as first line treatments in the
prevention of fractures
Testosterone is not recommended for treatment
of osteoporosis in men
Individuals > 50 yo on ≥ 3 months of glucocorticoids
equivalent to prednisone ≥ 7.5 mg daily in the
preceding yr
should start on alendronate, risedronate or zoledronic
acid at outset of the glucocorticoid and continued for
at least the duration of the glucocorticoid
What Osteoporosis Canada
Says:
Individuals ( M or F) already at high risk for fracture
who are also taking glucocorticoids (≥ 7.5 mg
prednisone/day x 3 months or more should be
considered for teriparatide daily
Men on anti-androgen therapy should be evaluated
for fracture risk and osteoporosis therapy
considered to prevent fractures
Don’t Forget Non-Prescription
Treatments
Weight bearing exercise
Falls risk assessment
multifactorial intervention (ie
home safety, cataract sx,
med review, physio
assessment)
1200 mg calcium daily from
all sources & the emphasis
on dietary sources
Vitamin D 800 to 2,000
units/ day
Summary
We can reduce falls and fractures by
Reducing prescribing cascades
Regular review and pruning of medication lists
Using medications with a high risk for falls more
cautiously
Assessing men for fracture risks too!
Questions ?
References and Resources
Hamilton HJ, Gallagher PF, O’Mahony D. Inappropriate prescribing and
adverse drug events in older people. BMC Geriatrics 2009; 9:5.
Barry PJ et al. START (Screening Tool to Alert doctors to the Right Treatment)—an
evidence-based screening tool to detect prescribing omissions in elderly patients.
Age Ageing. 2007;36:632-638.
Garfinkel,D;Mangin,D; Feasibility Study of a Systematic Approach for Discontinuation
of Multiple Medications in Older Adults. Arch Intern Med. 2010;170(18):1648-1654
http://www.osteoporosis.ca
From: Feasibility Study of a Systematic Approach for Discontinuation of Multiple Medications
in Older Adults: Addressing Polypharmacy
Arch Intern Med. 2010;170(18):1648-1654. doi:10.1001/archinternmed.2010.355
Figure Legend:
Improving drug therapy in elderly patients—the Good Palliative–Geriatric Practice algorithm. Revised from Garfinkel
et al with permission from the Israel Medical Association Journal.
Date of download: 9/18/2013
Copyright © 2012 American Medical
Association. All rights reserved.
Arch Intern Med. 2010;170(18):1648-1654. doi:10.1001/archinternmed.2010.355
Absolute 10-year Fracture-Risk Tools
Tools validated in Canada (choice based on personal
preference and convenience)
CAROC: Joint initiative of the Canadian Association of
Radiologists and Osteoporosis Canada1
FRAX: Fracture Risk Assessment Tool developed by the
World Health Organization2
There are large differences in fracture rates from country to
country3-5
Assessment tools need to be country specific
1. Leslie WD, Berger C, et al. Osteoporosi Int; In press..
2. Leslie WD, Lix LM, et al. Osteoporosi Int; In press.
3. Kanis JA, et al. J Bone Miner Res 2002; 17(7):1237-1244.
4. Melton LJ, III. Endocrinol Metab Clin North Am 2003; 32(1):1-13.
5. Leslie WD, et al. J Bone Miner Res 2010; in press.
CAROC tool
Assesses 10-YEAR FRACTURE RISK for Women
and Men using age and BMD stratifies into 3 zones:
low risk (< 10%), medium (10-20%), and high risk
(>20%)
Fragility fracture after age 40 or recent prolonged
systemic glucocorticoid use, increases CAROC
base risk by one category (i.e., from low-risk to
moderate or moderate risk to high)
The T-score for the femoral neck is derived from the
National Health and Nutrition Education Survey III
(NHANES III) reference database for white women.
Canadian Association of Radiologists and Osteoporosis Canada
(CAROC) Risk Assessment Tool
10-year Risk Assessment for Men
(CAROC Basal Risk)
Age
Low Risk
Moderate Risk
High Risk
50
above -2.5
-2.5 to -3.9
below -3.9
55
above -2.5
-2.5 to -3.9
below -3.9
60
above -2.5
-2.5 to -3.7
below -3.7
65
above -2.4
-2.4 to -3.7
below -3.7
70
above -2.3
-2.3 to -3.7
below -3.7
75
above -2.3
-2.3 to -3.8
below -3.8
80
above -2.1
-2.1 to -3.8
below -3.8
85
above -2.0
-2.0 to -3.8
below -3.8
Papaioannou A, et al. CMAJ 2010 Oct 12. [Epub ahead of print].
Canadian Association of Radiologists and Osteoporosis Canada
(CAROC) Risk Assessment Tool
Risk Assessment Using FRAX
Uses age, sex, BMD, and clinical risk factors to
calculate 10-year fracture risk*
BMD must be femoral neck
FRAX also computes 10-year probability of hip fracture
alone
This system has been validated for use in Canada1
There is an online FRAX calculator with detailed
instructions at: www.shef.ac.uk/FRAX
* composite of hip, vertebra, forearm, and humerus
1. Leslie WD, et al. Osteoporos Int; In press.
FRAX Tool: On-line Calculator
www.shef.ac.uk/FRAX
www.shef.ac.uk/FRAX.
Using CAROC to decide which
risk category (see chart for men)
Men ≥ 65 yo with T score < - 3.7 considered high risk
Men ≥ 50 yo & Fragility or Vertebral #
& T score in moderate risk range are determined to be high risk
Men any age, on equiv of ≥ Prednisone 7.5 mg/day
x 3 months & T score in moderate risk range are determined to
be high risk
Men any age with clinical hypogonadism and T score in the
moderate risk range are determined to be high risk
Treatment should be offered to men considered to be at
high risk for a fracture
More about Treatments for
Men
Although testosterone treatment in hypogonadal men increased
BMD at spine and hip, no trials showed fracture risk reduction so
use is not recommended
Teriparatide reduced the risk for moderate or severe fractures in
men with osteoporosis
Denosumab (Prolia™) increases bone mass in men with
osteoporosis at high risk for fracture, (history of osteoporotic
fracture, or multiple risk factors for fracture) or patients who have
failed or are intolerant to other available osteoporosis therapy.
SubQ: 60 mg as a single dose, once every 6 months
However it is currently a Limited Use Benefit on ODB for women
(Teriparatide effects on vertebral fractures and BMD in men with osteoporosis, Osteoporos Int, 2005 May: 16(5): 510-6
Kaufman JM et al