Ch. 1 - 4 Flashcards
Intro to Pharmacy Law, Federal Law vs State Law, HIPAA, and Federal and State Regulations Governing Pharmacy
What is law?
a system of principles or a rule of conduct that is designed to handle issues or violations without the use of force
What is pharmacy law?
a collection of laws, standards, and regulations that govern pharmacy practice and the medication supply chain
What does federal pharmacy law encompass?
the production, distribution, and disposal of all medications within the US
Who writes the pharmacy state laws?
they are written and passed by the state legislature and administered by the state board of pharmacy
What is the rule to follow on whether to use federal or state law?
always follow the more strict law
What did the COBRA of 1985 do?
allowed employees leaving a job to elect to continue with the employer’s health coverage
What act was modified by Title I of the HIPAA regulations?
COBRA
What does HIPAA Title II do?
restricts the transferring of healthcare data, allows patients more rights with their protected health info, and put into place a stronger system for securing PHI
What does the Privacy Rule of 2003 do for patients?
it gave patients the rights of confidentiality and protection of their PHI
What do medical records do?
they contain a patient’s jealth information and document all medical history in chronological order
What does HIPAA stand for?
the health insurance portability and accountability act of 1986
The release of PHI information to an outside entity is called this?
disclosure
HIPAA modified this 1985 act to limit exclusions for pre-existing health conditions?
COBRA
What act was passed to ensure the safety of medicinal products in the interstate commerce system?
the Pure Food and Drug Act of 1906
What did the Federal Food, Drug, and Cosmetic Act of 1938 do?
required that products available to the public be proven safe, effective, and properly labeled
What added the provision for the labeling of legend drugs?
The Durham-Humphrey Amendment of 1951
What medications can only be prescribed by a licensed practicioner?
legend drugs
Who enforces the Durham-Humphrey Amendment of 1951?
the FDA
What is the Kefauver-Harris Amendment of 1963?
it requires that all drug manufacturers prove efficacy, safety, and purity of drugs to the FDA before marketing
What led to the Kefauver-Harris Amendment?
the thalidomide tragedy
What is child-resistant packaging?
packaging that is designed to be significantly difficult for children under 5 years old to open or obtain
What is the Combat Methamphetamine Epidemic Act of 2005?
this law was passed to limit the illicit use of methamphetamine by restricting access to medications used in the manufacturing process
What are the limits for methamphetamines sales?
3.6 grams per person per day and no more than 9 grams per person per month
What is the Omnibus Budget Reconciliation Act of 1990?
requires pharmacists to counsel medicaid patients on their medications
