Legislature(2005 - 2006)CAPITOL 106
04/11/2006 03:00 PM House HEALTH, EDUCATION & SOCIAL SERVICES
Audio | Topic |
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Start | |
HB467 | |
SB177 | |
HB426 | |
HB482 | |
HB467 | |
Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
+= | HB 467 | TELECONFERENCED | |
+= | HB 426 | TELECONFERENCED | |
+= | HB 482 | TELECONFERENCED | |
+= | HB 29 | TELECONFERENCED | |
+ | TELECONFERENCED | ||
+= | SB 177 | TELECONFERENCED | |
+= | HB 468 | TELECONFERENCED | |
HB 467-ADMINISTRATION OF MEDICATION BY A NURSE 3:10:42 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." [Before the committee was HB 467, Version 24-LS1265\G.] 3:12:13 PM [Treated as adopted and before the committee was CSHB 467, Version 24-LS1265\F, Mischel, 4/7/06.] DEREK MILLER, Staff to Representative Michael "Mike" Kelly, Alaska State Legislature, introduced the Committee Substitute (CS) to HB 467, paraphrasing from a written statement which read as follows [original punctuation provided]: 1)Would we be permitting nurses to administer non- prescribed dietary supplements based on the language in page 1, line 5? Answer: No we would not, because the definition of "prescribed remedy or dietary supplement" beginning on page 1, line 14 of the bill addresses this concern. 2) Does this bill only allow the administration of remedies and dietary supplements if an Advanced Practice Nurse (APN) prescribes them, or does it encompass all professionals with prescriptive authority? Answer: No, under Title 8 Advanced Nurse Practitioners, physicians, physician assistants, dentists and podiatrists can prescribe. 3) How can we insert language into the bill that will ensure that the Board of Nursing and the nursing community at-large incorporate safeguards or a set of guidelines for nurses to follow for administration of dietary supplements? Answer: Yes, and I will provide a CS for the committee to adopt with the language that would charge the Board of Nursing to establish standards and regulations for the administration of prescribed remedies and dietary supplements. 3:15:16 PM RICK SHIKORA, Certified Public Accountant (CPA), stated support for CSHB 467, Version F, and paraphrased from the following written statement [original punctuation provided]: My 98 year old grandmother is a resident of the Fairbanks Pioneers' home and is the reason this bill is before you today. But i didn't ask that this issue be addressed just for her benefit, but for many similarly situated individuals. The board of nursing in its own testimony has indicated that it has not resolved this issue despite its being up before it three or four times. I will attend the upcoming June meeting of the board of nursing to help them with ideas for the regulations. I have previously provided them with some of my thoughts in policy form and that document could easily be a base with which to start. I wholeheartedly support committee substitute for hb467 as it provides clear direction for the board to address this critical issue, yet leaves them with the latitude to make sure that the most paramount issue, safety of the patient, is protected. I urge you to pass this committee substitute today. 3:17:17 PM CATHERINE GIESSEL, Master of Science in Nursing (MSN), Registered Nurse (RN), Advanced Nurse Practitioner (ANP); Chairperson, Alaska Board of Nursing (ABN), testified in opposition to HB 467 and maintained her initial concerns for this legislation stating: You are asking [the Board of Nursing] to establish standards for something that is non-approved. That is ... contradictory [because] standards refer to creating a level of quality or excellence that is acceptable as the norm. ... I'm not sure that [standard] is the proper term to use. ... In line 9, page 1, it talks about the Board of Nursing including in these standards safeguards. Essentially what you're asking the Board of Nursing to undertake is a task that the federal government, with all of its resources has not undertaken to do, and that is to assure safeguards. We have established a safeguard and that is that these substances are not safe. ... I'm not quite sure how ... that standard could be attained. It goes on in the CS to say ... [page 1], line 11, "[standards must include safeguards that prevent the administration] ... if the prescription is for an amount of the remedy or supplement that is outside the manufacturer's recommended dosage for ... a patient of the same physical condition." ... You're asking [nurses] to go by the manufacturer's recommended dosage. The manufacturers are the financial beneficiaries of this product, therefore have a vested interest in how much of it they're selling. Why would we consider the manufacturer's recommended dosage reliable? [Manufacturers] have no liability for adverse responses to these products; these substances are not regulated [and] the recommended dosage varies between manufacturers. ... I'm not sure you're creating a standard or a level of excellence that is attainable. At the end of that sentence it refers to a patient of the same physical condition. For a registered nurse to establish the physical condition of a patient, ... would require her to actually do a medical examination and make a medical diagnosis; this falls outside of her scope of practice. When I look at the definition ... [page 2], [line 3], ... referring to herbal, and vitamin remedies. I would point out that the two supplements ... brought to the boards attention ... [are neither] herbs or vitamin remedies. I would perhaps suggest that Representative Kelly might want to look at that definition .... I would also bring to the committee's attention SB 313. This bill would... [place] an herb ... into the category of a class two controlled substance. ... On a database called Up-To-Date ... [an] article on this particular family of herbs [describes] the kidney disease ... caused from [the herb] ... being given in a weight reduction clinic. ... I hope [this] ... illustrate[s] to you the unregulated and dangerous position that these herbs and substances are in. ... I don't know if you have yet received the letter from ... [two] pharmacist [s] ... in Anchorage. Both of these letters will be in support of the board's position that [the administration of supplements] is an unsafe practice. 3:23:17 PM CHAIR WILSON asked whether Ms. Giessel could suggest language and terms that would help to improve this bill and make it more workable and inclusive. 3:23:52 PM MS. GIESSEL offered the term "dietary supplement" be incorporated to encompass some of the supplements discussed. However, she opined that a language change would not bring the bill into line with the Board of Nursing's stance. She offered to provide further data to illustrate that supplements are "dangerous" and not benign substances that can be taken without concern. 3:25:02 PM REPRESENTATIVE ANDERSON asked who endorses the legislation as it is currently written. MR. MILLER directed attention to the letters in the committee's packet, including one from the Alaska Nurses Association (ANA) indicating the recommendations/action they have taken on this bill. REPRESENTATIVE ANDERSON inquired on whose behalf Ms. Giessel was testifying. MS. GIESSEL indicated that she represents and speaks on behalf of the Alaska Board of Nursing (ABN), and that she has no affiliation with the ANA. CHAIR WILSON pointed out the letter of support received from the Alaska State Nursing Home Association (ASNHA). REPRESENTATIVE ANDERSON clarified: [Ms. Giessel] ...the Board of Nursing has authorized you, the Board of Nursing meaning under the Department of Occupational Licensing, ... the peer review that licenses nurses in the industry, ... have requested that you testify today. MS. GIESSEL replied, "You are correct." 3:27:10 PM CHAIR WILSON opined that the language of the bill provides latitude for the board to comply with the nursing regulations, and that perhaps the term "guidelines" rather than "standards" could prove helpful. She suggested that the board could stipulate appropriate requirements to ensure safeguards such as a provision that a supplement must carry an endorsement stamp from the United States Pharmacopeia (USP). 3:28:09 PM MR. MILLER stated that these points are what the ANA expects to bring before the Board of Nursing, for creating safeguards in implementing this bill. 3:28:38 PM CHAIR WILSON established that subsequently the bill will be in the Finance Committee. REPRESENTATIVE CISSNA described her own usage of dietary supplements without adverse effects, concern from her health care provider, or research literature that would cause alarm. She asked, "Why is [taking a supplement] so dangerous?" 3:30:10 PM MS. GIESSEL established that this bill is being written for the use of a myriad of supplements. She pointed out that the situation under which a healthy outpatient self administers supplements, is a different scenario than having these supplements administered to a category of people in resident facilities, who may have multiple disease diagnoses and who are taking multiple medications. She stressed the vulnerability of this class of patients and maintained concerns for side effects, allergic reactions, and the viability of a supplement product. 3:33:06 PM REPRESENTATIVE CISSNA stated that it is her understanding that current law allows nurses the choice to abstain from administering a substance if they so choose. 3:33:32 PM MS. GIESSEL clarified that it is not law which provides that possibility but rather the ethical code of nursing. She offered a summary of the position originally established by the Board of Nursing in the late 1990's: Because we cannot assure the purity of the substance[s] ..., the Board of Nursing has taken the position that it is outside the scope of practice for a registered nurse to administer nutritional supplements, herbal or homeopathic supplements, or other non-FDA approved medications. MS. GIESSEL directed attention to the committee packet and the example provided in the Alaska Board of Nursing Position Paper, March 2006, page 2, paragraph 3, which provides an example of how this ethical code is implemented. 3:34:59 PM CHAIR WILSON asked whether a nurse would have her license revoked if she violated the code of ethics. MS. GIESSEL responded that violations of the Nurse Practice Act are scrutinized on an individual basis, making it difficult to make a blanket statement of what might be imposed. However, it is a possibility that a license could be revoked if a complaint were filed and found to be justified. 3:35:28 PM MR. MILLER held forth Representative Kelly's position stating: The facilities are equipped with the proper tools to enable them to be able to follow through with a policy like this; between the doctors, the pharmacies and the pharmacists, the facility, the administrators ... the patient willingness, the willingness of the nurse, and ... the patient need for some of these supplements, that we can go ahead and move forward with this policy. MR. MILLER pointed out that this effectively involves six or seven levels of safeguards prior to a supplement reaching the patient. Despite these layers of protection, because of the current Board of Nursing policy, facility residents are not able to receive these supplements, hence the frustration of those people who would choose to receive or to administer these supplements. 3:36:38 PM REPRESENTATIVE GARDNER requested a synopsis of the Board of Nursing mission statement. 3:36:51 PM MS. GIESSEL pointed out that it is in the committee packet and stated it as: "To ensure public safety through the regulation of safe nursing practice." She explained that when the board writes a policy or takes a position they look at the implications with a broad population in mind. Referring to Mr. Miller's remarks, she said that there are pharmacists who are aligned with the Board of Nursing position on this issue, and she pointed out that assisted living homes do not have affiliated pharmacists. 3:38:09 PM REPRESENTATIVE ANDERSON stated his understanding that the Board of Nursing is against the administering of these remedies or dietary substances, in residential facilities because "of the fear that they are dangerous in many respects and the nurses may not have an understanding of their effects." 3:38:47 PM MS. GIESSEL clarified that it is not fear but a conclusion drawn from documented scientific review, based on clinical evidence. She stated: [The board] has taken ... an objective impartial look at the medical evidence that is available which does not support these as safe substances. And that's the basis of our decision. REPRESENTATIVE ANDERSON agreed that taking an excessive amount of a supplement may cause harm, and asked to have a doctor provide an opinion. MICHAEL ELLENBURG, M.D., Comprehensive Medicine, Limited Liability Company ((LLC), agreed with the concern for administering supplements in an assisted living home where a formulary would need to be established and drug interaction scrutinized. He opined that there could be various negative results when combining supplements with other medications. However, he opined that supplements could be used safely. REPRESENTATIVE ANDERSON suggested that Dr. Ellenburg's testimony is helpful in providing an additional opinion for parties interested in this bill. As this bill passes to the Finance Committee, he offered that it will carry with it an objective to attempt to delineate safe quantities. CHAIR WILSON stated that the legislature will not be making those decisions. The bill provides for appropriate restrictions to be made at the board level. REPRESENTATIVE ANDERSON pointed out that it would be important to continue the process of moving this bill, and given the calendar it would be imperative to move it from this committee today. CHAIR WILSON stated that the bill would be set aside for discussion later today. REPRESENTATIVE GARDNER expressed her reason for not supporting the bill, stating: This bill is asking the Board of Nursing to make a finding that is possibly contrary to their mission statement. ... I ... don't feel, ... as a non-medical professional person, ... as a legislator, that I have the authority, the expertise to tell [the board] ... to do something that they disagree with medically. 3:45:48 PM MR. MILLER maintained that by denying this bill we deny access of people in resident facilities to certain substances which they want and need. Neither does the bill require that nurses administer anything unwillingly. He opined that this is a common sense approach to this problem, and further, said that it is not contradictory to the mission of the Board of Nursing. It could be argued that the mission is not being fulfilled by denying the administration of these dietary supplements and remedies that the patient's request, he suggested. 3:46:44 PM CHAIR WILSON said that passage of this bill puts it in the hands of the Board of Nursing for implementation. REPRESENTATIVE GARDNER said that access to supplements is not being denied, but if the Board of Nursing ascertains that it is outside the scope of practice for nurses to administer supplements, other support would need to be employed for that service. She opined that if the Board of Nursing does not support this action by nurses, it would not be appropriate for the legislature to contravene that decision. 3:48:07 PM REPRESENTATIVE CISSNA offered that the bill language affords latitude to provide a broad spectrum result, which should protect everyone involved. Further, she stated a personal desire for the future possibility that supplements be appropriately reviewed and clinically administered in residential facilities. 3:49:33 PM REPRESENTATIVE ANDERSON suggested holding the bill. CHAIR WILSON set the bill aside for further consideration later in today's meeting. 3:50:06 PM HB 467-ADMINISTRATION OF MEDICATION BY A NURSE CHAIR WILSON announced that the final order of business would be further committee attention to HOUSE BILL NO. 467, "An Act relating to the administration of prescribed remedies and dietary supplements by a nurse." [Before the committee was HB 467, Version 24-LS1265\G.] [Treated as adopted and before the committee was CSHB 467, Version 24-LS1265\F, Mischel, 4/7/06.] 4:56:22 PM REPRESENTATIVE MICHAEL "MIKE" KELLY, Alaska State Legislature, testified as sponsor of HB 467, and stated that support for this bill has been provided from doctors, nurses, assisted living facility administrators, and Pioneers' home administrators. He opined that there is general consensus for the need to provide this service to facility residents. He reiterated the intent for safeguards provided in the bill, and reminded the committee that other states have adopted similar statute, thus models exist which the Board of Nursing may choose to implement. Given the examples of professional support and the patients awaiting assistance, he urged the passage of the bill. 4:59:42 PM REPRESENTATIVE SEATON inquired whether the language change in Version F creates a mandate that nurses "shall", versus the permissive language of Version G which read "may". CHAIR WILSON pointed out that the page 1, line 6, "shall" is a direction to the board regarding the establishment of standards. REPRESENTATIVE SEATON clarified that the board would have the latitude to adopt appropriately permissive language. REPRESENTATIVE ANDERSON offered to make a motion to move the bill. 5:01:13 PM REPRESENTATIVE GATTO recalled that a previous version of the bill, provided language which allowed a nurse to decline administration of a substance. REPRESENTATIVE KELLY clarified that Version F maintains that a nurse is allowed to decline to administer a substance. This legislation authorizes but does not order a nurse to administer substances, therefore, the nurse will still be protected. He reminded the committee that the bill addresses prescribed substances only. 5:02:01 PM REPRESENTATIVE GATTO stated his understanding that prescription medicine is regulated by accurate dosage, but over-the-counter remedies are unregulated and the dose may vary. He indicated concern for a nurse administering non-USP certified substances when the nurse is held liable [the substances he/she administers]. While this legislation doesn't require a nurse to administer supplements, he inquired whether there was language in Version F to allow a nurse to "opt out" of administering non- prescriptive substances. REPRESENTATIVE KELLY pointed out that Version G included the following language: "A registered nurse may administer a prescribed remedy." Responding to a question, he opined that the term "may" implies that the nurse can refuse to administer a prescribed remedy. 5:05:40 PM REPRESENTATIVE KELLY explained that the current CS [Version F] goes further than the previous version, by authorizing the Board of Nursing to establish appropriate standards for administration. Further, he said if those standards follow what has occurred in other states, there will be a list of requirements that must occur. Those requirements include the following: the facility desires to establish a procedure for administration of supplements; a physician prescribes and specifies a dosage for a supplement; control procedures for the dating, lot identification, and sealing of supplements are implemented; and the patient or representative signs a request/release form to authorize the administration. Version F stipulates that the Board of Nursing will establish such procedures and provides a nurse the authority for administration [of prescribed remedies and dietary supplements]. 5:07:19 PM REPRESENTATIVE SEATON stated: I'm concerned ... about the same point. ... If I could ask [Madam Chair] as a nurse. ... The Board of Nursing shall establish these standards. That means it's going to bring [administration of supplements] within the scope of practice for a nurse. If it's within the scope of practice for a nurse, and there's a prescription, does the nurse have the ability to say she doesn't want to administer [the substance] .... CHAIR WILSON replied, "Always." 5:08:12 PM REPRESENTATIVE GATTO asked whether the sponsor would approve the addition of the following language: "Nothing in this statute shall require a nurse to administer nonprescription medication." CHAIR WILSON said that the proposed legislation specifies that the substance to be administered must be prescribed. 5:08:29 PM REPRESENTATIVE KELLY interjected that the substance must be prescribed and the board imposed requirements met. He highlighted that several barriers of scrutiny will be required before a substance may be administered, and pointed out that the nurse is provided the right to refuse to participate. 5:09:01 PM REPRESENTATIVE GATTO related his understanding that the term "prescription" is defined as something a pharmacist must distribute. However, a physician can prescribe Vitamin A, which he characterized as different than a prescription with clear dosage specifications. CHAIR WILSON pointed out that on page 1, line 5, the legislation refers to "Administration of prescribed remedies and dietary supplements", and reiterated that it won't even be considered if it isn't prescribed. She then drew Representative Gatto's attention to page 2, lines 2-4, which define "prescribed remedy". 5:10:17 PM REPRESENTATIVE GARDNER opined that Representative Gatto's concern is at the heart of the concern of the Board of Nursing in that the legislation addresses remedies and supplements that have no established safeguards since they aren't approved by the Federal Drug Administration (FDA). CHAIR WILSON said the aforementioned is why the Board of Nursing is going to review it and grapple with this issue after the legislation passes. 5:11:23 PM REPRESENTATIVE GARDNER said she didn't understand that to be what the legislation is doing. She asked if Chair Wilson was saying the Board of Nursing will review each [substance] and approve and disapprove [substances]. She further asked if that is the sponsor's intent. 5:11:43 PM REPRESENTATIVE KELLY said that the Board of Nursing will need to exercise its judgment in screening these substances. Furthermore, the legislation has so many steps that it creates a safer environment, he opined. 5:12:41 PM REPRESENTATIVE GARDNER commented that the intent makes sense. However, she related her understanding that the Board of Nursing has already exercised its judgment and has drawn the line at FDA-approved [substances] because those have been tested with regard to dosage, quantity, and purity of the substance. The aforementioned testing has not occurred or has not been independently verified by an external body with these substances that aren't FDA-approved. REPRESENTATIVE KELLY said that's the case now. However, many believe that is too restrictive. Therefore, [Version F] asks the Board of Nursing, with its professional ability, to establish standards to permit these substances [not approved by the FDA] to be administered. 5:14:26 PM REPRESENTATIVE SEATON opined that Representative Gardener's concern is satisfied because the Board of Nursing will make the decisions for what and how standards are upheld, as well as establish standards for supplement authorization and the scope of service. REPRESENTATIVE ANDERSON moved to report CSHB 467, Version 24- LS1265\F, Mischel 4/7/06, out of committee with individual recommendations and the accompanying fiscal notes. An objection was stated. A roll call vote was taken. Representatives Seaton, Anderson, Cissna, and Wilson voted in favor of CSHB 467, Version F. Representatives Gatto and Gardner voted against it. Therefore, CSHB 467(HES) was reported out of the House Health, Education and Social Services Standing Committee by a vote of 4-2. 5:16:06 PM
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