Pharmacy Law Final Review 2

alchemist04's version from 2018-12-10 23:27


Question Answer
List four means for the FDA to enforce the FDCA(i) Injunctive action (ii) Criminal Proceedings (iii) Warning Letters (iv) Seizures
DEA form 222use for ordering CS I and II drugs
DEA form 224For any company that wants to dispense pharmaceutical products e.g pharmacy
DEA form 225For manufacturer, wholesaler, distributors, NTPs, importers and exporters
HIPAAHealth Insurance Portability and Accountability Act
Goal of HIPPAto improve effectiveness and efficiency of health care system


Question Answer
Four aspects of health information under HIPAA(i) NPI (ii) Security (iii) Privacy (iv) Transaction and Code Set (T&C)
Who is covered under HIPAAPatient
Exclusions to PHI include(i) Treatment (ii) Payment (iii) Operation
A “limited data set” is a PHI that excludes direct identifiers of the patient, such as(i) name (ii) address (iii) Phone number (iv) Social Security number
HITECHHealth Information Technology for Economic and Clinical Health


Question Answer
Under HITECH, if a covered entity uses an electronic health record, what shd the covered entity do?the entity will require to account for all disclosures, including TPO w/n 3 years prior to the date of the request.
Covered entities have how many days to act on PHI request? (a) 30 days (b) 60 days (c) 90 days (d) 7 days(a) 30 days and may be extended for another 30 days
Under HIPAA, patient can request for PHI up to how many years? (a) 1 yr (b) 3 yrs (c) 6 yrs (d) as long as needed by the patient(c) 6 years
if a breach has occurred, the pharmacist must notify the affected individual(s) by ----------- (or electronically if the individual has agreed) w/n ----- days after the breach was discovered1st Class mail w/n 60 days
If a breach involve more than 500 individuals, pharmacy must notify the media w/n -------- and notify DHHS ---------60 days and DHHS immediately
What is the potential penalty for a student accidentally leaving their clinical notes on the bus? Posting the information on social media$100 fine per violation, up to $25,000 per person for all violation in a calendar year


Question Answer
What does OBRA stands for?Omnibus Budget Reconciliation Act of 1990
What is the primary goal of OBRA?Safe money and reduce healthcare cost
What are the 3 major provisions of OBRA?(1) Rebates (2) Demonstration projects (3) DUR = directly related to pharmacy practice
DUR primarily deal with ------Healthcare outcomes
What are the 3 parts of DUR?(1) Prospective review (2) Educational review (3) Retrospective review


Question Answer
Who is responsible for the retrospective and prospective drug utilization reviews (DUR)?Retrospective reviews = Physicians and Pharmacists; Prospective reviews = Pharmacists
Four groups covered by Medicare are?(1) 65 yo and above (2) Pt w/ end stage renal disease (3) Pt w/ permanent disability (4) Exposure to Environmental hazard
Which part of Medicare covers Hospitalization Insurance?Part A
Which part of Medicare covers prescription drugs that patient cannot self administeredPart B
Which medicare part is Medicare Advantage?Part C


Question Answer
Which Medicare Part covers prescription drug benefits from among a multitude of private plans approved by CMS?Part D
A patient walks down to your pharmacy for a flu shot, which Medicare part is most likely going to cover her Flu shot prescription?Part B
The two components (parts) of Medicare that pay for prescription drugs arePart B and D
Which of the following falls under "excluded lists"? Choose all that applies (a) Contraceptives (b) Cough and cold drugs used to treat SXs (c) Vitamin D (d) Prenatal vitamins (e) Weight loss and weight gain meds(b) and (e)
Exception to drug formularies under Medicare Part D include?(a) Antidepressants (b) Antipsychotics (c) Anticonvulsants (d) Antiretroviral (e) Antineoplastic (f) Immunosuppressants
EAC vs AWP Estimated Acquisition Cost vs Average Whole Price; EAC = the state Medicaid Agency’s best estimate of what the pharmacists pay for the drug; AWP = the manufacturer’s suggested price for wholesalers to sell to pharmacies
ERISAEmployee Retirement Income Safety Act