Subjects - Business

Step 3. Evaluate the risks and decide whether existing precautions are adequate or more should be done.

Consider how likely it is that each hazard could cause

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

harm. This will determine whether or not you need to do more to reduce the risk.

Even after all precautions have been taken, some risk usually remains. What yo

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

Examples of combination products may in

u have to decide for each significant hazard is whether this remaining risk is high, medium or low.

Firstly, ask yourself whether you have done all the things

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

that the law says you have got to do.

As an example, there are legal requirements on prevention of access to dangerous parts of machinery. Then ask yourself wh

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

ther generally accepted industry standards are in place. But do not stop there, think for yourself, because the law also says that you must do what is reasonabl

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

Combination pro

y practicable to keep your workplace safe.

Your real aim is to Make All Risks Small by adding to your precautions as necessary.

If you find that something nee

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

ds to be done, draw up an action list, and give priority to any remaining risks which are high, and those which could affect most people.

In taking action ask

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

yourself:

1. Can you get rid of the hazard altogether?

2. If not, how can you control the risks, so that harm is unlikely?

In controlling risks apply the pri

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

ciples below, if possible in the following order:

1. Try a less risky option.
2. Prevent access to the hazard (eg by installing guards).
3. Organise

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

work to reduce exposure to the hazard.
4. Issue personal protective equipment.
5. Provide welfare facilities (eg washing facilities for removal of con

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

tamination) and first aid.

Improving health and safety need not cost a lot. For instance, placing a mirror on a dangerous blind corner to help prevent vehicle

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

Following aspects would a

accidents or putting some non-slip material on slippery steps, are relatively inexpensive precautions considering the risks.

And failure to take simple precaut

dd to the challenges in developing combination products:

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

ons can cost you a lot more if an accident does happen.

But what if the work you do tends to vary a lot, or if you and your employees move from one site to ano

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

ther?

Identify the hazards you can reasonably expect and assess the risks from them. Then, if you spot any additional hazards when you arrive at the site.

Get

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

information from others on site, and take what action seems necessary.

But what if you share a workplace?

Tell the other employers and self-employed people w

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

orking there about any risks your work could cause them, and also the precautions you are taking. Also, think about the risks to your own workforce from those w

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

Professional from academic institutions, pharmaceutical industries, health care indust

o share your workplace.

But what if you have already assessed some of the risks?

If. for example you use hazardous chemicals and you have already assessed the

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

risks to health and the precautions you need to take under the Control of Substances Hazardous to Health Regulations (COSHH), you can consider them checked and

.

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

move on.

More information about legal requirements and standards can be found in the HSE publications:

An Introduction to Health and Safety.
Essentials

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

Companies that provide selfless information through particip

of Health and Safety.
Management of Health and Safety at Work: Approval Code of Practice.

That's it for this section... I'll cover Steps 4 and 5 in Part 3

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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