Chapter 2Pharmacy Law, Regulations, and Standards

Learning Objectives Differentiate the meanings of the terms

laws, regulations, professional standards, and ethics.

List and describe the major effects on the profession of pharmacy by significant pieces of statutory federal drug law in the twentieth century.

Discuss the impact of various provisions of the Patient Protection and Affordable Care Act of 2010 on health care and the practice of pharmacy.

Learning Objectives Discuss the roles of government

regulatory agencies such as the Food and Drug Administration, the Drug Enforcement Administration, the Occupational Safety and Health Administration, and the national and state boards of pharmacy.

Differentiate the meanings of the terms licensure, registration, and certification for pharmacy technicians.

Learning Objectives Enumerate the duties that may legally be

performed by pharmacy technicians in most states.

Define the term standard of care and its legal impact on the responsibilities of the pharmacy technician.

Explain the potential for tort actions on a pharmacy technician related to negligence, malpractice, or the law of agency and contracts.

Discuss the importance of drug and professional standards.

Introduction There are a variety of control

mechanisms when it comes to pharmacy.

This allows manufacturing to bring safe products to market and safe and effective care for patients.

Professional standards create guidelines for practice, for pharmacists and technicians.

Violations to laws and standards have consequences.

The Need for Drug Control Drug approvals and pharmacy practice are

generally stricter in the U.S. than any other country.

Various groups and organizations exercise control on pharmacy practice: Federal, state, and local legislative bodies Federal and state regulatory agencies Court system United States Pharmacopeia (USP) Joint Commission Professional organizations Individual institutions

Laws A law is a rule that is passed and

enforced by the legislative branch of government.

The law offers a minimum level of acceptable standards.

The legislature sees to the passing and enforcement of laws for the protection of the public.

Violation to laws may result in damages, fines, probation, loss of licensure or incarceration.

Regulations A regulation is a written rule and

procedure that exists to carry out a law. Regulations include drug approval

processes, distribution and dispensing allowances.

Regulations can also affect pharmacy practice like, licensure, registration, and certification requirements.

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

Standards A standard is a set of criteria to measure

product quality or professional performance against a norm.

Standards exist for both drug products and professional behavior. The USP

The Joint Commission provides a higher standard of care in hospitals and other healthcare facilities.

Accreditation by the Joint Commission is like a Good Housekeeping seal of approval.

Accreditation is voluntary, though many insurances require it for reimbursement.

Ethics Ethics are standards of behavior of

personal conduct within a profession. In a legal challenge, the behavior of the

professional is compared with the standards of other professionals practicing in the community.

“Standard of care” holds healthcare professionals accountable for actions and decisions in the workplace.

History of U.S. Statutory Pharmacy Law During the 19th century drugs were

unregulated; medicines did not have to be prove safe or effective.

“Miracle cures” were hawked by boisterous charlatans from town to town.

What was the primary ingredients in these so-called medicines?

Statutory laws were established in the 20th century to protect the public from the dangers of unregulated drug manufacturing, marketing, and use.

Pure Food and Drug Act of 1906 Passed by Congress to regulate the

development, compounding, distribution, storage, and dispensing of drugs.

Designed to prevent interstate transportation or sale of adulterated and misbranded food and drug.

Required labels not to contain false information about the drugs’ strength and purity.

Coca-Cola did what during the early developmental stages of this legislation?

This act, even amended, proved unenforceable, and new legislation was required.

Federal Food, Drug, and Cosmetic Act of 1938 More than 100 people died as a result of

poisoning by a sulfa drug product that contained diethylene glycol in 1937 was the catalyst for change in the pharmaceutical industry.

This legislation created the FDA and required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug to obtain FDA approval.

Federal Food, Drug, and Cosmetic Act of 1938 This act only required drugs to be safe

for human consumption, not that they be effective or useful.

Pharmaceutical manufacturers were required to conduct and submit toxicology students on animals and clinical trials on humans.

The FD&C Act of 1938 clarified the definitions of adulterated and misbranded drugs.

Federal Food, Drug, and Cosmetic Act of 1938 Adulterated product – a product that

differs in drug strength, quality, and purity. Misbranded product – a product whose

label includes false statements about the identity or ingredients of the container’s contents.

More than 80% of drug ingredients are manufactured overseas, often beyond the jurisdiction of the FDA.

“Off-label” involves promoting a drug for which there is little of no scientific evidence to support indication of the use of that drug.

Durham-Humphrey Amendment of 1951 Amendment to the FD&C Act of 1938; states that

stock drug containers do not have to include “adequate directions for use” as long as they contain “Caution: Federal Law Prohibits Dispensing without a Prescription.”

Dispensing by a pharmacist with a label met the law’s requirements.

Distinction between legend drugs (or prescription drugs) and patent drugs (OTC, or nonprescription drugs).

Authorized the taking of prescriptions verbally over the phone; set guidelines for refills, with limitations for refills on prescriptions subject to abuse.

Kefauver-Harris Amendment of 1962 Passed in response to the birth of thousands of

infants with severe congenital birth defects whose mothers had taken thalidomide.

Extending the FD&C Act of 1938 to require drugs to be safe and effective for humans.

Drug manufacturers must submit a NDA with the FDA before initiating human clinical trials.

After extensive trials (7-10 years) and results proved the drug was both safe and effective, the manufacturer could then submit a NDA seeking approval to market the product.

“Patent” protection was offered by the government to compensate for innovation and research costs.

Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substance Act (CSA) was

created to combat and control drug abuse and to supersede previous federal laws regarding drug abuse.

Controlled substances classified drugs with the potential for abuse and physical or psychological dependence.

Schedules or five categories that controlled substances were ranked into.

Poison Prevention Packaging Act of 1970 This act was passed to prevent accidental

childhood poisonings from prescription and nonprescription products.

This act, enforced by the Consumer Product Safety Commission, required most OTC and prescription drugs to be packaged in a child-resistant container that cannot be opened by 80% of children under 5 but can be opened by 90% of adults.

Patients can request that medications be packaged in non-child-resistant containers.

What medications are commonly dispensed in non-child-resistant containers?

Drug Listing Act of 1972 This act gave the FDA authority to

compile a list of currently marketed drugs. Each new drug was assigned a unique and

permanent product code, National Drug Code (NDC).

The NDC consists of 10 or 11 characters that identify the manufacturer or distributor, the drug formulation, and the size and type of its package.

The FDA is able to maintain a database of drugs via this code.

Orphan Drug Act of 1983 Orphan drug is intended for use in patients suffering

from a rare disorder (less than 200,00 people). This act encouraged the development of orphan

drugs by providing tax incentives and allowing manufacturers exclusive licenses to market such drugs.

More than 350 orphan drugs have been approved by the FDA. Cuprimine, developed to treat Wilson disease (1 in

30,000) Tobramycin & Pulmozyme, developed to treat cystic

fibrosis Statins, developed in 1985 for the treatment of

homozygous familial hypercholesterolemia; used today in the treatment of high cholesterol

Drug Price Competition and Patent-Term Restoration Act of 1984

Prior to the 1980s, brand name drugs were primarily dispensed and prescribed.

1984, mounting pressure led to the passing of the Drug Price Competition and Patent-Term Restoration Act (Waxman-Hatch Act), encouraging the development of generic named drugs.

Generic drugs are comparable to their brand name counterparts in dosage form, strength, route of administration, quality, performance, safety, and intended use.

Drug Price Competition and Patent-Term Restoration Act of 1984

This act streamlined the process for generic drug approval and extended patent licenses.

Patent license extensions allowed the manufacturer of the brand name drug to recoup research and development costs.

More than 80% of prescriptions dispensed in community pharmacies today are dispensed with generic drugs.

Generic drugs can be substituted (under regulations) for brand name drugs unless the prescriber writes “brand only” or “do not substitute”.

Medications currently on the market are labeled by their generic, brand and at times chemical name.

Prescription Drug Marketing Act of 1987 The Prescription Drug Marketing Act of 1987

required that all drug wholesalers be licensed by the states.

Also prohibited the sales, trading, or distribution of drug samples, by mail or common carrier, to persons other than those licensed to prescribe them.

Prohibited the reimportation of a drug into the U.S. by anyone except the manufacturer.

With which country do we see a great reimportation of drugs?

Anabolic Steroid Act of 1990 Anabolic steroids, synthetic drugs that mimic the

human hormone testosterone. These steroids build muscle mass, enhance

strength, and performance with many serious adverse effects.

In response to illicit traffic, anabolic steroids were classified a Schedule III drugs, allowing the FDA to enforce the law for legal drugs as well as illegal imports.

Prescriptions for anabolic steroids like, AndroGel, Androderm, and Testim, and testosterone injections can be refilled a max of 5 times of for up to 6 months from the date written, whichever comes first.

Omnibus Budget Reconciliation Act of 1990 Required states, participating in the state

Medicaid reimbursement program, to establish standards of practice for drug utilization review (DUR) by the pharmacist.

The act required “a review of drug therapy before each prescription is filled or delivered to an individual…”

A pharmacist or technician, following this law, must also offer pharmacist counseling service to the patient or customer.

Omnibus Budget Reconciliation Act of 1990 OBRA – 90 enforces screening

prescriptions and counseling by providing Medicaid reimbursements only to patients at pharmacies that adhere to this act.

Manufacturers are required to rebate state Medicaid programs the difference between the manufacturer’s best price and the average price submitted.

Reimbursements to pharmacists have not kept pace with inflation.

Dietary Supplement Health and Education Act of 1994 DSHEA was passed in 1994 providing

definitions and guidelines on dietary supplements: vitamins, minerals, herbs, and nutritional supplements.

This legislation stated manufacturers were not required to prove efficacy or standardization to the FDA, they simply had to prove the safety of the supplement and make truthful claims.

The FDA has limited oversight on dietary supplements and may only review “false claims” advertisements and monitor safety.

Dietary Supplement Health and Education Act of 1994 If “miracle” cures or treatment claims are

made the FDA can require manufacturers to provide scientific research and proof to back up those claims.

If the FDA wants to remove a dietary supplement from the market it may do so; however it must hold public hearings and the burden of proof is shifted to the FDA to prove the dietary supplement is unsafe.

In 2006, what product was removed from the market by the FDA?

Health Insurance Portability and Accountability Act of 1996

The Health Insurance Portability and Accountability Act (HIPAA) made provisions directly affecting healthcare facilities – including pharmacies.

“Portability” of moving health insurance from one employer to another without denial or restrictions.

Former employers must offer COBRA (Consolidated Omnibus Reconciliation Act of 1985) benefits – continued medical coverage for up to 18 months, at the employees expense.

Health Insurance Portability and Accountability Act of 1996

HIPAA most affects confidentiality of patient medical records, including prescriptions.

HIPAA has placed safeguards to protect patient confidentiality.

All healthcare facilities must provide a data privacy policy document and proof that document was given to the patient.

Pharmacy personnel, under penalty of law, not reveal any information on any patient outside of the pharmacy workplace; non-compliance with this regulation is grounds for immediate termination.

Medicare Modernization Act of 2003 Medicare Modernization Act (MMA) or

Medicare Part D, was introduced in 2003 and became effective in January 2006.

Medicare Part D provides prescription drug coverage to patients eligible for Medicare benefits.

Patients must pay an extra premium, in addition to their Medicare premium, and might be penalized if they elect not to join.

Medicare Modernization Act of 2003 Development of the health savings account

(HSA) for patients under 65; pay a monthly premium and carry a high deductible; the premium is tax deductible and whatever amount is not used carries over to the next year.

Consumer-driven health plan (CDHP) allows the individual to choose which physician to see, which prescriptions to fill and where and which surgical procedures to accept from the premium.

Pharmacy technicians are involved in educating patients on Medicare Part D, in addition to other insurance programs.

Food and Drug Administration Modernization Act of 2004 Passed to update the labeling on

prescription medications. Products previously labeled: “Caution:

Federal Law Prohibits Dispensing without a Prescription” were changed to read “Rx only.”

The law also authorized fees, to be paid by the applicant drug manufacturer, be added to an NDA to provide additional resources to the FDA process and accelerate the review and approval of new drugs.

Combat Methamphetamine Epidemic Act of 2005 This act was pass in response to illegal

production of methamphetamine; incorporated into the Patriot Act in 2006 and took effect in September 2006.

All products that contained pseudoephedrine were reclassified and restricted in what can be purchased at one time or in a 30-day period.

All pseudoephedrine containing products are stored “behind the counter” and the purchaser had to present legal i.d.

A sales log must be kept of all sales and pharmacy personnel had to complete training for the handling of these products.

Patient Protection and Affordable Care Act of 2010 The controversial, Affordable Care Act (Obama

Care), mandated universal healthcare coverage for all citizens of the U.S. by 2014 under threat of penalty.

Increasing access healthcare for more than 32 million uninsured individuals.

Provided catastrophic coverage for high-cost illnesses.

Addressed the “donut-hole” in Medicare Part D promising its gradual elimination by 2019.

Continual questions and concerns arise on the implications of this legislation.

Regulatory Law – Role of National Oversight Agencies The minimum level of acceptable standard has

been discussed via the laws, acts, and amendments introduced in this chapter.

The laws, acts, and amendments, used by the FDA and DEA, address a broad scope of issues as well as provide a basic structure for the safe use of drug products and pharmacy practice.

Regulatory law is the system of rules and regulations established by governmental bodies (FDA, and state boards of pharmacy) to carry out the laws of the state or federal government.

Food and Drug Administration The Food and Drug Administration

(FDA) is under the Department of Health and Human Services (HHS), consisting of several organizations: The Center for Drug Evaluation and Research

(CDER) The Office of Pediatric Therapeutics The Center for Devices and Radiological

Health The Center for Biologics Evaluation

(vaccinations) The Office of Orphan Products Development

Food and Drug Administration Pharmacy is most impacted by the CDER,

which is involved in the following: New drug development Generic drug review OTC drug review Postdrug approval activities

The FDA has the responsibility and authority to enforce the law, but has no legal authority over the practice of pharmacy in each state.

The FDA has the ability to create and enforce regulations; requiring all manufacturers to file applications for investigational studies and approval of new drugs, etc.

Food and Drug Administration The FDA enforces packaging, labeling,

advertising, and marketing guidelines for medications.

The FDA has been known to ask manufacturers to cancel advertising campaigns, or present a new campaign to clear up any misconceptions.

OTC marketed medications undergo the same level of scrutiny by the FDA.

The FDA also is responsible for the publishing of specific reference material, Approved Drug Products with Therapeutic Equivalence Evaluations (FDA Orange Book).

Drug Enforcement Administration The Drug Enforcement Administration

(DEA) is primarily responsible for enforcing the laws regarding both legal and illegal addictive substances.

Inspections of medical facilities, including pharmacies is a function of the DEA.

The DEA works closely with state agencies responsible for physical inspections and local investigations.

The DEA has established an audit trail to track the flow of narcotics from manufacturer to warehouse to pharmacy to patient.

Registration with the DEA Through the Controlled Substance Act (CSA),

every person, institution, or business involved with controlled substances must be registered with the DEA.

DEA numbers are issued to prescribers allowing them to write prescriptions for controlled substances.

Hospital registration is for 1-3 years; pharmacies are issued 3 year registrations.

Wholesalers must also be registered with the DEA; 2012 DEA suspended the license of a Florida wholesaler & two pharmacies that purchased controlled substances from the wholesaler.

Prescribers of Controlled Substances CSA defines who may prescribe

controlled substances. Practitioners are authorized to prescribe

controlled substances by the jurisdiction in which they are licensed.

Practitioners include: physicians, nurse practitioners (APRNs), dentists, veterinarians, and podiatrists.

Prescriptions must be written for a legitimate purpose in the practitioners scope of practice.

Prescribers of Controlled Substances Physician Assistants (PAs) cannot write

for schedule II prescriptions because they are not licensed with the DEA.

A prescription for a controlled substance written by a foreign physician cannot be filled in the U.S.

Controlled substance prescriptions are limited by how they can be received except in the case of an emergency use by a hospice patient.

Occupational Safety and Health Administration The Occupational Safety and Health

Administration (OSHA) is part of the Department of Labor.

Its primary mission is to ensure the safety and health of America’s workers through a variety of resources.

OSHA uses its resources to stimulate management commitment and employee participation.

What sorts of things is OSHA responsible for?

National Association of Boards of Pharmacy The National Association of Boards of

Pharmacy (NABP) is the only professional organization that represents all 50 state boards of pharmacy.

Developing a national pharmacist examination for licensure, administered by local state boards of pharmacy.

Reciprocation is the administrative process of ensuring that pharmacists are eligible for relicensure to practice pharmacy in another state; coordinated by the NABP.

National Association of Boards of Pharmacy Providing guidance to state boards by

verifying licensure legality of online pharmacies.

Coordinates issuance of provider identification numbers, unique to more than 70,000 pharmacies.

The NABP has put into place pharmacy practice standards to help state boards develop their own practice standards.

State Boards of Pharmacy State boards of pharmacy organized under

the NABP has leaders from the pharmacy community and representatives appointed by the governor.

Applications are reviewed, examinations are administered, licenses qualified applicants, and regulates the practice of pharmacy by personnel.

Licensure – the process by which the state board grants permission to an individual to engage in a given occupation upon finding that the applicant has obtained the minimum degree of necessary competency to safeguard the public.

State Boards of Pharmacy Registration – the process of being

enrolled on a list created by the state board of pharmacy.

State boards maintain a database of all active pharmacists licenses, technicians and inspects all new pharmacies.

Develops and administers pharmacy law exam for licensure or reciprocation of pharmacists from another state.

Has the authority to suspend or revoke the license or registration of a pharmacist or technician/

State Boards of Pharmacy States may enforce more stringent

regulations then what has been set by the federal government.

State boards may reclassify prescription drugs as scheduled or place an already scheduled drug in a more restrictive status.

Technicians need to have a good understanding of the state board regulations for the state in which you practice, as well as familiarity with facility policies and procedures.

Legal Duties of Pharmacy Personnel No statutory federal definition of a

pharmacy technician exists, and no uniform definition of the role and duties of a pharmacy technician has been adopted by all states.

Each state has their own criteria for pharmacy technicians and therefore there are many differences among states in the role and responsibilities of technicians.

Violation of Laws and Regulations Certain violations can result in a case being

brought against the party who violated the law.

Plaintiff is the party or person filling a case, the party being sued or the case is against is the defendant.

The plaintiff must provide sufficient evidence to prove his or her case; this is burden of proof.

Reasonable doubt is the standard of proof in a case involving crime against local, state, or federal government.

Violation of Laws and Regulations The prosecutor or plaintiff must provide

convincing evidence that the party committed the act beyond any “reasonable” doubt.

Cases involving a licensed or registered healthcare provider may be examined by the state board and determine whether the defendant’s license should be revoked or suspended.

Civil Laws Civil law is given to areas of the law

that concern citizens of the U.S. and wrongs they may commit against each other but not generally against the local, state, or federal government.

Common law the system of precedents established by decisions in cases throughout legal history.

Individuals involved in a criminal case can also be involved in a civil case.

Torts A tort, in the context of civil law, refers

to personal injuries; wrongs that one citizen commits against another.

Local, state, and federal governments do not take part in lawsuits that involve crimes that occurred between two citizens, not against the government and/or its laws and regulations.

What are some examples of torts?

Negligence and Standard of Care The most common tort in the

medical/pharmacy arena is negligence – the failure to provide the minimum standard of care.

Standard of care – the level of care expected to be provided by various healthcare providers in the local community.

When the standard of care is not met and results in injury, a patient may sue the provider for malpractice, a form of negligence.

Negligence and Standard of Care (1) Level of training and (2) geographic

area are taken into account when considering standard of care.

Why do you think level of training and geographic area are always taken into account when considering standard of care?

Standard of care criteria apply to pharmacists as well as technicians.

Negligence and Burden of Proof When negligence or malpractice case is brought,

burden of proof is on the plaintiff to prove the four Ds of negligence: duty, dereliction, damages, and direct cause.

The plaintiff must prove the defendant had a duty to provide care; that the defendant was derelict in their duty (failure to do one’s job); that the dereliction cause actual damages; that damages were a direct cause of the dereliction.

Burden of proof is lower in civil courts; the plaintiff must prove “preponderance of the evidence” or that the defendant is more likely than not to be guilty.

Professional liability insurance protects businesses and personal assets from a civil lawsuit involving negligence and malpractice.

Law of Agency and Contracts The law of agency and contracts is

based on the Latin term respondeat superior, “let the master answer.

The employee is an “agent” for his/her employer and may enter into agreements on behalf of the employer.

Give an example of how a contract is made in the pharmacy.

Invasion of privacy can result in a lawsuit; violations of HIPAA can carry heavy personal fines and immediate termination.

Drug and Professional Standards Professional standards are guidelines

for acceptable behavior and performance.

Professional organizations help advance the pharmacy profession by setting high professional standards, above and beyond what is required by law and regulation.

United States Pharmacopeia The United States Pharmacopeia (USP) is an

independent, nonprofit, scientific organization whose mission is to set public, quality standards for prescription drugs, OTC drugs, and dietary supplements marketed in the U.S.

The United States Pharmacopeia National Formulary (USP – NF) is a book of standards; all new drugs approved by the FDA must meet applicable standards.

USP – NF General Chapters <795> and <797> are standards for storage, packaging, and preparation of nonsterile and sterile compounded preparations.

National Professional Organizations Professional organizations advocate the

establishment of high standards in order to advance the pharmacy profession.

Professional organizations also support education and training of pharmacy personnel.

Certification is supported by professional organizations in order to establish professional standards.

The ASHP has developed a national accreditation training program for pharmacy technicians.

Accreditation – the status achieved by a college or university that meets quality standards and fulfills requirements.

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Created by Jennifer Majeske, Mineral Area College

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