Subjects - Business

First, you need to appreciate that discipline involves handling the behaviour of apparently ‘problem people’.

‘Problem people’ key facts:

• The behaviour is the problem, not

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

the person

• Seeing people as a problem can be dangerous and destructive, in relationships and in managing people

• It is vital to separate out the person from the problem

A problem

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

Examples of combination products may in

erson is someone whose behaviour does not meet the normal standard we expect. It follows, therefore, that we will need to be clear what the standard expected is. We will look at this sh

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

ortly.

Defining Discipline

Dictionary definitions of discipline mention:

• Instruction

• Maintaining order

• Mental training

• A system of rules

• Controlling behaviour

Is

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

Discipline Punishment?

The view of discipline as punishment may originate from childhood associations, and the view that discipline is all about a ‘wrong’ to be ‘corrected’.

A balance

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

Combination pro

needs to be struck between viewing discipline as punishment or improvement.

The Improvement/Punishment Balance

To punish is to:

• Cause the offender to suffer

• Inflict a

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

penalty

• Chastise

• Give a penalty for wrongdoing

• Reprimand

• Correct

To improve is to:

• Make better

• Use for good purpose

• Become better

• Progress

• Be more prosper

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

us

The Improvement/Punishment Balance

Conclusion:

The key aim of discipline at work is to encourage unsatisfactory employees to improve. (The word discipline derives from t

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

he Latin Verb discere. This means to teach or mould.) Keeping the focus on improvement, means having a view that discipline is about trying to gain, and not using blame.

When Is Punishm

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

nt Valid?

You should use punishment as a final sanction only, when everything else has failed. Remember, the prime objectives have to relate to gaining improvement.

Key Facts

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

iscipline is:

• Conforming to a system of rules for conduct

• Ways and norms and expectations of behaviour

• Sometimes hidden in peoples/companies’ beliefs and values

• Usually accepted

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

Following aspects would a

as necessary by the majority

• Sometimes imposed by mandatory legislation

• Visible when relationships between a company and an employee are unsatisfactory to the company

• One of the m

dd to the challenges in developing combination products:

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

asures that helps employees keep to the standards expected

• A way to help employees improve

• A way companies can deal fairly with those who do not keep to the standards

Prime Object

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

ives

The prime objectives for disciplining need to be concerned with:

• Improving, correcting, preventing, re-aligning

• Bringing about conformity to standards

• Encouraging improve

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

ent, and higher levels of performance

In Summary: Misconduct Offences

Offences can always be categorised as either performance issues or relationship/behaviour issues.

Work per

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

ormance issues are about:

• Poor attendance and absence

• Poor careless work output

• Failure to follow rules, such as health and safety

Work relationship issues are about:

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

Professional from academic institutions, pharmaceutical industries, health care indust

• Refusal to obey reasonable instructions

• Disruptive behaviour

Misconduct offences normally lead to disciplinary action, whereas the following gross misconduct offences normally lead to

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

dismissal.

Gross Misconduct Offences

Again, these offences can be categorised as either performance or relationship issues.

Work performance issues are:

• Gross negligence

.

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

causing loss, damage

• Serious disregard of health and safety legislation

• Deliberate damage to company property

Work relationship issues are:

• Theft, fraud

• Assault, fighti

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

Companies that provide selfless information through particip

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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