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P1 Winter Law Exam 1 > Exam 1 > Flashcards

Exam 1 Flashcards

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1
Q

Four categories of professional behavior

A
  1. Ethical and legal
  2. Ethical and illegal (always do what is the best for the patient)
  3. Unethical legal (avoid)
  4. Unethical and illegal (avoid)
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2
Q

Categories of legal processes

A
  1. Criminal 2. Civil 3. Administrative
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3
Q

Criminal legal process

A
  1. Gov vs person 2. Violation of statutes 3.Punish/rehab
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4
Q

Civil legal process

A
  1. Person vs person 2. Usually involves injury and compensation
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5
Q

Administrative legal process

A
  1. Agency vs. licensee (Board vs. pharmacist) 2.Usually involves investigation and discipline
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6
Q

Liability

A

Legal responsibility. Actions or conduct creating civil liability may result in criminal liability, and actions or conduct creating criminal liability may result in civil liability.

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7
Q

Vicarious liability

A

Pharmacists responsible for technician action. Company is responsible for their employee’s action

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8
Q

Tamper Resistant Prescription Pads

A

Required for all Medicare & Medicaid prescriptions. Appears to have had little impact on fraudulent prescriptions

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9
Q

Federal Antitrust Laws

A

Goal is to promote competition. Two primary laws: Sherman Antitrust Act and Robinson-Patman Act

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10
Q

Sherman’s antitrust laws

A

Applies to all competitive markets. Maintains competition

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11
Q

Robinson-Patman Act

A

Volume discount. Large purchaser get discounts

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12
Q

Negligence/Malpractice

A

Standards of care violation. Examples of Malpractice:

Quality of drug dispensed; Incorrect drug; Incorrect quantity or dosage; Failure of duty to warn/inadequate counseling

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13
Q

Four elements of negligence

A
  1. Duty owed 2. Breach of duty 3. Causation 4. Damages

All four elements must be proven for a finding of legal liability.

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14
Q

Negligence per se

A

Harm resulting from the violation of a statute or rule (failure to provide counseling, for example)

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15
Q

Punitive damages

A

Knowingly breaching the duty. Excess compensation/ with goal of punishing defendant. Usually given if there is “wanton and reckless disregard” or “morally culpable” conduct

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16
Q

Defenses to negligence

A

Comparative negligence: plantiff “shared” contribution

Statute of limitations: claim time limit

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17
Q

Tort

A

A civil wrong that causes other person a harm and results in legal liability

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18
Q

Four elements of legal contract

A
  1. Mutual agreement 2. Legally competent parties 3. Consideration (e.g value) 4. Lawful purpose/object
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19
Q

Uniform commercial code

A

Covers laws of sale

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20
Q

Elements of breach of warranty

A

Existence of a warranty. Warranty breached or broken. Failure of warranty is the cause of injury.

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21
Q

1906 Pure Food and Drug Act

A

To protect public from misbranded and adulterated drugs. Wasn’t regulated well.

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22
Q

Food Drug and Cosmetic Act

A

Current main law. FDA regulate drug safety but not efficacy!

Drug quality regulation. Label with “adequate directions for use” required

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23
Q

Durham-Humphrey Amendment

A

Established Prescription, OTC category. Based on public can use it correctly

24
Q

Kefauver-Harris Amendment

A

Require proof of safety and efficacy. Good Manufacturing Practices (GMP). adverse reaction reporting

25
Q

Drug Price Competition and Patent-Term Restoration Act

A

Aka. Hatch-waxman amendment. Made generic drug approval process more efficient

26
Q

FDA orange book

A

Lists bioequivalent drugs (FDA approved)

27
Q

Drug Quality and Security Act

A

Regulates compounding and drug supply chain. Large compounding pharmacies under FDA as outsourcing pharmacies. Traditional compounding pharmacies can register with state board

28
Q

Drug Supply Chain Security Act

A

Requires recording of all prescription drug sales

29
Q

Label vs labeling

A

Label = written on the package or the container. Labeling = all labels and drug inserts and advertisement

30
Q

FDCA (food drug cosmetic act)

A

FDA can enforce FDCA via civil or criminal charges.

31
Q

Product Recall class I

A

Could cause serious health problems or death

32
Q

Risk Evaluation and Mitigation Strategies (REMS)

A

Makes sure the benefits of the product outweighs the risk. FDA enforcement on manufacturers

33
Q

Poison Prevention Packaging Act

A

child-resistant packaging for OTC and Rx. Patients can opt-out in writing for prescription drugs (w/exceptions). Administered by the US Consumer Product Safety Commission

34
Q

Schedule I of Controlled substances

A

Schedule I – high potential for abuse or no medical use or lack of information on use

35
Q

Anabolic Steroids Control Act

A

Placed anabolic steroids in schedule III

36
Q

Methamphetamine DEA schedule

A

C-III (in Oregon)

37
Q

DEA registration requirement

A

Required for physicians, pharmacies, wholesalers. Physicians w/o DEA can use the hospitals. Employees of registered entities don’t need

38
Q

C-II prescription should have…

A

written date; practitioner signature. NO REFILL; patient address
DEA #. May specify “don’t fill until”

39
Q

Multiple C-II Prescriptions Written on the Same Date

A

Filled sequentially

Allowed up to 90 day supply

40
Q

Valid DEA number

A

AS1234563 • 1 + 3 + 5 = 9 • (2 + 4 + 6) x 2 = 24 • 9 + 24 = 33 Last numbers must match • The first letter of the last name of the practitioner is second letter of the registration number (Ex: Dr. Smith)

41
Q

Rule making procedure

A

• Notice
– B of P “Notice of proposed rulemaking and
statement of need”
• Hearing
• Filing and Publication
– Board considers testimony and votes to approve
rule (or not!)
– Board files final rule with the Oregon Secretary of State and it is added to OAR Chapter 855

42
Q

In which condition can you fax a C-II medication prescription? (4)

A

-must get original before dispensing; Parenteral may be faxed and be used as original; For resident of long-term care facility. It may also be used as original; for hospice patient. Can serve as original. Prescriber must put “hospice patient” on Rx

43
Q

In which cases do you not need a Rx to dispense C-II? (1)

A

-individual practitioner may administer or dispense in his/her clinic without Rx

44
Q

When is verbal Rx allowed for schedule II medications? (1)

A

Emergency situations• Receive paper prescription within 7 days• “Central fill” pharmacies (Outsourcing pharmacies) can not do this!

45
Q

Who can administer/dispense C-II meds? (2)

A

Individual practitioners, only used in the clinic. Institutional practitioner with Rx written by an individual practitioner.

46
Q

C-II meds partial filling rule:

A
  1. Not enough drug at the pharmacy.fill the rest within 72 hours.
  2. For patients in LTCF or who are terminally ill. fill the rest within 60 days. 3. May record in a computer
47
Q

C-II refill rule

A

No refill

48
Q

C-III and IV refill rule:

A

May refill up to 5 times or until 6 months from the issue date

49
Q

C III/IV/V partial filling, faxing rule

A

Partial filling is and faxing (if from practitioner and verifiable) is allowed

50
Q

State Board of Pharmacy qualification

A

7 members: 5 pharmD, 2 public members. Must be residents. Appointed by gov. and confirmation by senate

51
Q

Product recall class II

A

Class 2. Might cause temporary health problems. Only pose a slight threat or a serious nature.

52
Q

Product recall class III

A

Class 3. Won’t cause health problems

53
Q

Control subs schedule II

A

Schedule II – high potential for abuse, has medical use, abuse may lead to dependence

54
Q

Control Sub schedule III

A

Less abuse and dependence potential than II, has medical use

55
Q

Control sub. Schedule IV

A

Lower potential for abuse relative to III., has accepted medical use, abuse may lead to limited problems

56
Q

Control Sub schedule V

A

Lowest abuse potential

P1 Winter Law Exam 1 (1 decks)

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