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.
Who must register with the iPLEDGE program?
Wholesalers, prescribers, pharmacist, and patients must register with iPLEDGE.
The Joint Commission requires __ patient identifiers be used in the hospital setting.
The Joint Commission requires 2 patient identifiers be used in the hospital setting.
How must we verify patient’s identification before dispensing Non-controlled substances?
There is no federal or state requirement to verify patient’s identification before dispensing non-controlled substances.
Patient Counseling Requirements for New prescriptions
The pharmacist must counsel all patients on new prescriptions
Any refusal for counseling must be made directly to the pharmacist (not a technician or clerk) – can to certified techs
Patient Counseling Requirements for Refills
The pharmacist or pharmacy staff member must make the offer for counseling to all patients before dispensing refills.
Patient counseling must cover: (8+)
The name and description of the medication.
The dosage form, dose, route of administration, and duration of drug therapy.
Special directions and precautions for preparation, administration, and use by the patient.
Common side effects, adverse effects, interactions, and therapeutic contraindications.
Techniques for self-monitoring drug therapy.
Proper storage.
Prescription refill information.
What to do when a dose is missed.
Which book includes Approved drug products?
Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the “Orange Book”)
FDA Orange Book rating:
A-rated =
B-rated =
A-rated = therapeutically equivalent
B-rated = not therapeutically equivalent (should not be substituted)
AB rating means that it is ok to substitute
The pharmacy must notify the patient and prescriber before substituting the manufacturer of an _____ drug for another manufacturer.
The pharmacy must notify the patient and prescriber before substituting the manufacturer of an anti-epileptic drug for another manufacturer.
Traditional compounding, regulated under 503A, is the preparation of drugs to fit the unique needs of an individual patient pursuant to a prescription: (4)
To change a solid formulation to liquid formulation
To provide a strength that is not commercially available
To add flavoring for palatability
To exclude inactive ingredients that a patient is allergic to
Cannot ship > __% of the total prescription filled across state lines as compounding
Cannot ship > 5% of the total prescription filled across state lines
USP 795, USP 797, and USP 800 standards
795 Non sterile
797 Sterile
800 Hazardious
Which act allowed sterile compounding facilities to voluntarily register as outsourcing facilities under 503B?
The Drug Quality and Security Act of 2013 allowed sterile compounding facilities to voluntarily register as outsourcing facilities under 503B
Outsourcing Facilities (503B)
Needs to meet ____ requirements and be inspected by ____
Can compound drugs in bulk ____ prescriptions for specific patients
___ be shipped across state lines
Needs to meet CGMP requirements and be inspected by FDA
Can compound drugs in bulk without prescriptions for specific patients
Can be shipped across state lines
Who is the Regulatory body for Non-traditional compounding (Outsourcing Facility)
FDA
Who is the Regulatory body for Traditional Compounding
State boards
Who is the Regulatory body for Manufacturing
FDA
Who does the Standards/Regulations for Manufacturing
FDA drug approval process
Labeling with adequate directions for use
CGMPs
Who does the Standards/Regulations for Non-traditional compounding (Outsourcing Facility)
503B - B as in Bitch
CGMPs
Who does the Standards/Regulations for Traditional Compounding
503A - as in Ass
USP standards
Is an Individual Rx Required for Manufacturing
NO
Is an Individual Rx Required for Non-traditional compounding (Outsourcing Facility)
No
Is an Individual Rx Required for Traditional Compounding
Yes
Is there Interstate Distribution for Manufacturing
Yes
Is there Interstate Distribution for Non-traditional compounding (Outsourcing Facility)
Yes
Is there Interstate Distribution for Traditional Compounding
Yes, certain limitations ( <5% rule)
Who has to read OSHA’s Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs
&
The American Society of Health-System Pharmacists (ASHP) technical assistance bulletin on handling cytotoxic and hazardous substances
As part of training to prepare sterile hazardous drugs, staff members must read:
OSHA’s Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs
&
The American Society of Health-System Pharmacists (ASHP) technical assistance bulletin on handling cytotoxic and hazardous substances
Pharmacies that wish to compound must have a
Pharmacies that wish to compound must have a sterile compounding modifier registration.
If the pharmacy prepares high-risk CSPs, the pharmacist must report a record of all high-risk CSPs prepared to the Board every
If the pharmacy prepares high-risk CSPs, the pharmacist must report a record of all high-risk CSPs prepared to the Board every quarter.
Hospitals do NOT need to report
antineoplastics, pregnancy category X, hormones, transplant drugs - are examples of?
Hazardous drugs include: antineoplastics, pregnancy category X, hormones, transplant drugs
Handling Hazardous Drugs
Need how many pairs of Chemotherapy Gloves and Shoe Covers
Chemotherapy Gloves
(two pairs for compounding
Shoe Covers
(two pairs for compounding)
Only ____ drugs and schedule __ drugs can be verified by the telepharmacy and dispensed at the satellite clinic.
Only non-controlled drugs and schedule V drugs can be verified by the telepharmacy and dispensed at the satellite clinic.
What kind of medications can be donated to charitable programs?
Unused prescription drugs can be donated, controlled substances are excluded.
__________ are the best option for patients to dispose of their prescription medication.
Community-based drug “take-back” programs are the best option for patients to dispose of their prescription medication.
Report the theft to law enforcement and state board. If scheduled drug is lost or stolen, it must be reported to the:
Report the theft to law enforcement and state board. If scheduled drug is lost or stolen, it must be reported to the:
DEA using Form 106
TN Board of Pharmacy by emailing TNtheftorloss@usdoj.gov
How long must Prescription records be maintained?
Prescription records must be maintained for at least 2 years.
A DEA Form ___ (or its electronic equivalent) is required for each distribution, purchase, or transfer of schedule I or II controlled substance.
A DEA Form 222 (or its electronic equivalent) is required for each distribution, purchase, or transfer of schedule I or II controlled substance.
When the pharmacy orders schedule II drugs from a wholesaler. The pharmacy fills out Form 222 and keeps the __ page
When the pharmacy orders schedule II drugs from a wholesaler. The pharmacy fills out Form 222 and keeps the 3rd page (Copy 3, or the “Blue” Copy).
When the wholesaler sends the schedule II drug to the pharmacy. The wholesaler keeps the ___ page and sends the DEA the ___ page
When the wholesaler sends the schedule II drug to the pharmacy. The wholesaler keeps the 1st page (Copy 1, or the “Brown” Copy) and sends the DEA the 2nd page (Copy 2, or the “Green” Copy).
When is the DEA Form 222 Required (6)
When the pharmacy orders schedule II drugs from a wholesaler.
When the wholesaler sends the schedule II drug to the pharmacy.
When a pharmacy sends unused schedule II drugs back to a supplier.
When a pharmacy is sending unused schedule II drugs to a DEA-approved
disposal facility, which is called a “reverse distributor”.
When a pharmacy provides schedule II drugs to another pharmacy who is out of stock and needs them to dispense a prescription.
When a pharmacy provides schedule II drugs to a physician for administration or dispensing to a patient.
When is the DEA Form 222 NOT Required (2)
When the schedule II drug is being dispensed to the patient.
When the schedule II drug is being transferred from the central fill pharmacy to the retail pharmacy.
The Purchaser keeps which copy of the DEA form 222?
The purchaser keeps the 3rd copy, the blue copy
The Supplier keeps which copy of the DEA form 222, and sends which copy to the DEA?
Supplier gets brown, aka copy 1
Dea gets green Aka copy 2
The supplier must forward a copy of the electronic order (CSOS) to the DEA within ___ business days.
The supplier must forward a copy of the electronic order to the DEA within two business days.
Lost CSOS Orders
If an unfulfilled order is lost, the purchaser must provide the supplier with:
The unique tracking number
The date of the loss
A statement that the goods from the first order were never received
Lost CSOS Orders
Records must be readily retrievable and kept for ___ years.
Records must be readily retrievable and kept for two years.
Lost CSOS Orders
If the purchaser executes another order to replace the lost order, the lost order (along with the __________) and the _____________ must be electronically linked.
If the purchaser executes another order to replace the lost order, the lost order (along with the statement of loss) and the replacement order must be electronically linked.
Incomplete CSOS Cannot be Fulfilled
An electronic order is invalid if any _______ is missing, if it is not signed with a __________, if the digital certificate is _______, or if the purchaser’s ______will not validate the digital signature.
An electronic order is invalid if any required data field is missing, if it is not signed with a DEA-issued digital certificate, if the digital certificate is expired, or if the purchaser’s public key will not validate the digital signature.
Invalid electronic orders cannot be corrected; a new order must be executed.
If the entire order is voided, the ______ must make an electronic copy of the order, write “Void” on the copy, and return it to the ______.
If the entire order is voided, the supplier must make an electronic copy of the order, write “Void” on the copy, and return it to the purchaser.
The _______ is not required to keep a record of orders that were not filled, but the _________ must keep an electronic copy of the voided order.
The supplier is not required to keep a record of orders that were not filled, but the purchaser must keep an electronic copy of the voided order.
Paper DEA Form 222
Can the order be endorsed to another supplier?
yes
Paper DEA Form 222
When must supplier report transaction to DEA
By the end of the month during which the order was filled
CSOS
Can the order be endorsed to another supplier?
No
CSOS
When must supplier report transaction to DEA
Within 2 business days of filling the order
Paper DEA Form 222
Limits of item per order
10 items
Paper DEA Form 222
What drugs can be ordered
Schedule I, schedule II
CSOS
Limits of item per order
No limits
CSOS
What drugs can be ordered
Schedule I, II, III, IV, V, and non-scheduled drugs
Who can sign the DEA Forms 222?
I. The person who signed the last DEA registration
II. The person with the power of attorney
III. All pharmacists
I and II
A valid DEA number begins with __ letters followed by ___ digits.
A valid DEA number begins with 2 letters followed by 7 digits.
Hospital, clinic, practitioner, teaching institution, pharmacy
First Letter of DEA #
A, B, F, or G
Mid-level practitioner
First Letter of DEA #
M
Manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program
First Letter of DEA #
P or R
DATA-waived
First Letter of DEA #
X
DEA number BT6835752
Verify it
Step 1: Add the first, third, fifth digits
Step 2: Add the second, fourth, sixth digits
Step 3: Multiply the result of step 2 by two
Step 4: Add the results of step 1 and step 3
Step 1: 6 + 3 + 7 = 16
Step 2: 8 + 5 + 5 = 18
Step 3: 18 * 2 = 36
Step 4: 16 + 36 = 52
The last digit of this sum should be the same as the last digit of the DEA number.
Written Prescriptions for Controlled Substances require: (9)
Prescribers full name Prescriber's address DEA number Patient's full name Patients full address Date issued Prescribers signature (manually signed) Number of Refills authorized Drug name, strength, dosage form, quantity, directions for use
A prescriber may orally authorize schedule __ prescriptions.
A prescriber may orally authorize schedule III, IV, or V prescriptions.
Oral prescriptions of schedule II drugs are not valid except in emergencies
A prescriber can fax a schedule II prescription so the pharmacy can begin processing the prescription. The original prescription must be received and verified against the faxed prescription before it is ______.
A prescriber can fax a schedule II prescription so the pharmacy can begin processing the prescription. The original prescription must be received and verified against the faxed prescription before it is dispensed.
Three exceptions where a faxed prescription for a schedule II drug can serve as an original:
The drug is compounded for ________ to the patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal route.
The patient is a resident of a ____.
The patient is enrolled in a _______.
Three exceptions where a faxed prescription for a schedule II drug can serve as an original:
The drug is compounded for direct administration to the patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal route.
The patient is a resident of a LTCF.
The patient is enrolled in a hospice care program.
Schedule III-V prescriptions may be transmitted by fax and serve as the original prescription as long as:
Schedule III-V prescriptions may be transmitted by fax and serve as the original prescription as long as the prescriber manually signs the prescription.
Prescribers must use a _______ method or a digital certificate to sign and transmit e-prescriptions.
Prescribers must use a two-factor authentication method or a digital certificate to sign and transmit e-prescriptions.
If the initial prescription was received and dispensed, then the ______ prescription must be voided. If the initial prescription was received but not dispensed, then the ______ prescription must be voided.
If the initial prescription was received and dispensed, then the second prescription must be voided. If the initial prescription was received but not dispensed, then the initial prescription must be voided.
when must Prescriptions must be dated and signed?
Prescriptions must be dated and signed on the date when issued.
The pharmacist is never allowed to make changes to the: (3)
The pharmacist is never allowed to make changes to the:
Patient’s name
Controlled substance/s prescribed (except for generic substitution)
Prescriber’s signature
The written prescription can be converted to an oral prescription if the patient’s name, controlled substance, or signature needs to be corrected/added for a schedule ____ drug.
The written prescription can be converted to an oral prescription if the patient’s name, controlled substance, or signature needs to be corrected/added for a schedule III-V drug.
The dispensing data of schedule II – V drugs must be reported to the CSMD how often?
The dispensing data of schedule II – V drugs must be reported to the CSMD on a daily basis.
Controlled Substance Monitoring Database
If a patient does not have SSN, driver’s license or telephone number, use, _________ as an identifier when reporting.
If a patient does not have SSN, driver’s license or telephone number, use, “000-00-0000” as an identifier when reporting.
Controlled Substance Monitoring Database
If a patient refuses to provide a SSN, driver’s license or telephone number, use, ________ as an identifier when reporting
If a patient refuses to provide a SSN, driver’s license or telephone number, use, “999-99-9999” as an identifier when reporting
Controlled Substance Monitoring Database
Dispensers(pharmacies) must check database on _____ and then every ______; OR when they suspect abuse.
Dispensers(pharmacies) must check database on first fill and then every 12 months; OR when they suspect abuse.
For each refill dispensed of a schedule III or IV drug, the pharmacist must notate: (3)
For each refill dispensed of a schedule III or IV drug, the pharmacist must notate:
His or her initials
The date dispensed
The amount dispensed
If the amount dispensed is not notated for each refill, it is assumed that the pharmacist dispensed a refill for the full face amount of the prescription.
Prescription Refills
Non-scheduled Expiration
1 year
from written date
Prescription Refills
Schedule II Expiration
1 year
from written date
Prescription Refills
Schedule III Expiration
6 months
from written date
Prescription Refills
Schedule IV Expiration
6 months
from written date
Prescription Refills
Schedule V Expiration
1 year
from written date
Prescription Refills
Non-scheduled Refill Limit
No limit
Prescription Refills
Schedule II Refill Limit
0 refills
Prescription Refills
Schedule III Refill Limit
5 refills
Prescription Refills
Schedule IV Refill Limit
5 refills
Prescription Refills
Schedule V Refill Limit
No limit
Prescriptions for opioids and benzodiazepines may not be dispensed in quantities exceeding a _____ supply.
Prescriptions for opioids and benzodiazepines may not be dispensed in quantities exceeding a 30-day supply.
For electronic recordkeeping system, all pharmacists involved with
refilling schedule III-IV drugs for the day must verify and document that the
refill data entered into the system is correct by either:
Signing and dating a hard copy printout of each day’s refills
Printout must be provided to each pharmacy within ________ of the date of dispensing the refill
Signing a statement in a bound logbook or a separate file that the electronic refill data is correct
For electronic recordkeeping system, all pharmacists involved with
refilling schedule III-IV drugs for the day must verify and document that the
refill data entered into the system is correct by either:
Signing and dating a hard copy printout of each day’s refills
Printout must be provided to each pharmacy within 72 hours of the date of dispensing the refill
Signing a statement in a bound logbook or a separate file that the electronic refill data is correct
The pharmacy must have a back-up procedure in the event that the electronic system experiences downtime.
The schedule II prescription may be also be filled in increments for
The schedule II prescription may be also be filled in increments for terminally ill patients or residents of a long-term care facility.
Partial Filling of Schedule II Drugs
The ________ must notate on the prescription that the patient is terminally ill or a LTCF patient.
The pharmacist must notate on the prescription that the patient is terminally ill or a LTCF patient.
Partial Filling of Schedule II Drugs
For each partial filling, the dispensing pharmacist must record the ____ of the partial filling, _______, _______, and the __________ of the dispensing pharmacist.
For each partial filling, the dispensing pharmacist must record the date of the partial filling, quantity dispensed, remaining quantity, and the identification of the dispensing pharmacist.
Partial Filling of Schedule II Drugs
The pharmacy is unable to supply the full quantity (e.g., out of stock) – Deadline to Fill Remaining Balance
Within 72 hours after the first partial filling
Partial Filling of Schedule II Drugs
Partial filling for terminally ill patients – Deadline to Fill Remaining Balance
Within 60 days after the issue date
Partial Filling of Schedule II Drugs
Partial filling for LTCF residents – Deadline to Fill Remaining Balance
Within 60 days after the issue date
Partial Filling of Schedule II Drugs
The partial fill is requested by the patient or the practitioner that wrote the prescription – Deadline to Fill Remaining Balance
Within 30 days after the issue date
Partial Filling of Schedule II Drugs
Partial filling of an emergency oral prescription – Deadline to Fill Remaining Balance
Within 72 hours after the issue date
Schedule III, IV, and V controlled substances can be partially filled if:
It is recorded in the same manner as a ____
The total quantity dispensed in all partial fills does not exceed the total quantity prescribed
No dispensing occurs beyond _____ from the written date
Schedule III, IV, and V controlled substances can be partially filled if:
It is recorded in the same manner as a refill
The total quantity dispensed in all partial fills does not exceed the total quantity prescribed
No dispensing occurs beyond 6 months from the written date
Pharmacists can only dispense controlled substances with a _______.
There are no exceptions, even for emergency situations.
Pharmacists can only dispense controlled substances with a prescription.
There are no exceptions, even for emergency situations.
Emergency dispensing of orally authorized schedule II prescriptions is allowed
Emergency Filling of Schedule II Drugs
The prescriber must provide a valid prescription by the _____ following the oral order:
Must include statement “Authorization for Emergency Dispensing” on the face and date of oral order
The prescriber must provide a valid prescription by the 7th day following the oral order:
Must include statement “Authorization for Emergency Dispensing” on the face and date of oral order
If the original prescription is not received, the pharmacist must report to the local DEA office
The label: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
Must be placed on?
In addition to the label requirements for all prescriptions, schedule II - IV must have the following statement on the label:
“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
A central fill pharmacy can fill prescriptions for retail pharmacies if they are under a _____ or if they have a __________.
A central fill pharmacy can fill prescriptions for retail pharmacies if they are under a contractual agreement or if they have a common owner.
Both the retail and central fill pharmacies must be ____________ in order to process and deliver prescription drugs to the patients
Both the retail and central fill pharmacies must be licensed by the state of Tennessee in order to process and deliver prescription drugs to the patients
Additional label requirements for central fill pharmacy:
(2)
Additional label requirements for central fill pharmacy:
Retail pharmacy’s name and address
Unique identifier (such as the central fill pharmacy’s DEA number)
schedule III, IV and V are allowed _____ transfers communicated directly between two licensed pharmacists.
schedule III, IV and V are only allowed one transfer communicated directly between two licensed pharmacists.
The only exception is if the pharmacies share a “real-time, online database of the patients (such as stores in the same chain), then there is no limit on amount of transfers for schedule III, IV, or V prescriptions.
Schedule II prescriptions are prohibited from having refills and are not transferred.
