Advice Pool - Business

The permissive and participatory conduct which most employees take for granted, eventually escalates into the more serious assaultive behavior commonly referred to as employee on employee workplace violence starts with innuendos, a bad word

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

, or simple jokes taken out of context or used to inflame another. Initiation of a proper and thorough investigation is possible under the auspices of a Threat Assessment Team. Banter between employees if left alone by supervisors becomes

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

Examples of combination products may in

tense and often results in a more aggressive response. The truth of the matter is that in most cases this banter is perceived as harmless shop talk.

Supervisors often believe that this healthy shop talk builds camaraderie and does not detrac

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

t from performance. However, such permissive behavior empowers the potential perpetrator who may feel he enjoys the partiality of the supervisor. After all, he does his job, pumps out the numbers and meets the "bosses" demands. Regardless o

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

f the relationship and his performance, definite and clear action should be taken initially to curtail the potential of an explosive situation from impacting the workplace. The spontaneous reaction by the victim although surprising could be

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

Combination pro

sufficiently volatile to affect bystanders as well.

Remembering that the business owner is ultimately responsible for the actions they fail to take in any situation places the decision in question. The prevention of workplace violence req

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

uires a proactive response. Security is everyone's responsibility but ultimately management's duty. The exposure to violent behavior by non employees is yet another issue which will be presented in future articles.

In a permissive environment, t

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

he uninformed employee has no idea that emotions tied into simple acts of harassment are an explosive combination often leading to a spontaneous counter response by the victim. While the response is unfortunate in terms of who ultimately p

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

recipitated the incident, the victim who is now taking the action into his hands becomes the aggressor and must be held accountable.

Using a Threat Assessment Team or a trained group of individuals would be the proper approach in this scenar

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

io and in future incidents. The conduct of the Threat Assessment Process would involve the total analysis of information and intelligence available about the participants, the incident and the environment in order to render a fair and imp

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

artial outcome. Being properly trained is key. Knowledge of how to conduct a fact finding investigation is critical to the successful determination of the type of disciplinary action or criminal prosecution it might bring. The process should

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

Following aspects would a

be synchronized and well coordinated and reflective of the organization's leadership team, if possible to insure that the preliminary responsibility of conducting the fact finding investigative process does not fall on the shoulder's of th

dd to the challenges in developing combination products:

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

e Security Director long after the fact. The major players of the Threat Assessment Team might include at a minimum: the Immediate Supervisor, Personnel & Human Resource Managers, Employee Assistance, Safety and Security Managers to insure a thor

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

ough Threat Assessment (Investigation) is conducted.

In Assessing the above scenario the root cause of the confrontation was the unabated name calling, verbal abuse and innuendos, created by a permissive and improperly supervised environment.

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

Supervisors who fail to step in to correct this type of behavior can be held civilly liable and responsible for their failure to act early or appropriately to prevent escalation or confrontations. In cases of death or serious injury between employe

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

es or customers, wrongful death law suits are often filed in addition to criminal prosecution. Not knowing is no longer a legitimate excuse.

When supervisors fail to act appropriately, management has the burden of investigating the incident, deali

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng with the issue of the aggressor over the contributory behavior of the instigator and decide on the appropriate progressive disciplinary actions (or if necessary, referral to local police for prosecution).

And, so while a Zero Tolerance Policy

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

is necessary and highly recommended, it should not be an absolute standard in administering discipline until the "root cause" of the contributory behavior becomes clear through the Assessment Process. When controlling or addressing the pote

.

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

ntial fruits of unwelcome behavior or to more appropriately, prevent incidents dealing with a Workplace Security Issue, every situation should not be resolved in the same manner with the same administrative decision. Any broad-brush approac

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

Companies that provide selfless information through particip

h to enforcing the Zero Tolerance Policy sours the innocent bystanders and prejudices the potential witnesses who may fear retaliation or retribution, factors which may further complicate the disciplinary process and/or criminal referral.

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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