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The holidays are notorious for over indulging on food, overexertion while shoveling snow, and high levels of stress.

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

Unfortunately, this puts many people in the emergency room needing immediate medical care.

What happens in the emerg

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ncy room when the hospital is understaffed because the doctors and staff are on vacation and they're short-staffed? Y

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

our care may suffer.

Here are 5 important tips to help you through the holidays if you wind up in the emergency room

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

1. Make sure you are seen by an attending emergency room doctor. An attending is a doctor who has completed all of

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

is postgraduate training, and is now working for the hospital. Most emergency rooms are staffed by doctors-in-trainin

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

g, called residents, and are supposed to be supervised by a senior physician. If you are seen by the resident doctor,

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

you should ask to also be personally evaluated by the attending physician.

2. If you are able, ask lots of questions

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

"Why do I need this test," "What is the purpose of this medication," "Are there any alternatives to treat me, other

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

than what you are recommending?" "What will happen if I choose not to have the treatment?" Do not accept what is give

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

to you blindly.

3. If you have x-rays, an MRI scan or a CAT scan, ask whether the attending radiologist has read th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

films. Do not rely on the radiology resident in the emergency room to read the films. "Oh, but the attending isn't i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

n now, he reads it the next day." No good. If the attending radiologist isn't available, ask the emergency room docto

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

to read the films himself.

4. If you are given medication, either in pill form or by intravenous line, you must ask

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

if there's the potential for an allergic reaction. Allergic reactions can kill you. You must ask.

5. If you are alle

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rgic to any medication, make sure the emergency room staff notes it on your chart, and make sure you are given an 'al

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ergy bracelet' to let everyone know about your allergies. In practically every hospital, allergy bracelets are availa

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

le to warn hospital staff about a patient's allergies. Don't rely on a note in your chart to inform the doctors and h

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ospital staff about your allergy.

Veteran New York malpractice lawyer Gerry Oginski says "Keeping these tips in mind

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

while in the emergency room will minimize your risk of being a medical malpractice victim during this holiday season.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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