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The House Select Committee on Opioids and Substance Abuse met on May 15 to hear invited testimony on Prescription Monitoring Program (PMP) legislation, prescribing practices, and overutilization and diversion of addictive prescriptions.

This report is intended to give you an overview and highlight of the discussions on the various topics the committee took up. This report is not a verbatim transcript of the hearing; it is based upon what was audible or understandable to the observer and the desire to get details out as quickly as possible with few errors or omissions.

 

Opening Comments

  • Chair Price – Will hear from licensing boards and practitioners regarding overprescribing, have heard that practices are changing

 

Allison Benz, Texas State Board of Pharmacy

  • Updating the committee regarding the PMP, was transferred to the BOP from DPS
  • BOP is beginning to connect the PMP to systems in other states
  • Price – Did not fully understand that we could talk to other states, is this all 50 states? Neighboring states?
    • Not all 50, connected with all border states
    • Depends on other states’ laws
  • Price – How recent was this?
    • Started immediately after transfer, last year and a half
  • Pharmacies are now required to submit controlled substance prescription info by the next day, previously 7 days
  • Effective Sept. 1, 2019, Pharmacists and prescribers will be required to check the PMP for addictive agents, requirement has exemption for cancer/hospice care and veterinarians
  • BOP can also send notices to prescribers and pharmacies with patients over certain thresholds, currently 5 prescriptions, from 5 prescribers, filled at 5 pharmacies (“555” concept)
  • Wholesalers also required to submit info to the BOP
  • Provides info on amount of prescription of opioids in TX, opioid prescribing may be decreasing, benzodiazepine prescribing is staying the same, and stimulant prescribing is increasing
  • Texas rates are a little lower than US overall rates
  • Also presents data on geographic prescribing trends and age group trends
  • Price – So even though our rate of prescriptions has decreased, the strength of opioid dose has increased?
    • Yes
  • Price – It looked like the strength had been going down in Texas, but still higher than US average?
    • Correct
  • Price – So the rate has somewhat decreased, the dosages above 50 MMEs have gone down a little bit
  • Price – Is the PMP software that can be installed anywhere? How does it look from a clinical perspective?
    • PMP is an online system, any computer can access
    • There is an option to integrate the system from a hospital/ER/etc. perspective and it comes up as part of the regular workflow
  • Price – Is there a fee for the license/capability?
    • No
  • Price – So no cost to access PMP, but there is a cost to integrate?
    • Yes
  • BOP has also seen patients getting a prescription for opioids & benzodiazepines together, drastically increases risk
  • Have also seen increased stimulant prescriptions in younger populations, which may be an issue in the future
  • Could possibly require electronic prescriptions for controlled substances, has been very effective in other states
  • Would like to add clinical alerts for increased notification to prescribers and pharmacists, as well as NarxCare to provide additional info on each patient and risk scores
  • Also going to request funding for integration so licensees do not have to; will be asking for $2.5 million per year for all prescribers and pharmacists
  • Solo, integration would be $50/year per prescriber or pharmacist
  • Dean – Regarding the cost of integration for hospital/physician/etc., my understanding is that it doesn’t cost anything
    • If they just want to log in and access, there is not cost
    • Integration, which removes need to access separate system, there is a cost & they pay for it directly; LAR request for integration funding would mean they would not pay for this
  • Dean – And the $12.5 million is integration for the whole system?
    • Correct
  • Murphy – Do you have numbers on how many have paid to have this integration?
    • Can get exact numbers, very small percentage now
    • Kroger is integrated, Walmart and other larger chains are working on it; Prescriber numbers are smaller
    • With funding, those paying for it now would not need to
  • Price – So the law passed in the 85th requiring physicians to check the PMP will be effective 2019?
    • Correct
  • Price – Is there any health care professional required to check it today?
    • No
  • Price – So out of all of the provider groups, some are doing it voluntarily
  • Price – And integration might make this coming requirement to check easier
    • It takes about 90 seconds to a few minutes to log in and check, can mean a large amount of time to check all patients
  • Sheffield – We are presupposing that all offices have electronic records, do you have any idea how many still use paper charts?
    • Can check on this
  • Sheffield – And there is federal legislation that would require electronic usage
    • Unsure
  • Sheffield – Asks the Chair, any reason we can’t make the opioid pharmaceutical companies pay the integration fee of $2.5 million?
  • Dean – Asks after prescription trends in East Texas
    • In East Texas, you see a higher rate of prescriptions, but less dose
    • Basically, less does, but more frequent
  • Minjarez – Is there a process for users to provide feedback and make the system more efficient?
    • Nothing within the system, but we would look at calls, etc. we receive
  • Minjarez – Is there anything outstanding that needs to be addressed with the system?
    • Can’t think of anything

 

Brint Carlton and Scott Freshour, Texas Medical Board

  • Presents pictures of an illegal pain clinic in Southeast Texas
  • SB 11 (81) required registration of clinics with the TMB, with additional regulation for certain clinics
  • SB 315 (85) passed additional regulation and powers, i.e. subpoenas and inspections
  • Currently 73 active clinics, historical total of 48
  • Medical directors of pain management clinics are also subject to CE/presence requirements
  • Price – What is the prescription breakdown between practitioners part of a pain management clinic or a family practitioner? 73 clinics across the state likely means most prescriptions do not come from them
    • Majority of controlled substances aren’t coming out of the registered clinics, but out of the unregistered ones
    • Freshour, TMB – We don’t have specific statistics, but this was looked at in-depth by Sunset; Sunset found that regulated clinics are prescribing less compared to other sources
    • SB 315 was very helpful at gong after unregulated clinics that are trying to hide their operations
  • Sheffield – Can you give us examples of timeframes for prescribing at unregulated clinics
    • Unregulated clinics are no longer at blatant
    • These clinics are also now splitting prescriptions and instructing patients to go to different pharmacies, PMP has been useful to track this
    • Gives example of supposed OBGYN clinic where PMP checks found 50% of the population is male
  • Sheffield – Can you speak to the practice of opening and reopening?
    • Found that clinics operate for around 2 months, then close and open elsewhere under another name
    • Physicians are kind of replaceable parts as well
  • Price – What triggers the investigation typically? Complaints? Independent research?
    • Until SB 315, our authority was complaint-driven only
    • We were challenged in federal court over inspections of some unregistered pain clinics, judge ruled that we could only inspect regulated clinics
    • SB 315 was passed to cure this legal defect, inspections were corrected & we were granted subpoena power for patient records in some instances
    • Now we look at PMP, 555 alerts, top 50 prescribers lists, etc. to determine needed inspections
  • Physicians and PAs also use PMP< registration is encouraged currently for prescribers of controlled substances
  • Board rule currently requires prescribers to consider reviewing PMP, with rational noted in record if review is determined to be unnecessary
  • Exemptions exist for cancer patients and patients in hospice care
  • Physicians are also able to delegate authority to PAs and APRNs, physician must register and prescribing is typically limited to schedules 3-5
  • Price – Have heard of lack of prescribers for MAT drugs & that physicians needed to DEA authority; some doctors were hesitant to seek this due to possible issues with law enforcement
    • Freshour, TMB – With suboxone, methadone, and other agents, you do need a separate registration
    • Extensively regulated by state and federal authorities
    • Have seen suboxone used for pain management, also have seen it concurrently used with opioids
  • SB 315, SB 584, require TMB to adopt guidelines for prescribing opioid antagonists, guidelines will be incorporated into existing rule, eligible for adoption at June board meeting
  • Price and Freshour discuss medical education requirements for prescribers; in addition to pain management, TMB has education requirements for tick-born diseases, sexual assault victims
  • Price – Is there any CME that is on this topic, not specifically limited to pain management, but also other areas?
    • Freshour, TMB – There are a lot of courses available through TMA, etc.; TMB itself in not a provider, but we do have links
  • Regarding enforcement, have had 13 temporary suspensions since 2013, currently 4 to 6 more being considered
  • In 2017, we restricted 22 physicians prescribing and revoked 4 licenses
  • 2012-2014, TMB had over 200 actions addressing prescribing
  • Sheffield – How many investigators are on staff now and how many would you need to fully address problem?
    • Carlton, TMB – Currently 5-6 vacancies in investigative staff out of 40 available
    • Traditionally we used RNs, but they can make more money working in the private sector elsewhere; TMB salaries for investigators are a little on the low side
    • Have recently started to open this up to non-RNs, but takes time to train
  • Coleman – Do you have any data from before 2012? Problem started way before then and data would be useful; Could be that pill mills weren’t the problem, but physicians prescribing opioids as a matter of course
    • Carlton, TMB – This is something we are working on to see if there are better ways to take care of pain
    • Also looking at physician ratings, patients tend to rate physicians higher when they have less pain, and opioid prescribing could feed into this
  • Coleman – My concern is that we are targeting a boogieman without tackling the real issue
    • Carlton, TMB – There are multiple reasons for the crisis, but pain management clinics should be looked at and addressed
  • Coleman – Didn’t say they shouldn’t be, but I would guess there are more prescriptions for opioids outside of clinics
    • Freshour, TMB – Sunset found that registered clinics prescribed less
  • Coleman – What about people like my dentist? If you add in all of the prescribers, there has to be more; can’t have this many addicted people with just the pill mills being the cause
    • Freshour, TMB – Discusses trends in using opioids to treat pain
  • Coleman – Concerned that we don’t focus on a smaller part of the larger problem only

 

Carlos-Nicholas Lee, Texas Society of Anesthesiologists

  • Since the 1990s to now, opioid prescriptions have tripled and the US represents 80% of usage worldwide
  • According to the CDC, 1 out of 15 anesthesia patients ends up chronically dependent on opioids; however, usage for anesthesiologists has changed dramatically & narcotic usage has been cut by half
  • Electronic records will be required across the industry due to the ACA, anesthesiologists have begun to implement
  • Post-hospital tracking has increased awareness of prescribing practices
  • Price – Do you expect changes in prescribing due to shortage will have lasting effects?
    • I believe it will
    • Goal is to get patients out of the hospital quickly, many newer surgeons are noticing that patients can do without narcotics
  • With further education and improved discharge/mental health incentives, we are on a good path
  • Klick – Some payors are now limiting prescription opioids to 7 days, but there are probably some procedures where 7 days is not adequate, so you have thoughts on this?
    • We assign larger cases to a nurse to watch over
    • Looking currently on whether patients have a functional pain, whether goals for the patient are not being met due to pain, etc.
  • Klick – Concerned about cases like burns, would hate to see patients without their needs addressed

 

Troy Fiesinger, Texas Medical Association

  • Shares personal experience of accident and recovery; highlights that care needs to be tailored to each patient, opioids can be used in limited situations to help with recovery
  • Discusses trends where prescription opioids dropped off for a time, and then this was matched with a rise in illegal drug use; several states have had to confront this problem
  • TMA offers many continuing education courses on opioids, resources are available
  • Big fan of PMP, works much better than personal visits from DPS and allows for more in-depth tracking of prescriptions
  • Would like to see direct connection to EMRs, can have issues where EMRs do not allow integration
  • Price – Asks after reporting by companies
    • Big companies all are, but data suggests there could be gaps from smaller entities
  • Price – So does other state data come through up front?
    • There are checkboxes for state data that can be presented in the report
  • Coleman – It doesn’t make sense to me that people would not have considered opioids addictive, have known generally that these drugs were addictive; have we gone back and looked at how this became the normal mindset in the 1990s?
    • I have heard theories regarding the maker of OxyContin influencing medical practice
  • Heard in school that we were not treating pain adequately, data this approach was based on has now been proven false
  • Coleman and Fiesinger discuss mental illness interactions with pain management; Fiesinger notes that behavioral health resources are very important
  • Price – We’ve heard about the value of MAT, what process might a family medicine physician follow to help addicted individuals, but that don’t necessarily want to enter programs?
    • Access to addiction treatment is crucial, methadone is heavily restricted
    • Naltrexone has been indicated for treating alcoholism, but have not tried it for opioids
    • Would take specialized training and education, not as simple as just starting prescribing
    • But, data is promising, and is much cheaper than sending a patient to an addiction program
  • Price – What’s your experience with CME? What’s available and what is needed?
    • CMEs are there, we want to do the right things for patients; my professional association requires
    • There are regulatory levers in place, practice incentives, etc.
  • Alvarado – National Institute on Drug Abuse conducted a very in-depth look at opioids versus medical marijuana; committee should consider brining experts in to testify on this, states where this is legal have seen a 20% decrease in overdose in recent years
    • Price – Worth looking at this
    • Price – Have heard from people concerned that committee’s intent is to take opioids away from patients in need, but intent is to study the issue, explore legislation, and provide options for those addicted to create better outcomes; everything should be on the table
  • Alvarado – Glad to hear this, haven’t heard of anyone overdosing on marijuana
  • Sheffield – Can you comment on the genetics of addiction?
    • In general, there are metabolization issues, inheritance patterns for addiction
  • Klick – Have heard from patients in my area that drug screenings are very high
    • Have not seen this, screening does not cost this much
  • Klick – We need to very careful not to price individuals out
  • Dean – When we started this committee, received many comments from constituents that we should not take away their needed medications; what’s your opinion on the treatment that could block the receptors that cause addiction?
    • Have heard of this being used to respond to community need, I would likely not use it as my practice focuses on long-term care of chronic conditions
  • Dean – Asking if there should be incentives and if it would be effective
    • Incentives could help study risks
  • One of the big remaining issues is what patients do with drugs after they are finished; TMB should explore a safe disposal program
  • Price – I think this is a huge issue, medication cleanouts are occurring more across the state and this is a very positive thing

 

Stacey Hail, UT Southwestern

  • Highlights Len Bias law, makes it a felony when providing a misdemeanor amount of drugs causes bodily injury
  • Opioid addiction issue is a varied issue with many causes
  • Fan of the PMP, however it is time consuming to check the system when it takes 1-2 minutes per patient on a 30-patient shift
  • Another challenge is that practitioners often only see patients once, PMP data from other states has made checking on these patients easier
  • Also helps to check on physician prescribing and from a criminal prosecution perspective
  • Integration into electronic medical record could help with time concerns in the ER
  • Another option would be to exempt ER physicians from having to check the PMP, ER physicians treat acute pain and are often not the source of long-term prescriptions
  • ER physicians are exploring other methods like non-opioid drug mixtures and nerve blocks
  • Discusses peripheral opioid receptors, e.g. injecting receptors in the knee or other areas instead of the bloodstream
  • Would need to work with insurance to cover alternative treatments
  • Could also encourage prescribers to offer other methods to patients before prescribing opioids
  • One of the reasons for this epidemic is that pain was considered part of the patient’s vital signs; prescribing opioids was built into the system and patient satisfaction should not be connected to opioid prescription
  • Sheffield – Asks Hail to expand more on pain as a vital sign and how this changed the industry
    • These drugs were encouraged as nonaddictive in the past, many tried to seek out the nonaddictive opioid
    • There was definitely a push to treat acute pain with opioids, physicians also prescribed opioids to treat pain and avoid discipline

 

Bree Watzak, Texas A&M

  • Texas A&M offers a variety of resources, i.e. those that help identifying recurring patients
  • Physicians take classes proactively, also take courses as part of TMB or court-ordered action
  • Also periodically review charts from other states and conduct office visits as part of TMB order, end result is a document suggesting further improvement; hoping to bring this to Texas as well

 

Jeff Lush, NACDS, TFDS, Kroger Company

  • Kroger was the first company to integrate PMP into its pharmacy
  • Also involved NABP and NARxCHECK
  • Kroger did have to invest resources to deal with each states’ specific environment and proprietary software dev, but has resulted in a flexible and easily accessible system
  • NARxCHECK scores are made available to pharmacists doing utilization reviews, helps identify risk factors
  • Have seen a reduction in errors, an increase in PMP reviews, and a reduction in prescribing errors
  • Pharmacists appreciate the ease-of-use of the system, also drives pharmacist reviews and attention to where it’s needed most
  • Price – Everyone seems to be on the same page, encourages witnesses to point out unique aspects in their practice

 

Michael Wright, Texas Pharmacy Business Council

  • There is a shared responsibility re: opioids throughout the industry, e.g. manufacturers, distributors, prescribers, and pharmacists, etc.
  • Presents document with 7 recommendations on improvements to PMP:
    • Requiring out-of-state pharmacies to report to Texas PMP if they dispense controlled substances in Texas; law likely needs some corrections, especially for neighbor states
    • Allowing Texas Medicaid and state insurance access to PMP, 32 other states allow this access
    • Should specify in statute that PMP data is not available to the public or available through public information requests
    • Allow patient or guardian to receive PMP data on behalf of a child
  • Price – Would assume HIPAA protects info in the system, is this a “belts and suspenders” recommendation?
    • Yes
  • Price – You suggest we provide legal immunity to doctors not providing info to the PMP?
    • There will be cases where PMP is not used, exemption present in other states
  • Price – I need to understand this better, it’s an exemption for those choosing to go another way and not for those prescribing, but not reporting?
    • Correct

 

Justin Hudman, Texas Pharmacy Association

  • Pharmacy community is strongly committed to working on this problem
  • Regarding naloxone, state passed legislation that dramatically expanded availability, Association has made attempts through standing order to increase availability
  • Recommends legislature direct HHSC to establish its own standing order that allows all pharmacists statewide to access naloxone; other states have done this
  • Rose – How does the recommendation differ from SB 854?
    • That bill allowed medical board to essentially establish guidelines
    • Recommendation centers on the idea that not just directly prescribed patients should have access
  • Klick – Many law enforcement officials could benefit if they accidently come into contact with fentanyl, etc.
    • Exactly, this is a life-saving medication that helps treat overdose and availability should be expanded
  • Price – Would like to have a sense of what is required on pharmacist and prescriber front, also how costly it would be

 

Audra Conwell, Alliance of Independent Pharmacists

  • Patients are moving to independent pharmacies for opioid prescribing
  • Have heard from numerous pharmacists that they are wanting patients to handle all prescriptions at a particular pharmacy; they don’t just want to be opioid dispensers
  • Medication drop off programs where pharmacies collect medications could drive crime to them, also has costs associated as DEA needs to control/pick up the secure drop off box
  • Rose – Can you elaborate on why patients are moving away from large pharmacies and moving to local pharmacies?
    • Several large pharmacy chains have announced that they will not fill for more than 7-days, patients are looking to independent pharmacies to fill these prescriptions

 

Jeremy Ashley, Brookshire Grocery Company

  • Supports mandatory electronic prescribing for all controlled substances, can increase safety, improve patient care, and improve ability to track prescription and utilization
  • Mandates drive upward trends in electronic prescribing, states with electronic prescribing
  • White – Do we need to have a rule exception or carve-out for rural areas?
    • Should be a case-by-case approach
  • White – And the cost to the pharmacy? Who is going to pay for it?
    • Surescripts acts as the go-between
  • White – Is there any difference in using this process for other controlled substances?
    • Similar
  • Murr – Who would evaluate the rural pharmacies on a case-by-case basis? Have issues with people assessing these areas who do not understand the area
    • I feel like it should be a collaboration between as many stakeholders as possible
  • Moody – Would like some information on new sanction that can moved some pharmacy theft penalties to a state jail felony
    • Wright, Texas Pharmacy Business Council – This was a Texas Pharmacy Business Council bill last session, supported by entire industry
    • Have been tracking implementation and will present this info in the future; loss of inventory

 

Boyd Bush and Bryan Henderson, Texas State Board of Dental Examiners

  • Dental Board has passed rules related to opioids, passed additional education requirements
  • Price – Is this education unique to those with access to the PMP? Is there a requirement for CE for these individuals?
    • Henderson, TSBDE – Not unique, ADA came out with guidelines to do some sort of CE
    • 2 hours mark was chosen because anything longer is likely longer than any CE available
  • Dentists are also required to do a PMP self-query, also have rules coming up holding dentist responsible for reviewing PMP before prescribing, also making them responsible for unauthorized checks and access
  • Nevarez – Regarding the 555 alerts, if you are older it may not be unusual to have more than 5 prescribers, prescriptions, etc.; but how easy is it to accumulate more than 5 pharmacies?
    • I could see ways, not sure where “555” concept came from
    • In a short period of time you could pick up 3 prescriptions at different pharmacies for chronic conditions
  • Nevarez – Could be easy to do in an urban area, might be more concerning in rural area
  • Klick – Does 5 pharmacies refer to company name or locations? Could see issues if each CVS pharmacy location was counted as the same
    • Not sure
  • Also passed rules regarding Board responsibilities & criteria looked at for reviewing licensees; also send letter to those that end up on the “555 list”
  • Also discussing creating a code in data tracking for those who land on the list multiple times
  • Board is looking into recommendations from the ADA, including:
    • Mandatory CE on prescribing and opioids
    • Statutory limits on dosage and duration no more than 7 days, with exemptions for cancer and hospice care
    • Registering and using the PMP fully
  • Price – Are there many procedures where a dentist needs to prescribe a pain-management agent for longer than a week?
    • In clinics, some conditions that involve head and neck pain; in a pain clinic, rarely is it the dentist that prescribes
    • For family practitioners, no; oral surgeons perhaps, but these would usually be hospitalization procedures
    • 7 days at best is pretty standard dental practice

 

James ”Dusty” Johnston, Texas Board of Nursing

  • Nurse Practice Act gives Board authority to license APRN and to regulate practice, including prescriptive authority
  • Requirements for delegation include face-to-face meetings, adherence to guidelines, etc.
  • APRNs generally are only authorized to prescribe schedule 3-5 medications, can prescribe schedule 2 in hospital, with hospital guidelines, and as part of treatment plan for hospice
  • Board was authorized to access PMP in the 85th, Board receives the 2,000 top prescribers and reviews for APRNs on the list, look at prescribing practices, investigations, etc.
  • Board also required to cooperate with the Pharmacy Board to develop criteria and evaluate utilization
  • Pharmacy Board recently sent an email to all APRNs seeking registration to PMP, Nursing Board has posted notice
  • Board required to promulgate requirements for prescribers, will likely go before the Board in July; issues under review include encouraging review of PMP before prescribing, providing rational if they choose not to review, etc.
  • Historically have had guidelines for pain management, includes proper assessment, evaluate alternatives, develop proper treatment plans, have patient’s consent, proper consults and meetings with delegating physician, etc.
  • Even excluding APRN prescribing, nurses still have a prominent role in administration of medications; very important to have proper training, education, and oversight
  • Have not heard of witnesses speak to practitioners with substance abuse disorders, also a very serious area for consideration
  • Would like 2,000 prescriber list to be worked on and only show practices area of interest, e.g. APRNs only
  • Have had difficulties getting records, existing subpoena authority sometimes means practitioners are hard to track down & delegating physician may not have required documents

 

Chris Kloeris, Texas Optometry Board

  • Optometrists are limited to schedules 3-5 and of limited duration
  • Board has taken several steps to educate prescribers, have published articles in newsletters, considering continuing education requirements
  • Will be considering rules changes at the next board meeting to comply with recent legislation

 

Hemant Makan, Texas Department of Licensing and Regulation

  • Much of the work to implement 85th legislation is similar to other boards
  • Podiatry functions were consolidated into TDLR, TDLR maintained PMP maintenance fee, maintained information transfer, etc.
  • As of March 20, 2018, 33% of podiatrists are registered with the PMP
  • Podiatrists are satisfied with the 555 standard, TDLR understanding is that any lower would sweep many more individuals into the category
  • Podiatrists are limited to treatment of the foot, so TDLR expects practice to be limited; pharmacists are very vigilant regarding limited practice information and very active in reporting suspicious information
  • Podiatrists need 50 hours of CE every 2 years, 2 hours in Ethics that can include opioid abuse courses; Advisory Board may be considering a requirement

 

John Hawkins, Texas Hospital Association

  • THA Board has approved use of voluntary prescribing guidelines for ER departments; one of the key elements of the guidelines is that prescribers check the PMP
  • From hospital perspective, system reliability and integration of hospital EMR with the PMP are key
  • Cost is also ultimately a concern, EHR vendors often have a cost associated with integration into their systems, appreciate Pharmacy Board LAR consideration of cost
  • Price – Prescribers in the hospital are not always the hospital, so each prescriber would be considered separate for cost purposes?
    • Yes, each prescriber is considered separately, there are probably opportunities to get favorable pricing
  • Dean – From an appropriations perspective, we heard $2.5 million to integrate the system, do we know what an integrated system looks like and what is needed to make it friendly?
  • Price – My understanding is that some sophistications are fairly far down the road, other states have been successful
  • Price – Will likely be more analysis on cost and how it will be covered, whether it will be through enhanced fees or other mechanisms
  • Dean – We need to know the design of the system, etc. before we can really look at it
    • It is achievable, EMRs are pretty sophisticated, key is having interface built and having data real time
    • One thing we can do is study the cost more thoroughly