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Law Review

Hawaii Law

What was established under the Pure Food and Drug Act of 1906? Prohibited the sale and transport of adulterated or misbranded food, drinks and drugs.
How did the Kefauver Harris Amendment of 1962 change drug advertising? It required advertisements to disclose accurate information about drug side effects.
Which law established the ruling that drug manufacturers had to: 1) Prove their drug was safe for human consumption through trials and studies and 2)Submit a New Drug Application (NDA)? Food Drug and Cosmetic Act of 1938
What was the purpose of the Durham Humphrey Amendment of 1951? The separation of OTC and Rx (legend) drugs and companies had to label legend drugs with: "Caution: Federal law prohibits dispensing without a prescription" and refills may only be authorized by the prescriber.
What was the importance of the Comprehensive Drug Abuse Prevention and Control Act of 1970? Regulated sale/distribution of narcotics. Drug Enforcement Agency (DEA) was formed. Created controlled substances category for drugs and they were ranked based on their abuse potential (Schedule I - V)
Which Amendment was made to the Food Drug and Cosmetic Act in response to the Thalidomide tragedy that caused limb birth defects in newborns during the 1960s? The Kefauver Harris Amendment of 1962
Which act required childproof packaging on most drugs dispensed in a pharmacy with the exception of ones for emergency situations (ex: nitroglycerin, birth control pills, inhalers, ointments and creams)? 1970 Poison Prevention Packaging Act
The Drug Listing Act of 1972 authorized the FDA to compile a list of legal drugs for sale in the US and each drug was given a unique identifier based on what code? The National Drug Code (NDC) which is usually a 11-digit number.
Which Act was passed to promote the research and development of new drugs, vaccines, and diagnostic agents that were intended for the treatment of rare diseases (<200,000 American citizens)? The Orphan Drug Act of 1983 which included fast track drug approval and numerous incentives for drug developers.
Which Act required pharmacists to conduct a Drug Utilization Review (DUR) or offer counseling to patients on all new prescriptions? The Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
Which 1996 Act created rules regarding the privacy/security of patient health information? The Health Insurance Portability and Accountability Act(HIPAA).
What is the procedure of a Class I recall? An attempt must be made by the product manufacturer/distributor to notify the patient that the drug they are taking could cause serious harm or death.
What is the severity of a Class II recall? The probability of serious harm is not likely and the effects may be temporary or reversible
Which Class of recall is not likely to cause any serious adverse effects to the customer? Class III recall
Since recall notices can not be communicated/sent over the phone, in what way can they be dispersed? Fax, email, standard mail
List all of the items on a dispensed prescription drug label Pharmacy (name/address/number), patient (name/address), doctor (name/address), Rx number, date filled, drug (name/strength/quantity/directions), pharm or tech initials, exp date, refills, statement: "Federal law prohibits dispensing without prescription"
Drugs with NO accepted medical use in the US and with the highest abuse potential (ex: heroin, marijuana) belong to which class of medications? Controlled I substances (C-I)
Drugs with moderate abuse potential that can be refilled up to 5 times in 6 months per Federal law (ex: Vicodin, Tylenol #3, anabolic steroids, LSA) are part of which class of medications? Controlled III substances (C-III)
Drugs with high abuse potential, no refills, must be kept under lock and key, and whose ordering must be done through DEA 222 forms belong to which class of medications (ex: morphine, Oxycontin, Ritalin, cocaine)? Controlled II substances (C-II)
Drugs with low abuse potential that may be refilled up to 5 times in a 6 month period per Federal law (ex: benzodiazepines, barbiturates) belong to which class of medications? Controlled IV substances (C-IV)
Drugs with very low abuse potential that have unlimited refills for 1 year (ex: Lomotil, cough syrup containing codeine) belong to which class of medications? Controlled V substances (C-V)
How often does the inventory of controlled substances need to be taken? Every 2 years
Which form is used to report lost or stolen controlled substances? DEA form 106
Which form is needed for a pharmacy to dispense controlled substances? DEA form 224
How do you check a DEA number for authenticity? 1st letter indicates type of health care provider. 2nd letter of DEA # is the 1st letter of registrant's last name. (Sum of digits 1,3,5) + (2 x Sum of digits 2,4,6)= total. The last digit of the total is the last digit of the DEA # (i.e. check digit.
If the Federal and State laws differ, which law should be follow? The more stringent law
What do the first five, middle four, and last two digits of an NDC number represent? Manufacturer, drug, and package size
Per Federal Law, what is the maximum amount of refills for C-III and C-IV within a 6 month period? 5 refills
If only the month of expiration is given for a drug, on which day of the month does it expire? The last day of that month
Pseudoephedrine is a behind the counter product that requires the purchaser to present a photo ID. What is the maximum amount that can be purchased by an individual in 1 day and 1 month? 3.6 grams of pseudoephedrine in 1 day and 9.0 grams in 1 month
After initial use of a Levemir pen or vial, the product is only good for how many days? 42 days
When can a pharmacist fill a prescription for Methadone? A. maintenance of a patient's addiction. B. detoxification of an addicted patient. C. analgesic purposes. D. a and c C. analgesic purposes
How many members serve on the Board of Pharmacy in Hawaii? 7 total members (5 are licensed pharmacists that have been active for at least 5 years and 2 are public members) - 4 of the 7 members are residents of Honolulu.
Per Hawaii State law, what is the maximum amount of refills on a prescription for C-III, C-IV, and C-V drugs? 2 refills
Per Federal law, once a prescription for a C-II drug has been issued, it becomes invalid if it isn't filled after how long? 90 days
Per Hawaii State law, a C-II prescription must be filled within ___ days of the issue date and must be picked up within ___ days of the fill date: 7 days, 7 days
Per Hawaii State law, what are the minimum and maximum size dimensions of a prescription for a controlled substance? Max of 8 1/2 x 11 inches and minimum of 3 x 4 inches
This book identifies approved drug products and compares their therapeutic equivalence to suggest whether different drugs can serve as appropriate substitutes: The Orange Book
Per Hawaii State law, how many hours of Continued Education (CE) must a pharmacist obtain biannually to renew their license? 30 hours in a 2 year span (Pharmacist Letter monthly quiz = 1 hr each)
Per Hawaii State law, how many times can refills of legend drugs be transferred from one pharmacy to another? Only once unless the pharmacies are part of the same chain and share the same electronic system
Per Hawaii State law, how long does a pharmacy have to keep their prescriptions on record? 5 years
Per Hawaii State law, How long must a purchase in the Pseudoephedrine log book be kept? 2 years
Per Hawaii State law, what is the pharmacist allowed to change on the prescription without notifying/confirming with the physician? The patient's address only
Pharmacists now have the authority to immunize pharmacy patrons as young as what age? 18 years old
Which of the following duties is a pharm tech permitted to perform per Hawaii law? A) accept new or transferred prescriptions B) counsel on OTC products C) record keeping D) perform drug utilization reviews E) none of the above C. record keeping
If a pharmacist uses a paper filing system for storing controlled substance prescriptions, which of the following medications should be marked with a red "C"? a. All CIIs b. CIII, CIV, and CVs c. CIII and CIV only d. All non-controlled prescriptions B. C-III, C-IV, and C-V
On a controlled substance inventory, opened containers with which of the following drugs must be counted exactly? a. CIIs b. CII, CIII, and CIVs in any size of container c. All controlled substances d. Only CII, CIII, and CIVs in opened containers A. C-II
When a DEA inspector conducts an audit of your controlled substances, what percent error are you allowed? a. 0% b. 3% c. 5% d. 10% A. 0%
Dispensing a C-V, OTC cough syrup containing codeine is limited to which of the following? a. 240 ml within 48 hours b. 180 ml within 48 hours c. 120 ml within 48 hours C. 120 mL within 48 hours
The advertising of OTC products is regulated primarily by: a. FDA b. FTC c. HHS d. DEA B. Federal Trade Commission (FTC)
The authority to grant practitioners a license to prescribe drugs resides with: a. the federal government b. the state government c. the local district court d. none of the above B. State government for the state in which they practice
Dr. John, a DEA-registered internist, calls on Friday evening requesting that you dispense #15 Levo-Dromoran tablets to Susan Folkes. You are satisfied the situation is an emergency. Dr. John must supply you with a signed Rx within how much time? 72 hours
It is legal for a prescriber to write a controlled substance Rx for themselves if it is for a legitimate medical purpose. True or False? True
Can the pharmacy accept an oral C-II prescription? If so, when? And what additional information is needed? Yes, in emergency situations. Need an oral code.
Can a prescription drug be exchanged or returned by the customer? If so, when? The National Take Back Initiative is a way drugs can be returned for disposal purposes, but the return of meds to a pharmacy for any reason is prohibited.
Per Hawaii state law, the pharmacist is required to offer the generic equivalent product if the doctor has not specified that the brand must be dispensed. What is one exception to this rule where you have to dispense the brand? Anti epileptic drugs indicated for epilepsy can not be dispensed in the equivalent generic form unless specified by the prescriber and patient.
Per Hawaii state law, which of the following prescriptions can be accepted from out of state? a. Lopressor 50 mg b. Lomotil 2.5 mg c. Vicodin 5/500 mg d. None of the above e. All of the above a. Lopressor 50 mg since it is the only non controlled substance in the list.
Per Hawaii state law, when making a in-state Rx transfer between pharmacies, what information should the pharmacist receiving the transfer obtain from the pharmacist/pharmacy making the transfer? All required Rx elements, name of transferring pharmacist and all of their pharmacy info, Rx number, original issue date, date of last refill, refills remaining
The misuse of a substance to the extent deemed detrimental or deleterious to the user, others, or society: Abuse
What is the number to dial for the poison control center? 1-800-222-1222
Under which circumstances may protected health information be released without authorization? a. Public health activities (ex: STD reporting) b. At spousal request during divorce proceedings c. Domestic violence victims d. Both A and C Answer: D
The Drug Efficacy Study Implementation (DESI) was a program begun by the FDA after the Kefauver-Harris Amendment was passed. What was the purpose of this program? The Pure Food and Drug Act of 1938 required drugs to be safe, but the DESI program, as part of the Kefauver-Harris Amendment, tested drugs prior to 1962 for efficacy.
Who created the Good Housekeeping Seal of Approval and is referred to as the father of the Pure Food and Drug Act of 1906? The Pure Food and Drug Act of 1906 is also called the Wiley Act, which is named after the father Harvey Wiley
What tragedy led to the 1938 Food, Drug, and Cosmetic Act of 1938? The sulfanilamide elixir poisoning crisis
What was the purpose of the Delaney clause that was created in 1952 as part of the Durham Humphrey Amendment? Prohibited carcinogenic food additives
Which pregnancy category is properly labeled? a. A - shows risk in animals but none in humans b. C - evidence of risk or no adequate studies available; weigh risk and benefits c. D - risk clearly outweighs and benefit and drug is contraindicated Answer: Category C is correctly described. Category A does not show risk to animals/humans and Category D is not necessarily contraindicated. Sometimes the benefits can outweigh the risk
They can't make claims to be useful in diagnosing, mitigating, treating or curing a specific disease or class of diseases: Dietary supplement
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 required drug manufacturers of these products to do what? They must report incidents defined as a serious adverse event (death, life-threatening experience, inpatient hospitalization, persistent or significant disability/incapacity, congenial anomaly/birth defect) within 15 days to the FDA
How often is a pharmacist's license renewed and how many continuing education (CE) credits must be collected in that span of time? License renewal every 2 years and requires 30 CE credits. They must maintain records for 3 yrs and must be issued certificate of completion
Which medical device class do pacemakers fall under? a. Class I b. Class II c. Class III d. Class IV Pacemakers are devices intended to support or sustain human life, so they fall under Class III. There is no Class IV.
What was established under the Safe Medical Device Act 1990? Drug manufacturers have to report significant medical device adverse events to the FDA and have a way to track the devices in the event of a product recall.
Which form is filled out by consumers and/or health care providers in the event of an adverse event from drugs or devices? How long do facilities have to report device-related deaths to the FDA and manufacturer? Form 3500 is filled out as part of Medwatch and facilities have 10 days to report device-related deaths
What are the maximum limits of Codeine for it to remain as a Schedule 3 substance? What about Schedule 5? Schedule 3 - 1.8 mg/100 mL; Schedule 5 - 200 mg/100 ml
When does an exact count (or measure of liquid) need to be recorded and tracked in a pharmacy? a. Schedule II drugs b. Schedule II,III drugs c. Schedule IV, V drugs d. All Schedule drugs (II - V) Answer: A - Schedule II drugs (C2)
Which agency regulates vaccines and other biological products? Public Health Service
What is the Nuremberg code? Set of research ethical principles for human experimentation. Example: Person involved should have legal capacity to give consent. Experiment should be conducted as to avoid all unnecessary physical and mental suffering and injury.
Clinical studies of a drug performed on a small group of healthy volunteers to determine safe dosages: a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials A. Phase I trials
Post market study of a drug: a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials D. Phase IV trials
During what phase is a drug approved for selling? a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials C. Phase III trials
A new drug application (NDA) is submitted for approval: a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials C. Phase III trials
Determining proper drug dosage and pharmacokintinetics are done during this phase: a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials A. Phase I trials
In additon to safety, effectiveness is evaluated in drugs and side effects on a small group of people are observed. a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials B. Phase II trials
Drug treatment is tested against standard treatment and/or placebo to determine ranges for effectiveness, safety and dosage range. a. Phase I trials b. Phase II trials c. Phase III trials d. Phase IV trials C. Phase III trials
Which statement about generic vs brand drugs is false? a. generics must be chemically equivalent b. active ingredient of generics must enter the blood stream at the same rate c. all ingredients in the generic must be the same C. Brand products can often contain multiple ingredients while generics will only have one
What form do you send to the prescribing physician when a medication for their patient is no longer covered by insurance? Answer: Prior authorization form (PA); the physician has the choice to either fill out this form and send it to the insurance company to attempt to get the medication fill covered or they can switch the patient to something on the insurance formulary
According to Hawaii State Law, can a new prescription for a controlled substance be transferred between two Hawaii pharmacies? No; in-state transfers are permitted for controlled substances usually but not if it is the first time filling a new prescription. Controlled prescriptions must be filled once by the original pharmacy before being transferred.
Created by: cg2014