Advice You - Business

“Mary is still out with a back injury and I don’t know when she will be returning. I got a note from her doctor and it said she will be out indefinitely. Frankly, I can’t believe she w

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

as hurt that bad.”

This is often a typical exchange about a work related injury and the beginning of an out of control and costly workers’ compensation claim.

When the supervisor was

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

Examples of combination products may in

asked about whether he had spoken to Mary or to Mary’s doctor, the response was “No, I don’t want to seem like I’m harassing her and I don’t think I have the right to speak to the doct

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

or.” Unfortunately, this is the farthest thing from the truth.

No matter how good an organization’s safety program is, work related injuries will still occur. Employers must, therefor

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

, develop a positive “post-injury response” system which is designed to care for their injured employee, to help them get the employee back to work quickly, and to minimize their worke

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

Combination pro

s’ compensation costs.

So what should employers do when an injury occurs? What should their post-injury response system look like? An effective multi-component system should include t

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

he following steps:

Take care of the injured employee: When someone becomes injured, this is your priority. Whether it is providing first aid or escorting the person to the hospital,

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 tone of the case will be established in the first few minutes after the injury. Employees are most vulnerable immediately after the injury. Questions are flowing through their head:

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

“Will I be OK?” “Will I lose my job over this? “How will I be able to pay the mortgage if I’m out of work without a paycheck?” The employer needs to step in to reassure the employee th

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

at they will be OK and that they will have a job. There will be plenty of time later to fill out those insurance forms. The priority now is taking care of the injured employee.

Establ

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

sh a medical provider relationship: If an injured employee needs medical treatment, a relationship with doctors, medical specialists and a hospital or clinic are key. You want to be ab

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

Following aspects would a

e to get employees immediate medical treatment. You do not want them spending hours in an emergency room. Finally, physicians should know and understand your workplace so that they can

dd to the challenges in developing combination products:

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

work with the employee and the organization to provide quality care and to help the employee to return to work when they are medically fit.

Establish a modified or light duty program

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

This is the key to reducing your workers’ compensation costs. Studies show that when employees return to work, under proper medical supervision, they heal quicker, feel better about t

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

emselves and are able to remain productive.

Analyze all accidents: The true cause of all accidents must be determined so that it can be prevented in the future. What kind of message i

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

s sent to an injured employee who returns to work and sees the same situation exists that caused his or her accident? Analysis and correction form the basis of your safety program and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ends a powerful message to all employees that safety is important.

Develop a relationship with the insurer: As your partner, they can be key to the early, successful resolution of thi

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

claim. Without their help, claims can linger indefinitely.

Reducing your workers’ compensation cost requires a comprehensive program where employers partner with their employees, med

.

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

ical providers and the insurer. Its key, however, is simple: if you take care of your injured employee, ensure that they get the best medical treatment, and provide an atmosphere of ca

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

Companies that provide selfless information through particip

ing and trust, you will find that your workers’ compensation costs will drop and equally important, your employees will be happier, more productive, and have less work related injuries

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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