women’s health seminaromr.dgtlpub.com/2009/2009-06-30/pdf/omr_2009-06-30.pdf · women’s health...

June 2009 Volume 76 Number 6 • www.oma.org

EditorialPhysician engagement vital in Ontario’sevolving health-care environment

Disability Income InsuranceA primer for OMA members

Practice ManagementStarting your own medical practice:perils, pitfalls and rewards

Relativity UpdateReport from the RVIC MethodologyReviewWorking Group

Alternate Level of CareNew provincial definition takes effect July 1

Lobby Day 2009 at Queen’s ParkMedical students and residents deliverstrong message to MPPs

PM41144507

Dedicated to Doctors. Committed to Patients.

10TH ANNUAL OMA

Women’s Health SeminarFosters Unique Forum for Physicians to Connect

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BETTER HEALTH FOR YOU AND YOUR FAMILYThe OMA Physician Health Program is a confidential

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and their family members who may be experiencing

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Confidential Toll-Free Line 1-800-851-6606

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PresidentDr. S. Strasberg, Downsview

President ElectDr. M. MacLeod, London

Past PresidentDr. K. Arnold, Thunder Bay

Chair of the BoardDr. M.S. Kennedy, Thunder Bay

Honorary TreasurerDr. D.C. Weir, Toronto

SecretaryDr. S. Wooder, Stoney Creek

District

1 Dr. D.J. Hellyer, Windsor

2 Dr. M. MacLeod, London

Dr. M. Toth, Aylmer

3 Dr. C. Cressey, Palmerston

4 Dr. D.M. Goodwin, Niagara Falls

Dr. V. Tandan, Hamilton

5 Dr. T. Nicholas, Aurora

Dr. J. Tracey, Brampton

6 Dr. J. Ludwig, Peterborough

7 Dr. A. Steacie, Brockville

8 Dr. G. Beck, Ottawa

Dr. A. Kapur, Ottawa

9 Dr. P. Bonin, Sudbury

10 Dr. K. Arnold, Thunder Bay

11 Dr. S. Chris, North York

Dr. C. Jyu, Scarborough

Dr. C. Pinto, Etobicoke

Dr. S. Strasberg, Downsview

Dr. A. Studniberg, Scarborough

Elected by Council

Dr. M.S. Kennedy, Thunder Bay

Dr. Wayne Tanner, Toronto

Dr. V. Walley, Peterborough

Dr. D.C. Weir, Toronto

Dr. S. Wooder, Stoney Creek

Academic representative

Dr. Blake Woodside, Toronto

Dr. Alan Hudak, Orillia

Addiction Medicine J. Daiter

Allergy and Clinical Immunology B. Wong

Anesthesiology S.C. Bodley

Cardiac Surgery V. Rao

Cardiology W. Hughes

Chronic Pain Physicians H. Jacobs

Clinical Hypnosis M. Dales

Clinical Teachers B. Woodside

College and University Student Health V.A. Jaeger

Community Health Centre & Aboriginal Health

Access Centre Physicians K. Mardell

Complementary Medicine L. Rapson

Critical Care Medicine L. Milosevic

Dermatology S. Gupta

Diagnostic Imaging M. Prieditis

Emergency Medicine M. Haluk

Endocrinology andMetabolism J. Shaban

French-Speaking Physicians T. Dufour

Gastroenterology J. Axler

General and Family Practice D. Bridgeo

Genetics L. Velsher

Geriatrics A. Baker

GP Psychotherapy D. Cree

Group Practice G. Maley

Hematology andMedical Oncology P. Kuruvilla

Hospitalist Medicine K. Rhee

HSO Physicians J. Craig

Hyperbaric Medicine A.W. Evans

Independent Physicians J. Szmuilowicz

Infectious Diseases N. Rau

Internal Medicine M. Wilson

Interns and Residents A. Pardhan

Laboratory Medicine B. Mullen

Medical Students N. Hawkins, A. Vellathottam

Nephrology B. Nathoo

Neurology R. Yufe

Neuroradiology A.J. Fox

Neurosurgery F. Gentili

Nuclear Medicine J.P. Cliché

Obstetrics and Gynecology B. Mundle

Occupational and Environmental

Medicine M. Cividino

Ophthalmology W.K. Brydon

Orthopedic Surgery T. Wilson

Otolaryngology -HeadandNeck Surgery O. Smith

Palliative Medicine D. Robinson (Acting Chair)

Pediatrics H. Yamashiro

PhysicalMedicine andRehabilitation D. Berbrayer

Plastic Surgery D.S. Woolner

Psychiatric Hospitals, Schools L.J. Genesove

Psychiatry D. Brownstone

Public Health Physicians H. Shapiro

Radiation Oncology G. Morton

Reproductive Biology C. Librach

Respiratory Disease H. Ramsdale

Rheumatology P. Baer

Rural Practice R. Dawes

Sleep Disorders A. Soicher

Sport Medicine W. Elliott

Surgery, General P. Barron

Surgical Assistants D. Esser

Thoracic Surgery R. Zeldin

Urology F. Papanikolaou

Vascular Surgery W.R. Tanner

ONTARIOMEDICAL SECRETARIES ASSOCIATION–

HEALTH CARE ASSOCIATES

President Sharon Fry, Rosseau

(OMA Committee Chairs, see page 6)

Executive Committee

Directors

Chair of OMA Council

Executive Committee,Board of Directors, Section ChairsSection Chairs

In Class SeminarsCyberMed In Class Seminars will resume in September for the fall Semester. Course schedules

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Each of our software courses is broken down into groups of tutorials. Each tutorial is a 3-5 minute

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RegistrationRegistration for all our seminars is available online at www.oma.org/cybermed. You can also

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Internet 2: Practical & Secure Surfing Session E: July 7 – 21

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Website Essentials: Session E: July 21 – Aug 4

Session F: Sept 1 – 15

Session G: Oct 13 – 27

Session H: Nov 24 – Dec 8

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Session F: Sept 15 – 29

Session G: Oct 27 – Nov 10

Session H: Dec 8 – 22

CyberMed_1Pg_June09_2:CyberMed 6/5/09 11:24 AM Page 1

JUNE 2009 VOL. 76 NO. 6

“Breakthroughs inWomen’sHealth”themeof10thAnnualWomen’sHealth Care SeminarA record-breaking 240 participants attended the recent10th Annual OMAWomen’s Health Care Seminar.Hosted by the Outreach to Women PhysiciansCommittee, the day-long event provides a uniqueforum for women in medicine to connect with oneanother both professionally and personally, whileparticipating in valuable CME sessions. The seminaralso helps foster and strengthen relationships betweenwomen physicians, medical residents and students,and the Ontario Medical Association.

FEATURES7 Editorial: physician engagement

When we consult frontline physicians and learn fromtheir experiences, we are better able to fully understandissues and devise practical solutions. Physicians provide aunique perspective to decision-making because we’re inthe trenches providing care to patients on a daily basis.We know what’s working and what isn’t. And, we bringthat true patient perspective to the table.

14 Relativity updateThe issue of relativity has long been a concern for theprofession. During the recent OMA Council Meeting,delegates heard a presentation from the Relative ValueImplementation Committee (RVIC) MethodologyReviewWorking Group, which has been directed byCouncil to undertake a review of the current RVIC fee-for-incomemethodology that aims to narrow inter-specialty income disparities among Ontario physicians.

22 OMA2009Honours and AwardsThe OMA hosted approximately 200 physician honorees,their families, friends and colleagues at the recent galadinner and awards presentation, held during the 129thAnnual General Meeting in Toronto. A photo featurehighlights the award recipients by category, along with acomplete list of 2009 honorees.

26 Disability income insurance—aprimerfor OMAmembersThe OMA Insurance Services Department has preparedan overview of disability income insurance in the formof common questions and answers to help membersdetermine the appropriate type and level of incomecoverage required. A reminder fromOMA PresidentDr. Suzanne Strasberg emphasizes the importance ofmaintaining adequate disability insurance coverage.

29 Newprovincial Alternate Level of Care(ALC) definition effective July 1Physicians are being encouraged to take a leadershiprole in adopting a new provincial definition of AlternateLevel of Care, that will take effect July 1. The standardizeddesignation aims to facilitate improved data capture onALC patients in all acute and post-acute hospitals inOntario, and subsequently enhance patient flow andrelated wait times. A backgrounder on the developmentof the new standard is provided.

Cover design: Bryan Davidson, Artful Dodger Communications Inc.Cover photos: The Canadian Press Images/Anand Maharaj Ontario Medical Review • June 2009 3

18

CAPSULENEWS

2 CyberMed Skills seminars: complimentarye-learning courses and accredited CME forOMAmembers

10 Council Committee on Structure andBylawsseeksmember input onOMAdelegate electionprocess: online survey deadline July 10

11 Listing of OMA Executive Committee andBoard of Directors for 2009-2010

37 OMAPregnancy and Parental Leave BenefitsProgramavailable to physicians

40 OMACorporateHotel Directory: preferredrates formembers at Ontario hotels

JUNE 2009 VOL. 76 NO. 6

FEATURES (continued)

32 LobbyDay 2009 at Queen’s ParkNearly 40Ontariomedical students and residents delivereda strong message to members of provincial parliamentduring the annual Lobby Day at Queen’s Park, held April20. Participants called on MPPs to ensure equal access tomedical school by regulating tuition fees, and increasingOntario Student Assistance Program funding levels toreflect the true cost of a medical education.

COLUMN38 PracticeManagement: starting your own

medical practice—exploring the perils,pitfalls, and rewardsThere aremany things to think about when establishingyour ownmedical practice, starting with your personaland professional goals. Other considerations include:choosing a community and building in which to practise;obtaining all relevant licences, memberships and insur-ance; assembling a good advisory team of professionals;negotiating a lease; hiring staff; implementing amedicaloffice system; and establishing sources for supplies.

Departments

1 OMA Executive Committee, Board of Directors,Section Chairs

6 OMA Committee Chairs

9 Readers’ViewsTreatment of childhood overweight and obesity;Physician input sought to enrich asthma flow sheet.

35 Health Policy ReportProvincial Alternate Level of Care (ALC) Definition;Cancer System Quality Index and Cancer CareOntario; Bill 179 — An Act to Amend RegulatedHealth Professions Statutes; Financial ServicesCommission of Ontario (FSCO) Report — AutoInsurance Recommendations; Mandatory Reporting.

51 Classifieds

56 Medectoon

56 Advertisers’ Index

Ontario Medical Review • June 2009 5

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Financial Planning and Oversight Committee S. Wooder

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Medical Audit Oversight Committee D. Hellyer

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Physician LHIN Tripartite Committee T. Nicholas

Physician Services Committee G. Beck

RVIC Working Group M. MacLeod

Workplace Safety & Insurance Board Steering Committee J. Tracey

(A complete listing of Agreement cluster committeeswill be provided once the status of each is finalized.)

Governance

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Annual Meeting Planning Committee K. Arnold

Audit Committee R. Mann

Awards Committee G. Flynn

Board Planning Committee M. MacLeod

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EDITORIAL

Physicianengagement

I was asked to offer perspective onthe role of physicians in commu-nity engagement and strategies toencourage physician involvement.This is an area of increasing impor-tance to our members and to theOMA. In recent months, we haveencountered a number of instancesof unilateral decision-making affect-ing health resource allocation andaccess to care at the community level.

Also, Local Health IntegrationNetworks (LHINs) are exertingincreasing influence in the health-care system. We want and need to beconsulted at the earliest stages inthose LHIN activities that affect ourmembers and our patients.

From an engagement perspective,in our experience at the OMA, weknow that when we consult with ourmembers we are a better Associationand we get sounder solutions — andimproved outcomes.

In fact, I would say that we aregetting better and better at realizing

that when we consult frontlinephysicians and learn from theirexperiences, we are better able tofully understand the issues anddevise practical solutions. Decisionsand policies that are made in aconciliatory process always have abetter end-product than those thatare imposed.

On a broader provincial systemlevel, the same principle holds true.Physicians provide a unique per-spective to decision-making becausewe’re in the trenches providingcare to patients on a daily basis. Weknow what’s working and whatisn’t. And, we bring that true patientperspective to the table.

In 2006, when LHINs were in-troduced, the OMA proposed thateach LHIN establish a PhysicianAdvisory Committee. The govern-ment declined this recommenda-tion and instead introduced multi-disciplinary Health ProfessionalAdvisory Committees (HPACs) —

with four physician representativeson each— that would be advisory tothe LHIN CEOs. While not our firstchoice, we have worked within thelocal HPACs to try and bring thephysician perspective to the table.

The OMA felt that it was importantto have input into LHINs from theirinception, as experience demon-strates that when physicians areincluded in the health-care planningprocess, solutions can be developedthat all can be content with, and thatultimately lead to better patient care,as the main concern for physicians isaccess to services and resources forpatients. Physicians have training andexpertise that health-care plannersshould be capitalizing on. And, inmost cases, if the consultations areconducted in the rightmanner; physi-cians are happy to be involved.

There are many examples inOntario of decisions that involveddirect physician engagement wherethe outcomes were extremely posi-tive.

When the government of Ontarioinc luded anes thet i s t s in the i rdiscussions on how to alleviate theshortage in hospital operatingrooms, they got Anesthesia CareTeams — a better solution than theone initially proposed.

Recently, I enjoyed the opportunity to represent

our members before an audience of health-

care leaders at anOntario Hospital Association

(OHA) forum on “Community Engagement in an

Evolving Health-Care Environment.”

Ontario Medical Review • March 20081 7Ontario Medical Review • June 2009

(continued on page 16)

Treatment of childhoodoverweight and obesityDear Editor:I wanted to congratulate the authorof the terrific review article on child-hood obesity (“OMA BackgroundPaper and Policy Recommendationson Treatment of Childhood Over-weight and Obesity,” February 2009,Ontario Medical Review, pp. 19-36*).

I also wanted to make a commentabout the statement in the Psychiatricsection that says “Generally, child-hood obesity does not result frompsychiatric disorders nor does itcause them.”

While there may be no direct link,the various medications used to treatchildhood (and for thatmatter adult)psychiatric disorders, particularly theatypical antipsychotics, commonlycause appetite stimulation and in-creased fatigue with the end result ofovereating, reduced physical activityand significant weight gain.

Sadly, this gives rise to even poorerself esteem in this already emotion-ally fragile group, which in turn can

result in even more overeating, avicious cycle indeed.

Hopefully, the future will bringnew and improvedmedicationswith-out these undesirable side-effects.

Lorne S. Parnes, MD, FRCSCDepartment of OtolaryngologyUniversity of Western Ontario

Editor’s note:*The background paper was pre-pared by Aura Hanna, PhD, a seniorpolicy analyst in the OMA HealthPolicy Department.

Physician input sought toenrich asthma flow sheetDear Editor:I had the pleasure of attending theOMA Annual General Meeting onMay 1 and 2, 2009, on behalf of theFamily Physician Airways Group ofCanada.

I write to thank colleagues andOMACouncil members for their gra-ciousness and interest in our presence.

I shared with a great number ofphysicians an Asthma Flow Sheet,and received great feedback and inter-est for this tool, which helps primarycare practitioners recognize andaggressively manage asthmatics to tryto achieve better control.

This project is still in draft form;its goals are to create a primary caretool to facilitate care for asthmaticsand potentially to look for incentivebonuses to implement and improveasthma outcomes.

Anyone who has interest in see-ing this tool and sharing theirthoughts can contact the writer viae-mail ([email protected]).

We welcome all input into thisimportant project and thank allthose who have already contributed.Alan Kaplan,MD, CCFP(EM), FCFPChair, Family Physician Airways

Group of CanadaPresident of IPCRG 5th World

Respiratory Conference (to be held inToronto, June 2-5, 2010)

Website: www.ipcrg-toronto2010.orgOMR

Readers’ Views

Ontario Medical Review • March 20098 9Ontario Medical Review • June 2009

Letters to the Editor should be addressed to:

OntarioMedical Review150 Bloor StreetWestSuite 900Toronto, OntarioM5S 3C1Fax: 416.340.2232E-mail: [email protected]

The OntarioMedical Reviewwelcomes readers’views. Note: lettersmay be edited for space andclarity. Please supply your name, address anddaytime phone number.

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Ontario Medical Review • June 200910 xxOntario Medical Review • June 2009

Member survey onOMAdelegate electionprocess:

deadline July 10

The OMA Council Committee onStructure and Bylaws is seeking inputfrom members on the issue of dele-gate elections.

The Committee has developed anonline survey, which poses the fol-lowing question: “Do you support hold-ing all Section Executive and CouncilDelegate elections by mail or electronicballot only?”

In an e-mail tomembers announc-ing the survey, Committee Chair Dr.Janice Willett stated, “Currently,Sections may elect their Council del-egates and alternate delegates ateither an annual meeting, or by mailor electronic ballot, while SectionExecutives can be elected by anymeans as laid out in each Section’srules and regulations.

“It is believed that the proposedchange to conduct Section Executiveand Council delegate electionsexclusively by mail or electronic bal-lot would enable everyone withinthe Section to participate in the elec-toral process, and ensure that thoseleaders who are elected truly repre-sent the broader membership.

“The Committee believes that ifthis change is implemented, the costsassociated with holdingmail or e-bal-lot elections should not be borne bythe Sections. Consequently, the Com-mittee recommends that the Asso-ciation work in conjunctionwith eachSection to handle the various timing,implementation and logistical issuesrelated to the process of conductingmail or electronic ballot elections, asit currently does withDistricts.”

All members are encouraged tovisit the online link (https://www.oma.org/membersurvey/cos/survey.asp), review the backgroundmaterial,and respond “yes” or “no” to thequestion. The survey deadline isFriday, July 10. OMR

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Ontario Medical Review • June 2009xx 11Ontario Medical Review • June 2009

Executive Committee andBoard ofDirectors 2009 - 2010

Executive Committee

PRESIDENT

Dr. Suzanne Strasberg

Downsview

PRESIDENT-ELECT

Dr. Mark MacLeod

London

PASTPRESIDENT

Dr. Kenneth Arnold

Thunder Bay

CHAIROF THEBOARD

Dr. M. Stewart Kennedy

Thunder Bay

HONORARY TREASURER

Dr. Doug Weir

Toronto

SECRETARY

Dr. Scott Wooder

Stoney Creek

District Directors

District 1Dr. Deborah J. Hellyer,Windsor

District 2Dr. Mark MacLeod, London

Dr. Michael Toth, Alymer

District 3Dr. Christopher Cressey, Palmerston

District 4Dr. Michael Goodwin,Niagara Falls

Dr. Ved Tandan,Hamilton

District 5Dr. Timothy Nicholas, Aurora

Dr. John Tracey, Brampton

District 6Dr. John Ludwig, Peterborough

District 7Dr. Adam Steacie, Brockville

District 8Dr. Gail Beck,Ottawa

Dr. Atul Kapur,Ottawa

District 9Dr. Pierre Bonin, Sudbury

District 10Dr. Kenneth Arnold, Thunder Bay

District 11Dr. Stephen Chris,North York

Dr. Christopher Jyu, Scarborough

Dr. Chris Pinto, Etobicoke

Dr. Suzanne Strasberg,Downsview

Dr. Allan Studniberg, Scarborough

Directors Elected by Council

Diagnostic Assembly

Dr. Virginia Walley, Peterborough

General and Family Practice Assembly

Dr. M. Stewart Kennedy

Thunder Bay

Dr. Scott Wooder

Stoney Creek

Medical Assembly

Dr. Doug Weir

Toronto

Surgical Assembly

Dr. Wayne Tanner

Toronto

Academic Representative

Dr. Blake Woodside

Toronto

Section of Interns &ResidentsObserver

Dr. Alim Pardhan

Toronto

Section ofMedical StudentsObserver

Ms. C. Nicole Hawkins, Kingston

Mr. Andrew Vellathottam, London

FEATURE

RelativityUpdateby Mark MacLeod, MDChair, Relative Value Implementation Committee (RVIC)Methodology ReviewWorking Group

The task is significant and is beingpursued in consultation with OMAclinical Sections, Assemblies, andthe OMA Board. The followingupdate draws on the Committee’sReport to Council, which is avail-able on the OMA website.*The issue of relativity has long

been a concern for the profession. In2004, OMA Council supportedmotions requesting that both fee rel-ativity and income disparities beaddressed throughnegotiations. And,in 2007, the negotiations consulta-tions process involving physicianleaders and the general membershipreconfirmed that fee relativity andincome disparities are top priorities.As such, the 2008 Physician Serv-

ices Agreement includes general feeincreases in each year, where half ofthe general increase will be appliedon an equal percentage basis to eachOHIP Specialty, and the remaininghalf will be used to correct disparities

in relativity. There is 2.5%, 1.5%, and2.125% available for relativity adjust-ments in October 2009, October2010, and September 2011 respec-tively. The 2.5% available in October2009 has been allocated across spe-cialties based on the RVICmethodol-ogy. Future relativity allocations willbe made based on a revised or newmethodology if one can be devel-oped.The current RVICmethodology is a

fee-for-income approach, developedin 2003-2004, aimed at narrowinginter-specialty income disparities. Avariant of the fee-for-incomeapproachto allocationswas used by theOMA in1991.The premise behind fee-for-

income allocations is that differencesin net earnings are, at least in part,due to fee differences that advantageone Section relative to another.Unlike a fee-for-service approach(i.e., RBRVS Commission), this

methodology does not adjust the val-ues of individual fee codes, but ratheridentifies a pool of funds that are tobe used for such code adjustments.The RVIC Methodology Review

Working Group Terms of Referenceincluded an evaluation of the follow-ing elements of the RVIC formula:- Hours of work.- Sources of income.- Practice overhead expenses.- Definition of full-time equivalent(FTE).

- Magnitudeof relativity target adjust-ments.

- Review timelines, accuracy, andreliability of available data sources.The timelines for the review and

recommendations were short. EachSection was provided with a briefreview of the previous relativitymethodology and asked for com-ments and suggestions.Despite the short timelines, 31

Sections submitted written responses( h t t p s : / / w w w . o m a . o r g /members/negotiations/rvic.asp).These submissions were thoughtfuland helpful.There were many recommenda-

tions brought forward. However, thelargest objections or concerns withthe existing RVICmethodology were:1. A uniform criticismof self-reporteddata that is not and cannot be veri-fied.

2. Data sources used that are out ofdate.

3. Exclusion of some income (i.e.,capitation payments, alternativepayment plans, etc.).

During the recent OMA Council Meeting,

delegates heard a presentation from the

Relative Value Implementation Committee

Methodology Review Working Group, which has

been directed by Council to undertake a review of

the current RVIC fee-for-income methodology

that aims to narrow inter-specialty income dis-

parities among Ontario physicians.


OMR_14Rev.pdf 1OMR_14Rev.pdf 1 6/18/09 3:11:39 PM6/18/09 3:11:39 PM

Also, some of the concerns and rec-ommendations of the Sections werein direct opposition to one another.The Working Group attempted to

address all the concerns expressed bySections, however, the main objec-tions described above took the fore-front and led the Working Group todevelop a newmethodology and rec-ommendations that are intended toprovide more accurate results in thefuture, and provide for more balanceand fairness overall.The new model, entitled Com-

parison of Average Net Daily Income(CANDI), is described in the Com-mittee Report online, along with aquestion and answer document.**OMA Council delegates discussed

the merits of the proposed CANDImodel and posed a number of ques-tions to the Committee. There wasextensive deliberation and muchvaluable feedback provided.Council delegates further pro-

vided their input on a series of strawpoll questions about the principlesfor the RVIC Working Group goingforward. The results appear in thesidebar opposite.Ultimately, Council voted to

defer modifying its position on rela-tivity until the November 2009meeting.The RVIC Methodology Working

Group has been directed by Councilto continue its work, and additionalconsultations with OMA Sectionswill begin in the immediate future.Additional reports will be forth-

coming via the OMA E-mail and FaxNetwork. Please refer to the OMAwebsite for additional information.Questions or comments from

members may be forwarded to theRVIC Working Group, c/o ElizabethPirko, OMA Corporate Affairs, viae-mail at: [email protected]

OMR

*https://www.oma.org/members/negotiations/FinalReportofRVICReviewWG2009-04-16.pdf**https://www.oma.org/members/negotiations/QandAProposedCANDIMethodologg2009-04-16.pdf

Relativity Update


Draft Summary of StrawPolls on RVICWorking GroupPrinciples Presented to OMA Council onMay 3, 2009

1. That as much clinical income as feasible be used in the calculations.Support – 85%Not Support – 15%

2. That where possible income be attributed to individual physician incomes.Support – 92%Not Support – 8%

3. Where income cannot be attributed to individuals, that it be attributed byspecialty, prorated to the proportion of physicians in that specialty who receivethat income.Support – 88%Not Support – 12%

4. That a training opportunity cost modifier be used.Support – 90%Not Support – 10%

5. That the impact of unsociable hours be recognized in the methodology.Support – 88%Not Support – 12%

6. That an overhead modifier be used.Support – 95%Not Support – 5%

7. That the OMA would work to update and refine data sources continuouslyto input into any relativity methodology in use.Support – 98%Not Support – 2%

8. That the OMA would undertake further studies of hours worked, incomeearned, overhead costs, and training opportunity costs.Support – 89%Not Support – 11%

9. That the target used for relativity correction is the average specialist income.Support – 78%Not Support – 22%

10. That wherever possible, individual OHIP specialty groups would be identifiedfor purposes of relativity.Support – 95%Not Support – 5%

11. That a complexity modifier be used.Support – 24%Not Support – 76%

12. That intensity/risk modifiers be used.Support – 23%Not Support – 77%

OMR_15rev.pdf 1OMR_15rev.pdf 1 6/18/09 3:12:18 PM6/18/09 3:12:18 PM

When the government took phy-sician advice and provided fundingfor Shared Care Pilots for primarycare patients, it got an innovativemodel of care, one that helps physi-cians manage their practices so thatthey can see more patients and pro-vide better,more comprehensive care.

Despite the evidence, there are alsosome examples where local decision-making has not involved physicians.This can be seen recently in one areaof the province where, residents andtheir physicians were told that theywere ineligible for services becausethey didn’t live in the right geographicarea. In another region in Ontario,local hospital restructuring was deter-mined with little or no input fromphysicians, and likely patients.

In rural Ontario, the Ministryof Health and Long-Term Care isthinking about closing many emer-gency rooms and making them“urgent-care centres.” Or, in somecases, closing entire hospitals to thedetriment of the local community.

Through our locally elected physi-cians we have been working hard totry to demonstrate the need for localdecision-makers to involve physi-cians early, before they’ve made adecision — not after they’ve alreadystarted implementing.

While there are nomagical answersfor how to effectively engage phy-sicians, through our own experience

and research at the OMA, we havedevised some suggestions to helpcommunities effectively reach theirphysician population.

It is imperative to involve physi-cians early in the process on topicsthat are relevant to them and theirpatients. Simply bringing a plan orconcept to physicians when it isbasically already set in stone is notthe way to garner support. If you candemonstrate the relevancy to practicelife, it is likely you will engage thedoctor and get constructive feedback.

It is also important to determinewhether it is frontline or formal physi-cian leaders who should be at thetable— Iwould suggest a solidmix offrontline physicians, informal physi-cian leaders, and elected physicians.On a similar note, physician selectionfor local planning initiatives shouldbe open and transparent, and accessi-ble to all whowant to be considered.

When planning meetings andconsultation sessions, it is vital thatthey are not scheduled at times thatconflict with patient care or thephysician’s practice. Patient care ispriority number one, and thereshould be recognition of the reali-ties of the physician’s work life.

Prior to engagement, it is impor-tant for organizations to understandthe “physician culture,” as failure todo so can be amajor barrier tomean-ingful engagement.

In some cases, health-care deci-

sion-makers can be distanced fromthe relationships with patients whoare in need of care; however, physi-cians have a primary and frontlineresponsibility to ensure the bestlevel of care for their patients.

For most physicians, their pri-mary focus is their practice and theirresearch, and therefore, they arecommitted first and foremost to thequality of care they deliver to theirpatients, and secondly to the “busi-ness” and paperwork of their prac-tices. This leaves little time to engagein other activities. Appropriate andsuccessful physician engagementstrategies must be compatible withthe realities of the physician’s worklife and schedule. Meetings can’toccur at 10 a.m. on weekdays.

From April 2007 to December2008, the OMA and the LHINs co-hosted more than 20 workshopsthat brought the medical commu-nity and LHIN leaders together toestablish an ongoing, meaningfuldialogue. More than 800 physicianshave participated.

It has also been recognized thathospital staff associations are excellentforums to advance hospital physi-cian/LHIN leadership discussions spe-cific to local issues and solutions.

In discussion on encouragingphysicians to be involved in planningprocesses, it’s important to emphasizethat while the final decisionsmay notbe exactly as the physicians wouldhave liked, at the very least, havingthe opportunity for input can go along way toward building respectfuland functional relationships.

Early andmeaningful involvementof physicians and developing a localphysician engagement plan will pro-duce positive results in health-careplanning, healthy physician rela-tions, and comprehensive, sustain-able local health-care solutions.

Dr. Suzanne StrasbergOMA President

Ontario Medical Review • June 200916 2Ontario Medical Review • March 2008

(continued from page 7)

FEATURE

10th Annual OMAWomen’s Health Care Seminar

Breakthroughs inWomen’sHealth:milestone event offers unique forum forwomenmembersto connect and participate in valuable CME sessions

by Dr. Joy WeisbloomChair, OMAOutreach to Women Physicians Committee

Hosted by the Outreach to WomenPhysicians Committee, the seminaris held each spring in conjunctionwith the OMA Annual General Meet-ing.The day-long event provides a

unique forum for women in medi-cine to connect with one anotherboth professionally and personally,while participating in valuable con-tinuing medical education sessions.The seminar also helps foster andstrengthen relationships betweenwomen physicians, medical resi-dents and students, and the OntarioMedical Association.To help celebrate this year’s mile-

stone 10th anniversary seminar —themed “Breakthroughs in Women’sHealth” — the Committee invitednoted neurologist, scientist, andCanada’s first female astronaut, Dr.Roberta Bondar, to deliver the key-note address.Dr. Bondar’s inspiring speech,

entitled “Through a Pale Blue Ceil-ing,” chronicled her many profes-sional accomplishments, includingher extraordinary journey on thespace shuttle Discovery in 1992. Shecaptivated audience members with apresentation that featured a slide-

show of incredible photographs fromher journey into space, as well as fas-cinating personal anecdotes.Dr. Bondar’s address was followed

by a series of clinical sessions focus-ing on advances and developments inthe areas of breast cancer diagnosisand management, cardiovascularcare, and the evolution of prenatalscreening in Ontario.Following are highlights from the

morning sessions:• Dr. Kala Sridhar, a medical oncol-ogist at Princess Margaret Hos-pital, discussed declining deathrates among women as a result ofseveral important breakthroughsin the screening, diagnosis andtreatment of breast cancer. Dr.Sridhar also presented the risk fac-tors of breast cancer, and providedexamples of early detection, andadvances in treatment.

• In a presentation entitled “Updateon Cardiovascular Disease inWo-men,” Dr. Michele Turek, deputyhead, division of cardiology,OttawaHospital, discussedpreven-tion, assessment and treatment ofcardiovascular disease — the lead-ing cause of death, morbidity andhospitalization among women.

• Dr. NanOkun, director of prenatalscreening at Mount Sinai Hospital,discussed advances in prenatalscreening in Ontario. Dr. Okunprovided a review of current stan-dards of prenatal care, and anoverview of pregnancy disordersfor which screening is applied.OMA President Dr. Suzanne Stras-

berg delivered a luncheon address toparticipants, emphasizing the needfor female participation in medicalpolitics and decision-making.“As female physicians comprise an

increasing proportion of practicingphysicians, it is essential that theyparticipate actively in policy discus-sions to ensure that their voices areheard, and to effect positive change,”said Dr. Strasberg.She also commented on the im-

portance of events like the Women’sHealth Care Seminar, which bringsphysicians, medical students and res-idents together in an environmentthat enables them to network, discussissues, and learn about female patientcare needs.The afternoon sessions focused on

mental health issues, stress manage-ment, medical incorporation, andwomen physicians in leadershiproles. Following are highlights fromthe afternoon sessions:• Dr. Marie-France Tourigny-Rivard,professor of psychiatry, Universityof Ottawa, presented a plenarysession on the topic of mental

Arecord-breaking 240 participants attended

the 10th Annual OMAWomen’s Health Care

Seminar, held April 30 in Toronto.

Ontario Medical Review • June 200918 1Ontario Medical Review • June 2009

health. Dr. Tourigny-Rivard, whois actively involved in the MentalHealth Commission of Canada (asthe expert in geriatrics), discussedthe five priorities and key projectsunderway by the Commission.She touched on her personal expe-riences, and on the importance ofparticipating in the Commission’sconsultations and activities.

• Adam Farber, OMA Legal Counsel,conducted an interactive work-shop on the topic of medical prac-tice incorporation. The sessionprovided an overview of medicalincorporation, and outlined theOMA incorporation services avail-able tomembers.

• Dr. Tatyana Barankin, physicianco-ordinator for the OMA Phy-sician Health Program, led aninteractive session on the topic ofstress management and life-workbalance for women physicians. Dr.Barankin touched on the impor-tance of improved knowledge andskills in stress management andthe prevention of burnout.

• Dr. JanetDollin associate professor,department of family medicine,University of Ottawa, conducted aleadership workshop for medicalwomen. The workshop exploredsome of the issues that remain asbarriers to women who assumeleadership roles in medicine. Dr.Dollin reflected on the leadershipskills she has gained in her career,and discussed the skills needed toovercome the obstacles to leadingeffective change.

AcknowledgmentsCongratulations to all the membersof the Outreach to Women Phy-sicians Committee on the resound-ing success of the 10th AnnualWomen’s Health Care Seminar.Once again, the seminar providedan excellent forum for showcasinginspiring female medical leadership,and advances in women’s healthcare.The members of the Outreach to

Women Physicians Committee are:Dr. Joy Weisbloom (Chair), Dr.Rachel Forman, Dr. Kelly Grant, Dr.

Cynthia Maxwell, medical studentobserver Nicole Hawkins, and OMABoard representative Dr. Gail Beck.Thank you to Dr. Suzanne Stras-

berg, and to all of the presenters andparticipants, for supporting thisseminar year after year. Thank youas well to all the OMA staff whohelped organize this event.The Committee looks forward to

offering another outstanding pro-gram for 2010.For more information on the 10th

annual Women’s Health Care Semi-nar, and to view the presentations intheir entirety, please visit the OMAwebsite (https://www.oma.org/Health/Womens_Issues/2009.asp).Formore information on theOut-

reach to Women Physicians Com-mittee, please contact CatherineFlaman, OMA Public Affairs andCommunication Department, at1.800.268.7215 or 416. 599.2580, ext.3114, or e-mail: [email protected]. OMR

Women’s Health Care Seminar


Canada’s first female astronaut, Dr. Roberta Bondar, delivered the keynote address at the10th Annual Women’s Health Care Seminar.

Members of the OMA Outreach to Women Physicians Committee (from left): medicalstudent observer Nicole Hawkins, OMA Board representative Dr. Gail Beck, Dr. Cynthia Maxwell,Committee Chair Dr. JoyWeisbloom, Dr. Rachel Forman, andDr. Kelly Grant.

PHOTOS:CPIMAGES/A.MAHARAJ

INDICATIONNEW

Fibromyalgia pain is real. And so is treatmentwith LYRICA.

LYRICA® C.P. Pharmaceuticals International C.V., owner/Pfizer Canada Inc., Licensee

2009

The effi cacy of LYRICA in the management of pain associated with fi bromyalgia for up to 6 months was demonstrated in a placebo-controlled trial in patients who had initially responded to LYRICA during a 6-week open-label phase.There have been post-marketing reports of angioedema in patients, some without reported previous history/episodes, including life-threatening angioedema with respiratory compromise Caution should be exercised in patients with previous history/episodes of angioedema and in patients who are taking other drugs associated with angioedema.In clinical trials and in post-marketing expe-rience, there have been reports of patients, with or without previous history, experiencing renal failure alone or in combination with other medications. Caution is advised when prescribing to the elderly or those with any degree of renal impairment.The most commonly observed dose-related adverse events in LYRICA-treated patients were: dizziness (22.7-46.5%), somnolence (12.9-20.7%), weight gain

References: 1. LYRICA Product Monograph. Pfi zer Canada Inc., March 2009. 2. Mease PJ et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fi bromyalgia. J Rheumatol 2008;35:502-14.

* A multicenter, double-blind, 13-week, randomized trial. 748 patients who met the ACR criteria for fi bromyalgia and who had an average mean pain score of ≥4 on an 11-point numeric rating scale (NRS) during the baseline assessment were randomized to LYRICA 300 mg/day (n=185), 450 mg/day (n=183), 600 mg/day (n=190), or placebo (n=190). Patients were allowed to take acetaminophen up to 4 g/day as needed for pain relief. The number of completers was: LYRICA 300 mg/day (n=123), 450 mg/day (n=121), 600 mg/day (n=111), or placebo (n=130). The primary endpoint was the reduction in endpoint mean pain scores (mean of the last 7 daily pain scores while on study medication). Pain-related sleep diffi culties were assessed using the Medical Outcomes Study-Sleep Scale (MOS-SS), a scale that runs from 0-100. Mean baseline MOS-SS score for overall sleep problem index was 65.0.

(7.6-13.7%), peripheral edema (5.3-10.8%). The most commonly reported (≥5% and twice the rate of that seen in placebo) treatment-related adverse events were: dizziness (37.5%), somnolence (18.6%), weight gain (10.6%), dry mouth (7.9%), blurred vision (6.7%), and peripheral edema (6.1%). Adverse events were usually mild to moderate in intensity. Discontinuation rates due to adverse events for LYRICA and placebo, respectively, were 20% and 11%. There was a dose-dependent increase in rate of discontinuation due to adverse events.

LYRICA is contraindicated in patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.

Dosage reduction is required in patients with renal impairment (creatinine clearance <60 mL/min) and in some elderly patients as LYRICA is primarily eliminated by renal excretion.

See Prescribing Information for complete Warnings and Precautions, Adverse Reactions, Dosage and Administration and patient selection criteria.

50K

YRE-DP8-OMR.indd 1 4/14/09 3:18:33 PM

See prescribing summary on page 48

LYRICA is the fi rst treatment indicated in Canada for the management of pain associated with fi bromyalgia in adults

1

2

=== 2*

50K

YRE-DP8-OMR.indd 2 4/14/09 3:18:11 PM

FEATURE


The Ontario Medical Association played host to approximately 200

physician honorees, their families, friends and colleagues at the recent

gala dinner and awards presentation, held during the 129th Annual

General Meeting in Toronto. The following photo feature highlights the

award recipients by category. Individual profiles of all the winners appear in

the 2009 Honours and Awards booklet posted on the OMA website

(https://www.oma.org/Info/Awards/Awards_2009.pdf).

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From left: Master of Ceremonies Dr. Janice Willett, Canadian Medical Association President Dr. Robert Ouellet,incoming OMA President Dr. Suzanne Strasberg, and OMA Past President Dr. Ken Arnold at the 129th OMAHonours and Awards Ceremony.

2009Honours&Awards

2009 OMA Awards Ceremony


OntarioMedical Association LifeMembership AwardsOMA Life Membership is awarded to those members who have made an outstanding contribution to the work ofthe Association, the medical profession and medical science, or common good at the provincial level, and havereached the age of 65 as of December 31 in the year preceding the OMA Annual Meeting that the awards are to bepresented. Under exceptional circumstances, candidates under 65 years of age may be considered. This year’srecipients are shown below.

Dr. John M. BonnBrighton

Dr. John MakiSudbury

Dr. Simon Odonnell McCallHawkesbury

Dr. Robert J.R. McKendryOttawa

Dr. Eric MendumHavelock

Dr. Michael David WymanWillowdale

Dr. Romas Vincent StasAjax

Dr. Wilfred M. SteinbergToronto

Dr. Donna StewartToronto

Presidential AwardThe Presidential Award is awarded in recognition ofexceptional and long-standing humanitarian service tothe greater community (in Ontario or elsewhere) thatbrings honour to the medical profession. The awardrecipient by his or her actions expresses the highestqualities of service by a physician that we all admire.This year’s recipient is Dr. Peter R. Newman.

Dr. Peter R. NewmanNorth York



OntarioMedical AssociationHonoraryMembershipHonorary membership is awarded for having achievedeminence in science and/or humanities such as outstand-ing service to the OMA, the medical profession, medicalscience or common good at the provincial level. This year’srecipient is Mr. Stewart Saxe, a Partner at Baker & McKenzieLLP Toronto, who served as lead negotiator/negotiationsadviser for the OMA Negotiations Committee.

Mr. Stewart SaxeToronto

T.C. Routley Challenge Shield RecipientThis year’s recipient of the T.C. Routley Challenge Shield Award is the Kitchener-Waterloo Academy of Medicine. Donated in 1947 by Dr. T. Clarence Routley, thefirst full-time secretary of the OMA from 1918 to 1938, the Shield is awarded tothe Branch Society which, through its programs and activities, most adequatelyfulfils the objectives of service to its members, its community, and the medicalprofession.

CanadianMedical AssociationHonoraryMembershipAwards forOntarioMembersCMA Honorary Membership is awarded to those memberswho have made outstanding contributions to the CMA onits Board of Directors, Committees, General Council or toCanadian medicine. CMA Honorary members fromOntario are nominated by the Board of Directors of theOMA, and elected by unanimous vote of the Board ofDirectors of the CMA. Members will have reached the ageof 65 and have been active members of the CMA for thepreceding 10 years. This year’s recipients are Dr. WilliamTucker and Dr. Michael Wyman (opposite).

Dr.William Stewart TuckerToronto

Dr. Michael David WymanWillowdale

Resident Achievement AwardThe Resident Achievement Award is awarded for outstanding contribution to theadvancement of postgraduate training. This year’s recipients are Dr. Jennifer Flemming(Queen’s University), Dr. Jean-Pierre Martel (University of Western Ontario), andDr. Alim Pardhan (McMaster University).

Dr. Jennifer FlemmingKingston

Dr. Jean-Pierre MartelLondon

Dr. Alim PardhanHamilton



2009OMAAward Recipients

CanadianMedical AssociationHonoraryMembership Awards for OntarioMembers

Dr. William Stewart Tucker, Toronto

Dr. Michael Wyman,Willowdale

OntarioMedical AssociationLifeMembership Awards

Dr. John M. Bonn, Brighton

Dr. John Maki, Sudbury

Dr. Simon Odonnell McCall,Hawkesbury

Dr. Robert J.R. McKendry,Ottawa

Dr. Eric Mendum,Havelock

Dr. Romas Vincent Stas,Ajax

Dr. Wilfred M. Steinberg, Toronto

Dr. Donna Stewart, Toronto

Dr. Michael Wyman,Willowdale

OntarioMedical AssociationHonoraryMembership

Mr. Stewart Saxe, Toronto

Presidential Award

Dr. Peter R. Newman,North York

Resident Achievement Award

Dr. Jennifer Flemming,KingstonQueen’s University

Dr. Jean-Pierre Martel, LondonUniversity of Western Ontario

Dr. Alim Pardhan,HamiltonMcMaster University

T.C. Routley Challenge Shield Recipient

The Kitchener-Waterloo Academyof Medicine

Glenn Sawyer Service Award Recipients

Dr. William Caughey, Bracebridge

Dr. Raphael Cheung,Windsor

Dr. Michael Green, Port Hope

Dr. Melvin Goldberg,North York

Dr. Harry Hall,Orillia

Dr. Garry Humphreys, Peterborough

Dr. Claire Perreault, Sudbury

Dr. Dennis Pitt,Ottawa

Dr. Leslie Solomon,Hamilton

Dr. Dany Tombler,Cornwall

Dr. Paul Willoughby,Woodstock

Dr. John Derek Wyant, Thunder Bay

Dr. Sheila-Mae Young, Lindsay

Dr. Paul Zalan, Toronto

Community Service Award

Mr. E.G. Sean Adams,Cornwall

Ms. Maureen Harris, Simcoe County

Ms. Sheelagh Hendrick, Thunder Bay

Mr. Richard Levert, Sudbury

Ms. Marita Zafirro,Hamilton

Medical Student Achievement Award

Adrian Edgar,HamiltonMcMaster University

Nicole Hawkins,KingstonQueen’s University

FEATURE

Disability Income Insurance:a primer for OMAmembers

by OMA Insurance Services Department

Q. If I become disabled, when does thebenefit payment begin?A. The elimination period (EP) repre-sents the waiting period between theonset of an illness or injury and whenyou become entitled to benefits. Thebenefit payment begins on the dayfollowing the completion of the EP.You have a choice of several elimina-tion periods — 30 days, 60 days, 90days, etc. The longer the EP, the lowerthe cost of your coverage. Physiciansshould review their budgets to deter-mine how long they can weather ashortfall in income. This will helpdecide whether you should opt for ashorter waiting period, or if a longerone will suffice. It’s important toknow that whatever EP you choose,your first payment will likely be twoto four weeks later, therefore, youmust plan for this extra time accord-ingly.

Q. What is my benefit period?A. Most disability plans designed forthe professional market provide sick-ness or injury benefits until yourecover, or reach age 65, for claimscommencing prior to age 63.

Q. What is the definition of total dis-ability?A. Total disability means you are:• Unable, as a result of illness or

injury, to perform the substantialand material duties of your regularoccupation;

• Under the regular care of a physi-cian; and

• Not engaged in any other gainfuloccupation.

Q. What is the definition of residual dis-ability?A. If you are not totally disabled butsuffer a loss of earned income of at

least 20% due to sickness or injury,residual benefits are payable. Forexample, if your earned income wereto be reduced by 40%, you wouldreceive 40% of your total disabilitybenefit.

Q. Are there other optional benefits thatmay be purchased?A. In addition to the standard featuresdescribed above, the following bene-fit provisions are available as optionalriders that may be purchased:• Own Occupation Rider— The Own

Occupation Rider allows you to beconsidered totally or partially dis-abled from your regular occupa-tion, even if you find work inanother occupation or field ofmedicine. You may be gainfullyemployed in an occupation otherthan your regular occupation andstill receive partial or total disabil-ity benefits. This rider terminatesat age 65. Your occupation for thepurpose of the Own OccupationRider will be determined at thetime of a claim by what you weredoing immediately prior to theonset of disability. What is beinginsured is not any specific occupa-tion, but rather the duties youwere performing prior to becom-ing disabled.

Q. Do I really need the Own Occup-ation Rider?A. Remember the standard defini-tion (Regular Occupation) providesbenefits if you cannot perform theessential duties of your regular occu-

Imagine how your life and goals would change in

the event of a disability. Your ability to earn an

income is one of your most important assets.

Disability income insurance is designed to help

protect you and your family by providing a source

of monthly income if a sickness or injury prevents

you from working. Disability insurance is a com-

plex product. Following is a brief overview to help

you obtain the coverage you need.


pation and you are not working atanything else. You should give con-sideration to how likely it might bethat you would be unable to per-form the essential duties of youroccupation but still be able to work(or want to work) at some otheroccupation.

• Cost of Living Adjustment (COLA)Rider— This rider is designed toindex monthly disability incomebenefits during a period of total orresidual disability based on thechange in the Consumer PriceIndex up to a set maximum rateper year.

• Guaranteed Insurability Benefit(GIB) Rider — The GIB (some-times referred to as Future IncomeOption) rider allows you toincrease your monthly disabilityincome coverage in the future (ageand amount restrictions apply,depending on the plan) withoutproviding evidence of good health.Your income will determine youreligibility.

• Retirement Protection Rider (RPR)— This rider is designed to con-tribute benefits above and beyondyour monthly disability incomebenefit amount into a non-regis-tered retirement savings plan dur-ing a period of total disability. Itprovides you with the security ofbeing able to continue to save forretirement during a prolongedperiod of total disability.

Q. How do I apply for coverage?A. The OMA Insurance ServicesDepartment would be pleased toanswer your questions and addressyour insurance needs. Please contact416.340.2252 or toll-free 1.800.268.7215 and press 0; via e-mail:[email protected]; or visit: www.o m a i n s u r a n c e . c o m > G r o u pInsurance>Disability Insurance.

Note: This material is designed to pro-vide a broad general overview. Beforeyou make a decision to purchase orreplace existing coverage, you should askfor a detailed analysis of the provisions ofthe coverage contemplated. OMR

Disability Income Insurance

Ontario Medical Review • February 20062 27Ontario Medical Review • June 2009

Disability Insurance Coverage:Important Reminder

The OMA is active on many fronts addressing member concerns

related to the College of Physicians and Surgeons of Ontario (CPSO)

mandatory questioning of physician serological status on its annual

registration renewal form.

Some of our discussions have focused on the issue of disability. The

OMA Board of Directors wants to ensure that members are well in-

formed, and also well protected.

In our revised OMA Principles Regarding Physicians and Blood Borne

Pathogens, all physicians are encouraged to maintain adequate dis-

ability insurance that will provide necessary support and coverage in

the event that they are:

• Disabled by a blood borne disease, or

• Not disabled by a disease, but subject to imposed practice restrictions.

The Board wants to remind all members that appropriate and ade-

quate disability insurance coverage is vital to protect your income in

the event of illness or injury.

The OMA Insurance Services Department recently circulated an infor-

mation letter to all members that provided important details about

disability insurance. These letters were mailed May 28. Please take the

time to review the information and contact the OMA if you have any

questions or concerns. You may also refer to the OMA Insurance web-

site for additional information (http://www.omainsurance.com/).

Note: The Canadian Medical Protective Association (CMPA) suggests

that if you have any individual concerns regarding the mandatory

questions on the CPSO application forms, or if you receive a follow-

up letter from the College questioning your completion of the forms

or your compliance with the policy, please contact the CMPA for

advice at 1.800.267.6522/613.725.2000, or e-mail (feedback@

cmpa.org).

Dr. Suzanne Strasberg

OMA President

FEATURE

Physicians encouraged to adopt standardized designation

Newprovincial Alternate Level of Caredefinitioneffective July 1:measure aims to facilitate real-time data capture,improve patient flowand ER/ALCwait times

by Peter Nord, MD

We know that this has been an issuefor decades, but with the recent gov-ernment focus on ER wait times,there now is the political will toaddress this problem.

The term Alternate Level of Care(ALC) is a clinical designation thatidentifies patients who no longerrequire the intensity of resources orservices provided in their currentsetting and are waiting for an alter-nate level of care.

ALC patients often wait weeks,months, and sometimes years inacute and post-acute hospitals fortransfer to an alternate level of care.

This in turn prevents other patientsfrom accessing these beds and receiv-ing care in a timely manner.

According to the Canadian Insti-tute for Health Information (CIHI),ALC patients accounted for 18% ofall acute care hospital days in On-tario during October to December2008.

This is most likely an underestima-tion of the percentage of beds occu-pied by ALC patients, as limited dataare available on ALC patients waitingin post-acute hospitals, and there isno standardized approach for desig-nating patients across Ontario.

The Ministry of Health and Long-Term Care (MOHLTC) is imple-menting a number of initiatives toreduce ER/ALC wait times; however,it has become evident that to makesignificant progress in this area, wemust have timely and reliable dataon ALC patients in all acute andpost-acute hospitals in Ontario.

To do this, the Wait Time Infor-mation System (WTIS), which cur-rently captures wait times for surgeryand diagnostic imaging, will be ex-panded to capture ALC wait times in92 acute and 21 post-acute hospitalsby 2011. This will capture data on95% of acute care beds and 96% ofrehabilitation, complex continuingcare, and mental health beds in theprovince. However, before we cancapture near-real time ALC data inOntario, we need to ensure that clin-icians are designating patients ALCconsistently in acute and post-acutehospitals across the province.

On behalf of the Ministry andeHealth Ontario, the Wait TimeInformation Program (WTIP) atCancer Care Ontario has led thedevelopment of a Provincial ALCDefinition and is working with allacute and post-acute hospitals to

Moving patients efficiently through our

health-care system is perhaps the greatest

challenge we currently face in Ontario.

The inability to move patients through the contin-

uum of care has a number of consequences, as it

compromises the availability of beds, increases

emergency room (ER) wait times, increases elec-

tive surgical cancellations, and limits hospital

surge capacity.


(continued on p. 30)

adopt the definition by July 1, 2009.This definition was developed inconsultation with stakeholders fromacute care, mental health, complexcontinuing care, rehabilitation,Community Care Access Centres(CCACs), MOHLTC, Local HealthIntegration Networks, CIHI, theOntario Hospital Association, andthe Ontario Health Quality Council.The definition was developed to beapplicable across the continuum ofcare, for all patient populations. Itwas also designed to be easilyapplied by clinicians as it containssupporting notes on when to con-sider ALC designation.

As physicians, we need to take aleadership role in adopting thisstandardized definition as it willallow us to capture accurate ALCdata to identify gaps in services andresources in our hospitals and com-munities. Once we have this data,we will be able to ensure that re-source allocation decisions are madeto address the needs of our patients.

Designating patients ALC is aclinical decision that requires yourjudgment and expertise to ensurethat it is applied correctly. As theWTIP Physician Champion for ALC,I encourage you to become familiarwith the provincial definition (seesidebar, right) and to adopt it intoyour practice as of July 1, 2009.

To support the adoption of thedefinition, an ALC Site Lead hasbeen identified at every hospital inOntario, and they have been pro-vided with support materials andcase studies on the provincial defini-tion. If you have any questions,please contact your ALC Site Lead ore-mail: [email protected], or visit the Canacer CareOntario website (http://www.can-cercare.on.ca/ocs/alc). OMR

Dr. Peter Nord is V.P. Medical Affairsand Chief of Staff, Providence Health-care, and Wait Time InformationProgram Physician Champion for ALC.

Provincial ALC Definition


Provincial Alternate Level of Care (ALC) Definition

The ALC definition applies to all patient populations waiting in allpatient care beds in an acute or post-acute care hospital in Ontario.The health-care system aspires to deliver care in a setting that is con-gruent with the clinical needs of a patient as defined by the patient’shealth status, treatment plan and goals. The provincial ALC definitionis as follows:

DefinitionWhen a patient is occupying a bed in a hospital and does not require theintensity of resources/services provided in this care setting (Acute,Complex Continuing Care, Mental Health or Rehabilitation), thepatient must be designated Alternate Level of Care (ALC)1 at that time bythe physician or her/his delegate. The ALC wait period starts at the timeof designation and ends at the time of discharge/transfer to a dischargedestination2 (or when the patient’s needs or condition changes and thedesignation of ALC no longer applies).

Note 1The patient’s care goals have been met or• progress has reached a plateau or• the patient has reached her/his potential in that program/level of careor• an admission occurs for supportive care because the services are notaccessible in the community (e.g., “social admission”).

This will be determined by a physician/delegate, in collaboration withan interprofessional team, when available.

Note 2Discharge/transfer destinations may include, but are not limited to• home (with/without services/programs),• rehabilitation (facility/bed, internal or external),• complex continuing care (facility/bed, internal or external),• transitional care bed (internal or external),• long-term care home,• group home,• convalescent care beds,• palliative care beds,• retirement home,• shelter,• supportive housing.

This will be determined by a physician/delegate, in collaboration withan interprofessional team, when available.

Final NoteThe definition does not apply to patients:• Waiting at home,• Waiting in an acute care beds/services for another acute care bed/ser-

vice (e.g., surgical bed to a medical bed),• Waiting in a tertiary acute care hospital bed for transfer to a non-ter-

tiary acute care hospital bed (e.g., repatriation to community hos-pital).

FEATURE

LobbyDay2009atQueen’s Park:Ontariomedical students and residentsmeetwithMPPs during annual event

by Nicole Hawkins, Queen’s University Med Class 2009Andrew Vellathottam, University of Western Ontario Med Class 2009

This year’s event, entitled “How toCampaign an Idea,” was hosted bythe Ontario Medical Student Asso-ciation (OMSA) and the OMA, withsupport from the Professional Asso-ciation of Internes and Residents ofOntario (PAIRO).In preparation for Lobby Day,

participants gathered at the newOMA office on Sunday, April 19, totake part in a day-long communica-tions and advocacy training session,where they received instruction onthe tools needed to deliver a solid,unified message to MPPs.Dr. Robert Conn, CEO of PAIRO,

and founder of the Canadian InjuryPrevention Foundation (known asSmartRisk), led a session on com-munication fundamentals, and howto effectively target a message.Drs. Mark Preston, Andrew Toren

and Melise Keays of PAIRO thenwalked participants through keyissues, and gave them a chance torole-play a meeting with an MPP.CTV Queen’s Park anchor Paul Blisswas also on hand to share his knowl-edge on the world of media.Monday morning began with a

tour of Queen’s Park, including thelegislative chamber and the galleryof the Speaker’s throne. Throughoutthe day, students had an opportu-nity to to meet with their MPPs.Special lunch guest Dr. Kuldip

Kular, Parliamentary Assistant to theMinister of Health and Long-TermCare, delivered a keynote address onprovincial politics and the impor-tant role of health care.Dr. Joshua Tepper, the Assistant

Deputy Minister of Health HumanResources Strategy, and a family

physician, spoke on the value ofmedical student and physician lead-ership.OMA President Dr. Suzanne

Strasberg also spoke to participantsabout the importance of being aleader and getting involved.Elizabeth Witmer, Progressive

Conservative Party Health Critic,and France Gelinas, New Demo-cratic Party Health Critic, discussedtheir respective party policies, andthe changes they would like to see toOntario’s health-care system.The day ended with a reception

featuring Ontario Premier DaltonMcGuinty, who took time to speakdirectly with participants.OMA CEO Jonathan Guss also

spoke, congratulating participantson their advocacy work with respectto resident interest relief.On behalf of the OMSA, OMA,

and PAIRO, we would like to thankall MPPs and participants for theeffort that went into making thisevent such a success.For more information, contact

Catherine Flaman, OMA PublicAffairs and Communications De-partment, at 1.800.268.7215, ext.3114, or by e-mail ([email protected]).Photo highlights from the event

appear opposite. Additional photosare posted on the OMA website(www.oma.org).

OMR

Ontario medical students and residents deliv-

ered a strong message to members of provin-

cial parliament during the annual Lobby Day

at Queen’s Park, held April 20. Participants called

on MPPs to ensure equal access to medical school

by regulating tuition fees, and increasing Ontario

Student Assistance Program funding levels to reflect

the true cost of a medical education.

Ontario Medical Review • June 200932 1Ontario Medical Review • February 2006

OMA Lobby Day 2009

Ontario Medical Review • February 20062 33Ontario Medical Review • June 2009

Nearly 40 Ontario medical students and residents attended the recent Lobby Day at Queen’s Park. The group delivered a strong call for equalaccess tomedical education for all students. The day included a talk fromOntario Premier DaltonMcGuinty, andmeetings with MPPs.

Ontario Premier Dalton McGuinty (right) and OMA CEO JonathanGuss addressed medical students and residents about maintainingidealism as they prepare to begin their careers as physicians.

From left: Thornhill MPP Peter Shurman meets with Lobby Daymedical student participants StevenWong and Katie Armstrong ofthe University of Toronto.

Queen’s University medical students pose with MPPs. From left:Chris Brown, Willowdale MPP David Zimmer, Eric Mutters, MelissaPickles, Richmond Hill MPPMoridi Reza, and Alex Atfield.

Students and residents had the opportunity to enact a session ofparliament, with participants representing different political parties.

ALLIM

AGES:Richard

Bell,www.rickbell.com

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PROVINCIAL ALTERNATE LEVEL OF CARE (ALC) DEFINITION

On July 1, 2009, all acute and post-acute hospitals inOntario will begin using a standardized ProvincialAlternate Level of Care (ALC) Definition to designatepatients.

The Wait Time Information Program at Cancer CareOntario (CCO) was asked by the Ministry of Health andLong-Term Care to lead the adoption of the ProvincialALC Definition, and to support Ontario hospitals uponimplementation. CCO worked with an array of health-care stakeholders, and in March 2009, the ALC definitionwas approved by the Ministry. Detailed information forphysicians appears on pages 29-30 of this issue.

OMA Staff Contact: Jenn Yiokaris (ext. 2883)

CANCER SYSTEMQUALITY INDEX AND CANCER CARE ONTARIO

On April 28, 2009, Cancer Care Ontario, through itsCancer System Quality Index (CSQI), launched the 2009Cancer System Quality Indicators. This representsOntario’s fifth annual update on the performance of thecancer system. The CSQI tracks Ontario’s progressagainst cancer, and illustrates where quality and perfor-mance improvements are needed. It also reports on 28evidence-based quality measures covering every aspect ofcancer control, from cancer prevention to end-of-lifecare. The CSQI website (www.csqi.on.ca) lists eachindicator by its Local Health Integration Network(LHIN), and includes cancer statistics in each LHIN.

OMA Staff Contact: Jenn Yiokaris (ext. 2883)

BILL179—ANACTTOAMENDREGULATEDHEALTHPROFESSIONSSTATUTES

OnMay 11, the Minister of Health and Long-Term Careintroduced Bill 179, An Act to Amend Regulated HealthProfessions Statutes, in the legislature. The bill wouldamend 15 health profession acts, including chiropody,chiropractic, dental hygiene, dietetics, massage therapy,medical radiation technology, medicine, midwifery,naturopathy, nursing, optometry, pharmacy, physiother-apy, psychotherapy and respiratory therapy. The billwould also amend several pieces of related health legisla-tion, including the Regulated Health Professions Act.

The legislative changes that have been introduced setthe framework for expanded scopes of practice for eachhealth college affected. The OMAwill be actively involvedin commenting on the bill as it moves through legislature.While the OMA believes certain legislative changes con-tained in Bill 179 provide professions with overly broadpowers, the Ministry indicates that a number of regulatorylimitations will be placed on these provisions.

The OMA will carefully review and respond to the pro-posed regulatory changes as they become available.

OMA Staff Contact:Ada Maxwell (ext. 2942)

FINANCIAL SERVICES COMMISSIONOF ONTARIO REPORT—AUTO INSURANCE RECOMMENDATIONSOnMarch 31, 2009, the Financial Services Commission ofOntario (FSCO) released the “Report on the Five YearReview of Automobile Insurance.”

Health Policy Report

A summary of current health legislation and policy developments

•Provincial Alternate Level of Care (ALC)Definition•Cancer SystemQuality Index and Cancer Care Ontario•Bill 179—AnAct toAmendRegulatedHealthProfessions Statutes•FSCOReport—Auto Insurance Recommendations•Mandatory Reporting

by OMAHealth Policy Department

This document contains a number of recommendationsthat would significantly change the current structure formotor vehicle injury claims. The OMA has submitted aresponse to the Minister of Finance, who is reviewingFSCO’s recommendations.

FSCO suggests that assessment requests and treatmentplans should only be completed after a referral is madeby the health professional primarily responsible for theclaimant’s rehabilitation. In most instances, this will be afamily physician. However, the actual role the physicianmust play in the new claims process is still unclear. Thisneeds to be specifically defined.

FSCO has also recommended limiting the costs ofassessments and the fees associated with the completionof auto insurance forms. The impact of these financiallimitations on physicians remains uncertain, and theOMA cautions against taking such a step. Physiciansshould retain their discretion to set appropriate paymentschemes as outlined by the “OMA Physician’s Guide toThird Party and Other Uninsured Services.”

Finally, FSCO suggests that the maximum medicaland rehabilitation benefit available by regulation bereduced from $100,000 to $25,000. The OMA has indi-cated that the proposed threshold is simply too low toaccommodate claimants who have sustained a serious

injury. We will keep physicians informed of any furtherdevelopments.

OMA Staff Contact: Juhee Makkar (ext. 2978)

MANDATORY REPORTING

In April, the College of Physicians and Surgeons ofOntario (CPSO) amended its policy on MandatoryReporting in response to legislative changes that will comeinto effect with the Health Systems Improvement Act(HSIA). The HSIA amends the Regulated Health Pro-fession Act and requires that persons who operate healthfacilities report instances of incapacity and incompetenceof health professionals working in that facility. Previously,facility operators were only required to report instances ofsexual abuse by health professionals. As of June 4, 2009,when the HSIA came into force, facility operators, includ-ing physicians, are now equired to report if they have rea-sonable grounds to believe that a regulated healthprofessional practising at the facility is incompetent, inca-pacitated or has committed an act of sexual abuse.Physicians should be aware that the term “facility”includes private clinics.

OMA Staff Contact:Ada Maxwell (ext. 2942)OMR

Health Policy Report


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Maybe it’s time to geta second opinion.

With home delivery, classified advertis-ing in theOntarioMedical Review reachesabout 24,500 physicians, interns & resi-dents, &medical students eachmonth.The OMR publishes classified adver-tisements in the following categories:

RATES: $50 minimum for the firstfour lines; $5.00 each additional line;each line based on approximately 35spaces/characters, $5 for box number.

DEADLINES: Classified ads must bereceived in writing by the 10th of eachmonth prior to the month of publica-tion. Notice of cancellation must besubmitted in writing by the 10th ofthe month prior to publication.

REGULATIONS: The Ontario MedicalReview reserves the right to makeeditorial changes to classified ads.

The OMR does not assume responsi-bility for claims or offers made inclassified ads and urges readers toinvestigate thoroughly any opportu-nities advertised.

The OMR complies with the provi-sions of the Ontario Human RightsCode 1981 in its editorial and adver-tising policies.

Please contact:Margaret Lam416.340.2263or1.800.268.7215,ext.2263E-mail: [email protected]

ADDED VALUEOMR Classified Advertisementsare posted online:OMAWebLink@ http://www.oma.org

• Office Space• Real Estate• Locum Tenens• Positions Vacant• Practices• Services Available• For Sale• Upcoming Events• Miscellaneous

WithOMRClassifieds,yourmessage...

HITSHOME!HITSHOME!

Take advantage of the Pregnancy and Parental Leave BenefitsProgram (PPLBP) which allows you to take paid time away from yourpractice. Part of the wonder of parenting is experiencing the changesyour child goes through during his or her first few months at home.Don’t miss out on these precious milestones — apply for the PPLBP.

To find out more information about this program,including eligibility requirements, please visitwww.oma.org/Membership/Programs/pplbp.aspor call 416.340.2896.

Learn and grow together.

Are you thinking of startingor adding to your family?

Practice ManagementOMAMEMBER SERVICES

Starting your own medical practice:exploring the perils, pitfalls, and rewards

by Grant Lum, MD

There are many things you need tothink about when establishing yourown medical practice, and eachpractice is different. Following is anoverview of some of the matters thatrequire careful consideration beforemoving forward.

First, you need to determine yourpersonal and professional goals.Once you have a vision of what youwant to achieve, you’ll need tochoose a community in which topractise. Part of that decision will bebased on where you plan to live,and whether you want to commute.

Are you big city, small town, orsuburban by nature? Do you want towork in an underserviced area (wherethere may be practice incentivesavailable)? If so, then what aboutaccess to other physicians and diag-nostic equipment, etc? Are you plan-ning an academic practice, with tiesto a large teaching hospital, or doyou want admitting privileges in acommunity hospital?

You’ll also need to assemble agood advisory team of professionals

to draw on, including an accoun-tant, financial planner, corporatelawyer, employment lawyer, possi-bly a real estate lawyer, a leasingagent, and business advisor, consul-tant or coach, to help you realizeyour vision.

Once you’ve identified your pre-ferred practice type, and the com-munity you’d like to work in, thenthere are business considerations tothink about, such as choosing a spe-cific practice location, and findingout whether there are any “compet-ing” practices nearby.

After you’ve selected your ideallocation, the next step is to negotiateyour lease. You’ll need to considerseveral issues, including net rentalcosts, taxes, maintenance and in-surance costs, the lease term, thelandlord’s responsibilities, your re-sponsibilities, liability issues, hoursof operation, subleasing, etc.

Usually, during the lease negotia-tion process, or once the lease is set-tled, you will need to plan the layoutof your practice space. You should

hire an office designer or architect todraw the plans, and then obtainquotes from contractors to completeconstruction. Using a reference fromtrusted friends or colleagues is al-ways the best option, however, if youdon’t have that luxury, then speak-ing to a contractor’s previous clientsabout their experience, and actuallylooking at some completed projects,is a good way to evaluate a contrac-tor’s work.

To help guide you in the layoutplanning process, you should givecareful consideration to the flow ofpeople (i.e. patients and staff) andthings (e.g., equipment, furniture)within and around the practicespace. Your designer, architect, inte-rior decorator, and even a feng shuispecialist, can provide valuableinput at this stage.

You will need to set up varioushardware systems, for example, tele-phone, debit/credit, fax, photocopier,and computers (for scheduling,billing, accounting, and possiblypatient records).

So you decided to take the plunge and start your own medical practice. You’re in

the minority these days. Most new graduates look to join an existing

practice. But if you’re an individualist, who wants to see your vision come

to fruition, it can be a bit like running a marathon: hard work, but satisfying!

Ontario Medical Review • June 200938

39Ontario Medical Review • June 2009

If you don’t use an electronicmedical record (EMR) system, you’llneed a filing system — this could beas simple as a single filing cabinet,or as elaborate as a system of rollingfloor-to-ceiling shelving units in-stalled on their own tracks.

You will need specific medicalequipment, supplies, and furniture,as well as general office supplies andfurniture. You must also set up ser-vices for office cleaning, biohazarddisposal, and maintenance for yourequipment.

You’ll need to hire staff and im-plement a human resources planthat determines roles and responsi-bilities, office policies and proce-dures, and codes of conduct — bothfor yourself and your staff.

Finally, you’ll have to find pa-tients. This just might be the easiestpart of this whole process!

Speaking from personal experi-ence — and I’ve been through thisenough times to know — setting upyour own medical practice is neveras easy as it first seems; it’s alwaysmore rewarding when it’s done thanwhen you’re in the process of doingit; and it’s worth the time and effortto build something you’re proud of,that looks, feels and works the wayyou want it to.

Good luck!OMR

Dr. Grant Lum is a sportsmedicine physician, andMedical Director of Athletic Edge SportsMedicinein Toronto.

The Practice Management column isprovided by the OMA Member ServicesDepartment. Physicians with questionsabout practice management, or who re-quire confidential assistance on specificissues related to practice management,are encouraged to contact the OMAPractice Advisory Service at 416.340.2911, or 1.800.268.7215, ext. 2911,or e-mail: [email protected].

Are there any rules about accepting newpatients inmypractice?

Yes. The College of Physicians and Surgeons of Ontario (CPSO) has

developed a helpful document, entitled “Accepting New Patients:

Frequently Asked Questions About Policy,” that sets out expectations for

physicians when accepting new patients. A copy of this FAQ document is

posted on the CPSO website at: http://www.cpso.on.ca/uploadedFiles/

downloads/cpso documents/policies/policies/Accepting_qa.pdf. The

CPSO Policy for Accepting New Patients can also be found online at:

http://www.cpso. on.ca/policies/policies/default.aspx?ID=2506

Ten things to considerwhen starting a practice

1. What are your personal and professional goals?

2. What is your ideal office location and design?

3. Have you obtained all relevant licences/memberships (e.g., CPSO,

OMA, OHIP Billing Number, hospital privileges, etc.)?

4. Do you require financing? Have you spoken to a financial advisor?

5. Have you determined your insurance needs? You’ll require malprac-

tice insurance (contact the Canadian Medical Protective Association),

business and personal insurance. OMA Insurance is an excellent

source for more information (contact: [email protected]).

6. Have you determined how many staff you will need to run an effec-

tive practice?

7. Have you selected professional advisors (e.g., accountant, lawyers,

etc.)?

8. Have you thought about the medical office systems you will require

(e.g., filing system or electronic medical record system, telephone sys-

tem/service provider, accounting/billing system, etc.)?

9. Will you lease or purchase medical supplies, equipment and furni-

ture (e.g., exam beds, diagnostic equipment, etc.)?

10. Have you established a source(s) for office supplies, equipment and

furniture (e.g., prescription pads, appointment/business cards, let-

terhead, desks, waiting room chairs, etc.)?

H

AJAXHilton Garden Inn Toronto/Ajax

BARRIEComfort Inn & Suites

BELLEVILLEBest Western BellevilleFairfield Inn and Suites by MarriottRamada Hotel, Resort and Conference Centre

BURLINGTONHomewood Suites by Hilton Burlington

CAMBRIDGEHilton Garden Inn Kitchener/CambridgeHomewood Suites by Hilton Cambridge-Waterloo

COBOURGBest Western Cobourg Inn

COLLINGWOODTyrolean Village Resorts at Blue Mountain

CORNWALLBest Western Parkway Inn & Conference Centre

GANANOQUEColonial Resort & Spa

GRIMSBYCasablanca Winery Inn

HAMILTONSheraton Hamilton Hotel

MUSKOKA & AREADeerhurst ResortDelawana Inn Spa & Conference ResortDelta Grandview Resort

KINGSTONAmbassador Conference ResortFour Points Hotel & Suites by Sheraton KingstonHoliday Inn Kingston-WaterfrontRadisson Hotel Kingston Harbourfront

KITCHENER-WATERLOOBest Western St. Jacobs Country InnDelta Kitchener-WaterlooHampton Inn & Suites by Hilton KitchenerHoliday Inn Kitchener-Waterloo Hotel &

Conference CentreRadisson Hotel Kitchener Waterloo

LONDONBest Western Lamplighter Inn & Conference

CentreBest Western Stoneridge Inn & Conference

CentreDelta London ArmouriesFour Points by Sheraton LondonHampton Inn by Hilton LondonHilton LondonResidence Inn by Marriott, London DowntownStationPark All Suite Hotel

MISSISSAUGADelta Toronto Airport WestFour Points by Sheraton Toronto Airport

Hampton Inn & Suites by Hilton Toronto AirportHampton Inn by Hilton Toronto Mississauga WestHilton Garden Inn Toronto/MississaugaHomewood Suites by Hilton Toronto-

Mississauga

NIAGARA FALLSAmericana Conference Resort & SpaHilton Niagara FallsSheraton Fallsview Hotel & Conference

Centre

NIAGARA-ON-THE-LAKEPillar and PostPrince of WalesQueen’s Landing

NORTH BAYBest Western North BayClarion Resort Pinewood Park

OAKVILLEHilton Garden Inn Toronto/OakvilleHomewood Suites by Hilton Toronto-Oakville

ORANGEVILLEHockley Valley Resort

ORILLIABest Western Mariposa Inn & Conference Centre

OTTAWAAlbert at Bay Suite HotelBest Western Victoria Park SuitesBrookstreetCartier Place Suite HotelDelta Ottawa Hotel and SuitesFairmont Chateau LaurierHoliday Inn Hotel & Suites, Downtown OttawaLes Suites Hotel, OttawaLord Elgin HotelMinto Suite HotelNovotel OttawaOttawa MarriottSheraton Ottawa HotelWestin Ottawa

PETERBOROUGHBest Western Otonabee InnHoliday Inn Peterborough Waterfront

PICTONThe Waring House Inn & Conference

Centre/Cookery School

SARNIAHoliday Inn Sarnia/Point Edward

SAULT STE. MARIEHoliday Inn Sault Ste. Marie Waterfront

ST. CATHARINESFour Points by Sheraton St. Catharines

THUNDER BAYPrince Arthur Waterfront Hotel & SuitesValhalla Inn Thunder BayVictoria Inn Hotel & Convention Centre

TIMMINSDays Inn & Conference CentreHoward Johnson Inn, Timmins

TORONTO (GTA)Best Western ParkwayBest Western Roehampton Hotel & SuitesCambridge Suites Hotel TorontoComfort Inn North YorkComfort Suites City Centre TorontoCosmopolitan TorontoCourtyard by Marriott Downtown TorontoCrowne Plaza Toronto Don ValleyDelta MarkhamDoubletree by Hilton Toronto AirportFairmont Royal YorkFour Points by Sheraton Toronto LakeshoreThe Grand Hotel & SuitesHilton Garden Inn Toronto/VaughanHilton Suites Toronto/Markham Conference

Centre & SpaHilton TorontoHoliday Inn Express North YorkHoliday Inn Express Toronto EastHoliday Inn Toronto YorkvilleHyatt Regency TorontoInterContinental Toronto CentreInterContinental Toronto YorkdaleLe Meridien King EdwardMarriott Toronto Airport HotelMetropolitan HotelNovotel Toronto CentreThe Old Mill Inn & SpaPantages HotelPark Hyatt TorontoRadisson Hotel Toronto EastRadisson Suite Hotel Toronto AirportRenaissance Toronto Hotel DowntownSheraton Centre Toronto HotelSheraton Gateway HotelSheraton ParkwayThe Suites at 1 King WestToronto Airport MarriottToronto Marriott Downtown Eaton CentreTravelodge Toronto NorthWestin Bristol Place Toronto Airport, TheWestin Harbour CastleWestin Prince TorontoWindsor Arms HotelWyndham Garden Hotel Toronto

TRENTONHoliday Inn Trenton

WINDSORCaesers WindsorHampton Inn & Suites by Hilton WindsorHilton WindsorHoliday Inn Downtown Windsor

41Ontario Medical Review • June 2009

June09_hotel_directory_pp40-41:Layout 1 6/8/09 12:16 PM Page 2


Prescribing Summary

Patient Selection Criteria

Safety Information

THERAPEUTIC CLASSIFICATION:Olmetec® – Angiotensin II AT1 Receptor Blocker (ARB). Olmetec PLUS® –ARB and diuretic.INDICATIONS AND CLINICAL USEOlmetec® is indicated for the treatment of mild to moderate essentialhypertension. Olmetec® may be used alone or in combination with athiazide diuretic. Olmetec PLUS® is indicated for the treatment of mildto moderate essential hypertension in patients for whom combinationtherapy is appropriate. Olmetec PLUS® is not indicated for initialtherapy.Geriatrics (≥65 years of age): No overall differences in effectivenessor safety were observed between elderly patients and younger patients,however greater sensitivity cannot be ruled out.Pediatrics <18 years of age): The safety and effectiveness in pediatricpatients has not been established.CONTRAINDICATIONSOlmetec® and Olmetec PLUS® are contraindicated in patientshypersensitive to these drugs, any ingredients in the formulations, orany component products of the containers. Because of its hydro -chlorothiazide (HCTZ) component, Olmetec PLUS® is contraindicated inpatients with anuria, and in patients who are hypersensitive to othersulfonamide-derived drugs.

WARNINGS AND PRECAUTIONS

Cardiovascular:Hypotension in Volume- or Salt-Depleted Patients: In patients withan activated renin-angiotensin system, such as volume- or salt-depleted patients (i.e., those being treated with high dose diuretics),symptomatic hypotension may occur after initiation of treatment withOlmetec® or Olmetec PLUS®. Treatment should start under closemedical supervision. Similar considerations apply to patients withischemic heart or cerebrovascular disease, in whom an excessive fall inblood pressure could result in myocardial infarction or cerebrovascularaccident. If hypotension does occur, the patient should be placed in thesupine position and, if necessary, given an intravenous infusion ofnormal saline. A transient hypotensive response is not acontraindication to further treatment, which usually can be continuedwithout difficulty once the blood pressure has stabilized and when fluidand electrolyte imbalances have been corrected.Hepatic/Biliary/Pancreatic: No adjustment of dosage is required forpatients with mild hepatic impairment. Data is lacking with respect tothe use of 20 mg and 40 mg of olmesartan medoxomil; therefore, alower starting dose is recommended in patients with moderate liver

Serious Warnings and Precautions: When used in pregnancy,ARBs can cause injury or even death of the developing fetus.When pregnancy is detected, Olmetec® and Olmetec PLUS®

should be discontinued as soon as possible.

disease and the maximum dose of 20 mg Olmetec® or 20/12.5 mgOlmetec PLUS® daily should not be exceeded. Care should be exercisedin patients with liver disease, especially in those patients with biliaryobstructive disorders, as the majority of olmesartan is eliminated in thebile. No information is available in patients with severe liver disease;therefore, use of Olmetec® or Olmetec PLUS® in this group of patientsis not recommended. Thiazides should be used with caution in patientswith impaired hepatic function or progressive liver disease, since minoralterations of fluid or electrolyte balance can precipitate hepatic coma.Renal:Impaired Renal Function: Use of Olmetec® or Olmetec PLUS® shouldinclude appropriate assessment of renal function. The use of Olmetec®

and Olmetec PLUS® in patients with severe renal impairment is notrecommended since there is limited experience in this patient group.Endocrine and Metabolism:With Olmetec PLUS®, periodic determinations of serum electrolytes todetect possible electrolyte imbalance should be performed atappropriate intervals.SPECIAL POPULATIONSPregnant Women: Drugs that act directly on the renin-angiotensin-aldosterone system (RAAS) can cause fetal and neonatal morbidity anddeath when administered to pregnant women.The use of ARBs is not recommended during pregnancy. When preg -nancy is detected, Olmetec® or Olmetec PLUS® should be discontinuedas soon as possible. Epidemiological evidence regarding the risk ofteratogenicity following exposure to angiotensin-converting enzymeinhibitors (another class of therapeutic products interfering with theRAAS) during the first trimester of pregnancy has not been conclusive;however, a small increase in risk cannot be excluded. Given the currentevidence available on the risk with ARB, similar risks may exist for thisclass of drugs. Patients planning pregnancy should be changed toalternative anti-hypertensive treatments which have an establishedsafety profile for use in pregnancy. When pregnancy is diagnosed,treatment with angiotensin II antagonists should be stoppedimmediately, and, if appropriate, alternative therapy should be started.The use of ARBs during the second and third trimesters is known toinduce human fetotoxicity (decreased renal function, oligohydramnios,skull ossification retardation) and neonatal toxicity (renal failure,hypotension, hyperkalemia).Infants with a history of in utero exposure to ARBs should be closelyobserved for hypotension, oliguria, and hyperkalemia. If oliguria occurs,attention should be directed toward support of blood pressure and renalperfusion. Exchange transfusion or dialysis may be required as a meansof reversing hypotension and/or substituting for impaired renal function;however, limited experience with those procedures has not beenassociated with significant clinical benefit.It is not known if olmesartan can be removed from the body byhemodialysis.Thiazides cross the placental barrier and appear in cord blood. Theroutine use of diuretics in otherwise healthy pregnant women is notrecommended and exposes mother and fetus to unnecessary hazardincluding fetal or neonatal jaundice, thrombocytopenia and possiblyother adverse reactions that have occurred in adults.Nursing Women: It is not known whether olmesartan is excreted inhuman milk, but olmesartan is secreted at low concentration in the milkof lactating rats. Because many drugs, including thiazides, areexcreted/appear in human milk and because of their potential foraffecting the nursing infant adversely, a decision should be madewhether to discontinue nursing or discontinue the drug, taking intoaccount the importance of the drug to the mother.ADVERSE REACTIONSAdverse Drug Reaction OverviewOlmetec® (olmesartan medoxomil) has been evaluated for safety in3825 patients/subjects treated for essential hypertension, including900 patients treated for at least 6 months and more than 525 for atleast 1 year. Of these, 3275 patients were treated with olmesartanmedoxomil monotherapy in controlled clinical trials.

CANADA

IN

®

®

olmesartan medoxomil20 mg, 40 mg tablets

olmesartan medoxomil - hydrochlorothiazide20/12.5 mg, 40/12.5 mg, 40/25 mg tablets


Administration

Study References

In controlled clinical trials, discontinuation of therapy due to clinicaladverse experiences occurred in 2.4% (79/3278) and 2.7% (i.e.,32/1179) of patients treated with Olmetec® and placebo or activecontrol, respectively.Treatment with Olmetec® was well tolerated, with an incidence ofadverse events similar to placebo. Events generally were mild, transientand had no relationship to the dose of olmesartan medoxomil.Olmesartan medoxomil - hydrochlorothiazideOlmesartan medoxomil - hydrochlorothiazide has been evaluated forsafety in 1243 patients treated for essential hypertension. Treatmentwith olmesartan medoxomil - hydrochlorothiazide was well tolerated,with an incidence of adverse events similar to placebo. Events generallywere mild, transient and had no relationship to the dose of olmesartanmedoxomil - hydrochlorothiazide.In the clinical trials, the overall frequency of adverse events was notdose-related. Analysis of gender, age and race groups demonstrated nodifferences between olmesartan medoxomil - hydrochlorothiazide andplacebo-treated patients. The rate of discontinuations due to adverseevents in all trials of hypertensive patients was 2.0% (25/1243) ofpatients treated with olmesartan medoxomil - hydrochlorothiazide and2.0% (7/342) of patients treated with placebo. The following potentiallyserious adverse reactions have been reported with Olmetec®/OlmetecPLUS® in controlled trials: syncope, hypotension.DRUG INTERACTIONSDrug-Drug InteractionsAgents Increasing Serum Potassium: Since Olmetec® decreases theproduction of aldosterone, potassium-sparing diuretics or potassiumsupplements should be given only for documented hypokalemia andwith frequent monitoring of serum potassium. Potassium-containingsalt substitutes should also be used with caution.Lithium Salts: As with other drugs which eliminate sodium, lithiumclearance may be reduced in the presence of olmesartan. Therefore,serum lithium levels should be monitored carefully if lithium salts are tobe administered with olmesartan medoxomil. Lithium generally shouldnot be given with diuretics. Diuretic agents reduce the renal clearanceof lithium and add a high risk of lithium toxicity.To report an adverse effect, please call the Schering-Plough CanadaMedical Information Department at 1-800-463-5442.

DOSAGE AND ADMINISTRATIONRecommended Dose and Dosage AdministrationOlmetec®: Dosage must be individualized.The usual recommended starting dose of Olmetec® is 20 mg once dailywhen used as monotherapy in patients who are not volume-contracted.For patients requiring further reduction in blood pressure after 2 weeksof therapy, the dose of Olmetec® may be increased to 40 mg. Dosesabove 40 mg do not appear to have greater effect. Twice-daily dosingoffers no advantage over the same total dose given once daily. Ifpatients miss a dose, they should wait until their next scheduled dose.Patients should not double their dose.Olmetec® may be administered with or without food.Elderly Patients: No adjustment of dosage is generally required inelderly patients. If up-titration to the maximum dose of 40 mg daily isrequired, blood pressure should be closely monitored.Renal Impairment: Owing to the limited experience of higher dosagesin this patient group, the maximum dose in patients with mild tomoderate renal impairment is 20 mg once daily.Concomitant Diuretic Therapy: If blood pressure is not controlled byOlmetec® alone, a thiazide diuretic may be added.Olmetec PLUS®: Olmetec PLUS® is not for initial therapy. Dosage mustbe individualized. To minimize dose-dependent side effects, it is usuallyappropriate to begin combination therapy only after a patient has failedto achieve the desired effect with monotherapy. The dose of OlmetecPLUS® should be determined by titration of the individual components.Replacement Therapy: Once the patient has been stabilized on theindividual components as described below, Olmetec PLUS® may be

substituted if the doses on which the patient was stabilized are thesame as those in the fixed combination.Dose Titration by Clinical Effect: Olmetec PLUS® is available instrengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. Apatient whose blood pressure is inadequately controlled by olmesartanmedoxomil or HCTZ alone may be switched to once daily Olmetec PLUS®.Dosage should be individualized. Depending on the blood pressureresponse, the dose may be titrated at intervals of 2-4 weeks.The antihypertensive effect of Olmetec PLUS® is related to the dose ofboth components over the range of 10 mg/12.5 mg to 40 mg/25 mg.The dose of Olmetec PLUS® is one tablet once daily. More than onetablet daily is not recommended. If patients miss a dose, they shouldwait until their next scheduled dose. Patients should not double their dose.Elderly patients: No adjustment of dosage is generally required inelderly patients. If up-titration to the maximum dose of 40/25 mg dailyis required, blood pressure should be closely monitored.Renal Impairment: Owing to the limited experience of higher dosagesin this patient group, the maximum dose in patients with mild tomoderate renal impairment is 20 mg/12.5 mg once daily.

1. Oparil S, Williams D, Chrysant SG et al. Comparative efficacy ofolmesartan, losartan, valsartan, and irbesartan in the control of essentialhypertension. J Clin Hypertens (Greenwich) 2001;3(4):283-91,318.* 12-week randomized, multi-site, double-blind, parallel-group study designed to compare the efficacy of startingdoses of selected ARBs in 578 patients. The study consisted of a 4-week single-blind placebo run-in, followed byan 8-week double-blind active treatment phase. Eligible patients were assessed by ABPM at week 4 (baseline)and week 8. Recommended starting doses of each agent were used: Olmetec® 20 mg/day, Diovan† 80 mg/day,Cozaar† 50 mg/day, Avapro† 150 mg/day. The primary efficacy variable was to assess the comparative efficacy ofOlmetec® measured by change in sitting cuff DBP from baseline to week 8. Secondary efficacy variables included:change in sitting cuff DBP from baseline to week 2 and 4, change in sitting cuff SBP from baseline to week 2, 4and 8, change in mean 24-hour ADBP and ASBP from baseline to week 8. Baseline SBP/DBP values (mmHg) were:Olmetec® 157/104, Diovan† 155/104, Cozaar† 157/104, Avapro† 156/104.† All other trademarks are property of their respective owners.

SUPPLEMENTAL PRODUCT INFORMATIONWARNINGS AND PRECAUTIONSCardiovascular: Valvular Stenosis:There is concern on theoretical grounds that patients with aortic stenosis might be at a particular risk ofdecreased coronary perfusion, because they do not develop as much afterload reduction.Renal: Impaired Renal Function: As a consequence of inhibiting the RAAS, changes in renal function may beanticipated in susceptible individuals. In patients whose renal function may depend on RAAS activity (e.g., patientswith severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors (ACEi) or ARBs hasbeen associated with oliguria, progressive azotemia and (rarely) with acute renal failure and/or death. Similareffects may be anticipated in patients treated with Olmetec® or Olmetec PLUS®.In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serumcreatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartanmedoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides mayprecipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.If progressive renal impairment becomes evident consider withholding or discontinuing diuretic therapy.The use of olmesartan medoxomil in patients with severe renal impairment is not recommended, since there isonly limited experience in this patient group. In patients with more severe renal impairment, loop diuretics arepreferred to thiazides, so Olmetec PLUS® is not recommended.For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly thosewith impaired renal function), Olmetec®/Olmetec PLUS® should be initiated under close medical supervision andconsideration should be given to use of a lower starting dose.Endocrine and Metabolism:With Olmetec PLUS®, all patients receiving thiazide therapy should be observed for clinical signs of fluid orelectrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia. Serum and urine electrolytedeterminations are important when the patient is vomiting excessively or receiving parenteral fluids. Warningsigns or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst,weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue,hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolongedtherapy.Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may causecardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis(e.g., increased ventricular irritability).Although any chloride deficit during thiazide therapy is generally mild and usually does not require specifictreatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacementmay be required in the treatment of metabolic alkalosis. Dilutional hyponatremia may occur in edematous patientsin hot weather. Appropriate therapy is water restriction rather than administration of salt, except in rare instances,when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy ofchoice.Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.Thiazides may decrease urinary calcium excretion.Thiazides may cause intermittent and slight elevation of serumcalcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence ofhidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.Thiazides may decrease PBI levels without signs of thyroid disturbance.Hyperglycemia may occur with thiazide diuretics. Insulin or oral hypoglycemic agents requirements in diabeticpatients may be altered and latent diabetes mellitus may become manifest during thiazide diuretic therapy.Sensitivity/Resistance:Hypersensitivity reactions to HCTZ may occur in patients with or without a history of allergy or bronchialasthma, but are more likely in patients with such a history.Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.Pregnant Women, Animal Data: Olmetec® – No teratogenic effects were observed when olmesartanmedoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximumrecommended human dose [MRHD] of olmesartan medoxomil on a mg/m2 basis) or pregnant rabbits at oraldoses up to 1 mg/kg/day (half the MRHD on a mg/m2 basis; higher doses could not be evaluated for effects


on fetal development as they were lethal to the does). In rats, significant decreases in pup birth weight andweight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥8 mg/kg/day.The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHDof 40 mg/day.

Olmetec PLUS® – No teratogenic effects were observed when 1.6:1 combinations of olmesartan medoxomiland HCTZ were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the MRHD ona mg/m2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (280 times the MRHD on a mg/m2 basis).In rats, however, fetal body weights at 1625 mg/kg/day (a toxic, sometimes lethal dose in the dams) weresignificantly lower than control. The no observed effect dose for developmental toxicity in rats,162.5 mg/kg/day, is about 28 times, on a mg/m2 basis, the MRHD of Olmetec PLUS® (40 mg olmesartanmedoxomil/25 mg HCTZ/day).

DRUG INTERACTIONSDrug-Drug Interactions:Diuretics:Patients on diuretics, and especially those in whom diuretic therapy was recently instituted, may occasionallyexperience an excessive reduction in blood pressure after initiation of therapy with olmesartan. The possibilityof symptomatic hypotension with the use of olmesartan can be minimized by discontinuing the diuretic priorto initiation of treatment. No drug interaction of clinical significance has been identified with thiazidediuretics.Pravastatin:Olmetec® decreased the Cmax and AUC of pravastatin by approximately 25% and 21%, respectively. Sincethere is a high degree of variability in the bioavailability of pravastatin, this finding is not considered to beclinically relevant.Warfarin:There was no effect on either the pharmacokinetics or pharmacodynamics of warfarin when co-administeredwith olmesartan medoxomil in healthy volunteers.Digoxin:No pharmacokinetics or pharmacodynamics effects were reported when olmesartan medoxomil was co-administered with digoxin in healthy volunteers.Antacids:The bioavailability of olmesartan was not significantly altered when co-administered with antacids[Al(OH)3/Mg(OH)2].Cytochrome P450 Enzyme System:Unlike some other ARB, olmesartan medoxomil is not metabolized by cytochrome P450 enzymes. Interactionswith drugs that inhibit, induce or are metabolized by these enzymes are not expected.Hydrochlorothiazide:When administered concurrently the following drugs may interact with thiazide diuretics; Agents IncreasingSerum Potassium: Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene,amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serumpotassium. Since olmesartan decreases the production of aldosterone, potassium-sparing diuretics orpotassium supplements should be given only for documented hypokalemia and with frequent monitoring ofserum potassium when olmesartan medoxomil therapy is initiated. Potassium-containing salt substitutesshould also be used with caution. Concomitant thiazide diuretic use may attenuate any effect that olmesartanmay have on serum potassium. Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotensionmay occur. Antidiabetic Drugs (oral agents and insulin): Due to the potential for hyperglycemia in patients onthiazides, dosage adjustment of the antidiabetic drug may be required. Cholestyramine and Colestipol Resins:Absorption of HCTZ is impaired in the presence of anionic exchange resins. Single doses of eithercholestyramine or colestipol resins bind the HCTZ and reduce its absorption from the gastrointestinal tract byup to 85 and 43 percent, respectively. Corticosteroids, ACTH: Intensified electrolyte depletion, particularlyhypokalemia may occur. Non-steroidal Anti-inflammatory Drugs (NSAIDs): The administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natiuretic and antihypertensive effects of loop,potassium-sparing and thiazide diuretics. Therefore, when Olmetec PLUS® and NSAID agents are usedconcomitantly, the patients should be observed closely to determine if the desired effect of the diuretic isobtained. Other Antihypertensive Drugs: Diuretic additive effect or potentiation of antihypertensive effect mayoccur. Pressor Amines (e.g., Norepinephrine): In the presence of diuretics, possible decreased response topressor amines may occur but the effect is not sufficient to preclude their use. Skeletal Muscle Relaxants,Non depolarizing (e.g., Turbocurarine): Thiazide drugs may increase responsiveness to the muscle relaxant.Drug-Food Interactions: Olmetec® and Olmetec PLUS® may be administered with or without food.Drug-Herb Interactions: Interactions with herbal products have not been established.Drug-Laboratory Interactions: Interactions with laboratory tests have not been established.

ADVERSE REACTIONS Treatment with Olmetec® and Olmetec PLUS® was well tolerated, with an incidence of events similar toplacebo. Events generally were mild, transient, and had no relationship to the dose.

a Body systems in which patients in either treatment group experienced events and in which at least one eventwas reported in >1% of patients in either treatment group.

Less Common Clinical Trial Adverse Drug Reactions (<1%): Other (potentially important) adverse eventsthat have been reported in controlled or open-label trials with an incidence of greater than 0.5%, regardlessof causality: Cardiac disorders: tachycardia. Ear and labyrinth disorders: vertigo. Gastrointestinal disorders:abdominal pain, dyspepsia, nausea. General disorders and administration site conditions: chest pain, edemaperipheral. Infections and infestations: gastroenteritis. Metabolism and nutrition disorders:hypercholesterolemia, hyperlipidemia, hyperuricaemia. Musculoskeletal and connective tissue disorders:arthralgia, arthritis, myalgia. Renal and urinary disorders: albuminuria. Respiratory, thoracic and mediastinaldisorders: cough. Skin and subcutaneous tissue disorders: rash. Facial edema was reported in 5 patientsreceiving olmesartan medoxomil. Angioedema has been reported with other angiotensin II antagonists.Abnormal Hematologic and Clinical Chemistry Findings: In controlled clinical trials, clinically importantchanges in standard laboratory parameters were rarely associated with administration of olmesartanmedoxomil.Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases ofapproximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently.

Post-Market Adverse Drug Reactions: Other adverse events reported rarely in post-marketing use include:asthenia, angioedema, vomiting, hyperkalemia, rhabdomyolysis, renal failure acute, blood creatinineincreased, alopecia, pruritus, urticaria, palpitations, syncope, and blood uric acid increased.

a Adverse events reported in >1% of patients in the Total Olmesartan Medoxomil + HCTZ treatment group.

Other adverse events that have been reported with an incidence of greater than 1.0%, whether or notattributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil -hydrochlorothiazide in controlled or open-label trials:Gastrointestinal disorders: abdominal pain, dyspepsia, diarrhea. General disorders and administration siteconditions: chest pain, edema peripheral. Infections and infestations: gastroenteritis. Investigations: alanineaminotransferase increased, aspartate aminotransferase increased, creatine phosphokinase increased,gamma-glutamyltransferase increased. Musculoskeletal and connective tissue disorders: arthritis, arthralgia,back pain, myalgia. Nervous system disorders: vertigo. Renal and urinary disorders: hematuria. Respiratory,thoracic and mediastinal disorders: cough. Skin and subcutaneous tissue disorders: rash.Less Common Clinical Trial Adverse Drug Reactions (<1%): Facial edema was reported in 2/1243 patientsreceiving olmesartan medoxomil - hydrochlorothiazide. Angioedema has been reported with angiotensin IIreceptor antagonists.Abnormal Hematologic and Clinical Chemistry Findings: In controlled clinical trials, clinically importantchanges in standard laboratory parameters were rarely associated with administration of olmesartanmedoxomil - hydrochlorothiazide.Liver Functions Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently.

Placebo (n=555) Total olmesartan medoxomil (n=2450)

¥GT increased 13 (2.3%) 57 (2.2%)

CPK increased 6 (1.1%) 40 (1.6%)

ALT increased 9 (1.6%) 33 (1.3%)

AST increased 6 (1.1%) 25 (1.0%)

Table 1: Adverse Events Occurring >1% in Placebo-controlled Monotherapy Studiesa

System Organ Class (SOC) Placebo (n=555)

Total olmesartan medoxomil (n=2540)

MedDRA preferred term n % n %Gastrointestinal disorders

Diarrhea 4 (0.7) 27 (1.1)

General disorders and administration site conditions

Influenza-like illness 16 (2.9) 79 (3.1)

Infections and infestationsUpper respiratory tract infection 27 (4.9) 83 (3.3)

Bronchitis 10 (1.8) 51 (2.0)

Rhinitis 9 (1.6) 40 (1.6)

Pharyngitis 6 (1.1) 33 (1.3)

Sinusitis 11 (2.0) 29 (1.1)

Injury, poisoning and procedural complications

Injury 7 (1.3) 34 (1.3)

Metabolism and nutrition disorders

Hyperglycemia 15 (2.7) 32 (1.3)

Hypertriglyceridemia 6 (1.1) 29 (1.1)

Musculoskeletal and connective tissue disorders

Back pain 8 (1.4) 41 (1.6)

Nervous system disordersHeadache 40 (7.2) 141 (5.6)

Dizziness 5 (0.9) 70 (2.8)

Renal and urinary disordersHematuria 10 (1.8) 49 (1.9)

Table 2: Adverse Eventsa Occurring >1% in Placebo-controlled Cohort

System Organ Class (SOC) Total

placeboALONE

TotalHCTZ

ALONE

Totalolmesartanmedoxomil

ALONE

Totalolmesartanmedoxomil

+ HCTZ

(n=42) (n=88) (n=125) (n=247)MedDRA preferred term n (%) n (%) n (%) n (%)Ear and labyrinth disorders

Ear disorder 0 (0.0%) 0 (0.0%) 0 (0.0%) 5 (2.0%)

Gastrointestinal disordersNausea 0 (0.0%) 1 (1.1%) 2 (1.6%) 7 (2.8%)

Abdominal pain 1 (2.4%) 1 (1.1%) 4 (3.2%) 5 (2.0%)

Dyspepsia 0 (0.0%) 4 (4.5%) 2 (1.6%) 5 (2.0%)

Diarrhea 1 (2.4%) 2 (2.3%) 4 (3.2%) 4 (1.6%)

Gastroenteritis 1 (2.4%) 0 (0.0%) 0 (0.0%) 3 (1.2%)

General disorders and administration site conditionsFatigue 0 (0.0%) 1 (1.1%) 3 (2.4%) 5 (2.0%)

Influenza-like illness 0 (0.0%) 1 (1.1%) 1 (0.8%) 3 (1.2%)

Immune system disordersHypersensitivity 0 (0.0%) 1 (1.1%) 1 (0.8%) 3 (1.2%)

Infections and infestations

Upper respiratory tract infection 0 (0.0%) 6 (6.8%) 8 (6.4%) 16 (6.5%)

Urinary tract infections 1 (2.4%) 1 (1.1%) 1 (0.8%) 8 (3.2%)

Pharyngitis 0 (0.0%) 1 (1.1%) 1 (0.8%) 4 (1.6%)

Rhinitis 2 (4.8%) 0 (0.0%) 3 (2.4%) 4 (1.6%)

Sinusitis 1 (2.4%) 2 (2.3%) 3 (2.4%) 3 (1.2%)

Injury, poisoning and procedural complicationsInjury 0 (0.0%) 3 (3.4%) 1 (0.8%) 6 (2.4%)

Metabolism and nutrition disordersHyperuricemia 1 (2.4%) 2 (2.3%) 0 (0.0%) 10 (4.0%)

Hyperglycemia 1 (2.4%) 2 (2.3%) 0 (0.0%) 5 (2.0%)

Hyperlipemia 0 (0.0%) 1 (1.1%) 1 (0.8%) 4 (1.6%)

BUN increased 0 (0.0%) 0 (0.0%) 0 (0.0%) 4 (1.6%)

Musculoskeletal and connective tissue disordersBack pain 1 (2.4%) 2 (2.3%) 3 (2.4%) 5 (2.0%)

Myalgia 0 (0.0%) 1 (1.1%) 4 (3.2%) 5 (2.0%)

Nervous system disordersDizziness 1 (2.4%) 7 (8.0%) 1 (0.8%) 23 (9.3%)

Headache 3 (7.1%) 4 (4.5%) 11 (8.8%) 13 (5.3%)

Renal and urinary disordersHematuria 0 (0.0%) 0 (0.0%) 0 (0.0%) 6 (2.4%)

Pyuria 0 (0.0%) 1 (1.1%) 1 (0.8%) 4 (1.6%)

Urine analysis abnormal 0 (0.0%) 0 (0.0%) 0 (0.0%) 4 (1.6%)

Respiratory, thoracic and mediastinal disordersCough 0 (0.0%) 0 (0.0%) 2 (1.6%) 5 (2.0%)

Vascular disordersHypotension 0 (0.0%) 0 (0.0%) 0 (0.0%) 3 (1.2%)


Creatinine, Blood Urea Nitrogen: Increases in blood urea nitrogen (BUN) and serum creatinine of >50% wereobserved in 1.3% of patients. No patients were discontinued from clinical trials of olmesartan medoxomil -hydrochlorothiazide due to increased BUN or creatinine.Hemoglobin and Hematocrit: A greater than 20% decrease in hemoglobin and hematocrit was observed in0.0 % and 0.4% (one patient), respectively, of olmesartan medoxomil - hydrochlorothiazide patients, comparedwith 0.0% and 0.0%, respectively, in placebo-treated patients. No patients were discontinued due to anemia.Post-Market Adverse Drug Reactions: Other adverse events reported rarely in post-marketing use include:asthenia, angioedema, vomiting, hyperkalemia, rhabdomyolysis, renal failure acute, blood creatinineincreased, alopecia, pruritus, urticaria, palpitations, syncope, and blood uric acid increased.

DOSAGE AND ADMINISTRATIONThe side effects of olmesartan medoxomil are generally rare and independent of dose; those of HCTZ aremost typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g.,pancreatitis) do occur with HCTZ. Therapy with any combination of olmesartan medoxomil and HCTZ will beassociated with both sets of dose-independent side effects. To minimize dose-independent side effects, it isusually appropriate to begin combination therapy only after a patient has failed to achieve the desired effectwith monotherapy.HCTZ is effective in doses between 12.5 mg and 50 mg once daily. If a patient is taking HCTZ, Olmetec® maybe added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressurecontrol. If large doses of HCTZ have been used as monotherapy and volume depletion or hyponatremia ispresent, caution should be used when adding Olmetec® or switching to Olmetec PLUS® as marked decreasesin blood pressure may occur. Consideration should be given to reducing the dose of HCTZ to 12.5 mg beforeadding Olmetec®.

OVERDOSAGELimited data are available in regard to overdosage in humans. The most likely manifestation of overdosagewould be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal)stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. Thedialyzability of olmesartan in unknown. For HCTZ, the most common signs and symptoms of overdoseobserved in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia)and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia mayaccentuate cardiac arrhythmias. The degree to which HCTZ is removed by hemodialysis has not beenestablished.

STORAGE AND STABILITYStore at 15-30°C.DOSAGE FORMS, COMPOSITION AND PACKAGINGDOSAGE FORM: Olmetec® (olmesartan medoxomil) is available as film-coated tablets. Each tablet contains20 mg or 40 mg olmesartan medoxomil. PACKAGING: 20 mg and 40 mg tablets: Blister cards of 7 tablets(4 cards/carton). INACTIVE INGREDIENTS – Olmetec®: hydroxypropylcellulose, hydroxypropylmethylcellulose,lactose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, talc, andtitanium dioxide.DOSAGE FORM: Olmetec PLUS® (olmesartan medoxomil - hydrochlorothiazide) is available as film-coatedtablets. Each tablet contains: 20 mg olmesartan medoxomil and 12.5 mg of hydrochlorothiazide (20/12.5 mgtablets), 40 mg olmesartan medoxomil and 12.5 mg of hydrochlorothiazide (40/12.5 mg tablets) and 40 mgolmesartan medoxomil and 25 mg of hydrochlorothiazide (40/25 mg tablets). PACKAGING: 20 mg/12.5 mg,40 mg/12.5 mg, and 40 mg/25 mg tablets: Blister cards of 7 tablets (4 cards/carton). INACTIVE INGREDIENTS –Olmetec PLUS®: hydroxypropylcellulose, hypromellose, lactose, low-substituted hydroxypropylcellulose,magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide.

Product Monographs available to healthcare professionals upon request from the Schering-Plough CanadaMedical Department at 1-800-463-5442.

Placebo (n=42) HCTZ (n=88)OlmesartanMedoxomil

(n=125)

OlmesartanMedoxomil +HCTZ (n=247)

CPK increased 2 (4.8%) 2 (2.3%) 3 (2.4%) 4 (1.6%)

¥GT increased 1 (2.4%) 1 (1.1%) 3 (2.4%) 3 (1.2%)

ALT increased 2 (4.8%) 1 (1.1%) 3 (2.4%) 3 (1.2%)

AST increased 1 (2.4%) 1 (1.1%) 3 (2.4%) 3 (1.2%)

Schering-Plough Canada Inc.Kirkland, QC H9H 4M7

© Schering-Plough Canada Inc., 2009All rights reserved.

® Trademark of Daiichi Sankyo Company,Limited, used under license by Schering-Plough Canada Inc.

CANADA

IN


Patient Selection Criteria

THERAPEUTIC CLASSIFICATION: Bone Metabolism Regulator

INDICATIONS AND CLINICAL USEOsteoporosis: Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men, to improve bone mineral density. Glucocorticoid-Induced Osteoporosis: Treatment and prevention of glucocorticoid-induced osteoporosis in men and women. Paget’s Disease of Bone.

CONTRAINDICATIONSKnown hypersensitivity to any component of this product. Hypocalcemia.Use in the Elderly: No dosage adjustment is necessary.Pediatric Use: Safety and efficacy in children and growing adolescents have not been established.Use in Obstetrics: Not intended for use during pregnancy.Use in Nursing Mothers: Not intended for use with nursing mothers. It is not known whether risedronate is excreted in human milk.

Safety Information

WARNINGS AND PRECAUTIONSGeneralAdequate intake of calcium and vitamin D is important in all patients.Very rarely patients have reported osteonecrosis of the jaw while receiving ACTONEL or other drugs in this class (see SUPPLEMENTAL PRODUCT INFORMATION for more details). Musculoskeletal pain (rarely severe) has been reported as a common adverse event in patients who received ACTONEL for all indications. Consider discontinuing use if severe symptoms develop (see SUPPLEMENTAL PRODUCT INFORMATION for more details).Not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).Health professionals should be particularly careful to emphasize the importance of the dosing instructions to patients with a history of esophageal disorders (e.g., inflammation, stricture, ulcer or disorders of motility).

ADVERSE REACTIONS(See SUPPLEMENTAL PRODUCT INFORMATION for full listing.)Adverse Drug Reaction OverviewGenerally similar to placebo and of mild or moderate severity. Discontinuation of therapy due to serious clinical adverse events occurred in 5.5% of ACTONEL 5 mg daily-treated patients and 6.0% of patients treated with placebo.

Prescribing Summary

To report an adverse event, contact Procter & Gamble Pharmaceuticals Canada, Inc. at 1-800-565-0814 or the Canada Vigilance Program at Health Canada at 1-866-234-2345.

DRUG INTERACTIONS(See SUPPLEMENTAL PRODUCT INFORMATION for full listing.)OverviewAntacids containing polyvalent cations should be administered at a different time of day (e.g., calcium, magnesium, iron and aluminum). Not expected to interact with other drugs based on the effects of protein binding displacement, enzyme induction or metabolism of other drugs (see DRUG INTERACTIONS in the Product Monograph).

Administration

DOSAGE AND ADMINISTRATIONTreatment of Postmenopausal Osteoporosis: Daily (5 mg), weekly (35 mg Once-a-Week), 75 mg (on two consecutive days per month, on the same calendar days each month), or 150 mg (once-a-month on the same calendar day each month), taken orally. Prevention of Postmenopausal Osteoporosis: 5 mg daily or 35 mg Once-a-Week, taken orally. Treatment of Osteoporosis in Men, to improve bone mineral density: 35 mg Once-a-Week, taken orally. Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: 5 mg daily, taken orally. Treatment of Paget’s Disease of Bone: 30 mg daily for 2 months, taken orally. Re-treatment may be considered. Recommended Dose and Dosage AdjustmentFor all indications and doses: The patient should be informed to pay particular attention to the dosing instructions, as clinical benefits may be compromised by failure to take the drug according to instructions. Specifically, ACTONEL should be taken on an empty stomach at least 30 minutes before consuming the first food, drink (other than plain water) and/or any other medication of the day. The tablet should be swallowed whole — do not chew.Renal Impairment: No dosage adjustment is necessary in patients with a creatinine clearance ≥30 mL/min or in the elderly. Missed DosePatients should be instructed that if they miss:A dose of ACTONEL 5 mg, they should take 1 tablet of ACTONEL 5 mg as they normally would for their next dose. Patients should not double their next dose or take 2 tablets on the same day.A dose of ACTONEL 35 mg Once-a-Week on their regularly scheduled day, they should take 1 tablet on the day they first remember missing their dose. Patients should then return to taking 1 tablet Once-a-Week as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.A dose of ACTONEL 30 mg, they should take 1 tablet of ACTONEL 30 mg as they normally would for their next dose. Patients should not double their next dose or take 2 tablets on the same day.If one or both tablets of ACTONEL 75 mg monthly duet are missed, and the next month’s scheduled doses are more than 7 days away, the patient should be instructed as follows:

If both tablets are missed, take one ACTONEL 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning.If only one ACTONEL 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered.


Patients should then return to taking their ACTONEL 75 mg monthly duet on two consecutive days each month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. If one or both tablets of ACTONEL 75 mg are missed, and the next month’s scheduled doses are within 7 days, patients should wait until their next month’s scheduled doses and then continue taking ACTONEL 75 mg monthly duet on two consecutive days each month as originally scheduled.Patients should be instructed that if they miss a 150 mg dose of ACTONEL (1 tablet of 150 mg), and the next month’s scheduled dose is more than 7 days away, they should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their ACTONEL 150 mg as originally scheduled.If a dose of ACTONEL 150 mg is missed, and the next month’s scheduled dose is within 7 days, patients should be instructed to wait until their next month’s scheduled dose and then continue taking ACTONEL 150 mg.Patients should not take more than 150 mg of ACTONEL within 7 days.

SUPPLEMENTAL PRODUCT INFORMATIONADVERSE REACTIONSClinical Trial Adverse Drug ReactionsMost adverse events reported in ACTONEL trials were either mild or moderate in severity, and did not lead to discontinuation from the study. The overall safety profile observed in these studies showed no substantive difference from that observed in the ACTONEL 5 mg daily versus ACTONEL 35 mg, 75 mg or 150 mg treatment studies.Musculoskeletal pain, rarely severe, has been reported as a common adverse event in patients who received ACTONEL for all indications. In clinical studies of ACTONEL the following adverse events (AEs) were the most commonly reported (ACTONEL/placebo): Postmenopausal osteoporosis — dyspepsia (5.2%/4.8%),nausea (4.8%/5.0%) and abdominal pain (4.1%/3.3%); Glucocorticoid-induced osteoporosis — dyspepsia (5.7%/2.9%), nausea (5.7%/5.3%) and abdominal pain (4.0%/4.7%); (ACTONEL/Didronel®): Paget’s disease — diarrhea (13.1%/9.8%), arthralgia (9.8%/8.2%) and nausea (8.2%/4.9%).For more details see ADVERSE REACTIONS in the Product Monograph.Once-a-Week Dosing: In a 1-year study comparing ACTONEL 35 mg Once-a-Week to ACTONEL 5 mg daily for the treatment of osteoporosis in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar with the exception of “arthralgia”. Specifically, 1.5% of patients taking ACTONEL 35 mg Once-a-Week experienced arthralgia compared to 0.7% of placebo patients.Two Consecutive Days per Month: In a 1-year treatment study comparingACTONEL 75 mg on two consecutive days per month to ACTONEL 5 mg daily, in postmenopausal osteoporosis women, the overall safety profiles of the two oral dosing regimens were similar with the exception of arthralgia (1.5% vs. 1.0%), vomiting (1.1% vs. 1.0%),gastritis erosive (1.0% vs. 0.3%), acute phase reactions, without regard to causality, (7.6% vs. 3.6%) and fever or flu-like symptoms, without regard to causality, (0.6% vs. 0.0%).Once-a-Month Dosing: In a 1-year treatment study in postmenopausal osteoporosis women comparing ACTONEL 150 mg Once-a-Month to ACTONEL 5 mg daily, the overall safety profiles of the dosing regimens were similar with the exception of diarrhea (3.1% vs. 0.5%), vomiting (1.5% vs. 0.6%),arthralgia (1.5% vs. 0.9%), myalgia (1.1% vs. 0.3%), acute phase reactions, without regard to causality,(5.2% vs. 1.1%) and fever and flu-like symptoms, without regard to causality, (1.4% vs. 0.2%).Treatment of Osteoporosis in Men, to Improve Bone Mineral Density: In a 2-year study using ACTONEL 35 mg Once-a-Week and placebo in men with osteoporosis, the overall safety and tolerability profiles of the two treatment groups were similar with the exception of hypoaesthesia (ACTONEL 35 mg,2%; placebo, 1%), nephrolithiasis (ACTONEL 35 mg, 3%, placebo, 0%), benign prostatic hyperplasia (ACTONEL 35 mg, 5%, placebo, 3%) and arrhythmia (ACTONEL 35 mg, 2%; placebo, 0%).Glucocorticoid-Induced Osteoporosis: ACTONEL 5 mg daily has been studied in two Phase III glucocorticoid-induced osteoporosis trials, and the adverse event profile of this population was similar

to that seen in postmenopausal osteoporosis trials with the exception of back and joint pain. Back pain was reported in 8.8% of placebo-treated patients and 17.8% of ACTONEL-treated patients; joint pain occurred in 14.7% of placebo patients and 24.7% of ACTONEL patients.Endoscopic Findings: Positive findings on endoscopy were also generally comparable across treatment groups. There were a higher number of reports of mild duodenitis in the ACTONEL group; however, there were more duodenal ulcers in the placebo group. Clinically important findings (perforations, ulcers or bleeding) among this symptomatic population were similar between groups (39% ACTONEL; 51% placebo).For more details see ADVERSE REACTIONS, Endoscopic Findings in the Product Monograph.Paget’s Disease of Bone: ACTONEL has been studied in over 390 patients with Paget’s disease of bone.The adverse experiences reported have usually been mild or moderate and generally have not required discontinuation of treatment. In a Phase III clinical study, ACTONEL and Didronel® (etidronate disodium tablets) showed similar adverse event profiles: 6.6% (4/61) of the patients treated with ACTONEL 30 mg daily for 2 months discontinued treatment due to adverse experiences, compared with 8.2% (5/61) of the patients treated with Didronel® 400 mg daily for 6 months. For more details see ADVERSE REACTIONS,Paget’s Disease of Bone in the Product Monograph.Less Common Clinical Trial Adverse Drug ReactionsThe following adverse drug reactions were reported in ≤1% of patients who received ACTONEL for all indications. Uncommon (0.1-1.0%): duodenitis, iritis; rare (<0.1%): abnormal liver function tests, glossitis.Abnormal Hematologic and Clinical Chemistry FindingsAsymptomatic mild decreases in serum calcium and phosphorus levels have been observed in some patients. Rare cases of leukemia have been reported following therapy with bisphosphonates. Any causal relationship to either the treatment or to the patients’ underlying disease has not been established.Post-Market Adverse Drug ReactionsReported rarely: hypersensitivity and skin reactions (angioedema, generalized rash and bullous skin reactions, some severe); ophthalmologic (iritis and uveitis); osteonecrosis of the jaw.In post-marketing reporting, osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. The majority of reports occurred following dental procedures such as tooth extractions and have involved cancer patients treated with intravenous bisphosphonates, but some occurred in patients receiving oral treatment for postmenopausal osteoporosis and other diagnoses. Many had signs of local infection, including osteomyelitis. Osteonecrosis has other well-documented multiple risk factors.It is not possible to determine if these events are related to bisphosphonates, to concomitant drugs or other therapies, to the patient’s underlying disease or to other co-morbid risk factors (e.g., anemia,infection, pre-existing oral disease). A dental examination with appropriate preventative dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g.,cancer, immune suppression, head and neck radiotherapy or poor oral hygiene). While on treatment,these patients should avoid invasive dental procedures if possible. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment prior to the procedure reduces the risk of osteonecrosis of the jaw. Clinical judgment, based on individual risk assessment, should guide the management of patients undergoing dental procedures.

DRUG INTERACTIONSDrug-Food Interactions:Clinical benefits may be compromised by failure to takeACTONEL on an empty stomach (see DRUG INTERACTIONS, Overview and DOSAGE AND ADMINISTRATION in the Prescribing Summary).Drug-Herb Interactions: Interactions with herbs have not been studied.Drug-Laboratory Interactions: Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ACTONEL have not been performed.

OVERDOSAGEDecreases in serum calcium following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients.Administration of milk or antacids containing calcium may be helpful to chelate ACTONEL (risedronate sodium) and reduce absorption of the drug. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug if performed within 30 minutes of ingestion. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.Full Product Monograph available on request: 1-800-565-0814 or from Procter & Gamble Pharmaceuticals Canada, Inc., P.O. Box 355, Station A, Toronto, Ontario M5W 1C5.

50090295CDN.RIS.09.01.11EM77004-AFU9

Manufactured and Distributed by:Procter & Gamble Pharmaceuticals Canada, Inc.Toronto, Ontario M5W 1C5

Copyright © 2009 Procter & Gamble Pharmaceuticals Canada, Inc. All rights reserved.

Marketed with: sanofi-aventis Canada Inc.Laval, Quebec H7L 4A8

Ontario Medical Review • June 200948 xxOntario Medical Review • May 2009

of pregabalin-treated patients discontinued treatment due to vision-related adverse events (primarily blurred vision). Of the patients who did not withdraw, the blurred vision resolved with continued dosing in approximately half of the cases (see Product Monograph, Post-Marketing Adverse Drug Reactions).

Patients should be informed that if changes in vision occur, they should notify their physician.

Peripheral Edema: LYRICA may cause peripheral edema. In controlled clinical trials, pregabalin treatment caused peripheral edema in 6% of patients compared with 2% of patients in the placebo group. In these studies, 0.5% of pregabalin patients and 0.2% of placebo patients withdrew due to peripheral edema (see Product Monograph, ADVERSE REACTIONS, Peripheral Edema).

In controlled clinical trials of up to 13 weeks in duration of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. In the same trials, peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function.

Higher frequencies of weight gain and peripheral edema were observed in patients taking both LYRICA and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering LYRICA and these agents.

Congestive Heart Failure: In controlled clinical studies, events of congestive heart failure were reported at an infrequent rate (between 0.1% and 1%; see Product Monograph, ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions).

There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin (see Product Monograph, ADVERSE REACTIONS, Post-marketing Adverse Drug Reactions). Although this adverse reaction has mostly been observed in elderly cardiovascular-compromised patients during pregabalin treatment for a neuropathic pain indication, some cases have occurred in patients without reported edema or previous history of cardiovascular disease. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.

Weight Gain: LYRICA may cause weight gain. In pregabalin-controlled clinical trials with durations of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 8% of pregabalin-treated patients and 2% of placebo-treated patients. Few patients treated with pregabalin (0.4%) withdrew from controlled trials due to weight gain (see Product Monograph, ADVERSE REACTIONS, Weight Gain). Pregabalin-associated weight gain was related to dose and duration of exposure.

Pregabalin-associated weight gain did not appear to be associated with baseline BMI, gender, or age. Weight gain was not limited to patients with edema and was not necessarily due to edema-related events (see Product Monograph, WARNINGS AND PRECAUTIONS, Peripheral Edema).

Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of pregabalin-associated weight gain are unknown.

While the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed, in controlled and longer-term open-label clinical trials with diabetic patients, pregabalin treatment did not appear to be associated with loss of glycemic control (as measured by HbA1c).

Dizziness and Somnolence: LYRICA may cause dizziness and somnolence. In controlled studies, pregabalin caused dizziness in 31% of patients compared to 9% in placebo. Somnolence was experienced by 22% and 7% of the patients treated with pregabalin and placebo, respectively. These events begin shortly after the initiation of therapy and generally occur more frequently at higher doses. In these studies, dizziness and somnolence led to withdrawal of 5% (placebo: 0.6%) and 3% (placebo: 0.3%) of the pregabalin-treated patients, respectively.

Abrupt or Rapid Discontinuation: Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache, and diarrhea. Pregabalin should be tapered gradually over a minimum of one week rather than discontinued abruptly (see Product Monograph, ADVERSE REACTIONS, Adverse Events Following Abrupt or Rapid Discontinuation).

ADVERSE REACTIONS

Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in clinical trials may not reflect the rates observed in practice and should not be compared to the rates in clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Clinical Trial Adverse Drug Reactions: Most Common Adverse Events in All Pre-marketing Controlled Clinical Studies of Neuropathic Pain: The most commonly

PRESCRIBING SUMMARY

PATIENT SELECTION CRITERIA

THERAPEUTIC CLASSIFICATION: Analgesic Agent

INDICATIONS AND CLINICAL USE

LYRICA is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia in adult patients.

LYRICA is indicated for the management of pain associated with fibromyalgia in adult patients.

LYRICA may be useful in the management of central neuropathic pain in adult patients for which it has been issued marketing authorization with conditions to reflect the promising nature of the clinical evidence and the need for a confirmatory study to verify its clinical benefit. Patients should be advised of the nature of the authorization.

CONTRAINDICATIONS: Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.

SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Angioedema

There have been post-marketing reports of angioedema in patients, some without reported previous history/episode(s), during initial/acute and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), neck, throat, and larynx/upper airway. There have been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Some of these patients did not have reported previous history/episode(s) of angioedema. LYRICA should be immediately discontinued in patients with these symptoms. During the pre-marketing assessment of pregabalin in clinical trials, angioedema was reported as a rare reaction (see Product Monograph, ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions and Post-Marketing Adverse Drug Reactions).

Caution should be exercised when prescribing LYRICA to patients with previous history/episode(s) of angioedema and related events. In addition, patients who are taking other drugs associated with angioedema (eg, ACE-inhibitors) may be at increased risk of developing this condition.

Hypersensitivity

There have been post-marketing reports of hypersensitivity reactions (e.g. skin redness, blisters, hives, rash, dyspnea, and wheezing). Pregabalin should be discontinued immediately if such symptoms occur (see Product Monograph, Post-Marketing Adverse Drug Reactions).

Renal Failure

In both clinical trials of various indications and post-marketing database, there are reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other medications. Discontinuation of pregabalin should be considered as it has shown reversibility of this event in some cases. Caution is advised when prescribing pregabalin to the elderly or those with any degree of renal impairment (see Product Monograph, Special Populations, Renal; Abrupt or Rapid Discontinuation; ADVERSE REACTIONS, Post-Marketing Adverse Drug Reactions; and DOSAGE AND ADMINISTRATION).

Tumorigenic Potential: In standard preclinical in vivo lifetime carcinogenicity studies of pregabalin, a high incidence of hemangiosarcoma was identified in two different strains of mice. The clinical significance of this finding is uncertain. Clinical experience during pregabalin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans.

Ophthalmological Effects: In controlled studies, pregabalin treatment was associated with vision-related adverse events such as blurred vision (amblyopia) (6% pregabalin and 2% placebo) and diplopia (2% pregabalin and 0.5% placebo). Approximately 1%

Ontario Medical Review • May 20092 49Ontario Medical Review • June 2009

observed adverse events (≥5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: dizziness, somnolence, peripheral edema, and dry mouth. Adverse events were usually mild to moderate in intensity.

Adverse Events from a Controlled Clinical Study in Central Neuropathic Pain Associated with Spinal Cord Injury: The most commonly observed treatment-related adverse events (≥5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: somnolence, dizziness, asthenia, dry mouth, edema, myasthenia, constipation, thinking abnormal, amblyopia, and amnesia. Adverse events were usually mild to moderate in intensity.

Most Common Adverse Events in Controlled Clinical Studies in Fibromyalgia: The most commonly observed treatment-related adverse events (≥5% and twice the rate of that seen in placebo) in pregabalin-treated patients were: dizziness (37.5%), somnolence (18.6%), weight gain (10.6%), dry mouth (7.9%), blurred vision (6.7%), peripheral edema (6.1%), constipation (5.8%), and disturbance in attention (5.3%). Adverse events were usually mild to moderate in intensity.

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug, you may notify Health Canada by telephone: 1-866-234-2345

ADMINISTRATION

Dosing ConsiderationsPatients with Impaired Renal Function: Pregabalin is primarily eliminated from the systemic circulation by renal excretion as unchanged drug. In some elderly patients and those with a medical history of significant renal insufficiency, daily dosages should be reduced accordingly (see Table in Supplemental Product Information).

Adults: Neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia: The recommended starting dose for LYRICA is 150 mg/day, given in two or three divided doses (75 mg BID or 50 mg TID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Efficacy of LYRICA has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week.

For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used. However, in clinical trials, LYRICA 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced markedly higher rates of adverse events and discontinued the trial more frequently (see Product Monograph, ADVERSE REACTIONS, Tables 1 and 5). Doses above 600 mg/day have not been studied and are not recommended.

Central neuropathic pain: The recommended starting dose for LYRICA is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Efficacy of LYRICA has been demonstrated within the first week. Based on individual patient response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week.

For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, a maximum daily dose of 600 mg (300 mg twice a day, BID) may be considered. Doses above 600 mg/day have not been studied and are not recommended.

Pain associated with fibromyalgia: The recommended dosage is 300 to 450 mg/day, given in two divided doses. The recommended starting dose for LYRICA is 150 mg/day, given in two divided doses (75 mg BID), with or without food in patients with a creatinine clearance rate of at least 60 mL/min. Based on individual response and tolerability, the dose may be increased to 150 mg BID (300 mg/day) after one week. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg BID (450 mg/day). In some patients, efficacy of LYRICA has been demonstrated within the first week.

For patients who experience significant and ongoing pain and can tolerate pregabalin 300 mg/day well, maximum daily dose of 600 mg (300 mg twice a day, BID) can be used. However, in clinical trials of fibromyalgia, LYRICA 600 mg/day did not provide additional significant efficacy and patients treated with this dose experienced significantly higher rates of adverse events and discontinued the trial more frequently (see Product Monograph, ADVERSE REACTIONS, Tables 7 and 10). In view of the dose-related adverse events, the decision to treat patients with doses above 450 mg/day should be based on clinical judgment of the treating physician. Doses above 600 mg/day have not been studied and are not recommended.

Administration: LYRICA is given orally with or without food.

Supplemental Product InformationSpecial Populations: Renal: There have been reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other medications. Discontinuation of pregabalin showed reversibility of this event in some cases (see Product Monograph, WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS, Post-Marketing Adverse Drug Reactions; and DOSAGE AND ADMINISTRATION). Because pregabalin is eliminated primarily by renal excretion, the dose of pregabalin should be adjusted as noted for elderly patients or those with renal impairment (see Product Monograph, ACTION AND CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Pregnant Women: There are no adequate and well-controlled studies in pregnant women. Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labour and Delivery: The effects of pregabalin on labour and delivery in pregnant women are unknown.

Nursing Women: It is not known if pregabalin is excreted in human breast milk; however, it is present in the milk of rats. Because of the potential for adverse reactions in nursing infants from pregabalin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatrics (<18 years of age): The safety and efficacy of pregabalin in pediatric patients (<18 years of age) have not been established.

WARNINGS AND PRECAUTIONS: See the Product Monograph for further information on the following: tumorigenic potential, ophthalmological effects, peripheral edema, congestive heart failure, weight gain, dizziness and somnolence, sexual function/reproduction, and special populations.

DRUG INTERACTIONS

Overview: Since pregabalin is predominately excreted unchanged in the urine, undergoes negligible metabolism in humans (≤2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, LYRICA (pregabalin) is unlikely to produce, or be subject to, pharmacokinetic interactions.

Drug Abuse and Dependence/Liability: Pregabalin is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, physicians should carefully evaluate patients for history of drug abuse and observe them for signs of LYRICA misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behaviour).

ADMINISTRATION

Dosage Adjustment Based on Renal Function: Dosing adjustment should be based on creatinine clearance (Clcr), as indicated in Table 1.

Pregabalin is effectively removed from plasma by hemodialysis. Over a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%. For patients receiving hemodialysis, pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose adjustment, a supplemental dose should be given immediately following every 4-hour hemodialysis treatment (see Table below).

Table 1. Pregabalin Dosage Adjustment Based on Renal Function

Creatinine Clearance (Clcr)(mL/min)

Total Pregabalin Daily Dose (mg/day)a

Recommended Dose Escalation*Dose Regimen

Starting dose

up to

Maximum daily dose

≥60 150 300 450 600 BID or TID

30-60 75 150 225 300 BID or TID

15-30 25-50 75 100-150 150 QD or BID

<15 25 25-50 50-75 75 QD

Supplementary dosage following hemodialysis (mg)b

Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mgPatients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mgPatients on the 50-75 mg QD regimen: take one supplemental dose of 75 mg or 100 mgPatients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg

TID = Three divided doses; BID = Two divided doses; QD = Single daily dose. * Based on individual patient response and tolerability. a Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose. b Supplementary dose is a single additional dose.

OVERDOSAGE

Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans: The highest known dose of pregabalin received in the clinical development program was 15,000 mg in 1 patient. The types of adverse events experienced by patients who received an overdose were not clinically different from other patients receiving recommended doses of pregabalin. In post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose (dose range from 800 mg/day up to 11,500 mg as a single dose) included affective disorder, somnolence, confusional state, depression, agitation, and restlessness.

Treatment or Management of Overdose: There is no specific antidote for overdose with pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. A Certified Poison Control Center should be contacted for up-to-date information on the management of overdose with pregabalin.

Hemodialysis: Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

AVAILABILITY OF DOSAGE FORMS

LYRICA is available in dosage strengths of 25 mg, 50 mg, 75 mg, 100 mg*, 150 mg, 200 mg*, 225 mg*, and 300 mg capsules.

* Not commercially available in Canada

For a copy of the Product Monograph or full Prescribing Information, please contact: Pfizer Canada Medical Information at 1-800-463-6001 or visit www.pfizer.ca.

™Pfizer Inc, used under licenseLYRICA® C.P. Pharmaceuticals International C.V., Pfizer Canada Inc., Licensee

© 2009 Pfizer Canada Inc. Kirkland, Quebec H9J 2M5

Ontario Medical Review • June 20091

ClassifiedsOFFICE SPACE AVAILABLEAAA+ CLARKSON VILLAGE—MISSIS-SAUGA: For lease. Fabulous opportunityto lease prime front location in free-standing all medical retail pad in newClarkson Village professional complex.Best exposure in this high-traffic, walk-inlocation with parking in front. Close tonot one, not two, but three hospitalswithin short distance. Join with existingmedical practitioners opening soon,space available from 800 sq. ft. to 3,769sq. ft. divisible to suit your needs. Callme for information at (905) 568-4858,Mississauga. Canada-wide toll free at1-800-463-9403. Stephen D. Taylor,broker of record, Taylor Real EstateServices Inc.

BADEN—MEDICALSPACEAVAILABLE:Free rent for the first year! 10 minutessouth of Kitchener-Waterloo. Healthoffice currently includes dentist anda massage therapist. 2,400 sq. ft. ofshared space with pharmacist. Perfectfor new grad or new family practice.Be the first GP in this thriving youngcommunity. Contact Rick/Nancy at

(519) 634-9468, or e-mail ([email protected]).

BOXGROVEMEDICAL CENTRE—NOWOPEN: Four-storey, 60,000 sq. ft. medicalbuilding located at the 9th Line andHighway 407. Prime medical spaceavailable for lease. X-ray, lab, rehab andurgent care on-site. For info, contactHoward at (416) 357-7509.

DUFFERIN/CLARK: A turnkey medicaloffice up to 2,500 sq. ft. Great location,four exam rooms and a reception, freeparking. Beside dentist, physiotherapist,dietician and a pharmacy. Dense resi-dential and commercial area. Call Hanyat (647) 501-4269.

MEDICAL BUILDING AT MAIN andDanforth, Toronto: Excellent expo-sure and prime location. X-ray, laband pharmacy on premises. Steps toMain subway station and GO Train.Su i tes o f approx imate ly 600 and1,400 sq. ft . avai lable immediately.Attractive terms and rates. For leas-ing inquiries, please call Brad Stone-burgh at (416) 364-5959, ext. 403, or

Classifieds

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Advertisements accepted by mail, e-mail orfax. Copy deadline, notice of cancellationand/or changes to existing advertisementsmust be submitted in writing no later thanthe 10th of the month prior to the monthof publication.

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Please submit requests to:Margaret LamOntarioMedicalAssociation150Bloor StreetWest, Suite900Toronto,OntarioM5S 3C1Tel: 1.800.268.7215, ext. 2263 or416.340.2263Fax: 416.340.2232E-mail: [email protected]

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51Ontario Medical Review • June 2009Ontario Medical Review • June 20091

e-mail ([email protected]).Website (www.par-med.com).

MEDICAL CLINIC FOR LEASE: Prime PortCredit Mississauga area. Ground floorhigh-traffic location. Fully built out withfive examination rooms and receptionarea. Ample parking, next to pharmacyand Tim Hortons. Ideal for medical anddental. Call Ted at (905) 542-1794.

NEWMARKET — NEW OFFICE SPACEAVAILABLE: 700 sq. ft., second floor,unf inished, f ree park ing, separateentrance from first floor office. Pleasecall Dr. Wong at (416) 400-0707, or e-mail([email protected]).

ON STEELES NEAR YORK UNIVERSITY:Busy plaza, 1,500 sq. ft. on main floor.Ample free parking, beside a dentist andoptometrist. Reasonable rent at $12 persq. ft. net. Call Sam at (416) 629-7711.

PAR-MED REALTY LTD: Specializing inmedical office building leasing, propertymanagement, and building sales. Wehave over 70 medical office buildings inour portfolio throughout Ontario. Leasinginquiries, call Brad Stoneburgh (416) 364-5959, ext. 403, e-mail ([email protected]).Website (www.par-med. com).

PRIME SCARBOROUGH LOCATION:Turnkey space available for F/T or P/Tassociate at Lawrence/Midland MedicalClinic. Family practice, walk-in, specialist,on-site lab, ECG and pharmacy. ContactTim at (416) 877-9453, or e-mail ([email protected]).

RICHMOND HILL — OFFICE SPACE:1,500 sq. ft. Small medical/dental build-ing on Bayview Ave. Office is down oneflight of stairs, lots of free parking. E-mailAllan ([email protected]).

RICHMONDHILL—RENT-FREEmedicalspace next to dental clinic. Yonge Streetaddress at corner of Major Mack. Closeto hospital, lab and X-ray. Surroundedby specialists and close to pharmacies.Main floor with ample free parkingon Yonge Street and ease of access.Excellent opportunity for new grads.Contact (416) 450-2772, or e-mail ([email protected]).

STONEY CREEK/WEST HAMILTON:Leasing opportunities (or part owner-ship). New approved plaza to be builton busy Hwy. 8 (Queenston Rd.) in fast-

developing Stoney Creek, medical officespace available from 775 to 8,430 sq. ft.Send inquiries to ([email protected]), orcontact Denno at (905) 208-9373.

WOODBRIGE — 1,400 SQ. FT.: Fullyfurnished medical clinic for lease. Primelocation. Adjacent to pharmacy, dentalclinic. Please call (416) 723-3644.

WOODBRIDGE — MEDICAL SPACEavailable within busy medical building:X-ray, lab and pharmacy on premiseswith free parking. Will renovate to suit.Very reasonable leasing options withfirst year rent-free. Call Gary (416) 418-6716.

FORRENT

FAMILY LAKESIDE COTTAGEGETAWAY:Just 99 min. from Toronto. Full house-keeping cottages with BBQ set onspacious grounds. Kids programs, kayaks,canoes, waterskiing and wakeboarding.Boat andmotor rentals available. 18-holegolf next door. Call today 1-800-267-1310, or visit (www.scotsmanpoint.com).

REAL ESTATE

DISNEY/ORLANDO REAL ESTATE:Unbelievable buying opportunities,former Ontario resident. Call KathyJaworski, Cozy Homes Real Estate, Inc.at (352) 223-3389, or e-mail ([email protected]).

LOCUMTENENS

GROUP OF FAMILY DOCTORS in mid-Toronto seeks locum for July/August2009. Busy, new office, EMR, 70:30 split.Well-run office, congenial staff. ContactGail via e-mail ([email protected]).

LOOKING FOR LOCUM COVERAGE:Effective immediately. You will workcovering one physician’s patients who ison sick leave. No on-call. North York,ON. Call (416) 993-5103, leavemessage.

POSITIONSVACANT

90:10 SPLIT OR FLAT RENT: Brampton,Markham, Etobicoke. Brand new, bright,clean medical centres seeking GPs forwalk-in and family practice. F/T or P/T.Relocate or start a new practice. Newgrads and specialists welcome. EMR orpaper. Turnkey. Call in strictest confi-dence (647) 403-1810.

$200/HOUR — GP required immedi-ately at Mississauga outpatient clinic.Hours: 8 a.m. to 11 p.m. seven days aweek. Call Angela at (905) 897-8928.

$250 PERHOUR— Pediatrician, internist,surgeon, subspecialist in busy outpatientclinic in Mississauga. Dr. Stein (416) 464-0238.

ASSOCIATE MD NEEDED to join familydoctor in Mississauga: 80/20. X-ray& lab on-site. Please call Dr. Afsar at(905) 279-6661 or (416) 575-9031. E-mail([email protected]).

ATIKOKAN, ONTARIO: The canoeingcapital of Canada is actively recruitingfamily physicians with a love of pris-tine wilderness. We provide rural fam-i ly pract ice care, working with theAtikokan Family Health Team and anelectronic medical record. Our prac-tice includes in-patient hospital care,obstetrics and emergency. Atikokan’saccredited hospital has PACS, video-conference technology, and Meditechaccess. Atikokan is a clinical teachingsite for medical students and familymedicine residents through the Nor-thern Ontar io School of Medicine.Physicians are funded by the Ruraland Northern Physician Group Agree-ment, which provides eight weekspaid vacat ion/CME, and an emer-gency department alternate paymentplan for on-call services. We qualify forthe OMA CME reimbursement pro-gram, the UAP incentive program andtuit ion re imbursement program.Locums are funded by HealthForce-Ontario’s locum program. Come andenjoy Atikokan’s community spirit andrecreational opportunities, includingthe Beaten Path Nordic Ski Club, thedownhill skiing, mountain biking andsnowmobile clubs, Atikokan Voya-geur’s hockey, and the Quetico Wild-erness Park’s centennial in 2009. Findout more by contacting Dr. JoanneSpencer, Chief of Staff, at (807) 597-4215, (807) 597-2721 (clinic), or (807)597-4681 (home), or e-mail ([email protected]). Visit our hospitalwebs i t e a t (www.aghosp i t a l . on .ca).

BAYVIEW/RICHMOND HILL : Busyclinic requires evening or weekendshifts. Bonus, FHG available. ContactDr. Lorne Kliman at (647) 284-3759 orDr. David Kirsh at (416) 809-8175.


Classifieds

BRAMPTON, ONTARIO: Full-time/part-time family physician required for busyfamily practice/walk-in clinic. Attractivemodern office with lab. Option to joinFHG, high fee-for-service split or flatmonthly rate. Tel. (416) 949-3830, fax(647) 340-2586, or e-mail ([email protected]).

BRAMPTON, ONTARIO— SPECIALISTS:Dermatologist, pediatrician, internist,and psychiatrist required for medicalcentre with several GPs and large patientbase. Attractive modern office with lab.High fee-for-service split or flat monthlyrate. Tel. (416) 949-3830, fax (647) 340-2586, or e-mail ([email protected]).

CONSULTING PSYCHIATRIST/MEDICALPSYCHOTHERAPIST needed for a newprivate mental health clinic in Maple(Vaughan), Ontario opening in July 2009.The clinic will offer a range of servicesto children, youth, adolescents, adultsand families. Time commitment and/orareas of practice to be set by clinician.Please reply to e-mail ([email protected]).

DOWNTOWN TORONTO — Familyphysicians/general practitioners: F/T,P/T, or locum to join in an establishedpractice with large existing patient base.Professionally managed and efficientlyrun. Located at the University/Dundasintersection. Flexible working hours andopportunity for joining into a FHG.Please contact Dominic, tel. (416) 271-8585, fax (416) 551-5611, or e-mail([email protected]).

DOWNTOWN TORONTO SPECIALISTlooking to share newly renovatedmedical office at Bay/College. X-ray/labon-site. Contact Dr. Keesal at (416) 323-0630, or e-mail ([email protected]).

EXCELLENT OPPORTUNITYwith attrac-t ive spl i t for young and/or ret i reddoctors. Join the group in a new walk-in clinic at 8 Shadlock Street (SteelesAve. East), Markham, L3S 3K9. Locatedin a very busy plaza having a medicalcentre with cardiologist, gastroen-terologist, gynecologist, pedorthistand psychiatrist, dental clinic, phar-macy, physiotherapy and diagnostics.Contact Satish at cell (647) 338-0045,or (905) 471-8980. E-mail ([email protected]).

EXPERIENCED BUSINESS CONSUL-TANT is retiring and plans to open achain of walk-in clinics in and aroundthe GTA. Young and retiring physiciansinterested in just to work or being partof the project; to work and grow with-out the hassle of investment, manage-ment and going through bureaucracy.Please contact Pal Gill at (416) 801-8502, or e-mail (palgil l46@hotmail .com).

FAMILY OR ER PHYSICIANS: GreaterToronto or Ottawa. Part-time home visitswith MedVisit. Evenings or weekends(no overnight call) . Net $200/hour.Experienced drivers available. Call Dr.Tom Burko at (416) 631-0298 or 1-800-355-6668. E-mail ([email protected]),website (www.medvisit.ca/doctors).

FAMILYPHYSICIAN,WALK-INDOCTORS,neurologist, dermatologist, pediatricianrequired for a busy, organized medicalcentre. Low overhead, EMR, part of FHG.E-mail ([email protected]).

FAMILY PHYSICIANS: Join a dynamicwell-established group practice! Fulltime or part time available. Located inToronto, the AlbanyMedical Clinic (FHG)provides comprehensive medical carein an EMR environment to the Torontocommunity at our centrally locatedfull-service facility. Our clinic providesnumerous ancillary services, sharedsupport staff ( including nursing), awalk-in clinic and on-site specialists.We offer the ability to build a practicequickly with significant overhead reduc-tions and the benefits of a group prac-tice. Associate and partnership optionsavailable. The model for efficient pri-mary care for more than 65 years. Pleasecontact Dr. B. Adno at (416) 462-2002 ore-mail ([email protected]) Visit(www.albanyclinic.ca).

FAMILY PHYSICIAN—SCARBOROUGH:Established family practice seeks phy-sician to replace retiring MD. Potentialfor above-average earnings (70:30split). Nursing and administrative sup-port staff. Please contact Antonia at(416) 757-2720, or e-mail ([email protected]).

GENERAL SURGEON — ONTARIO:Brockville General Hospital is seekinga general surgeon to fil l a full-timevacancy. You will be one of four generalsurgeons. Preferred skills include lap-

aroscopy, endoscopy, and ERCP. TheBrockville General is a two-site hospitalwith a combined total of 141 beds,serving a catchment area of 96,000.A recent $32 million dollar expansion(2003) saw the addition of four newOR suites , digita l imaging and CT.Tert iary care/academic centres inOttawa and Kingston are just one houraway. Brockvi l le , Ont . (populat ion22,000), is conveniently located alongHwy. 401 in the beautiful ThousandIslands region; two hours west of Mon-treal and three hours east of Toronto.Website (www.brockville.com). UAPeligible. Contact Carlene MacDonald,Physician Recruiter, Brockville GeneralHospital, e-mail ([email protected]),tel. (613) 345-5645, ext. 1154, or visit(www.bgh-on.ca).

GET AWAY FROM THE BIG SMOKE!Ourmedical doctor has retired from thecharming little town of Erin, Ontario (45minutes from Toronto). Large existingpatient base. Come andmake the coun-try your home and practice. Please callDr. Katrina Kulhay at (519) 833-0558.

GROWING MEDICAL CLINIC in highlypopulated area (Markham/Eglinton)in Scarborough is looking for familydoctors to join a full-time pediatricianand a part-time family physician. Attrac-tive and negotiable split. Please callJaya at (416) 265-6663.

INTERNAL MEDICINE— BROCKVILLE,ON: The Department of Internal Medi-cine at Brockville General Hospital isseeking a general internist with sub-specialty interest to supply services forthe Brockville General Hospital andsurrounding communities. You will beone of five internists. Our current com-plement consists of a cardiologist (1),generalist/respirology (1), generalist(2). This is a community-based prac-t ice opportunity . Opportunity forlocum is also available. The BrockvilleGeneral Hospital is a community hos-pital serving a regional population ofapproximately 66,000. We are a two-site corporation with a combined totalof 141 beds. New (2003) ER, ICU (fivebeds), stepdown (four beds), digitalimaging and CT. Access to tertiary carecentres one hour away in Kingstonand Ottawa. The City of Brockvi l le(population 22,000), website (www.brockville.com), is conveniently lo-cated along Hwy. 401 in the beau-


Classifieds

t i f u l Thousand Islands Region: 210km. west of Montreal and 340 km. eastof Toronto. Website (www.brockvilletourism.com). Contact Carlene Mac-Donald, physician recruiter, BrockvilleGeneral Hospital at (613) 345-5645,ext. 1154. E-mail (macca@ bgh-on.ca),or visit (www.bgh-on.ca).

KITCHENER FAMILY PRACTICE (FHO)looking to replace retiring partner.15-person call group. No hospital call.Fully integrated EMR (Practice Solu-tions), experienced staff, small med-ical bui lding with very reasonablerent. Lab and pharmacy on-site. Assetsof well-equipped office free. Aboveaverage FHO income. Practice avail-able summer 2009. E-mail ([email protected]), or call (519) 741-1254after 6 p.m.

LAMP COMMUNITY HEALTH CENTREhas an opening for one full-time andone part-time family physician in itsnew satellite in east Mississauga. Bepart of a collaborative team with anurse practitioner, nurse, social workerand other health-care providers. Ourclients are diverse and interesting andour staff is waiting to welcome you toour team. Someon-call,mostly telephone,no hospital work or obstetrics, and nooverhead. Salaried full-time and part-time position plus on-call stipend,incentives and excellent benefits.Possible opportunity for a long-termlocum. This new facility is located at the

corner of Dixie/Dundas streets and isclose to GO Transit. If interested, contactSandra Van at (416) 252-6471, or e-mail([email protected]).

MARKHAM, ON: Smart Health MedicalClinic is seeking locum (July to October2009) , a part-t ime/ful l-t ime familyphysician. Opportunity to buy in or joinas associate or set up new practice(including solo versus family healthteam). Location in Markham, RichmondHill close to Scarborough. Locumneededfor four months. Walk-in optional. Newgraduate/retiring or physician whowants to earn extra income is welcome.Fu l l y equ ipped and fami l i a r wi thelectronic medical records. Split up to60:40. Chinese language is an asset.Please cal l Dr . Howard Wu at (647)501-4289/(905) 948-9738, or e-mail([email protected]).

MISSISSAUGA, ON: Family doctorsrequired for a busy, new, totally comput-erized (EMR), walk-in/family practiceclinic. Hours 9 a.m. to 9 p.m. seven days aweek. Full-time and part-time shiftsavailable. Call (416) 831-7899.

NEWMARKET— LOCUM/ASSOCIATEwanted to assist female family physicianin solo practice. New plaza, first floor,EMR, 70:30 split. Please call Dr. Wongat (416) 400-0707, or e-mail ([email protected]).

NORTH YORK, ONTARIO: Paperlesscomputerized new clinic in a medicalbuilding with pharmacy, lab and X-ray.No set-up cost. Part time or full time.Move existing practice or build up fromwalk-in clinic. Support staff for EKGs,PFTs, venipuncture for income supple-ment. Please contact Mr. Samuel at (647)400-0401.

OTTAWA: FAMILY MEDICINE full-timeor part-time positions available in anattractive building in a beautiful newcommunity. Free parking and on-sitelab. Contact Dr. Ashikian at (613) 822-0171 from 9:00 a.m. to noon, or 1:00 p.m.to 3:00 p.m., Monday to Friday. Fax (613)822-1838, or e-mail ([email protected]).

PHYSICIANS— ON: Have you consid-ered providing eye exams? EyelogicSystems Inc. is a leading provider ofadvanced eye-care systems and solu-tions. Our business is expanding to pro-

vide fullymanaged exam centres. We arecurrently searching for licensed MDs inthe province of Ontario to conduct eyeexaminations. Work hours are flexible—create your own schedule in this turnkeyopportunity. No investment. No over-head. Earn $150/hr. plus $0.58/km. travela l lowance . Mult ip le locat ions tochoose from in the GTA and acrossOntario. We provide training to doctorswithout experience and refresher train-ing to those with experience. ContactMark McDonald at 888-854-7780, ore-mail ([email protected]).

PHYSICIAN WANTED TO SUPERVISECardiolite stress tests at private clinic inOakville and/or downtown Toronto. Canbe a GP or specialist. Must have currentACLS and good ECG interpretive skills.Generous compensation to qualifiedphysicians. Please contact AndreaJones at (416) 485-5793 for more infor-mation.

PSYCHIATRISTS, MEDICAL PSYCHO-THERAPISTS are needed at a busyprivate mental health clinic. Pleasecontact Sue at (416) 778-1496.

RICHMOND HILL, ONTARIO: RichmondHill After-Hours Clinic requires phy-sicians for daytime shifts 9:00 a.m. to5:00 p.m. , as wel l as evenings andweekends. Guaranteed minimum70:30 split. Contact Dr. Ian Zatzman at(905) 884-7711. Fax (905) 553-5360.E-mail ([email protected]).

SALARIED COSMETIC PHYSICIAN:Möcelle Edan (Canada) Inc. has asalaried position available for a part-time or full-time cosmetic physician(GP or dermatologist) . This is a rareopportunity to work in a prestigiousspa-inspired setting. Recent grads andretired MDs are welcomed to apply.Please e-mail, fax or mail CV or expres-sions of interest to: Director, BusinessDevelopment, Möcelle Edan (Canada)Inc. TD Canada Trust Tower, 161 Bay St.27th floor, Toronto, ON, M5J 2S1. E-mail([email protected]). Fax 1-866-655-7686.

TORONTO—DOWNTOWNUNIVERSITYAVE.: Beautiful clinic seeks full-time FPphysician for new family practice posi-tion. Ideal location, EMR, nurse, staff/admin. included. Corporate profes-sional patients. Available immediately.For clinic info, visit (www.emkiro.ca).


Classifieds

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For more information,

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Send inquiries via e-mail ([email protected]).

YONGE/EGLINTON: Two-physicianclinic needs to replace MD. Medicalbuilding, large practice, EMR, subwayaccess, parking, lab, X-ray, physio on-site. Full time, part time. Hours 8:30 a.m.to 5:30 p.m. Mon. to Thurs., 8:30 a.m. to7:30 p.m. Fri., negotiable. Compensation:fee-for-service, CCM, split negotiable.Contact Gail at (416) 483-8382, e-mail([email protected]).

POSITIONSWANTED

EXPERIENCED DISPENSING AUDIOLO-GIST seeking to share space in ENT orfamily practice. Please contact Colleenat (647) 281-0915.

PRACTICES

RECENT FP GRAD looking to take overpractice (FHG/FHO) in Mississauga,Brampton or west GTA. Please call (416)837-3323.

START YOUR OWN PRACTICE/WALK INCLINIC: Unlimited potential/patients.Bui ld ing avai lable at no cost . Onehour north of Toronto. Call (905) 722-6257, or e-mail ([email protected]).

SERVICES AVAILABLE

ARYA & SHER, HEALTH LAWYERS:Pract ice focused on represent ingmedical practitioners, clinics, hospitals,and health-care companies. Businessand regulatory issues, including pro-fessional incorporations, businessregistrations, contracts, partnership/shareholder issues , tax and estateplanning, employment, leasing, med-ical real estate, and regulatory matters.Call Kashif Sher, LLB, MBA at (416) 218-8373, or e-mail ([email protected]).Website (www.aryasher.com).

BILLING AGENT— ELECTRONIC datatransfer direct to MOHLTC for medicalpractitioners of all specialties, in all ofOntario. Multiple locums welcome.Medical Billing and Secretarial Services(905) 342-3232.

CLOSING YOUR PRACTICE? Freerecord storage! (For qualifying physi-cians) Canada-wide. Compliant, physi-cian-managed. Since 1997. Call RSRS at

1-888-563-3732, ext. 221, or e-mail([email protected]).

COOPER MARGEL AND BICK LLP:Chartered accountants and licensedpublic accountants practising in Mark-ham since 1978. Assisting you in all youraccounting and consult ing needs,personal, corporate, estate and trustincome tax matters. “We can make adifference.” 1001 Denison St., Suite 202.Tel. (905) 475-6795, ext. 223. Visit (www.cmbaccountants.com).

GOING EMR? Need to scan your patientrecords? Find out how we can do it forfree. Contact Sid Soil at DOCUdavitSolutions today at 1-888-781-9083,ext.105, or e-mail ([email protected]).

OHIP BILLING SOFTWARE— $199 percomputer — Klinix Assess: You get thecomplete software package of billing,scheduling, and medical records, plusproduct support and updates for anannual licence fee of $199 per computer.Satisfaction guaranteed in the first 120days or return Klinix Assess for yourmoney back. No fine print. Demos at(www. klinix.com). Toll-free 1-877- SAVE-199.

RETIRING, MOVING OR CLOSING yourpractice? DOCUdavit Medical Solutionsprovides free patient record storageacross Canada with no hidden costs.Contact Sid Soil at DOCUdavit Solutionstoday at 1-888-781-9083, ext.105, ore-mail ([email protected]).

UPCOMING EVENTS

2010 CME CRUISES: New cruises nowavailable. Caribbean, Panama Canal,Mexican Riviera and South East Asia.Contact Sea Courses Cruises to receiveour compl imentary e-newslet teroffering advance notice of new CMEcruises, travel articles, and promo-tional offers. Phone 1-888-647-7327,e -mai l (cruises@seacourses .com).Vis i t (www.seacourses.com) “WhereCompanions Cruise free.”

MEDICAL WOMEN’S CME CRUISE:Sail ing from Boston to Montreal onboard the “Maasdam” (Holland AmericaLine). Conference theme: Caring forthe Caregiver. This is also the NorthAmerican Regional Meeting of theMedical Women International Associ-

ation. Companion cruises free. Visit(www.seacourses.com) for completelist of Sea Courses CME cruises. Phone1-888-647-7327, e-mail ([email protected]).

MEDITERRANEAN CME CRUISE: Cruiseto Greece, Turkey and Egypt on board“Celebrity Equinox” August 31 – Sept-ember 13. Topics: Respirology, infec-tious diseases, and cardiology. Com-panion cruises free. Visit (www.seacourses.com) for complete list of SeaCourses CME cruises. Phone 1-888-647-7327, e-mail ([email protected]).

FOR SALE

MEDICALOFFICE CLOSURE (JULY 2009)SALE: All items less than five years old.Two Ritter exam tables (series 104), twodesks and chairs, stools, examinationlamps. Cash and carry. Call (416) 408-0403.

MISCELLANEOUS

A MUSIC CAMP FOR BOOMERS whost i l l love the music of their youth:Now there’s finally a music camp foryou. Boomer Music Camp is uniquelydesigned with boomers in mind. RunsAugust 16-21. Visit (www.boomermusiccamp.com) for details.

WE ARE PLEASED TO ANNOUNCEthat the Beau Cote Centre for EatingDisorders, located on Bowen Island,British Columbia, has received a three-year CARF accreditation for its residen-tial eating disorders program. A three-year CARF accreditation is the highestlevel of accreditat ion that can beawarded. Beau Cote is committed toclinical excellence, cutting edge treat-ment, and state-of-the-art program-ming that integrates sound medical,psychiatric, and psychological proto-cols. Dr. Laird Birmingham, MedicalDirector and International Eating Dis-order Leader, Dr. Alexander Goumeni-ouk, Psychopharmacologist , andCertified Eating Disorder Specialists,Dr. Beverley Richardson and Dr. NormaBenedict, lead our multidisciplinarytreatment team and guide treatmentplanning and case management. TheBeau Cote Centre is a licensed facilityunder Vancouver Coastal Health, andCARF Accredited. 1-888 947-9003 toll-free, (604) 947-9003, website (www.beaucote.ca). OMR


Classifieds

Medec

Ontario Medical Review • June 200956 1Ontario Medical Review • July/August 2003

A&L Computers.................................10

Association of Hearing Instrument

Practitioners of Ontario ....................34

Beau Cote Centre for Eating

Disorders ...........................................16

Cappellacci DaRoza LLP ...................10

Elecompack Systems Inc ................8,31

Eli Lily Canada Inc ............................36

Health Services Ontario ....................50

IVF Canada ........................................28

Klinix Software ....................................4

Meyers Norris Penny LLP..................37

OMA CyberMed Skills.........................2

OMA Physician Health Services........IFC

OMA Pregnancy and Parental Leave

Benefits Program (PPLBP) ................37

OMR Added Value.............................54

OMR Classifieds ................................37

OntarioChiropractic Association .......IBC

Pfizer Canada............................9,20-21

Record Storage & Retrieval

Services ..............................................28

Sanofi-Aventis Pharma......................OBC

Schering-Plough...............................12-13

York-Med Systems Inc ...........................17

Prescribing Information:

Actonel .........................................46-47

Lyrica ............................................48-49

Olmetec........................................42-45

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_OCA08002_OntMedReview_OFFICE_8.1 1 5/11/09 10:04:25 AM

IN POSTMENOPAUSAL OSTEOPOROSIS

NEW ACTONEL 150 mg Once-a-MonthThe FIRST and ONLY once-a-month dosing option in Canada for the treatment of postmenopausal osteoporosis1** Comparative clinical significance is unknown.

Help protect her from fracture by prescribing ACTONEL

2†

2†‡

† Vertebral fractures: ACTONEL 5 mg 2.4% vs. placebo 6.4%; p<0.001, 0-1 year. ‡ Composite score for hip/pelvis, clavicle, humerus, leg and wrist.

Nonvertebral fractures: ACTONEL 5 mg 5.2% vs. placebo 8.4%; p=0.02, 0-3 years.

2-4§||

4

§ Randomized, double-blind, placebo-controlled study of 2,458 postmenopausal women with at least one vertebral fracture at baseline. All patients received 1 g/d calcium and, if baseline vitamin D serum levels were low, up to 500 IU/d vitamin D.

|| The overall incidence of adverse events was similar to placebo. Most adverse events reported were mild or moderate. The most common gastrointestinal events in clinical postmenopausal osteoporosis studies were (ACTONEL 5 mg vs. placebo): dyspepsia (5.2% vs. 4.8%), nausea (4.8% vs. 5.0%), abdominal pain (4.1% vs. 3.3%), constipation (3.7% vs. 3.6%), diarrhea (2.9% vs. 2.5%) and flatulence (2.1% vs. 1.8%).

Manufactured and Distributed by:Procter & Gamble Pharmaceuticals Canada, Inc.Toronto, Ontario M5W 1C5

Copyright © 2009 Procter & Gamble Pharmaceuticals Canada, Inc. All rights reserved.

Marketed with:sanofi-aventis Canada Inc.Laval, Quebec H7L 4A8

CDN.RIS.09.03.05EM77004-AOU9

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ACTONEL is indicated for the treatment (5 mg, 35 mg, 75 mg, 150 mg) and prevention (5 mg, 35 mg) of postmenopausal osteoporosis. ACTONEL is also indicated for the treatment of osteoporosis in men, to improve bone mineral density (35 mg). ACTONEL is contraindicated in patients with known hypersensitivity to any component of the prescribed product. ACTONEL is contraindicated in patients with hypocalcemia. This and other disturbances of bone and mineral metabolism should be effectively treated before starting ACTONEL therapy. Adequate intake of calcium and vitamin D is important. ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min). Since some bisphosphonates have been associated with upper gastrointestinal disorders, careful attention should be paid to the ACTONEL dosage and administration instructions, especially in patients with a history of esophageal disorders. ACTONEL should be taken on an empty stomach at least 30 minutes before the fi rst food, drink (other than plain water) and/or medication of the day, while in an upright position with suffi cient plain water (≥120 mL). Patients should also not lie down for at least 30 minutes after taking ACTONEL. In postmarketing reporting, osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. Clinical judgement, based on individual risk assessment, should guide the management of patients undergoing dental procedures. Musculoskeletal pain, rarely severe, has been reported as a common adverse event in patients who received ACTONEL for all indications. In clinical trials, the overall incidence of adverse events with ACTONEL 5 mg daily was comparable to placebo. The most commonly reported adverse events were (placebo vs. ACTONEL 5 mg) abdominal pain (3.3% vs. 4.1%), dyspepsia (4.8% vs. 5.2%) and nausea (5.0% vs. 4.8%). The overall safety and tolerability profi le of ACTONEL 35 mg Once-a-Week is similar to that of ACTONEL 5 mg daily. The overall safety profi le, including the incidence and pattern of upper gastrointestinal events of ACTONEL 75 mg on two consecutive days per month, is similar to that of ACTONEL 5 mg daily. The adverse events reported (ACTONEL 75 mg vs. ACTONEL 5 mg) in more ACTONEL 75 mg–treated patients than 5 mg daily were arthralgia (1.5% vs. 1.0%), vomiting (1.1% vs. 1.0%), gastritis erosive (1.0% vs. 0.3%), acute phase reactions, without regard to causality (7.6% vs. 3.6%) and fever or fl u-like symptoms, without regard to causality (0.6% vs. 0.0%). The overall safety profi le, including the incidence and pattern of upper gastrointestinal events of ACTONEL 150 mg Once-a-Month, is similar to that of ACTONEL 5 mg daily. The adverse events reported (ACTONEL 150 mg vs. ACTONEL 5 mg) in more ACTONEL 150 mg–treated patients than 5 mg daily were diarrhea (3.1% vs. 0.5%), vomiting (1.5% vs. 0.6%), arthralgia (1.5% vs. 0.9%), myalgia (1.1% vs. 0.3%), acute phase reactions, without regard to causality (5.2% vs. 1.1%) and fever and fl u-like symptoms, without regard to causality (1.4% vs. 0.2%). Please refer to accompanying Prescribing Information for full dosing instructions and other important information. Product Monograph available on request.

References: 1. Brogan Inc. GPM® database and the Compendium of Pharmaceuticals and Specialties 2009; February 19, 2009. 2. Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA. 1999;282(14):1344-1352. 3. Reginster J-Y, Minne HW, Sorenson OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int. 2000;11:83-91. 4. ACTONEL® Product Monograph, Procter & Gamble Pharmaceuticals Canada, Inc., September 17, 2008.

women’s health seminaromr.dgtlpub.com/2009/2009-06-30/pdf/omr_2009-06-30.pdf · women’s health...

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