Exam 3
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360 Terms
What does OBRA stand for?
Omnibus Budget Reconciliation Act.
Why is OBRA ’90 important to pharmacy?
It was the first federal law to directly regulate pharmacy practice standards.
What was the primary goal of OBRA ’90?
To save money and reduce healthcare costs.
What model of pharmacy care did OBRA ’90 adopt?
The pharmaceutical care (pharmacist care) model.
What does pharmaceutical care focus on?
Pharmacists taking responsibility for patient care and medication-related needs.
What did OBRA ’90 require states to establish?
minimum standards for pharmacy practice.
Who must adopt the minimum pharmacy practice requirements?
Individual states must adopt them.
What happens if states do not establish the required standards?
they risk losing federal Medicaid funding.
Why did OBRA ’90 connect pharmacy standards to Medicaid funding?
To encourage states to establish and enforce minimum pharmacy practice standards.
What is one major part of OBRA ’90's basic framework?
Drug manufacturer rebates to the Medicaid program.
What does OBRA ’90 require drug manufacturers to provide to Medicaid?
Their drugs at their “best price.”
What does “best price” mean?
The lowest price at which a manufacturer sells a drug to any customer.
How does Medicaid receive the manufacturer rebate?
The manufacturer pays the state the difference between the Average Manufacturer Price (AMP) and the best price.
What is the purpose of manufacturer rebates under OBRA ’90?
to help Medicaid save money on prescription drugs.
Who receives the manufacturer rebate?
The state Medicaid program.
What did OBRA ’90 fund?
Demonstration projects.
What was the purpose of the demonstration projects funded by OBRA ’90?
To evaluate whether Drug Utilization Review (DUR) requirements improved patient care and decreased healthcare costs.
What does DUR stand for?
Drug Utilization Review.
What were the two main goals evaluated in the demonstration projects?
Improved patient care.
Decreased healthcare costs.
What did OBRA ’90 establish regarding DUR?
Two types of Drug Utilization Review programs.
What are the two types of DUR programs established by OBRA ’90?
Retrospective DUR
Prospective DUR
What is prospective DUR?
Reviewing a patient's medication therapy before the medication is dispensed.
What is retrospective DUR?
Reviewing a patient's medication use after the medication has been dispensed or used.
What is the purpose of the DUR board?
To oversee retrospective Drug Utilization Review (DUR).
What must each state establish for retrospective DUR?
A DUR board made up of physicians and pharmacists.
What does the DUR board review?
Medication use data.
What does the DUR board compare medication use data against?
Target criteria (standards used to evaluate appropriate medication use).
What happens when a provider does not meet the target criteria?
the DUR board can recommend and establish educational programs for that provider.
What authority does the DUR board have?
It can recommend and establish educational programs for providers who are not meeting target criteria.
What is the purpose of Prospective DUR?
To evaluate 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 can the DUR board do with data generated from Pro-DUR?
Examine the data to determine whether drug use problems are being resolved or continuing.
What are the two things the DUR board looks for when reviewing Pro-DUR data?
Whether drug use problems are being resolved.
Whether drug use problems are continuing.
What are the three main components of Prospective DUR?
Screening
Counseling
Patient profile
What is the purpose of screening in Pro-DUR?
Pharmacists must detect potential drug use problems before the prescription is dispensed.
How many general categories of potential drug use problems does OBRA identify for screening?
Seven general categories.
Does computer software replace a pharmacist's professional judgment during screening?
No. Computer software helps identify potential problems, but pharmacists must use their professional judgment.
What does OBRA require pharmacists to do regarding patient counseling?
Make an offer to counsel the patient or caregiver.
Who can receive counseling from the pharmacist?
the patient or the patient's caregiver.
Does OBRA require pharmacists to follow a specific counseling script?
No. OBRA lists information that counseling could include, but pharmacists use their professional judgment to determine the counseling content.
What does the phrase "common severe side effect" generally mean?
Common OR severe side effects.
Who may make the offer to counsel in some states?
Ancillary personnel or other methods may be used in some states.
Do all states have the same requirements for offering counseling?
No. Some states allow ancillary personnel or other methods to make the offer, while others require counseling.
Can a patient refuse or decline counseling?
Yes. Patients have the right to waive counseling.
What does OBRA require pharmacies to do regarding patient profiles?
Obtain, record, and maintain specific patient information.
Why is reviewing the patient profile important before dispensing a prescription?
It helps pharmacists identify potential medication problems and provide appropriate counseling.
How does the patient profile help with screening and counseling?
It provides important patient information that helps pharmacists detect potential drug therapy problems and determine what counseling is needed.
When must a pharmacist conduct a prospective drug review?
Before each new prescription is dispensed or delivered to a patient.
What is the purpose of a prospective drug review under MGL Chapter 94C, Section 21A?
To identify potential drug therapy problems before the patient receives the medication.
What are the potential drug therapy problems a pharmacist must screen for?
Therapeutic duplication.
Drug-disease contraindications.
Drug interactions, including serious interactions with OTC medications.
Incorrect drug dosage.
Incorrect duration of drug treatment.
Drug allergy interactions.
Clinical abuse or misuse.
All of the above
What is therapeutic duplication?
When a patient is prescribed two or more medications that have similar therapeutic effects unnecessarily.
What is a drug-disease contraindication?
When a medication may be harmful because of a patient's existing medical condition.
Does prospective drug review include interactions with OTC medications?
Yes. Pharmacists must screen for serious interactions with nonprescription and OTC medications.
What must a pharmacist do when someone presents a new prescription?
Offer to counsel the patient.
How can a pharmacist or their designee offer counseling?
Face-to-face communication with the patient.
Telephone communication.
Are there exceptions to the usual face-to-face or telephone counseling methods?
Yes. Alternative counseling methods may be used when the patient's needs or availability require them.
What happens if a patient chooses to have their prescription delivered somewhere other than a pharmacy?
The pharmacy can meet counseling requirements by providing access to a toll-free telephone service.
What is the purpose of the toll-free telephone service?
To allow the patient to communicate with the pharmacist at the pharmacy.
Where must the toll-free telephone number appear?
On a label attached to each prescription drug container dispensed to the patient.
What counseling methods are acceptable for medical assistance and third-party reimbursement programs?
Any of the previously listed counseling methods or a combination of them.
What must a pharmacist do if a patient accepts the offer to counsel?
Counsel the patient to the extent the pharmacist considers appropriate.
Who determines how much counseling is appropriate for the patient?
The pharmacist, using professional judgment.
What are the 8 types of information that pharmacist counseling may include?
Name and description of the medication.
Dosage form, dosage, route of administration, and duration of therapy.
Special instructions and precautions for preparing, administering, and using the medication.
Common or severe side effects, interactions, and contraindications, including how to avoid them and what to do if they occur.
Techniques for monitoring medication therapy.
Proper medication storage.
Prescription refill information.
What to do if a dose is missed.
All of the above
What should a pharmacist explain about a medication's dosage?
The dosage form, amount to take, route of administration, and duration of treatment.
What should a pharmacist explain about medication side effects?
Common or severe side effects, possible interactions, contraindications, how to avoid them, and what to do if they occur.
What does self-monitoring drug therapy mean?
Teaching patients how to monitor their own response to medication and recognize potential problems.
What missed-dose information should pharmacists provide?
Instructions explaining what the patient should do if they forget to take a dose.
Is a pharmacist required to counsel a patient who declines the offer?
No. Pharmacists are not required to provide counseling if the patient declines the offer.
When must a pharmacist conduct a prospective DUR under 247 CMR 9.17?
Before each new prescription or medication order is dispensed or delivered to a patient or their agent.
What can a pharmacist review when conducting a prospective DUR?
Computerized alerts.
The patient's medication record.
Each new and renewed prescription or medication order.
What is the purpose of prospective DUR under 247 CMR 9.17?
To promote appropriate medication therapy by identifying potential drug-related problems.
What are the 10 potential drug therapy problems pharmacists must make a reasonable effort to identify?
Over-utilization or under-utilization.
Therapeutic duplication.
Drug-disease contraindications.
Drug-drug interactions.
Drug-food interactions.
Incorrect dosage or duration of treatment.
Drug-allergy interactions.
Abuse or misuse.
Significant changes in the drug, dose, or directions.
Age-related contraindications.
All of the above
What are the 10 potential drug therapy problems pharmacists must make a reasonable effort to identify under 247 CMR 9.17?
Over/under-utilization, therapeutic duplication, drug-disease contraindications, drug-drug interactions, drug-food interactions, incorrect dosage or duration, drug-allergy interactions, abuse or misuse, significant medication changes, and age-related contraindications.
What is over-utilization?
When a patient uses more medication than necessary or prescribed.
What is under-utilization?
When a patient uses less medication than prescribed or needed.
What is therapeutic duplication?
When a patient takes two or more medications with similar therapeutic effects unnecessarily.
What is a drug-disease contraindication?
When a medication may be harmful because of the patient's medical condition.
What is a drug-drug interaction?
When two or more medications interact and affect each other's safety or effectiveness.
What is a drug-food interaction?
When food or beverages affect how a medication works or is absorbed.
What dosage-related problems must pharmacists identify?
Incorrect medication dosage or incorrect duration of drug treatment
What is a drug-allergy interaction?
When a patient is prescribed a medication they are allergic to or that may cause an allergic reaction.
What must pharmacists look for regarding medication abuse or misuse?
Signs that a patient may be using medication improperly or inappropriately.
What significant medication changes must pharmacists identify?
Changes in the medication, dosage, or directions for use.
What are age-related contraindications?
When a medication may be unsafe or inappropriate because of the patient's age.
What must a pharmacist do after identifying a potential drug therapy problem during a prospective DUR?
The pharmacist must take appropriate steps to ensure proper patient care. This may include:
Consulting with the prescribing practitioner.
Directly consulting with the patient or the patient's agent.
Documenting any actions taken in response to the drug utilization review.
What sources can pharmacists use as current standards when conducting a prospective DUR under 247 CMR 9.17(3)?
American Hospital Formulary Service Drug Information
United States Pharmacopeia Drug Information
American Medical Association Drug Evaluations
Plumb's Veterinary Drug Handbook
Other peer-reviewed medical literature
All of the above
Who must be offered pharmacist counseling services when receiving a prescription medication?
Every person who receives a prescription medication must be offered counseling by a pharmacist or the pharmacist's designee.
What responsibility does the pharmacist have when using a designee to offer counseling?
The pharmacist must ensure the designee is appropriately trained to make the offer to counsel.
Who is legally allowed to counsel a patient under 247 CMR 9.18?
only a licensed pharmacist and a pharmacy intern
When must a pharmacist or pharmacy intern provide counseling?
Every new drug therapy.
Any drug therapy that the pharmacist considers significant to the patient's health and safety, based on professional judgment.
What is the pharmacist's responsibility when counseling a patient about a prescription?
The pharmacist or pharmacy intern must provide the information they believe is necessary for the patient to understand how to properly use their prescription.
What administration instructions may be included in patient counseling?
Dosage form (tablet, capsule, liquid, etc.).
Dose.
Route of administration (oral, topical, injection, etc.).
Duration of therapy (how long to take it).
All of the above
What special instructions may be included in patient counseling?
Special directions for preparing, administering, and using the medication correctly.
What self-monitoring information may be included in patient counseling?
Techniques the patient can use to monitor their drug therapy, such as checking blood pressure or blood glucose when appropriate.
What storage and disposal information may be included in patient counseling?
How to properly store and dispose of the medication.
What prescription information may be included in patient counseling?
Information about prescription refills.
What should a patient be told to do if they miss a dose or experience an adverse reaction?
The pharmacist or pharmacy intern may explain what action the patient should take if they miss a dose or experience an adverse reaction.
What is a pharmacy required to have for private patient counseling?
A designated patient consultation area that:
Has a sign stating "Patient Consultation Area."
Provides adequate visual and auditory privacy for confidential counseling.
Can be accessed from outside the prescription dispensing area without going through a stockroom or prescription dispensing area.
What are the requirements for the patient counseling rights sign?
Must be at least 11 inches tall by 14 inches wide.
Must be placed conspicuously next to each prescription dispensing area.
Letters must be at least ½ inch tall.
Must inform customers of their right to pharmacist counseling.
When must a pharmacy make counseling available?
Counseling must be available at all times when the pharmacy is open for business.