Answers - Insurance

The industry of retirement and long term care have become big business. The simple fact is that people are living longer but can't maintain their own home enviorment. There are many options that c

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

ome into play ,usually the first choice families make is when they are in crisis, mom or dad has taken a fall or change in condition. They end up in the ER or hospital with the staff and social wor

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

Examples of combination products may in

ker telling them mom or dad can't be left alone anymore. Just imagine hearing this at 3am on a week night when you have to be at work at 9am . This becomes even harder when siblings don't agree.

T

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

he truth is it is hard to accept that you now must be the person who makes choices and decisions for the person who taught you how. If you or the aging person is lucky you have already started a 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

nversation and even have long term care insurance to help off-set the cost , if not its a scary place to be. The first and most important thing to remember is The marketers for the facilities you

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

Combination pro

might be looking at are not your friends. The job they are paid to do and if do well is to make you think they are only looking out for the persons well being. These people are in it to make money,

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

I know because I worked in long term care all aspects for over 20 years.

There are several retirement communities that spout they are not for profit when in fact they are managed by a management

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

company that is all about the bottom line. You need to know it will not be the people you interact with daily that will make the decisions that directly related to the care of yourself or loved one

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

The choice of vendors.pharmacies and staffing numbers are decided by someone that is very rarely in the building.

The second important thing is to not look to the lic. agencyof assisted living wh

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

o provides their lic. to give care, They will not protect you or your loved ones interest. The assisted living facilities are now providing nursing home care but are not required to have the same

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

professional caregivers and are not subject to the same scrutiny as nursing homes. They do not even require a real nurse to be there, someone just needs to sign the oversight form monthly. The majo

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

Following aspects would a

rity of medication is administered by someone who took a week long course only.

Even when on a licencing visit when they find medications have not been signed out as given these facilities are no

dd to the challenges in developing combination products:

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

fined but you can believe the resident has been charged for it. When actually you don't know its been given. The Lic agency will follow-up on a complaint( only because this is mandated by law) but

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

seldom do they find the complaint founded when it is in reference to the number of staff required to provide service or care to a certain number of residents. Recently a local lic. agency agreed

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

with a facility that stated 1 nurse and one cna could adequately care for 53 residents on 6 wings on two seperate floors. Including the need for incontinent care and medication administration.

The

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

monthly rent for some of these residents exceeds $4000.oo because of the level of care they need,remember many leases are service based which means you pay if dad so much as needs someone to remov

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

Professional from academic institutions, pharmaceutical industries, health care indust

his socks and shoes. The premiums paid by you for long term care(if you have this insurance) result in the insurance company making payment based on the services the facility says you or your love

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

d one require but does anyone from the insurance company physically come to the facility and see that these services are truelly being provided on a consistent basis?

The majority of time a form i

.

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

s faxed to be completed and is usually completed by someone who does not do or even see the care as it is provided.The bottom line is with out changes,without the demand of accountability nothing w

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

Companies that provide selfless information through particip

ill change and that is why I am sad to say I have left the healthcare feild.I wish now to educate and advocate I will not be part of the problem I hope to be part of the solution.

Lisa Knipple LP

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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