1 2 CITY COUNCIL 3 CITY OF NEW YORK 4 -------------------------------x 5 THE TRANSCRIPT OF THE MINUTES 6 of the 7 COMMITTEE ON HEALTH 8 -------------------------------x 9 10 February 28, 2008 Start: 10:18 a.m. 11 Recess: 12:36 p.m. 12 City Hall 250 Broadway, 14th Floor 13 New York, New York 14 B E F O R E: 15 JOEL RIVERA 16 Chairperson, 17 COUNCIL MEMBERS: John Liu 18 Helen Sears Kendall Stewart 19 Inez Dickens Rosie Mendez 20 21 22 23 24 LEGAL-EASE COURT REPORTING SERVICES, INC. 17 Battery Place - Suite 1308 25 New York, New York 10004 (800) 756-3410 2 1 2 A P P E A R A N C E S 3 Dr. Issac Weisfuse 4 Deputy Commissioner Division of Disease Control NYC Department of Health and Mental Hygiene 5 Susie Rush 6 Assemblymember Amy Paulin's Office 7 Mike McGuire Vice President of Anti-Infectives 8 Hoffman La Roche 9 Dr. Danielle Ompad Associate Director of the Center of Urban 10 Epidemiologic Studies NY Academy of Medicine 11 Cameron Gelisse 12 Brooklyn Borough Coordinator JPAC for Older Adults 13 Sheetal Bhatia 14 Program Manager American Lung Association 15 Barbara Ellman 16 Associate Director for Policy Medical Society of New York State 17 Dr. Toni Olashawerey 18 NYC Adult Immunization Coalition 19 Anne Fellow National Association of Chain Drug Stores 20 Macary Marciniak 21 Pharmacists Society of the State of New York 22 23 24 25 3 1 COMMITTEE ON HEALTH 2 CHAIRPERSON RIVERA: Good morning. I 3 am Joel Rivera, the Chairperson for the New York 4 City Council's Committee on Health. We are here 5 today to talk about the Avian flu. The Health 6 Committee held a hearing about the City's 7 preparedness for an Avian flu pandemic in 2005. 8 Although there appears to be less 9 public panic since then, and bird flu is not on the 10 cover of the newspapers anymore, the 11 threat of the Avian flu and the possibility of a 12 pandemic are still terribly real. 13 For the most part, Avian flu has so 14 far only infected those humans who have come into 15 close contact with sick birds. However, experts 16 warn that the virus could mutate, and it could 17 become possible for people to transmit the virus to 18 each other. If that were to happen, an Avian flu 19 pandemic could occur. International group World 20 Health Organization and governments at all levels 21 have developed plans designed to prevent Avian flu 22 from spreading beyond birds and to contain and 23 minimize any epidemic that might occur. 24 As part of the pandemic strategy, the 25 Bush Administration released in November of 2005 the 4 1 COMMITTEE ON HEALTH 2 federal government has stockpiled a variety of 3 supplies to support international efforts and 35 4 million courses of antiviral drugs for Americans. 5 Additionally, the federal government 6 approved the first Avian flu vaccines for humans in 7 April 2007, and has so far collected enough doses 8 for six million people. 9 The City also has a pandemic flu 10 preparedness and response plan. The Department of 11 Health and Mental Hygiene is one of the lead 12 agencies in the City's planned response to Avian 13 flu. We hope to hear today what progress had been 14 made in preparing the City to prevent Avian flu and 15 to confront a pandemic if one were to occur. 16 Specifically, the Committee wants to 17 know whether the City's plans have changed in any 18 way, and whether the City is better prepared than it 19 was at the time of the last hearing in 2005. 20 In addition to Avian influenza, we 21 are also go to hear testimony on Resolution 1231, 22 this resolution which I have sponsored calls on the 23 State Legislature to pass Assembly Bill 2140 and 24 Senate Bill 1312. These bills would allow 25 pharmacists to provide influenza and pneumonia 5 1 COMMITTEE ON HEALTH 2 vaccines to adults. 3 Every year, influenza and pneumonia 4 kills 3,000 adults in New York City. Many of these 5 deaths could have been prevented by vaccinations. 6 Despite our best efforts, New York City has been 7 unable to meet the federal goal, or even catch up to 8 the national average for vaccination rates. We must 9 do more. Pharmacists are allowed to give 10 vaccinations in 47 states. In those states, 11 research shows that 18 to 64 year olds were 27 12 percent more likely and those over the age of 65 13 were 22 percent more likely to be vaccinated against 14 the flu. 15 Clearly, this strategy works in other 16 places and should be allowed to work in New York. 17 Before I begin, I would like to 18 introduce my colleagues who are here with us today. 19 We have Council Member Rosie Mendez and Council 20 Member Inez Dickens with us, and, of course, Adira, 21 our Counsel for the Committee. 22 So at this point in time, I want to 23 call the Administration up, and we have with us 24 today Dr. Weisfuse. Just state your name for the 25 record, you may proceed with your testimony. 6 1 COMMITTEE ON HEALTH 2 DEPUTY COMMISSIONER WEISFUSE: Good 3 morning, Chairman Rivera and members of the Health 4 Committee. My name is Dr. Isaac Weisfuse. I'm a 5 Deputy Commissioner for Disease Control at the New 6 York City Department of Health and Mental Hygiene. 7 As the Chair mentioned, I last testified on the 8 topic of Avian and pandemic flu before the City 9 Council on November 17th, 2005, and today, what I 10 would like to do is give you an update on where we 11 are in our preparedness to deal with a pandemic flu 12 outbreak. 13 Just a few basics to get on the 14 table. Pandemic flu is different than the annual 15 seasonal flu. A pandemic means a global disease 16 outbreak that occurs when a new influenza virus 17 emerges for which people have little or no immunity, 18 and it has the ability to be easily transmitted from 19 person to person. In a flu pandemic disease may 20 spread quickly between humans and cause serious 21 illness. 22 There has been a great deal of 23 publicity about Avian or bird flu, also know as the 24 H5N1 virus, which has spread widely across poultry 25 in affected countries. Nonetheless, there have been 7 1 COMMITTEE ON HEALTH 2 relatively few humans infected, although the 3 mortality rate for those infected is extraordinarily 4 high. Since 2003, according to the World Health 5 Organization there have been 359 human cases of 6 Avian influenza and tragically 226 deaths. None of 7 these cases occurred in the United States, and all 8 of the people had close contact with poultry, 9 although there were several clusters that may have 10 involved some very limited person- to- person 11 transmission. The WHO is monitoring the situation 12 closely, and thus far there is no evidence of 13 efficient and sustained human- to- human 14 transmission of the virus. 15 Now we don't know if Avian flu or 16 H5N1 will lead to a pandemic, and as I mentioned, we 17 can't predict whether or when a pandemic will occur. 18 However, against the backdrop of this uncertainty, 19 we are planning for this possible public health 20 emergency. So what I'd like to do is give you a 21 brief synopsis of some of the things we're preparing 22 trying to emphasize new initiatives that we've 23 instituted since we've last testified before the 24 Council. 25 First of all, surveillance, that is 8 1 COMMITTEE ON HEALTH 2 the ability to understand whether a new kind of flu 3 is present or not present in New York City and to 4 what extent it's affecting our population is really 5 a critical element of our response. We have a well- 6 tested system for year- round influenza surveillance 7 currently. We know that information about the 8 number of cases, who is dying from the flu and how 9 it is being transmitted are going to be critical to 10 our ability to manage the emergency and the 11 outbreak. 12 Since 2005, we've enhanced our 13 surveillance system to enable us to better detect if 14 a pandemic should arrive in New York City. These 15 enhancements have included plans to monitor 16 influenza- related hospitalizations and deaths, and 17 in 2005, we added novel influenza strain with 18 pandemic potential to the reportable disease list in 19 our New York City Health Code. 20 In addition, the Department has 21 improved our surveillance for identifying and 22 responding to animal mortality events. 23 The second issue I wanted to base on 24 briefly is laboratory capacity. When I last 25 testified in 2005, if we had a rule out H5N1 lab 9 1 COMMITTEE ON HEALTH 2 specimen, we would have had to send that specimen up 3 to the New York State Department of Health in 4 Albany, but since that time, we've bought new 5 equipment and supplies, we've cross trained 6 personnel, and we've worked with our hospitals in 7 New York City on protocols for sample submission, 8 and therefore, we have established our own ability 9 locally to do influenza rapid testing capabilities 10 at our public health laboratories. So this has been 11 a very good step forward. 12 We've been recipient of a number of 13 guidelines on what's called community mitigation 14 that have been put out by the federal government to 15 try to decrease the possibility of person- to person 16 transmission if a pandemic should arrive in the 17 United States. In a follow- up to date, we've 18 developed materials to inform the public about how 19 to care for sick loved ones at home, and we're 20 developing systems to coordinate subsistence support 21 for those in need. We've reached out to businesses 22 to raise awareness of the need for pandemic flu 23 planning and to educate them about absenteeism 24 challenges they may face. 25 We've had a specific focus on small 10 1 COMMITTEE ON HEALTH 2 businesses because they frequently don't have the 3 wherewithal to do a lot of planning to deal with a 4 pandemic. 5 We've also engaged in a very 6 constructive dialogue and working relationship with 7 our Department of Education to ensure that critical 8 school services continue if schools are closed due 9 to a pandemic, and they are analyzing ways to keep 10 children learning even if they are not in school. 11 I would also say that we have tried 12 to focus on what we call vulnerable populations of 13 which there are many in New York City to try to 14 understand how we can help out and deal with those 15 populations to make sure they can get through a 16 pandemic as well as any other citizen. 17 We've also been working very hard 18 with the health care system because we know that 19 during a pandemic the health care system is going to 20 be overwhelmed with patients, so we need to work 21 with them in advance to make sure that we give the 22 best possible care to individuals who are ill with 23 flu. 24 Since 2003, we've been working with 25 the hospitals and other health care institutions on 11 1 COMMITTEE ON HEALTH 2 bio-emergency plans, including ensuring the ability 3 of hospitals to expand their capacity to care for 4 large numbers of patients. This work has included 5 Health Department educating hospital emergency staff 6 about pandemic response and conducting an influenza 7 drill. 8 During this drill, we actually sent 9 fake patients to emergency departments who had 10 illnesses that would require, for example, isolation 11 and perhaps personal protective equipment to make 12 sure that these hospitals reacted appropriately. 13 In addition, we've been working with 14 the emergency medical services, community health 15 centers and nursing homes to strengthen the health 16 care network for pandemic response to address gaps 17 identified through data analysis, including building 18 stockpiles of personal protective equipment and 19 ventilators. So we actually have purchased extra 20 ventilators for the City of New York. 21 We've also been working with our 22 Office of the Chief Medical Examiner to deal with a 23 mass fatality plan as well. 24 In terms of the important use of 25 antiviral medications, we know that these drugs can 12 1 COMMITTEE ON HEALTH 2 decrease severe complications of influenza and 3 reduce hospitalizations, especially if used early in 4 the course of illness. They may also be used to 5 prevent acquisition of influenza. The Department 6 has worked closely with the state and federal 7 government to manage and plan for the receipt, 8 storage, distribution and use of antiviral drugs for 9 treatment of ill persons. We understand that the 10 capacity for production of antiviral drugs is 11 increasing, and there is ongoing national discussion 12 about the best way to use and distribute the drugs 13 for prevention. 14 Now, last time I testified that the 15 vaccine manufacturing process is such that will take 16 between six and nine months to actually get a 17 pandemic flu strain specific vaccine out to the 18 population, and unfortunately, this is still the 19 case although the federal government is funding a 20 number of entities to try to develop new 21 capabilities, new technologies to short cut this 22 process. 23 However, if it happened today, we 24 would still have to wait for a vaccine, but we're 25 already working on how this vaccine would be 13 1 COMMITTEE ON HEALTH 2 distributed, and we've identified over 300 potential 3 vaccination locations throughout the City. We used 4 experience in the past couple of seasons on 5 influenza shortages to test our plans to distribute 6 and conduct mass vaccination clinics. 7 Furthermore, we've enhanced our City- 8 wide immunization registry computer system expanding 9 its ability to record pandemic vaccine 10 administration and adverse events. So if we had to 11 roll this out today, at least we would have a system 12 to track what we're doing and we'd have the 13 locations within which to do it as well as the 14 protocols. 15 We also understand that mental health 16 will become a big issue during a pandemic. There 17 will be lots of stress on all of us in society. 18 We're trying to prepare to address the tremendous 19 consequences that will develop because of a 20 pandemic. So our mental health emergency response is 21 planning to use some predesignated community-based 22 and professional agencies to help out in any 23 location or through hotlines to make sure that 24 people get mental health resources as needed. 25 We also know that public 14 1 COMMITTEE ON HEALTH 2 communication is going to be a key in dealing a 3 pandemic, so we actually are developing our 4 communication plan which takes advantage of tv, 5 radio, internet and the City's 311 system. We 6 invest considerable time and effort to maintain 7 current contact information for the full range of 8 media in New York, so we can utilize every avenue in 9 the case of a pandemic to reach the public and give 10 them information about how to access medical care 11 and other services. 12 We had a special project to look at 13 ethnic media -- They may not come out daily. They 14 may be just weekly, or on radio -- to make sure 15 that they understand who we are and how we can get 16 press releases to them. We've also worked on 17 developing some rapid translation capabilities, so 18 we can give them press releases and other 19 information that they can then put into their media. 20 This has really not been a total 21 exhaustive review of all the things that we've been 22 doing, but I think gives you a sense of the breadth 23 of the kinds of activities that we're engaging in. 24 We're certainly hopeful that a number of these 25 activities if not all of them will be helpful to New 15 1 COMMITTEE ON HEALTH 2 York City in a variety of emergencies not just for a 3 pandemic. 4 I want to just spend a few minutes 5 discussing what has been a hot button issue in 6 public health and pandemic response, which is use of 7 antiviral drugs. As I stated before, there is 8 currently discussion at the federal level about 9 whether these antiviral drugs may be used for 10 prophylaxis or prevention, meaning if you take the 11 drug, you keep from getting infected or not. 12 We also need to understand that a lot 13 of the real answers to whether these drugs will be 14 effective will only be known at the time when the 15 particular strain of pandemic flu is know and 16 characterized. So we can't absolutely say with 17 certainty that any drug that we have now will 18 necessarily be effective against that pandemic 19 strain. It's very important that we do all the 20 preparatory work that we need to now, but the actual 21 sensitivities of that pandemic strain will be 22 closely looked at by WHO and CDC and by us to make 23 sure we're applying the appropriate drug to deal 24 with that issue. 25 The federal government has decided to 16 1 COMMITTEE ON HEALTH 2 stockpile Tamiflu, which is an antiviral drug, as 3 well as another drug called Relenza. New York 4 City's share of the federal stockpile will be 5 distributed through something called the Strategic 6 National Stockpile, which is depots of not only 7 antivirals, but antibiotics and other medical 8 equipment that are across the country and are 9 available at our request and the Governor's request 10 to be released by the federal government and shipped 11 here within 12 hours of that request. 12 In addition, the federal government 13 negotiated an agreement with Roche Pharmaceuticals 14 to make additional Tamiflu available for purchase by 15 state and local governments at a discount rate for 16 the sole purpose of stockpiling for a future 17 pandemic. In other words, under this agreement, we 18 are not allowed to use it for seasonal flu even 19 though it's indicated for seasonal flu as well. 20 New York State purchased the New York 21 City allocation of Tamiflu with State funds, and New 22 York City and New York State are in total agreement 23 that those antivirals are to be used by New York 24 City residents and will be stored here locally, so 25 they will be under our control. 17 1 COMMITTEE ON HEALTH 2 Roche Pharmaceuticals, the drug 3 company that manufactures Tamiflu, has been actively 4 promoting the stockpiling of its product by 5 government and the private sector. In fact, we've 6 met with representatives of the company who 7 suggested the City would be politically vulnerable 8 if it did not purchase additional Tamiflu and 9 implying that we cannot trust New York State to 10 provide the City with the drugs they purchased for 11 us. They are marketing aggressively, as is their 12 right, but their interests are not identical with 13 public health. Antivirals are just one aspect of a 14 pandemic flu preparedness, and as I said, we don't 15 know right now that Tamiflu will be necessarily the 16 best drug although we certainly hope the pandemic 17 strain will be susceptible to a variety of drugs. 18 We also understand that there has 19 been some issues with seasonal influenza virus being 20 resistant to Tamiflu, so this is a concern to us and 21 something that we're monitoring very closely. I 22 will say that Roche has worked very well with the 23 federal government and other public health entities 24 to assure that we can increase the amount of time 25 that their product can be stored safely and used. 18 1 COMMITTEE ON HEALTH 2 That's been very welcomed by public health 3 communities because it means that instead of a shelf 4 life of say five years, we've been able to work with 5 the company to extend it to seven years, which has 6 been very, very helpful. 7 In terms of our plans, the CDC has 8 reviewed our health plans and told us there were no 9 major gaps, and although that sounds like not a big 10 deal, that, in fact, is the highest rating possible 11 for our plans. 12 Our Strategic National Stockpile 13 plan, which is again where we would get most of our 14 antivirals from received a score of 97 out of 100, 15 which is we're tied with three other jurisdictions 16 for the top mark in the United States. Our 17 reviewers of our health care plans indicated that 18 our communications and community containment plan 19 have been recommended as a model for other 20 jurisdictions. 21 We're a little bit harder on ourself, 22 however, we know there is a lot more to do. We're 23 thankful for the praise and the good ratings, but we 24 know that this is a very large issue, something that 25 we are continually working on, and therefore will 19 1 COMMITTEE ON HEALTH 2 never consider ourselves totally prepared because of 3 the potential impact of a pandemic. This is made a 4 little bit more difficult by the fact that although 5 CDC has provided us with a separate stream of 6 pandemic funding over the past three years, we're 7 not going to be getting any funding starting in 8 August, 2008. So it will be our challenge to 9 continue to move forward without that source of 10 funding. 11 When I last testified, I told you 12 there is much to learn about pandemic flu and our 13 plans would have to be flexible. We have learned a 14 great deal in that time and have developed a solid 15 plan and will continue to refine. I'm happy to 16 answer any questions that you may have. 17 CHAIRPERSON RIVERA: Thank you very 18 much. You actually answered a substantial amount of 19 initial questions that I had. One of them actually 20 you mentioned about current resistance for the 21 seasonal flu by some of the drugs that we currently 22 have on hold. One question is there is reports of a 23 new drug coming out next year, or the year after, 24 that has a tri- facta approach. You can combat 25 three different strains of the influenza. Will that 20 1 COMMITTEE ON HEALTH 2 have any impact, or is it possible that it may have 3 a benefit in case of a pandemic? 4 DEPUTY COMMISSIONER WEISFUSE: I think 5 there are a couple of things that are in the 6 pipeline. One is there is discussion on a national 7 level of broadening the approach to the annual flu 8 vaccine, and that will be helpful because when they 9 make the vaccine, they need to make sure it matches 10 against the circulating strains. There have been 11 some questions about that, so they're talking about 12 sort of expanding the scope of the vaccine to make 13 sure that for seasonal influenza there's a greater 14 degree of protection. 15 My understanding that one very good 16 initiative is an antiviral on the pipeline that will 17 allow for intravenous, that is through the vein, 18 dosing and administration, which is useful because 19 there are people who for whatever reason can't take 20 an oral medicine or are too sick to take an oral 21 medicine, and that's a very positive thing because 22 we don't have that now. I understand that that is 23 actively being worked on. 24 So there are things in the pipeline. 25 There are probably many companies working on other 21 1 COMMITTEE ON HEALTH 2 drugs that I'm not aware of, but it is something 3 that we need to be concerned about because we know 4 from a whole host of venues in public health and 5 bugs in public health that antibiotic resistance is 6 a truly national and international problem. 7 Unfortunately, these viruses, in the case of flu and 8 other viruses, are adaptable. They can adapt to 9 deal with some of these medications, so we can't put 10 all our eggs in one basket as a society. So we're 11 certainly very encouraging of a lot of that 12 development work that's going on. 13 CHAIRPERSON RIVERA: Thank you very 14 much. 15 We've also been joined by Council 16 Member Kendall Stewart. Does anyone on the 17 Committee have questions? Council Member Inez 18 Dickens. 19 COUNCIL MEMBER DICKENS: Thank you, 20 Mr. Chair, and thank you for your testimony. At 21 this time, per your testimony, there is no evidence 22 of sustained human- to- human transmission of Avian 23 flu, but you also indicated that those that have 24 been infected were in close proximity to poultry. 25 Is there evidence that this could possibly change, 22 1 COMMITTEE ON HEALTH 2 since we're discussing pandemic? That's number one. 3 And when we speak of poultry, are we talking about 4 all poultry, such as geese, ducks as well as 5 chickens? 6 DEPUTY COMMISSIONER WEISFUSE: Right 7 now, the best public health evidence is your right, 8 that physical contact with sick or dead poultry has 9 really been the main risk factor for acquisition of 10 H5N1, and the transmission from person- to- person, 11 although it has happened in a very limited way such 12 as within families, as an example, hasn't really 13 taken off and hasn't happened. 14 We don't know if that -- That would 15 require probably some mutations of the virus in 16 order to allow that to happen. We don't know if 17 those mutations are going to occur, but taking a 18 step back for a second, we know that generally 19 speaking we average about two to three pandemics per 20 century. So in the 1900's, there was 1918, 1957 and 21 1968. They weren't all of equal severity, and if 22 you look back to the 1800's and 1700's, although the 23 amount of information we have about them is less for 24 obvious reasons, they were there as well. So we 25 have to be concerned. Whether H5N1 is going to be a 23 1 COMMITTEE ON HEALTH 2 pandemic strain, we can't say, but this generation 3 needs to take seriously the fact that at some point 4 in time there will be another pandemic, and we need 5 to be able to get through it as well as we can. 6 In terms of the kinds of poultry 7 infected, it really has run across different Avian 8 species. It does get into water fowl, which poses 9 some interesting problems because we know that a lot 10 of these water fowl are migratory. They migrate 11 across borders and go from place to place depending 12 on the season, and so the question has been what is 13 the role of these migratory birds in spreading H5N1 14 across countries versus poultry? Probably the best 15 guess is that there's probably some of both in terms 16 of spread across boundaries. 17 If you look at maps put out by WHO, 18 there has been a sort of increasing number of 19 countries, especially in the Far East and Africa and 20 also now in Europe, that have had birds with H5N1. 21 But poultry does seem to play a role because man's 22 contact with poultry is lot more intense than it 23 might be with wild fowl or migratory wild fowl or 24 water birds, as an example, so they both probably 25 play a role, but the epidemiological evidence in 24 1 COMMITTEE ON HEALTH 2 terms of human cases seems to indicate this handling 3 of poultry. Now whether the poultry then were 4 infected by wild water fowl that were going from 5 place to place is an open question. 6 COUNCIL MEMBER DICKENS: Just one last 7 question. Is something being done to check fowl, 8 chickens, migratory birds so that they're not sold? 9 I mean is something really be done to stop that? 10 For instance, in North Carolina, 11 there was a whole full exposure where these chickens 12 were being inspected and killed in order to be sold 13 throughout the Eastern states and they were letting 14 infected birds -- I'm not talking about the Avian 15 flu, but infected with other things -- through, so 16 that's why I'm asking. 17 DEPUTY COMMISSIONER WEISFUSE: There 18 has been a number of initiatives to look at birds in 19 North America and United States, so let me just run 20 through them very quickly. First of all, people 21 have looked at the flyways for migratory birds and 22 thought there is a connection between the Asia and 23 North American Alaska, so there are a number of 24 initiatives to track wild birds as they come over in 25 Alaska to try to see if they are infected with H5N1, 25 1 COMMITTEE ON HEALTH 2 and then there are other North American initiatives 3 to trap wild birds. 4 In terms of poultry, I'm most 5 familiar with some of the initiatives that we, along 6 with colleagues in the State, have taken along the 7 lines of poultry in New York City. We have about 90 8 live bird markets across the City, and we've been 9 concerned for a while to make sure that the quality 10 and the safety of those birds are extraordinarily 11 high. We've worked with the New York State 12 Department of Agriculture and Markets to look at 13 that issue, and they've done, I think, a very good 14 job. They have a couple of safety measures in 15 place. 16 Number one, they make sure that the 17 poultry markets themselves don't buy directly from 18 the farm, but they buy from a distributor that they 19 license and that the records are kept about which 20 distributor they use and then the distributor has a 21 record keeping system to understand which farms they 22 use. There are many different farms that contribute 23 poultry, probably including North Carolina, to New 24 York City markets. 25 In addition, there are cleanliness 26 1 COMMITTEE ON HEALTH 2 standards for both the poultry market as well as for 3 the distributors to make sure that after a shipment, 4 for example, takes place, there is a washing down, a 5 decontamination of the trucks that occurs. 6 Then, they also do testing of the 7 flocks in the poultry market to make sure there is 8 no Avian influenza in those flocks, and they do that 9 routinely. 10 Obviously, if Avian influenza or 11 another kind of influenza was introduced that market 12 would be shut down, the chickens or other poultry or 13 other animals would be culled and there would be a 14 clean up process involved in that. So it very much 15 is a multi- agency issue, but there are standards in 16 place right now to assure that, but we have to 17 realize if it were to get into the poultry markets, 18 we along with the State and other federal entities 19 are going to have to deal with it, and we've been 20 discussing that issue with them. 21 COUNCIL MEMBER DICKENS: Thank you. 22 CHAIRPERSON RIVERA: Council Member 23 Kendall Stewart. 24 COUNCIL MEMBER STEWART: Thank you. 25 Doctor, you spoke about stockpiling antiviral drugs. 27 1 COMMITTEE ON HEALTH 2 Can you tell us a little bit more because I'm 3 getting the feeling that it's one form of 4 stockpiling that the federal government and not so 5 much New York City or even the State? Can you tell 6 you more about it? 7 DEPUTY COMMISSIONER WEISFUSE: Sure. 8 First of all, stockpiling, there's a lot of it going 9 on, and it's not just drugs. So, for example, the 10 Strategic National Stockpile does have drugs, but it 11 also has medical equipment and other things we might 12 for a variety of emergencies. The Strategic 13 National Stockpile is a federal program. They are 14 located at 12 places across the country. I don't 15 know where they are, but they've assured us that at 16 least the initial what they call push pack, which is 17 about the third of the size of a jumbo jet would get 18 to us within 12 hours of request. Actually, on 19 September 11th, they got here in four or five hours 20 because it was requested because we might need 21 medical emergency equipment. 22 They also have behind that what they 23 call Vendor Managed Inventory, which will ship up 24 needed goods, so that includes antivirals, that 25 stockpile. 28 1 COMMITTEE ON HEALTH 2 The second stockpile is the stockpile 3 that we are working with the State Health Department 4 at locating in this area for the use of New York 5 City residents, and I can get you at another time 6 exactly how many doses that involves, but I believe 7 it's somewhere in the magnitude of 850,000 treatment 8 courses. 9 Then New York State, aside from that, 10 also has its own stockpile, which if pandemic flu or 11 another flu broke out in New York City, they would 12 provide to us as well. So we have a number of 13 different sources to be able to tap into should we 14 need antivirals. 15 COUNCIL MEMBER STEWART: You spoke 16 about these sites for the distribution of this 17 medication in case there is a pandemic. What will 18 happen in terms of if was just located in New York 19 City? Where would you be concentrating on to really 20 distribute this medication? Would it be in the 21 housing projects? Would it be at the hospitals? 22 Where would it be so that it could be much more 23 effective in terms of your treatment? 24 DEPUTY COMMISSIONER WEISFUSE: Part of 25 it depends on the amount of availability, but if it 29 1 COMMITTEE ON HEALTH 2 happened today -- Let's just state that because a 3 year from now we could have a different 4 availability. If it happened today, we would focus 5 on health care treatment settings, such as clinics, 6 hospitals, other venues where people would get a 7 brief evaluation and get medicine. We are working 8 to expand that network of places where that can 9 happen, and if we had enough -- because we need 10 some at limited medical evaluation to take place of 11 patients to make sure there's nothing else going on, 12 so we would stock those places that normally see 13 patients to be able to give antivirals. 14 We're also working with a number of 15 different entities that pose specific issues, and 16 this is where I get into the vulnerable population 17 issue. So, for example, people who are homebound, 18 they're not going to be able to go to their doctor 19 if they get sick, so we're working with 20 organizations such as Visiting Nurse Services to 21 push out antivirals to their population or 22 populations of people who can't easily access any of 23 the facilities to be able to provide those treatment 24 courses under guidance of the Health Department, 25 using an algorithm that we all agree to. So we're 30 1 COMMITTEE ON HEALTH 2 working with some of those places that may have 3 difficulty to be able to push out antivirals in 4 place that either access the care or mobility may be 5 a problem. 6 We've worked a lot with our 7 Department of Corrections. Obviously if pandemic 8 flu were to occur in one of our jail systems, we 9 need to make sure that those individuals are being 10 treated appropriately and that they have access to 11 drugs. So we're trying to look in a lot of these 12 little kind of important niches, if you will, where 13 we need to put in some special plans, and that's 14 what we're doing. 15 COUNCIL MEMBER STEWART: Well if you 16 have all those plans, and you said that the $12.7 17 million dollars you got last year or previously, 18 you're not to sure you're going to be getting any 19 money this year. How is that going to be going 20 forward? 21 DEPUTY COMMISSIONER WEISFUSE: Our 22 understanding is that starting in August '08 that 23 that money has now been cut by the federal 24 government, so we're going to have to -- You know 25 a lot of that money has to do with planning, 31 1 COMMITTEE ON HEALTH 2 although some of it has gone for stockpiling. For 3 example, we used some of that money to buy personal 4 protective equipment and to buy ventilators, and 5 we're going to have to sort of reach within as best 6 we can to keep this process moving forward. 7 COUNCIL MEMBER STEWART: What is the 8 Administration's take on that in the sense that if 9 the money is not coming from the federal government, 10 are you looking for the money from the State or are 11 you looking at it from the City? What are you 12 looking? 13 DEPUTY COMMISSIONER WEISFUSE: I don't 14 think we've concluded our deliberations. I guess 15 we're still in the hope that some advocacy or the 16 federal government -- which we've done -- will 17 help, and I certainly bring it forward to your 18 attention in the hope that you could weigh in on 19 this as well. So I think we've totally concluded 20 about that, but we're going to have to probably look 21 at our internal resources first to see how this 22 planning process can continue. 23 COUNCIL MEMBER STEWART: Thank you. 24 CHAIRPERSON RIVERA: Thank you very 25 much. We've been joined by Council Member Helen 32 1 COMMITTEE ON HEALTH 2 Sears, and I see no other questions from the 3 Committee. Thank you very much. 4 At this point in time, I'm going to 5 turn over the chair position to Inez Dickens, as I 6 am actually leaving the City in about an hour. 7 Thank you. 8 ACTING CHAIRPERSON DICKENS: Good 9 morning, and the next person to give testimony is 10 Ms. Susie Rush from Assemblywoman Amy Paulin's 11 Office, please. 12 MS. RUSH: Good morning. My name is 13 Susie Rush, staff member to State Assemblywoman Amy 14 Paulin. I'd like to read a statement on behalf of 15 Assemblywoman Paulin. 16 For the last several years, I have 17 sponsored legislation, which is before the Council 18 Members today, to allow licensed pharmacists to 19 administer flu and pneumonia vaccines to adults in 20 New York State. We are one of only three states in 21 the country that does not allow trained pharmacists 22 to administer these vaccines. 23 Not surprisingly, we have one of the 24 lowest immunization rates in the country, and we 25 know that each year between 5,000 and 7,000 New 33 1 COMMITTEE ON HEALTH 2 Yorkers die from vaccine- preventable diseases and 3 more than 75,000 New Yorkers are admitted to 4 hospitals due to flu- like symptoms. Yet studies 5 show that when states allow pharmacists to 6 administer vaccines, adult immunization rates 7 improve dramatically and without incident. 8 Allowing pharmacists to give adults 9 flu and pneumonia vaccines will enable us to 10 increase public awareness of the need for an annual 11 flu shot and expand access to life- saving health 12 care for all New Yorkers, particularly for our most 13 vulnerable, such as the elderly and the poor. 14 Pharmacists are a useful resource in 15 communities especially for those trying to find a 16 medical home, or where, for example, in rural 17 communities and inner- city neighborhoods, there may 18 be no physician available. As pharmacies are widely 19 distributed throughout traditionally under- served 20 areas of the State, arming pharmacists with the 21 vaccines may help us reduce the racial and ethnic 22 disparities in immunization rates. Pharmacists 23 will, therefore, serve as physician extenders to 24 provide vaccines to those who may otherwise go 25 without the immunization due to cost, inconvenience 34 1 COMMITTEE ON HEALTH 2 or lack of a medical home. 3 Ensuring access becomes even more 4 critical in the event of a mass emergency, such as a 5 flu pandemic. Public health officials have been 6 reported to be urging local and state governments to 7 prepare for such an event because it can result in a 8 large number of people becoming ill at the same time 9 and resulting in the deaths of thousands or even 10 millions. State Health Commissioner Dr. Richard 11 Daines has acknowledged that caring for a large 12 number of patients during a severe pandemic would 13 seriously overburden hospitals throughout the state. 14 According to the Journal News, during a severe 15 Category 5 pandemic, computer models predict that 16 the number of hospital admissions for treatment of 17 influenza would be 770,000 over a six- week period, 18 whereas during an average flu season the number of 19 hospital admissions is approximately 228,000. 20 In such a health crisis, community 21 pharmacists can play an invaluable role, serving as 22 reliable sources of public health information and 23 advice to the public and supporting other health 24 care providers. Pharmacies are located in urban, 25 suburban and rural settings throughout the state, 35 1 COMMITTEE ON HEALTH 2 near population centers of diverse size, and many 3 with extended operating hours. Pharmacies can also 4 act as a vast storage resource since they are 5 equipped to store refrigerated medications. And 6 because they are staffed by licensed professionals, 7 pharmacies can be used to transmit data from field 8 workers and receive instructions from public health 9 authorities. 10 Improving the State's ability to 11 provide preventative care to meet the health care 12 needs of the 21st century remains one of my top 13 priorities, and this bill is an important step 14 toward ensuring the public's health. 15 I am pleased that the City Council 16 has come here today to consider a resolution that 17 calls on my colleagues in the Assembly and the 18 Senate to enact my bill. Your formal support will 19 be a forceful voice in Albany and will demonstrate 20 both your recognition of the necessity of providing 21 access to these live saving vaccines and your 22 commitment to preventative health care to ensure 23 that we keep all New Yorkers healthy and safe. 24 Thank you. 25 ACTING CHAIRPERSON DICKENS: Thank 36 1 COMMITTEE ON HEALTH 2 you, Ms. Rush, and thank to Assemblymember also for 3 sending you down to read into the record her 4 testimony supporting our resolution, so thank you. 5 Mr. Mike McGuire, if you have written 6 testimony, please provide it to the Sergeant- at- 7 Arms, and when you begin, please state your name for 8 the record and your company. 9 MR. MCGUIRE: My name is Mike McGuire, 10 Vice President of Anti- infectives at Roche 11 Laboratories. I'm responsible for Tamiflu in the 12 United States and also for the pandemic plan for 13 Roche in the event of a pandemic. I would just like 14 to thank Chairman Dickens and the Council Members 15 for the opportunity to speak to you today about a 16 couple of things actually. I'll take you through 17 some of the overview of what we have seen with the 18 H5N1 virus and talk about some of the medical 19 interventions, and also a little bit about 20 stockpiling. 21 You may already know that there have 22 been a number of pandemics over the years. What we 23 see here is three in the 20th century. The most 24 severe was the Spanish Influenza of 1918, which is 25 the one everybody worries about the most because it 37 1 COMMITTEE ON HEALTH 2 was so impactful on mortality and morbidity within 3 not only the United States but the world. 4 My point on this slide is really if 5 you look at that second line there are a number of 6 different viruses that can cause a pandemic, so it's 7 not one particular virus, and I think you've heard 8 that from Dr. Weisfuse as well. It could be H5N1. 9 It may not be, but the impact of a pandemic can be 10 devastating and in fact if you take a look at what 11 happened in 1918 with regards to the mortality death 12 rate, we were on a steady decline over time. Here 13 you see a sharp rise in what could happen if a 14 pandemic is to occur within the United States. 15 So what we've seen is in the past 300 16 years we've had ten pandemics. We can never really 17 predict when this is going to happen, but we 18 certainly know that the WHO has said that all we 19 need to have is efficient human- to- human 20 transmission to a pandemic to occur. And what may 21 be different in 2008 from 1918 is the ability for 22 people to move globally throughout the world within 23 24 hours. 24 One of the parts about influenza is a 25 person can actually be infected with the virus and 38 1 COMMITTEE ON HEALTH 2 not showing any symptoms for 48 hours, but actually 3 shedding that virus and potentially infecting other 4 people. So it's important that we actually have 5 some plans in place. 6 If you take a look at the mortality 7 rates of two of the seasons I just talked to you 8 about before, the very severe one and the moderate 9 ones, I'll just draw your attention to the 10 hospitalizations, the ICU and the mechanical 11 ventilation. Our health care system will be 12 extremely stressed in the event of a pandemic, and 13 in fact there probably won't be enough ventilators 14 or ICU care for individuals. 15 So is the strategy really to 16 stockpile more ventilators, or is the strategy to 17 prevent people from actually going to the hospital 18 and being infected? That is where you're starting 19 to see the federal government move forward on some 20 of their plans with regards to post- exposure 21 prophylaxis, and I'll go into that in a little bit 22 more detail. 23 Sorry for the eye chart on this, but 24 not only is there a human toll on this, there's GDP 25 toll. If you notice on the second column, about 39 1 COMMITTEE ON HEALTH 2 four from the bottom, the impact on New York State 3 would be approximately $50 billion dollars in that 4 time period, and this comes from Trust for 5 American's Health. 6 So the CDC has made an assessment, 7 and this is as of October of 2006, what we certainly 8 know is that if the virus becomes sustainable and it 9 becomes efficient moving from person- to person, we 10 could have an extremely high mortality rate, as what 11 you've heard from Dr. Weisfuse and what we've seen 12 in Indonesia and other parts of the world. 13 There is no real natural immunity to 14 H5N1 virus, and we are working on vaccines right 15 now. We don't have one, and it could be a little 16 bit of time before a vaccine is actually available, 17 tested and made ready. 18 So what are the other types of 19 potential medical interventions that we have? Well 20 just so you know, we, Roche, stand firmly on the 21 fact that vaccination is the best way to go if you 22 have a vaccine ready and will match the virus that 23 is circulating. 24 What we've seen this year, just an 25 example, is a break in the vaccine. That's why 40 1 COMMITTEE ON HEALTH 2 we're seeing such a high flu season this year. The 3 vaccine did not cover about 60 percent of the virus 4 that is circulating. So the issues with regards to 5 vaccines are not only can you produce it in time, 6 but will it actually match what is circulating 7 within the population. 8 That leaves us to the antivirals, and 9 there are a number of antivirals. There's Tamiflu 10 and Relenza, both are in the same class of 11 neuraminidase inhibitors, and then we have some 12 older antivirals, amantadine and rimantadine. There 13 are some studies that actually show some of the 14 older antivirals are effective in certain species of 15 H5N1, and we do have some limited information on 16 Tamiflu efficacy, which I'll go through in a few 17 minutes with you. 18 The chart here is basically what Dr. 19 Weisfuse was talking about before. The U.S. 20 Government is stockpiling 81 million treatments. 21 Those treatments, or those prescriptions if you 22 will, are mostly for treatment. There is no 23 prophylaxis involved. So if you take a look at the 24 first column and you say we're not going to 25 intervene with any type of antiviral, which you see 41 1 COMMITTEE ON HEALTH 2 is potentially through modeling, the predicted death 3 rate is close to 700,000 people in the United 4 States. The federal government plan calls for a 25 5 percent stockpile, so we use the model of 29 6 percent. If you were to use that, you could reduce 7 mortality almost in half to about 300,000. If you 8 would treat the infected patients, family members 9 and prophylax the family members to a tune of about 10 57 percent, you could reduce the mortality down to 11 about 145,000 individuals. Obviously, if we could 12 treat and prophylax everyone in the United States, 13 we'd reduce the death rate to about 50,000. 14 Now the federal government is looking 15 at this post exposure prophylaxis and are 16 considering moving forward with regards to this 17 strategy. There's another reason why this strategy 18 is extremely important is that if you prophylax an 19 individual you will still be in contact with the 20 virus. Your body will develop natural immunity to 21 that virus. You will not show the signs and 22 symptoms, but we also will not see the potential for 23 resistance occurring because what happens is as your 24 infected the virus is replicating more and more and 25 more, the more opportunity the virus has to 42 1 COMMITTEE ON HEALTH 2 replicate, the higher the chance of the mutant virus 3 coming out or a resistant virus. 4 So with regards to Tamiflu, it's very 5 difficult for us to clinical trial in H5N1. We 6 don't know where it's going to occur. We don't know 7 how it's going to occur. So we've done our best in 8 Southeast Asia and Indonesia to make sure Tamiflu is 9 available for health care workers and infected 10 patients. The best we can do in terms of modeling 11 is take a look at animal studies, and as you can 12 see, we've done it in ferrets and we've done it also 13 in mice. We do show we have activity that works 14 against the virus. We do know that in some cases in 15 humans where the drug was provided, it was provided 16 late to the individuals, usually on day six or 17 seven, and unfortunately, a lot of them did not 18 survive because of the fact the virus is involved 19 for such a long period of time. We are continuing 20 to try to do studies. We are working with NIH in 21 order to do studies in health care workers for 22 prophylaxis, when and where an outbreak should 23 occur. 24 With regards to the resistance 25 profile, I'd just like to take a moment. We have 43 1 COMMITTEE ON HEALTH 2 until recently not seen a tremendous amount of 3 resistance to Tamiflu. There is a resistant strain 4 of H1N1 that has been found in Europe. The 5 difference with regard to this is this strain was 6 not induced by Tamiflu. So in other words, none of 7 the individuals were taking Tamiflu and then 8 developed resistance. This was a resistant strain 9 that we did see early in our clinical trials, but 10 was not transmissible from person- to- person. We 11 are investigating what has changed with that virus, 12 but as fast as it's appeared, it could disappear in 13 the future as well. I can tell you we take the 14 resistance issue very strongly. We have a 15 monitoring system, working with WHO and CDC, to 16 monitor this as well. 17 It's not only Roche's belief that 18 Tamiflu would be an appropriate product, but WHO has 19 also recommended both Tamiflu and Relenza for the 20 treatment of folks with H5N1 or a pandemic, and 21 they've also recommended chemoprophylaxis or what we 22 just talked about before post- exposure prophylaxis. 23 Councilman Stewart, just a little 24 while ago, asked a question about stockpiling. The 25 reason why stockpiling becomes so important, as 44 1 COMMITTEE ON HEALTH 2 you'll see in a few minutes, is the ability for all 3 of us to manufacture to meet surge capacity. When 4 the infection occurs, it will be widespread. It'll 5 be difficult not only for Roche to make Tamiflu and 6 Glaxo to make Relenza, it will be difficult for the 7 manufacturers of masks. It will be difficult for 8 the manufacturers of ventilators and ventilator 9 equipment to keep up with the demand. So what we 10 need to do is we need to stockpile not only 11 antivirals, but we need to stockpile all of these 12 other elements as well. 13 Our manufacturing is geared towards 14 what happens in the season. It's not geared towards 15 what may happen in the future. In order to respond, 16 we have long time for scale up. We need to have the 17 materials at hand, and our manufacturing cycle time, 18 as what you'll see in a few minutes, can last 19 between six to nine months depending on availability 20 of product. 21 We've taken a number of steps since 22 1997 to become more prepared for a potential 23 pandemic. We have donated 5.1 million treatments to 24 WHO for use in Southeast Asia in the region to put a 25 fire blanket on the pandemic should it start. We've 45 1 COMMITTEE ON HEALTH 2 worked with a number of global authorities and 3 governments. We have ramped up our capacity to 4 produce tenfold since 2004, and we have established 5 a number of relationships with folks in the supply 6 chain that could help us. 7 We actually can produce 400 million 8 treatments a year. I can tell you we are not 9 producing 400 million treatments a year. There is 10 no demand for 400 million. We produce to what the 11 demand is, but we have the capacity to move up to 12 400 million treatments. 13 At the request of the federal 14 government, we built a dedicated supply chain here 15 in the United States that can produce 80 million 16 treatments throughout the year. This was built just 17 in case a pandemic were to occur and foreign 18 governments would not allow us to move the materials 19 from country to country. So we're now self- 20 sustained within the United States. 21 The federal government plan, as I 22 mentioned before, calls for 81 million treatments. 23 That is for treatment. That does not include any 24 type of prophylaxis that may be involved with any 25 type of health care workers or infrastructure of 46 1 COMMITTEE ON HEALTH 2 people. We prioritize our orders as they come in. 3 We want to make sure we take care of seasonal 4 influenza, government orders and then non government 5 orders, which would be corporations. 6 This is a very complicated chart. 7 I'll make it simple for you. What we actually start 8 with is a shikimic acid which comes from the star 9 anise plant, or anisette for those of you who may be 10 familiar with that. We manufacture it a little bit 11 differently then the manufacturers of anisette. We 12 come up with our process, and this is the process 13 that takes six to nine months to complete. You can 14 see it's a complicated process that we need to go 15 from factory to factory. It's not made in a 16 production facility like an automotive would be. 17 If you take a look at this slide in 18 2005 this was our supply chain based on demand. We 19 could produce about $150 million treatments. At 20 that point in time, we recognized that would not be 21 big enough. We went out and contacted other 22 manufacturers for us to help produce the product as 23 quickly as possible. This actually brought us to 24 the ability to produce 400 million treatments of 25 Tamiflu. 47 1 COMMITTEE ON HEALTH 2 I would just like to say with regards 3 to Dr. Weisfuse just one comment with regards to the 4 aggressive marketing of Tamiflu. I'm not sure it's 5 marketing as well as education. I think there are a 6 lot of misconceptions around our ability to provide 7 Tamiflu to the government and to the general 8 population that people need to understand, and we 9 need to understand why stockpiling is so important. 10 I will say that we are doing everything we can, 11 continuing to do animal studies, trying to institute 12 human studies in which they really measure the 13 efficacy of Tamiflu and do we have to use a 14 different dose on some of the different strains that 15 could be circulating and cause a pandemic. 16 The last thought I leave you with is 17 it may not be H5N1. It could be any type of 18 influenza strain that could come across our paths 19 and we need to be ready whatever that may be. 20 The rest of these slides actually 21 talk about the general efficacy and safety of 22 Tamiflu. I will leave that for the Council if you 23 want to review that, so I can save you that time and 24 be willing to take any questions. 25 ACTING CHAIRPERSON DICKENS: Thank you 48 1 COMMITTEE ON HEALTH 2 so much, Mr. McGuire. I think my colleague has a 3 question. Council Member Sears 4 COUNCIL MEMBER SEARS: Thank you, 5 Madam Chair, and I'm sorry, but I'm going to have to 6 leave, so I appreciate one question. The question 7 has to do with stockpiling because obviously in 8 order to be prepared for that kind of stuff there 9 has to be stockpile. My question is what is the 10 longevity of that? 11 Secondly, would you stockpile one 12 particular vaccine, or would you stockpile several 13 because you stockpile something that has nothing to 14 do with that pandemic? What kind of a situation and 15 a costly one does that create? 16 MR. MCGUIRE: The first question with 17 regards to the longevity of these antivirals, right 18 now, for the federal and state stockpiles we have a 19 shelf life of seven years. We actually believe the 20 product will be stable beyond the seven year time 21 period. We continue to do tests every year on the 22 product for real time data, provide that to the FDA. 23 It is a very, very stable compound. 24 With regard to vaccines, that is the 25 dilemma of which vaccine do you make and how much do 49 1 COMMITTEE ON HEALTH 2 you make of it. There is certainly evidence just 3 like we see this year if you were to give a vaccine 4 and it's mismatch you will probably get some type of 5 immunity for the individual, which may result in 6 less severe symptoms. The issue will be, when the 7 pandemic comes, is how quickly can they identify 8 that specific strain and make the vaccine. They are 9 trying to advance some new technologies. The old 10 technologies are egg- based, which take a long time 11 to sell cultural base. Hopefully, we can shorten 12 that time period, but as it stands now, it'll 13 probably be a good four to six months before the 14 first vaccine rolls off the production line, and 15 then you made need, obviously as you know, $300 16 million of those doses. In some cases, you may need 17 two doses, so there is a real concern of during the 18 first wave of a pandemic because a pandemic could 19 come in two and three waves over 18 months. Will 20 you have enough to inoculate individuals, and then 21 the concern is if you do is the second wave the same 22 as the first wave and do you have to create a new 23 vaccine. 24 So it's very, very difficult on the 25 vaccine side, and I have a lot of sympathy for the 50 1 COMMITTEE ON HEALTH 2 manufacturers and what they are going through. 3 COUNCIL MEMBER SEARS: Absolutely. 4 Thank you. It shows what a very complex issue this 5 is. 6 MR. MCGUIRE: Yes, madam. 7 COUNCIL MEMBER SEARS: Thank you. 8 Thank you, Madam Chair. 9 ACTING CHAIRPERSON DICKENS: Council 10 Member Kendall Stewart. 11 COUNCIL MEMBER STEWART: I want you to 12 follow up on that issue of the stockpiling because 13 we know that viruses mutate, they change, and every 14 year, there's a different strain. How can you 15 stockpile for something that you don't know what it 16 is going to be like? 17 MR. MCGUIRE: For the antivirals, for 18 oseltamivir, it is effective against all strains of 19 we know of for influenza A and B. That's what makes 20 it one of the medical interventions. I will say 21 it's not a silver bullet, but it is one of the 22 medical interventions that would be there. So that 23 is the difference between the antiviral and the 24 vaccine, which is as you know more specific to 25 specific strains that may be circulating or for the 51 1 COMMITTEE ON HEALTH 2 strain that we may anticipate. That is why WHO, 3 CDC, other governments have stockpiled antivirals 4 that cover that broader spectrum of viruses. It may 5 be an H5N1. It could be what we saw in the 6 Netherlands a couple of years ago at a poultry farm 7 was an H7N7, and once again the antivirals worked 8 against that strain as well. 9 COUNCIL MEMBER STEWART: So you have a 10 track record that seems to be working on that. 11 Let me change the topic a little bit. 12 One of the things that we are trying to consider 13 is a resolution to allow pharmacists to administer 14 the vaccines. Now, with any medication there a 15 risk. The only thing that would be a problem for 16 the pharmacists to administer is because sometimes 17 there might a problem where there is a bad reaction 18 to that administering of the vaccine. They are not 19 considered doctors, so if they perform that duty, 20 there's a risk. So I want to know what you think 21 about that. 22 MR. MCGUIRE: It would be difficult 23 for me to say not being in the vaccine market. 24 Tamiflu is an oral pill for the treatment and 25 prophylaxis of influenza. I would imagine that 52 1 COMMITTEE ON HEALTH 2 through any type of an invasive procedure given 3 anywhere, even in the doctor's office, there's 4 always an opportunity for something to occur. It's 5 a delicate and difficult issue to wrestle through. 6 I don't have as near as much experience in the 7 vaccine side of things as I do actually in the 8 antiviral side of things, so it would be difficult 9 for me to say for you on that. 10 COUNCIL MEMBER STEWART: On the other 11 hand, even if there is a risk, there may be a 12 greater benefit for the population to get this 13 vaccine and maybe prevent it from spreading. Even 14 if you have one person, they have a reaction, or one 15 person may die from the administering of this 16 vaccine, but the greater population would benefit 17 from not getting sick. 18 MR. MCGUIRE: And that is the 19 mainstay, I think, of treating or preventing 20 influenza is vaccination. I think as we've seen in 21 previous years with the correct match to what is 22 circulating you certainly have the ability to reduce 23 the amount of influenza that the population runs 24 into, and therefore reduce any type of morbidity and 25 mortality that you have out there. That's why in 53 1 COMMITTEE ON HEALTH 2 the presentation, in my comments is that our belief 3 is actually vaccines are our first line if they are 4 available to match what's circulating. If not, and 5 until they come, you have options with regards to 6 antivirals which you can use. 7 COUNCIL MEMBER STEWART: Thank you. 8 ACTING CHAIRPERSON DICKENS: Thank 9 you, Council Member. I have a question, Mr. McGuire, 10 about the stockpiling. In Dr. Weisfuse's testimony, 11 he indicated that Roche Labs suggests that New York 12 City should not rely upon New York State for 13 stockpiling of Tamiflu. Does that mean that New 14 York City is not stockpiling it? One, and two, what 15 is the justifiable background reasoning to that 16 statement? 17 MR. MCGUIRE: I don't know. I was not 18 involved in those discussions to know how that was 19 said and in the light of what was said. I do know 20 that through the State there have been purchases for 21 New York City for coverage, but I don't know in 22 terms of what that was meant. 23 I think one of the things we all need 24 to think about is if we're using antivirals for 25 treatment and to treat people who become ill, how do 54 1 COMMITTEE ON HEALTH 2 we ensure we get people to come to work? How do you 3 ensure that you get your health care professionals, 4 your nurses, your physicians who will be the front 5 line responders to this to come to work. You have 6 to protect them. 7 Right now, the stockpile does not 8 have enough to protect folks for prophylaxis, and 9 that's why the government is looking at that. 10 We have had, actually, corporations 11 purchase for prophylaxis to protect their employees 12 from energy and water, so that they can continue to 13 come to work so that they will not be bringing the 14 virus home. What we'll want to do is probably not 15 allow movie theaters and schools to be open, but I 16 think what we need to begin to think about now is 17 how are we going to ensure that the right people we 18 need at the right time are there. 19 One of the solutions could be taking 20 a look at a broader stockpile which would include 21 enough to prophylax critical infrastructure. 22 ACTING CHAIRPERSON DICKENS: Thank 23 you. Also, you indicated, I believe, that the shelf 24 life of the antiviral drugs is about seven years. 25 Is that correct? 55 1 COMMITTEE ON HEALTH 2 MR. MCGUIRE: Yes, madam. Just at the 3 end of last year, the FDA moved that to seven years 4 for us. 5 ACTING CHAIRPERSON DICKENS: At the 6 end of say in year nine what happens with all the 7 stockpiling that we did and a pandemic did not 8 occur? 9 MR. MCGUIRE: That is exactly what 10 we're working with HHS and FDA on. What our plan is 11 is to continue to test our product, and provide that 12 information to the FDA to say that if this product 13 is stored under the same conditions, in year nine 14 our samples still show activity, that product is 15 still good. We plan on continuing to test the 16 stability of the product all the way up to the year 17 2016 at this point in time. 18 ACTING CHAIRPERSON DICKENS: What if 19 the stability proves to be jeopardized in year nine? 20 MR. MCGUIRE: Then we would have to 21 take a look at what we would need to do. What it 22 may be is it would be somewhat less effective. We 23 may need to provide more doses. We haven't run 24 across that. We haven't figured that out yet, to be 25 honest with you, with the government of how we would 56 1 COMMITTEE ON HEALTH 2 do that. All of our studies so far show that we 3 believe we're stable for at least ten years, and we 4 believe stored under the right conditions could even 5 be further. 6 ACTING CHAIRPERSON DICKENS: All 7 right. The reason I ask that is because, and I'd 8 like you to please get back to Chair Rivera on it is 9 because of the becoming inhibitive for the storage 10 and the costs actually of the purchase of antivirals 11 drugs. If New York City has invested, as we should, 12 in stockpiling when there is evidence of it then 13 what happens to all the stockpiles that we have? 14 Roche Labs is suggesting stockpiling several, and 15 not just one. So would you get back to the Chair 16 with that information, please? 17 MR. MCGUIRE: Yes, madam. 18 ACTING CHAIRPERSON DICKENS: Thank 19 you. 20 MR. MCGUIRE: Thank you. 21 ACTING CHAIRPERSON DICKENS: Thank you 22 for your testimony. 23 The next panel will be in favor of 24 Resolution 1231, Ms. Danielle Ompad, Cameron 25 Gelisse. Please come forward. And is this Bhatia, 57 1 COMMITTEE ON HEALTH 2 Ms. Bhatia? Please come up. 3 If there are not three seats, please 4 move three over. 5 When each of you speak, please begin 6 with your name and your affiliation, and would you 7 please begin, Ms. Ompad? 8 DR. OMPAD: Good morning. My name is 9 Danielle Ompad, and I am the Associate Director of 10 the Center of Urban Epidemiologic Studies at the New 11 York Academy of Medicine, and I'm also an 12 Epidemiologist. I'd like to thank you for the 13 opportunity to discuss the City Council Resolution 14 2131 calling upon the State Legislature to enact 15 A2140 and S1312, thereby amending the education law 16 to allow pharmacists to immunize adults for 17 influenza and pneumonia. On behalf of the Academy, 18 we appreciate the City Council Health Committee's 19 interest in the issue, which has been the subject of 20 important research at the Academy and has led the 21 Academy to directly engage our local community to 22 increase immunization rates. 23 Our research has also led us to fully 24 support the City Council resolution because we 25 believe it will increase rates of immunization, 58 1 COMMITTEE ON HEALTH 2 particularly among hard to reach populations who may 3 not be connected with traditional health care. 4 The New York Academy of Medicine, 5 which was founded in 1847, is an independent not- 6 profit which uses research, education, community 7 engagement and evidence- based advocacy to improve 8 the health of people living in cities, especially 9 disadvantaged and vulnerable populations. The 10 impact of these initiatives reaches into 11 neighborhoods in New York City, across the nation 12 and around the world, and we look forward to working 13 with the City Council on this and many other issues 14 of mutual importance. 15 As has been discussed previously, 16 every year ten to 20 percent of the American 17 population falls ill with influenza and on average 18 36,000 people die from influenza- related 19 complications. Immunization reduces the illness and 20 death that results from influenza and respiratory 21 tract infections that result from the underlying 22 influenza. 23 Influenza immunization rates among 24 the elderly, the population that accounts for 90 25 percent influenza- related deaths, rose steadily for 59 1 COMMITTEE ON HEALTH 2 a number of years, but have now leveled off between 3 60 and 70 percent. In New York City, the City 4 Health Department reports a City- wide rate of 5 immunization of 60 percent of adults aged 65 and 6 over. 7 Efforts to increase vaccination rates 8 have historically targeted individuals at high risk 9 for complications due to influenza, including the 10 elderly and those with certain chronic health 11 conditions. Despite recommendations from the 12 advisatory committee on immunization practices, 13 vaccination coverage among high- risk populations 14 has been generally low. 15 We systematically reviewed 56 studies 16 published between 1990 and 2006, evaluating programs 17 in different settings from within medical settings 18 and venue- based and community- based approaches, in 19 an effort to identify programs that successfully 20 increase immunization rates. In the U.S., the 21 Healthy People 2010 goals include 90 percent 22 vaccination coverage for adults aged older than 65 23 and 60 percent for high- risk adults age 18 to 64. 24 Only a handful of the studies we reviewed actually 25 managed to meet these Healthy People 2010 goals. 60 1 COMMITTEE ON HEALTH 2 Of the 56 studies we examined, more 3 than half the studies occurred in primary care 4 settings. One in four were large scale regional 5 programs. Then we had a smattering of tertiary care 6 facilities or hospitals, nursing homes and long- 7 term care facilities, and only about three percent 8 of the studies included community engagement. Thus 9 most of the studies in the literature examine 10 vaccination within the context of primary care 11 settings or large scale regional programs. In 12 short, these programs targeted people who were 13 already connected to the health system, an important 14 limitation of these types of approaches in their 15 inability to reach people who are not already 16 engaged for the health care system. 17 Two studies in our review 18 specifically examined the effectiveness of pharmacy- 19 based vaccination programs in the U.S.. One compared 20 urban chain pharmacies in Washington where 21 pharmacists can administer vaccinations, and then 22 they compared them to pharmacies in Oregon where 23 they could not, and the found that the vaccination 24 coverage in Oregon remained stable, but it increased 25 in Washington. 61 1 COMMITTEE ON HEALTH 2 The other study compared vaccination 3 coverage in eight states where pharmacists could 4 administer vaccines to eight states where they could 5 not, and vaccination coverage increased by about 11 6 percent in states where they could vaccinate in 7 pharmacies and only about 3.5 percent in states 8 where they could not. 9 Data from several sources included 10 the National Health Interview Study suggests that 11 immunization rates are lower in racial and ethnic 12 minority groups as compared to Whites, a disparity 13 that exists for all age groups, including elderly 14 persons covered by Medicare and populations 15 specifically targeted by public health 16 interventions. 17 Of particular concern is what is know 18 as hard- to reach, or HTR populations. While there 19 is no uniform definition of HTR populations, they 20 have typically been defined from the perspective of 21 the absence of a regular linkage with the health 22 care system. Although data is limited HTR groups 23 such as the housebound elderly, disenfranchised 24 groups, people living in disadvantaged urban 25 communities, undocumented immigrants and substance 62 1 COMMITTEE ON HEALTH 2 users may be less likely than individuals receiving 3 routine health care services to receive influenza 4 immunization. 5 While failure to be immunized is 6 related to lack of health insurance and having a 7 regular provider, other barriers to access in care 8 may include culturally derived attitudes and belief 9 systems, negative experiences with past treatment, 10 language and other barriers in patient/provider 11 relationships and legal status. Some groups harbor 12 substantial myths about and distrust of the medical 13 system. Previous research has shown that their 14 attitudes appear to be strong predictors of being 15 immunized. 16 Members of HTR groups may also be at 17 increased risks of morbidity and mortality secondary 18 to influenza because of increased incidence and 19 prevalence of medical conditions for which influenza 20 vaccine is recommended, for example, asthma and 21 diabetes, and reduced immune system activity due to 22 life style factors. 23 As I've talked about, a number of 24 interventions have been shown to be effective for 25 increasing vaccination coverage among the general 63 1 COMMITTEE ON HEALTH 2 population, including provider- based interventions, 3 interventions aimed at increasing community demand 4 and importantly enhancing access to immunization 5 services. 6 Studies on how best to immunize HTR 7 populations are sparse however. Existing research 8 suggests that most inventions are strengthened by 9 multiple approaches, particularly those that are 10 community- based. 11 In light of this limited data about 12 vaccine access in HTR populations, we at the academy 13 sought to fill this gap. We assessed the various 14 influenza vaccinations in the disadvantaged areas of 15 East Harlem and the Bronx. Of 760 total 16 respondents, 62 percent have received a vaccination 17 at some point in their life. Having access to 18 routine medical care, receipt of health or social 19 services, having tested positive for HIV and current 20 interest in receiving influenza vaccination were 21 significantly associated with having received the 22 influenza vaccination in the previous year. Of 23 participant surveys, 80 percent were interested at 24 getting the vaccination at the time of the survey, 25 and among those who had never received the influenza 64 1 COMMITTEE ON HEALTH 2 vaccination, 73 percent were actually interested in 3 getting one. So in summary we found that 4 participants who were unconnected to health or 5 social services, or government health insurance are 6 less likely to have been vaccinated in the past, but 7 these persons were willing to receive the vaccine if 8 it was available. 9 Because HTR populations experience 10 significant barriers to vaccination, especially the 11 lack of access to primary health care, we worked to 12 increase interest in receiving influenza vaccination 13 in a non- traditional urban setting. The Harlem 14 Community and Academic Partnership, which is a 15 network of community- based organizations and health 16 leaders affiliated with the Academy, carried out 17 Project VIVA, which stands for Venue Intensive 18 Vaccine for Adults. Project VIVA included a set of 19 intervention activities aimed at increasing 20 acceptance of influenza vaccination among Hard- to- 21 Reach populations in East Harlem and the Bronx, and 22 I've given a copy of our cartoon so that you see 23 that types of materials we have produced. Following 24 Project VIVA activities, individuals living in 25 intervention neighborhoods we more interested in 65 1 COMMITTEE ON HEALTH 2 receiving influenza vaccine than before the 3 intervention. Specifically, members of the HTR 4 populations, persons reporting a prior influenza 5 vaccine, and persons medically indicated to receive 6 the vaccine were more likely to be interested. 7 The Academy has also conducted 8 studies focused on increasing the role of 9 pharmacists in providing syringes, information and 10 referrals to injection drug users. These studies 11 suggest that pharmacists are willing and able to 12 take on new roles and that HTR populations will seek 13 services and care from pharmacists when it's made 14 available. We believe this research demonstrates 15 both the demand for and the feasibility of 16 delivering vaccine to members of HTR populations in 17 non- traditional urban settings, like pharmacies. 18 New York City has taken important 19 steps to increase vaccination rates, and we applaud 20 the New York City Department of Heath and Mental 21 Hygiene's efforts to track flu vaccination rates, 22 increase provider awareness, and undertake public 23 education. Efforts to expand immunizations amongst 24 HTR populations will require creative and intensive 25 efforts and must include community based efforts to 66 1 COMMITTEE ON HEALTH 2 promote vaccination in non- traditional settings and 3 at times convenient to HTR populations. 4 Current strategies for vaccination 5 all too often miss the HTR folks. This population 6 cannot be ignored, and the strategies we implement 7 today, and the lessons we learn will be vital if and 8 when we face pandemic influenza. We, therefore, 9 urge the passage of City Council Resolution 1231 and 10 S1312 and A2140, creating another venue for adult 11 immunization and to increase rates of immunization, 12 particularly among the most vulnerable. 13 Thank you for the opportunity to 14 testify, and I look forward to any questions you 15 might have. 16 ACTING CHAIRPERSON DICKENS: Thank 17 you, Ms. Ompad. I going to hold all questions until 18 the full panel has spoken, but I just want you to 19 know I like this. 20 Cameron, please give me the 21 pronunciation of your last name again. 22 MR. GELISSE: Yes, my name is Cameron 23 Gelisse. Good morning, Chairperson Dickens and 24 members. I am the Brooklyn Borough Coordinator for 25 JPAC, the Joint Public Affairs Committee for Older 67 1 COMMITTEE ON HEALTH 2 Adults. JPAC is a non-partisan interdenominational, 3 multi-cultural social action coalition of older 4 adult representatives from senior centers, community 5 groups, coalitions and independent individuals from 6 throughout Metropolitan New York. For 30 years, JPAC 7 and its members have been fighting for programs and 8 protections that benefit the lives of older adults 9 in the New York City area. 10 JPAC supports any legislation that 11 increases the accessibility of flu shots to senior 12 citizens. JPAC is therefore supporting City Council 13 Resolution 1231, which calls upon the State 14 Legislature to enact Assembly bill A2140 and State 15 Senate bill S1312, which amend the education law to 16 allowing immunizing agents to be administered to 17 adults by CDC approved and certified pharmacists. 18 Seniors are the most vulnerable 19 population when it comes to influenza and pneumonia. 20 It is reported that 90 percent of the more than 21 3,000 influenza deaths annually in New York City 22 occur in adults over the age of 65 and that 80 23 percent of these deaths could be prevented by 24 vaccination. 25 I'll diverge for a moment. As 68 1 COMMITTEE ON HEALTH 2 Brooklyn Coordinator, which is not only where I do 3 most of my work, but also where I live in Central 4 Brooklyn, these numbers, as staggering as the 5 average City- wide numbers are, they really increase 6 even more. In Central Brooklyn, only 37 percent of 7 adults 65 and older got a flu shot during last 8 year's flu season compared to 59 percent City- wide. 9 The death rate from influenza and pneumonia for 10 people aged 65 to 84 in Bed Stuy and Crown Heights 11 is twice that and other areas of Brooklyn, such as 12 Coney Island and Sheepshead Bay. 13 It's important to note that 14 vaccination rates vary by race as well as 15 neighborhood. Only about half of Black New Yorkers 16 were vaccinated in 2005/2006 flu season compared to 17 two thirds of the White population. Seventy- eight 18 percent of Central Brooklyn is Black. 19 So that said it is certainly not 20 JPAC's intent to replace doctors providing this 21 service, but rather to reach out to seniors who 22 cannot easily access the vaccine through their 23 doctors and provide an extra army of immunizers in 24 the case of an emergency such as an outbreak of the 25 Avian flu. 69 1 COMMITTEE ON HEALTH 2 Similar legislation in 47 other 3 states has shown a huge increase in immunizations to 4 seniors across the board. An average of 22 percent 5 of seniors were more likely to be vaccinated for the 6 flu in states that allow pharmacists to administer 7 the vaccination than those that do not. For seniors 8 who rely on Medicare, it is frequently very often 9 difficult in accessing conveniently located doctors. 10 Having the opportunity to go to a properly trained 11 neighborhood pharmacists who are able to provide 12 these vaccinations will likely increase the number 13 of vaccinated older adults saving lives and 14 enhancing the quality of life to older adult New 15 Yorkers. 16 Representing JPAC here today, again I 17 urge you to pass Resolution 1231 calling upon the 18 State Legislature to adopt this legislation as 19 specified in the New York State Senate as 1312 and 20 New York State Assembly A2140. We believe that not 21 only will the passage of this legislation help 22 scores of seniors and other New Yorkers to obtain 23 vaccinations which save lives, but also helps the 24 City to prepare in the event of a preventable 25 outbreak and saves countless health care dollars by 70 1 COMMITTEE ON HEALTH 2 decreasing emergency room visits and 3 hospitalizations for influenza and pneumonia. Thank 4 you. 5 ACTING CHAIRPERSON DICKENS: Thank you 6 so much for your testimony, Mr. Gelisse. 7 Now, Ms. Sheetal Bhatia. 8 MS. BHATIA: Good morning. My name is 9 Sheetal Bhatia, Program Manager for the American 10 Lung Association of the City of New York. 11 For more than 100 years, the American 12 Lung Association of the City of New York has worked 13 to prevent lung disease and promote lung health 14 among the residents of the five boroughs. In that 15 regard, on behalf of the organization, I am pleased 16 to provide the following testimony in support of 17 Resolution 1231, a resolution calling upon the State 18 Legislature to enact A2140 and S1312, an act to 19 amend the education law in relation to allowing 20 immunizing agents to be administered to adults by 21 pharmacists. 22 Influenza, more commonly known as the 23 flu is a serious infectious disease that spreads 24 easily from person to person, primarily when an 25 infected individual coughs or sneezes. Influenza can 71 1 COMMITTEE ON HEALTH 2 be transmitted even before symptoms appear and for 3 many days after the symptoms begin. Typical 4 influenza symptoms include abrupt onset of high 5 fever, muscle and joint pain, chills, a dry cough, 6 headache, runny nose and a sore throat. Often, in 7 the early stages, these symptoms are confused with 8 that of a cold, and the severity of the illness is 9 underestimated. 10 Each year, an estimated 2.6 million 11 New Yorkers get the flu, causing illness and even 12 death in certain high- risk populations, such as 13 adults and children with heart, kidney and lung 14 conditions, including asthma. The impact cannot be 15 overstated. Annually, the flu causes 192 million 16 days spent in bed, 70 million lost working days and 17 346 million days of restricted activity. 18 Nationally, an average of 36,000 people die from the 19 flu and its complications. Here in New York City, 20 flu and pneumonia are the third leading causes of 21 death. 22 The truth is the majority of these 23 deaths are preventable. The best tool against 24 getting the flu is the flu shot. A yearly influenza 25 vaccination is up to 92 percent effective in 72 1 COMMITTEE ON HEALTH 2 preventing influenza and reducing the severity of 3 the influenza. Even in years when vaccine does not 4 cover the specific influenza strain circulating 5 among the population, it offers cross- protection to 6 other strains of the flu, thereby reducing severity 7 and burden of illness. Although mild side effects 8 including soreness at injection site are possible, a 9 person cannot get influenza from the vaccine. 10 However, despite longstanding 11 immunization recommendations for people with chronic 12 lung diseases like asthma, only 40 percent of these 13 adults and ten percent of these children are 14 actually immunized. This leaves the vast majority 15 of people with asthma at increased risk for serious 16 complications and illness from influenza infection. 17 We applaud the Council for keeping 18 pressure on our New York State legislators to pass 19 legislation which would give pharmacists the ability 20 to provide flu and pneumonia immunizations. Allowing 21 pharmacists to immunize is quickly becoming the 22 standard of care in this country, but sadly New York 23 lags behind as one of the only three states 24 nationwide that do not allow pharmacists to 25 administer vaccinations. 73 1 COMMITTEE ON HEALTH 2 Allowing pharmacists to vaccinate 3 results in higher influenza vaccination rates, 18 to 4 64 year olds are 27 percent more likely to be 5 vaccinated and those over 65 are 22 percent more 6 likely to be vaccinated for flu in states that allow 7 pharmacists to provide vaccinations than in states 8 where pharmacists were not allowed to vaccinate. 9 Influenza vaccination rates among those over age 65 10 grew at triple the rate states that passed 11 legislation that allowed pharmacists to provide 12 vaccinations compared with the states that did not. 13 Pharmacists offer a natural entry 14 point for targeting those who are at high risk for 15 influenza and its complications. People at elevated 16 risk, for example, those with chronic conditions, 17 regularly see their pharmacist to refill their 18 prescriptions, providing an opportunity for flu 19 vaccination. 20 Further, pharmacists are now require 21 to receive doctoral level training, which includes 22 course work in physiology, pharmacology, drug 23 administration, drug interactions and patient 24 management. These critical skills make them strong 25 candidates for providing immunizations. 74 1 COMMITTEE ON HEALTH 2 In addition, considering the growing 3 international concern of widespread flu disease, 4 pharmacists' ability to administer vaccine would be 5 vital additional resource in the event of a health 6 emergency, such as a pandemic influenza outbreak. 7 As a safe and cost- effective way to 8 prevent illness and save lives, vaccinations must be 9 as widely available as possible. Enabling 10 pharmacists to administer flu and pneumonia 11 immunizations is an effective way to prevent these 12 respiratory diseases and drastically increase the 13 amount of people who receive influenza 14 immunizations. Resolution No. 1231, calling on the 15 State Legislature to enact A2140 and S1312 is a 16 common sense solution to increased immunization 17 rates and a healthier New York City and New York 18 State. 19 The American Lung Association of the 20 City of New York is pleased to work with the New 21 York City Council, and our elected leadership to 22 ensure that we increase immunizations, decrease the 23 incidence of influenza and allow New York City 24 residents to breathe easier. Thank you. 25 ACTING CHAIRPERSON DICKENS: Thank 75 1 COMMITTEE ON HEALTH 2 you, Ms. Bhatia, for your testimony. 3 I want to also acknowledge that my 4 colleague Council Member John Liu was here, but 5 because New York City only has 51 Council Members 6 and we have at least 70 committees and 7 subcommittees, we're forced to have them all 8 simultaneously often times. So please forgive the 9 fact that he had to leave. 10 Questions from my colleague, Council 11 Member Kendall Stewart. 12 COUNCIL MEMBER STEWART: Thank you. 13 As far as the resolution is concerned we are trying 14 to have the State pass this bill to allow 15 pharmacists to administer the vaccine. Don't you 16 think it should be also that we should encourage 17 some sort of mandatory vaccination of children in 18 schools or senior centers? Do you have any take on 19 that? 20 DR. OMPAD: I'm not sure about 21 mandatory, but we recently submitted a grant to the 22 National Institute of Health to work with the New 23 York City Department of Health and CAMBA in Central 24 Brooklyn and East Flatbush -- 25 COUNCIL MEMBER STEWART: That's my 76 1 COMMITTEE ON HEALTH 2 area. Let's get it straight. 3 DR. OMPAD: -- To actually work at 4 increasing immunization among the elderly in non- 5 traditional venues some of which include senior 6 centers. 7 As the Department of Health has been, 8 we'll be working with the Visiting Nurse Service to 9 provide those vaccines in non- traditional venues, 10 but it's a small project, and so I think pharmacies 11 actually offer a great opportunity to expand access 12 to vaccines. Not just focused in Brooklyn, but 13 actually focused throughout New York City and New 14 York State. 15 As for children, most of our work at 16 the Academy has focused on vaccines for adults, so I 17 have limited ability to comment on that. 18 MR. GELISSE: I certainly would like 19 to see more vaccinations offered at senior centers 20 throughout the entire area. I'd certainly say, on a 21 personal note, I wouldn't like to see people to try 22 to enforce on some of my members that are older 23 adults in the community to tell they had to have a 24 vaccine. I think that would a rather poor reaction 25 from them. To try and force that on them, I don't 77 1 COMMITTEE ON HEALTH 2 know how well that would go over. 3 COUNCIL MEMBER STEWART: I believe if 4 you market it by saying you're going to have a 5 vaccine that would prevent the flu and pneumonia -- 6 A lot of folks don't realize that the flu is one 7 thing. Anybody can get the flu and get over it, but 8 pneumonia is very difficult to treat and sometimes 9 difficult to catch. You can have walking pneumonia. 10 That's why most people die when you're talking 11 you'll die from the flu. It's not actually. It's 12 the things that happen thereafter like getting 13 pneumonia that causes them to die. So if you tell 14 them and you mention pneumonia, I think they will be 15 up to take it. Say you're going to have a shot here 16 to prevent the flu and pneumonia. That will sell it 17 over to the seniors. 18 MR. GELISSE: I certainly believe that 19 if it marketed that way I don't think it would need 20 to be enforced. I think you would have a huge 21 voluntary -- It pretty much would not have to be 22 enforced that way. 23 COUNCIL MEMBER STEWART: I haven't 24 seen much of the programs that are going out there 25 except for when there are some hospitals where you 78 1 COMMITTEE ON HEALTH 2 hear people talking about giving the flu shots, but 3 I haven't seen programs out there going to churches 4 and saying well listen, you need to have the flu 5 shot. It's going to be the flu season, and the 6 indication is that is that it's going to be a 7 difficult one this year. You need to take the shot. 8 I haven't seen a lot of programs like that. I 9 would like to encourage that. 10 MS. BHATIA: Thank you, and actually I 11 will take that feedback to my organization. I think 12 that's a good idea and definitely I will take this 13 idea to my organization, and hopefully we will see 14 if we could get more programs around that. 15 COUNCIL MEMBER STEWART: Thank you. 16 ACTING CHAIRPERSON DICKENS: Thank 17 you, Dr. Stewart. 18 I have one question. I understood 19 when Ms. Ompad testified to the hard-to-reach 20 population. Mr. Gelisse, you also testified that 21 there was a distinct disparity in Brooklyn in 22 regards to immunization versus City-wide 23 immunization. Do you think that that is because of 24 a high immigrant population? The hard-to-reach that 25 Dr. Ompad is referring to, is that the disparity in 79 1 COMMITTEE ON HEALTH 2 the research that you're talking about? 3 MR. GELISSE: Within the older adult 4 community, I would say yes, largely part due to the 5 high immigrant population. Also just do to the lack 6 of services and programs in those areas. 7 ACTING CHAIRPERSON DICKENS: So not 8 necessarily due to it. 9 MR. GELISSE: No, I wouldn't say 10 solely due to the immigrant population. 11 ACTING CHAIRPERSON DICKENS: But due 12 to the lack of programs that Dr. Stewart is talking 13 about. 14 MR. GELISSE: Yes. 15 ACTING CHAIRPERSON DICKENS: All 16 right. Thank you, and thank you so much for your 17 testimony. 18 Ms. Barbara Ellman -- is Mr. 19 Barbara Ellman here? -- In opposition to Reso. 20 1231. Is that correct? When you begin, please 21 begin with your name and your affiliation. Thank 22 you. 23 MS. ELLMAN: My name is Barbara 24 Ellman. I'm the Associate Director for Policy for 25 the Division of Governmental Affairs of the Medical 80 1 COMMITTEE ON HEALTH 2 Society of the State of New York. On behalf of the 3 Medical Society and of the 25,000 physicians it 4 represents, I want to thank you for inviting MSNY 5 here today to discuss legislation A2140 and S1312, 6 which would amend the scope and practice of a 7 licensed pharmacists to permit pharmacists to 8 administer vaccines for flu and pneumococcal disease 9 to adults. 10 First, let me state for the record, 11 that the Medical Society unequivocally supports the 12 goal of increasing vaccination rates among adults 13 and the Medical Society is committed to parties to 14 move us to that goal. However, the approach 15 reflected in the measure if not the preferred means 16 by which New York City, and, indeed, the State of 17 New York, should accomplish this objective. 18 Consequently, for the reasons which I 19 will elaborate upon, the Medical Society of the 20 State of New York is strongly opposed to this 21 measure. 22 The issue of vaccine immunization is 23 more complicated than simply determining which 24 health care professional are capable through their 25 education and training to administer an 81 1 COMMITTEE ON HEALTH 2 immunization. Frankly, there is a sufficient supply 3 of health care practitioners to administer influenza 4 and pneumococcal immunizations to adults, including 5 approximately 400,000 registered physicians, nurse 6 practitioners, physician assistants, registered 7 professional nurses and licensed practical nurses 8 who are already recognized by law has having 9 received the necessary education and training to 10 provide such immunizations in accordance with their 11 scope of practice in New York State. 12 The real reasons for low vaccination 13 rates arise out of a number of systemic and societal 14 problems which derive from, one, the often changing 15 insurance status of our uninsured and underinsured 16 populations, Medicaid, Child Health Plus and Family 17 Health Plus populations. 18 Two, the ability of primary care 19 providers to obtain a supply of vaccine in 20 quantities sufficient to inoculate their patient 21 population. 22 Three, patient knowledge and self- 23 awareness of the importance of obtaining regular 24 vaccinations and responsibility to schedule an 25 appointment to obtain a vaccination. 82 1 COMMITTEE ON HEALTH 2 They're problems are not easily 3 addressed, and until remedied, they will remain 4 obstacles to improvement of City and State 5 immunization rates. 6 MSNY continues to work with all 7 affected parties to redress these problems with the 8 hope that we will enhance, coordinate and care 9 delivery through increased access to a reliable 10 medical home and improve overall health outcomes for 11 all New Yorkers. 12 With regard to the issue of universal 13 coverage, we are pleased that Governor Elliot 14 Spitzer has already taken concerted action to 15 address the problem of the uninsured. Under his 16 leadership, a task force entitled the Partnership 17 for Coverage is currently exploring effective 18 alternatives to incrementally enhance insurance 19 coverage opportunities for all New Yorkers. We've 20 provided testimony on this subject, and I've 21 attached a copy of it to the written testimony, 22 which you have. 23 In recent years, the vaccine supply 24 has been anything but stable. Moreover, we've 25 experienced an absurd dynamic within the vaccine 83 1 COMMITTEE ON HEALTH 2 market in which large retail establishments, 3 including large chain pharmacies and big box stores 4 are favored over individual physicians and other 5 health care providers when times of limited supply 6 have laxed the market strength to leverage a 7 meaningful supply of vaccines away from these large 8 chain stores. 9 As an aside, we note that Governor 10 Spitzer is exploring a strategy to assure that 11 physicians have an adequate supply of vaccine. In 12 his proposed budget for Fiscal Year 2008/2009, 13 Governor Spitzer has proposed that the Commissioner 14 of Health conduct a study on the feasibility through 15 state market leverage of making vaccines universally 16 available to children and adolescents up to age 19 17 without charge to the patient or physician. This is 18 a good first step in assuring that physicians and 19 other primary care providers have an adequate supply 20 of vaccine to assure that patients can obtain 21 vaccinations as part of their regular health care 22 routine. 23 Given to current market dynamic, 24 however, many commercial establishments will 25 continue to advertise flu clinics open to all comers 84 1 COMMITTEE ON HEALTH 2 where vaccinations are administered by licensed 3 health care providers such as registered 4 professional nurses and nurse practitioners. This 5 practice, while sometimes affording a consumer or 6 customer of such establishment the only opportunity 7 he or she may have to obtain a vaccination has 8 significant negative implications for the health 9 care of a physician's patient. 10 Despite to focus on implementing 11 inoperative health information technology in today's 12 health care system, we are years away from a fully 13 operational inter- operative health care delivery 14 system. Therefore, now and for many years to come 15 in almost every instance where a patient receives an 16 immunization in a clinic offered by a pharmacy or 17 other retail store, the patient's physician will not 18 be notified. Consequently, the patient's medical 19 record will not reflect this vitally important 20 information. 21 Some immunization, such as the 22 pneumococcal vaccine are not given annually, but at 23 five or more year intervals. This needs to be 24 documented in the patients medical record in order 25 to ensure that the patient is being vaccinated at 85 1 COMMITTEE ON HEALTH 2 the recommended intervals. Immunizations at too 3 frequent or too long an interval can have a 4 seriously negative effect on the patient. It is 5 well documented that separating a patient from his 6 or her physician for segments of medical care 7 results in poor outcomes for the patient. 8 We believe the measure which you now 9 consider Assembly 2140, Senate 1312 will further 10 fragment health care delivery for immunizations, and 11 will result in a decline in the quality of care 12 provided by our health care system and an increase 13 in the overall cost of care. 14 Moreover, since immunization clinics 15 are already occurring in pharmacy establishments, we 16 also question the need for the legislation. Current 17 law, Section 6527 of the Education Law, allows a 18 physician to order a non- patient specific regimen 19 to a registered professional nurse for administering 20 immunizations; the emergency treatment of 21 anaphylaxis; administering Purified Protein 22 Derivative, PPD, tests; and administering tests to 23 determine the presence of the Human Immunodeficiency 24 virus. This provision enables the pharmacy to hire 25 a nurse to administer immunizations at the clinics 86 1 COMMITTEE ON HEALTH 2 sponsored by the pharmacy. This measure would, 3 therefore, provide no additional opportunity for 4 vaccination that doesn't already exist under the law 5 now. 6 Moreover, Executive Law already 7 provides the Governor with the necessary authority 8 to declare a state of emergency suspending current 9 law and empowering certain individuals to provide 10 immunizations in the event that a tragic set of 11 circumstances exists, such as an outbreak of Avian 12 flu or an act of bio- terrorism which necessitates 13 massive immunization of the citizenry. This 14 measure, therefore, is not necessary. 15 This bill should be viewed solely as 16 a bill to expand the scope of practice of a 17 particular health care profession. The Medical 18 Society advocates strongly against such measures, 19 particularly when there is no demonstration of need. 20 The fact that this bill authorizes a pharmacist to 21 receive specialized training in drug administration, 22 drug interactions, physiology, pharmacology and 23 patient management actually means that they haven't 24 received such training in their years of education. 25 This makes the pharmacist no different than any of 87 1 COMMITTEE ON HEALTH 2 the other non physician Title 8 providers recognized 3 by law who are not authorized by law to administer 4 immunizations. 5 In our opinion, the further 6 fragmentation of the health care delivery system and 7 the less than optimal patient care inherent in such 8 authorization should weigh heavily against this 9 measure. We urge you to consider our perspective 10 and opinion, as you continue your review of this 11 proposal. 12 Moreover, we would like to explore 13 additional and continuous efforts to educate the 14 public, our patients, as to the importance of 15 regular immunization. To a large degree, the 16 patient must embrace personal responsibility for 17 scheduling an appointment on a routine basis with 18 his or her physician or other primary care provider. 19 At the same time, physicians must make inquiry 20 regarding immunization status a routine part of an 21 annual visit. Together, government, health care 22 providers and patients can work toward improving the 23 immunization rates in New York State. 24 I thank you for providing the Medical 25 Society of the State of New York with this 88 1 COMMITTEE ON HEALTH 2 opportunity to present our thoughts and positions on 3 the important issues you address today. We look 4 forward to working with you in the future on these 5 and other matters effecting the health care needs of 6 all New Yorkers. 7 ACTING CHAIRPERSON DICKENS: Thank you 8 so much, Ms. Ellman. 9 My colleague, Council Member Stewart, 10 please. 11 COUNCIL MEMBER STEWART: Thank you. I 12 am a bit perplexed here. There are only three 13 states that do not allow this. New York is one of 14 them. Could you tell me that the laws or something, 15 they are doing something wrong and only us -- How 16 do you explain that? How do you answer that? 17 MS. ELLMAN: If you look at what the 18 other states allow, they are very different. They 19 don't all allow everything that New York is looking 20 to allow. 21 COUNCIL MEMBER STEWART: So you were 22 saying that there may some provisions within that 23 law that you would agree to. That's what you're 24 saying? 25 MS. ELLMAN: No, actually what we're 89 1 COMMITTEE ON HEALTH 2 saying is that there really is no need for the law, 3 that there are plenty of people that can already 4 immunize and there are flu clinics in pharmacies 5 already where they have nurses there to immunize. 6 There is no need for pharmacists to have to 7 immunize. 8 COUNCIL MEMBER STEWART: But is has 9 shown by this increase by using pharmacists in the 10 other states that there is a great increase, at 11 least three times the increase in terms of people 12 becoming immunized, so there has to be some benefit 13 in it if three times more people are being immunized 14 in those states. 15 MS. ELLMAN: I think in some of the 16 states that are more rural and have fewer providers 17 who do immunize this could be a means to getting 18 more people immunized. I just don't see in New York 19 that it's going to make the difference that it would 20 in a state like Wyoming or Nevada or some place like 21 that. 22 COUNCIL MEMBER STEWART: I'm really 23 perplexed about it that we would have organizations 24 like American Lung Association, the New York Academy 25 of Medicine and all of those who said it's a good 90 1 COMMITTEE ON HEALTH 2 idea, it's a good thing, and you guys are opposing 3 it. I don't see the real -- and to know that so 4 many other states are doing it and may have been 5 doing it for quite a while and seeing the great 6 benefit of it and you're opposing it. That's what I 7 can't figure out. 8 Is it taking away business from the 9 doctors? I don't think so because it's going to be 10 free. 11 MS. ELLMAN: And I actually can't 12 understand why the pharmacists would want the 13 additional work. 14 COUNCIL MEMBER STEWART: I don't think 15 they actually want it. They just want to make sure 16 that New York is safe and be able to get the vaccine 17 at the flick of a finger, and that's an area whereby 18 people go for medicine. They go in there to try to 19 buy over- the- counter medication for the flu and 20 all of those things. It could one of those ways in 21 which we can say listen. To prevent the flu, you 22 can go and get a flu vaccine, and you can go to any 23 pharmacists. That's what we want to say and be able 24 to do that. 25 If you go to a doctor, you may have 91 1 COMMITTEE ON HEALTH 2 to pay to see the doctor. If you go to the 3 pharmacists, he can just give it to you. I'm 4 looking at things like that. So I'm trying to get 5 what's the main reason why one or two states would 6 oppose it. 7 I'm not to sure of the states, but 8 I'm saying they haven't done it yet. 9 MS. ELLMAN: Most doctors' offices who 10 do give the flu vaccination you don't pay for a 11 visit. You pay for the vaccination, which you would 12 also have to pay for in a pharmacy. 13 COUNCIL MEMBER STEWART: No, but if 14 the State is providing it free -- The State 15 provides it free. You don't pay it. 16 MS. ELLMAN: Why would the State 17 provide it free to a pharmacist and not to a 18 physician? 19 COUNCIL MEMBER STEWART: When we do 20 promotion of vaccine and they take doctors and 21 nurses and we do a promotional thing. We don't 22 charge for it. We go and have a forum and say 23 listen, free vaccination, but we can't do that all 24 the time, and we can't keep it there all the time 25 because some of the things you have to keep it in 92 1 COMMITTEE ON HEALTH 2 special condition. So I am saying in a pharmacy, 3 that's a place that will always have it there. You 4 can always go and get it done there. That's what 5 we're looking at, but you don't have to pay for it. 6 MS. ELLMAN: I think that what we 7 would like you to think about though is the fact 8 that there is no reporting of the fact that the 9 patient has had this immunization to that patient's 10 doctor, and patients do not tend to remember what 11 they've had or when they've had it. I mean I have 12 trouble sometimes remembering when I had 13 immunizations, and I just think that it's dangerous, 14 particularly with something like the pneumococcal 15 vaccination, which you don't give on an annual 16 basis. You give it every five years, so if the 17 patient doesn't remember that they had it or they 18 forget to schedule it and they wait longer than the 19 five years, it can have bad consequences. 20 COUNCIL MEMBER STEWART: But that's 21 one area. What about the regular flu vaccine? 22 MS. ELLMAN: Well again though, the 23 doctor has no way of knowing whether the patient has 24 had it or not. 25 COUNCIL MEMBER STEWART: You tell me. 93 1 COMMITTEE ON HEALTH 2 If they've had a flu vaccine this year and nine 3 months later they have another, would it cause 4 anything? 5 MS. ELLMAN: I don't know. I'm not a 6 doctor. 7 COUNCIL MEMBER STEWART: That's the 8 point. The point is it may not cause anything 9 having two vaccines because vaccine doesn't cause 10 the flu. It will not cause the flu. It's something 11 that after you get it, your body builds up antigens 12 against the flu. So the point is I don't see the 13 objection for not allowing pharmacists to be able to 14 administer vaccine. The mere fact that you talk 15 about having nurse practitioners and all those folks 16 being able to do it, a pharmacists has more training 17 in drugs and the reactions of drugs and things like 18 that than a nurse practitioner or any of those 19 folks, so to me to say that the pharmacist should 20 not be allowed to do it I really don't get it. I 21 would like to get more information on that more so 22 because we have the doctors' association opposing, 23 but there's so many other groups that want it and 24 see the benefit in it and so many other states that 25 have done it, and we haven't seen any negative 94 1 COMMITTEE ON HEALTH 2 backlash from this. 3 MS. ELLMAN: I don't think that the 4 other groups are thinking about the same negative 5 things that the physicians think about, the lack of 6 the medical home, the fact that the physician does 7 not have a record of whether the patient has had it 8 or not. 9 COUNCIL MEMBER STEWART: But what 10 about the 30 percent of the population that don't 11 have a physician, or don't go to the doctor unless 12 they are really sick? 13 MS. ELLMAN: They can go to the flu 14 clinics that are already being held at the pharmacy. 15 COUNCIL MEMBER STEWART: Yes, but they 16 have to pay for that. That's what I'm saying. That 17 may have to pay for that. They have to go see a 18 doctor and then they pay for that. That's the only 19 reason why I see anybody opposing that is for 20 monetary gain, and to me, I don't -- 21 MS. ELLMAN: I don't think that the 22 physicians are making money off of giving 23 immunizations, but I just can't really argue against 24 a free vaccination versus one you have to pay for. I 25 have no control over that. 95 1 COMMITTEE ON HEALTH 2 COUNCIL MEMBER STEWART: All right. 3 Thank you. I think I would want to get some more 4 information about the other states as to what 5 negative things they have found since this has been 6 implemented, and I haven't seen anything, no 7 paperwork, as far as negative drawback from having 8 this implemented in these other states. I'm not to 9 sure how long they have been doing it, but the fact 10 is by now, we should have known. Just New York and 11 two other states, that to me something is wrong here 12 because usually New York sets the trend to almost 13 everything, and to know all the other states are 14 doing it and we're not doing it means that either 15 one, we have big lobbyist that are preventing us 16 from doing it, two, we've been lacking in doing our 17 job. Thank you. 18 ACTING CHAIRPERSON DICKENS: Thank you 19 so much, Council Member, and thank you, Ms. Ellman 20 for your testimony. You made a statement -- Well 21 there's two things. One, the two other states that 22 do not allow pharmacists to administer immunizations 23 may be your organization could be in contact with 24 the medical society of those states to gather the 25 information that my colleague is asking for and make 96 1 COMMITTEE ON HEALTH 2 sure that the Chairman, Chairman Rivera, of this 3 Committee gets that information. 4 MS. ELLMAN: I will do that. 5 ACTING CHAIRPERSON DICKENS: The other 6 thing is you said something very interesting, and I 7 would like to get the name of those physicians that 8 I could go to and get an immunization and I don't 9 have to pay for that office visit because every time 10 I've ever gone, I not only pay for that 11 immunization, I pay for that office visit. So I 12 think that was very interesting. I would like to 13 know who those physicians are. 14 MS. ELLMAN: I go every year for my 15 flu shot. I can give you the name of my physician, 16 but he has a nurse that gives the shot. I go in, I 17 get my shot and I leave. 18 ACTING CHAIRPERSON DICKENS: Oh, so 19 then I don't see the doctor. I see a nurse. 20 MS. ELLMAN: Well it's his nurse that 21 works in his office. 22 ACTING CHAIRPERSON DICKENS: So 23 therefore I don't pay for an office visit because I 24 really am seeing a nurse. 25 MS. ELLMAN: Just to get the shot, 97 1 COMMITTEE ON HEALTH 2 yes. 3 ACTING CHAIRPERSON DICKENS: So 4 there's no medical history given to her anyway then, 5 and no retention of medical records because I just 6 walked in to your doctor's office and saw your 7 nurse. 8 MS. ELLMAN: No, there is a medical 9 record that's entered into the record in that office 10 that I go to see the doctor. 11 ACTING CHAIRPERSON DICKENS: Very 12 interesting. It wasn't a doctor that gave it to 13 you. Thank you. Thank you so much for your 14 testimony. 15 All right. The last panel, Dr. Toni 16 Olashawerey, and I apologize if I tormented that. 17 Anne Fellows, please come up, and Macary Marciniak. 18 I know I'm torturing these names, and I apologize to 19 you. 20 I assume all of you are in favor. 21 DR. OLASHAWEREY: Yes. 22 MS. FELLOWS: Yes. 23 MS. MARCINIAK: Yes. 24 ACTING CHAIRPERSON DICKENS: Very 25 good. All right, and Doctor, would you begin, and 98 1 COMMITTEE ON HEALTH 2 as each of you speaks, please begin with your name 3 and your affiliation. Thank you. 4 DR. OLASHAWEREY: Good afternoon. My 5 name is Dr. Toni Olashawerey, and I'm representing 6 the New York City Adult Immunization Coalition. The 7 New York City Adult Immunization Coalition is an 8 alliance of health care professionals, public health 9 officials and community leaders whose main goals are 10 to provide leadership and advocacy as well as 11 promote better health and improve vaccination 12 coverage levels among adults. 13 In addition, we seek to remove 14 barriers to adults receiving immunizations and 15 reduce the ethnic and racial disparities in 16 vaccination coverage that exists in New York City. 17 New York City has one of the lowest 18 adult vaccination rates in the country for people 65 19 and older, 65 percent for influenza vaccination 20 rates overall, and in New York City, coverage rates 21 are even lower at 59 percent. In some 22 neighborhoods, especially those that are 23 predominantly Black and/or Latino there are greater 24 disparities. Less of half of Blacks in New York 25 City receive influenza vaccination annually. 99 1 COMMITTEE ON HEALTH 2 Coverage rates are as low as 38 percent in some 3 communities. Nearly 3,000 people die each year from 4 influenza and pneumonia and it remains the third 5 leading cause of death in New York City. 6 By allowing pharmacists to immunize, 7 a range of public health issues will be addressed. 8 Increasing vaccination coverage rates will be 9 accomplished. In states that allow pharmacists to 10 immunize, vaccination rates have increased 27 11 percent. 12 In addition, the vaccination rates 13 among persons 65 and older grew at a rate of three 14 times that in states that do not allow pharmacists 15 to immunize in addition to access to care. 16 Pharmacies are widely distributed 17 throughout traditionally under- served areas in New 18 York State and they can reduce the considerable 19 ratio and ethnic disparities in immunization rates. 20 Lastly, pharmacists offer a natural 21 entry point for patients that are high- risk for 22 influenza and pneumonia. Patients with chronic 23 conditions, such as diabetes and HIV/AIDS regularly 24 see their pharmacists to refill prescriptions, and 25 providing an opportunity to receive their influenza 100 1 COMMITTEE ON HEALTH 2 and pneumococcal vaccination during these refill 3 visits would offer an excellent opportunity for 4 increased access to care. 5 For these reasons, we urge you to 6 support and prioritize A2140 in order to improve 7 immunization rates across New York State and protect 8 the health of our seniors. Thank you. 9 ACTING CHAIRPERSON DICKENS: Thank you 10 so much, Dr. Toni, if I may say. May I call you Dr. 11 Toni? 12 DR. OLASHAWEREY: Yes, everyone does. 13 ACTING CHAIRPERSON DICKENS: All 14 right. Ms. Fellows. 15 MS. FELLOWS: Hi. I'm Anne Fellows. 16 I'm with the National Association of Chain Drug 17 Stores. We support the Resolution A1231, and I 18 wanted to address some of the questions that have 19 been raised earlier about pharmacists, how it's 20 worked in other states. You have my testimony, but 21 I'm going to go a little bit off of it. 22 One of the things that this proposal 23 does is that it would require the pharmacist when 24 they give the immunization to give the patient a 25 form in triplicate, which then they can keep one for 101 1 COMMITTEE ON HEALTH 2 own records, give one to their doctor. As has been 3 mentioned earlier, the patient has to take 4 responsibility for their record keeping. That's 5 what the doctor recommends. That's what we 6 recommend also. We always work in close contact 7 with physicians in this and in any other area. 8 In those states where we have had 9 these programs in place it has worked well. As 10 you've heard, you've increased immunization rats. 11 It has been a good partnership with the health care 12 community. A lot of patients these days have more 13 than one doctor, so you're still going to have to 14 exchange medical information about what one doctor 15 is doing with another doctor. 16 Pharmacists are often the ones that 17 will point out to patients that their medications 18 are not going to react well together. We have 19 played this role of being part of the health care 20 community, and we think we could play a vital role 21 in this process also. 22 Another thing that this law would 23 require is that the pharmacist be trained. The 24 newer pharmacists coming out of college today -- 25 It's a five, six- year program. They are trained in 102 1 COMMITTEE ON HEALTH 2 this area. They are certified. They would give the 3 certification to the State and be allowed to. Some 4 of the older ones who have not been trained, if they 5 decide they want to provide this service, would be 6 trained, and it would even include CPR training 7 under the New York proposal. 8 So we think it's a good idea. New 9 Hampshire is about to pass it, so you'll then be one 10 of two states that have not passed it, the other 11 being Maine. We think it would be a good idea, and 12 I'd be glad to answer any questions about specific 13 practices. 14 ACTING CHAIRPERSON DICKENS: Thank you 15 so much, Ms. Fellows. Macary Marciniak. 16 MS. MARCINIAK: Macary Marciniak. 17 Thank you. 18 ACTING CHAIRPERSON DICKENS: Thank 19 you. 20 MS. MARCINIAK: Chair Dickens, 21 distinguished members of the Committee on Health and 22 guests, thank you for the opportunity to speak with 23 you today regarding the critical issue of 24 pharmacists and immunizations. My name is Macary 25 Marciniak, and I'm an Associate Professor at Albany 103 1 COMMITTEE ON HEALTH 2 College of Pharmacy and a Clinical Pharmacy 3 Specialists with Price Chopper Pharmacy. I am a 4 pharmacist and I'm a member of the American 5 Pharmacists Association and the Pharmacists Society 6 of the State of New York. It's an honor and 7 privilege to speak on behalf of the Pharmacists 8 Society of the State of New York and share my 9 knowledge and experience with pharmacist providing 10 immunizations. 11 Pharmacists are health care 12 professional whose education and training make them 13 well- qualified to address the immunization needs of 14 patients. Today's pharmacist is a graduate of a 15 six- year Doctor of Pharmacy degree program. The 16 Doctor of Pharmacy degree curriculum integrates 17 anatomy, physiology, disease processes, pharmacology 18 and pharmacotherapy. Communication and counseling 19 skills are critical and are emphasized throughout 20 the entire curriculum. Pharmacists are trained to 21 take medical and medication histories and to 22 identify and resolve medication therapy problems. 23 Vaccines are drugs and, as such, pharmacists are 24 educated about immunizations and take responsibility 25 for ensuring that the medication needs, in 104 1 COMMITTEE ON HEALTH 2 particular, the vaccine needs of patients are 3 addressed. Indeed, pharmacy school curricula 4 include the requisite knowledge and skills for 5 pharmacists to identify patients in need of 6 immunizations, initiate conversation and educate 7 patients about these medications, and provide the 8 vaccines, if needed. 9 Nationwide, pharmacist administration 10 of immunizations is the standard of care. As of 11 today, 47 states permit pharmacists to administer 12 vaccines to patients. New York, along with Maine 13 and West Virginia, are the outliers. Since 1997, 14 APhA has offered a curriculum to train pharmacists 15 in immunization advocacy, facilitation and delivery. 16 APhA's national program, Pharmacy- Based 17 Immunization Delivery, has been developed by an 18 advisory panel that includes physicians and 19 pharmacists and is recognized by the Centers for 20 Disease Control and Prevention. Over 30,000 21 pharmacists have been trained to date with about 3 22 million vaccine doses administered by pharmacists. 23 Recently, the Pharmacists Society of 24 the State of New York has licensed this training 25 program from APhA, and last month, we launched our 105 1 COMMITTEE ON HEALTH 2 Train- the- Trainer program. We trained 30 3 pharmacists who will be going throughout New York 4 State to serve as regional trainers, and through the 5 Pharmacists Society of the State of New York, our 6 goal is to develop pharmacists who can travel 7 throughout the state to train more an more 8 pharmacists to immunize. Our goal is to then build 9 this network of pharmacists who are ready, willing 10 and able to immunize once this legislation passes. 11 In addition to the 47 states where 12 pharmacists can immunize, 28 states permit student 13 pharmacists to immunize underneath the supervision 14 of a trained pharmacist and providing that they have 15 completed the same training program. 16 At Albany College of Pharmacy, I 17 developed, coordinate and teach a class called 18 Immunizations and Emergency Preparedness. This 19 course is based on APhA's Pharmacy- Based 20 Immunization Delivery training program. Upon 21 successful completion of the class, students receive 22 the same certificate of completion that pharmacist 23 will. Many of the other colleges and schools of 24 pharmacy nationwide and in New York State utilize 25 this same training program. In this way, our 106 1 COMMITTEE ON HEALTH 2 graduates will be ready to immunize patients as soon 3 as they enter practice. 4 In fact, our student pharmacist in 5 Albany are already serving as immunization advocates 6 and facilitators. I serve as an advisor for the 7 APhA Academy of Student Pharmacists Chapter at 8 Albany College of Pharmacy. It's the student branch 9 of our national professional organization. 10 In 1997, APhA's Academy of Student 11 Pharmacists created Operation Immunization, which is 12 the largest service project in the history of 13 student organizations. Through Operation 14 Immunization, student pharmacists work in 15 cooperation with local pharmacists practitioners and 16 other health care providers to educate the community 17 about immunizations. In the history of this 18 program, over 538,000 people have been immunized and 19 thousands more educated about immunizations through 20 the work of student pharmacists. 21 Our APhA- ASP Chapter at Albany 22 College of Pharmacy has won the regional award for 23 Operation Immunization for the past four years in a 24 row. The innovative projects the students have 25 undertaken have included presentations on human 107 1 COMMITTEE ON HEALTH 2 papillomavirus and the new vaccine Gardasil to local 3 high school students, presentations on shingles and 4 the new vaccine Zostavax to local senior citizens, 5 volunteering at immunization clinics in the Capital 6 District and distributing immunization information 7 and record cards to local pharmacies as well as to 8 patients at the American Diabetes Association and 9 American Lung Association events. 10 I'd like to add that record cards in 11 one form of documentation that is given to patients 12 when they receive a vaccine in a community pharmacy 13 setting, in addition to the method of the triplicate 14 forms that can be used as well. 15 Our students have even worked with a 16 local travel agency to promote immunizations to 17 their clients. So through our students efforts 18 alone, we have reached thousands of patients in the 19 Capital District, and their work is a model for 20 other student pharmacists and pharmacists in our 21 state. 22 It's clear that pharmacists, student 23 pharmacists and pharmacies offered numerous 24 advantages in the provision of immunization 25 services. The equivalent of the United States 108 1 COMMITTEE ON HEALTH 2 population visits a pharmacy each week. Every day, 3 pharmacists have regular contact with patients in 4 need of immunizations. In fact, these individuals 5 can be identified through our prescription record. 6 Pharmacies already serve as sites for 7 immunization clinics. Each fall, we host nurses to 8 come into our pharmacies and administer 9 immunizations to our patients. When pharmacists are 10 able to immunize, we will have another trusted and 11 trained health care professional on the front lines 12 who is able to immunize New Yorkers. 13 Additionally, pharmacy access is 14 unparalleled. Pharmacies are on just about every 15 street corner and offer the added convenience of 16 evening, weekend and holiday hours, times when many 17 other health care providers are unavailable. And 18 patients listen to their pharmacists, 50 to 94 19 percent of people respond to a pharmacist 20 recommendation to be vaccinated and people are 74 21 percent more likely to be vaccinated if prompted by 22 their pharmacist than if not prompted. 23 I applaud the New York City Council 24 Committee on Health for their resolution to support 25 A2140 and S1312, which would allow pharmacists to 109 1 COMMITTEE ON HEALTH 2 administer influenza and pneumococcal immunizations 3 to adults in New York State. This bill has 4 significant potential to improve the health of the 5 people in this state. It is a travesty that the 6 legislature has waited so long to take action on 7 this vital issue, for it is truly our citizens who 8 are at a loss. This legislation is absolutely 9 needed, and, in fact, is long overdue. It is time 10 for New York State to allowed trained pharmacists to 11 administer immunizations to patients. 12 Thank you for the opportunity to 13 speak with you today. I appreciate your time and 14 consideration on this important matter, and I look 15 forward to answering any questions that might have. 16 ACTING CHAIRPERSON DICKENS: Thank you 17 so much, Dr. Marciniak. My colleague, Council 18 Member Stewart. 19 COUNCIL MEMBER STEWART: I'm glad that 20 you folks spoke after I spoke because I felt that I 21 was really getting at the last witness which is not 22 me, but the fact is I blame us as legislators not 23 doing something before. Why we would have 47 states 24 allowing this and doing this and we are not doing 25 it? What are the reasons? No one has brought up 110 1 COMMITTEE ON HEALTH 2 any really valid reason why it shouldn't be done 3 except for the fact that we're having another health 4 professional doing the job. So I'm happy that we 5 can move this forward, and the fact that we have 6 pharmacists almost on every other block that we can 7 go to, and they are like the local doctors, the 8 local advisers that deal with more health problems, 9 and if this is one where we can protect our 10 constituents in terms of preventing them from 11 getting the flu or pneumonia, I think it's a well 12 worth effort. 13 I don't have any questions, I guess. 14 ACTING CHAIRPERSON DICKENS: Well, on 15 behalf of my colleague who had to leave, Council 16 Member Sears of Queens -- I guess, Ms. Fellows, 17 this is dedicated to you. Since most pharmacies are 18 located in large chain stores that also sell food, 19 sundries et cetera and seem to have little space for 20 expansion, storage, hygiene conditions to handle the 21 increased number of people, patients who would come 22 there, and in addition to the large chain, the small 23 pharmacy has even less space than the large chain 24 stores, would there be mandated a minimum and/or a 25 maximum amount of space for the patients? How would 111 1 COMMITTEE ON HEALTH 2 the vaccine be stored in places such as that? Would 3 private rooms be required for injections in both 4 sites? 5 MS. FELLOWS: I'm going to let my 6 colleague address it because she works at a grocery 7 store that has a pharmacy, Price Chopper. 8 MS. MARCINIAK: Thank you. Yes, I do 9 work within a supermarket pharmacy chain where we do 10 sell assorted items but also have a pharmacy 11 department within the supermarket. So you have a 12 number of issues or questions related there, so in 13 terms of space, currently, many of the chain 14 pharmacies in particular already do offer 15 immunization clinics in our pharmacies. So the 16 nurses come into our clinics and we set up space 17 wherever it might be most appropriate, so we already 18 have space available because it's already currently 19 being used as we speak. 20 Even a lot of the independent 21 pharmacies in New York City also do offer 22 immunization services. They actually sometimes are 23 even more advanced than the chains because they're 24 independent or might only have one or a couple of 25 stores. It's sort of easier for them to make some 112 1 COMMITTEE ON HEALTH 2 changes. They actually are more of our practice 3 leaders in doing some more of the advanced services 4 that we see pharmacists offering today. The space 5 issue is already there because we're already just 6 accommodating another provider to come in. 7 There are a lot of chains who 8 actually do have private rooms in their stores, and 9 that's becoming more common. I can say my pharmacy 10 that I particularly work in we do have a private 11 room, and we have patients do their immunizations in 12 that room as well as other education and counseling 13 sessions that we offer. So some pharmacies might 14 already have a private room, but many already have 15 the space because we're already used to hosting 16 immunization clinics in our stores. 17 So as the legislation stands now 18 there is no mandate on space, and I don't think that 19 that's actually necessary since we already have 20 space and already do host these people into our 21 stores. 22 In terms of vaccine storage, we're 23 already very well- equipped for that. Every 24 pharmacy, by law, does have to have a refrigerator 25 to keep refrigerated medications. Vaccines are just 113 1 COMMITTEE ON HEALTH 2 another example of a refrigerated medication. For 3 New York, our bill right now is looking just at 4 influenza and pneumococcal vaccine, and those two 5 are both stored in a refrigerator, so we would 6 already have that space because we already have a 7 refrigerator that stores cold medications. So 8 that's already been addressed too with the current 9 situations in pharmacies. 10 ACTING CHAIRPERSON DICKENS: Thank 11 you. Now, the chain store that you work at, is that 12 within New York City? 13 MS. MARCINIAK: No, we have stores 14 throughout six states in the Northeastern United 15 States. We are about as far south as like 16 Poughkeepsie, kind of far over to the west in 17 Syracuse, and also have stores in Massachusetts, 18 Connecticut, New Hampshire, Vermont and 19 Pennsylvania. 20 ACTING CHAIRPERSON DICKENS: Well that 21 would be a question for the five boroughs of New 22 York City, and that's because of the high cost per 23 square footage within New York City. Many of our 24 large chains do not have a private room, so that's 25 why that question has been raised, and how would it 114 1 COMMITTEE ON HEALTH 2 be addressed, or would an immunization just be given 3 out in public? 4 MS. MARCINIAK: Most often the way 5 it's done right now if you don't have a private room 6 is you'd probably have a table, probably something 7 about this size, and you can also have privacy 8 screens that you can put up. Those are like 9 portable things that you can move from site to site, 10 but I'll say that in a lot of the clinics that we 11 have in the Albany area, the nurses that come in 12 don't even use the privacy screen. We just have a 13 table, and you try to shield the area as best as you 14 can with some materials in the area, but privacy 15 screens are very inexpensive and very portable. 16 It's an easy way to prop it up so that when a 17 patient opens up their shirt so you can their arm, 18 they're not visible to the entire room. Most often 19 it's a table, some are usually adjacent to the 20 pharmacy area, or perhaps in the front of the store, 21 somewhere in the main area where it can get a lot of 22 visibility. 23 Also, particularly in the supermarket 24 setting, but even in other chain settings, there's a 25 lot of break rooms available as well. So a lot of 115 1 COMMITTEE ON HEALTH 2 times, immunizations clinics are hosted in the break 3 room, in an area that is accessible to most patients 4 as well. That would be the two suggestions for 5 those who don't have private rooms. 6 ACTING CHAIRPERSON DICKENS: Thank 7 you. Council Member Stewart. 8 COUNCIL MEMBER STEWART: I don't see 9 the real beef over privacy because it's a vaccine 10 which basically you get a shot in the arm. If 11 someone comes in and wants a B- 12 shot, we give 12 them a shot in the arm. We don't have to take them 13 in the private room and all that. It's the same 14 thing with the flu vaccine. I don't see it as a big 15 thing with privacy. 16 MS. MARCINIAK: We do try to educate 17 people to, if they can, to wear maybe a sleeveless 18 shirt that day, or a short sleeve shirt. It makes 19 it a lot easier, and then there is no need -- You 20 know, it's very easy. 21 COUNCIL MEMBER STEWART: Yes, so I 22 don't see it as an issue as far as privacy is 23 concerned. What I would be concerned about is the 24 fact that how do we get the information out there 25 that you can get the shots at the pharmacy. 116 1 COMMITTEE ON HEALTH 2 MS. FELLOWS: Sometimes what they'll 3 do is they'll put signs on their doors saying that 4 these are the days the flu clinics will be offered 5 at our store. You can go to the website of the 6 store, and it will list which location is offering 7 shot when. There's a variety of outreach. It's 8 considered a community outreach, a positive thing 9 for the store to be doing in their community, so 10 they try to advertise as much as they can. That's 11 in stores where the pharmacies right now are 12 allowed. I now in Massachusetts that's how they 13 handle, and so it's considered a positive plus 14 benefit your store can offer. 15 COUNCIL MEMBER STEWART: Recently, we 16 did a vaccine promotion whereby we had a doctor, 17 nurse, pharmacist and everybody was given a shot. 18 It's not a place that you have any privacy. It's 19 just like you take your blood pressure, you test for 20 your sugar, and did you have your shots? No, you 21 didn't. You give them a shot, and it's as simple as 22 that. So I didn't see the question of privacy, so 23 that is nothing I should be worried about. 24 MS. MARCINIAK: I would also say that 25 pharmacists are going to emulate what the typical 117 1 COMMITTEE ON HEALTH 2 standards are in practice now, if not, go even 3 better. I'd also say let's look to what the 4 immunization clinics right now are doing. We have 5 clinics that we offer in our area in like local 6 shopping malls. You know, how do they address 7 privacy issues? Or senior centers, as you were 8 mentioning earlier? There's many venues we use that 9 are not in a health care setting, sort of the non- 10 traditional settings, so we can do the same things 11 everyone else is doing with respect to privacy, but 12 in a lot of cases, we can do even better because we 13 do have some private areas already established. 14 ACTING CHAIRPERSON DICKENS: Well, 15 thank you so much. There is a disparity in the 16 gender thinking here, so I do like the thought of 17 the privacy screens. Thank you so much for coming 18 down, and giving us testimony on supporting this 19 resolution. 20 MS. MARCINIAK: Thank you. 21 MS. FELLOWS: Thank you. 22 ACTING CHAIRPERSON DICKENS: Seeing no 23 other persons having to give testimony, this hearing 24 is closed. 25 (Hearing concluded at 12:36 p.m.) 118 1 2 CERTIFICATION 3 4 5 STATE OF NEW YORK ) 6 COUNTY OF NEW YORK ) 7 8 9 I, LORI KLEIN, do hereby certify that 10 the foregoing is a true and accurate transcript of 11 the within proceeding. 12 I further certify that I am not 13 related to any of the parties to this action by 14 blood or marriage, and that I am in no way 15 interested in the outcome of this matter. 16 IN WITNESS WHEREOF, I have hereunto 17 set my hand this 28th day of February 2008. 18 19 20 21 22 --------------------- 23 LORI KLEIN 24 25 119 1 2 C E R T I F I C A T I O N 3 4 5 6 7 8 9 I, LORI KLEIN, do hereby certify the 10 aforesaid to be a true and accurate copy of the 11 transcription of the audio tapes of this hearing. 12 13 14 15 16 17 18 19 20 21 22 ----------------------- LORI KLEIN 23 24 25