Federal Regulation of Pharmacy Practice (Ch. 6)
Call Kai
Learn
Practice Test
Spaced Repetition
Match
Flashcards
Knowt Play1/110
Earn XP
Description and Tags
Chapter 6 (left off on slide 19)
111 Terms
What was the first federal law to directly regulate pharmacy practice standards?
The Omnibus Budget Reconciliation Act (OBRA) of 1990.
What was the primary goal of OBRA '90?
To save money in healthcare.
What model of pharmacy care did OBRA '90 adopt?
The pharmaceutical care (pharmacist care) model.
What is the pharmaceutical care model?
A model where pharmacists take responsibility for patient medication care.
What does OBRA '90 require states to establish?
Minimum standards for pharmacy practice.
Why must states establish OBRA '90 standards?
To continue receiving federal Medicaid funding.
What happens if states do not establish the required standards?
They risk losing federal Medicaid funding.
Who must adopt the minimum requirements established by OBRA '90?
Individual states must adopt and establish them.
Did OBRA '90 create the pharmaceutical care model?
No. It adopted a model that pharmacy had already developed.
What is the main purpose of OBRA '90 in pharmacy practice?
To establish minimum federal requirements and promote pharmaceutical care.
What does OBRA '90 require drug manufacturers to provide to the Medicaid program?
Drug products at their "best price."
What does "best price" mean under OBRA '90?
The lowest price at which a manufacturer sells a drug to any customer.
How does OBRA '90 help Medicaid receive the manufacturer's best price?
Manufacturers must pay rebates to the state.
How is the manufacturer's rebate amount calculated?
The difference between the Average Manufacturer Price (AMP) and the manufacturer's best price.
What is a drug rebate under OBRA '90?
Money the manufacturer pays back to the state to make up the difference between AMP and the best price.
Who receives the drug rebates under OBRA '90?
The state Medicaid program.
What is the main purpose of OBRA '90's rebate requirement?
To help Medicaid obtain lower drug prices and reduce healthcare costs.
What did OBRA '90 fund demonstration projects to evaluate?
Whether Drug Utilization Review (DUR) requirements would improve patient care and decrease healthcare costs.
What does DUR stand for?
Drug Utilization Review
What were the two main goals of the DUR demonstration projects?
Improve patient care.
Decrease healthcare costs.
Why did OBRA '90 fund demonstration projects?
To determine whether DUR requirements were effective in improving patient care while reducing costs.
How many types of DUR programs does OBRA '90 establish?
two types, retrospective and prospective
What are the two types of DUR programs established by OBRA '90?
Retrospective DUR
Prospective DUR
What is retrospective DUR?
A review of a patient's medication use after the medications have been dispensed.
What is prospective DUR?
A review of a patient's medication therapy before the medication is dispensed.
What must each state establish for retrospective DUR?
A DUR board made up of physicians and pharmacists.
What is the purpose of the DUR board?
To oversee retrospective Drug Utilization Review (DUR).
What does the DUR board review?
Medication use data and compares it to target criteria.
What are target criteria?
Standards used to evaluate whether medications are being used appropriately.
What authority does the DUR board have if providers are not meeting target criteria?
It can recommend and establish educational programs for those providers.
Who may receive educational programs from the DUR board?
Healthcare providers who are not meeting the target criteria.
What is the main purpose of retrospective DUR?
To review medication use, identify problems, and help improve prescribing practices through provider education.
What is Prospective Drug Utilization Review (Pro-DUR)?
A review of a patient's prescribed drug therapy before the prescription is dispensed.
When does Prospective DUR take place?
Before the medication is dispensed to the patient.
What is the purpose of Prospective DUR?
To evaluate a patient's prescribed drug therapy before the medication is dispensed.
What can the DUR board do with data collected from Prospective DUR?
Examine the data to determine whether drug use problems are being resolved or continuing.
What does the DUR board look for when reviewing Pro-DUR data?
Whether medication use problems are improving or still occurring.
What is the difference between Retrospective DUR and Prospective DUR?
Retrospective DUR: Reviews medication use after dispensing.
Prospective DUR: Reviews prescribed drug therapy before dispensing.
What is the first component of Prospective DUR?
Screening
What must pharmacists do during the screening process during a prospective DUR?
Detect potential drug use problems before the prescription is dispensed.
How many general categories of potential drug use problems does OBRA '90 identify for screening?
Seven general categories.
What is the purpose of screening during Prospective DUR?
To identify potential medication-related problems before the patient receives the medication.
Does computer software replace a pharmacist's professional judgment during Pro-DUR?
No. Computer software helps identify potential problems, but pharmacists must still use their professional judgment.
Why is a pharmacist's professional judgment important during Pro-DUR?
Software cannot replace the pharmacist's responsibility to evaluate potential drug use problems.
What does OBRA '90 require pharmacists to do regarding patient counseling?
Make an "offer to counsel" the patient or their caregiver.
Who can receive an offer to counsel?
The patient or their caregiver.
Does OBRA '90 require pharmacists to follow a specific counseling script?
No. It provides several points that counseling could include, but pharmacists use their professional judgment to determine what information to discuss.
How does a pharmacist determine what information to include during counseling?
By using professional judgment based on the patient's needs.
What does the phrase "common severe side effect" generally mean?
It is generally understood to mean either a common side effect or a severe side effect.
Does a patient have the right to refuse counseling?
Yes. Patients have the right to waive counseling.
What does OBRA '90 require pharmacies to do regarding patient profiles?
Obtain, record, and maintain specific information about each patient.
Why is maintaining a patient profile important?
It provides important patient information that helps pharmacists identify potential medication-related problems.
When should a pharmacist review the patient's profile?
Before dispensing the medication.
Why is reviewing the patient profile before dispensing important?
It is critical for effective medication screening and patient counseling.
What does HIPAA stand for?
Health Insurance Portability and Accountability Act of 1996.
What is the general purpose of HIPAA?
To improve the efficiency and effectiveness of the healthcare system.
What is the main focus of HIPAA regarding health information?
To regulate the privacy and security of health information.
What does HIPAA protect?
The privacy and security of patients' health information
Which government agency enforces HIPAA?
The Department of Health and Human Services (HHS)
What are the two main purposes of HIPAA?
Improve the efficiency and effectiveness of healthcare.
Protect the privacy and security of health information.
What are the four main areas HIPAA targets?
Transaction and code sets.
National provider identities.
Security of health information.
Privacy of health information.
What is the purpose of HIPAA's transaction and code set standards?
To establish uniform standards for electronic claims and data transmission.
Why does HIPAA establish uniform standards for electronic claims and data transmission?
To improve efficiency and lower healthcare costs.
What is the purpose of national provider identities under HIPAA?
To create uniformity and simplicity while reducing costs.
What does HIPAA address regarding health information security?
Protecting the security of health information.
What does HIPAA address regarding health information privacy?
Protecting the privacy of health information.
What is the difference between HIPAA security and privacy?
Security: Protects health information from unauthorized access.
Privacy: Protects how patients' health information is used and shared.
What does HIPAA require covered entities to develop to protect health information?
Physical, technical, and organizational safeguards.
What are the three types of security safeguards required by HIPAA?
Physical safeguards.
Technical safeguards.
Organizational safeguards.
What is the purpose of HIPAA's security safeguards?
To prevent health information from being improperly accessed, altered, deleted, or transmitted.
What does improperly accessing health information mean?
Someone without proper authorization viewing or obtaining protected health information.
Can covered entities choose their own security measures under HIPAA?
Yes. They have flexibility to develop their own security measures.
What must covered entities do when choosing their own security measures?
Ensure their measures meet HIPAA's objectives and standards.
Does HIPAA require every covered entity to use the exact same security procedures?
No. Entities have flexibility as long as they achieve HIPAA's required security objectives and standards.
What is the main focus of HIPAA's privacy requirements?
Protecting patients' rights regarding their health information and controlling how and when that information can be used.
What do HIPAA privacy requirements determine?
How and when a patient's health information may be accessed, used, or shared.
Which government agency is responsible for developing and enforcing HIPAA privacy regulations?
The Department of Health and Human Services (HHS).
Who must comply with HIPAA?
Covered entities and their business associates.
What are covered entities?
Health plans and healthcare providers that conduct certain transactions electronically.
Can a covered entity exempt parts of its operation from HIPAA?
Yes. It may exempt the non-healthcare parts of its operation.
Who are business associates?
Individuals or organizations that perform services for covered entities and handle protected health information (PHI) on their behalf.
What are the two main groups that must comply with HIPAA?
Covered entities and business associates.
What does PHI stand for?
Protected Health Information.
What types of information can be considered PHI?
Both electronic and hard-copy health information.
What must health information relate to in order to qualify as PHI?
A person's past, present, or future physical or mental health, healthcare services provided, or payment for healthcare.
What is the second requirement for information to qualify as PHI?
the information must be able to identify the patient.
Does PHI include both past and future health information?
Yes. It includes information related to a patient's past, present, or future health.
What are the two main requirements for information to be considered PHI?
It must relate to a person's health, healthcare, or payment for healthcare, and it must be able to identify the patient.
Does PHI only include electronic health records?
No. PHI includes both electronic and hard-copy health information.
What is a Notice of Privacy Practices?
A notice that explains how a pharmacy handles patients' protected health information (PHI) and their privacy rights.
What must a pharmacy provide to patients regarding privacy?
A Notice of Privacy Practices containing required information.
Where must the Notice of Privacy Practices be posted?
In a prominent and visible location within the pharmacy.
Who must be able to access the Notice of Privacy Practices?
It must be made available upon request to any person.
What must a pharmacy do if it has a website?
Post its Notice of Privacy Practices on its website.
What was the purpose of the proposed rule to amend the Notice of Privacy Practices?
to make the notice easier for patients to understand.
What information should the updated notice help patients better understand?
The pharmacy's privacy practices and patients' rights regarding their PHI.
What must a pharmacy do regarding the Notice of Privacy Practices?
Make a good-faith effort to provide the notice to patients and obtain a written, signed acknowledgment that they received it.
How often must a pharmacy obtain a patient's acknowledgment of the notice? (Notice of Privacy Practices)
Only once for each patient.
Can a pharmacy refuse treatment if a patient refuses to sign the Notice of Privacy Practices?
No. The pharmacy cannot refuse treatment because the patient refuses to sign.
Can a written Notice of Privacy Practices acknowledgment be obtained in different ways?
Yes. A written acknowledgment may be obtained through several different methods.