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Teck TalkCEJanENG
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11:29 AM
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TECH TALK • CE
T H E N AT I O N A L C O N T I N U I N G E D U C AT I O N
PROGRAM FOR PHARMACY TECHNICIANS
January/February 2005
FREE CE
FOR TECHNICIANS
Tech Talk CE is Canada’s first
national ongoing continuing
education correspondence program specifically designed for
technicians. It's brought to
you by the publishers of
Pharmacy Practice, who have
been producing CE lessons for
pharmacists for the past 10
years. Tech Talk CE is generously sponsored by Novopharm. A lesson will appear
in each issue of Tech Talk,
which appears bimonthly in
Pharmacy Practice (January,
March, May, July, September,
November).
Update on COX-2 controversy
By Rosemarie Pavlakovic Patodia, BScPhm, CGP
Statement of objectives
Upon completion of this lesson, the pharmacy technician should be able to:
1. Explain the basic differences between traditional NSAIDs and COX-2 inhibitors.
2. Review the status of COX-2 inhibitors in light of recent safety concerns.
3. Discuss the role of the pharmacy technician in managing major drug withdrawals.
Instructions
1. After carefully reading
this lesson, study each
question and select the
one answer you believe to
be correct. Circle the
appropriate letter on the
attached reply card.
2. Complete the card and
mail, or fax Mayra Ramos
at (416) 764-3937.
3. Your reply card will be
marked and you will be
advised of your results in
a letter fromTech Talk.
4. To pass this lesson, a grade
of 70% (7 out of 10) is
required. If you pass, you
will receive 1 CEU.
Please allow 6-8 weeks for
notification of score.
Please note: Tech Talk CE is
not accredited by the
Canadian
Council
for
Continuing Education in
Pharmacy (CCCEP).
Introduction
Recent news of the withdrawal
of rofecoxib (Vioxx) from the
worldwide market has increased
interest in medications for
arthritis. Vioxx, similar to celecoxib (Celebrex) and valdecoxib
(Bextra), is a COX-2 selective
inhibitor, a member of a relatively new class of anti-inflammatory medications sometimes
referred to as “coxibs.” This lesson will review current knowledge about COX-2 selective
inhibitors in light of recent
studies. It will further discuss
the pharmacy technician’s role
in helping manage the implications of the drug withdrawal to
patients receiving long-term
therapy.
The role of COX
The “COX” in the name
“COX-2 selective inhibitor” is
an acronym for cyclooxygenase. Cyclooxygenase is an
enzyme that helps convert
arachidonic acid to prostaglandins. In general, prostaglandins have a variety of
functions in the body, including
maintaining kidney function
and protecting the stomach lining and normal blood clot formation. Prostaglandins can
also cause joint inflammation.
COX-1 is one type of this
enzyme. It specifically acts on
blood components called platelets, protects the stomach lining, and is involved in kidney
function, among other physiologic actions. COX-2 is responsible for producing mediators
of pain and inflammation as a
result of injury or tissue damage and is also involved in
kidney function. Drugs that
inhibit COX-2 stop production
of prostaglandins that are involved in the inflammatory
process. The degree to which a
medication inhibits each subtype of COX enzyme is referred to as “selectivity.” For
example, celecoxib is nine
times more selective for COX2 than COX-1, and naproxen
is 0.3 times as selective for
COX-2 as COX-1 (essentially,
not selective).1
An educational service for Canadian pharmacy
technicians, brought to you by Novopharm
www.novopharm.com
Traditional NSAIDs
Traditional nonsteroidal antiinflammatory drugs—often
referred to as NSAIDs—include agents such as ibuprofen
(e.g. Advil), naproxen (e.g.
Naprosyn), sulindac, diclofenac
(e.g. Voltaren) and flurbiprofen
(e.g. Froben). These medications inhibit the activity of
both COX-1 and COX-2. By
doing so, traditional NSAIDs
inhibit prostaglandin synthesis
in the stomach and gastrointestinal tract, in the kidneys (all
negative effects) and in the
musculoskeletal system (a beneficial effect). This action on
prostaglandin synthesis explains many of the adverse
effects associated with NSAIDs,
including stomach bleeds and
kidney problems. NSAIDs are
mainly used for the relief of
pain and inflammation due to
musculoskeletal injury or damage. They are used to treat
arthritis pain and inflammation,
acute muscular or joint pain and
chronic pain not related to
arthritis. They are all effective
TECH TALK • CE
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in the treatment of pain, with
no apparent significant differences in effectiveness among
the agents within this group
of medications.
There are several concerns about the long-term
use of traditional NSAIDs
that must be considered
before using them in a
patient. The most common
issue to consider is the risk of
gastrointestinal effects, more
specifically bleeding. A number of factors can increase a
patient’s risk of gastrointestinal bleeding with these
traditional NSAIDs, including older age (over 60), history of ulcer complications, the
use of high doses of NSAIDs
or more than one NSAID,
the use of anticoagulant
medication (e.g. warfarin) or
prednisone with the NSAID,
and a history of cardiovascular disease.2 A physician
should evaluate the patient’s
level of risk versus potential
benefits of the medication
before prescribing it for longterm use, and pharmacists
should discuss these issues
with patients who are purchasing
over-the-counter
NSAIDs.
For elderly people (over
65 years of age), long-term
use of traditional NSAIDs is
not advocated, at least not
without the addition of a
medication to protect the
stomach (i.e. a gastroprotective agent).3 Gastroprotective
agents have been shown to
decrease the risk of stomach
Page 2
bleeds with traditional
NSAIDs by either protecting
the stomach mucosa (inner
lining) or by reducing acid
production. The patient’s
physician will generally prescribe either misoprostol
(Cytotec) or a proton-pump
inhibitor (PPI) with an
NSAID to protect the stomach.4 Misoprostol, which
protects the stomach lining,
can be used as a single product or in a combination
product (i.e. Arthrotec). The
use of misoprostol has been
limited in many people due
to the side effect of diarrhea
that can occur in higher doses
(i.e. 200ug four times daily),
and it should not be used in
women who are pregnant
because it can lead to miscarriage. Proton-pump inhibitors
include pantoprazole (Pantoloc), lansoprazole (Prevacid),
omeprazole (Losec) and esomeprazole (Nexium). These medications reduce acid production and can prevent
stomach ulcers and bleeding
that can occur with NSAIDs.
COX-2 selective inhibitors
Traditional NSAIDs inhibit
COX enzyme subtypes 1 and
2, so they are effective at
reducing pain and inflammation, while they increase the
risk of stomach bleeds and
kidney problems. COX-2
inhibitors and traditional
NSAIDs have been shown to
be similar in terms of their
ability to reduce pain and
inflammation. COX-2 selec-
tive inhibitors primarily
inhibit the activity of this
enzyme subtype. By being
selective, they do not act on
the COX-1 enzyme subtype,
or do so minimally. Since the
COX-1 enzyme is responsible for prostaglandin production that protects the gastrointestinal tract, there is a
lower likelihood that COX-2
selective inhibitors will cause
stomach bleeds. COX-2
selective inhibitors can lose
their selectivity when used in
higher than normal doses
used for arthritis, so they can
potentially cause stomach
problems in some patients.
COX-2 selective inhibitors
do not inhibit production of
thromboxane, a substance
that causes platelets in the
blood to stick together and
form clots. By allowing
thromboxane production to
continue, a person who is
already at risk of clots may be
more likely to develop a
blood clot that could lead to a
heart attack or stroke.
Traditional NSAIDs such as
naproxen may have less of
this effect since they inhibit
both COX-1 and COX-2.1, 5, 6
Current status
COX-2 selective inhibitors
are relatively new medications, with the first one, celecoxib, launched in 1999.1
Recently, rofecoxib was
withdrawn from the market
due to evidence that it
resulted in an increased incidence of cardiovascular events
CE Faculty
CE Coordinator:
Margaret Woodruff
B.Sc.Phm., MBA
Professor, Pharmacy
Technician Program
Humber College,
Etobicoke, ON
Author:
Rosemarie Pavlakovic Patodia,
BScPhm, CGP
Pharmacist and Manager,
Community Professional
Programs
CE2
Shoppers Drug Mart
Toronto, ON
Clinical Editor:
Lu-Ann Murdoch, B.Sc.Phm.
Reviewer:
Debbie Benjamin, CPhT
York Central Hospital in
Richmond Hill,
Director, Membership
Services for CAPT
11 Northgate Dr.
Bradford, ON
For information about CE marking,
please contact Mayra Ramos
at (416) 764-3879 or
fax (416) 764-3937 or email
[email protected].
All other inquiries about Tech Talk
CE should be directed to
Laurie Jennings at (416) 764-3917
or laurie.jennings@pharmacygroup.
rogers.com.
(including stroke and heart
attack) compared to placebo
(sugar pill). This was found in
a study that was testing the
effectiveness of rofecoxib in
preventing the recurrence of
colon polyps (which can lead
to colon cancer).7 The
increased cardiovascular risk
was only seen in patients who
had used rofecoxib continuously for at least 18
months. The withdrawal of
Vioxx by the manufacturer
had a significant impact
because of the widespread
worldwide use of this medication (80 million people).
It is considered the biggest
prescription drug withdrawal
in history.8
There was earlier evidence of possible cardiovascular effects with rofecoxib. A
study in 2000 (VIGOR trial)
showed that rofecoxib was
more likely to cause cardiovascular problems than
naproxen, a traditional
NSAID.9 This study led to a
change in the Vioxx product
monograph to indicate that
rofecoxib should be used with
caution in patients with
cardiovascular disease. Another study that occurred in
the same year showed no difference in the incidence of
cardiovascular events in
patients taking celecoxib,
ibuprofen or diclofenac.10
There has been much controversy around the cardiovascular effects of COX-2 inhibitors, and it is not yet
known whether these effects
are consistent across all of the
COX-2 inhibitors. Some
experts suggest that the cardiovascular effects shown by
rofecoxib are a class effect
(i.e. caused by all COX-2
inhibitors); however, this has
not been proven, nor is it supported by all experts in the
field.5,6,11,12 To date, there have
been no studies with COX-2
inhibitors that were designed
to test for cardiovascular
effects.
Although the current evi-
Teck TalkCEJanENG
12/21/04
11:29 AM
consult with their physician
or pharmacist prior to using
any over-the-counter medications for pain or arthritis.
Pharmacy technician’s role
Pharmacy technicians should
be aware of the recent issues
around COX-2 selective
inhibitors and be able to
direct patients accordingly.
Directing patient concerns
Pharmacy technicians are
often the first pharmacy team
members encountered by
patients, so it is important
that they acknowledge and
understand patients’ fears
and concerns regarding their
medications and their health.
While demonstrating empathy and patience, technicians
should refer patients with
concerns to the pharmacist
for further consultation and
help to manage workflow in
the pharmacy when pharmacists are called to spend extra
time counselling.
Contacting patients
Technicians should also
understand the importance of
contacting patients who have
not returned their recalled
medication to the pharmacy
(this has already been done
for rofecoxib). Informing
patients about the withdrawal
of a medication is a vital step
that the pharmacy technician
can organize. Running reports to determine which
patients need to be called,
organizing who will call and
when the calls will be made
are just some of the steps that
could be taken.
Medication disposal
Pharmacy technicians should
ensure that medications are
returned to the pharmacy
and disposed of in an environmentally-friendly manner,
through a medication waste
disposal service. Technicians
can help educate patients
about the reasons for bringing the discontinued medica-
tion to the pharmacy for disposal: to prevent inadvertent
use by and harm to another
person, to prevent environmental damage, and to prevent adverse events that could
occur if the medication were
to be taken at a later date.
Reimbursement
Technicians can ensure that
medication returns are documented and patients are reimbursed accordingly. Manufacturers will often post on
their website and/or send
directions to the pharmacy
about reimbursement. If not,
then it is a good idea to contact the drug manufacturer for
questions about reimbursement of returned medication
or any other details of the
withdrawal.
Summary
COX-2 selective inhibitors
are unique anti-inflammatory
medications that are selective
for a subtype of cyclooxygenase enzyme that is produced
in response to inflammation
and injury. They are theoretically less likely to cause
stomach bleeds than traditional NSAIDs. The recent
withdrawal of rofecoxib from
the market has placed the
whole class of COX-2 selective inhibitors under scrutiny
for their potential to cause
cardiovascular effects. Many
patients and physicians are
now avoiding COX-2 selective inhibitors, suspecting a
class effect. Pharmacy technicians should be familiar with
the issues around this controversy in order to best serve
the needs of their patients by
referring concerns to the
pharmacist, and handling
returns, reimbursement and
drug disposal.
References:
1. Wright JM. The doubleedged sword of COX-2
selective NSAIDs. CMAJ
2002;167(10):1131-7.
2. Hunt RH et al. Recom-
mendations for the appropriate use of anti-inflammatory drugs in the era of
coxibs: defining the role of
gastroprotective agents.
Can J Gastroenterol 2002;
16(4):231-40.
3. Fick DM, Cooper JW,
Wade WE et al. Updating
the Beers criteria for
potentially inappropriate
medication use in older
adults: results of a US consensus panel of experts.
Arch Intern Med 2003;163
(22):2716-24.
4. Hawkey CJ and Langman
MJS. Non-steroidal antiinflammatory drugs: overall risks and management.
Complementary roles for
COX-2 inhibitors and proton pump inhibitors. Gut
2003;52:600-608. http://
gut.bmjjournals.com/cgi/
content/full/52/4/600
Accessed November 8,
2004.
5. Mukherjee D, Nissen SE
and Topol EJ. Risk of cardiovascular events associated with selective COX-2
inhibitors. JAMA 2001;
286(8):954-9.
6. Solomon DH, Glynn RJ,
Levin R et al. Nonsteroidal
anti-inflammatory drug
use and acute myocardial
infarction. Arch Intern
Med 2002;162:1099-1104.
7. Merck Frosst website.
www.merckfrosst.ca/e/pro
ducts/vioxx.html,
Accessed November 9,
2004.
8. Topol EJ. Failing the public
health – rofecoxib, Merck
and the FDA. N Engl J Med
2004;351:1707-9.
9. Bombardier C, Laine L,
Reicin A et al for the VIGOR study group. Comparison of upper gastrointestinal
toxicity
of
rofecoxib and naproxen in
patients with rheumatoid
arthritis. N Engl J Med
2000;343:1520-8.
10. Silverstein FE, Faich G,
Goldstein JL et al.
Gastrointestinal toxicity
CE3
TECH TALK • CE
dence does not clearly support an increased risk of
heart attack or stroke with
COX-2 selective inhibitors
other than rofecoxib, many
physicians are choosing alternative options for therapy of
arthritis and other pain conditions. Traditional NSAIDs
combined with stomach protection (misoprostol or PPI) is
one alternate option. Depending on the condition
being treated, other alternatives include medications
such as acetaminophen, narcotic pain relievers, glucosamine and/or topical
analgesics. Acetaminophen
has very little anti-inflammatory effect and is generally
only used for the relief of
pain in osteoarthritis and other pain conditions. Narcotic
(opioid) pain relievers, such as
codeine and oxycodone, are
also effective for pain but do
not reduce inflammation due
to arthritis. Patients using
these medications should be
careful since opioids can
cause sedation, which can be
dangerous for someone who
must drive or operate
machinery. Glucosamine is a
natural health product with
some evidence of effectiveness in the treatment of
osteoarthritis, with or without
chondroitin. It is generally
used three times daily (total
daily dose of approximately
1500 mg per day) and most
patients tolerate it well.
Patients should be aware that
glucosamine may require up
to three weeks to have an
effect and those with diabetes
need to monitor blood glucose closely since glucosamine may be associated
with hyperglycemia in some
patients with diabetes. Other
products, such as topical rubs
containing menthol, capsaicin or methylsalicylate, or
topical prescription NSAIDs
(e.g. diclofenac sodium [Pennsaid]) can also be effective
for joint pain and swelling.
Patients should be advised to
Page 3
TECH TALK • CE
Teck TalkCEJanENG
12/21/04
11:29 AM
with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis
and rheumatoid arthritis.
The CLASS study: a randomized controlled trial.
JAMA 2000;284:1247-55.
11. Konstam MA, Weir MR,
Reicin A et al. Cardiovascular thrombotic events
Page 4
in controlled clinical trials
of rofecoxib. Circulation
2001;104:2280-88.
12. Rahme E, Pilote L and
LeLorier J. Association
between naproxen use
and protection against
acute myocardial infarction. Arch Intern Med
2002;162:1111-1115.
Missed something?
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are available at:
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and www.novopharm.com
QUESTIONS
1. The recent withdrawal of
rofecoxib was due to:
a. An increased risk of heart
attack and stroke compared
to placebo
b. Reduced effectiveness of
this drug compared to
another arthritis medication
c. An increased risk of
stomach bleeds compared
to placebo
d. It was not effective for
people with colon cancer
2. How can pharmacy technicians assist with major
drug withdrawals, such as
Vioxx?
a. Ensure appropriate medication waste disposal.
b. Contact patients who
are taking the medication
affected.
c. Reimbursing patients according to the manufacturer’s guidelines.
d. All of the above.
3. Which of the following is
true regarding COX-2
selective inhibitors?
a. They include valdecoxib,
naproxen and celecoxib.
b. They are more likely to
CE4
cause stomach bleeding
than traditional NSAIDs.
c. They are a relatively new
medication category.
d. They should not be used
in people over 65 years of
age.
4. Which of the following is
a possible side effect of
nonsteroidal anti-inflammatory medications (NSAIDs)
for arthritis?
a. Kidney problems
b. Low blood pressure
c. Colon cancer
d. Miscarriage
5. Which of the following, if used with a traditional NSAID, increases
the risk of stomach
bleeding?
a. Misoprostol
b. Prednisone
c. Glucosamine
d. Acetaminophen
6. Which of the following is
true of the COX enzyme?
a. It can cause damage to
the stomach lining.
b. It facilitates the conversion of arachidonic acid to
prostaglandins.
c. The COX-1 subtype is
produced in response to
inflammation and injury.
d. It produces substances
that cause kidney problems.
7.Which of the following
is true of alternatives to
rofecoxib for arthritis
pain and inflammation?
a. Naproxen should be
avoided or used with caution in people with a history
of stomach bleed.
b. Glucosamine should be
used with chondroitin for
maximal effects.
c. Oxycodone treats inflammation due to arthritis.
d. Acetaminophen can cause
drowsiness so it should be
used with caution.
8. Why are proton-pump
inhibitors used with traditional NSAIDs?
a. To prevent kidney
problems.
b. To prevent stomach
bleeding complications.
c. To prevent heart disease.
d. To prevent diarrhea due
to the NSAID.
9. In addition to their use for
treating pain and inflammation, COX-2 inhibitors are
also being studied for prevention of:
a. Prostate cancer
b. Lung cancer
c. Recurrent colon polyps
d. None of the above
10. Why is the status of all
COX-2 inhibitors under
scrutiny today?
a. There is evidence that
they are not effective for
the management of pain
and inflammation due to
arthritis.
b. They commonly cause
stomach bleeding like traditional NSAIDs.
c. They have caused cancer in some patients.
d. It is unclear whether or
not the potential adverse
cardiovascular effects of
rofecoxib are a class effect
shared by all other COX-2
selective inhibitors.
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