TSBP Adopts New Rule Requiring Pharmacists to Verify Prescriptions Meet Applicable Medical Standard of Care
Posted Jun 30 2010 9:21am
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.