P1246341507UFWMN

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(No Transcript)
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Chapter 2
Pharmacy Law, Regulations, and Standards for
Technicians
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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

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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

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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

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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.

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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

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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)

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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

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Discussion
What are the dangers of inadequate control of
drugs and medications?
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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
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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

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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

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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

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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

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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

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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

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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

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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

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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

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Comprehensive Drug Abuse Prevention and Control
Act of 1970
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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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
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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

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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

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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

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Discussion

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

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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.

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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

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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

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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
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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

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Food and Drug Administration (FDA)
Safety Note
The FDA regulates OTC labeling so it is
understandable to a layperson
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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
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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

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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
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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
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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

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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

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DEA Form 222
triplicate form required for ordering C-II
substances
Visit the DEA Web site
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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

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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

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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

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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

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Terms to Remember

• MedWatch
• Vaccine Adverse Event Reporting System (VAERS)

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Discussion
What are the main duties of national oversight
agencies?
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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.
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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

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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

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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

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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
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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

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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
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Terms to Remember

• United States Pharmacopeia (USP)
• National Association of Boards of Pharmacy (NABP)
• United States Pharmacopeia-National Formulary
  (USP-NF)

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Discussion
Why is there a need for organizations to set and
administer drug and professional standards?
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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.
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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

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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

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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

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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

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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

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Discussion
Why do some rules and regulations vary from one
state to another?
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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.
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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.

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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

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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

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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

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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

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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

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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

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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
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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

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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

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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
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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

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Discussion
What kinds of penalties are assessed in judgments
involving civil law?
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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.
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Terms to Remember

• plaintiff
• defendant
• civil law
• law of agency and contracts
• tort
• standard of care
• malpractice