Advice You - Business

I do not claim that I have already succeeded or have already become perfect! I like that quote from Philippians. It is a very accurate reflection of the principles of quality improvement—always try to provide a better product

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

or a better service. Learn from the data of the past but keep your eye on the better future.

There are so many areas that can be improved in healthcare because it is so complex. Let me illustrate three representative situat

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

Examples of combination products may in

ons, though. Perhaps they will trigger an idea in your mind where you might want to begin a new project or improve on one you have already begun.

--Collaborate more closely with the patient. In the Institute of Medicine’s “C

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

ossing the Quality Chasm” there are several illustrations of this. It suggests that doctors should interact with patients not only in one to one settings but also electronically, as by email or in small group settings. Instru

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

cting patients about healthy diets could probably be best accomplished in small group settings with a dietician or other trained staff. Test results could easily be emailed. Another suggestion is to give the patient more info

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

Combination pro

mation to better let them make choices. For instance, the patient should certainly know the side effects of a drug you as a doctor might suggest as well as available alternative medication. This attention to the customer (pat

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

ent) is a reflection of the best practices in the competitive retail market. I believe this approach will become more important in healthcare as quality and pricing become more transparent. On August 22 President Bush signed

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

an order instructing all federal agencies that provide health coverage—Medicare, Medicaid and other agencies—to disclose the quality and cost of care provided to beneficiaries.

--Staffs should collaborate more effectively. Th

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

re should be continuous communication among all staff. I do not only mean that the physicians and nurses should have better communication. Everyone on staff is important, even personnel who provide cleaning services. I recen

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

ly read that the source of high levels of catheter infections in an ICU was traced to bacteria in a paper towel dispenser in a bathroom at one hospital. This just shows that efforts to contain such infections are important at

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

ll levels.

Recently on the iSixSigma website there was an illustration of a project by representatives of staffs from discharge, nursing and physicians to cut down the time of patient discharge. The time was measured from ord

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

Following aspects would a

er entry to discharge until the patient left the hospital. The baseline data had a mean of 184.8 minutes. The mean time after process improvement was 47.8 minutes. Everyone benefited from this marked improvement—the hospital

dd to the challenges in developing combination products:

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

the staff and the patients. The title of the article is “Creating a Lean Six Sigma Hospital Discharge Process.” It is a very good sample of staff collaboration.

--Improve in diagnosis. One of the most commonly missed disea

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

es is alcoholism. In a study done by the Center on Addiction and Substance Abuse done by Columbia University it was reported that 25% of the cost of Medicare is due to abuse of tobacco, alcohol and other substances. While mos

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

t doctors know their patients’ use of tobacco products very few are aware of the extent of alcohol abuse and addiction. SAMHSA (Substance Abuse and Mental Health Services) estimates that 5% primary care physicians’ patients ar

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

addicted to alcohol. The Columbia report indicated that it believes that the extent of medical problems caused by alcohol dependency and abuse is greatly underestimated and costs much more than reported. Hence many chronic d

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

Professional from academic institutions, pharmaceutical industries, health care indust

seases such as depression or heart problems have their root in alcohol consumption or covary with the amount of alcohol consumed. If primary care physicians would screen for this substance as they do for tobacco, much progress

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

could be made in improving the general health of the public. One need only ask along with tobacco questions “How much did you consume the last time you drank alcohol?” and “How many times have you consumed alcohol in the past

.

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

two weeks?” If there is suspicion of alcohol problems, the physician could then give one of several easily administered screening questionnaires, as the CAGE test.

I hope that these short illustrations have stimulated you to

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

Companies that provide selfless information through particip

hink about possible improvements at your healthcare site. The task of improvement will never be done but it is ever so rewarding in both money saved and earned, time saved, satisfaction of the staff, and benefit to the patient

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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