Transcript Chapter 2

Chapter 2
Pharmacy Law,
Regulations,
and Standards
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Learning Objectives
Discuss the roles of the
– Food and Drug Administration
– Drug Enforcement Administration
– Occupational Safety and Health
Administration
– National and state boards of
pharmacy
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The Need for Drug Control
• Laws
• Regulations
• Standards
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Discussion
What might happen without adequate
drug control?
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Laws
• Laws are rules passed and enforced
by the legislative branch of
government.
• Laws offer a minimum level of
acceptable standards.
• Violations may result in various
punishments.
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Regulations
• A regulation is a written rule and
procedure to carry out a law.
• Many regulations are published by
federal agencies.
• When a law and regulation conflict,
the more strict one applies.
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Standards
• A standard is a set of criteria to
measure product quality or
professional performance against a
norm.
• Organizations set standards that must
be met before their approval can be
earned.
• Ethics provide standards of personal
conduct within a profession.
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History of US Statutory
Pharmacy Law
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Pure Food and Drug Act of 1906
• Passed to fight abuses in drug
formulation, labeling, and marketing
• Forbade drug labels from containing
false information
• Proved to be unenforceable
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Food, Drug, and Cosmetic
Act of 1938
• Response to manufactured drugs that were
more powerful and potentially dangerous
• Created the FDA
• Required drug makers to
– File new drug applications (NDAs)
– Prove that the product was safe for human use
– Conduct studies and submit results
• Required drugs to be safe, but not
necessarily effective
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Food, Drug, and Cosmetic
Act of 1938
The Act expanded
the definitions of
adulterated and
misbranded drugs.
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Terms to Remember
Controlled Substances Act (CSA)
laws created to combat and control drug
abuse
controlled substance
a drug with potential for abuse;
organized into five schedules that
specify the way the drug must be stored,
dispensed, recorded, and inventoried
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Poison Prevention Packaging
Act of 1970
• Passed to prevent accidental
childhood poisonings
• Applies to both prescription
and OTC drugs
• Requires child-resistant
containers that
– Cannot be opened by 80%
of children
– Can be opened by 90% of
adults
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Poison Prevention Packaging
Act of 1970
The Act
allows
some drugs
to be
dispensed
in nonchildproof
packages.
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Drug Listing Act of 1972
• Gives FDA authority to compile a list
of currently marketed drugs
• Each drug given unique National Drug
Code (NDC)
• Allows FDA to maintain a database of
drugs by
– Use
– Manufacturer
– Active ingredients
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Terms to Remember
brand name
the name under which the manufacturer
markets a drug; also known as the trade
name
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Terms to Remember
generic name
a common name that is given to a drug
regardless of brand name; sometimes
denotes a drug that is not protected by a
trademark; for example, acetaminophen
is the generic drug name for Tylenol
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Drug Price Competition and PatentTerm Restoration Act of 1984
• Was a response to pressure to
reduce drug costs
• Encouraged the creation of generic
drugs
• Extended patent licenses to allow
manufactures to recoup research and
development costs
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Drug Price Competition and PatentTerm Restoration Act of 1984
• Generics are comparable
to brand name drugs in
–
–
–
–
–
Dosage form
Safety
Strength
Quality
Performance
• Generics must demonstrate bioequivalence
to brand name product.
• Over 60% of prescriptions in community
pharmacies are filled with generics.
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Health Insurance Portability and
Accountability Act of 1996
• HIPAA has wide-ranging provisions.
• For pharmacies, impact is mostly on
confidentiality of patient records:
– Must document and provide to patient
information on how health information is
safeguarded
– Must have an employee training
program with yearly renewals
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Food and Drug Administration
Modernization Act
• Passed to update labeling on
prescription medications
• Authorizes new drug application
(NDA) fees which are used by FDA to
accelerate review of new drugs
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Medicare Prescription Drug,
Improvement, and Modernization
Act of 2003
• Better known as Medicare Part D
• Provides prescription drug coverage to
patients eligible for Medicare
– Voluntary program
– Patients pay an extra premium
– Usually have a deductible
• Also established health/savings accounts
(HSAs)
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Combat Methamphetamine
Epidemic Act of 2005
• Methamphetamine
– Highly addictive stimulant
– Made from OTC products
• Restricts the availability of
products used to make it:
– Pseudoephedrine
– Phenylpropanolamine
– Ephedrine
• Products must be stored “behind the counter” and
purchases must be documented.
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Terms to Remember
Food and Drug Administration (FDA)
the agency of the federal government
that is responsible for ensuring the
safety and efficacy of food and drugs
prepared for the market
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Food and Drug
Administration (FDA)
• Primary responsibility and authority to
enforce the law
• No legal authority over the practice of
pharmacy in each state
• FDA activities
– Requires manufactures to file applications for
investigative studies and drug approvals
– Provides guidelines for packaging and
advertisement
– Oversees the recall of dangerous products
– Produces annual Orange Book reference
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Drug Enforcement
Administration (DEA)
• Most of its effort spent on illegal drug
trafficking, but also supervises legal
use of controlled substances
• Inspects medical facilities and
pharmacies; usually just those where
suspicious activity has been detected
• Maintains an audit trail of narcotics
from manufacturer to warehouse to
pharmacy to patient
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Drug Enforcement
Administration (DEA)
• CSA defines who may prescribe controlled
substances.
• Prescriptions must be written for a
legitimate reason related to the physician’s
practice (e.g., dentist can prescribe
narcotics for dental pain but not for back
pain).
• Except for emergencies, prescription must
be written rather than phoned or faxed.
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Occupational Safety and
Health Administration (OSHA)
• Ensures the safety and health of US
workers
• OSHA’s role in pharmacies, hospitals,
and home health care is to
– Protect against inadvertent needle sticks
– Ensure safe disposal of syringes
– Oversee policies to protect employees
from unnecessary drug exposures
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National Association of
Boards of Pharmacy (NABP)
• Has no regulatory authority
• Primary role is to develop national
pharmacist license examination
• Coordinates reciprocation of
pharmacists practicing in other states
• Provides guidance to state boards of
pharmacy
• Developed Model State Pharmacy
Practices Act for national continuity
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State Boards of Pharmacy
• Consist of leaders from the pharmacy
community and also consumer members
• Review applications and administer
examinations developed by NABP
• Maintain a database of active
pharmacists
• Inspect all new pharmacies
• Provide regulations regarding refilling of
prescriptions
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Legal Duties
of Pharmacy Personnel
• Role of the pharmacy tech
– Not defined by federal statute
– Not uniformly defined from state to state
– Constantly changing
• Some states limit the ratio of
pharmacy techs to pharmacists.
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Legal Duties
of Pharmacy Personnel
• Duties not required to be done by
pharmacists may be carried out by
the pharmacy technician.
• All technicians’ duties must be carried
out under the direct supervision of the
pharmacist.
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Duties Typically Performed
by Pharmacy Technicians
Preparing Doses of Extemporaneously Compounded,
Sterile Medications
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retrieving medications from shelf or supply cabinet
selecting equipment for the compounding operation
using aseptic equipment and procedures
weighing and measuring
admixing parenteral products
preparing labels
selecting containers
packaging
maintaining and filing records of extemporaneous
compounding
– cleaning area and equipment
(See Table 2.6)
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Duties Typically Performed
by Pharmacy Technicians
Transporting Medications to and from floors/units
– preparing cart, tray, or other means of
conveyance
– delivering controlled drugs
– maintaining delivery records
– distributing medications to wards
– organizing medications for administration to
patients
– retrieving, reconciling, and recording credit for
medications not administered
– returning unused medications to unit dose bins
and injectables to stock
(See Table 2.6)
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Violation of Laws
and Regulations
• Civil laws
• Torts
• Law of agency
and contracts
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Violation of Laws
and Regulations
• Plaintiff must prove his or her case –
burden of proof.
• Punishments may include
– Fines
– Probation
– Incarceration
• Licensed healthcare providers may
have licenses revoked.
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Civil Laws
• Concern wrongs against another
citizen, but not necessarily against
local, state, or federal law
• Derived from English common law
• Defendant may face both civil and
criminal proceedings for the same act
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Torts
• A tort refers to personal injuries.
• Governments (local, state, federal) do
not take part in these lawsuits.
• Examples of torts include
– Broken contracts
– Negligence
– Malpractice
– Slander
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Terms to Remember
malpractice
a form of negligence in which the
standard of care was not met and was a
direct cause of injury
standard of care
the usual and customary level of
practice in the community
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Terms to Remember
law of agency and contracts
the general principle that allows an
employee to enter into contracts on the
employer’s behalf
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Professional Organizations
• Mission statements are to set high
standards and advance practice of
pharmacy
• Seek to provide a standard of care
beyond the minimum required by law
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Professional Organizations
Set standards for
– Postgraduate residency training
• American Pharmacists Association (APhA)
• American Society of Health-System Pharmacists
(ASHP)
• American Society of Consulting Pharmacists (ASCP)
– Online electronic billing
• National Council for Prescription Drug Programs
(NCPDP)
– Certification in specialty areas
• National Institute for Standards in Pharmacist
Credentialing (NISPC)
– Internet pharmacies
• Verified Internet Pharmacy Practice Sites (VIPPS)
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Professional Organizations
Professional organizations for
pharmacy techs focus on certification
and acquisition of advanced knowledge
and skills:
– Pharmacy Technician Certification
Board (PTCB)
– Institute for Certification of Pharmacy
Technicians (ICPT)
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