© paradigm publishing, inc.. 2 pharmacy law, regulations, and standards © paradigm publishing, inc

2


Pharmacy Law, Regulations, and Standards


Chapter Topics

• The need for drug control• History of U.S. statutory pharmacy law• Regulatory law–the role of national oversight

agencies• Legal duties of pharmacy personnel• Violation of laws and regulations• Drugs and professional standards


Learning Objectives• Differentiate between laws, regulations, professional standards, and ethics.• Describe how statutory law has impacted the pharmacy profession in the

twentieth century.• Discuss the impact of the Patient Protection and Affordable Care Act of 2010

on health care and pharmacy practice.• Discuss the roles of government regulatory agencies and the state boards of

pharmacy.• Differentiate between licensure, registration, and certification for pharmacy

technicians.• List the duties that may legally be performed by pharmacy technicians.• Define standard of care and its legal impact on the responsibilities of the

pharmacy technician.• Explain the potential for tort actions against a pharmacy technician.• Discuss the importance of drug and professional standards.


The Need for Laws and Standards

• Laws allow pharmaceutical manufacturers to bring safe products to market.

• Laws allow pharmacy personnel to provide safe and effective patient care.

• Standards guide pharmacy personnel in their practice.

• Pharmacy personnel must have a thorough understanding of laws and standards to ensure that medications are dispensed safely.


Definitions

• Law: a rule that is passed by the government. The law offers a minimum level of acceptable standards.

• Regulation: a rule and procedure that exists to carry out a law. For example, the DEA regulates all aspects of controlled substances.


Definitions (continued)

• Standards– Sets of criteria are used to measure product quality

or professional performance against a norm. For example, the Joint Commission specifies standards of care in healthcare facilities.

• Ethics– Pharmacy personnel must follow standards of

personal conduct and behavior adopted by their profession.


History of U.S. Statutory Pharmacy Law

• Medicines in United States were unregulated during the 19th century.

• Medicines did not have to be proven safe or effective.

• Some products contained opium extracts or high alcohol content.

• Concerns about purity undermined confidence in medicinal treatments.

• Death and injury sometimes occurred.

• Statutory laws were established to protect the public.


History of U.S. Statutory Pharmacy Law (continued)

• Pure Food and Drug Act of 1906– This act prohibited the interstate transportation or

sale of adulterated and misbranded food and drugs.

– It required that labels not contain false information about the drugs’ strength and purity.

– Coca-Cola changed its product’s active ingredient from cocaine to caffeine.

– The act ultimately proved unenforceable.



• Federal Food, Drug, and Cosmetic (FD&C) Act of 1938– The act formed after 100 people died from sulfa

products containing a chemical found in antifreeze.– The FD&C created the Food and Drug Administration

(FDA).– The law required manufacturers to file a new drug

application (NDA) for FDA approval.– It required that drugs be proven to be safe but not

necessarily effective.



• Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 (continued)– Adulterated product

• Product that is inconsistent in strength, quality, and purity• A drug contaminated with other drugs or chemicals that

may or may not be harmful(A recent incident of adulteration was linked to a fungal meningitis outbreak.)

– Misbranded product• A product whose label contains false or inaccurate

statements about its identity or ingredients



• Durham-Humphrey Amendment of 1951– Prescription containers to be labeled “Caution: Federal

Law Prohibits Dispensing without a Prescription”– Established the distinction between legend (prescription)

drugs and patent (OTC) drugs

• Kefauver-Harris Amendment of 1962– Required that drugs be proven both safe and effective– Was passed in response to thalidomide’s association with

birth defects



• Comprehensive Drug Abuse Prevention and Control Act of 1970– Controlled drugs ranked into

five schedules

• Poison Prevention Packaging Act of 1970– OTC and prescription drugs

required to be packaged in a child-resistant container



• Drug Listing Act of 1972– Each form of a drug assigned an NDC number

• Orphan Drug Act of 1983– Provided incentives for development of orphan

drugs (drugs used in rare disorders)



• Drug Price Competition and Patent-Term Restoration Act of 1984– The development of generic drugs

was encouraged to reduce healthcare costs.

• Prescription Drug Marketing Act of 1987– All drug wholesalers must be

licensed by states.– Only prescribers can obtain

medication samples.– Drugs may not be reimported into

the United States by anyone other than the manufacturer.


In the Know: Short Answer

• Which agency was created as a result of the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938?

Food and Drug Administration (FDA)• Which act established the distinction between

prescription and OTC drugs?Durham-Humphrey Amendment of 1951

• The Drug Price Competition and Patent-Term Restoration Act of 1984 encouraged the development of __________ drugs to decrease costs.

generic



• Anabolic Steroid Act of 1990– Designated anabolic steroids as

a Schedule III class

• Omnibus Budget Reconciliation Act of 1990 (OBRA 90)– Requires through State

Medicaid programs that pharmacists review patient profiles and offer counseling

– Medicaid reimbursement provided only to pharmacies offering counseling



• Dietary Supplement Health and Education Act (DSHEA) of 1994– Manufacturers of dietary

supplements are not required by the FDA to prove efficacy or standardization.

– Only had to prove safety of the supplement and make truthful claims

the FDA does not regulate dietary supplements



• Health Insurance Portability and Accountability Act (HIPPA) of 1996– Patients can move health insurance from one employer to

another without denial for pre-existing conditions.– Patient records are strictly confidential.

• Medicare Modernization Act (MMA) of 2003– It’s also known as Medicare Part D.– Prescription drug coverage is provided to patients who are

eligible for Medicare on a voluntary basis.

• Food and Drug Administration Modernization Act of 2004– Prescription container labels were changed to include “Rx only.”



• Combat Methamphetamine Epidemic Act of 2005– Restricts the sale of

pseudoephedrine (PSE), an OTC medication used to make methamphetamine

• Patient Protection and Affordable Care Act (ACA) of 2010– Mandated universal

healthcare coverage for all U.S. citizens by 2014



• Patient Protection and Affordable Care Act (ACA) of 2010 (continued)– Impact on the healthcare system

• The revenue needed for the program is to come from lower reimbursements to healthcare providers and hospitals.

• Overpayments and subsidies to existing insurance programs are decreased.

• Fraud and waste are targeted.

Laws and regulations vary from state to state


Regulatory Law:National Oversight Agencies

• Food and Drug Administration (FDA)– Watchdog agency for public

safety– Responsible for ensuring the

safety and efficacy of food and drugs prepared for the market

– No legal authority over pharmacy practice in each state

The FDA regulates labeling so it is understandable to a layperson


Regulatory Law: National Oversight Agencies (continued)

• Food and Drug Administration (continued)– Requires manufacturers to file new drug

applications – Provides guidelines for packaging, labeling, and

advertising– Oversees product recalls– Publishes the FDA Orange Book



• Drug Enforcement Administration (DEA)– Enforces laws regarding legal and illegal addictive

substances– Maintains an audit trail of controlled substances from

manufacturer to warehouse to pharmacy to patient– Requires registration for all individuals, institutions,

and businesses involved in controlled substances



• Drug Enforcement Administration (continued)– Determines and monitors which

practitioners may prescribe controlled drugs

– Limits prescriptions to legitimate medical purposes in the course of pharmacy practice

– Requires written prescriptions for controlled substances unless in an emergency situation

When a conflict occurs between a state and a federal law or regulation, the more stringent law or regulations always applies.



• Occupational Safety and Health Administration (OSHA)– Ensures the safety and

health of U.S. workers– Regulates healthcare

environments • Protects workers against

inadvertent needle sticks• Ensures safe disposal of

syringes• Protects employees from

unnecessary drug exposure



• National Association of Boards of Pharmacy (NABP)– Develops the national pharmacist license examination– Coordinates reciprocation of pharmacists practicing in

other states– Verifies the licensure of online pharmacies for the state

boards of pharmacy– Provides a model of pharmacy practice standards for the

state boards – Has no regulatory authority like that of the FDA or DEA


In the Know: True or False• The FDA has legal authority over the practice of

pharmacy in each state.false

• The FDA regulates labeling so it is understandable to a layperson.

true• The DEA develops the national pharmacist license

examination.false

• The DEA maintains an audit trail of controlled substances.

true


Regulatory Law: State Level

• State Boards of Pharmacy – Review applications for

licensure and registration– Administer NABP exams and

the state law exam– License applicants– Inspect all new pharmacies– Regulate the practice of

pharmacy personnel– Regulate controlled and

nonscheduled substances


Regulatory Law: State Level (continued)

• State Boards of Pharmacy – Licensure

• The process by which a state board grants permission to an individual to engage in a given occupation

• Reviews documentation showing that the applicant has attained the minimum degree of necessary competency

– Registration• The process of being enrolled on a

list created by the state board of pharmacy

The processes of licensure and registration are both in place to safeguard the public.


Legal Duties of Pharmacy Technicians

• Not defined by federal statute • No uniform definition• Changes as the role of pharmacists change

© Paradigm Publishing, Inc. 32

Legal Duties of Pharmacy Technicians (continued)

• In most states, under the direct supervision of a pharmacist:– Dispensing of medication– Keeping pharmacy medication records– Pricing and billing of medications– Preparing doses of premanufactured products


In the Know: Explain the Difference

• What is the difference between being licensed vs. being registered by the state board?

Licensure shows that the applicant has attained a minimum level of competency, whereas registration means the person is enrolled on a list.



• In most states, under the direct supervision of a pharmacist:– Compounding sterile and nonsterile medications– Performing customer service during prescription drop-

off and pickup – Transporting medications to patient care units in the

hospital– Checking and replenishing drug inventory



• Differences in regulations among states– Some states specify the scope of practice of pharmacy

technicians, others define it by what the pharmacist must do.

– Many states specify a ratio of technicians to pharmacists.

– Some states allow any pharmacy technicians to compound IV solutions, others only allow certified pharmacy technicians to do this. Still, others only allow pharmacists to compound IV solutions.


Violation of Laws and Regulations

• Civil laws– Areas of the law that

concern the wrongdoings that citizens commit against one another

– Tort• Refers to personal injuries• Injured party is plaintiff• Whomever caused injury is

defendant• Examples: negligence,

malpractice, broken contracts


Violation of Laws and Regulations (continued)

• Standard of care– The level of care expected to be provided by various

healthcare providers in the local community– Two criteria to consider when judging care provided

to a patient:• Level of training• Geographic area



• How standard of care applies to pharmacy technicians:– Behavior of a pharmacy technician would be

compared to that of a pharmacy technician in same geographic area

– A certified technician held to a higher standard than one who is not certified



• Negligence– Failure to provide the minimum standard of care

• Malpractice– Failure to meet an ordinary standard of care

resulting in injury, loss, or damage



• In a negligence or malpractice lawsuit, watch for the four Ds:– Duty to provide care was established between the parties.– Dereliction: defendant was derelict in his or her duty.– Damages were done to the plaintiff.– Direct cause is established linking the defendant’s

dereliction to the damages done.

• If the defendant is found guilty, he or she may be ordered to pay an award of money to the plaintiff.



• Law of agency and contracts– Applies to the employee–employer relationship– Employee is an “agent” of employer, may enter

into contracts on employer’s behalf– A pharmacy technician may act as an agent for a

pharmacist or pharmacy



• How the law of agency and contracts applies to pharmacy technicians:– A technician agrees to fill a patient’s prescription.– The pharmacist and technician are obligated to provide a

service.– If a mistake is made, the pharmacy and/or pharmacist

are liable.– The pharmacist must answer for all of the acts of his

employees.– Technician can be liable if dispensed the prescription

without being checked by the pharmacist.


In the Know: True or False

• If a mistake is made in filling a prescription, the pharmacy and/or pharmacist is liable.

true

• A pharmacy technician can be liable if a prescription is dispensed without being checked by the pharmacist.

true



• Law of agency and contracts – Invasion of privacy may result in a lawsuit.• Intellectual property contained in the medical record is

the property of the patient.• Protected information may not be shared without

consent of the patient.• The pharmacy is held responsible for the actions of its

personnel if a violation occurs.– Heavy personal fines– Immediate termination of employment


Drug and Professional Standards

• United States Pharmacopeia (USP)– Sets standards for

prescription drugs, OTC drugs, and dietary supplements• Book of standards is called

the United States Pharmacopeia-National Formulary (USP-NF)

• All new drugs approved by the FDA must meet applicable USP-NF standards


Drug and Professional Standards (continued)

• United States Pharmacopeia (USP)– Sets standards regarding the practice of pharmacy

by pharmacists and pharmacy technicians• USP-NF General Chapter <795> addresses nonsterile

compounding standards.• USP-NF General Chapter <797> addresses sterile

compounding standards.• USP standards are adopted by state boards of

pharmacy and the Joint Commission.



• National Professional Organizations– Organizations advocate high standards of practice in

order to advance the pharmacy profession.– Mission statements provide a standard of care that is

above and beyond the minimum of what is required by federal and state pharmacy laws and regulations.

– Several organizations have jointly developed a curriculum for pharmacy technicians.



• Certification– Voluntary process by which a nongovernmental

organization recognizes an individual who has met predetermined qualifications set by that organization

– Pharmacy Technician Certification Board (PTCB)• Mission is to develop, maintain, promote, and administer

a high-quality certification and recertification program for pharmacy technicians• Certified pharmacy technicians earn higher salaries, work

more effectively with pharmacists


Chapter Summary• Government and professional organizations exercise control over

drugs to ensure quality and prevent harm.• Controls over the use of drugs are embodied in laws, regulations, and

drug standards.• Statutory laws have improved public safety by ensuring the safety and

efficacy of drugs.• The DEA provides regulatory oversight of controlled substances.• The Medicare Modernization Act of 2003 provides voluntary drug

insurance for Medicare beneficiaries.• The Affordable Care Act of 2010 mandates healthcare coverage for all

citizens of the United States.• The FDA regulates and enforces investigational and new drug

applications to further protect the public.


Chapter Summary (continued)

• OSHA regulations protect workers when handling hazardous substances.• State boards license pharmacies, pharmacists, and pharmacy technicians.• The legal status of pharmacy technicians varies from state to state, but

they must always act under the direct supervision of licensed pharmacists.• Pharmacy has the potential for tort actions because of negligence.• Violations of patient confidentiality can result in legal issues and

termination of employment.• Standards for drugs are set by the United States Pharmacopeia (USP).• Standards for the practice of pharmacy are set by state board of pharmacy

and various professional organizations.• National pharmacy organizations support the advanced training and skills

necessary for pharmacy technicians to become certified.

© paradigm publishing, inc.. 2 pharmacy law, regulations, and standards © paradigm publishing, inc

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