**Drug Importation Issues**

**Submitted to the**

**U.S. Department of Health and Human Services**

**Task Force on Drug Importation**

**Elena Rios, MD, MSPH**

**President & CEO**

**National Hispanic Medical Association**

**CEO, Hispanic-Serving Health Professions Schools, Inc.**

**1411 K St., NW, S. 1100**

**Washington, DC 20005**

**(202) 628-5895**

Surgeon General Carmona and Task Force Members, it is an honor to be
here today representing the National Hispanic Medical Association and
the Hispanic-Serving Health Professions Schools, Inc. both non-profit
associations dedicated to improving the health of Hispanics and other
underserved in the United States.

According to the US Census, the Hispanic population is now the largest
ethnic group in the U.S. and exists in nearly all major areas of the
country -- the group with the least proportion of persons with health
insurance and access to health care according to key health system
indicators. In addition, this group faces barriers to health care
services based on language, cultural barriers and the severe lack of
Hispanics in all levels of the health workforce, where Hispanic
physicians for example are only 5% of the total US physicians. The 2002
Institute of Medicine's Report on Unequal Treatment discussed specific
recommendations to facilitate the inclusion of more populations with
cultural backgrounds. Furthermore, the IOM reports on quality have
pointed to the need for a Patient-Centered approach in health policy in
2004. Both Senator Frist and Senator Daschle have introduced legislation
that show us various pathways to eliminate health disparities in our
health system and they include enhancing minority research and data
collection, promoting programs to increase minority health professionals
and strengthening the leadership of the Office of Minority Health and
cultural competence curriculum development. I recommend that your
deliberations include these recommendations.

Drug importation discussions, we feel, require a review of the public
safety and feasibility as well as a cost/benefit analysis for the
pharmaceutical distribution chain, as you are doing. However, we are
interested in educating physicians and health providers about the
inclusion of cultural principles into public health activities. You can
provide an imported drug to a regional wholesaler, but the eventual
distribution to the local pharmacy in the Hispanic neighborhood and
moreover, the awareness of that new service to the community requires
its own protocols of outreach and education and information sharing.

As the "Unequal Treatment" report demonstrates, a major effort is needed
on the part of both private and public partners, to develop
linguistically and culturally appropriate services in a drug importation
process. At the Federal level, we feel that the FDA should partner with
the Office of Minority Health and its Regional Minority Health
Consultants to develop the culturally appropriate messages, marketing
and product protocols. We recognize the importance of the OMH Center for
Linguistic and Cultural Competence in Health Care for developing the
CLAS Standards and other projects to show us how to navigate the system
in health care. In addition, the OMH has been successful by the fact
that Kaiser Permanente, NCQA, JAHCO, the medical school and residency
programs accreditation bodies, the Family Practice CME Module Project
and other major health institutions have adopted cultural competence
principles and the CLAS Standards and are using them voluntarily. There
is a momentum that this Task Force cannot ignore on the recognition that
Quality Care is needed for our diverse communities in order to improve
the health of all America.

NHMA feels strongly that there should be demonstration projects and
research done by Hispanics with the community that demonstrates the
effectiveness of any new interventions that impact on health care
delivery. Lastly, you must consider including more diversity in the
leadership bodies created as critical to making any new program a
success.

**Prescription Drugs and Hispanics**

[Use of Prescription Drugs]{.underline}

Hispanics are less likely to use prescription drugs. Indeed, policy
focused on the increased access to prescription drugs should include
educational efforts targeted to Hispanic community about the importance
of therapy and the providers the importance of adequate treatment to all
patients.

In 2003, the Department of Veteran Affairs studied 12 month use of
antipsychotics in the VA in Minnesota. Antipsychotics less common for
African Americans and Hispanics[^1]

According to the Ambulatory Medical Care Survey, utilization of
antidepressant pharmacotherapy was less than half the rate for whites in
1994-95 in Hispanics and Blacks.[^2]

[Border Crossing Behavior]{.underline}

140 miles from the US-Mexico border, 14% had crossed the border to seek
medical care

80% of the respondents were uninsured, 28% reported purchasing
medications --antibiotics and pain meds highest[^3]

A 2003 study of US residents purchasing medications in Mexico indicated
they do so for various reasons and for chronic diseases, most often for
antibiotics and the number 1 reason was prices.[^4]

In El Paso, Texas, a study on purchasing prescription medications in
Mexico, more than 80% of patients had purchased US prescription drugs
without a prescription.[^5]

[Access to Information]{.underline}

The Institute for Communications Research of Texas Tech University
conducted a phone survey of 522 adult Hispanics and only 13% used media
for health information --the majority reported family and friends were
the main source of health information.[^6]

[Issues of Licensure in Hispanic Communities]{.underline}

Los Angeles County Health Department created a new office that increased
law enforcement to curb sale of illegal sale of pharmaceuticals by
unlicensed vendors (clinics of foreign physicians unlicensed as well as
pharmacies providing medications without prescription) --found 280
investigations, 121 arrests and \$4.5 million of drugs in first 20
months. The Department also started an educational program in those
communities most affected by this behavior.[^7]

The Canadian Medical Journal reported in 2000, about the increasing
seniors taking buses to Canada to purchase medications with pharmacies
who have physicians writing scripts nearby or in some cases sell without
scripts.[^8]

**Task Force Key Questions**

I.  Scope and Volume of Imported Drugs

Products need to be subject to the same level of labeling, research, and
critical debate before being subject to use for all populations in the
US. I don't believe that certain drugs that are deemed under
prescription in the US should be divided into 2 groups -- one that has
lesser risk and could be more acceptable to the public. The fear is that
the lesser regulated product will be faster to be given to the poor and
minority groups.

II. Pharmaceutical distribution chain and the modifications to assure
    safety of imported products

Importation should be limited to be able to better track the product,
like the blood supply in the US.

Adequate reporting for foreign sources should be assured if quality
problems are found with imported products by having a targeted
communications technology system set-up to media companies, pharmacies,
alert systems through the CDC.

In addition, Hispanic Spanish-speaking communities need a special
targeted approach with reimbursement for translators and interpreters
for regional data banks for the pharmacies and health facilities
involved.

III. Foreign health agencies role with safety of exported drugs to the
     US.

World Health Organization should be a partner to discuss this and
include the responsibility of public health leadership to meet and
develop safety protections or share current protections being utilized
in other countries.

Certainly, for the Hispanic community, PAHO and the Latin American
countries could be a focus of important discussion.

IV. Limitations that may inhibit Secretary's ability to certify the
    safety of imported drugs.

Inability to limit the underground trade that would develop when new
distribution patterns are started by importation of drugs. Better to
have checks and balances in the registration and inspections and
recordkeeping and redundancies with oversight linked to the Federal
government infrastructure and its contracting institutions.

There should be a feedback system that allows for rapid recall, linked
to the CDC new information systems to relay information back to
providers on a timely basis, as well as to connect with the
international points of contact.

V.  Estimate of agency resources and activities for recommendations of
    the Task Force.

Other than FDA\-\--Homeland Security, CDC alert systems, Customs,

HRSA educational curriculum for primary care workforce

Clinics, Corrections, Migrant Clinics, DOJ,

OMH needs to be expanded for technical assistance and coordination of
national efforts to increase diversity in the system. Hispanic issues as
mentioned above. Demonstration programs needed and more Hispanic health
research and the training of more officials in public health on Hispanic
health issues.

VIII. New costs to provide assurances of import security.

This would include language and culturally appropriate services.

IX. Impact on drug research and development.

Need to continue to have R&D in the U.S. and to increase the focus on
Hispanic research subjects and the need to develop physician practice
networks in Hispanic communities.

[^1]: Copeland LA, et al. Racial disparity in the use of atypical
    antipsychotic medications among veterans. Am J Psychiatry. 2003
    Oct;160(10):1817-22.

[^2]: Sclar DA, et al. Ethnicity and the prescribing of antidepressant
    pharmacotherapy: 1992-1995. Harv Rev Psychiatry. 1999
    May-Jun;7(1):29-36.

[^3]: Macias EP, Morales LS. Crossing the border for health care. J
    Health Care PoorUnderserved. 2001 Feb;12(1):77-87.

[^4]: Calvillo JP. Pilot study of a survey of US residents purchasing
    medications in Mexico: demographics, reasons, and types of
    medications purchased. Clin Ther.2003 Feb;25(2):561-77.

[^5]: Casner PR. Purchasing prescription medication in Mexico without a
    prescription. West J Med.1992 May;156(5):512-6.

[^6]: Hudson JC. Hispanic preferences for health care providers and
    health care information. Health mark Q. 1996;14(1):67-83.

[^7]: Fielding, JE, et al. Halting the illegal sale of prescription
    medications in Los Angeles County. J Public Health Manag Pract. 2001
    May;7(3):59-64.

[^8]: Korcok M. Cheap prescription drugs creating new brand of US
    tourist in Canada, Mexico. CMAJ. June 27 2000;162(13).