Pharmacy Law Exam 1 LECOM

Three parts of the U.S. Constitution

Preamble, Articles, Amendments

Part of the constitution that describes the purpose of document and government.

Preamble

Part of the constitution that establishes how the government is structured and how the Constitution can be changed.

Articles (there are seven articles)

Part of the constitution that are changes to the constitution. The first ten are called the Bill of Rights.

Amendments

Cornerstone of U.S. government and the supreme law of the land. It describes the structure of federal government and the rights of the people. It was effective since 1788 with 27 amendments to date.

U.S. Constitution

What are the principles within the U.S. Constitution?

-Inherent rights: rights that anyone living in America has.

-Self government: government by the people.

-Separation of powers: branch with different powers.

The 3 branches of Government:

-Congress (legislative branch)

-President (executive branch)

-Judges (Supreme Court and Lower Courts) (judicial branch)

Branch of government that makes laws of the nation.

Examples: Food Drugs Cosmetics Act and Controlled Substance Act

Congress or legislative branch

Branch of government that provides leadership and enforces laws.

President

Branch of government that explains and interprets laws.

Judges (supreme court and lower courts)

Where does it state in the U.S. constitution that Legislative Powers granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives.

Article I

Where in Article I of the U.S. Constitution does it give congress a power to regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes? (Interstate Commerce Clause)

Section. 8.

Where in the U.S. Constitution the Supreme Court/Federal Judiciary is addressed? Judicial power is vested in one supreme court and inferior courts, and the judges will have power to hear cases and interpret the law and the constitution.

Article III

Where in the U.S. Constitution does it state Executive Power shall be vested in a President of the United States of America?

Article II

Where in the constitution does it state the U.S. Constitution is the supreme Law of the Land (Supremacy Clause)? Judges have to uphold the constitution and federal laws, if state laws or constitutions conflict.

Article. VI.

The cluster of Amendments to the U.S. Constitution that had to do with freedom of speech, religion, the press, peaceful assembly, and rights to jury trial. It became law on December 15, 1791.

The bill of rights

Which amendment states powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the States respectively, or to the people?

Amendment X (10th)

Which amendment states equal protection and due process? Meaning states cannot deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws. Government must respect all the legal rights that are owed to a person.

Amendment XIV (14th)

What makes up the Judicial Branch?

Lower court > court of appeals > Supreme Court

Branch of government that has power to evaluate and interpret laws passed and to determine constitutionality of them.

Judicial branch

What is stare decisis/precedent? (In judicial branch)

Decisions made in prior cases are followed in current cases and will be followed in future cases with same facts. Allows anticipation of how courts will decide.

What government regulates interstate and international trade, and make laws necessary and proper to carry out its powers?

National (federal) government

What government regulates intrastate business, issue licenses, and take measures for public health and safety?

State government

T/F: Each state has its own constitution, similar to federal.

True

In state government, what's used to protect the public health, safety and welfare?

General police powers

In state government, what's used to issue laws applicable to state citizen/residents?

Substantial independent authority

The hierarchy of laws (after the constitution):

-federal statutes

-state constitution

-state legislation

-ordinances

When can state law and federal law coexist?

When state law is stricter than federal law.

When do state law and federal law conflict?

When state law goes against federal law.

The 4th branch of government legally created to oversee complex matters of government. They pass rules and regulations; not laws, but they have "force of law".

Examples of some of these:

-Federal: DOJ, DEA, FDA...

-State: State Board of Pharmacy; DMV

Administrative agencies

Interprets and explains the Constitution and laws.

Judicial branch

Makes laws for the nation (congress).

Legislative branch

Provides leadership and enforces laws (president)

Executive branch

What does Supremacy Clause of the U.S. Constitution require?

For judges to uphold the constitution and federal laws if state laws conflict.

T/F: The government must respecc all the legal rights owned to a person.

True

T/F: Procedural due process does NOT require an individual be notified of changes to their rights.

False

T/F: individuals (under most circumstances) are to be given the opportunity to be heard before being deprived of privileges (e.g. liberty and property).

True

Stare Decisis/Precedent includes:

-allows anticipation of how courts will decide a case

-Once established, can be modified or overruled by courts permitted to do so, or changed by the legislature through statutes.

State government receives the authority to regulate pharmacy practice and the distribution of drugs through the _______________ of the constitution. This amendment gives the states all powers not delegated to the federal government or prohibited by the Constitution.

Amendment X (10th)

A pharmacist steals controlled substances from the pharmacy and sells them to drug dealers.

What law type does this scenario fall under?

Criminal law

A patient is harmed by a misfilled medication dispensed by the pharmacy and would like to seek money from the pharmacy to pay for their medical bills.

What law type does this scenario fall under?

Civil law

A pharmacist neglects to complete their continuing education requirements for licensure and tells the Board of Pharmacy on the renewal application that it was completed.

What law type does this scenario fall under?

Administrative law

Often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Includes the combining of two or more drugs.

Drug Compounding

Compounded drugs are not ______

FDA-approved

A drug may be compounded for a patient who:

cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.

Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when:

an FDA-approved drug is not medically appropriate to treat them

Some compounders engage in activities that can put patients at risk and/or undermine the drug approval process. What's an example?

FDA has observed that some compounders have made false and misleading statements that compounded drugs are safe and effective, by incorrectly suggesting the drugs had met the standard for FDA approval.

T/F:

Compounded drugs are approved by FDA

False, they are not approved by FDA

What are the risks associated with compounded drugs?

-They do not have the same safety, quality, and effectiveness assurances as approved drugs.

-Unnecessary use exposes patients to potentially serious health risks

-FDA does not verify their safety, effectiveness, or quality before they are marketed

-Poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.

What is the difference between pharmacy compounding and manufacturing?

Manufacturers of drug products are subject to various FDA requirements that traditional compounding is not subject too (e.g. registration of facility, inspections, CGMPs, IND applications, other rules and regulations specific to manufacturers)

For compounded products to be exempt under 503A (from FDA adequate directions for use, CGMP, and new drug requirements) the following points must be met:

- Drug product is compounded for a patient based on the receipt of a valid prescription order.

- Drug compounding is performed by a licensed pharmacist (in a licensed pharmacy)/ licensed physician.

- Anticipatory compounding is permitted in limited quantities (history of receiving valid orders).

- Complies with USP chapters on compounding using bulk substances.

- Usage of bulk drug substances that are manufactured by an establishment that is registered with the FDA.

- May not use drugs on an FDA list of items that have been withdrawn/ removed because they have been found to be unsafe or not effective.

- The compounder cannot compound regularly (essentially copies of commercially available products)

- May not distribute more than 5% of the total prescriptions dispensed or distributed by that

pharmacy absent a memorandum of understanding (MOU) between their state and the FDA.

Section 503B created a new category where compounders of sterile products may voluntarily register to become an "outsourcing facility". What are these requirements?

■ Meeting FDA CGMPs (though to a lesser extent than manufacturers have to meet)

■ Permitting FDA inspections according to a risk-based schedule

■ Prohibiting the sale/transfer of products by an entity other than the outsourcing facility

■ Meeting DQSA labeling requirements for each container

■ Meeting other FDA requirements such as reporting adverse events and disclosing product information

DQSA also requires FDA and states to:

work together / communicate more on certain issues; requires to publish drug lists for those with difficulties compounding, removed from market, and bulk drug substances.

Practice of taking a finished drug product from the manufacturer's container and placing it into a different container (but not including reconstitution, diluting, or a pharmacy removing a nonsterile drug product and placing it in a different container to dispense directly to a patient)

Repackaging

Repackaging may be necessary for:

- Specific patient needs, reduce waste, or prevent abuse or diversion

- Unit-dose or blister packs

Repackaged drugs are not exempt under:

503A and 503B like compounded products from FDCA requirements (new drug approval, misbranding, etc.)

What guidance has FDA issued when it does not intend to enforce FDCA for repackaging activities by 503A or 503B facilities:

- If repackaged by a pharmacy, it is distributed only after the receipt of a valid prescription for an identified patient; the repackaged product contains an appropriate BUD.

- To determine appropriate BUD: depends on product and labeling (e.g. for nonsterile product without an in-use time, for nonaqueous formulations BUD not to exceed 6 months or expiration date, whichever is shorter).

FDCA Levels of Compliance and Enforcement:

1. Manufacturing

2. OutSFac

3. Traditional Pharmacy

Give examples about FDCA requirements and examples.

1. Must meet all FDCA requirements (e.g. Labeling/new drug approval /CGMPs...)

2. Not required to meet all FDCA requirements that

manufacture is if complies with FDA guidances (e.g. compounding (503B) and repackaging)

3. Not required to meet all FDCA requirements that

manufacture is if complies with FDA guidances

(e.g. compounding (503A) and repackaging)

Which of the following statement(s) regarding compounding is/are accurate? Select all that apply

A. Traditional compounding involves mixing or combining multiple products to create a product to meet the needs of an individual patient.

B. Compounded drugs have been approved by the FDA

C. Compounding serves a very limited purpose in pharmacy practice and it can only be done by specially licensed pharmacies.

D. Compounded drugs have the same safety, quality, and effectiveness assurances as non-compounded drugs.

E. Currently, the FDA has more oversight of compounding than seen in recent decades.

F. Manufactured and compounded drugs are regulated the same by the FDA

A) Traditional compounding involves mixing or combining multiple products to create a product to meet the needs of an individual patient.

E) Currently, the FDA has more oversight of compounding than seen in recent decades.

A pharmacy is asked to compound 2 NA products together (Drug A and Drug B). Both expire in Dec. 2022. Assuming no information to the contrary, what Beyond-Use Date should the pharmacy use?

a. 3 days from the date of compounding

b. 14 days from the date of compounding

c. 30 days from the date of compounding

d. 6 months from the date of compounding

e. 1 year from the date of compounding

f. December 2021

d) 6 months from the date of compounding

Over the last year, a pharmacy has compounded on average 500gm a month of a product. The highest amount compounded in one month over the last year is 650gm, and the lowest is 400gm. How much can the pharmacy prepare in advance of prescriptions?

a. None; pharmacies can not prepare prescriptions in advance of receiving prescriptions

b. 250gm

c. 400gm

d. 500gm

e. 650gm

f. 1000gm

e) 650gm

Which of the following statements regarding a 503A Pharmacy is/are true?

True or False:

a. A pharmacy can never compound a product for a patient if one is commercially available.

b. A pharmacy could compound a product with minor differences to a manufactured product if the prescriber indicates patient need due to a clinical significant difference.

c. If a manufactured drug is currently on a drug shortage list, the pharmacy can compound it for a patient.

d. A pharmacy can compound a product if the strength differs by at least 5% from the manufactured product.

a. False

b. True

c. True

d. False

What are two important points that the Durham-Humphrey 1951 Amendment to FDCA makes?

1. Distinguishes RX (legend) from OTC drugs

2. Also allowed for verbal transmissions of prescriptions (in addition to written) and refills if authorized.

FDA can classify as RX drug if:

The product is unsafe for use except under the supervision of a practitioner because of toxicity or method of use, or for collateral measures; or if its subject to NDA

When labeling of dispensed drugs (eg by pharmacy) exempt from FDCA requirements for manufacturers, but labeling must still not be:

- False or misleading;

- Not be an imitation drug;

- Not sold under name of another drug;

- Packaging and labeling must comply with compendia and PPPA standards

When labeling of dispensed drugs (eg by pharmacy) who gets exempted from the FDCA requirements?

Manufacturers

What is the minimum FDCA information that must be on a pharmacy label?

name/address of dispenser; serial number and

date or RX or its filling; name of prescriber; name of patient; directions for use and cautionary statements

Date after which drug should not be used, and can't exceed

manufacturer's expiration date

Beyond Use Date (BUD)

Many states require _______ or ________ on pharmacy label.

expiration; BUD

BUD shall not be later than expiration date on

manufacturer's container or 1 year from date drug is dispensed, whichever is earlier.

USP Standard

RX switch to OTC can occur when a:

• Manufacturer requests switch in NDA or SNDA

• Manufacturer/others request switch in citizen petition

• FDA may add or amend an OTC monograph

______ status requires that a product be labeled adequately so consumers can self-diagnose, treat, and manage without practitioner involvement.

OTC

________ is when a authorized prescriber can't delegate authority to employee/agent to authorize refills (unless state law allows); however, employee/agent typically allowed to communicate

authorized refills to pharmacy.

Prescription Refill Authorization

Each state determines who can prescribe and at what degree

Prescriptive authority

RPhs have rights but should never obstruct a patient's legal right to receive a lawful medication:

Conscientious Objection

Most states allow CPAs between prescribers and RPhs; some states permit limited prescriptive rights for RPhs:

Collaborative Practice Agreement

Which law dictates who can dispense prescription drugs; states may allow others in addition to pharmacists, such as prescribers.

State laws

Recall from before that RX labeling is geared towards HCP; however there are 2 types of labeling mandated by federal law that manufacturers must supply to be given to patients:

1. PPI

2. MedGuides

(CMI is also a form of written information but not mandated by law/rule)

Private sector effort to provide useful written information; not regulated by FDA; not a substitute for PPI or MedGuide; but should give out for all dispensed RXs

CMI

FDA can require for product or class of drugs w/serious and significant concern (needed to prevent adverse effect/serious risks/patient adherence crucial)

MedGuides (may also be part of REMS program)

____ goal is to have 1 single, easy-to-read document w/ most important information - termed "PMI" or Patient Medication Information - until PMI comes about, understand differences/when required to give, and that written info is not a substitute to verbal counseling!

FDA

Drugs are often prescribed and dispensed for indications other than those listed in approved labeling is called:

Off-label; unlabeled; unapproved

_____ allows for some drugs to be legally prescribed and dispensed for off-label indications; and in some circumstances is appropriate, rational, and accepted medical practice.

FDA

Pharmacists should be concerned with unreasonable risks and liability; pharmacists must exercise professional judgment and take steps if risk is unreasonable. What must the Pharmacist do with any concern

Document them in Patient profile

Hazardous drugs are defined and identified by

NIOSH

NIOSH identifies hazardous drugs into 3 tables, what are these?

1. Antineoplastics

2. Non-antineoplastics

3. Drugs with reproductive effects

_______ requires list of HZD, proper facility, trained personnel, safe work practices, proper use of protective equipment, policies for HZD waste segregation and disposal.

USP 800

Orange book (Approved Drug Products with Therapeutic Equivalence Evaluations) is _____ a federal law but a _______ to assist

pharmacists in determining bioequivalence / therapeutic equivalence of a product compared to a reference product.

NOT; reference

What are some ways that state laws are different for generic drugs?

- how generic is defined,

- whether it is mandatory or permissive substitution,

- how prescriber is to communicate brand only,

- notification to substitution to patient or prescriber

- pharmacy labeling,

- NTI drugs

Within the realm of generic substitution what are two terms that sometimes get confused as the same?

Therapeutic equivalence and therapeutic substitution

"______" of drug supply chain is manufacturing to distribution (may involve wholesalers, repackagers, warehouses, transportation) to pharmacies to dispensing to patient allows for various points of potential diversion and introduction of counterfeit products.

Normal Stream

Drug Supply Chain Security is to help secure supply chains involving:

PDMA and DSCSA

State licensing of wholesalers; banning reimportation; banning sale/trade/purchase of drug samples and coupons; prohibiting resale of drugs purchased by hospitals (limited exceptions).

PDMA

Federal pedigree requirements; applies to trading partners (manufacturers, wholesalers, repackagers, 3rd party logistic providers, and dispensers) (see next couple slides for more info)

DSCSA

Over 10 years what 5 important provisions did Track and Trace put into place?

1. Product Identification

2. Product Tracing

3. Product Verification

4. Detection and Response/notification

5. Wholesale and Third-party logistics provider licensing

Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages (eg, bar code).

Product identification

Drug distributors to report information to FDA (eg license status and contact info); TPL to obtain state or fed license.

Wholesale and Third-party logistics provider licensing

Trading partners (manufacturers, wholesale distributors, repackagers, dispensers) to provide information about a drug and who handled it each time sold/transferred.

Product Tracing

Quarantine and investigate suspect products and notify FDA and other stakeholders

Detection and response / notification

Trading partners to have systems in place to verify the product

Product verification