Advice You - Business

As the biggest investment a business is likely to make is staff, any time lost to sickness can be costly. This cost must be measured not only in terms of lost production and sick pay, but also in t

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

erms of employee morale. Whenever an employee is off sick, there is a knock-on effect on those colleagues who have to cover.

Recent reports have highlighted that sickness is costing British busine

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

Examples of combination products may in

ses up to ?1.75 billion a year, or roughly ?500 per employee. Although the problem is far worse in the public sector, the private sector is still averaging 6.5 days of sickness absence a year per e

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

mployee. Improved management of a company's sickness absence could mean serious savings.

Sickness reporting:

The first area to consider is the reporting of sickness. Before anything can be

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

done to reduce absence levels it helps to know what they are. Everyone needs to know precisely what they are required to do if they are too ill to come in to work. Make sure employees are aware tha

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

Combination pro

they should phone, not leave a message, and speak to their manager or an equally senior person if they are not available.

Tell employees they must phone in as early as possible to advise why they

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

are unable to make it to work and when they expect to return. It is not unreasonable to ask these questions and it may mean they are less likely to take that occasional day off.Unless their contra

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

ts of employment state otherwise, employees are only required to provide a doctors certificate for periods of absence exceeding seven days. But employees can be asked to complete an absence stateme

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

t, which details when they were off and why. This can then be signed off and put on their employment file.

The return to work interview:

When an employee's returns from sickness, ensure th

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

at they have a 'return to work' interview. This should be done even if they have only had one day off sick. This is a simple but effective tool and will make employees think twice before taking an

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

ccasional day off.

The Bradford Factor:

Long-term sickness can be planned around and dealt with. The worst type of sickness, as far as a business is concerned, is the regular but sporadic

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

Following aspects would a

ay off. In order to be able to deal with this, an objective monitoring system will be required. It might be worth considering the Bradford Factor, which is not a hugely complicated scientific ide

dd to the challenges in developing combination products:

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

a, but a simple means to highlight those who regularly take a single day off.

The Bradford Factor measures both the number of sick days and the number of absences. The formula is:

S x S x

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

= 'Bradford Factor'

(S is the number of spells of absence in the last 52 weeks and D is the number of days' absence in the last 52 weeks).

For example, an employee who takes 10 individual sick d

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

ys in a year will have a Bradford Factor of (10 x 10 x 10) 1000. Whereas an employee who has a total of 10 days sick on one occasion in a year because of a virus or bad bout of flu will only have a

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

Bradford Factor of 10. As it concentrates on instances more than actual day’s absence, the Bradford Factor allows a business to have a table of sickness. Those without satisfactory explanations fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

their regular short-term absences can then be dealt with formally through disciplinary procedures. As ever, it is essential that consistency is applied when dealing with sickness absence. It is wo

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

th remembering that genuine sickness should be dealt with in a sympathetic and understanding way, with particular attention paid to the Disability and Discrimination Act and its requirements.

I

.

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

n summary:

• Ensure that sickness absence is monitored.

• Make sure everyone is aware of sickness reporting procedures.

• Carry out a return to work interview.

• Introduce an objective meas

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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