Law exam 1 - law exam PDF

Preview

Summary

law exam ...

Description

Pharmacy Law E1- Frankhauser

Nunez Spring 2017

Chapter 1: Why Do Pharmacy Students Study Law? x Law component on Pharmacy Boards Multistate Pharmacy Jurisprudence Exam (MPJE) x Pharmaceutical products are highly regulated by Federal & State Governments o Custodians of the nation’s drug supply x Impacts day to day pharmacy practice x Duty of Pharmacist- fill RX and fill it correctly o C-2 never expires Federally, but in MA it expires after 30 days if written in MA  If the RX was written in a touching state or Maine by MD only, expires in 5 days o C-2 can be taken over the phone for emergencies- day supply depends on the amount needed to get the patient through the emergency period AKA no legal limit o If one RPh is working, you can have max 4 support personnel but NEED to have at least 1 intern and one CPT or 2 interns/CPTs. If not, you can only have 3 people working with the one RPh and 1 needs to be a certified tech or an intern. You CANNOT have 3 registered tech’s working x Malpractice o Misstep could cost a person his/her life What is Legal? x The answer of what is legal is not always easily derived- it depends! o What is the best for the patient? This is the USUAL legal answer o Use GOOD professional judgment to determine what’s best for the patient  The law is not always easily derived; often it’s “gray” and the answer may be “it depends” x Example: 247 CMR (Code of Massachusetts Regulations) has a provision that the pharmacist may only work 12 hours in a day o What happens if a parent brings in an RX at 9PM, the pharmacist has already worked 12 hours that day. Could the pharmacist stay & fill that RX?  Law: if there’s a reason, and it’s in the best interest of the patient, you CAN Why Do We Regulate Medical Drugs? x Potential risk to the user x Government needs to protect people from harming themselves through risky choices o Why not allow people to look for themselves?  Market Failures Market Failures:  Public Goods⇾ orphan drugs, vaccines  Externalities⇾ overuse of antibiotics = resistance  Natural Monopolies⇾ period of exclusivity, cost of new drug development  Information Asymmetry⇾ information for educated professionals to make decisions about drug use Limits of the Law: x Minor violations o “No pharmacy can operate without occasional, very minor technical legal violations.”

Pharmacy Law E1- Frankhauser

x

Nunez Spring 2017

o Assume no real impact on the quality of drug therapy/patient safety, then it’s OK Ex: A patient enters your pharmacy in Friday night & needs a refill on his/her heart medication. The patient has no refills remaining, the physician is not available & the patient is leaving for vacation at 6AM the next morning. o You are the pharmacist on duty, what do you do?

Sources of U.S. Law: x Federal Government, State Government, Local Government o Federal & State Governments have 3 branches o Local Government has “Weights/Measures” board that goes in & inspects the scales x U.S. Constitution o Supreme Law of the U.S.  Any Federal or State statute or regulation that conflicts with the U.S. Constitution is invalid AKA unconstitutional Federal Government x 3 Branches- each branch serves as a check to the powers of the other branches so 1 isn’t more powerful than the other 2 o Legislative- make laws  Federal: Congress composed of: House of Representatives and Senate x Controlled Substance Act- written by the Legislative Branch x OBRA 90- written by the Legislative Branch o Required pharmacists to make the offer to counsel patients o Executive- branch of the government responsible for effecting & enforcing laws  Federal: President, State: government x Executive branch takes the law & makes regulations on it (expand on it)  Departments & independent agencies x Agencies also called Administrative Agencies o Judicial- interprets laws  Courts make laws through judicial opinion—common law executive branch: Administrative Agency (found in the Executive Branch) x Legislature may create an Administrative Agency to implement changes in policies or to administer law when the Legislature itself can’t perform o Legislature yields power to Administrative Agency x Agencies are viewed as expert in the field’s Key Federal Agencies that Impact Pharmacy:  Centers for Medicare and Medicaid Services (CMS)- reimbursement policy for Medicare & Medicaid  Food & Drug Administration (FDA)- Federal Food, Drug and Cosmetic Act  Federal Trade Commission (FTC)- Federal Trade Commission Act  Drug Enforcement Administration (DEA)- administer Federal Controlled Substances Act

Pharmacy Law E1- Frankhauser

Nunez Spring 2017

Administrative Agency: x Regulation must: o Be within the scope of the Agency’s Authority o Based on a statute that gives the Agency authority to promulgate regulation o Reasonable relationship to public health, safety & welfare Administrative Agencies Legislative Functions: x An Agency can make regulations in a process called Notice & Comment Rulemaking o To do this they post it in the daily publication, Federal Register (FR)  The process ensures that constituents whose interests are affected by the actions of the agency receive notice of any proposed regulation  Public can then have an opportunity to comment on the proposed regulation  Agency considers all comments & may incorporate them before final promulgation x Notice & Comment Period o The statutory time frame during which an agency publishes a proposed regulation  Published in Federal Register or code of Federal Regulations o Received public feedback on the regulation o After this period expires, the regulation can take effect Administrative Agencies Judicial Functions: x Hearings- resemble civil or criminal court proceedings o Evidence, arguments, decisions x Agency’s decision is subject to judicial review o Exhaustion of remedies o Court to examine record of Administrative hearing Federal Register (FR): x Daily publication in which U.S. administrative agencies publish: o Federal actions o Proposed regulations o Final regulations o Governmental notices Code of Federal Regulations: x The annual collection of all executive agency regulations published in the daily Federal Register, combined with previously issues regulations that are still in effect o 50 titles- focus will be on Title 21 legislative branch: How Do Bills Become Laws? x Legislative Process o Bills originate by lobbying groups, citizens, government, or President o Bills need a Sponsor  Sponsor must be a Senator or Representative  Sponsor introduces Bill in Congress  Presented to the Bill committee with jurisdiction over the Subject

Pharmacy Law E1- Frankhauser

o

o o o o o o

Nunez Spring 2017

x In Committee- public hearings, investigations, work with Sponsor of Bill Prior to Bill proceeding to a vote, the Bill needs the consent of a majority of the Committee  If the Committee votes in favor- a report detailing the purpose, reasons for approving the Bill & any changes in existing laws that the Bill would cause is generated Bill is then placed on the Calendar Debate After passage of the Bill in one chamber, the Bill goes to another chamber’s committee If the House and Senate version is different- conference committee then rectifies the differences After the same Bill is passed in both chambers, the bill is signed by the President of the Senate & Speaker of the House. The Bill is then presented to the President of the U.S. Bill becomes a law when the President signs r if the President fails to return the Bill within 10 days to Congress  If the President Disapproves, it’s VETO’ed and the President must provide reasons x Congress can override a Veto with 2/3 veto

judicial process: Federal Court System- authorizes the Supreme Court and authorizes Congress to establish additional federal courts as necessary District Court = Trial Court o 12 Districts o Jurisdiction over U.S. Constitution or questions of federal law, ambassadors, consults, admiralty or maritime, cases with US as a Party, States vs. States, diversity of citizens Court of Appeals o Hear appeals from the lower court o Review administrative agency decisions US Supreme Court o 9 Justices o Lifetime Appointment o Court decides on the cases it wants to review Other Courts o Tax, Custom, and Patent and Trademark Common Law: x Law based on prior judicial opinions x US Common Law is derived from England o Exception is Louisiana- based on French & Spanish Law x Stare decisis o To abide by decided cases  Provides for continuity of decisions  Expedite judicial decision making o Not flexible principle  Court may vary from precent if: x Factual distinctions

Pharmacy Law E1- Frankhauser x

Nunez Spring 2017 Changing times or circumstances- Duty to Warn

10th Amendment of the US Constitution x States have the power to legislate in all areas except those prohibited or given to Congress by the U.S. Constitution o State has authority to regulate in any area Congress has regulated as long as there is NO CONFLICT between State and Federal Law  If conflict exists, Federal law prevails over state l aw under the Supremacy Clause of the US Constitution x Generally, states can pass laws to protect the health, safety & welfare of the public o State government modeled after the Federal System: executive, legislative, judicial  In MA, the highest court is the Supreme Judicial Court (SJC) x Appellate Courts, Trials Courts, Other Courts (Probate, Family, Juvenile, Traffic and Small Claims Court) Key State Agencies in Massachusetts:  Department of Medical Assistance (DMA)- Medicaid policy & reimbursement  Department of Public Health (DPH) o Board of Registration in Pharmacy (BOP)- Pharmacy Practice Acts Examples of Federal versus State: ¡ Federal law on Controlled Substances in C-4 can be filled for 6 months or 5 refills, if authorized by Prescriber o What is the State of Greenacre proposes a law that allows for 12 refills on a C-4?  State law is less strict than Federal law. There is a CONFLICT between State and Federal- Federal law prevails o What if the State of Greenacre proposes a law that allows for no refills on a C-4?  State law is more strict than Federal law. There is NO CONFLICT- State law prevails Example of Criminal, Civil & Administrative Action: ¡ 1. Criminal- pharmacist sells a controlled substance (C-4) without prescription ¡ 2. Civil- buyer of the controlled substance takes the drug & experiences an allergic reaction & the Pharmacist had knowledge of the allergy prior to dispensing the med ¡ 3. Administrative Action- pharmacist appears in front of BOP for unprofessional conduct Chapter 2: Federal Food, Drug & Cosmetic Act (FDCA): x Provides for the comprehensive regulation of all drugs introduced into interstate commerce o The intent of the law is to protect consumers from adulterated or misbranded foods, drugs, cosmetics or devices x Under the Act, no new drug may be marketed & sold unless it has been proven both safe & effective for its intended use & approved by the federal FDA

Pharmacy Law E1- Frankhauser

Nunez Spring 2017

Historical Overview Prior to the FDCA: Pure Food & Drug Act (1906): concern for the risks to public health & safety associated with unsanitary & poorly labeled foods, and drugs promoted Congress in 1906 to pass the Pure Food & Drug Act x The law prohibited the adulteration & misbranding of foods & drugs in interstate commerce o In 1912, the Act was amended to prohibit false & fraudulent efficacy claims- the act failed to achieve its purpose  It was difficult to enforce because it requires the government to prove fraudulent intent on the part of the one who made false statements on the label x Sulfanilamide elixir tragedy of 1937 o Sulfanilamide as one of the first of the “miracle” anti-infective sulfa drugs marketed. Manufacturer produces the drug in an elixir form to mask the taste with diethylene glycol (antifreeze) as a solvent- no toxicity tests had been conducted⇾ solvent was found to be deadly poison and 107 DEATHS were attributed to this elixir  This product was adulterated & misbranded BUT the Pure Food & Drug Act had not granted the FDA the authority to ban unsafe drugs x FDA removed the elixir on a misbranded TECHNICALITY- elixirs must contain alcohol, the elixir of sulfanilamide did not contain alcohol. o If this product DID contain alcohol, it would’ve been kept on the market because there was “no fraudulent intent.” Food, Drug and Cosmetic Act (FDCA, 1938): provided that no NEW DRUG could be marketed until proven safe for use under the conditions described on the label & approved by the FDA x The law expanded the definition of misbranding & adulteration under the earlier act. o Labels must contain adequate directions for use & warnings about the habit-forming properties of certain drugs (applies to cosmetics & devices as well) Durham-Humphrey Amendment (1951): established 2 classes of drugs⇾ RX and OTC x The FDCA required all drugs to be labeled with “adequate directions for use” BUT drugs on the market at this time were not safe for use except under medical supervision o Durham- Humphrey Amendment was enacted to solve this problem  Durham-Humphrey provided that the labels of prescription drugs need not contain “adequate directions for use” so long as they contain the legend, “Caution: Federal law prohibits dispensing without a prescription” x Today: the federal legend is “RX only” on a product  When dispensed by a pharmacist, inclusion on the label of directions for use from the prescriber satisfies the “adequate directions for use” requirements x Ex: Take 1 tablet by mouth TID  Amendment also authorizes oral prescriptions & refills of prescription drugs x Ex: telephone/verbal order; prior to 1951 all RX’s were new RX’s Food Additives Amendment (1958): x Congress amended the FDCA to require that components added to food products must receive premarket approval for safety o Anticancer provision (Delaney Clause)- prohibit the approval of any food additive that might cause cancer

Pharmacy Law E1- Frankhauser

Nunez Spring 2017

Color Additive Amendments (1960): x Requires manufacturers to establish the safety of color additives in foods, drugs and cosmetics o The FDA can approve a color for one use, but not the others (ex: external use only) Thalidomide: on the market today as an anticancer drug x Thalidomide- a popular sedative that was being marketed in Europe (1950s) o The FDA withheld final approval of the NDA pending safety information o In 1961, it was confirmed that Thalidomide caused birth defects in thousands of infants  Due to the FDA refusal to allow marketing of the drug in the US, the number of birth defects in the US was low o Congress enacted the Kefauver-Harris Amendment Kefauver-Harris Amendment (1962): x Strengthened the new drug approval process by requiring drugs to be proved not only safe but also effective o The efficacy requirement was made retroactive to all drugs marketed between 1938-1962 x Amendment also: o Transferred jurisdiction of RX drug advertising from the Federal Trade Commission to the FDA- any drug advertisements for RX are reviewed by the FDA but if they’re OTC advertisements they’re still reviewed by the Federal Trade Commission o Established the Good Manufacturing Practices (GMP) requirements o Added more extensive controls for clinical investigations, such as informed consent & reporting of ADR Medical Device Amendment (1976): x Under the 1938 FDCA Act, the FDA has no authority to review medical devices for safety & efficacy before marketing o Prompted by public safety concerns with certain devices, Congress amended the FDCA in 1976 to provide for more extensive regulation administrative authority regarding the safety & efficacy of medical devices x Amendment requires o Classification of devices according to their function o Premarket approval o Establishment of performance standards o Conformance with GMP regulations o Adherence to record & reporting requirements Orphan Drug Act (1983): x Pharmaceutical manufacturers had urged Congress to recognize that the NDA process was too expensive to warrant development & marketing of drugs for diseases that affected few people o In 1983, Congress passed legislation to provide tax & exclusive licensing incentives for manufacturers to develop & market these drugs, or biologicals, for rare conditions (< 200,000 Americans) x If your product gets approved under the Orphan Drug Act, you’re the only manufacturer that can market that product for X number of years.

Pharmacy Law E1- Frankhauser o

Nunez Spring 2017

In order to help the companies, recoup the amount of money used to get the product approved- they charge $15,000-20,000 for their meds

Drug Price Competition & Patent Term Restoration Act (1984): x AKA Waxman-Hatch Amendment o Enacted to streamline the generic approval process while giving patent extensions to brand-name companies during this time, in certain circumstances, to innovator drugs  Government told brand-name companies in order to get that extension, they need to allow generic companies to use their ANDA x The intent is to make generic drugs more readily available to the public while providing incentives to manufacturers to develop new drugs Prescription Drug Marketing Act (1987): x Due to growing alarm that a secondary distribution system for prescription drugs was threatening the public health & safety and creating an unfair form of competition o Law established sales restrictions & record keeping requirements for prescription drug samples o Prohibits hospitals & other health care entities from reselling their pharmaceuticals to other businesses & requires state licensing of drug wholesalers

Tex t

The Generic Drug Enforcement Act (1992): x Occurred when some FDA staff accepted bribes from generic drug industry personnel in order to facilitate the approval process of certain generic drug products o FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies  Imposes severe civil penalties for any false statements, bribes, failures to disclose material facts & other related offenses Prescription Drug User Fee Act (1992): x The FDA and Congress took the approach that private industry should shoulder part of the costs for new drug approval rather than the taxpayers o Requires manufacturers to pay fees for applications & supplements when the FDA must review clinical studies  Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies & hopefully speed up the NDA review Nutrition Labeling & Education Act (NLEA, 1990): x Mandates nutrition labeling on food products & authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations Dietary Supplement Health & Education Act (DSHEA, 1994): x Dietary supplement manufacturers felt that the NLEA left too much authority with the FDA and unduly restricted the promotion of dietary supplements x DSHEA defines dietary supplements & permits manufacturers to make certain claims that otherwise would’ve been illegal under the FDCA x FDA to regulate dietary supplements more as goods than as drugs

Pharmacy Law E1- Frankhauser

Nunez Spring 2017

Dietary Supplement: x Dietary Supplement- A product that is intended for ingestion and to supplement the diet o Contains any one or more of the following  A vitamin, a mineral, an herb or other botanical, an amino acid  A dietary substance for use by humans to supplement the diet by increasing the total dietary intake  A concentrate, metabolite, constituent, extract or combination of the previous x Manufacturers may make limited health claims of dietary substance that describe the relationship between a food substance & a disease o Ex: “Folic acid may reduce the risk of neural tube birth defects.” x To make the claims, the manufacturer must receive FDA approval for the health claim as judged by the “significant scientific agreement” standard x Today, the FDA has appeared to relax its standard for evaluation, stati...