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Title: P1246341507UFWMN


1
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2
Chapter 2
Pharmacy Law, Regulations, and Standards for
Technicians
3
Chapter 2 Topics
  • Need for Drug Control
  • Brief History of Statutory Pharmacy Law
  • Regulatory LawRole of National Oversight
    Agencies
  • Drug and Professional Standards
  • State Boards of Pharmacy and Legal Duties of
    Pharmacy Personnel
  • Violation of Laws and Regulations

4
Learning Objectives
  • Distinguish among common law, statutory law,
    regulatory or administrative law, ethics, and
    professional standards
  • Explain the potential for tort actions under the
    common law related to negligence and other forms
    of malpractice
  • List and describe the major effects on pharmacy
    of the major pieces of statutory federal drug law
    in the twentieth century

5
Learning Objectives
  • Discuss the role of the Food and Drug
    Administration, Drug Enforcement Administration,
    the United States Pharmacopeial Convention, and
    state boards of pharmacy
  • Enumerate the duties that may legally be
    performed by pharmacy technicians in most states

6
Need for Drug Control
  • Before 1951, U.S. federal law made no distinction
    between drugs that can and cannot be purchased
    without a prescription from a physician.
  • In some countries any drug can still be dispensed
    or sold without legal restriction.

7
Need for Drug Control
  • Various groups and organizations exercise
    controls on contemporary pharmacy
  • courts
  • federal, state, and local legislative bodies
  • federal and state regulatory agencies
  • United States Pharmacopeia (USP)
  • professional organizations
  • individual institutions such as community
    pharmacies, hospitals, long-term care
    facilities, and home healthcare organizations

8
Drug Control
  • Professional Organizations Web Links
  • American Pharmacists Association (APhA)
  • American Association of Colleges of Pharmacy
    (AACP)
  • National Association of Boards of Pharmacy
    (NABP)
  • Joint Commission on Accreditation of
    Healthcare Organizations (JCAHO)
  • American Society of Health-System Pharmacists
    (ASHP)
  • Academy of Managed Care Pharmacy (AMCP)

9
Drug Control
  • The law offers a minimum level of acceptable
    standards
  • Ethics offer guidelines for personal conduct
    within a profession
  • State boards of pharmacy and professional
    organizations have established standards for the
    provision of healthcare
  • Additional levels of accreditation beyond minimum
    level required by law

10
Discussion
What are the dangers of inadequate control of
drugs and medications?
11
Discussion
What are the dangers of inadequate control of
drugs and medications? Answer the possibility
of inappropriate use, adverse reactions, and
interactions with other drugs
12
Brief History of Statutory Pharmacy Law
  • In nineteenth century drugs in the United States
    were unregulated
  • medicines did not require proof that they were
    either safe or effective
  • Traveling medicine shows proclaimed miracle
    cures
  • no regulations on labeling
  • no research to support claims

13
Brief History of Statutory Pharmacy Law
  • Most potions contained a high content of alcohol
  • Some caused injury or death
  • To combat abuses in both formulation and
    labeling, in 1906 the U.S. Congress passed the
    first of a series of landmark twentieth-century
    laws to regulate drugs

14
Pure Food and Drug Act of 1906
  • Purpose was to prohibit the interstate
    transportation or sale of adulterated and
    misbranded food and drugs
  • Did not require drugs be labeled but required
    that drug labels not contain false information
    about the drugs strength and purity
  • Proved unenforceable and new legislation was
    required

15
Food, Drug, and Cosmetic (FDC) Act of 1938
  • The most important piece of legislation in
    pharmaceutical history
  • Created the FDA
  • Required pharmaceutical manufacturers to file a
    new drug application (NDA) with each new drug
    before marketing

16
Food, Drug, and Cosmetic (FDC) Act of 1938
  • Extended and clarified the definitions of
    adulterated and misbranded drugs
  • Defined the relevant official compendia as the
    United States Pharmacopeia and the National
    Formulary

17
Food, Drug, and Cosmetic (FDC) Act of 1938
  • Gave FDA the power to conduct inspections of
    manufacturing plants to ensure compliance
  • Act applied to interstate transactions, as well
    as to intrastate transactions
  • Required only that drugs be safe for human
    consumption NOT that they be effective or useful
    for the purpose for which they were sold

18
Durham-Humphrey Amendment of 1951
  • States drug containers do not have to include
    adequate directions for use as long as they
    include Caution Federal Law Prohibits
    Dispensing Without Prescription
  • Distinguished between legend (prescription) drugs
    and over-the-counter (OTC) (nonprescription)
    drugs
  • Authorized
  • verbal prescriptions
  • prescription refills

19
Kefauver-Harris Amendment of 1962
  • Extended the FDC Act of 1938 to require that
    drugs not only be safe for humans but also be
    effective
  • Requires drug manufacturers file an
    investigational new drug application (INDA) with
    the FDA before initiating a clinical trial in
    humans
  • Once proven safe and effective, manufacturer may
    submit an NDA seeking approval to market the
    product

20
Comprehensive Drug Abuse Prevention and Control
Act of 1970
  • Commonly referred to as the Controlled Substances
    Act (CSA)
  • Created to combat and control drug abuse and to
    supersede previous federal drug abuse laws
  • Classified drugs with potential for abuse as
    controlled substances
  • Ranked controlled substances into five
    categories, or schedules
  • ranging from those with great potential for abuse
    (Schedule I) to those with little such potential
    (Schedule V)
  • narcotics are most highly regulated

21
Comprehensive Drug Abuse Prevention and Control
Act of 1970
22
Comprehensive Drug Abuse Prevention and Control
Act of 1970
  • Created the Drug Enforcement Administration
    (DEA), an arm of the Department of Justice
  • charged with enforcement and prevention related
    to the abuse of controlled substances like many
    narcotic pain medications

23
Poison Prevention Packaging Act of 1970
  • Passed to prevent accidental childhood poisonings
    from prescription and nonprescription products
  • Enforced by the Consumer Product Safety
    Commission
  • Requires most over-the-counter (OTC) and legend
    drugs be packaged in child-resistant containers
  • cannot be opened by 80 of children under five
  • can be opened by 90 of adults
  • Older patients may request a non-child-resistant
    container other exceptions are provided for by
    law

24
Drug Listing Act of 1972
  • Gives the FDA the authority to compile a list of
    currently marketed drugs
  • Each drug is assigned a unique and permanent
    product code
  • known as a National Drug Code (NDC)
  • ten characters that identify manufacturer or
    distributor, drug formulation, size and type of
    packaging
  • FDA requests, but does not require, the NDC
    appear on all drug labels

25
Orphan Drug Act of 1983
  • An orphan drug is one that is intended for use in
    a few patients with a rare disease or condition
  • developing such a drug would be prohibitively
    expensive, given the small market
  • The Orphan Drug Act encourages the development of
    orphan drugs by
  • providing tax incentives
  • granting manufacturers exclusive license
  • Over 250 orphan drugs have been approved by the
    FDA

26
Drug Price Competition and Patent-Term
Restoration Act of 1984
  • Encouraged creation of both generic drugs and new
    drugs by streamlining the process for generic
    drug approval and extending patent licenses
    required for the NDA approval process
  • A given drug typically has several names
  • chemical names
  • generic name a common name given to a drug
    regardless of brand name
  • one or more brand name(s) name(s) under which
    the manufacturer markets a drug

27
Drug Price Competition and Patent-Term
Restoration Act of 1984
  • Generic drugs with the same chemical composition
    as brand name products
  • can be substituted in prescriptions
  • Once the original patent expires, any
    manufacturer may market a generic drug
  • usually is less costly than the brand name

28
Prescription Drug Marketing Act of 1987
  • Prohibits
  • reimportation of a drug into the United States
    (United States seniors getting prescription
    medication from Canada)
  • sale or trading of drug samples
  • distribution of samples (provisions for samples
    added in response to prescription drug samples
    being illegally diverted and distributed)
  • to persons other than those licensed to prescribe
    them
  • except by mail or by common carrier

29
Omnibus Budget Reconciliation Act of 1990
(OBRA-90)
  • Requires states to establish standards for drug
    use review (DUR) by the pharmacist
  • Requires pharmacist to offer to counsel the
    patient, offering to discuss with the patient all
    matters of significance
  • Uses Medicaid participation to enforce clinical
    pharmacy practices
  • although initially required for patients eligible
    for Medicaid benefits, most state boards of
    pharmacy have required counseling for all
    patients

30
Omnibus Budget Reconciliation Act of 1990
(OBRA-90)
  • Requires manufacturers rebate to state Medicaid
    programs the difference between the
    manufacturers best price for a drug (typically
    the wholesale price) and the average billed price

31
Dietary Supplement Health and Education Act
(DSHEA) of 1994
  • Provided definitions and guidelines on diet
    supplements
  • manufacturers are not required to prove safety,
    efficacy, or standardization to the FDA as they
    are with prescription and nonprescription drugs
  • The FDA may only review false claims
    advertisements and monitor safety of diet
    supplements

32
Dietary Supplement Health and Education Act
(DSHEA) of 1994
Safety Note
  • The FDA does not regulate diet supplements
  • because diet supplements are sold with
    nonprescription products, many consumers are
    unaware of this subtle difference in regulation

33
Health Insurance Portability and Accountability
Act (HIPAA) of 1996
  • Included portability of moving health insurance
    from one employer to another without denial or
    restrictions
  • Affects the confidentiality of patient medical
    records
  • has placed safeguards to protect patient
    confidentiality
  • requires healthcare facilities to provide
    information to the patient on how they protect
    the patients health information

34
Health Insurance Portability and Accountability
Act (HIPAA) of 1996
  • In pharmacy, HIPAA requirements include
  • restrictions on transmission of prescription data
  • provision of an area for private counseling
  • a training program for employees
  • For pharmacy technicians, HIPAA means
  • they must not reveal any information on any
    patient outside the pharmacy
  • violations would be grounds for immediate
    termination and legal action

Learn more about HIPAA on the Web
35
Food and Drug Administration Modernization Act
  • Updates the labeling on prescription medications
  • products labeled legend are to be changed to
    read only
  • legend is the term that has been used to indicate
    whether a drug was available by prescription or
    over-the-counter (OTC)
  • the new labeling requirements were implemented in
    2004
  • Authorizes fees to be added to a new drug
    application (NDA) process to accelerate the
    review and approval process for new drugs

36
Medicare Prescription Drug, Improvement, and
Modernization Act of 2003
  • Drug prescription coverage to patients eligible
    for Medicare benefits
  • voluntary insurance program
  • extra premium
  • Provides reimbursement for services a pharmacist
    may provide such as
  • medication management therapy services (MMTS)
  • annual in-depth review of the patients
    medication profile

37
Medicare Prescription Drug, Improvement, and
Modernization Act of 2003
  • Includes the development of health service
    agencies (HSAs)
  • a consumer-driven health insurance program
  • health insurance option for patients under 65
    years of age
  • Under an HAS, the patient or his or her family
    agree to pay a monthly premium and carry a high
    deductible
  • the premium is fully tax deductible
  • whatever amount is not used during that calendar
    year carries over to the next year

38
Discussion
  • How have the various laws changed the way drugs
    have been used over the years?
  • Are more laws needed?

39
Discussion
  • How have the various laws changed the way drugs
    have been used over the years?
  • Answer The laws have addressed a broad scope of
    issues and provided a basic structure for the
    safe use of drug products and for the practice of
    pharmacy.

40
Terms to Remember
  • adulterated
  • misbranded
  • FDA
  • new drug application (NDA)
  • United States Pharmacopeia
  • National Formulary
  • controlled substances
  • Drug Enforcement Administration (DEA)
  • child-resistant containers
  • orphan drug
  • generic name
  • brand name

41
Regulatory LawRole of National Oversight
Agencies
  • Acts and amendments provide the minimum level of
    acceptable standards
  • The FDA and DEA oversee and enforce the standards
    for drug use that the laws have established

42
Food and Drug Administration (FDA)
  • Has primary responsibility and authority to
    enforce the law and create regulations to assist
    in providing the public with safe drug products
  • Requires all manufacturers to file applications
    for investigation studies and approval of new
    drugs
  • Provides guidelines for packaging and
    advertisement
  • Oversees the recall of dangerous products
  • Has no legal authority over the practice of
    pharmacy in each state

Visit the FDA
43
Food and Drug Administration (FDA)
  • Has regulations for manufacturers to follow while
    researching new chemical entities and developing
    those chemicals into drug products
  • Continues oversight even drugs are approved
  • Issues guidelines as to how the product may be
    packaged, labeled, advertised, and marketed to
    physicians (and now the public)
  • Manufacturers may not make speculative or false
    claims
  • OTC medications also undergo this scrutiny
  • labels of OTC products must conform to a
    preferred format

44
Food and Drug Administration (FDA)
Safety Note
The FDA regulates OTC labeling so it is
understandable to a layperson
45
Food and Drug Administration (FDA)
  • Can force manufacturer to recall a drug product
    if it is contaminated, of poor quality, or causes
    serious adverse reactions

Recall Classes for Drugs
46
MedWatch
  • MedWatch is a voluntary program that allows any
    healthcare professional to report a serious
    adverse event, product problem, or medication
    error that is suspected of being associated with
    the use of an FDA-regulated product
  • a clearinghouse for information on safety alerts,
    including drug recalls
  • Provides information on safety-labeling changes
    to the product package insert

47
MedWatch
  • Manufacturers must file a report if an adverse
    drug reaction is reported
  • Designed to detect side effects not identified
    from research studies
  • Reports can be made
  • online
  • by phone (1-800-FDA-0178)
  • by mail

Visit MedWatch online
48
Vaccine Adverse Event Reporting System (VAERS)
  • Vaccine Adverse Event Reporting System (VAERS) is
    a postmarketing surveillance system operated by
    the FDA and the Centers for Disease Control (CDC)
  • collects information on adverse events that occur
    after an immunization
  • Reports can be made online, via an 800 number
    (1-800-822-7967), or submitted by mail on a
    downloaded form

Visit the VAERS site
49
Drug Enforcement Administration (DEA)
  • Branch of the U.S. Justice Department responsible
    for regulating sale and use of drugs with abuse
    potential
  • responsible for enforcing laws regarding both
    legal and illegal addictive substances
  • directs most of its efforts toward illegal drug
    trafficking
  • supervises legal use of narcotics and other
    controlled substances

50
Drug Enforcement Administration (DEA)
  • Issues licenses
  • to medical practitioners to write prescriptions
    for scheduled drugs
  • to pharmacies to order scheduled drugs from
    wholesalers
  • Inspects medical facilities, including pharmacies
  • Tracks narcotics from manufacturer to warehouse
    to pharmacy

51
DEA Form 222
triplicate form required for ordering C-II
substances
Visit the DEA Web site
52
DEA Registration
  • Required by the Controlled Substances Act (CSA)
    for individuals or business handling controlled
    substances
  • Each pharmacy registers
  • pharmacy employees are not required to register
  • registration varies from 1 to 3 years in length
  • Laws vary from state to state
  • some state laws are more stringent than the
    federal CSA
  • the most stringent of the laws will be followed
  • If federal law is more stringent, it is followed
  • If state law is more stringent, it is followed

53
Prescriber
  • The CSA defines who may prescribe controlled
    substances
  • Practitioners
  • include physicians, dentists, veterinarians
  • are authorized to prescribe controlled substances
    by the jurisdiction in which they are licensed

54
Dispensing of Schedule II Drugs
  • Prescriptions for Schedule II substances must be
    hand-signed by the prescriber except in
    emergencies
  • to minimize fraudulent use
  • to maintain a record-tracking system
  • An emergency supply of a Schedule II drug can be
    provided to a patient without a written
    prescription in most states

55
Right to Refuse a Controlled-Substance
Prescription
Safety Note
  • A pharmacist has the right to refuse to fill a
    prescription for a controlled substance
  • in legitimate concern that a prescription was not
    written in good faith
  • if forgery is suspected

56
Terms to Remember
  • MedWatch
  • Vaccine Adverse Event Reporting System (VAERS)

57
Discussion
What are the main duties of national oversight
agencies?
58
Discussion
What are the main duties of national oversight
agencies? Answer National oversight agencies
create and enforce regulations to provide a
workable version of the provisions of federal law.
59
Drug and Professional Standards
  • The United States Pharmacopeia (USP)
  • independent scientific organization
  • official quality standards for prescription
    drugs, OTC drugs, and dietary supplements
  • The National Association of Boards of Pharmacy
    (NABP)
  • professional standards for pharmacists

60
United States Pharmacopeia
  • Develops quality standards for
  • medicines
  • healthcare delivery
  • related products and practices
  • Develops authoritative, unbiased information on
    drug use
  • Manufactured drug products must conform to USP
    standards

61
United States Pharmacopeia
  • Publishes the United States Pharmacopeia-National
    Formulary (USP-NF)
  • contains standards for medicines, dose forms,
    drug substances, excipients or inactive
    substances, medical devices, and dietary
    supplements
  • Official compendia for drugs marketed in the
    United States
  • designated by the FDC Act of 1938

62
United States Pharmacopeia
  • USP Chapter 797 sets standards for storage,
    packaging, and preparation of sterile compounded
    products
  • adopted by many accrediting agencies, including
  • state boards of pharmacy
  • Joint Commission on Accreditation of Healthcare
    Organizations (JCAHO)

For a summary of USP Chapter 797, visit the USP
Web site
63
National Association of Boards of Pharmacy (NABP)
  • The NABP represents all fifty state boards of
    pharmacy
  • assists in developing, implementing, and
    enforcing uniform standards
  • develops licensing exams for pharmacists
  • Coordinates reciprocation of pharmacist licenses
    from one state to another
  • Meets regularly to discuss national trends and
    issues in pharmacy law

64
National Association of Boards of Pharmacy (NABP)
  • Verifies the licensure of online pharmacies
  • Internet VIPPS program (Verified Internet
    Pharmacy Practice Sites)
  • Has no regulatory authority
  • unlike the FDA or DEA
  • Coordinates issuance of NCPDP Provider ID
    number
  • Developed the Model State Pharmacy Practice Act
    (MSPPA)

Visit the NABP on the Web
65
Terms to Remember
  • United States Pharmacopeia (USP)
  • National Association of Boards of Pharmacy (NABP)
  • United States Pharmacopeia-National Formulary
    (USP-NF)

66
Discussion
Why is there a need for organizations to set and
administer drug and professional standards?
67
Discussion
Why is there a need for organizations to set and
administer drug and professional
standards? Answer These organizations represent
professional and ethical opinions on which laws
and enforcement are based.
68
State Boards of Pharmacy and Legal Duties of
Pharmacy Personnel
  • Leaders from the pharmacy community
  • Activities vary from state to state
  • ensure that pharmacies and pharmacists adhere to
    state practice guidelines
  • can suspend or revoke pharmacy/pharmacist license
    or registration
  • provide regulations regarding
  • refilling of prescriptions
  • status of certain drugs

69
State Boards of Pharmacy and Legal Duties of
Pharmacy Personnel
  • No statutory federal definition of the role of
    the pharmacy technician exists
  • no uniform definition of role and duties of
    pharmacy technicians from state to state
  • roles and duties of pharmacy technicians are
    changing
  • Requirements for pharmacy technicians vary by
    state
  • some require licensure or registration with the
    board
  • some require passing national certification exams
  • many limit numbers of pharmacy technicians

70
State Boards of Pharmacy and Legal Duties of
Pharmacy Personnel
  • Scope of practice by technicians varies by state
  • some specifically authorize certain duties
  • others detail what the pharmacist must do
  • by default, duties not required to be done by the
    pharmacist may be carried out by the technician
  • in all states all technicians duties must be
    carried out under the direct supervision of a
    licensed pharmacist

71
State Boards of Pharmacy and Legal Duties of
Pharmacy Personnel
  • Technicians must know applicable laws and rules
    of the state and practice site
  • pharmacies have a policy and procedure manuals
  • detail respective duties of technician and
    pharmacist
  • professionals in training institutions and/or
    state boards of pharmacy can advise on
  • state-specific statutes and regulations
  • registration and/or certification
  • duties that the technician may lawfully undertake

72
State Boards of Pharmacy and Legal Duties of
Pharmacy Personnel
  • Technician practice references include
  • Pharmacy Law Digest
  • annual NABP Survey of Pharmacy Law
  • Pharmacy Technician Certification Board Web site

73
Discussion
Why do some rules and regulations vary from one
state to another?
74
Discussion
Why do some rules and regulations vary from one
state to another? Answer Not all aspects of
pharmacy practice are governed by federal law,
and state agencies, such as the Board of
Pharmacy, set up guidelines that best match the
needs of their areas.
75
Violation of Laws and Regulations
  • When cases are filed in court the
  • party or person filing the case is called the
    plaintiff
  • party being sued or that the case is against is
    called the defendant
  • Burden of proof
  • responsibility of plaintiff to prove his /her
    case
  • in crimes against the government the burden of
    proof reasonable doubt . Prosecutor or
    plaintiff must provide convincing evidence that
    the party committed the act, beyond any
    reasonable doubt of a normal person.

76
Violation of Laws and Regulations
  • If the defendant is a licensed healthcare
    provider (i.e., physician, nurse, pharmacist)
  • the appropriate state medical board may examine
    the case and determine whether or not the partys
    license should be revoked or suspended

77
Civil Law
  • Civil law is a term given to areas of the law
    that concern the citizens of the United States
    and the wrongs they may commit against one
    another
  • Covers issues such as
  • contracts
  • tort a wrong against another

78
Law of Agency and Contracts
  • Law of agency and contracts is based on the Latin
    term respondeat superior, which translates to
    let the master answer
  • General principle that applies to the
    employee-employer relationship
  • contracts made by employees are just as valid as
    if the physician or the pharmacist who employed
    them made the contract

79
Law of Agency and Contracts
  • A contract is made in the pharmacy when the
    technician receives a prescription from the
    patient at the window
  • by agreeing to get the prescription filled an
    implied contract now exists
  • pharmacy and pharmacist are obligated to provide
    the patient with a service
  • if a mistake is made, the pharmacy and/or
    pharmacist may be held liable, even though he or
    she was not the one who entered into the contract
    to provide service
  • The pharmacist must answer for all of the acts
    of the employees

80
Torts
  • Tort is the term that refers to personal injuries
  • a wrong that one citizen commits against another
  • In a tort, the injured party sues the party that
    caused the injury
  • Governments do not take part in tort lawsuits
  • the wrong was between two citizens and not
    against the government and/or its laws and
    regulations
  • The simplest tort is the broken contract

81
Torts
  • Standard of care is a level of care expected to
    be provided by various healthcare providers
  • Used to judge the type of care provided to a
    patient based on
  • Two criteria always taken into account include
  • the level of training of the healthcare provider
  • normal practices for the geographical area in
    which the healthcare provider works
  • Only those healthcare providers who work in the
    same geographical area and have the same level of
    training would be compared

82
Torts
  • A pharmacy technician is not expected to provide
    the same service or standard of care to a patient
    as the pharmacist. Similarly, a cardiologist
    would be expected to provide a different service
    or standard of care than that of a nurse
    practitioner at his office.

Practice Note
83
Torts
  • Malpractice a form of negligence in which the
    standard of care was not met
  • In a case of negligence or malpractice, the
    burden of proof is on the plaintiff to prove the
    four Ds of negligence
  • duty damages
  • dereliction direct cause
  • The burden of proof in civil court is lower than
    in a criminal case
  • plaintiff must prove his/her case by a
    preponderance of the evidence

84
Torts
  • In malpractice, a guilty defendant found guilty
    may be ordered to pay an award of money to the
    plaintiff
  • contributory negligence may be determined if two
    or more causes are a factor in the negligence and
    personal injury to the patient
  • All pharmacies, most practicing pharmacists, and
    some pharmacy technicians carry professional
    liability insurance to protect their business and
    personal assets

85
Torts
  • Cases exist where the patient is found to have
    contributed to his or her own injury (e.g., not
    taking medication as directed) and found to be
    comparatively negligent.
  • In this case, the total award may be reduced by
    a certain percentage, depending on the judge or
    jurys determination.

Practice Note
86
Torts
  • When a crime is committed in violation of a state
    or federal law, the party is prosecuted
  • the victim or his or her family also sue the
    party in civil court for monetary damages
  • The person may be tried twice, facing two
    separate plaintiffs
  • in the criminal case, the defendant might face
    monetary fines, probation, or prison
  • the civil case might result in monetary awards to
    the victim/plaintiff

87
Discussion
What kinds of penalties are assessed in judgments
involving civil law?
88
Discussion
What kinds of penalties are assessed in judgments
involving civil law? Answer Penalties under
civil law generally involve monetary repayment
equivalent to damages suffered, although
sometimes will include loss of licensure.
89
Terms to Remember
  • plaintiff
  • defendant
  • civil law
  • law of agency and contracts
  • tort
  • standard of care
  • malpractice
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