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TABLE OF CONTENTS PRESIDENT’S Fit Feet Special Olympics p. 3 MESSAGE More Tools p. 5 APMA – Toronto Insurance Trends p. 8 July 30-August 2, 2009 Supersize your RRSP p. 10 Provincial Updates p. 11 Report of the CPEF p. 14 Insurance Liaison Update p. 16 A Student Perspective p. 17 Mark your Calendars p. 18 Mario G. Turanovic, D.P.M. :: Since our last newsletter, podiatrists have been busy at a variety of activities across PLAN TO ATTEND The Americans the country. From Foot Health Awareness to involvement with th the Fit Feet program for Special are coming! Olympics athletes, CPMA mem- 19 bers have been demonstrating :: Thanks to a strong working relationship and a signed friend- WORLD the importance of taking care of ship protocol with the CPMA, for the first time ever, the Ameri- your feet. CONGRESS can Podiatric Medical Association is leaving U.S. soil to host its annual scientific seminar in Canada. From July 30 to August 2, A number of our members also OF 2009, Toronto’s Convention Centre will play host to an enormous participate in various charity walks, such as the Weekend to group of podiatrists. PODIATRY End Breast Cancer. Every oppor- The APMA’s Annual Scientific Conference is renowned for its exten- tunity we seize to promote the MAY 26-28, 2007 sive academic program. In addition to a broad range of workshops benefits of seeing a podiatrist and seminars on a variety of podiatry related topics, the conference and educating Canadians about COPENHAGEN also draws a significant list of exhibitors to showcase the latest good foot health helps to pro- DENMARK products and materials. mote our profession. I applaud everyone’s efforts to date, and The 2006 conference in Las Vegas, Nevada drew the largest del- encourage more of our mem- egate number in history. Let’s work to make the 2009 conference bers to get involved wherever in Toronto an even greater event. ■ and whenever they can.■
This newsletter has been made possible through an educational grant from DERMIK the dermatology division of sanofi-aventis Canada Inc. Makers of PrPenlac®, PrLoprox® and PrTopicort®. Precision • Reliability • Versatility • Value
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orthotics Please call for more information or visit us on the web. Paris Orthotics Ltd. www.parisorthotics.com 3630 East 1st Avenue Vancouver BC V5M 1C3 Toll Free: 1.800.848.0838
Paris Trade Ad.indd 1 1/17/06 10:08:21 AM Haflpage 2 11/8/05 1:15 PM Page 1
Fit Feet March into the Canadian National Games of Special Olympics
:: This past July, the National The general comment from Games of Special Olympics athletes and coaches alike was was held in Brandon, Manitoba. one of great appreciation for Over 1000 athletes from 10 the podiatrists participating in • Friendly, attentive staff provinces and two territories the games and providing the were there to compete. For the screenings. • Exacting standards first time in the history of the Saucony, New Balance, and National Games, the Fit Feet • Dependable service Spenco provided donated program was held. Podiatrists goods, such as bags, socks, • Trusted quality from British Columbia, Alberta, and insoles. When these were Manitoba and Ontario were given to the athletes, they all there to conduct the screenings. were surprised and truly ap- Close to 200 athletes were preciated their ‘gifts’. The word www.precision orthotics.com screened during the four day spread that the ‘foot guys’ had period. Many athletes had these great gifts, which helped never had their feet examined encourage more athletes to at- before. Most of the conditions tend the screenings. • Fine finishing seen mirrored those observed I am hopeful that all future Na- • Prepaid overnight shipping in the podiatrist offices. The tional Games will now have the most common conditions noted • BAPFOL Accredited Lab Fit Feet screenings as part of were skin and nail problems in the event. By doing so, we can addition to flat feet of vary- ensure that the athletes foot ing degrees. If follow-up care health is looked after, which was needed the athletes were enables them to continue to instructed to seek podiatric compete. care in their province. A ‘report card’, indicating the conditions Dr. Kel Sherkin found and then stating that fol- Canadian Director low-up care was needed, was Fit Feet Healthy Athletes given to the coaches who were Special Olympics■ instructed to pass the report cards on to the parents/guard- ians of the athletes to ensure that treatment was obtained. For information call toll-free 1-800-661-8221
#4-744 Fairview Road Victoria BC V9A 5T [email protected]
CONNECTING on an International Level :: As a member of the CPMA, The FIP mission is to ensure cine, the FIP has already made with the American Podiatric you are automatically a mem- access to high-quality foot and significant strides in countries Medical Association’s annual ber of the Federation Interna- ankle care for all people, through around the world. In addition scientific conference. Next tionale des Podologue (FIP). FIP collaboration with national and to a very comprehensive World year, the 19th World Congress is an international federation international organizations of Foot Health Awareness Month will be May 26 to 28, 2007 in of podiatric organizations rep- podiatrists and other health program and materials, the FIP Copenhagen, Denmark. With a resenting 55,000 podiatrists organizations. By providing a is also embarking on a project in broad range of topics and ses- worldwide in 23 countries on focus for global leadership and South America to improve foot sions, the conference will have five continents. development of podiatric medi- health for many of the poor. something for everyone, so make plans now to attend. For Earlier this year, FIP was more information, visit www. awarded the Humanitarian fipworldcongress.org■ Award from the APMA for its efforts to enhance the podiatry profession and foot care inter- nationally.
FIP is also behind the World Congress of Podiatry, which occurs every three years. In 2004, the World Congress was held in Boston in conjunction
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MORE TOOLS for better practice management :: In the last CPMA newsletter, to bring to physician practices a As the patient interacts with Use What You’ve Got ! I presented some of the unique web-based, interactive patient the program, each click is re- Bringing information to your pa- and effective ways to market a education program named corded to create a permanent tients about the benefits of or- medical practice using the web. Emmi. In easy-to-understand record of what the patient saw, thotics, general foot health tips For the most part, the methods language, Emmi walks patients heard and did while viewing the or guidelines for selecting better I described could be found at through the entire surgical ex- program. As a result, Emmi pro- footwear is a routine conversa- a very low or negligible cost, perience from pre-op to post- vides (and is the only program tion you will have with most needed little up-front invest- op, including risks and alterna- that can) tangible proof that a patients. Why not utilize your ment in time and would work tives. patient has accessed critical patient’s waiting room time to for any type of business. Once information about the planned get the message across? We’ve Emmi is built on the premise up and running, these tools procedure and was informed of all seen the methods employed that educating patients about continue to provide on-line all of the risks associated with by our dentists: the flat screen an upcoming surgery is both exposure for your practice with it. While Emmi will never re- on the waiting room wall show- critical and time consuming very few new inputs. For anyone place the physician and staff as ing the horrible “befores” and for the physician and his or that would like further reading the most important source of joyful “afters” with new ve- her staff. Emmi, which covers on this subject, there is a very patient education, it can serve neers. Or, advertising the latest a wide and growing range of good article on Podiatrytoday. as a powerful adjunct to what a tooth and gum treatment tools surgical procedures, effectively com(http://www.podiatry- practice is already doing. and plugging services found in illustrates and synthesizes dif- today.com/article/3164) that the practice. It provides the pa- ficult, intimidating and often AdvancedMD™ is an on-line discusses this in greater depth. tient a break in the monotony of scary information about up- practice management tool waiting but also sparks interest This time, I’d like to present coming surgeries and presents which requires practices to in the services offered. This some electronic tools and ap- it in an easy-to-understand, only have desktops with access is accomplished with a small plications that can be found on conversational and almost to the Internet. Through secure investment in a flat screen the web to bring efficiencies comforting manner. servers, the application ensures and a “slave” PC that can run a specifically to medical practice patient data is secure and your Even people who are not fa- PowerPoint slide show. You can and enable the practitioner to appointments and scheduling miliar with computers easily customize your presentation to maximize time with patients. are centralized in one location understand Emmi. In addition, leverage the services you offer but available for anyone in the Emmi™ (Expectation Manage- since the patient is able to view and demystify some of the pro- office to see. Scheduling, chart- ment of Medical Information) Emmi at home (through an In- cedures and services available ing and billing can be input Imagine the impact on your ternet connection and a special to the patient. and viewed in the same way. practice if each and every sur- password), they often share For those of you who manage Paul Fouad is General Manager of Pre- gical patient had a clear, accu- the information with family and mier Medical Supply, a distributor of multiple practice locations as surgical and medical supplies located in rate picture of what to expect friends, which helps to create well as surgery days and on- Calgary, Alberta. Paul can be reached at when undergoing a procedure. supportive expectations for call, now you can view patient [email protected] ■ Now imagine if you could ac- everyone involved. information as long as you can complish this goal quickly and In addition to its obvious ben- get access to the Internet. The easily – educating patients at efits as a patient education tool, on-line appeal is further en- their own pace, and in their own Emmi also helps manage risk. hanced by the fact that there home. Most experts agree that the is no investment in a “bullet- The Ohio State Medical As- majority of medical malpractice proof” network in each of your sociation, through its business lawsuits are first and foremost locations and gives flexibility to arm OSMAdvantage, has part- the result of missed patient ex- develop new physical locations nered with Rightfield Solutions pectations. without having to take every- thing with you between offices.
APMA Speech
CPMA President Mario Turanovic spoke before the APMA House of Delegates on March 27, 2006. Provided below is his speech.
:: Good morning, Mr. Speaker, Mr. President, members of the use the argument that it was already being done by our fellow Board of Trustees, delegates and all other distinguished guests. It is DPMs south of the border. So therefore we are very grateful for both a pleasure and an honour to be here in front of you today. I’m being able to use the advancements made to our profession by told that I’m the first CPMA president to speak before the APMA the hard work of the APMA as a positive example in being able to House of Delegates. I truly appreciate the invitation. achieve our goals.
As you may already know, the CPMA and the APMA have a very Since the signing of our friendship protocol, the APMA’s resources, good working relationship. In fact, one of my predecessors, Dr. help and advice have always been available. We certainly appreci- Neil Koven, worked closely with the APMA executive to develop a ate your assistance and willingness to help. I know that our ex- signed friendship protocol between our two great organizations. ecutive director has been especially grateful for the assistance and guidance of Glenn Gastwirth and his staff over the past years and I I’d like to take a moment to share with you the state of podiatry in hope that our wonderful relationship continues for as long as there Canada. In case you didn’t know, Canada has the highest concen- is an APMA and a CPMA. tration of Doctors of Podiatric Medicine outside of the U.S. and all our DPMs were trained in U.S. colleges of podiatric medicine. Our I’d now like to ask Dr. Schofield to come up to the podium. numbers aren’t as large as your’s but perhaps collectively we can We were very fortunate to have some of the APMA executive qualify as the 51st state? No doubt, an acey deucy state at that! attend the International Region VII annual conference held at the In Canada, each province is responsible for establishing its own beautiful Lake Louise resort in Alberta last October. As a token of standard of podiatric health care. Currently half of the country has our friendship and appreciation for the collegiality shared between the DPM standard. Because our parliamentary system is derived our two associations, I presented hockey jerseys to those execu- from the British system, so too has some of our health care system. tives in attendance. I’d now like to add Dr. Schofield to the hockey Some of our remaining provinces currently use the chiropody stan- team we are slowly building. dard, and a couple of provinces don’t have any foot care legislation Dr. Schofield, I wish you and your association a fabulous year. It yet. Moving Canada to a DPM standard nationally is something has been a pleasure to provide you and your colleagues with a that we at the CPMA are constantly striving towards. Canadian report. I look forward to continued cordial relations. To give you an example of how things have progressed over the Thank you and God bless. ■ past 23 years that I’ve been in practice, I can use my home province of Alberta to illustrate the positive changes. When I first graduated and started practicing, we had very limited prescribing rights, no hospital privileges and very little recognition of our profession by the medical community.
Now, our prescribing privileges extend to all non-narcotic medica- tions and the prescribing of all narcotic analgesics will be available before the end of 2007. We have hospital staff and admitting privi- leges and a full scope of practice for the foot and ankle. This puts us in a position of working closely with vascular, orthopedic and plastic surgeons in the hospitals. As a result of this, we are also in the process of being integrated into the College of Physicians and Surgeons of Alberta and are becoming recognized as an integral component of primary health care.
Personally, I feel that one of the reasons that we have enjoyed this fairly rapid evolution is because every time that we requested an Incoming APMA president Dr. David Schofield expresses his appreciation of the Canadian hockey jersey presented to him by improvement from our government regulators we could always Dr. Mario Turanovic, president of the CPMA.
ECCO shed light on Foot Health Awareness Month
:: To promote Foot Health news outlets in key markets able materials and supportive Awareness Month this past across Ontario expressed im- soles. Style was not forgotten May, ECCO Shoes Canada, mediate interest in booking Dr. however as some fun, colourful Inc. conducted a month long Hill to discuss healthy summer shoes for summer were show- media tour across southern footwear. cased by Dr. Hill, proving that Ontario. with ECCO you don’t have to Over the course of the me- As one of the first comfort shoe dia tour, Dr. Hill conducted sacrifice fashion for comfort. manufacturers to receive the spokesperson offering profes- an impressive number of live Overall the ECCO media tour Canadian Podiatric Medical As- sional insights on common foot and pre-taped interviews with generated over 2 million audi- sociation’s Seal of Acceptance problems related to summer news outlets such as CHUM- ence impressions. With over on selected products, ECCO footwear. FM, CTV/CFTO and CFPL-AM. 70% of foot problems due to wanted to draw attention to the One of the most successful ill-fitting shoes, this media Combining ECCO’s well known interviews was with Ottawa’s importance of wearing quality, tour helped shed light on Foot comfortable footwear. ECCO reputation for designing com- number one morning show, Health Awareness Month and partnered with Dr. Jim Hill, a fort footwear with the timeli- A-Channel Morning viewed by the importance of quality, com- Windsor-based podiatrist and ness of Foot Health Awareness over 98,000 people. During fortable footwear for overall member of the Ontario Podi- Month proved to be a success- the six-minute segment, Dr. Hill ECCO CPMA Ad 11/18/05 2:08 PM Page 1 foot health. ■ atric Medical Association. Dr. ful formula in securing inter- was able to speak about the im- Hill acted as the official ECCO views with the media. Major portance of proper fit, breath-
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Insurance Trends I am pleased to advise that this past insurance year for 2005 to plaintiff. Shortly after the surgery the plaintiff noticed pain, tin- 2006 we have seen a slight decrease in the frequency of claims gling and numbness in the foot that the surgery was performed being reported. In total we have four new claims, one from Alberta, on. In July 2006 allegations of nerve damage and pain & suffer- one from British Columbia and two from Ontario. This is an im- ing have been made. provement over recent years. One significant difference between • Statement of claim is for $50,000. Non pecuniary damages and the most recent claims over past claims however is that our soci- an additional $100,000 for pecuniary damages plus interests ety has become far more litigious and demanding. The statement and costs. of claims for patient losses have jumped significantly as you can see in the case studies below: Case Number 3 • In February 2004 a practitioner performed a surgical treatment Case Number 1 of Morton’s Neuroma. In February 2006 a writ was served • In August 1999 a practitioner treated a patient for an ingrown claiming that as a result of the surgery the plaintiff is experienc- toenail. The removal procedure was performed and treatment ing intensified pain and discomfort which eventually lead to the for infection also provided. Written post surgical instructions patient being disabled. Even though the plaintiff followed all pre were given to the patient that advised the dressing should remain and post operation procedures the plaintiff alleges an incorrect on the toe for 48 hours. After the 48 hours, the plaintiff removed diagnosis, that the procedure and treatment selected was con- the dressing to discover that a tourniquet had not been removed traindicated for the plaintiff’s conditions, and further alleges that from the surgery. The result was an ischemic injury, necrosis, the practitioner failed to apprise of all material facts, attempting numbness and vascular problems. to treat a condition and perform procedures which he knew or ought to have known he was not capable of doing. • Judgment was for $54,000. and Legal Expenses were $8,300. • Amount being sued for - $500,000. Case Number 2 • In August 2003 a McBride bunionectomy was performed on the Making your insurance a priority! ■
Podiatrists on the Front Lines as Dangerous Disease Looms Large for Older People Peripheral Arterial Disease “Because a simple foot exam in their feet. Comprehensive • wounds or ulcers on the feet Affects Millions and Often Has can reveal P.A.D., podiatrists diabetic foot exams performed and toes that are slow to heal No Symptoms are in a position to diagnose by podiatrists are essential for The P.A.D. Coalition is an alli- the disease and save limbs and people with diabetes. It is im- ance of leading health organi- :: As people age, it’s often even lives,” said Joseph Capo- portant that pain in the feet and zations and government agen- what they can’t see or feel that russo, DPM, Secretary of the legs never be ignored. Because cies united to raise public and can hurt them. This adage cer- P.A.D. Coalition. “That’s why the feet can show early signs of health professional awareness tainly holds true for Peripheral the American Podiatric Medical serious diseases like P.A.D. and about lower extremity P.A.D. Arterial Disease (P.A.D.). Often Association (APMP) is joining diabetes, it is important that Committed to improving P.A.D. described as a silent disease, with other leading physicians people discuss any foot pain patient outcomes, the Coalition P.A.D. is a narrowing or clogging and organizations as a member with a podiatrist. is coordinated by the Vascu- of arteries in the legs caused of the Coalition to urge people Common warning signs for lar Disease Foundation. Visit by plaque. This disease affects to get any foot or leg pain P.A.D. include: www.APMA.org and www. 8-12 million Americans, with checked by a podiatrist.” PADCoalition.org for more in- symptoms ranging from pain • fatigue or pain in the feet and Due to narrowing and block- formation from walking to more serious legs during walking ing of blood vessels in the legs, complications such as lower- (Article courtesy of the American patients with P.A.D. are more • foot or toe pain at rest that limb amputations. People aged Podiatric Medical Association) ■ 50 and over are the highest risk prone to foot problems. Minor often disturbs sleep for P.A.D., and the risk increases cuts, sores or blisters are slow for smokers, people with diabe- to heal or don’t heal at all due to tes, high blood pressure, high a lack of blood flow to the feet. cholesterol or a family history P.A.D. is especially danger- of the disease. Since P.A.D. of- ous for persons with diabetes ten shows no symptoms, it can because they may have nerve progress to dangerous levels damage or neuropathy and before it is detected. may not be able to feel injuries Manitoba hosts successful conference
:: Kudos to the Manitoba Podiatry Association for hosting a successful conference in 2006. Despite its small numbers, members of the MPA rallied together to coordinate a con- /BSSPX5PF-PPQTmUTNBMMFSUPFT ference that was well attended by many podiatrists across 8JEF5PF-PPQTmUUIFCJHUPF Canada. The exhibitor hall also provided a wide array of or- thotics and shoe companies as well as a few more diverse "DUJPO5PF-PPQT exhibitors. 5IFVOJRVFDVTIJPOJOHBOEHSJQPGPVSGPBNMJOFENBUFSJBM NBLFTUIFTFTUSBQTJEFBMGPSSFQPTJUJPOJOHUIFUPFT"DUJPO The MPA conference also played host for the 2006 Annual 5PF-PPQTUSFBU General Meeting of the Canadian Podiatric Medical Associa- 'SBDUVSFT -JHBNFOUJOKVSJFT tion. Good food and good discussions made it a great meeting. )BNNFSUPFTBOE$MBXUPFT +BNNFEUPFT Thanks to those who attended. Next year’s CPMA AGM takes 0WFSMBQQJOHUPFT 3PUBUFE5PFT place in October at the Holiday Inn on King in downtown To- $BMM+-3FIBCUPPSEFSZPVSGSFF ronto, Ontario. DBUBMPHVFBOE$BOBEJBOQSJDFMJTU
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November 4 and 5, 2006 was mation was sent to Dr. Hedy held in conjunction with The Fry, MP for Vancouver. University of British Columbia BRITISH Thanks go to Dr. Tim Kalla, who Continuing Medical Education Division. In addition to increas- started the events, Dr. Joseph COLUMBIA ing the profile of our profession Stern, who micromanaged the :: BCAP continued with its three prior to the event; around the in the medical community, the budget, and our members who major events on an annual basis same calls as last year were event also enables members donated their time for the pub- in 2006. answered. Over 6000 posters to invite referring physicians to lic section. Thanks also to those were sent to B.C. physicians to attend. who contributed to funding the “Ask a Podiatrist” telephone ho- make their patients aware of the event. tline is in its third year of opera- During Diabetes Awareness event date. tion. Thanks go out to Dr. Joseph Month, BCAP and the CDA Management of the BCAP is Stern and Dr. Joseph Wong-Sing During Foothealth Awareness held its 5th Public Forum on Di- an ongoing task that requires for offering their board room for Month, BCAP members and abetes. The event provided free dedication from its members the function, Dr. Ian Yu for or- “MTS Logistics” collected and foot screening, retinal screening for success. I thank those in the ganizing the event for the third forwarded slightly used shoes (through The British Columbia provincial as well as the national to the Canadian Diabetic Asso- year and those members who Optometry Association), blood association for their continued ciation (CDA) for distribution. glucose monitoring and Pro- volunteered their time. Personal effort in promoting our profes- thanks to Dr. Roy Mathews Thanks to Dr. Joseph Stern for Care shoe fitting through New sion. who brought coffee that early managing this event. Balance Canada. This is the only morning. Advertising switched multidisciplinary public event in Michael Y. Choi, D.P.M. The Third Annual Live Well from television to radio a week Canada on diabetes and infor- President, BCAP ■ with Diabetes Conference on
to doctors and networking with the Physiotherapists Associa- ALBERTA tion of Alberta. We are just on the edge of our second phase of a three phase We continue with our transition initiative to increase aware- to the College of Physicians and :: While Alberta’s economy We are still hearing compli- ness about podiatry and the Surgeons, and most recently we continues to boom, so does ments on the Region VII confer- importance of Albertans taking finalized an office based surgery opportunity for podiatrists in ence that the Alberta Podiatry good care of their foot health. list, which was presented to the Alberta. Most recently, our ef- Association hosted in October Through one-time funding from Non Hospital Surgical Facility forts to secure a surgical fee 2005 at Lake Louise. While the Alberta Health, our awareness Committee. schedule in line with orthopae- association took a break from campaign focuses on three We are also pleased with the dic surgeons for hospital-based conferences in 2006, we are key audiences: general public, recent growth in our mem- surgeries was implemented. already working on the next general practitioners and phys- bers – within the last couple of We are now finalizing the de- four years. June 2007 will see iotherapists. The first phase months we have four new U.S. tails for retroactive payment as us at the Delta Lodge in Kanan- strategically coincided with graduates who moved to our well as an on-call stipend for askis, and in years 2008-2010 Foot Health Awareness Month province to practice. those podiatrists who are on our conferences will take place in May, and included movie the- the on-call rotation. at the beautiful Banff Springs atre trailers, transit advertising, Mario Turanovic, D.P.M. Hotel. letters, postcards and posters President, APA ■ 11 PROVINCIAL UPDATES
We also joined the specialty nipeg along with the CPMA’s MANITOBA Annual General Meeting. Using medical team of EMTs, para- medics, physicians, nurse prac- the theme “Learn, Take Home neurological and vascular as- titioners and podiatrists at the and Apply!”, the conference sessments and diabetic screen- ‘Weekend to End Breast Can- included a wide range of lead- ings. The 500 people lined up :: The Manitoba Podiatry cer’ in June, when thousands ing North American suppliers for assessments overwhelmed Association (MPA) general of men and women took to the exhibiting their merchandise as our 16 volunteers! Wal-Mart regulations were passed in May streets of Winnipeg to walk the well as an excellent line up of and our Brandon members did 2006 and the College of Po- 60 kilometre route. speakers who were acclaimed a similar symposium in Octo- diatrists of Manitoba expects to for their enthusiasm to convey ber for rural communities. Dr. In July, members volunteered at start work on the prescription evidence-based material in a Stephanie Wu from the Dr. Wil- the Special Olympics “Fit Feet” privilege regulations and surgi- user-friendly manner. liam Scholl College of Podiatric screening program in Brandon, cal regulations in the new year. Medicine provided a lecture to Manitoba. This was an exciting Lots of good things are happen- Now that the general regula- the general public as well as a and personally rewarding event ing with the Manitoba Podiatry tions have been passed we can multi-professional breakfast to see all the athletes passing Association and we look for- move forward on the increase lecture on The Management through the screening program. ward with anticipation for lots of scope of practice. of Neuropathy. The event was Our members also worked more in 2007. hard organizing The Canadian In April 2006, our association covered by three different tele- Hayley Edwards BSc. Hons. Podiatry Conference held Sep- partnered with Wal-Mart for a vision channels, four times in Pod. Med. Manitoba Podiatry diabetic foot symposium for the tember 28 to October 1, 2006 one week, and put the MPA in Association President ■ general public that provided free a good light. at the Fairmont Hotel in Win-
ONTARIO Homeopathy and they will also This year’s Foot Health Month have access to the “Doctor” campaign was a great success. title and have scopes of prac- Through a multi-pronged pro- tice and authorized acts that gram, we ran a series of radio :: Over the past year, the themselves “Doctor” if they will overlap those of podiatry to ads on two stations and distrib- OPMA has spent considerable hold an earned doctorate de- one degree or another. uted brochures to approximately time and effort making submis- gree granted by an educational 7000 runners at different Our College’s recommendation sions to Ontario’s Health Pro- institution accredited or ap- running events throughout the that HPRAC review returning to fessions Regulatory Advisory proved by any certifying body month. As well, a one day ‘Ask a podiatry model of footcare in Council (HPRAC) on a number approved by the College in the Your Podiatrist’ phone program Ontario was submitted to the of the health professional regu- discipline in which they regis- was conducted, made possible Minister in the Spring. While latory issues. HPRAC released tered to practice. This clearly through the generous support the next opportunity for an its report “New Directions” applies to podiatry in Ontario of New Balance Toronto and HPRAC referral will probably in April and its expected that and will bring our podiatrists New Balance Canada most of the recommendations into step with other provinces not occur before spring 2007, will be implemented through and U.S. states. However, a our profession in Ontario hasn’t Kel Sherkin, D.P.M. been this close to removal of omnibus legislation tabled in number of new professions will President — Ontario Podiatric the podiatric cap and a com- the Ontario Legislature this be regulated in Ontario, such as Medical Association ■ Fall. HPRAC recommended Kinesiology, Traditional Chinese mitment to a podiatry model that practitioners may call Medicine, Naturopathy and for at least 25 years. 12 PROVINCIAL UPDATES
QUEBEC
:: In 2005, there was an graduation from Doctor of Congratulations to important overhaul at the Podiatry (DP) to Doctor of Po- Quebec Order of Podiatrists diatric Medicine (DPM). The • Dr. Martin Brain, newly elected president of following the president election 3rd year students inaugurated of Serge Gaudreau, DPM, suc- the university podiatry clinic in the Ontario Podiatric Medical Association ceeding to Dr. François Allart May. The rotations went very who was terminating 8 years well this summer and they are • Dr. Micheal Choi, recently re-elected as presi- in office. We now have fresh supervised by a team of 15 cli- dent of the British Columbia Association of new management at the helm nicians over the course of 20 (Jean Tanguay, LL), two new hour+ clinical weeks. Podiatrists U.S. graduated members now The program is expanding as practicing in the province and our first year students made • Hartley Miltchin, Toronto area DPM, has 69 active podiatrists. the enrollment swell to 68 ac- been chosen as the official podiatrist to In spring 2006, the UQTR tive students. Miss Universe Canada. changed the appellation of Not only are we looking at the the diploma to be issued upon future now; we are in it. ■
NEW AGREEMENT creates level playing field for two provinces
:: In response to repeated requests from business communities in cedures and guidelines that affect trade, investment and labour Alberta and British Columbia to eliminate economic barriers, the mobility. The agreement comes into force on April 1, 2007, with two provinces recently signed the British Columbia-Alberta Trade, April 1, 2009 identified as the end of the transitional period to Investment and Labour Mobility Agreement (TILMA). This agree- fully implement the agreement. ment, Canada’s most comprehensive internal trade agreement, Fortunately, the podiatry profession in Alberta and B.C. is very creates a market of 7.5 million people and Canada’s second largest similar, which will result in little to no changes required. Profes- economy. sions with greater disparity will have work to do to comply with The agreement is comprehensive, applying to all government the agreement.° measures such as legislation, regulations, standards, policies, pro-
13 Report of the Canadian Podiatry Education Foundation
:: CPEF was established in 1984 to promote foot health through The website will also include sections on careers in podiatric medi- education: to the public, of students, and of professionals. cine and foot-related health issues. I would like to recruit your as- sistance in sending original material on patient education for post- STUDENT ASSISTANCE PROGRAM (SAP) ing at the CPEF web site – www.cpef.ca. Any suggestions would be Since the inception of CPEF, one of its goals is to help needy stu- greatly appreciated. Please direct any email to [email protected] dents defray part of the tuition cost which is currently more than In conclusion, I would like to thank the Board of Directors for their USD 24,000 per year. In the year ending 2005, $4000 was dis- time and effort spent on behalf of the Foundation. I look forward to bursed. This year there are six complete applications. The Board an eventful year. of Directors have instituted a new requirement as a condition to provide the loan – having a guarantor co-sign the loan before new Joseph Wong-Sing loans are being disbursed. CPEF President ■
On the other side, the SAP Committee has been successful in A Non-profit Charitable Organization collecting loans: in 2005 $12,500 and thus far in 2006 $6,500. (Charitable Registration Number 88610 3597 RR0001) I applaud the hard work of the SAP Committee. 203-2309 West 41st Ave, Vancouver, B.C. Canada V6M 2A3
CANADIAN PODIATRY SCHOOL FUND The Canadian Podiatry School Fund ($27,240) is invested in long term investments. Contribution to the School Fund is pegged at What you inhale is NOT an option! 10% of the membership dues collected. For 16 years, membership dues were collected by the CPMA on behalf of CPEF. This arrange- Choosing between built-in vacuum and ment stopped around 2002 to the detriment of the future of podia- waterspray IS your option! try education in Canada, however, starting in 2007, the CPMA will provide $10 per member towards the CPEF. ORTHOFEX ORTHOSPRAY FUND RAISING The profession was generous in the last fundraising campaign and • built-in vacuum their support is much appreciated. We plan to continue with direct • flexible handpiece appeal on a regular basis.
Consider the Foundation the recipient when looking for a write off • low noice or if you would like to honour someone or leave a bequest. As a ORTHOFEX ORTHOSPRAY charitable organization the foundation can issue tax deductible receipts. More important, it helps to perpetuate the profession. • built in waterspray
WEB SITE www.cpef.ca • better spray control The web site is being written as you read this. Download- • low noise able forms for the Student Assistance Program and Research Applications will soon be available. When completed, the students can email the forms back to us. This will save tre- mendous time and postage costs. For members, certain areas EUROPEAN FOOTCARE SUPPLY Distributors for Orthofex, Suda and EKS will be password accessible – such as minutes of meetings and Tel/Fax 403.271.6805 [email protected] financial statements.
14 FIP Report
:: The FIP meeting in Oslo, mittee, which has produced As always, another key aspect ence. Promotional information Norway in April 2006 enabled quality materials for member of the FIP is garnering corpo- has been shared with podiatrists considerable dialogue and countries to use. 2006’s poster rate support. The Oslo meeting around the world and CPMA sharing of viewpoints from the campaign focused on a Man on included a number of corporate members are encouraged to many countries represented at the Moon concept, with a child’s members, and the interaction attend. the meeting, including Canada, foot stepping on the moon. between them and member Through involvement with FIP, which resulted in a solid over- country representatives was The FIP is also embarking on a Canada continues to enhance view of podiatry news around beneficial for both parties. project with South American the association’s profile and the world. The meeting also countries to bring better foot With the 2007 World Congress keep abreast of evolving podia- provided the opportunity for care to many under developed conference taking place May try issues around the world. member countries to hear first- communities. As well, two new 26 to 28, 2007 in Copenhagen, hand about some of the initia- Dr. Robert Chelin member companies have come Denmark, the FIP Board of Di- tives that FIP is working on. Vice President on board – Hong Kong and Cy- rectors have also been involved Federation Internationale des The FIP has a very strong Foot press. in supporting and promoting Podologues ■ Health Awareness Month com- this truly international confer- Working together for Proud to be associated with greater results Canadian Podiatrists since 1995 :: Over the years, the CPMA has continued to build a strong relationship with the APMA. In addition to a signed friendship protocol, the two associations share resources, information and goodwill. Through ongoing dialogue and meetings, the CPMA and the APMA has evolved into a collegial relationship that is beneficial to both organizations.■
Insurance Services
Karen McGee, Account Executive
(604) 990-7440 (604) 986-5783 Fax
CPMA President Mario Turanovic with APMA past president Harold Glickman and APMA current president David Schofield. Auto • Home • Commercial • Marine • Life
15 INSURANCE Liaison Update
:: Because of the ongoing foot problems. us as practitioners and they gary, Alberta this past May. problems with abuse and ex- also provide significant sav- While standing at a booth may Many of the insurers have in- cessive utilization, many insur- ings for insurance companies. dicated to us that they have a seem like a waste of time, in ers are tightening coverage for Additionally, the implementa- lot of different plans and some reality it provides a unique op- orthotics. The good news is that tion of our recommendations plans have better coverage than portunity for face-to-face con- the podiatry profession contin- position insurers in a positive others. Ultimately, it is up to the tact with insurers, their claims ues to be well recognized by in- light with their plan sponsors plan sponsors (employers) to representatives and managers. surers which, for the most part, determine what coverage they and employees by providing means that their subscribers The conversations that ensue want for their employees. the best possible quality in foot often lead to policy changes are required to see a podiatrist care through treatment by po- to have orthotics fabricated. It While insurers ultimately do or changes in insurers’ direc- diatrists. seems that other practitioners what works best for them, tion, which is beneficial for our This year, we continued our will no longer be covered for the recommendations that we profession. orthotics, though. Insurers feel have put forth to them have tradition of attending the an- that it is in the best interest of served both parties well over nual Canadian Life & Health Lloyd Nesbitt, DPM their subscribers to see a foot the years. Our recommenda- Insurance Association confer- Chair, CPMA Insurance specialist for the treatment of tions and suggestions benefit ence, which was held in Cal- Liaison Committee■ Half page ad 11/8/05 1:14 PM Page 1
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16 From a student perspective
:: The perspectives of Cana- care as a consequence of the in Toronto would be getting a and this has become a hin- dian Podiatric Medical stu- shortage of podiatrists. higher level of care if Podia- drance towards its evolution. dents across the United States trists were able to go there and Additionally Martins thinks that In regards to the Michener are primarily centered on the practice.” The focus is recog- clinical research would “open Institute of Chiropody, there following four areas of concern: nizably different as well in that the eyes of the Ontario govern- are four transfer students from chiropody is geared towards ment from depriving its citizens • current podiatric licensing cap Michener at TUSPM who have conservative care whereas the access to quality foot care of 1993 in Ontario, provided me with their per- and ultimately prove that elec- • comparing the level of educa- tive limb-saving surgeries saves tion provided at the Michener tax dollars in the long term.” Institute of Chiropody to Podiatric Medical School The different scopes of practice • scope of practice in different from province-to-province are provinces, and also a concern for Canadian • financial aid. students. Most students from Many students from Ontario Ontario are opting to practice expressed concern and frustra- in the U.S. instead of the other tion with the podiatric licensing provinces. Ramy Fahim from cap, which makes it difficult to OCPM states, “I aspire to come balance their desire to be a Podi- back and practice in Ontario atric Physician with their desire one day upon the completion of to remain, and practice, in their my residency,” but is uncertain home province. For instance, whether this will ever be pos- fourth year student Daryll Mar- sible. Overall, most students tins at TUSPM states, “I feel as hoping to return to Canada are if I have been abandoned by my just concerned with being able Student Association president Miguel Cunha meets with province; I have no other option CPMA president Dr. Mario Turanovic to practice at the level in which but to turn away from my fam- they were trained in the U.S. ily, friends and culture to pursue at TUSPM, the focus is more Last but not least, a few students my desire to practice podiatric spectives on the most notable surgically oriented. Additionally expressed their concerns about medicine.” differences in education when comparing both schools. Ken students have pointed out that loans and lack of scholarship Will the scope of practice Kep pointed out that his educa- the chiropody school compared options. Ramy Fahim relates change for chiropodists if a tion at TUSPM is more com- to TUSPM is more focused on that he would be interested stronger education / degree prehensive in terms of overall biomechanics and orthotics in receiving more assistance program is initiated? Why patient healthcare. As Ken training. Darryl Martins, an- than his current loan provides. won’t the Ontario government points out, “here, there seems other transferee, believes that In general, students would like at least allow Canadian stu- to be more of a medical holistic one major factor gradually not only more financial options dents educated in both the US approach/mindset to treating elevating the strength of the but also to be better educated and Canada to practice their full the patient where you’re re- Podiatric Medical community and informed on what financial scope of practice? garded as one of the patient’s in the U.S. is the abundance of aid is available to them while clinical research/ literature con- studying within the U.S. The overall consensus reached physicians whereas in Canada ducted within Podiatric Medi- by the students from Ontario chiropodists aren’t viewed the Miguel Cunha cal Schools. Martins believes is that there is a dire need for same.” Sydney Yau relates that President, Temple has a higher academic that the incentive to publish more podiatrists in Ontario and Podiatry Student Association ■ is lacking within the Ontario the patients there are being de- standard than Michener and Podiatry / Chiropody society prived of access to quality foot that he feels that, “the people 17 ADVERSE REACTIONS ® In the vehicle controlled clinical trials conducted in the US, 9% (30/327) of patients treated with PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER and 7% (23/328) of patients treated with vehicle reported treatment emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. With the Classified MARK your exception of Skin and Appendages, the incidence of these adverse events, within each body system, was similar between the treatment groups and was less than 1%. For Skin and Appendages, 8% (27/327) and 4% (14/328) of patients in the ciclopirox and vehicle groups, respectively, reported at least one adverse event. Periungual erythema and erythema of the proximal nail fold were the most common TEAEs causally related to Advertisements study drug. These events (coded as “rash”) were reported in 5% (16/327) of patients treated with PENLAC and CALENDAR 1% (3/328) of patients treated with vehicle. Other TEAEs thought to be causally related to study material in the US vehicle-controlled studies included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the PENLAC group and 2% [7/328] in the vehicle group). NAIL LACQUER PRACTICE FOR SALE in Application site reactions and/or burning sensation of the skin were considered causally related to study drug in spected and collaborative care- Topical Antifungal Agent Chilliwack, British Columbia. 1% of both PENLAC- and vehicle-treated patients (3/327 and 4/328, respectively). based clinic with many diverse INDICATIONS AND CLINICAL USE Use of PENLAC for 48 additional weeks was evaluated in an open-label extension study conducted in patients Located in a medical office April 27–29, 2007 Please read this entire section carefully to fully understand the indication for this product. previously treated in the vehicle-controlled studies. Three percent (9/281) of patients treated with PENLAC health practitioners. Referrals Topical treatment with PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is indicated as part of a experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in building across from Chilliwack BCAP Podiatry Conference comprehensive nail management program in immunocompetent patients with mild to moderate onychomycosis the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. from other practitioners at (due to Trichophyton rubrum) of fingernails and toenails without lunula involvement. The comprehensive U OF BC, Robson Square, Vancouver, B.C. The remainder of TEAEs considered causally related to study drug occurred at an incidence of <1%. Regional Hospital. Three treat- management program includes frequent removal of unattached, infected nails (e.g., monthly) by a health care In controlled and open-label clinical trials conducted with ciclopirox nail lacquer, 8% outside of the US, adverse Synergea is significant and very For more information contact [email protected] professional with special competence in the diagnosis and treatment of nail disorders, including minor nail events reported were consistent with those seen in the US studies. ment rooms in this turn-key procedures. PENLAC should therefore be used only under medical supervision. The safety and efficacy of daily use Post-Marketing Experience supportive of tremendous prac- for longer than 48 weeks have not been established. (See PRECAUTIONS.) practice with a large waiting Contact dermatitis has been reported as an adverse reaction in post-marketing surveillance of ciclopirox-containing tice growth. The Amaranth Pivotal Clinical Trial Data products, including ciclopirox nail lacquer, 8%. PENLAC was used to treat onychomycosis of the great toenail (without lunula involvement) in two double-blind, placebo- room and reception area. Good DOSAGE AND ADMINISTRATION Whole Foods Market situated controlled pivotal studies. Patients were treated once daily for up to 48 weeks in conjunction with monthly removal of the PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER should be used as a component of a comprehensive rapport with physicians in the unattached, infected toenail by the investigator. At baseline, patients had 20-65% involvement of the target nail plate. next door also offers a strong management program for onychomycosis. Removal of the unattached, infected nail – as frequently as monthly community. Chilliwack serves Endpoint ITT Population – by a health care professional, weekly trimming by the patient, and daily application of the medication are all referral base. Efficacy Variable Study 312‡ Study 313‡ integral parts of this therapy. Careful consideration of the appropriate nail management program should be given as a referral base for the outly- May 26–28, 2007 to patients with diabetes. (See PRECAUTIONS.) Ciclopirox Placebo Ciclopirox Placebo For more information or to FIP World Congress of Podiatry Nail Care By Health Care Professionals ing communities servicing a Treatment Success1 8/107 (8%) 1/107 (1%) 13/115 (11%) 1/115 (1%) Removal of the unattached, infected nail – as frequently as monthly – trimming of onycholytic nail, and filing of Copenhagen, Denmark excess horny material should be performed by professionals trained in the treatment of nail disorders. population of over 80,000. discuss this opportunity fur- Treatment Cure2 6/110 (6%)† 1/109 (1%) 10/118 (9%) 0/117 (0%) For more information visit www.fipworldcongress.org Nail Care By Patient Enjoy the close proximity of the ther, please contact Dr. Judy Mycological Cure3 30/105 (29%) 14/105 (13%) 39/113 (35%) 10/114 (9%) Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after PENLAC is removed with isopropyl alcohol. water, mountains, farmlands, Forrester directly at dc4kids@ 1 Treatment Success: negative culture, negative KOH, ≤10% involvement target nail PENLAC should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails telus.net or contact Ruth at 2 Treatment Cure: negative culture & KOH, Global Evaluation Score = Cleared with the applicator brush provided. culture and diversity of the city. 3 Mycological Cure: negative culture, negative KOH PENLAC should be applied evenly over the entire nail plate. 403-247-2947 to schedule an ‡ Denominators differ across variables because of missing data If possible, PENLAC should be applied to the nail bed, hyponychium, and the under surface of the nail plate when Contact: Joseph Wong-Sing it is free of the nail bed (e.g., onycholysis). † p=0.055. All other values statistically significant (CMH ≤0.02, stratified by centre) at (604)261-3513 or email appointment to visit the centre PENLAC should not be removed on a daily basis. Daily applications should be made over the previous coat and Post-treatment efficacy assessments were scheduled only for patients who achieved treatment cure. Some data removed with isopropyl alcohol every seven days. This cycle should be repeated throughout the duration of and see for yourself the holistic, on the post-treatment efficacy of the product are available for 12 patients. Twelve weeks after stopping ciclopirox therapy. [email protected] ■ treatment, 3/6 patients maintained treatment success, and 6/9 patients maintained negative mycology reports. June 15–17, 2007 AVAILABILITY OF DOSAGE FORMS healing environment and the CONTRAINDICATIONS PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is a clear, colourless to slightly yellowish solution for Alberta Annual Podiatry Conference PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is contraindicated in individuals who have shown services offered. You can also topical application to fingernails, toenails and immediately adjacent skin only. It is available in 6 gram glass bottles Kananaskis, Alberta hypersensitivity to any of its components. with screw caps, which are fitted with brushes. visit their website at www.syn- For more information contact 1-888-220-3338 WARNINGS PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is not for ophthalmic, oral, or intravaginal use. ergea.ca ■ For use on nails and immediately adjacent skin only. INDEPENDENT PRACTICE or visit www.albertapodiatry.com PRECAUTIONS No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic Opportunity in Northwest antifungal agents for onychomycosis. Therefore, the concomitant use of PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER and systemic antifungal agents for onychomycosis, is not recommended. (See INDICATIONS Calgary, Alberta AND CLINICAL USE.) The Synergea Family Health The effectiveness and safety in the following populations have not been studied, as the clinical trials with PENLAC excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression Centre has a great opportunity List your classified ad here – you (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required for an on-site full-time Doc- will reach out to all podiatrists medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe August 16–19, 2007 plantar (moccasin) tinea pedis were also excluded. tor of Podiatric Medicine in across Canada. Whether you’re So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by their beautiful facility with looking for an associate, someone APMA Annual Scientific Seminar the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes to buy your practice or product or Philadelphia, Pennsylvania mellitus or diabetic neuropathy. state-of-the-art computer If a reaction suggesting sensitivity or chemical irritation should occur with the use of PENLAC, treatment should be systems, educational systems have something to sell, list it here. For more information, visit www.apma.org discontinued and appropriate therapy instituted. Use in Pregnancy and dedicated staff! Central Send your information to askus@ Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, podiatrycanada.org using the of ciclopirox as ciclopirox olamine/kg/day, or in rats and rabbits receiving topical doses of up to 92.4 and administration provides for all 77 mg/kg/day, respectively, did not indicate any significant fetal malformations. subject line “classified ad”.■ Teratology studies with ciclopirox free acid were performed in rats with oral doses of 20, 50, or 125 mg/kg/day your administrative needs. and in rabbits with oral doses of 12.5, 32, or 80 mg/kg/day; no significant fetal malformations were noted. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. PENLAC should The Synergea Family Health be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Centre is a multi-disciplinary It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, health centre located in the October 11–14, 2007 caution should be exercised when PENLAC is administered to a nursing woman. Pediatric Use beautiful Arbour Lake district. OPMA Annual Conference Safety and effectiveness in pediatric patients have not been established. Toronto, Ontario (downtown theatre district) Geriatric Use Within walking distance of the Vehicle-controlled clinical trials of PENLAC conducted in the US did not include sufficient numbers of patients aged For more information call 1-866-424-6762 Crowfoot Business Centre at 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. Nosehill Drive and John Laurie NOTE: Plan to attend the 2007 Annual General Meeting of the Complete product monograph available on request (1 800 265-7927). Blvd, it is a vibrant, well-re- CPMA, which will take place in conjunction with the OPMA con- sanofi-aventis Canada Inc. ference in Toronto. 2150 St. Elzear Blvd. West Laval, Québec H7L 4A8 18
K 2006/08/04_BAO2 130719_Ad_Penlac_En_pi ADVERSE REACTIONS ® In the vehicle controlled clinical trials conducted in the US, 9% (30/327) of patients treated with PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER and 7% (23/328) of patients treated with vehicle reported treatment emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. With the exception of Skin and Appendages, the incidence of these adverse events, within each body system, was similar between the treatment groups and was less than 1%. For Skin and Appendages, 8% (27/327) and 4% (14/328) of patients in the ciclopirox and vehicle groups, respectively, reported at least one adverse event. Periungual erythema and erythema of the proximal nail fold were the most common TEAEs causally related to study drug. These events (coded as “rash”) were reported in 5% (16/327) of patients treated with PENLAC and 1% (3/328) of patients treated with vehicle. Other TEAEs thought to be causally related to study material in the US vehicle-controlled studies included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the PENLAC group and 2% [7/328] in the vehicle group). NAIL LACQUER Application site reactions and/or burning sensation of the skin were considered causally related to study drug in Topical Antifungal Agent 1% of both PENLAC- and vehicle-treated patients (3/327 and 4/328, respectively). INDICATIONS AND CLINICAL USE Use of PENLAC for 48 additional weeks was evaluated in an open-label extension study conducted in patients Please read this entire section carefully to fully understand the indication for this product. previously treated in the vehicle-controlled studies. Three percent (9/281) of patients treated with PENLAC Topical treatment with PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is indicated as part of a experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in comprehensive nail management program in immunocompetent patients with mild to moderate onychomycosis the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. (due to Trichophyton rubrum) of fingernails and toenails without lunula involvement. The comprehensive The remainder of TEAEs considered causally related to study drug occurred at an incidence of <1%. management program includes frequent removal of unattached, infected nails (e.g., monthly) by a health care In controlled and open-label clinical trials conducted with ciclopirox nail lacquer, 8% outside of the US, adverse professional with special competence in the diagnosis and treatment of nail disorders, including minor nail events reported were consistent with those seen in the US studies. procedures. PENLAC should therefore be used only under medical supervision. The safety and efficacy of daily use Post-Marketing Experience for longer than 48 weeks have not been established. (See PRECAUTIONS.) Contact dermatitis has been reported as an adverse reaction in post-marketing surveillance of ciclopirox-containing Pivotal Clinical Trial Data products, including ciclopirox nail lacquer, 8%. PENLAC was used to treat onychomycosis of the great toenail (without lunula involvement) in two double-blind, placebo- DOSAGE AND ADMINISTRATION controlled pivotal studies. Patients were treated once daily for up to 48 weeks in conjunction with monthly removal of the PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER should be used as a component of a comprehensive unattached, infected toenail by the investigator. At baseline, patients had 20-65% involvement of the target nail plate. management program for onychomycosis. Removal of the unattached, infected nail – as frequently as monthly Endpoint ITT Population – by a health care professional, weekly trimming by the patient, and daily application of the medication are all Efficacy Variable Study 312‡ Study 313‡ integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes. (See PRECAUTIONS.) Ciclopirox Placebo Ciclopirox Placebo Nail Care By Health Care Professionals Treatment Success1 8/107 (8%) 1/107 (1%) 13/115 (11%) 1/115 (1%) Removal of the unattached, infected nail – as frequently as monthly – trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in the treatment of nail disorders. Treatment Cure2 6/110 (6%)† 1/109 (1%) 10/118 (9%) 0/117 (0%) Nail Care By Patient Mycological Cure3 30/105 (29%) 14/105 (13%) 39/113 (35%) 10/114 (9%) Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after PENLAC is removed with isopropyl alcohol. 1 Treatment Success: negative culture, negative KOH, ≤10% involvement target nail PENLAC should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails 2 Treatment Cure: negative culture & KOH, Global Evaluation Score = Cleared with the applicator brush provided. 3 Mycological Cure: negative culture, negative KOH PENLAC should be applied evenly over the entire nail plate. ‡ Denominators differ across variables because of missing data If possible, PENLAC should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). † p=0.055. All other values statistically significant (CMH ≤0.02, stratified by centre) PENLAC should not be removed on a daily basis. Daily applications should be made over the previous coat and Post-treatment efficacy assessments were scheduled only for patients who achieved treatment cure. Some data removed with isopropyl alcohol every seven days. This cycle should be repeated throughout the duration of on the post-treatment efficacy of the product are available for 12 patients. Twelve weeks after stopping ciclopirox therapy. treatment, 3/6 patients maintained treatment success, and 6/9 patients maintained negative mycology reports. AVAILABILITY OF DOSAGE FORMS CONTRAINDICATIONS PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is a clear, colourless to slightly yellowish solution for PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is contraindicated in individuals who have shown topical application to fingernails, toenails and immediately adjacent skin only. It is available in 6 gram glass bottles hypersensitivity to any of its components. with screw caps, which are fitted with brushes. WARNINGS PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only. PRECAUTIONS No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of PENLAC (Ciclopirox Topical Solution, 8% w/w) NAIL LACQUER and systemic antifungal agents for onychomycosis, is not recommended. (See INDICATIONS AND CLINICAL USE.) The effectiveness and safety in the following populations have not been studied, as the clinical trials with PENLAC excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy. If a reaction suggesting sensitivity or chemical irritation should occur with the use of PENLAC, treatment should be discontinued and appropriate therapy instituted. Use in Pregnancy Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day, or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively, did not indicate any significant fetal malformations. Teratology studies with ciclopirox free acid were performed in rats with oral doses of 20, 50, or 125 mg/kg/day and in rabbits with oral doses of 12.5, 32, or 80 mg/kg/day; no significant fetal malformations were noted. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. PENLAC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when PENLAC is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Vehicle-controlled clinical trials of PENLAC conducted in the US did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. Complete product monograph available on request (1 800 265-7927).
sanofi-aventis Canada Inc. 2150 St. Elzear Blvd. West Laval, Québec H7L 4A8
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PENLAC is generally well tolerated: treatment related side effects were periungal REVISED MATERIALREVISED erythema (5%) application site reactions and/or burning sensation of the skin (1%) and nail disorders (2%), including shape change, irritation, ingrown toenail and discolouration.
Penlac is indicated as part of a comprehensive nail management program in immunocompetent patients with mild to moderate onychomycosis (due to T. rubrum) of fingernails and toenails without lunula involvement. The comprehensive management program includes frequent removal of unattached, infected nails (e.g. monthly) by a health care professional with special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. Penlac should therefore be used only under medical supervision. The safety and efficacy of daily use for longer than 48 weeks have not been established. Since studies evaluating the concomitant use of systemic antifungals and Penlac have not been conducted, concomitant use is not recommended. 25K CMY 50K CMY 75K CMY Please read the Indications and Clinical Use section, in the product monograph carefully before prescribing. Please refer to the product monograph for warnings, precautions, and patient selection information.
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