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Main Subject - Employers - Protect Yourself from Custody Battles that Hold Your Company Hostage
Child custody? How'd that get to be an employer's concern?
When an employee faces child custody litigation, it will effect their ability to do their job. And it often causes legal consequences for their employers as well. Un
When an employee faces child custody litigation, it will effect their ability to do their job. And it often causes legal consequences for their employers as well. Un
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
less you know where to draw the lines regarding your legal obligations and exposure, you could find your employee's custody difficulties costing the company in a variety of ways.
Custody problems have a major impact in the w
Custody problems have a major impact in the w
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
orkplace, where they effect other employees, as well as hurting the bottom line. Worse yet, they can be disruptive in the workplace for a long time. Unlike other kinds of employee stress, a custody dispute could keep creating
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
turmoil until the employee's youngest child turns 18. A matter may seem to be resolved, only to rise again years later as the child's circumstances change.
Financial Costs Add Up
The widespread effects of custody litigatio
Financial Costs Add Up
The widespread effects of custody litigatio
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n on employers isn't a new issue. It's just that nobody has been noticing how many negative ways it creates problems in the workplace. But you need to, because the risks and harmful consequences to your enterprise of ignoring
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it are significant. When you consider the impact on other employees, your personnel policies, and financial exposure, this article should be a wake-up call.
Impact on the Employee's Performance
Impact on the Employee's Performance
- Absence for appoin
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
tments with attorney, evaluations, court dates, etc.
Stress making them more distracted, and even ill (so more sick leave)
Co-workers having to pick up the slack, so they feel put upon
Unavailable for travel or
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
extended hours
Involving other employees in the unfolding dramatic developments, which sidetracks them all from the job at hand
Likely self-medication with drugs or alcohol to deal with emotional strains
Depre
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ssion, anger and other emotional spill-over on the job
Impact on the Supervisor or Employer
Extra supervision is usually required to compensate for erratic employee performance issues. Distracted employees aren't cap
Impact on the Supervisor or Employer
Extra supervision is usually required to compensate for erratic employee performance issues. Distracted employees aren't cap
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
able of doing their best work. Plus, you need to be vigilant as to how custody developments effect co- workers, and the extent to which they're pulled into the personal problems. Constant updating and consoling distracts ever
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
yone involved from their work. In an effort to be "understanding" it's easy for supervisors to fall into enabling behaviors, that are harmful both for the business and the employee. These could include:
- "Covering U
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
p: Providing alibis, making excuses or even doing the work rather than confronting the issue that they're not meeting their responsibilities.
Rationalizing: Developing reasons why their continued behavior is understand
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
able or acceptable.
Withdrawing: Avoiding contact with the employee or their problems.
Blaming: Blaming others for the continued problem behavior or performance.
Controlling: Taking responsibility for their
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
performance by moving them to a less important job (or reducing their obligations)
Threatening: Saying you'll take action (ceasing to cover up, taking formal disciplinary action) if they don't improve." Quoted from Win
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Your Child Custody War, Chapter 11.
Be Alert to the Company's Risks
The employer must never sacrifice company policy under such circumstances. It should already have policies in place to deal with these matters - an
Be Alert to the Company's Risks
The employer must never sacrifice company policy under such circumstances. It should already have policies in place to deal with these matters - an
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
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
d then stick with them. If the personnel matters are mis-handled, even for well-meaning reasons, the legal exposure would be costly in both dollars and time.
And don't overlook the related issues which put the company at ris
And don't overlook the related issues which put the company at ris
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
k: possible workplace violence (one need only pick up the paper), compromised company confidentiality (as private work-related matters are made public records through court submission) and accidents, which are more likely whe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n a person is distracted. And that doesn't even address the costs related to lost jobs. (It costs approximately $125,000 to hire and orient a new employee.) Custody matters often trigger relocations or resignations.
No workp
No workp
.
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
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
lace is immune. Just because custody-related problems haven't come up before, it's unwise to disregard the headaches it can cause. Knowing the proper way to support the employee and where to draw the line serves them as well
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
as the organization.
If you want to protect your business from being held hostage when an employee goes through a custody dispute, you need reliable information. Because the consequences to your operation could be crippling.
If you want to protect your business from being held hostage when an employee goes through a custody dispute, you need reliable information. Because the consequences to your operation could be crippling.
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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