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Physician-Driven Efforts Drawing Attention to Obesity Epidemic

The New Hanover Regional Medical Center’s Family Medicine Residency Program is seeking an individual with leadership and residency program experience to fill the position of Program Director available in the Family Medicine Program. Family Medicine is one of four graduate education residency programs located at New Hanover Regional Medical Center in Wilmington, North Carolina. Other programs include General Surgery, OB/GYN and Internal Medicine. This program is in affiliation with the University of North Carolina at Chapel Hill School of Medicine and the Coastal Area Health Education Center (Coastal AHEC). New Hanover Regional Medical Center is a 769 bed hospital located in ocean port city of Wilmington, North Carolina.

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The applicant must be a Board Certified Family Physician with either an MD or DO degree and experience in residency education as well as practice management and administration. This is a mature program which includes inpatient and outpatient care including maternal – child care. This director works in conjunction with hospital administrative staff for departmental operations as well as Coastal AHEC’s Graduate Medical Education Division of the graduate medical education program.

The program offers an experienced and diverse faculty, a state of the art outpatient care center, and an excellent work environment with an electronic medical record.

The Family Medicine Program has both an MD and DO residency training pathways.

This position offers a competitive salary and excellent benefits package including an academic faculty appointment with the University of North Carolina at Chapel Hill‘s School of Medicine.

Please send a letter of interest, and curriculum vitae to: Mark D. Darrow, MD, President/CEO of Coastal AHEC PO Box 9025, Wilmington, NC 28402-9025 Email: mark.darrow@coastalahec.org Fax: (910) 762-3521 UNC-Chapel Hill, Coastal AHEC and New Hanover Regional Medical Center are Equal Opportunity/ADA Employers. Websites are www.nhhn.org and www.coastalahec.org.

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NCFP

Vol 2 • No 4

Ta b l e o f C o n t e n t s

Fall 2006

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North Carolina Well Represented at AAFP Annual Congress in D.C.

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Academy to Lead Provider Training Efforts in Primary Care - Mental Health Project

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Change or Die

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National Conference Great for Medical Students

Screening for Visual Impairment

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Foundation News

PUBLISHED BY THE NORTH CAROLINA ACADEMY OF FAMILY PHYSICIANS The North Carolina Family Physician is published quarterly by the NORTH CAROLINA ACADEMY OF FAMILY PHYSICIANS P.O. Box 10278 Raleigh, NC 27605 919.833.2110 • fax 919.833.1801 www.ncafp.com

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Coming Soon: A New Kindergarten Health Assessment

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Abstract: Male Osteoporosis: A Clinical Review from a Family Medicine Office

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Having a Place at the Table

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Membership News

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Health Disparities Grant Activities Feature Online Training Program and Content at Annual Meeting

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Academy Briefs

2006 NCAFP Board of Directors NCAFP Executive Officers President J. Carson Rounds, MD President-Elect Michelle F. Jones, MD Vice President Christopher S. Snyder, III, MD Secretary/Treasurer Elizabeth B. Gibbons, MD Board Chair Karen L. Smith, MD, FAAFP Executive Vice President Sue L. Makey, CAE Past President (w/voting privileges) Conrad L. Flick, MD The District Directors District 1 Donald Keith Clarke, MD District 2 Robert Lee Rich, Jr., MD District 3 Victoria S. Kaprielian, MD District 4 William A. Dennis, MD District 5 Sara O. Beyer, MD District 6 Thomas J. Zuber, MD District 7 Shannon B. Dowler, MD At Large R.W. Watkins, MD, MPH At Large Richard Lord, MD IMG Physicians Constituency Ofelia N. Melley, MD Minority Physicians Constituency Claudia E. Gonzalez, MD New Physicians Constituency Jessica J. Burkett, MD Resident Director Jennifer L. Mullendore, MD, (GAHEC) Resident Director-Elect Parker McConville, MD, (GAHEC) Student Director Oritsetsemaye Otubu, (UNC) Student Director-Elect Mary Jean Deason, (UNC) AAFP Delegates and Alternates AAFP Delegate L. Allen Dobson, MD AAFP Delegate Conrad L. Flick, MD AAFP Alternate Mott P. Blair, IV, MD AAFP Alternate George H. Moore, Jr., MD FP Department Chairs and Alternates Chair (WFU) Michael L. Coates, MD Alternate (Duke) J. Lloyd Michener, MD Alternate (ECU) Valerie J. Gilchrist, MD Alternate (UNC) Warren P. Newton, MD, MPH NCAFP Council Chairs Child & Maternal Health Shannon B. Dowler, MD Governmental Affairs Advisory Robert Lee Rich, Jr., MD Health Promotion & Disease Prev.

Mott P. Blair, IV, MD Mental Health Michelle F. Jones, MD Professional Services Brian Forrest, MD Health Disparities Karen L. Smith, MD NCAFP Editorial Committee Chair William A. Dennis, MD Shannon B. Dowler, MD Elizabeth B. Gibbons, MD Richard Lord, MD David C. Luoma, MD

CREATED BY: Virginia Robertson, President vrobertson@pcipublishing.com Publishing Concepts, Inc. 14109 Taylor Loop Road Little Rock, AR 72223 FOR ADVERTISING INFORMATION: Steve McPherson smcpherson@pcipublishing.com 501.221.9986 • 800.561.4686 edition

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North Carolina Well Represented at AAFP Annual Congress in D.C. “Fix It Now!” “Fix it Now!” - Those three words represented the refrain of nearly 2,000 family physicians as they descended on Capitol Hill as part of AAFP’s Rally for America’s Health on Wednesday, September 27. Speakers at the rally asked elected officials to make the 2007 session the Health Care Congress. Nearly 40 doctors from North Carolina attended the rally and met with many of the members of North Carolina’s Congressional delegation including Senator Richard Burr, Rep. David Price and Rep. Mike McIntyre. Some of the messages delivered included increased Medicare payments, funding and assistance for implementation of health information technology, a call for medical liability reform and support of primary care graduate medical education.

Members of the NCAFP Leadership Team attending the meetings included: President J. Carson Rounds, MD; President-Elect Michelle F. Jones, MD; Vice President Christopher Snyder, III, MD; Board Chair Karen L. Smith, MD; GAAC Chair Robert L. Rich, MD; AAFP Delegate L. Allen Dobson, MD; AAFP Delegate Conrad L. Flick, MD; AAFP Alternate Delegate George H. Moore, JR, MD; AAFP Alternate Delegate Mott p. Blair, IV, MD; Executive Vice President Sue L. Makey, CAE; and Gregory K. Griggs, MPA, CAE, Director of Professional Services on the Academy’s staff.

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CHANGE OR DIE

by Dr. J. Carson Rounds, NCAFP President Broken lines, broken strings, Broken threads, broken springs, Broken idols, broken heads, People sleeping in broken beds.

Ain’t no use jiving Ain’t no use joking Everything is broken.

- Bob Dylan (I like the Kenny Wayne Shepherd version the most) The May 2005 issue of Fast Company had a provocative article on change; the title was so good I borrowed it for this article.

Writing about the need for corporations and executives to make change and new challenges an integral part of their corporate culture, Alan Deutschman pointed out the difficulties inherent in changing behavior, even when we are faced with death if we don’t change. Evidence from our literature (and our daily practices) reports that 90% of people who have undergone coronary artery bypass grafting have not changed their lifestyle when evaluated two years after surgery. “…[T]he root cause of the health crisis hasn’t changed for decades, and the medical establishment still [can’t] figure out what to do about it.” People are sick because of how they choose to live their lives.

There are parallels here to our health care “system.” We spend the most money per capita in the world yet we have a system that ranks only 37th in the world in outcomes. You and I are unhappy with what appears to be an insurmountable task: do more with less.

Increasingly complex management of an exploding number of patients with chronic diseases, increasingly complex preventative care, medical illiteracy (at least half of your patients leave your office not understanding what they need to know and do), and the pressure to perform in a system that pays primarily on the quantity, not quality, of services provided (and pays poorly for cognitive services compared to procedures) all contribute to the current chaos.

“The short, rushed visits with overfilled agendas that cause patients dissatisfaction simultaneously breed frustration in physicians.”

Not surprisingly, medical students are not choosing primary care.

We all know the numbers: a 50% drop in US medical students choosing family medicine residencies from 1997 to 2005. The percentage of 3rd year internal medicine residents who plan to enter general internal medicine has dropped from 55% in 1998 to 20% in 2005. Historically, interest in Family Medicine has followed a sine wave pattern, waxing and waning over time. We may be in another period of waning interest, but if nothing changes we could face a sustained downturn in student interest. The idea that PAs and FNPs will be able to fill the void fails on several levels, from an education that doesn’t prepare them for that, to the simple fact that they are choosing to work in specialty practices at rates paralleling the choices of US medical students.

SO, where do we go from here? I agree with Dr. Bodenheimer that “fixing primary care” – I would argue that it isn’t just primary care that would be fixed – “requires actions on the part of primary care practices (microsystem improvement) and the larger health care 4

system (macrosystem reform).” What is going to motivate us to make that change? If people don’t change their lifestyles after bypass surgery, how will we change what we do every day, and push the system around us to change? Evidence suggests we should focus on the reason for the change. If we use fear of obsolescence or anger over our mistreatment in the current system as a motivator, we may well find ourselves like the 90% of post-CABG patients who succumb to the inherent rigidity of our brains brought on by repetitive behaviors. The work of Dean Ornish in lifestyle changes in patients with coronary artery disease offers a model for us in both microsystem change and in motivating ourselves to change. His work has shown that “Joy is a more powerful motivator than fear” and than “radical, sweeping, comprehensive changes are often easier for people that small, incremental ones.” It also requires multifaceted support – 77% of the patients in Ornish’s studies have been able to change lifestyles, supported by attention from a group of

“We have an opportunity to change that which is broken, to change how we live our lives.” dieticians, psychologists, nurses, yoga and meditation instructors, and doctors. We need to develop systems in our offices to allow the same kind of care for our patients with chronic illnesses, a model radically different than what most of us were taught to do. In turn, we need multifaceted support from somewhere to support us in our change.

North Carolina is in a unique situation to give you that support.

With the guidance and support of your Academy, Community Care of North Carolina (CCNC) has evolved over the last decade into a system that supports a team approach to the care of chronic disease.

It is physician-driven and patient-centric. Higher physician satisfaction and better quality of care are the results. If you are not involved in CCNC, I urge you to become involved and take advantage of this resource. CCNC will serve as the foundation network for the Improving Performance in Practice (IPIP) project. This project aims to lead a transformation of quality-of-care of chronic diseases across all primary care practices in North Carolina. It will provide you the support you need to transform your practice, and your life. It will be a difficult task, but one that can be met with the North Carolina Academy of Family Physicians

National Conference Great for Medical Students

By Aye Otubu, NCAFP Student Director type of support embedded in the project.

Macrosystem change is happening. CMS has proposed changes that should significantly improve your Medicare payments for evaluation and management services beginning in 2007. This year, the AMA House of Delegates called for a change in payment systems to “incentivize” an increase in the number of primary care physicians, recognizing the need for more primary care physicians. A comprehensive health system should “be of the highest priority” according to the AMA delegates. There is an opportunity for the AAFP to work with the AMA to lead reforms that support a primary care-based system with payment incentives to attract medical students back to Family Medicine and a liability system that preserves access and drives down cost.

There is clear evidence in the literature that a primary carebased system improves quality and decreases cost. The AMA, CMS, and increasingly, private purchasers of health insurance, are all recognizing this simple fact. Health insurance companies are beginning to recognize this as well.

While much remains to be done, I am hopeful that the macrosystem support we need to make the microsystem changes will continue.

We have an opportunity to change that which is broken, to change how we live our lives. The recent AAFP News notes the partnership of IBM and the AAFP in developing a model of care for the nation. IBM is interested in “creating a momentum for reform and transformation.” We have allies who see the value in what we do, and CAN DO, if the “dysfunction in the system” is addressed. Keep the faith, take care of yourselves, keep fighting for your patients every day, and believe that we are the future.

Thank you for all you do every day!

A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.

- Mohandas Gandhi

If you’re interested in family medicine then you should definitely go to the National Conference for Family Medicine Residents and Medical Students in Kansas City. I went for the first time this summer and I was blown away by how well organized and coordinated it was, not to mention the array of relevant seminar topics, workshops, and guest speakers on the agenda. I especially enjoyed the opening session with guest speaker Dr. Regina Benjamin, a truly phenomenal family physician who lives in rural Alabama. Her clinic on the Gulf coast of Alabama was destroyed by hurricane Katrina, but instead of giving in to the devastation, she got creative and found new ways to care for her community. Then, when her rebuilt clinic was subsequently destroyed by fire, she remained resilient and continued to provide care to her patients. That’s dedication! That, to me, is what family medicine is all about, and that spirit of dedication resonated throughout the conference.

The conference also provided plenty of networking opportunities. It was really exciting to meet so many students from all over the country who were motivated and were doing impressive things in their communities and even internationally. The outstanding exhibition hall provided one of the numerous venues for networking and was filled with over 200 residency programs from all over the country. What an awesome opportunity it was to be able to meet with so many program directors and learn about so many different programs, all in the same room.

The student congress was another great feature of the conference. During congress sessions, students were able to express concerns and ideas to their student delegates and learned how to write resolutions. Our resolutions were then sent to the AAFP congress. It was truly empowering to realize the potential effect we can have in legislation, even as students.

When the conference sessions were over for the day, there was plenty of time to tour the city. Kansas City is known for it’s delicious Bar-b-q and smooth jazz, so it was great to be able to experience the culture of the city.

It was truly a phenomenal conference and I recommend anyone who is even slightly interested in a career in family medicine or just curious to know more about it to consider attending this conference next year. Also, there are some scholarships available from the Academy for interested students and individual schools also provide sponsorship, so please do not let money be a deterrent. Hope to see you there!

The 2007 National Conference for Family Medicine Residents and Medical Students is scheduled for August 1-4, 2007 in Kansas City. To obtain information about travel scholarships and available stipends, please contact Peter Graber, NCAFP Director of Resident & Student Programs, at (919) 833-2110 or by email at pgraber@ncafp.com

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Coming Soon: A New Kindergarten Health Assessment Adam Zolotor, MD, MPH, University of North Carolina School of Medicine, Department of Family Medicine North Carolina family physicians will be seeing a new Kindergarten Health Assessment (KHA) form in their offices by the Spring of 2007. Efforts led by the North Carolina Division of Public Health to redesign the form have been fueled by needs to improve the communication between physicians, parents, and schools, and to identify and meet the health and developmental needs of children entering grade school. A secondary and equally-exciting opportunity is the ability to systematically collect data on the health and well-being of our five year olds. This form has been through many iterations in its more than twenty years of use. It was originally designed as a communication tool and is often treated as an admission ticket, rather than as an opportunity, to identify health and development issues.

This can impede school success and put children at risk if misunderstood or ignored.

The development of the new KHA form has been spearheaded by the Division of Public Health. They have assembled an advisory committee with representatives from Public Health, Public Instruction, the North Carolina Academy of Family

Physicians and the North Carolina Pediatric Society. A draft version of the KHA form has been piloted in two counties (Guilford and Wake) for the 2006-07 school year. One of the important design features of the new form is to allow the back (or second page) to be copied for anonymous public health data collection. This has changed the normal flow of the form, but allows the schools to provide anonymous data that will be analyzed.

Data entry will be completed by the end of 2006 and analysis available early 2007. In the pilot counties, data will be available at the level of the county, school district, school, and perhaps clinic or provider, representing a powerful tool for public health surveillance and clinic population review. The Division of Public Health plans to roll out this data collection and surveillance opportunity to other counties for 2007, with the goal of population-level health surveillance of children entering kindergarten.

In addition to the development of the new form, the Division of Public Health wants parents, teachers, and clinicians to view this as a ‘window of opportunity’. This is the last chance to identify problems with health,

HAVING A PLACE AT THE TABLE Many issues are currently affecting the day-to-day practice of medicine for family physicians in North Carolina. Some concerns are legislative, like tort reform and Medicare reimbursement. Other key issues involve certifications and changing scope of practice.

Many practices are being influenced by new models of care such as retail health clinics.

However, with all of these issues that are important to family medicine, the most important one is that family physicians are aware, involved, and most of all, included in the important discussions and negotiations that will change the way we practice. If we are not “at the table” then we will have to accept what others have negotiated and created on our behalf. One example is that recently the American Board of Medical Specialties agreed to adopt changes to create a Board Certification for Sleep Medicine. Even though many family physicians have sleep labs, do their own interpretation and CPAP titration, the American Board of Family Medicine was left out of the loop for being eligible, while pediatricians, ENTs, and 6

internists were included. Family Physicians are the backbone of the US healthcare system and it is crucial that we are included in discussions and policy changes that may affect how we are able to treat our patients in the future.

Therefore, whatever your practice type or location, your voice needs to be heard in discussions about the future of Family Medicine.

There are multiple ways you can do so. You can be involved through councils and committees of the NCAFP and AAFP. You can certainly stay aware of current legislative issues and contact your representatives.

When you hear about restrictions on credentialing or certification for family physicians, you can make the Academy aware and put in a call or email to the American Board of Family Medicine and the AAFP. These organizations represent you and the interest of family physicians but cannot successfully represent your interests if you do not let your concerns be heard. Many of the current complaints and problems with the healthcare system might be modified if our voices are loud-

behavior, or development before a child enters school. This should be an opportunity for the parent or doctor to raise concerns that may impact learning and communicate those concerns to the teacher and school nurse. A parent-raised concern may be more seriously addressed by the school if validated by an involved clinician. Also, the Division of Public Health is working with the Department of Public Instruction to improve dialogue back from the school (teacher or nurse) to acknowledge concerns raised by the doctor on the KHA. Completing this communication loop is essential for doctors and parents to feel like this form is of value and worth the effort in assessment.

Finally, the Division of Public Health and the advisory committee are evaluating a web-based KHA tool. Currently, they are considering making this an add-on module to the NC Immunization Registry (NCIR).

This could evolve into a powerful tool for doctors, parents, and teachers to chart and communicate about heath concerns and an important tool for population-based health surveillance. Details about this are still being developed.

By Brian R. Forrest, MD, Chair NCAFP Professional Services Council er. Optometrists have certainly made their voices heard. In recent years they have gained prescribing privileges and have had several other practice-relevant issues addressed legislatively. Why? Because they have had a strong voice. Family physicians now need to be heard because our concerns directly relate to our ability to provide comprehensive care to our patients.

Keep this in mind when you get email surveys or questionnaires from the NCAFP or AAFP. Answering these is important because that is one of the ways to know what the needs of practicing physicians are and to hear your voice. Also, when you are considering what organizations to lend your financial support, consider FAMPAC. These contributions help give family physicians a place at the table so that your interests can be represented and not overlooked or pushed aside for other organizations. If every family physician only gave $100 to their PAC then we could actually get something done rather than just being content to grumble about the things that are making taking good care of patients difficult.

North Carolina Academy of Family Physicians

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Increasing Immunization Coverage May Reverse Rising Reports of Pertussis Many people are unaware that reports of pertussis, commonly called whooping cough, have been rising in the United States (US)1 and pose serious consequences for infants who are too young to be fully immunized. Until recently, pertussis immunization was limited to infants and young children 6 weeks through 6 years of age. Fortunately, in 2005 the Food and Drug Administration licensed 2 combination tetanus/diphtheria/acellular pertussis (Tdap) booster vaccines; one for adolescents and one, ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed), for both adolescents and adults.2 To provide further protection against pertussis,

has steadily increased, reaching 25,827 in 2004, the largest number since 1959.3 Because of underreporting and misdiagnosis, the true number of pertussis cases is most likely even higher, estimated at 600,000 adults annually.2 In recent years, pertussis has had a significant impact on particular age groups. For example, between 2003 and 2004 reported pertussis cases increased 73% in children 4 years of age or younger4 and 122% overall.5 Adolescents 10-19 years of age and adults over 20 years of age still accounted for a clear majority (approximately 66%) of the reported cases.5 The implications of these rising case numbers are alarming. Most young infants with pertussis still must be hospitalized, and some cases can be fatal.6 From 2001-2003, 91% of the deaths from pertussis were among infants younger than 6 months of age and 75% were among infants younger than 2 months of age.3

Why are reports of pertussis on the rise?

the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted to recommend that adolescents 11-18 years of age and adults 19-64 years of age receive a single dose of Tdap vaccine in place of a single dose of tetanus/diphtheria (Td) booster vaccine. ADACEL vaccine provides adolescents and adults with protection against pertussis and may help reduce the spread of pertussis to vulnerable infants.

Physicians like knowing that ADACEL vaccine can be used concomitantly with hepatitis B or influenza vaccines and that it has a safety profile comparable to Td vaccine in both adolescents and adults.

ACIP also has voted to recommend that healthcare personnel (HCP) who have direct patient contact receive a single dose of Tdap booster vaccine as soon as feasible (if they have not previously done so), especially those who have direct contact with infants less than 12 months of age.

The ACIP recommendation redefines the standard of care for preventing pertussis, a vaccine-preventable disease reported at its highest rates in decades.

Reports of pertussis on the rise The number of pertussis case reports in the US

One reason for the increase in pertussis cases may be that immunity to pertussis “wears off” over time—approximately 5-10 years after completing the childhood vaccination series1— which means adolescents and adults who think they have immunity can be susceptible to the disease and may transmit pertussis to infants.

Adolescents and adults also tend to have milder forms of pertussis, or even be asymptomatic; but those who develop even mild pertussis disease may still transmit the organism to unimmunized or underimmunized infants. In families, this is often the case.

In a study to determine the source of infant pertussis, family members, especially new mothers, were found to be an important source among identifiable cases. The study found that, among 264 cases of infant pertussis infection with a known or suspected source, 75% of the sources were family members and 32% were mothers.6 Therefore, immunization with ADACEL vaccine for parents and family members may help reduce the spread of pertussis to infants.

ADACEL vaccine recommended for adolescents, adults, and HCP The ACIP has voted to recommend vaccination with ADACEL vaccine for new mothers and those family members who are in close contact with infants younger than 12 months of age.2 Specific finalized or provisional recommendations for immunization beyond the completed diphtheria/tetanus/pertussis

(DTP) or diphtheria/tetanus/acellular pertussis (DTaP) childhood vaccination series include: • A single dose of Tdap vaccine for adolescents 1118 years of age instead of Td for those who have yet to receive a Td booster1 • A single dose of Tdap vaccine (ADACEL vaccine) for adults 19-64 years of age instead of a Td booster; the booster dose is recommended if it has been more than 10 years since the last Td booster, but shorter intervals after Td vaccine are acceptable.2

The role of health-care personnel With the availability of ADACEL vaccine for adolescents and adults, HCP need to redefine the standard of care for infant pertussis by immunizing not only the child but all close contacts as well. HCP will play a major role in increasing Tdap immunization.

HCP can help reduce the increasing rates of pertussis infection by first making sure that, if they work in hospitals or ambulatory-care settings, they have received immunization with ADACEL vaccine to protect themselves, their patients, and family members.

This is especially important for those in direct contact with infants less than 12 months of age.

HCP also need to make sure that family members in contact with infants are up-to-date with their pertussis vaccinations and that infants and young children have completed their DTaP childhood vaccination series.

Raising awareness among new mothers and their families To help reduce the spread of pertussis to vulnerable infants, HCP and their organizations should develop campaigns to raise awareness among new mothers and their families about the importance of Tdap vaccine. Providers can use existing office visits as an opportunity to increase Tdap vaccinations among adolescents and adults. Through the commitment of HCP, plus the availability of Tdap vaccines, the standard of care for providing protection against pertussis in the US is being redefined.

References: 1. Centers for Disease Control and Prevention (CDC). Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-3):1-44.

2. CDC. National Immunization Program. ACIP votes to recommend use of combined tetanus, diphtheria and pertussis (Tdap) vaccine for adults (Advisory Committee on Immunization Practices): March 2, 2006. Available at: http://www.cdc.gov/nip/vaccine/tdap/tdap_adult_recs.pdf.

Accessed March 10, 2006.

3. CDC. Pertussis. In: Atkinson W, Hamborsky J, McIntyre L, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book. 9th ed. Washington, DC: Public Health Foundation; 2006:79-96.

4. CDC. Summary of notifiable diseases—United States, 2003.

MMWR. 2003;52:1-85.

5. CDC. Pertussis Surveillance Report?8/12/05. MKT11970.

6. Bisgard KM, Pascual FB, Ehresmann KR, et al. Infant pertussis: who was the source? Pediatr Infect Dis J. 2004;23:985-989.

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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed ™ ADACEL Brief Summary: Please see package insert for full prescribing information

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INDICATIONS AND USAGE ADACEL vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age. The use of ADACEL vaccine as a primary series, or to complete the primary series, has not been studied. See DOSAGE AND ADMINISTRATION for use in tetanus prophylaxis in wound management. ADACEL vaccine is not indicated for the treatment of B pertussis, C diphtheriae or C tetani infections. As with any vaccine, ADACEL vaccine may not protect 100% of vaccinated individuals.

CONTRAINDICATIONS Known systemic hypersensitivity to any component of ADACEL vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination with ADACEL vaccine. Because of uncertainty as to which component of the vaccine may be responsible, additional vaccinations with the diphtheria, tetanus or pertussis components should not be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. The following events are contraindications to administration of any pertussis containing vaccine: (1) • Encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose.

• Progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established, the condition has stabilized, and the benefit clearly outweighs the risk.

ADACEL vaccine is not contraindicated for use in individuals with HIV infection. (1) WARNINGS Because intramuscular injection can cause injection site hematoma, ADACEL vaccine should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer ADACEL vaccine in such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection. (1) If any of the following events occurred in temporal relation to previous receipt of a vaccine containing a whole-cell pertussis (eg. DTP) or an acellular pertussis component, the decision to give ADACEL vaccine should be based on careful consideration of the potential benefits and possible risks: (2) (3) • Temperature of *40.5°C (105°F) within 48 hours not due to another identifiable cause; • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; • Persistent, inconsolable crying lasting *3 hours, occurring within 48 hours; • Seizures with or without fever occurring within 3 days.

When a decision is made to withhold pertussis vaccine, Td vaccine should be given. Persons who experienced Arthus-type hypersensitivity reactions (eg., severe local reactions associated with systemic symptoms) (4) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given emergency doses of tetanus toxoid-containing vaccines more frequently than every 10 years, even if the wound is neither clean nor minor. (4) (5) If Guillain-Barré Syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of ADACEL vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (1) The decision to administer a pertussiscontaining vaccine to individuals with stable central nervous system (CNS) disorders must be made by the health-care provider on an individual basis, with consideration of all relevant factors and assessment of potential risks and benefits for that individual. The ACIP has issued guidelines for immunizing such individuals. (2) A family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine. (2) The ACIP has published guidelines for vaccination of persons with recent or acute illness. (1) PRECAUTIONS General Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.

ADACEL vaccine should not be administered into the buttocks nor by the intradermal route, since these methods of administration have not been studied; a weaker immune response has been observed when these routes of administration have been used with other vaccines. (1) The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated.

Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents and equipment should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Prior to administration of any dose of ADACEL vaccine, the vaccine recipient and/or the parent or guardian must be asked about personal health history, including immunization history, current health status and any adverse event after previous immunizations. In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of ADACEL vaccine must be carefully considered.

The ACIP has published guidelines for the immunization of immunocompromised individuals. (6) Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal. (1) The immune response to ADACEL vaccine administered to immunocompromised persons (whether from disease or treatment) has not been studied. A separate, sterile syringe and needle, or a sterile disposable unit, must be used for each person to prevent transmission of blood borne infectious agents.

Needles should not be recapped but should be disposed of according to biohazard waste guidelines.

Information for Vaccine Recipients and/or Parent or Guardian Before administration of ADACEL vaccine, health-care providers should inform the vaccine recipient and/or parent or guardian of the benefits and risks. The health-care provider should inform the vaccine recipient and/or parent or guardian about the potential for adverse reactions that have been temporally associated with ADACEL vaccine or other vaccines containing similar components. The vaccine recipient and/or parent or guardian should be instructed to report any serious adverse reactions to their health-care provider. Females of childbearing potential should be informed that Aventis Pasteur Inc. maintains a pregnancy registry to monitor fetal outcomes of pregnant women exposed to ADACEL vaccine. If they are pregnant or become aware they were pregnant at the time of ADACEL vaccine immunization, they should contact their health-care professional or Aventis Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE). The health-care provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. (7) The toll-free number for VAERS forms and information is 1-800822-7967 or visit the VAERS website at http://www.fda.gov/cber/vaers/vaers.htm.

Drug Interactions Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. (See PRECAUTIONS, General.)

For information regarding simultaneous administration with other vaccines refer to the ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections.

Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed with ADACEL vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pregnancy Category C Animal reproduction studies have not been conducted with ADACEL vaccine. It is also not known whether ADACEL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ADACEL vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with ADACEL vaccine. The effect of ADACEL vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered ADACEL vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and later during pregnancy on gestation day 29, 0.5 mL/rabbit/occasion (a 17-fold increase compared to the human dose of ADACEL vaccine on a body weight basis), by intramuscular injection. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study. (8) Pregnancy Registry Health-care providers are encouraged to register pregnant women who receive ADACEL vaccine in Aventis Pasteur Inc.’s vaccination pregnancy registry by calling 1-800-822-2463 (1-800-VACCINE).

Nursing Mothers It is not known whether ADACEL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ADACEL vaccine is given to a nursing woman.

Pediatric Use ADACEL vaccine is not indicated for individuals less than 11 years of age. (See INDICATIONS AND USAGE.) For immunization of persons 6 weeks through 6 years of age against diphtheria, tetanus and pertussis, a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) may be used, unless otherwise contraindicated.

Geriatric Use ADACEL vaccine is not indicated for individuals 65 years of age and older. No data are available regarding the safety and effectiveness of ADACEL vaccine in individuals 65 years of age and older as clinical studies of ADACEL vaccine did not include subjects in the geriatric population.

ADVERSE REACTIONS The safety of ADACEL vaccine was evaluated in 4 clinical studies. A total of 5,841 individuals 11-64 years of age inclusive (3,393 adolescents 11-17 years of age and 2,448 adults 18-64 years) received a single booster dose of ADACEL vaccine.

The principal safety study was a randomized, observer blind, active controlled trial that enrolled participants 11-17 years of age (ADACEL vaccine N = 1,184; Td vaccine N = 792) and 18-64 years of age (ADACEL vaccine N = 1,752; Td vaccine N = 573). Study Product information as of June 2005 MKT10383

2

Manufactured by: Aventis Pasteur Limited Toronto Ontario Canada

participants had not received tetanus or diphtheria containing vaccines within the previous 5 years. Observer blind design, ie, study personnel collecting the safety data differed from personnel administering the vaccines, was used due to different vaccine packaging (ADACEL vaccine supplied in single dose vials; Td vaccine supplied in multi-dose vials). Solicited local and systemic reactions were monitored daily for 14 days post-vaccination using a diary card. Participants were monitored for 28 days for adverse events which were not specifically queried on the diary card, ie, unsolicited adverse events, and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, hospitalization and serious adverse events. Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained via a scripted telephone interview. Approximately 96% of participants completed the 6-month follow-up evaluation. In the concomitant vaccination study with ADACEL and Hepatitis B vaccines, local and systemic adverse events were monitored daily for 14 days post vaccination using a diary card. Local adverse events were only monitored at site/arm of ADACEL vaccine administration. Unsolicited reactions (including immediate reactions, serious adverse events and events that elicited seeking medical attention) were collected at a clinic visit or via telephone interview for the duration of the trial, ie, up to six months post-vaccination. In the concomitant vaccination study with ADACEL vaccine and trivalent inactivated influenza vaccines (see Clinical Studies for description of study design and number of participants), local and systemic adverse events were monitored for 14 days post vaccination using a diary card. All unsolicited reactions occurring through day 14 were collected. From day 14 to the end of the trial, ie, up to 84 days, only events that elicited seeking medical attention were collected. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

Serious Adverse Events in All Safety Studies Throughout the 6-month follow-up period in the principal safety study, serious adverse events were reported in 1.5% of ADACEL vaccine recipients and 1.4% in Td vaccine recipients. Two serious adverse events in adults were neuropathic events that occurred within 28 days of ADACEL vaccine administration; one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm. Similar or lower rates of serious adverse events were reported in the other trials and there were no additional neuropathic events reported.

Solicited Adverse Events in the Principal Safety Study The frequency of selected solicited adverse events (erythema, swelling, pain and fever) occurring during Days 0-14 following one dose of ADACEL vaccine or Td vaccine were reported at a similar frequency in both groups. Few participants (<1%) sought medical attention for these reactions. Pain at the injection site was the most common adverse reaction occurring in 62-78% of all vaccines. In addition, overall rates of pain were higher in adolescent recipients of ADACEL vaccine compared to Td vaccine recipients. Rates of moderate and severe pain in adolescents did not significantly differ between the two groups. Rates of pain did not significantly differ for adults. Fever of 38°C and higher was uncommon, although in the adolescent age group, it occurred significantly more frequently in ADACEL vaccine recipients than Td vaccine recipients. (8) The rates of other local and systemic solicited reactions occurred at similar rates in ADACEL vaccine and Td vaccine recipients in the 3 day postvaccination period. Most local reactions occurred within the first 3 days after vaccination (with a mean duration of less than 3 days).

Headache was the most frequent systemic reaction and was usually of mild to moderate intensity.

Adverse Events in the Concomitant Vaccine Studies Local and Systemic Reactions when Given with Hepatitis B Vaccine The rates reported for fever and injection site pain (at the ADACEL vaccine administration site) were similar when ADACEL and Hep B vaccines were given concurrently or separately. However, the rates of injection site erythema (23.4% for concomitant vaccination and 21.4% for separate administration) and swelling (23.9% for concomitant vaccination and 17.9% for separate administration) at the ADACEL vaccine administration site were increased when coadministered. Swollen and/or sore joints were reported by 22.5% for concomitant vaccination and 17.9% for separate administration. The rates of generalized body aches in the individuals who reported swollen and/or sore joints were 86.7% for concomitant vaccination and 72.2% for separate administration. Most joint complaints were mild in intensity with a mean duration of 1.8 days. The incidence of other solicited and unsolicited adverse events were not different between the 2 study groups. (8) Local and Systemic Reactions when Given with Trivalent Inactivated Influenza Vaccine The rates of fever and injection site erythema and swelling were similar for recipients of concurrent and separate administration of ADACEL vaccine and TIV. However, pain at the ADACEL vaccine injection site occurred at statistically higher rates following concurrent administration (66.6%) versus separate administration (60.8%). The rates of sore and/or swollen joints were 13% for concurrent administration and 9% for separate administration. Most joint complaints were mild in intensity with a mean duration of 2.0 days. The incidence of other solicited and unsolicited adverse events were similar between the 2 study groups. (8) Additional Studies An additional 1,806 adolescents received ADACEL vaccine as part of the lot consistency study used to support ADACEL vaccine licensure. This study was a randomized, double-blind, multi-center trial designed to assess lot consistency as measured by the safety and immunogenicity of 3 lots of ADACEL vaccine when given as a booster dose to adolescents 11-17 years of age inclusive. Local and systemic adverse events were monitored for 14 days post vaccination using a diary card. Unsolicited adverse events and serious adverse events were collected for 28 days post vaccination. Pain was the most frequently reported local adverse event occurring in approximately 80% of all subjects. Headache was the most frequently reported systemic event occurring in approximately 44% of all subjects. Sore and/or swollen joints were reported by approximately 14% of participants. Most joint complaints were mild in intensity with a mean duration of 2.0 days. (8) An additional 962 adolescents and adults received ADACEL vaccine in three supportive Canadian studies used as the basis for licensure in other countries. Within these clinical trials, the rates of local and systemic reactions following ADACEL vaccine were similar to those reported in the four principal trials in the US with the exception of a higher rate (86%) of adults experiencing ‘any’ local injection site pain. The rate of severe pain (0.8%), however, was comparable to the rates reported in the four principal trials. (8) Postmarketing Reports In addition to the data from clinical trials, the following adverse events have spontaneously been reported during the commercial use of ADACEL vaccine in other countries. These adverse events have been very rarely reported (<0.01%), however, incidence rates cannot precisely be calculated. The reported rate is based on the number of adverse event reports per estimated number of vaccinated patients. General disorders and administration site conditions: injection site bruising, sterile abscess; skin and subcutaneous tissue disorders: pruritus, urticaria.

Reporting of Adverse Events The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records of the manufacturer and lot number of the vaccine administered in the vaccine recipient’s permanent medical record along with the date of administration of the vaccine and the name, address and title of the person administering the vaccine. The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table. These include anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this ADACEL vaccine package insert. (7) (9) (10) The US Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. Reporting of all adverse events occurring after vaccine administration is encouraged from vaccine recipients, parents/guardians and the health-care provider. Adverse events following immunization should be reported to VAERS. Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or visit the VAERS website at http://www.fda.gov/cber/vaers/vaers.htm. (7) (9) (10) Health-care providers should also report these events to Pharmacovigilance Department, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE).

DOSAGE AND ADMINISTRATION ADACEL vaccine should be administered as a single injection of one dose (0.5 mL) by the intramuscular route. SHAKE THE VIAL WELL to distribute the suspension uniformly before withdrawing the 0.5 mL dose for administration. Five years should have elapsed since the recipient’s last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine. For individuals planning to travel to developing countries, a one-time booster dose of ADACEL vaccine may be considered if more than 5 years has lapsed since receipt of the previous dose of diphtheria toxoids, tetanus toxoids or pertussis-containing vaccine.

Do NOT administer this product intravenously or subcutaneously.

STORAGE Store between 2° - 8°C (35° - 46°F). DO NOT FREEZE. Discard product if exposed to freezing. Do not use after expiration date.

REFERENCES 1. CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35. 2. CDC. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children. Recommendations of the ACIP. MMWR 1997;46(RR7):1-25. 3. CDC Update. Vaccine side effects, adverse reactions, contraindications and precautions - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35. 4. CDC. Update on adult immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1991;40(RR-12):1-52. 5. CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28. 6. CDC. Use of vaccines and immune globulins in persons with altered immunocompetence. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18. 7. CDC. Current trends - Vaccine Adverse Event Reporting System (VAERS) United States. MMWR 1990;39(41):730-3. 8. Data on file at Aventis Pasteur Limited. 9. CDC. Current trends - national vaccine injury act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200. 10. FDA. New reporting requirements for vaccine adverse events. FDA Drug Bull 1988;18(2):16-8.

Printed in USA Distributed by: Aventis Pasteur Inc. Swiftwater PA 18370 USA 2021114/2021543

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Increasing Immunization Coverage May Reverse Rising Reports of Pertussis Many people are unaware that reports of pertussis, commonly called whooping cough, have been rising in the United States (US)1 and pose serious consequences for infants who are too young to be fully immunized.2 Fortunately, in 2005 the Food and Drug Administration licensed 2 combination tetanus/diphtheria/acellular pertussis (Tdap) vaccines, one for adolescents and one for adolescents and adults3; until that time, pertussis immunization was limited to infants and young children.

With the availability of Tdap vaccines, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted to recommend that adolescents and adults 11-64 years of age receive a single dose of Tdap in place of a single dose of tetanus/diphtheria (Td) booster vaccine. Tdap vaccine provides adolescents and adults with protection against pertussis, and may help reduce the spread of the disease to vulnerable infants.

ACIP also has voted to recommend that health-care personnel (HCP) who have direct patient contact receive Tdap (if they have not previously done so), especially those who have direct contact with infants less than 12 months of age.

Reports of pertussis on the rise The number of reported pertussis cases in the US has steadily increased, reaching 25,827 in 2004, the largest number since 1959.2 Because of underreporting and misdiagnosis, the true number of pertussis cases is most likely even higher, estimated at 600,000 adults annually.3 In recent years, pertussis has had a significant impact on particular age groups. For example, between 2003 and 2004 reported pertussis cases increased 122% overall and 73% in children 4 years of age or younger.4,5 Adolescents 10-19 years of age and adults over 20 years of age still accounted for a clear majority (approximately 66%) of the reported cases.5

Nearly 50% of Pertussis Sources Are Parents6 In a CDC study of 774 reported cases Unknown source of infant pertussis, interviews were 57% (n=352) conducted in 616 of the families to determine the source of the disease A source was defined as a person with an Known or acute cough illness who had contact with the suspected source case-infant 7 to 20 days before the infant’s 43% (n=264) onset of cough The source was identified for 43% (264) Of the 264 with known of the infants with pertussis. Within this or suspected source, the source was: subgroup of infants, the known or Grandparents 8% suspected source of pertussis was*: Siblings 20% • The mother in 32% • A parent in nearly 50% Others 25% (Child-care workers, • A family member in 75% friends, etc.)

Fathers 15% *It is unknown whether immunizing adolescents and adults against pertussis will reduce the risk of transmission to infants.

Mothers 32%

Tdap recommended for adolescents, adults, and HCP ACIP has voted to recommend Tdap vaccination for new mothers and those adolescents and adults who are in close contact with infants, especially younger than 12 months of age. Specific finalized or provisional recommendations for immunization beyond the completed diphtheria/tetanus/pertussis (DTP) or diphtheria/tetanus/acellular pertussis (DTaP) childhood vaccination series include: • A single dose of Tdap for adolescents 11-18 years of age instead of Td for those who have yet to receive a Td booster1 • A single dose of Tdap for adults 19-64 years of age instead of a Td booster; the Tdap dose is recommended if it has been more than 10 years since the last Td booster, but shorter intervals after Td vaccine are acceptable.3

The implications of rising numbers of reported pertussis cases are alarming. Most young infants with pertussis still must be hospitalized, and some cases can be fatal.6 From 2001-2003, 91% of the deaths from pertussis were among infants younger than 6 months of age and 75% were among infants younger than 2 months of age.2

The role of HCP

Why are reports of pertussis on the rise?

HCP can help reduce the increasing rates of pertussis infection by first making sure that, if they work in hospitals or ambulatory-care settings, they have received Tdap immunization to protect themselves, their patients, and family members. This is especially important for those in direct contact with infants less than 12 months of age.

One reason for the increase in pertussis cases may be that immunity to pertussis “wears off” over time—approximately 5-10 years after completing the childhood vaccination series1—which means adolescents and adults who think they have immunity can be susceptible to pertussis and may transmit the disease to infants.

Adolescents and adults also tend to have milder forms of pertussis, or even be asymptomatic; but those who develop even mild pertussis disease may still transmit the organism to unimmunized or underimmunized infants. In families, this is often the case.

In a study to determine the source of infant pertussis, family members, especially new mothers, have been found to be an important source.

The study found that, among 264 cases of infant pertussis infection with a known or suspected source, 75% of the sources were family members and 32% were mothers.6 Tdap immunization for parents and family members may help reduce the spread of pertussis to infants.

With the availability of Tdap vaccine for adolescents and adults, HCP need to redefine the standard of care for infant pertussis by immunizing not only the child but also those who come in close contact with the child. HCP will play a major role in increasing Tdap immunization.

HCP also need to make sure that family members in contact with infants are up-to-date with their pertussis vaccinations and that infants and young children have completed their DTaP childhood vaccination series.

Raising awareness among new mothers and their families To help reduce the spread of pertussis to vulnerable infants, HCP and their organizations should develop campaigns to raise awareness among new mothers and their families about the importance of Tdap immunization. Providers can use existing office visits as an opportunity to increase the use of Tdap immunizations among adolescents and adults. Through the commitment of HCP, plus the availability of Tdap vaccines, the standard of care for providing protection against pertussis in the US is being redefined.

References: 1. Centers for Disease Control and Prevention (CDC). Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-3):1-44. 2. CDC. Pertussis. In: Atkinson W, Hamborsky J, McIntyre L, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book. 9th ed. Washington, DC: Public Health Foundation; 2006:79-96. 3. CDC. National Immunization Program. ACIP votes to recommend use of combined tetanus, diphtheria and pertussis (Tdap) vaccine for adults (Advisory Committee on Immunization Practices): March 2, 2006. Available at: http://www.cdc.gov/nip/vaccine/tdap/tdap_adult_recs.pdf. Accessed March 10, 2006. 4. CDC. Summary of notifiable diseases—United States, 2003. MMWR. 2003;52:1-85. 5. CDC. Pertussis Surveillance Report—8/12/05. MKT11970.

6. Bisgard KM, Pascual FB, Ehresmann KR, et al. Infant pertussis: who was the source? Pediatr Infect Dis J. 2004;23:985-989.

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Increased Vaccination Coverage May Counteract Rising Reports of Pertussis Did you know that reports of pertussis, commonly called whooping cough, have been rising in the United States (US) for years,1 reaching a 45-year high of more than 25,000 reported cases in 2004?2 These statistics show that, although pertussis is a vaccine-preventable disease, it remains a highly contagious health threat—one that poses serious consequences for infants who are too young to be fully immunized.2 Until recently, there were only pertussis vaccines for infants and young children. Fortunately, in 2005 the Food and Drug Administration licensed 2 combination tetanus/diphtheria/acellular pertussis (Tdap) booster vaccines to provide adolescents and adults with protection against pertussis.3 Only one of these, ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine), is licensed for both adolescents and adults.

To provide further protection against pertussis, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention has voted to recommend that adolescents 11-18 years of age and adults 19-64 years of age receive a single dose of Tdap vaccine in place of a single dose of tetanus/diphtheria (Td) booster vaccine.3 When there are multiple cases of pertussis in a household, older persons are often found to have the initial case; ADACEL vaccine provides adolescents and adults with protection against pertussis, which may help reduce the spread of the disease to vulnerable infants.

Physicians like knowing that ADACEL vaccine can be used concomitantly with hepatitis B and influenza vaccines and that it has a safety profile comparable to Td vaccine in both adolescents and adults.

ACIP also has voted to recommend that health-care personnel (HCP) who have direct patient contact should receive a single dose of Tdap booster (if they have not previously done so) as soon as feasible, especially those who have direct contact with infants less than 12 months of age. Pertussis infection has a greater impact on infants than other age groups. Most young infants with pertussis still must be hospitalized, and some cases can be fatal.4 From 2001-2003, 91% of the reported deaths in the US from pertussis were among infants younger than 6 months of age and 75% were among infants younger than 2 months of age.2 Why are reports of pertussis increasing?

There are a few factors contributing to the increase in reported pertussis cases: • Immunity to pertussis “wears off” over time, approximately 5-10 years after completing the childhood vaccination series, so adolescents and adults who think they have immunity can still be susceptible to pertussis and may transmit pertussis to infants1 • Adolescents and adults tend to have milder forms of pertussis, or even be asymptomatic; but those who develop even mild pertussis disease may still transmit the organism to unimmunized or underimmunized infants One study to determine the source of infant pertussis found that, among 264 cases of infant pertussis infection with a known or suspected source, 75% of the sources were family members and 32% were mothers.*4 These results demonstrate the need to reduce infant pertussis infection by emphasizing immunization of adolescents and adults.

ADACEL recommendations for adolescents, adults, and HCP ACIP has voted to recommend ADACEL vaccine for new mothers and those adolescents and adults who are in close contact with infants less than 12 months of age.3 Specific finalized or provisional recommendations for immunization beyond the completed diphtheria/ tetanus/pertussis (DTP) or diphtheria/tetanus/acellular pertussis (DTaP) childhood vaccination series include: • A single dose of Tdap vaccine for adolescents 11-18 years of age instead of Td for those who have yet to receive a Td booster1 • A single dose of Tdap vaccine for adults 19-64 years of age instead of a Td booster; the Tdap dose is recommended if it has been more than 10 years since the last Td booster, but shorter intervals after Td vaccine are acceptable3 ACIP also recommends that HCP make sure that their own vaccinations are up-to-date, as are those of any family members in contact with infants (especially new mothers) and that all infants have completed their childhood vaccination series. Remember to immunize not only the child but all close contacts as well.

To help reduce the spread of pertussis to vulnerable infants, HCP and their organizations should develop campaigns to raise awareness among new mothers and their families about the importance of Tdap vaccine. Through the commitment of HCP, plus the availability of Tdap vaccines, the standard of care for providing protection against pertussis in the US is being redefined.

ADACEL Safety Information ADACEL vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 11 through 64 years of age.

As with any vaccine, ADACEL vaccine may not protect 100% of vaccinated individuals. There are risks associated with all vaccines.

The most common local adverse events include injection site pain, erythema, and injection site swelling. The most common systemic adverse events include headache, body ache, tiredness, and fever.

ADACEL vaccine is contraindicated in persons with known systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances. Because of uncertainty as to which component of the vaccine may be responsible, no further vaccination with the diphtheria, tetanus, or pertussis components found in ADACEL vaccine should be carried out. Because intramuscular injection can cause injection site hematoma, ADACEL vaccine should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer ADACEL vaccine to such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.

Before administering ADACEL vaccine, please see accompanying full Prescribing Information.

*It is unknown whether immunizing adolescents and adults against pertussis will reduce the risk of transmission to infants.

References: 1. Centers for Disease Control and Prevention (CDC). Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-3):1-44. 2. CDC. Pertussis. In: Atkinson W, Hamborsky J, McIntyre L, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book. 9th ed. Washington, DC: Public Health Foundation; 2006:79-96. 3. CDC. National Immunization Program. ACIP votes to recommend use of combined tetanus, diphtheria and pertussis (Tdap) vaccine for adults (Advisory Committee on Immunization Practices): March 2, 2006.

Available at: http://www.cdc.gov/nip/vaccine/tdap/tdap_adult_recs.pdf. Accessed August 23, 2006. 4. Bisgard KM, Pascual FB, Ehresmann KR, et al. Infant pertussis: who was the source? Pediatr Infect Dis J. 2004;23:985-989.

Health Disparities Grant Activities Feature Online Training Program and Content at Annual Meeting

Academy to Lead Provider Training Efforts in Primary Care - Mental Health Project

North Carolina's patient population continues to diversify, making cultural competency a bigger health care issue now than ever before. Language and cultural barriers can prevent patients from receiving appropriate treatment. Providers, faced with these barriers, find it difficult to diagnose and educate patients.

The NCAFP recently received grant funding from the North Carolina Health and Wellness Trust Fund for an initiative to provide physicians with the tools and knowledge needed to help eliminate health disparities. Funding from the grant will be utilized in part for two major educational initiatives aimed at helping physicians provide culturally-appropriate care. The first of these initiatives includes a partnership with The Carolinas Center for Medical Excellence (CCME), formerly known as Medical Review of North Carolina.

CCME has created an online course to educate clinicians regarding culturally-appropriate care with the goal of eliminating health disparities. The Culturally and Linguistically Appropriate Services (CLAS) training can be completed in as little as six hours. It's divided into nine modules based around three themes: culturally competent care, language access services and organizational supports for cultural competence.

Participants in the CLAS online training can receive up to nine CME credits at no cost. In addition to access to the online training, CCME has developed materials and resources that may be useful to current residents and practicing physicians, including: county and region-level demographic data and information on health disparities; and North Carolina-specific resources on eliminating health disparities and offering culturally appropriate care. For more information about the online training, visit www.thecarolinascenter.org/ncdisparities or call 1-919-380-9860 x2215.

The issue of culturally appropriate care will be also prominently discussed during this year’s Annual meeting to be held at the Grove Park Inn November 30 through December 3.

Karen L. Smith, MD, NCAFP Board Chair and NCAFP Health Disparities Council Chair, will provide a brief overview of the Academy’s Health Disparities Initiative, prior to a presentation on Culturally Appropriate Care and the Culturally and Linguistically Appropriate Services (CLAS) Standards. Zori Rodriguez, MA, Health Disparities Manager for the American Academy of Family Physicians, will deliver the presentation on Friday, December 1, at 2:15 p.m.

For those physicians interested in more in-depth information about Health Disparities in North Carolina and how to implement the CLAS standards in your practice, a special two-hour workshop will be held on Friday afternoon beginning at 5:15 p.m. following the general sessions. The workshop will include: specific strategies to address disparities in the clinical setting; statistics about health disparities in NC; and information on state and national resources. For additional details, please contact Gregory K. Griggs, MPA, CAE, the Academy’s Director of Professional Services at ggriggs@ncafp.com.

The NCAFP will be leading provider training efforts as part of a new partnership formed to bring health care services for “mind and body together”. Grants from the Kate B. Reynolds Charitable Trust and Astra Zeneca will allow the ICARE Partnership to pursue its mission to develop systems of care that are Integrated, Collaborative, Accessible, Respectful and Evidence-Based in order to improve access and outcomes for patients requiring mental health, developmental disability and substance abuse services (MS/DD/SAS).

The ICARE Partnership was formed to increase collaboration and communication between primary care and MS/DD/SAS providers across the state and improve provider capacity for coordinated services across the health care system. NCAFP PresidentElect Michelle F. Jones, MD, is leading the Academy’s efforts as part of her presidential focus for 2007 and beyond.

The N.C. Foundation for Advanced Health Programs (NCAFHP) is actually administering the grant to help launch the ICARE Partnership and to provide initial organizational and grant support.

Several other organizations have been tapped to lead various aspects of the project, including the N.C. Area Health Education Centers (curriculum development and website design); the N.C. Psychiatric Association (clinical consultation design); and of course the NCAFP (provider training and technical assistance.

Many North Carolinians continue to have inadequate access to MS/DD/SA services and these services are often poorly coordinated with those delivered by primary care providers such as family physicians. Family physicians and other primary care providers are often asked to address unmet MH/DD/SAS needs without sufficient specialty back-up and information services. The ICARE Partnership seeks to improve patient outcomes by increasing access to quality, evidence-based integrated health care services for North Carolina.

In addition to the organizations mentioned above, other organizations involved in the project include: Duke AHEC/Duke Department of Psychiatry, the NC Autism Society, the NC Council of Community Programs, the NC Department of Health and Human Services (specifically the Division of Medical Assistance, the Division of MH/DD/SAS and the Office of Rural Health and Community Care), the NC Pediatric Society, the NC Psychological Association, the Southern Regional AHEC, and the WFUHS Department of Pediatrics/NWAHEC. In its initial three years, the ICARE Partnership will focus on three project areas: Statewide Education and Assistance; Local Model Development; and Process and Policy Change.

The focus of education and technical assistance efforts in the first year of the project will center on providing primary care physicians with the skills in assessing and managing crisis situations relevant to mental health and substance abuse issues. The first step in this training will take place at the Academy’s Annual Meeting during a lecture on Thursday morning, November 30. In addition, Dr. Michelle F. Jones will provide a brief overview of the project as part of a session on Current Academy Issues on Friday morning, December 1.

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SCREENING FOR VISUAL IMPAIRMENT The AAFP recommends screening to detect amblyopia, strabismus, and defects in visual acuity in children younger than age 5 years.(1) This statement represents the official AAFP position regarding visual screening in the preschool age child and is supported by the current recommendation from the U.S. Preventive Services Task Force regarding the same subject. Currently, all graduates of U.S. AAFP residencies are taught to perform visual screening as part of the ageappropriate well child screening, and physicians in North Carolina have performed this screening competently for years with little error.

cian offices has typically consisted of assessment of ocular movements, cover testing, assessment of visual acuity with a Snellen chart and other basic maneuvers, and has often been performed by an office nurse or assistant while that individual completed the other basic measurements of the well child screening. The screening physician would typically review the results from that assessment and then repeat and/or perform additional measures to validate any unusual finding. This basic screening would

…the provision would have required all children entering kindergarten to undergo a mandatory eye exam by an optometrist or ophthalmologist…

In fact, the North Carolina screening system has been very successful, with opportunities for screening at many points in a young child’s life, even in their own schools.

Children that have identified concerns have been referred to optometrists and ophthalmologists for follow-up for many years.

Even those unable to pay for further examination have been able to seek funding through the Senator Kenneth Royall Vision Screening Program.

But as you are already aware, recently, the North Carolina legislature called into question the sensitivity/accuracy of this screening process and attempted to mandate a new standard which would supercede this process and replace the well child screening with a process requiring students to receive a formal eye exam by an optometrist or ophthalmologist prior to entering kindergarten.

This article is written to provide a review of the actions of the North Carolina Academy of Family Physicians’ (NCAFP) Governmental Affairs Advocacy Committee (GAAC) in responding to these proposed actions.

Visual screening as performed in physi12

typically detect approximately 99 percent of most childhood visual problems, which would then lead to the appropriate referral to an eye care provider for further verification.

This mechanism has served North Carolina well and was not questioned legislatively until about five years ago when a series of efforts were initiated, typically around budgetary planning sessions, where various legislators attempted to place a new eye exam screening mandate into budgetary discussions which were voted down during committee votes with little discussion.

During these early attempts to legislate a new screening mandate, the NCAFP, along with other organizations such as the N.C. Society of Eye Physicians and Surgeons, Prevent Blindness North Carolina and others communicated to all interested that a mandated comprehensive exam was medically unnecessary. The topic was discussed at the GAAC during these legislative years

where the NCAFP position was reaffirmed and subsequently communicated to the appropriate legislators by the Academy’s governmental affairs consultant and staff.

With the start of the 2005 legislative long session, some legislators renewed efforts to reinsert mandatory comprehensive eye exams, once again occurring during budgetary discussions. These provisions were taken in and out of discussion several times and each time the Academy communicated our opposition to these proposed provisions.

During a 12th hour budgetary session in August of 2005, legislative leaders were able to place a last minute eye exam provision into the budgetary discussions which were passed without notice before the NCAFP or other interested groups were able to mount any significant opposition. The 2005-2006 budget was then subsequently passed and signed by the Governor, mandating the comprehensive eye exam. As passed, the provision would have required all children entering kindergarten to undergo a mandatory eye exam by an optometrist or ophthalmologist, with the cost of that eye exam to each family being estimated at approximately $90.

Beginning with the August and subsequent September GAAC sessions, extensive discussions were held to reaffirm NCAFP’s opposition to the mandated eye exams.

Secondary to the last minute passage of the provision, it was agreed that little was left that could be done during the current legislative session. At that time, a decision was made to bring the issue to the N.C. Medical Society at their Annual Meeting. Academy delegates, in conjunction with the N.C. Pediatric Society, were able to obtain passage of a resolution opposing the mandated exams. Additionally, we reviewed other possible routes of opposition including alerting taxpayers about the expense of the exams as well as reviewing the added costs of mandated exams to the Medicaid program with the Division of Medical Assistance.

During this time other groups also began

North Carolina Academy of Family Physicians

By Robert L. Rich, MD Chair, NCAFP Government Affairs Advisory Council to mobilize in opposition to the exams with the Society of Eye Physicians and Surgeons meeting directly with the governor’s staff in early fall. Additionally, the N.C. School Board Association held a series of meetings and elected to file a lawsuit to halt implementation of the eye care exam secondary to the anticipated disruptions to the entering class of kindergarteners in the fall of 2006. This lawsuit was filed in late 2005 and a judge subsequently issued a stay delaying implementation of the provision until the suit could be decided.

During this time, GAAC and NCAFP executive staff met, and upon recommendation from the Academy’s government affairs consultant, elected to take a neutral stance in reference to the lawsuits due to the acrimonious political nature of the public debate about the eye exam provision.

Soon after the start of the 2006 legislative short session, the N.C. Senate voted to repeal the mandatory eye exam provision.

Later during the 2006 session, the N.C. House agreed to make major changes in the eye exam mandate. This time, NCAFP’s Governmental Affairs Consultant and staff were able to meet with key legislative staff and other interested parties to negotiate changes in the eye exam mandate, which ultimately passed. As approved, HOUSE BILL 2699 calls for vision screening conducted by a licensed physician, optometrist, physician assistant, nurse practitioner, registered nurse or other eye care professional. For further details about the exact wording of the bill and its other provisions, please feel free to contact Academy staff members who could provide you with a copy of the actual bill.

The article above summarizes actions of the Academy’s Government Affairs Advisory Council in response to the various activities of the N.C. legislature regarding mandatory vision exams. You will note that our actions vary in response from a passive to more active approach, and our chosen course of action is made after discussion in Council meetings with input from the various members of the Council as well as NCAFP staff members. In general, we have chosen our actions in respect of the relationships and agreements that we have developed with our legislators and staff

FAMPAC Appeal As we face the upcoming elections and subsequent legislative session in 2007, the next General Assembly may not be as favorable to Academy goals and philosophies as in past years. Therefore, we feel that it is imperative that our contributions to FAMPAC (the official political action committee of the N.C. Academy of Family Physicians) be substantially increased. We are asking each practicing physician in North Carolina to contribute a minimum of $100 dollars. We realize that we are asking each of you to con-

members at various governmental agencies over the years.

If you do not agree with the course of action we have taken or if you are interested in the work we are doing, I encourage you to become an active member of the GAAC which typically meets monthly during the legislative session and also during the Spring and Winter meetings. If you do not wish to join the GAAC but still wish to influence the actions of our state government, I encourage you to contact Academy staff, as well as your state Representative and/or state Senator. Your state chapter has

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tribute a substantial amount, but the issues slated to come before the 2007 Legislature could substantively impact your bottom line and could negatively impact your ability to practice in our state. Please join us in contributing to FAMPAC. To make a contribution, you can contact Greg Griggs at the Academy’s office at (919) 833-2110 or email him at ggriggs@ncafp.com. In addition, a contribution form is available online at the Academy’s website at: http://www.ncafp.com/fampac

developed policy positions regarding most governmental affairs activities, and NCAFP staff members can furnish you a series of talking points to use when meeting with your legislator.

Additionally, I strongly encourage you to contribute to FAMPAC which is the official political action committee of the NCAFP. FAMPAC needs your contribution now as we enter the fall elections. I look forward to seeing you at the next GAAC meeting!

(1) Recommendations for Clinical Preventive Services-American Academy of Family Physician web site.

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FOUNDATION NEWS

Abstract: Male Osteoporosis: A Clinical Review from a Family Medicine Office Authors: Melissa Guerra, Marc Peter Guerra, MD Faculty Advisors: Dr. Andrew Harver, UNC-Charlotte, and Dr. Timothy Taft, UNC- Chapel Hill

NCAFP FOUNDATION SILENT AUCTION - 11 YEARS AND GOING STRONG! The NCAFP Foundation Silent Auction is going into its 11th year and we want you to continue the tradition with us!

For 11 years the Silent Auction has been helping the Foundation keep its programs and projects alive and thriving, and this is your special invitation to join us! This fun and popular fundraiser will be held during the Winter Family Physicians Weekend, November 30 – December 3, 2006 at The Grove Park Inn Resort & Spa in the breathtaking mountains of Asheville. This year’s auction will be held on Thursday and Friday in the Exhibit Hall, giving our guests plenty of time to view the items and make their bids. Please consider donating an item(s) to the auction. What are we looking for? Pieces of artwork (paintings, prints, pottery), sports and college memorabilia, weekend getaways, children’s toys, Christmas items and collectibles…and more!

Don’t be shy – get in on the fun! And remember – all donated auction items are tax deductible. If you’re interested in how you can be a participant, contact Marlene Rosol, Development Coordinator, at (919) 833-2110, (800) 8729482 [NC only], or mrosol@ncafp.com. Thank you!

FOUNDATION GRANTS TWO SCHOLARSHIPS The NCAFP Foundation is pleased to announce that two student scholarships were granted this year. The recipients are Cherrie Crowder and Jessica Triche, both medical students at the ECU School of Medicine. Congratulations, Cherrie and Jessica! All NC medical students are eligible to apply for one of four scholarships yearly. Applications are available through the four FMIG programs. You can also download the 2007 application on the NCAFP website (www.ncafp.com). For more information on student scholarships, or how you can make a donation to the Scholarship Program, please contact Marlene Rosol, Development Coordinator, at (800) 872-9482 [NC only], (919) 833-2110, or mrosol@ncafp.com.

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Traditionally, osteoporosis is considered a silent disease affecting postmenopausal women. However, in a clinical review from a primary care/family medicine office, 311 men over an 8-year period of time underwent bone density scanning/DEXA scans to assess high-risk clinical indications, which included: hypogonad state, steroid use, thyroid or parathyroid disease, renal insufficiency, inflammatory arthritis, back pain, Dilantin use, history of fracture, tobacco use, alcohol use, and plain film findings of osteopenia.

Two hundred and fourteen of these males, ages 17 to 92 tested positive for osteopenia (T score -1.25) or osteoporosis (T score -2.5 or greater) in either hip neck, hip total, or lumbar spine total. Surprisingly, 78% of the men studied (166 out of 214) were less than 70 years of age, 12% (25 of 214) were less than 40, and 4% (9 out of 214) were less than 30 years of age.

The 214 individuals in this study were characterized for steroid use, hypogonad state, low impact fractures, low back pain, renal insufficiency, and high-risk medicines (example: Dilantin use) and excessive tobacco or alcohol abuse.

In a recent report of the Surgeon General on bone health and osteoporosis: “Osteoporosis and fractures no longer should be thought of as an inevitable part of growing old. By focusing on prevention and lifestyle changes, including physical activity and nutrition, as well as early diagnosis and appropriate treatment, Americans can avoid much of the damaging impact of osteoporosis.” Osteoporosis in men is grossly underdiagnosed and undertreated despite its significant threat to aging bone. With 30% of all hip fractures occurring in men and a higher mortality rate for men (31% versus 17% for women) during initial hospitalization and in the first year after fracture, family physicians are key in identifying male patients at risk for osteoporosis. The American Academy of Orthopedic Surgeons and the American Academy of Family Physicians have recently identified this topic as a frontier in desperate need of study.

Osteoporosis is defined as a decrease in bone mass greater than expected for a person’s sex, age, and race. The presence of osteoporosis predicts an increased risk of fracture of the spine, proximal femur, and distal radius.

Osteoporosis and osteoporotic related fractures traditionally are seen as conditions of post menopausal/elderly women; however, these problems do occur in men. Major risk factors for osteoporosis in men have been reported as: glucocorticoid use for longer than 6 months, osteopenia seen on plain films, low impact fractures, hypogonadism, advancing age, tobacco abuse, hyperparathyroid disease, renal failure, and dilantin intake. Suboptimal bone growth related to poor nutrition or low calcium intake during childhood and adolescence is as important as bone loss related to the development of osteoporosis. Osteoporosis can be clinically silent until fractures occur, therefore early detection and treatment by physicians is essential to decrease morbidity and mortality resulting from osteoporotic fractures.

The findings from this primary care based clinical review of 214 osteoporotic men challenge traditional thoughts. Traditionally, male osteoporosis has been suggested to be an elderly disease with age of onset older than females due to male’s larger and longer bones and greater total bone mass.

However, the following clinical review characterizes 214 osteoporotic men from one primary care office. This is the first study of its kind, as most male osteoporotic studies are based out of tertiary care centers and VA Medical Center hospitals, thereby preferentially selecting an older population. Surprisingly, 78% of the males studied (166 out of 214) were less than 70 years of age, 12% (25) were less than 40, and 4% (9) were less than 30.

The 214 individuals were characterized for history of steroid use, hypogonadism, low impact fractures, renal failure, high-risk medications (Dilantin), and excessive tobacco or alcohol abuse. The findings from this primary care practice review challenge some traditional thoughts regarding males and osteoporosis.

For example, the median age of males affected was 48; furthermore, 86% of the affected individuals had associated moderate-to-severe back pain suggesting that this was not an asymptomatic disease in this patient population. These findings have implications on the presenting characteristics of this disease and the critical need to rethink and reset criteria for testcontinue on next page

North Carolina Academy of Family Physicians

ACADEMY BRIEFS

MEMBERSHIP NEWS

ECU Student Studies NC’s Obstetrical Care Trends During Elective Rotation Program

Don’t Be Left Behind!

(Reelection Reminder) Don’t be left behind! If you were last reelected in 2003, you have until the end of 2006 to report 150 hours of CME in order to maintain your Academy membership. Requirements include at least 75 AAFP prescribed credits, a minimum of 25 group learning activities, no more than 25 from enrichment activities, plus caps on other activities. Hours reported should be obtained between January 1, 2004 through December 31, 2006. For further details, review the AAFP CME Requirements for Members, reprint 101. You can also visit the NCAFP website at www.ncafp.com, the AAFP website at www.aafp.org, or call Marlene Rosol, NCAFP Membership Coordinator at 919-833-2110 or 800-872-9482 [NC only].

KEEP US UPDATED! Members – please be sure to keep all of your contact info up to date! This includes your home and business address, phone, fax, and email address. To update, contact Marlene Rosol, NCAFP Membership Coordinator, at mrosol@ncafp.com, 919-833-2110 or 800-872-9482 [NC only].

2006 NCAFP Winter Family Physicians Weekend

Jessica Triche, a fourth-year medical student at the Brody School of Medicine, recently completed a four-week study of obstetrical care accessibility in North Carolina. The research was part of the NCAFP Foundation’s Student Elective Rotation, a self-directed family medicine research/internship program open to all NC medical students who demonstrate an interest in family medicine.

Triche is working to finalize a report discussing overall trends and the need for increased accessibility through the use of incentive programs or adaptive prenatal care relationships with obstetricians.

Planning Continues for 2007 Family Medicine Day -

Saturday, May 19, 2007 Representatives from several NC residency programs met in Kansas City during the 2006 National Conference to discuss the status of next year's family medicine recruitment day, scheduled for Saturday, May 19, 2007. The event is being sponsored by the NCAFP and the NC AHEC program and is targeted at introducing rising third- and fourth-year medical students to the state's family medicine residency training programs. Participating students will have the opportunity to attend a series of workshops and to meet with residency program representatives. Each student will be provided overnight lodging at no cost. The next planning meeting will take place at 9:00 am on Saturday, Dec. 2, 2006 in Asheville during the Academy's Annual Meeting.

up to 26 prescribed credits for registration and event information, go to www.ncafp.com/wfpw

Nov. 30 - Dec. 2, 2005 Grove Park In – Asheville, NC

Scheduled topics include: • Rhinitis • Restless Leg Syndrome • Adolescent Immunization • Osteoporosis Testing Common Orthopedic & Sport Medicine Problems • Health Disparities • Three-Hour Cancer Forum • COPD • Depression & Anxiety • Urinary Incontinence

continued from last page ing for osteoporosis in our male patients. A recent VA Medical Center study entitled: “Screening Men 70 Years and Older for Osteoporosis: Are We Missing Osteoporosis in Younger Men?” Our study from a family practice concurs and documents that 78% of the osteoporotic males studied who were less than 70 years of age. Furthermore, since many of these osteoporotic males suffered from back pain, this has implications on the presenting characteristics of this disease as well as how we may rethink appropriate

work-up and referral of back pain in younger and middle-aged male individuals. A second study focusing on chronic back pain in males and osteoporosis is critical so that early diagnosis and treatment of osteoporosis can be affected while avoiding inappropriate referrals and inappropriate treatment regimens (example: steroid injections into an already osteoporotic back).

For a complete copy of the clinical review, email the NCAFP at ncafp@ncafp.com.

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The North Carolina Academy of Family Physicians, Inc. P.O. Box 10278 Raleigh, NC 27605

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