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.
Internet Pharmacies: TSBP & Federal Investigations & Prosecutions
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.
In addition some patients are not legitimate recipients of medical drugs. Many are actually drug dependent or even drug dealers who like the quick and anonymous access to controlled substances provided by the internet and Cash on Demand delivery. It is not uncommon for such unscrupulous individuals to sell their ill-begotten medication for double the price paid.
The potential danger presented by these prescribing practices has led law enforcement and administrative agencies to zealously prosecute internet pharmacies which follow the above pattern. For example, in 2003 ten individuals and three companies were prosecuted under a 108-count indictment for illegally selling prescription drugs over the internet to patients who had never seen a doctor. The defendants included six physicians and two pharmacists who were charged with violations of the Federal Drug and Cosmetics Act for improperly placing into interstate commerce mislabeled drugs and controlled substances. One pharmacist admitted to dispensing at least 9,055 prescriptions for non-controlled substances, and 43,066 prescriptions for Schedule III and IV controlled substances. He was sentenced to sixty months incarceration and was ordered to pay a $140,318.
A 2003 case focused on the website Kwikmed.com and its affiliates. The website allowed a consumer to purchase prescription drugs after filling out a health and symptom questionnaire which were supposedly being reviewed by a physician. The indictment alleged that in fact the majority of cases involved no such review, let alone an actual physical examination. One of the physicians associated with the website plead guilty to five felony counts including conspiracy, introduction of misbranded drugs into interstate commerce, failure to register as a drug manufacturer, mail fraud, and conspiracy to commit money laundering. This indictment was the result of investigations by the FDA and U.S. Postal Service.
These cases are the result of stepped up efforts of federal and state agencies and law enforcement to eliminate certain internet pharmacies and punish those involved with them. The Department of Justice has made clear since 2001 that their focus has been on web sites that involve a questionnaire without any physical examination or any confirmation of the patient-supplied answers. In 2004, the Office of National Drug Control and Policy announced the President’s National Drug Control Strategy for 2004. The policy included increased efforts and budgeting directed towards a crackdown on internet pharmacy including the authorization of such hi-tech police techniques as web crawlers and data mining to locate and prosecute illegal “pill mills.” The Policy also called for better cooperation between the FDA, DEA, FBI, IRS, various other federal agencies, and state agencies and law enforcement in finding and shutting down such illegal activity.
State agencies have also made it clear that they will not tolerate this form of internet pharmacy. For example, the Texas State Board of Pharmacy has explicitly stated that internet pharmacy which is based on either an online or telephonic consultation, such as a questionnaire, without a valid patient-physician relationship is illegal and can subject a pharmacist or physician to discipline and possible criminal action. The statutory and regulatory basis for their conclusion begins with Section 483.021(a) of the Texas Dangerous Drug Act which mandates that a pharmacist determine prior to dispensing a prescription that, in their professional opinion, the prescription is valid. Further, Section 291.34(b)(1)(B) of the Texas Pharmacy Rules holds that for a prescription to be valid it must be based on a valid patient-physician relationship. Finally, according to the rules of the Texas State Board of Medical Examiners, physicians who use the internet “must establish a proper physician-patient relationship, which at a minimum includes:
- establishing that the person requesting the treatment is in fact who the person claims to be;
- establishing a diagnosis through the use of acceptable medical practices such as patient history, mental status exam, physical examination, and appropriate diagnostic and laboratory testing to establish diagnoses and identify underlying conditions and/or contraindications to treatment recommended/provided;
- discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options; and
- ensuring the availability of the physician or coverage of the patient for appropriate follow-up care.
The mere use of a physician review questionnaire completed under the honor-system cannot meet this standard and can imperil both a pharmacist and physicians’ license, not to mention expose them to criminal sanctions.
The condemnation of “questionnaire” prescribing is not limited to Texas. In 2000, a special committee on conduct and ethics of the Federation of State Medical Boards noted that the “prescribing of medications by physicians based solely on an electronic medical questionnaire clearly fails to meet an acceptable standard of care and is outside the bounds of professional conduct.” The American Medical Association has concurred with this statement stating that such practice does not meet the requisite standard of medical care. In 2001, the California State Board of Pharmacy fined Total Remedy and Prescription Center $88 million and charged two of its pharmacists with filling prescriptions in violation of that state’s rule requiring a prior good faith examination by a doctor with a California license.
Many of the targets of this war on internet pharmacy are simply everyday professionals who were simply looking for a new source of business without a proper awareness of the very real legal traps present in internet pharmacy. If a doctor or pharmacist enters online pharmacy and only later does it come out that his or her partners have not been following the rules, the authorities will still try and hold the otherwise innocent practitioners liable for their partners’ malfeasance. A claim of ignorance, even if genuine, will not stop a prosecution or disciplinary action from being initiated. In fact, my law office has represented individuals who have gone so far as consulting an attorney and hiring a private investigator to determine the legality of the online pharmacy with which they were doing business.
The world of internet pharmacy can be a dangerous place for all those involved. The current crackdown on internet pharmacy and its participants shows every sign of continuing. Any physician or pharmacist considering entering such a venture or who already practices in one should exercise extreme caution. An informed professional can better protect themselves by requiring such assurances as VIPPS or SquareTrade Licensed Pharmacy Program certification of all websites before entering into a business arrangement. Developed by the National Association of the Boards of Pharmacy and the National Community Pharmacists Association respectively, these certifications mandate that internet pharmacies conform to certain practice guidelines. Further, a doctor or pharmacist would be wise to consult with an attorney knowledgeable with the fast developing law affecting internet practice. The worst course a professional could take is to ignore any warning signs such as inconsistent prescriptions or suspect practices, as deliberate ignorance of possible violations of state and federal law will not provide a defense to later investigation(s) or prosecution(s). The consequences of doing so amid the current regulatory climate are simply too dire.
