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tv   Opioid Addiction and Treatment Hearing - Part 2  CSPAN  March 12, 2018 12:16pm-2:14pm EDT

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case of yick wo v hopkins. the unanimous ruling written by associate justice stanley matthews found in favor of the laundromat owner and established that equal protection under the 14th amendment applies to immigrants as well as citizens. examine this case and the high court's ruling with mae ngai at columbia university and author of "the lucky ones: one family and the extraordinary invention of chinese america." and josh blackman. watch landmark cases live tonight at 9:00 eastern on c-span, or listen with the free c-span radio app. for background on each case while you watch order your copy of the landmark cases companion book, it's available for $8.95 plus shipping and handling at cases. for an additional resource there
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is an link on our website to the national constitution center's interactive constitution. >> and back now to the house energy and commerce subcommittee hearing on opioids. researchers, treatment specialists and pharmaceutical representatives testify on the legislative options to regulate synthetic opioids. >> i think we will ask our witnesses to take our seats. are you okay if we start? i don't see gene here. is that all right with you?
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very well. i think we have successfully transitioned -- almost successfully transitioned. we still have a couple of vacant chairs. there we go. well, i think we've transitioned to our second panel today. we do want to thank our witnesses for being here and taking the time to testify before the subcommittee. once again, each witness will have the opportunity to give an opening statement and that will be followed by a round of questions from members. so today, this afternoon the second panel we will hear from mr. frank fowler, chief of police, syracuse, police department, dr. patrick beardsley, professor department of pharmacology and toxicology virginia commonwealth university. dr. john mulder, i have you out of order. dr. mulder, there you are. director trillium institute. dr. ponnie subbiah chief medical officer indivior, dr. david kan,
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president of california society of addiction medicine, richard nance, community department of alcohol prevention and treatment. thomas cosgrove, partner could think ton and burlg, llp, dr. andrew kolodny, brandeis university, and richard logan owner of l & s pharmacy. we appreciate each of you being here today and are grateful for your forbearance on what has been a long afternoon. chief fowler, you are recognized for five minutes to give a summary of your opening statement. and, chief, make sure your microphone is -- >> how about now? are we okay? all right. thank you. thank you, chairman burgess, ranking member green and the dished members of the committee on the energy and commerce. i am here today to make an effort to paint a picture of a
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community that has been ravaged by synthetic drug abuse. beginning in 2013 the syracuse police department responded to an increase in the use and subsequent overdose of synthetic marijuana known as spike. the syracuse police department implemented various means of tracking the problem in addition to our law enforcement efforts. in 2015 the syracuse police department saw its largest number of overdoses from the use of synthetic marijuana, the largest number of overall cause for services, cause for services related to overall overdoses and persons down. also made the largest number of arrests related to the substance. while the department took steps to get these drugs off the streets, new chemical formations of spike were beginning to --
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were beginning to be further into circulation. in addition to all of the syracuse police department's efforts, the only thing that we could charge a person with was a local law violation issuing them an appearance ticket and releasing them. this is just one example of the dangerous synthetic compounds that are flooding our streets. toxic synthetic drugs are designed to mimic drugs like marijuana, lsd, cocaine, ecstasy and other hard drugs. they could be more potent than the real thing and oftentimes are more deadly. in addition, these drugs are not simply affecting the users. my officers and other first responders are put in harm's way simply by coming in contact with these often lethal substances. as a local law enforcement official we need hr-2851, the
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sitsa act which was introduced by congressman cad co. this bill takes a big step towards eradicating these harmful substances and protecting our community. it will give my officers the tools they need to target synthetic substance and the criminals who distribute and traffic them. under this bill a drug set to spike could be temporarily or permanently added to the new schedule under the controlled substance act. as little as 50 days after the chemical compound has been identified. the abusers of this synthetic drugs are not simply confined to my jurisdictions. colleagues of mine from across the country are dealing with the same issues and have expressed a need for a solution. hr-2851 is that solution.
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i urge this committee to pass this bill and to give us the tools we need to combat this deadly epidemic. thank you again for this community and i welcome your questions. >> dr. beardsley, you're recognized for five minutes, please. >> mr. chairman and members of the house sube. committee i'm patrick beardsley. in addition to my faculty appointment i'm a member of the expert committee on drug dependence for the world health organization, a committee that is the first step for processing drugs for their international control. thank you for the community to be here today to discuss hr-2851. we are all dedicated to finding paths that take us away from our present opioid crisis. i believe one path will be through research. there is a perpetual need to strike a balance between the regulatory control of drugs to ensure public safety and the necessity for researchers who have access to controlled drugs
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to further skriens. the controlled substances act the csa explicitly recognize both those needs and i am personally sympathetic to both needs. as a researcher of the drugs of abuse, however, i have concerns that sitsa upsets that balance. i would like to take the next few minutes to identify my concerns. it is my opinion that the attorney general has already been able to effectively regulate all synthetic opioids that are known to be a current problem via the present csa. effective february 6 of this month the dea issued a scheduling order that included all fentanyl related substances that were not currently scheduled to be included in schedule i. fentanyls constitute the greatest portion of all synthetic opioids abused. a few non-fentanyl synthetic opioids that have been identified as abused have previously been scheduled. because most if not all
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currently abused synthetic opioids are currently scheduled and you the csa it is unclear now schedule a will help address the current problems with abused synthetic opioids. considering 13 fentanyls are identified in sitsa it is likely all will be transferred. public health would be enhanced transferring these compounds from schedule i to sked all a conditions is also unclear. the addition of another category of drugs by sitsa to the csa a problemat problematic. it adds mother level of costly bureaucracy to researchers who work with drugs of abuse. registrants with only a schedule 2 to 5 registration will have to obtain a schedule a registration. all registrants whether they hold a schedule 1 or schedule a registration will have to submit protocols to the attorney general for his approval to justify the use of each drug in schedule a.
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functionally this arrangement is similar to how research with schedule 1 drugs are handled. it can take a year or longer to obtain a schedule 1 registration and it can require many months to have a new drug added to one's existing schedule 1 registration. similar delays that are now impeding research with schedule 1 drugs transfer to schedule a drugs sitsa will provide nothing to the researcher that will hasten our understanding of synthetic opioids through science and will likely impede this process. this problem is compounded by an absence of a mechanism in sitsa for removing a drug from schedule a once it is scheduled. under sitsa the attorney general has the power to place a compound in schedule a based upon a drug's structure and in the absence of additional scientific information commonly provided by hhs and nida, the national institute of drug abuse, this can result in miscapital fictions of drugs and missed opportunities for discovering medications we need
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to confront the opioid crisis with. determining scheduling driven by chemical structure can be misleading. for example, the chemical structure of morphine and naloxone are similar. the other is commonly prescribed and is the other is an antagonist to the other. banning a compound may inadvertently add an antidote to the abused compound. in addition to my concerns regarding sitsa i do have discussion s. ugss that would make conducting research with synthetic opioids and controlled substances in general more efficient, far less costly and bring much relief from the bureaucratic burden of constructing rye search with them. my statement time doesn't permit me to enumerate them but my suggestions can be found in my written statement and i would be happy to discuss them later if asked. i've tried to identify a few concerns i have with sitsa adds a researcher and i welcome any
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questions you may have. thank you. >> thank you, dr. beardsley. dr. moulder you're recognized for five minutes. >> thank you, chairman and members of the committee. i am john mulder, a physician who has been practicing in the field of hospice and palliative medicine for over 30 years. i have cared for a lot of folks, thousands over that period of time. i'm here in support of house bill 5041 and appreciate representative walberg as well as representative dingell and representative hudson for crafting and advancing this bill. it's pretty straightforward. this bill would allow hospice -- licensed hospice personnel to destroy medication in the home that's left over after a patient dies or in cases where someone is still living but the medication has been changed, leaving excess medication in the house it would allow for them to properly dispose of that.
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every year in america we care for between 1.5 and 2 million hospice patients. i would submit that virtually every one has medication left over. we can't predict when someone is going to die and therefore we prescribe medications typically in small amounts but they die and medications are left over. so the matt mat tick extrapolation is pretty straightforward. we end up with tens of millions of doses of controlled substances that are left in the homes of our hospice patients every year. at this point in time our hospice personnel are not legally allowed to handle that. they can make recommendations, but as we've already heard in earlier testimony, the availability of take back programs, the process of using the mail in envelopes and other processes that are in place legally are sometimes onerous and families typically don't take advantage of that. that just leaves too many medications left on the shelf and ultimately potentially to be
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sometimes innocently but sometimes nefariously abused by the -- by family members or diverted. so when we are talking about a quick and easy way to get rid of millions of doses of controlled substances off the streets, potentially off the streets, this is a very simple and i would note bipartisan effort that has -- that to me makes an awful lot of sense. and that's it. that's it. the only thing i would add is just the one thing i've noticed in a lot of legislation both federal as well as state is that in the effort to push forward legislation a lot of times the role of hospice in the care of the patients and the unique and special plate of hospice patients is sometimes overlooked and sometimes a legislative burden and barrier could have the potential of introducing preventable suffering for our hospice patients. so i would ask the committee and members be mindful of the unique nature of hospice concerns and to take advantage of the resources of the national
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association of home care and hospice as a resource for additional input. i as well am available to answer any questions or concerns that some might have about this issue. >> thank you, dr. mulder. i appreciate your team. dr. saabia. >> i'm dr. ponnie subbiah i'm a nurlg joist. and also indivior. we have a 20 year commitment to the vision that all patients have access to evidence-based treatments. we've developed the first medication for treatment of opioid dependence in the u.s. today we have a portfolio of treatments for opioid addiction as well as a pipeline of candidates to address unmet patients like this and other disorders including alcohol use disorder and schizophrenia. to address the opioid epidemic it is important to understand the patient journey. it is complex and often
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misunderstood. a diggs is a brain dis and not a northerly failure. social stigma, prejudice and miss consensuals about addiction coupled with feelings of guilt and shame often prevent people from seeking help, even when people want help krangs and withdrawal symptoms can be so intense that there is generally only a small window of time when a person can emotionally and physically pursue treatment. the healthcare system, however, does not always encourage treatment during that window due to structural barriers to care. this is one reason that many of those who need help go untreated. any patient in need of treatment for opioid use disorders should have access to the medication assisted treatment prescribed by their healthcare professional. indivior's focus on patient needs to drive decisions inspired an r & d team to develop sublocade.
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the first monthly extended release injection for subcutaneous use. in the face of this growing addiction crisis, fda granted the product fast track approval and priority review designation. now, it is indicated for the treatment of moderate to severe opioid use discord in patients as part of a complete treatment plan that includes counseling and psychosocial support. sublocade uses a delivery system which allows for once monthly doses and is intended to be administered by only healthcare providers. it will be distributed through a restricted distribution system which is part of a risk evaluation and mitigation strategy program. the goal of that program is to mitigate serious harm or death that could result from intravenous administration, self administration by the patient. all healthcare settings and pharmacies that order and dispense sublocade must be certified and established procedures to verify that the medication is dispensed directly
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to healthcare provider for administration by healthcare provider only. as every patient's journey towards recovery is different, access to all evidence-based treatment options is critical. sublocade represents one such option. government policies impacting these treatments must adapt to ensure patients to have access to new innovative medical technologies. historically treatments have been daily oral medications and the controlled substance act allows for dispensing this medication directly to patients, however, sublocade as required by our fda approval can only be administered directly by the healthcare provider and cannot be dispensed directly to the patient. in recent years the distribution of injectable products has evolved from a traditional buy and bill system where physician practices purchase drugs directly from a distributor to one that allows specialty
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pharmacies to ship a patient's prescription directly to administering provider. for example, current long-acting inject i believe treatments used for schizophrenia utilize both the distribution methods to ensure optimal patient access to these medications. current law, however, is ambiguous and could impede patient access to new treatment invasions. we agree with representatives costello and nolan that the law needs to be clarified so that these next generation products can be accessed directly by healthcare providers by a specialty pharmacy restricted delivery system as well as the traditional buy and bill system. we support the proposed legislation to remove ambiguity in the current law to ensure that patients are opioid use disorder and their providers have the same level of access to these innovative treatments as they do to other inject i believe products. this technical clarification will ensure the safest distribution channels for these new medical technologies.
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thank you again for the opportunity to address the committee. together we can transform addiction from a human crisis to a recognized treatable disease. thank you. >> thank you for your dem. dr. kan, you're recognized for five minutes, please. >> chairman burgess and ranking member green thank you for inviting me to participate in this hearing. thank you to the subcommittee for your leadership in addressing our country's opioid epidemic. my name is dr. david kan and i'm the president of the california society of addiction medicine. a chapter of the american society of the addiction medicine also known as a. sam. this testimony is offered on behalf of astam. established in 1951 it is a national medical specialty society of more than 5,000 physicians and allied health professionals whose mission is to increase access to high quality addiction treatment. i'm board certified in addiction medicine and psychiatry. i have served ten years in federal service at a va methadone program within the san
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francisco v achlt mea medical c. i'm the current medical director of bright heart health which provides telemedicine services in 21 states across the united states. my testimony will focus on three facts, number one, addiction involving opioid use is effectively treated with a combination of medications and psychosocial interventions and asam has published guidelines that detail best practices for the use of these medications. number two, there is significant barriers to accessing medications for addiction involving opioid use in a nationwide treatment gap. number three, changes to the controlled substance act to facilitate the use of telemedicine and new medication formulations can expand access to medications for addiction involving opioid use to close the gap. there are currently three medications, methadone, nal tracks own or bup a morphine that have substantial evidence for their effectiveness treating addiction. given the bills being considered today i will focus my remarks on the safety and effect i have been of buponorphine.
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be campaigned to meth bone buponorphine is much safer with lower overdose deaths. the direct healthcare services for treated opioid dependent patient per year exceed $20,000. asam has published clear standards of care for clinicians treating patients with addiction as well as prescribing guidelines. despite the strong evidence used for the use of buponorphine very few eligible patients are offered medications to help treat their disease. studies have shown 80% of patients with opioid addiction don't receive any treatment and the majority of states don't have enough treatment providers to provide the capacity to meet the need. other access barriers include transportation difficulties, limited hours of operation and few prescribers who accept medicare or medicaid making treatment next to impossible. making smart and targeted changes to the controlled substances act to facilitate treatment of buponorphine and for a diggs involving opioid use
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via telemedicine are steps this congress should take to expand addiction treatment access. telemedicine provides significant opportunities to reach for patients. the ryan haight act allows expansion via telemedicine by generally requiring an in person medical evaluation or the presence of a patient in a da registered hospital or clinic. consistent with the stare and national practice guidelines asam recommends that the requirement for an in person physical exam by the prescribing clinician be revised to allow for a physical exam to be conducted by another licensed appropriately licensed healthcare professional and documented in the patient's medical record. additionally asam recommends limiting this exception to the in person physical exam requirement only to those physicians who hold additional certification or practice in a qualified practice setting per the definitions in the 2016
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samsa rule that raise the data 2000 prescribing limit. it would increase access while ensuring high quality care from component healthcare providers and safety for the patients. secondly asam encourages congress to amend the controlled substances act to allow for specialty pharmacies to -- rather than relying on the buy and build method for obtaining and being reimbursed for the medications. such a change is not a new pathway for medication delivery, it would allow for these controlled substances to be delivered as many noncontrolled substances are already. it is a technical common sense fix that will expand treatment access while potentially reducing buponorphine diversion. asam urges the subcommittee to advance a bill to approve it. thank you for the opportunity to trent present today. >> thank you, dr. can. richard nance, you're recognized
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for five minutes. >> thank you. i appreciate the opportunity to testify on an issue that's impacting community based addiction and mental health centers across the country. thanks to representative car 'tis, matsui for their leadership on the two discussion draft bills focused on the ryan haight act. i'm honored to be here on behalf of the national council for behavioral health a national group that represents 2,900 member centers. since 1998 i have served as the director of utah county's department of drug and alcohol prevention and treatment, i'm a member of the national council, also a licensed clinical social worker in the state of utah. my department provides a comprehensive range of drug and alcohol prevention and treatment services including medication assisted treatment for opioid addiction and abuse. over 40% of people i have in treatment in my agency right now
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are there for an opioid issue and over 30% of them are receiving medication assisted treatment. that's nearly 400 out of 850 clients i have in treatment today. i'm here to discuss an issue that limits community addiction and mental health centers ability to provide patients access to treatment using telemedicine. medically appropriate treatment for behavioral health conditions sometimes involve controlled substances, unfortunately today thousands of centers across the country are unable to utilize telemedicine that results in prescription for a controlled substance through the dea's narrow interpretation of the ryan haight act. in my remarks i will explain why this is and why the matsui harper bill provides the relief we need. let me state up front, first, though, the national council appreciates and affirms the importance of the ryan haight act as recent reports have shown with the act in place it's still too easy to go on line and buy substantials without a valid prescription.
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in november of 2016 two junior high students in utah ordered a drug called u-4700 synthetic opioid analog sometimes are efrd to as pink, took the drug and overdosed and died. these studies underscore the importance of the dea's vij tans over the online ecosystem and rogue actors that claim to be tolling telemedicine and operating an online pharmacy but are functionally pill mills. our goal ask to allow licensed dea regulated community addiction and mental health centers staff by regulated and licensed professionals to be able to comply with the ryan haight act in order to improve patients access to care. so what we're asking is that you regulate us. i don't know too many people who would come in and here and ask you to regulate us. here is how the situation plays out in utah and illustrates the problem around the country. the act allows for prescription of controlled substance without a prior in person examination in limited circumstances known as telemedicine exceptions.
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the most common way telemedicine is allowed is when the patient is located in a dea registered hospital or medical clinic and is being treated by a dea registered provider for -- located off site. the problem is dea has interpreted the hospital and clinic exception so narrowly that it often does not apply to community-based addiction and mental health centers. for an example, one patient at one of utah's community addiction and mental health centers is in crisis, i'm giving you an example here, the patient may need addiction treatment involving medication assisted treatment with a controlled substance like is a locks own. the center staffed with social workers, nurses, counselors and licensed mental health professionals sometimes including physicians due to shortages of providers in parts of utah the center where our patient is located rarely has a dea registered doctor on site, but the center does have the ability to connect the patient to a dea registered addictionology gist using telemedicine technology.
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the problem is my center is licensed by the utah department of human services as a drug and alcohol treatment agency, not licensed as a hospital or a medical clinic by the utah department of health as a dea requires. as such my licensed center is unable to register with the dea. we can't provide the needed care to patients ud using telemedicine. with he must wait for a dea registered doctor to go on the road before a patient gets a prescription for controlled substance to treat their opioid addiction. this is one illustration of the problem. as discussed am my written statement there are many other examples how the written interpretation of hospital or clinic is keeping legitimate centers to from treating patient when controlled substances are needed. the harper matsui bill hopes to remedy this. final the opioid epidemic is the subject of today's hearing it's
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critical that the dea allows centers to use telemedicine to treat other mental health conditions, too. this is discussed also further in my written statements. thank you very much. i appreciate the opportunity to be here and i'm willing to take questions. >> thank you, mr. nance. mr. cosgrove, you're recognized for five minutes, please. >> thank you, chairman burgess, ranking member green and members of the subcommittee for the opportunity to testify today. my name is tom cosgrove and until last year i was an official at the food and drug administration responsible for current good manufacturing practice enforcement and compliance within the center for drug evaluation and research or cedar. in that role i was responsible for ensuring manufacturing quality and compliance for the thousands of drug manufacturing facilities around the world that make med skins distributed in the united states. since december of 2017 i've been a partner at the law firm of covington and burlg here in washington. covington represents a number of clients in the food, drug and cosmetics industries that use tableting and encapsulating
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machines, the subject of the draft bill under consideration which is the tableting and en kpaps lagt act of 2018. the crews expressed here are my own. i share congress and the public's concern about the opioid abuse epidemic and am edge kranld to see so much action in congress and society at large aimed at ending the crisis. in my role at fda i was aware of the acute problem of the importation of the elicit opioids, opioid an logs and synthetic drugs from overseas through international mail facilities. this appears to be a different issue, however, than the use and regulation of tableting and encapsulating machines in the united states. virtually all manufacturers of solid oral drugs in the united states use tableting or encapsulating machines in some form, at least as those terms are defined under the draft bill. this includes prescription, nonprescription and many animal drugs covering everything from innovative new drugs to otc products that people use daily. in addition, dietary supplement
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manufacturers commonly use tableting and encapsulating machines as part of their manufacturing processes. one need only walk down the health and wellness aisle of a local supermarket to get a sense of the products manufactured using tableting an encapsulating machines. tableting machines are often used in the manufacture of candy, cosmetics and certain household products such as cleaning agents. where the draft bill to be enacted is now written lawful domestic manufacturers using tableting and encapsulating machines to produce legally marketed noncontrolled products including nondrug products they would be subject to the csa's strict requirements for controlled substances. a straightforward reading of the draft bill at hand would appear to require manufacturers to register with the dea and with state authorities in each location that they hold or separate a machine. manufacturers apparently would need to store tableting an encapsulating machines in
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secured areas such as the ones used to safeguard controlled substances themselves. this includes things like electronically monitored saves, steel cages or vaults that mean certain specs specifications. manufacturers hoping to dispose or replace malfunctioning machines could need to transfer machines to companies specifically registered by dea to render those machines nonretrievable. in addition manufacturers might need to comply with paperwork requirements such team they move a machine. such requirements in facted could cause domestic manufacturers to incur direct costs of machine registration, recordkeeping, security and disposal and indirect costs from training, education and audits to ensure compliance. we live in a time also where there is enormous pressure on drug manufacturers to move their operations overseas for cost reasons. in fact, one of fda's main challenges today is keeping up with the pace and explosion of drugs being manufactured overseas in places like india
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and china. ironically the draft bill would burden most the companies that have nothing to do with opioids or other controlled substances because these companies would need to establish scratch. furthermore, congress has already amended the csa to give dea special authority to regulate. in 1988, congress passed the chemical diversion and trafficking act or the cdta, that act is described in the written testimony of ms. gibson who testified earlier daird and i today. if congress decides that enhanced regulation is needed, i would encourage a more tailored approach that builds on existing authorities. first, i would want to better understand why dea's existing authorities are not sufficient. one potential further approach would be to are consider amending the cdta such that companies would also register
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equipment with dea beyond only reporting transactions. this could be tethered with an appropriately crafted exemption for firms regulated by fda. they could develop a more robust database and would not be suddenly regulated as if holding controlled substances. if congress decides to move forward on this, i'd be happy to serve as a resource in deliberations going forward. thank you for the opportunity to testify and i'd be happy to take any questions. >> thank you. you are recognized for five minutes, please. >> thank you, chairman burgess, ranking member and members of the health sub committee for the opportunity to testify today. i am the co-director of opoid policy research, but also director of physicians for responsible opoid prescribing. my testimony today is on behalf
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of prop. as you all think when solutions to the opoid crisis, i think it is very important to frame the problem and to frame it the right way. i believe that the correct way to frame the opoid crisis is as an epidemic of opoid addiction, not everyone who dies of an opoid overdose was suffering from opoid addiction, but the studies tell us that the vast majority of the people dying are opoid addicted. if we frame the problem the right way as an epidemic, the big picture strategies become much more clearer. we have to accomplish two things, we have to prevent more people from becoming opoid addicted, and we have to see that the people who are addicted are accessing effective treatment. when i say epidemic, i'm not exaggerating. from 1997 to 2011, there was a 900% increase in the number of
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people suffering from opoid addiction. and it is that increase in the number of americans with opoid addiction that explains why we're experiencing record high levels ever overdose deaths, seeing a soaring increase in infants being born dependent. to bring the epidemic under control, we have to prevent new cases of the disease, that is primarily through cautious prescribing. and i'll focus the remainder of my statement on hr 2063, a bill to mandate prescriber education. although i do not support the bill in its current form, i'm strongly in favor of mandatory education for dea registrants who intend to prescribe more than a three day supply of opoid analgesics. and i commend the co-sponsors for introducing this
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legislation. the need for this law becomes clear when we look at the cause of our opoid addiction epidemic and the cdc has been perfectly clear about why we're experiencing this epidemic. what the cdc has shown us, and we have a slide up here, the green line at the top represents opoid consumption or prescribing in the united states. the red line represents deaths involving prescription opoids and the blue line represents addiction involving prescription opoids. the cdc has really been saying that as that green line went up, addiction and overdose deaths went up right along with it as the prescribing increased, it led to the epidemic that we have today. the reason that that green line began to go up so rapidly, the reason the medical community began prescribing so aggressively, is because we doctors were responding to a brilliant multifaceted marketing
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campaign that changed the culture of opoid prescribing in the united states. starting in the '90s, we began hearing that patients were suffering because we were too stingy with opoids. we began hearing that we should stop worrying about addiction, that even with long term use, the risk of addiction was much less than 1%. we began hearing that opoids were safe and effective for conditions like low back pain where the leading experts tell us they are neither safe nor effective. we would have been less gullible if we had just heard these messages dwrekirectly from drug companies, but as we heard earlier, these messages came to the medical community from every different direction. in particular, we were hearing these messages from professional societies, the american academy of pain medicine and the american pain society in 1997 put out a consensus statement calling for much greater use of opoids and claiming the risk had
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been overblown. my greatest concern is hr 2063 is that it relies on these organizations and other professional groups with industry ties to provide the government mandated prescriber education. one of the most important lessons from the crisis is the need for strict firewalls between pharmaceutical company marketing and medical education. had marketing not been so cleverly disguised as education, we might not have an opened addiction epidemic today. if we learn from our past mistakes, we will not rely on the same industry funded professional societies that got us into this mess to provide the education we need to get out of it. it may be hard for you to believe that in the midst of our opoid addiction epidemic that doctors are still overprescribing. but we are. the united states continues to prescribe more opoids than any other country on earth. millions of dollars are were spent misinforming the american
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medical community about opoids, but very little has been done to correct the record. that is why prescriber education must be made mandatory and that is why the content for the education must be developed and administered by individuals and organizes who do not accept payments from pharmaceutical companies. thank you. >> mr. logan, you are recognized for five minutes please. >> chairman burgess, ranking member gleareen, thank you for holding this hearing. i'm dr. richard logan. i've been a community practice pharmacist since 1975. and currently own two pharmacies in southeastern missouri. oddly enough in duty to my duties as a community practice pharmacist, i have spent the last 25 years as a missouri certified police officer and in may recently retired pry description drug diversion
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investigator or the mississippi county sheriff department. i'm here today on behalf of the national community pharmacists association to present some of my experiences and view points focusing on viable solutions to prevent drug an abuse and diversion while maintaining legitimate access of patients to needed medications. ncpa represents america's community pharmacists, including owners of more than 22,000 independent community pharmacies just like mine. our job has health care professionals is to help patients safely navigate medication related treatment across multiple disease states. we are focused on positive dwrout co outcomes and safe medication usage, yet as pharmacists, we struggle to meet these goals in the midst of an opoid epidemic that kills hundreds of people
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daily and over 200,000 americans since 1999. my flagship pharmacy is in missouri. it is the first pharmacy across the mississippi river on i-57 and highway 60 from illinois, tennessee and kentucky. my state has no adequate functioning pdmp and as such, is a magnet for those who would abuse prescription opoids. it is not unusual for travelers to drive hundreds of miles from eastern kentucky, ohio, or other areas distant from me to visit a pill mill in georgia or florida and end up at my prescription counter with prescriptions for narcotics. lots of narcotics. common sense tells me that somewhere between missouri thoss have passed a pharmacy. i once investigated a traveler who had driven across southern
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missouri, had seen eight physicians and visited 18 pharmacies in search of opoids. i've served on many search warrant teams, made many arrests, some at my own prescription counter, had lots of convictions, dnodged bullets spent nearly 25 years fighting drug abuse, was responsible for putting together a bi-county prescription drug task force that led to many arrests and still, still, i feel like i've done nothing to stem the tide. it is just that overwhelming. all the while as a practicing pharmacist, i go to bat for my legitimate patients who need opoid therapy so that proceed d life and not be declined therapy due to the stigma attached.duct life and not be declined therapy due to the stigma attached. as the final check points, pharmacists play a vital role in
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ensuring all medications including controlled substances are appropriate for their patients. pharmacists are often the last professional an opoid patient sees and the first professional to realize that a patient is slipping into an abusive pattern. pharmacists must monitor their patients and work in collaboration with other health care providers, understand the risks and benefits of opoid therapy, and keep the best interests of the patient at the center of all decisions. there are promising policies that congress or the administration could move forward that would have a positive impact on mitigating or preventing abuse. go one such policy is included in the fight against opoid abuse act. to provide for the development and dissemination of programs and materials for training pharmacists, health care providers, and patients on
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indicators that a prescription is fraudulent, forged or otherwise indicative of abuse or diversion. this is not only a common sense policy, it is one that fits in well with the dea 360 stwraenlg to engage all of those involved with opoid treatment. ncpa supports such efforts to bring greater diversity and education to other health care providers and patients regarding a pharmacist declining to fill a controlled substance. ncpa offers itself as a resource if necessary. thank you. >> thanks to all of our witnesses for your testimony. certainly been insightful. at this time i would like to yield to the gentleman from oregon, chairman of the full committee, for your questions. >> thanks again for your leadership on this issue and your subcommittee's good work.
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and to all our witnesses, thank you for your testimony. it is very helpful in our work. i want to ask chief fowler, you provided a crime analysis report as part of your written testimony, the primary focus is overdoses related to spike or synthetic marijuana. have you seen other synthetic drugs on the streets in your community, what has been the impact of these substances, and is synthetic marijuana the worst analog drug on the streets of syracuse or do you have data that fentanyl or other opoids are worse? >> so currently spike, the one that i spoke about, is the one that we're having the most problem with. but fentanyl is certainly a tremendous problem and it ranks second. >> which is the most deadly? >> fentanyl is indeed the most deadly. we see the most deaths associated with overdoses with fentanyl. >> and what is the practical effect of spike? what happens when you come on a
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scene? >> it's marketed as a synthetic marijuana, but itit hallucinogec effect and what we see is people and what i could best term as psychosis. they are acting out in a very bizarre fashion, oftentimes violent, incoherent, and then they exhibit a number of medical issues in which they have to be addressed at the local hospital. >> such as? >> rapid breathing, some even pass right out after they have exhausted themselves from running around and acting in a very bizarre way, sweating profusely. and i'm not a medical expert. i would imagine that everything that accompanies a person's heart rate rising, their blood
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pressurizing, i would imagine that that has some type of medical effects on a person. but i'm not a medical expert so i can't tell you what those are. but the bizarre behavior and violent behavior, that is something that i can identify with. >> and what is the youngest age that you have seen? >> quite young. when this first came on the scene, what we discovered was it it was sitting right on the shelf in the local convenience stores. >> wait a minute. it was on what? >> when it first came on the scene, it was sitting right on the shelf of local convenience stores in these very colorful packages. and i personally overheard a couple of high school students talking about why it is that they would choose to use spike over marijuana is because they happened to be on probation and if they were to have to give a urinalysis test, that this
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substance would not appear. and so they were using this to get away with being a probation violation. so our young people started to use the substance and they were experiencing the same things that everyone else was. these episode of psychosis during the schools, on the streets. and so we see all ages. >> so the legislation is drafted very focused on the fentanyl analogs. in your police department's experience, what other synthetic drugs do you think we should be addressing comprehensively by class? what else should we be looking at here? >> well, i think that all of the synthetic drugs that we can identified we need to take a look at them because what is happening is that they are all
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appearing on our streets. the minute that we bring one substance under control, a different or another substance will pop up. and we have a simultaneous problem with spike and febntany right now about that. >> so broadly speaking do you fo feel like your department has the tools you need when you come being a cross synthetic illicit drugs? we want to get this right, so what are we missing here that would be helpful in your efforts? >> law enforcement is only as effective as the laws that we enforce. >> right. >> and when you look at let's take spike for example because that is what i talked about the most, right now it is not scheduled and the only thing that we can do is give people an appearance ticket for a local law violation. >> what does that mean, a local law enforcement violation?
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>> we went to our local legislators and had them enact a local ordinance. >> against spike? >> against spike, yes. to make the substance illegal. and that is the charge that we utilize. >> what is the penalty? >> it's a violation, so -- >> so a traffic ticket in effect? >> basically. >> so it is not a determent to speak of. >> not at all. not at all. >> all right. thank you. and thanks again to the whole panel. you all have been most helpful in our work and we'll continue down this path, pass new laws so you have the tools you need to stop this to the best of your ability. but we need your input, so thank you very much. >> thank you, are sir. >> the chairman yields back and the chair will recognize miss caster from florida. >> thank you very much. thank you for being here. dr. kahn, in your testimony, you talk about the significance
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barriers to access for folks who are suffering from opoid addiction and you say we have a significant addiction treatment gap in america. you cite the journal of american medical association, a report in 2015 that says 80% of americans with opoid addiction do not receive treatment. and you've recommended and a lot of you here have recommended some ways to tackle the problem. it seems like it is so pie piecemeal. do a little more tele medicine, buprenorphine formulations and distribution. but this is a public health crisis. and what i'm hearing at home from parents and others, there is just no capacity out there. there is just no, you know -- even in the affordable care act
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we have new requirements that insurance cover essential health benefits including mental health. under medicaid, yes, you have some treatment options. but it is just not happening on the ground. so what else can you recommend to us to help improve the long term treatment that so many americans will need to tackle their addiction? >> thank you for that question. i think tele medicine is one piece of the entire puzzle. there is a very much broader puzzle when it comes to reducing stigma around the illness that is part of the effectiveness of tele medicine that beam donpeop have to be publicly identified as being treated. and we need to expand access to all forms of treatment both different formulations and different avenues in which people can get that type of treatment. if i think about opoid use disorder as a physician, about 80 prlgs 8 8 80% of the effect size is
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predicted by medications alone. meaning you can reduce the risk for accidental overdose. and counseling is significant. it is incredibly important this changing people's lives. but we need to create expanded access, we need to keep people alive. this is not a position -- this is a position that has been considered in the american society of addiction medicine and certainly a position that csam has taken that we need to reach out to those that we don't see. i don't worry about the patient that i'm treating because they are in front of me and i can monitor them. however, the person who leaves my practice or dg appear from care, i worry about because i know that they are not receiving treatment. >> so you au mr. nance, you are ground doing this. what will it take for us really to make sure that the folks who need long term treatment receive that long term treatment? >> dr. ka that. in is right, tht problem we face is capacity.
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you mentioned it yourself. we have the ghas utah to treat less than 20% of the people that need drug and alcohol treatment. so workforce is a huge factor. if we don't have the staff to deliver the services, we can't provide the treatment. effective evidence based treatments are important as well. and we strive very hard to identify those that we can afford, implement them, train our staff to implement them to -- >> are you recommending to us that we need to do more in workforce training for doctors, nurs nurses, counselors? >> yes, we need to provide more behavioral health staff, but other specialties need more training and education on how to identify and refer someone to treatment and provide some of those treatments themselves. >> and dr. koenig, you cited some stark constituents. what are your recommendations to tackle the barriers for access
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jama says 80% of americans s s addiction don't receive any treatment. how do we get to that? >> i very much appreciate that question. i think the only way we'll get there is with a plas sif federal investment in the billions. we have to create a treatment system that doesn't really exist yet. the majority of the state license drug and alcohol treatment programs don't ever buprenorphine. many don't even have enough physician time to be able to prescribe buprenorphine. among people who are getting it right now, even people with good insurance often have to pay out of their own pocket for the doctor's visit, their medicaid or commercial insurance is only on paying for the prescription. if we really want to see deaths start to come down, it has to be easier to get treatment than it is to get a bag of dope. if someone who is opoid addicted, when they wake up in the morning, they will need to use. many people will have something by the bedside because they will be feeling very sick when they start to wake up. if they have $20 in their pocket
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and they know where they can go get heroin, even if it has fentanyl in it, that's what they will do. and if finding a why is more expensive and more difficult, we're not going to start to see overdose deaths start to come down. so we have as to buiv sthave tom that didn't exist and i don't see any other way other than investing billions for that system. >> thank you very much. i yield back my time. >> chair recognizes the gentleman from kentucky mr. guthrie. >> thank you very much for being here. this is very informative. thank you for your inciteful testimony. knowing that you have firsthand experience treating patients with opoid addiction as well as utilizing tele medicine builds your credibility both as atione. when using medication assisted treatment, how common is it for you to pair this medicine with cognitive behavioral therapy and is it important that any changes
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to the ryan haight that increases access to medicated assisted treatment not be so tailored that the result unintentionally cuts off behavioral therapy? >> thank you for those questions. the first answer, how often do i combine treatment with therapy, and you mentioned cognitive behavioral therapy, which is a very specific type of therapy, but about we use multimodal therapies that we pick because of the patient assessment. what is it that they need. and within my practices, within the v.a., within my company, it is 100%. 100% of patients receive psycho their you pew tick entyou thera intervention. i forgot the second question.yo intervention. i forgot the second question. >> is it important that any changes to ryan haight that increase access to medicated assisted treatment not be so tailored that the result unintentionally cuts off behavioral therapy? >> i think the room for psycho therapeutic intervention should always be available. and when we talk about the
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qualified practice setting within the data 2016 amendment, it does cover those things that the people have the capacity to provide the therapy if it is indicated. >> thank. and doctor, thank you for the michigan home care and hospice association support. in your testimony, you note that roughly 98% of hospice care days are provided in a patient's residence. you go on to explain that at a moderate size hospice care with 2,000 patients per year, approximately 1 million pills would be prescribed per year. so if 98% of these prescriptions roughly 1 million pills are going into homes, isn't this statistic alone enough to validate the need for safe disposal? is it your belief that save disposal would reduce the likelihood of misuse or diversion and are you able to give some examples of safe disposal hospice workers have
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used in the past or currently use in states that allow this type of -- >> yes. and i'll give you some examples. >> perfect. >> so going back a few years, i've had the privilege of working in the hospice industry for over 30 years. and we've seen -- it was very common in past years, a nurse would come out, she would declare the death, she would sit and work with the be reabereave family and with a witness she would either crush and flush the pills or in case of liquid just put them down the sink and turn the faucet on. in later years when they said maybe we shouldn't be doing the flush thing, most of the nurses would carry kitty litter in their trunk and they would bring in some of that, they would crush the pills, mix in the kitty litter and dispose of it back at the office. i suppose it ended up in a
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landfill somewhere, but i don't really know. but that is how they did it in the past. as soon as i -- >> will the gentleman yield for on one minute? we also have the epa under our injuri jurisdiction. be careful, they might be watching. you didn't hear that from me. >> again, that is in the past. that is in the past. and i think some of the more recent strategies are simply because of that, they didn't want opoids ending up in our water supply and landfills. so more recently when the laws were amended and changed and introduced that restricted the personnel and who could really take back medications, that really put the hands off and i want to say that goes back about 2013, 2014. i don't remember the exact dates. but that is how they did it in the past. i don't know how they are doing it in states that currently allow that. but now -- and there has also
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been another trend that we saw developing where patients' families would say you can't touch that, that is mine now. he died, bruh i iut i inherit everything that was his and those are my pills. >> that is certainly an area when you styou start looking at volume that we have to address. i yield back my time. >> the chair recognizes the gentle lady from california, five minutes for questions. >> thank you. as i mentioned in my questioning to dea, the purpose of the discussion draft i'm working on are representative harper is to expand access to treatment where it is not currently available. we're seeking to do this within the current ryan height tele medicine prescribing framework. mr. nance, you are familiar with the community behavior health planning system in utah. and see a need for additional access to remote prescribing for the patients you serve. can you expand upon the need
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that you see for more access to medication assisted treatment and the challenges that clinics and their patients face? >> sure. here is a visual representation of one of the challenges. this is pretty good shot of the road from moab down to branding, utah. from my office to branding is about a 300 mile drive. there are good 4,000 people who live in blanding. if someone down there has an opoid addiction problem and frontier areas have a higher rate than the rest of the country in general, their access to treatment is very, very limited. so i kind of hang out with some farmers from time to time and one of the funny things i've heard one of them say was the darn beavers can irrigate better than i can, but the water has to get to the end of the row. so we need to have access to tele health treatment so that if
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a client shows up ain blanding and needs opoid addiction treatment, that that can be provided for them through a physician that may be located in proho or salt lake or where a majority of the population of the state live. if we can't do that, we will have a higher delt rate than we already do. we had 600 last year in the state of utah. 187 of those were heroin and all the rest were prescription opiat opiates. so we need qualified professionals to provide services in those small outlying towns across the country, no the just in utah. >> so you're dealing with putting doctors on the road to do in-person exams, is that right? >> yes, i'm sorry, if my addiction ol guest was to drive to branding, it would take her two days away from the office to possibly see one patient. if that patient showed up.
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people with opiate disorders are typically sick and disorganized, they have a difficult time keeping appointments. that would take the ability away for her to see somewhere between 48 and 60 patients in my own office and would cost us close to $2,000 in her time and travel time and overnight stay to be able to see that one patient. >> so you mentioned that it is important for the committee to allow tele medicine be used for mental health treatments as well not just substance use disorder. why is that? >> same thing. in usually utah, there aren't that many psychiatrists that go around. right now we've been doing tele health through project echo at the university of utah as kind of a platform. same thing happens in new mexico. and it is pretty easy for a child psychologist and there are even fewer than those to be able
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to use tele health technology to evaluate a patient at that remote site. but if they are going to write a prescription for a controlled substance by benzodiazepine for anxiety disorder or adhd, that face-to-face issue still exists under the ryan mait ahaight act. >> you expressed strong support for preventing fraudulent remote prescribing. there may be concerns that opening new pathway to registration for nondea registered clinics may lead to fraudulent prescribing. we we need to ensure that there are sufficient requirements on both the clinic where the patient prevents and the doctor doing the prescribing remotely. for clinics you represent, how are they authorized and what is the regulatory undersight they undergo? >> we are licensed by the utah state department of human services. we have licensing inspection
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every year. we also get an inspection from the utah medicaid program. we also get a contract compliance audit from the department of human services. and a peer review visit. we get at least three or four overvisits every year. on our centers are licensed, our staff are licensed. and what i'm proposing we do is kind of an agency to agency practice model that is very similar to the vermont hub and spoke model. if you are not familiar, you should look that up. it is on addiction i believe website. vermont is kind of small. i think the furthest distance between one side and another might be 100 to 150 miles. it is a lot further than states in the west. >> well, i have a lot more questions, but i also know we'll be working on a discussion draft on i'll be hopefully conferring with you and others. so thank you very much. >> and national council staff will be happy to be a resource for you as well.
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>> the chair would observe the project echo was a product of the energy and commerce committee. the chair now recognizes the gentleman from indiana. >> thank you. dr. kan, section 303 was something that meant to expand available treatment and give patientsbasically on treatment options and also included requirements for individual treatment plans and other things. how is samhsa doing with implementing the new -- some of changes made? >> i probably couldn't comment on how samhsa is doing. i think dr. mccann katz could provide that testimony. >> i've already asked her. >> then i would defer to her on the answer. >> all right.
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i didn't likeler answer, but that is okay. mr. nance. >> this has been a great -- >> are you getting good guidance from samhsa? >> yeah, what samhsa has done is transmitted the guidance to the department of mental health. we had several meetings back in the spring of 2017, the funding was made available to us, we had to write applications to that which complied with the state guidance. so it has been really helpful. i had 10 hours a week of a physician prescriber prior to the cares act. and now i have her full final the physician i had on contract with before would not prescribe buprenorphine for me, now i have a full-time physician that will prescribe buprenorphine and we can make it available to the other parts of the state. >> hhs would increase the number of people. from 100 in any practice to the
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hhs -- >> yes, that has. both on an ongoing basis for people who are qualified but also emergent circumstances. >> good to hear. >> if i could add something to that. i think the caps have been increased, but if you look at the physicians or health care providers who have been waveriv ed, not many are prescribing up to capacity. we also have to overcome stigma of treatment. >> i agree. and in fact for long acting buprenorphine, has insurance companies and cms paying for this? >> this project just got approved and it will be on the market -- >> by fda? that is different. >> that's right. so it is not right now in the market. it will be in the market starting in march. >> so i'm asking did cms give a coverage decision on it? >> not yet.
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>> because what we're finding in a lot of areas in health care right now as we get fda approved products, and then we get delayed payment decisions from cms which is preventing access to patients. so that is a big problem if that is the case, we need to -- i'd appreciate knowing about that because we try to have impact on that. and i was interested in your testimony about talking about continuing education for physicians. do you think -- is there anything the federal government can do to encourage maybe what i would call ground level training, which is not after people are already out of medical school and practicing, but i've been talking with the association of american medical colleges for example about implementing more training programs for assessing pain and properly treating pain in medical schools and certainly
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residency programs. do you have any thoughts on knot problem are the older doctors. doctors who are in their 20s and 30s, they have come of age during our opoid addiction epidemic, many have lost friends to opoid overdoses. they are much less likely to fall for the nonsense that you can prescribe long term and a patient won't get addicted. the bigger problem are doctors my age and older who had it drilled into them for 15 years that we need to prescribe more and more. >> and i commented on that during the testimony from the dea. i'm in that boat. i went into practice in 1995, we all understood that. dr. kan, last question. the existing laws in-person medical evaluation as well as allowable exemptions, you explained that the in-person evaluation can be excepted if a patient being treated by and
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physically located in a dea registered hospital or clinic. does this cause geographic access problems? and you may somewhere answhave in part, particularly for patients in rural areas that nt c can't get to a dea registered hospital? >> asam does not have a position on this issue. we lose 20% of our patients because we can't get a physician to them between the time that they call and the 72 hours that we set up the goal to meet with them. and we send the physicians to the patients. we don't require them to travel to us. >> i yield back. >> chair recognizes the gentleman from texas, mr. green. >> thank you. and mr. comes glosgrove, your ty
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was basically not make it harder to import the pieces of equipment that make pills? >> i don't think it is necessarily that. i think my testimony really is focused on making sure that legitimate users of tableting and encapsulating machines are not suddenly stuck with the requirements of the controlled substances act. i think there can be ways for importation to be monitored and blocked in appropriate circumstances, but what we don't want is nows of facilities around the country to suddenly have controlled substances within their walls. >> for example i assume some company in the united states actually produces these machines also. >> i believe that is correct. i think some are also imported from germany and other countries. >> okay. thank you for sharing your experiences as a researcher. we're proud of our efforts to try to close up nih funding. you note in your testimony it will take over a year to obtain schedule one registration.
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i heard from others that the requirements such as storage requirements can be cost prohibitive and can be a disincentive to research the substances. you note the confusion in the application process, delay in obtaining approved registration and young researchers prevented from researching. to what extent does this confusion and hurdles in-habt hi inhibit researchers from taking up projects? >> thank you for that question. there is a huge hurdle in becoming a schedule one ren registrant for instance. the application process entails submitting security requirements
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detailing how much drug you'll be using in your protocol, detailing -- in my case i work with lavatory animals. i have to identify how many doses i'll be giving each animal and for what roots of administration i have to estimate the amount of drug i'll be administering to be approved with the protocol. and just that point is particularly difficult to estimate the amount of drug one needs. >> we have a piece -- i only have five minutes, so we heard from hhs however that hr 2851 attempts to streamline the research or registration process, but we heard from hhs that there may still be a barrier to research that may have negative impact on drug development. could you reiterate why you think this and what steps we can do to remove those hurdles
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including getting between virginia and the dea on which registration you get first? that seems pretty silly. we ought to be able to deal with that. >> right. first off, with sitsa, a drug can be put in schedule a only based upon structure. that is problematic because there are many drugs that have similar structures. some of which are drugs of abuse, some of which are antidotes to those drugs of abu abuse. so if a drug is scheduled, it is really a disincentive for a researcher to begin conducting research with that drug. and if the drug is in a schedule for no other reason than its structure, we'll never know whether takes drug of abuse or breakthrough medication. so that is one instance in which scheduling a drug just based on structure can be a disincentive for conducting research with these drugs.
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and for younger researchers to go through the hurdles of obtaining schedule one registration for instance, that is yet another hurdle. >> well, i can see there is -- we don't want to do anything that would eliminate the potential for research because that is the other thing that we want to do because otherwise -- be that as it may, we'll see what we can do. doctor, do you think -- do you believe requiring 12 hours of continuing education every three years is a practical requirement for health care practitioners to prescribe opoids? >> i do think that we should be mandating prescriber education. i think that we should allow doctors who don't intend to prescribe more than a three day supply of opoids to opt out. if we had an opt out, then you are not making people take training irrelevant to their practice. many doctors would opt out because three days is more than enough. you would reduce the number of doctors able to prescribe aggressively. and for on doctors who do major
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surgery or treat cancer, they would take the training. and i think that is the way to go. i'd like to point out that for buprenorphine, a medicine much safer than oxycodone, we have an eight hour training requirement. and then we limit the number of patients the doctor can treat. whereas for the drugs that are causing addiction, causing overdose deaths, we have no training requirement and we have no caps on the number of patients that they with can pree to. >> thank you. i yield back. >> chair recognizes the gentle lady from indiana, miss brooks. >> thank you. i'll follow up and i assume you heard from my last -- from the last panel from dea that i too am working on a bill but slightly different. while fewer hours, it comes in part from the president's commission on combatting drug addiction opoid crisis and it was a top recommendation that all prescribers should be required to have continuing medical education. i know you agree with that.
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ours cams for three hours, but it is not just about preventing the overdose, it is also about education on physicians and other practitioners learning how to detect of their own patient base that they already have, not just the prevention of the addiction, but also what they -- how they can learn more about just addiction at large. do you believe that state licensing agencies are equipped to produce and manage education programs of this type? because i know you are not in favor of other organizations plowing that tra producing that training. what about state licensing agencies possibly in conjunction with best practices from hhs? >> it took a while for policymakers on a state and federal level to recognize that this opoid epidemic was being fueled by a very aggressive prescribing, that the medical community really needed to change course. and many state legislatures have
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responded by passing laws mandating prescriber education on a state level. i don't believe those systems are working the way they typically work is that every why in the state who has a registration, whether or not they ever intend to prescribe an opoid, has to take a course on pain treatment. it is usually online. the content for these courses is awful. in many cases the courses are taught by the same doctors who were teaching the courses that really got us into this mess. i don't think that is the way to go. i think this should be done on a federal level, linked to dea registration, with an opt out for doctors who don't want to prescribe more than three days. let them opt out, but then they are not allowed to prescribe more than three days. that would overnight shrink the pool of doctors capable of a prescribing aggressively. we really do want to teach more than how to prescribe, but we need to teach about addiction. >> and i will probably be submitting for the record
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because i have a couple other questions for another panelist when other model programs or ideas you might have on the specific types of courses and so forth. but dr. kan, my concern, and you've testified about the fact that so few people receive treatment, but yet many people have medical professionals in their lives or they do see medical professionals. would you say it is uncommon for primary care physicians or the physician that has prescribed the opoids to detect and to diagnose an addiction? >> i would say that it is quite common. a comment earlier i agree with that the change in the oichd opoids is going to cost in the billions of dollars, but the changes we can have now, we need to educate prescribers of how to identify problematic use. for example we know that 234ir from 15% to 45% of patients take be prescribed opoids have a urine drug screen that is negative for the opoid, they may
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have something else in the drug screen, or there are other problems. i think in a treating the opoid epidemic, one of the main emphases we see is that primary care needs to be taught how do it. i think booub uprenorphine is l insulin. i think of opoid use disorder with chronic exposure changes the brain. and for some patients, they need buprenorphine just as some who suffer there diabetes need insulin. and i will argue to you insulin is far more randangerous than buprenorphine. >> and please share with me aside from continued medical education, what else can we do to better equip physicians primary care who are not trained addiction specialists as to what they should be doing? >> i think what we need to quap them with is the access to the specialists. the greatest difficulty that primary care priors see, they don't know who to send the person to because the addiction
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specialist they referred them to may be a cash practitioner or they may not have access to treatment. so we need to educate a workforce that once the primary care provider identifies the person, they could be sent to a specialist. this is a vermont hub and spoke model. because they have hubs, when they stasbilize, they go back t the primary care provider. it is i had my dax waiver, but i was required to get it because the model they use is they have intensive treatment and then back to the primary care provider when somebody stabilized. if they destabilize, go back to the hub. >> thank you all for your work. >> chair recognizes the gentleman from virginia, mr. griffith. >> thank you very much. mr. nance, let me say thank you for your testimony that you have given thus far on tele medicine. it is a very important field for us to get in and explore. my district is in the east, but
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takes very rural district and while we don't have the miles that you have, sometimes getting around a mountain particularly when the weather is not the best or when people are having problems to begin with as you pointed out can be a problem. so i agree with many of the things you say and appreciate everybody's testimony today. it's been very informative. dr. beasley, if i might just briefly, you talk about drugs and compounds may be structurally similar and we heard comments earlier about the long history of opoids and sometimes we treat one opoid with another opoid. and so i'm just curious, naloxone, are you certain that that doesn't have an addictive problem down the road? do you think that works for us no matter what? >> i'm absolutely certain that naloxone does not have addictive properties. >> because it is the antidote. >> as an antagonist to opoids that are abused.
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more or less it reverses their effects. >> that takes me to you, mr. lowe begalogan. one of your recommendations is to allow fapharmacists to prescribe innaloxone. what is your experience and how has increased access improved patient treatment? >> there is a long answer to that question. >> can i get a shorter one? you can send the written longer one if you'd like. >> naloxone is a life-saving drug. when it is used, it is in a life or death situation. if it is not used, there is no treatment there democratafter. in that instance the more we
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distribute, the easier it is to get whether provided by a health care professional, ems or family member, it doesn't matter. we have to get it in the hands of the people who need it. and as of now, if i'm not mistaken, naloxone is available through pharmacies in every state. >> okay. you referenced a virginia program, virginia's medicaid addiction and recovery services has a new benefit for medicaid patients which benefit includes coverage for sbert provided by pharmacies. and i wrote that down. i'm bad with all those names too. but could you explain how that program works and specifically how it worked in virginia and what good that does? >> i'm going to defer to ncpa for that answer. i can tell you about what is happening in missouri. >> all right. tell me what is happening in missouri.
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>> not much. >> okay. but it seems like what they are looking for is giving the pharmacists the authorities to say hey, we think this person might be a problem and instead of having law enforcement swoop in, have some education and try to get treatment for that individual first. is that your understanding of the program? >> the whole goal of the program is to keep addiction addiction and not make addiction criminal. we don't want a person who is ill being treated in the legal system. from both sides of my life, my pharmacy health care side and my law enforcement side, we want those people properly assigned and properly treated. >> so do we. doctor, i know earlier you were scratching your head a little bit. that's what us lawyers call conditional relevancy. i was setting up his question by asking you something. about you now i'll ask you
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questions directly to you. and you talked about how adding a new drugyou now i'll ask you questions directly to you. and you talked about how adding a new drug to the additional schedule one registration may take months. for folks back home, you have to get permission do -- you you do schedule one reregistrations, y do research 00 on the drugs on schedule one. >> that's correct. >> so could you tell us so we can all better understand how taking months to get schedule one registration for researcher can gum up the process? >> well, it interrupts the research process if you have to wait four months in order to get approved for using a drug. the initial process for even applying to have a schedule one drug added to your registration is lengthy for the researcher
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himself. it takes several hours to propo prepare a protocol and that also has research costs in terms of down time. in my case, i do research in four laboratories very close together -- buildings are very close together. and yet i have to have four schedule one registrations, four schedule two to five registrations and four commonwealth of virginia registrations do that research. that all adds cost a. >> cost, time and makes it harder to come up with good results? >> well, it ends up creating a bureaucratic morass that can almost make research untenable. >> i appreciate all of you and i yield back. >> chair recognizes the gentleman from georgia, mr. carter. five minutes for questions. >> thank you. before i start, i want to compliment you and staff, this is an outstanding panel.
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i mean seriously, we got boots on the ground. so often with all due respect, we only have people from academia, but this is truly boots on the ground and i can't tell you, i'm so impressed. i'm sorry i had to leave a little earlier. but let me get started. dr. kan, tele medicine, i have a bill we're considering. but the ryan haight act limits expanded access to buprenorphine. and i'm just wondering, if you could speak to that very quickly. about how we could do away with that so that we could be able to prescribe it if we needed to but because of this act as i understand it, we're not able to. >> if we can add it to the recommendation that we can rely on another prior that would be extremely helpful. with my company, we rely on emergency department physicians. we pair with emergency
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departments to get them started on buprenorphine and quickly matriculated into care. the short version is that the drug dealers are open 24/7. and we need to do the same. >> mr. nance, you mentioned this also about the limitations that ryan haight act is causing us. can you comment on that very quickly? >> can you ask me a more specific question. >> >> jujust about splauparticu limits the expanded access to treatment with some of the drugs that we need to treatment the addiction with like buprenorphine. >> yeah, the whole point of my testimony is that especially in rural and frontier areas, you have very, very few licensed providers who will actually be willing to provide buprenorphine. in utah, we have -- my friend at the dea says we have 503 licensed trained buprenorphine prescribers. only 125 of them are actually
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practicing and prescribing buprenorphine. but if you go on the buprenorphine treatment on hair website, there are only about 70 listed. so you have a huge potential labor pool out there, but they are reluctant do it. >> specifically with the telemedicine, if we were able to have the physician to prescribe it then and i understand it, they can't because of the ryan haight act. >> right. it is very, very difficult and you have to have the first face to face, and you have to get it there as a separate definition inside of the ryan haight act and we can open up those situations in extreme -- >> and so i want to the ask you, did you ever get mdp in missouri? >> i keep getting asking these questions with long answers. >> okay. i need to make it quick. yes/no? >> well, we have an executive order signed that examines prescriptions written and
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adjudicated through a third party insurance, and prescribes blame to over prescribers. >> okay. you really need it. for many years, and for a long time 49 of 50 states had it, and missouri was the only one who didn't vit, and it needs to go across the state lines as you pointed out earlier in the testimony, you are right on the state line and you will get them as i did in my pharmacy from many states, and this is why it is so very important, and i wanted to mention a few things, that mr. kos grove, you mentioned some farm suitle cal factories are moving oversea, and is that because of the tax laws, because we have changed it and i hope that we have changed that. >> i am not an expert in tax law, but i know that a number is going ooverseas is dramatically lower. >> if it is because of the
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taxing problem, then we have resolved that problem with the jobs and tax act. and so, i want to make shure tht we all understand that. and now, with the new drug act, you are having to use the specialty pharmacies and only the practitioners would be given access, and was that mandated in any way? because access a big issue for access. obvio obviously, that would limit access there. >> this is in discussion with the fda and it is part of the risk evaluation and mitigation strategy program. because a lot of the doctors, some of them do not want to do the buy-in bill, and so there had to be another way in the restricted distribution system, so if a doctor in utah wanted to prescribe sublocade, they can contact one of the pharmacies that we are working with, and get a named patient prescription sent to that dock for for use in
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only that patient. >> and one last thing. dr. molder, thank you. i was a hospice consultant pharmacist for many years, and quite often in congress, with we have the tendency to overreact and you pointed out something important that there are truly people who need the drugs, and we have to be sure they get these drugs, and have access to them. and thank you for pointing that out. >> yes. >> thank you. >> i yield back. >> thank you. and does the gentleman from michigan wish to be recognized for questions? >> yes, mr. chairman. >> you may be recognized for five minutes sglchls thank y. >> thank you for letting me sit in on this panel. and my compliments to you, dr. molder, because it is a a tough, tough field that you are in and a compassion field and we want to make sure that we do things right. i am delighted in how you are
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thinking of how the carry are on the impact of the end of life issues with the human beings in need and make sure that what we use, and use appropriately does not end up causing problems for others down the road. in our home state of michigan, mr. molder, we have seen real challenges with the diversion and misuse of the leftover medications that have contributed to the opioid crisis. hospice and hospice personnel could play a key can role in ensuring that the drugs are properly disposed of, but the current dea regulations pose a challen challenge. can you the tell us what they face when the individual is passed away and there is unused medication, and how does the current law specifically prevent hospice personnel from destroying the medication to make sure it is not diverted to
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another person. >> and so this is going to have to do with the takeback decision s if they are going to be receiving these medications for the purpose of distributing them somewhere else or destroying them. it is kind of the reverse distributor process. they have to be license ed d by dea as a reverse distributor to take the medications in. i think that i am using the right terminology and the pharmacists can correct me if i am not, and when that comes to ineffect, they cannot by law take the medication, and they are not allowed to do anything with them, and that is the primary limitation. >> is that the same problem in a actual physical hospice facility? >> no, it really isn't, and part of that has to do with how the facilities are licensed. that is may vary from state-to-state, but it does not exist forle example, because we have our hospice operating in
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the same facility, and we don't have that restriction. >> in your opinion, what type of licensing should a hospice worker have to destroy unused medication is something that needs to be further clarified in my big hr-4041. >> yes, the registered nurses, and the criteria nurses who have already licensure and could very logically be certified to be able to manage that the process. >> so they have the background and the training and the certification, if they are retired and volunteer services, would that carry over? >> i would not extend it to the volunteer, and although they function in many capacities as the surrogate position of the hospital, the financial situation is different and the regulatory system is different
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and so i would be reluctant to subscribe that to my personal volunteer. >> thank you. i appreciate the entire panel from sitting in, and i yield back. >> the chair thanks the gentleman. the chair observes that i delayed my question iing to all others to catch trains, planes or automobiles or whatever they need to do. dr. molder, i really was encouraged to the hear you use the term we are going to miss some episodes of preventable suffering, and it worries me, too. >> thank you. >> one of my first committee hearings is why are doctors not prescribing enough pain medicine to the point that others have made on the panel, and the pendulum has swung both ways, and so i worry that we live in the land of the unintended consequences here in the united states house of representatives.
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and so it worries me that perhaps some of the things that we are contemplating today are going to be put into the realm of preventable suffering, and so thank you for what you do and bringing it to our attention as well. >> thank you for the comment, and we will be looking forward to the diligence of the committee to make sure it does not happen. >> forever hopeful. >> mr. logan, first off, i want you to know that in the appropriations bill for labor, health and human services, the house of representative asked in september, a tnd the senate has never taken any action, and it is not law, but the bill we passed in september actually did r carve up some dollars for people who don't have a pdmp available and so it would be available. i am a big believer in the pdmps and i think that they are useful. i worry about burdening people
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with too many inputs in the electronic health record, but at the same time or too many queries of the database, but this is one that can be useful. let me ask you, and i mean, you have described the situation where you, your pharmacy is, and you are on the big highway which is the crossroads of the nation, and people come from all over the country with prescriptions that they have received somewhere else, and then they prese present them to you, and did i understand that correctly? >> yes, you did. >> and i got the impression that i may have been overcalling it, but i got the impression that you felt that sometimes, i don't want to infer anything, but do you feel that sometimes the prescription is perhaps overly generous with the amount of medication that is dispensed? >> any time i see multiple prescriptions for multiple people in one vehicle in quantities of excess of 180
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oxycodone, i think that is excessive, yes. >> and so with your keen powers of observation, you are able to deduce that may be an overprescribing situation. >> thank god it don't take no rocket scientist. >> and that is kind of the po t point. our representative from to a agency, from dea and he is not here any longer, but i was under the impression that every time i wrote a triplicate prescription for a controlled substance that it goes in whether i had the pdmp or not, it goes into the database and somebody is monitoring that at the state or the federal level, and so it is not a surprise that to somewhat not a surprise that they are going out the doors or the pills are going out of the door. so, two weeks ago, the secretary when he was here, the cms has a lot of data at the disposal and
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it knows that who under the care in medicare or medicaid is receiving an unfor the rid number of pills, and it also knows the pharmacies to which it is reimbursing payment where an untorrid number of pills, and is that reasonable to assume. >> inordinate number of prescriptions are cash, and there is no claim generated for them. and so what you are tealing with at a payer level is paid claims, pdes we call them. if there is no cash claim or no pdmp, it never happened. >> which is back to the point of the pdmp that is important to put the money forward and we have had this committee authorized the bill called well over ten years ago to provide that kind of help, and it got
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tied up in the a appropriations process and although it is authorized on many occasion, it is never fund and i tried to correct it last september so it would be funded, but the point is that it is not a surprise that there are people who are overprescribing, and you can know. you can know who they are. maybe the claims data is, maybe it is something that you brought up the point which i had not seen which is a cash transaction, but the pharmacy has a record of the number of pills and aren't you required to account for every controlled substance dose that comes through the shelves? >> yes, the pharmacist'ses duty of care is to determine the legality of the tre skripgpresc and the numbers on it are filled out, and is there a valid patient relationship, and have
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been diagnostic relationships to be done d, the and lot of times the pharmacyist has ishas to g gut feeling, taand the independt pharmacist is in a unique position. we determine our own destiny. we can say, yes, we will fill it, or no, we won't. we where the buck stops, but there are people who work for companies who may not have the discretion to determine the legality and the legitimacy and go strictly on the legality of the prescription. >> and the point i was getting at a, it is at some level that data is available, because whether it is be an independent pharmacist or the chain pharmacy and all of those dosages of those controlled substances have to be accounted for somewhere.
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>> and even in the controlled substances inventory mandated by dea or purchases through the wholesale wholesalers. >> so it is knowable if a location is receiving an unusual or untorrid amount of product, is that the -- >> absolutely. and >> doctor, you obviously you and i do see it a little bit dit differently on some of the approaches, but i will say this, i look at the doctors as the allies in this and not the adversaries, and if we treat the doctors as allies, they will be our ally, and if we treat them as adversaries, they are are going to be our adversaries, and they unnecessarily complicate the lives of our physicians to the point where some of them give up and we will have preventable pain that is not prevented or that is not treated. i just worry that putting the
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onus on the practicing physician to do some mandatory training is dish don't know that if it is going to solve the problem, if the problem is as big as dr. logan deskrcribes at the crossroads pharmacy, and yet that data is known, and somebody know has the pills are going out of the door, right? >> well, yes. i think that we do agree that doctors are not to blame, and the doctors are responding to brilliant marketing and that is why we are seeing the litigation from the counties and the states across the country, and the attorney general sessions suggested yesterday that the federal government is going to be helping out. there is an understanding that the medical community has been deceived about the ever ka si of the drugs. the pill mill doctors, and we have to try to stop them, because they are killing a lot of people, but they are not the root of the problem. the bigger problems are the well meaning doctors and dentists who are inadvertently creating
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customers for the doctors. we have to stop the doctors, because they kill people, and this epidemic is not going to the end unless we prevent more people becoming opioid addicted. >> this is where we disagree. and i have practiced in the '80s and the '90s and i can rarely remember writing a prescription for more than 12 doses of a controlled substance and i have had a surgical practice, and somebody who is operated on is going to have pain relief and i recognize that. it did seem like in the old days that we could allow for a refill on the prescription, and that may be a state function in texas, but it seems like it went away at some point. i don't know if that led to the conclusion that people will write larger number of pills so they can get more on the weekend, a ind don't knnd i don and i don't have any data to
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back that up, but the world changed somewhere where between the late 1990s and the end of the first decade of the 2020th century century. >> yes, and we know what year the -- of the 20th century, and we know what year it took off and it is 196 and it is not just oxycontin, but it is others where the prescribing begins to explode. in 2014, the fall of 2014 we put vicodin into a more restrictive category to not be phoned in more easily and where you could not write the refills, and maybe influence on the quantity of the prescription, but the overall impact of that change was a dramatic reduction of the number of hydrocodone pills prescribed. the bigger part of the problem was starting in 1996, and multi faceted campaign that was very effective that told doctors that we need to prescribe more, and
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many doctors are badly misinform and in the ideal world we would not have to have the doctors taking a training course, but we could rely on the doctors buck in the case, the doctors cannot weigh the risk versus the patient in front of them. >> i disagree, because that is what we are trained to do, and so we will fundamentally disagree with that and i have gone way over time and since i am chairman, i can do that. and i don't know any of the doctors who are writing the prescriptions that mr. logan is presented with at 2:00 or 3:00 in the morning, and maybe you can force them to take a continuing education course, but it is not going to alter their behavior in the least. i alsoing ing agree with you th of the courses that are available, and i took more my cme last august, i did and online course on the opioid use and the proper prescribing and
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one thing that i have learned over the years is learn how the take a test, but i disagreed with the philosophic premise of the large school coming can out of the east, but i was able to answer the questions that they wanted and i got the goal i wanted which is my continuing education hours. you have been generous with the time today and i do appreciate you, mr. green. and do you have a follow-up? >> i am not going to be asking for the full 6:00 that you took -- >> you see, i was aggravating the time that you took on your side of the dias. >> i am curious if you have any response to the chair or any of the efforts that we have done, because we need to find a balance and we know that we have an epidemic, and there overkill which is some of the testimony, but we also know that we need to deal with the issue.
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anybody else have anything to what the chair responded to? >> yes, doctor. >> i think that the the main thing that you heard from all of us is that it requires a multi pronged approach, and it is going to require the treatment, and telemedicine and going to require medication and all of those are going to be important and today, it is encouraging to allowing all of us to give the perspectives. >> that is what the hearing is all about. >> and one more thing, i had a constituent in the district who worked for many years for construction and he needed an opioid, and one of the chain drugstores, wall green's that i work for all of the time as they help to do the immunizations in my area, and they have the independent pharmacist has the right to decide that. so i asked the regional director, and could this fellow go to another wall greene's, ge
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said that we found his medication at not the most reputable pharmacy that we should have, and there is an issue of the people that need to survive, and the lifestyle and the work as we get older and we fell down and we are 30 years old and when you are 65, you say, hey sh, that hurts. but anyway. thank you, mr. chairman. >> the chair will not refer to you as an enabler. and i would like to thank the witnesses to be here and the time that you have invested. as you can see, it is important topic and we will have multiple hearings on this. woi uld lao toik submit statements from congressman david kusoff, national chain of drugstores, university of texas, johns hopkins university, cvs health, rayburn and pursuant to the committee members, they have ten days to submit questions for the record and i ask the witnesses to submit those responses within 10 business days of the receipt of said
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questions. and without objection, this hearing is adjourned. on capitol hill, the house is back for legislative work
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starting at 2:00 p.m. and house lawmakers will consider gun violence bills, and also a measurement to fund the government past the march 31st deadline. the senate is meeting today at 4:00 p.m., and they are going to look at banking regulations the be eased by the end of the week. at some point, the senate plans to consider the nomination of kevin mcalin for the borders and customs organization. you can also see more information on this on c-span 2. vladimir putin had unveiled what he called a new generation of missiles, and this speech came a few weeks before the russian presidential elections where mr. putin is expected to win the presidency. he has talked about the advanced weapons, and the military preparedness of the country.


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