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Let me ask you a few questions. Does your workplace get in the way of the work you do? How does it affect your (or your employees) productivity? Are there missed deadlines, too many workers compensation claims, or too many a

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

bsences? How does this affect your company’s bottom line? Here is how you can solve some of these problems.

If you find yourself answering yes to any of these questions, it is possible that you have a workplace ergonomics

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

Examples of combination products may in

roblem. Ergonomics is a fairly common buzzword in today’s workplace, and it carries significant impact for both the employer and the employee.

In simple terms, ergonomics is the science of fitting jobs to people with the

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

oal of reducing or eliminating the potential for work related injuries, often known as muscular-skeletal disorders, or MSDs.

MSDs are caused or aggravated by workplace risk factors such as sustained or repeated exertions, a

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

kward postures, exposure to excessive heat, humidity, or cold, high noise levels, poor illumination, and uncomfortable, unnatural manipulations. Common symptoms are decreased range of motion or grip strength, loss of functio

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

Combination pro

, swelling, cramping, redness or loss of color, soreness, headaches, blurred vision, and hearing loss.

These conditions usually result in lowered productivity, increased rework, increased medical and insurance costs, increa

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

ed employee absences (and the need of finding additional manpower), and workers compensation claims. Complaints or problems leading to an OSHA (Occupational Safety and Health Administration) or MIOSHA audit can lead to sig

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

ificant fines. Employees talk, and this can make it hard for your company to attract and retain high quality people, leading to higher recruiting costs.

With the goal of cutting costs and improving productivity, business o

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

ners should take a proactive role in identifying and reducing or eliminating workplace hazards. OSHA recommends the following steps:

1. Review and analyze injury and illness records and look for patterns that could identif

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

a work related ergonomics factor. Use your OSHA 300 Logs and supporting 301 forms and worker’s compensation claims as a starting point.

2. Analyze the jobs and look for ergonomic risk factors, such as repetitive and/or pr

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

longed movements requiring twisting the wrist and other joints, bending, poor illumination, vibration, exposure to temperature extremes, non-adjustable seating, slip hazards, and poor lifting practices.

3. Survey your emplo

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

Following aspects would a

yees to determine the existence of ergonomic hazards.

4. Gain awareness of common contributing factors for your industry.

5. Take corrective actions as necessary.

Although corrective actions can be expensive, there are a

dd to the challenges in developing combination products:

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

umber of benefits. First, these tend to be one-time instead of long-term expenses. Proper ergonomic conditions are a major factor in improving production and cost efficiency, and there’s plenty of evidence to support this:

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

A 15% performance improvement of State Farm clerical workers.

· Productivity of workers at Blue Cross-Blue Shield improved by over 4.4%.

· Another study, with even more impressive results, is available at www.combo.com/e

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

go/ergoecon.htm.

Overcoming and eliminating ergonomic hazards is a three-stage process, starting with engineering controls that involve physical changes to the job and work environment, work practice controls that involve f

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

llowing proper work methods, and administrative controls, such as training, employee rotations, and rest breaks.

As for regulatory enforcement and the potential of fines, Congress struck down OSHA’s Final Ergonomics Program

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

Professional from academic institutions, pharmaceutical industries, health care indust

Standard in 2001. OSHA is developing guidelines for specific industries and will assist businesses to help them address ergonomic issues in the workplace. Although the guidelines are not enforceable, OSHA conducts inspection

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

for ergonomic hazards, issues citations under the General Duty Clause, and issue ergonomic alert letters where appropriate. Since these citations can be costly, it is in employers’ best interest to take a proactive approac

.

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

.

In Michigan, MIOSHA is developing a proposed standard that will establish minimum requirements for all general industry employers that have employees with exposure to ergonomic hazards as well as the minimum requirement f

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

Companies that provide selfless information through particip

r ergonomic awareness training and the process for assessing and responding to ergonomic occupational risk factors. More information is available at www.michigan.gov/cis. Click on the link to MIOSHA in the left-hand column

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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