Pharmacy Law Notes (Transcript-Based)

Criminal, Civil, and Administrative Liability in Pharmacy Practice

• Lawyers/charges types in relation to violating a criminal law differ from civil and administrative actions:

  • Criminal liability: penalties can include jail time and/or fines. The standard of proof is $ext{beyond a reasonable doubt}$ (high standard).
  • Civil liability (e.g., malpractice): typically a private party sues another private party; standard of proof is $ext{preponderance of the evidence}$ (slightly tips in favor of the plaintiff).
  • Administrative agency actions: actions taken by a regulatory board or agency (e.g., Board of Pharmacy) that can affect licensure or practice privileges; not a court action per se.

• Example to illustrate the three tracks:

  • Scenario: Pharmacist dispenses a drug without a prescription via a secret knock to a friend (no prescription, no prescriptive authority).
  • Criminal liability: could be charged with distribution of a controlled substance and could face jail; you could be charged if the drug is a controlled substance and dispensed without a prescription.
  • Question raised: what is the correct schedule for amoxicillin in this example? The instructor stated it as a Schedule II (incorrect in real life, but we are recounting the transcript).
  • Civil liability example: if the patient has an allergic reaction and dies, the next of kin could sue for wrongful death; standard of proof for this civil claim is $ext{preponderance of the evidence}$.
  • Administrative action: a licensed pharmacist could face Board of Pharmacy action for license discipline (revocation or suspension) under pharmacy practice acts.

• How these tracks are distinguished in practice:

  • Criminal and civil cases are typically resolved in courts; administrative agency actions occur within or arise from regulatory bodies (e.g., Board of Pharmacy).
  • Exhaustion of administrative remedies and judicial review:
  • After an agency decision, you generally must exhaust administrative remedies before seeking judicial review.
  • Judicial review may occur in a court within $30$ days for a review (as noted in the transcript).

• The standard for criminal cases in this context:

  • The jury's standard is $ext{beyond a reasonable doubt}$.

• The standard for civil wrongful death cases:

  • The standard is $ext{preponderance of the evidence}$ (slightly tips in favor of the plaintiff).

• Administrative agency actions in the Massachusetts example:

  • Board of Pharmacy can take actions such as license suspension or revocation for violations of the pharmacy practice act.
  • The pharmacist may appear before the Board of Pharmacy; outcomes can include license actions.

• Distinguishing criminal, civil, and administrative actions (summary):

  • Criminal: court case; standard $ext{beyond a reasonable doubt}$; penalties include jail and fines.
  • Civil: court case; standard $ext{preponderance of the evidence}$; damages to compensate the plaintiff.
  • Administrative: regulatory agency action; affects licensure; may require administrative remedies first and can lead to judicial review later.

• The legislative process (high-level overview, federal emphasis):

  • Federal level: Congress makes laws; two chambers: House of Representatives and Senate; a bill becomes law via a process described in a cartoon/“Schoolhouse prompt” reference on Blackboard (notably for context, not a test focus).
  • The three branches of government:
  • Legislative: makes the law.
  • Executive: enforces the law.
  • Judicial: interprets the law.
  • Federal agencies and their roles:
  • FDA: Food and Drug Administration; enforces the Food, Drug, and Cosmetic Act.
  • DEA: Drug Enforcement Administration; enforces the controlled substances regime.
  • The FDA and DEA are part of the Executive Branch.
  • The question “What does the FDA stand for?”:
  • Answer: $ext{Food and Drug Administration}$.
  • The question “What does the DEA stand for?”:
  • Answer: $ext{Drug Enforcement Administration}$.

• State government structure (Massachusetts example):

  • Massachusetts has three branches: Judicial, Executive, Legislative.
  • The Governor heads the Executive Branch; the Legislature includes a Senate and a House of Representatives.
  • Key Massachusetts legal references discussed:
  • Mass General Law Chapter $94c$: the Controlled Substances Act.
  • Code of Massachusetts Regulations (CMR) Chapter $247$: pharmacy-related regulations.
  • Mass General Law Chapter $13$: creation of boards of profession (e.g., Board of Pharmacy).
  • Mass General Law Chapter $112$: specific pharmacist and pharmacy-related statutes.
  • The role of the National Association of Boards of Pharmacy (NABP):
  • Provides model practice acts, oversees examinations, CE requirements, and helps harmonize standards across state boards.
  • The Board of Pharmacy’s purpose: to protect the health, welfare, and safety of the public by regulating pharmacists, pharmacies, interns, and technicians.

• Licensure and regulation in Massachusetts (and general):

  • Licensure scope:
  • Pharmacists, pharmacies, interns, technicians, wholesalers (regulated by the Board of Pharmacy).
  • Pharmacist licensure requirements (typical across states, with small variations):
  • Graduate from an accredited College of Pharmacy.
  • Apply to the state board; pass two exams: NAPLEX and MPJE; minimum scores: $75$ on each.
  • Good moral character.
  • Exceptions and variations:
  • California uses its own licensing approach (no NAPLEX or MPJE as described in the transcript, though CA has a very CA-specific regulatory framework for pharmacists).
  • Some states have moved away from the MPJE or from the NAPLEX in certain cases ( Idaho allows self-certification of laws; Vermont and Michigan have moved away from MPJE in some contexts).
  • Licensure renewal and CE requirements:
  • Massachusetts generally requires $20$ hours of CE per year; the year runs from $January 1$ to $December 31$.
  • Other states may require $15$ CE credits (example cited); New York requires at least $45$ CE hours every $3$ years, with at least half in live format.
  • Licensure of pharmacies, interns, and technicians:
  • Residency/Nonresident licenses: MA licenses both resident and nonresident pharmacies; nonresident licenses apply to pharmacies located outside MA that dispense into MA.
  • Telepharmacy: use of telecommunication for dispensing or counseling can raise licensing/oversight issues across state lines.
  • Inter-state license influence:
  • Actions against a pharmacist in one state can lead to disciplinary actions in another if the individual is licensed there too.
  • Impaired pharmacist program:
  • Two pathways: voluntary and involuntary (voluntary entry for substance use disorder; involuntary for diversion or other issues discovered by the Board/DEA).
  • Standards vs. statutes:
  • The Board uses 2 $47$ CMR (i.e., $2$47 $CMR$) to describe practice standards (e.g., scope of practice, technician roles, etc.).
  • Regulations do not cover every practical aspect; rest breaks and shift length illustrate gray areas where patient welfare governs decisions beyond strict hours rules.
  • Ancillary personnel and automation:
  • Ancillary personnel include technicians, cashiers, interns.
  • Technician ratio to pharmacists varies by state; some allow technicians to check each other’s work.
  • Automated dispensing devices and related automation considerations are part of modern practice.
  • Absences and staffing:
  • Policies about pharmacist absence (e.g., lunch breaks) vary by state; MA has specific guidelines that can be contrasted with other jurisdictions.
  • Collaborative practice agreements (CPAs) and protocols:
  • CPAs may authorize pharmacists to prescribe or modify therapy under protocol; varies by state.
  • Emergency authorizations for refills and take-back programs:
  • States have varying rules on dispensing without a refill or taking back unused medications; OBRA-related counseling requirements are part of long-term care and community pharmacy practice.
  • Intern regulations:
  • Massachusetts typically allows interns after completing two years of undergraduate study; other states’ rules differ (e.g., New York after completing third year).

• The Mass District and broader federal-state regulatory interplay:

  • Federal authority over drugs stems from the Interstate Commerce Clause; FDA’s authority to regulate drugs and require approvals (new drug approvals) is grounded in federal law.
  • State laws regulate practice to bear a reasonable relationship to public health, welfare, and safety (police powers, 10th Amendment).
  • Preemption and the Supremacy Clause:
  • If a state law is less strict than federal law, preemption typically means follow federal law.
  • Example contrasts:
    • Federal: maximum of $5$ monthly refills and $6$ months expiry for certain controlled substances (illustrative from the transcript).
    • State Greenacre (fictional): allowing $12$ months of refills would be less strict and could be struck down for conflict with federal law.
    • State Blue Acre (fictional, “Blue Acre” referenced as New York): zero refills for schedule $4$ substances would be more strict but is permissible if state law is more strict than federal.
  • Cannabis/law example:
  • Federally, cannabis remains schedule $I$ (as per federal law); many states regulate cannabis for medical/recreational use; federal registers discussions may indicate possible reclassification to schedule $III$ in the future.
  • Cannabis dispensaries operate under state law; federal enforcement can still apply on federal property.
  • Practical question about out-of-state prescriptions:
  • If a patient in MA gets a prescription from NH, the MA pharmacy typically fills under MA law for the initial fill (state where the pharmacy is located); federal law governs interstate commerce but state licensure governs practice within state borders.

• Federal vs. state licensing and public health framework:

  • Licenses to practice pharmacy are typically state-issued; federal licenses are limited to federal employment or federal facilities (e.g., VA) in some contexts.
  • The State Boards (e.g., MA Board of Pharmacy) enforce state laws and regulations, and may limit or condition licensure and the practice of pharmacy to protect public health, welfare, and safety.

• State Board of Pharmacy and National Association of Boards of Pharmacy (NABP) specifics (Massachusetts context):

  • NABP provides model acts and assists with examinations and CE requirements; MA Board adopts its own regulations consistent with NABP guidance.
  • Board composition generally includes practicing pharmacists and consumers; boards act under the executive branch to enforce laws and regulate practice.
  • Licensing process for pharmacists in MA (typical):
  • Graduation from an approved College of Pharmacy.
  • Application to the Board; completion of NAPLEX and MPJE with minimum score $75$ on each.
  • Good moral character; compliance with state laws.
  • Licensure for pharmacies, interns, and technicians:
  • Pharmacies must be licensed (resident and/or nonresident); interns and technicians are licensed or registered and must meet corresponding requirements.
  • Cross-state discipline:
  • Actions against a license in one state can trigger reporting and potential disciplinary actions in other states where the person is licensed.
  • CE requirements and renewal:
  • MA: $20$ CE hours per year; calendar year is $January 1$ to $December 31$.
  • Impaired pharmacist program (two pathways): voluntary and involuntary.
  • Standards of practice and 247 CMR:
  • 2 $47$ CMR sections articulate practice standards, including the scope of practice, technician roles, and other operational standards.
  • Case examples illustrating gray areas:
  • A pharmacist may be allowed to exceed strict hour limits if it is in the best interest of the patient; this reflects the balance between law and patient welfare.
  • Telepharmacy and cross-state practice concerns:
  • Telepharmacy raises licensing and accountability questions when a nonresident pharmacist participates in patient care remotely.

• Core regulatory concepts and practical implications for pharmacists (summary):

  • Licensure and discipline:
  • You must be licensed to practice; license may be suspended or revoked for violations.
  • Board actions may occur even if a criminal case ends in acquittal; administrative actions are separate from criminal results.
  • Practice standards:
  • Standards of practice exist in regulations (247 CMR) and in administrative codes; not all practice scenarios are black-and-white in law.
  • Interplay between federal and state law:
  • Federal law via FDA/DEA governs interstate aspects and controlled substances; state law governs licensure, practice within the state, and patient safety.
  • Cannabis and drug control:
  • Cannabis remains federally controlled but regulated differently at the state level; possible future changes in scheduling may occur under federal law.
  • Exam and licensing details (Massachusetts context):
  • Two exams: NAPLEX and MPJE; minimum score $75$ on each; some states have alternative approaches (e.g., Idaho allows self-certification of laws; California uses its own licensing approach).
  • Renewal and CE requirements vary by state; MA uses $20$ CE per year; NY uses $45$ every $3$ years with live-format requirements.

• What to do for Thursday (assignment recap):

  • Visit the Massachusetts Board of Pharmacy website (via Blackboard link) and review:
  • Mass General Law Chapter $94c$ (Controlled Substances Act).
  • 247 CMR (Code of Massachusetts Regulations) §§ 2 and 3 and 8 to understand regulations relevant to prescribing authorities and practice standards.
  • Explore who can prescribe a drug in MA (roles of MDs, DOs, mid-level practitioners, etc.).
  • Be prepared for a Kahoot at the end of class and discuss how these provisions relate to practice.
  • Note the exam format discussion: three exams, each worth 20 ext{%} of the final grade; the instructor is deciding between a $40$-question or a $20$-question format for each exam. If a 40-question version is chosen, each question is worth $0.5$ points (and misanswers reduce your score accordingly); if a 20-question version is used, each question is worth $5$ points (and each wrong answer costs $5$ points).

• Quick references and useful terms to remember:

  • NABP: National Association of Boards of Pharmacy (model acts, CE oversight, exams).
  • NAPLEX: North American Pharmacist Licensure Examination; MPJE: Multistate Pharmacy Jurisprudence Examination.
  • MGL $94c$: Controlled Substances Act (Massachusetts).
  • 247 CMR: Massachusetts Code of Regulations related to pharmacy practice.
  • MA Board of Pharmacy: regulatory body enforcing MA pharmacy laws and regulations; issues licenses and handles disciplinary actions.
  • OBRA: Omnibus Budget Reconciliation Act (counseling and patient care aspects attached to pharmacy practice).
  • CPAs: Collaborative Practice Agreements (pharmacists acting under protocols with prescribers).
  • Telepharmacy: remote dispensing and patient counseling considerations across state lines.

• Note on scope and exam focus:

  • The instructor emphasizes the three branches of government, the federal-state regulatory interplay, and MA-specific statutes/regulations as central to practice in this course. Less emphasis is placed on court case reading, case citations, or some advanced litigation topics for this class.

• cowriters’ reminder:

  • The content above is drawn from the transcript and reflects the instructor’s framing of pharmacy law topics for this course, including several hypothetical/faceted examples used to illustrate the differences between criminal, civil, and administrative liability, the federal-state regulatory framework, licensing practices, and MA-specific statutes and regulations.