Essential VIII

E-folio Essential VIII

Jennifer Burrier
Frostburg State University
RN-BSN Nursing Program

Essential VIII

E-Folio Essential VIII

Essential VIII is necessary for the Bachelor of Nurses program to have students examine
how personal and professional values affect ethics in a professional nursing practice. Numerous
scenarios were studied to examine why decisions were made. Concepts, theories and values
were explored that assist in ethical decision making in a healthcare setting. Each student
performed an Ethical Lens Inventory- Ethics Game to become aware of their ethical
preferences and ethical approaches (EthicsGame).

NURS405 Ethics in Contemporary Nursing

Practice fulfilled the requirement for Essential VIII in the RN-BSN Nursing Program
Exemplar
This project fulfills Essential VIII because it explored a hot topic in the current
healthcare setting. Many sides were explored, but a conclusion had to pick one side of the
dilemma on what is the correct side to choose. The topic was on pharmaceuticals that are
manufactured outside the United States and the high cost of pharmaceuticals in the country,
mostly due to price setting. Medications sold outside of the United States can be a risky venue,
since they are not regulated by the FDA and may not be the correct formulation. The conclusion
was that regulating pharmaceuticals are for the consumers safety and those that buy medications
outside the country or unauthorized sources are gambling and potentially putting themselves in
danger.
Reflection
This exemplar relates to the AACN Essential IIIV because it explored ethical/legal
frameworks and the effects on society. It explored a contemporary issue in healthcare, one that

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many nurses might encounter in their career. Core values will be routinely examined during the
career of a practicing nurse.

References
American Association of Colleges of Nursing The Essentials of Baccalaureate for Professional
Nursing Practice. Washington DC, Author

EthicsGame Baird, Catharyn. www.ethicsgame.com

Essential VIII

Out of Country Pharmaceuticals

Jennifer Burrier
Bachelor of Nursing Program
Frostburg State University

Essential VIII

I chose to write about out of country pharmaceuticals because I have worked eight years
in drug and vaccine development research and also because there is a current movie, Dallas
Buyers Club, which portrays a man infected with HIV in the 1980s buying antiviral meds out
of country and smuggling them in because he is frustrated with the limited treatment in the US.
Prescription medications can be very costly and many Americans have trouble affording them.
A major reason why prescription medications are so expensive is because there is a great
deal of research and development in creating new pharmaceuticals. The first step in research is
often screening synthetic or natural compounds in a lab with cell cultures to see if they are toxic
and if they might provide protection against viruses or show promise of therapy. This is
basically a shot in the dark, where 1:10,000 compounds might end up becoming an approved
drug (Ogbru, O. 2013) . The promising compounds continue to have research in a laboratory,
then eventually in animals and possibly humans if they show potential. Often in takes 7-10 years
for a drug to be developed for the market and up to 500 million dollars to go through the research
process (Ogbru, O. 2013). The drug has to be approved by the FDA before it is marketed to the
public and about 1 in 3 medications that are marketed make enough revenue to make up for the
costs for researching the failed medications (Ogbru, O. 2013).
Marketing is another reason why pharmaceuticals are so expensive. Drug companies are
very competitive in trying to have their medications recognized, especially if there are similar
acting medications from different companies. Millions are spent in marketing to the public and
healthcare providers and to conduct marketing studies (Ogbru, O. 2013). Pharmaceutical
companies have intellectual property rights to the medications they have developed in keeping
their patents for twenty years, but often the patents are applied before clinical trials, so they

Essential VIII

might only have the patent for 10 years before generic medications are available. (Gregory, P.
2012).
The United States sets prices for medications sold in the country to compensate the
pharmaceutical countries, but other countries such as Canada, France and Germany do not charge
higher prices for medications to compensate drug companies for the propriety rights (Gregory, P.
2012). Unites States medication prices are also set to allow for Medicaid and other public health
services to receive the drug makers best prices (Gregory, P. 2012).
The FDA is involved in inspecting drug manufacturing plants. The FDA validates that the plants
follow Good Manufacturing Practices and that the medications have appropriate labeling, the
FDA only is involved in medications that are sold in the United States (FDA 2011). Under the
Federal Food, Drug and Cosmetic Act, established in 1938, any sale of a medication without
FDA approval is illegal in the United States (FDA 2011). Many American pharmaceutical
countries are now manufacturing their medications in different countries such as China, India,
and Mexico, and it is estimated that 80% of the substances to make medications sold in the
United States have been manufactured outside of the country (Rubin, R. 2010). Many
Americans are confident in medications made in the US, but are less confident of medications
that have been manufactured outside of the United States (Rubin, R. 2010).
Although the FDA regulates and inspects pharmaceutical manufacturing plants in the
United States and in foreign countries, it is increasingly difficult for the FDA to regulate outside
countries due to the massive globalization of manufacturing plants (Barnes, K. 2007). The FDA
Is only able to inspect 7% of foreign manufacturing plants and less that 2% of Chinas
manufacturing plants (Barnes, K. 2007). The FDA inspects US manufacturing plants every two

Essential VIII

years without prior warning, but it is difficult to surprise foreign manufacturing plants due to
having to set up translating services (Barnes, K. 2007).
Counterfeit medications are another problem with medications coming from sources
outside of the United States. The FDA is not able to verify a medications potency, proper
labeling, proper storage of the medication and if the medication is legitimate if the medication is
not filtered by the FDA (Bihari, M. 2013). The medications can be past the expiration dates and
there can be potentially dangerous side effects, including death (FDA 2011). In 2002 New York
had 25,000 counterfeit Viagra pills from China and India confiscated that were sold over the
Internet. The pills had the manufacturers logo- Pfizer stamped on them and the potency of the
active ingredients varied, some did not have any active ingredients in them at all (FDA 2011).
Medications from outside countries might have instructions in different languages that
might not be understood or might not have directions at all (Bihari, M .2013). Even if a drug
might be approved in other countries for use it does not necessarily mean that the medication is
approved for use in the United States (FDA 2011). Any international shipment of medications
that does not have FDA approval is illegal in the United States (FDA 2011).
Canada is very popular for people to get medications outside of the country, but it cannot
be guaranteed that the medications were made in Canada. Canadian Internet pharmacies that
supply medications online have prescriptions from wholesalers, and when the FDA seized
medications from Canada in Miami, New York and Los Angeles, it was found that a large
number of the medications were originally made in India, Costa Rica and Israel (FDA 2011). It
was estimated in 2006 that 2 million Americans were buying their medications from Canadian
resources (Rubin, A and Rubin, H 2013).

Essential VIII

Internet sales of medications are dangerous because many are not U.S. state licensed
pharmacies or might not be pharmacies at all (FDA 2012). Many controlled medications are
advertised, such as Xanax, vicodin, oxycontin and Ritalin can be found when searching about
buying the medications. The Pharmaceutical Research and Manufactures of American, known as
PhRMA, is the lobbying branch of the pharmaceutical companies in the United States and they
are trying to protect American buyers from unsafe medications made in foreign plants, even if
the drugs imported may have been made in a facility that was inspected and improved by FDA
inspectors (Rubin, A and Rubin, H. 2013). In 2011 Google was fined 500 million dollars for
being aware that Canadian pharmacies were advertising selling Ritalin and Oxycontin without
prescriptions on its site (Rubin, A. and Rubin, H. 2013). Google now requires that
advertisements with Canadian pharmacies be certified by the Canadian International Pharmacy
Association and they can only advertise to Canadian residents (Rubin, A. and Rubin, H. 2013).
Advertisers of American Pharmacies are regulated by the National Association of Boards of
Pharmacy (Rubin, A. and Rubin, H. 2013).
The FDA has some allowances for letting some people use medications that have not
been approved for use in the United States. If the treatment is not available in the United States,
especially in rare forms of illnesses where treatments are legal in other countries, the FDA might
allow a person to use medications from other countries (FDA 2011). The medication is to be
used solely for personal use and it has to be proven that a licensed Doctor is responsible for their
treatment and can verify that the treatment is legitimate (FDA 2011). The medication supply is
for three months or less, and it is not be resold for others to use, it is solely for individual use
(FDA 2011).

Essential VIII

I can see both viewpoints and I think medications can be extremely expensive and create
a hardship for many to be able to afford them, but I think its too unsafe to buy medications in
other countries. There is no guarantee that the medications are the correct formulation or if they
have been manufactured properly. The medications might have been stored at improver
temperature and sterility of medications could be compromised. The medications might be
expired and ineffective. There are many counterfeit medications and they are almost impossible
to trace where the origin of them might be. There are reasons why medications are prescribed
and it is scary that in Mexico a person can get many medications like birth control, cardiac
medications, and antibiotics without a prescription (FDA 2011).
Regulations in the country are for a reason and are for the publics safety. Those that
chose to buy medications from out of country sources or unauthorized locations are gambling
and potentially putting themselves in danger. It goes to show that you get what you pay for.
References
FDA Failure on Foreign Inspections Frightening
Barnes, Kristy 11/05/2007
htpp:www.outsourcing-pharma.com/foreign-inspections
outsourcingpharma.com

Foreign Pharmacies-Buying Drugs from Canada and Mexico

Bihari, Michael MD 2/25/2013
http://healthinsurance.about.com/od/prescriptiondrugs/a/foreign_pharmacies.htm

Obama Care Will End Drug Advances and Europes Free Ride (Unless China Steps In)

Essential VIII

Gregory, Paul R. 7/01/2012

http://www.forbes.com/sites/paulroderickgregory/2012/07/1/obama-care-will-end.com

Why Drugs Cost So Much

Ogbru,Omudhome, PharmD 11/29/2013
htpp://www.medicinenet.com/script/main/art.asp?articlekey=18892

Crossing the Border to Obtain Cheaper Prescription Drugs

Rubin, A, Rubin, H 10/11/2013
http://therubins.com/medicare/drugcost4.html 11/29/2011

Voters Trust Drugs Made in USA

Rubin, Rita 08/03/2010
http://usatoday30.usatodya.com/news/health/2010-08--3-recall03_ST_N.htm

Buying Prescription Medicine Online: A Consumer Guide

http://fda.gov/Drugs/ResourcesForYou/ucm080588.htm 11/29/2013

Imported Drugs Raise Safety Concerns

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143561.htm 11/29/2013