PHAR 728 Flashcards
Who grants power to the board of pharmacy? Who approves board members and who does this board report to?
State legislature
Governor
Executive branch (governor)
Two divisions of law regulating pharmacy in Oregon
Statutes and Rules
Describe ORS
Oregon Revised Statutes
Enacted and altered by legislature vote, board of pharmacy implements and regulated CH 475 (controlled substances, illegal drug cleanup, paraphernalia and precursors) and CH 689 (pharmacists, drug outlets and sales)
Describe OAR
Oregon Administrative Rules
Written and adopted by board of pharmacy, must be allowed by statute, usually more specific to an area of practice, rules found under Ch 855 which is subdivided into 23 divisions
Procedures for rule making in Oregon
Notice, Hearing, Filing and Publication
Breakdown OAR 855-019-0400 (what do the different numbers mean)
855 - indicates BOP rule
019 - division
0400 - division subsection
Provide an example of Vicarious Liability
Pharmacist is responsible for technicians actions (or the pharmacy for the employees actions).
In other words, responsibility of the superior for the act of the subordinate
Describe the federal court system
Independent regulatory agencies and 94 district courts that fall under 12 courts of appeal. 94 district courts and specialized US claims courts fall under court of appeals for the federal circuit. There are also legislative courts, military appeal courts etc. These all fall under supreme court.
Medicare was established in _____________
1965 - part of the SS act of 1935
Medicare Part D excludes coverage for
Weight loss or gain drugs, fertility drugs, ED drugs, cosmetic or hair growth products, cough and cold drugs, vitamins and minerals (with the exceptions of prenatal vitamins and fluoride)
When did Medicare/Medicaid begin requiring tamper proof prescription pads?
2008
Has had little to no impact
Describe Federal Antitrust Laws
Prescription drug market is hyper-competitive, so the goal is to promote competition. Composed of 2 primary laws: Sherman-Antitrust Act, Robinson-Patman Act
Describe the Sherman Antitrust Act
Passed in 1890 and applies to all competitive markets, prohibiting competitors from entering into agreements that inhibit competition. Helps to keep markets competitive and prices low.
Describe Robinson-Patman Act
Prevents discriminatory pricing to like competitors, allows volume discounts (so large purchasers usually get lower prices) and keeps hospitals and HMOs from competing with retail pharmacies for discounted drug prices
Define Malpractice
Negligence occurring in the practice of professionals (standards of care violation). Examples of malpractice include incorrect drug or quality of drug dispensed, quantity or dose errors as well as inadequate counseling.
What are the 4 elements of negligence?
Duty owed (to counsel, dispense accurately, etc.)
Breach of duty
Causation
Damages
All four elements must be proven to find legal liability
Define Negligence per se
Harm resulting from the violation of a statute or rule (such as failure to provide counseling)
What are “punitive” damages?
Excess compensation with the goal of punishing the defendant
Describe comparative negligence
When the plaintiff could have avoided the consequences of the defendants actions, but didn’t, therefore there is a shared contribution
What does the Oregon Statute of Limitations say about when a malpractice claim must be filed?
Within two years of the date of the discovered injury, and in no case more than 5 years from the date of the negligent
Describe Tort
A civil wrong that unfairly causes someone else to suffer loss or harm resulting in legal liability for the person who commits the act
Four elements required for a legal contract
Mutual agreement, legally competent parties, consideration of anything of value promised to another in contract, and lawful purpose or object
Which agency is responsible for Controlled Substances Act? Food Drug and Cosmetic Act? Poison Prevention Packaging Act?
DEA, FDA, Consumer Product Safety Commission
Where can Federal Laws be found?
Federal register (published daily and online)
Code of Federal Regulations (CFR) - updated more slowly than federal register
Two primary regulatory agencies that regulate drug laws
FDA (food with exception of meat poultry and egg products, drugs, biologicals, medical devices, blood, cosmetics, and medical/consumer products that emit radiation) represents 25% of US economy
DEA - concerned with illegal drug use
Laws apply to all U.S. states
Describe Pure Food and Drug Act
1906 - inspired by unsafe/ineffective remedies; opposition was finally overcome by Upton Sinclair’s “The Jungle.’
Act protects public from adulterated and misbranded food and drugs (Uniform throughout US)
Describe Food Drug and Cosmetic Act
1938 - Current main US drug law established by FDA to regulate safety but not efficacy, some quality regulations (drugs can’t be marketed until proven safe) and all drugs must be labeled with directions for use
Describe Durham-Humphrey Amendment
1951 - established category of RxOnly or “legend” drugs as well as OTCs based on whether or not the public could use them safely with adequate directions for use
Describe Kefauver-Harros Amendment
1962 - required proof and safety of efficacy, established good manufacturing practices (GMP) and strengthened both clinical trial safeguards and adverse reaction reporting
Describe Orphan Drug Act
1983 - an orphan drug is one that has little or no commercial value, such that drug development costs exceed any possible return on investment
Provides tax and licensing incentives to develop such drugs
Describe Drug Price Competition and Patent-Term Restoration Act
1984 - also called Waxman-Hatch Amendment, streamlined generic drug approval process to make them more readily available
What is the FDA “Orange Book?”
Lists drugs that are bioequivalent
Describe Prescription Drug User Fee Act (PDUFA)
1992 - requires drug and biologics manufacturers to pay fees for product applications; FDA uses this money to hire more application reviewers to speed up process
Describe Dietary Supplement Health and Education Act
1994 - established labeling requirements, authorized FDA to establish GMP for supplements, defines dietary supplements and ingredients as food.
Manufacturer must prove product is safe before marketing, FDA approval not required, prohibits disease prevention claims and regulates allowable claims (such as mechanism of action)
Describe Food Drug and Modernization Act
1997 - reauthorizes the prescription drug user fee act of 1992
Includes measures to accelerate review of devices, regulate advertising of unapproved uses of approved devices, and regulate health claims for foods
Describe FDA Amendments Act (FDAAA)
2007 - PDUFA expanded to provide application fee, outlines best pharmaceuticals for children, and the pediatric research equity act
Describe Drug Quality and Security Act
2013 - regulates compounding and drug supply chain, large compounding pharmacies may register with FDA as outsourcing facilities, traditional compounding pharmacies remain under State Boards of Pharmacy, Drug Supply Chain Security Act (DSCSA) requiring records for all Rx sales
Describe Phases of Human Clinical Drug Trials
Phase 1: 20-100 patients, several months, monitoring for safety and kinetics
Phase 2: 100-500 patients, months to 2 years, dose-response for safety and efficacy
Phase 3: 500-5000 patients, 1-4 years, monitor for safety and dosage efficacy
Pharmacies are not subject to GMP unless ____________________________________
They are manufacturing products for resale to other pharmacies, physicians or retail outlets
Define an “adulterated” drug
A drug is adulterated unless it is manufactured in accordance with GMP; drug that consists in whole or in part of any filthy, putrid or decomposed substance; if it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated; if the strength differs, or quality/purity falls below standards
FDA can enforce FDCA via ______ and _______ charges
Civil, criminal charges
What are the main differences between the 3 classes of recalls?
Class 1 - dangerous or defective product that could cause serious health problems or death
Class 2 - Products that might cause a temporary health problem, or pose a slight threat of a serious nature
Class 3 - Unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws
Why was the New England Compounding Center Significant?
Lack of sterility at site which was located right net to a recycling center, owned by the same people
What are the key differences between compounding and manufacturing?
Compounding is regulated by the State boards while Manufacturing is regulated by the FDA and is mass production.
What does the NDC identify?
Manufacturer, drug product and package type
How would you decipher the NDC 0777-3105-02?
0777 = labeler 3105 = product code 02 = package code
Describe REMS
Risk Evaluation and Mitigation Strategies used to ensure that benefits outweigh risks of prescription drugs; goes beyond labeling strategies; Authorized by the Food and Drug Administration Amendments Act of 2007; enforced by FDA on manufacturers; manufacturers required to monitor compliance by healthcare personnel
Give some examples of REMS
Patient Package Insert or Medication Guide, Communication Plan, Elements to Assure Safe Use, etc.
What is the MedWatch equivalent for vaccines?
Vaccine Adverse Event Reporting System (VAERS)
Describe Poison Prevention Packaging Act
1970 - requires child-resistant packaging for OTC and prescription meds (patients can opt out in writing for prescriptions under ORS); several exceptions exist including nitroglycerin and geriatric medications; Administered by the US Consumer Product Safety Commission
Describe the DEA
Branch of US Justice Dept. and formerly the Bureau of Narcotics and Dangerous Drugs (BNDD)
Administers the controlled substance act
Which act plays a major role in scheduling of drugs?
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, or the Controlled Substances Act (CSA)
Part of the Code of Federal Regulations (CH. 21) - aka CFR
Which 3 dangerous drug types sparked the 1965 Drug Abuse Control Amendments?
Depressants, stimulants and hallucinogens
Describe the Controlled Substances Act
Regulated by the DEA (state BOPs regulate medical use of controlled substances)
Includes provisions for rehab under community mental health programs, research in treatment of drug abuse as well as the import/export of controlled substances
The ______________________ determines the scheduling of drugs
DEA
What power does a BOP have when it comes to drug scheduling?
They can make a drug more restrictive than Federal law, but must publish their intent to schedule an item
Describe the various schedules
1 - high potential for abuse or no medical use or lack of info on use
2 - high potential for abuse, has medical use, abuse may lead to dependence
3 - less abuse and dependence potential than 2, has medical use
4 - lower potential for abuse relative to 3, has accepted medical use, abuse may lead to limited problems
5 - lowest abuse potential
Describe the Anabolic Steroids Control Act
1990 - prevents abuse, especially in athletes; placed in CIII by DEA; penalties for both possession and distribution
Describe Comprehensive Methamphetamine Control Act
1996 - regulates OTC sale of ephedrine and pseudoephedrine; precursors for synthesis of meth; scheduled as a CIII in Oregon
What are 4 valid exemption from registering with the DEA?
Employee of a registrant or wholesaler, patient or a common carrier
What is a DEA 222?
A form prepared by purchaser in triplicate (one item on each numbered line) with the number of items ordered noted in a provided space.
Information for each item includes drug name, dosage form, strength, quantity in container and number of containers
The form also has the name and address of the supplier, date, and purchaser signature.
Copies 1 and 2 go to supplier, and the third is filed at the pharmacy.
How can a C-II be ordered electronically?
CSOS - DEA controlled-substances ordering system
What is special about prescribing for narcotic detoxification or maintenance?
Requires a separate DEA registration specific for these practices
Electronic prescriptions for controlled substances are legal but require______________________
Dual authentication
Paper prescriptions for C-II meds ____________ be refilled
Can’t
Multiple prescriptions for a C-II medication can be given to a patient on the same day, in order for the patient to receive sequentially up to a _____ day supply
90
How many refills can you get for C3-5 medications? Transfers?
Maximum of 5 refills or 6 months from date of issue; can only transfer one time
DEA C-5 can be refilled up to 1 year (same as non-scheduled)
How would you validate DEA number AS1234563
1 + 3 + 5 = 9
2 + 4 + 6 = 12 x 2 = 24
9 + 24 = 33 (last number matches last number of DEA number, 3)
The first letter of the last name of the practitioner is the second letter of the registration number
What does “PRN” mean in the context of a non-controlled substance prescription?
The medication can be refilled in proper context for a period of one year (6 months if used for controlled substances)
Which chapters of ORS are crucial to pharmacy?
475 (drugs) and 689 (pharmacy)
Oregon pharmacy rules are found in chapter _____ of _____. Which divisions are most pertinent to practice of pharmacy?
855, OAR
19, 41
Which is more specific to pharmacy practice, ORS or OAR?
OAR
What does the board of pharmacy enforce?
Regulations
Who determines BOP budget?
State legislature
Pharmacy board members are approved by the _________________ and confirmed by the ______________
governor, senate
What is contained within ORS chapter 475?
Controlled substances, illegal drug cleanup, paraphernalia, and precursors
A prescription to obtain a CS for office use __________ be used
can’t
Can a CII be faxed?
Yes, but original prescription must be received before dispensing
What is the protocol/regulations for a CII under emergency situations?
quantity limited to emergency duration, prescriber must be called to validate identity and paper prescription must be received within 7 days.
Central fill pharmacies do not have this ability.
Prescription requirement for C-II
Parenteral medication may be faxed and serve as original (same with resident of longer term care facility).
Above also applies to hospice but the prescriber must note “hospice patient” on Rx
What protocol is taken for partial filling of a C-II?
Must note amount dispensed and fill the remainder within 72 hours (or notify prescriber if can’t fill within this time)
What are the rules on faxing C3-5s?
Faxing is accepted but must come from the practitioner
Methamphetamine is schedule ___ in Oregon
1
Methamphetamine is schedule ____ in the US
2
Drug paraphernalia does not include _________________________ or ________________
Hypodermic syringes, needles
ORS Ch 689 covers…
Pharmacists, drug outlets, drug sales
Who makes up the board of pharmacy?
The State Board consists of 7 members appointed by the governor and confirmed by the Senate (all members must be residents of this state)
5 must be licensed pharmacists; 2 must be members of the public who aren’t licensed pharmacists or a relative of one of the pharmacists on the board
What are the 3 primary Pharmacy Licensure Exams?
North American Pharmacy Licensure Exam (NAPLEX)
Multistate Pharmacy Jurisprudence Exam (MPJE)
Foreign Pharmacy Graduate Equivalency Exam (FPGEE)
Who develops and manages the pharmacy licensure exams?
National Association of Boards of Pharmacy (NABP)
They set national standards but DO NOT regulate; all regulation done by state and federal governments
How long are officer terms on the state board?
1 year - officers shouldn’t serve longer than 1 consecutive term
A _________________ must be completed if someone wishes to engage in the practice of pharmacy (as a licensed pharmacist).
Internship
Drug outlets must register every _____ year(s) with the BOP
1
As far as penalties are concerned, the maximum amount that an individual can be fined is __________ while the maximum amount an outlet can be fined is _________.
$1,000
$10,000
Pharm Techs must renew their licenses every _______ year(s).
1
The original record of every prescription filled by a pharmacy must be kept on file for ___ years at the pharmacy
3
What 2 things must a pharmacist consider when approving and filling an out-of-state prescription?
That the prescription was issued by a practitioner with a legitimate practitioner-patient relationship to the patient in question, and that it is authentic
A pharmacist may administer vaccines to persons who are at least ____ years of age
7
What is the goal of PRN?
Professional Recovery Network of Oregon is a program with a mission to reach fellow colleagues before substance abuse or mental health problems cause impairment and impact their work
