PPLE Final Exam Review

Flashcards covering pharmacy ethics, federal and state law, food and drug laws, controlled substances, and prescribing.

What is reflection on and application of moral norms to human motivation and conduct?

Ethics

What are the three theories of ethics?

Virtue ethics, Deonto-logical ethics, and Utilitarian ethics

Define virtue ethics?

Character of the moral actor

Define deonto-logical ethics?

Whether the act conforms to a universal rational duty

Define utilitarian ethics?

Whether the act results in maximum of good consequences over bad ones

Name the major bio-ethics principles?

Autonomy, Non-maleficence, Beneficence, and Justice

Define autonomy.

Self-determination

Define non-maleficence.

Obligation to do no harm

Define beneficence.

Promote patient best interest; benefits outweigh harm

Define justice.

Fair allocation of benefits and burdens (distributive justice)

Name the rules of healthcare ethics.

Informed consent, confidentiality, veracity (truth-telling), fidelity (loyalty)

What is the focus of professional ethics?

Supporting pharmacist-patient relationship and relationship to the society at large

What is conscientious objection?

RPh has the right to practice conscientious objection, but not the right to prevent pt from receiving lawfully available service

What entities enact statutes?

Legislatures, such as Congress or state legislatures

What entities promulgate regulations?

Administrative agencies, such as the FDA or state BOP

What entities pass ordinances?

Local governments, such as cities or counties

What is the objective of criminal actions?

To deter, punish, or rehabilitate

What is the objective of civil actions?

To compensate the injured party

What is the objective of administrative actions?

Disciplinary determination: warning, fines, license revoked/suspended/probation

In the US Federal Court system, what cases does the US Supreme Court have original jurisdiction over?

Cases involving ambassadors, public ministers, consuls, or when a state is a party

Which clause of the U.S. Constitution gives the federal government authority to regulate drugs?

Interstate Commerce Clause

Which act prohibited adulteration and misbranding of drugs in interstate commerce?

Pure Food and Drug Act of 1906

How does the FDA directly regulate vs indirectly regulate?

FDA rulemaking authority is direct, issuing guidance documents is indirect.

Under the FDCA, what is considered a drug?

Articles recognized by USP, official homeopathic pharmacopeia, or NF; Articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease; Articles other than food intended to affect the structure or any function of the body

What must be present to allow dietary supplement manufacturers to make health claims not approved by FDA?

Claims are not false or misleading and are accompanied by an FDA disclaimer

What are the requirements for recall communication?

Mfg must notify seller and seller must notify consumer. Written notes for class 1-3 recalls sent by first-class mail with envelope marked in red URGENT: DRUG RECALL

What is the highest safety-related warning that medications can have assigned by the FDA called?

Box Warning

What is REMS?

Drug safety program FDA requires to certain drugs to ensure benefits outweigh the risks. Reinforce medication use behaviors and actions that support safe use of medication

how long are the records of controls substances required to be kept?

Records must be kept for 2 years

What is the limit on the number of dosage units is a pharmacy allowed to distribute to another registrant a year?

Total number of dosage units distributed to another registrant must not exceed 5% of total units of CSs distributed in one year

Must a practitioner keep records of controlled substances prescribed?

Practitioner does not need to keep records of CSs administered unless they regularly engage in dispensing/administering and charges patients

What form is required for distribution of C1 or C2 drugs?

DEA form 222

How quickly must a registrant notify the DEA of theft or significant loss of any controlled substance?

Within 1 day of discovery

What databases must physicians and dispensing pharmacist refer to prior to prescribing or dispensing a controlled substance?

FL PDMP

What is the acute pain prescribing limit in Florida?

Base 3 days supply; 7 days with prescriber judgement and ACUTE PAIN EXCEPTION on prescription

What CEs pertaining to CSs must PAs complete?

File with DOH affidavit for minimum 10 hours of CME in the specialty the PA has prescriptive privileges with each licensure renewal; 3 out of 10 hours must be on safe and effective use of CSs

What CEs pertaining to CSs must ARNPs complete?

ARNPs must complete at least 3 hours of CE on safe and effective prescribing of controlled substance medications

Are PAs or ARNPs allowed to prescribe or dispense controlled substance in pain management clinic?

Only licensed physician may dispense or prescribe CSs on premises of a registered pain management clinic; PAs and ARNPs are not allowed

Define Expedited Partner Therapy

Allows physicians and ARNP to use EPT as method to treat patients and their sexual partners with diagnosed STD when the sexual partner is unlikely or unable to seek treatment