PHARM-AID: Pharmaceutical Redistribution to Haiti

Reducing United States Drug Waste for Mutual Benefit

N I C O L E L A RA M E E

Figure 1: Pharmaceuticals (Backhaus, 2011)

The Idea:
Repurposing expired U.S. pharmaceuticals for
developing nations in need of essential medicine
access and affordability

The Pharmaceutical Problem:

In 1979, the Food and Drug Administration passed a regulation
requiring drug manufactures to stamp an expiration date on their
products1
21 CFR 211.1372
The expiration date is the date at which manufacturers can still
guarantee the full potency and safety of the drug1
The expiration dates are extremely conservative and performing
expiration testing for longer periods of time slows the ability to bring
new drugs to market1
Also reduces turnover, cutting manufacturer revenues
Most of what is known about drug expiration dates comes from a
study conducted by the FDA at the request of the Department of
Defense1
Shelf Life Extension Program (SLEP)3
This study discovered that 90% of over 100 drugs, both prescription
and over the counter, were perfectly good to use even 15 years after
the expiration date1
Study performed by Lee Cantrell and published in the Archives of
Internal Medicine showed similar results4

Figure 2: Expiration Date (Huffington Post, n.d.)

Haiti: A Recent History

The poorest country in the Western Hemisphere5

January 12, 2010: A 7.0 magnitude earthquake hit

just southwest of Port-au-Prince, the Haitian capital6
More than 230,000 left dead and 1.5 million left
homeless7
Cholera was introduced, affecting 689,448 people7
Continued weather-related disasters have caused
much of the nation to descend into serious food
insecurity7
The net effects of the environmental, social, and
civil instability from these events have further
challenged Haitis already fragile infrastructure7
Figure 3: A People in Crisis (Britannica, 2016)

The Haitian Need for Essential Medications:

The lowest paid
government worker would
need 2.5 days wages to
treat an adult respiratory
infection with generic
medicines from the public
sector, and treatment of
pediatric bacterial infections
with Originator Brand (OB)
medicines from a retail
pharmacy would cost 24.6
days wages5

According to the latest household survey (ECVMAS 2012), more than 6

million out of 10.4 million (60%) of Haitians live under the national poverty line
of US $2.42 per day, and over 2.5 million (25%) live under the national
extreme poverty line of US $1.23 per day8
In addition to being one of the poorest countries, Haiti is also one of the most
unequal, with a Gini coefficient of 0.61 as of 20128
Study conducted by Chahal et al. and published in the Journal of Global
Health (2013) determined that Haiti faces inadequate medication access for
its residents5
Objective of the study was to determine the availability, prices, and
affordability of essential medicines in Haiti and to compare these findings to
other countries5
Cross-sectional nationwide survey (2011) of availability and consumer prices of
60 essential medicines in Haiti, conducted in 163 medicine outlets in four health
care sectors: public, retail, nonprofit, and mixed sectors5
Affordability was calculated by comparing the costs of treatment for common
conditions with the salary of the lowest paid government worker5

Results:
For generic medications, the availability in public, retail, nonprofit, and mixed
sectors was 23%, 37%, 24%, and 23% of medications, respectively5
Most of the available medicines were priced higher than the International
Reference Price5
5

List of the 60 Essential Medicines Surveyed in the Chahal et. al Study:

Figure 4: List of Surveyed Medicines in Haiti (Chahal et al., 2013)

Mortality & Burden of Disease for Non-Communicable Diseases in Haiti:

Figure 5: Haiti NCD Mortality (WHO, 2014)

Pharmaceutical Drugs to Treat Cardiovascular Disease (CHD):

1. Atenolol 50mg cap/tab

2. Captopril 25mg cap/tab
3. Simvastatin 25mg cap/tab

Drug Manufacturer:
Simvastatin
Brand Name: Zocor

Figure 6: Merck Logo (Merck, n.d. )

Merck As A Global Health Player:

We must try to remember that

medicine is for the patient. We
try never to forget that medicine
is for the people. Is is not for the
profits. The profits follow, and if
we have remembered that, they
have never failed to appear. The
better we have remembered it,
the larger they have been. We
cannot rest until the way has
been found, with our help, to
bring our finest achievements to
everyone.
-December 1950 speech at the Medical College of
Virginia Richmond by the late Merck president
George W. Merck

Figure 7: Merck 125 Years (Merck, 2016)

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Vehicle, Federal-Level Venue: H.R. 1891

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Stakeholders:
Governmental:

Non-Governmental:

Key Stakeholder:

Key Stakeholder:

Haiti Ministry of Public Health and Population

(MSPP)

Merck

Other Stakeholders:

U.S. Food and Drug Administration (FDA) [HHS]

U.S. Embassy Port-au-Prince: Economic and Commercial
Section (ECON)
U.S. Agency for International Development (USAID)
Pan American Health Organization (PAHO)
World Health Organization (WHO) [UN]
Pan American Health Organization (PAHO)
The World Bank [UN]
The World Trade Organization (WTO) [UN]
UN Development Program (UNDP) [UN]
Office of Global Affairs [HHS]
Agency for Healthcare Research and Quality (AHRQ) [HHS]
Centers for Disease Control and Prevention (CDC) [HHS]
Health Resources and Services Administration (HRSA) [HHS]
National Institutes of Health (NIH) [HHS]
U.S. Chamber of Commerce
International Policy Committee; Western Hemisphere
Task Force

Other Stakeholders:

Bill & Melinda Gates Foundation:

Discovery & Translational Sciences Team
Development Policy and Finance Team
Integrated Delivery Team
The Rockefeller Foundation
Advance Health Core Issue Area
The Local Haitian Community
International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA)
The Pharmaceutical Research and Manufacturers of America
(PhRMA)
The Ford Foundation
The National Pharmaceutical Association (NPhA)
The American Association of Pharmaceutical Scientists (AAPS)
The World Economic Forum
YMCA: YMCA DHaiti

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Merck As A Key Stakeholder:

13

Figure 8: Merck CEO (Merck, 2016)

Policy Paramours:
Sponsor

Figure 9: Paul Ryan (Wikipedia, n.d.)

Sponsor

Figure 10: Mia Love (Wikipedia, n.d.)

Sponsor

Figure 11: Buddy Carter (Wikipedia, n.d.)

Co-Sponsor

Figure 12: Peter Roskam (Illinois Review, 2006)

Paul Ryan:

Mia Love:

Earl Buddy Carter:

Peter Roskam:

Speaker of the House

Representative (R-WI 1st
District)

Representative (R-UT
4th District)

Representative (R-GA 1st

District)

Representative (R-IL 6th

District)

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Endnotes:
1Harvard

Health Publications: Harvard Medical School, Drug Expiration Dates Do They Mean Anything?,
Harvard Health Publications, 28 Feb. 2016 < http://www.health.harvard.edu/staying-healthy/drug-expiration-dates-dothey-mean-anything>
2Legal Information Institute, 21 CFR 211.137, Cornell University Law School, 28. Feb. 2016 <
https://www.law.cornell.edu/cfr/text/21/211.137>
3Association of State and Territorial Health Officials, Federal Shelf Life Extension Program, ASTHO, 28. Feb 2016
< http://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-AuthorizationToolkit/Federal-Shelf-Life-Extension-Program-Fact-Sheet/>
4Lee Cantrell, et al., Stability of Active Ingredients in Long-Expired Prescription Medications, JAMA Internal
Medicine, 28 Feb. 2016 < http://archinte.jamanetwork.com/article.aspx?articleid=1377417>
5Harinder Chanal, Availability, Prices, and Affordability of Essential Medicines in Haiti, NCBI, 28 Feb. 2016 <
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868824/>
6Richard Pallardy, Haiti Earthquake of 2010, Britannica, 28 Feb. 2016
<http://www.britannica.com/event/Haiti-earthquake-of-2010>
7Janet Lin, Haiti Seed Grant, n.d.: 3
8The World Bank, Overview, The World Bank: Working for a World Free of Poverty, 28 Feb. 2016 <
http://www.worldbank.org/en/country/haiti/overview>

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References:
Association of State and Territorial Health Officials (ASTHO). (2011, December). Federal Shelf Life Extension Program. Retrieved March 1, 2016, from http://www.astho.org/ Prog rams /P repa red nes s/ Pub lic-He alt h-Emerg ency-Law /Eme rgency-U se- Aut hor iza tio n-To olk it/F eder al-Sh elf-Lif e-Exten si on- Progr am-Fact-She et/
Backhaus (Photographer). Pharmaceutical s [Photograph]. Retrieved from https://www.setac.org/g rou p/ AG Phar ma
Britannica (Photographer). A people in crisis [Photograph]. Retrieved from http://www.britan nica.com/ event /Hai ti-ea rth quake- of-201 0
Britannica. (2016, January 29). Haiti earthquake of 2010. Retrieved March 1, 2016, from http://www.britan nica.com/ event /Hai ti-ea rth quake- of-201 0
Cantrell, L., Suchard, J. R., Wu, A., & Gerona, R. R. (2012). Stability of Active Ingredients in Long-Expired Prescription Medications. Arch Intern Med Archives of Internal Medicine, 172(21), 1685. Retrieved March 1, 2016, from http://archinte.jamanet wo rk.com/ar ticl e.aspx?ar ticl eid =137 7417
Chahal (Photographer). 60 essential medicines surveyed in Haiti [Table]. Retrieved from http://www.ncbi.nlm.nih.gov /pmc /art icle s/ PM C386 8824 /#S1
Congress.gov (2015, May 1). H.R. Bill 1891: 114th Congress. Retrieved March 1, 2016 from https://www.congre ss.gov/ bi ll /11 4th-co ngre ss /ho use- bi ll /18 91?q= %7 B% 22s earch %22 %3 A%5B %22 hai ti %22 %5D %7D& res ultIn dex=2
Embassy of the United States: Port-au-Prince Haiti. (n.d.). Message from the ambassador. Retrieved March 1, 2016, from http://haiti.usembas sy.gov/ bus in es s.html
Harvard Health Publications: Harvard Medical School. (2015, September 2). Drug expiration dates: Do they mean anything? Retrieved March 1, 2016, from http://www.health.h arvard.e du /stay ing- heal thy/ drug- expi rati on- date s-do-t hey-m ean-a nyth ing
Huffington Post (Photographer). Expiration date [Photograph]. Retrieved from http://i.huffpost.com/gen /282 3192 /i mages /o- MEDIC ATION-E XPIRY-face book. jpg
Illinois Review (Photographer). Peter Roskam [Photograph]. Retrieved from http://illinois revie w.type pad.com /i ll in oi srevi ew /i mages /r oskam 3.jpg
Inside Gov. (n.d.). Representative Earl L. "Buddy" Carter. Retrieved March 1, 2016, from http://members-of-congres s.in si degov.com /l /12 293 /Ear l-L-Bu ddy-C arter
Merck (Photographer). Merck logo [Photograph]. Retrieved from http://www.merck.com/abo ut/fe atur ed-s tor ies /12 5th_ ann iver sary.htm l
Merck (Photographer). Merck CEO [Photograph]. Retrieved from http://www.merck.com/about /feat ure d-st ori es /125t h_a nniv ersa ry.htm l
Merck (Photographer). Merck 125 years [Photograph]. Retrieved from http://www.merck.com/about /feat ure d-st ori es /125 th_a nn ivers ary.htm l
Merck. (2013, November). Kenneth C. Fraizer. Retrieved March 1, 2016, from https://www.merck.com/abo ut/ lea der shi p/ executiv e-comm ittee /K CF-B io_ Nov_2 013.p df
Merck. (2015). Zocor. Retrieved March 1, 2016, from http://www.merck.com/pro duct /us a/p i_ci rcula rs /z /z ocor /z ocor_ pi.p df
The Pan American Health Organization (PAHO), & The World Health Organization. (2016, February 29). About PAHO. Retrieved March 1, 2016, from http://www.paho.org/h q/ ind ex.php? opt ion =com_co nten t&vi ew= artic le& id= 91&Ite mid =220 &la ng=e n
The World Bank. (2016). Haiti overview. Retrieved March 1, 2016, from http://www.worl dba nk.org/ en /coun try/ hait i/ overv iew
The World Health Organization (Photographer). Haiti NCD Mortality [Chart]. Retrieved from http://www.who.i nt/ nmh /cou ntri es /ht i_e n.pdf?ua =1
The World Health Organization. (2014). Haiti: Noncommunicable

diseases. Retrieved March 1, 2016, from http://www.who.int /nm h/co unt rie s/ hti _en.p df?ua= 1

United States Department of Health and Human Services (HHS). (2016, February 1). HHS organizational chart. Retrieved March 1, 2016, from http://www.hhs.gov/a bou t/age ncie s/ orgchar t/ ind ex.html
U.S. House of Representatives (Photographer). Danny Davis [Photograph]. Retrieved from http://davis.house.gov/ up load s/D anny KDavi s.jpg
U.S. House of Representatives. (n.d.). Biography. Retrieved March 1, 2016, from http://buddycarter.hous e.gov/a bout /
U.S. House of Representatives. (n.d.). Committees. Retrieved March 1, 2016, from http://davis.house.gov/comm itte es /
Unknown Photographer (Photographer). Buddy Carter [Photograph]. Retrieved from https://www.google.com /s earch?q =bu ddy+ca rter &so urce= lnm s&t bm= isch &sa =X&v ed=0 ahUK Ew jj2- 6EoZ7L Ah W B6SYKH dnF B1kQ_ AUICSgD &b iw =105 0&b ih= 666# imgrc= z z5paS Qb1 _xUs M% 3A
Unknown Photographer (Photographer). Paul Ryan [Photograph]. Retrieved from https://www.google.com /sea rch?q= pau l+rya n&e spv= 2&b i w=10 50& bih =666 &s ource =ln ms &tbm =i sch& sa=X &ved= 0ahU KEw jf zO3ko J7LAhUB RyYKH daX Ad AQ _AUIBygC# imgrc= ui 6cUnceFahFy M% 3A

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