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If you could reduce the number of serious mistakes in your life with a solution that costs nothing, would you do it? Many hospitals are reducing deaths and injuries from mistakes. Their solution is not more te

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

chnical training for surgeons, or fancy new equipment. The remedy is much simpler - teaching people to talk to each other in a clear, concise way.

“Poor communication in medical practice is one of the most co

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

Examples of combination products may in

mon causes of medical errors,” said Richard M. Frankel, Ph.D., professor of medicine at the Indiana University School of Medicine, and a research scientist at the Health Services Research and Development Cente

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

r on Implementing Evidence-Based Practice.

Indeed, 60 percent of death-and-injury events are the direct result of communication errors, according to the Joint Commission on Accreditation of Healthcare Organiz

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

tions

The most crucial situation is where a patient or task is handed from one person to another. A simple misunderstanding can lead to a patient getting the wrong medicine, or worse.

Now think about your jo

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

Combination pro

b, and your family. How often are mistakes the result of some miscommunication? If you analyze it, you’ll find that a great many mistakes in life come from two or more people suffering a simple “failure to com

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

unicate.”

One solution is the use of a “communication model.” Dr. Frankel said that many health professionals are adopting a very simple conversation technique first developed in the military and aviation, wh

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

ere fast-but-accurate briefings can mean the difference between life and death not just for one person, but for hundreds or thousands. The day I spoke with him (Friday, June 30), Dr. Frankel was getting on a p

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

ane to Kenya, where he is lending his expertise to help administrators who operate a large AIDS treatment center.

There are different models. Most involve a structured way to have a multi-step conversation in

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

just a minute or two. “It’s not rocket science,” Dr. Frankel said. One example is the S-B-A-R model:

S – Situation. Describe the problem in a simple sentence.
B – Background. Anticipate the listener’s q

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

estions about the situation and provide those answers.
A – Assessment. Summarize your observations about the situation.
R – Recommendation. Provide a specific recommendation for solving the problem.

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

Following aspects would a

The use of such a formula forces both the speaker and the listener to move through a discussion in a predictable, logical flow. It cuts through hierarchy. It allows people with differing communication st

dd to the challenges in developing combination products:

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

les to “get on the same page.” It puts more weight on the conversation. It causes the listener to react to the speaker’s recommendation, rather than passively taking in the information. And it saves time by cu

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

tting through extraneous detail. A SBAR briefing can be done in as little as 60 seconds or less.

A major Illinois hospital implemented the SBAR approach and reduced cases of harm to patients by more than half

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

in the first year, according to The Wall Street Journal.

This technique was created in the aviation field, where NASA and other agencies recognized that hierarchy interferes with communication in a crisis, Dr

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

. Frankel said. Surgeons, ship captains and others at the top of a hierarchy often don’t receive critical information because underlings are unable or unwilling to speak up in a clear and assertive way. “In me

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

Professional from academic institutions, pharmaceutical industries, health care indust

icine we see that certain surgeons who intimidate others have a much higher complication rate, because their style breaks down the communication loop,” Dr. Frankel said. The SBAR model provides a tool to overc

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

ome hierarchical barriers that can end up killing people.

Just as a conversation model like SBAR can help doctors and nurses reduce deaths, injuries and malpractice claims, improving interpersonal communicati

.

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

n can help all of us save money, enhance relationships, and reduce mishaps in our own lives.

“Any kind of manufacturing process, personal service or service organization has tremendous potential to benefit” f

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

Companies that provide selfless information through particip

rom the use of SBAR, Dr. Frankel said.

Try the SBAR approach in your work, or even at home. Once you get used to it, it becomes second-nature, and your day-to-day interactions will become much more productive

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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A culvert pipe is a cutting under or beside a road that allows water to drain, rather than pooling and creating hazardous conditions. Technically, only an enclosed channel under a road could be further classified as a culvert, and a cutting next to a road is recognized as a ditch.

Conducting an effective misconduct investigation can make the difference between winding up in court and making the work place safer. This article takes a look at the psychology of workplace investigations and when employers should consider outsourcing the investigation process to avoid perceptions of bias or favoritism.

Looking for Business in all the wrong places? Opening Face-to-Face Relationships and Cracking the Networking CODE. Right Place -- Wrong Focus Right Focus -- Wrong Place

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