Legislature(2005 - 2006)CAPITOL 106
04/06/2006 03:00 PM House HEALTH, EDUCATION & SOCIAL SERVICES
| Audio | Topic |
|---|---|
| Start | |
| HB467 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 467 | TELECONFERENCED | |
| += | SB 177 | TELECONFERENCED | |
| += | HB 482 | TELECONFERENCED | |
| = | HJR 30 | ||
| + | TELECONFERENCED |
ALASKA STATE LEGISLATURE
HOUSE HEALTH, EDUCATION AND SOCIAL SERVICES STANDING COMMITTEE
April 6, 2006
3:04 p.m.
MEMBERS PRESENT
Representative Peggy Wilson, Chair
Representative Paul Seaton, Vice Chair
Representative Carl Gatto
Representative Vic Kohring
Representative Sharon Cissna
Representative Berta Gardner
MEMBERS ABSENT
Representative Tom Anderson
COMMITTEE CALENDAR
HOUSE BILL NO. 467
"An Act relating to the administration of prescribed remedies
and dietary supplements by a nurse."
- HEARD AND HELD
SENATE BILL NO. 177
"An Act eliminating the requirement that persons using titles or
descriptions of services that incorporate the terms
'psychotherapy,' 'psychotherapeutic,' or 'psychotherapist' be
licensed by the Board of Psychologist and Psychological
Associate Examiners."
- SCHEDULED BUT NOT HEARD
HOUSE BILL NO. 482
"An Act relating to harassment, intimidation, and bullying in
schools."
- SCHEDULED BUT NOT HEARD
HOUSE JOINT RESOLUTION NO. 30
Relating to public health and a prevention compact.
- BILL HEARING CANCELED
PREVIOUS COMMITTEE ACTION
BILL: HB 467
SHORT TITLE: ADMINISTRATION OF MEDICATION BY A NURSE
SPONSOR(s): REPRESENTATIVE(s) KELLY
02/13/06 (H) READ THE FIRST TIME - REFERRALS
02/13/06 (H) HES, FIN
03/28/06 (H) HES AT 3:00 PM CAPITOL 106
03/28/06 (H) <Bill Hearing Postponed to 03/30/06>
03/30/06 (H) HES AT 3:00 PM CAPITOL 106
03/30/06 (H) -- Meeting Canceled --
04/04/06 (H) HES AT 3:00 PM CAPITOL 106
04/04/06 (H) <Bill Hearing Postponed to 04/06/06>
04/06/06 (H) HES AT 3:00 PM CAPITOL 106
WITNESS REGISTER
DEREK MILLER, Staff
to Representative Michael "Mike" Kelly
Alaska Legislature
POSITION STATEMENT: Presented HB 467 on behalf of
Representative Kelly, sponsor.
CATHERINE GIESSEL, Registered Nurse (RN)
Advanced Nurse Practitioner;
Chairperson, Alaska Board of Nursing
Anchorage, Alaska
POSITION STATEMENT: Testified in opposition of HB 467.
GENA EDMISTON, Registered Nurse (RN)
Associate Administrator
Denali Long-term Care Center
Fairbanks Memorial Hospital
Fairbanks, Alaska
POSITION STATEMENT: Testified in support of HB 467.
RICK SCHIKORA, Certified Public Accountant (CPA)
Fairbanks, Alaska
POSITION STATEMENT: Testified in support of HB 467.
MIKE POWERS, Administrator
Fairbanks Memorial Hospital
Fairbanks, Alaska
POSITION STATEMENT: Testified in support of HB 467.
CHARLOTTE DAVIS, Registered Nurse (RN)
Fairbanks, Alaska
POSITION STATEMENT: Testified in opposition to HB 467.
VIRGINIA SMILEY, Director
Division of Pioneer Homes
Department of Health and Social Services (DHSS)
Juneau, Alaska
POSITION STATEMENT: Testified in support of HB 467.
NANCY DAVIS, Registered Nurse (RN)
Representative
Alaska Nurses Association (ANA)
Juneau, Alaska
POSITION STATEMENT: Testified in opposition to HB 467.
ROD BETIT, President
Alaska State Nursing Home Association (ASNHA)
Juneau, Alaska
POSITION STATEMENT: Testified in support of HB 467.
ACTION NARRATIVE
CHAIR PEGGY WILSON called the House Health, Education and Social
Services Standing Committee meeting to order at 3:04:48 PM.
Representatives Seaton, Gatto, Cissna, and Wilson were present
at the call to order. Representatives Kohring and Gardner
arrived as the meeting was in progress.
HB 467-ADMINISTRATION OF MEDICATION BY A NURSE
3:05:40 PM
CHAIR WILSON announced that the first order of business would be
HOUSE BILL NO. 467, "An Act relating to the administration of
prescribed remedies and dietary supplements by a nurse."
3:06:10 PM
CHAIR WILSON stated that her intention would be to hear and hold
HB 467, to allow continued committee discussion.
REPRESENTATIVE SEATON moved to adopt HB 467, Version 24-
LS1265\G, as the working document. There being no objection,
Version G was before the committee.
3:07:10 PM
DEREK MILLER, Staff to Representative Michael "Mike" Kelly,
Alaska Legislature, sponsor, introduced HB 467 on behalf of
Representative Kelly, paraphrasing from a written statement,
which read as follows [original punctuation provided]:
Before you today is HB 467. This bill was introduced
with the goal of working out a reasonable solution to
the current Board of Nursing policy that prevents most
registered nurses in the state of Alaska from
administering prescribed remedies and dietary
supplements for patients in a nursing facility, an
assisted-living home, or an Alaska Pioneers' Home. In
recent years the Board of Nursing has determined that
it is outside of the scope of practice for a nurse to
administer remedies that are not FDA approved even if
the patient requests them, the doctor prescribes them,
and the facility has approved written procedures for
administering them. We believe this is too
restrictive and HB 467 would allow nurses to
administer such remedies provided that it is a
prescribed remedy or dietary supplement administered
within the manufacturer's recommended dosage.
This legislation was introduced after Rep. Kelly
received a letter from Rick Schikora in Fairbanks.
Mr. Schikora's grandmother lives in the Fairbanks
Pioneer Home and she has bad knees and dementia. Her
doctor prescribed glucosamine and fish oil pills and
nurses were willing to administer them, but because of
the Board of Nursing decision, the Pioneer Home
discontinued their administration. Mr. Schikora was
forced to go to the Pioneer Home daily to give her the
prescribed remedies.
This seems to just make good sense to fix this problem
and we have found many lay and professional folks who
agree. We think current policy is not in the best
interest of the patient and we propose a common sense
solution. Other states have found ways to safely
administer these supplements and HB 467 would permit
Alaska to do the same.
3:08:55 PM
REPRESENTATIVE SEATON referred to page 1, line 14, and page 2,
lines 1-2, and read, "'prescribed remedy or dietary supplement'"
includes over-the-counter, herbal, and vitamin remedies
prescribed by a person authorized under this title to prescribe
the remedy or supplement." He asked who would be authorized
under this title to prescribe remedies or supplements; would
more than one category of persons be identified to prescribe;
and do supplements generally require prescriptive authority
prior to purchase.
MR. MILLER responded that prescriptive authorization would be
required for the administration of supplements in this context,
and that the prescription would be written by a physician. He
stated that there may be other individuals who would be provided
prescriptive authority under this statute.
3:10:01 PM
REPRESENTATIVE SEATON asked to have statute checked in this
regard to ascertain if a requirement exists for the prescription
of supplements. Further, he inquired:
[Is] ... this bill ... saying that even if [a
substance] doesn't need to be prescribed, it ...
[could] only be administered by a nurse if it ...
[were] prescribed by a physician.
MR. MILLER confirmed that the bill provides for a nurse to
administer prescribed substances only, including dietary
supplements.
3:10:39 PM
CHAIR WILSON inquired who would have prescriptive authority.
MR. MILLER stated that he would be able to provide the committee
with that information at a later time.
3:11:17 PM
CATHERINE GIESSEL, Registered Nurse (RN), Advanced Nurse
Practitioner; Chairperson, Alaska Board of Nursing, stated her
history of work in the field of health care, and highlighted her
care for patients of various ages and facilities. She
paraphrased from the following Alaska Board of Nursing Position
Paper, March 2006, which read as follows [original punctuation
provided]:
Background
The Alaska Board of Nursing is charged with the
regulation of nursing practice to ensure public
safety. The Board of Nursing enacts regulations to
implement safe nursing practice, reviews and validates
license application credentials and oversees nursing
education. The Board of Nursing also reviews issues,
utilizing scientific findings and best practices
recommendations, to ensure that the Alaska public
receives safe nursing care.
The Alaska Board of Nursing has considered the issue
of nurse licensee administration of nutritional
supplements, herbal and homeopathic preparations and
other non-FDA approved medications several times over
the last decade. Each time the Alaska Board of
Nursing has maintained that the administration of
nutritional supplements, herbal and homeopathic
preparations and other non-FDA approved medications is
an unsafe practice and outside the scope of practice
for nurses in Alaska.
Deliberations
The Board of Nursing reviewed the issue of
administration of herbal preparations in December
1998. The case brought to the Board related to a
resident of an assisted living home whose physician
prescribed a number of ingested therapies, including
St. John's Wort and over-the-counter Tylenol. (1) The
Board determined that "it is outside the scope of
practice for nurses to administer remedies that are
not FDA-approved". Rationale was based on the unknown
interactions of these substances with pharmaceutical
medications and the fact that education about these
substances was not part of the nursing education
curriculum. The Board underscored the fact that a
licensed nurse must practice within their scope of
practice, regardless of the presence of a prescription
by a licensed physician.
The Board of Nursing again discussed the issue in
March 1999 when it was asked to reconsider its
decision. This time the question related to the
administration of homeopathic remedies. The Board
reviewed the contents of a reference book, Nursing
Responsibility Regarding Herbal Remedies, by the
National Organization for Homeopathic Remedies. This
reference did not indicate that it was within the
nurse's responsibility to administer supplements or
homeopathic remedies. The Board upheld its previous
position statement that the administration of non-FDA
approved substances and nutritional supplements is an
unsafe practice and outside the scope of practice for
nurses in Alaska. (2)
On March 15, 2002 the Board was approached by a member
of the Alaska Mental Health Trust, to review the
position on administration of non-FDA substances. At
that time the Board of Nursing reviewed a document
from the North Carolina Board of Nursing, "The Role of
the Registered Nurse in recommending the use of over-
the-counter pharmaceutical products and non-
prescription devices". This reference stated, "Over-
the-counter pharmaceutical products and non-
prescription devices such as, but not limited to,
splints, point stimulators/electro-stimulation units,
positioning assists, blood glucose machines, and take-
home blood pressure machines, are not subject to the
prescribing and dispensing regulations of North
Carolina. Consistent with G.S. 90-171.20 (7) of the
Nursing Practice Act and Administrative Rule 21 NCAC
36.0224 (a) - (h), the registered nurse may recommend
the use of an over-the-counter pharmaceutical product
and non-prescription device for an identified health-
related need of a client as part of his/her nursing
practice. The registered nurse who makes such a
recommendation is held accountable for having the
knowledge to make such nursing care decisions safely
and to monitor the outcomes of his/her actions. The
practice of recommending over-the-counter
pharmaceutical products and non-prescription devices
must also be consistent with the established policies
of the system in which the registered nurse practices
as well as consistent with the client's overall
health-related plan of care." (3)
The Board also reviewed an article summarizing
opinions of other Boards of Nursing who approve
alternative therapies administered by Registered
Nurses. Therapies discussed in the research article
were alternative therapies that were non-invasive. (4)
This was not relevant to the administration of non-FDA
approved supplements or substances.
On September 26, 2003 the Board of Nursing was asked
to approve nurse administration of a non-FDA approved
substance, memantine, to a resident in a Pioneer Home.
The substance, memantine, was a medication used in
Europe and currently undergoing FDA scrutiny. The
Board queried the other sixty one (61) Boards of
Nursing concerning their position on the
administration of non-FDA approved medications which
have been used in clinical trials and are awaiting FDA
approval, and specifically memantine. Thirty-one
state boards responded with 14 banning the practice, 5
allowing it if the nurse is knowledgeable and the
administration was in conjunction with medical
research, and 12 states responding with no specific
position on this. After discussion, the Board tabled
the topic for the March 2004 Board meeting. (5) In the
interim, the FDA approved the substance as the
medication, Namenda.
The Board was asked to approve administration of
nutritional supplements to a Pioneer Home resident on
March 8, 2006. After more than two hours of
discussion with a family member and thoughtful
deliberation, over a two-day period, the Board
reiterated and continued the position that
administration of nutritional supplements, herbal and
homeopathic preparations and other non-FDA approved
medications is unsafe and therefore outside the scope
of practice for a licensed nurse in Alaska.
The Board of Nursing is charged with ensuring public
safety by the regulation of nursing practice (AS
08.68.100). There exist grounds for the Board to
deny, suspend or revoke the license of a nurse in
Alaska for several reasons, one of which includes
intentionally or negligently engaging in conduct that
has resulted in a significant risk to the health or
safety of a client or in injury to a client (AS
08.68.270 (1) - (10)). Unprofessional conduct (12 AAC
44.720 (9)) includes assuming duties and
responsibilities, on repeated occasions, without
sufficient preparation or for which competency has not
been maintained (12 AAC 44.770 (2)).
The Food and Drug Administration (FDA), through the
Center for Drug Evaluation and Research (CDER),
reviews and approves pharmaceuticals in the United
States for efficacy, safety, purity and other quality
assurance markers. This rigorous review attempts to
assure safety for the American public but, even then,
some pharmaceuticals are withdrawn from the market
after approval, due to safety concerns that arise with
increased use by a diverse population.
There is widespread use by Americans of nutritional
supplements, herbal preparations, and vitamins, as
well as pharmacologic agents obtained from foreign
countries via the Internet. (6) There have been
increasing reports of interactions, potentiation of
effect and adverse reactions between nutritional
supplements, herbal and homeopathic preparations and
other non-FDA approved medications and
pharmaceuticals.
The FDA does not regulate the production of
nutritional supplements because they are classified as
food products. In addition, the Dietary Supplement
Health and Education Act of 1994 (DSHEA) restricts the
FDA from regulating any product that is labeled as a
"supplement" and makes no disease treatment claims.
There is no regulatory oversight of production in
quality, purity, or contents of these products or
official monitoring of adverse events; this
responsibility is left to the manufacturer. There
have been adverse events resulting in injury and even
death with the use of these ingested products. (7, 8,
9,10,11,12.13)
The United States Pharmacopeia (USP) is an
independent, nonprofit organization that establishes
public standards of quality for medicines, dietary
supplements, and related products. In October 2001,
the United States Pharmacopeial Convention, Inc. (USP)
launched a verification program for dietary
supplements in order to evaluate the ingredients
listed on the label. The program provides independent
testing and review to verify ingredient and product
integrity, purity, and potency for manufacturers who
choose to participate. However, USP does not
comprehensively address the issue of safety.
Two references are available to the medical community
that contain information on some nutritional
supplements: the PDR for Herbal Medicines (1998) and
the German Commission E Therapeutic Monographs. These
documents contain limited information on indications,
contraindications, side effects, interactions with
other drugs and dosage.
Nurses are not educated in the use of nutritional
supplements, herbal and homeopathic preparations and
other non-FDA approved medications in bachelor's or
diploma Registered Nurse programs or Licensed
Practical Nurse programs. This testimony was given by
Dr. Carolyn Keil, University of Alaska Anchorage
faculty, on December 10, 1998, and affirmed on March
10, 2006 by Terri Olson, MSN, University of Alaska
Anchorage faculty.
The populations of clients in Alaska's long-term care
facilities and assisted living facilities are a
vulnerable population with multiple disease diagnoses
and prescribed pharmaceutical medications. This group
of people is highly susceptible to adverse events and
interactions between nutritional supplements, herbal
and homeopathic preparations and other non-FDA
approved medications and prescribed pharmaceuticals.
Nurses administering pharmaceuticals have a wealth of
experience, knowledge and resources to draw upon to
safely administer these medications to the clients.
This is not the case with administration of non-FDA
approved substances, about which little information
may be known or available to the nurse.
The licensed nurse is accountable for her actions and
has a duty to the patient that cannot be supplanted by
healthcare provider prescription or facility policy.
This responsibility applies even when a healthcare
practitioner has ordered a certain therapy. The nurse
is held responsible to understand the implications of
any therapy administered to the patient.
Conclusion
It is incumbent on the Board of Nursing to review the
medical evidence and make objective judgments to
protect public safety. The Board is aware that its
decisions have widespread impact on vulnerable,
dependent persons of all ages in a variety of
healthcare settings, who expect and trust in safe
nursing care. Nurse licensees in Alaska look to the
Board for evidence-based, best practices guidelines.
The Board of Nursing considered all the above facts.
Based on impartial, objective review of the facts, the
Board of Nursing for the State of Alaska finds that it
is unsafe and therefore outside the scope of practice
for a licensed nurse to administer nutritional
supplements, herbal and homeopathic preparations and
other non-FDA approved medications
The Board of Nursing acknowledges the rights of
patients and their families to make the decision to
self-administer these supplements or substances to
themselves or their family members.
MS. GIESSEL continued her testimony and explained how some
supplements, that may otherwise be considered safe, could cause
adverse effects if administered in the company of prescribed
medication, and she provided examples. She stressed that nurses
are not trained in the area of non-FDA approved drugs, or how to
recognize complications from non-regulated supplements. She
said that elderly patients are vulnerable, and public safety is
a key issue. She underscored that nurses are held accountable
for the care provided to a patient and that these types of
substances are outside the scope of practice for a nurse.
Referring to a research paper provided in the committee packet,
she deemed that the sample was insufficient with only 13 of the
nation's 61 nursing boards polled. Finally, she highlighted
that signed waivers do not provide a nurse with adequate legal
protection.
3:24:59 PM
REPRESENTATIVE GARDNER asked what would happen if a physician
gave orders, which a nurse considered to be contrary to the
patient's welfare.
MS. GIESSEL responded that, in such a situation, it is a nurse's
responsibility to decline to carry out a physician's order; not
a rare occurrence. Responding to a question, she opined that
the research regarding supplements is not highly regarded or
publicized, as it is often conducted by the supplement industry,
and she stated that information on negative health effects
caused by supplements is not commonly available.
3:28:19 PM
REPRESENTATIVE GATTO offered information on two supplements, no
longer available on the market as it was alleged that they may
have caused negative health effects, thus supporting her
concerns.
MS. GIESSEL explained the difference of how the FDA scrutinizes
approved drugs versus the accountability standard placed on the
supplement industry. She stressed that negative affects of non-
regulated supplements are not subject to the same reporting and
obligation for recall. Additionally, she said that although the
FDA may investigate when a supplement is reported to be
injurious, the department is limited in its resources to
determine the safety of the majority of substances available
from the supplement industry.
3:30:17 PM
REPRESENTATIVE SEATON stated his understanding that a
physician's decision would be considered inadequate when
recommending a supplement, and that a nurse would be unable to
legally administer prescriptions for substances other than FDA
approved drugs.
MS. GIESSEL explained that Alaskan law allows physicians, nurse
practitioners (NPs), and physician assistants (PAs) prescriptive
authority; however, the person on a patient's medical team who
administers the prescribed substance is the registered nurse
(RN). Further, she stated that the reason non-FDA approved
substances are at issue is because of the Alaska Pioneer Nursing
Home policy; allowing the administration of over-the-counter
substances. She said:
It's not that [the] physicians are not doing their
job, it's that the nurse is responsible to know what
she's administering, what side effects to look for,
and whether or not this is going to interact with
other medications that the individual is taking. ...
The nurse is doing ... her or his part in being one of
those people that assures patient safety in this whole
delivery of health care scheme.
3:33:56 PM
GENA EDMISTON, Registered Nurse (RN), Associate Administrator,
Denali Long-term Care Center, Fairbanks Memorial Hospital,
stated support for HB 467, and explained the policy of the
Denali Center, which provides for the pharmaceutical review of
medicinal or supplemental substances which are administered to
residents/patients. She explained that this assures an
additional level of review, which can be implemented when a
pharmacy is available.
3:36:19 PM
CHAIR WILSON asked what the Denali Center's current policy is
for having the nurses administer medications.
MS. EDMISTON responded that Denali Center has a pharmacy policy,
and she reiterated the review process of every substance that is
administered to residents of the center or the hospital.
However, she said that in the hospital setting the patient would
usually be self administering supplements, which is not the case
in the long-term facility. She provided an example of a
commonly used supplement that the nurses administer to residents
of the Denali Center.
3:38:00 PM
REPRESENTATIVE SEATON inquired whether there are any
restrictions placed on non-FDA approved Native foods, made
available to facility residents.
MS. EDMISTON stated that she is not aware of any food issues.
She opined that it is difficult for her to imagine not being
able to provide a patient with a necessary supplement. She
pointed out that many of the residents do not have family
members nearby who would be able to visit regularly and
administer these type of supplemental needs.
3:40:04 PM
REPRESENTATIVE GATTO stated his understanding of the
inconsistency in the standardization of many supplements, and
asked whether establishing a proper dose has been an issue.
MS. GIESSEL responded:
That is a difficult question to answer because with a
lot of these substances their effects are difficult to
quantify. ... I can't really say in my experience that
I've seen a lot of variation in terms of response. And
yes, you are absolutely right, there is no
standardization of any of these products.
3:43:14 PM
RICK SCHIKORA, Certified Public Accountant (CPA), stated support
for HB 467, and explained his personal interest in the issue.
He described the situation of his grandmother, as a resident at
the local Pioneer's Home, in need of a non-prescribed
supplement. Although this supplement had been being
administered, he said that he eventually received a letter from
the Pioneer's home stating that, due to an inquiry from the
Alaska Board of Nursing, the facility would be discontinuing
this service. Noting that his grandmother's health began to
decline when the supplements were discontinued, he began to
administer to her needs, on a daily basis, which he had to
provide off of the premises. Although he was able to take up
this care for his grandmother, he realized that many nursing
home residents do not have the benefit of an outside person who
can assist them in this type of situation. His understanding is
that, although the nurses do not object to providing this care,
because of the stance that the Alaska Board of Nurses has taken,
they are fearful of losing their licenses. He said:
The nursing board has not been specific in their
characterization of this and ... I don't have the
exact quote but ... [the board's caution to nurses
stated] "it's outside of the scope of practice," ...
and ... "we may not support you." ... It was for those
reasons that the nurses are afraid to participate in
this. The Pioneer's Home does have a policy that says
that ... they will get a coordinator to handle this
and that the nurses can provide this administration to
residents if they wish .... ... Based on that ... I
put together a policy that was submitted to the Board
of Nursing [available in the committee packet]. ... It
doesn't require anybody to do anything that they feel
is outside of their scope of practice. ... I think
Alaska ... ought to be on the forefront of trying to
accommodate in these situations, but we ought to do it
in a fashion that doesn't require the nurse to do it,
and doesn't punish her if she does. ... There's a lot
of older ... [residents] over at the Pioneer's Home,
and I'm sure there will be in the future, that won't
have somebody that can go over and administer [to
them]. ... I'm serious about seeing something happen
where the board of nursing either authorizes this or
state law gets changed to basically require them to
authorize it.
3:52:30 PM
MIKE POWERS, Administrator, Fairbanks Memorial Hospital, stated
support for HB 467, and referred to Ms. Giessel's testimony as
being both accurate and erroneous. He concurred that safety is
above all the primary concern for hospitals and long-term care
facilities. However, a call for reasonableness should be held
that would allow for nurses to provide even better care, which
may include the administration of some of these supplements. He
suggested a meeting of the interested parties, and stressed that
common ground must be sought that will improve the entire health
system.
3:56:18 PM
REPRESENTATIVE GARDNER asked whether Mr. Schikora's suggestions
have been reviewed by the nursing board.
MR. POWERS responded, "I don't know."
CHAIR WILSON interjected that Mr. Schikora testified to having
provided the nursing board with his paperwork and that it was
reviewed. Additionally, she reported her understanding that the
Nursing Board has subsequently provided Mr. Schikora's
suggestions to a subcommittee for review.
MR. MILLER added that the Board of Nursing did review Mr.
Schikora's document; however, the Alaska Nurses Association
(ANA) letter requested that the Nurses Association Professional
Practice Committee investigate the issue and provide
recommendations to the ANA at large. The ANA will then forward
the recommendation that they adopt to the Board of Nursing.
3:57:53 PM
CHARLOTTE DAVIS, Registered Nurse (RN), spoke in opposition to
HB 467, and paraphrased from a letter submitted to the
committee, which read as follows [original punctuation
provided]:
As a registered nurse, I am urging you to defeat
passage of House Bill # 467 regarding the
administration of prescribed remedies and dietary
supplements by a nurse. There are numerous reasons
this bill should be defeated, however, I will
concentrate on the most important reasons. They are
as follows with a more complete discussion below:
™Dietary supplements, herbals, and vitamin remedies
are not FDA approved.
™These products are not drugs (which require FDA
approval) and do not require a prescription from a
health care provider.
™Administration of these products is not an
acceptable standard of nursing care.
™The State of Alaska Board of Nursing states nurses
shall not administer these supplements.
™The manufacturer sets the dosage of supplements
without sound scientific study on efficacy or
safety.
™Administration by a nurse of supplements violates
the ANA Code of Ethics regarding safety.
™Administration of these supplements is outside the
scope of nursing practice. Malpractice insurance
companies may not defend claims made against a
nurse's license.
™The vulnerable residents of these facilities
deserve the same standard of care as every other
citizen from nurses whose licenses have equal
value with the other 8,000 nurses in Alaska.
Further discussion on these points is as follows:
The short title states Administration of Medication by
a Nurse. Herbals, vitamin remedies, and dietary
supplements are NOT medications. The Food and Drug
Administration (FDA) categorizes them as food so the
FDA regulatory focus can only be on the product labels
and claims by the manufacturers. The FDA does NOT
approve food supplements for particular uses, in
particular doses, or routes of administration.
The bill states "unless the prescription". The FDA
must prove drug products are safe and effective for
their intended use BEFORE prescribed by a health care
provider and administration by a nurse. A health care
provider does not prescribe but only advises use of a
remedy or dietary supplement. Health care providers
who do advise or prescribe use of dietary supplement
could be sued if there were adverse affects, an
unintended side-effect over time, or a carcinogenic
effect. The nurse in turn can also be sued for
administering the supplement even when prescribed by a
health care provider.
A nurse has the duty to provide care and to follow an
acceptable standard of care. These standards of care
come from different sources including Nurse Practice
Acts, American Nursing Association, Joint Commission
on Accreditation of Healthcare Organizations, and Case
Law. The nurse is accountable for knowing the standard
of care, adhering to that standard, and reporting any
breaches in that standard of care by others. The
administration of non-FDA approved supplements is NOT
an acceptable standard of nursing care.
The State of Alaska Board of Nursing has repeatedly
taken the position over the years, most recently in
March 2006, that nurses shall not administer non-FDA
approved supplements. I support my Board of Nursing on
this issue.
HB 467 states, "unless the prescription is for an
amount of the remedy or supplement that is outside of
the manufacturer's recommended dosage." The
manufacturer sets the dose, route, and frequency of
the supplement use. It is the manufacturer who is
responsible for the safety of the dietary supplement
products but there is no provision for the FDA to
approve dietary supplements for safety or
effectiveness. These same manufacturers are not
required by law to record, investigate or forward to
the FDA any reports of injuries, illnesses, or deaths
that may be related to the use of the supplement.
After the product is on the market, the FDA has the
responsibility for showing that a dietary supplement
is "unsafe," to restrict its use of remove it from the
market. The recall of all ephedra products on the
market after injury and deaths is one example of the
FDA responsibility.
The American Nurses Association's Code of ethics
states "The nurse promotes, advocates for, and strives
to protect the health, safety, and rights of the
patient." Supplements may interfere with other
herbals, drugs, or treatment regimens. Combinations
cannot only be dangerous by life threatening (kava
beans, ephedra, St. Johns Wort). Supplements may
interfere with tests, procedures, and cause
complications with surgery. How many more supplements
are currently on the market that the manufacturers
have determined as "safe"? As a nurse, it is outside
my scope of practice to determine the safety of these
supplements.
After repeated calls to my malpractice insurance, I
could not get a definitive answer to any hypothetical
question I posed regarding this issue. They would not
state they would defend a claim if I knowingly
practiced outside of my scope of practice or outside
the acceptable nursing standard of care. They will
only defend a claim once it is filed.
Finally, the bill states "a registered nurse ... to a
resident of a nursing facility, an assisted living
home, or an Alaska Pioneers' Home". Why is this bill
intended for only residents of these facilities and
not those who live at home or who are in a medical
facility? The elderly and disabled (most vulnerable
in our society) deserve an even higher standard of
safety then those who can advocate for themselves. Why
is this bill intended only for a registered nurse
caring for those residents? My license is no less
valuable then those who work in home health care or
medical facilities.
Please defeat passage of this bill. I will be
available for any questions. I have listed my home
number above or you may reply to this email.
4:03:02 PM
REPRESENTATIVE SEATON clarified that this bill would restrict an
RN to the administration of prescribed substances.
Additionally, it does not mandate that an RN administer any
substance, and further, if a prescription is written to exceed
the manufacturer's recommended dose, the RN would be disallowed
from its administration. He asked if that was Ms. Davis'
understanding of the bill action.
MS. DAVIS stated that her understanding of this bill is to
provide facility residents a means to comply with prescription
administration policy. She maintained that this would be a mute
issue if the substance were to be self administered by the
patient, a family member, or a hired agent. The non-
standardization aspect of these products is her primary concern,
she said.
4:05:21 PM
VIRGINIA SMILEY, Director, Division of Pioneer Homes, Department
of Health and Social Services (DHSS), stated support for HB 467,
paraphrasing from a written statement, which read as follows
[original punctuation provided]:
For the record I am Virginia Smiley, director of the
Division of Pioneer Homes for the Department of Health
and Social Services. Madame chair, I would like to
give you a very brief overview of the division's
position on RNs involvement in administering dietary
supplements.
The Pioneer Homes has a procedure for administering
supplements that includes a written order from the
primary prescribing practitioner, who indicates brand
name and dosage. We require a release form signed by
the resident or his representative, privately
purchased supplements by the family in original,
sealed packaging whose label must include brand, lot
number, expiration date, resident's name, room number,
dosage and frequency.
In addition, our pharmacy is informed of any
supplement so they can monitor it in reference to
resident diagnosis, disease or possible drug
interaction.
Finally our policy includes voluntary agreement by an
RN to administer supplements reviewed on a case-by-
case basis.
We prefer to have a RNs involvement in supplement
administration for the very same reasons we have their
involvement in medication administration.
CHAIR WILSON asked who administers the supplements.
MS. SMILEY responded that the RN is the administrator, and she
continued with her written statement as follows:
If a nurse is unsure about something that has been
ordered, the nurse has an obligation to get in touch
with the primary care provider and ASK questions: why
it is being ordered, or could it interfere with other
meds.
We expect our nurses to 1) know their patients, and 2)
know the risk/benefit of each medication ordered. We
expect them to treat supplements accordingly.
We would much rather have a nurse involved with a well
planned procedure for supplement administration than
have a family member bringing in a zip-lock bag full
of unknown, unmarked pills, dispensing them in an
unsupervised, unstructured manner.
And I would disagree that administering something
ordered by a care provider violates any code of ethics
or is outside the scope of nursing practice.
Practitioners have an obligation to try to do
everything they can to improve the quality of life for
their patients. And that may include monitoring and
administering a supplement that has shown a benefit to
an individual patient.
The Board of Nursing has, by their own admission, been
grappling with this issue since 1998 yet there is
still nothing in statute or their regulations that
direct nurses on how to handle this specific issue;
there have only been Board of Nursing opinions or
positions.
In conclusion, the Pioneer Homes supports the passage
of HB 467.
4:10:49 PM
NANCY DAVIS, Registered Nurse (RN), Representative, Alaska
Nurses Association (ANA), compared the casual use of supplements
in the United States to usage in other countries, and opined
that this country has not "moved as far forward" on this issue.
Self administration of a supplement is certainly different from
having a nurse administer it, she cautioned. She reported how
the ANA membership across the state is divided on this issue,
however, she said that every nurse does have a desire to be
informed on safety and developing health concerns held in the
profession. The Board of Nursing is the standard bearer for the
ANA, and as such the board is obliged to define nursing
practices for the profession. She said that it would be remiss
not to look at what is current on the issue of supplements, and
for that reason the ANA is convening their Professional
Practices Committee. She explained that the U.S. Pharmacopeia
(USP) has a process for review and standardization of
supplements, if a manufacturer voluntarily submits their product
for verification. The product receives a USP stamp on the label
for having been subjected to this approval. Reminding the
committee that nurses have a professional obligation for the
safety of patients, she opined that through joint board
discussion a safe, appropriate, reasonable, professionally
responsible position would be adopted. Further, she provided
suggestions why some supplement companies may not choose to
submit their products for verification and review by the USP.
She echoed the ANA's stated opposition to HB 467, stressing that
it would be preferential to handle this issue through a process
whereby the State Board of Nursing would examine and develop
standards for professional nursing practices.
4:18:17 PM
REPRESENTATIVE CISSNA described her personal use of supplements
under the supportive advice of a Nurse Practitioner (NP). She
expressed concern for the quality of life of the elderly who are
currently in need of daily administration of supplements, while
this issue is in the process of being addressed.
MS. DAVIS conceded that studies are available regarding some
substances, and noted that the National Institute of Health's
Office of Dietary Supplements provides reports on the efficacy
of certain supplements. She cautioned that this bill would be
providing standards for the administration of a large variety of
supplements, some that are commonly used, and others possibly
more obscure. Further, she opined that this issue would be best
handled, through the collaborative efforts of the ANA with the
Alaska Pharmaceutical Association (AkPhA), and the Alaska Board
of Medicine.
REPRESENTATIVE CISSNA asked whether a time-line exists for
resolving this issue.
MS. DAVIS responded that the ANA expects to bring this topic
before the Board of Nursing, at the June meeting.
4:21:58 PM
ROD BETIT, President, Alaska State Nursing Home Association
(ASNHA), stated support for HB 467, and noted the scope and
membership of the state facilities which he represents. He
agreed that this issue is in need of resolution. Further, he
said that the permissive nature of the bill allows latitude for
resolution of conflicts. He echoed the need to have supplements
made part of the health care decision process.
4:25:27 PM
REPRESENTATIVE GARDNER asked whether specific language was
needed in the bill that would clarify a nurse's ability to
freely decline to participate in the administration of
supplements.
MR. BETIT responded that the bill, as drafted, provides
allowance for the nurse to decline and generally implies no
repercussion. However, specific language to this effect could
be worked out, he said. Responding to a question, he stated
that he was not in receipt of the document titled "Licensed
Nurse Administration of Non-FDA Approved Over-the-Counter Drugs
and Nutritional Supplements," which enumerates a seven point
policy.
4:26:40 PM
CHAIR WILSON asked Ms. Giessel, whether pharmacists are more
knowledgeable on the effects of supplements than nurses.
MS. GIESSEL opined that pharmacists have access to a wealth of
information and can access the FDA website. However, she said,
"How many ... truly understand the supplements ..., I couldn't
tell you."
4:27:32 PM
CHAIR WILSON closed public testimony and announced that the bill
would be held for further discussion. She directed the
committee's attention to page 2, lines 1-2, [previously read
into the record by Representative Seaton], and she suggested
close scrutiny of the language therein.
ADJOURNMENT
There being no further business before the committee, the House
Health, Education and Social Services Standing Committee meeting
was adjourned at 4:28:57 PM.
| Document Name | Date/Time | Subjects |
|---|