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It has been predicted that the baby boomer generation will be the most effected by the changes health care system with regard to nursing care. The current health

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

care system is in a state of flux. With insurance companies constantly raising rates and premiums, and the hospital stays becoming less frequent, the end result i

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

Examples of combination products may in

s that health care must extend to the home. The impact of this new era of home care will have various effects on the population that is served. Although it is tru

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 that home care has been in existence for almost as many years as the profession of nursing itself, the amount of clients that home care now serves is quite a bi

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

larger than the past as well as more medically demanding. What this situation implies for the nursing profession is a larger responsibility in ensuring that clie

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

Combination pro

nts who are discharged within one to two days receive the necessary teaching and follow up nursing care to ensure progressive healing and a maximum return to well

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

ness.

In order to help ensure the goal for the client after discharge, the hospital nurse must be acutely aware of what the clients teaching needs will be from t

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

he time of admission.

For instance, those clients that have chronic respiratory disorders will need to be taught how to assess themselves for the danger signs an

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

symptoms of circulatory overload. The patient needs to be taught that a weight gain more than one to two pounds per day may indicate circulatory overload and lea

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

d to respiratory distress. While this teaching plan may seem simplistic, the fact remains that many of these respiratory compromised clients are released from the

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

hospital prior to their blood work and medical condition stabilizing.

The problems arise when the client is not functioning at a cognitive level to utilize the

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

Following aspects would a

teaching from the nurse. Even more crucial is the need for family to be involved and their desire and willingness to participate in home care. When all falls thro

dd to the challenges in developing combination products:

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

gh, which happens more frequently than not, the client is the one who suffers the consequences. As it happens, family cannot always coordinate with the nurse’s sc

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

hedule, follow through teaching may not be completed by the nurse on that particular shift. Sometimes by no ones fault, the system fails the patient just from lac

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

k of time. The solutions to this dilemma cannot be elucidated in one or two sentences. As the old saying goes, “it takes a village to raise a child”, “similarly i

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

t takes a village to promote the wellness of an individual”. With this said, one can infer the difficulties in promoting the physical and emotional wellness of a

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

Professional from academic institutions, pharmaceutical industries, health care indust

lient recently discharged from the hospital.

To at least begin to offer some solution’s, would be to hire more nurses. Since this is not logical in keeping with

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

the hospitals policy to save monies, there has to be other possible solutions. One solution would entail a network that extends from the hospital to the home. The

.

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

homecare nurse begins working with the patient and nurse before discharge. Facilitation of communication, along with the care of genuinely concerned individuals

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

Companies that provide selfless information through particip

involved in the health care system will make a positive difference in the quality of the client’s life.

Learn more about nursing education at The NET Study Guide

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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