Pharmacy Ethics

Law and Ethics in Pharmacy Overview

• Laws, standards, and ethics all regulate pharmacy and drugs.
• Law: A rule or regulation from a governing body enacted to protect society, maintain order, and uphold living standards; violating a law has criminal penalties.
• Standards: Guidelines for practice established by professional organizations to establish etiquette within a specific profession.
• Ethics involves the study of values or principles governing personal relationships rooted in morals, behaviors, or rules shaped by family, culture, and society
• Medical ethics: Discipline for evaluating merits, risks, and social concerns related to medical activities.
• Pharmacists and technicians must uphold legal and ethical standards.

Code of Ethics Principles

• Beneficence: Actions should positively benefit patients without prejudice.
• Fidelity: Promises are kept, patient needs are fulfilled correctly and promptly, and patient confidentiality is maintained.
• Veracity: Tell the truth to benefit patients and prevent drug diversion or medication errors.
• Justice: Act lawfully, fairly, and equally.
• Autonomy: Self-reliance, where pharmacy technicians support pharmacists with initiative, reliability, and dependability
• Pharmacy staff should acknowledge and encourage patients to participate in healthcare decisions.
• All pharmacy actions should primarily benefit patients with consistency and uniformity.
• Consider consequences to ensure the best outcome for pharmacy and patients
• Sensitivity, kindness, patience, reliability, and tact expected when pharmacists, pharmacy technicians, and patients interact.

Common Legal Terms

• Assumption of risk: Patient disregards advice and takes responsibility.
• Defendant: The accused in a court action.
• Deposition: Out-of-court oral testimony with same truth requirements as in court.
• Interrogatory: Written questions answered under oath in court-like manner.
• Jurisdiction: Court's power to hear a case and make a judgment.
• Litigant: Party to a lawsuit.
• Litigation: A lawsuit or court contest.
• Plaintiff: Person initiating a civil lawsuit, or prosecution in criminal cases.
• Statute of limitations: Law limiting the period to sue, varying from one to three years.
• Subpoena: Court order for an individual to appear as witness or be deposed.

Structure of US Government

• Federal, state, and local governments create and uphold laws.
• Legislative Branch: Congress (House of Representatives and Senate) creates laws.
• Executive Branch: President, Vice President, and smaller organizations enforce laws.
• Judicial Branch: Supreme Court and lower courts interpret laws.
• Federal government creates, enforces, and interprets laws for the general population.
• State and local governments handle specific laws within their jurisdictions.

Regulatory Agencies and FDA

• Regulatory agencies: Government departments creating specific rules for legal compliance in an area.
• FDA: Pharmacy's regulatory agency, a branch of the U.S. Department of Health and Human Services.
• FDA: Regulates all drugs except illegal ones, initiates, implements, and enforces drug administration legislation.
• FDA: Approves drugs, OTC/prescription drug labeling, and standards for manufacturing.
• FDA's core mission: Medical drugs and devices are proven safe and effective.
• Drug approval process: The FDA requires preclinical testing, complex clinical trials, and regulatory approval after trials.
• Process duration and cost: Drug approval can take 10-15 years and millions of dollars.
• Clinical Trials: 1/1000 potential drugs reaching clinical trials after preclinical testing, where 9/10 later fail.
• New drugs: Requires committee or new drug specialization division review, based on proposed use.

Drug Trial Phases

• Clinical trials assess safety, efficacy, and effectiveness that are divided into phases
• Phase 0: Exploratory, the drug gets tested in 10-15 healthy volunteers.
• Phase I: Assesses toxicity and safety on 20-80 healthy volunteers.
• Phase II: Explores efficacy and less-common side effects on 100-300 volunteers with the targeted condition.
• Phase III: Tests the drug in 1000-3000 subjects with the targeted condition to assess clinical efficacy.
• Phase IV: Optional, depends on trial end points
• New Drug Application: After Phase III, drug sponsor may file with FDA to manufacture and sell the drug
• FDA review of application usually has a 180-day turnaround
• United States: Arguably the most stringent regulations regarding medical drug and device approvals.

Types of Law

• Society changes: Laws adapt to current realities and govern future ones.
• Constitutional law: Derived from federal and state constitutions.
• Statutory law: Established by legislation via enacted statutes.
• Administrative law: From governmental administrative agencies.
• Common law: Created by judges from previous court decisions.
• International law: Based on treaties between countries.
• Criminal law: Relates to offenses against the public or society.
• Civil law: Focuses on private citizens' rights, also known as case law
• Tort and contract laws: Derived from civil law.

Criminal Law Overview

• Criminal law: Governs individual's relationship to the state.
• Violations: Practicing pharmacy without a license is criminally liable.
• "Harming the general public": Offenses under criminal law are described as
• Criminal Law Offenses: Treason, felonies, and misdemeanors
• Accused: has the right to due process with opportunity to defend against charges.
• Criminal law: Governs intent to defraud customers via drug quality, pricing, or misleading information.

Differentiating Misdemeanors and Felonies

• Misdemeanors: Punishable by fines or up to 1-year imprisonment in county jail.
• Infractions: Lesser offenses like traffic violations, punishable by fines without imprisonment.
• States classify misdemeanors: Typically into classes (e.g., Class A, B). Felonies: Serious, punishable by larger fines or over 1-year imprisonment in state penitentiary.
• First-degree felonies: Evokes the most severe penalties
• Felons: Commonly lose rights, including gun possession, running for office, and voting which are reinstated in most states after completion of sentence.
• Treason: Overthrowing or harming the government, attempt to assassinate the president or destroying government buildings

Civil Law Overview

• Civil law: Governs relationships between individuals
• Civil Law Focus: Involves noncriminal acts related to personal or government entities
• Actions include: Slandering, libel, privacy violations, personal bodily harm, unprofessional behavior
• Civil law is also known as case law, decided by judges or juries
• Tort and contract laws: Direct involvement in pharmacy practice.
• Administrative law: Plays a role in pharmacy regulatory compliance

Tort Law Overview

• Tort law: Seek a remedy to those harmed by someone else's wrongful acts
• Tort: A private wrong against another person or their property.
• Medical malpractice: Regulated under tort law.
• Elements of Tort Law: Plaintiff must prove the defendant was legally obligated to act, the defendant failed to fulfill this obligation, and damage resulted from this failure.
• Tort law examples: Libel and slander, assault and battery.
• Intentional torts: Person's rights infringed upon intentionally.
• Unintentional torts: Committed without intent to harm (negligence, malpractice). Negligence: Not acting or doing something a reasonable person would or wouldn't do
• Malpractice: Negligence within a profession may also be called professional negligence.

Proving a Negligence Claim

The plaintiff must prove these elements in a negligence case:

• Defendant owed the plaintiff a duty of care.
• Defendant breached their duty of care.
• Injury was a result of the defendant's negligence
• Plaintiff suffered injury compensable under law

Contract Law Overview

• Contract law: Pertains to agreements that create obligations between parties.
• Obligations: Can be created, eliminated, or changed.
• Legal Recourse: Written and oral contracts both offer legal avenues
• Parties Bound: Both written and oral contracts compel parties to act in a predictable manner.
• Uniform Commercial Code: Directly affects contract law, providing uniformity to sales and transactions.
• Restricted individuals: Involves minors, the mentally ill, and intoxicated persons restricted from contracts.

Administrative Law Overview

• Administrative law: Rules/regulations of federal agencies (regulatory law).
• Enactment: Administrative law agencies are authorized by Congress. Examples: OSHA, IRS, FDA, SSA, CMS.

Illegal Actions

• Law violation is considered a crime and is classified as either a misdemeanor or a felony.
• Shoplifting: Considered a misdemeanor
• Illegal selling of drugs, arson and burglary: Classified as felonies
• Criminal: the individual who is violating a law
• Accessory: Individual aiding a crime perpetrator can be directly or indirectly

Pharmacy Law Violations

• Pharmacy law violations: Fines or license revocation/suspension.
• State-level misdemeanor penalties: Exist for pharmacy act violations.
• Pharmacy boards: Set rules for pharmacy law enforcement/administration.
• Boards of pharmacy: Act as the administrative agency, not legislative.

State vs Federal Pharmacy Regulations

• State function: Pharmacy practice regulation is primarily done at the state, based on protecting citizens' health and safety.
• Similarity principles: State pharmacy laws can differ, but are rooted in similar principles and objectives of pharmaceutical practice.
• State pharmacy law: Requires minimum qualifications; no unlicensed pharmacy practice
• State Legislation Exceptions: Allows exceptions to the licensing requirement. Pharmacy board: Serves as subagency of the health department licensing division.
• License Revocation: Process is involved and not easily revoked Due Process: State has a right to suspend, revoke, or terminate one's license and they must do so after proper legislature and for just cause
• Licensed pharmacists: Practice safeguarded by federal and state constitutions as property right.
• Certificates of registration: Valid for 1-2 years.
• Continuing education: Required for maintaining certification and licensure
• Revoking certificates: May be cancelled or revoked in special circumstances
• MSPPA: Developed by the NABP to promote uniformity and flexibility in state pharmacy practices.

State Law Considerations

• State Law: They often offer unique state law regulations and are stricter than federal laws.
• Federal vs State laws: State laws must be followed in instances in which there are differences between the two.

Pharmacy Law at the Federal Level

• Enforcement: Rules, regulations, laws are enforced by local, state, and federal entities.
• Adaptive: The laws are reviewed to change as the industry and societal needs evolve
• Creating new regulations: The laws and regulations are continuously evolving through the government and regulatory agencies.

Pure Food and Drug Act of 1906

• Regulation: The bill regulated the development, compounding, distribution, storage and dispensing of drugs. Prohibition: The act prevented interstate distribution or sale of adulterated and misbranded food and drugs.
• Did NOT include Cosmetics or ban unsafe drugs
• Manufacturers could make false drug statements and weren't required to identify medication contents.
• 1912 False Statement Problem: Congress included within the definition of misbranding fraudulent claims for the curative powers of the drugs.
• Shirley Amendment of 1912: Governed labeling when deliberate fraud was shown to have been used to establish a violation
• Monograph (package insert) to be supplied along with Drug packaging due to the fact that drug container sizes do not leave room for thorough information.
• Package Inserts or Monographs include wording that is accurate, summaries safe and effective use, and data by human experience.

Package Guidelines for drugs

• Monographs need to include for example the, clinical studies, referenced information and patient counseling.
• Must detail: indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and drug interactions also must denote any potential for drug abuse.

Manufacturers Inserts

• Boxed Warning: Bold border often called a "black box warning" because of it's look.
• High Level Medications: Products will commonly have a black box warning due to the risk they carry consumers .
• Adverse effects: necessary information to avoid or decrease potentially adverse effects.

Pregnancy FDA Categories

• FDA requires pregnancy categories determining risks for abnormalities if taken
• A: No risk after studies
• B: Animal studies show no risk, but human studies are inadequate
• C: Animal studies show adverse effects, human studies are inadequate, benefits outweigh risk.
• D: Human studies show positive fetal risk, but potential benefits still outweigh risks
• X: Drug should be avoided because studies have shown it to be risky without benefits

Harrison Narcotics Act of 1914

• Treaty Intention: The act was influenced and intended to prevent to recreational usage of opium
• Post Act: Opium was no longer purchasable without the usage of a prescription making it more difficult to obtain for those without medicinal purposes. Documentation: The act documented the registration of practitioners, dispensing practices, and any new regulations on any sale and distribution of coca leaves and other opium related derivatives.

Food, Drug, and Cosmetic Act of 1938

The bill Amended the Pure Food and Drug Act and required the FDA and manufacturers to file and regulate new drug applications FDA concerned with these aspects: packaging, safety, purity, strength and effectiveness

• Granted the FDA more power to inspect, and approve new applications. The FDA has since made investigation of drugs to be safely used and approved for use within humans

Durham-Humphrey Amendment of 1951

• Prescription drugs defined: Prescription required before dispensing (legend drugs), and OTC medications. This created to establish clear criteria for any decisions
• No Restrictions: OTC and Non-legend medications do not require medical supervision/or prescription.

The Kefauver-Harris Amendment of 1962

• Prescription Advertisements: Drug advertisements now to be subject to FDA review
• Drug Investigators: Now required qualification review
• Manufacturers: Registered and inspected frequently with accountability measures

The Controlled Substance Act (CSA) of 1970

• Manufacture distribution substance potential abused was created to regulate
• Controlled substances Act: Classified drugs into five schedules V being the least dangerous to 1 being the highest potential abuse drug and were enforced by the DEA

Drug Schedules

• Schedule 1 High potential for abuse non medicinal purposes except for research
• Schedule 2 The abuse use has a high potential for abuse but is also accepted for medical usage which can lead to psychological and or physical dependence ex opiates.
• Schedule Three: Accepted medicinal use has moderate abuse potential and contains limited substance quantities
• Schedule 4: Little abuse rate related to schedule 3 drugs commonly consisting of barbiturates, Hypnotics and other minor sedatives
• Schedule Five: Presents the lowest risk of a controlled substance frequently has narcotics and antitussives

All prescriptions must come from medical practitioners and cannot be faxed or called except for care facilities any other refills outside of 6 months require a doctors authorization

Individual Registration Process

• Dispensation and distribution requires DEA registration otherwise is exempt must be from 1-3 years
• Pharmacists Exception: Individual pharmacists are not required to register except for when they are the sole proprietor
• Form 224: Form used for registration

DEA Registration and Controlled Substance Regulations

• Must be renewed 60 days before expiration after fraud it can be revoked or suspended
• Two letters precede the registration code and are followed by seven digits
• Number Validation: Technicians must add the second forth and sixth digits together
• Double Step One: Multiply by 2 then add to the some of the first third and fifth digits.
• Seventh Digit Match: If after calculating the digits matches the Seventh digit the Number is valid
• DEA Form 222: Controls order substances from Schedule one and Schedule two. Which can only be ordered manufactured and distributed by drug wholesalers DEA license is required for those ordering substances schedule III, IV,V directly Form requires: Company information ordering date number and names registration for a DEA

Controlled Substances

• Limited different items can only be up to 10 on Form 222.

• Required information needed needed NDC, date packaging all is required when processing an order

• DEA Certificate is required to have a copy on file for the individual purchase to be shipped only to certificate address

Pharmacy DEA Forms

• DEA Form 106: Controls lost reports from and pharmacy Reports to the DEA must company details and any type of substance with local policing and marking systems
• DEA Form 41 Used controlled disposal of controlled substance
• Retail pharmacies requests permission the DEA before destroying all substances requiring to be request must also by approved of this 2 weeks prior two witnesses must also be made after destroying 4 copies must be made and one has been sent to the DEA

DEA Regulations and Hospitals

• Post 2014 hospitals have collector that are also authorized now by these registrations online only

Compliance

• Schedule 2 form Returns DEA Form 222 must be used and returned to one dea Registrant to another requiring all number with substances label property

Inventory:

• Inventory must be kept in the back in the DEA the record was to be inspected make sure it contains substance only controlled and it is separated,
• Pharmacy is maintain schedule to drugs and it to record what is on the stand must be kept in a cabinet of drugs

Controlled Substances and Maintaining Records

• Stock Records: The controlled substance of hand must be kept completely and accurately over 2 years. Many states extend this to five years and officials must make record completely available.
• Locked Cabinets: It is Required to lock control to drug cabinet and to perform counts and measurements regularly

Prescription Oversight and Guidelines

• Practitioner is needed two prescriptions must be only valid used for office are stock they are violate the substance if one resupplies from legitimate prescriptions
• Prescription refills schedule 12 drug schedule 345 maybe refill if authorize three prescriptions must be 30 days or you feel after 6 Months must wait not must wait before practitioner review prescriptions and electronically transmitter are prescriptions
• The pharmacist must control authorize orders

Poisoning

• 80% of the patients cannot open child proof containers but 90% of the adults

The Occupational Safety and Health Act of 1970

• The act establishes safety within work space environment through the department of labor requiring to have blood pathogens

Other requirements for OSHA

• Requirements of eyewash stations documentation of training, and has it for every area where hazardous waste and or contamination is prevalent, requires the use of MSD

Other acts regulating drugs

• 1972: The drug Listing Act
• 1976 the medical device Amendments
• 1983 the orphan drug act
• 1984 Drug price competition
• Patent term Restoration Act
• 1987 the prescription drug marketing Act
• 1990 Anabolic steroid act
• 1990 The Omnibus budget reconciliation act of
• 94the dietary supplement health 96 health protection against the information.
• 2000 the drug and addiction prevention 03 the Medicare prescription
• 2005 the combat act of
• 2006 an acutane program
• 2008 Ryan Haight Act
• 2010 patient and affordable care 2012 sythetics act
• 2013 the drug quality of security
• 2016 the comprehensive addiction FDA
• CDC DEA

Pharmacy Law Regulations

• USP: United standards pharmacopeia,

• Health techs- moral and legal for those entrusted to provide care to the sick and the patient

Key Ethical Points

• Ethics relates to greater thoughts judgments or actions about things deemed morally sound or unsound
• Ethics encompasses:
• Fidelity
• Justice
• Respect
• Truthfulness
• Accountability
• People adopt these principles to provide for good practice and the overall care of their patients

Examples of Ethical Issue/Scenarios:

• Abortion: Ending baby to save mom?
• Euthanasia: Permissible to end terminally ill patient pain?
• Life Support :When should we withdraw?
• Organ donorship: Should a baby's life be to conceive so to provide organs?

Professional Ethic Examples

• Respect
• Nonmaleficence
• Beneficiance
• Justice

Code of Conduct Theme

• Pharmacist code for the patient are always trustworthy safe
• patient's privacy is key and must make a proper decision

Pharmacist role

• Must keep up with field pharmacys
• Always think to the community general society

Patient Pharmacist relationship.

• Patient and pharmacists needs always know complete records and need a discussion

Health Advocate

• help them with their best course at every time in case

Autotomy

= Healthcare Providers cannot infringe on their rights for choices.

Automonmy - Rights

• Medical care -right and have access

Healthcare provider

You MUST make decision. You cant actually decide. Patients rights.

Patient rights

• the extent will and will not treat patients.

Code of the Ethics for Pharmacist

• APhA- they had
• Always treat patients well by being with good character

Maintenance and Health

• safe proper health and care safety practice must OSHA