Advice You - Business

In the early 1900’s, the United States workplace began a rapid transition from an agricultural economy to an industrial one. Family members began worki

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

ng in factories, away from the home setting. The onset of the change from agricultural to industrial brought new problems into the workplace. By 1917,

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

Examples of combination products may in

ompanies throughout America began to see a need for helping with the personal problems, as a way of improving workplace productivity.

In the 1940's, t

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

e Macy company was the very first company to establish a employee assistance program, as a method of addressing alcoholism that was beginning to appear

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

in white collar workers. It wasn’t until the 1970’s, when grants were established to form workplace employee assistance programs, that the EAP became

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

Combination pro

firmly planted in our workplace, and developed widespread popularity.

There is a growing awareness that problems faced by employees affect workplace p

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

oductivity. Alcoholism, drug abuse, and marital issues can have a negative impact on employee performance, and diminish workplace productivity. If an e

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

ployee is dealing with divorce, death, or insurmountable stressors at home, they will produce less work, then the employee who doesn’t face these issue

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

.

As companies gain increasing awareness that issues outside of work, do impact productivity, the need for employee assistance programs grows.

From a

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

n employer standpoint the motivating force in hiring EAP counselors is to make more money. It is far less expensive to address personal issues, than it

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

is to ignore them, for a company’s profitability.

Employee Assistance Programs are designed to help a worker improve productivity. They offer short te

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

Following aspects would a

m counseling services in stress management, family issues, and substance abuse counseling. They often utilize referral services such as private counsel

dd to the challenges in developing combination products:

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

rs, doctors and community mental health centers to help employees with personal problems, as a method of improving productivity, which will then improv

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

e profitability.

However, like everything else in today’s economy, businesses are complex and multifaceted. There is a growing recognition, that one o

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

one counseling is sometimes not enough, there are other issues faced by organizations. Issues such as team work, organizational development, and leade

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

ship skills and training, and so EAP also addresses them. As if that isn’t enough for an employee assistance program to tend to, growing cutbacks and l

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

Professional from academic institutions, pharmaceutical industries, health care indust

yoffs create internal stressors, not necessarily related to problems outside the workplace, but inside the workplace. As a result, EAP has become more

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

complex as it tackles internal stressors faced inside the workplace.

Employee Assistance Programs are frequently multifaceted, with counselors in thes

.

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

settings wearing many hats. Responsibilities of counselors in these settings have expanded from one on one counseling for workers dealing with persona

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

Companies that provide selfless information through particip

issues outside the organization, to training and education about stressors occurring inside the organization, and having an impact on work performance

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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