Legislature(1995 - 1996)
04/25/1995 01:45 PM L&C
* first hearing in first committee of referral
= bill was previously heard/scheduled
= bill was previously heard/scheduled
SENATE LABOR AND COMMERCE COMMITTEE April 25, 1995 1:45 P.M. MEMBERS PRESENT Senator Tim Kelly, Chairman Senator John Torgerson, Vice Chairman Senator Jim Duncan Senator Judy Salo MEMBERS ABSENT Senator Mike Miller COMMITTEE CALENDAR HOUSE BILL NO. 231 "An Act relating to the interview requirements of the State Medical Board." CS FOR HOUSE BILL NO. 168(HES) "An Act relating to temporary permits for certain optometrists." SENATE BILL NO. 158 "An Act relating to pharmacists and pharmacies." PREVIOUS SENATE COMMITTEE ACTION HB 231 - No previous action to record. HB 168 - No previous action to record. SB 158 - No previous action to record. WITNESS REGISTER Marveen Coggins, Legislative Aide Representative Cynthia Toohey State Capitol Juneau, AK 99801-1182 POSITION STATEMENT: Sponsor of HB 231. Catherine Reardon, Director Division of Occupational Licensing P.O. Box 110806 Juneau, AK 99811-0806 POSITION STATEMENT: Supported HB 231 and HB 168. Theresa Sager, Legislative Aide Senator Mike Miller State Capitol Juneau, AK 99801-1182 POSITION STATEMENT: Sponsor of SB 158. Chris Coursey Alaska Board of Pharmacy HC 83, Box 1734 Eagle River, AK 99577 POSITION STATEMENT: Supported SB 158. Maggie Sarber P.O. Box 6635 Ketchikan, AK 99901 POSITION STATEMENT: Supported SB 158. Richard Holm 167 Santa Claus Lane North Pole, AK 99705 POSITION STATEMENT: Supported SB 158. Kendal Kaihai 4737 Villanova Dr. Fairbanks, AK 99709 POSITION STATEMENT: Supported SB 158. Tim Boehmer 12640 Ridgewood Rd. Anchorage, AK 99516 POSITION STATEMENT: Supported SB 158. Jacki Warren 2200 Providence Dr. Anchorage, AK 99516 POSITION STATEMENT: Supported SB 158. Jack Heesch Alaska Academy of Physicians' Assistants Alaska Nurses Association P.O. Box 201608 Anchorage, AK 99508 POSITION STATEMENT: Supported SB 158. Robert Niebert, President Alaska Pharmaceutical Association 710 Birch Anchorage, AK 99501 POSITION STATEMENT: Supported SB 158. Ursula Gahler Alaska Pharmacy Association 1413 Mary Ellen Way Juneau, AK 99801 POSITION STATEMENT: Supported SB 158. Dave Williams, Director Division of Medical Assistance Department of Health and Social Services P.O. Box 110660 Juneau, AK 99811-0660 POSITION STATEMENT: Supported SB 158. ACTION NARRATIVE TAPE 95-19, SIDE A Number 001 HB 231 INTERVIEWS BY THE STATE MEDICAL BOARD CHAIRMAN KELLY called the Senate Labor and Commerce Committee meeting to order at 1:45 p.m. and announced HB 231 to be up for consideration. MARVEEN COGGINS, Legislative Aide to Representative Cynthia Toohey, explained that under existing law, physicians applying for permanent licensure must be interviewed in person by the Alaska State Medical Board or a member of the Board. This mandated interview is cumbersome, expensive, and of limited value since the license application process which takes place prior to the interview is extensive and thorough. An interview is unlikely to reveal any information not already known. HB 231 would allow the interview to be discretionary. HB 231 is supported by the Alaska State Medical Association, the Alaska State Medical Board, and the Division of Occupational Licensing. There is a $0 fiscal note. CATHERINE REARDON, Director, Division of Occupational Licensing, supported HB 231. SENATOR SALO moved to pass HB 231 from committee with individual recommendations. There were no objections and it was so ordered. HB 168 PERMITS FOR NONRESIDENT OPTOMETRISTS SENATOR KELLY announced HB 168 to be up for consideration. SAM KITO, Alaska Optometric Association, said HB 168 was introduced at their request. The purpose is to allow permits to be issued to non-resident optometrists for the purpose of assisting or substituting for an optometrist licensed under Alaska Statute 08.72. He explained that Alaska has a lot of solo practitioners in remote and semi-remote areas of the state. If a practitioner becomes injured or seriously ill, or must be temporarily out of his office, he presently has to close down his clinic. This can be a hardship to his patients, especially if it is for several months. CATHERINE REARDON said she supported HB 168. SENATOR TORGERSON asked why anyone who holds a valid license should be from Canada, Australia, or New Zealand. MR. KITO explained that those licenses were compatible with the ones in the United States. Number 46 SENATOR SALO moved to pass HB 168 from committee with individual recommendations. There were no objections and it was so ordered. SB 158 PHARMACISTS AND PHARMACIES SENATOR KELLY announced SB 158 to be up for consideration. THERESA SAGER, Legislative Aide to Senator Mike Miller, said this legislation was brought to their attention by the Alaska Pharmaceutical Association. She said they worked with Mr. Chris Coursey who would give them a brief overview. CHRIS COURSEY, Alaska Board of Pharmacy, said they had been working on this issue for four years. He noted that the committee had a sectional analysis in their packets that he had prepared. The pharmacy community, some years ago, recognized the need to revise and update the statutes which, in general, are antiquated and obsolete. Most of the statutes are dated from the 1930's through the 1970's and do not reflect the current practice of pharmacy. In addition, many of the statutes have been introduced in a piecemeal fashion and are overly restrictive or specific and would be more appropriate addressed in regulation. For example, 08.80.350 requires pharmacies to have reference texts which are no longer published, requires records to be kept for five years, while federal regulations require records to be kept for two years, and has a grading system and examination which is obsolete. MR. COURSEY noted there are several major omissions in the existing statutes. Nowhere is the practice of pharmacy defined, nor are there any provisions for the use of support personnel. There is existing, but very vague, language in the area of discipline or unprofessional conduct. In Section 2, line 12 - 19, people who engage in the practice of pharmacy needs clarification, as well as the reference to "distribution" other than dispensing, he advised. Number 180 Section 16 on page 7, line 17, the intent of the Board of Pharmacy is to apply to those facilities that are currently licensed by the Board. There is no intent to license practitioner offices, medical clinics, etc., that are not currently licensed. SENATOR KELLY asked on page 10, line 24, if the standards of immorality were being lowered. MR. COURSEY said that was not the intent, but rather they are actually broadening the ability of the Board to discipline or sanction a licensed person. Number 290 SENATOR SALO was concerned with the elimination of #9 and #10 which make a controlled substance available to a person, except upon prescription, etc. She thought that would be one of the more serious offenses in the pharmaceutical world. MR. COURSEY explained that controlled substances are specifically addressed in regulations with disciplinary guidelines. SENATOR KELLY asked if they exist in regulation only because they are authorized by #9 and #10. SENATOR SALO noted that she thought MR. COURSEY explained the intent of section 20 was to cover situations in which a disciplinary action or licensing action is taking place, in case the owner of a pharmacy, for instance, isn't a licensed pharmacist. Number 324 SENATOR KELLY asked what the substitution of equivalent drug products in section 21 meant. MR. COURSEY replied that the statute is basically the same as what exists now except that some of this is dealt with in regulation. There is no intent to weaken or lessen this area. SENATOR KELLY asked, once again, if the deleted the specific language from statute, if the Board would have to address it all. MR. COURSEY replied they wouldn't have to. SENATOR SALO noted that they wanted a pharmacist to have the ability to substitute generic drugs largely for cost reasons. SENATOR KELLY said he would like to hear from the doctors whether or not this language is sufficient. He was concerned that this would not allow a pharmacy to stock a whole lot of drugs if they could get away with just stocking generic drugs. MR. COURSEY said when the existing statute was passed, medical doctors were the only group of practitioners who were authorized to prescribe and dispense. At this time, we have advanced nurse practitioners, physicians' assistants, and dispensing opticians who dispense. The advanced nurse practitioners have dispensing regulations within the Board of Nursing which sets the same standards for dispensing as a pharmacist is held to. As for enforcement, MR. COURSEY said, the Board of Pharmacy would not be enforcing action against another practitioner group. They do believe the Board of Pharmacy should be the entity establishing minimum standards for dispensing of drugs such as labeling and record keeping. Number 403 SENATOR KELLY asked if the Board is attempting to regulate outside of Alaska. MR. COURSEY said under 08.80.158 they register pharmacies located outside of the state. These are essentially mail order pharmacies that do business within the state. The new definition of pharmacy, by referring to pharmaceutical care services, further refines and limits the definition to apply to a pharmacy where a licensed pharmacist is present. SENATOR SALO said the pharmacists in her home town like this bill and she is likely to support it, but she questioned section 22, the confidentiality section, which wasn't there before. She was particularly concerned with number three saying that she thought pharmaceutical records should be as confidential as medical records are within a doctor's office or clinic. She asked why other persons or government agencies might have access to them. MR. COURSEY replied that meant other persons or agencies authorized by law, for example, the Division of Occupational Licensing, in an investigation of a physician or pharmacy or prescription records subpoenaed by a court. SENATOR SALO asked, regarding number two in the confidentiality section, if that kind of availability of records was aimed at someone who might be abusing prescription drugs by going to several different places. She asked if there was an intention of sharing information between pharmacies. MR. COURSEY said this legislation was not too involved with a person who was abusing drugs, necessarily, but for a patient, for example, who has prescriptions issued by multiple prescribers who may not be aware of other drugs being prescribed. SENATOR TORGERSON was concerned that a Board member has the authority to go into someone's business and red line a product he believes may be misbranded. The Board consists of five pharmacists and two people from the general public and he thought the professionals should be specified for this action rather than just any Board member and section b should have some sort of official time line. MR. COURSEY responded that he didn't have any problem with any of his suggestions. Number 475 SENATOR TORGERSON asked if Section 2, Number 11, to seize all drugs or related material found by the Board to constitute danger, meant that the Board has the authority to say an FDA approved drug is not allowed to be prescribed in Alaska. He commented that that seemed like very broad authority for the Board. Referring to language on page 7, line 29, SENATOR TORGERSON asked for an example of what would not be in the public interest. MR. COURSEY gave the example of a pharmacy owned by a non-pharmacist whose pharmacy license is up for renewal, but he doesn't have any licensed pharmacist employed. SENATOR TORGERSON said that, again, he thought that was very broad based language and wasn't in the best interests of the public. Number 500 SENATOR KELLY asked his staff to get a list of the repealers in section 32. He asked what the registration fee was for pharmacists in Alaska. MR. COURSEY replied that it was $180 per license period (two years). SENATOR KELLY noted that the fiscal note says the request for an executive secretary would drive the price up. MR. COURSEY replied that they are not requesting a secretary at this time. SENATOR KELLY asked if he would request higher dues before it is filled. MR. COURSEY replied yes and that they believe the Board should be self supporting. CATHERINE REARDON, Director, Division of Occupational Licensing, supported the general effort of the bill to update and make more comprehensive the pharmacy statute, but believed work was needed to get it into shape for passage. She also noted that the intent of the bill is not to limit the dispensing authority of physicians' assistants, nurse practitioners, doctors, and dispensing opticians, but the actual wording of the bill does restrict them. Mr. Coursey also made it clear that the intent is to only apply this bill to drug stores, but the actual wording may be broader. If fees were to be raised for hiring an executive secretary, they would go up $283 bi-annually. MS. REARDON said they are not comfortable with increasing fees that much. The other costs of the bill are relatively miner, she said - contractual services for printing new statute and regulation books. SENATOR KELLY wanted clarification of the fiscal note. MS. REARDON explained that the fiscal note was above and beyond the amount that is in the budget. She clarified that the fee would be an increase of $283. TAPE 95-19, SIDE B Number 590 MS. REARDON said she thought the reason the executive secretary language was in the bill was in case they wanted to request one through the budget process at a later time. She thought this was a misunderstanding. If the legislature desires to give them that position and fund it, they could do it any time without this language. SENATOR KELLY asked her if she meant that the legislature could fund another position and then the licensing fees would automatically go up, because the Boards are self supporting. MS. REARDON agreed that is basically what happens, although it wouldn't be instantaneous, but would happen the next time the renewal period came around. SENATOR KELLY asked if the section were deleted, would that remove the fiscal note from the bill. MS. REARDON said that would remove everything except the reprinting of statutes and regulations which they would have to consider absorbing. MS. REARDON explained that the reason for having the executive secretary in the fiscal note was to let the committee know how much one would cost. SENATOR KELLY asked who was currently doing the clerical support for the Board. MS. REARDON replied within the Division of Occupational Licensing there are quite a few licensing examiners who are range 12 positions working here in Juneau. Number 506 MS. REARDON thought the embargo and the sealing sections needed more work in outlining the exact process. In reference to Senator Torgerson's comment about the Board having the authority to prohibit the sale of drugs that weren't FDA approved, she said. Her understanding of current Alaska law is that pharmacies may carry non-FDA-approved drugs, because physicians may prescribe, with informed consent of the patient, drugs that are not FDA-approved. So she thought some thought was needed in that area as well. The statute currently requires fluency in spoken and written English as a requirement for a pharmacy license. This bill maintains that requirement, she explained. It is an unusual requirement, but the justification is that understanding and communicating in English are necessary to properly dispense drugs. However, in statute, we do not require that of physicians and other health care providers of whom the same argument might be made. Number 465 MS. REARDON pointed out that, in addition to the repealer, the new section 08.81.40 replaces the current reciprocity statute and, therefore, the existing statute should be repealed. Finally, on page 6, line 25 under reciprocity we are requiring that we look at the requirements that the person was subject to in their other state, perhaps 10 years before, and compare them with the state's requirements 10 years before, which would be fairly difficult for them to do, so they request language instead that says, "The qualifications necessary to be licensed in this state at this time." One more point MS. REARDON mentioned was in section 9, removal only for cause of Board members. The reasons are set out on page 4, line 29, she explained, and it is their position that occupational boards should serve at the pleasure of the governor. The current statute does say that Board members may be removed by the Governor for cause. This is very unusual. The Medical Board and the Nursing Board do not contain the "for cause" criteria. The Board has a lot of power and they feel it is important that someone have the ability to redirect boards and their policy decisions. Number 446 SENATOR KELLY announced a recess from 2:45 - 2:55 p.m. MAGGIE SARBER, Ketchikan, said she was testifying on behalf of Mary Christianson, who was not able to attend the meeting. She said the bill they have before them represents specific statute revisions that pharmacists across the state have endorsed to better reflect the current practice of pharmacy in Alaska. She supported SB 158 in its entirety. RICHARD HOLM, North Pole pharmacist and past president of the Alaska Pharmaceutical Association, supported SB 158. He added that they would find very few doctors or pharmacists who would object to making generic substitutions, because to a large extent they are already doing it under Medicaid regulations. Regarding FDA approval, he cautioned the committee to not use language referring to FDA approval, because it is specific to mass-produced manufactured drug items. Historically pharmacy and practitioner prescriber have used many preparations that are not FDA approved, nor would they ever be. He said that definitions they use in this statute have to be broad in nature, because of the changes that are coming over the pharmacy industry. KENDAL KAIHAI, Fairbanks pharmacist, said this legislation is important for pharmacists and patients they are dealing with. The rules governing pharmacy now make for some very difficult situations. SENATOR KELLY said that the committee would work on this bill and have it before them on Thursday. TIM BOEHMER, pharmacist at Providence Hospital, clarified that the removal for cause (of Board members) issue was national language and the current language is acceptable. SENATOR KELLY asked if, in using national language, he was referring to a model that was enacted by the National Association of Pharmacists. MR. BOEHMER answered that was correct; it was a model practice act that was put forward by that Association. With the executive secretary, they intended some modification of the current licensing examiners position to accommodate someone who could be clearly involved in dealing with an urgent situation, like the case in New York where tylenol was adulterated with cyanide, when the public needs to be protected quickly. Number 291 JACKI WARREN, Director of Pharmacy at Providence Hospital, said SB 158 is important to Alaska. She has responsibilities related to both inpatient practice and retail pharmacy and, she said, we need to put our Board in the position of being able to provide guidance on how support personnel should be addressed and give them further language that will put them in line with the model. Page 11, Section 21 Substitution of Equivalent Drug Products needed more clarification. She explained the way a physician controls the dispensing process is by checking "dispensed only as written" on the prescription. SENATOR KELLY asked if there was another law requiring the dispensed only as written language or could the Board of Pharmacy change the ability of the physician to check that box. MS. WARREN replied that she thought the language on line 22 took care of that concern. Number 160 JACK HEESCH, Alaska Academy of Physicians' Assistants and the Alaska Nurses Association, supported SB 158, because they believed the pharmacy statutes are outdated and need revision. However, they think some of the definitions may be over-reaching. On page 2, line 12, for instance, the practice of pharmacy (page 16, line 16) means the interpretation, evaluation, and dispensing of prescription drug orders and drug administration, etc. They would like additional verbiage to cover the fact that there are people out there practicing under their own licenses who are allowed to dispense medications and clarify that the Board of Pharmacy is not going to be regulating nurses or physicians' assistants or dispensing opticians. SENATOR KELLY asked if that was the status quo. MR. HEESCH said it was in that regard. He said the other concern they have is specifically on page 12, line 25 which they consider somewhat onerous, because it might require record keeping well beyond the bounds of necessity. Number 222 ROBERT NEIBERT, President, Alaska Pharmaceutical Association, said the Association supports the bill whole-heartedly. He assured the committee that as long as a physician has the dispense only as written authority, every pharmacist understands that, unless the product is therapeutically equivalent, they aren't going to substitute something that is inferior. Samples fall under federal regulations and so does record keeping, he said. The Pharmacy Practice Act, he thought, was to make sure no one would get in trouble with the feds if there was a major drug recall and there needed to be a way to identify the recalled product and get it back to the manufacturer. SENATOR SALO asked him if the confidentiality language was part of the national model. MR. NEIBERT replied that is where it came from, but in reality they are finding that medicaid patients records available to anyone using their medicaid I.D. number. There isn't much confidentiality, because the state is demanding it in other areas. SENATOR SALO asked if there were circumstances where it would be useful to have information kept for longer than two years and if it was that much of a problem to store with today's technology. MR. NEIBERT said prescriptions are still hard copy and take up a lot of room. A normal prescription is only valid for 12 months to begin with; controlled substances are good for only six months. There is no practical reason to keep records beyond even that. Two years is reasonable. SENATOR SALO asked what if you're dealing with thalidomide, for instance, with ensuing litigation. MR. NEIBERT said an example of this type of thing is with DES which they heard nothing about over 20 years. Even a five-year limitation wouldn't have helped that. Number 64 URSULA GAHLER, Alaska Pharmaceutical Association, said she has been frustrated with Alaska statutes which have not kept pace with national trends and rapidly changing technology. For example, she said, advances in technology have made it possible for computer controlled delivery systems which didn't even exist when the current statutes were written. New drugs have been created, she said, that require special handling and equipment are not currently addressed. Current statutes required her to purchase specific, very expensive reference texts which are not useful to her. As statutory requirements, the Pharmacy Board has no latitude to update pharmacy requirements such as this without legislative approval which is a waste of money and valuable legislators' time. Because of restrictive statutes it has been difficult and costly for some licensed practicing pharmacists from other states to be licensed in Alaska which limits the ability to import experienced professional pharmacists to the state. The new statutes empower the Pharmacy Board with the ability to adjust and regulate rapidly changing pharmacy practices. She noted that the people who have worked on updating the statutes have worked over a period of four years and are well respected experts in the profession of pharmacy and have adopted recommendations from the National Association of Boards of Pharmacy to fit the unique needs of Alaska. DAVE WILLIAMS, Director, Division of Medical Assistance, complimented the Division of Occupational Licensing on the work related to this bill. He didn't want to leave them with the impression that at the point of sale a person's whole record would be flashed before every pharmacist in the state. The intent is to let them know if there is a refill time due so there aren't early refills and to let them know if the patient is eligible and, therefore, might pay their bill with medicaid. MR. WILLIAMS said that he would like to check some issues with the Division of Public Health regarding duties of the epidemiologist and drugs that might be compromised. SENATOR KELLY said he would work with the sponsor, state agencies, the Alaska Pharmaceutical Association, and the Alaska Board of Pharmacy to come up with a version of the bill that would receive the legislature's approval. SENATOR KELLY adjourned the meeting at 3:30 p.m.