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My fax machine has too many faxes in it every morning
Analog office: .. My fax machine has too many faxes in it every morning which my staff put on a pile on my desk and then I try to read them and act on them by scribbling illegible notes on them and putting them in piles on someone else’s desk. Digital office: My fax machine has too many faxes in it every morning .. which my staff scan into my EMR and then I try to read them, and act on them often using a separate system functionality – so need to leave the “reading” work stream, do the action, then return to “reading”Reassuring Lab Results just arrived (by fax, mail, local printer, etc)
When I get labs back – most of them are normal. I can: Initial them (digitally or pen/paper) and put them in the chart (paper or digital) Tell the patient that “no news is good news” (which is terrible customer service, BTW) But some will call (they should!) So the chart gets pulled (paper office) And someone calls them back (usually nurse) And sometimes answers the questions And sometimes the patient still wants to talk with the provider So now it comes to me Like 50 other ones I stay in the office until 8 PM calling my patients back And they ask other questions when we are on the phone Or they are not home so I leave a message So there is a loose end that I have to manage tomorrow.I am a specialist – seeing a new patient for the first time.
I don’t have any records – so my nurse or AA calls the referring provider, pharmacy (for medication list), and hostpial (for recent H & P/Discharge summary) I wait Some of it arrives via fax Most of it arrives tomorrow I call the preferring provider’s office. wait The provider comes to the phone Can’t remember much about the patient Asks her staff to pull the chart We wait and talk about our kids in College Our waiting rooms fill up with angry patients and well-dressed drug reps with too much cologne Chart is “not found” – it must be in a big pile somewhere We both get frustrated – referring provider hums a few bars from memory. We hang up. I make decisions with the patient based on incomplete data I dictate my progress notes I sign them (barely review them) when they come back in 3 days from the transcriptionist They go into the chart (digital or paper) My staff faxes a copy of my note to the referring provider.I am a provider writing a prescription for Clarinex
The patient has seasonal allergies
Has tried “everything else”
The drug reps left a pile of these and I gave some to the patient last time she was here
They work “wonderfully”
She wants more
So I write a prescription
Which she takes to CVS
And they want to charge her $107.50
Because it’s not covered
So she calls my office
And my nurse says she’ll work on it
So she gets the chart
So she looks up the insurance company (BlahBlah Healthcare)
And then she calls the “prior authorization” phone number
And waits on hold
Until a person answers
Who sends a fax
Which the nurse gets 4 hours later
And gets the chart again
And she fills out the form on the fax
And she puts it on my desk with a “sign here” sticky note on the signature line – and pointing to the (empty) justification section
I get it on my desk the next morning
I fill in the blank sections of the form and put back on the nurse’s desk
Who faxes the form …
3 days later the patient calls and asks if this is done.
Different nurse pulls the chart and sees the copy of the fax that was sent to the insurance company – so she says yes.
Patient goes to CVS who tries to charge her $107.50 again
Patient goes home and calls the office
Nurse pulls chart again
Nurse calls BlahBlah Healthcare. Turns out they haven’t processed it. They will process it and will let us know if it’s denied (They won’t let us know it it’s approved).
Nurse calls patient and tells her to try CVS again in a few days.
Patient gets angry and yells at nurse
Nurse was depressed anyway and quits her job – slamming the door on her way out, hitting a child in the head as he comes in for his 3-year well-child visit. He is conscious, but has a laceration on his forehead that will require repair. The kid’s mother says she’ll sue the physician “for everything he’s worth” as she drags the kid off toward the emergency room.
She hits a raccoon on the way home, barely missing an Oak tree as she tries to avoid little Rocky.
She calls her physician and requests some Xanax to “calm my nerves” – beginning a life of dependence on benzodiazepines and poverty. She stops making payments on her mortgage, loses her home, and was last seen living over a ventilation grate near the Misys offices in New York City.
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"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, MD, director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective [for this age group]."
The statement was based on a review of data and the discussions held at an October 2007 joint meeting of the Nonprescription Drugs and Pediatric Advisory committees. The agency is reviewing data regarding use of these medicines in children ages 2 to 11. It will communicate additional recommendations in the near future.
"It's critically important for parents to receive clear information about the risks and lack of benefit from these drugs," said American Academy of Pediatrics President Renee Jenkins, MD, in a statement. The AAP supported the FDA's Jan. 17 action as an important first step. "We urge FDA to continue its analysis of the existing data on these medicines intended for children over age 2 and take appropriate action, including initiation of immediate, rigorous scientific studies as needed to determine the drugs' safety and efficacy."
In the meantime, the agency urges those who choose to use these products for the 2-11 age group to follow the dosing directions on the OTC medication's label; check the "drug facts" label to learn what active ingredients are contained in the products because many contain multiple ones; and use only measuring spoons or cups that are packaged with the medicine or made especially for measuring drugs.
Suggestions on ways to soothe kids with coughs and colds are available on the AAP's Web site (www.aap.org/publiced/br_infections.htm).
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"This is one of the very best times to be involved in immunization because of all the excitement," noted Lance Rodewald, MD, director of the Centers for Disease Control and Prevention's Immunization Services Division.
But just a few years ago, the stalwart tetanus vaccine was in short supply, seasonal influenza vaccine was hard to come by, and manufacturers were leaving the field, citing low profits and high production costs.
Now, new vaccines are hitting the market. Shingles, human papillomavirus and rotavirus vaccines were introduced in 2006. In 2005 two Tdap vaccines were approved to help fight pertussis in teens and young adults. Last month, data were published in the Journal of the American Medical Association showing that a meningococcal vaccine protects infants from four types of the meningitis bacteria, and manufacturer Novartis is expected to seek approval to take it to market.
Flu vaccine is also plentiful this year, and last year's National Influenza Vaccine Summit, an annual event sponsored by the AMA and the CDC, attracted representatives from more than 100 groups interested in ensuring this year's smooth flu season.
Not that it's all a rosy picture. Clinical trials for Merck's promising HIV vaccine were halted last fall when the vaccine was found to be ineffective. Also, a current shortage of haemophilus influenzae vaccine type B, or Hib, resulted when Merck recalled the product after production problems.
Nevertheless, excitement is bubbling in the public health world about the renewed interest in vaccines. Experts cite several reasons for this resurgence, ranging from new science to existing policies and changed attitudes.
Dr. Rodewald and others credit the Vaccines for Children Program, which was implemented in 1994, with creating consistent demand. The federal entitlement program provides free vaccines for more than half the children in the nation.
The program provides "a large and rather assured market," said William Schaffner, MD, professor and chair of the Dept. of Preventive Medicine at Vanderbilt University in Nashville, Tenn.
| The U.S. gives free vaccines to more than half the children in the country. |
Although the VFC program capped the prices of existing vaccines at 1993 levels, the cap came off for new vaccines. "So that created a favorable environment for the manufacturers to want to go through the very expensive research and development phase," Dr. Rodewald said.
Of course, he noted, the purchase price for vaccines has risen dramatically as a result, placing a strain on budgets.
But profits from vaccines were virtually nonexistent until recent years, and manufacturers were discouraged from investing the time and money in their development. As recently as the late 1970s, tetanus vaccine cost 17 cents per dose, said Paul Offit, MD, chief of infectious diseases at the Children's Hospital of Philadelphia.
The arrival in 2000 of the pneumonia vaccine for young children, Prevnar, brightened the economic picture for manufacturers when it became the first vaccine to earn more than $1 billion, Dr. Offit said. The HPV vaccine, Gardasil, was launched in 2006 as a nearly $2 billion vaccine. "So there is definitely a sense that there is more money in vaccines than there was previously."
Still, they are not nearly as lucrative as medications that people take daily, such as the statin Lipitor, which has sales of $12 billion a year.
But other advantages to vaccine production have become increasingly evident, Dr. Offit noted. "There is a fairly beaten path in how to make them, and there is, to some extent, protection from liability in children's vaccines," he said. "The third thing is that they are patent independent. Once their patent runs out, there aren't all these generics that hop onto the market, because it is expensive to make a vaccine, and the market isn't big enough to support them."
Vaccines may have hit a low point in the 1990s, Dr. Offit said. Concerns over the use of the preservative thimerosal resulted in its removal from vaccines. In addition, Rotashield was withdrawn from the market when cases of intussusception were reported. Lastly, the anti-vaccine movement was growing stronger.
Today, new technology and knowledge are helping to fuel the resurgence, Dr. Rodewald said. One big advance has been the ability to produce conjugate vaccines. The process was developed in the 1980s but is paying off now with such vaccines as Prevnar and the meningococcal conjugate vaccine, Menactra, which was licensed in 2005.
| The anthrax vaccine in its modern form was developed in the 1940s. |
The HPV vaccine uses virus-like particles made with genetic engineering techniques that were refined since their development in the 1980s, he added. Also, "20 years ago we had no idea that cervical cancer was caused by HPV," said Rick Haupt, MD, MPH, executive medical director for Merck Vaccines and Infectious Diseases, which released Gardasil to fight this cancer.
Dr. Schaffner summed up the scenario on the development side: "As the science was moving along, the manufacturing was suddenly a little less risky, and the market was more assured."
At the same time, the country became more interested in health maintenance and the prevention of illness, he added.
Notice was taken by those in public health that, not only were the immunized children healthier, but so were their families, said Myron Levine, MD, director of the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore. "What this means for public health is that if you vaccinate infants, you have an important extra public health advantage of great economic importance, because you are actually preventing disease in other ages."
The Bill and Melinda Gates Foundation's investment in vaccine development also sparked interest in supplying vaccines to people in the developing world, Dr. Levine said. Half of the money for the public-private group, the Global Alliance for Vaccine and Immunization, was provided by the Gates foundation.
The alliance has brought vaccines to some of the poorest countries in the world and prompted even more support from the Gates foundation. "When the richest guy in the world says this was the best investment he ever made, he provides the antidote to the anti-vaccine lobby in the country," Dr. Levine said.
And new vaccines are showing up in the pipeline. Sanofi Pasteur's dengue vaccine is entering clinical trials this year, just as reports of the mosquito-borne virus's spread along the United States border with Mexico were announced. Meanwhile, work on an HIV/AIDS vaccine continues. But Dr. Rodewald doesn't expect to see any reach market for several years. "For now, I think there will be a little bit of a slowdown in the newly vaccine-preventable diseases, and we are hoping that it will pick up a little later. We have a chance now to catch our breath."
But while doing so, promoters of immunizations can't relax about the need for widespread vaccination to make sure vanquished diseases remain defeated. "We are so successful at using vaccines that many parents aren't aware of these illnesses," Dr. Schaffner said. He related that one mother was confused about why he was talking about polo shirts. He was actually talking about polio, but she had never heard of the disease.
Additional societal issues to resolve include how to successfully integrate the administration of all the new vaccines into the health care schedules of children and, increasingly, teens and adults, and how to pay for them, he said.
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However, the study results showed no real difference between the two treatment groups in the two-year, randomized trial -- at least when it came to measuring plaque buildup in carotid arteries.
The initial response was to question whether the drug still had a place in physicians' medicine chests. But physician groups, including the American College of Cardiology and the American Heart Assn., soon adopted more measured positions, weighing in to say physicians should stay the course in prescribing Vytorin, and patients now taking the drug should not panic.
The study also found that patients using the combination drug experienced a 58% drop in LDL cholesterol, while those on the statin alone had a 41% drop. Overall, the safety profiles of the drugs were similar.
The data were released by the pharmaceutical companies Merck and Schering-Plough, which make the drugs. They also have been submitted for presentation at the American College of Cardiology's Annual Scientific Session this spring.
"Obviously a positive study would have been more favorable," said Skip Irvine, a spokesman for Merck/Schering Plough Joint Ventures. "This was a very challenging study, given the high hurdle [it] set, the population [people with heterozygous familial hypercholesterolemia], and their very high LDL levels at baseline."
Given the study's two-year duration and doses -- 10 mg of ezetimibe and 80 mg of simvastatin -- "we were very pleased to see that overall the safety profiles of ezetimibe/simvastatin and simvastatin alone were similar and generally consistent with their product labels," he said.
But the study created a stir for another reason. Although the trial concluded in April 2006, Merck and Schering-Plough did not release the results until mid-January -- a span that drew the attention of congressional committees.
The House Committee on Energy and Commerce began an investigation into the trial Dec. 11, 2007. Committee Chair John Dingell (D, Mich.) said in a Jan. 14 statement that the inquiry would continue despite the data's release. The announcement that the study "failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug," said Dingell.
Irvine said the companies are "fully cooperating with the committee and are in the process of responding to requests for information."
The focus is now shifting to large, ongoing comparison studies of the drugs. Those trials are testing whether the use of the combination simvastatin and ezetimibe will reduce heart attacks or deaths more than the use of simvastatin alone. Results aren't expected for two to three years.
"It will be very important for those larger studies, directed at assessing cardiac outcomes, to be completed so we can fairly assess the potential of ezetimibe," said Daniel W. Jones, MD, the heart association's president.
An American College of Cardiology statement recommends that major clinical decisions not be made on the basis of the Enhance study alone and adds "there should be no reason for patients to panic."
Steven Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic and immediate past president of the ACC, cautioned that ezetimibe should be used only if a statin fails to reduce cholesterol adequately, since the combination drug demonstrated no added benefit and patients would still be exposed to side effects.
Ezetimibe "is still recommended for patients who cannot meet their cholesterol goals when they are on the highest statin dose they are able to take," said Lisa Martin, MD, director of the Lipid Research Clinic at George Washington University Medical Center in Washington, D.C. "The good news was there were very few cardiac events in either group."
But the whole issue of LDL-cholesterol lowering may need to be reconsidered. "Maybe it's not just lowering LDL," she said, since the lowered cholesterol did not result in lowered arterial plaque. "That's something we will have to find out in the future."
The end point of the Enhance trial, also known as the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia trial, was the change in intima-media thickness measured in three sites in the carotid arteries.
The measures showed no statistically significant change.
Thomas Weida, MD, a family physician in Hershey, Pa., is interested in knowing how the difference in intima thickness translates clinically. "That's going to need a bigger study," said Dr. Weida, who is a board member of the American Academy of Family Physicians.
Dr. Weida also questioned the study population. The 720 people enrolled all had heterozygous familial hypercholesterolemia, a genetic condition that causes high cholesterol at young ages. "They tested this on a fairly rare group, so does their experience translate over to the vast majority of people with high cholesterol that we see?" asked Dr. Weida.
The study really didn't change anything, said James M. Wilson, MD, Hall chair in cardiology at St. Luke's Episcopal Hospital/Texas Heart Institute in Houston. "What we need to say is: It's a negative study. It's not particularly meaningful just yet, but let's see what happens in the clinical trial. Let's see if it shows itself to be a benefit, as we all think it will."
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