Verification of Controlled Substance Rxs

Verification of Controlled Substance Rxs

Jesse C. Vivian, B.S. Pharm., J.D.
Professor, Department of Pharmacy Practice and Allied Health Professions,Wayne State University, Detroit, MI

Pharmacists learn very early in their careers that they have a legally required duty to verify the validity of prescriptions that call for controlled substances (see SIDEBAR). Filling prescriptions that have not been issued for legitimate medical purposes can result in all kinds of negative sanctions including loss of state pharmacist licenses and revocation of federal controlled substances registration for the pharmacy. Accordingly, pharmacists routinely take steps to insure that the prescriber is authorized to issue a controlled substance prescription and has done so within a legitimate physician-patient relationship for a therapeutic purpose. If the verification process is not handled with a great deal of caution and sensitivity, the legitimate patient may be offended to think that a pharmacist is questioning his or her honesty. This could, of course, jeopardize patient loyalty and adversely affect prescription volume and profits, leading employers to consider that verification duties are adverse to the pharmacist employee-employer relationship. Thus, a tension exists between a pharmacist’s legally mandated duty to verify controlled substance prescriptions and duties owed to the employer. A recent case from the Utah Supreme Court discusses the fine line between the verification duties of pharmacists and the rights of employers to operate a pharmacy in an orderly fashion.1

21 CFR § 1306.04(a) states:

A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is on the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

The pharmacist-plaintiff was interviewed by the president of the corporate defendant for a pharmacist’s position in 1993. The pharmacist stated that he had been fired by his previous employer because he reported another employee for stealing narcotics. The president responded that he would never take action against a pharmacist for following the law and, in fact, expected his pharmacists to do everything “by the book.” The pharmacist was hired and signed an acknowledgment form that he received and read the corporation’s employee handbook. That handbook contained an “at will” employment clause, meaning that employees could be terminated with or without cause.

Over the next 18 months, 30 complaints about the pharmacist’s rude behavior and poor treatment were received by the store management. In many instances, the pharmacist had angered patients after questioning their controlled substance prescriptions. On other occasions he told patients that he was out of stock on drugs that were in stock just to avoid filling the prescriptions. Managers repeatedly counseled the pharmacist on the proper treatment of patients and warned him about the excessive complaints. During this same period of time, the pharmacist received five letters of commendation, three of which were from police agencies, complimenting him on his thoroughness in detecting fraudulent prescriptions. The pharmacist was fired in 1995 and told that he was being terminated because of the continued complaints about him from patients.

The pharmacist filed a lawsuit claiming that he was fired in violation of an implied contract and for reasons that violate public policy. The corporation denied the charges. The trial court granted the corporation’s motion for summary disposition and dismissed the complaint.

The pharmacist asserted that an implied contract was created when the president of the company stated that the pharmacist would not be reprimanded for following the law. The Supreme Court dismissed this argument because the pharmacist subsequently signed the acknowledgment form in the employee handbook that contained the at-will employment clause. This clause, stated the Court, modified and superseded any implied promise made by the president.

As to the public policy claim, the pharmacist alleged that he was fired for questioning the validity of patients’ controlled substance prescriptions as mandated by federal law. As a general matter, most states have adopted some form of employee protection against employer retaliation when an employee refuses to break a law or otherwise follows some legal requirement against the wishes of the employer. In this case, the pharmacist claimed that the federal verification law requires pharmacists to check on prescriptions that are “unusual.”2 He also claimed that it is the policy of the state to require pharmacists to check the validity of prescriptions to determine if they were issued in the usual course of treatment.

A majority of the Supreme Court justices concluded that while the federal regulation at issue does indeed embody a public policy, that policy only prohibits pharmacists from knowingly filling improper prescriptions. The majority opinion states:

Section 1306.04 does not mandate or even authorize a pharmacist to question every prescription or to conduct an investigation to determine whether an otherwise facially valid prescription has been issued other than in the “usual course” of the doctor’s practice. But when faced with a prescription that is irregular on its face—”no date, no physician signature, an obviously toxic dose”—section 1306.04 requires further inquiry.3 However, after inquiring and obtaining the necessary information, a pharmacist cannot use section 1306.04 as a basis to refuse to fill a prescription. Therefore, section 1306.04 does not set forth the public policy [pharmacist] suggests—it does not establish a policy requiring pharmacists to verify prescriptions.

The Court went on to “easily conclude” that the regulation does not contain a clear and substantial policy prohibiting an employer from firing pharmacists for questioning prescriptions. Assuming, however, that the regulation does advance a public policy of the type asserted by the pharmacist, the Court concluded that the pharmacist failed to establish that he was terminated for questioning the validity of prescriptions. The defendant showed ample evidence that the pharmacist was fired for rudeness and angering patients.

One judge of the Supreme Court filed a concurring opinion in which she agreed that the employer was justified in firing the pharmacist for rudeness and the poor treatment of patients. She chided that majority’s interpretation of the federal verification regulation stating that it is “unnecessary and probably unwise to engage in extensive analysis about the public policy question.”

The majority opinion is troublesome for several reasons. It narrowly construes a fairly specific federal statute that has been interpreted for many years to require pharmacists to verify the validity of prescriptions and to refuse to dispense controlled substances if the prescription is not valid.4 However, in the face of many precedents to the contrary, it states that pharmacists are only to question a prescription that is “irregular on its face.” By “irregular,” the Court means that information is missing, such as the date or the physician’s signature, or that the dose is obviously toxic. It is only when this information is missing or incorrect, according to the Court, that a pharmacist has a duty under the regulation to ask questions. Under this Court’s interpretation, the regulation “does not mandate or even authorize a pharmacist to question every prescription or to conduct an investigation to determine whether an otherwise facially valid prescription has been issued other than in the ‘usual course’ of the doctor’s practice.”

This narrow reading of the regulation fails to take into account the clear duty of pharmacists to determine that the prescription was issued for a legitimate medical purpose. The question most courts ask, at least in the context of a case where a pharmacist is charged with illegal distribution of controlled substances, is whether the pharmacist knew that the purported prescription was not issued for a legitimate medical purpose or in the usual course of medical practice.5 In such a case, the key element of knowledge is shown by proof that the pharmacist deliberately closed his eyes to the true nature of the prescription.6 In the present case, the Court’s narrow interpretation of the federal regulation completely ignores the level of duty and knowledge required of pharmacists.

It is also troubling that the majority opinion concludes that the regulation “does not establish a policy requiring pharmacists to verify prescriptions.” A substantial line of case law indicates the opposite is true.7 It is fairly clear that pharmacists do, in fact, have a well-established duty to verify the legitimacy of controlled substance prescriptions and face onerous penalties for failing to do so.

Why the disconnect between this Court’s reading of the regulation and those of so many other courts? The majority may have felt compelled to address the pharmacist’s concerns and rationalize why the employer should retain the right to fire him without being liable for violating a public policy against retaliation. Unfortunately, the majority fails to realize the damage that may have done in taking this approach. Lawyers might erroneously counsel pharmacists not to question controlled substance prescriptions out of concern for their employment status. Worse, pharmacists might dispense controlled substances to illegitimate sources rather than risk employment termination over angering a patient who may or may not have a right to these medications.

It would have been better for the majority to say that the verification duty imposed by federal law does not give a pharmacist the right to be rude and disrespectful of patients. The Court also could have stated that the regulation does not give pharmacists the right to lie and say the pharmacy is out of stock of a particular medication when that is not true. The best course of action would have been to follow the advice of the concurring judge and say simply that the evidence showed the pharmacist was fired for rudeness and not for violating his duty to question the legitimacy of prescriptions.

In any event, despite the lack of clarity on the part of the majority of judges in the case, pharmacists must still verify that controlled substance prescriptions have been issued for proper reasons. Employment concerns aside, that is still the law. If anything, this case makes clear that in following this duty, pharmacists must still use civility and common sense to minimize the risk of offending patients, even those who present questionable prescriptions.

1. Ryan v. Dan’s Food Stores, Slip Op. No. 970213 (August 18, 1998), 1998 Utah Lexis 64. 2. 21 CFR § 1306.04(a) states, in part, that to be legitimate, a prescription must be issued in the “usual course of professional practice.” 3. Here, the court cites Kampe v. Howard Stark Prof. Pharmacy, 841 S.W.2d 223, 226 (Mo. Ct. App. 1992) in support of its interpretation. This is an interesting use of case law precedence because Kampe is a malpractice case in which the pharmacist argued that the regulation imposed a duty on pharmacists to advise patients on the appropriateness of drugs that have been prescribed for them. The Missouri Court of Appeals rejected that argument. It is difficult to understand how these cases are related. 4. United States v. Hayes, 595 F.2d 258 (5th Cir.) cert. denied 444 U.S. 866, 62 L. Ed. 2d 89, 100 S. Ct. 138 (1979); United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980) cert. denied 449 U.S. 869, 66 L. Ed. 2d 89, 101 S. Ct. 206 (1981); United States v. Kershman, 555 F.2d 198, 200 (8th Cir.) cert. denied, 434 U.S. 892, 54 L. Ed. 2d 178, 98 S. Ct. 268 (1977). United States v. Lawson, 682 F.2d 480 (4th Cir.) cert. denied, 459 U.S. 991 (1982). 5. United States v. Hayes, 595 F.2d 258, 260 (5th Cir.) cert. denied 444 U.S. 866, 62 L. Ed. 2d 89, 100 S. Ct. 138 (1979). 6. United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980) cert. denied 449 U.S. 869, 66 L. Ed. 2d 89, 101 S. Ct. 206 (1981); United States v. Kershman, 555 F.2d 198, 200 (8th Cir.) cert. denied, 434 U.S. 892, 54 L. Ed. 2d 178, 98 S. Ct. 268 (1977). 7. See Note 5, supra.