Advice Pool - Health and Fitness

You are in pain and need to know what to expect in your first pain management visit. Behind your concern is the unspoken question—will it hurt?

Pain Management physicians are medical do

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

ctors first and pain management specialists second, so chances are your first visit will involve a thorough history and investigation as to the cause and source of your pain. The physici

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

Examples of combination products may in

ans credo is “First do no Harm,” so for a pain management specialist, the first visit will involve a careful and comprehensive taking of past history, allergies, current and past drug re

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

gimens, previous surgeries, family history and a complete physical exam including and examination of heart, lungs and nervous system.

At a Pain Management physician center, you may be a

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

sked to participate in your care and treatment options, and an important part of this procedure is the sharing of information with your physicians. As a part of the comprehensive history

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

Combination pro

and physical exam, you will be evaluated by an anesthesiologist, board certified in pain medicine. The evaluation consists of the history and physical exam, including review of diagnosti

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

c studies, previous treatments, and medical records from prior physicians.

It will be important to the pain management specialist to know whether you have been treated by any other 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

management physicians and if you have undergone any treatments, including surgeries. Your doctor will review copies of previous diagnostics, including X-rays, MRIs, CTs, or myelograms.

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

Comprehensive patient work-ups include history evaluations, physical examinations, review of any diagnostic tests and often the prescription of further diagnostic tests.

Diagnostic fluo

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

roscopic injections are often used to confirm precise anatomic location of pathologic and painful structures. The pain medicine specialist, after a careful evaluation, often performs di

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

gnostic injections usually with fluoroscopic guidance. These injections isolate and confirm the source of the patient’s pain. The pain can emanate from soft tissue, tendons, ligaments,

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

Following aspects would a

muscles, bones, joints, discs and nerve structures. Once identified, these painful structures are medically treated.

Comprehensive treatment plans are formulated and an individual plan

dd to the challenges in developing combination products:

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

of treatment will be developed for you and discussed with the referring or primary care physician. Your physician will also discuss your diagnosis and treatment options with you. The tr

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

eatment schedule and follow up evaluation visits will be determined to fit your needs and individual schedule.

Pain Medicine is a new and rapidly evolving medical specialty dealing with

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

Acute and Chronic Pain. Over the last twenty years, many chemical and anatomic pain pathways have been identified and studied. With recent advances in technology, new techniques and m

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

nimally invasive procedures in interventional pain medicine have eliminated the sources of pain, allowing many patients to return to a normal level of activity while avoiding the need fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r surgery with its potential for infection and lasting consequences.

With the ageing of the population, the number of people suffering from degenerative disc disease, spinal stenosis an

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

d sciatica has dramatically increased. A well-trained spine pain specialist can help most of these patients.

In pain management, family involvement is often crucial to a successful out

.

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

come. Pain Management physicians may actively encourage the patient to bring supportive family members to the first visit and participate in the process.

Before, there were two approach

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

Companies that provide selfless information through particip

es to pain—medicine or surgery. Now comes a third option, Pain Management with minimally invasive techniques performed by Board Certified physicians in Anesthesiology and Pain Management

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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