Top Adding - Legal

Granny comes to visit from out of town. While enjoying some delicious iced tea on your porch, she has chest pains and asks you to call 911. The ambulance driver / EMT asks you whet

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

her Granny is on any heart medication. You search her purse, and find only a business card for her local pharmacy. So you call – “Hello, I am Mrs. Jones’ granddaughter, it’s an eme

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

Examples of combination products may in

gency, and I need to know whether Granny is on any heart medicatiion."

Response: “We can’t disclose that to you Ma’am. We are sorry.”

Well why can’t they tell you? After all, it’

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

s a simple question and may serve to assist in Granny’s care.

Well, they can’t because of bureaucrats, and maybe, just maybe, the bureaucrats knew what they were doing. HI

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

AA – the Health Insurance Portability and Accountability Act of 1996, now includes very specific provisions regarding the privacy of one’s medical records. Not only can th

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

Combination pro

pharmacy not give you Granny’s prescription information, but they could be fined by the federal government if they did.

Why would it be important to keep your healthcare

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

records private? Well for one, if you apply for a job, what if the employer could call all of your treating physicians and find out if you are going to be a “health risk”

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

r even worse, if you are going to use the insurance so much that rates increase? What if doctors could release Granny’s health care information to anyone who asked? Do you think sh

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

may receive a few solicitations over the phone from salesmen trying to relieve her hypertension for the low, low price of $19.99 a month?

So while the privacy requirements of HIP

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

AA may serve to add extra work for you or your family in the case of an emergency, it underlying purpose is protection. The best way to avoid this protection from becoming a pain i

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

to be prepared.

Be prepared, and get copies of your records. Going to a specialist or new physician? It would be helpful if you brought a copy of your health car

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

Following aspects would a

records with you.

Want a second opinion? It’s much easier for the new doctor to learn about the old doctor’s treatment from the actual records, than to rely upon your memory.

Wa

dd to the challenges in developing combination products:

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

nt to visit an attorney and discuss nursing home, physician or hospital malpractice? Having the records themselves is far more important than anything else.

And how do you

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

get your records if you want them? 1. The person who actually received treatment (or their legal representative) needs to be the one requesting the records. This means, th

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

t Granny needs to ask for her own records.

2. Make the request in writing. A call to the pharmacy is not sufficient.

3. Make sure the request is dated, because health care provid

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

ers only have 30 days to provide your records.

4. Be prepared to pay for copying costs – at least reasonable costs.

5. If you think something is missing – ask about it right away

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

Professional from academic institutions, pharmaceutical industries, health care indust

Was there some lab work last year? Better ask now before you forget or they get misplaced.

It’s also important to keep updated copies of your own records. If you have a loved one

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

who has been in a Nursing Home or Assisted Living facility for a long time – ask for a copy of their records every few months. It will be a very telling experience to examine what

.

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

has or has not been recorded in the records. Better to ask every few months, than have something horrible happen and only then learn, that Granny’s dehydration levels or blood suga

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

Companies that provide selfless information through particip

s weren’t being monitored, or that her doctors hasn’t been there in months.

So the moral of the story is – get a copy of your records, you never know when they might come in handy

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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