Exam 1 Flashcards
Four categories of professional behavior
- Ethical and legal
- Ethical and illegal (always do what is the best for the patient)
- Unethical legal (avoid)
- Unethical and illegal (avoid)
Categories of legal processes
- Criminal 2. Civil 3. Administrative
Criminal legal process
- Gov vs person 2. Violation of statutes 3.Punish/rehab
Civil legal process
- Person vs person 2. Usually involves injury and compensation
Administrative legal process
- Agency vs. licensee (Board vs. pharmacist) 2.Usually involves investigation and discipline
Liability
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.
Vicarious liability
Pharmacists responsible for technician action. Company is responsible for their employee’s action
Tamper Resistant Prescription Pads
Required for all Medicare & Medicaid prescriptions. Appears to have had little impact on fraudulent prescriptions
Federal Antitrust Laws
Goal is to promote competition. Two primary laws: Sherman Antitrust Act and Robinson-Patman Act
Sherman’s antitrust laws
Applies to all competitive markets. Maintains competition
Robinson-Patman Act
Volume discount. Large purchaser get discounts
Negligence/Malpractice
Standards of care violation. Examples of Malpractice:
Quality of drug dispensed; Incorrect drug; Incorrect quantity or dosage; Failure of duty to warn/inadequate counseling
Four elements of negligence
- Duty owed 2. Breach of duty 3. Causation 4. Damages
All four elements must be proven for a finding of legal liability.
Negligence per se
Harm resulting from the violation of a statute or rule (failure to provide counseling, for example)
Punitive damages
Knowingly breaching the duty. Excess compensation/ with goal of punishing defendant. Usually given if there is “wanton and reckless disregard” or “morally culpable” conduct
Defenses to negligence
Comparative negligence: plantiff “shared” contribution
Statute of limitations: claim time limit
Tort
A civil wrong that causes other person a harm and results in legal liability
Four elements of legal contract
- Mutual agreement 2. Legally competent parties 3. Consideration (e.g value) 4. Lawful purpose/object
Uniform commercial code
Covers laws of sale
Elements of breach of warranty
Existence of a warranty. Warranty breached or broken. Failure of warranty is the cause of injury.
1906 Pure Food and Drug Act
To protect public from misbranded and adulterated drugs. Wasn’t regulated well.
Food Drug and Cosmetic Act
Current main law. FDA regulate drug safety but not efficacy!
Drug quality regulation. Label with “adequate directions for use” required
Durham-Humphrey Amendment
Established Prescription, OTC category. Based on public can use it correctly
Kefauver-Harris Amendment
Require proof of safety and efficacy. Good Manufacturing Practices (GMP). adverse reaction reporting
Drug Price Competition and Patent-Term Restoration Act
Aka. Hatch-waxman amendment. Made generic drug approval process more efficient
FDA orange book
Lists bioequivalent drugs (FDA approved)
Drug Quality and Security Act
Regulates compounding and drug supply chain. Large compounding pharmacies under FDA as outsourcing pharmacies. Traditional compounding pharmacies can register with state board
Drug Supply Chain Security Act
Requires recording of all prescription drug sales
Label vs labeling
Label = written on the package or the container. Labeling = all labels and drug inserts and advertisement
FDCA (food drug cosmetic act)
FDA can enforce FDCA via civil or criminal charges.
Product Recall class I
Could cause serious health problems or death
Risk Evaluation and Mitigation Strategies (REMS)
Makes sure the benefits of the product outweighs the risk. FDA enforcement on manufacturers
Poison Prevention Packaging Act
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
Schedule I of Controlled substances
Schedule I – high potential for abuse or no medical use or lack of information on use
Anabolic Steroids Control Act
Placed anabolic steroids in schedule III
Methamphetamine DEA schedule
C-III (in Oregon)
DEA registration requirement
Required for physicians, pharmacies, wholesalers. Physicians w/o DEA can use the hospitals. Employees of registered entities don’t need
C-II prescription should have…
written date; practitioner signature. NO REFILL; patient address
DEA #. May specify “don’t fill until”
Multiple C-II Prescriptions Written on the Same Date
Filled sequentially
Allowed up to 90 day supply
Valid DEA number
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)
Rule making procedure
• 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
In which condition can you fax a C-II medication prescription? (4)
-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
In which cases do you not need a Rx to dispense C-II? (1)
-individual practitioner may administer or dispense in his/her clinic without Rx
When is verbal Rx allowed for schedule II medications? (1)
Emergency situations• Receive paper prescription within 7 days• “Central fill” pharmacies (Outsourcing pharmacies) can not do this!
Who can administer/dispense C-II meds? (2)
Individual practitioners, only used in the clinic. Institutional practitioner with Rx written by an individual practitioner.
C-II meds partial filling rule:
- Not enough drug at the pharmacy.fill the rest within 72 hours.
- For patients in LTCF or who are terminally ill. fill the rest within 60 days. 3. May record in a computer
C-II refill rule
No refill
C-III and IV refill rule:
May refill up to 5 times or until 6 months from the issue date
C III/IV/V partial filling, faxing rule
Partial filling is and faxing (if from practitioner and verifiable) is allowed
State Board of Pharmacy qualification
7 members: 5 pharmD, 2 public members. Must be residents. Appointed by gov. and confirmation by senate
Product recall class II
Class 2. Might cause temporary health problems. Only pose a slight threat or a serious nature.
Product recall class III
Class 3. Won’t cause health problems
Control subs schedule II
Schedule II – high potential for abuse, has medical use, abuse may lead to dependence
Control Sub schedule III
Less abuse and dependence potential than II, has medical use
Control sub. Schedule IV
Lower potential for abuse relative to III., has accepted medical use, abuse may lead to limited problems
Control Sub schedule V
Lowest abuse potential
