Advice Pool - Legal

In the summer of 2000 I worked for a large hospital as one of their staff Respiratory Therapist. Things had finally slowed down so I took my break and headed to the women's rest room. I ope

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

n the stall door and there floating in the bottom of the toilet was an empty glass morphine vial and a receipt for the prescription. I immediately contacted the nursing supervisor and event

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

Examples of combination products may in

ually the police were called in, as the type of vial that had been dispensed was the type used on the medical floors by the nurses.

The owner of the medical record number was called. A sl

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

eepy woman's voice answered the phone (Its was 2 am when the call was made). Jane Brown (not her real name) was asked to come down to the hospital emergency room as her medical record numbe

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

r had been used to get a prescription filled for a controlled substance. They escorted Jane to the pharmacy to have the pharmacist identify her as the woman who had filled the prescriptio

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

Combination pro

n. Turns out that Jane and the woman who claimed to be Jane were not one and the same. Jane was an intensive care nurse for this very hospital and had been at home asleep when her medical r

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

ecord number had been used to pick up the prescription. Jane was given a description of the woman who had impersonated her and she gasped as she realized it was her next-door neighbor. As

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

Jane thought back she remembered that her reminder card for one of her own personal appointments had disappeared from her fridge yet she had thought nothing of it.

Jane's neighbor (we wi

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

ll call her Mary) had not only stolen Jane's appointment reminder card (which had her name and medical record number on it), she had also stolen a few prescription pads from two different h

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

ospitals (complete with the doctors information on top) and had then proceeded to write herself out prescriptions for any of the major pain killers that she could get.

You would think that

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

now that they knew who had been impersonating Jane that that would be the end of it, not so. Jane now had to contact each of the hospitals Mary had gone to with documentation to show that

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

Following aspects would a

the person filling the controlled substance prescriptions was not her. Her medical records had to be pulled to remove the medical complaints and treatment given to Mary while she was impe

dd to the challenges in developing combination products:

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

rsonating Jane. Jane spent countless hours getting all this straightened out to clear up her good name.

Identity theft. When people hear that word most think of some ones credit card being

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

stolen over the internet or out of their wallet. What many people don’t realize is that credit card identity theft only accounts for 28% of all identity crimes being committed. Jane probab

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

ly would have eventually caught on even if I had not found the vial in the toilet, however that could have only been the result of getting a notice that a medical bill or a prescription bil

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

l was being denied. Many people are not aware of medical identity crimes until they either get a bill from a collection agency, a call from their insurance or see it on their credit report.

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

Professional from academic institutions, pharmaceutical industries, health care indust

One small preventative that we can all do is not keep medical record information (not even appointment reminder cards) in plain sight of visitors, no matter how much you trust them. Anothe

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

r tool one can use is a good identity theft shield program that will notify you immediately anything is added to your credit report as well as do the restoration work for you. This is a big

.

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

one, as the sooner you are made aware the sooner damage control can be done.

Thanks for reading
Stay safe and protected

For more articles on medical identity theft and prevention:

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

Companies that provide selfless information through particip

http://www.baltimoresun.com/business/bal-ambrose0515,0,5443957.column http://www.nbc13.com/nbc13investigators/2057120/detail.html http://www.worldprivacyforum.org/medicalidentitytheft.htm

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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