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According to the US Census Bureau, over 20% of the US population is of “foreign stock” - that is, they are either foreign-born or have at least one parent who was born i

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

n another country. In 2000, 47 million people in the United States spoke a non-English language at home, an increase of over 45% in just one decade. The number of nati

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

Examples of combination products may in

ve-born Americans with close ties to another country is expected to grow even more over the next few decades.

While these demographic changes present many challenges fo

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

educators, they also offer terrific opportunities to teach children about our world. Rather than trying to “Americanize” the ethnic community, we should make efforts t

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

o better involve English-as-a-second-language (ESL) students and bilingual families in the classroom by encouraging them to share their language and culture.

The benefi

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

Combination pro

s of such involvement are two-fold. First, it would teach a respect for diversity and build an interest in foreign languages and cultures among all students. Second, i

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

t would drive participation and build self-esteem among ESL and bilingual students with diverse backgrounds. It will encourage them to value their culture and language.

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

This cultural involvement will help all children thrive in our increasingly multiethnic and multilinguistic communities.

Following are several suggestions for teacher

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

of young children on how to involve ESL and bilingual families in bringing diversity into the classroom. Parents can build on these ideas at home and in playgroups, or

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

suggest them to their children’s teachers or daycare providers.

• Celebrate international holidays or festivals. Let students or immigrant parents share with t

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

e class the meanings, traditions and unique foods related to the holidays they celebrate.

• Read bilingual books out loud. Ask a bilingual or ESL student to rea

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

Following aspects would a

d a book in his or her native language and then let another student read the same book in English. This involves the ESL student and helps support literacy development

dd to the challenges in developing combination products:

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

in both languages. It also exposes the native English speakers to the sounds and text of other languages. For classrooms with very young children, a bilingual teacher

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

r parent can read the non-English version. If a native speaker is not available to read the foreign-language story, CDs or tapes of great stories are available in many

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

languages.

• Sing and listen to songs in other languages. Many young children, if encouraged, derive great pleasure from singing their favorite songs to friends

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

• Ask children to bring in stamps from other countries. Merylie Wade Houston, a founding member of the Early Childhood Diversity Network of Canada, suggests th

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

Professional from academic institutions, pharmaceutical industries, health care indust

at children deposit envelopes from their family mail into a class mailbox. “After talking about the stamps and where they came from, you can use them to make simple cog

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

nitive games, such as lotto, bingo and memory cards.”

• Display multicultural posters. Make the classroom inviting by displaying posters that have text in other

.

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

languages, illustrations of multicultural children or scenes from other countries.

By involving bilingual students and immigrant families in classrooms or daycare setti

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

Companies that provide selfless information through particip

ngs, we are demonstrating and teaching a respect for linguistic and cultural diversity. At the same time, we broaden the horizons of both native and non-native children

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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