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Are you uncomfortable with delivering disciplinary action, even involving employees you know deserve it? Y

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

ou're not alone. Disciplinary action is one of the least favored tasks a supervisor must occasionally perf

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

Examples of combination products may in

rm.

Disciplining employees is so dreaded by so many supervisors that many look the other way when trouble

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

develops, perhaps in the hope that the matter will correct itself. But most of the time it doesn’t – it te

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

nds to go from bad to worse. Rather than allow that to happen, take positive steps to prevent this potenti

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

Combination pro

l problem from becoming a real problem.

Consider this simple example. Assume you have an attendance polic

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

that calls for disciplinary action if an employee experiences four unexcused tardiness within a calendar

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

year. A little less than halfway through the year you become aware that a particular employee has already

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

ome in late twice without getting your permission. With more than half of the year remaining, you are conc

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

rned that she will be in a disciplinary situation before year's end.

Positive action begins with coaching

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

When the employee hits that second unexcused lateness, take that person aside and follow these five coac

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

Following aspects would a

hing steps.

Review the policy with the individual and point out the consequences that could lie

dd to the challenges in developing combination products:

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

ahead if the present rate of absenteeism continues.

Explain why the policy exists and why it mu

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

t apply equally to all employees.

Ask the employee for an explanation– what are any influences t

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

hat might be causing lateness.

Together come up with a specific plan to prevent any more unexcu

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

ed lateness.

Monitor and set a time to review the employee’s progress.

If employ

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

Professional from academic institutions, pharmaceutical industries, health care indust

es believe you rarely notice an absence or seem to care little whether they are regularly late, this behav

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

ior will continue. But if they know you are aware of their lateness and there are consequences, they'll th

.

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

nk twice about casually coming in late.

Conscious awareness of potential problems, plus the willingness t

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

Companies that provide selfless information through particip

assist employees through coaching, can go a long way toward nipping many disciplinary problems in the bud

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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