Advice Pool - Health and Fitness

A leading substance abuse center recently urged the nation's doctors to focus more closely on alcohol and drug use by their patients after finding that more t

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

han 9 out of 10 physicians didn't diagnose alcohol abuse when presented with its early symptoms.

A survey by the National Center on Addiction and Substance Abus

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

Examples of combination products may in

e at Columbia University found that physicians felt unprepared to diagnose abuse and lacked confidence in the effectiveness of substance abuse treatment.

Whe

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

presented with an adult showing early signs of alcoholism, some 94 percent of primary care physicians failed to diagnose substance abuse, the center reported.

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

And 41 percent of pediatricians didn't diagnose illegal drug abuse when presented with a classic description of a drug abusing teen-age patient.

The center said

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

Combination pro

that when the doctors were asked to suggest five possible diagnoses for the symptoms, they failed to include substance abuse.

Primary care physicians must stop

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

ignoring this elephant in their examining rooms. Medical schools, residency programs and continuing medical education courses have an obligation to provide th

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

training those physicians need to spot and deal with substance abuse.

Barry R. McCaffrey, director of the While House office of national drug control policy

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

, said he supports the call for additional training of physicians in substance abuse and addiction.

"Families have always relied on their doctors for health car

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

advice. Drug abuse rips families apart. Giving the right advice on drug prevention and treatment can keep a family together," he said. Substance Abu

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

se Statistics

The survey found that only about 20 percent of doctors felt very prepared to diagnose alcoholism and 17 percent felt prepared to diagnose

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

Following aspects would a

illegal drug use. In contrast, nearly 83 percent felt very prepared to identify high blood pressure, 82 percent to diagnose diabetes and 44 percent to identi

dd to the challenges in developing combination products:

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

y depression.

Some 86 percent felt treatment for high blood pressure is very effective, and 69 percent felt diabetes treatment is very effective.

But only 8 pe

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

rcent felt treatment is very effective for smoking, close to 4 percent believed it is effective for alcoholism and 2 percent for illegal drug abuse.

The cent

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

r said 58 percent of doctors don't discuss substance abuse with .their patients because they believe their patients lie about it. Some 35 percent listed time

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

constraints for not discussing it and 11 percent were concerned they won't be reimbursed for the time necessary to screen and treat a substance abusing patien

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

Professional from academic institutions, pharmaceutical industries, health care indust

.

The report recommended increased education programs for doctors in diagnosing and treating substance abuse, urged state licensing boards to require such train

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

ing and called on Medicare, Medicaid, private insurers and managed care to expand coverage for .

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

tment.html" target="_blank">substance abuse treatment

The survey of 648 physicians across the country has a margin of error of plus or minus 4 percentage

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

Companies that provide selfless information through particip

points, the center said. It also conducted a survey of 510 patients but noted that was done at only selected centers and was not statistically representative

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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