1.  Acts of the Legislature (Federal and State)

• Constitutional Enactments or New Statutes
• Constitutional or Statutory Amendments
• Treaties (Federal only)

2.  Decisions or Acts of Administrative Agencies

• Regulations
• Advisory Opinions
• Enforcement Guides
• Administration Proceedings

3.  Decisions of Courts (Common Law)

• Federal law usually prevails if there is a conflict
• However, states can co-legislate --> usually sets more strict requirements than federal law --> the more strict law must be followed!

• Rights not reserved to the federal gov't are reserved to the state governments
• Under "policy powers", states have right to regulate safety, health, and welfare matters

Article I, Section 8 of Constitution

• Federal gov't "retains" some powers (including relative to the 10th amendment provisions)
• Regulates "commerce among the states"
• Intent: harmonize laws of different states so you can expect a consistent product across all states --> includes safety, health, and welfare in some aspects (FDA, DEA, EPA, OSHA, etc.)

AKA Court or Judge Made Law

• Courts interpretation of how certain laws apply to certain facts
• Can have precendential value over subsequent cases in same or lower jurisdiction
• Can have persuasive value in later cases from different jurisdictions
• Can be challenged (appealed) in later proceedings in same case
• Case law can be distinguished from or challenged in later proceedings in different cases

1. Administrative - brought by gov't administrative agency (ex: Board of Pharmacy)
2. Civil - 2 private parties that have a dispute
3. Criminal - gov't against inidividual or organization for a criminal act

• Goal is to correct and/or punish a regulatory violation or remove a danger to the public
• Investigations by administrative (gov't) agencies regarding violations of laws, rules, or regulations
• Directly affects ONLY those individuals or organizations subject to the agency's jurisdiction
• Involves hearings before an agency tribunal
• Results in payments of fines and/or probation, suspension, or revocation of license or other permit
• May be appealed to a court

• Goal is to compensate/protect injured party
• Manages disputes between 2 or more private parties (non-government action)
• Penalties include monetary awards, specific performance of contracts, or injunctions against injurious action
• Tried before a court or mediated/arbitrated
• Can be settled anytime before a court decision
• Torts, contractual matters, etc.

• Goal is to punish the wrongdoer, and/or rehabilitate the wrongdoer, and deter future behavior by wrongdoer and others
• Society's method to punish individuals who commit specific statute violations
• Prosecutor acts on behalf of society
• Penalties involve fines, prison sentences or BOTH; some crimes involve capital punishment sentences
• Misdemeanors, gross misdemeanors, felonies, aggravated felonies, etc.

• Monetary Damages (pay for damages)
• Specific Damages (build my house)
• Injunctive Relief (keep 500 yards away)

Can have more than one of the above

1.  Offer and Acceptance (Mutual Agreement)

Intent to create mutual rights and obligations

2.  Consideration

An exchange of something of value

3.  Capacity to Contract

Must be of legal age; ability to comprehend the deal

• Must have a "meeting of the minds"
• Acceptance can happen by a promise to perform or act, or by the act or performance itself
• "Implied" Contracts --> no actual meeting of the minds --> accepting something of value with knowledge its not likely "free" or under such generous terms
• Courts apply "quantum meruit" --> "to as much as he is entitled" - an equitable remedy, based on fairness - allows courts to prevent a party from being unjustly enriched in certain circumstances

• An item or obligation conferred upon another for something in return
• Both parties get something
• Must be sufficient consideration (not necessarily equal value, but adequate)
• Cannot be "past" consideration
• Consideration must "move" from the Offeror --> if not, consideration may be absent

• Generally, you must be 18 yo or older to be bound to a contract
• You must have the mental capacity to enter into a contract
• You must not be under undue influence or duress

• Material misrepresentation by one party inducing the other party into the contract -- false statement regarding the goods or services
• Mistake in the basic understanding -- no meeting of the minds, can be unilateral or bilateral by mistake

• Compensatory Damages
• Punitive Damages
• Exemplary Damages (to deter similar acts by others in the future)
• Nominal Damages
• Liquidated Damages

Monetary Damage for Breach

• parties agree in the contract to the proper amount of damages for a particular breach (late, delayed, or sub-standard performance)
• Must bear a relationship to expected damages
• Amount of damages must be relatively uncertain at the time of the contract (best estimate of what it would cost the non-breaching party to be made "whole")
• Seen in many service contracts and leases

1.  Specific Performance

• Usually awarded in unusual circumstances (sale of rare art, real estate transactions, one of a kind items or services)
• Rarely awarded for services

2.  Injunctions

• Used to stop a party from acting in a particular manner
• Rare in contract breach situations
• Used when the contract calls for a party to refrain from certain actions

• the body of law that creates, and provides remedies for, civil wrongs that DO NOT arise out of contractual duties
• Applies to both intentional and unintentional acts

• Assault
• Battery
• False Imprisonment
• Intentional Infliction of Emotional Distress

1.  Negligence (simple, gross, strict liability, ultrahazardous activities)

• most common type of litigated tort
• failure to comply with the standard of care a reasonable person would exhibit, which failure is the actual and proximate cause of harm or damages to another

1. A duty owned
2. A breach of that duty
3. Harm or damages
4. Causation

• Reasonable Person Standard
• Use of Customary Practices
• Ordinary Care vs Highest Degree of Care
• Foresight, not hindsight, to be applied

Failure to Act

• within the "reasonable person" standard
• with ordinary care
• within customary practices
• with highest degree of care
• in accordance with applicable laws
• within a higher duty you've created

• No recovery, if no harm
• Actual damages
• Punitive or exemplary damages:

often in excess of actual damages awards

often for "willful or wanton" conduct (outrageous, unreasonable, recklessness)

Two Step Inquiry

1.  Actual Cause

• was act a substantial factor in causing the harm?
• largely scientific, forensic, factual inquiry
• without proving actual cause, NO liability

2.  Proximate Cause

• conduct that most directly caused the harm
• key concept is foreseeability of harm

• Making a false assertion about someone as being factual or true
• Libel -- printed or broadcast defamation
• Slander -- spoken defamation
• Truth is a defense to Libel and Slander claims
• Voicing an opinion is not Defamatory
• Damage is required (negative image, lost business)

• Negligence (professional liability)
• Breach of Privacy/Confidentiality
• Breach of Contract
• Intentional Misconduct/Recklessness

1. Identify your risks
2. Analyze those risks
3. Manage those risks (buy insurance, loss control or avoidance techniques)
4. Monitor your success or failure
5. Modify your strategy, as necessary

1.  Wrong Drug (Most common - 50%)

• Most often mistakes -- sound-alikes, hard to read SIG, proximity on shelf

2.  Wrong Strength (28%)

3.  Wrong Directions (8.7%)

• Narrow Therapeutic Index Meds
• Multiple Strength Meds
• Complex Disease State Meds
• Highly Prescribed Meds

Quality Improvement Initiatives

• Intended to identify "non-value" steps or steps prone to error
• Reduce activity to least necessary
• Ensure each step adds value
• Reduce errors, potential for error and near misses

• Preventing Healthcare Fraud and Abuse
• "Administrative Simplification"
• Medical Liability Reform

1.  Electronic Transactions and Code Sets Transcation Standards

2.  Security

• Administrative procedures
• Physical Safeguards
• Technical Security
• Electronic Signature
• Training and Documentation

3.  Privacy

• Protected Healthy Information
• Privacy Officer
• Business Associate Contracts
• Minimum Necessary Rule
• Authorization
• Patient Rights

1.  Privacy/Security

• establishes a minimum or floor for privacy/security
• it does NOT pre-empt state privacy laws
• adhere to the more stringent law

2.  National Identifiers
3.  Electronic Transactions and Code Sets
4.  E-Signatures

• Analyze HIPAA rules and requirements
• Develop/Revise policies and procedures
• Assess/Re-Assess Operations (Gap Analysis)
• Implement Policies and Procedures
• Educate and Train Workforce

• Notice of privacy/acknowledgement
• Authorizations
• Minimum necessary rule
• Business associates
• Marketing Rules
• Security issues

• To the individual
• For treatment, payment, or healthcare operations
• Pursuant to a valid "authorization"

• Applies whenever a covered entity (CE) uses or discloses PHI or when it requests PHI from another CE
• Requires a CE to make reasonable efforts to limit PHI to the minimum necessary to accomplish the purpose of the use, disclosure, or request
• Does NOT apply to treatment activities

NOPP details permitted uses and disclosures of PHI, such as:

Treatment (T)

Payment (P)

Healthcare Operations (O)

• Not required for TPO
• Is required for marketing, research and other limited non-TPO activities

1. Right of Notice regarding the covered entity's privacy policies
2. Right to Request Privacy Protections for their PHI
3. Right to Access their PHI
4. Right to Request Amendment of their PHI
5. Right to an Accounting of certain uses and disclosures of their PHI

• An IRB waiver of authorization is obtained
• The PHI is to be used in research protocol development
• The PHI relates to decedent research

6 yrs

Ex: acknowledgements, authorizations, listing of disclosures that require tracking, etc.

a "vendor" that uses or accesses PHI to provide services to or on behalf of a covered entity

Includes:

• consulting services
• software or hardware services
• billing and other financial services
• date aggregation/QA/UR/PI
• legal and accounting services
• practice management
• administrative/accreditation

BAs must sign a business associate agreement

1. Administrative Procedures
2. Physical Safeguards
3. Technical Security

• HIPAA is intended to be technology neutral
• It does NOT require any specific type of security element
• HIPAA ONLY requires Covered Entities to use reasonable safeguards to protect PHI
• What is reasonable for one CE may not be reasonable for another CE
• Reasonableness will change over time as technology changes and as the CE changes

• Informed consent must be obtained without coercion of any form
• Human experiments must be based up prior animal research
• Anticipated results should justify the experiment
• Only qualified scientists should conduct research
• Physical or mental injury or suffering should be avoided
• There should be no expectation of death or disabling injury from participation in the research

• Provides ethical basis for IRBs and guides how they should be designed
• Came out with respect to clinical trials that guides our research
• Kind of an update of the Nuremburg Code
• Developed in the US
• More detailed than the Nuremburg Code
• Congressional Report

• There is a minimum of 5 people, including a physician (for biomedical), a community representative, and a non-science member
• No IRB may consist entirely of members of one profession or one gender

• Must state the intention of research
• Study procedures in lay language
• Don't minimize risks or maximize benefits
• Alternative to study participation
• Confidentiality
• Who pays?

anything that is standard of care, the patient/insurance will pay

anything that is experimental = toss up, maybe patient or sponsor or insurance company

• Conflict of interest
• Voluntary participation
• Women of child-bearing potential (any known risks must be stated)

• There is genetic group testing
• Emergency medical procedures

All members of the community must be targeted for consent

Adequate time and means for feedback must be ensured

• Some or all of the research found by the reviewer(s) to involve no more than minimal risk
• Minor changes in previously approved research during the period (of one year or less) for which approval is authorized

Class B:

animals being held or bred in captivity, but not currently being used in research

Class C:

animals being used in research involving no pain, distress of use of pain-relieving drugs

Class D:

animals exposed to more than momentary pain or distress, in whom appropriate pain-relieving medications are used to alleviate pain

Class E:

animals exposed to more than momentary pain of distress in whom no pain relief is offered

• Applies to a code of conduct
• Implies quality of being in accord with accepted standards of right and good conduct
• Describes class of rules held by society to govern the conduct of its individual members

• Whenever two people with different value systems interact, there is the potential for an ethical conflict
• Pharmacists should know how to identify and resolve conflicts when they arise

Ethics is not:

value clarification

the study of moral development

the law

• Duty to do no harm
• Not concerned with improving others' well being, but rather with avoiding the infliction of harm
• Principle is violated in cases where life is ended

• Requires the pharmacist "to do good", show compassion and help others
• He/She should act in the best interest of the patient
• Obligation to preserve life, restore health, relive suffering, and maintain function
• Non-abondonment -- obligation to provide ongoing care

• Involves recognizing the right of a person to make their own decisions
• Autonomous patients have the freedom to decide what, if any, medical treatment they can accept based upon the advice of health practitioners
• The autonomous actions of one person must not infringe upon the rights of another

• Represent the patient's interest
• Best identified before critical illness
• In absence of specific advanced directives should use substituted judgement

• The strategy by which health providers allocate health services to their patients in an equitable manner
• Relates to equitable and appropriate treatment
• Involves how people are treated when their interests compete with those of others

• Refers to the extent to which society's institutions ensure that benefits and burdens are distributed among society's members in ways that are fair and just
• Many ethical issues due to limited or scarce resources, lack of access due to geographic remoteness, inability to pay, etc.

• Primarily concerned with establishing standards of norms for conduct
• How ought you to act
• What should you believe to be right or wrong?
• Prescriptive theory -- doesn't tell you what to do

• The morality of your action depends on the consequence
• Not concerned with the action, but how it affects the person
• To a consequentialist, lying is ok if it results in the patient getting better

• Duty to others
• The right action, not the goodness of something
• Does not look at desirability of end-points or morality
• Telling the truth is a good that outweighs the outcome

• Relates to character and morality
• Varies from religion to religion and even person to person within a religion

• Developed by society based on their customs, culture, heritage, etc.
• Hammurabi's Code