Print 🖨

The committee met to discuss interim charges.  This report only focuses on discussion regarding the following interim charge:
 
Charge #1. Assess the prevalence of nonmedical prescription drug use in the state (including opioid analgesics, stimulants, tranquilizers, and sedatives). Identify adverse health impacts. Recommend strategies to curb emerging substance abuse trends among children, pregnant women, and adults, as well as to reduce health care costs and mortality.
 
Dr. Maxwell

  • There is a movement from OxyContin and prescription drugs to heroin due to the cost and difficulty to snort or shoot it
  • Methadone is very effective and cheap, and if monitored correctly, it reduces withdrawal symptoms and does not provide a high
    • There was a peak in deaths due to 40mg diskettes, but they have cut off that supply to traditional pharmacies
  • Youth data on use of opioid drugs is going down slightly
  • Baby boomers have a higher use of drugs in their lifetime, and there is a fear that as they grow older they might have a tendency to abuse pain medicine
  • Hydrocodone has been recommended to be a schedule 3 drug to the FDA
  • Changing characteristics of the users – more younger people
  • 54% of all admissions for heroin treatment at DSHS are under age 30
  • Average age of people that die from and overdose in Texas is 36
  • How do you treat a pregnant mom with back pain, etc. without harming the fetus?
    • Area that needs a lot more research
  • Pharmacological treatments exists that help resist cravings and make the drugs not provide the normal euphoria
  • Naishtat – How accessible are these recommended pharmacological treatments?
    • DSHS funds some methadone programs
    • If we could get it on the formularies it would be much more accessible
  • Collier – over 500,000 pregnant woman in an insurance plan are on pain pills – is the rate higher for the uninsured?
    • Do not have the Texas data numbers, but is sure that it is higher
    • Surely the doctors get the education in school to not give opioids to pregnant women?
      • One of the subjects least talked about
  • Benzodiazepines – Xanax is the most popular in Texas
    • Usually used together with opioid
    • Hopes other witnesses will talk about the “Houston Cocktail” that is a significant problem
  • Laubenberg – A doctor is prescribing all three medications in the Houston Cocktail?
    • Yes. Usually in rogue clinics
  • Kolkhorst – we have made some steps in the right direction but we have further to go
  • Seeing a return of methamphetamine coming from Mexico that is 94% pure
  • Possible viewpoints to consider:
    • Prescription monitoring program needs to be strengthened
      • Seems like Sudafed is monitored more than other more dangerous drugs
    • Written treatment agreements
    • Pill counts – making sure that the right amount are there and the patient isn’t taking too much
  • Historically there wasn’t much concern or thought about prescription addiction
  • What is the normal medication treatment for a baby born with opioids in their systems?
  • Collier – did you speak with anyone in the medical field when crafting these recommendations?
    • Took them from the National Association of Pain Physicians publication
  • Kolkhorst –  every state is trying to tackle drug use in different ways, but there are a lot of national efforts and recommendations coming forward

 
Mike Maples, Commissioner Mental Health and Substance Abuse DSHS

  • Increase of the number of pregnant women with opioids in their system at the time of delivery is a priority for the department
  • Laubenberg – when did it become the trend to prescribe pregnant women opioids? What percentage of pregnant women are addicted?
    • How many babies are born in Texas annually? How many addicted births? Would like that data to determine how big this problem is
    • DSHS is looking at the overall medical expense and early interventions for neonatal abstinence
  • Highest population of persons admitted to the DSHS system are abusing opioids
  • Medicaid pays for opioid replacement therapies, as well as some DSHS programs
  • Seeing  an increase in heroin use due to the expense and more difficulty with obtaining opioids
  • Nationally the increase of women using opioids has increased 475% since 2000
    • Kolkhorst – Are these Medicaid, or blended population patients?
      • Blended number – will try to find a breakdown
  • Neonatal abstinence syndrome has tripled over the past 10 years
  • Dramatic increase in deaths due to overdoses, more in childbearing age women
  • Discussed a San Antonio model called the Mommies Program that has been successful
    • Has decreased NICU days
    • These collaborative efforts may be used as a model going forward
    • Cortez – what kind of funding will be needed to expand statewide?
      • There are dollars out there already that could be used for opioid substitution therapy, but they will be pricing it out both from the DSHS side and the hospital side
  • Collier – how many of these children go home with their mom or go into the foster system?
    • The goal is to keep the family intact, but will need to check with DFPS to see what the numbers are
  • Laubenberg asked for the date Texas received the SAMHSA grant to begin the Mommies Program
  • Kolkhorst – are we targeting non-medical use of prescription drugs and illegal drugs in the Youth Prevention Program?
    • Yes – focused on evidence based curriculum for prevention
  • Kolkhorst – there is a lot of money under the 1115 waiver being used locally to address these issues, mental health, primary care – planning a April 23rd joint hearing with County Affairs
  • Naishtat – are we ahead of the curve on neonatal abstinence syndrome compared to other states?
    • Believes we are in the same area
  • Kolkhorst – believes we can be more aggressive in addressing this problem

 
Ron Bordelon, Commissioner of Workers’ Comp

  • Texas has implemented many reforms to be one of the least expensive states for workers’ compensation
  • Workers’ Comp is not mandatory in Texas, one of 2 states
  • Many reforms that the legislature have put in place have improved the program
    • Evidence based treatment guidelines in 2007
    • Closed formulary in 2011
      • Significant impact in cost of narcotics in WC
  • Closed formulary – September 2011
    • Bifurcated implementation
    • Needed a dual approach to not adversely impact patients on these drugs
    • 2 year rollout for the older claims to find alternative treatments
    • The formulary includes all drugs that are FDA approved, not allowed on the formulary if it is on the N list
    • Drugs on the N list can be prescribed with prior authorization from the doctor
    • 100,000 claims on an annual basis
      • 66% percent drop of N list drugs (many of which are narcotics) being prescribed after the implementation of the closed formulary
    • Laubenberg – since the formulary changed, the drugs that are potentially addictive were not prescribed as much causing the huge decline in use of narcotics
      • WC mandated doctors with patients on these narcotics to work with them to find alternative treatments over the course of the 2 year rollout
    • WC implemented steps to limit any adverse problems after the rollout
    • Laubenberg asked for data on specific addictions before and after the closed formulary
    • There has been a change in prescribing behavior, and haven’t really seen any adverse problems since the rollout
    • Zedler – in the past injured workers were trying to get access to healthcare and had to jump through hoops – what is the denial rate now?
      • It has dropped in the last few years
      • Is it still hard to find a doctor to treat in the workers’ comp program?
        • There is more doctor participation today
    • Collier – asked about the process of appealing denials
      • Discussion of the due process available to those that have been on a medication and are denied coverage
      • The amount of prescriptions is about the same, just less of the N list drugs are being prescribed to avoid seeking prior authorization
    • Kolkhorst – it seems you have changed prescriptive behaviors that could be a best practices model

 
Steve McCraw, Director, DPS

  • The diversion of drugs is one of the fastest growing ways of addiction
    • Fraud, doctor shopping
  • Once you get hooked on opiates, the cheaper option is heroin
  • Need information quicker and faster in the hands of doctors and pharmacists
  • Prescription Access of Texas (PAT) is the tool to track these prescriptions
    • Very pleased with it, but can still improve upon it
    • Will receive 100,000 for improvements
    • Help to identify pill mills
  • Naishtat –  Some docs don’t use PAT because it is optional, how does that effect your job
    • The more participation either before or after the prescription is filled is desirable
    • Prevention is optional
  • Laubenberg – you are seeing black tar heroin in middle schools?
    • What is the gateway for these children?
    • Collier – what can we do to stop this from getting to our children?
  • Zedler – what are the capabilities of the PMP?
    • All the features are online for an officer to use around the state
    • TMB can access it
    • Mari Robinson, TMB
      • A law was passed last session to allow RNs, PAs, and LVNs, APNs and pharmacy techs to access the PMP
      • A formalized request must be made to DPS to get specific information on a doctor who has a standing complaint against him
      • There is a streamlined way to access information, but it must be done in a legal way
      • There are discussions in intra-agency workgroups whether Texas should hook our PMP database to other states to broaden our scope
  • Coleman – is it your experience for kids to trade pills for other drugs?
    • Does not have any direct knowledge
    • Coleman believes that prescriptions have now become a commodity to trade for other illegal drugs
  • Collier – is Ritalin monitored?
    • It is a schedule II drug that is in the system, along with Adderall
  • Laubenberg – TMB has inspection authority on pain management clinics and office based anesthesia
    • TMB receives complaints – generally from patients and friends and family
  • Sheffield – what are the top three things you would tell doctors that are committed to getting rid of the bad actors in the state?
    • Query the patient in the database and see if they are trying to abuse the system
    • If they did show up as abusing the system, reporting to law enforcement
    • As the number of doctors increase that are using the system, the more effective the system will be
    • Local pharmacies in his district are good at calling him and alerting him to his patients filling a prescription in a different town – what is the role of pharmacists?
      • The ability to look in the system and alert the doctors

Mari Robinson, TMB

  • CDC reports that overdose is the #1 cause of death in 2011 driven by prescription drug overdose
  • Drug overdose mortality increased in Texas 78% from 1999 to 2010
  • Pain management clinics must register and the TMB has oversight over the registered and licensees
    • Described some of the bad actors
  • The bad actor docs are not going to turn in their prescriptions into the PAT
  • 95 actions in the last year – sanctions against the bad actors
  • Discussed licensure procedures, operational procedures, certification processes of pain management clinics
  • Discussion of the strict laws in Louisiana that moved pill mills into Houston
  • Kolkhorst – Some pain management clinics are not renewing because they are exempt, some because their registration and certification has been revoked by TMB
  • Board rule related to prescribing for pain has been in law for years
  • There has been some backlash due to the new laws where docs are scared to prescribe any pain pills, pharmacies will only dispense a certain amount even if patients have valid prescriptions – this is a very complex issue.
  • Coleman – what are the illnesses that pain clinics legitimately prescribe medication for?
    • Back problems, but people trying to dupe the system know that and can present saying they have the same symptoms
  • Discussion of pill mills
  • Awarded a 30,000 grant from the Federation to provide pain management CME across the state
  • Collier – are you also seeing that there is not a lot of training in medical school on opioids
    • To make sustentative change in that area you would have to go through Higher Education Coordinating board and LCME
    • Any thoughts on limiting the amount of pills dispensed at a time?
      • Very difficult thing to do
      • Discusses the unintended consequences of creating new mandates – any violation would be subject to Board order
  • Zedler – how many field investigators do you have?
    • 27
    • Zedler – it is a question of priorities
  • Zedler – what leads doctors to quit filling pain medication?
    • The regulations and registrations dissuade them practicing in this area
  • Kolkhorst – is the intra-agency council still working in this area?
    • There is another version, and they have met once
    • Kolkhorst – We should reassemble with other stakeholders and cut to the chase

Gay Dodsen, Pharmacy Board

  • Pharmacies are just as responsible
  • There are some that are in it for the money, and only take cash
  • Younger people believe that prescription drugs are safe and that is just not true
  • Hydrocodone is the #1 medication prescribed in the US
  • The illegitimate clinics will prescribe the name brand because they have a higher street value
  • Kolkhorst – how do the insurance companies work into this?
    • They are not filing insurance claims for these transactions
  • DPS can tell the Board which clinics have not reported to them, which could be a sign of a bad actor
  • Kolkhorst – How many investigations do you do a year?
    • Some years 80 complaints, last year 40
    • Also inspect pharmacies for inconsistencies in filling opioids
  • Kolkhorst – what role do wholesalers play in this?
    • They have limited how much they will sell to certain pharmacies in the past two or three years if they suspect pill mill activity
  • The pill mills are getting a little bit better at what they are doing – the volumes have shifted and the doctors have started to prescribe some other drugs so the red flag doesn’t initially jump out at you
  • DAs have prosecutorial discretion, but they are not easy cases to make so they are hesitant
    • Need more education both with the DAs and SOAH
  • Kolkhorst – there isn’t much of a downside to operating a pill mill if you fly under the radar and you can’t really prosecute them

 
Cathy DeWitt, TAB

  • Recommends that DPS be enabled to track cash sales
    • Require the pharmacies to send that information into DPS
  • Kolkhorst – Are dentist prescriptions paid with cash too?
    • We need to look at that
  • 99% of the world supply of hydrocodone is used in the US
  • Prescription drug abuse costs employers about $26M
  • Employees that abuse drugs are more accident prone and can hurt other people
  • Prevention is key
  • Recommends not mandating using the PMP, but when providers get their license for the first time, why can’t they register with DPS at the same time?
  • Unsolicited reporting by DPS can save provider’s time
    • Is not currently automated
  • Education of physicians is important – there needs to be more education on pain management in medical schools
  • Need to modernize the PMP – should be a normal part of HIT
  • #1 prescribers of opioids are family doctors – also dentists and ER docs
  • Other states have done really great education campaigns, even teaming up with homebuilders to ensure they put a locked medicine cabinet in every new house built
  • The closed formulary in WC in Texas has been a model for the rest of the US
  • Medicaid cannot look at the PMP to see what drugs patients are getting outside of the system
  • Would like to see DPS fees that were swept in 2003 from paying for the PMP returned from GR
  • Good Samaritan law should be put in place, like 17 other states

 
Graves Owen, Texas Pain Society and TMA

  • A multi-tiered plan will be necessary to deal with this problem
  • Suggestions:
    • Put a good Samaritan law in place
    • Enhance funds for the PMP
    • PMP should use automatic data mining to identify bad actors
      • Would need a rule change at DPS, but the software is already in place
      • Using the PMP is already a standard of care so it does not need to be mandated
      • The PMP only became user friendly in 2012
    • Need to educate law enforcement officers to make sure consequences are carried through for doctor shopping
    • 94% of patients referred to pain management docs are not on the correct therapeutic medication
    • Need medical school education on pain management, especially chronic pain treatment
    • Safe harbors are needed for doctors
    • Need more data collection from wholesalers to the TSBP
    • Need to educate physicians about alternative treatments to opioids
      • Need to ensure they are accessible in the health care system, i.e. physical therapists, behavioral health therapists
    • Need to ensure physicians know appropriate and inappropriate use of pain medications
  • Texas is leading the nation in addressing the prescription drug abuse problem
  • Davis – do many of your patients already come to you addicted to pain medication?
    • The patients have to admit it to the doctor, and if they are addicted they won’t willingly admit that
    • Have to study behaviors and assess if there are co-morbity symptoms
  • Davis – Do you mean Safe Harbor protection from patients that attempt to blackmail providers into giving them the prescription?
    • Yes
  • Sheffield – this is the first person today to mention addiction and genetics
    • Some people are predisposed to addiction and can know they are addicted after taking the first pill
  • Zedler – how many hours of CME are a doctor required to take a year?
    • 48hrs over 2 years
    • 24hrs in category 1, 24hrs in ethics
    • Pain management could fall into category 1 CME
  • Zedler – how long would it take to teach the basic fundamentals of pain management?
    • Would speculate 15-20 hours

 
John Ulczycki, National Safety Council

  • Has jumped to the top of their focus because opioid abuse has jumped to the #1 killer in the US
  • Opioid abuse effects everyone, not just people from the other side of the tracks
  • Walmart is the #1 pharmacy in the US
  • Did a study called “Prescription Nation,” studying opioid abuse in each state
    • Texas is doing pretty good – ages 12 and over 4% abuse
    • Working population is 23% abuse
  • Ages 45-60 are more common to abuse and overdose
  • Where are they getting these drugs?
    • 27% from their own prescriptions
    • 26% taking from friends or family
      • Locking medicine cabinets is crucial
    • 23% of high risk users bought the drugs from friends or family
  • Need more take back programs to reduce access to unused drugs
  • Law enforcement have a locked box in a location periodically and people can dispose their unused drugs
    • They are very good programs, just need public education to use them
  • Cathy DeWitt – the next national take back day is April 23rd
    • Some larger pharmacies participate, it would be really interested to see how they tackle it because it is not uniform
  • Mandating doctors to use the PMP may have unintended consequences
    • Practical reasons that docs don’t use them, the intra-agency council should poll doctors to see why they don’t use it
    • Nationally 20% of doctors use the PMP
    • Need to find ways to encourage doctors to use the PMP more
  • Laubenberg – has no data been collected since 2009?
    • Not to his knowledge based on reporting mechanisms
  • There would be a cost to update the PMP to real time?
    • Cathy DeWitt – new rules have been passed to work toward that
  • Naishtat – How many states mandate docs participate in the PMP?
    •  16
  • Naishtat – Earlier I asked DPS if not mandating participation presents problems for law enforcement and they said it does
  • Naloxone needs to be discussed more in depth
    • We need a huge understanding of overdose prevention and education
    • Naloxone is like the EpiPen for overdoses
    • Can immediately save a life from overdose if it can get into the hands of people to use it
    • ER doctors can use it, EMTs can use it
      • People that would see the overdose though would be a family member or friend of fellow drug addict
      • A drug addict would be very hesitant to call for help
    • Giving doctors the ability to prescribe Naloxone to family members with patients in chronic pain would be able to save a life before an ambulance arrives
    • Working with doctor groups to rewrite guidelines under what circumstances they would prescribe these drugs
  • Need national education for employers and the public at large

 
Public Testimony
 
Sharon Brigner, PhRMA

  • Since 2000, PhRMA companies have invested more than $500B in research and development in new medicines, that when used appropriately, can and do save lives
    • When they are misused and abused, there are negative health consequences or death
  • Prescription drug abuse causes increased health care costs and costs in the justice system
  • Have been working with stakeholders to actively address prescription abuse
  • There must be a balance of access to medications for patients with legitimate health care needs while minimizing abuse
  • Recommend:
    • Promoting improvements of PDMPs
      • Help to reduce doctor shopping but support access
      • Need interoperability between states
      • Want it mandated by Medicaid and Medicare providers
      • Want increased training on how to use the database
      • Important to have real time data entry
        • OK is the only state that has this
        • Texas is 7 days
        • Kolkhorst – does the prescription show on the PMP if you don’t fill it?
          • No, only if filled
    • Increasing public education on appropriate use of medication
      • 70% of medications abused come from the home
      • Need safe storage and disposal
      • Take medications as prescribed, do not share with anyone, store appropriately and dispose properly
        • Most can be disposed of through the trash, but 17 cannot due to risk of abuse so you can flush them
        • Take backs are a nice option but hard to get to sometimes
    • Facilitating appropriate training and education of health care providers
      • Need to provide comprehensive medication management
      • Kolkhorst – Texas pharmacists are excellent at educating their patients
      • Encourage state medical associations to stay up on the guidelines
    • Enhancing incentives for the development of abuse deterrent formulations (tamper resistant)
      • 26 new meds in the pipeline to treat addiction
      • Some companies have formulated tamper resistant medications
      • Some assistance should be provided in these new formulations
        • Guidance and clarity from the FDA on how to demonstrate tamper resistant qualities
        • Payors do not provide favorable coverage payment for tamper resistant drugs
    • Combating diversion and fraud
      • Increased penalties
      • Compliance with registration and licensing laws
  • Collier – what else can be gained from interoperability between states?
    • Privacy is crucial
    • Access is usually limited to a health care provider
    • Have to have a relationship with that patient
    • When patients go into the emergency room, they are told that the health care provider looked up their prescription records if something seems questionable

Association of Substance Abuse Programs of Texas

  • Concerned that 24% of adults are using drugs not as prescribed, overdose as the #1 killer
    • Signs of addiction
  • Women giving birth on opioids are addicted
  • Teens a taking 24 Xanax a day
  • These people need medical attention because they cannot just stop
  • Very difficult to get treatment services in Texas
  • Need equal supply to the demand
  • Need more prevention services and treatment services
  • Once detoxed and medical emergency is passed, they aren’t going to stop without help
  • Dr. Lakey has said that the #1 driver in health care costs is substance abuse
  • Kolkhorst – are you getting any 1115 waiver funds to help?
    • Very regional, her organization will
    • The vast majority of funds are going to mental health care

Carly McConnell, Texas Standing Tall

  • Work in communities to prevent substance abuse among youth
  • Use data driven prevention methods
  • Prescription drugs are used commonly with alcohol by youth and that makes the situation even riskier
  • Provided specific statistics in youth substance abuse
  • Reduce access to unused medications in the home with take back programs
  • Host take backs with the DEA
    • 50,000 lbs of drugs were taken back in one day at 300 take back sites across Texas
  • Formed a take back workgroup with local coalitions
    • Developed a tool kit on how to host a take back program – currently in draft form
  • Recommendations:
    • Texas school survey should be expanded across the state
    • Increase the number of take back events and permanent take back boxes across the state
      • Law enforcement will need additional funds
    • Decrease the number of over prescribed medications and doctor shopping
  • Collier asked about Ecigarettes and the sale to minors and why they don’t fall under the nicotine FDA laws
    • Because they do not have tobacco
    • There are no marketing regulations
    • Kolkhorst put Collier in charge of looking into that

Shannon Edmonds, Texas District and County Attorney’s Association

  • Kolkhorst – asked about prosecution about pill mills
    • In smaller communities it is hard for their peers to consider an individual a felon
    • Hard to catch the small time offenders
    • Includes undercover work sometimes
    • Have to prove that it was intentional and with no medical reason for prescribing opioids
    • Juries have a hard time understanding these cases and see proof beyond a reasonable doubt
  • Kolkhorst wants them to be part of the workgroup