RX law Flashcards
The Pharmacist is responsible for: (9)
Certification of medical and prescription orders
Verifying prescriptions
Initialing orders and making appropriate comments
Providing patient counseling
Providing direct patient care services
Providing drug information to patients, caregivers, and health care providers
Supervision of compounding
Selecting drugs and suppliers
Daily opening and closing of a pharmacy
The CPPA must be filed with the licensing boards for all practitioners participating in the agreement no later than _______ following the effective date
The CPPA must be filed with the licensing boards for all practitioners participating in the agreement no later than 30 days following the effective date.
CPPA agreement must be reviewed every _____
Agreement must be reviewed every 2 years.
How old must the patient be to recieve CPPA (Collaborative pharamcy practice agreement) Contraception
Patient must be at least 18 years old or an emancipated minor.
What does the pharmacist provide the patient with during a CPPA Contraception?
Provides the patient with a self-screening risk assessment tool.
Under a state collaborative pharmacy practice agreement (CPPA), a trained pharmacist can furnish naloxone to: (5)
Persons who are currently using opioids or have a history of opioid use
Persons with a history of opioid intoxication, overdose, and/or recipients of emergency medical care for acute opioid poisoning;
Prisoners recently released from correctional facilities
Persons recently released from opioid detoxification abstinence programs;
Persons entering methadone maintenance treatment programs (for addiction or pain)
When a PIC leaves, the old and new PIC must perform a
When a PIC leaves, the old and new PIC must perform a controlled substances inventory together.
A pharmacist can only be the PIC for ___ pharmacy.
A pharmacist can only be the PIC for one pharmacy.
The PIC must be on duty at least ___% of the hours that the pharmacy is open.
The PIC must be on duty at least 50% of the hours that the pharmacy is open.
The PIC is not required to be on duty for more than __ hours a week.
The PIC is not required to be on duty for more than 40 hours a week.
A pharmacist can supervise ___ intern at a time.
A pharmacist can supervise one intern at a time.
Role of the Pharmacy Technician: (2)
A registered pharmacy technician processes and packages prescriptions.
Technicians can also make the offer for counseling for refills.
In addition to what all registered technicians can do, a certified technician may also: (3)
Receive new or transferred oral prescriptions
Receive and transfer copies of oral prescriptions between pharmacies
Participate in a tech-check-tech program
A single pharmacist can supervise ___ pharmacy technicians.
A single pharmacist can supervise 2 pharmacy technicians.
The PIC can ask the board for an increase for up to ___ technicians per pharmacist as long as the additional technicians are certified.
The PIC can ask the board for an increase for up to 4 technicians per pharmacist as long as the additional technicians are certified
Clerks are non‐licensed personnel with no specific training required and can perform the following tasks: (4)
Accept prescriptions at the “drop off” window
Verify patient’s insurance coverage
Type prescriptions
Complete the transaction at the point of sale or the “pick up” window
Can Clerks make the offer for counseling?
Clerks can make the offer for counseling for refills only.
A prescription shall contain the following information: (7)
Prescriber's name Practitiioner's signature Date of issuance Patient's name Name, strength, dosage form, and quantity of drug Directions for use Any refills authorized
How long should the prescription records be kept?
Records should be kept 2 years from the last day dispensed
Prescriptions for schedule II drugs must be:
Prescriptions for schedule II drugs must be written on a separate prescription form
If a prescription contains a schedule II drug and other types of drugs, a ______ can transfer the prescription for the other drugs to another form:
If a prescription contains a schedule II drug and other types of drugs, a pharmacist, intern, or technician can transfer the prescription for the other drugs to another form:
How can a pharmacist, intern, or technician can transfer the prescription for the other drugs to another form:
This can be done by scanning, photocopying, or writing by hand
It does not need to be on a tamper-resistant form
This is considered a valid prescription form and can serve as the original
Doctor of Osteopathic Medicine have unlimited prescribing or limited prescribing authority?
Unlimited Prescribing Authority
Medical Doctor have unlimited prescribing or limited prescribing authority?
Unlimited Prescribing Authority
Naturopathic Doctor have unlimited prescribing or limited prescribing authority?
Limited or No Prescribing Authority
Doctor of Oriental Medicine have unlimited prescribing or limited prescribing authority?
Limited or No Prescribing Authority
Ophthalmologist have unlimited prescribing or limited prescribing authority?
Unlimited Prescribing Authority
Optometrist have unlimited prescribing or limited prescribing authority?
Limited or No Prescribing Authority
Psychiatrist have unlimited prescribing or limited prescribing authority?
Unlimited Prescribing Authority
Psychologist have unlimited prescribing or limited prescribing authority?
Limited or No Prescribing Authority
Orthopedist have unlimited prescribing or limited prescribing authority?
Unlimited Prescribing Authority
Chiropractor have unlimited prescribing or limited prescribing authority?
Limited or No Prescribing Authority
Each condition must be met for a valid doctor/patient relationship (4)
A patient has a medical complaint
A medical history has been taken
A face-to-face physical examination
A logical connection between the condition and the drug
Is Self-prescribing, providing, or administering controlled substances allowed in the state of Tennessee.
No, Self-prescribing, providing, or administering controlled substances is NOT allowed in the state of Tennessee.
No scheduled drugs should be dispensed or prescribed for immediate family except in
No scheduled drugs should be dispensed or prescribed for immediate family except in emergency situations.
Prescriptions from Deceased Prescribers
Non-controlled drugs: New script is valid for?
Up to 90 days after the prescriber has died
Prescriptions from Deceased Prescribers
Non-controlled drugs: Refills are valid for?
Up to 180 days after the prescriber has died
Prescriptions from Deceased Prescribers
Schedule III-V drugs: New and refills are valid for?
Up to 90 days after the prescriber has died
– Wrong
DEA laws do NOT allow filling of any controlled substances to be filled after a prescriber dies.
Prescriptions from Deceased Prescribers
Schedule II drugs: New and refills are valid for?
Not valid after prescriber dies
In the United States, once a drug has been FDA approved for at least one indication, physicians are legally allowed to prescribe it for any other reason they feel is both ____ and ____ for the patient’s health condition.
In the United States, once a drug has been FDA approved for at least one indication, physicians are legally allowed to prescribe it for any other reason they feel is both safe and effective for the patient’s health condition.
Errors or omissions on a prescription for _____ can be revised by the pharmacist if it is minor or after consultation/documentation with the prescriber if it is significant.
Errors or omissions on a prescription for non-controlled drugs can be revised by the pharmacist if it is minor or after consultation/documentation with the prescriber if it is significant.
Expiration and Refill limit for Non-scheduled
Expiration - 1 year from written date
Refill Limit - No limit
Expiration and Refill limit for Schedule II
Expiration - 1 year from written date
Refill Limit - 0 refills
Expiration and Refill limit for Schedule III
Expiration - 6 months from written date
Refill Limit - 5 refills
Expiration and Refill limit for Schedule IV
Expiration - 6 months from written date
Refill Limit - 5 refills
Expiration and Refill limit for Schedule V
Expiration - 1 year from written date
Refill Limit - No limit
Prescriptions for opioids and benzodiazepines may not be dispensed in quantities exceeding a ___-day supply.
Prescriptions for opioids and benzodiazepines may not be dispensed in quantities exceeding a 30-day supply.
The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (3)
(a) Each partial filling is recorded in the same manner as a refilling,
(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and
(c) No dispensing occurs after 6 months after the date on which the prescription was issued.
PRN refills can be dispensed up to:
The prescriber’s specified date, or
Up to one year from date originally issued or dispensed (whichever comes first)
A pharmacist can dispense an emergency refill to a patient without proper authorization for a maximum of a _____ supply
A pharmacist can dispense an emergency refill to a patient without proper authorization for a maximum of a 72-hour supply
A pharmacist can dispense an emergency refill to a patient without proper authorization for a maximum of a 72-hour supply, if: (3)
Drug is maintenance therapy
Patient will suffer without the drug
Drug is not a controlled substance
If proper authorization cannot be obtained during the 72-hour period of an Emergency refill, then the pharmacist
If proper authorization cannot be obtained during the 72-hour period, then the pharmacist may dispense one additional consecutive 72-hour period.
Medical and prescription orders shall be transferred between pharmacy practice sites for the purpose of compounding and dispensing provided that the transferee, upon receiving such order directly from the transferor, records the following: (6)
- The name, address and original medical or prescription order serial number at the pharmacy practice site from which the order was transferred;
- The name of the transferor; and
- Date the order was originally issued and dispensed; 4. Original number of refills authorized on the original order;
- Date of last dispensing; and (iv) Number of valid refills remaining.
- The transferee informs the patient that the original medical or prescription order has been canceled at the pharmacy practice site from which it was obtained.
What must the Transferring Pharmacy record on the back of the prescription? (3)
The name and address of the receiving pharmacy,
the name of receiving pharmacist/technician, and transfer date is written on the back
Prescription Label Requirements (10)
Name and address of dispenser Pharmacy phone number Prescriber's name Patients name Prescription number Date of filling Expiration date Drug name and strength Directions for use Cautionary statements
The expiration date for multiple use containers is no later than either of the following:
The expiration date on the manufacturer’s container
One year from the date the drug is dispensed, whichever is earlier
Which act requires the use of child-resistant (C-R) containers for most OTCs, prescription drugs, and household chemicals
The Poison Prevention Packaging Act of 1970 requires the use of child-resistant (C-R) containers for most OTCs, prescription drugs, and household chemicals.
The prescriber can waive the use of C-R packaging for a single prescription at a time. The patient can provide a blanket waiver.
What are 5 exemptions to child resistant packaging?
Examples of exemptions:
- Sublingual nitroglycerin
- Sublingual and chewable forms of isosorbide dinitrate
- Hormone replacement therapy products that rely solely upon the activity of one or more progestin or estrogen substances, including oral contraceptive tablets and medroxyprogesterone (Provera) tablets
- Effervescent aspirin and effervescent acetaminophen
Labeling Requirements for Unit Dose Containers (6)
The drug name The quantity of the active ingredient The beyond use date The lot number The name of the manufacturer, packager, or distributor Any statements required by a compendia
The beyond use date for unit dose containers is no later than either of the following: 2
One year from the date the drug is dispensed
Expiration date on manufacturer’s container
Information required on a Med Pak label: 9 -10
Patient’s name
Prescription number for the patient med pak itself and a separate prescription number for each drug in the med pak
The name, strength, physical description, and total quantity of each drug
Direction for use
Storage,
cautionary statements
The name of the prescriber for each drug
Date of preparation
Beyond use date (no later than 60 days from the date of preparation)
The name, address, and telephone number of the pharmacy and the pharmacy’s registration number, if scheduled drug enclosed
when must a pharmacist perfome prospective DURs (Drug utilization Reviews)
Pharmacists must perform prospective DURs for all patients prior to dispensing a prescription.
How long must a Patient profile be kept?
Profile is kept for 2 years from last dispensing date
What should be included in a patient profile? 6
Patient’s name, address, telephone number
Gender
Date of birth
Drug allergies or intolerances, Adverse drug reactions, Disease state information
Medications –> Prescription, OTC, Natural products, AND medical devices
Three types of written information that can be given with a prescription:
Consumer Medication Information (CMI)
Patient Package Insert (PPI)
Medication Guide (MedGuide)
Which ones are approved by the FDA?
PPIs and MedGuides are approved by the FDA, while CMIs are not.
Dispensing drugs without the required written information is considered what?
Dispensing drugs without the required written information is considered misbranding.
When must CMIs (Consumer medication Information) be provided to patients?
CMIs must be provided to patients for every drug each time a new prescription is dispensed.
CMIs are developed by third party vendors (not the manufacturers), and are not approved by the FDA.
Patient package inserts (PPIs) for estrogen-containing drugs and oral contraceptives must be given to patients: 2
Every time the drug is dispensed in the outpatient setting
Prior to the administration of the first dose, then every 30 days in the institutionalized setting
PPIs are written by the manufacturers and approved by the FDA.
Who must supply the med guides?
The manufacturer must supply the MedGuides:
MedGuides are FDA-approved patient handouts that come with many prescription medicines that may have a serious and significant public health concern.
The MedGuide must be given: (5)
Every time the drug is dispensed to the patient in the outpatient setting
When the patient or patient’s caregiver requests it
If the MedGuide has been revised
If the drug is subject to a Risk Evaluation and Mitigation Strategy (REMS) that requires a MedGuide.
The first time the drug is being dispensed to a healthcare provider for administration to a patient in an outpatient setting
____ is an FDA-approved plan to reduce known risk with drugs with significant safety issues.
REMS is an FDA-approved plan to reduce known risk with drugs with significant safety issues.
What is the purpose of the iPLEDGE program
The purpose of the iPLEDGE Program for isotretinoin is to prevent severe birth defects by ensuring that:
No female patient starts isotretinoin therapy if pregnant
No female patient on isotretinoin therapy becomes pregnant
Females must use 2 forms of effective contraception (birth control) simultaneously.
