Subjects - Business

First Things First

Before you decide to confront an employee who is a possible

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

drug user, you should have documented your reasons. You or a supervisor will have noted evidence

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

Examples of combination products may in

f their performance, behavioral symptoms or physical signs which indicates that an employee may b

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 using drugs. You want to have this evidence written down.

Privacy is key

Whe

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

you decide to confront an employee about possible drug use, you want to make sure that it is in

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

Combination pro

rivate. It is a bad idea to have a confrontation in a public area, and it may even be illegal. If

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

a supervisor was involved in noting the behaviors and signs of drug abuse, you will probably wan

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

to have that individual present at the meeting. Make this decision carefully however, because th

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

e accused employee is more likely to be honest if he or she doesn't feel "ganged up" on.

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

Refer to your company policy

This is where it is important that you have a company poli

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

y that is clear and specific on what steps are taken in this situation. It is likely that you wil

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

Following aspects would a

l have already decided to order a "reasonable suspicion" drug test. If you have enough evidence t

dd to the challenges in developing combination products:

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

confront an employee, you will want to settle the matter quickly and only a drug test can really

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

do that. It is also important that your company policy spells out what happens if the drug test

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

s positive. The employee should also understand the consequences of a positive test as well as th

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

consequences of a refusal to test.

Confrontation is tough

It is never easy to

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

Professional from academic institutions, pharmaceutical industries, health care indust

call an employee into your office for a talk that could lead to hostility or angry feelings. If

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

ou can present your side with frankness and compassion, the conversation may lead you both to a b

.

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

etter understanding of the situation. Whether the employee does or does not have a problem with d

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

Companies that provide selfless information through particip

ugs, you can usually find a way to begin the process that can help your employee and your company

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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Subjects - Difficult Conversations: Employees Who Are Suspected of Using Drugs

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