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Aliteracy Part 3: Solution

Integrated Instructions: A Solution

Integrated Instructions ov

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

ercome the weaknesses of conventional instructions. In brief, Integrated Instructions address two fundamental flaws of conven

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

Examples of combination products may in

tional instructions:

They reflect the needs of the user instead of the convenience of the developer
They ha

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

ve easy-to-grasp graphics as a central focus, with text playing a supporting role Characteristics of Integrate

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

d Instructions The sample work instructions that appear throughout this paper reflect the author's 25 years of expe

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

Combination pro

rience in developing workplace documents. The format of Integrated Instructions evolved as part of a continuous study of docu

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

ment usability. While the development process itself is outside the scope of this paper, there is a short list of obvious att

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

ributes that characterize good and effective work instructions.

Instructions work best when:

Graphics dominate

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

There is minimal text

Text and graphics are integrated

There is a clear point of focus

Ther

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

e is no need to split concentration

There is a clear sequence of steps or procedures

The efficient and effe

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

tive appearance of Integrated Instructions suggests accuracy, simplicity and authenticity. This positive appearance sharply c

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

Following aspects would a

ontrasts conventional instructions that often appear cumbersome, inefficient, and hard to use--especially to an aliterate use

dd to the challenges in developing combination products:

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

r. Benefits of Integrated Instructions

Use of Integrated Instructions to document tasks and procedur

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

es offers these benefits:

Fulfill ISO, QS and JCAHCO requirements
More accurately document best work practi

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

ces

Allow faster, more effective worker training and orientation

Ensure better retention of content

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

i>Provide easier understanding for low literacy users

Provide easier understanding for non-English users

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

Professional from academic institutions, pharmaceutical industries, health care indust

ovide a high-impact work-site job aid

Reduce trial-and-error work methods

Help promote standardization

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

Assist in developing improved work methods

Enable more accurate work performance

More clearly identify

.

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

procedure steps

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