Law Exam 1

Describe the Orange Book, therapeutic equivalence and code "AB"

"Approved Drug Products with Therapeutic Equivalence Evaluations" -2 letter coding system starting with A or B -A-therapeutically equivalent to other pharmaceutically equivalent products -B-NOT to be therapeutically equivalent to other pharmaceutically equivalent products Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which: -There are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or Actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.

Explain "res ipsa loquitur":

"the thing speaks for itself" *Attributes negligence to a party if all of the following conditions are established*: 1) The event causing the plaintiff's injury would not have occurred unless someone such as the defendant was negligent 2) There is a more-than-likely possibility that the defendant caused the injury to the plaintiff since the event was caused by an instrumentality in the exclusive control of the defendant 3) The plaintiff did not contribute to the event that caused his or her injury

Describe "negligence per se":

*Arises when a statute or regulation is violated* The violation of a statute is negligence in itself if it causes harm of the kind the statute was intended to avoid and to a person within the class of persons the statute was intended to protect

Describe the drug recall classifications and when to notify patients

*Class I*: Is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death Action: Recall stock from pharmacy and notification of patients *Class II*: Is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote Action: Recall stock from pharmacy *Class III*: Is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences Action: -May include the stock from the pharmacy Ex: a drug has typo in the package insert. It is now misbranded and insurance might not pay for it

Describe key HIPAA and state confidentiality requirements for a pharmacy

*Each pharmacy must take reasonable steps to limit the use of, disclosure of, and the requests for PHI*: -Implement Policies and Procedure -Individuals be informed of the privacy practices of the pharmacy -Post entire notice of privacy practices -Notice given to every individual -Good faith effort to obtain the patients written acknowledgement of the receipt of the notice -Pharmacies to select a compliance officer -Manage and ensure compliance with HIPAA -Receive complaints -Provide information on privacy policy -Workforce members must receive training -Includes employees, volunteers, trainees -Allow disclosure to have "business associate" agreement Data safeguards

Describe the required federal labeling for an OTC drug

*Format of labels for all OTC drugs must include*: -Active ingredient -Use(s) -Warnings -Inactive ingredients -Purpose -Directions -Other information -Questions (optional) *OTC label also has* -Expiration date -Name and address of manufacturer, packager or distributor -Net quantity of contents -What to do if overdose occurs -National Drug Code Bar Code is required

Know the following: IND, NDA, sNDA and ANDA

*IND* - investigational new drug *NDA* - new drug application *sNDA*- supplemental new drug application -To modify the FDA approved label -Seeking a new medication Example: new indication on an already existing drug (extends the patent) *ANDA* - abbreviated new drug application -Submit for generic drug approval

Describe the postal regulations for mailing prescription drugs and controlled substances

*Mailing RX Drugs* -Plain outer wrapper or package -RX drugs - must be a practitioner or dispenser mailing to the ultimate user *Mailing CS Drugs* -Can't mail if the drug is unlawful -Between licensees registered with DEA -RX for CS - only who dispenses the drug may mail it to patients under their care *Requirements for mailing prescription drugs* -The mailer or the addressee is registered with DEA. -The mailer or the addressee is exempt from DEA registration as permissible by law. -The inner container of any parcel containing controlled substances is marked and sealed as required by the provisions of the CSA and its implementing regulations, and is placed in a plain outer container or securely wrapped in plain paper. -If the controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription. -The outside wrapper or container is free of markings that would indicate the nature of the contents

Describe the membership and duties of the Board of Pharmacy (BOP).

*Membership* 6 pharmacists, 4 public members, one technician (11 total) Appointed for: 4 year terms, 2 terms + 1 partial *Duties* -Protection of the public - has the obligation to discipline licensees who have adversely affected the public's health, safety, and welfare -Regulate, control, and inspect the character and standard of pharmacy practice and of drugs and devices manufactured, distributed, prescribed, dispensed, administered, or issued in this state -Procure samples and limit or prevent the sale of drugs and devices that do not comply with the law -Grant a drug control license for the place of practice of a dispensing prescriber -Grant a license to a manufacturer or a wholesale distributor of prescription drugs

Explain vicarious liability (respondent superior)

*Organizations can be liable for harm caused by their employees or agents* -the employee who caused the negligent act was acting within the scope of practice required by the corporation -The corporation or business entity will generally have more money, or so called deeper pockets, than the single employee Respondent superior - denotes master-servant relationship *Ex: suing the pharmacy AND the pharmacist for pharmacist mistake*

Describe the differences between a prescription drug and over the counter drug

*Prescription drug* -Dispensed pursuant to a prescription -Bearing the federal legend, "CAUTION: federal law prohibits dispensing without prescription" or "RX Only" -Designated by the board as a drug that may only be dispensed pursuant toa a prescription *OTC drug* -"Adequate directions for use" - "directions under which the lay person can use a drug safely and the purpose for which it was intended" -Recognized as safe and effective -Manufactured under current good manufacturing standards

Know the difference between "strict liability" and "respondeat superior"

*Strict liability*: liable for a defective product *Respondeat superior*: employer liable for actions of employee

Fair Labor Standards Act of 1938 (FLSA)

*What* Establishes current minimum hourly wage and exemptions, overtime pay, recordkeeping, and child labor standards *Who* All employees except those who qualify for narrow definitions of professional, executive, or administrative positions

Genetic Information Nondiscrimination Act of 2008

*What* Makes it illegal to discriminate against employees or applicants because of genetic information. *Who* Employers with 15 or more employees must comply with this law

Civil Rights Act of 1964 (amended through 1991)

*What* Makes it illegal to discriminate against someone on the basis of race, color, religion, national origin, or sex. Also protects pregnant women/ those filling discrimination *Who* Employers that control how work is done or if employees' work is essential to the business. *Employers with 15 or more employees for 20 weeks in current or prior year must comply with this law*

Age Discrimination in Employment Act of 1967

*What* Protects individuals who are 40 years of age or older from employment discrimination based on age.* *Who* *Employees* aged 40 and older. *Employers* with 20 or more employees for 20 weeks during current or prior year must comply with this law. *A job notice or advertisement may specify an age limit only in the rare circumstances where age is shown to be a "bona fide occupational qualification" reasonably necessary to the normal operation of the business

Family and Medical Leave Act of 1993

*What* Provides an entitlement of up to 12 weeks of job-protected, unpaid leave during any 12-month period to eligible, covered employees for the following reasons: Birth and care of the eligible employee's child, or placement for adoption or foster care of a child with the employee. *Who* Workers employed for 25 hours per week or more for one year. Care of an immediate family member (spouse, child, parent) who has a serious health condition. or more employees within a 75-mile radius must comply with this law. It also requires that employee's group health benefits be maintained during the leave.

Americans with Disabilities Act of 1990

*What* Provides civil rights protections to individuals with disabilities that are like those provided to individuals on the basis of race, sex, national origin, and religion. *Who* Disabled individuals or individuals who are associated with a disabled individual (spouse or dependent). *Employers with 15 or more employees must comply with this law*

Equal Pay Act of 1963

*What* Requires that men and women in the same workplace be given equal pay* for equal work. *Who* Any employee who can prove wages for the same work differing by sex. Covers both males and females. *All forms of pay are covered by this law, including salary, overtime pay, bonuses, stock options, profit sharing and bonus plans, life insurance, vacation and holiday pay, cleaning or gasoline allowances, hotel accommodations, reimbursement for travel expenses, and benefits

Identify when you can use non child resistant packaging and who can request the non child resistant package

*When* -Dispensing to patients in nursing home/hospital -Dispensing to Assisted living -Drugs to be administered by institutional personnel -Samples -Starter Packs -Topical application -Dosage form not intended for oral administration -Bulk containers received by pharmacy -PPPA -Prohibits reuse of safety container -Unit dose packaging *Who* -Patient -Caregiver -Physician

Identify the drug product identification requirement

-21 CFR requires imprinting of solid oral dosage forms -Both RX and OTC -Imprint code with size, shape, and color must allow ID of product and manufacturer or distributor -Are dietary supplements imprinted? NO

Describe tips on how to identify a fake and legitimate online pharmacy

-Allow you to buy a medication w/o a script -Do not have a licensed U.S. PharmD to answer questions -Prices that are too-good-to-be-true -Spam emails -Located outside of US/Ship worldwide

Describe the basic elements of the Prescription Drug Marketing Act

-Ban the reimportation of federal legend drugs manufactured in the US except when reimported by the manufacturer, or emergency use -Prohibits with few exceptions the sale purchase or trade of legend drugs by hospitals or health care entities or supplied to charitable institutions -Requires states to license wholesalers -Ban the sale, purchase, or trade and counterfeiting of drug coupons -Ban the sale, purchase, or trade of drug samples -Required the practitioner to request samples in writing -Mandates storage, handling and recordkeeping requirements for drug samples

Describe the powers of the inspector/investigative agent of the Board:

-Execute and serve search warrants, arrest warrants, administrative inspection warrants, subpoenas, and summonses issued under the authority of this state -Seize property pursuant to this article -Perform other law enforcement duties the administrator or the department of commerce (LARA) designates -Inspectors are employed by the Department of LARA

Federal Rule Making Process

-Future rulemaking activities announced in Unified Agenda (regulations.gov) -Agencies gather information -President may request opportunity to review the rule -Proposed rule posted to Federal Register for public comment -Agency concludes proposed solution accomplishes goals or solves problems identified with proposed rule -President and OIRA analyze draft final rules -Final rule published in federal register

Describe the Administrative Inspection Warrant

-Is a court order -Inspector must have probable cause -Affidavit of one or more persons -Identify the pharmacy or location -Identify what is to be seized -Receipt for property taken

Describe the pharmacy long-term care requirements

-Medication kits -ADD: automated dispensing device -Locked: meds and med kits -No sharing -Stop orders: drugs have an automatic stop time -Consultant pharmacist -Labeling

Identify types of insurance to spread risk

-Property insurance for pharmacy -Liability insurance for pharmacy -Individual professional liability insurance Don't assume employer carries it for you -Key person insurance - (someone who knows a lot of information "secrets") -Umbrella or excess liability insurance - (if you bought a home you could get this - gives more liability coverage than a home insurance would; generally speaking they are not that expensive) -Worker's compensation insurance

Identify the reasons to regulate drugs

-Public Goods - no incentive in the public domain to bring the drug to market Ex: Orphan drugs and vaccines -Externality - drug affects someone who did not consent to the effect & costs are not fully incorporated into the price the consumer pays -Natural Monopoly - fixed cost are high compared to variable cost initially and the average cost declines over time -Drugs given a exclusive period of marketing before competition is allowed -Information asymmetry - consumer is uninformed about true value of drug -Government regulations promote the dissemination of drug information -Strict liability

State Rule Making Process

-Request for rulemaking -Draft rule -Public hearing and public comment -Post-hearing draft rule -Joint committee on administrative rules (must submit rules w/in 1yr of public hearing) -Department adopts rules

Describe the requirements for post market surveillance for new drugs

-Requires reporting of ADRs -Identify problems that were not observed or recognized before approval -Problems that may arise because a drug may not be used as describe in the drug labeling

Identify common drugs that are exempted from child resistant packaging

-SL nitroglycerin -SL and chewable isosorbide mononitrate in <10mg dosages -Methylprednisolone in tablet form in packages containing not more than 84mg of the drug -Prednisone in tablet form when dispensed in packages containing no more than 105mg of the drug

Explain how the NDC is used

-Serves as a universal product identifier for drugs -Required on all prescription and over the counter (OTC) drug labels -A unique - 3 segment number -Identifies the labeler, product, and trade package size -*Does not denote approval by the FDA of its marketed products* -Not a determination that a product is a drug as defined by the act -*Does not denote that it is a product is covered by or eligible for reimbursement by Medicare, Medicaid, or other payer* -Used for identification purposes and data processing -Using the NDC linear bar code can help reduce medication errors -Drug products are identified and reported using the NDC

Describe when a patient can import a drug and the limitations

-The drug is for use for a serious condition for which effective treatment is not available in the United States; -There is no commercialization or promotion of the drug to U.S. residents; -The drug is considered not to represent an unreasonable risk; -The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and -Generally, not more than a 3-month supply of the drug is imported Controlled Substances -Return with no more than 50 dosage units on person and declare it on entering US -Illegal to import

Describe single patient access (Compassionate Use) and Right to Try Act

-Use of investigational medical product outside of a clinical trial -Sometimes referred to as single patient investigational new drug -There may be cost involved -FDA grants expanded access for almost all of the applications it receives

Identify how often and when the "side effects statement" has to be given to a patient

-applies to new and refill prescriptions -does NOT apply to authorized dispensers dispensing or administering prescription drug products to inpatients in a hospital or health care facility under an order of a licensed practitioner, or as part of supervised home health care.

Describe how drug samples are handled in a pharmacy

-may only be distributed by a practitioner licensed to prescribe or to the pharmacy of hospital or health care entity at the written request of the prescriber -written request by physician to RPh practicing in a hospital pharmacy within a hospital licensed under article 17 -does not include a controlled substance

Describe the three activities that are violations of the FD&C Act

1) Adulteration 2) Misbranding 3) Placing into interstate commerce an unapproved drug

Describe the four elements of negligence:

1) Duty 2) Breach of Duty 3) Harm 4) Causation of harm

Describe three conditions where the inspector may seize drugs from a pharmacy without a warrant

1) If the owner, operator, or agent in charge of the controlled premises consents. 2) In situations presenting imminent danger to health or safety. Ex: misbranded drugs, samples, etc. 3) In any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking. In any other situation in which a warrant is not constitutionally required

Describe the two types of sexual harassment and whether pharmacies must have policies for sexual harassment

1) Quid Pro Quo Harassment (Casting Couch) 2) Hostile Work Environment Harassment (Unwelcomed, deplorable, despicable advances)

Describe the four key elements of a contract

1) The agreement must be between two or more parties 2)The parties must both be competent to consent to such an agreement 3)The agreement must be for something of value 4)The agreement must be lawful

List three tests applicable to law created by administrative agencies:

1) Within the scope of the agencies authority 2) Regulation must be based on a statute 3) Have a reasonable relationship to the public health and safety

Describe details of the Patient Package Insert (PPI)

1970-Oral contraceptives Same year the DEA came into existence 1977-Estrogenic Drug products, IUDs and progestational drugs if used as a oral contraceptive Contains information for patients on how to safely use a drug product It is part of the FDA-approved labeling Contains information concerning the drug's benefits and risks *Shall be dispensed to patients Community or outpatient with every dispensing* *Institutional given before first administration and every 30 days* Physician cannot opt out patient *If Patient Package Insert not given to patient it is misbranded*

Describe the structure and purpose of the BOP disciplinary subcommittee

3 pharmacists + 2 public members Pharmacist cannot be chair of the board Chair of the board appoints the committee chair (one of the public members) At least 1 public member for an affirmative vote to impose sanction

Describe a generic drug and how to identify generic equivalent, how it is applied

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use

Describe what is a medication error

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer

Identify how "own use" is described in the Abbott Labs et al court case

Abbot Labs et al v. Portland Retail Druggists Association 1976 This case decided 'Own Use" doctrine defined it as drugs used: -For inpatient for use in hospital -For patients treated in hospital ER -For personal outpatient on hospital premises -For outpatients for personal use off the premises -For employees or student and dependents for personal use -For staff physician and dependents for personal use Court Case Did Not Allow -Refills for the discharged patients -Fill of a walk in patient RX with no connection -Physician office use

how to give side effects statement?

An authorized dispenser or pharmacy must choose one or more of the following options to distribute the side effects statement: (1) Distribute the side effects statement on a sticker attached to the unit package, vial, or container of the drug product; (2) Distribute the side effects statement on a preprinted pharmacy prescription vial cap; (3) Distribute the side effects statement on a separate sheet of paper; (4) Distribute the side effects statement in consumer medication information; or (5) Distribute the appropriate FDA-approved Medication Guide that contains the side effects statement.

Define an emergency rule, why it is made and how long it is valid:

An emergency rule is made when -an agency finds that preservation of the public health, safety, or welfare requires promulgation of an emergency rule and the agency states in the rule their reasons for that finding -the governor concurs in the finding of emergency *Valid until*: -an identical or similar rule is promulgated. -an identical or similar bill is enacted into law. -the administrator determines that the emergency rule is no longer necessary. -*Six months after the date of its filing** *which may be extended for not more than 6 months by the administrator upon filing a certificate of extension with the office of secretary of state before the expiration of 6 months after the date of its filing *TLDR: 6 months with a 12mon total if extended*

Where do you find Board of Pharmacy rules undergoing a change?

Annual supplement to the MI administrative code -published in MI register pursuant to section 8

Describe a hazardous drug and what categories of drugs are hazardous

Any drug identified by at least one of the following six criteria: -Carcinogenicity -Teratogenicity or developmental toxicity -Reproductive toxicity in humans -Organ toxicity at low doses in humans or animals -Genotoxicity -New drugs that mimic existing hazardous drugs in structure or toxicity [for examples see current National Institute for Occupational Safety and Health

What makes a drug a drug?

Articles intended for use in the diagnosis, cure, mitigation, treatment of prevention of disease in man or other animals Articles (other than food) intended to affect the structure or any function of the body of man or other animals

1988: Prescription Drug Marketing Act

Bans diversion of prescription drugs from legitimate commercial channels to prevent the sale of mislabeled, adulterated, subpotent, and counterfeit drugs to the public -requires drug wholesalers to be licensed by states -restricts importation from other countries -bans sale, trade, or purchase of drug samples -bans trafficking or counterfeiting of redeemable drug coupons

Define ethical behavior

Behavior that conforms to generally accepted social norms

Describe the BUD for non sterile compounded drugs

Beyond-Use Date (BUD) (see General Notices and Requirements and Pharmaceutical Compounding—Nonsterile Preparations <795>)—For the purpose of this chapter, the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded.

2009: Biologics Price Competition and Innovation Act

Biosimilar products are interchangeable with FDA approved biological product

Identify the state and federal agencies that have authority over pharmacy and drugs and what these agencies are enforcing:

Board of Pharmacy DEA - Drug Enforcement Agency US Department of Health and Human Services -FDA -Office for Civil Rights (HIPAA) -CMS (Medicaid/Medicare) -Consumer Product Safety Commission (childproof caps)

Identify the seven Federal employment laws and generally what employees are covered:

Buckle up

Describe the regulations that impact competition in pharmacy

Buckle up 3: Too fast, too buckley

Describe the major regulations regarding drugs in the US and their impact on pharmacy.

Buckle up, part 2: the buckling

Describe the legal requirements for DAW and how to apply.

Cannot dispense a generic if DAW -Prescriber writes in own handwriting "DAW" "dispense as written" "d.a.w." -If RX has statement prescriber still needs to in own handwriting put "d.a.w." -Verbal RX prescriber expressly indicates the RX is to be dispensed as communicated -The electronic form utilized in the transmission of a prescription shall not include "dispense as written" or "d.a.w." as the default setting.

What is tort law? List an example:

Civil wrong Wrongful acts committed against another person without a pre-existing contract, for which courts seek to determine and apply remedies Med dispensing error

Identify actions that would violate anti-trust laws

Collectively refuse to accept or participate in a third party plan Conspire to refrain from dealing with third party plan(s) Concentrated effort to not deal

Describe repackaging and assignment of Beyond Use Date (BUD) for repackaged products

Community: -Drugs without an in-use time in label -Meet other requirements of the law -Non Aqueous formulations: BUD 6 months or less if expires earlier -Aqueous oral formulation: BUD 14 days or less if expires earlier -Aqueous topical/dermal and mucosal liquids and semisolid formulations: BUD 30 days or less if expires earlier Nonsterile: *USP-795* BUD per guidance Sterile: *USP-797* BUD per guidance If repackaging to other chains/places (licensees), must be a registered repackager with the FDA If using in-house, do not have to be registered repackager with the FDA Multidose vials: -USP-797 -must be labeled as multi-dose vial -put date on it after opening: 28 days UNLESS manufacturer has data to support longer dating

Define adulteration:

Composition issues; drug's strength, quality, purity, etc -Dropping a tablet on the ground (contaminated drug) -A product with an unapproved color additive -Dilution

Define requirements for traditional pharmacy compounding

Compounding by licensed pharmacist in state licensed pharmacy (federal (f), state (s)) Pharmacies are exempt from the 3 sections of the FD&C Act if meet conditions in Act. -Compliance with cGMP -Labeling of drugs with adequate directions, as required of manufacturers -Approval under NDAs or ANDAs Compound per prescription for specific patient (f, s) Limited quantities before receipt of prescription based on history (f, s) -Compounded in compliance with USP chapters on pharmacy compounding (f) Compounding sterile pharmaceuticals-to be accredited or show compliance with USP standards by September 30, 2016(s) Drug substances used in compounding-use bulk drug substances with USP/NF monograph or a component of a FDA approved drug until final rules (f) Cannot compound using bulk drug substances: (f) -Withdrawn or removed from market for safety or not effective -On "demonstrably difficult" list Cannot compound regularly or inordinate amounts "copies" of commercially available products (f) Adds extensive record keeping for sterile products (exempts distribution within hospital) (s) Shall not offer excess compounded pharmaceuticals to other pharmacies for resale (f, s) Shall not distribute samples of compounded pharmaceutical to a health professional (s) May advertise or promote the fact that they provide compounding services (f, s) Cannot compound and manufacture drug products at same location (s) Department may promulgate rules (f, s) If provides compounding services must be licensed as pharmacy or manufacturer (s) If ships more than 5% across state lines, the state located in has signed a memorandum of understanding (MOU) with FDA State Boards to continue oversight and regulation State Boards to report to FDA compounding and other violations

Identify sources of law:

Constitution Legislature Administrative agencies Courts Notice and comment (public hearing) rulemaking

1970: Comprehensive Drug Abuse Prevention and Control Act

DEA comes into existence Replaced previous laws regarding abused drugs and categorizes drugs based on abuse and addiction potential compared to their therapeutic value: CI-CV

1951: Durham-Humphrey Amendment

Defined the kinds of drugs that cannot be used safely without medical supervision and restricted sale to prescription by licensed practitioner *Differentiated legend drugs from OTC*

Describe what is a FDA guidance document

Describes the agency's current thinking on a regulatory issue -guidance is not legally binding on the public or FDA, but it is wise to comply

2002: Public Health Security and Bioterrorism Preparedness and Response Act

Designed to improve the country's ability to prevent and respond to public health emergencies; provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced things that it regulates

Describe employer responsibilities for hazardous drugs

Develop a hazard communication program Identify all drugs considered hazardous in the workplace - ongoing process Post a list of hazardous drugs Include proper handling of drug and disposal -Using dedicated equipment for handling -Separate counting trays (powder residue) -Wearing gloves -Cleaning the equipment

Identify what is meant by DAW

Dispense as Written (no generics)

Describe the types of pharmacy errors

Dispensing -Mechanical errors most likely to cause physical Harm -Wrong drug -Wrong strength -Wrong directions Intellectual errors -Counseling -Drug review Personal injury -Libel -Slander -Release of confidential information (HIPAA) -False arrest -Malicious prosecution Prescribing -Drug review -Duty to warn -No Argument -Fill RXs correctly -Furnishes the requested or required information -Not obliged to intervene in physician's prescription decisions "learned intermediary doctrine" Administration -Dispense correctly but lack of communication or max dose not communicated -Monitoring patient drug use -Controlled substances -Personal non-bodily injury -Release of confidential inform

Describe what is drug product selection and substitution, and Michigan's use of Orange Book

Drug product selection -Pharmacist MAR or purchaser requests -Dispense a lower cost drug -Label-brand prescribed-drug dispensed -Pass on cost savings -Difference between the wholesale cost of the two drug products -Total charge can't exceed the charge for the original drug prescribed Michigan does NOT use the Orange Book (we dumb)

1983: Orphan Drug Act

Enabled FDA to promote research and marketing of drugs needed for treating rare diseases

Kefauver-Harris Drug Amendments

Ensured drug efficacy

1984: Drug Price Competition and Patent Term Restoration Act

Established ANDA process for making generic drugs available

2010: Patient Protection and Affordable Care Act

Established Health Insurance Marketplace Increased access to Medicaid Made care more affordable Eliminated annual limits on prescription coverage

1994: Dietary Supplement Health and Education Act (DSHEA)

Established specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements Defines "dietary supplements" and "dietary ingredients" as food, and provides categories of dietary supplements (vitamins, minerals, etc.)

Nonprofit Institutions Act 1938

Exempts non-profits and charitable institutions if purchase for their 'own use'

Identify the agencies to report drug medication problems or issues

FDA MedWatch -Report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of FDA-regulated Institute for Safe Medication Practices (ISMP) -Report to ISMP-MERP -Errors -Near-errors -Hazardous conditions Institute for Patient Medication Safety and Pharmacist Peer Review - Michigan Patient Safety Organizations (PSO) -PSO is a designation created by the Federal Patient Safety and Quality Improvement Act of 2005 to encourage clinicians and healthcare organizations to identify, analyze, and reduce the risks and hazards associated with patient care, including errors associated with the administration and use of medications

Describe a veterinary drug and how it applies to a pharmacist

FDA determines marketing status RX or OTC Caution: Federal law restricts this drug to use by on or the order of a licensed veterinarian Distributed only by persons authorized by the state "Adequate directions for use" also used for these products "Green Book" FDA Approved Animal Drug Pharmacist can dispense drugs prescribed by a veterinarian Animal drugs recognized in Public Health Code

Identify what off label use of drug is and how that applies to a pharmacist

FDA position: experimental use of an approved drug does not violate federal law Pharmacist May legally dispense an approved drug for an unapproved use -Never dispense if obviously fatal -Contact prescriber -Justification for off label use such as articles in legitimate sources -Dose or administration is unusual (references to support) -Pharmacist has to decide on whether to dispense or not based on information -Counsel patient on benefits and risks -Document

Describe requirements for outsourcing facilities

FDA registration "voluntary" (FDA may require registration as manufacturer) Comply with current good manufacturing practices (CGMP) Comply with all FDA requirements (f, s) Must be licensed as a pharmacy in Michigan (Michigan has no separate license category for outsourcing facility) Not required to be licensed as a pharmacy by the FDA Compound drugs not commercially available (s) Can't compound copies of drugs unless they are on shortage list (f) Compound without a prescription apply to the Department (s) May compound sterile products (f) Report adverse events regarding compounded products (f, s within 10 days) Provide FDA with certain information about the products they compound (f) Will be inspected by FDA according to a risk-based schedule Labeling requirements and to have statement " This is a compounded drug." (f) Ships across state lines By or under direct supervision of a licensed pharmacist in registered facility (f) Report information about products it compounds during the previous 6 months (f)

FDA requires patient package insert for oral contraceptives

FDA requires patient package insert for oral contraceptives

Describe fiduciary duty as it applies to the pharmacist

Fiduciary duty means that people or organizations have an obligation to those who have placed their trust in them Ex: Patients

Define a rule and have an understanding of the rule making process and when public comments may be made to a rule

First will be federal followed by state

Describe how the USP-NF is used as a reference

Food Drug and Cosmetic Act recognizes the USP-NF as the "official compendium" So does Michigan Public Health Code

*All pharmacy practice settings must have a clear sexual harassment policy*

Good.

Who appoints the Board of Pharmacy members?

Governor

Describe tax-free alcohol use at a community and hospital pharmacy

Hospital can use it if appropriate license acquired Community pharmacies cannot legally obtain tax free alcohol usually use tax paid 190 proof grain alcohol -Kept in a secure fire resistant room -Perpetual inventory must be maintained -Only practical if using huge volumes

List required components of a label:

Identify name and place of manufacturer, packer, or distributor Name of the drug Contain "adequate directions for use" Labeling is false or misleading Quantity of contents Drug liable to deterioration, unless packaged as required

Describe the difference between traditional pharmacy compounding, outsourcing facility and manufacturing

In contrast to "traditional" compounders, outsourcing facilities can, subject to satisfying relevant legal requirements, compound and distribute drugs without receiving prescriptions for individually identified patients, and without limitation on the quantity of drugs that they ship interstate

Identify violations of the fraud waste and abuse provisions of Medicare Part D as it relates to pharmacy

Inappropriate billing practices: Inappropriate billing practices at the pharmacy level occur when pharmacies engage in the following types of billing practices: Incorrectly billing for secondary payers to receive increased reimbursement. Billing for non-existent prescriptions. Billing multiple payers for the same prescriptions, except as required for coordination of benefit transactions. Billing for brand when generics are dispensed. Billing for non-covered prescriptions as covered items. Billing for prescriptions that are never picked up (i.e., not reversing claims that are processed when prescriptions are filled but never picked up). Billing based on "gang visits," e.g., a pharmacist visits a nursing home and bills for numerous pharmaceutical prescriptions without furnishing any specific service to individual patients. Inappropriate use of dispense as written ("DAW") codes. Prescription splitting to receive additional dispensing fees. Drug diversion. Prescription drug shorting: Pharmacist provides less than the prescribed quantity and intentionally does not inform the patient or make arrangements to provide the balance but bills for the fully-prescribed amount. Bait and switch pricing: Bait and switch pricing occurs when a beneficiary is led to believe that a drug will cost one price, but at the point of sale the beneficiary is charged a higher amount. Prescription forging or altering: Where existing prescriptions are altered, by an individual without the prescriber's permission to increase quantity or number of refills. Dispensing expired or adulterated prescription drugs: Pharmacies dispense drugs that are expired, or have not been stored or handled in accordance with manufacturer and FDA requirements. Prescription refill errors: A pharmacist provides the incorrect number of refills prescribed by the provider. Illegal remuneration schemes: Pharmacy is offered, or paid, or solicits, or receives unlawful remuneration to induce or reward the pharmacy to switch patients to different drugs, influence prescribers to prescribe different drugs, or steer patients to plans. TrOOP manipulation: When a pharmacy manipulates TrOOP to either push a beneficiary through the coverage gap, so the beneficiary can reach catastrophic coverage before they are eligible, or manipulates TrOOP to keep a beneficiary in the coverage gap so that catastrophic coverage is never realized. Failure to offer negotiated prices: Occurs when a pharmacy does not offer a beneficiary the negotiated price of a Part D drug.

1982: Tamper-resistant Packaging Regulations

Issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules

Describe a medical device safety alert

Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls

Describe products regulated by the FDA

LONG LIST: -Medical devices -Cosmetics -Drugs RX and OTC -Food additives -Bottled water -Blood products and other biologics -Transplanted tissues -Vaccines -Dietary Supplements -Infant formulas -Veterinary products -Tobacco products -Fluoride toothpaste -Antiperspirants -Dandruff shampoos -Sunscreens

Define misbranding:

Labeling or labeling representation issues *Examples*: -Reselling drugs from other countries -Nitro sublingual in not original pack (failure to comply with packaging requirements) -Dispense without rx -Dispense without authorized refill -Imitation of another drug (disp. generic as brand name only) -Dispensing without med guide -Dispensing without the patient packet insert

Compare the differences between legal and ethical:

Legal: Criminal sanction if deviate, professional responsibility Ethical: Standards defined by professional bodies See table 15-1 for complete listing

Describe the components of the package insert (PI)

Mandated by the FDA *Intended for health professionals (NOT PATIENTS)* Contains the essential information for safe and effective use of the drug *PI must contain certain headings* -Modified in 2000-Comprehensive Information Section Highlights of Prescribing Information at the beginning followed by the Full Prescribing Information -Highlights section summarizes the most important information -Black box warning if there is one, at the beginning -PI Black Box Warning-mandated by the FDA when use of drug may lead to death or serious injury -If there is a risk evaluation and mitigation strategies (REMS) for the drug it will appear as part of the labeling -Nothing prevents RPH giving the PI to the patient

Describe what "Learned Intermediary Doctrine" means

Manufacturer has the legal duty to warn prescribers of drug side effects and adverse reaction that it knows or should know. Courts have generally held that the prescriber is in the best position to decide which warnings to communicate to the patient. Manufacturer's duty to warn is fulfilled by providing the information to the prescriber who is the "learned intermediary"

Identify hospital conditions of participation for Medicare as it relates to pharmacy

Medicare conditions for participation for hospitals Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles. A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

2007: FDA Amendments Act

More authority to FDA on drug marketing Clinical trials more visible to public Establishes REMS program

Know classes of drugs that require a medication guide

NSAIDs PPIs Antidepressants Bisphosphonates Atypical antipsychotics ADHD drugs

Elaborate on the Consumer Medication Information

Not mandated by the FDA It is printed consumer medication information provided to patients at the time a new prescription is filled Is not a PPI or Medication Guide Usually given only at the time of first dispensing Usefulness is in question *This is trash*

Identify strategies for identifying suspect drug products

Notify FDA and immediate trading partners (wholesaler) Maintain Track and Trace records: 6 years Records of drug movement between manufacturers, wholesalers, and pharmacies

Describe a Market Withdrawal

Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal

Describe poison prevention packaging and list common medications that have do not to be packaged.

Poison prevention packaging act is enforced by the Consumer Product Safety Commission *Medications* -Sublingual dosage forms of nitroglycerin, -Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 milligrams or less. -Medroxyprogesterone acetate tablets -Prednisone in tablet form when dispensed in packages containing no more than 105 milligrams of the drug There are more meds: these were common

Describe the drug approval process for new drugs

Preclinical: animal testing Phase 1: safety in healthy volunteers Phase 2: efficacy in small group of patients with disease Phase 3: efficacy in large group of patients with disease

Sherman Antitrust Act 1890

Prevent conspiracy in restraint of trade Prohibits monopolies

Describe OBRA 90 counseling mandates and the Michigan counseling requirements

Primarily covers *Medicaid* patients Must discuss items in RPH judgment is significant -Techniques for self-monitoring drug therapy and actions required -Proper storage -Prescription refill information -Action to be taken in the event of a missed dose Reasonable effort to obtain, record and maintain records -Name, address, telephone number, date of birth, (or age) and gender -RPh comments relevant to the client's drug therapy -Patient history when significant, disease states, known allergies and drug reactions -Comprehensive list of medications and relevant devices

Describe the Drug Supply Chain Security Act requirements for pharmacies

Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically. Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market. Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages. Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous. Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found. Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database. Third-party logistics provider licensing: Third-party logistics providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license

Describe a dietary supplement

Product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet Vitamins, herbs, minerals

Robinson-Patman Act 1936

Prohibits a seller of commodities from selling comparable goods to different buyers at different prices, except in certain circumstances

Clayton Antitrust Act 1914

Prohibits fixing prices with other businesses Prohibits agreements to control the supply

1906: Food and Drugs Act

Prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs.

Describe responsibilities of the Food and Drug Administration (FDA).

Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective

Describe the purpose of the Freedom of Information Act:

Provide for public access to certain public records of public bodies Allow for public to lookup license of pharmacist

Define law:

Publicly enforced standards and rules that are created by courts, legislatures, executive orders, and administrative agencies Govern the relationship between private individuals and organizations and between both of these parties and the government

Describe what is meant by checking "exclusion lists" and why it is important to check the lists

Reasons to be excluded or on the list (not inclusive) -Felony conviction relating to health care fraud -Conviction relating to Medicare or Medicaid fraud -Felony convictions for other health care-related fraud, theft, or other financial misconduct -Felony convictions relating to unlawful manufacture, distribution, prescription, or dispensing of controlled substances. -Conviction relating to patient abuse -Felony or misdemeanor conviction relating to controlled substances -Conviction relating to fraud -License revocation or suspension -Defaulting on student health loan or scholarship obligations *If someone you employ/employed is on the list you risk a fine and recoupment of all monies the excluded employee was involved in handling (all prescription charges they should have been excluded from* Under Medicare Part D -Must do excluded party reviews -Check exclusion list of Office of Inspector General (OIG) -Check employees, new hires, volunteers, governing body members, consultants, others against exclusion lists on starting -Check on regular basis OIG suggestion is monthly because it updates list monthly

2012: FDA Safety and Innovation Act

Reauthorized PDUFA Reducing drug counterfeiting Detecting and reducing drug shortages Inspection of foreign drug manufacturers

Identify Medicare part D prescription record keeping requirements

Record keeping is 10 years for prescriptions Original format for period required by state law then can be transferred to electronic format Printed notice to patient when drug not covered starting 5-1-12 Conditions of participation -Hospitals similar to state requirements -CMS contracts with states to enforce -Community determined by third party contract has to meet Medicare part D reqs

Describe administrative law:

Regulates the operation and procedures of government agencies Board of Pharmacy; they can't send you to jail, but you will lose your license if you're convicted of a felony *Agency vs private party*

List components of the medication guide

Required by FDA on certain drug products *Part of the approved FDA labeling* *FDA requires a Medication Guide be provided* -When the patient or the patient's agent requests a Medication Guide. -When a drug is dispensed in an outpatient setting (e.g., retail pharmacy, hospital ambulatory care pharmacy) and the product will then be used by the patient without direct supervision by a healthcare professional. -The first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting, such as in a clinic or dialysis or infusion center. -When a drug is subject to a REMS that includes specific requirements for reviewing or providing a Medication Guide as part of an element to assure safe use (possibly in conjunction with distribution), the Medication Guide must be provided in accordance with the terms of the REMS, as when healthcare providers are required to review the Medication Guide with patients before patients are enrolled in a REMS program. -*Required with every dispensing* . *Community* -Must be given with each dispensing *Institutional* -Unnecessary if professional available to answer questions -Physician can request patient not get but patient can override

Describe REMS and understand the consequences of REMS

Required by Food and Drug Administration Amendments Act A required risk management plan that uses tools beyond routine labeling to ensure safe drug use Applies to approved prescription drugs, includes biologics and generics Does not apply to OTC products

1938: Federal Food, Drug, and Cosmetic (FDC) Act

Required new drugs to be shown safe before marketing; authorized factory inspections

1992: Prescription Drug User Fee Act (PDUFA)

Requires drug and biologic manufacturers to pay fees for product applications, supplements, and other services

1914: Harrison Narcotic Act

Requires prescriptions for products exceeding allowable limit of narcotics and mandates increased record-keeping for pharmacists who dispense narcotics

Describe "statute of limitations"

Sets a prescribed length of time for the plaintiff to file charges against the defendant Each state has its own period of time. It is generally 2-3 years.

Describe the generic drug approval process.

Submit ANDA → FDA reviews → approval/denial (simplified)

Explain the Purple Book

The "Purple Book" lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act

Describe a safety data sheet and how it relates to handling of hazardous drugs

The Hazard Communication Standard (HCS) requires chemical manufacturers, distributors, or importers to provide Safety Data Sheets (SDSs) (formerly known as Material Safety Data Sheets or MSDSs) to communicate the hazards of hazardous chemical products. The HCS requires new SDSs to be in a uniform format, and include the section numbers, the headings, and associated information under the headings Pharmacies - Provide access to SDSs for hazardous drugs that it distributes -Provide a warning on the label of hazardous drugs that it distributes, indicating that special handling precautions are necessary

Describe biologics and biosimilars and how biosimilars differ from generic drugs

The term "biosimilar" or "biosimilarity", in reference to a biological product that is the subject of an application under subsection (k), means- - that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and -there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. The term "interchangeable" or "interchangeability", in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product

2013: Drug Quality and Security Act

Title I pharmacy compounding and outsourcing facilities Title II Track and trace system of prescription drugs Enacted d/t New England Compounding Center disaster

Describe what is the "side effects statement"

Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Verbatim: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." Must be included with both new and refilled prescriptions when dispensed Specific letter height or type size to be used depending on the option chosen Does not apply to inpatients in hospital, health care facility or supervised home health care

List the three T's of Track and Trace

Transaction Info Transactions History Transaction Statement

Describe unit dose, and unit of use

Unit dose - A method of packaging a drug product into a non re-usable container designed to hold a quantity of drug intended for administration as a single dose directly from that container Unit of use - A method of packaging *drug product* into a single container which contains more than one dosage unit, usually sufficient quantity of medication for one normal course of therapy.

Describe ways to reduce risk in pharmacy practice

Verbal orders - write it down if not written it didn't happen -Right patient-Birth date -Expression of units -Decimals -Sound alike drugs -Drug names that look the same -Purpose of the medication Abbreviations -Any abbreviation for the word daily -Unit not U -Every other day not q.o.d. -Mcg -Subcutaneous or Sub-Q not S.Q. or S.C. -Cubic centimeter -Discontinue or discharge -A.S., A.D., A.U., O.S., O.D., O.U. write in full Units/Decimals -Use metric system -USP/NF does not recognize the apothecary system -No trailing zeros -No naked decimal points -500mg instead of 0.5g or 125mcg instead of 0.125mg Drug Names -Sound the same and or Look the same Consistency Environmental Issues -Lights -Interruptions -Distractions -Noise -Workload

Do the "MedWatchLearn-Teaching students, health professionals and consumers how to report problems to FDA"

Why not? I've got plenty of time.

Describe civil law:

Wrongs against a particular person or organization; relationship among individuals within society *private party vs private party* -Contract law -Tort law

Describe criminal law: List an example:

Wrongs against society as a whole, even if only a particular individual is harmed *Govt vs private party* Ex: Fraud

Define what is a generic drug

a generic medicine works in the same way and provides the same clinical benefit as its brand-name version -medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence

1973: Consumer Product Safety Commission

a governmental agency responsible for setting and monitoring safety standards for all consumer products

Explain cGMP and "deemed adulteration"

cGMP: current Good Manufacturing Practices Deemed adulteration if you do not follow cGMP Comply with cGMP if: Engaged in repackaging and relabeling beyond usual conduct of dispensing

t/f federal rules always supersede state rules

false

t/f rules can override a law or statute

false

Describe tamper-evident packaging

tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred