US Pharm. 2024;49(11):36-39.

What are the responsibilities of a pharmacist to comply with laws governing the practice of pharmacy? What are the various levels of responsibility that pharmacists have in connection with the operation of a pharmacy? What are a pharmacist’s obligations when there are not enough personnel in the pharmacy to ensure patient safety? These and other issues involving pharmacists’ duties to legal obligations warrant a thorough review.

Key Pharmacist Designations

Pharmacist in Charge: Most states require the pharmacy operator to designate a pharmacist licensed in that state as the pharmacist in charge (PIC) of the pharmacy.1 The Board of Pharmacy or other regulatory body must be notified in writing as to the PIC’s name, date of appointment, and location (address). State laws commonly address what the PIC must do concerning specific issues occurring in the pharmacy. The PIC is responsible for overseeing the operations and compliance with laws regulating pharmacy practice. Some statutes and regulations are narrow in scope, but others have much broader implications.

The PIC is responsible for compliance with all state and federal laws and regulations concerning the practice of pharmacy. To ensure that there are no PIC loopholes, the state will not issue a pharmacy license unless a PIC is designated on an application or renewal form. If a PIC designation changes, the regulatory authority must be notified, usually within 30 days. There are a host of other allowances where the PIC mandate may or may not be applicable. In some states, the PIC is limited to supervising no more than three pharmacies at a time.2 In other states, a PIC can be in charge of only one pharmacy at a time.3 Pharmacists should check the law in their state to determine the particular requirements.4

Pharmacist on Duty: Almost every state mandates the presence of a licensed pharmacist on duty (POD) when a pharmacy is open.5 The states vary widely as to whether the pharmacy could be open under the charge of a pharmacy intern or a certified (or a licensed) pharmacy technician. In some cases, if the pharmacist is not present in the pharmacy, anything constituting the practice of pharmacy is prohibited. However, the intern or technician may complete the transaction of a previously filled prescription by handing it to the patient or caregiver.

The difference between the POD and the PIC is that the POD is the one who is actually present in the pharmacy and responsible for the practice of pharmacy (POP). Although the PIC may not be working in the pharmacy at any given time, he or she is still responsible for the overall operations of the pharmacy. By way of example, consider a community pharmacy that employs two pharmacists with overlapping shifts, two student interns, and a couple of pharmacy technicians, in addition to some support staff or clerks. One of the pharmacists is the designated PIC and the other is a staff pharmacist. Under the applicable state law, both pharmacists can supervise the two technicians when either of the pharmacists is on duty. The POD is directly responsible for the conduct of a pharmacy technician supervised by that pharmacist. The PIC, however, is responsible for the overall training of the interns and most likely will have to certify to the state that each intern has met all of the practical educational experiences at the end of his or her internship. In other words, the PIC and the POD are responsible for operating the POP, but the PIC is the ultimate head of the pharmacy practice. Simply put, the PIC is the managing or chief pharmacist. Thus, the PIC may be a POD but a POD might not be the PIC.

What Constitutes the POP?

Before considering the duties of pharmacists to comply with the various laws concerning pharmacy practice, it is worthwhile to consider how the POP is defined. The term often means a health service, the clinical application of which involves fostering safety and efficacy in the prescribing, dispensing, administration, and use of drugs and related articles for illness prevention and for the maintenance and management of health. The POP usually includes something along the lines of the direct or indirect provision of professional functions and services associated with the POP. Professional functions comprise the interpretation and evaluation of the prescription; drug product (generic) selection; the compounding, dispensing, safe storage, and distribution of drugs and devices; the maintenance of legally required records; advising the prescriber and patient as required regarding the contents, therapeutic action, use, and possible adverse reactions or interactions of drugs; and the ordering and administration of qualified immunizing agents.6

Expanded Duties

In this age of elevated patient-safety mandates, a discernible trend exists in expanding the PIC’s responsibility to report any of these issues to the Board of Pharmacy or the state’s governing authority. The focus here is to reduce medication errors and improve patient welfare. A California law that took effect in 2024 included an expansive amendment to the statutes regulating the behavior of PICs.7 This was the direct result of a survey conducted by the California Board of Pharmacy showing that 91% of retail pharmacists reported insufficient staffing to ensure safe patient care, 83% reported insufficient time to provide safe patient consultation, and 78% reported inadequate time to perform proper health screenings before administering immunizations.

This law—known as the Stop Dangerous Pharmacies Act—is intended, among other things, to give pharmacists more autonomy over staffing decisions, and it requires the reporting of unsafe conditions.8 Although it is primarily concerned with chain pharmacies, the Act applies to all pharmacies in general. Why pay attention to some of the specific provisions of California law? The reason is that other states may soon follow these examples. In fact, hope has been expressed that the Act will improve the culture of safety in pharmacies and possibly have an influence on other states as well.8

Staffing Decisions

The recent amendment discussed in the previous section authorizes a PIC to “make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely.”9 In addition, it authorizes a POD—if the PIC is unavailable—to adjust staffing according to workload when necessary. The statute requires a PIC or POD to “immediately notify store management of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.”9 The amendment also requires management to “take immediate and reasonable steps to address and resolve those conditions”; if the conditions are not resolved within 24 hours, the PIC or POD must ensure that the Board of Pharmacy is notified.9 The Act requires the executive officer of the Board, “upon a reasonable belief that conditions within a pharmacy exist that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff, to issue a cease and desist order.”9 Under the Act, failure to comply with the cease-and-desist order is deemed unprofessional conduct (defined later) for a pharmacy organization.

The law now requires chain community pharmacies to be staffed, at all times, with at least one clerk or pharmacy technician who is fully dedicated to pharmacy-related services.10 Additionally, the law states that if staffing of pharmacist hours in a chain community pharmacy does not sufficiently overlap, scheduled closures for lunch breaks for all pharmacy staff must be established, posted publicly, and mentioned on the outgoing telephone message.

Other Pharmacist Designations

In addition to the establishment of a PIC and a POD, almost all state laws mandate that a pharmacist have “personal charge” (i.e., immediate physical presence) of a pharmacy that is open for business.11 This includes retail establishments, hospitals, or clinics where the POP takes place. Many states also recognize a “consulting pharmacist” and a corporate “director of pharmacy,” entailing specific responsibilities. For instance, the responsibilities of the organization’s director of pharmacy include the orderly, safe, and lawful provision of pharmacy services. This is in addition to the PIC’s duties as outlined earlier.

Consulting Pharmacist: A consulting pharmacist (i.e., not an employee of the organization) must be retained to approve the pharmacy’s policies and procedures in conjunction with the professional director and the Board of Pharmacy administrator and to visit the pharmacy regularly, usually at least quarterly. The statutes require the consulting pharmacist to certify in writing that the pharmacy is—or is not—operating in compliance with existing laws governing pharmacies. In addition to operational concerns, the consulting pharmacist must review system and staffing issues.12

Interns and Technicians: The POD is permitted to supervise only one technician at a time.13 Interns can perform any task that either of the pharmacists currently on duty delegates to the intern, except for acts that he or she is not authorized to perform or any procedure that requires the professional judgment of a pharmacist. Again, there may be variances of these issues between the states.14 California has adopted another part of the law stating that “a pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of his or her professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities.”13 Furthermore, an organization that employs a pharmacist cannot “discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right” to attempt to enforce this provision.15

Legal Requirements

Quotas: In one of the newer concepts aimed at ensuring patient safety, California law states that a community chain pharmacy is not allowed to establish a prescription quota for licensed pharmacists and pharmacy technicians.16 It is illegal to communicate that quotas of this type even exist. A quota is “a fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty.”17 A quota includes a fixed number or formula relating to the prescriptions filled; patient services rendered; programs offered to patients; and obtained revenue.17

Annual Reviews: Each year, the PIC must perform reviews of the policies and procedures governing the POP. The PIC is required to assess the pharmacy’s compliance with its policies and document corrective actions to be taken when it has been found that noncompliance has occurred.18

Break Times: In prior times, pharmacists rarely took time off from the pharmacy for lunch or other breaks. Newer provisions allow for pharmacists to take time away from the pharmacy. The pharmacy must be closed during that period. States vary as to whether an intern or technician may distribute (sell) a filled (dispensed) prescription medication to a patient or caregiver when the pharmacist is on a break or away from the pharmacy. Additionally, as noted previously, California law states that for a chain community pharmacy, if staffing of pharmacist hours does not adequately overlap, scheduled lunch-break closures that include all pharmacy staff must be established, publicly posted, and stated on the outgoing telephone message.19

Criminal Penalties: Interestingly and somewhat uniquely, violation of the California law under this amendment is a crime. In some states, a crime is a misdemeanor; in others, it is a felony. Lying to an entity responsible for administering the POP constitutes criminal perjury. Any person who willfully makes any false representations in procuring or attempting to obtain a pharmacy license is guilty of the felony of perjury.20

Unprofessional Conduct: Frequently, the PIC or the POD is responsible for preventing and/or reporting unprofessional conduct. Although this concept is common in most states, “unprofessional conduct” has multiple definitions and explanations as to what constitutes a violation.21 Each of the following activities constitutes unprofessional conduct22:
• Procuring a license by misrepresentation or fraud;
• Incompetence—i.e., the inability to do something successfully;
• Gross negligence;
• Committing any act involving moral turpitude (defined below), deceit, dishonesty, fraud, or corruption;
• Conviction of more than one misdemeanor or any felony involving use, consumption, or self-administration of any dangerous drug or alcoholic beverage, or any combination thereof (including controlled substances);
• Actions or conduct that would subvert a pharmacist’s efforts to comply with laws and regulations or to exercise professional judgment, including creating or allowing conditions that could interfere with a pharmacist’s ability to practice with safety and competency or allowing or creating an environment that could jeopardize patient care;
• Actions or conduct that would subvert a PIC’s efforts to comply with laws and regulations, exercise professional judgment, or make determinations about sufficient staffing levels to safely fill the pharmacy’s prescriptions or to provide other patient-care services safely and competently;
• Actions or conduct that would subvert a pharmacist intern’s or pharmacy technician’s efforts to comply with regulations and laws; and
• Establishing procedures and policies related to time guarantees to fill prescriptions within a specified time period, unless these guarantees are required by law or necessary to meet contractual requirements.

Mentioned in the above list, “moral turpitude” is a legal term that describes behavior that is morally wrong, unethical, or contrary to community standards of justice. It can also mean shameful, vile, or corrupt character or acts of vileness or depravity, or sexual immorality. Depending on the context, it could encompass criminal or civil activity.

Conclusion

As this discussion has demonstrated, pharmacy leaders have a wide variety of duties to comply with laws governing the POP. Newer provisions focus on circumstances within the pharmacy that will ensure that patients are treated safely. Conditions that tend to impair safety must be corrected or be subject to legal penalties.

REFERENCES

1. Michigan Compiled Laws Annotated (MCLA) §333.17748(2).
2. MCLA §333.17748(3).
3. See MCLA §333.17747.
4. See, e.g., CA BPC §4113.5. See also NABPLAW Online for a comprehensive list of standardized state pharmacy laws: https://nabp.pharmacy/news-resources/resources/publications/nabplaw-online. Accessed October 7, 2024.
5. Bika N. Pharmacist job description. Workable. https://resources.workable.com/pharmacist-job-description. Accessed October 7, 2024.
6. MCLA §333.17707(8).
7. CA Code, Business and Professional Code-BPC §4143 (hereafter BPC). See also Khachatryan K. California enacts first-in-nation pharmacy medication error reporting law. Healthcare Law Insights. www.healthcarelawinsights.com/2024/03/california-enacts-first-in-nation-pharmacy-medication-error-reporting-law. Accessed October 7, 2024.
8. AB §1286. See Pharmacy Times. California passes first-in-nation law to reduce medication errors, address pharmacy staffing concerns. www.pharmacytimes.com/view/california-passes-first-in-nation-law-to-reduce-medication-errors-address-pharmacy-staffing-concerns. Accessed October 7, 2024.
9. California Legislative Information. AB-1286 pharmacy: assembly bill no. 1286: chapter 470. https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202320240AB1286. Accessed October 7, 2024.
10. CBP §4113.6.
11. See note 5, supra.
12. Wikipedia. Consultant pharmacist. https://en.wikipedia.org/wiki/Consultant_pharmacist. Accessed October 7, 2024.
13. CA BPC §4115(c). See FindLaw. California code, business and professions code–BPC § 4115. https://codes.findlaw.com/ca/business-and-professions-code/bpc-sect-4115. Accessed October 7, 2024.
14. See note 4, supra.
15. CA BPC §4115(3).
16. CA BPC §4113.7.
17. CA BPC §4113.7(c)(1).
18. CA BCP §4119.10(d).
19. See note 10, supra.
20. 59 OK Stat §353.25 (2023). See Justia US Law. 2023 Oklahoma statutes: title 59: professions and occupations: §59-353.25: violation of act–penalty–perjury. https://law.justia.com/codes/oklahoma/title-59/section-59-353-25. Accessed October 7, 2024.
21. This discussion intentionally has excluded violations of controlled-substances statutes, rules, and regulations.
22. Casetext. Cal. Bus. & Prof. Code § 4301. https://casetext.com/statute/california-codes/california-business-and-professions-code/division-2-healing-arts/chapter-9-pharmacy/article-19-disciplinary-proceedings/section-4301-unprofessional-conduct-procurement-of-license-by-fraud-or-misrepresentation-or-by-mistake. Accessed October 8, 2024.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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