pharmacy types, registration, labeling
Federal "Legend" on all Rx medications
"Caution: Federal law prohibits dispensing without a prescription."
review: federal law requires a "legend" on all Rx meds
"Caution: Federal law prohibits dispensing without a prescription."
review: Controlled substances in schedules II - IV require "transfer warning":
"Federal Law prohibits transfer of this drug to any person other than the patient for whom it was prescribed
Exam Tip: Illinois does not require a___date for retail prescription labels. This is required under the laws of many states.
"beyond-use" date, "discard after", or expiratio
___ means a sole proprietor, partner or shareholder who owns in excess of 5% of outstanding stock of a corporation, or spouse or child of sole proprietor, partner or shareholder. This section does not apply to pharmacy owned by corporation which is publicly traded.
"owner"
for radioactive drugs, The immediate container shall be labeled with: The standard radiation symbol; • The words____ • The name and address of the pharmacy; • The ___ number; • Name of radionuclide; and • Name of___form.
1. Caution-Radioactive Material"; 2. Rx 3. chemical
If Rx is filled on file at another location, pharmacist filling must record in____the Rx order, name of ___pharmacy, Rx number, drug name, date of issuance, ___amount dispensed, and no. of refills___
1. WRITING 2. transferor 3. original amount 4. remaining
offsite institutional pharmacy records must include: Name of resident • Date of order; • Name, strength and dosage form of drug, or description of the medical device ordered; • Quantity dispensed (a separate record should be maintained when the quantity billed differs from the quantity dispensed, e.g., unit dose transfer systems); • Directions for use; • Quantity ____ • ___ name; • Prescriber's signature and/or DEA number when required for controlled substances; and • The drug name and identification code or the manufacturer in case of a generically ordered medication or a generic interchange.
1. billed 2. Prescriber's
Must also Notify the Division in writing of the name of the person responsible for and the location where the ____pharmacy's prescription files and patient profiles will be maintained. These records shall be kept for a minimum of 5 years from the date ____
1. closing 2. the last original or refill prescription was dispensed.
On day that the pharmacy closes what must be done? Conduct an _____ of the pharmacy's controlled substances and maintain the record for inspection by the Division for 5 years. o Return the pharmacy license to the Division's drug compliance investigator or other authorized Division personnel. o Notify the ____ in writing as to where the controlled substances inventory and records will be kept and how the controlled substances were transferred or destroyed. Records involving controlled substances must be kept available for 5 years for inspection by the Division.
1. inventory 2. division
Investigational new drugs shall be identified with the following info: Name of drug and strength (if applicable); • Beyond use date; • Reference code to identify _____number; • A label indicating _____ and • Name and location of the patient. When utilizing a unit-dose and medication cart system, the pharmacy may identify the name of the patient and the patient's location on the outside of the bin of the medication cart, when those carts are filled by the pharmacy.
1. source and lot 2. "For Investigational Use Only";
Rx label requirements: the name and address of the pharmacy wherein the same is sold or dispensed; • ______of the person, authorized to practice pharmacy under the provisions of this Act, selling or dispensing the same, • the date on which such prescription was filled; • the name of the patient; • the serial number of such prescription as filed in the prescription files; • the ____name of the practitioner who prescribed such prescriptions; • the directions for use thereof as contained in such prescription; and • the proprietary name or names or the established name or names of the drugs, the dosage and ___ except as otherwise authorized by regulation of the Department
1. the name or initials 2. last 3. quantity
Every licensed pharmacy shall conduct an annual self-inspection using forms provided by the Division. The annual self-inspection shall be conducted during the same month, every___ as determined by the pharmacy. Documentation of the self-inspection shall be maintained at the pharmacy for ___years. The primary objective of the self-inspection is to create an opportunity for a pharmacy to identify and correct areas of noncompliance with State and federal law. This includes, but is not limited to, recordkeeping, inventory, labeling and sanitation requirements.
1. year 2. 5
new pharmacy application must be filed whenever: •____% or more of the ownership of the business, other than a publicly traded business, to which the pharmacy licensee was issued is sold or otherwise transferred to a person or entity that does not hold any interest in the business issued the pharmacy license prior to the sale or transfer;or
10
Non-Controlled substances limited to___ months from original issuance date, regardless of number of refills remaining, or "prn" instructions
15
Newly established community pharmacies licensed with the Division must have a statement that the pharmacy is or will be engaged in the practice of pharmacy and will have medications stocked and sufficient resources to provide adequate services to protect the public it serves within____days of opening
30
Review: Pharmacy must open within thirty __ days of issuance of the pharmacy license
30
The PIC must provide the DPR with written notice ___ days prior to the installation of or at the time of removal of an automated storage and dispensing system.
30
procedures for closing a pharmacy: 1. notify division in writing ___days in advance of closing date 2. Notify customers of the closure at least 15 days in advance of the closing date and where the customer's records will be maintained
30
All refill data shall be maintained by the pharmacy on the premises for 5 years, in accordance with Section 18 of the Act. The pharmacy shall have the appropriate equipment on the premises to provide readily retrievable information in the course of an on-site inspection. A hard copy printout shall be provided to the Division, upon request, within __ hours
48
offsite institutional pharmacies must maintain records for___years
5
Written prescriptions that are dropped off at remote telepharmacy consultation sites must be delivered to the home pharmacy within ___hours
72
dispensed drugs from the ER should be limited to no more than a ___hour supply
72
A pharmacist may be the PIC for more than one pharmacy however, the PIC must work an average of at least ___ hours per week at each location where he or she is the PIC.
8
If a PIC is on a leave of more than ___days, a new PIC must be designated
90
a nuclear pharmacy shall have____facility separate from and exclusive of the "hot" laboratory, compounding, dispensing, quality assurance and office areas
A radioactive storage and product decay
which CSs must be inventoried by the PIC? (IL CSA)
All CII exact count CIII-CV approx. count
review: only need a BUD for meds prepared for immediate use (unlike for future use which always need) if___
BUD < 60 days from date of dispensing
however,_____CANNOT be returned to the pharmacy, even if for purposes of destruction, except in the event of a recall or a dispensing error!
CSs
Records by the automated dispensing systems must be maintained by the pharmacy and must be readily available to the___
DPR
example of consolidating refills
Digoxin 0.125 mg, qty. 30, SIG: 1 daily. Refills: prn. The pharmacist is permitted to "combine" or "consolidate" refills, and dispense more than 30 tablets on a single fill say for 90 day supply in order to maximize 3rd party plan benefits
review: Within 30 days after a change of a PIC, the ___shall be notified in writing by the departing PIC.
Division
Controlled substances in schedules II - V require "transfer warning": • "Federal Law prohibits transfer of this drug to any person other than the patient for whom it was prescribed.": T or F?
False, for II-IV not V as some V CS can be sold without a prescription
Scanned prescriptions shall be displayable on a computer terminal at just the home pharmacy: T or F? • All patient's demographic and prescription information shall be viewable at both the remote and home pharmacy in real time.
False, must be at both the remote and home pharmacy
review: pharmacy license expires 10 days after PIC dies: T or F?
False, used to be 10 days but law changed to 30 days!
Medications dispensed to a specific resident or patient via unit dose
Name of the resident; • Resident's room and bed number; • Date of order; • Name, strength and dosage form of drug, or description of the medical device ordered; • Directions for use; and • Prescriber's name.
Pharmacies that are not located in the facilities they serve and whose primary purpose is to provide purpose services to patients or residents of facilities licensed under the Nursing Home Care Act, the Hospital Licensing Act, or the University of Illinois Hospital Ac
Offsite Institutional Pharmacy Services
Pharmacy license also expires automatically 30 days after-__
PIC dies, is no longer employed by the pharmacy, or has license suspended or revoked. (THIS IS A CHANGE IN THE LAW - PREVIOUSLY, IT WAS TEN (10) DAYS!
Duties of PIC When Pharmacy Ceases Operations
PIC is responsible for proper handling and disposition of all drugs. • Notify DPR and forward to DPR a copy of the closing inventory of controlled drugs and a statement concerning intended manner of disposition of all legend drugs and prescription files (within 30 days). • DPR required to notify PIC of approval, or disapproval along with reasons for disposition, within 30 days of receipt of pharmacist's statement. If not approved, PIC has 30 days to notify DPR of alternative procedure. • If disposition or alternative plan is not completed within 30 days, the DPR may confiscate all legend drugs. The Notice of Intent to Confiscate shall be considered the final administrative decision of the DPR for appeal purposes. • In disposing of controlled substances, compliance with provisions of Illinois Controlled Substances Act concerning disposition of controlled substances shall be deemed compliance with this section
PIC definition: Pharmacist whose name appears on ____; and who is responsible for all aspects of the operation related to pharmacy practice. All pharmacies must have a PIC.
Pharmacy license
In another section of the regulations states that drugs dispensed from the ER must meet all labeling requirements pertaining to Retail pharmacies. Accordingly, If you get a question about an ER patient, apply the labeling requirements that apply to a ____label. For employees and discharge patients, use the labeling requirements set forth here
Retail pharmacy prescription
Labels on all medications dispensed by the pharmacy for immediate dispensing to a patient being discharged, emergency room patient and/or employee shall contain the following:
The name and dosage form of the drug; • The date filled; • The quantity dispensed; and • Directions for use.
In addition to the labeling requirements of pharmaceuticals, as stipulated in the Act, the immediate outer container of a radioactive drug, diagnostic agent or device to be dispensed shall also be labeled to include:The standard radiation symbol;
The words "Caution-Radioactive Material"; • The name of the radionuclide; • The name of the chemical form; • The amount of radioactive material contained, in milliCuries or microCuries, in the container contents at the time of calibration; • If the container contents are in liquid form, the volume in milliliters; • The requested calibration time for the amount of radioactivity contained; • The prescription number; and • The name or initials of the nuclear pharmacist filling the prescription
(a) A pharmacist may exercise professional judgment to dispense an emergency supply of medication for a chronic disease or condition if the pharmacist is unable to obtain refill authorization from the prescriber as long as it is a non-controlled substance: T or F?
True
There are no minimum requirements for hour of operation for a community pharmacy: T or F?
True
Can An automated dispensing and storage system may be used as an after-hours cabinet?
Yes
Can An automated dispensing and storage system may be used as an emergency kit.?
Yes
Can written Rxs be dropped off at remote tele-pharm consultation sites?
Yes
Can transfers from out-of-state pharmacies be done in IL, including CSs?
Yes, IL pharmacists may fill prescriptions for controlled substances issued by a practitioner actively licensed in another United States jurisdiction and who holds an active DEA registration in conformance with the Act and this Part
Any change of ownership of ___that owns a pharmacy shall not be considered a change of ownership of the pharmacy.
a parent company
Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, ____
a sign stating that situation shall be conspicuously displayed
Emergency kits shall be supplied and maintained under the supervision of a pharmacist. Drugs shall be removed from emergency kits only by authorized pharmacy personnel, persons authorized to administer medication pursuant to ___
a valid physician's order or a physician licensed to practice medicine in all of its branches in Illinois.
As of April 2022, no regulations have been adopted by the Department, and therefore the law has not been implemented. However, if asked about this law on the MPJE, the most important point is that Illinois is an "opt-in" state, meaning that it requires the patient to
affirmatively enroll in automatic refills
Illinois also permits pharmacy to make a digital image of the original prescription, and to maintain the digital image in lieu of the original prescription. Digital imaging system requirements: (1) contain all info required for manual records; (2) capability to produce hard copy when requested; and (3) system most not allow image to be ___.
altered, revised, or replaced after image is made
the drug return policy does not apply to a drug dispensed to a pt. of ___
an institutional healthcare facility ((even if dispensed by a retail pharmacy)
Dispensed should be limited to no more than a 72 hour supply, except
antimicrobials; • unit of use packages (inhalers, ophthalmics, otics, etc.); • drugs dispensed via a Remote Automated Pharmacy System.
Pyxis, Omnicell, etc. are also known as ___systems
automated dispensing and storage systems
Within 2 business days of receipt of a prescription cancellation transaction, pharmacy staff must either review the cancellation transaction for deactivation or provide that deactivation occurs__
automatically
When medication is removed from the cabinet or enclosure, written physician's orders authorizing the removal of the medication shall be placed in the___
cabinet
significant change to the Practice Act now permits a pharmacist to exercise professional judgment, and combine or consolidate refills without ___ in order to provide the patient with a greater quantity, up to the total number of dosage units authorized on the original RX, plus any refills
calling the doctore
If transferred RX is not picked up by patient, transferee pharmacist shall
cancel RX and notify original pharmacy of same.
Beginning January 1, 2021, a pharmacy using the National Council for Prescription Drug Programs' SCRIPT standard for receiving electronic prescriptions must enable, activate, and maintain the ability to receive transmissions of electronic prescription ___ and to transmit cancellation response transaction
cancellation
review: Drugs dispensed from the ER must meet all labeling requirements applicable to ___ pharmacies
community
When medication is removed from the pharmacy by an authorized nurse, a _____ shall be conspicuously placed in the pharmacy with the container from which the drug was removed so that it will be found by a pharmacist and checked promptly
copy of the physician's order authorizing the removal of said medication
Once a dispensed drug is removed from the premises by a patient or the patient's agent, that drug shall not be accepted for return or exchange by a pharmacy or pharmacist. • Does not apply to drugs returned for purposes of ___
destruction
The Department shall adopt rules to implement this Section. The rules shall ensure that discontinued medications are not ____whether prescribed through electronic prescriptions or paper prescriptions
dispensed to a patient by a pharmacist or by any automatic refill dispensing systems,
• Prescriptions dispensed at the remote pharmacy site must be ___from those dispensed at the home pharmacy
distinguishable
when does the license of a pharmacy expire?
expires on its own on March 31 of even numbered years
The Department may allow a pharmacy that is not located at the same location as its home pharmacy and at which pharmacy services are provided during an emergency situation, as defined by rule, to be operated as an emergency remote pharmacy. An emergency remote pharmacy operating under this subsection (d) shall operate under the license of the ___pharmacy
home
All medication dispensed to a specific patient in the institution shall be dispensed in a container____
identified with the name of the patient and the patient's location
Records by the automated dispensing systems shall include:
identity of system accessed; o identification of the individual accessing the system; o type of transaction; o name, strength, dosage form and quantity of the drug accessed; o name of the patient for whom the drug was ordered; o identification of the registrants stocking or restocking and the pharmacist checking for the accuracy of the medications to be stocked or restocked in the automated dispensing and storage system; and o such additional information as the pharmacist-in-charge may deem necessary
Policy and procedures for the use of the automated dispensing and storage systems shall include a requirement for pharmacist review of the prescription or medication order prior to the system profiling and/or removal of any medication from the system for ____
immediate patient administration
After-hour cabinets shall only be used___
in the absence of a pharmacist
An affidavit attesting to the completion of the inventory and preservation of the inventory record, bearing the date of the inventory and the name and signatures of the departing and the___, shall be submitted to the Division at its principal office within 30 days after the change in the pharmacist-in-charge. (Used to be 10 days)
incoming PIC
In addition to notifying the Division within 30 days, the departing PIC shall, on the effective date of the change,__the following controlled substances
inventory
Medications Prepared for Immediate Use requirements: Name of the resident; • Resident's room and bed number; • Dispensing date; • Name, strength and dosage form of drug, or description of the medical device ordered; • Quantity dispensed; • Directions for use; • Prescriber's name; and • Beyond use date if ____
less than 60 days from date of dispensing.
No sink shall be required for pharmacies that do not ___
maintain drug inventory
sufficient quantity to meet the immediate needs of the patient may be removed until a pharmacist is on duty and available to review the prescription or medication order. A pharmacist shall check such orders promptly___
once on duty
Medications for Future Use - Parenteral solutions to which drugs or diluents are added: Name, concentration and volume of the base parenteral solution; • Name and strength of drugs added; • Beyond use date and date of admixture. Beyond use date, unless otherwise specified in the individual compendia monograph shall be not later than the beyond use date on the manufacturer's container or ____year from the date the drug is repackaged, whichever is earlier; and • Reference code to identify source and lot number of drugs added
one
for onsite institutional pharmacy services, No prescription may be dispensed for a period in excess of ___ from the date of the original issuance of the prescription by the prescriber
one year
Drugs may be dispensed from the emergency room only by a practitioner licensed to prescribe and dispense, only to patients treated in the institution and only during hours in which___
outpatient institutional pharmacy services are not available.
PIC must notify DPR he has ceased being PIC, and___ must notify DPR of identity of new PIC, within 30 days. Failure to do so is grounds for discipline.
owner
Policies and procedures for the use of the automated dispensing and storage systems shall include the following: • List of medications to be stored in each system; • List of medications qualifying for emergency or first dose removal without___ review of the prescription or medication order
pharmacist prior
for onsite institutional pharmacy services The PIC shall maintain or have access to the following records for at least 5 years or as otherwise required by law: Records of medication orders and medication administration to patients; • ____records for controlled substances; • Records of packaging, bulk compounding or manufacturing; and • Records of actions taken pursuant to drug recalls
procurement
The automated dispensing and storage systems shall provide a mechanism for securing and accounting for ____
returned meds as well as for securing and accounting for wasted or discarded meds
The operations of the pharmacy and the establishment and maintenance of ___ are the dual responsibility of the pharmacist-in-charge and the owner of the pharmacy
security provisions
There has been a change in the law. The "transfer" of a prescription between pharmacies that ____ is no longer considered a transfer. This means: (1) technicians can effectuate the transaction, and (2) there is no limit on the movement of controlled substanceprescriptions
share a common database
Remote pharmacies are pharmacies that ___ in order to provide pharmacy care.
share services with home pharmacies
Cover all signage indicating "Drug Store" or "Pharmacy" as soon as practicable. The signage shall be removed in a timely manner. A ___shall be prominently posted that the pharmacy is closed
sign
when medication is removed from the pharmacy A form shall be available in the pharmacy upon which shall be recorded the ___
signature of the authorized nurse who removed the medication, the name, strength (if applicable) and quantity of medication removed
NOTE: At the time of filling, controlled substance prescriptions must be ___on the face of the prescription by the pharmacist. Initials or a unique identifier are not sufficient.
signed and dated
new pharmacy application must be filed whenever: More than half ___ of a business issued a pharmacy license change
the board of directors or executive officers
Emergency kits shall be sealed in some manner which will indicate when the kit has been opened. A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit. The beyond use date of the emergency kit shall be__
the earliest expiration date of any drug contained in the kit
Whenever any drug is not available from night cabinets or emergency kits, and the drug is required to treat the immediate needs of a patient, the drug may be obtained from___in sufficient quantity to meet the immediate need by a nurse authorized by the PIC.
the pharmacy
After hour cabinets are not the same as Automated Dispensing Units, which can be accessed when___
the pharmacy is open
After the closing date, only the pharmacist-in-charge, or other designated pharmacist, of the pharmacy discontinuing business shall have access to the prescription drugs until ___
those drugs are transferred to the new owner or other purchaser or are properly destroyed
In all cases in which electronic data processing equipment is used, the original prescription (either hard copy or an exact, ___) shall be retained on file according to law to assure access to the information contained on the prescription in the event of a computermalfunction
unalterable image
review: do not need BUD for meds dispensed to a specific resident or patient via__
unit dose
All written RXs and original transcript or copy of __ prescriptions to be maintained at pharmacy for at least five (5) years
verbal
Non-parenterals repackaged for future use • Brand and/or generic name; • Strength (if applicable); • Reference code to identify source and lot number and what else?
• Beyond use date. Unless otherwise specified in the individual monograph, the beyond use date shall be not later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and
