Pharmacy Law Exam 1 LECOM
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
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
What is required to be listed on an OTC drug facts panel?
-Active ingredient -Uses -Warnings -Inactive ingredients -Purpose -Directions -Other information
Drugs that are both RX and OTC
-Drugs may be approved for both -Strengths may vary or be the same -Labeling will vary for indication
Who relates info about recalls?
-Manufacturer can do recalls voluntarily or FDA can request a recall if manufacturer is not mandated -FDA can prescribe procedures for recalls -Manufacturer notifies seller; seller notifies consumers -Pharmacists is responsible for keeping up to date on recalls
Food, Drug, and Cosmetic Act (FDCA)
-Provides for the comprehensive regulation of all drugs introduced into interstate commerce -Intent of the law is to protect consumers from adulterated or misbranded products (e.g. foods, drugs, cosmetics, or devices)
NIOSH identifies hazardous drugs into 3 tables, what are these?
1. Antineoplastics 2. Non-antineoplastics 3. Drugs with reproductive effects
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.
Companies must warn that nicotine is ____ and must submit new and existing products for ___ approval
Addictive; FDA
Part of the constitution that are changes to the constitution. The first ten are called the Bill of Rights.
Amendments
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
Biologics
Come from living organisms
In state government, what's used to protect the public health, safety and welfare?
General police powers
What you put on a bottle
Label
LTCFs must ensure these are not 5% or greater
Medication Errors
Third segment of NDC number identifies what? (2 digits)
Package size
Class I recall
Reasonable probability of product causing serious medical harm or death
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
Rebates
Requires manufacturers to provide meds to Medicaid at their "best price" through rebates
What are the 2 elements of prospective DUR?
Screening prescription & Patient counseling
What symbol or legend should be on a RX label?
Symbol: RX Only Legend: "Caution: Federal law prohibits dispensing without a prescription"
T/F FDA has recall authority for limited products (ex: medical devices, biologics)
True
When do state law and federal law conflict?
When state law goes against federal law.
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
Which of the two does not have to adhere to GMP standard? a) 503A b) 503B
a) 503A
Which of the following is not a requirement for labeling a prescription drug? a) Name of the drug b) The drug's indication c) Side effects d) dosages e) Route, method, frequency, and duration of administration f) Contraindications g) Other warnings and precautions
a) Name of drug
Which USP pertains to the compounding of hazardous drugs? a) USP 795 b) USP 797 c) USP 800
c) USP 800
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.
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.
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
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
Poison Prevention Packaging Act allows manufacturers to market one size of an OTC product for elderly or handicapped people in noncompliant packaging BUT the package MUST include statement or warning:
"This Package for Households without Young Children" or the warning "Package Not Child Resistant"
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.
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
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).
Repackaging may be necessary for:
- Specific patient needs, reduce waste, or prevent abuse or diversion - Unit-dose or blister packs
HIPPA (Health Insurance Portability and Accountability Act)
-Allows portability and continuity of health insurance coverage and prohibit discrimination in health coverage -Regulates the privacy and security of health information
The 3 branches of Government:
-Congress (legislative branch) -President (executive branch) -Judges (Supreme Court and Lower Courts) (judicial branch)
Which 3 elements does HIPPA target?
-Health information -Transaction and code sets -National provider identities (NPI numbers)
Package insert must contain:
-Highlight section -Black Box warnings -Pregnancy warnings (No rule to give inserts out to patients)
What is a patient requests information from the nurse in the institutional hospital setting, should we give CMI or Medguide or both?
-If healthcare profession, then no medguide -If going home, medguide must be provided but CMI is optional
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.
In what ways can FDA enforce FDCA?
-Injunctive action (telling violator to cease illegal activity) -Criminal proceedings against violator (penalties including fines or prison) -Seize adulterated or misbranded products in interstate commerce -FDA may send warning letters as first step
Medicare Part B
-Insures beneficiaries against medical expenses; monthly premium charge; coverage can be waived -Partially covers outpatient diagnostic services, therapy; but not drugs unless can't be self administered
What does a RX label include?
-Name & address of manufacturer, packer, or distributor -Established name of drug product -Ingredient info (quantity and proportion of each active ingredient) -Quantity in terms of weight or measure -Net quantity of container -RX symbol or legend -Route of administration if not for oral use -Lot or control number -Statement directed to RPh specifying the type of container to be used in dispensing the drug -Expiration date; unless exempted
What is required to be on a Unit dose label?
-Name of drug -Quantity of active ingredient in each unit dose -Expiration date (if provided by manufacturer, if not must be determined) -Lot or control number -Name or place of business of man/product/distributor -Any special statements
OBRA requires written records of information about patients, what information should be documented?
-Name/address/Phone number/DOB/gender -Significant individual history (allergies, diseases) -Pharmacists comments related to drug therapy
What should be included in Patient Counseling?
-Name/description of medicine -Dosage form/dosage/route/duration of therapy -Special directions and precautions -Common side effects/interactions -Self monitoring/proper storage -Refill information -How to deal with a missed dose
Why does the FDA not routinely inspect pharmacies?
-Pharmacies have an exemption from this if, not engaging in manufacturing or similar activities; -FDA can inspect pharmacies if it has a reason to believe it is engaging in manufacturing or repackaging activities
Screening Prescriptions
-Pharmacists are to detect problems such as therapeutic duplication, drug-drug interactions, incorrect doses/strengths, drug-disease interactions, allergies, abuse/misuse -Computers can assist with screening but professional judgement must be used
Treatment
-Providing, managing, or coordinating health care -Dispensing, counseling, profiles, consulting with other health care providers
What are the components of OBRA 90?
-Rebates -Demonstration projects -DUR
What are the 3 components to DUR?
-Retrospective review -Educational programs -Prospective review
What are the 3 components to Prospective review?
-Screen of prescriptions before dispensing -Patient counseling by the pharmacist -Pharmacist documentation of relevant information
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.
National Drug codes (NDC)
-Unique 11 digit, 3 segment # -On all OTC and RX labels -Used to ID drugs; used a lot by insurance companies to process claims
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.
The hierarchy of laws (after the constitution):
-federal statutes -state constitution -state legislation -ordinances
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)
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)
What 3 requirements must meet the Poison Prevention Packaging Act?
1. Requires most OTC and RX drugs that the pharmacist will dispense directly to the consumer to be placed in child-resistant containers (special packaging) 2. A drug can only be dispensed ONE time in a child-resistant container or vial => pharmacy must use new lid and vial every fill, unless the vial is glass, then only a new lid is needed 3. Drugs can be dispensed in reversible containers, as long as dispensed in the child-resistant mode
In long term care, what is the maximum day supply allowed?
14 days
Repackaged drugs are not exempt under:
503A and 503B like compounded products from FDCA requirements (new drug approval, misbranding, etc.)
A container is considered Child-resistant if:
80% of children < 5 years old cannot open them
Child-resistant containers must be manufactured such that ______ of the children less than 5 years old of age cannot open them, whereas at least _____ of adults can.
80%/ 90%
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.
Federal Anti-Tampering Act was made because of deliberate contamination of Tylenol in 1982. What were some actions the law put into place?
Action of law: 1) made tampering, threats to tamper, conspiracy to tamper, and communication of false information that a product has been tampered with a criminal act 2) enforcement authority given to FBI, USDA (dept of agriculture), and FDA 3) required tamper evident packaging (NOT tamper proof) by MANUFACTURER (not pharmacists repackaging drugs into vial)
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
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
Drug was altered or contaminated is known as what?
Adulteration
Protected health information (PHI)
All health information that relate to past, present, or future physical or mental health; the provision of care; or payment for care, identify the patient or could reasonably be expected to identify the patient, prescriptions and payment records info
Prospective DUR
Allows Pharmacists the opportunity to consider prescribed drug therapy and apply what they know about proper medication use
Poison Prevention Packaging Act
Allows glass bottle and threaded plastic to be reused by just needing a new lid
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)
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)
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 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 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.
Part of the constitution that establishes how the government is structured and how the Constitution can be changed.
Articles (there are seven articles)
Date after which drug should not be used, and can't exceed manufacturer's expiration date
Beyond Use Date (BUD)
Drugs must be manufactured in accordance with what?
CGMPs (Current good manufacturing practices)
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
Qualified Health claim
Can "prevent something" but must be cleared by FDA
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
Which medical device class requires the most regulation because they pose the most potential harm to users and are usually life supporting or life sustaining? a) Class I b) Class II c) Class III
Class III
Most states allow CPAs between prescribers and RPhs; some states permit limited prescriptive rights for RPhs:
Collaborative Practice Agreement
Privacy regulations
Concerned with patient's rights and how and when the patient's information may be used
Branch of government that makes laws of the nation. Examples: Food Drugs Cosmetics Act and Controlled Substance Act
Congress or legislative branch
RPhs have rights but should never obstruct a patient's legal right to receive a lawful medication:
Conscientious Objection
Who enforced the Poison Prevention Packaging Act?
Consumer Product Safety Commission (CPSC)
This is intended to be rubbed, poured, sprinkled, and sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. What am I?
Cosmetic
A pharmacist steals controlled substances from the pharmacy and sells them to drug dealers. What law type does this scenario fall under?
Criminal law
LTCF must have a pharmacist complete these at least once a month for each resident
DRR
Federal pedigree requirements; applies to trading partners (manufacturers, wholesalers, repackagers, 3rd party logistic providers, and dispensers) (see next couple slides for more info)
DSCSA
When is the notice of privacy practice provided to a patient?
Day of service first provided and must also be posted on site and available upon request
DUR (Drug Use Review)
Deals Primarily with healthcare outcomes and includes retrospective reviews, educational programs, and prospective reviews
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.
Prescription drug label
Defined as label affixed to container
How can a drug be adulterated?
Depends on how improperly it was prepared, packed, held, exposed
Quarantine and investigate suspect products and notify FDA and other stakeholders
Detection and response / notification
This is an instrument, apparatus, machine and does not achieve any principal intended purposes through chemical action within or on the body of man or animals. What am I?
Device
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
This is intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; intended to affect the structure or any function of the body of man or other animals. What am I?
Drug
Second segment of NDC number identifies what? (4 digits)
Drug (Strength/dosage form)
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
Which drugs can be sold as OTC?
Drugs that do not require professional supervision
Where can pharmacies require to confirm trading partner authorization?
Either directly or through FDA or state authority
OBRA-90 (Omnibus Budget Reconciliation Act of 1990)
Elevates standard of care owed by pharmacists to all patients; Created National Policy adopting pharmaceutical care model
CGMPs apply to pharmacies that do what?
Engage in specific manufacturing activities
Security regulations
Entities can develop their own physical, technical, and organizational procedures as long as they meet minimal requirements to protect information from unauthorized access, alteration, deletion and transmission
In long term care, DRRs are done how often?
Every month, a patients info is checked and document any irregularities and report to physician
Provides leadership and enforces laws (president)
Executive branch
No new drug may be marketed and sold unless it has been proved both safe and effective for its intended use and approved by who?
FDA
Who approves specific information that is labeled on OTC drugs?
FDA
____ 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
_____ 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
Postmarket labeling
FDA can compel safety-related labeling changes when FDA becomes aware of serious drug risks
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.
Medwatch
FDA's safety information and adverse event reporting program
Compounded drugs are not ______
FDA-approved
Dispensing a recalled item violates which act?
FDCA; civil action measures could be taken if patient gets injured
T/F: All drugs utilize the Category A,B,C,D,X to warn of risks in pregnancy
False
T/F: Black box warnings are an optional way for manufacturers to warn of drugs that may lead to death of serious injury
False
T/F: Manufacturers must report serious adverse reactions related to their product to Medwatch
False
T/F: Pharmacists are not required to inform the patients they dispense to about the Medwatch contact information
False
T/F: The FDA has not authority to regulate tobacco
False
T/F: The FDA only uses internal employees for expert advice
False
T/F: REMS stands for Regulatory Evaluation of Medical suppliers
False
T/F: Procedural due process does NOT require an individual be notified of changes to their rights.
False
T/F: FDA cannot go after corporate officers when other employees violate the FDCA
False, FDA can go after corporate officers
T/F: I can import my hypertension medication because I found that it is cheaper in Mexico than in the US
False, can import only if it is used to treat very serious condition with no options in US and get 3 month supply
T/F: The orange book is federal law
False, it is state and used for generic substitution
T/F: When a drug has an NDC number that means it has been approved
False, not always approved. NDC is used to identify the drug
T/F: Compounded drugs are approved by FDA
False, they are not approved by FDA
Which act granted the FDA to regulate tobacco products?
Family smoking Prevention and Tobacco Act
Medical Foods
Food specially manufactured for use by people with medical disorders and administered on the advice of a physician. Ex: foods formulated without the amino acid phenylalanine, and folic acid, B6 and B12 combos
What does Supremacy Clause of the U.S. Constitution require?
For judges to uphold the constitution and federal laws if state laws conflict.
Class II of medical devices
General controls are insufficient to ensure safety and effectiveness; must meet additional standards before they can be marketed. Ex: Insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, electric heating pads
ANDA (Abbreviated New Drug Application) is devoted to which kind of drugs?
Generic drugs
Biosimilar
Generics for biologics (Cant have a strict generic, has no clinically meaningful differences)
Demonstration Projects
Goal is to determine if outcomes of patient care improve and the costs decrease when pharmacists provide DUR service to patients
Prescription drugs are labeled for who?
Health care professional, not patient
Prescription drugs need to have medical terms aimed towards who?
Healthcare workers
Purpose of REMS
Helps manage known or potential serous risks of a product/class; FDA can require in a pending NDA or postmarket
Unit dose is usually used in what setting?
Hospitals
Unqualified health claim
If no clearance by FDA and it says it prevents something, then it is misbranding
What is the crucial issue in determining a drug?
If the supplier made a therapeutic or health claim, or a structure/function claim
Covered entities
Includes Pharmacies
Special dietary foods include what?
Infant formulas and artificial sweeteners
Branch of government that explains and interprets laws.
Judges (supreme court and lower courts)
Branch of government that has power to evaluate and interpret laws passed and to determine constitutionality of them.
Judicial branch
Interprets and explains the Constitution and laws.
Judicial branch
Label and everything that comes with the bottle (package insert) is known as what?
Labeling
What is RX labeling?
Labeling directed towards practitioner for safe use (prescribing); All approved by FDA
Misbranding
Labeling of a product that is false or misleading; Imitation drugs
What is OTC labeling?
Labeling where product can be used safely by a lay person for purposes intended
Community pharmacies may use tax paid alcohol for compounding, purchased from authorized retailer/wholesaler; tax-free alcohol (190 proof) may not be obtained or used by community pharmacies but may be used by specific entities for specific purposes (e.g. laboratories for scientific research) and must be stored in a locked storeroom
Laws related to FDCA for the use of alcohol in pharmacy practice
Class I of Medical devices
Least regulation; pose least potential harm; manufacturers to register facility and list products. Ex: Needles, scissors, exam gloves, stethoscopes, and toothbrushes
Makes laws for the nation (congress).
Legislative branch
Class III Medical devices
Life supporting or life sustaining devices that must have premarket approval. Ex: Pacemakers, soft contact lenses, replacement hearth valves
What does the DSHEA (Dietary Supplement Health and Education Act) allow?
Limited health or disease claims that describe relationship between product and disease
What makes up the Judicial Branch?
Lower court > court of appeals > Supreme Court
What are some exceptions to the Federal Anti-Tampering Act?
Lozenges, insulin, dermatolgics
Medicare Part C
Managed Care
First segment of NDC number identifies what? (5 digits)
Manufacturer
Postmarketing surveillance
Manufacturer to continue to monitor drug after reaches market; must submit to FDA reports of any serious adverse drug reactions and any new information relating to drug's safety and efficacy
When labeling of dispensed drugs (eg by pharmacy) who gets exempted from the FDCA requirements?
Manufacturers
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)
Requires written patient authorization under HIPPA
Marketing
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)
What regulations do CGMPs give?
Minimum requirements for manufacturer's methods, facilities, and controls for making, packaging, and holding products
What is supposed to be in the bottle is not in the bottle
Misbranding
When dispensing prescription drug without a prescription, not providing required patient information; products not meeting REMS requirements are all another definition for what?
Misbranding
FDCA prohibits which two major offenses?
Misbranding & Adulteration
What is the general rule for advertising?
Must be truthful; contain adequate information; be a fair balance; not misleading
Hazardous drugs are defined and identified by
NIOSH
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 government regulates interstate and international trade, and make laws necessary and proper to carry out its powers?
National (federal) government
Qualified health claims
Needs disclaimer so it does not mislead, does not meet scientific agreement test, "scientific suggests but does not prove"
Unqualified health claims
No disclaimer needed; allowed by means of FDA regulation and met significant scientific agreement test
"______" 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
Information provided to each patient that contains on how pharmacy (or provider) intends to use the info, describes legal duties of provider, a statement of the patients rights and how to exercise them, how to file a complaint, and a contact within the company to contact with concerns is known as what?
Notice of Privacy Practices
______ status requires that a product be labeled adequately so consumers can self-diagnose, treat, and manage without practitioner involvement.
OTC
Drugs are often prescribed and dispensed for indications other than those listed in approved labeling is called:
Off-label; unlabeled; unapproved
Pharmacists must ___ to discuss with each patient or caregiver matters that are significant
Offer
Supplemental Application
Once NDA is submitted, if new evidence for a drug is found this form is submitted
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
Drug Supply Chain Security is to help secure supply chains involving:
PDMA and DSCSA
If an NDC number has 10 digits what must be done to identify it?
Pad with 0 to meet HIPPA requirements
Patient counseling
Pharmacist speaks with patient or caregiver about any problems of patients medications or info on how to properly use; must be offered to patients
Prospective review
Pharmacists look at prescribed drug therapy and apply what they know about proper medication use; Generates new data on patterns of actual medication use, used by DUR Board in DUR process; Requires a comprehensive review of patient's prescription order at the point of dispensing
Who by law is required to counsel in a Pharmacy?
Pharmacists only unless specific states allow for interns to counsel under RPH
Passed in 1970 by Congress with the intent of protecting children from accidental poisonings with "household substances"
Poison Prevention Packaging Act
Part of the constitution that describes the purpose of document and government.
Preamble
Three parts of the U.S. Constitution
Preamble, Articles, Amendments
________ 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
Medicare Part D
Prescription drug coverage (outpatient)
Each state determines who can prescribe and at what degree
Prescriptive authority
Branch of government that provides leadership and enforces laws.
President
Trading partners (manufacturers, wholesale distributors, repackagers, dispensers) to provide information about a drug and who handled it each time sold/transferred.
Product Tracing
Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages (eg, bar code).
Product identification
Trading partners to have systems in place to verify the product
Product verification
Medicare Part A
Provides hospitalization insurance without any charge to eligible individuals (Covers medical supplies and rental of medical appliances but not RX drugs for outpatients)
Operations
Quality assessment, fraud detection, audits, business managements
Does not require written patient authorization under HIPPA
Refill reminders
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.
When Cheerios claimed "Cheerios can reduce bad cholesterol by an average of 4%", the FDA did which of the following?
Sent General Mills a warning letter that the claim made cheerios and unapproved drug
What are 2 special categories of foods that have health claims?
Special dietary and Medical foods
What are two special categories of foods that cannot make health or disease claims?
Special dietary and medical foods
What government regulates intrastate business, issue licenses, and take measures for public health and safety?
State government
Which law dictates who can dispense prescription drugs; states may allow others in addition to pharmacists, such as prescribers.
State laws
Payment
Submission of claims for reimbursement, determining eligibility and extent of coverage and sending bills to patient
In state government, what's used to issue laws applicable to state citizen/residents?
Substantial independent authority
Pharmacy may use and disclose PHI (Patient history info) for what reason?
TPO (Treatment, Payment, Operations)
Changing a product from what it was intended to be by the manufacturer; a tamper-evident package is defined as one that has an indicator or barrier to entry which, if breached or missing, can reasonable be expected to provide visible evidence to consumers. What is this known as?
Tampering
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
Poison Prevention Packaging Act exempts RX drugs from the child resistant packaging requirement if either:
The physician prescribing the drug or the patient receiving the drug requests noncompliant containers (an be oral request, but wise for pharmacist to document request and a signature)
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
Within the realm of generic substitution what are two terms that sometimes get confused as the same?
Therapeutic equivalence and therapeutic substitution
What is required of a consumer if they are purchasing Tobacco from retailers?
Those under 18 must verify age and show photo ID, unless person is over the age of 26
Demonstration projects
To determine if Pharmacists provide cost-effective services
NDA is used for what purpose when it comes to OTC drugs?
To request OTC status or to switch RX drugs to OTC
T/F: An NDC number may use the following configuration: 4-4-2
True
T/F: Based on therapeutic claims, a court can likely consider a product a drug, even though the manufacturer says it is not.
True
T/F: Class III medical devices must have FDA premarket approval
True
T/F: Cosmetics can be deemed adulterated or misbranded
True
T/F: Drugs can be adulterated and misbranded at the same time
True
T/F: Pharmacists that repackage or relabel OTC products must comply with manufacturing labeling requirements
True
T/F: The FDA is only permitted to pass regulations to implement/clarify the FDCA
True
T/F: Unit dose products are not required to contain the same information that other prescription drug labels must contain
True
T/F: Each state has its own constitution, similar to federal.
True
T/F: The government must respecc all the legal rights owned to a person.
True
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
T/F: Waiving of counseling is allowed by patients, but it must be a knowing and voluntary refusal
True, if refusal occurs it must be documented
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
_______ 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
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
LTCF residents must be free from these
Unnecessary Drugs
FDA Medwatch is always ___
Voluntary
When can state law and federal law coexist?
When state law is stricter than federal law.
What's an example of a trading partners to provide subsequent purchaser with product tracing information (lot-level product tracing, transaction information, history, and statement) which is to be kept by partner (eg, dispenser) for at least 6 years.
Wholesale distributors providing to pharmacies electronically
What is required if PHI needs to be disclosed by other means than TPO?
Written patient authorization
Dietary supplements
a product intended for ingestion in the diet that contains one or more of the following: vitamins, minerals, herbs, amino acids,
Pursuant to the Prescription Drug Marketing Act, a prescriber can receive samples from a manufacturer by means of: a. A written request on a proper form each time the prescriber wants samples b. A standing written request for samples c. A verbal request from the manufacturer's representative d. The manufacturer can supply the samples without request
a) A written request on a proper form each time the prescriber wants samples
Which regulations govern biologics? a) FDCA & PHSA b) FDCA & CMS c) CMS & PHSA d) SAMSA & FDCA e) PHSA & SAMSA f) FDCA, PHSA, & IHS
a) FDCA & PHSA
The Drug quality and Security Act had what effect on the traditional compounding of community pharmacies pursuant to prescriptions? a) It reinstated the constitutional provisions of Section 503A enacted in 1997 by the FDAMA b) It shifted enforcement authority from state pharmacy boards to the FDA c) It established that pharmacy-compounded drugs are new drugs d) It prohibited pharmacies from compounding in anticipation of prescriptions
a) It reinstated the constitutional provisions of Section 503A enacted in 1997 by the FDAMA
Which of the following is mandatory by the FDCA? a) Post-marketing surveillance once an NDA is approved for marketing b) Submission of serious adverse events to the FDA MedWatch
a) Post-Marketing surveillance once an NDA is approved for marketing
How does the concept of conscientious objection apply to the pharmacy practice? a) Some state laws allow pharmacists the right to refuse to dispense prescriptions to which they have a moral or religious objections b) Conscientious objection decisions are individual ones not subject to state regulation c) Court decisions generally respect the right of a pharmacist to obstruct a patient's right to receive a prescription, provided the pharmacist is following a moral or religious objection d) The concept applies to medical practice, but not to pharmacy practice
a) Some state laws allow pharmacists the right to refuse to dispense prescriptions to which they have a moral or religious objections
The FDCA specified which of the following about prescribing prescription drugs? a) That they may be prescribed by practitioners licensed by law b) Which practitioners may be licensed by law to prescribe (ex: physicians, dentists, etc.) c) The scope of prescriptive authority of a practitioner d) All of these are correct
a) That they may be prescribed by practitioners licensed by law
Which USP pertains to the compounding of non-steral drugs? a) USP 795 b) USP 797 c) USP 800
a) USP 795
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
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
FDA does not routinely inspect pharmacies but the FDA is permitted to inspect:
any facility where drugs are held at reasonable times, within reasonable limits, and in a reasonable manner.
Which of the 2 is not allowed to use bulk drug substance? a) 503A b) 503B
b) 503B
A small pharmacy has a total of 120,000 prescriptions filled for 2020. How many of those are allowed to be compounded before the pharmacy is required to follow cGMP, adequate directions for use and new drug requirements? a) 12,000 b) 6,000 c) 18,000 d) 4,000
b) 6,000 (503A pharmacies are not allowed to compound more than 5% of that total prescriptions filled)
What is the purpose of FDA's warning letters? a) To warn manufacturers or compounders that they must cease operation or stop producing a specific product due to non-compliance b) To inform manufacturers or compounders compliance issues identified that must be corrected c) To warn manufacturers or compounders that the agency is seeking enforcement actions
b) To inform manufacturers or compounders compliance issues identified that must be corrected
Which of the following is true about FDA guidelines? a) FDA guidance must be followed as it is legally binding b) FDA guidance does not need to be followed as long as the manufacturer follows all laws and regulations c) FDA guidance should be followed even though it is not legally binding
c) FDA guidance should be followed even though it is not legally binding
Which of the following statements is incorrect regarding 503B compounders? a) 503B provides that a 503B compounder cannot compound drug products using a bulk drug substance, unless it appears on a list established by the FDA that the substance has a clinical need or if the substance is on the drug shortage list b) 503B compounders need to have prescriptions written for patients for compounding activities, even though they are permitted to compound reasonable amount of drugs before receiving the prescriptions c) In contrast to 503A compounders, 503B compounders are permitted to compound drugs that are essentially a copy of commercially available drugs d) 503B compounders must adhere to cGMP standard
c) In contrast to 503A compounders, 503B compounders are permitted to compound drugs that are essentially a copy of commercially available drugs
Pursuant to the Poison prevention Packaging Act, a community pharmacy may: a) Dispense a non-child-resistant container if, in the pharmacist's professional judgement, it is appropriate b) Dispense a non-child-resistant container upon a patient's request, but only if the request is in writing c) Reuse a child-resistant glass container with a new closure d) All of these are correct
c) Reuse a child-resistant glass container with a new closure
Which of the following is not a requirement for unit dose labeling? a) Name of drug B) Quantity of the active ingredient in each dosage unit c) Route, method, frequency, and duration of administration d) Expiration date e) Lot Number f) Name and address of the manufacturer, packer, or distributor g) The number of dosage units contained if more than one dosage, and strength per dosage unit h) "Warning: may be habit forming" if applicable I) The controlled drug symbol if required by the FDA
c) Route, method, frequency, and duration of administration
Drug Z has been on the market for a number of years and is very costly. Pharmacist Phil has just learned that there is another less expensive generic product available, Drug Y, with the same active ingredient and in the same dosage form as Drug Z. Knowing that Drug Y would save his patients money, Pharmacist Phil turns to the Orange book, which rates Drug Y as BC to Drug Z. How do you best describe the use of the Orange Book in this substitution decision? a) The BC rating means that the products are therapeutically equivalent b) The BC rating means Phil should not dispense the generic under any circumstances c) The BC rating means that the products are not therapeutically equivalent d) The BC rating should not be a factor in Phil's substitution decision
c) The BC rating means that the products are not therapeutically equivalent
A pharmacist may substitute a biosimilar to the prescribed biologic: a) Whenever the exercise of professional judgement warrants b) When the biosimilar is "highly similar" to the prescribed biologic c) When the Purple Book designates into the biosimilar with an "I" d) All of these are correct
c) When the purple book designates the biosimilar with an "I"
A pharmacist received a prescription for Zostate (fcf) with the direction to take t.i.d. (three times daily) for migraine headaches. Zostate is indicated only for anxiety and laveled for one-a-day use. Is it legal to use Zosat as prescribed? a) Yes, it is legal under FDCA and the pharmacist should dispense it b) Yes, it is legal under the FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, dispense the drug without further consideration c) Yes, it is legal under FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, exercise professional judgement regarding the reasonableness of the risk in deciding whether to dispense the prescription d) No, it's not legal to use Zostat in this manner and the pharmacist should not dispense it
c) Yes, it is legal under FDCA. However, the pharmacist should confirm the prescription accuracy with the prescriber and, if confirmed, exercise professional judgement regarding the reasonableness of the risk in deciding whether to dispense the prescription
When an FDA agent comes to inspect they do not need a warrant but must show...
credentials and notice of inspection.
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
Which of the following scenarios are considered adulteration? a) A pharmacist counting tablets on a tray where the residue of the previous drug counted remains on the tray b) An OTC drug does not have tamper-evident packaging c) Manufacturing facilities do not meet the current good manufacturing practice standard d) All of the above
d) All of the above
The Drug supply chain security Act: a) Preempts state pedigree laws b) Requires pharmacies to quarantine, investigate, and notify the FDA of suspect products c) Requires Pharmacies to receive a transaction history with the drug product d) All of these are correct
d) All of these are correct
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
Many states require _______ or ________ on pharmacy label.
expiration; BUD
Which of the following is not a requirement for labeling a non-prescription drug? a) Name of the drug with general pharmacological category b) The name and address of the manufacturer, packer, or distributor c) the net quantity of the contents d) adequate directions for use e) cautions and warnings f) adequate information for use g) A "Drug Facts" panel
f) Adequate information for use
Which of the following is not a federally required component that must be included on the label of a dispensed drug? Select all that apply a) The name and address of the dispenser b) Serial number and date of the prescription c) the name of the prescriber d) The name of the patient e) Directions for use and cautionary statements, if any f) The name of the drug, strength, and quantity dispensed g) Expiration date or beyond-use date of the drug
f) The name of the drug, strength, and quantity dispensed g) Expiration date of beyond-use date of the drug
Labeling
label assigned to person with accompanying information
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
Class III recall
not likely to cause adverse health consequences
Post-Marketing surveillance is ___ to report any serious reactions/side effects
required
Special Dietary Foods
supply a special dietary need and include infant formulas, artificial sweeteners and caloric supplements
Class II recall
temporary or medically reversible adverse health consequences
Drugs dispensed to institutionalized patients are exempt from the Poison Prevention Packaging Act if they are:
to be administered the drug by the institutions employees
Household substance is any substance customarily produced for or used in the household and is designated:
• A hazardous substance in the federal HSA • An economic poison under the federal Insecticide, Fungicide and Rodenticide Act • A food, drug, or cosmetic under the FDCA • A household fuel when stored in a portable container
What two systems must a dispenser have established in order to verify products and handle suspect/illegitimate products?
• Identify "suspect product" (reason to believe counterfeit or fraudulent, diverted or stolen; or adulterated or unfit for distribution and could lead to serious adverse health consequences). • Quarantine suspect products and investigate to determine if illegitimate; if yes notify FDA and immediate trading partners within 24 hours.
