i'd like to call the subcommittee on help now to order i'd like to thank everyone for coming the goal of today's a hearing is to determine whether the v a is meeting the pharmaceutical needs of our veterans we are conducting this hearing because of the concerns that we have heard from our veterans about proper access to knowledge formulary prescriptions concerns about adverse drug interaction and patient safety in recent report by the office of inspector general citing the need to better manage certain aspects of the primacy benefits program when properly design implemented formularies can provide drug therapy that is rational clinically appropriate safe and cost effective however patient's care may be compromised with the full form or larry system is not developed that ministered so that individuals can access drugs that they need i've heard from veterans who have voiced their prostration with the v a national formulary as being too restrictive to the point that accessing appropriate drugs is a barrier some veterans have pointed to a flawed subjective system by securing formulary drugs for example a veteran who was denied access to a non formal or drug at one v a medical center may be approved by another medical center which suggests that the decision may not be based entirely on clinical factors of also have concerned about patient safety and whether we are doing it not to prevent the adverse drug events among the medication errors leading to adverse events and missed doses duplicate therapy drug to drug interaction and adequate monitoring and preparation areas and finally the recent release to audit report from the office of inspector general raised concerns about the v a s management and non control drugs and consolidated male patient pharmacy contracts we have a panels here today of experts to help us explore these issues forward to hearing from them as well as i would like to recognize all of us and if she has an opening statement she would like to make thank you mr chairman and i appreciate all of you for being here this is one of the issues that is probably brought up more and more every time i get together with my veterans so i appreciate having the opportunity to ask questions many times people come to me and say how come these drugs are covered and all of a sudden i get a notice saying that this will no longer be covered anymore so again i thank the chairman for putting this together because this is one of those important issues that we need to get to the bottom of and make sure that we take care of our veterans motto here is if you are there we care and we need to make sure that we truly do care and don't just give it lip service thanks very much and i also want to thank you for your your leadership into advocacy for  was the executive vice president national council of patient information and education i'd like to think the four of you for coming forward today to to give us your thoughts and to help us deal with you pronouncing that correctly as you are thank you good afternoon mr chairman and members of the subcommittee my name is jack hoadley i'm a research professor at georgetown university's health policy institute and as a longtime analyst a prescription drug issue conducted quite a few different research projects on for larry's and other approaches to managing the use of prescription drugs in medicare and medicaid and private sector health plans clinical tool used by physicians rather than tool of the plan that's applied at the pharmacy so our analysis we wanted to compare the be a formulary with those used in some of the leading medicare part d plans and we used a sample of about one hundred sixty commonly prescribed drugs this was done in two thousand and seven we wanted to look at the counts of drugs in the v a formulary compared with counts of unrestricted drugs on medicare formulary unrestricted we mean a drug that's not doctor thank you mr chairman and members of the subcommittee i have a our point which i will refer to research that i and other economists have performed indicates that access to medical that is new drugs medical procedures and devices is one of the most important determinants of longevity four years ago i performed a study that examined the access to new drugs under the pharmacy benefits fact the age of the drugs was it was the relative gap was actually increasing and that's consistent with the hypothesis that implementation of the national formulary beginning in one nine hundred ninety seven reduced of studies and some other economists have as well about the impact of medical innovation and pharmaceutical innovation in particular on long jeopardy and other health outcomes and in this paper i present some significant number however there is other evidence that suggests that people's willingness to pay americans willingness to pay to extend their lives so the per patient value of that reduction in longevity  five thousand dollars per person i also use demographic published by the to compute the life expectancy of better and both before and after the national formulary was implemented and  hundred ninety seven and maybe even declined a little bit and that coincides pretty precisely with the implementation of the pharmacy benefits management system so i think that that is evidence that the hearing today they are really two levels of issues here on the table on which our written statement primarily concerns itself with is access to getting new medications on the formulary to begin with we believe that it is an appropriate cost management at the cost of proper clinical care many drugs are not making it on that's a clinical decision and that process by which things go on is a closed process in other words it is not a transparent process the advocates that veteran service organizations the medical societies do not have the opportunity to comment there is no recipient divisoria group that has a chance to have the say for what the better friends have and their families have to say about this what is a medical community in general have to say about this cutting to the chase what we propose and urge you to consider is moving to introduce legislation that will make the v a formulary mirror that d o d d o d formulary everything as soon as it's a approved as soon as practical which is usually a short period of time it goes on the d o d formerly the tri care formulary the veterans on active duty suddenly shouldn't be feel the pinch that those who are no longer on active duty either because a retired because of longevity or they've ended their term of service because they got wounded should have access to the full range of drugs that those on active duty should have and that is also incidentally an open and transparent process it is war and there are public meetings there are minutes and there are a number of recommendations which actually secretary shinseki could take even without such legislation but we would encourage encourage you to move ahead and to develop comprehensive legislation in association with your friends over at has a committee of the armed services committee who are thoroughly familiar with that process and move forward to do it one of the fallacies of lng limiting the formulary is that we're saving money we would argue that it's penny wise and pound foolish often times the lack of the proper medication at the proper time because it wasn't on the formulary leads to all kinds of health care impact that results in sicker patients and episodes that did not have to happen just as one example is diabetes and you may recall that patient advocate leadership summit last year with the veterans service organizations came together in washington and we focused on four diseases one of those was diabetes and what was stunned all of us in the veterans service organization community is that in f y two thousand and six two thirds of the cost of care for diabetes went into acute inpatient stays me say that again two thirds of the total cost of treating the one point two million diabetics who go to the v a for their health care was in inpatient treatment services what that means is when you have to put somebody in a hospital who's under a physician's care who has diabetes is it you failed you have failed big time and as a result of that that's very expensive it causes a secondary conditions which leads to amputate of limbs it causes the all kinds of secondary conditions which are then themselves service connected compensable this is particularly true for vietnam veterans where those of us who served in vietnam where diabetes is in fact service connected presumptive that's one level i don't have much time to comment on the second level except to say that the overall management people are generally happy with the timel of the medications assuming that they can get the medications that they need off of the formulary but by changing what goes on the formulary you have competent people to manage this system but i cannot stress too strongly that while they say that unions sometimes mirror the worst excesses of the business in industry in which they organize in this case the v a is mirrored the worse than past decade or fifteen years of the pharmaceutical industry which lost its way for a time and seems to be finding its way again where they forgot they were in the health business that's the business they're in and helping people get well stay well as long as possible and they're not in the cost containment or selling most widgets or having the highest cost reduction in the case of the government side or their cost margin and profit margin on a case that a private industry side but chairman once again thank you very much for holding this hearing today and i'd be happy to answer any questions or thank you very much  good afternoon mr chairman and members of the subcommittee i'm ray bowman executive vice president of the national council on patient information education nick pi i've been asked to testify this afternoon related to three areas the one the broad impact of formulary decision making and patient health care provider communication inform decision making about therapy choice and what medication is prescribed and ultimately to what extent patients affectively self manage their medication therapy please to help support the work of the subcommittee in my written testimony outlined specific safety issues driving arising from each of nearly a dozen medication use and safety issues that impact medication medication safety if i may i would address just one of these equally important and much medication safety issues as a way of demonstrating patients experience beyond simply not being able or willing to follow prescribers directions on the while for example for example of embodies the challenges of poly pharmacy the number of medicines available to treat many chronic disease and diseases has increased supports and promotes efforts to conduct medication reconciliation that results in a more complete medication record for providers and pharmacists in the joint commission  leadership and its members working to establish effective medication reconciliation within the hospital setting and back out to patients health care providers in the ambulatory care setting medication that he non adherence also brings  issues like the complexity of the medication regimen multiple prescribe do not communicate amongst themselves concerns about side effects and concerns about cost for example in my written testimony i describe develop medication therapy management guidelines for pharmacists such as the american farmer and the national association of chain drug stores develop and produce for example or the establishment of and roles and responsibilities of the medication safety officer within the hospital setting online medications safety self assessment tools designed to help health organizations assess the medication safety practices in their respective and services and through convening or participating in collaborative programs with both member and nonmember groups each of the following examples enables me to promote and disseminate a wide range of educational resources including educational videos medication personal medication list and questions that each consumer and and health care provider should discuss before any medication therapy is i we also have worked through creation of a dedicated reoccurring event talk about prescriptions for the purpose of which is to enable high quality medicine communication to have its rightful place in the public health expert project advisory teams newest most recent product maximizing your role as a teen influencer what you can do to help prescription drug abuse we worked with fourteen national expert organizations on developing that program and lastly we work through working with external coalitions as example where a member of the national coordinating council on medication error reporting and prevention and the safe medication disposal for main army program were a member project of that advisory team i would thank the subcommittee for inviting me to testify and i look forward to answering any questions you may have thank you very that the physicians have really collectively kind of bought into the formulary they have some role in helping to plan and have input into the formulary and then they're really committing themselves to prescribing from the formulary where possible and then getting exceptions where it's needed for particular patients circumstances so that's really part of the question asked in terms of your first question on the medicines study i think my findings are generally consistent with what that study found several years ago that system does seem to be operating well formulary does seem to be serving the needs of veterans and our sense is from our luck between the drugs that are on the formulary itself the relative ease with which exceptions seem to were able to prescribe adequately from the formulary and to get exceptions where needed at the time those surveys generally supported that idea could always be helpful to go back and conduct such surveys again to see whether drugs to be quite honest i have not looked at the current state of the v a formulary so i couldn't really comment on that but i would say it is my impression that there have not been dramatic changes in policy since supervised or reprimanded by the supervisor if they go off on the larry the answer is it's extraordinarily different difficult it takes a lot of time it's a conversation process and deliberately so and even incidentally for  expensive drugs that are on a formulary they'll put them on fourth or fifth screen back and make it difficult for people to access the more expensive drugs at some stations and nobody's really looked at that and nobody's policing  and the issue over trying to get medications that are not on the formulary that's always b s rejoinder is at the formularies fine because people can get anything that's not on the point when it's clinically indicated but that's just flat not t is a private practical matter we hear from clinicians all the time both in physiological and a neuro psychiatry that if they take things and make recommendations for drugs that are not on the formulary not only does it take an enormous amount of time when they under pressure to see patients face to face encounters with patients but it also they get spoken to they get spoken to enough times and they don't and they're down the road it's as simple as that and it is clearly a conscious policy it's part of is the way in which we have misapplied comparative effectiveness within the v a so that it becomes a race to the bottom so that the pharmacy is measured about cost avoidance below the national mean average well what happens if you have all hundred fifty two stations doing it of trying to get below the mean average well it continues to go down and that's the wrong measure what chief pharmacist and all pharmacists ought to be measured against is how much did you contribute to the overall wellness of the individual patients at this medical center and avoid inpatient stays and keep the patient more healthy and contributing for those of working age to the overall economy those should be the questions we should be asking and it's possible to develop metrics that way people are going to do what you measure them on it's as simple as that and we need to change the way in which we think about pharmacy at the v a and we need to change the way in which v a measures it internally one last thing if i may mention on that issue you asked about the i o m we do need to revisit the i because what the i o m said is there are no good metrics inside the v a to measure what's going on and to analyze it from the outside and that is still the case today and if they have measurements they're refusing to share it with anybody and once again stuff that happens and the back room is where bad stuff happens we are a democracy that should be done out in the sunshine and the way in which the d o d process happens is a totally public process with an advisory committee with and with on formulary will come to well go away just one last thing the theory is that clinical stuff is taken into account at the v a and with all due respect when you mention before about clinical evidence and it's a quote collaborative decision of the doctors well it's not it's not the green eyeshade boys always trump the cost always trumps clinical evidence when it comes to putting things on the be a formula every so that even when they are looking through the new molecular entity process that they've set up they can go all the way through that and have strong evidence about cost effectiveness as well as the efficacy of the drug and then the formulary people the pharmacy people can still  just on the basis of cost and impact on a pharmacy and this is just not right clinical decisions need to predominate throughout the v a and if we can't do that then we're certainly not delivering care second to none one could argue that then it's care second to all and that's not the way we should be doing business and frankly we have so many wonderful clinicians in the v a if we can fix the system and let them do their job we will be care second to none thank you thank  a that where you might have a soldier who's getting a certain drug that's on the deal do you formulary when they move to the v a system that they no longer are getting that or that drug is no longer available have you heard any complaints in  that regard as problems i have and also our friends in veterans modern warfare have told me many of those problems as well where people are kind of stunned because basically those who come out of walter reed and walter reed still has some problems particularly with the medical boards and with case management but it's overall you know a fabulous facility and all of a sudden the v a system back home in michigan or or togas or wherever the case may be and one of the things is formulary and difficulties particularly those who have t b i and seizures it's very difficult because a lot of those things are not on the formulary and therefore their doctors have to go through  their doctors are willing to do it but it's not right that they should jump through hoops those are the kinds of things that should automatically be presumed to be in and we need to balance the system so we go back to clinical input at every step of the way and  it has in place a responsive process in place for assuring access to medically necessary prescription drugs so or for exceptions to the formula they're actually as said in the study that's done almost a decade ago so obviously we need to look at how did how do you feel about the fact that that is actually written in this island study that obviously needs to be taken a look at now mr women you have said that we need to take a look at that again so it's one thing to say we need to take a look at it and another thing to do it so what would you suggest because you say most of these things are done behind closed how do you profess that we take this out and do it in the old then do another study first what would be your idea well the island study by the time you get it going it's going to take a year and a half and i would suggest that we many of the things in the recommendations section of my statement congresswoman i things that the secretary could start doing right now to open up this process while the congress considers whether or not to change the statute and mirror that which is used by d o t and tri care and tri care for life that mandating or just requesting with the secretary i think you can just request him that he contract with  m to do another study now the way in which that r f p request for proposal is drawn that contract with the institute of medicine is something that frankly the committee should have direct input in on as well as the veteran service organizations and other advocates because sometimes those contracts are designed to make sure that you don't get at what is part of the original intent  and so that would be one way of doing it secondly i think it would be useful to have the g a o in a short term look at some of the areas that we know are of concern as an example alzheimer's drugs hasn't had a tremendous and negative impact on people not having the latest alzheimer's drugs as many of you know some of our older veterans even some of the older vietnam vets but certainly the korean and world war two vets are subject to alzheimer's nobody could come up with a cure for alzheimer's yet and we're not suggesting that there is or you can do is slow it down so when you slow down those new medications that are coming on the market and have come on the market in the last four five three four five years from being a vailable to those well war two and korean that a member of your group what kind of suggestions could you give us because it sounds to me like a wonderful group to be able to help our veterans maybe take their medications the right way because first of all we're talking about the fact that we're having trouble getting them but once we get them we're finding out that one of the major problems is following up and making sure that they not only take it but they take in the right dose of the medication do you have any suggestions  art of medicine needs to come back into this part of the art of medicines communication so everything that we do is about moving patient health care providers to an equal footed physician discussion about i just have one question dr totally did you have a response to some comments made i think referred to your previous testimony that i didn't hear did you have any comments you want to make about the last few minutes of discussion question as well i think some of the effective or even more effective than some of the newer medications so it's important to realize the newer does not necessarily equal better drugs beyond that i think the question of the ability to get exceptions from the formulary is really a critical one and our numbers suggest you know we're seeing three quarters of a million prescriptions for a non formulary drug like lipitor for cholesterol there's a variety of those numbers that can be looked at by the real question could be served by  some kind of additional study survey of positions is one way to do that to simply find out whether the physicians that are treating the veterans do feel themselves that they're able to prescribe the drugs that they really want to prescribe or whether they feel it's difficult to get exceptions as mr wyden suggested in his comments or whether the numbers that i see in terms of the actual number of prescriptions for some of these nine formulary drugs suggest that they are able to get go i mean what is your sense of how quickly it would take to get an on formulary drug approved i mean i've seen it with a primary care doctor is it just a matter of him writing a special prescription that says talking to veterans who've been told this by their clinician and in some cases it can take up to two weeks to make that decision about whether or not to go with a formulary with some things like the atypical for schizophrenia they say you got to go for three months on the generics and then if it doesn't work then we'll try to use the typical well you know that's you know it's like it's like it used to when i was talking about before with the misuse of comparative effectiveness if you're part of the fifteen percent that the generic does not work as well for and your physician has some reason to believe that that is the case  your urine duck soup because you can't get this stuff that that you need and we've had that experience with diabetes medication that people were seeing somebody on the outside and then they go to the v a because  typically what happens is a vietnam vet in country finds out that it's service connected presumptive or he or she retires or loses their job and then they turn to be for their health care and they discover that the diabetes medication they've been on for five years or three years you can't get a v a and it's very hard for to get those exceptions it took us in from i think it was eight months nine months pressing hard to get the additional questions that will be asked in writing hopefully you will respond in a timely manner by really appreciate each of your testimonies here this afternoon so thank you the division within the f d a we have a blend of fan who's from the office of inspector general who's accompanied by irene barnett was also from the office of inspector general what i think all three of you for coming here this afternoon to give your testimony and we'll start off with the good doctor applications but safety and effectiveness i guess reactions reported during the clinical trials of the drug are included and the labeling information all drug products contain risk as a lot of benefit and it's often impossible to predict which individual may have increased sensitivity to particular drugs no amount of pre market that it can ovide all of the information about effectiveness or all the rest of it no drug when it's used by the  the frequency and seriousness of the address event and to determine day association with medication usage as more becomes known about the potential risks or benefits of a doctor often its f d a approved labeling would be  so that it better reflect information on appropriate use if labeling a lawn is inadequate to manage risk additional actions may include revising drug names or packaging issuing dear health care professional letters disseminating educationalist special risk medications or requiring restricted distribution programs f d a use a broad range of methods to communicate directly from actions of the public the different types of drug safety communication include labeling early communications about ongoing safety reviews public advisories health care professional sheets and other methods of communication such as video broadcast and conference call manufacturers also input from stakeholders about the structure function and scope of the project the director for the for the set of medication safety of the department of veterans affairs was among the participants at this day long meeting presenting on the issue of risk communication other initial steps to creating the sense in the system f d a is initiating various pilot efforts to for the science of medical products surveillance one of these pilots  will include our federal partners we look forward to the participation in this effort the effort involves creating a distributed system that will focus on developing methodology to obtain more information on   market drugs that well understood f d a had a critical role in the detection and management of safety issues that identified after drugs approved including a critical role in communicating information to the public  is to make the most up to date direct safety information available to the public in a timely manner so that health care professionals and patients can consider them for mission or when making decisions about medical treatment our ability to fulfill our mission is thank you sir chairman michaud and members of the subcommittee thank you for the opportunity to be here today and talk about accountability for non control drugs we recently issued to audit report that address about ninety five percent of those dollars went for non controlled drugs although non controlled drugs are not subject to the stringent inventory and oversight controls they are subject to diversion  expensive have a high street value or contain active ingredients that can be used to manufacture illicit drugs we reported medical facilities in the same could not adequately account for their non control drugs because of inadequate inventory management practices record keeping inaccurate pharmacy data at the same office we found differences ranging from a negative of thirty one hundred pills to a positive one hundred ninety two thousand at the medical center we also identified both positive and negative variances for example twenty four of thirty one medical facilities reviewed had a positive variance for at least one drug these positive different intil counts are significant because they represent pills that are available to or divert without anyone knowing they don't exist according to the record physical and mentors act as a check on the effectiveness of other inventory control however the system cannot maintain a perpetual inventory that would provide accurate information we also found problems with the recording of drug transactions for example the local pharmacy personnel were not consistently recording returned from the pharmacy physical three the pharmacy reengineering project to prove accountability for drugs although the system development was originally slated for completion in two thousand and five it has experienced significant  agreed with all of our recommendations and has provided acceptable plans to implement our recommendations that does finally conclude my statement will be happy to answer any questions you may have thank  uire and distribute pharmaceuticals and supplies has been an effective model it's actually managed and operated out of the national acquisition center the contracts that our review we did speak to pharmaceutical managers in the private sector and they did provide monitoring over non controlled drugs that they considered subject to diversion also during our review we found  a number of pharmacy managers were monitoring drugs even before our work and after we conducted our work and noted the differences between the physical inventories and  the actual drugs on on the shelf many of those managers took steps to monitor more drugs so i think at this point i would consider our recommendations a good step forward in a few years perhaps we'll go fly on safety issues that would may have a concern about and it's also affected be a population so specific studies are agreed upon where the study protocol is so divided the hypothesis is develop all the information that has been collected over the development period and this may started from the pre clinical period and sort of the three stages of a studies and so all the data