2024 Lecture 1: Introduction to Law PDF

Learning objectives =================== After attending the lecture and completing the assigned readings the student should be able to: - Identify the reasons why society regulates medication, as well as the limitations of regulations - Distinguish and describe the sources and types of la...

Learning objectives =================== After attending the lecture and completing the assigned readings the student should be able to: - Identify the reasons why society regulates medication, as well as the limitations of regulations - Distinguish and describe the sources and types of laws in the United States (statutory, judicial, administrative/regulatory) - Describe the federal and state legislative process (how laws get passed) - Describe the structure and function of the US judicial system - Identify how administrative agencies get their responsibilities (enforcement and rulemaking) - Identify and describe the various aspects of judicial law (court system, civil versus criminal, parties involved, statute of limitations) - Identify the various players who determine pharmacy law - Define and describe public policy - Identify and describe the phases of the public policy life cycle, who is involved in the public policy cycle, the types of policy instruments that may be used and their purposes, Required readings ================= - Abood R. Chapter 1: The law and the legal system. *Pharmacy Practice and the Law, 9^th^ ed.* Sudbury, MA: Jones and Bartlett Publishers; 2019. - The Beginner\'s Guide to Digital Participation: Get Started with Online Citizen Participation in Your Community. Brussels, Belgium: citizenlab. Accessed 28 February 2022. Guide\_beginner\_digital\_engagement\_CitizenLab\_2021.pdf.. Posted on Canvas. - Mackay M and Shaxton L. Understanding and Applying Basic Public Policy Concepts. Ontario, Canada: University of Guelph. Accessed 4 March 2022. Posted in Canvas. Sources of Law ============== What is Law? ------------ **Figure** **1: Who Determines Law**? (Federal or State) +-----------------------+-----------------------+-----------------------+ | **Citizens** | | | | | | | | - **Individuals, | | | | society, culture, | | | | or community | | | | identify a real | | | | or perceived need | | | | for protection, | | | | order, or | | | | behavioral | | | | standards.** | | | | | | | | - **Agree as a | | | | group to submit | | | | to a recognized | | | | authority in | | | | exchange for | | | | certain | | | | protections** | | | +=======================+=======================+=======================+ | Statutory Law |  | Case Law | | | Administrative | | | | Law | | +-----------------------+-----------------------+-----------------------+ | Legislative Branch | Executive Branch | Judicial Branch | +-----------------------+-----------------------+-----------------------+ | Makes Laws (Statutes; | Carries Out Laws | Evaluates Laws | | aka Acts) | | | +-----------------------+-----------------------+-----------------------+ | Congress, House of | President, | Fed -- Supreme Court, | | Representatives, | Vice-President, | Court of Appeals | | Senate | Cabinet, Federal | (Circuit Courts), | | | Agencies (Governor, | District Courts, and | | | Lt. Governor if one, | other Courts | | | State Agencies) | | +-----------------------+-----------------------+-----------------------+ Constitutional and Statutory Law Laws made by legislative bodies (aka Congress is one example) ---------------------------------------------------------------------------------------------- +-----------------------------------+-----------------------------------+ | Constitutional Law (Federal) | **Constitutional Law (State)** | +-----------------------------------+-----------------------------------+ | - [US | - [AZ State | | Constitution](https://www.arc | Constitution](https://www.azl | | hives.gov/founding-docs/constitut | eg.gov/constitution/) | | ion-transcript) | -- highest law in the state | | -- the highest law of the | | | country | - Preamble (Introduction) | | | | | - Preamble (Introduction) | - 30 Articles | | | | | - 7 Articles | | | | | | - 27 Amendments | | | | | | - Bill of Rights | | | (1-- 10) | | +-----------------------------------+-----------------------------------+ | Statutory Law (Federal) | **Statutory Law (State)** | +-----------------------------------+-----------------------------------+ | - [Federal | - [State | | Statutes](https://www.govinfo | Statutes](https://www.azleg.g | |.gov/app/collection/uscode) | ov/arstitle/) | | | | | - Referred to as US Code | - Referred to as AZ Revised | | (USC) | Statutes (ARS) | | | | | - Public Law | - Applies statewide and to | | | any other bodies that | | - Applies nationwide | affect AZ citizens | +-----------------------------------+-----------------------------------+ | Examples | **Examples** | +-----------------------------------+-----------------------------------+ | - [Food Drug and Cosmetic | - [Arizona Pharmacy | | Act](https://www.govinfo.gov/ | Act](https://www.azleg.gov/ar | | content/pkg/USCODE-2011-title21/h | sDetail/?title=32) | | tml/USCODE-2011-title21.htm) | (ARS Title 32 -- Chapter 18) | | (FDCA) (21 USC 1 -2252) | | | | - [Uniform Controlled | | - [Controlled Substances | Substances | | Act](https://www.deadiversion | Act](https://www.azleg.gov/ar | |.usdoj.gov/21cfr/21usc/) | sDetail/?title=36) | | (CSA) (21 USC 801-971) | (ARS Title 36 -- Chapter 27) | +-----------------------------------+-----------------------------------+ Administrative Law (aka Rules and Regulations) Laws made by administrative (executive branch) agencies ------------------------------------------------------------------------------------------------------ **Administrative laws** (rules and regulations) are promulgated by administrative agencies (executive branch) **Figure** **2: Federal Rules/Regulation Example**  ### How Do Administrative Agencies Get Their Authority? ###### Enabling legislation - Legislation that gives officials and/or agencies the authority (jurisdiction) to implement or enforce the law - Determined by US or State Statutes ###### Enabling Legislation that created FDA and Arizona State Board of Pharmacy ### Where Can You Go to Find Administrative Laws (Rules and Regulations) +-----------------------+-----------------------+-----------------------+ | Federal Level | **State Level** | **City/County Level** | +-----------------------+-----------------------+-----------------------+ | Federal Rules and | State Rules and | [Municipal rules | | Regulations (Final) | Regulations (Final) | (Ordinances)](https:/ | | | | /library.municode.com | | - [Final rules | - [Final rules | /az/glendale/codes/co | | published in the | published in **AZ | de_of_ordinances) | | Code of Federal | Administrative | | | Regulation | Code | | | (CFR)](https://ww | (AAC)**](https:// | | | w.ecfr.gov/cgi-bin/te | azsos.gov/rules/arizo | | | xt-idx?SID=3ee2863324 | na-administrative-cod | | | 16f26a91d9e6d786a604a | e) | | | b&mc=true&tpl=/ecfrbr | | | | owse/Title21/21tab_02 | | | |.tpl) | | | +-----------------------+-----------------------+-----------------------+ | Examples | Examples | Examples | +-----------------------+-----------------------+-----------------------+ | [21 CFR 1 -- | Arizona Board of | Zoning rules | | 1299](https://www.ecf | Pharmacy -- [AAC | | | r.gov/current/title-2 | R4-23-101](https://ap | Local taxes | | 1) | ps.azsos.gov/public_s | | | Food and Drug | ervices/Title_04/4-23 | Pseudoephedrine rules | | Regulations |.pdf) | | | | | | | [21 CFR 1300 -- | Arizona Medical Board | | | 1399](https://www.ecf | [R4-16-101](https://a | | | r.gov/current/title-2 | pps.azsos.gov/public_ | | | 1/chapter-II) | services/Title_04/4-1 | | | Controlled Substances | 6.pdf) | | | Regulations | | | | | Arizona Board of | | | [42 CFR 400 -- | Osteopathic Examiners | | | 699](https://www.ecfr | in Medicine and | | |.gov/current/title-42 | Surgery | | | ) | [R4-22-101](https://a | | | Centers for Medicare | pps.azsos.gov/public_ | | | & Medicaid Services | services/Title_04/4-2 | | | | 2.pdf) | | | | | | | | Arizona Regulatory | | | | Board of Physicians | | | | Assistants | | | | [R4-17-101](https://a | | | | pps.azsos.gov/public_ | | | | services/Title_04/4-1 | | | | 7.pdf) | | +-----------------------+-----------------------+-----------------------+ | Proposed Federal | **Proposed** Arizona | | | rules will be found | State rules will be | | | in the | found in the | | | | [**Arizona | | | [Federal | Administrative | | | Register](https://www | Register**](https://a | | |.federalregister.gov/ | zsos.gov/rules/arizon | | | ) | a-administrative-regi | | | | ster) | | | | | | | | [Example of ASBP | | | | Final Rulemaking | | | | Notice in Arizona | | | | Administrative | | | | Register](https://app | | | | s.azsos.gov/public_se | | | | rvices/register/2022/ | | | | 11/contents.pdf) | | +-----------------------+-----------------------+-----------------------+ ### Process to Create Administrative Law (DEA and CARA partial fills for CIIs) [Process infographic with more details](https://venngage.net/pl/TwdWDSMMSMo) Case Example: **LAW:** Comprehensive Addiction and Recovery Act (CARA) passed by Congress and signed into law by the President. - Allowed for partial fills of CII medications beyond current (at the time) DEA regulations. **Federal Agency:** Drug Enforcement Administration (DEA) **Federal Register:** [Proposed Regulations](https://www.federalregister.gov/documents/2020/12/04/2020-26291/partial-filling-of-prescriptions-for-schedule-ii-controlled-substances) Published on 12/04/2020 **Code of Federal Regulations:** [Final Regulation](https://www.federalregister.gov/documents/2023/07/21/2023-15508/partial-filling-of-prescriptions-for-schedule-ii-controlled-substances) Published on 07/21/2023 with effective date of 08/21/2023. **Code of Federal Regulations (CFR):** [21 CFR 1306.13 (b)](https://www.ecfr.gov/current/title-21/section-1306.13) partial filling of a prescription for a schedule II controlled substance at the request of the prescribing practitioner or patient ### For a regulation to be valid, it must meet the following criteria (tests): **The regulation must:** - be within the scope of the agency's authority. - be based on a statute that gives the agency the authority to promulgate the regulation. - bear a reasonable relationship to public health, safety, and welfare. ### Who Enforces Administrative Laws? ###### Federal Administrative Laws Figure 3: Federal Agencies that Enforce Administrative Laws from a Pharmacy Perspective (not all inclusive) ###### State Administrative Laws (AZ) Figure 4: State Agencies that Enforce Administrative Laws from a Pharmacy Perspective (not all inclusive) - Reminder: Administrative Agencies have ***legislative* and *judicial functions*** Judicial Law (aka Common Law) -- The Courts ------------------------------------------- (Look at Judicial Process section for additional information of the Abood textbook). - Judicial opinions = force of law (case law) ### Stare Decisis (See Abood et al. under "common law" for complete explanation) ***Stare Decisis = Decide to abide by decided cases -* sets precedent** **Purpose:** 1. Establish continuity of decisions 2. Expedite judicial decision-making **Application:** - Only applies to lower courts ***within the jurisdiction*** that the precedent has been set **Example:** - US 9^th^ Circuit Court of Appeals (9^th^ Circuit) has jurisdiction over the following states and territories: AK, AZ, CA, HI, ID, MT, NV, OR, WA, Guam, and Northern Mariana Islands - Decisions made by the 9^th^ Circuit only apply to the states and territories in the 9^th^ Circuit ### The Judicial Process ###### Who are the parties in a lawsuit? ###### Criminal, Civil, Administrative law +-----------------+-----------------+-----------------+-----------------+ | | **Criminal | **Civil Law** | **Administrativ | | | Law** | | e | | | | **(Think Judge | Law** | | | **(Think Law & | Judy)** | | | | Order)** | | **(ASBP in the | | | | | matter of: | | | | | Defendant -- | | | | | Pharmacist, | | | | | Intern, Tech, | | | | | Permittee, | | | | | etc.)** | +=================+=================+=================+=================+ | **Those | State vs. | Plaintiff vs. | ASBP in the | | involved:** | Accused | Defendant | matter of: | | | | | (Defendant) | +-----------------+-----------------+-----------------+-----------------+ | **Reason for | Violation of a | One party sues | Violation of | | case:** | statute | another | statute, rule, | | | | alleging an | or regulation | | | | injury | | +-----------------+-----------------+-----------------+-----------------+ | **Objective:** | Punish for | Compensate | Determine | | | violation | injured party | nature of | | | | for damages | violation and | | | | | if sanctions to | | | | | be imposed | +-----------------+-----------------+-----------------+-----------------+ | **Determination | ***"Guilty | Decisions based | ***Based on | | :** | beyond a | on 51:49%; must | determination | | | reasonable | have | of | | | doubt."*** | "***preponderan | Administrative | | | | ce***" | Agency (i.e., | | | | | ASBP)*** | +-----------------+-----------------+-----------------+-----------------+ | **Potential | Accused can go | Defendant can | Defendants may | | Consequences:** | to jail, fined | be prohibited | be fined, | | | | from doing | sanctioned, | | | | certain | prohibited from | | | | activities, | certain | | | | fined | activities, | | | | | etc. | +-----------------+-----------------+-----------------+-----------------+ | **Adjudication: | Various courts | Various courts; | Hearing | | ** | | arbitration | officer; | | | | | | | | | | Defendant may | | | | | appeal to | | | | | agency panel; | | | | | | | | | | May appeal to | | | | | civil court if | | | | | needed | +-----------------+-----------------+-----------------+-----------------+ ###### Statute of Limitations -- Civil Law *A time limit in which a suit must be file and brought before a governing body from the date when the problem first started* What is the statute of limitations in AZ? **2 years** from the ***time known or should have known*** for the majority of issues. ###### Filing a Civil Suit 1. Pay a fee 2. File a complaint in court 3. "Serve" complaint to the defendant 4. Discovery process 5. Motions made Approximately ½ of all civil lawsuits are settled by a judge. ###### The Trial (Criminal or Civil) Two choices: - Jury - Judge Who determines pharmacy law ===========================  ###### Can you identify situations that may have prompted our society to agree to the existence of laws dealing with drug products? - Misbranded products - Adulterated products - No standards in place - Product misrepresented Public Policy, Laws, and rule making ==================================== What is public policy? ---------------------- ***It is a decision made by the government to either act, or not act in order to resolve a problem.*** Examples include: Phases of the Public Policy Cycle: ---------------------------------- Source: Northern California Grantmakers. *Public Policy Grantmaking Toolkit.* \[NCG website\]. Available at: [http://www.ncg.org/toolkit/html/gettingstarted/index.html Accessed 1 Sept 2008](http://www.ncg.org/toolkit/html/gettingstarted/index.html%20Accessed%201%20Sept%202008). +-----------------------------------+-----------------------------------+ | **PHASE OF THE PUBLIC POLICY | **WHAT IT'S ABOUT** | | CYCLE** | | +===================================+===================================+ | **Problem identification (idea)** | Emergence of a problem that | | | requires the attention of the | | | public and decision-makers | +-----------------------------------+-----------------------------------+ | **Agenda Setting** | Who sets the agenda? | | | | | | - Policy makers | | | | | | - Elected officials | | | | | | - Citizens | | | | | | Places the problem on the | | | government's (or organization's) | | | agenda in order to find a | | | solution | +-----------------------------------+-----------------------------------+ | **Policy Formulation/Adoption** | Formulation of alternatives to | | | resolve the problem or address | | | the idea. | | | | | | Includes: | | | | | | - Policy analysis -- the | | | environment and internal | | | context | | | | | | - Research and analysis | | | | | | - Policy determination -- | | | decide which challenges will | | | be tackled and goals to be | | | achieved | | | | | | - Community organizing | | | | | | - Advocacy | | | | | | - Action planning -- clearly | | | state how will realize the | | | goals | +-----------------------------------+-----------------------------------+ | **Implementation** | Creating dialogue about the plan, | | | proposal, or decision | | | | | | Methods: | | | | | | - Federal register/Arizona | | | Administrative Register | | | | | | - Congress -- Bills | | | | | | - Public health departments | | | | | | - Standards of care | +-----------------------------------+-----------------------------------+ | **Evaluation** | Evaluate the outcomes of the | | | policy(ies); restart the cycle | | | | | | Litigation may be involved | +-----------------------------------+-----------------------------------+ Who is Involved in the Public Policy Cycle? ------------------------------------------- +-----------------------------------+-----------------------------------+ | Actor | Role | +===================================+===================================+ | Government | Social control of behavior; | | | coercion based on power | +-----------------------------------+-----------------------------------+ | Cabinet | Limited number of people with | | | power; | | | | | | Think Secretary of Health and | | | Human Services, Secretary of | | | Homeland Security, Secretary of | | | the Treasury, etc. | +-----------------------------------+-----------------------------------+ | Public Servants | Civil servants working in various | | | government agencies -- provide | | | technical knowledge and policy | | | advice; service providers | | | | | | Think: FBI, CIA, DOJ, FDA, CMS, | | | ATF, ICE, Border Patrol, IRS, | | | CDC, etc. | +-----------------------------------+-----------------------------------+ | Political Parties | Develop relationships in exchange | | | for political support | +-----------------------------------+-----------------------------------+ | Interest Groups | Seek to advance interests of | | | members; can have major influence | | | | | | Can force policy network to react | +-----------------------------------+-----------------------------------+ | Legal System | Interpret laws; acts | | | independently | +-----------------------------------+-----------------------------------+ | Public | Elects government, forms | | | opinions, joins interest groups | | | and coalitions, relies on various | | | media sources for information | +-----------------------------------+-----------------------------------+ Policy Instruments ------------------ Policy instruments -- techniques at the government's disposal to implement policy objectives. Purpose of policy instruments: - Achieve behavior change within individuals - Realize social, political, or economic conditions - Provide services to the public +-----------------------------------+-----------------------------------+ | Policy Instrument | Role | +===================================+===================================+ | Doing Nothing | Decide not to intervene; problem | | | may be self-corrective | +-----------------------------------+-----------------------------------+ | Information-based | Influence people through | | | knowledge transfer, | | | communication, and moral | | | persuasion (least coercive) | +-----------------------------------+-----------------------------------+ | Expenditure-based | Money is used as a direct | | | instrument to achieve the outcome | | | (grants, contributions, vouchers, | | | etc.) | +-----------------------------------+-----------------------------------+ | Regulation(s) | Government's role to command and | | | prohibit actions -- defines norms | | | and acceptable behavior or limits | | | activities | +-----------------------------------+-----------------------------------+ | Acting directly | Provide a direct service to | | | achieve outcome (instead of | | | working through citizens or | | | organizations to achieve goals). | | | | | | Examples: education; parks and | | | recreation, public health/CDC | +-----------------------------------+-----------------------------------+ ###### Current Pharmacy public policy issues - Gain provider status for pharmacists under the Social Security Act (which already recognizes other healthcare providers, including dieticians, nurse practitioners, physician assistants, nurse midwives, and clinical social workers). - Opioid epidemic -- federal responses, including the [CDC Update to 2022 CDC Clinical Practice Guidelines for Prescribing Opioids](https://www.federalregister.gov/documents/2022/02/10/2022-02802/proposed-2022-cdc-clinical-practice-guideline-for-prescribing-opioids) - [CARA](https://www.congress.gov/bill/114th-congress/senate-bill/524) - [US PREP Act](https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx) - [US "Test to Treat" for COVID 19 and Pharmacy Involvement](https://www.whitehouse.gov/covidplan/?utm_campaign=McDermottPlus%20Check-Up&utm_medium=email&utm_source=Eloqua) ###### Why are these important to the pharmacy profession and the General Public? +-----------------------------------+-----------------------------------+ | Provider Status | Comprehensive Addiction Recovery | | | Act (CARA) of 2016 | +===================================+===================================+ | May 2011 with *Improving Patient | **July 2016** [CARA became a | | and Health System Outcomes | federal | | Through Advanced Pharmacy | law](https://www.congress.gov/bil | | Practice: A Report to the Surgeon | l/114th-congress/senate-bill/524) | | General 2011* | | +-----------------------------------+-----------------------------------+ | 2013 -- Pharmacy coalition | Title VII Sec 702 amended the | | established (AACP, ACCP, AMCP, | Controlled Substances Act to | | APhA, ASCP, ASHP, CPNP, FMI, | allow pharmacists to partially | | IACP, NACDS, NASPA, NCPA, Rite | fill CII (schedule II) | | Aid Pharmacy, SNHPA, Walgreens) | medications if: | | | | | - APhA -- dedicating \$1.5 | \(1) such partial fills are not | | million dollars towards this | prohibited by state law; | | initiative | | | | \(2) a partial fill is requested | | | by the patient or prescribing | | | practitioner; and | | | | | | \(3) the total quantity | | | dispensed in partial fillings | | | does not exceed the quantity | | | prescribed | +-----------------------------------+-----------------------------------+ | 2014 -- Several states have | In 2017 and 2018 US Senators | | passed state statues (acts) that | Warren (D-Mass), Capito (R-WVA), | | have given provider status to | Grassley (R -- IA), Feinstein | | pharmacists within their state | (D-CA) and Representatives Clark | | (California, Arizona, Kansas, | (D-Mass) and Stivers (R-OH) wrote | | Wisconsin, etc.) | joint letters to the DEA urging | | | them to issue regulations and | | | guidance for partial filling of | | | CII medications as approved under | | | CARA. | +-----------------------------------+-----------------------------------+ | The Pharmacy and Medically | **Dec 2020** [DEA Published a | | Underserved Areas Enhancement Act | notice of proposed rulemaking for | | | the partial dispensing of CII | | Introduced in the following | prescription | | legislative sessions: | medications.](https://www.federal | | | register.gov/documents/2020/12/04 | | - 2015 -- 16 HR592/S109) | /2020-26291/partial-filling-of-pr | | | escriptions-for-schedule-ii-contr | | - 2016 - 17 | olled-substances) | | | | | - 2017 -- 18 | | | | | | - 2020 -- 21 | | | | | | - 2021 -- 22 (HR 2759/S1362) | | | | | | - 2022 -- HR 7213 | | +-----------------------------------+-----------------------------------+ | NACDS RxIMPACT: | Comments were open until February | | | | +-----------------------------------+-----------------------------------+ | February 2022 -- New coalition | Final rule published July 2023. | | website and name: | Effective in August 2023. | | | | +-----------------------------------+-----------------------------------+ ###### What do you think are the reasons that Provider status legislation has not passed yet? ###### ###### What do you think needs to happen to get Provider status for pharmacists passed in the US Congress? ###### To get more information on the Push for Pharmacist Provider Status See: Future of Pharmacy Coalition: Membership includes: - Abbott - American Pharmacists Association (APhA) - American Society of Health-System Pharmacists (ASHP) - AmerisourceBergen - Cardinal Health - CVS Health - Good Neighbor Pharmacy - Health Mart - Kroger Health - McKesson - Medicine Shoppe International - National Association of Chain Drug Stores (NACDS) - Walgreens Review Questions: =================