Archive for October 8th, 2008

Management of Skin and Soft-Tissue Infection — Polling Results

Source:  http://content.nejm.org/cgi/content/full/359/15/e20?query=TOC

NEJM

Volume 359:e20   October 9, 2008    Number 15

In early September, we presented a case of a college athlete with a skin and soft-tissue infection in Clinical Decisions,1 an interactive feature designed to assess how readers would manage a clinical problem for which there may be more than one appropriate treatment. Our patient was a healthy 20-year-old college basketball player who presented with a tender erythematous area on the right buttock. He reported that there was no direct trauma to the area. He had traveled throughout the United States for basketball games over the previous several weeks. He noted having subjective low-grade fevers the night before presentation and had a temperature of 37.7°C at presentation. The area of erythema was 5 by 3 cm and had a firm central area 2 cm in diameter. Although he reported that he does not like taking medications, he also expressed concern about being ready to play in his next basketball game in 1 week.

Of the three management options proposed, the most popular — receiving 4585 votes (41% of the 11,205 votes cast) — was incision and drainage plus an oral antimicrobial agent active against methicillin-resistant Staphylococcus aureus (MRSA). The second-most popular option, incision and drainage alone, received 3508 votes (31% of the votes cast). A close third, with 3112 votes (28% of the votes cast), was incision and drainage plus an oral antimicrobial agent active against methicillin-susceptible S. aureus (MSSA).

1

Coughing

                   1

When a healthy volunteer coughs, he expels a turbulent jet of air with density changes that distort a projected schlieren light beam (Panel A). A velocity map early in the cough (Panel B) was obtained from image analysis. Sequential schlieren images during the cough (Panel C and video) were recorded at 3000 frames per second. A maximum airspeed of 8 m per second (18 mph) was observed, averaged during the half-second cough. Several phases of cough airflow are revealed in the figure. The cough plume may project infectious aerosols into the surrounding air. There is an increasing interest in visualizing such expelled airflows without the use of intrusive methods because of concern regarding the transmission of various airborne pathogens, such as viruses that cause influenza and the severe acute respiratory syndrome (SARS).

Source: 

NEJM  Tang and Settles 359 (15): e19, Figure 1     October 9, 2008

(http://content.nejm.org/cgi/content/full/359/15/e19/F1)


OMNI Posting of 10/8/08

On this date in 1818, 2 English boxers became the first to use padded gloves.  They were Sir Henry de Sissy and Count Irving Pantywaist.
But I digress…
1)  This is a JAMA abstract from this week’s issue (there’s a link to the whole article).  It’s about diagnosing lower extremity DVT using 2-point US (femoral and popliteal) only plus a D-Dimer and repeating that  US if the D-Dimer returns positive.  The 3-month follow-up showed that this method was as good as a 1-time whole-leg Doppler US.  Naturally, this study’s findings are not going to change how you work up a case of suspected DVT.  However, if further studies verify its findings, then in the future, emergency physicians may be comfortable using a combo of the Wells’ Clinical Score + a quantitative D-Dimer + performing a 2-point US.  And charging for it!!!!!
2)  These 2 links serve to remind us that OTC cough and cold preps should not be advocated for kids under 4.  There is no recall and there will be labeling changes in the future.  This is all still controversial since pediatricians advocate that they shouldn’t be given to kids under 6.  Is this all much ado about nothing?  An FDA review of records filed with the agency between 1969 and September 2006 found only 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. However, most of the deaths involved children younger than 2. 
3)  You’ve heard of E. coli 0157.  This USA Today article serves to remind us of the other Gram-negative lurking in the back alleys of badly prepared foods:  E. coli 0111.  It was the one that sickened over 300 patrons at an Oklahoma restaurant this summer.  Usually a 0111 infection isn’t as serious as 0157, but in Oklahoma, 17 needed dialysis.  What happened to the restaurant you ask?  It’s closed now, but there are efforts to re-open it and invite some of the Wall Street CEOs to a well-deserved barbecue.
4)  These links will take you to what HHS thinks should be good physical activities for Americans from the very young to the just-about-dead.  Like using a 10-pound fork when twirling Fettucine Alfredo.  Seriously, it may be material you would want to download and offer to your patients as a promotional device on behalf of your ER — especially to those patients who have to walk in sideways as they go through the ambulance entrance.
5)  This is a NY Times article reminding us that when we go shopping for food, we’ll be able to find out its origin.  The new law gives retailers until March 30 to label the country of origin for foods including fruits, vegetables, beef, lamb, chicken, goat meat, ginseng, peanuts, pecans and macadamia nuts. Until now, only seafood has been subject to the labeling rule.  Now, would I buy tomatoes from sunny, funny China or tomatoes from a New Jersey truck farm that is abutting an oil refinery and a chemical processing plant and Newark? 
Good night,
Paul R.
PS To all of you who are receiving these missives for the first time, welcome.  This is an OMNI enterprise that attempts to provide emergency medicine-related educational content and current medical informational material in a timely and entertaining format.  While this has been created for OMNI and its associates, the OMNI website (omniphysicians.com) and its postings have had a growing international readership over this past year well into the thousands/month.

HHS: Physical Activity Guidelines for Americans

HHS Press Release, 10/7/08

HHS Announces Physical Activity Guidelines for Americans

Adults gain substantial health benefits from two and a half hours a week of moderate aerobic physical activity, and children benefit from an hour or more of physical activity a day, according to the new Physical Activity Guidelines for Americans. The comprehensive set of recommendations for people of all ages and physical conditions was released today by the U.S. Department of Health and Human Services.

The guidelines are designed so people can easily fit physical activity into their daily plan and incorporate activities they enjoy.

Physical activity benefits children and adolescents, young and middle-aged adults, older adults, and those in every studied racial and ethnic group, the report said.

“It’s important for all Americans to be active, and the guidelines are a roadmap to include physical activity in their daily routine,” HHS Secretary Mike Leavitt said. “The evidence is clear — regular physical activity over months and years produces long-term health benefits and reduces the risk of many diseases. The more physically active you are, the more health benefits you gain.”

Regular physical activity reduces the risk in adults of early death; coronary heart disease, stroke, high blood pressure, type 2 diabetes, colon and breast cancer, and depression. It can improve thinking ability in older adults and the ability to engage in activities needed for daily living. The recommended amount of physical activity in children and adolescents improves cardiorespiratory and muscular fitness as well as bone health, and contributes to favorable body composition.

The Physical Activity Guidelines for Americans are the most comprehensive of their kind. They are based on the first thorough review of scientific research about physical activity and health in more than a decade. A 13-member advisory committee appointed in April 2007 by Secretary Leavitt reviewed research and produced an extensive report.  

Key guidelines by group are:

Children and Adolescents — One hour or more of moderate or vigorous aerobic physical activity a day, including vigorous intensity physical activity at least three days a week. Examples of moderate intensity aerobic activities include hiking, skateboarding, bicycle riding and brisk walking. Vigorous intensity aerobic activities include bicycle riding, jumping rope, running and sports such as soccer, basketball and ice or field hockey. Children and adolescents should incorporate muscle-strengthening activities, such as rope climbing, sit-ups, and tug-of war, three days a week.  Bone-strengthening activities, such as jumping rope, running and skipping, are recommended three days a week.

Adults — Adults gain substantial health benefits from two and one half hours a week of moderate intensity aerobic physical activity, or one hour and 15 minutes of vigorous physical activity. Walking briskly, water aerobics, ballroom dancing and general gardening are examples of moderate intensity aerobic activities. Vigorous intensity aerobic activities include racewalking, jogging or running, swimming laps, jumping rope and hiking uphill or with a heavy backpack. Aerobic activity should be performed in episodes of at least 10 minutes.  For more extensive health benefits, adults should increase their aerobic physical activity to five hours a week moderate-intensity or two and one half hours a week of vigorous-intensity aerobic physical activity. Adults should incorporate muscle strengthening activities, such as weight training, push-ups, sit-ups and carrying heavy loads or heavy gardening, at least two days a week.

Older adults — Older adults should follow the guidelines for other adults when it is within their physical capacity. If a chronic condition prohibits their ability to follow those guidelines, they should be as physically active as their abilities and conditions allow. If they are at risk of falling, they should also do exercises that maintain or improve balance.

Women during pregnancy — Healthy women should get at least two and one half hours of moderate-intensity aerobic activity a week during pregnancy and the time after delivery, preferably spread through the week. Pregnant women who habitually engage in vigorous aerobic activity or who are highly active can continue during pregnancy and the time after delivery, provided they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.

Adults with disabilities — Those who are able should get at least two and one half hours of moderate aerobic activity a week, or one hour and 15 minutes of vigorous aerobic activity a week. They should incorporate muscle-strengthening activities involving all major muscle groups two or more days a week. When they are not able to meet the guidelines, they should engage in regular physical activity according to their abilities and should avoid inactivity.

People with chronic medical conditions — Adults with chronic conditions get important health benefits from regular physical activity. They should do so with the guidance of a health care provider.

For more information about the “Physical Activity Guidelines for Americans,” visit www.hhs.gov or www.health.gov/paguidelines.

Ohio Supreme Court & Medical Privacy

AP, 10/7/08 (http://www.chicagotribune.com/news/nationworld/sns-ap-ohio-abortion-files,0,2969140.story)

Ohio Supreme Court justices appeared skeptical Tuesday that an abortion clinic’s medical records on other patients are relevant to a lawsuit brought by parents of a 14-year-old girl who had an abortion without their consent.

Lawyers for the girl’s family argued that the information they seek is necessary to prove that Planned Parenthood of Cincinnati had a pattern of violating Ohio’s parental consent law and failing to report abuse. The unusual case pits a single plaintiff against the privacy interests of a decade’s worth of patients.

Planned Parenthood attorney Daniel Buckley says the clinic has a legal obligation to protect the privacy of its clients’ records.

Charles Miller, an attorney for the parents, told the justices the plaintiffs seek only three facts about other minors treated at the clinic: the girl’s age, whether she had a sexually transmitted disease, and whether she entered the clinic pregnant. He said about 200 cases a year would be involved.
Chief Justice Thomas Moyer questioned how any of those three details would advance the family’s case for damages.

“Where’s the linkage?” he asked.

The court did not indicate when it would rule.

The case involves a girl who was 14 at the time of her abortion in 2004, when the state’s parental consent law had not been completely settled by the courts. She had been impregnated by her 21-year-old youth soccer coach, John Haller.

The family’s lawsuit accuses the Planned Parenthood clinic of failing to get parental consent, report suspected abuse or to inform the girl of risks and alternatives. It seeks unspecified damages.

Court records say the girl gave Haller’s cell phone number as her father’s, and clinic officials thought they had reached the father when they called inquiring about parental consent. Haller was later convicted on seven counts of sexual battery.

An appeals court ruled last year that records on other patients weren’t necessary for the family’s lawsuit.

But family members believe they will find that Planned Parenthood routinely ignored signs that underage patients were sexually abused or statutorily raped by adults, Miller said.

Miller said the family hopes to show that Planned Parenthood’s history of reporting virtually no suspected abuse cases defies statistics on teenage pregnancies caused by older men.

But Justice Paul Pfeifer wondered what value the records would have when they don’t include the ages of the men involved. He noted that Ohio law requires neither the girl nor her parents to volunteer the identity of the father to employees of the clinic.

Buckley argued that the family already has all the access it needs to argue its case on behalf of the girl, including her own medical records, statements of the nurse, the doctor and the social worker.

He said the family is seeking unprecedented access to the medical records of third parties that will be of little use in the case. Federal courts, for example, ruled out using damages against third parties in an individual smoker’s case against tobacco giant Philip Morris, he said.

He also said that Planned Parenthood denies underreporting or ignoring cases of abuse.

Abortion rights foes — including Jack Willke, former president of the National Right to Life Committee, Cincinnati-based Citizens for Community Values and Republican members of Ohio’s congressional delegation — have lined up behind the family in the case.

Opposing the release of the records are the American Medical Association and a dozen associations representing domestic violence victims, obstetricians, gynecologists, pediatricians, psychologists and other medical professionals.

New Food Labeling Law

NY Times, 10/8/08 (http://www.nytimes.com/2008/10/08/dining/08fish.html?_r=1&scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt&oref=slogin)

AFTER six years of political skirmishing, labeling laws that are supposed to tell shoppers whether their tomatoes, apples or chicken are homegrown or imported have taken effect.

The new law gives retailers until March 30 to label the country of origin for foods including fruits, vegetables, beef, lamb, chicken, goat meat, ginseng, peanuts, pecans and macadamia nuts. Until now, only seafood has been subject to the labeling rule.

Some proponents say the labels will help consumers avoid products from countries like China, where food safety has been a problem.

But an inspection of how seafood is sold in many New York stores suggests that the law contains a significant loophole that, when coupled with a lack of resources for enforcement, raises questions about how great an effect the rules have.

Any stores that sell less than $230,000 worth of fresh and frozen fruits and vegetables are not required to label imports.

That immediately eliminates all fish markets as well as butcher shops, of which there are a considerable number in New York City. It also eliminates small grocery stores.

To see how well the seafood regulation has been implemented, and to get an idea of what consumers might find next April, I visited the fish counters of 25 supermarkets, grocery stores and fish markets in New York last week.

The supermarkets were all in compliance, although some country-of-origin labels were more clear than others and several were virtually illegible.

However, three stores that should have had the labels did not: Eli’s Manhattan and Grace’s Marketplace, on the Upper East Side; and the Garden of Eden on 23rd Street.

Kristyn Zylka, director of marketing for Garden of Eden, which has four stores in the city, said the company was embarrassed that the labels were not present because it is the store’s policy to label its seafood.

Both Ross Breen, general manager of Eli’s, and Joseph Doria Jr., one of the owners of Grace’s, said they did not know about the law.

On Monday, fish was properly labeled at all three stores.

By far the most informative and most readable country-of-origin signs observed were those at Wild Edibles in Grand Central Market, even though the store is exempt from the law.

“We do it for the customers,” said Steve Schafer, the manager.

At D’Agostino on Broadway and 110th Street, the signs’ lettering was small and very difficult to read.

One reason store owners might not know their requirements for imported seafood is that the Department of Agriculture has $1 million for enforcement of country-of-origin rules nationwide.

That money was meant to cover seafood, but for now, at least, it must also cover the new commodities. Lloyd Day, administrator of the department’s Agricultural Marketing Service, estimated last week that full rule enforcement would take $9.6 million.

Stores are not required to label fish if it has been processed in any way, like marinated catfish or shrimp on a skewer.

Similarly, stores are not required to label shrimp that has been peeled and cooked.

But those who prefer American shrimp will be able to identify it in most big stores, as long as the shrimp is still in its shell and uncooked.

The stores that were visited last week were also ignoring earlier regulations governing farmed salmon and fish that has been previously frozen and thawed.

The Food and Drug Administration requires that labels for farmed salmon say “color added.” Farmed salmon, naturally grayish, turn pink when they are fed various sources of carotenoids.

Only at Whole Foods at Columbus Circle and Eli’s was the farmed salmon so labeled.

Another F.D.A. regulation requires that previously frozen fish, thawed before sale, be labeled “previously frozen.” Freezing fish twice plays havoc with its texture and doesn’t do much for its flavor.

In the stores that were visited, only some thawed shrimp carried that information. Other thawed fish had no hint that it had been frozen.

On several occasions, employees behind the counter would point out the previously frozen fish when asked.

An F.D.A. spokesman said that the agency takes labeling violations seriously. But, he said, “Since it isn’t a safety issue, a violation of this type would not be a priority.”

Economic Woe & The Stress It’s Causing

The Hartford Courant (CT), 10/8/08 reports that “psychologists, therapists, and doctors say they are seeing evidence that the rise in unemployment, layoff fears, and worries about the economy are taking a toll on Americans’ physical and emotional health.”

The chairman of emergency department of one hospital said that “his emergency room has seen a spike in recent weeks in patients with” stress-related “symptoms, and predicts more — not only in his department, but in those of other towns and cities that are home to workers of the ailing financial sector.”

The Courant notes that “Rich O’Brien, a spokesman for the American College of Emergency Physicians, says he isn’t seeing economic stress-related symptoms in his hospital so much as he’s seeing unemployed patients anxious about what to do once their health insurance runs out.”

Ruling out DVT in just 1 visit

Intro:  This is a prospective, randomized, multicenter study assessing the incidence of symptomatic venous thromboembolism (VTE) during a 3-month follow-up period in patients spared anticoagulation on the basis of a normal initial workup with either serial 2-point ultrasonography plus D-dimer (2-point strategy) or whole-leg color-coded Doppler ultrasonography (whole-leg strategy).  

Click on this for the complete article:  Bernardi E, et al “Serial 2-Point Ultrasonography Plus D-Dimer vs Whole-LegColor-CodedDopplerUltrasonography for Diagnosing Suspected Symptomatic Deep Vein Thrombosis: A Randomized Controlled Trial” JAMA 2008; 300: 1653-1659.
ABSTRACT

Context  Patients with suspected deep vein thrombosis (DVT) of the lower extremities are usually investigated with ultrasonography either by the proximal veins (2-point ultrasonography [compression is applied to the common femoral vein at the groin and the popliteal vein at the popliteal fossa ]) or the entire deep vein system (whole-leg ultrasonography). The latter approach is thought to be better based on its ability to detect isolated calf vein thrombosis; however, it requires skilled operators and is mainly available only during working hours. No randomized comparisons are yet available evaluating the relative values of these 2 strategies.

Objective  To assess if the 2 diagnostic strategies are equivalent for the management of symptomatic outpatients with suspected DVT of the lower extremities.

Design, Setting, and Patients  A prospective, randomized, multicenter study of consecutive symptomatic outpatients (n = 2465) with a first episode of suspected DVT of the lower extremities who were randomized to undergo 2-point or whole-leg ultrasonography. Data were taken from ultrasound laboratories of 14 Italian universities or civic hospitals between January 1, 2003, and December 21, 2006. Patients with normal ultrasound findings were followed up for 3 months, with study completion on March 20, 2007.

Main Outcome Measure  Objectively confirmed 3-month incidence of symptomatic venous thromboembolism in patients with an initially normal diagnostic workup.

Results  Of 2465 eligible patients, 345 met 1 or more exclusion criteria and 22 refused to participate; therefore, 2098 patients were randomized to either 2-point (n = 1045) or whole-leg (n = 1053) ultrasonography. Symptomatic venous thromboembolism occurred in 7 of 801 patients (incidence, 0.9%; 95% confidence interval [CI], 0.3%-1.8%) in the 2-point strategy group and in 9 of 763 patients (incidence, 1.2%; 95% CI, 0.5%-2.2%) in the whole-leg strategy group. This met the established equivalence criterion (observed difference, 0.3%;95% CI, –1.4% to 0.8%).

Conclusion  The 2 diagnostic strategies are equivalent when used for the management of symptomatic outpatients with suspected DVT of the lower extremities.

On E. coli 0111

USA Today, 10/8/08 (http://www.usatoday.com/news/health/2008-10-07-e-coli_N.htm)

Braylee Beaver, 20 months old, is back to her playful self after a 12-day hospital stay in which she received dialysis treatment and was stuck with so many needles she thought she was being punished, says her father.

Beaver was allegedly sickened by an E. coli bacteria but not E. coli O157:H7, the type that most consumers are aware of. That bacteria drove the recall of almost 30 million pounds of meat last year and was blamed for an outbreak involving fresh spinach in 2006 in which five died.

Instead, the Centers for Disease Control and Prevention says Beaver and 313 others who ate food from an Oklahoma restaurant in August were sickened by E. coli O111, a rare type of E. coli that can also be deadly and is becoming increasingly familiar to public health officials.

From 1990 to 2007, O111 was linked to 10 reported illness outbreaks in the U.S., the CDC says. Four of the 10 were linked to food. Before the Oklahoma outbreak, in which one person died, the biggest O111 outbreak happened in New York in 2004. Unpasteurized apple cider was blamed for 212 illnesses.

Milder reactions

E. coli O111 is a Shiga toxin-producing E. coli, or STEC. It is one of a handful of non-O157 STECs that have caused 22 reported illness outbreaks in the U.S. from 1990 to 2007, the CDC says. Food caused 10 of the outbreaks.

Illnesses caused by the non-O157 STECs tend to be milder than those caused by O157, the CDC says. But some can cause equally severe disease and kidney failure, a danger of O157. In Oklahoma, 17 needed dialysis, state officials say.

The number of reported non-O157 outbreaks is small. But others may have gone unreported because doctors may not have looked for non-O157 E. coli in sick patients. “There’s a significant possibility that illnesses and outbreaks have been missed,” says Elisabeth Hagen of the Office of Public Health for the U.S. Department of Agriculture.

The CDC estimates that more than 25,000 non-O157 STEC infections occur each year in the U.S. — about a third the number of O157:H7 infections.

Research has also shown that other E. coli types may be more prevalent than thought, Richard Raymond, the USDA’s undersecretary for food safety, told officials meeting on the subject last October. He cited a recent study in Nebraska in which nearly 50% of E. coli infections there were non-O157:H7s. Other countries have seen the same, Hagen says.

Expanded testing

Cattle are a primary source of E. coli. While there are many types of E. coli, only O157:H7 is routinely tested for by the meat industry and the USDA. It was identified in the 1980s and was declared an adulterant in ground beef in 1994.

Given increasing infection reports, the USDA plans to begin some testing of ground beef for six other E. coli types, including O111, that are causing most of the non-O157 infections, Hagen says. Testing may begin within months, she adds.

It’s not clear whether more non-O157 STEC infections are occurring or whether they’re being identified more often, Hagen says. The USDA wants to determine how prevalent they are and find ways to reduce any risks to consumers. None of the 22 non-O157 outbreaks has been linked to meat. That has occurred in other countries.

“We think it’s a significant enough public health concern to see if it’s a problem,” Hagen says.

Food associations say they support study of other E. coli. But they say it’s too soon to say whether they should be called adulterants, which would cause recalls in the future. Proper cooking destroys E. coli.

“We need a much better understanding of what the landscape looks like,” says Robert Brackett of the Grocery Manufacturers Association. He also says that industry efforts to rid meat of E. coli O157:H7 — including washing cattle carcasses — work against other E. coli.

Oklahoma investigation

The Oklahoma outbreak, which state officials say ended last month, has been linked only to Country Cottage, an independent buffet-style restaurant in Locust Grove, Okla., but not to a cause. The restaurant has closed.

The CDC identified E. coli O111 as the culprit on Aug. 29, 10 days after Braylee had the biggest meal of her life, including chicken fried steak and potatoes.

When Braylee first got diarrhea, her parents thought it was a normal bug. Then her stools turned bloody and she was hospitalized, says her father, Jake Beaver. Her parents hope she’ll avoid lifelong kidney problems, which can arise.

“I didn’t know E. coli could do this,” Beaver says. “I just thought people got a little sick.”

Dana and Rick Boner of Monroe, Iowa, also thought their daughter, Kayla, had a regular bug last year when she fell ill on her 14th birthday. Kayla died 11 days later because of an E. coli O111 infection — the cause of which was never determined — her mother says.

“I didn’t even know there were any other strains but O157,” says Boner, an insurance agent.

She speculates that other non-O157 illnesses have gone undetected or incorrectly reported for years, given the lack of awareness about it.

“I want people to know there are other strains,” she says. “How could my child be the only person who got this?”

Physical Activity Guidelines for Americans

Here is the website for HHS’ new recommendations with regard to the importance of and the types of exercise:

http://www.health.gov/paguidelines/guidelines/default.aspx

For policy makers and health professionals
The 2008 Physical Activity Guidelines for Americans [PDF Version - 7.8 MB] provides science-based guidance to help Americans aged 6 and older improve their health through appropriate physical activity. Developed with health professionals and policymakers in mind, the Guidelines can help you

  • Learn about the health benefits of physical activity
  • Understand how to do physical activity in a manner that meets the Guidelines
  • Understand how to reduce the risks of activity-related injury
  • Assist others in participating regularly in physical activity

At-A-Glance: A Fact Sheet for Professionals [PDF Version - 180 KB] is a 1-page desk reference that presents the Guidelines for all population groups and the health benefits of physical activity as supported by the scientific evidence.

 

Contents

Download PDF version for printing [7.8 MB]

Letter from the Secretary

Acknowledgements

2008 Physical Activity Guidelines for Americans Summary

A Roadmap to the 2008 Physical Activity Guidelines for Americans

Chapter 1: Introducing the 2008 Physical Activity Guidelines for Americans

Chapter 2: Physical Activity Has Many Health Benefits

Chapter 3: Active Children and Adolescents

Chapter 4: Active Adults

Chapter 5: Active Older Adults

Chapter 6: Safe and Active

Chapter 7: Additional Considerations for Some Adults

Chapter 8: Taking Action: Increasing Physical Activity Levels of Americans

Glossary

Appendix 1. Translating Scientific Evidence About Total Amount and Intensity of
Physical Activity Into Guidelines

Appendix 2. Selected Examples of Injury Prevention Strategies for Common
Physical Activities and Sports

Appendix 3. Federal Web Sites That Promote Physical Activity

Inflammatory Bowel Disease & Vit D Deficiency

MedWire, 10/8/08 (http://www.medwire-news.md/news/article.aspx?k=52&id=78169)

Vitamin D deficiency is common among people with inflammatory bowel disease and is associated with increased disease activity and worse quality of life, researchers have found.

The findings emphasise the importance of regular vitamin D tests among patients with Crohn’s disease and ulcerative colitis, said lead researcher Dr Alex Ulitsky from the Medical College of Wisconsin in Milwaukee, USA.

Vitamin D, which is found in foods such as fish and eggs, helps the body absorb calcium and plays a major role in the growth of healthy bones.

Dr Ulitsky and team studied data on 504 patients with inflammatory bowel disease who participated in a long-term health study.

The patients underwent vitamin D tests and completed questionnaires on disease activity and quality of life at regular clinic visits over the course of the study.

The researchers found that nearly 50% of the patients were Vitamin D deficient at some point, with 11% being severely deficient.

Although vitamin D deficiency was not associated with an increased risk of bowel disease-related hospitalisation or surgery, it was significantly associated with greater disease activity in the patients.

Vitamin D deficiency was also associated with reduced quality of life in patients with Crohn’s disease, but not in those with ulcerative colitis.

Speaking at the annual meeting of the American College of Gastroenterology in Orlando, Florida, USA, Dr Ulitsky concluded: “All inflammatory bowel disease patients, irrespective of their disease, disease location or nature should have their Vitamin D levels checked regularly and corrected aggressively when insufficiency is found.”

Under 4: No-No

HealthDay, 10/7/08 (http://www.healthday.com/Article.asp?AID=620113):  Saying they were acting “out of an abundance of caution,” the makers of over-the-counter cough and cold medicines said Tuesday that the medicines should not be given to children younger than 4 years old.In addition, the companies announced that they would be using child-resistant packaging and new measuring devices for the products, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, told reporters at a Tuesday afternoon teleconference.

“This is another step in the reassessment of children’s over-the-counter cough and cold medications that has been going on,” Woodcock said. “We at FDA support these voluntary actions at CHPA [Consumer Healthcare Products Association]. We are continuing to assess the safety and efficacy of these products.”

The FDA has also taken steps to revise the OTC monograph — written in the 1970s — for these medicines; FDA monographs help determine how a drug will be marketed. The new monograph will take into account new research, some of which has yet to be completed.

The FDA has had discussions with the OTC [over-the-counter] industry about changing labels, Woodcock said, and, recognizing that the rule-making process would take several years at best, supported this voluntary action.

There will be a transition period while the new labels replace existing labels on products on pharmacy shelves. So parents and caregivers should adhere to the actual labels on the products they have and should consult with their doctor or pharmacist if they have any questions, Woodcock said.

Use of the over-the-counter medicines has been controversial, with pediatricians criticizing the marketing of the remedies for children under 6, citing reports of safety problems — even deaths — and a lack of evidence that they work.

“The number-one cause [of problems] is accidental ingestion, so the number-one advice is keep the medication out of the reach of children,” Woodcock said. “Number two is follow directions carefully and don’t give multiple medications, which may have the same ingredient.”

In announcing the new industry guidelines, Linda Suydam, president of the CHPA, said they “reflect industry’s overall commitment to the continued safe and appropriate use of children’s oral OTC cough and cold medicines,” the Associated Press reported.

Companies were voluntarily making the change “out of an abundance of caution,” she said. The association represents leading manufacturers and distributors of nonprescription, over-the-counter medicines and nutritional supplements.

The new instructions will appear on products distributed for the coming cold season, Suydam said. Companies will also add a warning to their product labels saying parents should not give young children allergy-relieving antihistamines to make them sleepy, the AP said.

Pediatricians welcomed Tuesday’s announcement by the industry, the news service said.

“It’s a huge step forward,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner and a leader in the push to stop marketing the medicines for young children. “There is no evidence that these products work in kids, and there is definitely evidence of serious side effects.”

Earlier this month, the FDA held a public hearing on the use of OTC cold medicines for children between 2 and 6 years old. But the agency put off a decision on whether they were safe, saying more data was needed.

Dr. John Jenkins, who heads the FDA’s Office of New Drugs, said at the time that agency officials were also concerned that an immediate ban, supported by leading pediatricians’ groups, might cause parents to give adult medicines to their children.

“We do not want to do something that we think will have a positive impact, only to have an unintended negative,” Jenkins said at the hearing, the AP reported. “That could be an even worse situation.”

Back in January, the FDA issued an updated health advisory that cough and cold preparations not be used to treat children under the age of 2 because of possible life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.

Just prior to that advisory, the makers of cough and cold remedies marketed for infants voluntarily recalled the products.

Despite scant evidence that such remedies are actually effective in children, or adults, an estimated 10 percent of American kids take one or more cough and cold medications during a given week.

Yet the preparations can do more harm than good, research suggests.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.

More information

Visit the FDA for more on its recommendation regarding over-the-counter cough and cold medications for young children.

McNeil & OTC Pedi Cough&Cold Meds

Dear Healthcare Professional:

At McNeil Consumer Healthcare, we are committed to the health and safety of your patients.  As part of this commitment, we would like to share important information related to over-the-counter (OTC) pediatric cough and cold medicines. As part of the industry’s continuing dialogue with the Food and Drug Administration (FDA), McNeil Consumer Healthcare announced today new voluntary actions that will help further encourage safe and appropriate use of children’s cough and cold medicines. 

After consulting with the FDA and other manufacturers, McNeil Consumer Healthcare will transition the labeling on children’s cough and cold medicines to state “do not use” in children under age 4 years; and the labels on children’s medicines containing a monograph antihistamine will also feature a warning, “do not use to make a child sleepy.” Pediatric cough and cold medicines remain safe and effective when used as directed; and because reports of adverse events are very rare, and mostly associated with misuse or accidental ingestion in younger children, the FDA supports the continued use of these medicines for symptom relief in children age 4 years and older.

As with other OTC labeling changes in the past, the FDA has indicated it does not believe this labeling change warrants the removal of products with the old labeling from store shelves during this time of transition. The transition of re-labeled McNeil Consumer Healthcare medicines should be complete before the end of the year. (Please see a complete list of affected McNeil Consumer Healthcare medicines below)

McNeil Consumer Healthcare’s pediatric cough and cold medicines will continue to include dosing information for children age 4 years and older.

The label changes do not apply to single-ingredient pain relievers/fever reducers such as INFANTS’ and CHILDREN’S TYLENOL® (acetaminophen) and INFANTS’ and CHILDREN’S MOTRIN® (ibuprofen) and also does not apply to single-ingredient allergy medicines such as CHILDREN’S ZYRTEC® (cetirizine) and CHILDREN’S BENADRYL® (diphenhydramine):

  1. Children’s TYLENOL® Plus Multi-Symptom Cold
  2. Children’s TYLENOL® Plus Cold
  3. Children’s TYLENOL® Plus Cough & Sore Throat
  4. Children’s TYLENOL® Plus Cough & Runny Nose
  5. Children’s TYLENOL® Plus Flu
  6. Children’s TYLENOL® Plus Cold & Allergy
  7. Children’s SUDAFED® Nasal Decongestant
  8. Children’s SUDAFED® PE Nasal Decongestant
  1. Children’s SUDAFED® PE Cold & Cough
  2. PEDIACARE® Multi-Symptom Cold
  3. PEDIACARE® Long-Acting Cough
  4. PEDIACARE® Decongestant
  5. PEDIACARE® NightRest Multi Symptom Cold
  6. PEDIACARE® NightTime Cough
  7. Children’s BENADRYL -D® Allergy & Sinus

The following children’s medicines that contain an antihistamine will be re-labeled to feature a new warning; “do not use to make a child sleepy”:

  1. Children’s BENADRYL® Allergy Liquid
  2. Children’s BENADRYL® Allergy Dye-Free Liquid
  3. Children’s BENADRYL® Allergy Perfect Measure
  4. Children’s BENADRYL -D® Allergy & Sinus
  5. Children’s TYLENOL® Plus Multi-Symptom Cold
  1. Children’s TYLENOL® Plus Cold
  2. Children’s TYLENOL® Plus Cough & Runny Nose
  3. Children’s TYLENOL® Plus Flu
  4. Children’s TYLENOL® Plus Cold & Allergy

Along with this action, we continue to support a national educational campaign that will build awareness for parents and caregivers about how to appropriately use these medicines.

We ask that you share this important information with parents and caregivers and recognize that your patients will likely have many questions.  To help answer some of these questions, we will continue our long-standing commitment of educating parents and caregivers about the appropriate use of over-the-counter medicines, with a specific focus on pediatric cough and cold medicines.  For this educational effort to have the greatest effect, we are seeking your help and commitment.

You can help facilitate the appropriate use of OTC pediatric cough and cold medicines by encouraging parents and caregivers to:

  • Read and follow the labeled instructions on OTC medicines
  • Use the dosing device that comes with a specific product
  • Keep all medicines out of the reach of children
  • Not administer two products containing the same active ingredients
  • Not administer adult medicines to children
  • Not use cough and cold or allergy medicines to sedate children

McNeil Consumer Healthcare is committed to working with the FDA to continue to provide parents and caregivers with appropriate treatment choices for children.

To help support you in educating parents and caregivers, you can turn to this Web site (TylenolProfessional.com) for additional information.  This site should serve as a continuing resource to help you and your staff in this education.

Thank you for your continued trust and support. If you have any questions please do not hesitate to call us at 1-888-222-0082.

Sincerely,
Edwin Kuffner
Edwin K. Kuffner, MD
Senior Director, Medical Affairs
McNeil Consumer Healthcare