Actual - Legal

First, lets make one thing clear, the vast majority of patients do not experience any form of Medical Malpractice. In fact

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 error rate seems to only be between 5 to 80 errors per 100,000 visits to medical practitioners. That not withstanding i

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

Examples of combination products may in

f you are one of those who become a victim of Medical Malpractice your error rate is 100%.

Diagnostic Errors are the singl

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

largest area of risk accounting for about one third of all Medical Malpractice claims. Don't forget this may not just be c

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

aused by a direct mistake by a doctor; it could be that the doctor is acting on incorrect information supplied by some othe

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

Combination pro

person, but it still results in an incorrect diagnoses.

Inadequate communication between various medical service provider

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

s was a major problem in producing claims, it is vital that doctors and other providers ensure that all relevant informatio

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

n is made available to avoid the risk of harm to the patient and prevent a suit for Medical Malpractice.

Incorrect record

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

eeping was the cause of many errors, these errors seem to be have been spread pretty evenly across the various medical disc

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

iplines, so it seems that bad record keeping affects all areas of the medical profession just as it does so many areas of e

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

eryday life.

Errors in prescribing medication were found to be responsible for 19.4% of injuries according to a recent Har

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

Following aspects would a

vard study, this hardly surprising when you consider that there is the potential to give incorrect dosage of a drug to some

dd to the challenges in developing combination products:

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

body and also give the correct drugs to the wrong person!

It seems that most medical errors are not the result of any one

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

erson failing in their duty of care towards the patient, but more in basic errors, in the way the system is organised. Simp

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

le things that would never have happened if the system had more safe guards built in.

To few staff is the final major fact

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

r in producing medical errors, it is hardly surprising that errors are made when already tired staff are called on to perfo

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

Professional from academic institutions, pharmaceutical industries, health care indust

rm extra duties. In a recent survey 50% of doctors and 70% of the public blamed overwork and tiredness as a major course of

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

errors in the medical system.

The above list of potential courses of Medical Malpractice claims is not exclusive, but it

.

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

oes cover the main areas, most of these could be avoided it the Doctors, Nurses, Dentists and other practitioners took more

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

Companies that provide selfless information through particip

care. But that means they need more time, and time costs money so we find ourselves back in the classic Catch 22 situation

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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