Some notable legislation came out of the 84th Legislative Session, at least as it relates to the practice of medicine in the state, and specifically the state’s efforts to fight prescription abuse. Senate Bill 195, passed in the most recent legislative session, serves up some significant changes to the Department of Public Safety’s (DPS) role in regulating the prescribing of controlled substances.
Effective September 1, 2016, a physician or practitioner in the state of Texas will no longer need to hold a Controlled Substances Registration (CSR) through the DPS. I see this as a positive change as requiring a state DPS registration alongside the federal registration already mandated by the federal Drug Enforcement Administration is redundant and unnecessary. Practitioner’s will probably be happy to have one less expiration date to track, and one less fee to pay.
Senate Bill 195 also moves the Prescription Access Texas (PAT) electronic prescription database from one state agency to another, specifically from the DPS to the Texas State Board of Pharmacy (Pharmacy Board). PAT has been available for wide use since 2012. Most practitioners who might have occasion to use PAT, are probably aware of it at this point. It makes prescribing data more easily accessible to physicians, pharmacists, and law enforcement. The primary utility for practitioners is the ability to access a patient’s full prescribing history and verify that patients are not receiving controlled medication from multiple sources. It is also useful to monitor whether the practitioner’s own prescribing authority has been used without their knowledge.
So, what is going to change now that PAT is moving under the Pharmacy Board’s operation and control? It appears improvements that have been considered include allowing access to prescription data from surrounding states or nationwide, creating a more user-friendly interface with increased functionality, and ensuring reliable access to the program. The legislature decided that the Pharmacy Board, as a healthcare agency, and an agency engaged in the regulation of filling prescriptions, is better equipped than DPS to implement those changes. We shall see.
A Texas pharmacist who is suspected of having a potential substance abuse or dependency problem or other mental health issue which could impact their ability to safely practice is almost always asked by the Texas State Board of Pharmacy or Professional Recovery Network (PRN) to undergo an evaluation with a mental health provider (MHP). This request is typically made in one of two contexts:
- A pharmacist has just been referred to PRN and is asked to undergo an evaluation to determine whether they suffer from an impairment issue, and, if so, what is the appropriate course of treatment; or
- The pharmacist has been invited to attend an informal conference with the Texas State Board of Pharmacy about a disciplinary issue and is also asked to complete a PRN-coordinated mental health evaluation prior to the scheduled conference.
In both instances the pharmacist should be wary of accepting and undergoing this process unassisted by legal counsel, particularly if the pharmacist has some doubt as to whether they suffer from an impairment or mental health issue. I have seen many, many pharmacists who have unwittingly undercut their own case by failing to hire an attorney until after they are evaluated by an MHP.
The potential pitfalls of this process are multifold. First, the pharmacist is always asked to see a mental health provider who is on PRN's pre-approved evaluator list. PRN's list is primarily composed of licensed chemical dependency counselors (LCDC) as, pursuant to their contract with the Pharmacy Board, PRN is required to pay for the evaluation and, as a lower level provider, an LCDC can charge a much lower rate than a forensic psychologist or psychiatrist.
Besides not possessing the same level of expertise as a physician or psychologist, it has been my experience that the LCDCs on PRN's list tend to repeatedly misdiagnose pharmacists with impairment issues they do not have. A classic case is a person with two alcohol related criminal offenses, such as two DWIs, which are multiple years apart. According to DSM-IV criteria, the near universally accepted gold standard for diagnosis in this area, this fact alone would not qualify the pharmacist for an alcohol abuse or dependency diagnosis. Yet, time and time again, my firm has been retained by a pharmacist who was improperly diagnosed based on stale criminal history or other criteria not recognized in addiction medicine.
Also an issue, most LCDC's are employed by or closely affiliated with a treatment center. Because of this, there is often a presumption on the part of the evaluator that the pharmacist must have a problem simply because they have been referred to their office. Additionally, the LCDC's connection to a treatment center creates an incentive to find some diagnosis in order to justify treatment.
Finally, many of the evaluators on the PRN's pre-approved list suffer from the perception, whether accurate or not, that in order to stay on the list and continue to receive referrals, they must find problems with the pharmacists sent to their office.
All of these factors combine to create a pool of pharmacists who are misdiagnosed with substance abuse or mental health issues they do not have. Once a pharmacist has been diagnosed with a problem they will at a minimum be required to enter into a five year monitoring agreement with PRN. If they refuse, PRN is required by law to refer their case to the Texas State Board of Pharmacy. Once the Pharmacy Board is involved, the Board's disciplinary policies mandate that the person be placed on a five-year Board Order which requires full PRN participation as well as workplace reporting and restrictions. In either scenario, the pharmacist will be required to regularly attend AA, abstain from alcohol and any other potentially addicting substances, and undergo expensive inpatient or outpatient treatment.
In most cases, such a poor outcome could have been avoided had the pharmacist hired an attorney prior to undergoing an evaluation with an MHP either by command of the Board or PRN. Our attorneys have years of experience working with both the Board and PRN and are familiar with evaluators on PRN's approved list. We have the knowledge necessary to collaborate with PRN to locate an evaluator who is fair and holds the expertise necessary for an individual case.
In matters involving allegations of impairment the selection of an appropriate evaluator is oftentimes the single most important point in the pharmacist's entire case. Once a pharmacist has received some form of impairment diagnosis, the damage is often irreparable. If you have been asked to undergo an evaluation by either PRN or the Board, it is absolutely crucial that you immediately contact an attorney familiar with both entities prior to moving forward.
In 2011, Courtney Bolin, LMSW, became the new Program Director of the Professional Recovery Network (PRN). Prior to assuming her duties as the new Program Director, Ms. Bolin had already worked for several years as a social worker / case manager with PRN. Since the start of her tenure, PRN has hired two new social workers, Ms. Emily Abel, LMSW, and Eden Folks, and instituted several notable changes in the program's operation.
For those unaware, the Professional Recovery Program is the official peer assistance program for the Texas State Board of Pharmacy, Texas State Board of Dental Examiners, Texas State Board of Veterinary Medical Examiners, and Texas Optometry Board. PRN accepts both third-party and self-referrals concerning licensed professionals who may be suffering from some kind of impairment issue, whether related to substance abuse or mental health.
If the person is determined to have an issue for which PRN can provide assistance, they will typically be referred to an appropriate expert for an evaluation and any treatment recommendations. Following this the licensee will be asked to sign a PRN participation agreement wherein they agree to follow-through with their treatment plan and conform with standard PRN monitoring conditions, such as drug and alcohol screening for a case involving substance abuse. So long as the individual complies with their contract, their participation in PRN remains confidential. Because of this, PRN referral and assistance can be an attractive option as it avoids the involvement of the professional's licensing board and the potential entry of a board order, which may be public.
In representing numerous pharmacists, dentists, veterinarians, and other licensed professionals, my firm has in the past conflicted with PRN when the client's and PRN's interests do not necessarily match. This has even involved contentious civil litigation with PRN resulting in a substantial award of attorney's fees and costs to one of our clients. Thankfully, under Ms. Bolin's tenure such disputes have been rare and both my office and PRN have almost always been able to work together towards the client's best interest. In addition to this general trend I have noticed several other developments which represent a positive direction for PRN participants.
For example, since assuming leadership of PRN, Ms. Bolin has instituted new protocols ensuring referred persons are better aware of how the PRN process works and the situations in which their case can be forwarded to their licensing board. In my opinion this had been a problem in the past as participants would contact PRN or even sign a contract under the misunderstanding that even if they elected to quit participating their case could not be referred to the board. Trust is integral to good recovery and a willingness to comply with treatment recommendations. Because of this I applaud PRN's upfront efforts to more clearly delineate boundaries and the limits of the program's confidentiality.
It has also been our experience as attorneys routinely representing pharmacists, dentists, and veterinarians before PRN and their respective boards, that Ms. Bolin is very willing to take a proactive approach and work with referrals and participants to ensure they are treated fairly and are not asked to comply with inappropriate treatment recommendations. This includes keeping an open ear to second opinions when the report and recommendations from the original evaluator are unreasonable or not reflective of objective data and prior treatment.
Finally, Ms. Bolin and other PRN personnel have been more ready to advocate on behalf of participants than was true in prior years. PRN has always claimed as one of its core principles a willingness to advocate on behalf of its participants, however, in my opinion such advocacy was often sacrificed to avoid confrontation with treatment providers or the Boards with which PRN contracts. As related above, recently PRN has been more involved in ensuring participants receive fair evaluations and treatment recommendations. This has also extended to other areas such as a recent case were PRN has been very helpful in advocating on behalf of a participant whose license is suspended in another state and all efforts at correcting this situation have been stonewalled.
I am encouraged by Ms. Bolin's stewardship and the fresh start it represents for the program. Hopefully PRN maintains their current direction as I feel it is better for participants and more conducive to maintaining their trust, ensuring good treatment outcomes, and assuring sustainable recovery and health.
Criminal Prosecution of Pain Management Physicians by State and Federal Law Enforcement is on the Rise
There has been a recent and rapid rise in the number of physicians being prosecuted for the alleged non-therapeutic prescribing of controlled substances under both state and federal law. In the last week alone I have received numerous phone calls from a variety of medical and osteopathic doctors who had been arrested and/or indicted by the federal government or a local law enforcement branch after a joint investigation by a task force of state and federal agencies such as the Texas Medical Board (TMB), Drug Enforcement Administration (DEA), a local sheriff’s and/or police office and the State Board of Pharmacy. These individuals are being charged by prosecuting attorneys in United States District Court (Federal Court) with crimes under the Federal Controlled Substances Act or in State Court for violations of the Health and Safety Code and the Medical Practice Act. In most cases the basic charge is the delivery of a prescription (to a patient and within the context of the physician’s medical practice) for a controlled substance without a valid therapeutic purpose. Many of the physicians I spoke with questioned why and how the government can substitute its’ clinical judgment for the physicians. Essentially this amounts to a physician being prosecuted and jailed for a standard of care based decision that was once a purely civil or administrative inquiry. My law practice has been handling these cases for years and over the last year the number of inquiries to our attorneys has increased tenfold suggesting the marked rise in government prosecutions is very real.
Oftentimes the Government relies on the sheer number of prescriptions written or the types / combinations of medications prescribed to make its’ case. It then utilizes experts to opine that a reasonable physician would not prescribe this combination of medications to this many patients and thus the treatment of patient X was non-therapeutic. This is a questionable way to go about proving a case, but it does not stop the Government from doing its investigation, arresting the doctor, forcing the surrender of their DEA issued controlled substances registration, initiating the inevitable discipline and loss of the physician’s medical license and the consequent destruction of their medical practice pending prosecution(s). While violations of the administrative rules surrounding the handling and use of prescriptive authority carry civil and administrative monetary provisions, violations of a state or federal statute mean confinement upon conviction and the inevitable loss of the physician’s career in medicine. For many physicians the result has been the very conservative treatment of patients and arguably the under treatment of both acute and chronic pain. I have thankfully yet to see the government pursue a case that involved palliative care.Continue Reading...
Several months ago I began a series of posts focused on the combined State and Federal taskforce sweeping the Houston metropolitan area targeting physicians and pharmacists viewed as engaged in the non-therapeutic prescribing and dispensing of narcotics, particularly for the treatment of pain. This process continues to develop and generate new sets of licensees' criminally indicted and/or scheduled for temporary suspension hearings before their respective licensing boards.
With respect to the Texas State Board of Pharmacy, the TSBP has been setting an average of at least two pharmacies, along with the employed pharmacists, every month for temporary suspension hearings. A temporary suspension hearing is an extraordinary remedy designed to immediately remove from operation a pharmacy or pharmacist whose continued practice represents an ongoing threat to the public welfare. A temporary suspension bypasses the normal disciplinary procedure by allowing the Pharmacy Board to immediately remove a licensee from practice pending a final resolution by the Board.
Such hearings can be held with little or no notice to the licensee and are decided by a three-member panel of the Board rather than an independent administrative law judge. For a number of reasons, these hearings are almost always difficult for the licensee. As the Board panel is generally comprised of lay persons without a legal background, the rules of evidence are usually only loosely followed if at all. The short notice given to the pharmacist or pharmacy, oftentimes less than two weeks, permits little preparation time especially given it typically takes the licensee a few days even to locate an attorney. Most importantly, as the panel is comprised of Board members, the hearing's decision-makers are usually very sympathetic and receptive to the arguments and evidence presented by Board Staff. A licensee often, and not without good reason, has the impression that the deck has been stacked against them.
If the Board panel does vote to temporarily suspend the licensee's certificate, the only recourse is to appeal this order to District Court in Travis County. This is also an expensive and time-consuming process and the review provided is limited to determining whether or not the agency abused its discretion, not a full re-weighing of the merits. Moreover, in the interim, the pharmacist and/or pharmacy remains suspended.
My office recently represented two pharmacists, and their respective pharmacies, at a temporary suspension hearing before the Pharmacy Board. The allegations were that the pharmacist had over a period of time dispensed thousands of units of hydrocodone, alprazolam, and carisprodal which they know or should have known were non-therapeutic. The evidence presented by Board Staff at the temporary suspension hearing primarily consisted of a patient list of what they considered the thirty "top-offenders." Notably, the Board investigator, who has no medical background, had never even reviewed these individuals' medical records prior to reaching this conclusion. My firm was able to present evidence and testimony that every one of these patients was receiving appropriate care for their illnesses which for most involved a large array of comorbities. In fact, one of the alleged "top-offenders" was the pharmacist's own elderly mother who was receiving appropriate care from several specialists.
My firm was also able to present evidence that virtually every one of these patients had filled scripts at several other pharmacies, including big chains such as Walgreens, CVS, Wal-Mart, and HEB. Not surprisingly not one of the corporate pharmacies had been prosecuted or disciplined by the Texas Pharmacy Board for filling the exact same prescriptions for the same patients.
Currently, there is no sign that the Pharmacy Board intends to slow down its prosecution of independent Houston pharmacies for the non-therapeutic dispensing of pain medications. Unfortunately, oftentimes the Pharmacy Board appears to schedule licensees for temporary suspension hearing with little to no investigation as to whether they are actually inappropriately dispensing prescriptions, a trend which I believe the case discussed above amply illustrates. A temporary suspension hearing can be completely devastating to an independent pharmacist and make the difference between continuing as an ongoing concern and going out of business even if the licensee is later vindicated. Any Texas pharmacist or pharmacy who receives notice of a temporary suspension hearing should immediately contact an attorney familiar with the Texas Pharmacy Board and its processes.
Over the past several weeks there has been an onslaught of temporary suspensions by the Texas Medical Board and Texas State Board of Pharmacy targeting Houston area physicians and pharmacists. These emergency suspensions have all stemmed from the joint state and federal task force combing Harris County for the non-therapeutic prescribing and dispensing of medications commonly used to treat chronic pain: primarily hydrocodone, soma, xanax, and klonopin. Presently, there is no sign that this barrage of suspensions will let up.
Most of the physicians, pharmacists, and pharmacies which have been temporarily suspended seem to have been selected because they have already been arrested or otherwise targeted by the Harris County task force. Moreover, many of these individuals have appeared in local media coverage of the crackdown. Temporary suspensions by the Medical and Pharmacy Board only allow for short notice to the affected practitioner meaning the licensee has little chance to prepare their defense.
Moreover, it has been my firm's experience with such suspensions that the licensee faces an uphill battle as the deciding panel is made up of three Board members, not an independent judge unaffiliated with the prosecuting agency. Generally speaking, such Board panels accept Board Staff's claims and evidence at face value particularly when the practitioner has been arrested or the subject of media attention. The evidence presented in such hearings is usually the testimony of DEA agents or local law enforcement who have been involved in the case. Oftentimes, this involves testimony from an undercover officer who received pain medication from a physician after falsely telling the practitioner they suffer from chronic pain and undergoing an assessment in conformance with the Medical Board's rules on pain management. It is unclear how this constitutes non-therapeutic prescribing as the physician is essentially being lied to by the undercover agent. A Houston pharmacist was likewise recently suspended based merely on the number of pain prescriptions dispensed by their pharmacy as well as the accidental early filling of a single prescription presented by an undercover officer.
Again, the evidence presented is often flimsy at best and likely would not result in an emergency suspension were the matter before an independent administrative law judge. Simply because a licensee has been arrested does not mean the unproven charges will result in a criminal conviction. The unfortunate result of the current approach by the Medical and Pharmacy Board is the suspension of innocent pharmacists and physicians along with those knowingly engaged in the provision of illegitimate pain medication.
A temporary suspension will dramatically impact a practitioner's career and remain a part of their permanent licensure record. Additionally, if the licensee is a physician a report will be generated with the National Practitioner Data Bank and remain there indefinitely. Once a physician or pharmacist is temporarily suspended their only recourse to overturn the suspension is to appeal the case to District Court in Travis County, a process which is neither timely nor inexpensive.
Legally speaking, the temporary suspension of a physician's or pharmacist's license is meant to be an extraordinary remedy designed to immediately remove such individuals from practice due to an imminent danger to the public were they allowed to continue working. Regrettably, it appears as though many of the persons who have been temporarily suspended in the past few weeks have legitimate defenses to the charges levied by their respective Boards. Any physician or pharmacist who receives notice of a temporary suspension hearing should contact an attorney immediately as there will be little time to prepare and a negative result could cause irreparable harm to their career and reputation.
Over the last few years substantial momentum has been steadily building on both the administrative and criminal fronts against physicians whose practice primarily or substantially involves pain management and the pharmacists who file their prescriptions. In many instances, this governmental clamp down is fully justified as every pharmacist and physician familiar with this practice area is well aware of the significant problem associated with the non-therapeutic prescribing of powerful narcotics and other controlled substances. Tragically, many physicians and pharmacies who provide legitimate pain control have also been captured in this ever-widening net. The consequences can be severe and can include the loss, restriction, or temporary suspension of the individual/entity's state license, loss of a physician's DEA and DPS controlled substances registrations, substantial monetary fines, and even criminal prosecution.
As an attorney who has defended numerous physicians, pharmacists, and pharmacies in both state and federal administrative and criminal actions, it has been my impression that the pace of this clamp-down has only increased. I hope to write a series of articles detailing different aspects of non-therapeutic prescribing/dispensing cases and what practitioners and pharmacists can expect should they be unfortunate enough to be targeted under this or a related claim. This article will focus on the combined state-federal task force presently sweeping Texas to shut-down so-called "pill mills."
The Pill-Mill Taskforce:
The expression “pill-mill” is becoming an increasingly recognizable term to the general public due to investigative journalistic pieces done by national news outlets like 20/20 and CBS News. A true pill-mill is typically comprised of a network of dubious physicians and pharmacists that dole out controlled substance prescriptions to individuals, based not on medical necessity, but on their cash value on the street.
Along with growing media exposure came the realization by government regulators and law enforcement officials that much of the pill-mill activity in Texas is based in Harris County. In response, a taskforce of interested state and federal agencies and law enforcement entities was formed to combat non-therapeutic prescribing in the Houston area. The taskforce includes members of the federal Drug Enforcement Agency (DEA), the Texas Medical Board (TMB), the Texas State Board of Pharmacy (TSBP), and local law enforcement. The taskforce has been very aggressive in pursuing and sanctioning Houston pain management clinics and pharmacies. As discussed above, the consequences can be severe and extend all the way to convictions for serious felony offenses.
Targeted Physicians and Pharmacies:
The joint task force uses several different methods to select targeted practitioners and dispensing pharmacies. These include utilizing databanks maintained by the DEA to pull down the largest prescribers and dispensers of certain medications within a given county. The task force also refers to the list of pain clinics which were required to register with the Texas Medical Board following the last Legislative session. Other red flags include all-cash transactions, high numbers of daily patients, large or atypical numbers of narcotics and other targeted medications, frequent use of the pain cocktail of Soma, Xanax, and Hydrocodone.
Once targeted, a physician or pharmacy is immediately placed on the defensive as they face a coordinated assault by law enforcement officials, the DEA and DPS, as well as the applicable state licensing agencies. These investigations are accusatory in nature and generally proceed on the presumption that the individual/entity is engaged or participating in non-therapeutic prescribing. Oftentimes the first indication that an individual has been targeted will be an armed raid of the person's practice or pharmacy and the seizing of their prescription or dispensing records. The physician or pharmacist may be asked on the spot to sign a statement or affidavit connected with the allegations or asked by the DEA or DPS to surrender their controlled substances registration.
Again, it bears reminding that the sudden arrival of the task force may only be because the targeted entity showed up high on the DEA's records on the volume of narcotics prescribed/dispensed or some other such indication which, by itself, has little bearing on whether or not such prescriptions are for a legitimate therapeutic need. I have represented several physicians targeted by the task force despite their having in place rigorous safeguards and practices designed to ensure that all prescriptions are for legitimate medical conditions and taken only at a therapeutic dose.
This task force represents the leading edge of regulatory pushback at what has increasingly been identified as a widespread problem: physicians and pharmacies who fuel prescription drug abuse by persons who lack a legitimate medical need. The problem is that this combined dragnet continues to ensnare numerous physicians and pharmacists who provide genuine and legitimate pain relief to Texas patients.
Any physician or pharmacist contacted or raided by the joint task force or any of its individual members should seek legal representation immediately. If you are raided by the task force you should contact an attorney on the spot and refrain from giving any oral or written statement, signing any documents, surrendering your license or controlled substance registration, or acquiescing to any demand without first seeking legal counsel. The stakes are very high and a mistake could permanently prejudice your ability to defend yourself.
Like most health licensing boards, the Texas State Board of Pharmacy possesses extensive authority to discipline pharmacists and pharmacies for violations of their enabling statute, the Texas Pharmacy Act. This includes criminal matters, negligent practice, fraud and deceit, suspected substance abuse/dependency, and anything the Board determines falls within the broad and ill-defined ambit of unprofessional conduct. Unlike most Texas medical licensing boards, however, the Pharmacy Board is also authorized to discipline pharmacists for violating another state's law pertaining to drugs or the practice of pharmacy. This grant of jurisdiction is expansive and raises unique regulatory pitfalls for Texas pharmacists whose practice reaches into other states or who hold licenses in multiple jurisdictions.
Normally, before a Texas licensing board can impose discipline on a licensee for violations of another state's law, the licensing board in the subject jurisdiction must have already entered a disciplinary order in their state. In this event, the Texas board, including the Pharmacy Board, can then discipline the licensed professional in Texas through their reciprocal discipline statute. Through reciprocal discipline the Pharmacy Board need only present the foreign order and is not required to separately prove up the underlying allegations. The same almost always holds true in any other states where the pharmacist or medical professional is licensed. This is one of the primary problems facing a Texas medical professional holding licensure in multiple states: an order in one state can cause a cascade effect of similar disciplinary actions in the other jurisdictions were they are licensed.
The Pharmacy Board's disciplinary statutes go even further, however, and authorize discipline for a violation of another state's laws even in the absence of any action by the other state. As an example, my firm recently represented a compounding pharmacy located in Texas which sold medications to practitioners located throughout the country. This pharmacy, which initially was not licensed in any other jurisdiction, was investigated and subsequently disciplined by the Texas Pharmacy Board due to their lack of the proper non-resident pharmacy permits required in many of these other states. This was despite the fact none of these other states had taken any action against the pharmacy nor were there any indications they planned to do so even after my client had made them aware they had ostensibly been in violation of their regulations. The pharmacy has now been subjected to a disciplinary order in Texas which it will need to report to all the other states in which it has or will soon be licensed. The end result could easily be a series of orders and fines in other jurisdictions pursuant to each state's reciprocal discipline statute. This is all because Texas elected to punish this pharmacy due to its failure to adhere to the law in other states even when such states had declined to impose discipline.
As can be seen above, this far-reaching grant of authority permits the Texas Pharmacy Board to essentially be the enforcer of other state's law and can have serious consequences to Texas pharmacists and pharmacies. Every licensee actively or merely planning to conduct business in another state would be well advised to ensure adherence to the other jurisdiction's laws pertaining to drugs and pharmacy. At a minimum this should involve consulting with an attorney to investigate whether licensing or out-of-state permitting is required by the other state. Failure to do so can lead to an otherwise avoidable disciplinary order in Texas, likely a significant impediment to the continued expansion of your business.
TSBP Adopts New Rule Requiring Pharmacists to Verify Prescriptions Meet Applicable Medical Standard of Care
Texas pharmacists should take note of a new Rule recently adopted by the Texas State Board of Pharmacy which places increased responsibility on the licensee to ensure that dispensed medications were prescribed for a valid medical purpose and pursuant to a proper patient-physician relationship. The Rule, which can be found at §291.29 in Title 22 of the Texas Administrative Code, is clearly aimed at controlling some of the worst abuses of internet pharmacy as well as the non-therapeutic prescribing of pain medications. The potential problem lies in that it creates a duty for pharmacists to verify that the prescriptions they dispense were generated by physicians working within their own practice standards as outlined in the Medical Practice Act and Rules of the Texas Medical Board. It is unclear to what extent this means Texas pharmacists are now expected to be fully educated on the applicable standards of care for Texas physicians, as interpreted by the TMB, in the treatment of chronic pain and use of internet and telemedicine.
Specifically, the rule requires a Texas pharmacist to “make every reasonable effort” to confirm that a prescription has been issued for a legitimate medical purpose. A licensee is prohibited from dispensing a prescription if the pharmacist “knows or should have known” that the order was issued without a valid pre-existing patient-physician relationship as defined in the Texas Medical Board’s administrative Rules. Interested pharmacists can find these Rules at §§174.4 and 190.8 in Title 22 of the Texas Administrative Code.
Internet pharmacies are expressly barred from dispensing a prescription unless such medication is for a valid medical purpose and the prescribing physician has conducted at least one in-person physical evaluation of the patient. Prescription by online questionnaire is explicitly noted as unacceptable. The Rule goes further to prohibit a pharmacist from dispensing medications in the absence of a valid patient-physician relationship or if the prescription is “otherwise in violation of the practitioner’s standard of practice.”
Plainly, the Pharmacy Board’s new Rule could be interpreted as imposing a wide-sweeping burden on Texas pharmacists to perform their due diligence and ensure they are not filling prescriptions that do not meet the appropriate medical standard of care or were prescribed without an in-person physical examination. The obvious target of the new regulation is pharmacists who are seen as functioning as the tail end of a “pill mill” whether such prescriptions are generated online or at a physician’s office. Pharmacists who fill large quantities of pain medications, particularly the popular chronic pain “cocktails,” or other suspect drugs such as cough syrup should be aware that under the new rule they could risk a disciplinary action by the Texas State Board of Pharmacy if a reasonable person would have known the prescriptions were not medically valid or were issued without a proper examination or physician-patient relationship. It is not simply enough that the pharmacist can disclaim actual knowledge; if a reasonable pharmacist should have known or suspected they were being asked to fill such prescriptions, they are potentially vulnerable to a disciplinary action by the Pharmacy Board.
It is important to stress that Section 291.29 refers back to parts of the Medical Practice Act and the Texas Medical Board’s own Rules to define what constitutes a non-therapeutic prescription or a valid patient-physician relationship. This may be confusing to Texas pharmacists who are unfamiliar with the law and regulations as it applies to physicians, However, as an attorney who has represented hundreds of physicians before the Medical Board, I can affirm the TMB takes a strict and conservative stance towards these same issues and regularly pursues practitioners whose primary practice involves the treatment of chronic pain on the basis that they engage in non-therapeutic prescribing of narcotics and related medications. The TMB is also zealous in pursuing physician’s engaged in telemedicine which does not conform to the strict standards outlined in their Rules on Telemedicine (which can be found at Chapter 174 in Title 22 of the Texas Administrative Code). Given the strong interweaving of Rule 291.29 with the Medical Practice Act, I its adoption was coordinated with the Texas Medical Board and that Pharmacy Board and TMB attorneys and Staff may start to synchronize their enforcement actions against “bad” physicians and the pharmacists who fill their prescriptions.
Thankfully, the recently adopted Rule does provide some guidance as to when a pharmacist should be on guard. Several potential warning signs of bad prescriptions are expressly listed: these include the number of prescriptions authorized on a day-to-day basis by a practitioner, the geographical distance between the practitioner and the patient, the manner in which the prescriptions are authorized and received by the pharmacy, and whether the pharmacist knows the prescriptions are issued based on a questionnaire or over the internet.
The bottom-line is Texas pharmacists need to be extra vigilant in confirming dispensed prescriptions were written in line with the applicable standard of care and were issued following a valid face-to-face medical examination. The adoption of §291.29 could potentially signal the beginning of a new round of enforcement actions by the Texas State Board of Pharmacy and any pharmacist unsure as to their possible liability would be wise to consult with an attorney familiar with the TSBP and the applicable legal standards.
As many pharmacists are aware, the Professional Recovery Network (PRN) is a peer assistance program designed to aid licensees seeking treatment and other assistance with problems related to alcohol and substance abuse as well as certain mental illnesses. In this role PRN can play a valuable part in helping troubled pharmacists receive the counseling and intervention they need to regain control over their lives while continuing to exercise their skills and expertise through their practice.
While PRN is commendable in this regard, a recurrent problem I encounter in representing pharmacists before the Texas State Board of Pharmacy is that PRN does not fully disclose upfront the significant limitations in their confidentiality protections and their captured role vis a vis the Pharmacy Board. As an attorney, I frequently see this lack of full disclosure on the part of PRN result in significant harm to a pharmacist’s ability to defend themselves in any related Board disciplinary action avoid the imposition of a severe and prolonged public disciplinary orders.
There are two primary ways in which pharmacists can become involved with PRN: These are through a referral, either by the individual themselves or a third party, or through a disciplinary investigation initiated by the Texas State Board of Pharmacy. In either case, PRN will take an initial history and likely perform an in-house assessment on the pharmacist licensee in addition to having the individual evaluated by an outside expert. Following this PRN, will present the pharmacist with a contract asking them to agree to participate for a number of years in a list of recovery activities and other requirements. This typically includes agreeing to complete an intensive inpatient or outpatient recovery program, regular attendance of AA or other support group meetings, submission to randomized drug testing, and potentially other restrictions focused on their ability to function as a PIC or working without being unsupervised by another pharmacist. Another mandated requirement is a consent form allowing PRN to turn the pharmacist’s entire file over to the Pharmacy Board in the event they fail to comply with any aspect of the agreement.
The fundamental problem is that up until this point pharmacists (even self-referrals) are not told that if they, for whatever reason, decide not to enter into the PRN agreement then PRN will forward their full file to the Pharmacy Board. Based on the stories of many of my clients, prior to this juncture licensees are assured that everything they tell PRN is confidential. As seen above, this is seriously misleading and, in my opinion, arguably illegal.
By this point the pharmacist has likely made numerous statements and admissions to PRN which will be turned over to the Texas State Board of Pharmacy and used as evidence in any disciplinary action. The licensee has probably also undergone an assessment with an addiction specialist or other mental health professional. This expert’s report will likewise be forwarded to the Board. With the receipt of the above damaging admissions and other evidence, which likely would not have been made had the pharmacist been aware that PRN does not, in fact, strictly maintain their confidentiality, the Board’s case is already fully formed and ready to prosecute. The licensee’s legal options at this time are likely very circumscribed even though this is often the first time they may consider contacting an attorney. With little room to maneuver, the pharmacist can essentially be forced to sign a public and long-term Agreed Order that significantly restricts their ability to function as an ongoing concern.
What pharmacist’s need to understand is that PRN is the Texas State Board of Pharmacy’s statutory peer assistance program under the Health and Safety Code and as such can function as an arm of the Board in disciplinary actions. The first and primary consequence of this captured status is the disclosure of supposedly confidential information to the Board. In the future I hope to write about other issues with this conflicting mandate and the way it can subvert PRN’s ostensible role as an agency set-up to encourage troubled pharmacists to seek need treatment and intervention.
The bottom-line is that every pharmacist who is dealing with or considering contacting PRN needs to be aware that any information or statements provided by them can be, and often is, turned over to the Pharmacy Board. Consulting with a Texas pharmacy license attorney either prior to or after you have made contact with PRN is likely a prudent step to ensure you aren’t unnecessarily jeopardizing your ability to continue practicing as a pharmacist..
In the past year the Texas State Board of Pharmacy has started attempting to strictly enforce their recent amendments to the Board’s administrative rules related to punishment for criminal offenses. These rules prescribe certain standard disciplinary sanctions for a wide-ranging list of specific offenses. Pharmacists with either a criminal record or a pending criminal case should take note as the sanctions involved are generally quite severe and can include revocation of a licensee’s registration by the Pharmacy Board.
For example, according to the guidelines a pharmacist who is convicted or placed on deferred adjudication/probation for a felony drug-related offense under Chapter 481 or 483 of the Health and Safety Code related to fraud, or the manufacture, delivery, theft, or possession with intent to deliver of drugs is subject to the denial or revocation of their pharmacist license until 20 years after the date of disposition. Even at the twenty year mark, the guidelines state the Texas State Board of Pharmacy’s intent to place the pharmacist on a five year probationary order.
For those pharmacists convicted or placed on deferred adjudication for the felony possession of drugs, the guidelines state that the Board will deny, revoke, or suspend the professional’s license if they are still on probation. Likewise, if the pharmacist is not on probation but it has been five or less years since the date of disposition, then they are eligible for a five year probationary order but only if they have first been evaluated by an addiction specialist who opines that they are safe to continue practicing pharmacy. Even if it has been over twenty years since the date of disposition, the TSBP still wants to place the pharmacist on a one year probationary order. Of additional note is that the guidelines apply essentially the same set of penalties to a pharmacist convicted or placed on deferred adjudication for misdemeanor possession.
It has been my experience as an attorney that the Texas State Board of Pharmacy tries to strictly adhere to these guidelines at the informal stage of the investigatory process only to become somewhat more receptive to mitigating evidence and other factors once a case has been filed at SOAH. Unfortunately, I have seen many pro se or poorly represented pharmacists accept the Board’s settlement offer, however harsh, at the informal stage out of sense that nothing better is possible.
Legally speaking, the TSBP’s sanction guidelines are only just that: guidelines. Although an Administrative Law Judge will give the guidelines some deference at a formal administrative hearing, Pharmacy Board attorneys are still required to show that under the specific factors present in that case, the requested sanction is warranted. On the flipside, it is the burden of the pharmacist and their attorney to draw out the mitigating factors and demonstrate why a lesser sanction is in order. This necessarily demands an intimate and working knowledge of the rest of the Pharmacy Board’s rules, the Texas Pharmacy Act, and other pertinent sections of the Texas Occupations Code, including Chapter 53, as to first, what are the relevant mitigating factors and second, how to get them into evidence.
Every pharmacist with a criminal record or a pending criminal case should be aware of the Texas State Board of Pharmacy’s new sanction policies. If you are in such a situation I strongly advise that you contact an attorney experienced in administrative law and representation before the Texas State Board of Pharmacy to discuss possible outcomes and preemptive courses of action.
Recently, the Texas State Board of Pharmacy has been engaging in a far-reaching investigatory sweep aimed at identifying unlicensed pharmacy technicians and pharmacy technician trainees. Pharmacists in the state of Texas need to be aware of these actions and any pharmacists ensnared by the Texas State Board of Pharmacy should contact an experienced professional licensing attorney immediately.
Recently, my firm has experienced an onslaught of calls from pharmacists whose pharmacies have been raided by Board investigators searching for the presence of unlicensed pharmacy technicians and pharmacy technician trainees, a violation of §§ 297 and 295.3 of Title 22 of the Texas Administrative Code. This is important as under § 295.3 of the Pharmacy Board’s Rules the pharmacist-in-charge has a standing duty to ensure the pharmacy is in compliance with all applicable laws and rules. This includes making sure that all employees are properly licensed. The usual result is a sizable administrative penalty and permanent mark on the pharmacist’s licensing record.
These violations are largely procedural: Pharmacy Technicians not paying renewal fees as required by § 297.4, or Techs are not properly applying for their temporary license, or not applying at all. Pharmacists need to be aware of the licensing status of their Technicians and Technician Trainees and should verify this on the Pharmacy Board website.
Oftentimes, early intervention by an experienced licensing attorney can defuse the situation and placate the Texas State Board of Pharmacy. The usual result in this type of case is an administrative penalty and a permanent mark of the pharmacist's licensing record. Under the applicable statutes and rules, however, the Board has the authority, and sometimes elects, to pursue a more serious sanction including the imposition of various encumbrances on the pharmacist's license which make it very difficult for them to continue as an ongoing concern.
If you are being investigated for this or any other reason, I strongly advise you to immediately contact an attorney familiar with the Pharmacy Board as they are one of the most aggressive state licensing Boards in Texas.
Within the last two weeks my firm has signed on as clients two pharmacists who have encountered first-hand the aggressive tactics used by investigators at the Texas State Board of Pharmacy. This is something I feel all pharmacists and pharmacy technicians need to be aware of so they do not inadvertently damage themselves or accidently forfeit their right to contest the Board’s charges.
The day after I had sent in my letter of representation to the Pharmacy Board regarding the first client, the pharmacist contacted me by phone to tell me that a Board investigator was at her pharmacy asking her to sign a sworn statement admitting to the Board’s allegations. I asked her to transfer the phone to the investigator who stated that he was not aware that my client was represented by an attorney. He apologized and it was clear that he was genuinely unaware that the pharmacist was represented. Nonetheless had my client been unable to get in contact with me at that moment she may have made potentially harmful admissions.
The second client informed me that the evening before he retained me an investigator showed up at his home to essentially interrogate him and, again, have him sign a sworn statement admitting to the Board’s allegations. The investigator represented himself as both an employee of the Board and a licensed peace officer. He asked numerous loaded questions in his quest for additional allegations and also told the pharmacist how lucky he was that the Board did not turn his matter over to the local prosecutor. Thankfully, my client had the good sense not to tell the investigator anything or sign any statements.
These two experiences are unfortunately typical. Oftentimes the first time a pharmacist even learns that they are being scrutinized by the Board is when an investigator suddenly shows up at their home or place of employment demanding records and signed confessions. Duly intimidated by the Pharmacy Board’s strong-arm police tactics the licensee frequently signs a premade confession or discloses potentially damaging information without first consulting an attorney.
Make no mistake, despite any entreaties to the contrary the Board and its investigators are not your friends and they are not there to objectively assess the allegations to determine their merit; they are there to build the Board’s case against you and parse out info that can lead to additional allegations. I emphatically recommend that as soon as an investigator is at your door to politely decline talking with them or giving any statements and immediately contact an attorney with experience before the Texas State Board of Pharmacy. At that point your livelihood and reputation are plainly at stake. Do not try and go it alone and do not think you can “work things out” with the investigator.
Texas State Board of Pharmacy Overreaches Statutory Mandate Regarding Deferred Adjudications/Community Supervision:
I am currently serving as the defense attorney in several cases before the Texas State Board of Pharmacy that involve clients who are presently on deferred adjudication/community supervision for drug related offenses. In all of these cases the Board has taken the position that their Rules mandate the outright revocation of the license of any pharmacist or pharmacist tech who is on community supervision or probation for a felony drug related offense regardless of the circumstances or any other factor. This is outrageous and a clear contravention of their statutory mandate.
All administrative licensing agencies are creatures of statute and accordingly must derive their authority to regulate from law passed by the state Legislature. The Texas Pharmacy Act sets forth the public mandate of the Texas State Board of Pharmacy in § 551.002 of the Texas Occupations Code. This Sections states that it is the purpose of the Pharmacy Act and the Pharmacy Board “to regulate in the public interest the practice of pharmacy in this state as a professional practice…” in such a way that will “promote, preserve, and protect the public health, safety, and welfare.” Tex. Occ. Code § 551.002. Try as it might, the Board must regulate and discipline pharmacists while remaining within the confines of this public mandate.
In defiance of § 551.002, the Board has, within the past three years, passed and frequently amended Title 22 § 281.64 of the Texas Administrative Code in such a way as to make it impossible for any pharmacist or pharmacist tech to retain their license if they are also placed on deferred adjudication. For example, under Rule 218.64 any pharmacist or pharmacist tech who has been convicted of or is currently on deferred adjudication or deferred disposition for a felony involving either 1) mere possession or 2) the manufacture, delivery, or possession with intent to deliver, fraud, or theft of drugs is automatically subject to the revocation or denial of their license. This is without regard to the individual’s culpability, rehabilitation, age at the time of offense, or current fitness to serve as a licensed pharmacist or pharmacist tech. In many situations the pharmacist is not even deemed eligible for licensure until 20 years has passed since the date of disposition.
This Rule is in clear conflict with the Board’s statutory mandate. That mandate requires the Board to regulate “in the public interest” and in such a way that will “promote, preserve, and protect the public health, safety, and welfare.” Tex. Occ. Code § 551.002. Licensure revocation based merely in the bare fact of being on community supervision or probation for a drug-related offense satisfies neither of these standards. This Rule takes no account of the pharmacist or pharmacist tech’s extent of involvement in the criminal offense, whether they were even aware a criminal offense was being committed, or whether their participation was minimal or expansive. No account is taken of the licensee’s subsequent rehabilitation, their youthfulness at the time of the offense, or their present and future value to the community. The only thing that matters is whether or not twenty years have passed since the date of disposition.
Keep in mind that under Chapter 53 of the Texas Occupations Code licensing agencies such as the Pharmacy Board are required to take into account a set of specified mitigating factors, many of which are listed above, when taking a disciplinary action against a licensee who has actually been convicted of the same offense. Arguably on this ground alone, the Pharmacy Board’s Rule 281.64 is ultra vires (A Latin phrase crucial to administrative law which translates as “beyond the powers”) and hence void.Continue Reading...
Last week I resolved three cases involving pleas of guilty or no contest to drug / alcohol related offenses and the subsequent investigations and prosecutions by the individual Client’s respective State licensing Board(s):
- The Texas Optometry Board
- The Texas State Board of Pharmacy
- The Texas Medical Board
In each case, although the Board did not have jurisdiction to discipline for the criminal status in-and-of-itself, each agency found a way to link the conduct (the actions behind the commission of the criminal offense) to the Client’s occupational practice and attempt to resolve the matter through a reasonable agreed order.
Neither the Texas Pharmacy Act nor the Texas Optometry Act afforded jurisdiction to the agency to discipline the license holder for the court ordered felony deferred adjudication probation(s). However, public scrutiny being what it is, each Board simply stated that the conduct was egregious and unbecoming of a licensee. Moreover, the Board’s mission was to protect the public and each agency felt this was something the public should know about.Continue Reading...
Authorized under Chapter 564 of the Pharmacy Act, the Professional Recovery Network (PRN) offers a means for chemically dependent and/or mentally ill pharmacists and pharmacy students to confidentially enter a recovery program with the goal of integrating them back into professional practice. Founded by the Texas Pharmacy Association, PRN provides an incentive for pharmacist’s suffering from mental illness or chemical dependency to commit to early treatment and thereby avoid additional harm to the public and themselves.
A person who has who has knowledge of an act or omission by a pharmacist that could provide grounds for discipline under Section 565.001(a)(4) or (7) of the Pharmacy Act- mental illness and intemperate use of drugs or alcohol respectively- may report the license holder to the PRN. In addition to such reports by concerned colleagues and family members, pharmacists and students are encouraged to self-report to PRN. The Pharmacy Board may also refer the professional to PRN in lieu of a disciplinary proceeding. Once PRN receives a report they will contact the pharmacist, if it was not a self-report, and refer them to a mental health evaluator. After meeting the mental health evaluator, the pharmacist will enter into a Recovery Support Agreement with the PRN committing themselves to treatment and recovery. The Agreement will outline the proposed treatment program and include specific recommendations made by the evaluator. By entering into the Support Agreement, the pharmacist or student will also consent to maintaining contact with the PRN Staff and an assigned mentor, providing written quarterly reports, and, if appropriate, undergoing random drug screens. The pharmacist’s mentor, who is either a pharmacist with a long history of sobriety or extensive experience in a twelve-step program, is there to support, advise, and advocate for the professional throughout treatment.Continue Reading...
A combination of increased competition from large chain brick-and-mortar pharmacies, mail-order refills, and the rise of the internet as a medium for both legal and illegal activity have driven many unsuspecting pharmacists into the dangerous world of “internet pharmacy.” Since at least 1999, various federal agencies led by the Drug Enforcement Agency and the FDA have combined efforts with state law enforcement and state licensing boards to crackdown on internet pharmacies. The result has been the revocation of professional licenses, stiff fines, and long prison sentences. Many of the pharmacists victimized by this legal dragnet have been severely prosecuted simply because they failed to exercise enough caution when entering the minefield of internet pharmacy.
The target of these law enforcement and regulatory efforts follows a typical pattern of organization and prescription/dispensing process. Oftentimes pharmacists and physicians will be approached by a “facilitator”, which may be in the form of a corporation or other entity who are seeking licensed medical personnel to participate. Fees are often paid on a per prescription basis and can be supplemented with generous handling fees for the pharmacists and consulting fees for the doctors. Such facilitators will point to doctors and pharmacists who have already signed on to give their business plan a deeper air of legitimacy and better induce the medical professional(s) to join.
Once the internet pharmacy contracts the necessary professionals, the prescription and dispensing of controlled substances begins. The patient, who may or may not be legitimate, first tries to order a drug online and is then asked to fill out a preliminary questionnaire which will be viewed by a physician. This doctor, who usually never sees the patient and often lives in a different state, reviews the questionnaire and prescribes the requested medication. The prescription is then transmitted to the pharmacist, who can be in yet another state, who fills it and ships it to the patient. Unfortunately, this process, especially the absence of a proper examination and diagnosis, violates most States’ regulatory rules and exposes all participants to administrative and criminal action.Continue Reading...