Social Space - Self Improvement

You can hear the ringing of the alarm in the distance, you feel too tired to drag yourself from the bed to shut it off. You have slept for hours yet still don't feel rested. Slowly you push your weary self from the bed. The last thing you feel like doing i

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

s fronting up for your shift. You feel absolutely drained; mentally, physically and emotionally. You are running on empty. You started your nursing career full of zeal and zest but the reality of the constant caring and the demands of the work environment

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

Examples of combination products may in

are far removed from your expectations. When you think about it you can see you are in a downward spiral. You have been avoiding making decisions and getting involved in your life. There certainly is no eagerness left for your job and just barely enough fo

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

r your relationships outside of work. The passion is gone. You literally feel like you have nothing more to give, overwhelmed even with the demands of nursing or perhaps experiencing feelings of sadness, anger or indifference. If this situation rings true

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

for you or someone you know - then professional burnout may be the culprit.

According to Maslach (1) burnout is a syndrome of emotional exhaustion, depersonalization, and decreased personal accomplishment that may occur in those occupations that wo

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

Combination pro

rk with people on a daily basis. From a nursing perspective burnout is experienced by nurses throughout the world and throughout the variety of clinical practice settings.

Causes of burnout There is no doubt that nursing has innate stresso

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

rs and the very nature of the work and the work environment holds a risk of professional burnout. How that risk unfolds is a complex interrelationship between multiple factors which include:

*The work: nurses deal on a daily basis with the best and worst

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

of all life and death entails and a multitude of in betweens.
*Working conditions: work load pressures, patient demands, power imbalances in the 'team' environment, staff shortages which compound the workload pressures, shift work and consequen

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

impact on fatigue levels. Consider also that at times nurses experience violence and even threats to their life as a simple fact of their everyday work environment.
*A unrelenting sense of responsibility, this feeling that you need to help and

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

assist - often in circumstances of funding constraints and workforce shortages it is impossible for you to deliver. There is often lack of clarity about just what it is you need to do to be a 'good' nurse.
*What nurse's experience on a day to d

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

ay basis if often far removed from what they thought and were promised when they entered nursing.
*Nurses and their competence are often over scrutinized and under supported. Even in this day of enlightenment we are still subjected to the blame

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

Following aspects would a

and train the nurse mentality when anything goes wrong.
*Talented boss or not? Does you boss have skills in leadership, team building and engagement? Are they prepared to say no to the hierarchy when their team is under resourced and over press

dd to the challenges in developing combination products:

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

red? Do they recognize and respect that you have a life outside of nursing? If so you are one of the lucky ones and this will probably be reflected in the burnout statistics for your work area.
*The nurse and their own individual circumstance

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

and set of coping resources and supports.

Burnout perspectives
Patients and Consumers of nursing services

Interestingly given that most of us pursue nursing as a career because we want to care and assist people we need to be

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

mindful of the fact that professional burnout can negatively impact the care provided to the very people we intend to help -- the patient!!

Nurses
There is great privilege in being able to support someone through the best and worst of w

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

hat life has to offer. There are however also great risks for the nurses own health in doing so, day in and day out. In essence; nursing is absolutely one of the most stress filled occupations around and professional burnout can have dire consequences to n

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

Professional from academic institutions, pharmaceutical industries, health care indust

rses.

Nursing Leaders

Be mindful that burnout will eventually cause withdrawal from the activity associated with the burnout. In case burnout amongst nurses hasn't caught your attention yet consider that in 2002 a US National Institutes of

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

Health (2) study reported that there was a 23% increase in burnout for each additional patient to nurse ratio and of those nurses who experience burnout a whooping 43% said they were planning to leave their job within the next year. Such statistics ar

.

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

e a call for action if any organisation intends to attract and keep its nursing workforce. Professional burnout is real and it has serious consequences for nurses and patients as well as nursing and health care leaders. We will explore strategies and

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

Companies that provide selfless information through particip

solutions in Part 2 Burnout Solutions.
(1) Maslach, C. (1982). Burnout: The cost of caring. Englewood Cliffs, New Jersey: Prentice Hall. (2)National Institutes of Health. (2002). More surgical patients die when nurses caseloads increase

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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In my opinion, video games are more than just addicting toys that keep people from being responsible, productive members of society. However, many people seem to disagree with me. A few days ago, I watched a show that covered the shootings by two eleven year-olds of students and teachers at a remote grade school in Arkansas.

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