Or (operating Room) Management Software:

OR (operating room) management software allows sophisticated and advanced access to the Web for acute and fine viewing of a surgeon’s work status and an expertise report of their activities. Surgeons and other staffs of a hospital may easily access and likewise print work schedules by just a few clicks through OR (operating room) management software. The program does not require any sort of cutting-edge technology or extra added IT based support.

OR (operating room) clinical information system management software offers great help to various hospitals that include superior communication. OR (operating room) management software is also used for Health Insurance Portability and Accountability Act of 1996 or HIPAA requirements.

Moreover, the key factor involved in OR (operating room) management software lies in steady discipline amongst staff members working in hospitals. OR (operating room) management software is cost effective, efficient, user friendly, and predictable and above all, it helps in managing prompt services of staff scheduling.

In addition, OR (operating room) management software assures best utilization of operation theaters and the respective time, that is available in OR.

However, OR (operating room) management software has certain advantages, which are as follows:

1. Guarantees best utilization of operating rooms and the time factor involved in the operating rooms.

2. It improves the availability for personal resources.

3. OR (operating room) management software increases the safety of a patient.

4. The software allows smooth working of all the operating rooms.

5. It helps to provide complete cost
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ing for almost every clinical procedure

By: Jenny Myflower

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OR (Operating Room) Management Software: article for imd-soft.com, by Jenni content

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Oral Surgeon Nyc And Removal Of Wisdom Teeth

Oral surgeon is a professionally qualified individual who is capable of doing different types of surgeries to correct dental defects. Oral surgery is very different from the other surgeries that are carried out by surgeons to correct other medical conditions. An oral surgeon NYC is the ideal person for you to approach if you are suffering from any severe dental conditions. Normally an individual has healthy teeth and it is due to some of the unhealthy lifestyle habits that we adopt that our dental condition starts to deteriorate. Oral surgery has been found to be effective in curing several dental conditions and removal of wisdom teeth is one such condition. In fact surgery is one of the most recommended procedures by dentists and one of the most widely adopted dental procedure by the public.

A study conducted by some dentists suggests that by the time an individual reaches his early twenties he is most likely to be advised by dentist to go for oral surgery to have the wisdom teeth removed. There are several reasons based on which dentist advice the removal of the wisdom teeth by an oral surgeon. A wisdom tooth mainly grows to help in eliminating the risk of infection and damage to the nearby teeth. You must remember that the growth process of the wisdom teeth takes a long time and the pain is very severe. Sometimes it may happen that wisdom teeth may be blocked from erupting fully by the gum tissue overlaying on the teeth. When wisdom teeth are prevented from erupting it is known as impacted.

Treating impacted teeth is not a difficult thing to do if one seeks the help of an efficient oral surgeon. There are oral surgeons that are specially trained to handle surgery that are connected with removal of wisdom teeth. This procedure can be done by an oral surgeon in his office and this does not
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require too much time. Certain factors like the health, age, weight, medical and pathological history must be considered by the dentist and oral surgeon before they go about doing the procedure. After finding info about all these aspects it may sometimes happen that the dentist may recommend the patent not to undergo the procedure if there is any amount of risk involved. However chances of happening this are very less. If you are found to be perfectly eligible for undergoing this procedure, you must make sure that you strictly follow whatever your oral surgeon asks you to.

Make sure that you take care of all the post operative steps which your oral surgeon asks you to follow. After all this will help you in being pain free very early, so you must make sure that you do that. It takes about 48 to 72 hours to recover after the operation. Again this differs from patient to patient depending on different factors. Bleeding is most like to take place after the surgery and this can create difficulty in consuming food right after the surgery. You must be cautious about this and make sure that you follow whatever procedure your dentist asks you to.

By: Erzana Jones

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Erzana Jones has special interest in dentistry and health related topics.She has been working for Manhattan dental SPA since the last 3 years.For more information about Manhattan Dental SPA,Dentist New York,Oral Surgeon NYC or any kind of dental emergency visit www.manhattandentalspa.com

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Dental Implant- A Comprehensive Smile Makeover Technique

Missing teeth is a problem that comes with an effective solution today. Your teeth were designed to last a lifetime, but sometimes they don’t. Replacing missing teeth is important not only to the health of other teeth but also to the also for your general health. Not only you loose your chewing ability when a tooth is lost but the unreplaced teeth can cause other teeth to be lost tipped or crowned and other subsequent teeth problems.

Dental Implants should always be considered as an option to replace a failing or missing tooth. Replacement of lost teeth with dental implants has been used for treating missing teeth for more than 50 years and is recognized as an effective treatment choice. Supported by the expertise of Implant Dentists this medical marvel is a solution that perhaps not only replaces the missing tooth but also preserves the supporting bones making it a preferred choice over fixed bridges, removable dentures and other outdated implant dentistry techniques.

With the support of highly qualified Riverside Implant Dentists, implant dentistry solutions come as a lease for a life time. Implant Dentists deploy state of art, technology and highly skilled work force dedicated to dental cures in a customized and holistic manner. A qualified Implant dentist makes sure that they leave no stone unturned in providing the patients with the best possible care.

Implant dentistry is not just concerned with replacing the missing teeth, but also aims at recollecting the lost smiles. Dental implants are substitutes for the roots of missing teeth. They act as an anchor for the replacement of tooth or crown. Implant patients can be of all ages and implants can be the right choice for everyone missing one or more teeth due to injury, disease or decay. But there are some conditions in which im
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plant dentistry may not be the right option for you. Here you can consult suitable Implant Dentists who could help you if you are a right candidate for the implant dentistry.

Your general dentist could be first source for knowing about implant dentistry. The key to efficient service lies with the implant dentist’s experience, training and credentials. At an implant clinic various implant dentists work as a team providing complete diagnostic to each patient with highest standards of treatment available. A general Implant Dentist team comprises of prosthodontists, periodontists and oral surgeons delivering a complete comprehensive and functional and best aesthetic dental care results to its clients.

Implant dentistry may seem an interesting option that implant dentist may provide to let you change your life forever. Provided you are fixing your appointment with specialized implant dentists. For finding the most qualified implant dentists with higher credentials you can refer to online sources. One such online reference source is Top3Dentists that will let you have a complete information over the implant dentistry procedures and will help you search a qualified Riverside Implant Dentist who lies geographically close to you.

By: Sandra Ray.

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Sandra is a renowned article author who has been reviewing several Implant Dentists in Riverside and is currently serving Top3Dentists with his reviews regarding Riverside Implant Dentist

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Toothache – Treatment For Toothache

Toothache or tooth pain is caused when the nerve root of a tooth is irritated. Dental (tooth) infection, decay, injury, or loss of a tooth is the most common causes of dental pain. Pain may also occur after an extraction (tooth is pulled out). Pain sometimes originates from other areas and radiates to the jaw, thus appearing to be tooth pain. The most common areas include the jaw joint (temporomandibular joint or TMJ), ear pain, and even occasional heart problems.

A toothache is usually the result of a cavity formed by the bacteria that cause tooth decay (known medically as dental caries). Cleaning out and filling the cavity brings a quick end to the pain. Without this treatment, however, the pain is likely to get worse.

Toothache is pain in the area of your jaw and face. It is usually caused when a nerve in the root of a tooth becomes irritated. However, other problems such as infection, decay, or the loss of a tooth, can also cause toothache

Toothache and jaw pain are common complaints. There may be severe pain to pressure, or to hot or cold stimuli. The pain may persist for longer than 15 seconds after the stimulus is removed. As the area of inflammation increases, the pain becomes more severe. It may radiate to the cheek, the ear, or the jaw.

The most common cause of toothache, or pain in the region of the jaws and face, is pulpitis – inflammation of the pulp of the tooth. The short, sharp pains usually occur in response to hot, cold or sweet stimuli.

Treatment for Toothache

Tooth decay is the primary cause of toothaches for most children and adults. Bacteria that live in your mouth thrive on the sugars and starches in the food you eat. These bacteria form a sticky plaque that clings to the surface of your teeth.

Ap
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ply an OTC antiseptic containing benzocaine directly to the irritated tooth and gum to temporarily relieve pain. Direct application of oil of cloves (eugenol) also may help. Don’t place aspirin or another painkiller directly against your gums, as it may burn your gum tissue.

An antibiotic will usually be prescribed if a fever or swelling of the jaw is present. Such procedures are generally done in stages, with pain and infection being cared for immediately, and reconstructive procedures being performed at a later time (weeks to months). You will be able to return to work or school while you recover. Dentists and oral surgeons may plan additional procedures at the most appropriate time.

A hot saltwater mouthwash (a teaspoon of salt to a cup of water) used to thoroughly rinse the painful area may help if the problem is caused by a tooth erupting.

For toothache that is caused by a loose or broken filling, the filling is taken out, any new decay is cleaned out, and a new filling is put in.

Onion may give bad odor temporarily, but in the long run it is very beneficial to dental hygiene. Onion can fight against the germs that accumulate on the teeth and hence prevent future problems with the teeth. People chomping on one raw onion a day are protected from toothache, apart from various other health benefits.

Using clove oil (Syzygium aromaticum) to numb the gums; the oil may be rubbed directly on the sore area or used to soak a small piece of cotton and applied to the sore tooth.

By: ab robinson

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Read about Body Building Tips and Girls Discussion Forum Message Board. Also Read About How to Solve a Problem

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Dental Lasers Are Patient Friendly Advancements In Dentistry

Dental Lasers, a patient friendly advancement in dentistry, are used in dental procedures involving the teeth and gums.

The use of dental lasers has provided more options and better dental services for patients. Dental lasers lack the heat and vibration of the dental drill making the procedure very comfortable for most patients. Furthermore, dental lasers eliminate the need for any kind of injection.

Patients can expect quicker procedures and faster healing. For soft tissue procedures ,dental lasers eliminate the need for suturing therefore the healing process is much faster. Lasers are also much gentler on the surrounding gum tissues.

This is why dental lasers have become an important part of dentistry. Dentists and oral surgeons have found that dental procedures performed using dental lasers is faster, safer and more effective than traditional dentistry. Many dental procedures done with dental lasers can be completed in minutes, not hours, especially routine ones such as teeth bleaching.

The precision that is possible with dental lasers means much less work is actually needed in the mouth so patients can expect a much faster turnaround.

Benefits may include:
• Soft tissue dental lasers eliminate the need for stitches.
• Dental lasers limit bleeding because the high-energy light beam aids in the clotting (coagulation) of exposed blood vessels. This inhibits blood loss.
• Dental lasers sterilize the areas they are being focused on minimizing bacterial infections.
• Tissue regeneration is accelerated.
• Wounds heal faster.
• Many laser dentistry procedures don’t require anaesthesia.
There are so many benefits to using dental lasers compared to standard traditional procedures that dental lasers are slowly becoming commo
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nplace in dental practices around the world.
The cost for this technologically advanced equipment is not cheap but the cost to clients can be kept at a minimum due to the time saved through shorter treatment times.

Clients can expect fast results combined with minimized discomfort, a win-win situation for both dentists and clients alike.

Dental practices using dental lasers in their treatment procedures can be found all across the USA. You can count on dental lasers as being the best way to:
• Replace, strengthen and stabilize your teeth
• Enjoy painless treatments with outstanding results.
• Achieve beautifully natural results enhancing your self-image.

Dental lasers are here to stay and we can smile confidently knowing we have access to these fantastic tools when we want to enhance our appearance.

By: Dr. Charles Zuman

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www.finequalitydental.com”>www.finequalitydental.com
offers people looking for the quality, comfort and results that people seeking
dental laser procedures expect an affordable range of Dental laser procedures from whitening, porcelain crowns, implants and more.Dr. Charles Zuman Dental Implants and Full Mouth Rehabilitation Specialist; also known as a combination of cosmetic dentistry and occlusion. He performs Root Cana

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Conventional Medical Equipment, New And Used, Financing And Leasing

Traditional medical equipment, used and new, lending and leasing is stillaccessible in today’s financial markets. In thiscritique, we are going to deal with some application only programs that are existing up to $125,000 and full documentation packages up to $250,000. In today’s market, many banks have either run out of money to loan or musteliminate their off lease inventories to generate working capital. Furthermore, some banks are no longer in business due to these tough economic times.

This economic calamity has affected everyone including banks and lenders. The accessible programs described here include you locating your own medical equipment and bringing to a conventional lender for leasing

The requirements for application only programs up to $125,000 are the following:

“A” Credit requires the following: Up to $125,000

• 5 years TIB (time in business) under current ownership
• 700+ credit score
”B” Credit requires the following: Up to $75,000
• 0-3+ years TIB (time in business) under current ownership
• 650-700 credit score
The rates on A and B paper will be slightly different.
Additionally, a filled out lease application dated and signed by the owners and summary page of the last three months business bank statements will get the lending process started.

A copy of an invoice, purchase order etc would be required from the qualified d
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ealer. Additionally, other information might beobligatory but this is taken on a case by case basis.

For financing up to $250,000, these are the following standards:

• 5 years TIB (time in business) under current ownership
• Full Financial Package is required will ALL applications • 675+ credit score
• Low 5 Average bank balance with no NSF’s or Overdrafts

Furthermore, the details of this program is listed below if a Corporation of any kind)

1. 2 current years corporate tax returns (COMPLETE WITH ALL SCHEDULES AND ATTACHMENTS)
2. Last 2 years profit & loss statements
3. Last 2 years balance sheets
4. Year to date profit & loss statements
5. Year to date balance sheets
6. 2 current years personal tax returns for ALL owners (COMPLETE WITH ALL SCHEDULES AND ATTACHMENTS)
7. Current signed and dated personal financial statements for ALL owners 8. COMPLETE application with ALL owners information and signatures

(if a Sole. Prop.)
1. 2 current years personal tax returns (COMPLETE WITH ALL SCHEDULES AND ATTACHMENTS)
2. Current signed and dated personal financial statements
3. Last 2 years profit & loss statements
4. Last 2 years balance sheets
5. Year to date profit & loss statements
6. Year to date balance sheets
7. COMPLETE application with ALL owners information and signatures

Once again, a signed and dated lease application would be essential to get the financing process started. A copy of an invoice, purchase order etc would be mandatory from the eligible seller. Also, other information be might be mandatory but this is taken on a case by case basis.

This application only and full documentation program would apply to following types of healthcare professionals:

Cardiologists, Radiologists, Dentists, Urologists, Vets, Surgeons, Physical Therapists, Neurosurgeons, OB/Gyns, Oncologists, Physical Therapists, Plastic Surgeons, Oral Surgeons, Proctologists, Oral Surgeons, Family Doctors, All MD’s, Cardiovascular Surgeons, etc

Furthermore, the types of medical equipment that would qualify under this application only and full documentation financing programs would be:

X Ray equipment, Bone Imaging, Cat Scans, Cardiac Monitors, MRI and Imaging equipment, Lasers and Monitors, Ultrasound equipment, Radiology equipment, Surgical tables and lights, anesthesia machines and vaporisers, microscopes, medical equipment etc

In these complicated economic times, there is still conventional banking available for the qualified applicant

Happy hunting for your medical equipment and related {financing..
|leasing|lending}

By: J.M Casa

Article Directory: http://www.articledashboard.com

J.M Luna has over thirty years experience in the financial field. This includes leasing, accounting and taxes, hard asset money and commercial lending.

U.S Corporate Capital Leasing assists the start up and seasoned business for finaning in all different industries.

www.cclgequipmentleasing.com/lease_medical.htm

www.cclgequipmentleasing.com

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Four Ways To Whiten Your Teeth

Wherever you are, the possession of a bright white smile makes you feel much better. It may not matter so much if teeth are crooked as that sometimes lends to a person’s character although straighter teeth are often healthier.

People with less than perfect teeth that are stained or show signs of dental decay tend not to get the same social acceptance as someone whose teeth are good. Practising good oral hygiene will help to keep teeth white but if you want a better shade of white there are other ways than just brushing.

Your sparkling smile may become dulled even though you keep your mouth healthy by brushing, flossing, and rinsing with a mouthwash.

Whitening teeth with a peroxide based solution is a very popular procedure for dentists and patients alike. Amongst the various kinds of techniques there are two main categories: treatment at home and treatment at the dentist’s surgery. While all techniques will generally provide the expected results there are advantages and disadvantages to all of them. Always consult your dentist or call your dental insurance plan provider if you are in any way unsure about dental treatments.

There are a number of techniques to help keep a perfect smile.

-Teeth whitening strips
-Tray-based teeth whitening solutions
-Paint-on teeth whitening
-Professional tooth whitening treatment

Teeth whitening strips are the simplest form of improving your dental looks. By wearing whitening strips coated with 6 whiter smile.

The advantage of using whitening strips is they can be worn inconspicuously throughout the day. The disadvantage is whitening strips lie across the front of the teeth and do not always reach between the teeth where some stains occur.

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Amongst dentists the tray-based whitening solution system is the most preferred and popular procedure for bleaching teeth. The tray is shaped to fit around the teeth, one tray for upper and one for lower teeth. In the tray is a bleaching gel that may continue to work for several hours.

Whitening strips, unlike the gel filled tray, cannot reach all areas – a definite advantage of the tray method. The disadvantage lies in the fact that the tray, unlike a simple brush application, needs to remain in the mouth for some time. Times vary depending on the manufacturer.

Paint-on tooth whitening is another way of applying a peroxide solution onto the teeth. A brush is used to apply the whitener to the teeth; after this the solution forms a thin film. The length of time the solution remains on the tooth varies between manufacturers. This length varies according to the manufacturer and may be anything from one hour to over-night. When the whitening solution has been on the teeth for the time recommended by the manufacturer a toothbrush is used to remove it.

The advantage of paint-on whitening is that trays are not necessary and the solution reaches all parts of the tooth. The disadvantage is that this does not work on existing dental work.

It would not be wise to start self-applied treatment without first consulting your dentist. Strict observance of the manufacturer’s instructions will ensure that no damage is done to existing dental work such as fillings and veneers. A considerable amount of expense and treatment time may be involved if any of these solutions are used incorrectly.

Some people may think that it is better to have the teeth whitening treatment carried out by a professional. The truth is that professional treatment and self-administered treatment both produce the same results over time. Time now becomes the most significant consideration. What may take one to two weeks to accomplish at home is usually completed in one session with a dentist.

Using a dentist has the obvious disadvantage of being expensive. If you do not have a comprehensive dental insurance policy which covers these sorts of treatments, the cost will be substantially more than buying over the counter products. Self-administered treatment may turn out to be more expensive than using dental insurance. Dentist-administered treatment has the advantage of being completed in the minimum amount of time. Seldom does a whitening session last for more than an hour. There is also the added advantage of the dentist giving your mouth a good check up at the same time, something you cannot do yourself.

By: Stephanie Andrew

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For more tips and advice on how to take care of your smile, visit our blog site www.insureyoursmile.co.uk and for great value dental health insurance plans for you and your family, visit www.dencover.com where you can apply online an

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Drug Research And Children

Recent studies are providing important new information about drug safety and effectiveness for children. Pediatricians say it’s about time.

Most drugs prescribed for children have not been tested in children. Before the Food and Drug Administration initiated a pediatric program, only about 20 percent of drugs approved by the FDA were labeled for pediatric use. By necessity, doctors have routinely given drugs to children “off label,” which means the drug has not been approved for use in children based on the demonstration of safety and efficacy in adequate, well-controlled clinical trials.

To be well-controlled, a study should have an adequate number of patients who receive the study drug and a control group–people who are similar to the group taking the drug being studied, but who are receiving some different type of treatment, such as another drug or an inactive pill (placebo).

Experts say the historical lack of pediatric drug testing is due to a combination of reasons. The primary reason is that pharmaceutical companies generally have viewed children as a market that would bring only small financial benefits. The drugs that have been adequately studied in children–vaccines, some antibiotics, and some cough and cold medicines–have a large market.

“It’s also harder to carry out studies in children,” says Dianne Murphy, M.D., director of the FDA’s Office of Pediatric Therapeutics. “You need child-friendly environments in every sense, from age-appropriate equipment and medical techniques to pediatric specialists who are sensitive to a child’s fear.”

Jeffrey Blumer, M.D., Ph.D., chief of pediatric pharmacology at Case Western Reserve University in Cleveland, says technical procedures that seem simple for adults, such as drawing blood or getting a urine sample, can be difficult with children.

The ethical issues are also stickier. F
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or example, while adults can give informed consent to participate in a clinical trial, children can’t because “consent” implies full understanding of potential risks and other considerations. Parents are involved in the decision to enroll children in a study, and children ages 7 or older can “assent” or “dissent,” meaning they can agree or disagree to participate in a study.

Blumer says, “I’ve had parents who are enthusiastic about a study and then a 7-year-old who hears everything involved and says, ‘No way!’”
Children Aren’t Small Adults

Rather than avoiding pediatric research because of the challenges, experts say it’s more important to build the foundation and resources needed to conduct the studies. Without them, children face significant risks.

In the absence of data, doctors use their medical judgment to decide on a particular drug and dose for children. “Some doctors stay away from drugs, which could deny needed treatment,” Blumer says. “Generally, we take our best guess based on what’s been done before.”

A common approach has been to use data from adults and adjust the dose according to a child’s weight. Experimenting over the years has taught doctors to use many drugs in children safely and effectively. But this trial-and-error approach has also resulted in tragedy, indicating that adult experiences with a drug aren’t always a reliable predictor of how children will react.

For example, in the 1950s, the antibiotic chloramphenicol was widely used in adults to treat infections resistant to penicillin. But many newborn babies died after receiving the drug because their immature livers couldn’t break down the antibiotic.

“Experience has shown us that we need to study drugs in children because they aren’t small adults,” says Ralph Kauffman, M.D., director of medical research at Children’s Mercy Hospital in Kansas City, Mo. “It’s not just about smaller weight,” he says. “There are dynamics of growth and maturation of organs, changes in metabolism throughout infancy and childhood, changes in body proportion, and other developmental changes that affect how drugs are metabolized.”
Proof Is in the Data

Fortunately, recent legislative changes that provide both a voluntary and a mandatory mechanism to conduct drug studies in children have resulted in a dramatic increase in pediatric drug trials. “There have been more studies conducted in children in the last five years than in the previous 30 years combined,” Kauffman says.

The information coming out of those studies has added pediatric information to the drug labeling for more than 80 drugs, and more changes are coming. Drug labeling is the guidance to doctors and other health care providers on how to use a drug. “We knew that we needed science to determine proper dosing for children the same way we do with adults,” says Murphy. “Now, we have confirmed it.”

Ibuprofen, one of the most common over-the-counter drugs on which parents rely to reduce children’s fevers, carried no dosing information for children younger than 2 years old until recently. Now, because of studies in thousands of young infants, the dose considered to be safe and effective for over-the-counter use has been established for children ages 6 months to 2 years.

The labeling has also been changed for Zantac (ranitidine), a drug used to treat gastroesophageal reflux. This condition can be life-threatening in infants. When reflux occurs, the stomach contents can flow up the esophagus and be aspirated into the lungs. This can harm the lungs of infants and result in breathing problems.

Studies have given doctors accurate dosing information for safer and more effective use of the drug to manage reflux in seriously ill infants. Richard Gorman, M.D., chairman of the Committee on Drugs at the American Academy of Pediatrics (AAP), a member of the FDA’s Pediatric Advisory Committee, and a pediatrician in Maryland, says, “Now I can use ranitidine with as much inform
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ation as doctors who use it in adults. I know the dose. I know the dosing interval.”

New discoveries have revealed underdosing, overdosing, ineffectiveness, and safety problems. Gorman says, “Even though the best and brightest pediatric minds have helped us establish dosages for children, we’re finding out that the dose is different than we thought in some cases. And that probably came as a surprise to most of us.”

The FDA is working with the AAP to educate pediatricians about new physician labeling changes through an online continuing medical education program called PediaLink.
What’s Spurring the Research?

The FDA has taken a carrot-and-stick approach to encourage pediatric studies, says William Rodriguez, M.D., the FDA’s science director for pediatrics. The carrot is the voluntary pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which was reauthorized in January 2002 and extended through 2007 as the Best Pharmaceuticals for Children Act (BPCA). The stick is the Pediatric Research Equity Act (PREA), which allows the FDA to require pediatric studies. Here’s an overview of each initiative:

The Pediatric Exclusivity Provision of the BPCA. The pediatric exclusivity provision has done more to spur pediatric studies than any other regulatory or legislative initiative so far. The provision allows companies to qualify for an additional six months of marketing exclusivity if they do the studies in children as requested by the FDA.

Patents protect a company’s investment by giving it the sole right to sell a drug while the patent is in effect. When patents or other periods of exclusive marketing for brand-name drugs are close to expiring, other drug companies can apply to the FDA to sell generic versions, without having to repeat the original developer’s clinical trials. So the trade-off is that by companies qualifying for an additional six months of exclusivity, there is a delay in the availability of lower-cost generic drugs.

The FDA has interpreted the provision so that the six months of exclusivity isn’t added only to the drug that was studied in the pediatric population, but also to any of the drug company’s formulations, dosage forms, and indications that contain the same active part of a molecule (moiety) and have existing marketing exclusivity or patent life. So if a company markets an oral formulation and a topical cream containing the same moiety, the six months of marketing exclusivity will be added to any existing exclusivity or patent protection for both products.

The process can be initiated either by a drug company or the FDA. A drug company may submit a proposal to the FDA to conduct pediatric studies. If the FDA agrees that studying a drug may produce health benefits for children, the agency will issue a “Written Request” addressing the type of studies to be conducted, study design and goals, and the age groups to be studied. Or the agency may issue a Written Request on its own initiative when it identifies a need for pediatric data. No matter how the studies are initiated, if the FDA determines that the data submitted fairly respond to the Written Request, then the company will be granted six months of pediatric exclusivity.

More than 100 drugs have been granted exclusivity so far. As of Dec. 31, 2004, 691 studies had been requested and 298 Written Requests issued. The FDA estimates that about 80 percent of the studies outlined in Written Requests will be conducted.

Kauffman says the exclusivity is proof that economics plays a large role in the lack of pediatric studies. “Once the economic disincentive was removed,” he says, “the dam broke completely open.”

Since the incentive under FDAMA did not apply to old antibiotics and other drugs that lack marketing exclusivity or patent protection, some categories of drugs have remained inadequately studied. For these products, BPCA provides a contract mechanism through the NIH to fun
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d pediatric studies. In addition, if a company that has a drug with existing exclusivity or patent protection chooses not to conduct the requested pediatric studies, the FDA can refer the Written Request to the Foundation for the National Institutes of Health to award grants so that third parties can conduct the needed studies.

The NIH, in consultation with the FDA and other pediatric experts, publishes an annual List of Drugs for Which Additional Pediatric Studies Are Needed in the Federal Register. Since BPCA went into effect, the FDA has issued 11 Written Requests for off-patent drugs and the NIH has published four requests for contracts.

PREA. In the early 1990s, the FDA implemented voluntary measures to encourage pediatric studies, but they were mostly unsuccessful. In 1997, the FDA published a proposed regulation that for the first time required manufacturers of new drug and biological products to conduct pediatric studies in some circumstances. The rule was finalized in 1998, and the first studies were required to be submitted starting December 2000.

The rule, however, had its critics. In December 2000, the Association of American Physicians and Surgeons, the Competitive Enterprise Institute, and Consumer Alert filed a lawsuit against the pediatric rule, challenging the FDA’s legal authority to require pediatric studies. And in October 2002, a federal district court concluded the FDA did not have that authority and the rule could not be enforced.

Former HHS Secretary Tommy G. Thompson responded in mid-December 2002 by announcing that his department would push for rapid passage of legislation that would give the FDA authority to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials on drugs.

“The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation,” Thompson said in a prepared statement. “Children need to have access to drugs that can benefit them, and these drugs need to be properly tested for pediatric use, not prescribed and sold without testing. Congress alone can speak clearly on the authority that FDA needs …”

On Dec. 3, 2003, President George W. Bush signed the PREA into law. This act basically mimics the old pediatric rule with a few additional provisions.

As was true with the pediatric rule, the PREA will address some of the gaps left by the pediatric exclusivity provision. Unlike the exclusivity provision, the new act requires pediatric studies and covers both drugs and biologics–medical products derived from living sources, such as vaccines, blood, and blood derivatives.

Under the PREA, the FDA can require pediatric studies of a drug submitted in a new drug application if the FDA determines the product is likely to be used in a substantial number of pediatric patients, or if the product would provide a meaningful benefit in the pediatric population over existing treatments. At the same time, the PREA does not delay the availability of drugs for adults.

“The BPCA and PREA have worked in tandem,” says Murphy. “We have told sponsors who submit a new drug application and who are required under PREA to conduct pediatric studies that they also may qualify for pediatric exclusivity.”
Building the Foundation

“There was no infrastructure for the research before,” says Floyd R. Sallee, M.D., Ph.D., a child psychiatrist and director of the pediatric pharmacology research unit at Cincinnati Children’s Hospital Medical Center. “I see the culture changing in industry and at FDA,” he says. “Drug companies have hired pediatric experts and there is a larger network of expertise to draw from.”

Sallee’s center is part of the Pediatric Pharmacology Research Unit (PPRU) Network, a group of centers that conduct pediatric drug trials with support from the National Institute of Child Health and Human Development (NICHD). The network was established in 1994 and now includes 13 P
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PRUs.

Shirley Murphy, M.D., (no relation to Dianne Murphy), joined the FDA in September 2002, as director of the Division of Pediatric Drug Development. She says linkages between the FDA, NICHD, AAP, and other organizations have been important for building a foundation for pediatric research, and children are getting more and better drugs as a result.

“What it means for parents is that they can feel more secure knowing that their children are being treated appropriately,” Shirley Murphy says. “FDA remains committed to keeping pediatric drug research a high priority.”

Several areas that will continue to receive the agency’s attention include the ethics involved with studying drugs in children. The FDA’s Pediatric Advisory Subcommittee has concluded that, generally, pediatric studies should be conducted in subjects who may benefit from participation in the trial. This means the subject has or is susceptible to the disease under study.

Shirley Murphy cites pediatric oncology as another important area for the agency. “The development of cancer drugs needs special consideration,” she says. Differences in the biology of tumors in children and adults usually make it difficult to prescribe children drugs based on adult data. And it has been typical for new cancer drugs to reach children late–only after they have been tested in adults.

As a result of pediatric initiatives, there have been about 30 studies initiated on cancer drugs, which will help researchers gain access to potential new cancer therapies for children.

While it may be challenging to enroll children in clinical trials for some diseases, that’s not the case with cancer. Most children receive their cancer therapy as part of a clinical trial. “Parents are desperate to have their children in these studies,” says Patrick Reynolds, M.D., Ph.D., a pediatric oncologist with Children’s Hospital Los Angeles. “They know very well what the odds are and they want to take a chance to find life-saving treatment. They also want to help other children. They don’t want to do nothing.”

Reynolds is a member of the FDA’s Pediatric Oncology Subcommittee, a group of outside experts who have met several times since 2000 to advise the agency on such questions as: In what phase of a drug development program should pediatric cancer studies begin? What trial designs should be used? How may data from adult studies be used in pediatric studies? How should adult and pediatric studies be coordinated when studying life-threatening diseases?

Reynolds calls both the pediatric rule and the exclusivity provision essential. “Children don’t have a voice in this,” he says. “Somebody has to stand up for them.”
Changing Drug Labels

Recent pediatric drug studies have resulted in the addition of pediatric information to the labeling for more than 80 drugs. The drug labeling provides guidance for doctors and other health care providers on how to use a drug. Here are examples of several changes that are considered significant for dosing and risk:

* Claritin (loratadine) syrup. Used to treat allergy and hives. Patients ages 2 to 5 years require a lower dose (5 milligrams) compared to a 10-milligram dose in older children and adolescents.
* Duragesic (fentanyl) transdermal patch. Used to manage chronic pain. It is now only to be used in patients older than 2 years who have been on opioids and are used to them. This medication is administered through a patch placed on the skin.
* Luvox (fluvoxamine maleate) tablets. Treats obsessive-compulsive disorder. The dose of the drug may need to be increased to the recommended adult dose in adolescents, but girls ages 8 to 11 years may need lower than the recommended dose.
* Midazolam hydrochloride syrup and injection. Used as a sedative. The drug was shown to have a higher risk of serious and life-threatening a
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dverse events for children with congenital heart disease and pulmonary hypertension. Research identified the need to begin therapy with doses at the lower end of the dosing range to prevent respiratory problems in this special pediatric population.
* Neurontin (gabapentin) capsules, tablets, and oral solution. Used as adjunctive therapy in the treatment of partial seizures in pediatric patients ages 3 to 12 years. Neuropsychiatric adverse events were identified in 3- to 12-year-olds.
* Pepcid (famotidine) tablets, injection, and oral suspension. Used to treat gastroesophageal reflux disease. Patients up to 3 months of age require a lower dose because their ability to get rid of the drug is less than that of older children and adults.
* Ultane (sevoflurane) volatile liquid for inhalation. Used in general anesthesia. Pediatric studies revealed rare reports of seizures in pediatric patients given this drug.

By: Leslie Johnes

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