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The FBI suggest that prevention and/or management of work place violence begins with having a plan of prepared policies, practices and structure

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

s in place to spot and defuse potential dangers before violence develops.

Important principles in forming an effective work place violence stra

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

Examples of combination products may in

egy include:

· There must be support from the top. If a company's senior executives are not truly committed to a prevention program, it is unli

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

ely to be effectively implemented.

· There is no one-size-fits-all strategy. Effective plans share a number of features, but a good plan must b

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

tailored to the needs, resources, and circumstances of a particular work force.

· A plan should be proactive, not reactive.

· A plan should t

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

Combination pro

ke into account the workplace culture; work atmosphere, relationships, traditional management styles, etc.

The following workplace elements may

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

foster a toxic climate and should be called to the attention of top executives for remedial action: intolerance, bullying or intimidation, lack

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

f trust among workers, high levels of stress, frustration and anger; poor communication, inconsistent discipline and erratic enforcement of comp

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

ny policies.

· Planning for and responding to workplace violence calls for expertise from a number of perspectives. A workplace prevention plan

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

will be most effective if it is based on multidisciplinary team approach.

· Managers should take an active role in communicating the workplace

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

iolence policy to employees. They must be alert to warning signs, the violence prevention plan and response and must seek advice and assistance

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

Following aspects would a

when there are indications of a problem.

· Practice your plan! No matter how thorough or well-conceived, preparation won't do any good if an em

dd to the challenges in developing combination products:

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

rgency happens and no one remembers or carries out what was planned. Training exercises must include senior executives who will be making decisi

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

ns in a real incident. Exercises must be followed by careful, clear-eyed evaluation and changes to fix whatever weaknesses have been revealed.

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

Re-evaluate, rethink, and revise. Policies and practices should not be set in concrete. Personnel, work environments, business conditions and 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

ciety all change and evolve and prevention must change and evolve with them.

Components of Workplace Violence Prevention can include the follow

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng:

· A statement of the employer's no threats and violence policy and complementary policies such as those regulating harassment and drug and

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

lcohol abuse.

· A physical security survey and assessment of premises

· Procedures for addressing threats and threatening behavior

· Designat

.

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

on and training of an incident response team.

· Access to outside resources, such as threat assessment professionals.

· Training of different

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

Companies that provide selfless information through particip

anagement and employee groups.

· Crisis responses measures.

· Consistently monitor behavioral standards and applicable disciplinary procedures

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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