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The environment of your workplace is vital to employee satisfaction, reduction of turnover, and productivity. It is also vital to the legal stability of your business. A hostile work environment can be the basis for

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

many types of employee complaints and causes of legal action. The Equal Employment Opportunity Commission lists as a basis for employee complaints the existence of a “hostile work environment.” The creation or contin

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

Examples of combination products may in

ation of a hostile workplace environment can be the beginning of a legal quagmire of lawsuits, wrongful termination suits, and discrimination complaints. The atmosphere of a harsh and antagonistic workplace can be a d

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

ath sentence for your business.

One of the biggest factors affecting hostility in the workplace is inequity and selective discipline. Employees frequently site favoritism and unfairness as their reasons for discomfor

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

and intimidation at work. It can also be the basis for proving a pattern of discrimination in your workplace. It is essential for all managers to apply coaching and discipline in an equitable fashion. Once employee

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

Combination pro

standards are established, infractions of these standards must be applied fairly and without bias. Failure to hold workers accountable to employee standards of conduct and behavior in a consistent manner will lead to

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

accusations of bias and favoritism. The consequences of such accusations are far reaching and will affect management credibility at all levels of your organization.

Establishing a written and clear code of employee c

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

nduct is only the first step in good human resource management. This written policy is only as good as the enforcement of its standards. Just as your personnel policies were written in a neutral and impartial manner

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

o must be the enforcement of these policies. Infractions and violations of personnel policies should be dealt with in an established way. Degrees of discipline such as verbal warnings and written warnings should be c

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

ontained in your protocols and associated time frames should be attached. Follow these protocols without regard to the personalities involved. Circumstances that mitigate infractions can and should be documented as p

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

rt of this process. There may be factors that make one breach of conduct different or less severe than another and there should be a venue for written comments in discipline documentation. But these mitigating circum

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

Following aspects would a

tances should not preclude discipline. You may know and understand why someone broke the rules and may indeed find these factors understandable but the perception of favoritism must be avoided at all costs. It may me

dd to the challenges in developing combination products:

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

n writing up an employee for something you feel was justified but to just dismiss the violation fails to take into account the perceptions of other employees and the effectiveness of your personnel policy. Take the ti

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

me to communicate your views and feelings about the infraction and document them properly. This is an exercise in fairness and consideration that you owe your employees. It can turn discipline into constructive coach

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

ng.

The perception of employees is the key to creating a work environment that is neutral to the personalities and personal preferences involved. Discrimination occurs when your employees perceive that they are being

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

treated differently than others. When the tardiness of one worker is excused because they have to take their child to day care but the tardiness of another worker without such a valid reason is cited with warnings can

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

Professional from academic institutions, pharmaceutical industries, health care indust

cause the perception of unfairness. In your warning to the employee with day care issues you can mention your empathy with working parents and suggest flextime options or carpooling as constructive suggestions but the

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

employee’s failure to adhere to work rules must be documented. Other employees may not know about their coworkers obligations and be angry when they are written up for tardiness and others are not. Hostility can be

.

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

voided by consistent and equitable enforcement of work rules.

Avoiding the impression of unfairness can go a long way to maintaining an impartial workplace, the satisfaction of employees, and the feeling that everyone

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

Companies that provide selfless information through particip

is being treated in the same way. It also takes the perception of bias out of the employee relations equation. Though it means hard choices it can mean the difference between a hostile and hospitable work environment

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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