Advice Pool - Health and Fitness

According to the 2004 DAWN (Drug Abuse Warning Network) report, out of nearly two million drug-related emerge

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

ncy room visits in 2004, almost 1.3 million were associated with drug misuse or abuse (https://dawninfo.samhs

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

Examples of combination products may in

a.gov/files/DAWN2k4ED.htm). This figure includes 495,732 visits associated with non-medical use of pharmaceut

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

cals, and 940,953 drug-related visits that involved illicit drugs or alcohol.

Bill Current, a drug-free work

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

place guru and consultant for Compliance Information Systems, stated, “In particular, the report highlights t

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

Combination pro

he national spike in prescription-drug abuse. As a whole, prescription and over-the-counter related emergency

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

room visits topped the list compared with other classifications of drugs.”

The DAWN report listed the fol

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

lowing breakdown figures for 2004:

495,732 involved prescription drugs;

383,350 involved cocain

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

215,665 involved marijuana;

162,137 involved heroin; and

102,843 involved stimulants, in

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

luding methamphetamines.

The report also demonstrates the tendency toward mixing various drugs, incl

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

uding alcohol. For drug-related visits:

30 percent were for one or more illegal drugs.

25 perc

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

Following aspects would a

ent were for pharmaceuticals;

15 percent were for illegal drugs plus alcohol;

10 percent were for

dd to the challenges in developing combination products:

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

pharmaceuticals plus alcohol.

”Drug-free workplace programs that ignore prescription drugs in favor of

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

just going after the more obvious illicit substances run the risk of allowing many substance abusers to conti

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

nue undetected,” says Current. “Benzodiazepines and barbiturates, two of the most commonly abused prescriptio

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

drugs, are often not included in a typical workplace drug test. Yet, the DAWN report suggests a need to expa

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd the panel of drugs for which companies screen applicants and employees.” Bill Current brings up a very val

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

id point. Employers should consider much more than the norm when screening potential and existing employees.

.

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

The DAWN report includes data collected from 417 hospitals and nearly two million emergency-room visits. The

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

Companies that provide selfless information through particip

Substance Abuse and Mental Health Services Administration (SAMSHA) is the federal agency responsible for DAWN

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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