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Actual - Malpractice - Error Or Accident
In this article we're going to try to differentiate between an error and an accident when applied to malpractice.
The first thing that needs to be said here is t
The first thing that needs to be said here is 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
hat this is not an exact science. That is why we have courts of law. That's why when something goes wrong with a procedure or operation it is not immediately de
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
erminable whether it is malpractice or not.
This article is going to get a little philosophical based on the beliefs and opinions of professionals and experts in
This article is going to get a little philosophical based on the beliefs and opinions of professionals and experts in
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 field of law and medicine. These are only beliefs and opinions and are not meant to be taken as facts. Again, if this was all fact then determining malprac
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ice would be very easy to do. It is not.
An error is defined by the experts in the field as "the failure to perform an intended action which would have been the
An error is defined by the experts in the field as "the failure to perform an intended action which would have been the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
correct action, given the circumstances." In other words, if the diagnosis calls for administering a shot of penicillin to a patient and the shot is not administ
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
red then that would be considered to be an error. It was clear that the shot should have been given and it wasn't.
An accident, on the other hand, according to
An accident, on the other hand, according to
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
the experts, is something that is unplanned and unforeseen. Usually an unexpected event that produces an adverse outcome.
Here is where we get into that gray ar
Here is where we get into that gray ar
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
a and why we need lawyers. An adverse outcome after committing an error, by this definition, must be considered an accident since nobody plans to make an error,
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
no one expects an error and no one has any desire for an error. Yet, errors still occur which produce the accident. It is up to the courts to basically decide i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the error was an "honest error," something that could happen to even a professional in the field, or an error that should have never happened if the procedure wa
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
s performed by someone who was trained in the field. Yes, a very gray area.
There are, to make this even more complicated, many types of errors.
There are inpu
There are, to make this even more complicated, many types of errors.
There are inpu
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
errors or errors of misconception. This is where a wrong diagnosis is made and based on this diagnosis the wrong action is performed. An example would be when
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
a diagnosis is made to remove an organ but later it was determined that the organ was healthy and didn't need removal.
Then there are intention errors or mistake
Then there are intention errors or mistake
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
. This is where the diagnosis is correct but the wrong action is performed. An example would be that a diagnosis is made to give someone 1000 mg of some drug.
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
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
The diagnosis is correct but by mistake the wrong dose is given and an overdose occurs.
Then there is an execution error. This is where the diagnosis is correct
Then there is an execution error. This is where the diagnosis is correct
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
and the right action is performed but the action is performed incorrectly. Given the same above example, 1000 mg is given but it is given through a Y port instea
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d of through a drip bag, which it should have been given through. Again, a fatal overdose occurs even though the right amount of solution is given. These errors
.
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
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
are then further divided into errors caused by the doctor's own distraction or lack of concentration and errors caused by outside surroundings, such as the operat
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ing room maybe not being set up properly with equipment out of place.
In our next article we're going to discuss how to talk about these errors and evaluate them
In our next article we're going to discuss how to talk about these errors and evaluate them
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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