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Many small business owners understand that maintaining a drug free workplace can have a positive impact on the safety of their employees and the productivity

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

of their workforce. Often however, they never quite get around to setting up such a program because they don't know where to start.

In fact, there are simp

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

Examples of combination products may in

e steps that can be taken one at a time. Take these small steps and when they have been completed, your company will have a comprehensive program in place t

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

hat will be legal and effective in terms of cost, increased worker safety and increased company productivity.

1. Prepare a written "Drug-Free Workplace" Pol

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

cy. For your legal protection and the protection of the rights of your employees, provide a copy to all employees and have them sign a statement that they ha

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

Combination pro

ve received and understand the policy. Keep the signed statement in their personnel file.

2. Post signs at your business location stating that "We Are a Dr

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

g Free Workplace". You may want to post the sign at the entrance to your building or in the lobby, the coffee room, and above the employee time clock.

3. Pr

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

ovide substance abuse prevention education materials to all supervisors, managers, and other employees. At least once annually remind employees in writing th

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

t your company maintains a Drug-Free Workplace.

4. Perform preemployment drug testing on every new hire. Those testing positive for drugs should have their

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

employment offer immediately rescinded. All applicants must sign a statement that they understand that they will be tested for drugs before beginning work a

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

d that they will not be hired if they test positive.

5. Provide substance abuse awareness training for supervisors and managers to help them to know the ind

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

Following aspects would a

icators of drug use among their employees. Train them in effective methods of isolating and preventing a possible drug related workplace problems.

6. Test e

dd to the challenges in developing combination products:

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

ployees for "reasonable suspicion" whenever evidence of their performance, behavioral symptoms or physical signs causes a supervisor to believe that an emplo

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

yee may be using drugs. Document this evidence in written form prior to testing.

7. Perform Post accident drug/alcohol testing when an employee is involved

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

n an injury, damage of property or loss of life. Many states may deny a Workers' Compensation claim when an accident is caused by an employee whose post-acci

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

dent drug test is positive.

8. Insure that your drug test provider uses federally certified labs for the analysis of all specimens. These labs are required

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

Professional from academic institutions, pharmaceutical industries, health care indust

o use the most accurate methods of testing available and their accuracy is confirmed on a regular basis through "blind testing." Also be sure that all positi

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

ve "screen tests" are retested with a GC/MS confirmation test.

9. Utilize the services of a Medical Review Officer (MRO) for all positive results to confirm

.

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

that the positive result is not due to the presence of a legally prescribed medication that the employee is taking.

10. Make sure that your company's writte

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

Companies that provide selfless information through particip

n testing policy is applied to all employees in a fair and impartial manner. You must make no exceptions to this policy or risk accusations of discrimination

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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