Advice You - Business

I recently gave a presentation on this topic at an Annual Conference of Human Resource Professionals. The room was full! So I t

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

hought the information might be timely for some of you.

What is burnout? What are the symptoms and causes? And if you're experie

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

Examples of combination products may in

cing it, what can you do?

The dictionary states that burnout is "exhaustion of physical or emotional strength or motivation usua

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

lly as a result of prolonged stress or frustration." I put usually in italics because even when you love your work like I do, you

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

can overdo and find yourself burned out.

Symptoms of burn out can be physical, behavioral and spiritual. Here are some signs tha

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

Combination pro

t you're heading for burn out:

• fatigue
• muscle tension
• headaches
• insomnia
• not keeping commitments

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

> • lack of effectiveness
• irritability
• anxiety
• sense of emptiness-nothing left to give
• lack of joy

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

r> • not able to laugh

Causes of burnout can come from within ourselves or from our organizations. Some common causes are high

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

xpectations of ourselves, denial of our basic needs like food and sleep, poor time management skills, inability to set boundaries

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

or to say no.

Organizational causes can be a culture of competitiveness, or one in which being constantly busy and overworked i

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

prized with email and phone calls taken along on "vacations." Insufficient training in new job roles or cramped, noisy environme

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

Following aspects would a

nts can also contribute to burnout.

Here are 3 ways to manage burnout: change the stressful situation, reduce your vulnerability

dd to the challenges in developing combination products:

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

to stress and/or change the way you react to stress that cannot be changed:

1. Change the stressful situation if you can. If the

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

re are some high stress aspects of your job, see if you can rotate this task with others. Limit the number of hours you are under

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

stress. Spend some time on career/life planning. Set your priorities and live by them.

2. You can reduce your vulnerability to s

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

tress by taking care of your physical self with good nutrition, exercise and enough sleep. Avoid nicotine and don't overdo caffei

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

Professional from academic institutions, pharmaceutical industries, health care indust

e and alcohol. Surround yourself with supportive people, work with a coach who will listen to you deeply and help you to create a

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

good balance of work and other aspects of your life.

3. Finally, change the way you react to stress. You can do this by modifyi

.

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

g your self-talk and self-criticism. Learn techniques to calm yourself - a few deep breaths can bring you right back to a cente

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

Companies that provide selfless information through particip

red place, able to face whatever stress is in front of you. Become a self-care expert and have some fun.

Copyright 2005 Ann Rona

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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