The Prescription Drug Abuse Problem.
The reality of living in 2012 in the State of Texas for a health care professional with prescriptive authority is that our state is currently mired in a growing prescription drug abuse problem. Because of this growing epidemic, law enforcement (both federal and state) and regulatory agencies have devoted significant time and resources in efforts to wage a full-out assault to curb this issue. There are no shortage of news reports or newspaper articles on this growing epidemic. As an example, the firm recently linked to a story appearing in the Austin-American Stateman via our twitter page, “Texas readies a new weapon against ‘doctor shopping’ for prescription drugs.”
Potential Issues Facing Texas Pharmacists.
If you are a pharmacist who owns and/or operates an independent pharmacy with a practice that has or currently dispenses any measurable quantities of alprazalom, hydrocodone, carisoprodol, and/or or other combinations of controlled substances for patients who have or claim to have been treated by pain management clinics and/or pain management specialists in Texas, chances remain high that you may be the current subject of an investigation by several different state and federal agencies. The end result is an exposure to criminal charges, the possible loss of your DEA/DPS certificate, and/or ultimately, the temporary or permanent loss of your pharmacy/pharmacist license(s). If you fit these criteria and also reside and practice in the greater Houston area, your chances grow even more exponentially because of the increased activity from law enforcement and regulatory authorities in this particular geographical area.
The TSBP and its Authority to Temporarily Suspend a Pharmacist and/or Pharmacy's License(s).
Like most health licensing boards, the Texas State Board of Pharmacy (TSBP) is vested with the ultimate statutory tool to safeguard the public interest, the temporary suspension of one’s license. This is an extraordinary measure and usually licensing boards reserve this remedy for the most egregious of matters. However, the recent trend at the TSBP is to use this measure as an offensive mechanism, forcing the pharmacist and pharmacy in a defensive posture from the onset. The TSBP, usually after a protracted investigation with other agencies, has been pursuing pharmacists and pharmacies using this measure as a means to eliminate the prescription abuse problem. Although notice and hearing are not required under the statute, the TSBP usually provides notice and a hearing before a three member panel of their executive Board consisting of two pharmacists and a public member. These Board members are usually flanked at the hearing by the Board's General Counsel, a litigation attorney, and any number of potential witnesses. The ability for a licensee faced with a temporary suspension hearing and one's ability to prepare and prepare effectively is made considerably more difficult given that one only receives approximately two weeks or less from the date of notice to the actual hearing. This problem is exacerbated because little, if anything at all, regarding the type of evidence that the TSBP is prepared to produce is known in advance.
The Temporary License Suspension Process at the TSBP.
By statute, the temporary suspension is to determine whether the pharmacist and/or pharmacy’s continuation in practice would constitute a continuing threat to the public welfare. However, this is far from what occurs at these hearings as the TSBP staff generally focuses on the underlying allegations and attempts to make its case regarding the underlying alleged violations. In its petition, the TSBP generally has alleged a laundry list of allegations based on violations of several federal and state statutes as well as the Board’s own rules. In essence, the TSBP staff will allege that a pharmacist/pharmacy, as required, failed to exercise sound professional judgment that a prescription is valid. By statute, a pharmacist may not dispense a controlled substance if he or she knows or should have known that the prescription was issued without a valid patient-practitioner relationship. See Texas Controlled Substances Act, TEX. HEALTH & SAFETY CODE § 481.074(a)(2). Moreover, he or she “may not dispense a prescription drug” if he or she “knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship.” See 22 TEX. ADMIN. CODE § 291.29.
The crux of the issues will likely turn on the allegation of unprofessional conduct. The TSBP defines “unprofessional conduct” to include dispensing a prescription drug order that is not issued for a legitimate medical purpose or in the usual course of professional practice, and dispensing a prescription drug while not acting in the usual course of professional pharmacy practice. See 22 TAC § 281.7(2)(A) and (20). In determining whether a pharmacist dispensed a prescription that was not issued for a legitimate medical purpose or in the usual course of professional practice, the TSBP can consider whether the pharmacist knew or reasonably should have known that the controlled substance or dangerous drug was not necessary or required for the patient’s valid medical needs or for a valid therapeutic purpose. See 22 TAC § 281.7(2)(A)(ii).
Considerations in Defending Against the Temporary License Suspension Action.
The defense in these proceedings requires a careful examination of the pharmacist/pharmacy’s action/conduct relative to these requirements. A pharmacist, if he or she is to be successful, must provide sufficient evidence to demonstrate that he or she made every reasonable effort. Although simplistic in nature, these proceedings are extremely difficult as a whole because of the difficult standards that appear to continually shift depending upon the panel and the TSBP's staff changing tactics. Although the three member panel should be impartial, it is more often the case that they give deference to the positions advanced by the TSBP staff. It appears that there is a pervasive belief that the pharmacist/pharmacy is part of a larger problem based on the quantity of controlled prescriptions dispensed and the pharmacist/pharmacy’s association (whether official or not) to pain management clinics/practitioners. This, unfortunately, tends to cause an unintended consequence to the pharmacist/pharmacy in guilt by association effect.
In any well-crafted defense, careful attention must be paid to the reasonable efforts taken by the pharmacist/pharmacy to ensure that the prescriptions have been issued for a legitimate medical purpose. Admittedly, and in other cases that I have handled, these cases are challenging because the TSBP staff’s sole motivation is to shut down the practice of the pharmacist and pharmacy and they have made very little effort to hide their disdain for these pharmacists/pharmacies because the TSBP staff believes that the pharmacist/pharmacy is contributing to the problem of the “pill mill” perpetuated by those pain management clinics and/or practitioners. Finally, and although the statute does provide for a mechanism to have this matter heard before an independent forum to the extent that a temporary suspension order is entered—an administrative law judge at the State Office of Administrative Hearings and/or a state district judge in state district court—these avenues are usually pursued after the TSBP panel has entered an order temporarily suspending the licenses of the pharmacist/pharmacy and from a tactical vantage, tis puts the TSBP in a very advantageous position procedurally.