DISCLAIMER
The following is a preliminary report of actions taken by the House of Delegates at
its 2005 Annual Meeting and should not be considered final. Only the Official
Proceedings of the House of Delegates reflect official policy of the Association.
AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES (A-05)
Report of Reference Committee E
Daniel W. van Heeckeren, MD, Chair
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In keeping with Resolution 601 (A-96), the Reference Committee recommends the
following consent calendar for acceptance:
RECOMMENDED FOR ADOPTION
1.
Board of Trustees Report 6 – Physician-to-physician communication
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Council on Scientific Affairs Report 9 – Expedited Partner Therapy (Patient
Delivered Partner Therapy)
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Council on Scientific Affairs Report 10 – Safety and Efficacy of Selective
Serotonin Reuptake Inhibitors (SSRIs) in Children and Adolescents
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Resolution 501 – “Keepsake” Fetal Ultrasonography
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Resolution 506 – Antidepressant Usage Among Children, Adolescents and
Young Adults
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Resolution 518 – Influenza Immunization for Health Care Workers
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Resolution 521 – Radiation Exposure
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Resolution 526 – Retain CLIA Cytology PT Program as Educational
In lieu of Resolution 537 - Updating Clinical Laboratory Improvements Act of
1988
9.
Resolution 527 – United States Bone and Joint Decade
RECOMMENDED FOR ADOPTION AS AMENDED OR SUBSTITUTED
10.
Board of Trustees Report 28 – Criminalization of Physician Departure From
Guidelines and Standards
Reference Committee E (A-05)
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11.
Council on Scientific Affairs Report 6 – Enhanced Physician Access to Food and
Drug Administration (FDA) Data
Resolution 512 – Requiring Full Disclosure of All Clinical Studies by
Pharmaceutical Companies
Resolution 516 – Funding for FDA Prescription Drug Surveillance
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Resolution 502 – Modifying DEA Position on Schedule II Prescriptions
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Resolution 504 – Advertising for Herbal Supplements
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Resolution 510 – Discrimination Against Diabetics
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Resolution 511 – Promotion of Rapid HIV Test
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Resolution 514 – Avian and Other Influenza Pandemic
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Resolution 517 – Flu Vaccine Supply
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Resolution 522 – Availability of Controlled Substances Via the Internet
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Resolution 525 – Electronic Prescribing
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Resolution 529 – Opposition to Prescription Prior Approval
RECOMMENDED FOR REFERRAL
21.
Resolution 507 – Prohibit Direct-to-Consumer Prescription Drug Advertising
Resolution 519 – Ban on Direct-to-Consumer Advertising of Prescription Drugs
Resolution 524 – Direct Marketing of Pharmaceuticals
Resolution 532 – Direct-to-Consumer Advertising of Pharmaceutical Products
Resolution 533 – Direct-to-Consumer Advertising of Prescription Drugs and Food
and Drug Administration-Approved Medical Devices
Resolution 534 – Truth in Direct-to-Consumer Advertising
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Resolution 508 – Physicians and Narcotic Prescriptions
Resolution 539 – Guidelines for the Ethical Management of Pain
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Resolution 515 – Folic Acid Fortification of Grain Products
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Resolution 528 – Pain Care for Patients
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Resolution 530 – National Minimum Newborn Screening Recommendations
RECOMMENDED FOR REFERRAL FOR DECISION
26.
Resolution 503 – Pharmaceutical Rebates to Nursing Home Pharmacies
27.
Resolution 513 – Support for a National Center on Pain Research
Reference Committee E (A-05)
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RECOMMENDED FOR NOT ADOPTION
28.
Resolution 505 – Request to Study the Feasibility of Implementing an AMA
Patient Safety Database
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Resolution 509 – Food and Drug Administration Standard for Approval of New
Drugs
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Resolution 538 – Mercury and Fish Consumption: Medical and Public Health
Issues
RECOMMENDED FOR REAFFIRMATION IN LIEU OF
31.
Resolution 520 – Expansion of FDA’s Mission and Authority
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Resolution 535 – AMA Endorsement of Appropriately Developed Preferred Drug
Lists
Reference Committee E (A-05)
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(1)
BOARD OF TRUSTEES REPORT 6 - PHYSICIAN-TOPHYSICIAN COMMUNICATION (RESOLUTION 725, A04)
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the recommendation contained in Board of Trustees
Report 6 be adopted and the remainder of the report be
filed.
HOD ACTION: Recommendations in Board of Trustees
Report 6 adopted and remainder of report filed.
At the 2004 Annual Meeting, Resolution 725 asked that our American Medical
Association (AMA) study and report back to the House of Delegates with
recommendations for action on how to improve communication between physicians and
among health systems as patients transition from one health care setting to another; and
to work with other interested organizations to improve physician-to-physician
communications.
This report describes existing AMA policy on patient discharge and transfer from
facilities and summarizes ongoing activities related to the concerns expressed in
Resolution 725 (A-04), including: (1) a description of relevant accreditation standards of
the Joint Commission on Accreditation of Healthcare Organizations (JCAHO); (2)
collaborative patient safety activities undertaken through the Institute for Healthcare
Improvement (IHI) “100K Lives Campaign”; and (3) AMA activities supporting the
development of the continuity of care record (CCR).
Your Reference Committee heard limited but favorable testimony in support of Board of
Trustees Report 6 describing the extensive efforts our AMA has and will continue to
undertake to improve communication between physicians as patients transition through
the health care system.
(2)
COUNCIL ON SCIENTIFIC AFFAIRS REPORT 9 EXPEDITED PARTNER THERAPY (PATIENTDELIVERED PARTNER THERAPY) (RESOLUTION 820,
A-04)
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the recommendations in Council on Scientific Affairs
Report 9 be adopted and that the remainder of the report
be filed.
HOD ACTION: Recommendations in Council on Scientific
Affairs Report 9 adopted and remainder of report filed.
Reference Committee E (A-05)
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This Council on Scientific Affairs (CSA) report is in response to Resolution 820, that was
referred by the House of Delegates at the 2004 Interim Meeting. It describes our AMA’s
current collaborative efforts with the Centers for Disease Control and Prevention (CDC)
on the issue of expedited partner therapy (EPT) and provides recommendations for
consideration by the House of Delegates.
It summarizes the findings from a meeting, Expedited Partner Therapy Stakeholders
Consultation, organized by the CDC on March 2-3, 2005, in which our AMA participated.
This meeting presented a systematic review of the science of EPT as well as significant
background information on the issues that need to be considered when implementing
EPT.
The report concludes that the CDC has already expended significant effort in
researching the scientific evidence for or against a more widespread implementation of
EPT. It appears from the presentations and discussions at the CDC-sponsored EPT
stakeholder meeting held in Atlanta on March 2-3, 2005, that the medical and scientific
evidence supports the use of EPT in treating the sex partners of patients who have been
diagnosed with either chlamydial or gonorrheal infections.
There was substantial supportive testimony on this CSA report. The CDC commended
the participation of the AMA on this issue and other testimony spoke to the importance of
continued AMA staff participation. Testimony also pointed out that significant barriers
exist to the implementation of EPT and that eventual AMA support of EPT would be
helpful. Finally, it was also acknowledged that as the issue matured, continued
monitoring on issues such as antibiotic resistance and the administration of i.v.
antibiotics by inappropriately trained personnel would be needed.
(3)
COUNCIL ON SCIENTIFIC AFFAIRS REPORT 10 SAFETY AND EFFICACY OF SELECTIVE SEROTONIN
REUPTAKE INHIBITORS IN CHILDREN AND
ADOLESCENTS (RESOLUTION 803, I-04)
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the recommendations contained in Council on
Scientific Affairs Report 10 be adopted and that the
remainder of the report be filed.
HOD ACTION: Recommendations in Council on Scientific
Affairs Report 10 adopted and remainder of report filed.
This report reviews approaches used in the United States to enhance pediatric
prescription drug labeling; summarizes recent regulatory actions related to the
prescription drug labeling of antidepressants and their use in children and adolescents;
evaluates the apparent safety and efficacy of antidepressants, particularly the selective
serotonin reuptake inhibitors (SSRIs) in children and adolescents; and reviews the
evidence on whether these drugs may have a causal role in the emergence of suicidality
or other harmful behavior during treatment.
Reference Committee E (A-05)
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Discussants expressed appreciation for the effort of the Council in addressing this
complex topic in a balanced and informative fashion. Testimony noted that the report’s
conclusions are largely consistent with the notion that these drugs can be helpful in
pediatric patients; that longer term studies are needed to better address safety and
efficacy concerns; and that the FDA should follow-up in assessing the clinical impact of
recent labeling changes for antidepressant drugs. It was also suggested that an
additional recommendation to support widespread dissemination of the report would be
helpful.
(4)
RESOLUTION 501 - “KEEPSAKE” FETAL
ULTRASONOGRAPHY
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 501 be adopted.
HOD ACTION: Resolution 501 adopted.
Resolution 501 asks our American Medical Association to: (1) adopt the current Food
and Drug Administration (FDA) policy on use of non-diagnostic fetal ultrasound, which
views “keepsake” fetal videos as an unapproved use of a medical device, and (2) lobby
the federal government to enforce the current FDA position, which views “keepsake”
fetal videos as an unapproved use of a medical device, on non-medical use of ultrasonic
fetal imaging.
Testimony was overwhelmingly in support of this resolution calling for the responsible
use of diagnostic ultrasound during pregnancy. Fetal ultrasonography is considered safe
when properly used and although there is no evidence to suggest that exposing a fetus
to unnecessary ultrasound is harmful, strong support was voiced endorsing its use only
where there is a clear medical benefit to the patient. Other testimony pointed out the
potential legal liability associated with this practice for physicians and that counseling
normally accompanying an ultrasound may be lacking.
(5)
RESOLUTION 506 - ANTIDEPRESSANT USAGE
AMONG CHILDREN, ADOLESCENTS AND YOUNG
ADULTS
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that Resolution 506 be adopted.
Reference Committee E (A-05)
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RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that the title of Policy H-60.944 be changed to read as
follows:
USE OF PSYCHOTROPIC DRUGS IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS
HOD ACTION: Resolution 506 adopted with title of Policy
H-60.944 changed.
Resolution 506 asks the AMA amend existing Policy H-60.944 by addition as follows:
Our AMA: (1) endorses efforts to train additional qualified clinical investigators
in pediatrics, child psychiatry, and therapeutics to carry out studies related to
the effects of psychotropic drugs in children, adolescents, and young adults;
and (2) promotes efforts to educate physicians about the appropriate use of
psychotropic medications in the treatment of children, adolescents, and young
adults.
Limited testimony from the sponsor and the American Academy of Pediatrics was totally
in support of this resolution. Your Reference Committee believes that the title of the
revised policy should also be changed to reflect the changes in policy.
(6)
RESOLUTION 518 - INFLUENZA IMMUNIZATION FOR
HEALTH CARE WORKERS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 518 be adopted.
HOD ACTION: Resolution 518 be adopted.
Resolution 518 asks the AMA to work to ensure that hospitals and skilled nursing
facilities have a system for measuring and maximizing the rate of influenza immunization
for health care workers.
Your Reference Committee heard limited testimony on this issue. Concerns were raised
about a mandate to immunize health care workers especially in times of vaccine
shortage. However, your Reference Committee is cognizant of the fact that even during
the influenza vaccine shortage of the 2004-2005 season, health care workers remained
highest on the Advisory Committee for Immunization Practices’ priority list for receiving
vaccine. It is also clear that the resolution does not ask for a mandate to vaccinate
healthcare workers, but that medical facilities have a system in place to increase
influenza immunization rates amongst its health care workers. Finally, your Reference
Committee is aware of the significant data, such as the Lancet report cited by the
authors of Resolution 518, indicating that immunization of health care workers leads to
Reference Committee E (A-05)
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reduced morbidity and mortality among patients. Accordingly, the Reference Committee
strongly supports adoption of Resolution 518.
(7)
RESOLUTION 521 - RADIATION EXPOSURE
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 521 be adopted.
HOD ACTION: Resolution 521 adopted.
Resolution 521 asks that our American Medical Association work with the public health,
radiology and radiation oncology specialty societies and all other interested parties to
study the issue of radiation exposure by the American public and develop a plan, if
appropriate, to allow the ongoing monitoring and quantification of radiation exposure
sustained by individual patients in medical settings.
Limited but fully supportive testimony was heard on this resolution. Your Reference
Committee agrees that the issues raised by Resolution 521 are relevant considering the
population exposure to radiation from current and emerging medical technology
procedures in radiology, radiation oncology, and nuclear medicine. Additionally, patient
safety and public health implications are important for AMA consideration.
(8)
RESOLUTION 526 - RETAIN CLIA CYTOLOGY PT
PROGRAM AS EDUCATIONAL
RESOLUTION 537 - UPDATING CLINICAL
LABORATORY IMPROVEMENTS ACT OF 1988.
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 526 be adopted in lieu of Resolution 537.
HOD ACTION: Resolution 526 adopted in lieu of
Resolution 537.
Resolution 526 asks that our American Medical Association advocate to the relevant
government agencies that the cytology proficiency testing program, a long dormant
provision of the Clinical Laboratory Improvement Amendments of 1988 that began
implementation in 2005, remain as an educational pilot program at least through 2007 or
until such time as the Clinical Laboratory Improvement Advisory Committee can review
the scientific data and provide an opinion on the validity of the grading criteria, the
clinical relevance of the grading criteria, the importance of using field validated Pap test
slides, and the need for a testing frequency of once a year.
Resolution 537 asks that our American Medical Association support allowing the up-todate scientifically proven cytology proficiency testing as developed by the College of
American Pathology or the American Society of Clinical Pathology to satisfy the cytology
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proficiency testing requirements of the Clinical Laboratory Improvement Amendments
Act of 1988.
Strong testimony was heard in support of Resolution 526 that seeks to retain the
educational status of the newly implemented cytology proficiency testing (PT) program
until it can be properly validated in terms of clinical relevance and scientific content.
Specific concerns were voiced about the value of utilizing the current national cytology
PT program since it relies on an outdated grading system and given that other, perhaps
more appropriate testing programs exist that are now being considered for national
approval. Testimony was not in favor of Resolution 537 that seeks AMA support of two
alternative testing programs since they are still under evaluation to determine if they
satisfy the cytology proficiency testing requirements of the Clinical Laboratory
Improvement Amendments Act of 1988.
(9)
RESOLUTION 527 - UNITED STATES BONE AND JOINT
DECADE
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 527 be adopted.
HOD ACTION: Resolution 527 adopted.
Resolution 527 asks that our American Medical Association support enhanced
educational efforts of the public and health care providers regarding the development
and maintenance of bone health, as well as the prevention and early detection of
osteoporosis.
Limited but fully supportive testimony was offered on Resolution 527 and adoption is
recommended.
(10)
BOARD OF TRUSTEES REPORT 28 CRIMINALIZATION OF PHYSICIAN DEPARTURE FROM
GUIDELINES AND STANDARDS (RESOLUTION 718, I04)
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the recommendation contained in Board of Trustees
Report 28 be amended by insertion and deletion on page
6, lines 21 – 22, to read as follows:
Reference Committee E (A-05)
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That our AMA condemn the criminalization of medical
decisions and actions by physicians and other health care
providers who in loyalty to their patients and who in proper
exercise of their clinical judgment depart from established
medical care and resource allocation guidelines or
standards for appropriate reasons, and that our AMA seek
and/or support legislation or rules/regulations at federal
and state levels preventing such criminalization.
RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that Board of Trustees Report 28 be adopted as amended
and that the remainder of the report be filed.
HOD ACTION: Recommendation in Board of Trustees
Report 28 adopted as amended and remainder of report
filed.
This report responds to referred Resolution 718 (I-04), which asked that our American
Medical Association (AMA) study and report back at the 2005 Annual Meeting as to: (1)
the need for a national clarification of the terms guidelines (parameters, algorithms, etc.)
vs. standards (mandating compliance) for medical care and resource allocation; (2) the
legal, moral, and ethical impact of appropriate departure from guidelines or standards,
the clarification of what constitutes appropriate departure, and the rights of physicians
and other health care providers accused of non-compliance with a guideline or standard;
and (3) the legal, moral and ethical impact of the criminalization of medical decisions and
actions of physicians and other health care providers who appropriately depart from
such guidelines and standards; and to condemn the criminalization of medical decisions
and actions by physicians and other health care providers who in loyalty to their patients
and who in proper exercise of their clinical judgment depart from established medical
care and resource allocation guidelines or standards for appropriate reasons, and that
our AMA seek and/or support legislation or rules/regulations preventing such
criminalization.
This report responds to actions taken at the state level during the influenza vaccine
shortage of 2004-2005. It addresses the practical difficulties that arise when the
government attempts to allocate medical resources. Government guidelines often lead
to inefficient results when they are solely in response to variable, short-term
circumstances.
While limited, testimony supported the recommendation of BOT Report 28. The original
sponsor of Resolution 718 (I-04) that prompted this report submitted an amendment to
add a recommendation to disseminate the report to the Centers for Disease Control and
Prevention (CDC) and to senior state public health officials. Your Reference Committee
agrees and believes that its amendment accomplishes the intent of the original sponsor.
Reference Committee E (A-05)
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(11)
COUNCIL ON SCIENTIFIC AFFAIRS REPORT 6 - ENHANCED PHYSICIAN ACCESS TO FOOD AND DRUG
ADMINISTRATION (FDA) DATA (RESOLUTION 529, A04)
RESOLUTION 512 - REQUIRING FULL DISCLOSURE OF
ALL CLINICAL STUDIES BY PHARMACEUTICAL
COMPANIES
RESOLUTION 516 - FUNDING FOR FDA
PRESCRIPTION DRUG SURVEILLANCE
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
CSA Report 6 be amended by addition of a new
Recommendation 5 to read as follows:
5. That our AMA support adequate funding to implement
an improved FDA postmarketing prescription drug
surveillance process.
RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that CSA Report 6 be adopted as amended in lieu of
Resolutions 512 and 516.
HOD ACTION: Recommendations in Council on Scientific
Affairs Report 6 adopted as amended in lieu of Resolutions
512 and 516.
This Council on Scientific Affairs (CSA) report is in response to Resolution 529, that was
referred by the House of Delegates at the 2004 Annual Meeting. This CSA report
reviews the system for drug approval and postmarketing surveillance in the United
States, its legal requirements, the type of information available to the Food and Drug
Administration (FDA) and its public availability. It recommends specific actions for
enhancing the transparency of this process, particularly as it relates to the availability of
clinically relevant information that affects risk/benefit decisions involving the use of
prescription drug products.
Resolution 512 asks the AMA to support and pursue the enactment of federal legislation
that will require pharmaceutical companies to fully disclose all their studies.
Resolution 516 asks that the AMA support development of a more effective postmarketing drug surveillance program by the Food and Drug Administration and adequate
funding to implement the (recently) improved FDA post-market prescription drug
surveillance process.
Testimony noted the relationship of CSA Report 6 to current AMA policy which favors
the establishment of a comprehensive clinical trial registry that also contains links to trial
results. There was general agreement on the need for more transparency in the conduct
of clinical trials and the faithful reporting of results. Some believe that federal legislation
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is required to accomplish this task. Attention also must be directed to completing and
reporting the results of post-marketing studies. Additional areas that may deserve
increased scrutiny include the impact of Prescription Drug User Fees on FDA-decision
making, and potential conflicts of interest involving FDA Advisory Committee members.
A common theme expressed in testimony was the need for increased FDA funding and
resources to accomplish improvements in drug safety activities, particularly as they
relate to postmarketing surveillance programs and efforts. Your Reference Committee
does not believe our AMA needs to pursue the enactment of federal legislation at this
time, but notes that it may be helpful for our AMA staff to develop principles for
appropriate legislation in this area.
(12)
RESOLUTION 502 - MODIFYING DEA POSITION ON
SCHEDULE II PRESCRIPTIONS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the following Substitute Resolution 502 be adopted:
RESOLVED, That our American Medical Association
continue to work with the Drug Enforcement Administration
to change its policy so that a patient might receive a
reasonable number of “do not fill before…” Schedule II
prescriptions for those stable patients who require
Schedule II drugs. (Directive to Take Action)
HOD ACTION: Substitute Resolution 502 adopted.
Resolution 502 asks the AMA to: (1) work with Congress to change Drug Enforcement
Administration policy so that a patient might receive a reasonable number of “do not fill
before...” Schedule II prescriptions (perhaps 4-6 at maximum for those stable patients
who require Schedule II drugs; (2) urge all the state medical societies to work toward a
solution of this problem by contacting their congressional delegations; and (3) monitor
and systematically publicize in a timely fashion federal regulations that affect the practice
of medicine.
General support was offered for the clinical practice of pre-dating and issuing multiple
prescriptions in order to improve convenience and reduce hardships for patients with
chronic, but stable conditions that are amenable to therapy with controlled substances.
Testimony noted that our AMA has been engaged in ongoing discussions with the DEA
to foster an improved practice climate for physicians who routinely used controlled
substances in the management of their patients. Our AMA has also commented on the
issue raised in this resolution and is awaiting final DEA action on this matter. Under
these circumstances a reasonable approach is to continue working with the DEA to
resolve this issue to the satisfaction of our AMA and our Federation partners. Testimony
was not heard on the third resolve of Resolution 502, but this requirement would need
further study before implementing.
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(13)
RESOLUTION 504 - ADVERTISING FOR HERBAL
SUPPLEMENTS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the following Substitute Resolution 504 be adopted:
RESOLVED, That the naming, packaging, and advertising
of dietary supplement products be such that they cannot
be confused with pharmaceutical products, and be it
further
RESOLVED, That Policy H─150.954 be reaffirmed.
HOD ACTION: Substitute Resolution 504 adopted.
Resolution 504 asks our AMA to: (1) strongly encourage the naming of herbal
supplements in a manner so that they cannot be confused with prescription drugs by
including “herbal” in the name; (2) strongly discourage the packaging of herbal
supplements in a way that makes them resemble prescription drugs; (3) strongly
discourage the advertising of herbal supplements in a way that resembles prescription
drug advertisements; (4) work with the appropriate agencies to strengthen regulations
regarding the advertising and distribution of herbal supplements; (5) encourage the Food
and Drug Administration to require that all herbal supplements carry an ingredient list
similar to that required for foodstuffs and pharmaceuticals.
This resolution addresses the potential for consumers to confuse dietary supplements
(that are marketed as herbal remedies) with over-the-counter (OTC) drugs. Testimony
noted that the Federal Food, Drug, and Cosmetic Act requires that dietary supplements
be labeled using the term “dietary supplement” or an appropriately descriptive alternative
that reflects the ingredients (such as “herbal supplement’). With respect to the fifth
resolve, the labels of all dietary supplements (including herbal remedies) are already
currently required to bear an ingredient list and a “Supplement Facts” panel similar to the
“Nutrition Facts” panel for conventional foods. The Council on Scientific Affairs offered a
substitute resolution that condensed and simplified the first three resolves. Testimony
also noted that the packaging of some herbal supplements may be designed to enhance
the safety of the product, similar to the case with OTC drugs. Our AMA is already doing
much of what is asked for in the fourth resolve and so reaffirmation of Policy H-150.954
is appropriate.
H-150.954 Dietary Supplements and Herbal Remedies
(1) Our AMA will work with the FDA to educate physicians and the public about
FDA’s MedWatch program and to strongly encourage physicians and the public
to report potential adverse events associated with dietary supplements and
herbal remedies to help support FDA’s efforts to create a database of adverse
event information on these forms of alternative/complementary therapies.
(2) Our AMA continues to urge Congress to modify the Dietary Supplement
Health and Education Act to require that (a) dietary supplements and herbal
remedies including the products already in the marketplace undergo FDA
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approval for evidence of safety and efficacy; (b) meet standards established by
the United States Pharmacopeia for identity, strength, quality, purity, packaging,
and labeling; (c) meet FDA postmarketing requirements to report adverse events,
including drug interactions; and (d) pursue the development and enactment of
legislation that declares metabolites and precursors of anabolic steroids to be
drug substances that may not be used in a dietary supplement. (3) Our AMA
work with the Federal Trade Commission (FTC) to support enforcement efforts
based on the FTC Act and current FTC policy on expert endorsements. (4) That
the product labeling of dietary supplements and herbal remedies contain the
following disclaimer as a minimum requirement: "This product has not been
evaluated by the Food and Drug Administration and is not intended to diagnose,
mitigate, treat, cure, or prevent disease." This product may have significant
adverse side effects and/or interactions with medications and other dietary
supplements; therefore it is important that you inform your doctor that you are
using this product. (5) That in order to protect the public, manufacturers be
required to investigate and obtain data under conditions of normal use on
adverse effects, contraindications, and possible drug interactions, and that such
information be included on the label. (6) Our AMA continue its efforts to educate
patients and physicians about the possible ramifications associated with the use
of dietary supplements and herbal remedies. (Res. 513, I-98; Reaffirmed: Res.
515, A-99; Amended: Res. 501 & Reaffirmation I-99; Reaffirmation A-00;
Reaffirmed: Sub. Res. 516, I-00; Modified: Sub. Res. 516, I-00; Reaffirmed: Sub.
Res. 518, A-04).
(14)
RESOLUTION 510 - DISCRIMINATION AGAINST
DIABETICS
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the first resolve of Resolution 510 be amended by
insertion and deletion on lines 6 -7 to read as follows:
RESOLVED, That our American Medical Association
oppose forcing insulin requiring/dependent persons with
diabetes diabetics to remove themselves from public view
to and administer injections in unsanitary conditions (New
HOD Policy); and be it further
RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that the second resolve of Resolution 510 be amended by
insertion and deletion on lines 9 – 10 to read as follows:
RESOLVED, That our AMA oppose discrimination and
inappropriate restrictions against persons with diabetes
diabetics in both public and work places.
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RECOMMENDATION C:
Madam Speaker, your Reference Committee recommends
that Resolution 510 be adopted as amended.
RECOMMENDATION D:
Madam Speaker, your Reference Committee recommends
that the title of Resolution 510 be changed to read as
follows:
DISCRIMINATION AGAINST PERSONS WITH DIABETES
HOD ACTION: Resolution 510 adopted as amended with
change in title.
Resolution 510 asks the AMA to: (1) oppose forcing insulin requiring/dependent
diabetics to remove themselves from public view and administer injections in unsanitary
conditions; and (2) oppose discrimination and inappropriate restrictions against
diabetics.
There was limited but supportive testimony on this resolution. Amendments proposed to
improve the resolution were accepted by the sponsor of the resolution and have been
incorporated by your Reference Committee. Finally, your Reference Committee is
aware of a preference for the term “persons with diabetes” over “diabetics” and this is
also reflected in the above amendments.
(15)
RESOLUTION 511 - PROMOTION OF RAPID HIV TEST
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the first resolve of Resolution 511 be amended by
insertion and deletion on lines 21 – 25 to read as follows:
RESOLVED, That our American Medical Association work
with any and all local and state medical societies, and
other interested US and international organizations, to
increase access to and utilization of Food and Drug
Administration (FDA)-approved rapid HIV testing in
accordance with the quality assurance guidelines for rapid
HIV testing developed by the Centers for Disease Control
and Prevention (CDC) by personnel appropriately trained
in test administration. Additionally, pre- and post-test and
results counseling should be performed in accordance with
guidelines established by the CDC (Directive to Take
Action); and be it further
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RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that Resolution 511 be adopted as amended.
HOD ACTION: Resolution 511 adopted as amended.
Resolution 511 asks the AMA to: (1) work with any and all local and state medical
societies, and other interested US and international organizations, to increase access to
and utilization of Food and Drug Administration (FDA)-approved rapid HIV testing by
personnel appropriately trained in test administration and results counseling; and
(2) report back on its efforts to increase access to FDA-approved HIV rapid testing at the
2006 Interim Meeting.
While your Reference Committee only heard supportive testimony for this resolution,
there was concern expressed that the rapid HIV test as approved for use under the
CLIA-waived category came with specific restrictions stipulated by the FDA to assure the
quality of the test. Thus, your Reference Committee is aware that using a CLIA-waived,
rapid HIV test comes with the following restrictions: The purchaser must: (1) be a
clinical laboratory; (2) have an established quality assurance program; (3) provide
training for testing personnel using the manufacturer’s instructional materials; (4) provide
information to persons being tested by giving each a copy of the manufacturer’s “Subject
Information” pamphlet prior to specimen collection and appropriate information when
providing test results; and (5) not use the test to screen blood or tissue donors. Finally,
testimony pointed out that the CDC has recently developed guidelines to ensure quality
control
when
using
a
rapid
HIV
test
(available
at:
http://www.phppo.cdc.gov/DLS/pdf/HIV/QA_Guidlines_OraQuick.pdf). Accordingly, your
Reference Committee offers the above amendment to address these concerns.
(16)
RESOLUTION 514 - AVIAN AND OTHER INFLUENZA
PANDEMIC
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the second resolve of Resolution 514 be amended by
insertion and deletion on lines 33 – 34 to read as follows:
RESOLVED, That in order to prepare for a potential
influenza pandemic, our AMA lobby Congress and the
Administration to ensure that appropriate funding is
provided to the Centers for Disease Control and
Prevention (CDC), and the National Institutes of Health
(NIH), and other appropriate federal agencies, to support
implementation of an expanded capacity to produce the
necessary vaccines and anti-viral drugs and to continue
development of the nation’s capacity to rapidly vaccinate
the entire population and care for large numbers of
seriously ill people. (Directive to Take Action)
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RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that Resolution 514 be adopted as amended.
HOD ACTION: Resolution 514 adopted as amended.
Resolution 514 asks the AMA to: (1) strive to increase the number of people vaccinated
annually against influenza, particularly high risk patients, by working with appropriate
stakeholders to expand understanding among physicians and patients about who is
included in the “high risk” population; and (2) lobby Congress and the Administration to
ensure that appropriate funding is provided to the Centers for Disease Control and
Prevention (CDC) and the National Institutes of Health (NIH) to support implementation
of an expanded capacity to produce the necessary vaccines and anti-viral drugs and to
continue development of the nation’s capacity to rapidly vaccinate the entire population
and care for large numbers of seriously ill people.
Your Reference Committee heard only supportive testimony on this resolution.
Testimony reflected the urgent need to address the potential for an influenza pandemic
immediately and that this issue may indeed be one of the most important heard at this
Annual meeting. Your Reference Committee is aware that other federal agencies such
as the Food and Drug Administration and the National Vaccine Program Office are also
involved in influenza pandemic planning and the proposed amendment addresses this
concept.
(17)
RESOLUTION 517 - FLU VACCINE SUPPLY
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that Resolution 517 be amended by insertion and deletion
on lines 21 – 24 to read as follows:
RESOLVED, That our American Medical Association urge
the federal government to support, as a national priority,
the development of safe and effective influenza new
vaccines employing new technologies and to continue to
support adequate distribution to ensure that there will be
an affordable, available and safe supply of influenza
vaccine all vaccines, including flu, on an annual basis.
(Directive to Take Action)
RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that Resolution 517 be adopted as amended.
HOD ACTION: Resolution 517 adopted as amended.
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Resolution 517 asks the AMA to urge the federal government to support the
development of new vaccines employing new technologies and to continue to support
adequate distribution to ensure that there will be an affordable, available and safe supply
of all vaccines, including flu, on an annual basis.
Testimony presented indicated the importance of new technologies to develop influenza
vaccines, especially as part of influenza pandemic preparedness. It was suggested that
this was a national security issue. However, as influenza vaccines are developed
through new technologies, it is important to ensure that they remain safe and effective.
Your Reference Committee believes that the intent of testimony is covered by the
amendment proposed.
(18)
RESOLUTION 522 - AVAILABILITY OF CONTROLLED
SUBSTANCES VIA THE INTERNET
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the following Substitute Resolution 522 be adopted.
RESOLVED, That our American Medical Association work
with the Drug Enforcement Administration to undertake
discussions with e-commerce entities, including credit card
companies, with the aim of stopping the unregulated flow
of controlled substances over the Internet (in ways
comparable to the ways that have been successfully
employed to stem the flow of tobacco products to minors
over the Internet); (Directive to Take Action) and be it
further
RESOLVED, That our AMA develop model federal
legislation to regulate the sale of prescription drugs,
including controlled substances, over the Internet. The
model legislation should include the following elements:
Internet Pharmacy. Any seller of prescription drugs over
the Internet should be a licensed and Verified Internet
Pharmacy Practice Sites (VIPPS)- or HHS-certified
pharmacy, use only US licensed pharmacists to dispense
prescriptions, and dispense prescription drugs pursuant
only to valid prescriptions as defined below.
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Valid Prescription. A valid prescription must be authorized
by a US licensed physician and require a valid patientphysician relationship, as defined in AMA Policy H120.949;
Pharmacy Disclosure. Any Internet pharmacy should
disclose identifying information on its Web site home page;
at a minimum, this information should include name,
address, and telephone number of the pharmacy; states
(or countries) where the pharmacy is licensed; and names
of pharmacists and their states (or countries) of licensure.
Mandatory Certification. Any Internet pharmacy should
obtain mandatory certification, either through the VIPPS
program of the National Association of Boards of
Pharmacy (supported by the AMA in Policy H-120.956) or,
alternatively, by a certification program established by the
Secretary of HHS; certified Internet pharmacies should
show a seal that links back to the certifying body.
Requirements of ISPs. The federal government should
have the authority to require Internet Service Providers
(ISPs) (e.g., Google, Yahoo) to prevent access (linkage) to
noncertified Internet sites that sell prescription drugs.
Requirements of Credit Card Companies. The federal
government should have the authority to require credit card
companies (e.g., Visa, MasterCard) to prohibit transactions
with noncertified Internet sites that sell prescription drugs,
(Directive to Take Action), and be it further
RESOLVED, That our AMA reaffirm policies H-120.949
and H-120.956 which (1) contain criteria for an acceptable
patient (clinical encounter) when using the Internet in
prescribing medications; (2) urge our AMA to work with
federal regulatory bodies to closed down Internet web sites
of companies that are illegally promoting and distributing
prescription drug products in the United states; and (3)
work with state medical societies in urging state medical
boards to ensure high quality medical care by investigating
and, when appropriate, taking necessary action against
physicians who fail to meet the local standards of medical
care when issuing prescriptions through Internet web sites
that dispense prescription medications. (Reaffirmation of
Current Policy)
HOD ACTION: Substitute Resolution 522 adopted.
Resolution 522 asks our American Medical Association to: (1) affirm that when
prescription drugs are obtained via the Internet, that this occur only based on medical
necessity as confirmed by a face-to-face evaluation of the patient and the existence of a
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doctor-patient relationship between patient and prescriber, or a formal consultative or
cross-coverage relationship between the prescriber and the physician with whom the
patient has an existing doctor-patient relationship; (2) cooperate with the Drug
Enforcement Administration to develop and implement effective means to halt the
inappropriate sale of controlled substances over the Internet, especially to minors and
people with addictions to controlled substances; (3) undertake discussions with Ecommerce entities, including credit card companies, with the aim of stopping the
unscrupulous flow of controlled substances over the Internet (in ways comparable to the
ways that have been successfully employed to stem the flow of tobacco products to
minors over the Internet); and (4) encourage state medical licensing boards to
investigate and prosecute as indicated cases in which physicians agree to use their
medical license to authorize prescriptions of controlled substances to persons via the
Internet or other E-commerce means when they have failed to establish a doctor-patient
relationship with the purchaser of the pharmaceutical (unless they are in an established
cross-coverage relationship with the original prescriber who has an established doctorpatient relationship with the Internet or E-commerce purchaser, or have been formally
consulted by the original prescriber who has such an established doctor-patient
relationship).
Testimony noted the urgent need to address the burgeoning use of the Internet as an
source for the illegal purchase of controlled substances, and strong support was
expressed to clean up the Internet regarding the illegal sale of prescription drugs. The
availability of Federation of State Medical Boards (FSMB) guidelines on the criteria for
establishing a valid patient-physician relationship also was noted and legislation that
seeks to establish nationwide standards has been developed. Doubts were expressed
about the potential ability to actually clamp down on illegally operating Internet sites, but
others expressed optimism that an effective approach could be developed by targeting
credit card companies.
Your Reference Committee notes that much of Resolution 522 is embodied in current
AMA policies H-120.949 and H-120.956. Only the third resolve is not currently covered
in AMA policy. The primary problem is the lack of a federal law to regulate Internet sales
of prescription drugs. Our AMA has testified twice before Congress on this and the
Council on Legislation (COL) has developed some principles. The key needs of any
federal law were addressed in the text of BOT Report 3 (I-04)─Prescription Drug
Importation and Patient Safety; these are similar to the COL principles. Therefore, your
Reference Committee recommends a substitute resolution to initiate some immediate
actions involving credit card companies, reaffirmation of current policies which address
the first, second, and fourth resolves, and the criteria which should be used to craft an
effective federal approach.
(19)
RESOLUTION 525 - ELECTRONIC PRESCRIBING
RECOMMENDATION A:
Madam Speaker, your Reference Committee recommends
that the first resolve of Resolution 525 be amended by
insertion and deletion on lines 22 - 25 to read as follows:
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RESOLVED, That our American Medical Association ask
petition the Drug Enforcement Administration to accelerate
the promulgation of digital certificate standards for direct
electronic
transmission of controlled substance
prescriptions to support the patient safety goals and other
governmental initiatives (Directive to Take Action); and be
it further
RECOMMENDATION B:
Madam Speaker, your Reference Committee recommends
that the second resolve of Resolution 525 be amended by
insertion and deletion on lines 27 – 28 to read as follows:
RESOLVED, That our AMA urge petition Congress to work
towards unifying unify state prescription standards and
standard vocabularies to facilitate adoption of electronic
prescribing (Directive to Take Action) .
RECOMMENDATION C:
Madam Speaker, your Reference Committee recommends
that Resolution 525 be adopted as amended.
HOD ACTION: Resolution 525 adopted as amended.
Resolution 525 asks that our American Medical Association (AMA) petition the Drug
Enforcement Administration (DEA) to accelerate the promulgation of digital certificate
standards for direct electronic transmission of controlled substance prescriptions to
support the patient safety goals and other governmental initiatives and to unify state
prescription standards and standard vocabularies to facilitate adoption of electronic
prescribing.
Limited testimony on this resolution supported adoption. Your Reference Committee
has amended the resolution to reflect the proper action for our AMA to take with the DEA
and Congress.
(20)
RESOLUTION 529 - OPPOSITION TO PRESCRIPTION
PRIOR APPROVAL
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that the following Substitute Resolution 529 be adopted.
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RESOLVED, That our AMA urge public and private payers
who use prior authorization programs for prescription drugs
to minimize administrative burdens on prescribing
physicians (Directive to Take Action) .
RESOLVED, That Policies H-285.965─Managed Care
Cost Containment Involving Prescription Drugs and H125.985─Principles of
a Sound Drug Formulary be
reaffirmed (Reaffirmation of Current Policy) .
HOD ACTION: Substitute Resolution 529 adopted.
Resolution 529 asks that our American Medical Association oppose federal or state
agency and health plan prior approval processes for prescription medications and
advocate to have such processes abolished.
Testimony noted that prior authorization for prescription drugs is a real concern for
physicians since it is often a cost control mechanism of managed care. However, others
noted the reality that this concept is here to stay, at least for the foreseeable future. For
example, the new Medicare Part D drug benefit (which embraces the AMA’s Principles
of a Sound Drug Formulary) will allow and approve Prescription Drug Plans that use
prior authorization to control costs. Such programs currently are in widespread use by
Medicaid and private health plans/PBMs, and testimony from one state delegation
confirmed they can be helpful, although complaints were voiced about the role of PBM
bureaucracies as a contributor to increased drug costs. Current AMA policy generally
accepts prior authorization as a given and its goal has been to make it as least intrusive
to physicians as possible. There is also the question of whether Resolution 529
conflicts with spirit of H-125.985 that supports the Principles of a Sound Drug Formulary.
Thus, while recognizing the frustrations associated with this practice, your Reference
Committee believes that the most reasonable alternative would be to not totally reject
prior authorization, but advocate for an efficient process that minimizes administrative
burdens on physicians.
H-285.965 Managed Care Cost Containment Involving Prescription Drugs
(1) Physicians who participate in managed care plans should maintain
awareness of plan decisions about drug selection by staying informed about
pharmacy and therapeutics (P&T) committee actions and by ongoing personal
review of formulary composition. P&T committee members should include
independent physician representatives. Mechanisms should be established for
ongoing peer review of formulary policy. Physicians who perceive inappropriate
influence on formulary development from pharmaceutical industry consolidation
should notify the proper regulatory authorities. (2) Physicians should be
particularly vigilant to ensure that formulary decisions adequately reflect the
needs of individual patients and that individual needs are not unfairly sacrificed
by decisions based on the needs of the average patient. Physicians are ethically
required to advocate for additions to the formulary when they think patients would
benefit materially and for exceptions to the formulary on a case-by-case basis
when justified by the health care needs of particular patients. Mechanisms to
appeal formulary exclusions should be established. Other cost-containment
mechanisms, including prescription caps and prior authorization, should not
unduly burden physicians or patients in accessing optimal drug therapy. (3)
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Limits should be placed on the extent to which managed care plans use
incentives or pressures to lower prescription drug costs. Financial incentives are
permissible when they promote cost-effectiveness, not when they require
withholding medically necessary care. Physicians must not be made to feel that
they jeopardize their compensation or participation in a managed care plan if
they prescribe drugs that are necessary for their patients but that may also be
costly. There should be limits on the magnitude of financial incentives, incentives
should be calculated according to the practices of a sizable group of physicians
rather than on an individual basis, and incentives based on quality of care rather
than cost of care should be used. Physician penalties for non-compliance with a
managed care formulary in the form of deductions from withholds or direct
charges are inappropriate and unduly coercive. Prescriptions should not be
changed without physicians having a change to discuss the change with the
patient. (4) Managed care plans should develop and implement educational
programs on cost-effective prescribing practices. Such initiatives are preferable
to financial incentives or pressures by HMOs or hospitals, which can be ethically
problematic. (5) Patients must fully understand the methods used by their
managed care plans to limit prescription drug costs. During enrollment, the plan
must disclose the existence of formularies, the provisions for cases in which the
physician prescribes a drug that is not included in the formulary and the
incentives or other mechanisms used to encourage physicians to consider costs
when prescribing drugs. In addition, plans should disclose any relationships with
pharmaceutical benefit management companies or pharmaceutical companies
that could influence the composition of the formulary. If physicians exhaust all
avenues to secure a formulary exception for a significantly advantageous drug,
they are still obligated to disclose the option of the more beneficial, more costly
drug to the patient, so that the patient can decide whether to pay out-of-pocket.
(6) Research should be conducted to assess the impact of formulary constraints
and other approaches to containing prescription drug costs on patient welfare.
(7) Our AMA urges pharmacists to contact the prescribing physician if a
prescription written by the physician violates the managed care drug formulary
under which the patient is covered, so that the physician has an opportunity to
prescribe an alternative drug, which may be on the formulary. (8) When
pharmacists, insurance companies, or pharmaceutical benefit management
companies communicate directly with physicians or patients regarding
prescriptions, the reason for the intervention should be clearly identified as being
either educational or economic in nature. (9) Our AMA will develop model
legislation which prohibits managed care entities, and other insurers, from
retaliating against a physician by disciplining, or withholding otherwise allowable
payment because they have prescribed drugs to patients which are not on the
insurer’s formulary, or have appealed a plan’s denial of coverage for the
prescribed drug. (10) Our AMA urges health plans including managed care
organizations to provide physicians and patients with their medication formularies
through multiple media, including Internet posting. (11) In the case where
Internet posting of the formulary is not available and the formulary is changed,
coverage should be maintained until a new formulary is distributed. (12) For
physicians who do not have electronic access, hard copies must be available.
(CEJA Rep. 2, A-95; Res. 734, A-97; Appended by Res. 524 and Sub. Res.714,
A-98; Reaffimed: Res. 511, A-99; Modified: Res. 501, Reaffirmed: Res. 123 and
524, A-00; Modified: Res. 509, I-00; Reaffirmed: CMS Rep. 6, A-03;
Reaffirmation I-04)
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H-125.985 Expanded Use of the AMA’s Principles of a Sound Drug
Formulary
Our AMA urges managed care organizations, pharmacy benefit managers, and
others who design benefit packages and/or make pharmacy benefit decisions, to
utilize the Principles of a Sound Drug Formulary System (as described in BOT
Rep. 28, I-00) as they develop their pharmaceutical benefit plan(s) and that the
Principles of a Sound Drug Formulary System be readily available on the AMA
web site. (Res. 520, A-01; Amended: Res. 514, A-02; Reaffirmed: CSA Rep. 2,
A-04; Reaffirmation I-04)
(21)
RESOLUTION 507 - PROHIBIT DIRECT-TO-CONSUMER
PRESCRIPTION DRUG ADVERTISING
RESOLUTION 519 - BAN ON DIRECT-TO-CONSUMER
ADVERTISING OF PRESCRIPTION DRUGS
RESOLUTION 524 - DIRECT MARKETING OF
PHARMACEUTICALS
RESOLUTION 532 - DIRECT-TO-CONSUMER
ADVERTISING OF PHARMACEUTICAL PRODUCTS
RESOLUTION 533 - DIRECT-TO-CONSUMER
ADVERTISING OF PRESCRIPTION DRUGS AND FOOD
AND DRUG ADMINISTRATION-APPROVED MEDICAL
DEVICES
RESOLUTION 534 - TRUTH IN DIRECT-TO-CONSUMER
ADVERTISING
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolutions 507, 519, 524, 532, 533, and 534 be
referred.
HOD ACTION: Resolutions 507, 519, 524, 532, 533, and 534
referred.
Resolution 507 asks that the AMA recognize and support efforts to control direct-toconsumer advertising of prescription drugs and work to strengthen federal efforts to
more effectively regulate such advertising.
Resolution 519 asks that our American Medical Association recommend a ban on directto-consumer advertising of prescription drugs and Food and Drug Administration
regulated medical devices.
Resolution 524 asks that our American Medical Association lobby for a true accounting
in advertising under the auspices of the Food and Drug Administration and work for a
ban on advertisements for medications or nutritional supplements without convincing
scientific evidence of their effectiveness.
Resolution 532 asks that our American Medical Association: (1) review the experience to
date with direct-to-consumer advertising of pharmaceutical products and prepare a
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report estimating the increased expenditures directly attributable to such marketing
efforts, as well as the impact of direct-to-consumer advertising on prescribing patterns,
treatment compliance, patient safety and the quality of health care; and (2) review and
evaluate strategies designed to minimize the potential negative impact of direct-toconsumer advertising of pharmaceutical products, including, but not limited to, proposals
to establish a time-limited moratorium on such advertising following initial approval of a
medication by the Food and Drug Administration.
Resolution 533 asks that our American Medical Association oppose all direct-toconsumer advertising of prescription drugs and Food and Drug Administration-approved
medical devices.
Resolution 534 asks that our American Medical Association support the concept that the
Food and Drug Administration (FDA) require inclusion of comparative quality data in
direct to consumer advertising of drugs, thus creating a basis for more informed
consumer choice and encourage the FDA to develop new standards for drug advertising
to consumers that are grounded in data derived from systematic research.
The issue of direct-to-consumer advertising (DTCA) has been extensively debated at
previous HOD meetings and the HOD has previously rejected the concept that the AMA
should formally challenge the reality that DTCA is legal. While acknowledging this
probability, the point was made that the environment of drug safety has changed within
the last few years, and many believe that DTCA has contributed to an exacerbation of
patient safety problems. Thus, physician interest in banning this practice has gained
renewed momentum. In response, some companies have voluntarily moved to limit
advertisements during the first year of marketing. Testimony also noted that PhRMA is
currently reviewing their member guidance on DTCA.
Others re-emphasized that DTCA is not illegal, and that so long as advertisements meet
FDA regulations for content, it is unlikely that this form of advertising for prescription
drugs will diminish or be prohibited. On the other hand, even though current
advertisements may meet FDA regulations for content, many view current DTCA
practices as focusing too much on benefits while not emphasizing risks. Some medical
specialties continue to maintain that DTCA has beneficial effects related to patient
education and may prompt them to visit physicians for diagnosis and intervention.
Formal efforts to "ban" or "prohibit" legal activities are difficult and can have unintended
consequences. In this case, an attempt to ban or prohibit DTCA would require statutory
changes that would have to survive First Amendment challenges. Currently, clarification
is required about how DTCA affects the patient-physician relationship, whether it
provides educational value, how it affects consumer perceptions of prescription drugs,
and whether DTCA results in cost-effective health outcomes. The intent of current AMA
policy is both to help define what are satisfactory DTCA and to advocate for the
necessary research to assess the impact of DTCA on the patient-physician relationship
and on health and economic outcomes.
Resolution 532 asks AMA to do a study reviewing experience to date with DTCA and to
evaluate strategies to minimize potential negative impact. This would likely be a CSA
report. Thus, it is possible and preferable to refer all DTCA resolutions so that they can
be considered together in a new analysis of DTCA that can be used to update AMA
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policy and guidance on this issue. The sponsor of Resolution 524 agreed that it also
should be referred with these other items.
(22)
RESOLUTION 508 - PHYSICIANS AND NARCOTIC
PRESCRIPTIONS
RESOLUTION 539 - GUIDELINES FOR THE ETHICAL
MANAGEMENT OF PAIN
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolutions 508 and 539 be referred.
HOD ACTION: Resolutions 508 and 539 referred.
Resolution 508 asks the AMA to advise physicians in this country of the dangers
involved in the current prosecutorial atmosphere when physicians prescribe legal
narcotics.
Resolution 539 asks that our American Medical Association work with the Administration
to craft straightforward and specific guidelines for prescribing opioids for chronic pain
that are endorsed by the United States Drug Enforcement Administration (DEA) and
which communicate clearly the DEA position, based on documents developed through
consensus between DEA and physician policy groups.
While concerns remain in the physician community about the nature of investigations
directed at physicians who commonly prescribe opioid analgesics, most testimony
opposed adoption of Resolution 508, noting that it had the potential for serious
unintended consequences including an increase in the undertreatment of pain.
Nevertheless, physicians are troubled by recent actions of the DEA in first developing,
and then removing guidance (in the form of FAQs) on the use of opioids in pain
management. Despite attempts by the DEA to reassure physicians that they have
nothing to fear if they are engaging in legitimate practice, concerns remain. Our AMA
has been actively engaged with the DEA to maintain a dialogue that fosters a balanced
approach to facilitating appropriate pain management while minimizing diversion of
controlled substances. The DEA’s final disposition of their guidance for the appropriate
prescription of controlled substances is still forthcoming. Despite the intuitive appeal of a
collaborative approach with government agencies to develop “specific guidelines for
prescribing opioids for chronic pain,” concerns about the implications of any “safe
harbor” also were expressed. Therefore, your Reference Committee believes further
study of this issue is required and recommends referral.
(23)
RESOLUTION 515 - FOLIC ACID FORTIFICATION OF
GRAIN PRODUCTS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 515 be referred.
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HOD ACTION: Resolution 515 referred.
Resolution 515 asks the AMA to: (1) urge the Food and Drug Administration to
recommend the folic acid fortification of all grains marketed for human consumption,
including grains not carrying the “enriched” label; (2) write letters to domestic and
international producers of corn grain products, including masa, nixtamal, maize, and
pozole, to advocate for folic acid fortification of such products; and (3) amend existing
Policy H-440.898 as follows (additions underscored):
Our AMA will: (1) encourage the Centers for Disease Control and Prevention
(CDC) to continue to conduct surveys to monitor nutritional intake and the
incidence of neural tube defects (NTD); (2) continue to encourage broad-based
public educational programs about the need for women of child-bearing potential
to consume adequate folic acid through nutrition, food fortification, and vitamin
supplementation to reduce the risk of NTD; (3) encourage the CDC and the
National Institutes of Health to fund basic and epidemiological studies and clinical
trials to determine causal and metabolic relationships among homocysteine,
vitamins B12 and B6, and folic acid, so as to reduce the risks for and incidence of
associated diseases and deficiency states; (4) encourage research efforts to
identify and monitor those populations potentially at risk for masking vitamin B12
deficiency through routine folic acid supplementation of enriched food products;
(5) urge the Food and Drug Administration to increase folic acid fortification to 350
µg per 100 g of enriched cereal grain; and (6) encourage the FDA to require food,
food supplement, and vitamin labeling to specify milligram content, as well as
RDA levels, for critical nutrients, which vary by age, gender, and hormonal status
(including anticipated pregnancy); and (7) encourage the FDA to recommend the
folic acid fortification of all grains marketed for human consumption, including
grains not carrying the “enriched” label.
Your Reference Committee heard limited testimony in support of this resolution and thus
was left with several questions regarding the ramifications of fortifying all grain products
intended for human consumption. While there is evidence that fortification of grains has
helped to reduce the incidence of NTDs in this country, your Reference Committee is
aware of recent studies indicating that folic acid intake from fortified foods is more than
twice the level originally predicted. These findings have prompted calls for studies on
long term effects of elevated folic acid intake, especially in those people who do not
have to worry about bearing children.
(24)
RESOLUTION 528 - PAIN CARE FOR PATIENTS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 528 be referred.
HOD ACTION: Resolution 528 referred.
Resolution 528 asks that our American Medical Association: (1) acknowledge the
existence of neuropathic pain resulting from neurobiological pathology, as established in
the scientific literature: (2) educate physicians, patients, payers, legislators and
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regulators to increase their understanding of both nociceptive pain and particularly
neuropathic pain; and (3) work with appropriate specialty societies and report on the
appropriate epidemiology, evaluation, treatment, and distinguishing characteristics of
nociceptive pain and neuropathic pain.
Testimony noted the broad support for this resolution by a number of cosponsors. Our
AMA has devoted significant resources to improving pain management, including
development of previous reports, interaction with the Federation of State Medical Boards
as it developed its Model Guidelines, and a web-based CME program. These activities
have focused primarily on acute pain management. There is an urgent need to address
chronic pain syndromes, including neuropathic pain. Most of the testimony supported
referral as the most appropriate disposition of Resolution 528 and your Reference
Committee concurs.
(25)
RESOLUTION 530 - NATIONAL MINIMUM NEWBORN
SCREENING RECOMMENDATIONS
Madam Speaker, your Reference Committee recommends
that Resolution 530 be referred.
HOD ACTION: Resolution 530 referred.
Resolution 530 asks that our American Medical Association: (1) support and recognize a
need for uniform minimum newborn screening (NBS) recommendations: (2) encourage
continued research on the benefits of NBS for certain diseases and the development of
new NBS technology; and (3) recommend the adoption of a national minimum uniform
screening panel for newborns by establishment of model state legislation and
encouragement of legislation for adoption by Congress, pending completion and a
review of the evaluation by the Advisory Committee on Heritable Disorders and Genetic
Diseases in Newborns and Children.
Your Reference Committee heard limited testimony against this resolution. Testimony
also pointed out that a final version of a report sponsored by the Department of Health
and Human Services is due for release within the next few months describing model
policies and procedures designed to equalize NBS programs, including a panel of
recommended disorders for inclusion in all state screening programs. It is anticipated
that this report will provide much-needed insights for addressing the many potential
hurdles facing expansion of NBS efforts in this country, including the limited financial
resources available to state programs and the added strain increased testing would
place on the current public health infrastructure in many states. Finally, the Council on
Scientific Affairs indicated that they were already in the process of preparing a report on
this matter and asked for referral of this resolution. Your Reference Committee concurs.
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(26)
RESOLUTION 503 - PHARMACEUTICAL REBATES TO
NURSING HOME PHARMACIES
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 503 be referred for decision.
HOD ACTION: Resolution 503 referred for decision.
Resolution 503 asks the AMA to adopt the position that nursing home pharmacies
should not accept pharmaceutical company rebates requiring nursing home physicians
to utilize specific drugs while disregarding the quality and effectiveness of other drugs,
where the rebate is accepted solely for economic reasons.
Only testimony from the sponsor of the resolution was heard. However, your Reference
Committee is aware of the potential complexity of this issue. Typically in an outpatient
setting, a third party payer that runs a pharmacy benefit plan will get rebates from
pharmaceutical companies and give the company’s product preferred status on the
plan’s formulary. Many of the contracts have some form of sliding scale that increases
the rebate from the manufacturer as certain product market share goals are met by the
plan.
In Resolution 503, the authors appear to be stating that long-term care (LTC)
pharmacies are negotiating these rebates for market share goals, and then the same
pharmacies are trying to move physicians to use these drugs regardless of whether they
are best for patients. If that is true, then the pharmacy has a conflict between its primary
goal of optimum patient care and an economic incentive to meet the market share goals.
Additionally, the legality for a pharmacy to receive a financial reward from a drug
company to favor its products must be questioned.
On the other hand, if the LTC facility actually includes the pharmacy within the facility,
then this is more typical of a hospital model. Hospitals routinely negotiate on the price of
drugs and have preferred drugs on the hospital formulary. In this case, our AMA’s drug
formulary policy (H-125.991) would apply and the rebates may be acceptable if medical
staff oversight is in place and other AMA formulary standards are met.
Accordingly, in order that clarification on the resolution can be obtained and the correct
action taken, your Reference Committee believes referral for decision to be the most
appropriate recommendation.
(27)
RESOLUTION 513 - SUPPORT FOR A NATIONAL
CENTER ON PAIN RESEARCH
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 513 be referred for decision.
HOD ACTION: Resolution 513 referred for decision.
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Resolution 513 asks the AMA to: (1) support the development of a center or institute for
pain research, similar to that described in the National Pain Care Act of 2003 (HR 1863),
that would assist in the distribution of funding toward more clinical and basic science
research regarding the treatment as well as the biology of pain; and (2) support efforts to
create public awareness on responsible pain management, symptom management, and
palliative care.
Your Reference Committee is in agreement with the significant testimony urging
additional funding for pain research, public education, symptom management, and
palliative care. The benefit of consolidating all pain research under one center was also
discussed. However there was contrary testimony suggesting that a national center for
pain within the National Institutes of Health (NIH) may not be the best way to increase
funding of this important issue. Our AMA’s Council on Legislation recommended
amending the resolution to remove specific reference to a congressional bill.
Your Reference Committee’s recommendation for referral for decision was based on
information presented that the NIH is currently in the process of consolidating its Centers
and Institutes. Thus, the timing of this resolution may be inopportune and adoption may
result in our AMA being perceived as not being sensitive to the issues currently
underway at the NIH. Accordingly, your Reference Committee recommends referral for
decision where all factors pertaining to this important issue can be properly considered.
(28)
RESOLUTION 505 - REQUEST TO STUDY THE
FEASIBILITY OF IMPLEMENTING AN AMA PATIENT
SAFETY DATABASE
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 505 not be adopted.
HOD ACTION: Resolution 505 not adopted.
Resolution 505 asks our AMA to study the feasibility of creating and implementing a
national patient safety error reporting database incorporating existing policy guidelines.
The sponsor of the resolution offered an amendment that would have reduced the fiscal
note substantially. However, your Reference Committee also heard much testimony on
the potential pitfalls of initiating discussion on a national patient safety database as
described in the resolution. While the sponsor was lauded for the intent of the
resolution, it was noted that such a database could be abused especially if it were
created with no safeguards for physician protection and no method to limit all peer
review from legal scrutiny.
Additionally, testimony also highlighted the National Quality Forum’s (NQF) current
initiative on patient safety. The NQF has assembled a group of experts comprising
many diverse stakeholders to put together a national standardized taxonomy on patient
safety that would facilitate the management of patient safety data across reporting
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systems and should support patient safety data management innovation. Finally, it was
pointed out that our AMA already has strong policy on patient safety.
For all these reasons, your Reference Committee believes that Resolution 505 should
not be adopted.
(29)
RESOLUTION 509 - FOOD AND DRUG
ADMINISTRATION STANDARD FOR APPROVAL OF
NEW DRUGS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 509 not be adopted.
HOD ACTION: Resolution 509 not adopted.
Resolution 509 asks the AMA work with congressional legislators to introduce legislation
for increased Food and Drug Administration pharmaceutical approval standards
requiring clinical trials that demonstrate the effectiveness and safety of these drugs in
comparison to standard therapy, active controls and placebos.
This resolution was presented as a “pro-patient/pro-physician” approach based on the
need for comparative drug efficacy and safety data to inform physician-decision making.
While discussants expressed support for the concept of enhanced access to
comparative information, most were skeptical about the role of the FDA drug approval
process in this quest. Not all drugs are studied just against placebo; many drugs are
already compared with standard therapy as part of the drug approval process. Several
other pitfalls were noted including creating a more restrictive drug approval process and
substantially increasing the cost of drug development and clinical trials. Others noted
that although the resolution is based on a fundamental assumption that “me-too” drugs
are inherently limited in value, many circumstances exist where this is not the case for
individual patients. Although physician practice and patient care can be enhanced by
the conduct of comparative studies, this goal should not be accomplished by burdening
the drug development process.
(30)
RESOLUTION 538 - MERCURY AND FISH
CONSUMPTION: MEDICAL AND PUBLIC HEALTH
ISSUES
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Resolution 538 not be adopted.
AMA policy is that: (1) Women who might become pregnant, are pregnant, or
who are nursing should follow federal, state and or local advisories on fish
consumption. Because some types of fish are known to have much lower than
average levels of methlymercury and can be safely consumed more often and in
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larger amounts, women should also seek specific consumption
recommendations from those authorities regarding locally caught or sold fish.
Because these advisories may differ, the most protective advisory should be
followed.
HOD ACTION: Resolution 538 adopted as amended.
Resolution 538 asks that our American Medical Association amend Policy H-150.947[1]
by insertion and deletion as follows:
AMA policy is that: (1) Women who might become pregnant, are pregnant, or
who are nursing should follow federal, state, and local advisories on fish
consumption. Some kinds of fish that are known to have much lower than
average levels of methylmercury can be safely eaten more frequently and in
larger amounts. Physicians should contact your federal, state, or local health or
food safety authority for specific consumption recommendations about fish
caught or sold in your local area. Because these advisories may differ, the most
protective advisory should be followed.
Testimony was only heard from the sponsor and one other witness. Your Reference
Committee sympathizes with the sponsor’s concern that the current AMA policy may
place their state in a uncomfortable position because its fish population is of lower
average levels of methylmercury and that their indigenous population may consume far
greater levels of fish than the average American. However, it agrees with opposing
testimony that the current resolution places too much onus on the physician to identify
the source of fish being consumed in their own locality. In states where many types of
fish are imported, this task may be impossible to accomplish. Your Reference
Committee is concerned that the resolution would also weaken the protections afforded
for a most vulnerable population of the public, pregnant women, and that, for this
population, a more conservative policy on fish consumption is proper. Finally, your
Reference Committee also believes that there is leeway in current policy to allow the
small populations residing in areas where fish is low in methylmercury content to
consume more fish than may be recommended in more general federal guidelines.
(31)
RESOLUTION 520 - EXPANSION OF FDA'S MISSION
AND AUTHORITY
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that Policy H-150.954 be reaffirmed in lieu of Resolution
520.
HOD ACTION: Policy H-150.954 reaffirmed in lieu of
Resolution 520.
Resolution 520 asks that our American Medical Association endorse efforts to expand
the Food and Drug Administration’s (FDA) mission and authority to include the full
spectrum of “alternative and complementary medicines” plus a still wider range of ‘food
additives and dietary supplements’ with special emphasis on the issue of chemical
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safety and that our AMA actively lobby the Congress and other appropriate national
health organizations for the introduction of appropriate legislation to accomplish this
task.
Your Reference Committee heard significant testimony that this resolution presents
another unfunded mandate to the Food and Drug Administration (FDA). Other testimony
specified that this resolution would “even the playing field” between physicians and the
practitioners of alternative and complementary medicine. However, your Reference
Committee is concerned that it is not clear what would encompass the “full spectrum” of
alternative and complementary medicine and that some complementary medicine
practices that may be recommended by physicians would fall into this gray area. While
the FDA has the regulatory authority over many products, including drugs, foods, and
medical and some other devices, food additives, and dietary supplements, because the
laws vary for each type of product, the level of regulation varies. Significantly, the FDA
does not have regulatory authority over procedures or professional practices, whether it
is an allopathic physician or a complementary medicine practitioner (e.g., chiropractor or
naturopath).
Thus, in order to accomplish what the resolution asks, the existing Dietary Supplement
Health Education Act (DSHEA) would have to be repealed. Our AMA’s goal has been to
change DSHEA to make the regulation of dietary supplements comparable to the drug
model and your Reference Committee is aware of significant effort by our AMA to
address the inadequacies of DSHEA.
Some testimony expressed concern over the inherent danger in giving the FDA too
much power over all complementary medicine as this could open the door for the FDA to
also have full authority over physician prescribing and off-label prescribing. Other
testimony supported the concept that our AMA should constantly support a strong and
adequately funded FDA that has sufficient regulatory authority to effectively regulate
medical products and foods.
Finally, your Reference Committee heard significant testimony supporting reaffirmation
of existing AMA policy on dietary supplements and DSHEA in lieu of this resolution and
agrees with this course of action.
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H-150.954 Dietary Supplements and Herbal Remedies
(1) Our AMA will work with the FDA to educate physicians and the public about
FDA’s MedWatch program and to strongly encourage physicians and the public
to report potential adverse events associated with dietary supplements and
herbal remedies to help support FDA’s efforts to create a database of adverse
event information on these forms of alternative/complementary therapies. (2)
Our AMA continues to urge Congress to modify the Dietary Supplement Health
and Education Act to require that (a) dietary supplements and herbal remedies
including the products already in the marketplace undergo FDA approval for
evidence of safety and efficacy; (b) meet standards established by the United
States Pharmacopeia for identity, strength, quality, purity, packaging, and
labeling; (c) meet FDA postmarketing requirements to report adverse events,
including drug interactions; and (d) pursue the development and enactment of
legislation that declares metabolites and precursors of anabolic steroids to be
drug substances that may not be used in a dietary supplement. (3) Our AMA
work with the Federal Trade Commission (FTC) to support enforcement efforts
based on the FTC Act and current FTC policy on expert endorsements. (4) That
the product labeling of dietary supplements and herbal remedies contain the
following disclaimer as a minimum requirement: "This product has not been
evaluated by the Food and Drug Administration and is not intended to diagnose,
mitigate, treat, cure, or prevent disease." This product may have significant
adverse side effects and/or interactions with medications and other dietary
supplements; therefore it is important that you inform your doctor that you are
using this product. (5) That in order to protect the public, manufacturers be
required to investigate and obtain data under conditions of normal use on
adverse effects, contraindications, and possible drug interactions, and that such
information be included on the label. (6) Our AMA continue its efforts to educate
patients and physicians about the possible ramifications associated with the use
of dietary supplements and herbal remedies. (Res. 513, I-98; Reaffirmed: Res.
515, A-99; Amended: Res. 501 & Reaffirmation I-99; Reaffirmation A-00;
Reaffirmed: Sub. Res. 516, I-00; Modified: Sub. Res. 516, I-00; Reaffirmed: Sub.
Res. 518, A-04)
(32)
RESOLUTION 535 - AMA ENDORSEMENT OF
APPROPRIATELY DEVELOPED PREFERRED DRUG
LISTS
RECOMMENDATION:
Madam Speaker, your Reference Committee recommends
that AMA Policies H-125.985 and H-125.991 be reaffirmed
in lieu of Resolution 535.
HOD ACTION: AMA Policies H-125.985 and H-125.991
reaffirmed in lieu of Resolution 535.
Resolution 535 asks that our American Medical Association support the concept of
evidence-based Preferred Drug Lists that identify preferred drugs within classes that
have first been compared for effectiveness and safety; and then given they are
equivalent, take cost into consideration.
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Discussion on this item included several elements central to the formulary development
and drug selection process including the proliferation of “me-too” drugs; the impact of
pharmaceutical detailing activities; implications of restrictive formularies for patient
management; the lack of a comparative evidence-base for many drugs or drug groups;
inappropriate uses of “preferred-drug lists” (PDLs) as a mechanism to pare drug costs;
and the limited relevance of PDLs to many drug groups including HIV therapies,
oncologic products, and many psychotropic medications. Additionally, many racial,
ethnic, and pharmacogenomic factors exist that impact drug disposition and patient
response to the extent that the design and clinical use of PDLs can be detrimental for
certain individuals.
Ethical Opinion 8.135 notes that when health care plans, whether publicly or privately
financed, establish drug formulary systems, physicians are obligated to advocate for
formularies that meet the medical needs of their patients. When scientifically based
evidence is available, physicians are ethically required to advocate for changes to the
formulary that would benefit the patient. Quality improvement rather than cost
containment should be the primary determinant for formulary exclusions. In order to be
cost efficient, however, physicians should select the lowest cost medication of equal
efficacy for their patients.
Our AMA’s Principles of a Sound Drug Formulary System, and current AMA policies H125.991 and H-125.985 embody the concept that formulary construction should be
evidence-based and not driven solely by cost considerations. The Principles document
states that formulary decisions should be based on cost factors “only after the safety,
efficacy and therapeutic needs have been established. Therefore, your Reference
Committee recommends reaffirmation of the relevant policies.
H-125.985 Expanded Use of the AMA’s Principles of a Sound Drug
Formulary
Our AMA urges managed care organizations, pharmacy benefit managers, and
others who design benefit packages and/or make pharmacy benefit decisions, to
utilize the Principles of a Sound Drug Formulary System (as described in BOT
Rep. 28, I-00) as they develop their pharmaceutical benefit plan(s) and that the
Principles of a Sound Drug Formulary System be readily available on the AMA
web site. (Res. 520, A-01; Amended: Res. 514, A-02; Reaffirmed: CSA Rep. 2,
A-04; Reaffirmation I-04)
H-125.991 Drug Formularies and Therapeutic Interchange
It is the policy of the AMA: (1) That the following terms be defined as indicated:
(a) Formulary: a compilation of drugs or drug products in a drug inventory list;
open (unrestricted) formularies place no limits on which drugs are included
whereas closed (restrictive) formularies allow only certain drugs on the list; (b)
Formulary system: a method whereby the medical staff of an institution, working
through the pharmacy and therapeutics committee, evaluates, appraises, and
selects from among the numerous available drug entities and drug products
those that are considered most useful in patient care; (c) Pharmacy &
Therapeutics (P&T) Committee: an advisory committee of the medical staff that
represents the official, organizational line of communication and liaison between
the medical staff and the pharmacy department; its recommendations are subject
to medical staff approval; (d) Therapeutic alternates: drug products with different
chemical structures but which are of the same pharmacological and/or
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therapeutic class, and usually can be expected to have similar therapeutic effects
and adverse reaction profiles when administered to patients in therapeutically
equivalent doses; (e) Therapeutic interchange: authorized exchange of
therapeutic alternates in accordance with previously established and approved
written guidelines or protocols within a formulary system; and (f) Therapeutic
substitution: the act of dispensing a therapeutic alternate for the drug product
prescribed without prior authorization of the prescriber. (2) That our AMA
reaffirms its opposition to therapeutic substitution (dispensing a therapeutic
alternate without prior authorization) in any patient care setting. (3) That drug
formulary systems, including the practice of therapeutic interchange, are
acceptable in inpatient hospital and other institutional settings that have an
organized medical staff and a functioning Pharmacy and Therapeutics (P&T)
Committee, provided they satisfy the following standards: (a) The formulary
system must: (i) have the concurrence of the organized medical staff; (ii) openly
provide detailed methods and criteria for the selection and objective evaluation of
all available pharmaceuticals; (iii) have policies for the development,
maintenance, approval and dissemination of the drug formulary and for
continuous and comprehensive review of formulary drugs; (iv) provide protocols
for the procurement, storage, distribution, and safe use of formulary and nonformulary drug products; (v) provide active surveillance mechanisms to regularly
monitor both compliance with these standards and clinical outcomes where
substitution has occurred, and to intercede where indicated; (vi) have enough
qualified medical staff, pharmacists, and other professionals to carry out these
activities; (vii )provide a mechanism to inform the prescriber in a timely manner of
any substitutions, and that allows the prescriber to override the system when
necessary for an individual patient without inappropriate administrative burden;
(viii) provide a mechanism to assure that patients/guardians are informed of any
change from an existing outpatient prescription to a formulary substitute while
hospitalized, and whether the prior medication or the substitute should be
continued upon discharge from the hospital; (ix) include policies that state that
practitioners will not be penalized for prescribing non-formulary drug products
that are medically necessary; and (x) be in compliance with applicable state and
federal statutes and/or state medical board requirements. (b) The P&T
Committee must: (i) objectively evaluate the medical usefulness and cost of all
available pharmaceuticals (reliance on practice guidelines developed by
physician organizations is encouraged); (ii) recommend for the formulary those
drug products which are the most useful and cost-effective in patient care; (iii)
conduct drug utilization review (DUR) activities; (iv) provide pharmaceutical
information and education to the organization's (e.g., hospital) staff; (v) analyze
adverse results of drug therapy; (vi) make recommendations to ensure safe drug
use and storage; and (vii) provide protocols for the timely procurement of nonformulary drug products when prescribed by a physician for the individualized
care of a specific patient, when that decision is based on sound scientific
evidence or expert medical judgment.
(c) The P&T Committee's
recommendations must be approved by the medical staff; (d) Within the drug
formulary system, the P & T Committee shall recommend, and the medical staff
must approve, all drugs that are subject to therapeutic interchange, as well as all
processes or protocols for informing individual prescribing physicians; and (e)
The act of providing a therapeutic alternate that has not been recommended by
the P&T Committee and approved by the medical staff is considered
unauthorized therapeutic substitution and requires immediate prior consent by
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the prescriber; i.e., authorization for a new prescription. (4) That drug formulary
systems in any outpatient setting shall operate under a P&T Committee whose
recommendations must have the approval of the medical staff or equivalent
body, and must meet standards comparable to those listed above. In addition:
(a) That our AMA continues to insist that managed care and other health plans
identify participating physicians as their "medical staff" and that they use such
staff to oversee and approve plan formularies, as well as to oversee and
participate on properly elected P&T Committees that develop and maintain plan
formularies; (b) That our AMA continues to insist that managed care and other
health plans have well-defined processes for physicians to prescribe nonformulary drugs when medically indicated, that this process impose minimal
administrative burdens, and that it include access to a formal appeals process for
physicians and their patients; and (c) That our AMA strongly recommends that
the switching of therapeutic alternates in patients with chronic diseases who are
stabilized on a drug therapy regimen be discouraged. (5) That our AMA
encourages mechanisms, such as incentive-based formularies with tiered copays, to allow greater choice and economic responsibility in drug selection, but
urges managed care plans and other third party payers to not excessively shift
costs to patients so they cannot afford necessary drug therapies. (BOT Rep. 45,
I-93; Reaffirmed by Sub. Res. 501, A-95; Appended: BOT Rep. 7, I-99; Modified:
Sub. Res. 524 and Reaffirmed: Res. 123, A-00; Reaffirmed: Res. 515, I-00;
Reaffirmed: CMS Rep. 8, A-02; Reaffirmed: Res. 533, A-03; Modified: CMS Rep.
6, A-03; Modified: CSA Rep. 2, A-04; Reaffirmation I-04)
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Madam Speaker, this concludes the report of Reference Committee E. I would
like to thank Sandy Chira, MD, Richard A. Wherry, MD, Maryam M. Asgari, MD,
MPH, John R. McGill, MD, Jack F. Menendez, MD, Edward H. Dench, Jr., MD,
and all those who testified before the Committee.
Sandy Chira
Rhode Island
John R. McGill, MD
American Society of Plastic Surgeons
Richard A. Wherry, MD
American Academy of Family
Physicians
Jack F. Menendez, MD
Georgia
Maryam M. Asgari, MD, MPH (Alternate)
American Academy of Dermatology
Edward H. Dench, Jr, MD
Pennsylvania
Daniel W. van Heeckeren, MD
Ohio
Chair