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Poor Sally!

I ran and picked up my ringing telephone. It was Sally. She was upset and was crying. I gave her the time and listened. Wha

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

t's up? And then she tells me, "that place is really the pits."

As we chatted together, she finally settled down and agreed that the nursi

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

Examples of combination products may in

ng profession is not as attractive as it was in the past. I remember those days well. I actually had the time to hold a hand, wipe a tear,

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

and give a hug. Those days are long gone. Today, we nurses rush through our day, leaving patients often frustrated.

The many things we d

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

, often go unnoticed by our supervisors. However, we were recognized during National Recognition of Nurses Week, but for some reason that d

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

Combination pro

idn't seem enough.

Sally started to sob again. "One nurse can't be all things to all people." "I am tired of this." "There's just too mu

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

ch to do in eight hours." "They want you to punch out on time and all you hear about is their budget."

I too sacrifice my lunch and often

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

break times. I feel the stress of hurrying through my tasks to finish them. My mind doesn't stop processing on my drive home, wondering if

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

I had forgotten to do something.

Workplace overload is a contributing factor to staff shortages. Job dissatisfaction is overheard everywhe

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

re. I often hear "I can't wait until I retire or "If I find something else, I am out of here."

This is very disturbing to hear, because I

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

relate to this every day. I hate it when nursing staff is short. Patient care is often compromised. I find myself not accepting overtime,

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

Following aspects would a

because I'm too exhausted to work another additional 8 hours. Most of the time, refusals for overtime doesn't go over well with management

dd to the challenges in developing combination products:

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

Most of us don't care and just go home.

The nursing force is aging. We are just getting older. Most want to retire. Others are looking

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

to something else that is less stressful and demanding.

As I attempted to console Sally on the phone, we considered other options to cope

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

with the workplace. "We do have a choice," I reminded her. "What's the choice," she asked. I rambled things off like, "we can quit," "we

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

can stay," or "we can find something else out there." "We're to old," she quipped. "No we are not, Sally!"

I told her I had surfed the

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

Professional from academic institutions, pharmaceutical industries, health care indust

Internet and finally found something. Oh, I had her attention now, as she stopped sobbing. "I didn't know you were so computer savvy." "W

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

e both are." "We use the computer at work all the time, putting those orders in, don't we?" "Tell me," she begged!

I'll call you tomorrow,

.

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

after work. "I can't wait," she replied.

Maria Hamilton is a Registered Nurse and an Internet Marketer specializing in online income prod

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

Companies that provide selfless information through particip

ucing programs.

To learn more about the program that is allowing Maria to quit her job and earn a substantial income online, visit her site

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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