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Chapter 2
Pharmacy Law,
Regulations, and
Standards for Technicians
Chapter 2 Topics
• Need for Drug Control
• Brief History of Statutory Pharmacy Law
• Regulatory Law—Role of National
Oversight Agencies
• Drug and Professional Standards
• State Boards of Pharmacy and Legal Duties
of Pharmacy Personnel
• Violation of Laws and Regulations
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
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
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.
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
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)
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
Discussion
What are the dangers of inadequate
control of drugs and medications?
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
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
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
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
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
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
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
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
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
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
Comprehensive Drug Abuse
Prevention and Control Act of 1970
Schedule
Medical Use
Examples
I
For research only
Heroin, LSD
II
Dispensing severely
restricted
Morphine, oxycodone,
meperidine
III
Prescriptions can be refilled Codeine with aspirin,
up to 5 times in 6 months
anabolic steroids
Same as for Schedule III
Benzodiazepines,
meprobamate
Some sold w/o a
Liquid codeine
prescription; must be 18
combination preps.
IV
V
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
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
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
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
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
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
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
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
Omnibus Budget Reconciliation
Act of 1990 (OBRA-90)
• Requires manufacturers rebate to state Medicaid
programs the difference between the manufacturer’s
best price for a drug (typically the wholesale price) and
the average billed price
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
Dietary Supplement Health and
Education Act (DSHEA) of 1994
• 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
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 patient’s health information
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
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 overthe-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
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 patient’s medication profile
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
Discussion
• How have the various laws changed the
way drugs have been used over the years?
• Are more laws needed?
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.
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
Regulatory Law—Role 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
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
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
Food and Drug Administration (FDA)
The FDA regulates OTC labeling so it is
understandable to a layperson
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
Class
Type of Drug
Class I (C-I)
A reasonable probability exists that use of the product
will cause or lead to serious adverse health events or
death.
Class II (C-II)
The probability exists that use of the product will cause
adverse health events that are temporary or medically
reversible.
Class III (C-III)
The use of the product will probably not cause an
adverse health event.
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
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
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
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
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
DEA Form 222
triplicate form required for ordering C-II substances
Visit the DEA Web site
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
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
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
Right to Refuse a ControlledSubstance Prescription
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
Terms to Remember
• MedWatch
• Vaccine Adverse Event Reporting System
(VAERS)
Discussion
What are the main duties of national
oversight agencies?
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.
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
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
United States Pharmacopeia
• Publishes the United States PharmacopeiaNational 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
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
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
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
Terms to Remember
• United States Pharmacopeia (USP)
• National Association of Boards of
Pharmacy (NABP)
• United States Pharmacopeia-National
Formulary (USP-NF)
Discussion
Why is there a need for organizations to set
and administer drug and professional
standards?
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.
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
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
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
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
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
Discussion
Why do some rules and regulations vary
from one state to another?
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.
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.
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 party’s license should be
revoked or suspended
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
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 employeeemployer relationship
– contracts made by employees are just as valid as if the
physician or the pharmacist who employed them made
the contract
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
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
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
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.
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
– dereliction
– damages
– 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”
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
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
jury’s determination.
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
Discussion
What kinds of penalties are assessed in
judgments involving civil law?
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.
Terms to Remember
•
•
•
•
•
•
•
plaintiff
defendant
civil law
law of agency and contracts
tort
standard of care
malpractice