Administrative Law Martha Dye-Whealan RPh, JD Pharm 543 Objectives (same as last class): Identify and distinguish the sources of law in the United States. Understand the hierarchy of laws. Understand the basic differences between common, statutory, and administrative law. Understand the basic structure of the federal and Washington State courts. 1 2 Objectives (in addition): Administrative Law (REVIEW) Understand where the Board of Pharmacy gets power to regulate the practice of pharmacy, etc.; understand rulemaking process. Understand issues involved in recent changes in WAC 246-863-095 and identify the changes in this rule. Understand pre-emption; federal v. state law. Body of law (usually regulations) created by administrative agencies. (WAC)/(CFR) Administrative agencies are created by legislatures, who delegate law making power to these agencies, which become part of the the executive branch of the federal government or individual states. 3 4
Administrative Agencies (REVIEW) Washington State Superior Courts and Administrative Agencies Federal and state administrative agencies also have judicial power to hold hearings and render decisions in order to enforce regulations they promulgate. Federal: Food and Drug Administration (in Dept of HHS) administers the Federal Food, Drug, and Cosmetic Act; Drug Enforcement Administration (in Dept of Justice) administers the federal Controlled Substances Act State: Board(s) of Pharmacy/Department of Health Superior Courts are the courts of general jurisdiction Washington Superior Courts also hear appeals from courts of limited jurisdiction, including administrative agencies. 5 6 Board of Pharmacy: Powers Granted by the APA See the Washington Administrative Procedure Act (RCW 34.05). Legislation which decrees how administrative agencies in Washington shall do the following: Make rules (regulations) Provide public access to agency rules, rulemaking proceedings APA (cont d) Conduct adjudicative proceedings: e.g. how the Board of Pharmacy would conduct a disciplinary proceeding against a pharmacist Have decisions from adjudicative proceedings appealed: Judicial review by Superior Court Enforce penalties Have rules reviewed by the state legislature (mandatory); known as legislative oversight. 7 8
Department of Health Board of Pharmacy, other professional licensing/regulation boards, now contained within the Department of Health. Majority of pharmacy regulations contained within WAC 246, Department of Health. How does the Board of Pharmacy conduct rulemaking? Board must solicit public comment on the subject of the possible rulemaking: at least 30 days before proposed rule is filed/published. Proposed rule published in state register: must be at least twenty days before rulemaking hearing where BOP will receive public comment regarding adoption of a rule. 9 10 Format of Publication of Proposed Rule: RCW 34.04.320 When publishing proposed rule, BOP must: Cite statutory authority to make rule; Give a short explanation of the rule, its purpose, and anticipated effects, including in the case of a proposal that would modify existing rules, a short description of the changes the proposal would make, and a statement of the reasons supporting the proposed action ; Format of proposed rule (cont d) Publish name of individual or individuals proposing rule; agency personnel administering rulemaking State whether rule is necessary as a result of federal or state court action, and, if so, cite the court case involved 11 12
Format of Proposed Rule (cont d) Recently Changed Rule: Pharmacist s Professional Responsibilities Publish When, where, and how persons may present their views on the proposed rule. Public comments usually can be submitted in written form, or at a public hearing, the date, time and location of which the BOP shall publish. And, most importantly, publish the DATE on which the agency intends to adopt the rule Several rounds of comments, at least four to five proposed rules, final rules effective 7/07. Although political issue driving the rule change was the controversy surrounding pharmacists who refused to dispense the morning after pill (ECP); there was much concern among the profession about two broader issues: 13 14 Recently Changed Rule: Pharmacist s Professional Responsibilities (cont d) Would a version of the rule which compelled pharmacists to dispense ECP also compel retail stores to maintain an extensive inventory of costly drugs, e.g. drugs for HIV, certain parenteral drugs (epoetin, G-CSF, triptans) in order to be able to dispense them immediately upon request (rather than effectively refusing to dispense them)? Recently Changed Rule: Pharmacist s Professional Responsibilities (cont d) Would there be a public backlash or a backlash from the medical profession that would produce a rule that would prevent pharmacists from intervening when a prescription as written had the potential to harm the patient or promote substance abuse, thus pushing the profession backward from a clinical role to a technical role? 15 16
FINAL RULE: WAC 246-863-095: RPh s professional responsibilities See compliance letter from BOP. Main thrust: pharmacist or ancillary personnel can be disciplined by the Board for the following conduct: destroying or taking away a prescription, violating patient s privacy, violating state or federal discrimination law, behavior that could be interpreted as intimidation or harassment. WAC 246-863-095; WAC 246-869-010 Other important obligation emphasized by rulemaking: the pharmacist may not delegate the decision to refuse to dispense a legally prescribed drug or device to support personnel Inventory concerns: addressed in WAC 24 6-869-0101, Pharmacies responsibilities 17 18 State vs. Federal Law; Pre- Emption Issue Supremacy Clause makes federal constitutional law the supreme law, enables Congress to displace state statutory and constitutional laws, and makes explicit that federal law binds state judges. What does this mean in practice? Federal Preemption, Express or Field: Congress can displace, or preempt, state law when it intends to and is acting within the scope of its constitutional powers: Express preemption: intent to supercede state law is declared within the body of the (federal) legislation. Field preemption: not expressed in statute, but courts subsequently look at the federal law and determine that Congress by implication intended to occupy the field. 19 20
Conflict preemption : Conflict Preemption (cont d): Conflict preemption: courts determine that an actual conflict exists between the two bodies of law, because either-- It is impossible to comply with both federal and state law. Example: Federal Food and Drug Act of 1906 imposed labeling requirements that conflicted with state labeling requirements at the time, McDermott v. Wisconsin (1913). State law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Example: Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA), which allows patients to sue for reimbursement of denied benefits, but not for damages stemming from the denial, preempts state statutory schemes that allowed patients to sue HMO s for damages/injuries resulting from the refusal of the HMO to cover treatment that a doctor has deemed medically necessary. Aetna v Davila (2003) 21 22 Possible to resolve preemption issue, see HIPAA Federal statute/regulations can expressly describe how statutory schemes can co-exist: Example, HIPAA: preempts state law to the extent that it is more protective of health information than state law. If state law provides greater protection of protected health information than HIPAA, then HIPAA Privacy Rule allows state law to prevail. 23