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LE
EXTREME
BEHAVIOR
QUERULOUSNESS AND
VEXATIOUS BEHAVIORS
DANGEROUS BEHAVIOR
protections
exclusives
La Personnelle
voir texte Sogemec p. 38
w w w.hydroquebec.com/affaires
* Certaines conditions sappliquent.
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LE
SPCIALISTE
EDITORIAL COMMITTEE
Dr. Bernard Bissonnette
Dr. Maurice Boudreault
Dr. Daniel Doyle
Me Sylvain Bellavance
Nicole Pelletier, APR, Delegated Publisher
Patricia Kroack, Communication Consultant
and Responsible for publications
REVISION
Angle LHeureux
GRAPHIC DESIGNER
Dominic Armand
TRANSLATION
Anne Trindall
PRINTING
Impart Litho
PUBLICITY
France Cadieux
Tl. : 514 350-5274 ou 1 800 561-0703
Tlc. : 514 350-5175
fcadieux@fmsq.org
CIRCULATION
11 800 exemplaires
PUBLICATIONS MAIL
Mailing Indicia 40063082
LEGAL DEPOSIT
1st quarter 2008
Bibliothque nationale du Qubec
ISSN 1206-2081
Le Spcialiste is published 4 times per year by the Fdration des
mdecins spcialistes du Qubec :
2, Complexe Desjardins, porte 3000, C.P. 216, succ. Desjardins,
Montral (Qubec) H5B 1G8
Tel.: 514-350-5000
Fax: 514-350-5175
Internet: www.fmsq.org
E-Mail: communications@fmsq.org
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by the Pharmaceutical Advertising Advisory Board (PAAB).
The Fdration des mdecins spcialistes du Qubec represents
the following specialties: Allergy and Clinical Immunology,
Anesthesiology, Cardiac Surgery, Cardiology, Community Health,
Dermatology, Diagnostic Radiology, Emergency Medicine,
Endocrinology, Gastroenterology, General Surgery, Geriatrics,
Hematology and Medical Oncology, Internal Medicine, Medical
Biochemistry, Medical Genetics, Medical Microbiology and
Infectious Diseases, Nephrology, Neurology, Neurology, Nuclear
Medicine, Obstetrics and Gynecology, Ophthalmology,
Orthopedics, Otorhinolaryngology, Pathology, Pediatrics, Physiatry,
Plastic Surgery, Pneumology, Psychiatry, Radiation Oncology,
Rheumatology and Urology.
Summary
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14
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23
32
33
34
36
37
39
41
Current Affairs
Interview with Dr. Michel Lallier, Vice President
Current Affairs
Business Relations in Obstetrics/Gynecology
Legal Issues
Did You Know That
Le Spcialiste: 10 Full Years!
In the News
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In the Medical World
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CURRENT AFFAIRS
Interview and report by PATRICIA KROACK, COMMUNICATIONS CONSULTANT
or the mixed method. Those paid under the flat mixed rate
already receive recognition for the courses they give. Those
paid by fees-for-service are not paid for actual teaching
and therefore suffer a clear loss. The goal here is for
everyone to be paid for the teaching they give.
L
Payment for teaching activities also includes other aspects.
For instance, we are studying the differentiation between
residents and clerks. There could be a fee schedule that
could be modulated based on the students level. But a
great deal of work still needs to be done on this subject,
which is still in the discussion stage.
Chair: The hourly rate is $80 to $84 for the period January 1August 31, 2007. Given the importance of the Chairs
responsibilities, the fee will be $150/hour as of September 1,
2007; $170 as of April 1, 2008 and $190 as of April 1, 2009. The
remuneration is retroactive to January 1, 2007
(*) UETMIS : Unit dvaluation des technologies et des
modes dintervention en sant
10
CURRENT AFFAIRS
DIANE FRANCOEUR, MD, FRSCS
Present situation
Obstetricians/gynecologists are called upon to deal with medical
and surgical emergencies on a daily basis and cannot respond
without other necessary (but less urgent) services being
postponed or simply left undone. An ideal practice mode could
change this situation. With that in mind, the Association des
obsttriciens gyncologues du Qubec has suggested an
operations mode to the MSSS that would provide Quebec
women with quicker access to the care they need.
Reorganization is essential that would make medical specialists
the centre of a multidisciplinary team, create specialized
medicine groups (SMG) and set up birth centres. But, first,
certain conditions must be met.
Prerequisites
Obstetricians and gynecologists offices are already overflowing
with patients and there must be an incentive to increase
productivity. On the hospital side, the glaring shortage of human,
financial and material resources blocks any improvement to
accessing OB/GYN care, such as ultrasound during the first and
second trimesters, prenatal screening and the management of
emergency situations.
We cannot ignore the present crisis regarding to the availability
of prenatal screening morphology ultrasounds. Immediate
dedicated financing is essential for the urgent training of
specialized ultrasound technicians and the acquisition of quality
ultrasound equipment, which must be available throughout
Quebec with the possibility of remote transmission for outlying
regions. The creation and financing of designated ultrasound
centres to screen for congenital abnormalities in hospitals via
the RUIS, is also vital, together with high-performance secretarial
assistance to manage emergency appointments and forward
information to the referring physician.
11
Management of emergencies
The MSSS requires that we guarantee access to second-line
care for patients at all times. If we are to
see patients in our offices (which are
already teeming) who are referred by a
hospital ER with a request for an urgent
(24 hours) or semi-urgent (1 week)
consultation, we must plan periods
when we will be available, at the
expense of elective appointments. This
method could be used by obstetricians/gynecologists who have decided
to take part in this type of agreement
and would apply only to physicians on
duty in hospital centres.
This type of practice presupposes the pooling of our professional
efforts through the creation of specialized medical groups
(SMGs) which, like family medicine groups (FMG), should receive
the funding necessary to ensure independent support in the form
of human resources (nurses, clerical staff) and material resources
(office computerization with electronic access to computerized
imaging and laboratory examinations, etc.). The offices would
have equipment permitting minor surgery under sedation,
together with basic surgical and resuscitation equipment.
Obstetric practice
Improving access to pregnancy care, with planned prenatal
testing and the identification of patients at risk, justifies an
increase in the number of first-line professionals, so that
obstetrician/gynecologists can be immediately available in case
of abnormal results or acute problems. Over the last ten years,
obstetricians/gynecologists have looked after approximately
60% of pregnancies. The remaining 40% were handled by family
physicians and merely 1 to 2% by birth centres. The
disproportionate amount of time specialists now devote to
primary care means that either parturients are seen too late for
access to screening or that semi-urgent gynecological care is
deferred. It is a poor use of obstetricians and gynecologists
expertise when they themselves have to deal with normal pre-,
peri- and postnatal care.
12
Conclusion
In conclusion, more rapid access to specialized OB/GYN care
and the improved management of emergencies requires
structured, hierarchical care. Primary care can easily be handled
by our partners in most cases, freeing obstetricians/
gynecologists to provide specialized second- and third-line care
in a timely fashion. This presupposes the availability of additional
human resources (general practitioners, nurses, midwives,
ultrasound and laboratory technicians) and also material
resources (hospital space and offices with modern ultrasound
and computer technology). The pooled efforts will ensure the
optimal use of obstetricians and gynecologists specialized
skills, with remuneration being based on the improved
management of a large portion of the patient population and
greater availability for urgent consultations.
-ODICATIONS AU 2nGLEMENT
SUR LASSISTANCE MmDICALE DE LA #334
PUBLIREPORTAGE
LEGAL ISSUES
Matre SYLVAIN BELLAVANCE
Symposium
of
the
Association dorthopdie
du Qubec (the AOQ)
held at Montebello were
rejected; the Symposium
included both continuing
medical education activities on back pain as well
as the AOQ annual
general meeting. Dr.
Adam contested this decision before the Quebec Court.
Quebec Court
The question to be settled was the relationship between two
sections of the Tax Act i.e. sections 128 and 157(c).
The facts
Dr. Robert Adam is an orthopedic surgeon who has been practising
in Abitibi for more than 30 years. Under the Master Agreement,
medical specialists located in remote regions are entitled to a
maximum of 20 days resourcing per year. During this time,
specialists can receive $375.00 per day for resourcing, in addition
to the payment of transportation and accommodation expenses.
In 1996, Dr. Adam took part in seven continuing education
activities. On his tax returns, he therefore deducted a total of
$12,000 covering the cost of taking part in conventions and
continuing education activities.
Upon analyzing his income tax return, Revenu Qubec
considered that four of his activities were related to further
education and three were conventions. The expenses for the
four educational activities were accepted but expenses for only
two of the conventions were approved. Revenu Qubec based
its decision on the fact that the Tax Act provided for a maximum
of two conventions per year. Expenses for the Annual
14
Section 128 is the general rule that allows any tax payer
earning a business income (which, generally speaking,
includes physicians fees-for-act or mixed method remuneration)
to deduct expenses incurred in earning this business
income. Section 157(c) is a specific rule which provides that
a tax payer can only deduct expenses incurred for a
maximum of two conventions per year.
Dr. Adams lawyer argued that it should first be determined
whether the expenses of the Montebello symposium represented
allowable expenses under the general rule at section 128. If so,
the expenses were deductible, despite the maximum of two
conventions set out in section 157(c). That would mean that
section 157(c) and hence the deduction of expenses for a
maximum of two conventions would only apply in cases where
section 128 did not allow such a deduction.
On the other side, Revenu Qubec lawyers argued that the
provisions of section 128 did not apply and section 157(c) should
prevail. Consequently, convention expenses could only be deducted
for a maximum of two conventions under this latter section.
In conclusion
The question remains open when it is shown that the physician earns a
specific income from the convention activity i.e. when he receives
payment of the resourcing costs. We consider that the Court of Appeal
did not totally set aside this argument of the Quebec Court and it could
always be argued that, under such circumstances, expenses could be
deducted for more than the limit of two conventions.
15
16
Le Sp
cialiste
s First
Edition
Ten years later, Dr. Provosts successor, Dr. Serge Lnis is sad to
relate that nothing has changed. A staffing distribution plan must
be able to distribute medical staff that actually exists. At present,
we are distributing shortages, estimated at 800 medical
specialists in 2008. This is not only impossible to manage, but
leaves absolutely no room for manoeuvre. Worse still, the plans
totally ignore human factors and other considerations such as
age or gender. For example, with the present type of planning, it
is still hard to factor in two physicians, husband and wife, who
would like to work in the same region or hospital; a replacement
because of illness; maternity leave; or a decrease in professional
activities for family reasons or age.
L
1
19 21 JUIN 2008
Prs ent pa r
En collaboration avec :
17
IN THE NEWS
New arrival at the FMSQ
Doctor Michle Drouin becomes Director, Analysis
and Fee Planning
On the job since the
beginning of the year, Dr.
Michle Drouin heads up a
new department: Analysis
and Fee Planning. One of
the functions of this new
entity
is
to
support
Economic Affairs in setting
up the fee schedule and
carrying out the distribution
policy. The new department
plays a central, strategic role
in the analysis and follow-up
of economic information as
a whole, in conjunction with Actuarial Services and
Information Technology.
Dr. Drouin is a diagnostic radiology medical specialist.
She has more than 15 years of clinical work, and acquired
solid medico-administrative experience in her capacity as
a Department Head and Chair of the CPDP. She has been
a member of the Association of Radiologists Board of
Directors for ten years, six of them on the Executive
Committee as Secretary.
A consultant to health establishments for ten years or so,
Dr. Drouin has been in charge of performance analyses
and organizational reviews of hospitals in various regions
of Quebec for the firms CGO and CGI.
GOLF !
18
New Books
Le Spcialiste
19
PUBLIREPORTAGE
Liquidits et souplesse
Il faut dabord considrer les liquidits,
ajoute Dr Stenzler. Je dispose dune marge
de crdit pour ma pratique. Je peux donc
faire un achat laide de cette marge, mais
cela rduira mes liquidits disponibles. Le
crdit-bail peut servir de solution de
rechange qui me permettra de ne pas
toucher mon coussin financier.
Une marge de crdit-bail prapprouve peut
tre avantageuse, ajoute Dave Magier, viceprsident, financement dquipement RBC
Banque Royale. Tout comme pour les
hypothques prapprouves, cette marge
de crdit-bail est assortie dune valeur
prtablie. Ainsi, les mdecins et dentistes
disposent de la souplesse ncessaire pour
profiter des occasions dachat rapidement,
leur gr et au moment propice.
Outre le montant dargent, pensez aux
autres modalits. Par exemple, vous pouvez
ngocier un crdit-bail pour y inclure
lentretien, les mises niveau et dautres
services. La dure dun crdit-bail joue
galement un rle ; il serait logique de
choisir un bail de cinq ans lorsque
lquipement peut durer de sept dix ans,
mais une autre solution serait plus adquate
si lquipement risque de devenir dsuet
dans trois ans.
la fin du bail, vous aurez loption de
racheter lquipement, ou encore de le
renouveler ou simplement de le retourner.
Vous profitez donc dune souplesse
maximale. Si vous songez au rachat, tenez
Les stratgies, les conseils et le contenu de la prsente publication sont offerts titre indicatif seulement, au profit de nos clients. Les lecteurs devraient consulter leur fiscaliste,
leur conseiller juridique, leur conseiller en affaires lors de la planification de limplantation dune stratgie ou dune stratgie de planification fiscale afin de sassurer que leur
situation particulire fait lobjet dun examen appropri reposant sur les derniers renseignements disponibles
Marques dposes de la Banque Royale du Canada, RBC et Banque Royale sont des marques dposes de la Banque Royale du Canada. (02/2008) VPS45024
www.facturation.net
Un produit de
DOSSIER
EXTREME
BEHAVIOR
L E S P C I A L I S T E V O L . 1 0 no 1 M a r s 2 0 0 8
23
EXTREME
BEHAVIOR
By Dr. Jacques Gagnona
Querulousness
You may have a colleague or friend who has at some time become the victim of a stubborn,
vindictive plaintiff who pursues his/her complaints, legal action and recrimination well beyond
reasonable bounds. Such actions give rise to considerable concern and consequences that are
worrisome from the point of view of both health and career. Let us hope that you never find
yourself in the sights of such a person.
personally had the experience of dealing with someone
who had mobilized considerable resources to win his case
which was, in actual fact, fairly minor against his
employer. In this legal saga, the person attacked his
employer, the chief executive of the company, his union
and the physicians who had assessed his case. He
multiplied his complaints to the Collge des mdecins du
Qubec, which rejected them. He lost his case on appeal after
what had been a costly legal saga for all concerned. It was more
than stubbornness; it was a case of someone who wanted to
win his point of view at any price, regardless of the cost.
Definition
Querulousness, as a social behavior manifested by the abusive
use of the court system, can be explained by the persons
psychological profile. By extension, we can include similar
behaviors that take place outside the judicial process: for
example, claims made to administrative or political authorities.
24
An exemple
Valery Fabrikant, born in 1940, is married and the father of 2
children. He was an Associate Professor of Mechanical
Engineering at Concordia University. His application to become
a titular professor had previously failed.
In 1992, he sued two colleagues requiring that they withdraw
their names from articles he had published. He accused Mr.
Justice Gold, the Universitys Chancellor, of appointing corrupt
judges to hear his case. On August 24, 1992, the eve of his
contempt of court hearing, he shot four professors who were
his colleagues and wounded a secretary.
Conclusion
Vexatious or querulous litigants suffer from a psychiatric disorder
that changes their social behavior. The cost is high for everyone:
their family, society and the functioning of the Courts. Judicial
procedures can limit the damage by declaring such people to
be vexatious (querulous) complainants, which means that they
must obtain prior permission from a judge before bringing a case
to court.
Psychiatry is poorly equipped to help such people because of
their projective defense. They do not feel ill; they believe they are
victims of the system. They are alert to any contradiction likely to
demonstrate their basic premise i.e. even therapists can form
part of the system persecuting them.
In theory, a therapeutic approach should concentrate on the
narcissistic injury that triggered the storm, focus on the person,
acknowledge behavior adaptation, and avoid criticizing vexatious
behavior. The care team must have an unshakable cohesion and
a high degree of transparency.
Neuroleptics, if the patient agrees to take them, seldom cure
systematic dementia but, in some cases, a reduction in tension
and behavioral lapses can be hoped for.
Close cooperation between psychiatry and the justice system
must be ensured in order to respond to the highly predictable
manoeuvres of people who bring their internal psychodrama
before the forum of a court of justice.
The long and difficult trial was stopped by the judge after five
months of delaying tactics and abusive language. Valery
Fabrikant was imprisoned for life. The Court rejected the
concept of psychosis, which would allow a verdict of not guilty
by reason of mental disorder.
Jacques Gagnon M.D., CSPQ, FRCP, Psychiatrist, C.H. MaisonneuveRosemont, Assistant Clinical Professor, Universit de Montral.
25
EXTREME
BEHAVIOR
27
EXTREME
BEHAVIOR
28
The same idea has already been put forward with regard to
Quebec law, where a reform of civil procedure comparable in
scope to the British reform, came into effect in 2002.
Other factors undoubtedly tend to exacerbate the problem, one
example most certainly being the increasing cost of legal
services which drives people going before the courts to act on
their own behalf. It would be futile to believe that the solution to
the problem is exclusively clinical in nature
Notes
1
10
11
29
un peu plus de 10 pour cent des cas de reflux gastrooesophagien. Au Qubec, l ou lon retrouve le taux de
recommandation le plus faible, le pourcentage stablit
un peu plus de sept pour cent.
Dans ce contexte, il nest pas surprenant dobserver que les
IPP soient, partout au Canada, le traitement le plus courant
pour le reflux gastro-oesophagien et la dyspepsie.
Si lon en juge par la proportion dinitiation de nouvelles
thrapies au Canada en 2006, il est parier que les IPP
auront tt fait de rejoindre et mme surpasser les IRH2
(FIGURE 2). En effet, au Qubec moins de 10 pour cent des
nouvelles thrapies taient inities avec un IRH2 en 2006.
Il sagit du plus faible pourcentage de toutes les provinces
canadiennes. Dans lensemble du Canada, prs de 25 pour
cent des nouvelles thrapies sont inities avec un IRH2. Ce
pourcentage augmente jusqu environ 50 pour cent dans
les quatre provinces maritimes et en Saskatchewan. Seules
lAlberta et lOntario accompagnent le Qubec en-dessous
de la moyenne canadienne. Le Pantoloc est le traitement
initial le plus souvent prescrit au Qubec, alors que dans
les autre provinces, les IRH2 ont encore la cote.
PUBLIREPORTAGE
% de recommandations
100 %
90 %
80 %
70 %
60 %
50 %
40 %
30 %
20 %
10 %
0%
10,4%
10,6%
7,9%
9,3%
7,4%
21,6%
83,6%
84,6%
86,7%
84,6%
83,7%
73,2%
NA
CA
DA
C- B
Pra
ir ie
IPP
io
ta r
On
ec
b
Qu
ri
Ma
tim
es
IRH2
% de nouvelle thrapie
FIGURE 2
Proportion dinitiation de nouvelle thrapie dIPP
et dIRH2 en 2006
FIGURE 1
Traitements de premire ligne recommands* pour
le reflux gastro-oesophagien en 2006
100 %
90 %
80 %
70 %
60 %
50 %
40 %
30 %
20 %
10 %
0%
NA
CA
DA
C-B
AB
SK
MB
ON
ec
N-
Qu
Prevacid Fastab
Nexium
Prevacid
Omprazole gnriques
Pariet
Losec (omprazole)
Pantoloc
IRH2
N- t T-N
Ee
IP
1
2
3
4
5
6
COMMERCIAL BENEFITS
Sogemec Assurances
www.sogemec.qc.ca
OUR SUBSIDIAIRIES
La Personnelle Assurances
www.sogemec.lapersonnelle.com
RBC Banque Royale
www.rbcbanqueroyale.com/sante
Htel Hyatt Regency Montral
www.montreal.hyatt.ca
OUR PARTNERS
Energie Cardio
www.energiecardio.com
U
VEA
NOU
Bell Mobilit
www.bell-association.ca
www.fmsq.org/sondage
COMMUNICATIONS CONSULTANT
Professor-Researcher-BusinessmanClinician-Surgeon-Urologist
When he started his clinical practice, he created a laboratory so
that he could continue his research, which he did by means of
research grants and bursaries. Among other activities, he
developed new monoclonal antibodies. In addition to teaching,
Dr. Fradet also combined his clinical work and laboratory
research in order to expand knowledge about screening for
urological cancers and develop the tools needed.
One idea kept coming back to him. If you can develop a
molecule or a test and have the ability to reproduce it and
market it, why not do it yourself and avoid having to sell the
intellectual property rights to a foreign laboratory? Putting his
business acumen to good use, Dr. Fradet began to explore
various avenues, tools and programs that would allow him to
L
LE SPCIALISTE VOL. 10 no 1 March 2008
33
34
AR but its still not all that obvious, even for the organizers.
We all tend to have the same background. Teaching, for a
long time, has been having a speaker up front showing
slides, and then we doze off. It is also easier to be passive.
While there is no need to make a 180 degree turn human
nature hates changes that are too sudden we could
change our approach so that the audience participates
more and we could incorporate self-management into
that. I am currently trying to suggest a project: select one
or two subjects from the various themes of our annual
activities, one that would raise questions that might be a
bit existential for some participants. For instance, is my
diagnostic and therapeutic approach to corneal ulcers up
to date? This question is raised during a talk. The speaker
suggests a self-managed program that candidates can
take later at home and comply with section 3 of the Royal
Colleges self-management accreditation program.
Seminars can also be a stimulus for self-management and
have the advantage of making a greater range of problems
available. Its up to participants to choose. Furthermore, its
not necessary for everyone to attend every session. That is
perhaps another way of encouraging self-management.
AR they reach the end of their courses. In fact, they are only
just beginning. What they learn today will be thoroughly
outdated in 10 years time. It will be absolutely different; if
they are still doing the same thing, its because they
havent done their work. Continuing education is an ability,
an attitude and a way of working acquired during
residency and which carries over into the practice.
Residents must master todays information, but above all
they must learn to apply tomorrows information.
35
Yearly dividends
Year 1
QPF
OAS
2-yearly dividends
Year 2
$7,000
Year 1
$7,000
Year 2
$7,000
$7,000
$6,028
$6,028
$6,028
$6,028
RRSP/RRIF
$51,690
$51,690
$51,690
$51,690
Dividend(1)
$35,000
$36,693(2)
$70,000
$0
$0
$0
$0
$1,351(3)
$99,718
$101,411
$134,718
$66,069
OAS clawback
- $6,028
- $6,028
Taxable income
$102,440
Total tax
- $23,697
Interest
Total income
Net income
Net income over 2 years
Benefit
$69,993
$104,556
- $24,273
$71,110
- $6,028
$146,190
- $36,182
$92,508
$141,103
$142,614
$1,511
36
(1)
(2)
(3)
- $203
$65,866
- $15,760
$50,106
SOGEMEC ASSURANCES
Dr. GILLES ROBERT
SOGEMEC
VIE
INVALIDIT
MDICAMENTS
MALADIE
DENTAIRE
SOGEMEC
LA PERSONNELLE
: : AUTOMOBILE
: : HABITATION
: : ENTREPRISE
: : CONTACTEZ-NOUS
1 800 361-5303
514 350-5070 / 418 658-4244
Par courriel ou Internet :
information@sogemec.qc.ca
www.sogemec.qc.ca
37
SOGEMEC ASSURANCES
CHANTAL AUBIN
$100,000
$10,000
Upgraded
coverage
$3,000
$3,000
$10,000
Software
38
$5,000
$15,000
$10,000
39
Control group
*p 0,01
Time (months)
40
References
1. Brown S, Inskip H, Barraclough B. Causes of the excess mortality
of schizophrenia. Br J Psychiatry 2000 ; 177: 212-217.
2. Allison DB, Casey DE. Antipsychotic-induced weight gain: a review
of the literature. J Clin Psychiatry 2001 ; 62 (Suppl 7): 22-31.
3. Poulin MJ, Cortese L, Williams R, Wine N, McIntyre RS. Atypical
antipsychotics in psychiatric practice: practical implications for
clinical monitoring. Can J Psychiatry 2005 ; 50: 555-562.
4. Baptista T, Kin NM, Beaulieu S, de Baptista EA. Obesity and
related metabolic abnormalities during antipsychotic drug
administration: mechanisms, management and research
perspectives. Pharmacopsychiatry 2002 ; 35: 205-219.
5. Taylor DM, McAskill R. Atypical antipsychotics and weight gain: a
systematic review. Acta Psychiatr Scand 2000 ; 101: 416-432.
6. Poulin MJ, Chaput JP, Simard V, Vincent P, Bernier J, Gauthier Y,
Lanctt G, Saindon J, Vincent A, Gagnon S, Tremblay A.
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BMJ 2001 ; 322: 763-767.
MOT DU PRSIDENT
DR GATAN BARRETTE
41
MD
sibles la marijuana ou dautres cannabinodes, de mme que pour les patients ayant des
antcdents de ractions psychotiques.
POPULATIONS SPCIALES : CESAMET nest pas recommand pour les femmes enceintes et
allaitantes ni pour les enfants de moins de 18 ans, car aucune tude na port sur linnocuit
du mdicament chez ce type de patient. tant donn que CESAMET lve la frquence
cardiaque en dcubitus et en station debout et cause une hypotension orthostatique, des
prcautions particulires doivent tre prises lors de ladministration du mdicament des
personnes ges ou atteintes dhypertension ou de maladie cardiaque.
atteints dun dysfonctionnement grave du foie ou ayant des antcdents de troubles affectifs
non psychotiques. CESAMET est incompatible avec lalcool, les sdatifs et les hypnotiques
ou autres substances psychotomimtiques. CESAMET nest pas recommand pour les
femmes enceintes et allaitantes ni pour les enfants de moins de 18 ans, car aucune tude
na port sur linnocuit du mdicament chez ce type de patient.
PRCAUTIONS : CESAMET dtriore souvent les habilets mentales et/ou physiques
incidence observe dans le cadre dessais cliniques sont les suivants : somnolence (66,0 %),
vertige (58,8 %), agitation psychologique (38,8 %), scheresse de la bouche (21,6 %),
dpression (14,0 %), ataxie (12,8 %), vision brouille (12,8 %), perturbation des sensations
(12,4 %), anorexie (7,6 %), asthnie (7,6 %), cphale (7,2 %), hypotension orthostatique
(5,2 %), euphorie (4,0 %) et hallucinations (2,0 %).
Les effets secondaires suivants ont t signals chez moins de 1 % des patients traits au
nabilone dans le cadre dessais cliniques : tachycardie, tremblements, syncope, cauchemars, distorsion de la perception du temps, confusion, dissociation, dysphorie, ractions
psychotiques et crises.
SIGNALISATION DEFFETS SECONDAIRES SOUPONNS : Sant Canada se charge de
surveillance des mdicaments et recueille des renseignements sur leurs effets secondaires
graves et inattendus. Si vous souponnez que vous avez subi une raction aigue ou
inattendue ce mdicament, vous pouvez en aviser Sant Canada par :
ADMINISTRATION
CHEZ LES ADULTES : La posologie de routine pour les adultes est de 1 mg ou 2 mg de
CESAMET, deux fois par jour. La premire dose doit tre prise la nuit prcdant la premire
administration du mdicament de chimiothrapie. La deuxime dose est gnralement
administre de 1 3 heures avant la chimiothrapie. Au besoin, ladministration de
CESAMET peut se poursuivre jusqu 24 heures aprs ladministration du mdicament de
chimiothrapie. La dose maximale quotidienne est de 6 mg en plusieurs administrations.
Afin de permettre des ajustements dans les doses en dedans des zones thrapeutiques,
des capsules de 0,5 mg de CESAMET sont disponibles. Ces ajustements peuvent savrer
ncessaires pour les besoins individuels des patients en ce qui a trait la raction et la
tolrance au traitement. Le surdosage peut se produire mme des doses prescrites si des
symptmes psychiatriques troublants sont prsents. Dans ces cas, le patient devra tre mis
sous observation dans un environnement paisible et des mesures de soutien, comme la
rassurance, devront tre utilises. Les doses subsquentes devront tre retenues jusqu
ce que les patients reviennent leur tat psychique initial; la posologie habituelle pourrait
tre r-instaure si lindication clinique est maintenue. Dans de tels cas, une plus petite
dose de dpart est suggre.
CESAMET est un mdicament en capsules contenant du nabilone et doit tre administr
par voie orale uniquement.
RENSEIGNEMENTS ADDITIONNELS SUR LE PRODUIT
EFFETS SECONDAIRES SIGNALS APRS LE DBUT DE LA COMMERCIALISATION :
Les ractions suivantes, listes par systme physiologique en ordre dcroissant de frquence, ont t signales depuis que
CESAMET a t mis en march. Tous les episodes sont inclus, sans gard lvaluation des causes. Systme sanguin et hmatopotique : Leucopnie. Systme cardiovasculaire : Hypotension et tachycardie. Yeux et oreilles : Troubles de la vision. Systme
gastro-intestinal : Scheresse de la bouche, nause, vomissements et constipation. Systme nerveux : Hallucinations, dpression
du SNC, stimulation du SNC, ataxie, stupeur, vertige, convulsions et paresthsie prilabiale. Effets psychiatriques : Somnolence,
confusion, euphorie, dpression, dysphorie, dpersonnalisation, anxit, psychose et labilit motionnelle. tats divers et mal
dfinis : tourdissements, cphale, insomnie, raisonnement anormal, douleurs thoraciques, absence deffet et dme facial.
SYMPTMES ET TRAITEMENT DU SURDOSAGE : Signes avant-coureurs et symptmes :
Les signes avant-coureurs et les symptmes rsultant dun surdosage sont des pisodes psychotiques pouvant
comporter des hallucinations, de lanxit, une dpression respiratoire et le coma (des cas de surdosage de plus de
10 mg/jour nont pas t signals ce jour).
TRAITEMENT :
On peut considrer quun surdosage sest produit, mme la dose prescrite, si des symptmes psychiatriques
incommodants sont apparus. Dans ce cas, le patient doit tre gard sous observation dans un milieu calme et des
mesures de soutien, y compris rassurer le patient, doivent tre prises. Ladministration du mdicament doit tre
suspendue jusqu ce que le patient revienne son tat psychique normal. Ladministration de routine peut alors tre
reprise, si cela est indiqu cliniquement. Dans ce cas, une dose initiale plus faible est conseille.
Lorsque des pisodes psychotiques surviennent, le patient doit tre trait de la manire la plus conservatrice possible.
Dans le cas dpisodes psychotiques moyens et danxit, un soutien verbal et un rconfort peuvent suffire. Dans les
cas plus graves, une mdication antipsychotique peut tre utile. Cependant, lefficacit des antipsychotiques dans le
soulagement des psychoses induites par les cannabinodes na pas t tudie de manire systmatique. Leur emploi
se fonde sur un nombre restreint de cas o des surdoses de cannabis ont t traites avec des agents antipsychotiques.
Compte tenu des interactions potentielles avec dautres mdicaments (c.--d. effets dpresseurs cumulatifs sur le SNC
du nabilone et de la chlorpromazine), les patients ainsi traits doivent tre surveills de prs.
On doit protger la voie arienne du patient et maintenir la ventilation et la perfusion. Les signes vitaux du patient,
les gaz sanguins, les lectrolytes sriques, etc. doivent tre mticuleusement mesurs et maintenus dans les limites
acceptables. Labsorption du mdicament dans le tractus gastro-intestinal peut tre rduite par ladministration orale
de charbon activ qui, dans bien des cas, est plus efficace que lmse ou un lavage. Il est recommand dutiliser le
charbon au lieu de la vidange gastrique. Ladministration rpte de charbon pendant un certain temps peut acclrer
llimination de plusieurs mdicaments. Il est important de protger la voie arienne du patient lors de la vidange
gastrique ou de ladministration de charbon.
Lutilisation de diurse force, de dialyse pritonale, dhmodialyse, dhmoperfusion de charbon ou de cholestyramine
na pas t signale. Sous un fonctionnement rnal normal, la plupart de la dose de nabilone est limine par le
systme biliaire.
Le traitement de la dpression respiratoire et du coma consiste en une thrapie symptomatique et de soutien. Des
prcautions particulires doivent tre prises lgard des risques dhypothermie. Si le patient montre des signes
dhypotension, lemploi de fluides, dagents inotropes et/ou de vasoconstricteurs est envisager.
STABILIT ET RECOMMANDATIONS DENTREPOSAGE
Conserver temprature ambiante contrle de 15-30 oC.
FORMES POSOLOGIQUES OFFERTES
Capsules de CESAMET 1 mg : chaque capsule de glatine dure no 2, corps blanc et calotte bleu opaque, portant le logo ICN
sur la calotte et linscription 3101 sur le corps, contient 1 mg de nabilone, disponible en bouteilles de 50 capsules.
Capsules de CESAMET 0.5 mg : chaque capsule de glatine dure no 4, corps blanc et calotte rouge opaque, portant le logo ICN
sur la calotte et linscription 3102 sur le corps, contient 0.5 mg de nabilone, disponible en bouteilles de 50 capsules.
CESAMET est considr comme un narcotique et assujetti aux contrles en vigueur pour ce type de substance.
Pour obtenir ce document, ainsi que la monographie complte rdige lintention des professionnels de la sant, communiquez
avec Valeant Canada limite/Limited au numro: 1-800-361-4261. Ce document a t rdig par Valeant Canada limite/Limited.
Dernire rvision : 15 septembre 2004.
Distributeur : Valeant Canada limite/Limited, 4787, rue Levy, Montral, Qubec H4R 2P9
0,5 mg
Service la clientle 1-800-361-4261
Rfrence : 1. Monographie de produit CESAMET, septembre 2004.
1 mg