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One of the more common criticisms employees in small or emerging businesses have of their owners is that they are often “arbitrary”, “capricious” or “unpredictable”. These descripto

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

rs always scored high on our consultant employee surveys. The reason is simple: without a written policy and procedure to guide them, decisions rendered by management, though often

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

Examples of combination products may in

fair, are interpreted differently by different employees. Also, managers do tend to be inconsistent over time without a written policy guideline.

Remember, it is the intent of any

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

policy of this nature to anticipate probable violations of company policy and to encourage employees to change their behavior before it becomes chronic or unacceptable and before di

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

charge becomes the only option.

Definition of Discipline Problems

Management discipline problems can be roughly divided into three categories:

Attendance: No-Show: Chronic absenc

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

Combination pro

e; Excessive Tardiness; Leaving Without Permission; Failure to Report Absence Before Starting Work

On-The-Job Behavior: Recurrent Errors; Failure to Carry Out Assignments; Refusal

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

to Accept Assignments; Use or Possession of Controlled Substances; Sleeping on the Job; Poor Housekeeping, Unauthorized Smoking; Fighting, Gambling, Failure to Use Safety Devices; V

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

iolation of Dress Code; Delaying or Restricting Operations; Distribution or Possession of Sexual, Political or Religious Material on Company Property; Threatening Supervisor; Posses

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

ion of Firearms or Other Weapons; Excessive Interruption of Work for Personal Business; Malicious Waste or Abuse of Company Property.

Other Acts: Theft, Embezzlement; Altering Time

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

Cards or Punching Another Employee’s; Falsifying Work Records; Removal or Use of Company Property for Personal Use; Misconduct Casting Discredit Upon the Company.

Seriousness of O

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

ffense and Consequences:

It is important to establish what occurs on the first and repeated offense in each case. Depending upon the violation and the number of repeated offenses,

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

Following aspects would a

consequences might be a verbal warning, a written warning, suspension or discharge. For less serious offenses, up to four repeats may be advisable with the consequence increasing on

dd to the challenges in developing combination products:

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

each repeated offense. For example, carelessness is a correctable behavioral problem (as long as it’s not related to safety) and might go through all four stages: Verbal Warning, Wr

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

itten Warning, Suspension and lastly, Discharge.

On the other hand, possession of controlled substances at work or intoxication or working under the influence of such substances co

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

uld and should be met with discharge on the first offense. Employee Assistance Programs (EAP) might mitigate the discharge if the employee agrees to participate. Consistency in Ap

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

plication of Policy:

Management must make a concerted effort to enforce all policies routinely and consistently, including the discipline policy, without regard to friendship, fami

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

Professional from academic institutions, pharmaceutical industries, health care indust

y considerations or favoritism of any kind. Failure to do so will weaken and perhaps nullify policies and certainly will create morale problems within the company.

This includes be

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

havior of all personnel up to and including the owner/CEO/President.

Legal Considerations:

Written warnings and discharges should be documented in writing with acknowledgements si

.

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

gned by the employee. In our current hyperactive litigious business climate, it is important that the company protect itself by showing due diligence in the enforcement of policies.

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

Companies that provide selfless information through particip

Written documentation available in the employees personal record related to disciplinary action will go a long way to protect the company in a labor dispute or potential litigation

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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