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Informing patients about identity theft risk is not a strict legal requirement but not informing them could lead to serious consequences, no

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

t only for the individual involved but also for the hospital or clinical practitioner who decided not to inform the patients of identity the

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

Examples of combination products may in

ft risk. In this article we will look at a number of ideas to help you establish how, when and whether you should inform your patients about

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

the possible risk of identity theft.

The first principle which you should always try to stick to is one of data security. Hopefully with p

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

roper security systems in place the need to inform patients about breaches in this security will be minimal. Data security involves systems

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

Combination pro

such as secure passwords on all your computers, data encryption, anti-spyware software and any other security measures which your IT special

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

ists may suggest. If these security measures are strictly adhered to and staff are trained in these and the importance of data privacy then

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

nforming patients about identity theft risk should only happen on the very rare occasion.

Some people feel that by informing patients too o

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

ften of the risk of identity theft that they will become de-sensitized to the risk, however, if you have correct security systems in place y

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

ou will hopefully not need to do it too often, and it is important that if there is a real risk of identity theft that the patients are info

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

rmed of this risk in order to take precautionary measures.

If the risk is high in a certain case of breach of security then it important th

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

Following aspects would a

at patients are informed of the risk of iden

dd to the challenges in developing combination products:

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

tity theft in a timely manner and they should also be informed of what the hospital is doing in order to catch the suspect and prevent f

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

urther harm from being done.

It would also be a good idea in these circumstances to provide guidance for patients concerned as to what meas

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

res they should be taking in order to protect themselves – such as contacting the credit bureaus, creditors and other parties.

Informing pa

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

tients about identity theft risk is not a strict legal requirement; however, if hospitals are found negligent in this then the consequences

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

Professional from academic institutions, pharmaceutical industries, health care indust

could be severe and amount to millions of dollars in fines. The consequences for the patients involved could also be severe, not only in ter

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

ms of financial risk but also in terms of personal health information that could land in the wrong hands. All data security measures should

.

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

be in place long before this need ever arises but if there is a serious risk of identity theft occurring then patients should be informed in

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

Companies that provide selfless information through particip

a timely manner and given guidance as to how they ought to proceed with protecting themselves and what the hospital is doing in this regard

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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