laws and ethics Flashcards
Regulatory agencies for pharmacy
Centers for Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), The Joint Commission, Occupational Safety and Health Administrations (OSHA), State Board of Pharmacy (SBOP)
FDCA Requirements for prescription labels
- Name + address of the pharmacy
- Serial number of the prescription (Rx number)
- Date of the prescription or its date of filling or refilling
- Name of the prescriber
- Name of the patient
- Directions for use
State law and requirements for prescription labels
- address of the patient
- initials or name of the dispensing pharmacist
- telephone number of the pharmacy
- drug name, strength, and manufacturer’s lot or control number
- expiration date of the drug
- name of the manufacturer
- amount of the drug dispensed
- refill information
legend drug requirements
- name and quantity of active ingredients
- amount of drug in container
- usual dosage of the drug
- federal legend
- route of administration
- a federal warning, if the drug is habit-forming
- name of all inactive ingredients
- lot or control number of the drugs in the container
- statement specifying the type of container to be used in dispensing
- the name and location of the manufacturer, packer, and distributer
- expiration date
FDA package insert requirements
- chemical structure of the drug, its clinical pharmacology, its indications, and its usage
- situations in which the drug should not be used (contraindications)
- warnings of side effects
- list of possible adverse reactions
- warnings of the potential for drug abuse and dependence
- usual dosage
- date of the most recent revision to the label
- how the drug is supplied
OTC drugs
- product name
- name and address of the manufacturer, distributor, repacker, and others
- established name of all active ingredients and the quantities of certain other ingredients
- total net contents
- any applicable cautions and warnings (required)
- name of any habit-forming drug that might be an ingredient
- directions for sage and effective use
contraceptives (auxiliary labels)
take as directed
NSAIDS (auxiliary labels)
may cause dizziness or drowsiness
narcotics (auxiliary labels)
this drug alone or with alcohol may impair your ability to drive
antibiotics (auxiliary labels)
take until gone
sulfa (auxiliary labels)
may cause sensitivity to light. take on an empty stomach and take with plenty of water
warafin (auxiliary labels)
do not take aspirin
C-1 Drugs
- no accredited medical use + no accepted safety standard
- high potential for abuse
- heroin
- LSD
- Marijuana
C-2 Drugs
- accepted medical use + high potential for abuse/ risk of dependence
- hydromorphone (dilaudid)
- methadone (dolophine)
- morphine
- codeine
- hydrocodone
C-3 Drugs
- accepted medical used + less potential for abuse than drugs in C-2
- moderate risk of physical or psychological dependence
- vicodin
- lortab
- tylenol
- anabolic steroids
C-4 drugs
- accepted medical use + less potential for abuse than druge in C-2 and C-3
- limited risk of dependence
- valium
- xanax
Drug approval process (phase 1)
clinical trials for maximum safe dose of the drug
Drug approval process (phase 2)
clinal trials for effectiveness of the drug
Drug approval process (phase 3)
double-blind study
Drug approval process (phase 4)
FDA ongoing approvals
medication modernization act of 2003
allows Medicare beneficiaries the opportunity to enroll in Medicare Advantage, or Medicare Part D, a voluntary prescription drug benefit plan for seniors
drug addiction treatment act of 2000
permits physicians who complete a training course and who register with the DEA to prescribe approved C-3, C-4, and C-5 medications as a means of maintenance or detoxification to patients with opioid addiction
health insurance portability and accountability act (HIPAA)
provides protections for patient confidentiality and privacy
dietary supplement health and education act of 1994
amended the federal food, drug, and cosmetic act to establish standards with respect to dietary supplements
consequentialism
the value of an action derives solely from the value of its consequences
nonconsequentialism
certain actions, in and of themselves, are wrong
social contracts
understood agreements between individual members of a society that lead to certain expectations of each other
rights-based ethics
theory based on a belief in human rights. Individuals in a democratic society should be allowed to do what they want without interference from outside forces
ethics of care
requires caregivers to focus on moral skills such as kindness, sensitivity, attentiveness, tact, patience, and reliability
principle-based ethics
theory based on a belief in universal guides to action. Personal approach in that the individuals moral beliefs guide action
virtue-based ethics
theory based on specific, idealized morals or virtues. An ideal-world approach, everyone agrees on what is correct or virtuous
law
a formalized, enforceable system of rules
patient bill of rights
- right to be treated with respect
- right to participate in your own healthcare
- right to access your medical records
- right for a second opinion about diagnoses and treatments
- right to confidentiality
- right to have a family member with you when discussing your healthcare
- right to know the names and titles/roles of healthcare staff
- right to be examined in private
- right to ask questions and express concerns
