E-Articles - Health and Fitness

Chronic untreated pain is debilitating, it dramatically affects a patient’s ability to participate in daily routines and in some cases takes away their will to l

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

ive. Tragically, many people are suffering chronic pain unnecessarily. This in part, due to them not being made aware of the importance of pain management and be

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

Examples of combination products may in

ng shown the simple tools necessary to achieve it. Lack of knowledge regarding the benefits and side effects of available medication is also a factor.

Many pati

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

nts associate morphine and methadone with drug addiction and are reluctant to take it due to their belief that it will cause them to become “high” or sedated, th

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

s and their attempts to brave out the pain, results in their pain spirally out of control. This could be prevented if they were informed that chronic pain effec

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

Combination pro

ively “uses up” medication and that these drugs when taken for the relief of pain associated with cancer, can dramatically reduce both the occurrence and intensi

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

y of pain, without causing sedation.

Not long after my husband’s terminal cancer diagnosis, I observed that despite his medication, he was in considerable pain

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

and this upset me greatly - determined to help him, I turned to the internet to learn about the progressive symptoms of his disease, the pain he would experience

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

and methods available to control it.

One of the most important things I learned, was that in order to obtain the best possible pain control – medication must be

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

taken at regular prescribed times, regardless of whether pain is or isn’t present, effectively keeping in front of the pain.

I learned that there are different

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

ypes of pain and that not all pain responds to the same medication; and how to measure intensity of pain and encouraged Brian to communicate to me - the type of

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

Following aspects would a

ain he was experiencing and its intensity by using a pain scale. Brian soon realized the benefits of this - It was an immense relief for him- to know that I und

dd to the challenges in developing combination products:

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

rstood what he was experiencing and more importantly – that I could do something about it.

Despite the large amount of methadone Brian was taking; he remained a

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

tive and alert, drove his car for eighteen months after diagnosis and was able to continue going fishing, which was the passion of his life. Keeping him out of

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

pain became the reason for my existence and I was vigilant in giving him his medication at prescribed times.

There were many occasions when caring but uninform

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

d loved ones and friends, said to me. “Brian does not need for you to be giving him medication at this time – he is not in pain”. And I would patiently explain

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

Professional from academic institutions, pharmaceutical industries, health care indust

to them, that the reason Brian was not in pain, was because the regular medication he was receiving effectively allowed for him to remain in front of it.

Experi

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

nce has taught me that knowledge is the key, to better quality of life, not only for the cancer patient but for those who care for them. My understanding of th

.

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

stages and symptoms of Brian’s disease, allowed for me to be one step ahead of its progression and gave me the opportunity to have medication and later, physica

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

Companies that provide selfless information through particip

aids such as oxygen, wheelchair etc – on hand BEFORE Brian needed them. This alleviated much of the fear, pain and discomfort he would otherwise have suffered

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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