CHAPTER
7
STATE REGULATION OF PHARMACY PRACTICE
CHAPTER OBJECTIVES
Upon completing this chapter, the reader will be able to:
▶ Identify the advantages and disadvantages of government regulation of professional practice.
▶ Describe the purpose of a state board of pharmacy.
▶ Recognize the functions of a state board of pharmacy.
▶ Discuss the grounds for disciplinary action against a licensed pharmacist.
▶ Describe the process through which disciplinary action is taken against a licensed pharmacist.
▶ Describe state regulation of institutional pharmacy practice.
▶ Discuss state regulation of third-party prescription programs.
▶ Describe the movement toward regulating for outcomes.
As discussed throughout previous chapters, the states regulate the practice of pharmacy directly through their police powers and the Tenth Amendment to the U.S. Constitution. The collection of state laws and regulations directed at pharmacies and pharmacists in a particular state is often called the pharmacy practice act. All pharmacists must have a thorough knowledge of the pharmacy practice act of each state in which they are licensed. Although state practice acts have many similarities, they also have many differences. It would be impossible in this book to attempt to discuss individual state laws and regulations. The intent of this chapter is to provide an overview of the state regulation of pharmacy practice so one can better understand the pharmacy practice act in a particular state.
American pharmacists purposely chose to become self-regulating healthcare professionals rather than externally regulated retail merchants. This conscious choice occurred during the last half of the nineteenth century, a time during which pharmacy emerged from other retailing activities as a significant component of the developing healthcare system. With most retail products, the tradition had been caveat emptor (let the buyer beware). However, pharmaceuticals sold at retail were among the first products in this country to which a new tradition of caveat vendor (let the seller beware) became applicable. Rules were developed to regulate the retail sale of pharmaceuticals. Many of these rules dealt with the sale of poisons and the requirement for appropriate labeling of such products, as well as records of those to whom they were sold. There were early lawsuits filed against pharmacists in the middle of that century, and these lawsuits held pharmacists liable for negligence in supplying the wrong medication to patients or for adulterating compounded products provided to patients. The notion that a provider of products could be liable for negligence was a new concept in the law, and it is no coincidence that it developed, at least in part, as the result of concern over the harm that could occur from the inappropriate use of pharmaceuticals.
By the beginning of the twentieth century, pharmacists had organized themselves and had developed clear systems of self-governance. This was an important development because it provided a framework for the organization and enforcement of federal drug laws that were soon to come. Had this state-level system of professional regulation not existed, federal authorities might well have sought far more extensive control over the practice of pharmacy. Lawyer-pharmacist James Hartley Beal and other pharmacy leaders were instrumental in the development of pharmacy as a self-regulated profession.
TAKE-AWAY POINTS• Self-regulation of the pharmacy profession began in the late nineteenth century.
• Self-governance continues at the state level, which limits the federal authority over the practice of pharmacy.
Varying countries use different approaches to regulation. In some countries, any drug can be purchased without a prescription, and anyone can be a pharmacist. Because there have been no widespread reports of mass deaths from adverse drug reactions in those countries, the open market system apparently works well there.
However, every country seems to aspire to the approach used by the United States and other developed countries. In most developed countries, licensed physicians prescribe medications, licensed pharmacists dispense them, and there are strict controls on who may be a physician or pharmacist. A lack of resources or some other practical barrier, rather than a lack of agreement with the underlying policies, is generally the reason that a country has not adopted this approach.
In the United States, it was only during the last part of the nineteenth century that states began to regulate professional practice through licensure. It was not until 1938 that pharmaceutical manufacturers were permitted to label their drugs for purchase only pursuant to a prescription. The formal classification of certain drugs as prescription only (i.e., limited to distribution by pharmacists on authority of a physician’s prescription) took effect relatively recently—in 1952. Thus, the use of licensure to control drug distribution does not have a long history.
Nevertheless, licensure appears to be a cornerstone of U.S. commerce, at least insofar as professional expertise is concerned. Unlike certification, which officially recognizes particular individuals as qualified but allows those not certified to offer the same services, licensure permits only those officially recognized as qualified to provide the service.
REASONS TO REGULATE PROFESSIONS
The justification generally given to require licensure for healthcare providers is that people without specific training cannot distinguish between qualified and unqualified providers, and people who need health care must be protected from unqualified providers. With regard to pharmacists, the objectives of licensure are threefold:
1. To increase the quality of health care
2. To reduce the cost of health care
3. To inhibit the criminal abuse of drugs
In theory, the licensure of pharmacists increases the quality of health care because patients receive the correct medication and a qualified person monitors their drug therapy. Licensure reduces cost because pharmacists ensure that patients who do not need a medication do not receive one and that patients who do need a medication receive the least expensive of the appropriate and available alternatives. The goal of inhibiting criminal abuse is met by establishing a closed system of distribution for abusable drugs and permitting only licensed healthcare personnel to distribute drugs to patients.
DIFFERING PERSPECTIVES ON REGULATION
It is possible to argue that licensure may not be necessary to ensure the quality of health care. Well-informed patients may be just as capable as licensed professionals of ensuring that they use correct and appropriate medications. Better general education of the public may promote effective drug therapy just as well as does professional licensure. In addition, a requirement for licensure tends to favor traditional approaches to therapy, to the exclusion of avant-garde or unusual modes of treatment that may be appropriate for some patients. In some ways, it could be argued that licensure may protect the professions more than it protects the public.
In regard to the goal of reducing the cost of health care, pharmacist licensure also is subject to challenge. There is certainly the potential for a licensed professional to protect a patient or whoever is responsible for paying the cost of the patient’s health care from paying for unnecessary procedures and products. For example, pharmacists have the authority to dispense cost-saving generic drug products under many circumstances. They can advise against the use of a product when it is not necessary; they can prevent patients from using drugs that have not been prescribed for them. On the other hand, the monopolistic nature of licensing can increase costs. Whether the increase in costs brought about by the monopoly is offset by the decrease in inefficient drug use brought about by professional oversight, the benefit of licensure is certainly subject to question.
Some regulators may view the restriction of access to controlled substances as the most important goal of pharmacist licensure. As custodians of the nation’s medicinal drugs of abuse, pharmacists have a vital role to play in the “War on Drugs.” Perhaps ominously for pharmacy, the criminalization of possessing drugs of abuse is the subject of constant criticism and reassessment. Current drug abuse policy is at best only marginally effective, and there are frequent calls for abandonment of the policy that criminalizes drug abuse. If the policy was changed, the pharmacist’s role in drug distribution could be diminished. Nonetheless, the decriminalization of drug abuse would require a significant shift in social policy.
TAKE-AWAY POINTS• In the United States, pharmacy is regulated through licensure.
• Licensure helps increase the quality of health care, reduce the cost of health care, and inhibit the criminal abuse of drugs.
State laws regulating the practice of pharmacy, often termed pharmacy practice acts, provide for an administrative agency, the state board of pharmacy. The purpose of the board is to protect the public health, safety, and welfare. Although some pharmacists may believe that the board of pharmacy acts against the interests of the pharmacy profession, they must remember that the board of pharmacy protects the public, not the profession. In fact, boards of pharmacy are sometimes called “watchdogs” for the consumer.
The national organization that brings individual state boards of pharmacy together is the National Association of Boards of Pharmacy (NABP; www.nabp.net). The NABP oversees the administration of a standardized examination that states use to evaluate the competency of applicants for pharmacy licensure. In addition, the NABP serves as a forum for the development of professional policies and standards. It also develops model legislation and regulations for use by member boards, supervises licensure transfer between states, and facilitates communication between states regarding pharmacist disciplinary actions.
Most members of the board of pharmacy are practicing pharmacists. Boards of pharmacy often have consumer members and may have members representing other healthcare professions. Appointment to the board of pharmacy is political, with members usually appointed directly by the governor.
Traditionally, the pharmacists on state boards of pharmacy had been independent community practitioners; often, they had been pharmacy owners. Chain pharmacists, hospital pharmacists, and others who did not own independent pharmacies had been underrepresented on state boards. One chain pharmacy, Rite Aid Corporation, challenged the composition of the New Jersey Board of Pharmacy in Rite Aid Corp. v. Board of Pharmacy, 421 F. Supp. 1161 (D.N.J. 1976). All five pharmacists on the New Jersey board at that time were independent practitioners. Rite Aid contended that the statute allowing for the appointment of board members was unconstitutional because the statute did not specifically provide that a chain pharmacist be included on the board. Rite Aid also argued that the process for selecting board members was unconstitutional because it was biased toward the selection of independent pharmacists. The court rejected both of these arguments, finding that the statute did not prohibit chain pharmacists from being on the board and that there was no evidence of bias in the selection of board members.
In an effort to become more representative of the entire spectrum of pharmacy practice, most state boards of pharmacy have attempted to ensure the inclusion of at least one chain pharmacist and one hospital pharmacist on the board. Some states require by law the inclusion of pharmacists from different practice settings.
TAKE-AWAY POINTS• State laws that regulate the practice of pharmacy, often called pharmacy practice acts, create state boards of pharmacy.
• Most board of pharmacy members are practicing pharmacists and represent the spectrum of pharmacy practice.
Perhaps the most important function of the state board of pharmacy is the granting of licenses to pharmacists and to pharmacies. Through this function, the state board of pharmacy ensures the competence of the individuals who practice pharmacy and the appropriateness of the physical facilities and business organizations within which they practice. The current approach to licensure heavily emphasizes structure and process factors, with little attention to the outcomes of drug therapy.
The requirements of licensure for pharmacists vary somewhat from state to state, but most states require that applicants to practice pharmacy meet five criteria:
1. Graduation from pharmacy school
2. Completion of specified internship requirements
3. Attainment of a specified age
4. A passing score on the licensure examination
5. Demonstration of good moral character
Generally, a pharmacist applicant must have graduated from an accredited school or college of pharmacy or the equivalent of an accredited school or college. The American Council on Pharmaceutical Education (ACPE) accredits pharmacy schools within the United States. The NABP administers an examination called the Foreign Pharmacy Graduate Equivalency Examination, which allows state boards of pharmacy to assess whether a foreign pharmacy school graduate’s education is equivalent to a U.S. pharmacy school graduate’s education. On the basis of the results of this examination, a state board may permit the candidate to take the state board licensure examination, or it may require additional course work before permitting the candidate to take the examination.
Citizenship can no longer be a requirement for licensure as a pharmacist in the United States for permanent residents. The 1975 case of Wong v. Hohnstrom, 405 F. Supp. 727 (D. Minn. 1975), involved a challenge to a Minnesota statute that required U.S. citizenship for licensure as a pharmacist. An applicant for licensure who was not a U.S. citizen but was otherwise qualified to become a licensed pharmacist had been turned down because of citizenship. The court held that the Minnesota statute was unconstitutional, however, and enjoined the state board of pharmacy from enforcing it. Nonetheless, a state may be able to deny licensure to a nonpermanent resident of the United States under its citizenship requirement (Van Staden v. Martin, 664 F.3d 56 (5th Cir. 2011)).
In all states, the written test required for licensure is the North American Pharmacist Licensure Examination (NAPLEX). In addition, states administer an examination on state and federal laws, either one developed specifically by that state or the Multistate Pharmacy Jurisprudence Exam administered under the auspices of the NABP. Some states include other examinations such as a practical demonstration of ability, an oral patient consultation examination, or an interview.
Pharmacists who are already licensed in one state might not be required to take the state board of pharmacy examination to become licensed in another state. State boards of pharmacy will grant licensure through a process known as license transfer. The qualifications of an applicant for licensure transfer are reviewed by the NABP, and a license can be granted in a second state based on license by examination in the first state.
Transfer of licensure is not automatic. In Sobel v. Board of Pharmacy, 882 P.2d 606 (Or. Ct. App. 1994), the Oregon Board of Pharmacy denied a pharmacy license to an applicant who sought to transfer his license from Texas to Oregon, and the denial was upheld on appeal. The Oregon board had determined that the applicant committed fraud in his application for transfer. Although the applicant indicated on his application that he had not been subjected to discipline in any other state, investigators for the Oregon board determined that the applicant had been disciplined in Texas. A state may not grant a pharmacist license to a pharmacist who is under discipline in another state.
Applicants for licensure generally are required to report prosecutions, convictions, illegal drug use, and in some cases even arrests. A state board will evaluate the applicant’s record to determine if the applicant lacks good moral character. The fact that an applicant might have been tried for a criminal violation and exonerated does not preclude a board from considering the event and using it as evidence of a lack of good moral character together with other facts (In the Matter of the Application of W.D.P., 91 P.3d 1078 (Haw. 2004)).
Pharmacists must renew their licenses periodically. Generally, they need only to pay a fee and, in most states, complete a specified number of continuing education (CE) credits. Various states require specific CE credits dedicated to certain topics, such as medication errors or pharmacy law. Although there has been some discussion of imposing requirements for demonstrated competence to be relicensed, there is currently no such requirement. Employers may, however, require specialty certification for employment, such as certification from the Board of Pharmacy Specialties (www.bpsweb.org/specialties/pharmacotherapy.cfm).
State boards of pharmacy issue licenses to business entities that wish to operate a pharmacy at a specified location. The state board will issue a license to operate a pharmacy only to those that meet established standards relating to structural matters (e.g., equipment), library, and assurance of pharmacist supervision. Each location must have a license. States vary in the number of categories under which a pharmacy may license (i.e., hospital, community, nonresident, sterile compounding, limited services) from only one category to multiple categories. These standards are set out in state statutes, regulations, or both. Court cases have exempted some locations from the need to have a pharmacy license to dispense pharmaceuticals, however. For example, in the case of Love v. Escambia County, 157 So. 2d 205 (Fla. 1963), the court concluded that a city-county indigent outpatient clinic was not a pharmacy because the nurse dispensed only prefabricated medications under physician supervision.
On the basis of the rationale that pharmacist control is necessary to maintain professional and ethical standards, ensure quality services, and adequately supervise pharmacist employees, some states have laws that restrict the ownership of pharmacies, at least in part, to pharmacists. North Dakota, for example, requires that most of a pharmacy corporation’s stock be owned by a pharmacist regularly employed in and responsible for the management, supervision, and operation of the pharmacy. The U.S. Supreme Court upheld this law in Board of Pharmacy v. Snyder’s Drug Stores, 414 U.S. 156 (1973).
Some states prohibit the ownership of pharmacies by physicians on the theory that, when a prescriber has an interest in the economic success of a pharmacy, the best interest of the patient may not be the primary factor in the selection of the medication to be prescribed. A group of California physicians challenged a law prohibiting physician ownership of pharmacies, arguing that it was unconstitutional because it singled out physicians as the only persons ineligible to obtain a pharmacy permit. The court upheld the law in Magan Medical Clinic v. Board of Medical Examiners, 249 Cal. App. 2d 124 (Cal. Ct. App. 1976).
Most states require that the pharmacy owner designate a particular pharmacist as the pharmacist-in-charge or PIC. Generally state laws prevent a person from being the PIC at more than one pharmacy. The PIC has the responsibility, usually together with the pharmacy owner, to ensure that the pharmacy and pharmacy personnel comply with all applicable laws and regulations. A nonpharmacist owner may not subvert or attempt to subvert the PIC’s efforts to comply. The pharmacy generally must provide the name of the PIC to the state board, and in some states the board must approve the PIC.
Nonresident (Mail-Order) Pharmacies
Licensing of nonresident, primarily mail-order pharmacies historically has been challenging for state pharmacy boards. In a relatively few years, mail-order pharmacy has captured a significant share of the overall prescription drug market. In the 1980s and early 1990s, as mail-order pharmacy developed, community pharmacy organizations lobbied hard for state laws to regulate the mail-order pharmacy industry. Many of the bills introduced, however, were considered by state attorneys general to unduly burden interstate commerce and thus to be unconstitutional. For example, early bills required that nonresident pharmacies be licensed in the same manner as in-state pharmacies. This requirement, however, meant that a mail-order pharmacy that mailed prescriptions to 50 states would have to comply with 50 different pharmacy practice acts, and the pharmacists would have to be individually licensed in 50 states. The U.S. Supreme Court has ruled that states can enact laws to evenhandedly serve a legitimate local public interest if the laws only incidentally affect interstate commerce (Pike v. Bruce Church, Inc., 397 U.S. 137 (1970)). Most legal experts, however, believed that state laws requiring nonresident pharmacies to conform to the same requirements expected of in-state pharmacies would be an excessive burden on interstate commerce.
As a result, most states today require that nonresident pharmacies that mail prescriptions into the state must only be registered with the state board. The state boards can require the nonresident pharmacy be licensed in its state of residence and to comply with special recordkeeping requirements and requests for information, and establish other requirements such as a toll-free phone service to communicate with patients. Generally, a state may not require a nonresident pharmacy to meet unduly burdensome requirements such as face-to-face counseling, or require the nonresident pharmacy to comply with more strict regulations than in-state pharmacies.
Technology has created new problems for states regulating nonresident pharmacies. Many mail-order pharmacies perform drug use review (DUR) and other cognitive functions in one facility and process the prescriptions in another facility, and these facilities may be in different states. Boards now have to consider whether to register the nonresident DUR facility, which does no dispensing, as a pharmacy, or instead register the individual pharmacists in the facility, or neither. This is a particular challenge to states that define a pharmacy as a place where dangerous drugs are stored and furnished, as discussed further under Telepharmacy.
Telepharmacy
Technology now allows pharmacists to provide pharmacy services to remote facilities (such as long-term care facilities [LTCFs] and nonprofit clinics) and underserved areas without being physically present. Automated dispensing systems (ADSs) permit pharmacists to remotely dispense a drug to an authorized person (a healthcare licensee) and to provide real-time counseling through audiovisual telecommunication devices to the patient. Telecommunication technology also allows the pharmacist to supervise a technician dispensing the medication at the remote site. Telepharmacy presents boards with many questions: Should a pharmacist that is licensed in one state but providing telepharmacy services in another state be licensed in the state where the telepharmacy services are provided? Should an out-of-state pharmacist not licensed in the state (or even an in-state pharmacist) who provides telepharmacy services be licensed as a pharmacy if the pharmacist is not currently working through a pharmacy? Should ADSs be allowed in urban areas where other pharmacies exist? How many ADSs should a pharmacist or pharmacy be allowed to operate? Should only certain drugs be permitted to be dispensed through an ADS? (The Drug Enforcement Administration [DEA] has approved the dispensing of controlled substances through ADSs only in LTCFs.) Telepharmacy and the use of ADSs present challenges but offer great opportunities.
Kiosks
Similar in concept to telepharmacy is the “kiosk,” resembling an ATM machine for prescription drugs. Located either adjacent to the pharmacy department or nearby, the kiosks allow patients to drop off new prescriptions and pick up refill prescriptions that do not require counseling without having to access the pharmacy department. The patient must consent to the use of the kiosk. Kiosks have been highly controversial, but advocates say they reduce the burden on pharmacists and allow them to spend more time with patients who require their services.
Nonresident (Internet) Pharmacies
The federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (discussed under the section “Internet Pharmacy Prescriptions” under the federal Controlled Substances Act) applies only to controlled substances. Some states have enacted laws prohibiting the dispensing of any prescription via the Internet if the person knows or should know that the prescriptions are not issued pursuant to a good faith prior examination by a prescriber. A good faith medical examination generally is interpreted as including a legitimate patient–physician relationship consisting of a physical examination and documentation on file of the patient’s medical records. Internet prescribing pursuant to questionnaires does not qualify. If a state has not passed specific Internet prescribing laws, the board might still be able to discipline pharmacies by establishing that Internet prescriptions are not valid as generally defined under state law, because there is not a legitimate physician–patient relationship. NABP has developed an accreditation process for Internet pharmacies called Verified Internet Pharmacy Practice Sites (VIPPS), and any pharmacy that has been accredited will display the VIPPS seal on its website. The NABP website also lists Internet pharmacies that are “not recommended” because they appear not to comply with state or federal law, as well as a mid-level list of Internet pharmacies called “Reviewed Internet Pharmacy Practice Sites,” containing sites appearing to comply with the law.
TAKE-AWAY POINTS• Pharmacy boards are responsible for granting licenses to pharmacists and pharmacies.
• Pharmacy boards determine the standards that must be met for licensure, which may vary between states.
• Newer issues that state pharmacy boards have been faced with regulating include nonresident pharmacies and telepharmacy.
State boards of pharmacy have broad discretion in the discipline of pharmacists and pharmacies. In most states, licenses can be suspended for a period of time or even permanently revoked. Many states allow for monetary civil penalties, public reprimands, or both. Nonetheless, disciplinary actions must be based on specified grounds and must follow administrative procedures outlined in state law.
In 1990, the Office of Inspector General (OIG) of the Department of Health and Human Services suggested that pharmacy boards focus too much on offenses such as drug or alcohol abuse, Medicaid fraud, and drug diversion and not enough on reviewing the quality of pharmaceutical care in their licensure actions. In essence, the OIG was saying that a pharmacist can be inept and negligent, but as long as the pharmacist is clean and honest, there will be no threat to the pharmacist’s license. Only in the past few years have state boards started considering outcomes, as discussed under An Alternative Approach to Regulation.
State boards of pharmacy are required to follow procedures specified in their state’s pharmacy practice and administrative procedures acts. In Empire State Pharmaceutical Society v. New York State Department of Education, 469 N.Y.S.2d 514 (Sup. Ct. 1983), the court enjoined a procedure in which penalties were imposed on pharmacists before a hearing. Although the right to notice and an opportunity to be heard before adverse action is taken against a citizen is a fundamental requirement of procedural due process under the U.S. Constitution, the New York board was issuing fines by mail; pharmacists were then allowed to contest a penalty that had already been determined. A pharmacist’s options at that point were to
• Pay the penalty.
• Make a statement in mitigation.
• Contest the charges and risk a more severe penalty if found guilty.
In the words of the court, the options were presented in a style intended to encourage the recipient not to contest the charges by making “an offer you cannot refuse.” The court held that this procedure was improper because it failed to afford the licensee 15-days’ notice before the imposition of the penalty. In effect, the procedure penalized those who opted to contest the charges, and it was for this reason ruled unconstitutional.
Revocation of a pharmacy license by one state may, in and of itself, serve as the basis for revocation in another state. Through centralized communication, boards of pharmacy inform each other of actions taken against licensees, thus making it difficult for a pharmacist who has been disciplined in one state to simply move to another state in which the pharmacist became licensed years earlier and continue, without interruption, the practice of pharmacy within the second state. However, standard procedural requirements apply to disciplinary action taken on the basis of discipline in another state.
A matter of procedure was the issue in Schram v. Department of Professional Regulation, 603 So. 2d 1307 (Fla. Dist. Ct. App. 1992). In this case, the pharmacist bringing the lawsuit had lost his license in Michigan, and the Florida board had revoked his Florida license on the basis of the Michigan revocation. The Florida board, having been notified of the Michigan revocation, mailed a registered letter to the pharmacist at the last address the pharmacist had provided to the Florida board. Because the pharmacist had moved from that address years before, the letter was returned as undeliverable. The pharmacist contended that the board had not exercised due diligence in attempting to locate him, particularly because correspondence from the Michigan board to the Florida board had contained the pharmacist’s current address. The court agreed that the board had not exercised due diligence, a requirement for notice of an administrative action. Therefore, the board’s order revoking the pharmacist’s license in Florida was vacated.
State pharmacy practice acts usually provide several grounds for disciplinary action against a pharmacist or pharmacy. Grounds commonly listed as justification for disciplinary action include such offenses as the provision of false or fraudulent information when applying for a license, violation of any of the statutes or regulations pertaining to the practice of pharmacy, conviction of a felony, conviction of an act involving moral turpitude, unprofessional conduct, immoral conduct or character, gross immorality, habitual intemperance, and incompetence.
If a licensee is a defendant in a criminal case brought in a court of law, the state board of pharmacy often does not bring disciplinary action based on the same incident until the defendant has been adjudicated as guilty. Nonetheless, in most states the board is not required to wait and can take action against a licensee before the judicial outcome in the criminal case. In Schwartz v. Florida Board of Pharmacy, 302 So. 2d 423 (Fla. 1974), the state had brought criminal action against a pharmacist for selling narcotics without a prescription. The board then proceeded with disciplinary action. The pharmacist requested that the board wait until the trial was over, but the board refused and ultimately revoked the pharmacist’s license. Contending that the board’s refusal to postpone the hearing violated due process, the pharmacist appealed; the court, however, found for the board.
In some states, the board may revoke a pharmacist’s license because of an act that led to criminal charges, even if the pharmacist was acquitted in court of the charges. This can occur because administrative procedure differs from criminal procedure. For example, the burden of proof is usually not as great in administrative proceedings as it is in criminal proceedings, so the prosecution has a greater chance to succeed. In addition, the rules of evidence permit the person or group making a decision about an administrative case to hear testimony and view documents that would not be admissible in a criminal case.
Nearly all pharmacy practice acts contain catchall phrases that can snare unsuspecting pharmacists who follow the letter, but not the spirit, of the law. Terms such as “unprofessional conduct” and “moral turpitude” can serve as the basis for a successful disciplinary proceeding, even if the pharmacist involved has disobeyed no specific legal requirement. Although these terms have been challenged as unconstitutionally vague because they do not give pharmacists clear guidelines about what they must do or refrain from doing to avoid problems with the board, most courts have upheld the discretionary use of such grounds for discipline by state boards of pharmacy.
Unprofessional Conduct
In Pennsylvania State Board of Pharmacy v. Cohen, 292 A.2d 277 (Pa. 1977), the board suspended a pharmacist’s license on the grounds of grossly unprofessional conduct. The pharmacist sold large quantities of empty gelatin capsules, along with lactose and quinine hydrochloride, to various customers, even though he knew that these purchases were for the purpose of manufacturing illicit drugs. His actions did not violate any specific law because nothing in the law forbade the sale of these items. Furthermore, although the pharmacy practice act listed 13 specific offenses that constituted unprofessional conduct, none of the 13 described the pharmacist’s activity. The court held for the pharmacist, ruling that a pharmacist in Pennsylvania cannot be disciplined for an unlisted act because that would require pharmacists to guess at what is prohibited.
A New Jersey court followed a different approach in In re Heller, 374 A.2d 1191 (N.J. 1977). A pharmacist was charged with grossly unprofessional conduct for selling narcotic cough syrups with great frequency to the same people at greatly inflated prices. The pharmacist had complied with all the specific requirements relating to the nonprescription sale of narcotic cough syrups, yet the board disciplined him. The pharmacist’s defense was that his conduct was not specifically listed among the acts deemed grossly unprofessional in the practice act. Unlike the Pennsylvania court in Cohen, the New Jersey court rejected this argument, ruling that the list is not exclusive because there is no need for the specific identification of conduct that is inherently wrong and obviously dangerous. The New Jersey Supreme Court reasoned that it would be absurd to immunize certain outrageous conduct from disciplinary action simply because it did not happen to be listed in the statute.
Generally, if a state provides that unprofessional conduct includes convictions for violations of the law, there must be a nexus between the convictions and competence to practice. This nexus need not be a strong one, however. In Griffiths v. Superior Court (Medical Bd. of California), 96 Cal. App. 4th 757 (2002), the court ruled that the board was justified in determining that three different misdemeanor convictions by a physician for reckless driving involving alcohol over a five-year period constituted unprofessional conduct.
Moral Turpitude
Determining “moral turpitude” is not an easy task. Many courts have determined that crimes involving fraud constitute moral turpitude because these are intentional acts contrary to honesty and good morals. In Schaubman v. Blum, 426 N.Y.S.2d 230 (N.Y. App. Div. 1980), a pharmacist legally dispensed a less expensive generic drug in place of the brand-name drug but illegally billed the state Medicaid agency for the brand-name drug. The excess amount was only $3.39. Nevertheless, the court upheld the board’s decision to revoke the pharmacy’s license as an effective means to deter Medicaid fraud. Betrayal of the public trust through Medicaid fraud is certain to bring about regulatory action. In State v. Brown, 637 So. 2d 669 (La. Ct. App. 1994), the court upheld a sentence of 39 months at hard labor and a $2,500 fine for a pharmacist who was found to have defrauded Medicaid of $3,270.
REINSTATEMENT OF A REVOKED LICENSE
Few things in life can really be said to last “forever,” and the revocation of a pharmacist’s license is no exception to that rule. Having lost one’s pharmacist license, it may be possible to get the license back by making application to the board for reinstatement and showing that the problem that originally led to revocation is no longer operative. In Schiffman v. Department of Professional Regulation, 581 So. 2d 1375 (Fla. Dist. Ct. App. 1991), a pharmacist successfully appealed a final order of the Florida Board of Pharmacy denying his application for reinstatement of his previously revoked license. The court noted that it is incompetent, unskilled, and unprofessional pharmacists who are a threat to public safety, not rehabilitated pharmacists. The plaintiff had at one time been found guilty of controlled substance diversion and had his pharmacist license permanently revoked, but he contended that he had been rehabilitated. The court ruled that the board must consider a petition for reinstatement on the basis of rehabilitation. A permanent revocation of a pharmacist’s license is not permitted under the law of Florida or of many other states.
Of course, a requirement that a board of pharmacy consider reinstatement of a pharmacist’s license does not mean the license will actually be reinstated. The board may not even have to listen to a former pharmacist’s arguments as to why a revoked license should be reinstated. In Jones v. Alabama State Board of Pharmacy, 624 So. 2d 613 (Ala. Civ. App. 1993), a former pharmacist contended that the board of pharmacy was required by due process to afford him a hearing on his motion for reinstatement of his license. The former pharmacist’s license had been revoked several years earlier, and the board denied his motion for reinstatement. The pharmacist offered several arguments as to why the board was not legally permitted to deny his motion for reinstatement without a hearing. However, the court ruled that the board of pharmacy had been granted broad discretionary authority, and absent a specific statutory or common law requirement that there be a hearing, the former pharmacist was not entitled to a hearing.
In the past, boards of pharmacy have had little choice but to revoke or suspend the license of a pharmacist who has been found to be impaired because of alcohol or drug use. Therefore, impaired pharmacists had been hesitant to seek assistance for their problem for fear of public humiliation and board of pharmacy discipline. Two circumstances have exacerbated this situation. First, the pharmacy profession was failing to recognize that alcoholism and drug abuse are diseases that require compassion and treatment rather than aberrant behavior that requires condemnation. Second, the severity of the consequences, should they admit their problem, was forcing impaired practitioners into the closet, and the danger these pharmacists may have posed to the public was unchecked. As a result, state pharmacy associations in many states lobbied for laws to establish programs to assist impaired pharmacists, and most of these laws passed. Most state boards of pharmacy are supportive of such programs, and state laws generally provide impaired pharmacists with two pathways into a rehabilitation program. One pathway allows the pharmacist to voluntarily enter into a rehabilitation program without board of pharmacy involvement or knowledge. The other route would be pursuant to a board of pharmacy disciplinary hearing.
Some state pharmacy laws require pharmacies to have written policies and procedures for taking action to protect the public when a pharmacist is discovered to be impaired. This may involve the pharmacy reporting the individual to the state board within a certain time frame.
TAKE-AWAY POINTS• State boards of pharmacy have discretion on how to discipline pharmacies and pharmacists, which could range from public reprimands, monetary civil penalties, license suspension, and/or license revocation.
• Grounds for discipline include providing false information on applications, violation of any statutes or rules pertaining to the practice of pharmacy, court convictions, moral turpitude, unprofessional conduct, and incompetence.
• State laws may permit the board of pharmacy the discretion to consider reinstating a revoked license.
• Most states have laws in place to assist impaired pharmacists.
ACTIONS AGAINST A PHARMACY LICENSE
License revocations, suspensions, and civil penalties may be assessed against the license of a pharmacy and against the license of a pharmacist. Sometimes a problem develops as the result of actions taken by those who run the pharmacy business, rather than those who practice pharmacy within the business, and the appropriate remedy is to act against the business’s pharmacy license and not the pharmacist’s professional license. However, in Sender v. Department of Professional Regulation, 635 N.E.2d 849 (Ill. App. Ct. 1994), the court reversed disciplinary action taken against a pharmacist “owner” on the basis of the misconduct of an employee in diverting controlled substances. The facts showed that the owner-pharmacist was merely a shareholder in the pharmacy corporation, with no supervisory role and with no authority to control the actions of those who engaged in diversion activities.
An Illinois appellate court reversed disciplinary action taken against a pharmacy for using nonpharmacists to perform tasks that only a pharmacist should perform. In Walgreen Co. v. Selcke, 595 N.E.2d 89 (Ill. App. Ct. 1992), the court distinguished between the scientific aspects of the practice of pharmacy and the business aspects of the practice of pharmacy. Describing the actions taken by two pharmacy employees who were not licensed pharmacists, the court concluded that these actions were clerical and supportive in nature. They were not intrusions into the practice of pharmacy. Therefore, disciplinary action against the pharmacy’s license was reversed.
Circumstances may warrant disciplinary action against both a pharmacist and a pharmacy. The revocation of a pharmacist’s license to practice pharmacy and his or her registration to operate a retail pharmacy were affirmed in In re 882 East 180th Street Drug Corp., 596 N.Y.S.2d 193 (N.Y. App. Div. 1993). An inspection of the pharmacy had disclosed the presence in the back room of large numbers of physician samples, drugs dispensed by other pharmacies, and other large quantities of pharmaceuticals in unlabeled or improperly labeled containers. The board found the pharmacist guilty of gross negligence and unprofessional conduct. The pharmacist claimed that the drugs were all brought to his pharmacy to be destroyed, although he admitted that none had ever been destroyed. He also asserted that none of the drugs so acquired were ever resold to patients. The board found this explanation to be literally “incredible.” The court upheld the license revocation for both the pharmacist and pharmacy in view of the threat to the public health posed by the pharmacist’s deliberate conduct.
TAKE-AWAY POINTS• Pharmacy licenses are subject to the same disciplinary actions and penalties as pharmacist licenses.
• Circumstances may warrant disciplinary action against the pharmacy license or both the pharmacy and pharmacist license.
States regulate not only who may practice pharmacy and where it may be practiced but also how pharmacy is practiced. Pharmacists do not dispense drugs in paper envelopes with illegible directions scribbled on them because the standard is to use prescription vials and machine-printed labels. Pharmacists know this to be the standard because it is specified in the law. Standards of practice in many states also stipulate that a pharmacist must be present in a pharmacy when the pharmacy department is open; otherwise, there would be access to drugs of abuse, and patients might acquire their medications without the opportunity to discuss them with a pharmacist. Standards of practice specify how pharmacy will be practiced, where it will be practiced, and who will practice it.
Because pharmacy is a self-regulated profession, many laws and regulations merely describe existing standards of practice, rather than establish new standards. For example, checking the work of technicians filling prescriptions is the law, but most pharmacists would do this regardless of the law because checking prescriptions is important to good patient care. Making a standard of practice a law or regulation allows for easier enforcement of the standards against professionals who deviate from the standards. Nonetheless, laws and regulations do not describe all standards of practice. For example, a state law may not specify that the generic drug substituted for the prescribed drug be therapeutically equivalent to the prescribed drug. Yet, this would be an important consideration by a pharmacist for substitution and thus a standard of practice. Laws and regulations do not often set standards of practice related to professional judgment because each situation may require a different judgment. Nonetheless, pharmacists are expected to act appropriately. For example, state law or regulation will require a pharmacist to screen a prescription for a drug–drug interaction but not describe the action a pharmacist should take when detecting the interaction. A pharmacist who detects a potentially serious interaction, yet takes no action because the law does not require it, has not met the standard of practice, or the intent of the law.
Although the states are empowered to regulate the practice of the professions directly, the federal government may indirectly regulate professional practice in two significant ways. First, the federal government regulates the drug product and correspondingly attaches requirements to the product that a practitioner can meet only by behaving in a particular way. Second, the federal government may establish conditions for participation in programs that it funds (or partially funds), requiring states to accept the conditions if they wish to continue receiving federal funds. The Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) establishes such conditions for participation in the Medicaid pharmaceutical program.
The DUR provisions of OBRA ‘90 enhance the ability of state enforcement authorities to conduct practice audits of pharmacies to determine whether the quality of practice in the pharmacies meets the standard of care. Claims for payment submitted by pharmacists to Medicaid or another provider of pharmaceutical benefits can serve as a performance database. This database can disclose whether patients who use a particular pharmacy are having drug-related problems despite the fact that the pharmacy has complied with structural requirements. Enforcement activity by the state board of pharmacy can ensure that practice standards are being met. Thus, the OBRA ‘90 mandate for improved quality of care enables state authorities to enforce practice standards by using data regarding patient outcomes.
A state’s legal definition of the practice of pharmacy is critical. Historically, many states defined the practice of pharmacy in limited terms of dispensing a drug product. Today most states have far broader definitions for the practice of pharmacy, reflecting the clinical roles that pharmacists perform such as DUR, drug therapy management, providing clinical consultations to other healthcare professionals and patients, and administering immunizations. The broader the definition, the more latitude provided the state board to implement regulations expanding the practice, as opposed to having to seek legislation. An expansive definition of the practice of pharmacy also establishes professional identity. It becomes instructive to courts and other administrative agencies when making decisions about pharmacy practice. To this end, many states have included a statement in the law that pharmacy is a learned profession, to distinguish it from the perception by some that pharmacy is a commercial business.
The legal definition of the practice of pharmacy is important for several other reasons. It is useful in making distinctions between pharmacists and physicians because a pharmacist may otherwise be accused of practicing medicine without a medical license. In most states, the law prohibits the practice of medicine by anyone who is not licensed as a physician. The law provides that a healthcare provider who is practicing within the boundaries of another profession is not practicing medicine illegally, however, even though the acts that person is performing may be construed as the practice of medicine. Thus, a pharmacist who is monitoring drug therapy within the definition of pharmacy practice is not illegally practicing medicine, but someone who has no license at all and monitors drug therapy is indeed illegally practicing medicine.
The definition of pharmacy practice also distinguishes between what functions only a pharmacist can perform and what functions a pharmacy technician may be permitted to perform. Technicians may not perform those functions included within the definition of pharmacy practice unless the law specifically permits technicians to do them. Just as pharmacists may now carry out some activities that only physicians have done in the past, so too may pharmacy technicians now perform some functions that only pharmacists have done. The expansion of the pharmacist into medicine and of pharmacy technicians into pharmacy is circumscribed by legal definitions, however.
The legal definition of the practice of pharmacy must distinguish pharmacy not only from other healthcare professions and ancillary personnel but also from unlicensed persons performing pharmacy-related functions. For example, is someone who makes decisions regarding which drugs will be included on a managed care organization’s formulary practicing pharmacy? Is someone who makes DUR decisions about whether a patient can receive a particular drug therapy practicing pharmacy? An even more fundamental question is whether pharmacy can be practiced outside of a facility licensed as a pharmacy. Defining what constitutes the practice of pharmacy and where it may be practiced has quality of care implications that many states must yet address.
For the past several years, pharmacy gradually has been shifting its mission from one centered on dispensing to one of providing professional patient care services. In order to allow pharmacists the time to provide professional services, they require assistance in performing routine nonjudgmental dispensing functions. To provide that assistance, states have authorized pharmacy technicians to work in community pharmacy practice, emulating what hospital pharmacies have done for several years prior. Although the duties and tasks that a pharmacy technician may lawfully perform in a community pharmacy are fairly standard among the states, the qualifications, licensure requirements, degree of supervision, and ratio of pharmacist to technician vary between states. Qualifications to become a technician range from no requirements in some states to completion of a board-approved technician program in other states, to national certification in yet other states. To attain national certification, a technician must pass a nationally administered standardized examination. Some states have established two tiers of technicians, certified and noncertified, although NABP would like to see all technicians nationally certified. In 2015, NABP will amend its model act to remove the term Pharmacy Technician and incorporate the term Candidate for Certified Pharmacy Technician, which will be redefined to provide a path for noncertified pharmacy technicians to become certified.
Many states have not required that technicians be licensed or registered with the state board. Recently, however, there has been a national trend among the states to license or register technicians. Some states may simply require licensure or registration to track pharmacy technicians and help prevent concerns such as diversion. Other states, however, go above this standard and may require specific competency requirements for technician licensure or registration, including successful completion of an accredited education and training program, or national exam. This trend has been accelerated by several factors, including recent studies documenting the incidence of dispensing errors, some high-profile injuries resulting from dispensing errors, negligence and even manslaughter lawsuits against pharmacists and pharmacies, and widespread media attention to dispensing errors.
In every state, a supervising pharmacist must check the work of the technician prior to dispensing the prescription to the patient, and that pharmacist is ultimately responsible for the accuracy of the dispensed product. The degree of supervision over ancillary personnel that a pharmacist must provide varies among the states and whether the laws, regulations, and state board combine to formulate a process approach or outcomes approach. Many states specify the supervision requirement as “direct supervision and control.” Interpretation of the “direct supervision and control” requirement raises controversies that individual state boards must address, such as whether the supervising pharmacist must be in physical proximity of the technician and observe the technician at all times (a process approach). Or, is it acceptable for the pharmacist to perform tasks remote from the technician and just check the technician’s prescription before dispensing to the patient (an outcome approach)? Some states have considered whether it would be appropriate to have a technician check another technician’s work, as opposed to a pharmacist checking, a practice that has been authorized by law in some states for hospital pharmacies.
Many states have ratio requirements, generally set at no more than two technicians to one pharmacist, while some states have no ratio requirements. Some states with requirements may allow for variances and increased ratios if the technicians have completed an educational program or are nationally certified. Application of the ratio requirements can cause controversy related to supervision. For example, is the intent of a 1:2 ratio requirement satisfied if a pharmacy has six pharmacists in the facility and 12 technicians, but only three of the pharmacists work with the technicians performing dispensing functions and the other three perform other tasks such as DUR and phoning prescribers? At least one state board has held that the ratio requirement is not satisfied unless one pharmacist is actually supervising two technicians, and this would appear to be the position of most state pharmacy boards.
In addition to technicians, pharmacies may generally employ nonlicensed personnel to assist in a clerk capacity, such as accepting prescriptions from patients, entering information into the pharmacy computer, answering the phone to receive refill requests, and selling the dispensed prescription to the patient. Some states by statute authorize these unlicensed personnel to perform specified clerical functions. In most other states, pharmacy boards tacitly permit these personnel even though the law does not address them.
Most states allow pharmacy students to work as interns starting their first year of pharmacy school and almost all states require that interns be licensed or registered with the board. Generally, interns are allowed to perform most functions that a pharmacist may perform under the direct supervision of a pharmacist. As with technicians, some states set ratio requirements for interns; others do not.
In addition to the assistance of interns, technicians, and clerks, pharmacists also enjoy the assistance of automation. Automated dispensing equipment and robotics have greatly facilitated the speed, efficiency, and accuracy of dispensing. The issue of whether a pharmacist must check a prescription dispensed by automation (with no technician involvement) arises, however, because many state laws are silent on this issue. Although the state board may not be able to directly cite a pharmacist for a violation if he or she does not check prescriptions, the pharmacist will be legally responsible for any error, both pursuant to a state board action and pursuant to a negligence lawsuit. It would not likely be difficult to establish that a pharmacist must check the dispensed prescription as a standard of practice.
One contributing cause of dispensing errors, pharmacists working long, continuous hours without breaks, has been identified. This has led to state laws limiting the number of continuous hours a pharmacist may work in a day. The laws also generally require that employers, depending upon the number of hours of the pharmacist’s shift, allow a meal break of usually 30 minutes, together with one or two other breaks of usually 15 minutes. When only one pharmacist is on duty, some states require that the pharmacist must remain in the pharmacy during the break but post a sign that the pharmacist is on break. Some other states allow the pharmacist to take the break away from the pharmacy department. However, the traditional rule of law in nearly all states required that a pharmacist must be present in the pharmacy at all times that the pharmacy is open. Closing a pharmacy for 30 minutes or 15 minutes could cause patients significant inconvenience and disrupt business. As a result, some states have changed their laws to allow the pharmacy to remain open with ancillary personnel during the pharmacist’s break and while the pharmacist is absent, provided that the pharmacist agrees. If the pharmacist is not comfortable and does not agree, the pharmacy must close during the break. If the pharmacy remains open, the ancillary personnel may not conduct any activities that require a pharmacist, such as dispensing a new prescription to a patient that requires verification by the pharmacist or counseling. The supervising pharmacist and PIC will generally be held responsible and accountable for the diversion of drugs or any pharmacy violations that occur in the pharmacist’s absence.
Pharmacy has recognized the importance of CE or continuing pharmacy education (CPE) for decades, but CE as a legal requirement for relicensure in most states did not occur until the 1970s. Today it is a requirement in every state, with most requiring 15 hours, or 1.5 continuing education units (CEU) per year; or 30 hours (3 CEUs) biennially. Some states require that a certain number of those hours be in a specific subject, such as law, and some states require that a certain number of the hours be from live programs. Some states require that the CE hours or units be approved by ACPE, other states more generally allow for CE hours approved by the board, and the rest of the states specify that either will qualify. Most states allow pharmacists extensions for hardship situations and do not require CE if the pharmacist chooses inactive licensure status.
A collaborative effort among NABP, ACPE, and ACPE providers, called CPE Monitor, provides pharmacists and technicians the opportunity to register on an electronic system so they can easily monitor their completed CPE credits. Licensees can register and receive an e-profile ID number at http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service.
ACPE providers require this ID number together with the licensee’s date of birth for the licensee to receive CPE credit. State boards of pharmacy will have access to CPE Monitor, if they desire, to conduct audits to determine whether licensees have completed the required CPEs.
COLLABORATIVE PRACTICE AGREEMENTS
For years, pharmacy has envisioned an expanded scope of practice where the pharmacist prescribes, adjusts, and monitors the patient’s drug-therapy regimen, based upon the diagnosis of another healthcare professional. That vision has advanced a step closer to reality in over 40 states through the enactment of laws authorizing collaborative practice agreements. The requirements vary from state to state, but in general many states now authorize a pharmacist to initiate or adjust a patient’s drug therapy pursuant to a written agreement between the physician and pharmacist. That agreement will contain the policies and procedures the pharmacist must follow including any formulary that might be applicable. The scope of authority granted the pharmacist under an agreement can often be as broad or as narrow as the parties agree. The DEA has determined that pharmacists practicing under these arrangements can receive DEA registration if they are authorized by the physician to initiate or adjust controlled substances.
PROSPECTIVE DRUG UTILIZATION REVIEW
Because of OBRA ‘90, every state now requires that pharmacies incorporate prospective DUR into the dispensing process. State regulations requiring counseling, screening, and the maintenance of patient medication records have expanded the scope of practice and most likely the standards of practice. Most states have adopted the same or similar language in their DUR regulations as that of OBRA ‘90. A few states, however, require that a pharmacist must counsel the patient, rather than permitting the pharmacy to offer to counsel as allowed by OBRA ‘90. A very few states apply the DUR requirements only to Medicaid patients.
An issue attracting considerable attention in the past few years is whether pharmacists should be required to counsel patients with limited English proficiency in the patient’s own language. In 2008, the attorney general of New York announced a settlement agreement with CVS and Rite Aid in which the two chains agreed to counsel all pharmacy customers in their own language and provide written translations in Spanish, Chinese, Italian, Russian, French, and Polish. The requirement to counsel and provide labels in the patient’s own language might ultimately be adopted in all states because of federal law. Title VI of the Civil Rights Act of 1964 guarantees equal access to services paid for with federal funds, and applies to providers receiving Medicare or Medicaid payments, including pharmacies. California and New York now require patient-centered standardized labels, including the requirement that the label be interpreted into certain languages other than English when requested by the patient.
TAKE-AWAY POINTS• States have specific practice standards regarding how pharmacy is to be practiced in the state.
• How each state legally defines the practice of pharmacy is very important, as it will provide for the scope of practice activities in which pharmacists may participate.
• State specific practice standards will address how ancillary pharmacy personnel, such as pharmacy technicians, may be utilized to assist pharmacists in nonjudgmental dispensing functions.
• The current trend for pharmacy technicians in many states is to require registration, licensure, and/or national certification.
• Most states recognize pharmacy students as interns, allowing them to perform pharmacist-only functions while under the direct supervision of the pharmacist.
• States require pharmacists to be on duty while the pharmacy is open; however, pharmacists may be permitted to take breaks in or out of the pharmacy if specific conditions are met.
• All states require pharmacists to complete ongoing CE.
• Most states now permit pharmacists to participate in collaborative practice agreements.
• All states now require pharmacists to incorporate prospective DUR into the dispensing process.
