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Main Subject - Aliteracy Part 2: Forms of Aliteracy
Aliteracy is the paradox of being able to read but choosing not to. The term was first coined in 1984 by Daniel Boorstin,
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
Librarian of Congress, in a publication tracking the decline of reading skills in the United States. Nearly 20 years afte
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
Boorstin's first alert, observers of American culture continue to report that aliteracy is widespread and growing.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rong>Two forms of aliteracy: functional and conditional
As initially coined and as it comes into wider use, the
As initially coined and as it comes into wider use, the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
term aliteracy refers to the paradox of being able to read but simply choosing not to. We'll use the phrase "functional a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
literate" to describe a person who
- Has poor reading skills and finds reading cumbersome and inefficient
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
oes little or no reading for entertainment Usually avoids any reading if possible Beyond this basic fu
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
nctional aliteracy, there are more complex levels of reading capacity. Developers of work instructions need to consider a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
much larger group of people we will call "conditional aliterates." These are people with satisfactory reading skills who
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
can and do read things like training materials, user manuals and periodicals. Under favorable conditions, they will do the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r best to understand work instructions, even poorly written ones. But it's a different matter when things go wrong--like
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
sudden machine stoppage, a frozen computer screen, a spill, an angry patient, or products falling off a conveyor belt--a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
nd the problem announces itself with signs like alarm bells, flashing warning lights, error messages, pain or smoke. Under
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
these conditions, it's a rare person who has the temperament to find and read a text-heavy instruction to learn what's wr
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ong and how to fix it.
The problem of poor reading comprehension caused by either form of aliteracy is further compounde
The problem of poor reading comprehension caused by either form of aliteracy is further compounde
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
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
by
- Increasing technical job demands
- Growing incidence of workers for whom English is not the native l
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
anguage Higher job stress related to workplace productivity pressures All of these conditions demand w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rk instructions that are easily accessible and that explain the task in a format that can be quickly and easily understoo
.
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
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
d. Unfortunately, what employers usually have available for assistance are pages of outdated text filed away in binders or
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
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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