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Actual - Honduras Has Many Needs
As a family physician, I had the chance to do six medical missions in the past three years. In 2005 and 2006, I had the opportunity to go help in Honduras. I can hon
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
estly say, in all the missions I have done, I have received more than I have given.
Challenges of Life in Honduras
Honduras is one of the most beautiful countries
Challenges of Life in Honduras
Honduras is one of the most beautiful countries
; 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
in the World with its spectacular mountains and gorgeous coastlines. Honduras although rich in minerals such as gold, silver, copper, lead, zinc, iron ore and timber
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
most of the people are very poor. Indeed Honduras is considered the Third Poorest Nation per capita in the entire Western Hemisphere and 66.8% of the 6.5 million po
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ulation base is considered to be impoverished. The challenges of the life in rural Honduras are not unbeatable although at first glance appear overwhelming. You see,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Hondurans are a naturally tough group of people living in what many believe is paradise. Volunteers often talk about the greenery;
"YES! All green mountains, no po
"YES! All green mountains, no po
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
llution, no noise, a nice fog in the morning and we could hear the monkeys in the background. One morning we saw a nice Toucan, very colorful."
Medical Needs
Due
Due
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
o the abundance of vegetation there are many hardy insects in Honduras and these tough insects own the domain. This means bugs bite much harder and with more vengea
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nce than one who is not familiar might imagine. One major problem is the rural poor of Honduras do not have purified water which causes most intestinal parasites 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
most that are seen by the medical mission teams. One medical volunteer to Honduras from Canada remembers;
"When we give them the medication, they get better but the
"When we give them the medication, they get better but the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
they re-drink the contaminated water and get re-infested. The poor quality of water also causes people to have fungal infections of the skin. The poor hygiene condi
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
tions also causes scabies and head lice in epidemic proportion."
Of course prescribing antibiotics is not always possible as one volunteer said because if they pres
Of course prescribing antibiotics is not always possible as one volunteer said because if they pres
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
cribe antibiotics, they have to check if it needs refrigeration and most people in rural Honduras do not have electricity. The issue with parasites is significant an
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
d the medical professionals and their assistants spend a lot of time dealing with these issues. One MD from Canada on a medical mission to Honduras stated;
"In the
"In the
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
S and Canada, if we you suspect a person has parasites, you do a stool sampling test and if it is positive you tell all your colleagues of your rare discovery. In Ho
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
nduras, the way, you diagnose if a person has parasites, you ask them “Do you have parasites?” and they answer “Yes!”Many Honduran children suffer from malnutrition
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
and these same problems are visible in many of the rural villages throughout the country. A medical mission volunteer told us with great concern;
"When I ask one mo
"When I ask one mo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
her why her child was not eating properly, she answered: “We are poor. I do not have money to buy food.” That broke my heart."
Writing articles and an e-book on the
Writing articles and an e-book on the
.
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
medical missions in Honduras and sharing the needs of the people has been the result of a joint effort.These articles were made possible by the help from Lance Wins
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
low who so generously put into words, in an amazingly efficient way, my experience in Honduras. This shows that there are numerous ways to help third world countries
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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