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With the recent improvements in medical science, and the startlingly sharp rise in the elderly population of most developed countries, it comes as no surprise that the demand for skilled

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

health professionals has soared dramatically. Most notable among these are the increasing demands for both nurses and nursing assistants.

Nursing assistants, in particular, are much s

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

Examples of combination products may in

ought after due to the great increase in their need among nursing homes, and private residence care. Nursing assistants can either work in institutions, or can be contracted to care for

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

patients in the patients own homes.

This is the only logical alternative for those with no one to care for them, or for those patients whose family members cannot provide the constant

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

nd persistent care that may be needed. And even if family members did have the time to devote, in all probability, they will lack the necessary nursing skills to provide the proper care

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

Combination pro

.

Ever Increasing Need

The demand for these occupations has skyrocketed in recent years. As a result of this dramatic increase, most countries face a serious lack of skilled health ca

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

re professionals, and have turned to overseas markets looking for foreign workers to fill the gap.

The hiring for these positions is fast and furious, and the demand for these jobs is n

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

ot expected to slow down anytime soon, leading to many countries churning out nurses and nursing assistants as fast as they can train them. The possibilities and benefits are enormous,

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

nd the profession has experienced a renaissance in relevance in today’s world.

The Nursing Assistant: Duties and Responsibilities

The nursing assistants responsibilities include assist

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

ing patients with their daily living. Most elderly, recuperating, sick, or convalescent individuals are physically or mentally challenged in some way. This makes going about their dail

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

y lives very difficult without assistance.

Nursing assistants help with patient ADL, or Activities of Daily Living, making sure the patient's are able to participate in all activities t

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

Following aspects would a

hat are both necessary, and allowed. Nursing assistants are usually supervised by registered nurses, or licensed practical nurses.

Nursing assistants typically assist in medication, cr

dd to the challenges in developing combination products:

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

ating nursing care plans, basic nursing care procedures, and should be observant enough to be able to report changes in a patients health status. The nursing assistant should also be ab

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

le to perform CPR and should be able to initiate a Code Blue Alert.

Education: How to become a Licensed Nursing Assistant

In order to practice their profession, nursing assistants have

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

to go through training and certification – which will yield a CNA or Certified Nursing Assistant credential upon successful completion.

While formal schooling is not usually required,

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

aspirants to the profession typically undergo training that could take anywhere from two weeks to two years. The theoretical aspect of the training should take a few weeks, while the ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

ual clinical training will take a few months to a few years. Tests are conducted both during and after completion of training to verify that the student is ready for actual practice.

W

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

ith nursing assistant education falling under the radar of regulatory boards, there have been initiatives to have the profession improved through emphasis on education, testing, and upgr

.

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

ading. This has spawned new professions which are a step up from current standards – these include Patient Care Technician, CNA2, as well as others.

These upgrades allow nursing assist

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

Companies that provide selfless information through particip

ants to perform more advanced procedures such as phlebotomy, catheter insertion, and gastric tube feeding – which are integral skills needed to care for elderly and convalescent patients

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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