Kansas Law Flashcards

1
Q

Practice of Pharmacy in Kansas is defined by the following:

A

Interpretation and evaluation of prescription orders; Compounding, dispensing and labeling drugs and devices as a result of prescription orders; Administering vaccines if meeting a vaccination protocol; Participating in drug selection according to state law and drug utilization reviews (DURs); Storing prescription drugs and devices safely while maintaining proper records; Consulting with patients and other health care practitioners about the safe and effective use of prescription drugs and devices; Performing collaborative drug therapy management (CDTM) pursuant to a written collaborative practice agreement (CPA) with one or more physicians who have an established physician-patient relationship; Participation in the offering or performing of acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy

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2
Q

CDTM

A

collaborative drug therapy management

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3
Q

What is CDTM?

A

practice of pharmacy where the pharmacist perform certain pharmaceutical related patient care functions for a specific patient.

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4
Q

CDTM don’t allow

A

Alter a physician’s orders or directions; diagnose or treat any disease; independently prescribe drugs; independently practice medicine and/or surgery

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5
Q

CPA

A

Collaborative Practice Agreement

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6
Q

What is a CPA?

A

A written agreement or protocol between one or more pharmacists and one or more physicians that allows for CDTM to occur

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7
Q

CPAs must be

A
  1. consistent with normal and customary specialty
  2. Consistent with competence and lawful practice of the physician
  3. Appropriate to the pharmacist’s trining and experience
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8
Q

CPAs must include the following statements

A

Methods, procedures, and decision criteria the pharmacist follows in CDTM; documentation procedures of CDTM decisions the pharmacist makes; communication procedures the pharmacist follows (within 48 hours of notification) to physician regarding changes in
a patient’s condition the pharmacist identifies and CDTM decisions made; situations in which the pharmacist must initiate contact with the physicians; procedures the pharmacist follows if an urgent patient health situation occurs (and an alternative health care provider the pharmacist should contact if the pharmacist cannot reach a physician)

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9
Q

How often does a CPA needed reviewed?

A

Every 2 years

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10
Q

How long does a signing pharmacist have to deliver a copy of the CPA to the board?

A

5 days

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11
Q

How many persons sit on the CDTM committee?

A

7

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12
Q

What is the makeup of the CDTM committee?

A

a member of the board who is appointed (non-voting member); three licensed pharmacists (2 must have CDTM experience); three persons licensed to practice medicine/surgery (2 must have CDTM experience)

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13
Q

Who submits appointment to the CDTM board?

A

KPhA and the Kansas Medical Society

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14
Q

CDTM Committee Term

A

2 years

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15
Q

Role of the Kansas BOP

A

Create rules and regulations that are used to carry out enforcement of law pertaining to the practice of pharmacy

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16
Q

How many members are on the board of pharmacy?

A

7

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17
Q

Who are the persons on the board of pharmacy?

A

6 licensed pharmacists and 1 representative of the general public

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18
Q

Term for the BOP?

A

4 years

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19
Q

How many terms can you serve on the BOP?

A

Maximum of 2 terms

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20
Q

BOP members appointed by

A

the governor

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21
Q

who is eligible for BOP appointment?

A

current resident of Kansas, actively employed or engaged in the practice of pharmacy in Kansas, have at least 5 years of experience immediately preceding appointment date.

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22
Q

How long do appointees have after being appointed to take and subscribe to the oath?

A

30 days

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23
Q

Positions on the Board

A

President, Vice President, Executive Secretary

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24
Q

Minimum number of meeting per year

A

4

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25
Notice required prior to meetings
10 days to all board members
26
Pharmacy technicians
medical professionals who work alongside pharmacists to help and support patients. They perform a wide range of tasks within a pharmacy, acting as a link between patients and pharmacists. The pharmacist working with the tech is responsible for assigning tasks that the tech has been trained to perform. Techs may receive a refill, renewal or continuation order for therapy provided that no changes have been made from the original prescription from a prescriber and the supervising pharmacist has authorized this function.
27
Who creates the tech training program?
PIC (Pharmacist in Charge)
28
What must the tech training course address?
Various pharmacy practice settings; tech duties and responsibilities, particularly in relationship to other pharmacy personnel; standards, ethics, laws, and regulations governing the practice of pharmacy; Identifying and employing pharmaceutical and medical terms commonly used in prescribing, dispensing, and record keeping of drugs (abbreviations, symbols, etc.); calculations required for common dose determinations; Identification of drugs, drug dosages, routes of administration, dosage forms, storage requirements, and manufacturer recalls; processes and procedures related to dispensing prescriptions or other drug distributions systems; procedures, and techniques for compounding, packaging, and labeling drugs
29
Time limit for a tech to complete training
180 days
30
How often does the tech training program need to be reviewed?
Annually
31
How long do you have to notify the board of hiring a tech?
30 days
32
Pharmacy interns
students who are pursuing a degree in pharmacy and are gaining on-the-job experience under a licensed pharmacist. Pharmacy interns must be registered with the board before they work or learn (pharmacy students not employed outside of IPPE or APPE rotations must obtain an intern license). Pharmacy interns must work under direct supervision and control of a pharmacist. The supervising pharmacist is responsible for ensuring that the intern is complying with laws and regulations. The supervising pharmacist is ultimately responsible for acts and omissions of the intern in the performance of their pharmacy intern duties. Pharmacy interns may receive new prescriptions under such direct pharmacist supervision.
33
Fee for intern application
$25
34
How long does an intern license last?
6 years
35
CQI
Continuous quality improvement
36
what is a CQI
program to assess errors that occur in the pharmacy with regards to dispensing prescription medications
37
Minimum requirements of CQI program
Meet quarterly (every 90 days); PIC must be in attendance; Review all new incident reports from events since the last meeting; establish preventative steps for incidents reviewed at the meeting; review each board newsletter published since last meeting; create a report of the meeting with the following: Names of persons who attended, Incident reports and newsletters reviewed (the board suggests using prescription numbers to identify incident reports reviewed), Steps taken or to be taken to prevent future incidents
38
If the board undertakes disciplinary action because of a CQI, what changes about the board meeting?
the sessions will be closed and attendance is restricted to the licensee, the agency, their attorneys, a witness, and board staff and members. No attende of a CQI meeting must testify to anyone other than the board as to what occurred in the CQI program. If disciplinary proceedings take place, no attendee is required to testify as well. The board must prove the findings of disciplinary hearings with independent records, peer review, and possibly in an open public hearing.
39
PDMP
Prescription Drug Monitoring Program
40
Purpose of PDMP
monitoring controlled substances and drugs of concern
41
What needs to be submitted to the board for each controlled substance prescription?
Dispenser identification (ID); date of prescription fill; prescription number; if prescription is new or a refill; national drug code (NDC) of drug dispensed; quantity; days supply; patient ID number; patient name, address, date of birth (DOB); prescriber ID number; date the prescription was issued; source of payment for the prescription
42
Who ensures that a registered pharmacist is on duty at all times when the pharmacy is open?
PIC
43
Can techs and interns enter the pharmacy and turn on data, video, or audio links without the pharmacist if they are available for electronic supervision?
Yes
44
If there is an interruption in data sharing, can the tech or intern continue to fill prescriptions?
No, no medication orders can be filled using electronic supervision until the connection is back up and running
45
Requirements to electronically supervise
a pharmacist must be licensed by the board and electronically connected to multiple medical care facility pharmacies at one time
46
How many techs/interns can an ESP supervise?
can only supervise one tech or student at one time. And only one tech or student can be electronically supervised in the pharmacy at any given time.
47
Is electronic supervision a sufficient substitute for direct supervision?
Yes
48
Who does data entry in an ESP setting?
Data entry can be performed by the pharmacy student, tech, or ESP, so long as it is verified by the ESP before the drug leaves the pharmacy.
49
Requirements for ESP (technology)
medication orders must be capable of being displayed on computer terminal at both sites; image quality must be sufficient to determine accuracy of the work done for the order; Patient demographic information must be reviewable in real time at both locations.
50
Before the drug leaves the pharmacy (in the ESP setting), what requirements must be met?
Patient profile, scanned medication order, and drug dispensed review by ESP; an image (paper or electronic) of the medication order and the drug must be captured and stored in pharmacy records for 5 years; a paper record including the following is made: Patient name, Order number, Name of pharmacy student or tech involved, Name of ESP
51
How long do you have to maintain records of ESP data transmissions?
5 years
52
Can registered pharmacies be accessed without a pharmacist on site?
No
53
Guidelines for evaluating security
Before distributing a CS, the registrant must make a good faith inquiry with the board to determine if they are registered to do so, if the registrant doesn’t know already; there must be operative systems to disclose suspicious CS orders to the registrant and the board. Suspicious orders include those of unusual size, if they deviate from a normal pattern, and orders of unusual frequency; CS listed in schedules 2-5 must not be distributed in an unwarranted manner to a practitioner, mid-level practitioner, pharmacist, or any other person; prescribers must provide effective controls and procedures to guard against theft and diversion of CS. To minimize opportunities for diversion, physical security must be provided and additional procedures to reduce access by unauthorized personnel
54
What information must be on a name tag?
person's name and designation
55
What is included in a notice of cessation of pharmacy operations?
Date the pharmacy stops operations; signed statement attesting that an inventory of CS was conducted; location, pharmacy registration number, contact information; Manner of disposition of remaining drug stock and all records required to be maintained
56
Must patients be notified of a pharmacy closure?
yes. All patients who received a prescription from the pharmacy within the past 2 years
57
How long does the pharmacy have to notify patients of pharmacy closure?
10 days
58
How can notification of closure be sent to patients?
Mail, phone, email, text message
59
Who can make a judgement to fill or refill a prescription?
Only a licensed pharmacist
60
What should be included in a judgement to fill or refill a prescription?
Reading and interpreting prescription orders; Determining if the prescription is expired (date of filling is >1 year from written date for most prescriptions); verifying and documenting the accuracy of the prescription (includes those that are compounded, verifying and documenting ingredient accuracy); interpreting and verifying patient medication records; performing drug regimen reviews; recording the pharmacist who verifies the accuracy of the completed prescription
61
Legitimate medical purpose
there is a valid pre-existing patient-prescriber relationship prior to a prescription order being issued. (internet based questionnaires, consultations via internet or phone do not count as legitimate)
62
Who gets an offer to receive counseling?
each new prescription (which includes each time a C2 is filled). Other cases are once yearly for maintenance meds, and if the pharmacy deems appropriate.
63
When are pharmacist not required to counsel?
if the patient or their agent refuses the counseling, or the pharmacist determines that counseling may harm the patient’s care or the relationship between the patient and their prescriber.
64
Dispensing physicians
licensed to practice medicine and surgery, purchase and keep drugs, and compound their own prescriptions to supply them to patients.
65
Requirements for packaging (per PPPA)
child-resistant containers and in light-resistant containers that are air- tight
66
Each drug should be clearly labeled with the following information
1. name, address, and telephone of dispensing physician 2. Full patient name 3. ID number assigned to the prescription 4. date of fill (or refill) 5. Adequate directions for use 6. Expiration date of drug dispensed 7. (at the discretion of the physician): brand or generic name; manufacturer or distributor name; strength of medication
67
Supervision
defined as the guidance and direction of a licensed practitioner who is physically present at the location where drugs are dispensed.
68
Can a pharmacist fill a prescription copy?
No pharmacist or pharmacy shall fill a copy of a prescription. Each copy must read “This prescription copy is issued for reference only.”
69
Can a prescription that has been dispensed be returned or resold, dispensed, or distributed by a pharmacist?
No. This does not include drugs in unit-dose systems with only one medication that have not reached the patient (and are still intact). What constitutes “dispensed” is a gray area. Most pharmacists consider the prescriptions that have left the pharmacy with the patient or their representative as dispensed, therefore not resalable.
70
Items Exempt from sales tax
Drugs (compounds or substances, not food, dietary supplements, or alcohol) that are recognized as drugs by authoritative organizations. They diagnose, cure, manage, treat, or prevent disease. Or they intend to affect the structure or function of the body (includes Insulin); equipment including Oxygen delivery, Kidney dialysis, Enteral feeding systems, Prosthetic devices (Replacement, corrective, or supportive device, Artificial replacements of missing portions of the body, Support a weak or deformed portion of the body. Prevent or correct physical deformity or malfunction); Mobility enhancing equipment (Increases the ability to move, In home or motor vehicles, Not used by persons with normal mobility); Hearing aids; Durable medical equipment (DME), medical supplies, and equipment (That primarily serves a medical purpose, Can withstand repeated use, Not worn in or on the body, If purchased by a nonprofit skilled nursing facility (SNF) or intermediate nursing care home, Includes replacement or repair parts)
71
Labels must include the following
dispensing pharmacy information, prescriber name, full patient name, prescription number, date of prescription fill or refill, directions for use, BUD, brand or generic name, manufacturers or distributor name, drug strength contents of the dispense product, necessary auxiliary labels and storage instructions
72
E scripts
electronic prescriptions (e-scripts) must be for a legitimate medical purpose. Pharmacists must exercise professional judgment in determining the accuracy, validity, and authenticity of e-scripts. They must be written by a prescriber acting within the course of a legitimate professional practice, or by an authorized prescriber or their designated agent. Transmitting agents must include their identity in the order
73
E-scripts must have the following recorded
transmitter's phone number, time and date of transmission, identity of the pharmacy intended to receive the transmission, any other federal and state law and reg requirements
74
Holding onto e-scripts?
reduced and kept (in hardcopy or electronic format) in the same manner as outlined for scripts which have a hardcopy original. E-scripts are considered the original prescription order if they meet all requirements.
75
Electronic controlled substances (opiates)
all CS prescriptions which have an opiate must be transmitted electronically unless: the electronic system that facilitate orders fail or electronic prescribing is not available due to financial hardship, technology limits that the prescriber can't reasonably control, exceptional circumstances that the provider demonstrates; the order is a compound with two or more ingredients and e-scribing is impractical; the prescriber is a vet; the provider determines that e-scribing would compromise timely delivery, negatively impacting their patients medical condition; the order is part of drug research or therapy protocols; the prescriber writes ≤ 50 prescriptions per year of CS; the FDA issues requirements that e-scribing cannot accommodate
76
How long is an e-scribing waiver good for?
6 months
77
Roles of a receiving pharmacist in a transfer
Advise the patient that the prescription at the transferring pharmacy must be canceled before the receiving pharmacist can fill it (the pharmacist must also notify the pharmacy that the prescription must be canceled); Ensure that the prescriber’s intent is fulfilled, and the transferred prescription is valid; obtain consent of the prescriber before refilling if the pharmacist determines that this must be done based on their professional judgment (Interference with the dispensing pharmacist’s professional judgment by any other pharmacy colleague may compromise the pharmacy’s registration); Follow Kansas prescription drug laws for orders transferred from other states (failure to do so breaks the law); Record (The prescription order, The transferring pharmacy name, The transferring pharmacist name, The prescription number, Drug name and original amount dispensed, Date of original dispensing, Number of remaining refills)
78
Roles of the transferring pharmacist in a transfer
ensure that the transferred prescription is valid and legal; provide accurate and complete information the receiving pharmacist needs; record the name of the pharmacy the prescription is transferring to (this is included with the date of transfer on the prescription); cancel the prescription on file so that no further medication may be dispensed from it (if it hasn't been filled at their pharmacy yet, and is transferred, than all previous orders at other pharmacies are canceled as well
79
Valid prescriptions that can be transferred
Must be between two licensed pharmacists directly or one pharmacist who operates a suitable electronic device; Must have refill authorization and refills lawfully allowed; must not be expired
80
The transferring pharmacist must write what on the face of the prescription
“VOID”; name and address of pharmacy the prescription was transferred; Date of transfer; full name of both the receiving and transferring pharmacist
81
Transfers of C3-5 must have what additional information
a record on the back of the prescription of the name, address, and DEA registration of the dispensing pharmacy
82
Dispensing pharmacy must keep a record of C3-5 transfers that includes
“TRANSFER” written on the face of the prescription; Written date; first fill date; Original refills authorized; remaining authorized refills; Date of last refill; Original prescription number; Name, address, telephone of transferring pharmacy (and transferring pharmacist); Name, address, telephone of prescriber; DEA registration (if a C3-5 prescription is transferred)
83
Must be readily available in a shared prescription file
prescriber refill authorization or if there are no authorized refills; if the prescription is expired; any additional information from the original prescription; name and address of the pharmacy who last dispensed the drug
84
Controlled substances can be dispensed without a prescription if:
Done so by a pharmacist, supervision by a pharmacist is only allowed after he/she has fulfilled his/her professional and legal responsibilities; A max of the following is dispensed to the same purchaser in a 48h period: (8 oz (240 mL), or 48 dosage units of opium-containing substance; 4 oz (120 mL) or 24 dosage units of other controlled substance); The purchaser is 18 y/o or older; The pharmacist requires every purchaser who is not known to the pharmacist to provide suitable identification (includes proof of age); A bound record book for dispensing is maintained by the pharmacist that contains: (Name and address of purchaser, Name and quantity of controlled substance, Date of each purchase, Name or initials of dispensing pharmacist)
85
PIC is responsible for what in terms of electronic data storage systems
Adopt a written policy and procedures manual for using the system (Includes a back-up plan to document refills if the system fails to makes sure refills are authorized by the original prescription and max refills haven’t been exceeded); assure that only licensed pharmacists can make judgment functions and that only licensed pharmacists have complete control over dispensing; be responsible for drug information within the system, includes daily backup which is performed to restore information in case of system failure; assure that a written prescription is on file with all information from the original script; Numerically identify each written prescription by prescription number; Maintain confidentiality, adequate security, and system safeguards; Maintain a written or electronic prescription daily log which includes the following (The original prescription number, Written date, Full patient name and address, Name and address of the prescriber (and DEA if required), Name, strength, dosage form, and quantity of medication prescribed, Quantity dispensed (if different from quantity prescribed), Total number of refills authorized)
86
New drugs can't be handled unless
1. an active approval of such drug exists 2. an approval exists with the secretary showing proof of safe and effective use, drug composition, description of methods for producing the drug, and proposed labeling
87
New drug applications are good for how long
180 days
88
What is considered prepacking or repackaging?
the transfer of a drug to another container in advance of its immediate need
89
Rules associated with prefacing/repackaging
Pharmacists must do this, or directly supervise when it occurs. If it is done apart from the prescription drug prep area, the area must be enclosed and locked when the pharmacist is not there. The pharmacy who packages must have a shared services agreement to supply or dispense these prepacks. Containers and storage conditions must match the manufacturer’s recommendations to preserve drug stability. Expiration date is either based on that which was set by the manufacturer or the type of packing material used. It cannot be more than 12 months (one year) from the date of packaging (pick the earliest).
90
Records with lot numbers must be kept for what purposes
for the purpose of recalls
91
What is an ingestible event marker?
prescription drug device that records patient-logged events using a timestamp (primarily to assess adherence and mark when a medication is taken).
92
When can a pharmacist use the packaging of an ingestible event medication?
Pharmacists can use an ingestible event medication package if it is ordered from a valid prescription or after obtaining consent from the practitioner, caregiver, or patient. These packages are the drug and an additional event marker.
93
Rules regarding non-sterile compounds
Any pharmacist can compound a non-sterile prep that is commercially available, but it must be different from an FDA approved product and there must be sufficient documentation of a specific medical need for an individual patient
94
What can't be compounded
1. drugs withdrawn from the market by the FDA for safety reasons 2. Drug components that do not meet requirements of an official compendium (any actions related to the management of these, such as receiving, storing, using, etc.) 3. Those that contain active ingredients that do not meet monograph or official compendium requirements 4. Using non-FDA approved drug components
95
Can you compound before receiving an order?
Yes
96
What can't pharmacists compound?
pharmacists cannot compound bulk chemicals for food-producing animals (like cows, chickens, or pigs).
97
If a pharmacy sells a compounded prep, what must they keep on an invoice
1. name and address of practitioner 2. drug compounded (lot and expiration date of each component contained within) 3. quantity sold 4. date of transaction
98
Rules for the designated compounding area
Must be well-lit well-ventilated, clean, sanitary, and free food or beverages. Protections for light, heat, and evaporation which may deteriorate items must be arranged. Protection from theft and unauthorized removal must be included as well.
99
Formulation record information
Ingredients, quantities, strength, dosage form of each prep; equipment used to compound; mixing instructions; container used in dispensing; Storage requirements; BUD to be assigned; Quality control procedures that include identification of each person involved in the compounding process and direct supervision or checking the preparation is included; The source of the formulation (name, entity, or publication); Name or initials of person creating the record; Date that the record was established at the pharmacy
100
Original Order the was made
Name and strength of non-sterile prep; identifier that distinguishes non sterile prep records from others (such as sterile preps); Name of the manufacturer or repackager (lot and expiration date of each component); Total number of dosage units or quantity compounded; Name of each person who compounded; Name of the pharmacist or their designee who verified the accuracy; Date of compounding; Internal ID number (if used, such as a prescription number); Prescription number (if used); Quality control procedure results; Assigned BUD (if no validated information exists, the BUD cannot be later than expiration date of any component of the formulation)
101
BUD for non- aqueous and solid formulations
6 months or the earliest expiration date of any of the product ingredients
102
BUD for water-containing oral formulations
14 days maximum when stored in the fridge
103
BUD for water-containing, non-oral formulations
30 days maximum (less if the intended duration of therapy is shorter)
104
How long do formulation records need to be kept?
5 years
105
Examples of sterile preparations
bladder irritation solutions, TPN solutions, and IV solutions
106
Requirements of a sterile compounding area
must contain primary engineering with unidirectional airflow that maintains an ISO class 5 environment Activities and materials that are not involved with compounding are not allowed in such areas
107
Low risk sterile preparations
Prepared for administration to 1 patient or batch prepared and has suitable preservatives to be given to more than one patient; prepared by simple or closed system aseptic technique of no more than 3 sterile pharmaceuticals.
108
BUD for low risk sterile preparations
Room temperature ≤ 48 hours, Refrigerator ≤14 days prior to administration, Freezing temperatures ≤45 days prior to administration
109
Medium risk sterile preparations
batch prepared or intended for use by more than one patient or a patient on multiple occasions; created by compounding process which includes aseptic manipulations other than single volume transfers or use of ≥4 manipulations
110
Examples of medium risk sterile preparations
sterile preps for pump or reservoir; batch, reconstituted sterile preps; batch pre-filled syringes; TPN solutions which are compounded
111
BUD for Medium risk sterile preparations
Room temperature ≤ 30 hours, refrigerator ≤ 9 days, freezer ≤ 45 days
112
High risk sterile preparations
Compounded from non-sterile ingredients; Compounded with non-sterile containers or equipment; Contain non sterile water and stored for >6 hours before being sterilized; Exposure to air quality less clean/pure than ISO 5 environment for >1 hour; The compounding pharmacist cannot verify the chemical purity and content strength of ingredients required to meet compendium specifications. Includes information from the supplier or direct examination; Stored in the following conditions and no sterile testing has been done (Room temperature and administered >24 hours after compounding, Refrigeration temperatures for >3 days,Freezing temperatures (or colder) for ≤45 days);Immediate use preps
113
High Risk Sterile Prep BUDs
Room temperature 24 hours, refrigerator 3 days, freezer 45 days
114
Immediate use preparations
those where a sterile prep is compounded after an order is made for use within one hour of the start of compounding the sterile prep. Any sterile prep used for immediate use can be compounded outside of primary engineering control if both of these two conditions are met: 1. Administration to the patient begins within one hour of the start of compounding; 2. Compounding is done by a simple or closed-system aseptic transfer from licensed manufacturers (mini-bag plus containers)
115
Multi-dose containers must have what BUD
28 days
116
Sterile preps made in a segregated area (not the hood) have what BUD
12 hours
117
Single-dose containers have to be used with in how many hours?
1 hour
118
Pharmacists cannot compound the following sterile products
Preparations using components withdrawn from the market by the FDA for safety reasons; Preparations containing drug components that are not guaranteed to meet official compendium requirements; Preparations that are investigational new drugs (INDs) without receiving an FDA-sanctioned application; Bulk chemicals for food-producing animals; Sterile preparations that are “copies”
119
Resources required for sterile compounding
Primary engineering certified by an inspector to test aseptic conditions (certified within the past 6 months); Documentation that inspection has occurred for 5 years or since the date of installation; Documentation of air filter and high efficiency particulate air (HEPA) filter maintenance for 5 years or since date of installation; Documentation of disinfecting and cleaning for 5 years or since date of installation; Sink with hot and cold running water; Refrigerator, temp is monitored and recorded each business day; Freezer, temp is monitored and recorded each business day; Reference materials on IV incompatibilities and stabilities (electronic libraries must be readily available); Policy and procedure manual, with documented review every 2 years by PIC or designee
120
If a fridge or freezer alerts the pharmacist of out of range temperatures, do you need to keep a daily log of the temperatures?
No
121
PICs must maintain uniform formulation records for each sterile preparation that includes what information
Quantities, strength, dosage form of components; Equipment used to compound; Mixing instructions; Container used in dispensing; Storage requirements; BUDs; Quality control procedures (clarity, completeness, pH, mixing adequacy); Sterilization methods; Source of formulation; Name of pharmacist verifying accuracy of formulation record
122
Additional records that need to be kept for sterile preparations
Name and strength of sterile preparation; Formulation record reference; Name of manufacturer or repackager; Lot and expiration date of each component; Total number of dosage units or quantity compounded; Name of person(s) who compounded the sterile preparation; Name of the pharmacist (student or intern other direct supervision) who verified accuracy; Date of compounding; Assigned internal ID number and prescription number (if assigned); Results of quality control procedures; Results of sterility testing
123
How long do you keep formulation records?
5 years
124
Garbing and washing procedural steps
Don (“put-on”) shoes or shoe covers; Don head and facial hair covers; Wash hands with soap for 20 seconds or use aseptic hand scrub according to manufacturer instructions; Don a gown that is non shedding; Immediately perform antiseptic, hand-cleaning procedures when entering the work area (use alcohol-based, surgical hand scrub); Don sterile, powder-free gloves, disinfect such gloves after touching any non sterile area
125
What are CAIs?
Compounding Aseptic Isolator- exclusions to such garbing and washing procedures
126
Labeling for sterile preps
Name and quantity of each component; BUD; Prescribed flow rate; Name or initials of each compounder; Special storage instructions
127
Training required for sterile preparations
practical or academic sterile compounding training, along with training in clean room and laminar flow technology, and quality assurance techniques. Training must include one successful media fill test and glove fingertip test. PICs are responsible for ensuring that all personnel are trained and have demonstrated the following before performing sterile admixture services (Comprehensive knowledge of SOPs related to sterile admixture services, Familiarity with compounding techniques, Aseptic technique (media fill test and glove fingertip tests to prove))
128
If doing high risk sterile preps, how often do you need to do a media fill test/ glove tests?
twice yearly
129
Cleaning of the ISO 5 hood
At the start of each shift, Every 30 minutes during continuous compounding periods that involve sterile preps, Prior to compounding each batch, After a spill or known contamination, Daily (counters, work surfaces, floors), Monthly (walls, ceilings, storage shelves)
130
Air pressure of the antearea
5 pascals
131
Airflow speed
0.2 meters per second
132
Acceptable levels of microbial growth
ISO class 5: 1 colony-forming unit (CFU) per cubic meter of air; 3 CFUs per contact plate of surface sample ISO class 7: ≤10 CFUs per cubic meter of air; 5 CFUs per contact plate of surface sample ISO class 8: 100 CFUs per cubic meter of air; ≤100 CFUs per contact plate of surface sample
133
Annual report on substances must be submitted to whom
The house of representatives and senate
134
The annual report of controlled substance scheduling musts to look at
scheduling, rescheduling, or deletion
135
Reasoning for scheduling changes, things to consider
Actual or relative potential for abuse; Scientific evidence of pharmacological effect (if known); State of current scientific knowledge; History and current pattern of abuse; Scope, duration, and significance of abuse; Risk to public health; Potential to produce psychological or physiological dependence liability; If a drug is an immediate precursor of a substance already controlled
136
Who is legally authorized to prescribe CS?
practitioners, mid-level practitioners
137
What must be contained in a controlled substance prescription?
Full name, address, and registration of practitioner; Name and address of patient; Drug name, strength, dosage form, quantity prescribed and directions for use; Manual signature; All written with ink, indelible pencil, or typewriter
138
Can a prescription be prepared by another person in the office of the physician?
Yes, but the prescriber still holds full responsibility
139
Special intern code is assigned to who in a hospital
interns, residents, foreign physicians, or foreign medical graduates
140
What form is required for distributing of C1s and C2s?
DEA form 222
141
Can C2s be refilled?
No
142
What options are available for C3-5 prescriptions?
A paper prescription manually signed (which may be faxed and transmitted by the prescriber or their agent); An electronic prescription digitally signed (with a digital certificate); An oral prescription from a prescriber promptly reduced to writing
143
Expiration date of C3-5
6 month expiration and cannot be refilled more than 5 times
144
How long do you have to keep Controlled substance prescriptions?
5 years
145
Are there limits on CS that practitioners can prescribe?
No quantity limits
146
If you have multiple C2 prescriptions, what is the days supply limit per each?
90 days
147
What can pharmacists add/change on a C2 prescriptions?
Add: issue date (if not already written), DEA number Change: drug strength, quantity, and directions for use (after consulting with the prescriber or their agent) Select: dosage form if one is not written
148
Expiration date for C2s
6 months from the original written date
149
Emergency C2 prescription dispensing
1. All emergency situation criteria are met: immediate administration of CS is necessary for proper treatment of ultimate user, no appropriate alternative treatment is available, it is not reasonably possible for the prescriber to provide a written prescription before dispensing 2. quantity prescribed and dispensed is limited to only the amount adequate to treat the patient during the emergency period: any dispensing beyond emergency period must be done through a written, signed prescription 3. The prescription is immediately reduced to a hard copy by the pharmacist and contains all information required for such controlled prescriptions 4. Reasonable effort is made by pharmacists who do not know prescribers of such prescriptions to determine if the emergency C2 authorization came from the prescriber (e.g., through use of a call back number) 5. A written prescription for the emergency quantity prescribed is delivered to the dispensing pharmacist by the prescriber within 7 days of the emergency authorization (this is to be attached to the emergency order) (If this is not delivered, the pharmacist must notify the nearest DEA office; If the pharmacist does not, this pharmacist will lose the opportunity to authorize such emergency C2 prescription orders)
150
Emergency C2 prescription labels
Date of filling, Name, address, and telephone number of dispensing pharmacist, Prescription number, Full patient name, Prescriber name (including physician assistant (PA) and advanced practice registered nurse (APRN) designation if applicable), Directions for use and cautionary statements, Brand name or corresponding generic name of medication, Manufacturer or distributor (or abbreviation), Expiration date
151
When are partial C2 fills allowed?
when the pharmacist cannot supply the full quantity called for in a written or emergency prescription
152
Requirements for partial C2 fill
must make note of the quantity supplied on the face of the written prescription or record of emergency prescription Remaining portion must be supplied within 72 hours of the first partial fill (if it can't be filled, notify the prescriber, and no further quantity is allowed to be supplied without a new prescription) Unused controlled substance prescription medications cannot be returned to the pharmacy they were dispensed from
153
LTCF and Terminally ill patients- partial C2 fills
must record whether the patient is in LTCF or terminally ill on the back of the script, the dispensing pharmacist must record the date of the partial fill, quantity dispensed, remaining quantity, and ID of dispensing pharmacist total quantity of partial fills cannot be more than the total quantity prescribed. Expiration date of 60 days from written date.
154
C3-5s
filled based on written or oral prescription MCF may administer or dispense C3-5s pursuant to a written prescription order signed by a prescriber, but not prescribe C3-5s. Refills must be written on the back of the prescription Oral refills are allowed as long as they are not more than 5 refills or for orders longer than 6 months from the issue date.
155
Transfer of on hold prescriptions
Not allowed by the DEA if they were received by fax, verbal, or handwritten methods
156
On-hold e scripts
Can be forwarded if it can be forwarded appropriately
157
C3-5s
Only refills can be transferred
158
Automated data processing systems
used to store and retrieve refill information as an alternative to recording on the back of a prescription.
159
ADS must have the ability to
retrieve the original prescription order and any the following information related to C3-5 refills: Original prescription number, written prescription date, full name and address of the patient, name, address, and DEA number of the prescriber, name, strength, dosage form, and quantity of CS prescribed, quantity dispensed (if different than quantity prescribed), total number of refills authorized
160
The refill history for 6 months must be available from the ADs and contain what information
includes the name of controlled substances refilled, date of refill, quantity dispensed, ID code or initials of dispensing pharmacist for each refill, and total number of refills dispensed to date for that prescription order
161
If the ADS prints out a daily CS report it must be
verified, dated, and signed by the pharmacist who refilled the prescription order; maintained in a separate file for 5 years from the dispensing date; Printouts which provide each day’s CS prescription order refill data must be provided within 72 hours of the refill date and must be verified and signed by each pharmacist involved with dispensing. A bound logbook or separate file may replace such a system, that includes a statement that each pharmacist involved in dispensing signs that attests to the fact that refill information has been reviewed and is correct. This logbook must be maintained for 5 years after the dispensing date.
162
Zero report
Must be filed if no scheduled substances are dispensed. Cannot cover more than a 7 day period Must be reported to the board by the end of the following business day
163
K-TRACS
Kansas's PDMP
164
PDMP data can be provided to:
Prescribers or dispensers of controlled substances and drugs of concern for the purpose of providing pharmaceutical or medical care for their patients; When a person is trying to obtain substances in a manner that appears to be misuse, abuse, or diversion; Individuals who request their own PDMP info in accordance with the board’s policies and procedures; Designated representatives from professional licensing, certification, or regulatory agencies overseeing those who prescribe or dispense such drugs; Local, state, and federal law enforcement charged with carrying out the law of such drugs (includes those under grand jury subpoena or court order in a criminal action case); Representatives from the department of health and environment who seek information for those receiving Medicaid insurance; PDMP program advisory committee members in order to operate the program; Those at the board needing to administer or enforce laws pertaining to this area; Medical examiners, coroners, and others who determine cause of death
165
Who can the board provide PDMP data to that aren't in the previously covered entities
Public or private entities for statistical, research, or educational endeavors
166
Patients or their personal rep can request PDMP data, the written request must contain:
Patient name, full name of rep if applicable; Address (patient or rep); Phone number (patient or rep); Time period of information request
167
Valid forms of ID includes
Permanent or temporary driver’s license or permit (issued by a US or Canadian source); State ID card (issued by a US or Canadian source); US armed forces ID card (for active duty, reserve, or retired members and their dependents); Merchant marine ID card (issued by US coast guard); State liquor control ID card (issued by liquor control US or Canadian source); Enrollment card issued by Indian tribe located in Kansas (must include security features comparable to those used on Kansas driver’s licenses)
168
Must the requests be authenticated?
Yes, with patient information
169
Do prescribers and other HCPs need to submit written requests for PDMP information
Yes
170
What must be contained in a record of ephedrine/pseudoephedrine purchasing?
Name and address of person receiving or managing the product; Name of product and quantity purchased; Date and time of purchase; name or initials of pharmacist, tech, intern, or clerk that sold the product (Include pharmacist who supervised its sale); Signature of the person purchasing the product
171
How long do methamphetamine tracking logs need to be kept?
5 years
172
Drugs of concern
Butalbital, APAP, and caffeine Preps that have ephedrine or PSE Promethazine with codeine Gabapentin
173
Where do unused medication get returned to?
Qualifying center
174
Medications accepted by donation centers
In original or pharmacist sealed unit dose packaging; Tamper evident packaging; Unit of use or sealed; Unused injectables; Unexpired; Non-adulterated or are not believed to be by accepting or dispensing person; Non-CS, unless the board designates them to be so; From medication assistance program (MAP) or drug product donation program may be accepted
175
Before transferring prescriptions, donating entities must
Determine quality and suitability of each unused medication (Done so by pharmacist’s verification that the medication: is identifiable, sealed, airtight container, is not expired, is not a CS, is not adulterated, is not a restricted medication); Ensure all PHI is removed; consult with qualifying center to determine (if they are willing to accept each unused medication, that a consulting pharmacist practices there, if they are registered to accept unused medications)
176
Obesity
excess adipose tissue which results in a BMI ≥ 30 or BMi of 27 + other risk factors
177
Controlled substances for obesity can be dispensed or prescribed unless
Treating physician personally examines the patient (includes checking blood pressure, pulse, heart and lung exam, weight and height recording, and other appropriate diagnostic tests) [Comorbidities, this exam plus the patient’s history determines if CS are indicated, both must be recorded in the patient’s record by the physician]; Nutritional counseling is prescribed (including behavior modification and exercise for weight loss), which must also be recorded to have occurred; No more than a 30 days supply at a time is prescribed or dispensed; Amphetamines cannot be used for obesity treatment
178
What is the weight loss threshold for "not achieving successful treatment"
≥5% weight loss
179
If a patient doesn't lose ≥5% of their weight in the first 90 days, what happens?
no additional CS for obesity treatment can be prescribed or dispensed
180
If dispensing an amphetamine, the patient's file must contain a diagnosis of
Narcolepsy; Drug-induced brain dysfunction; Hyperkinesis; Depression (unresponsive to other treatment forms) [May also be used in the differential diagnosis psychiatric evaluation of depression]; Obesity (diagnosed in accordance with rules relating to its treatment); Other disorder or disease that amphetamines have been proven to be safe and effective by research and accepted by the scientific community [The board of healing arts must approve these indications prior to use]
181
Who can keep an epinephrine kit on hand?
Accredited schools
182
What is a pharmacists responsibility when being consulted for an episode kit?
pharmacist is responsible for developing procedures around use and maintenance of the epi kit, maintaining control and accountability for the kit, and periodically verifying physical inventory.
183
Vaccine administration
administer only an influenza (flu) vaccine to anyone ≥6 y/o and any other vaccine authorized to anyone ≥12 y/o. This must be under a vaccination protocol.
184
Licensing requirements for pharmacists
≥18 years old graduate from a school or college of pharmacy approved by the board 1740 hours of pharmaceutical experience pass approved examination apply for licensure on a form furnished by the board
185
Foreign graduate requirements
Passing the internet-based test of English as a foreign language (TOEFL iBT) and meeting minimum scores in reading, listening, speaking, and writing (22, 21, 26, and 24 respectively) constitute reasonable communication in English. Pass a foreign pharmacy graduate equivalency examination (FPGEE) with a minimum score of 75 Obtain a foreign pharmacy graduate examination committee (FPGEC) certification from the National Association of Boards of Pharmacy (NABP)
186
Renewal period for pharmacist license
2 years
187
CE requirements
30 hours
188
Date of renewal
June 30 at 11:59
189
Fees for registrations
New pharmacy registration: $150; Pharmacy registration renewal: $125; Pharmacist application: $250; Pharmacist examination fee: $100; Pharmacist reciprocal licensure: $125-250; Pharmacist renewal: $150-200; Pharmacist evaluation: $250 (paid directly to the examination service); Pharmacist education and training evaluation from non- approved college: $250; Reciprocal licensure: $250; Pharmacist penalty: $200-500; Pharmacy technician fee: $20; Pharmacy intern fee: $20; New manufacturer registration: $500; Manufacturer registration renewal: $400; New wholesaler distributor: $500; Wholesale distributor renewal: $400; Wholesale distributors not dealing with prescription drugs: $50
190
Behavioral Circumstances that must be reported to the board within 30 days
Unprofessional conduct; Violation of the FDCA; Violation of the Kansas CS act; Conviction of any felony; Disciplinary action taken against the individual
191
If applying for wholesale distribution status, what information must be provided?
Name, business address, and telephone number; Trade or business names used; Addresses, telephone numbers, and names of contact persons for all facilities used for storage, handling, and distribution; Type of ownership or operation; Name of owner, operator (or both) [Partnership: all partner names, name of partnership, Corporation: name and title of each officer and director, corporate names, and the name of the state of incorporation, Proprietorship: name of sole proprietor, name of business entity]; Other information as the board deems appropriate
192
Requirements for wholesale distributor registration issuance and maintenance
Application and/or renewal fees; Surety bonds; Periodic inspections; Designated representative; Designated registered agent; Storage of drugs and devices (and examination and treatment for those the board finds to be unacceptable); Handling, transportation, and shipment of drugs and devices; Security; Due diligence with other trading partners; Records that are created and maintained (including transaction records); Procedures for operation and requirement compliance
193
Entities who engage in management of controlled substances in what capacity need to register yearly?
Manufacturer, distributor, or dispenser
194
Individuals exempt from registering annually that engage in the management of controlled substances
Agents or employees of such registered manufacturers, distributors, or dispensers when acting in the usual course of their employment; Common carrier or warehouseman in possession in the usual course of employment; Ultimate user or person in possession of a CS pursuant to a lawful order (e.g., the patient); Persons licensed by the state board of healing arts, veterinary examiners, or dental board; MLPs; Native American Church members possessing or using peyote for religious ceremonies
195
Factors considered to determine if an application for management of controlled substances is in public interest
Establishment and maintenance of effective controls against diversion of controlled substances into illegitimate channels; Compliance with applicable state and local law; Conviction of the applicant relating to any controlled substance; Past experience in managing controlled substances; Furnishing of false or fraudulent material; Suspension or revocation of federal registrations pertaining to controlled substances; other relevant factors
196
PBM
Pharmacy Benefits Manager
197
Requirements to be a PBM
a valid certificate of registration issued by the commissioner must be obtained To obtain this certificate, must submit an application in a form the commissioner provides and includes: name, address, official position, and professional qualifications of each responsible person conducting the PBM; name and address of agent for service; Application fee of $140
198
Pharmacy technicians must be registered with the board wand meet the requirements of:
Graduated from an accredited high school or equivalent (such as a General Education Development (GED)) or enrolled and in good standing in a high school education program; Pass ≥1 exams identified and approved by the board after becoming registered (The two approved by the board are the Pharmacy Technician Certification Board (PTCB) and the National Healthcare Association (NHA) Exam for the Certification of Pharmacy Technicians (ExCPT)); Techs need only pass the examination one-time and do not need to renew it to maintain their license; Complete an application for registration and submit a fee of $50 (A history of felony conviction is taken into consideration, but is not an automatic bar to licensure)
199
Ratio of pharmacy techs to pharmacists
The current ratio is 4:1. 2:1 is the techs haven't passes a certification examination by the board
200
Adulteration
Filthy, putrid, or decomposed; Produced, prepared, packaged, or held under insanitary conditions (because it may have been contaminated with filth and rendered injurious to health); Methods or facilities used for its manufacturing, processing, packaging or holding do not conform with good manufacturing practices (GMPs); Containing or in a container has a poisonous or deleterious substance; Contains a color additive that is unsafe (if for coloring only, unsafe via these rules and regulations); Appears or claims to be a drug recognized in an official compendium and its strength, quality, or purity falls below that stated in the compendium (Determinations of strength, quality, or purity must be made using tests or methods set forth in the compendium, this does not apply if the drug labeling plainly states that the strength, quality, or purity, for homeopathic drugs, the homeopathic pharmacopeia requirements apply); Contains a strength that is different from what it is represented to possess; Purity or quality falls below that it is represented to possess; Has been mixed or packed to reduce its quality or strength; Cosmetics that have poisonous or deleterious substances that may cause injury
201
Misbranding
Have false or misleading labeling; Do not have the name and place of business of the manufacturer, packer or distributor; Do not have an accurate statement of the quantity of contents (weight, measure, numerical count); Have required statements or information not prominently placed clearly according to usual conditions of purchase and use; Are for human use and have narcotic or hypnotic substances that are habit forming (unless the name and quantity of such substances and a statement of “WARNING - MAY BE HABIT-FORMING”); Attempt to pass as a drug recognized in an official compendium when it is not; Are liable to deterioration unless stated as such with precautions; Are in containers that are made, formed, or filled to be misleading; Are in imitation of another drug; Are dangerous to health when used in the dosage and frequency of duration as prescribed; Attempts to pass for insulin (wholly or in part) unless it comes from a certified batch; Are color additives whose purpose is for coloring only, but are not labeled as such; Quantity of each ingredient to the extent required for compound drugs are not listed, including other information in brief summary (side effects, contraindications, effectiveness); Use a trademark, trade name, or other identifying mark, imprint, or device of another or any likeness with the intent to defraud; Are for human use and are habit forming, toxic, or potentially harmful, unsafe for use except under the supervision of a practitioner licensed by law to administer it, and are not administered upon a written prescription of a practitioner licensed to administer such a drug.
202
PIC
Pharmacies must have a PIC within 30 days of starting operations. PICs cannot oversee more than one full- time pharmacy operation (defined as on-premises pharmacists serving 30 hours or more each week). If a PIC was required to provide services at more than one pharmacy where each pharmacy required services <30 hours per week, this would be permissible.
203
Pass score for PIC exam
85%
204
PICs for medical care facility
Supervising personnel in distribution and control of drugs for all pharmaceutical services in facility; Develop a policy and procedure manual that governs storage, control, and distribution of drugs (which must be approved by a pharmacy and therapeutics committee); Maintenance of emergency medication kits; Develop policies and procedures for when a pharmacist is not on the premise; Maintain documentation of at least quarterly checks of drug records and conditions of drug storage; Participate in the pharmacy and therapeutics committee; Establish a drug recall procedure that can be implemented; A written procedure for records maintenance of drug distribution, prepackaging, and bulk compounding; Maintain adequate drug information references; Pharmacist supervision of all pharmacy techs and for confining their activities (as well as maintaining records of training and related education, and procedures for pharmacy techs); Establishing policies and procedures for mixing or preparation of parenteral admixtures; Security of pharmacy, drug distribution systems, and personnel; Inventory all CS before leaving position and within 72 hours of beginning functioning; Developing programs as needed to fulfill their responsibilities
205
PICs of non-medical care facility Responsibilities
Developing, supervising, and coordinating all pharmaceutical services; Personally available to the extent required to ensure comprehensive pharmacy services; Developing a staff of additional licensed pharmacists and supportive personal as needed; Maintain records in pharmacy describing the training and education of all personnel; Inventory all CS before leaving position and within 72 hours of beginning functioning
206
When can the board come inspect pharmacies?
The board has the right to enter and inspect any of these locations during business hours. Findings may be submitted for analysis to the department of health and environment. Analyses may be published. The board, authorized agents, or employees may inspect controlled premises and practitioners’ offices during business hours, in a lawful manner, upon presenting appropriate credentials
207
What can be inspected by the board?
Any books, inventories, records, or other documents required to be kept; All pertinent equipment, finished/unfinished materials, containers, and labeling found; Processes, controls, and facilities; Inventory any stock of any controlled substance and obtain stables upon payment
208
Fine for each penalty found by the board
$1000
209
Reference library for a community pharmacy
Kansas Pharmacy Practice Act and regulations (an updated copy); Kansas Uniform Controlled Substances Act and regulations (an updated copy); Drug information references, which are recognized/ established, one in each of the following areas: Toxicology, pharmacology, and drug interactions, Drug equivalencies, Medical dictionary
210
How long are records kept at a community pharmacy?
5 years
211
Institutional Drug Room
Must be under the supervision of a pharmacist, or a practitioner licensed to practice medicine and surgery that is employed part time or more. They will be responsible for the recordkeeping and storage of medications used by that drug room. All prescription-only drugs dispensed or administered from the drug room will be in either pre- packaged units, in the original manufacturer’s bulk packaging, or in patient-specific, pharmacy-labeled packaging.
212
Drugs dispensed from the institutional drug room must contain the following information
Patient name; ID number assigned to the drug provided; Brand name or corresponding generic name, strength, manufacturer name or abbreviation; Auxiliary labels, storage instructions, BUD; Instructions for use; Name of institutional drug room
213
Supervisor of the institutional drug room must approve/ develop
Programs for training and supervision of personnel on the storage, control, and provision of drugs; Written policy and procedures manual for the storage, control, and provision of drugs for when a pharmacist/ practitioner is not on duty; Written procedures for documenting all reportable incidents and steps taken to avoid a repeat of a reportable incident
214
Quarterly reviews of drug records, storage conditions, and drugs stored within the drug room.
Record of all drugs provided to each patient, maintained in the patients file, and shall include the order/written protocol for it; If the order was given orally, electronically, or by phone, the order shall be recorded by the person who created the copy and maintained as part of the permanent file.; The records will include the following information: (Full name of patient, Date drug was provided, Name, quantity, and strength of drug provided, Directions for use, Prescribers name and (if applicable) the supervising practitioners name.)
215
Outsourcing Facilities registration requirements
Name of the facility (includes all business and trade names); Name of owner and operator (can be person, partnership, corporation, or sole proprietor); Full address; Telephone number; Copy of FDA registration and current inspection report; PIC information (name and license number)
216
Things considered by the board when looking at outsourcing facility registration
Drug related convictions at federal, state, and local level (for wholesale, sample, retail distribution, and controlled substance medications); Felony convictions under federal and state laws; Experience in manufacturing or distribution; Furnishment of false/fraudulent materials; Suspension or revocation current or previous; Compliance with registration under previous registrations; Compliance with maintaining and making available records required; Any other factors consistent with public health and safety
217
Outsourcing facilities must meet
Be of a suitable size and construction for cleaning, maintenance, and operation, as well as free of infestation (such as by insects, rodents, birds, or vermin); Contain storage with adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security; Contain a quarantine area for prescription-only products deemed unfit for distribution; Contain a quarantine area for products awaiting testing before distribution; Not a location for personal dwelling or residence (commercial space); Maintain storage space for 5 years of records for all shipments; Be secure, meaning that it does not allow unauthorized entry, is well-lit and controlled, and prescription-only areas are further limited and/or secure (Includes equipment with alarm system for after-hours entry, and security system that protects against theft and/or diversion of products and records); Store all prescription-only drugs at appropriate temperature and conditions in accordance with manufacturer recommendations; Contains equipment for monitoring and documentation of at least once daily checks of temperature and humidity
218
Outsourcing facility records must be kept for how long
5 years
219
"Records" from outsourcing facilities include
Source of drug/device with name, principal address, and shipping address; Identity and quantity of drug/device received, distributed, or disposed of; Date of receipt, distribution, or disposal
220
Shared services
includes preparing, packaging, compounding, or labeling an order, done by one pharmacy in place of another pharmacy, who will deliver the order to the patient or patient representative
221
To take part in shared services, what requirements must be met
Share a common electronic file or appropriate technology to allow access to sufficient information to order; Have the same owner or written contract outlining the shared service; Maintain records of who was involved in processing, filling, dispensing, and counseling; Report to the board within 30 days of any disciplinary action taken by another board; Maintain tracking of order during each step; Maintain a mechanism to identify on the prescription label all pharmacies involved; Provide protection, confidentiality, and integrity of patient information; Be able to obtain records within 72 hours
222
Nonresident pharmacies must meet the requirements to establish and maintain registration in KS
Some exemptions exist: Number of prescriptions dispensed or expected to be in Kansas, number of patients served or expected to be in Kansas, Any effort to promote pharmacy services in Kansas, Contract between pharmacy and employer/organization to provide pharmacy services to employees/beneficiaries in Kansas, Medical necessity, Effect on health/welfare of persons in Kansas, Any other relevant matters
223
Medications allowed to be distributed in home health or hospice
Sterile water and saline for injection or irrigation; Heparin flush solutions; Diphenhydramine injectables; Epinephrine injectables
224
The pharmacist providing emergency kits ensure that
A pharmacist maintains the drug until it is administered upon physician order; The kit is locked or sealed in a manner to prevent tampering; The kit has an expiration date corresponding to earliest expiration of a med in kit, but no more than one year; All drugs are returned/restocked after use alongside of the prescriber’s order
225
Requirements for unit dose
All medication shall be packaged in unit-dose containers and meet requirements of Kansas law, unless the manufacturer specifies different requirements; A pharmacist is responsible for filling and refilling of such systems, and the prescribers’ orders; Must comply with all requirements for prescription orders, including inventory and recordkeeping; Packaging shall take place at the address of pharmacy providing unit-dose system; Must be sufficiently labeled; Must provide verification check at point of patient administration; Delivery-time-cycle or hours of exchange are defined by pharmacist and needs of facility; Pharmacist is solely responsible for dispensing under unit- dose system
226
Verbal medication orders can be given to whom?
a nurse, pharmacist or another physician. Physician must coutnersign within 7 days
227
PIC at family planning clinics are responsible for
Developing programs for supervision of personnel involved ƒ Development of policy/procedures on drug storage, control, and distribution; Documentation of at least quarterly checks for drug records, storage conditions, and location; Recall procedure that is reasonable; Procedures for maintaining records of distribution and prepackaging
228
Labels for prepackaged drugs at facilities must contain:
Brand name or generic name; Manufacturer/distributor name or easily identifiable abbreviation; Drug strength; Contents in weight, measure, or numerical count; Lot of drugs (if not contained in suitable log); BUD
229
Who can access the pharmacy area and remove a supply of a drug
Designated nurses
230
What must the drug supplies be labeled with
Name, address, and telephone number of the facility; Full name of patient; Adequate direction for use of the drug; Name of prescriber; Date was distributed; ID number; Brand or generic name of drug; Necessary auxiliary labels and storage instructions; BUD
231
Unlawful Acts
Processing, storing, or distributing an adulterated or misbranded food, drug, device or cosmetic (Adulteration or misbranding such products, receiving or delivering such products knowing them to be adulterated or misbranded); False advertising; Refusing entry, inspection, or taking of a sample that is authorized by Kansas law; Making a false promise (guaranty) to a person who has received a drug, device, food, or cosmetic in good faith; Removing or disposing of a detained or embargo article; The following actions done to an article held for sale, resulting in misbranding: (Alteration, Mutilation, Destruction, Obliteration, Removal of whole or any part of labeling, Any other act); ; Forging, counterfeiting, simulating, falsely representing, or using without authority an identification method; Using of a person to one’s own advantage; Revealing any information that constitutes a trade secret; Failure of manufacturer, packager, or distributor to maintain labeling requirements; Defrauding a trade name (and associated/related actions) ƒ Dispensing a different drug or brand of a drug in place of that which was prescribed without permission; Knowingly performing actions related to diseased animals for human consumption (killing, selling, trading, etc.) [Includes purchasing or obtaining possession of with the intent of use for human consumption, Does not include immediate slaughter for government meat and poultry inspection]; Offering or exposing for sale animals not properly prepared according to content and temperature, or protected from vermin or other substances which may injure it; Using a communication facility (public and private transmissions of communication, such as radio, computer, computer networks, etc.) when committing (including conspiracy), causing, or facilitating a felony
232
Unlawfully obtaining a prescription only drug includes
Making, altering, or signing a prescription order (by persons who are not a practitioner or MLP); Distributing a prescription order that is known to be false; Possessing a prescription with the intent to distribute it and knowing it to be false; Possessing a prescription-only drug knowing it to have been obtained by a false prescription; Providing false information to a practitioner or MLP with the intent to deceive, in order to obtain a prescription-only drug; Actions surrounding the sale of a prescription-only drug unlawfully obtained
233
Reasons to suspend, revoke, deny, or put a license on probation
Conviction of a misdemeanor involving moral turpitude, gross immorality, or any felony (The licensee must be sufficiently rehabilitated to warrant public trust in order for the board to reverse their actions); Found to be guilty of unprofessional conduct or professional incompetency; Found to be addicted to liquor or drug habit to a degree to render them unfit to practice pharmacy; Found to have violated a provision of the FDCA, CS act of Kansas, or any rule or regulation; Filled a prescription not in strict accordance with the prescriber; Found to be mentally or physically incapacitated to a degree to render the licensee unfit to practice pharmacy; Has not met CE requirements; Is a PIC or consultant pharmacist and has not complied with laws relating to each; Knowingly submitted misleading, deceptive, untrue, or fraudulent misrepresentation on a claim form, bill, or statement; Has had a license to practice pharmacy acted against in another state or country (evidence of being a copy of the record of the action of the other jurisdiction, examples are suspension, censure, revocation, etc.); Self-administered any CS without a prescription order; Assisted suicide; Has not supplied legally requested information to the board or it’s representatives; Has violated or failed to comply with any lawful order of the board; Has violated PDMP requirements; They present an immediate risk to the public (and immediate protection of public interest is required)
234
Toxic Vapors
Alcohols (methyl, isopropyl, propyl, butyl); Aliphatic acetates (ethyl, methyl, propyl); Acetone; Benzene; Carbon tetrachloride; Cyclohexane; Freons (halogenated hydrocarbons); Hexane; Methyl ethyl ketone; Toluene; Trichloroethane
235
A responsible individual must:
Be actively engaged in the practice of healing arts in Kansas; Be licensed by the state board of healing arts (for medicine, surgery, or chiropractic); Accept responsibility to persons they delegate or supervise; Review and keep current the agreements or protocols between themselves and such persons; Know or have reason to believe persons or delegates can perform only acts and functions the responsible licensee can; Be within the customary specialty, competence, and lawful practice of the responsible licensee; Develop protocols when supervising or responsible individual is absent; Comply with rules and regs regarding limits and conditions of delegation
236
Supervising physician
one who has continuous and ultimate responsibility for medical services of a PA who they are supervising
237
Four Roles of APRNs
Clinical Nurse Specialist Nurse Anesthetist Nurse midwife Nurse practitioner
238
APRNs may prescribe and administer under a written protocol authorized by a responsible physician. These protocols shall contain:
Medical plans of care for each disease or injury the APRN will prescribe for; Information on drugs (such as class) which the APRN may prescribe for each disease or injury; Name, address, and telephone number of responsible physician; Drug samples that APRNs may receive, sign for, and distribute
239
Prescriptions written by APRNs must include:
Name, address, and telephone number of APRN practice location (also of responsible physician); Be signed by the APRN (including the letters “APRN” following their name); DEA number (when controlled substance is prescribed)
240
Prescriptions written by PAs must contain
Name, address, and phone of responsible physician and PA; Be signed with “P.A.” following their signature; Contain a DEA number if controlled substance is prescribed; Indication of whether the prescription is (A direct order of supervising physician, authorized by a written protocol, prescribed in an emergency situation)
241
Legality of termination of pregnancy
No person shall be required to perform, refer for, or participate in medical procedures or in the prescription or administration of any device or drug which results in the termination of a pregnancy or an effect of which the person reasonably believes may result in the termination of a pregnancy, and the refusal of any person to perform, refer for, or participate in those medical procedures, prescription or administration shall not be a basis for civil liability to any person.
242
Reportable incidents
preventable medication errors involving prescription drugs and resulting in the patient receiving any of the following: the wrong drug, incorrect drug strength, incorrect dosage form, inadequate or incorrect packaging, labeling, or directions. Also included are incidents where a drug is received by the wrong patient, or dispensing occurs that results in or has the potential to result in serious harm to the patient.
243
Peer review functions include:
Evaluate and improve the quality of health care services rendered by providers; Determine that services were indicated and performed in compliance with the standard of care; Determine that the cost of health care was reasonable; Evaluate qualifications, competence, and performance of providers; To act on matters relating to the discipline of an individual provider; Reduce morbidity or mortality; Establish and enforce guidelines designed to keep the cost of healthcare within reasonable bounds; Conduct research; Determine if hospital facilities are being properly utilized; Supervise, discipline, admit, and determine privileges of a hospital’s medical staff; Review professional qualifications or activities of health care providers; Evaluate the quantity, quality, and timeliness of health care services; Evaluate, review, or improve methods utilized in a medical care facility or by healthcare providers
244
Vending Machines
up to 12 separate drugs
245
DMSO
label must contain: description of contents, percentage of DMSO in the solution, and the manufacturer's name and address
246
Benzylpiperazine
C1
247
Codeine (certain subjects)
C1
248
Heroin
C1
249
Marijuana
C1
250
Mescaline
C1
251
Peyote
C1
252
Psilocybin
C1
253
Amphetamine
C2
254
Opium (raw and extract)
C2
255
Codeine
C2
256
Dronabinol
C2
257
Hydrocodone
C2
258
Hydromorphone
C2
259
Lisdexamfetamine
C2
260
Methamphetamine
C2
261
Methylphenidate
C2
262
Morphine
C2
263
Oxycodone
C2
264
Oxymorphone
C2
265
Alfentanil
C2
266
Carfentanil
C2
267
Fentanyl
C2
268
Levorphanol
C2
269
Methadone
C2
270
Nabilone
C2
271
Pentobarbital
C2
272
Remifentanil
C2
273
Sufentanil
C2
274
Secobarbital
C2
275
Tapentadol
C2
276
Thiafentanil
C2
277
Amobarbital
C3
278
Anabolic steroids
C3
279
Benzphetamine
C3
280
Buprenorphine
C3
281
Cannabidol
C3
282
Chlorhexadol
C3
283
Chlorphentermine
C3
284
Codeine and derivatives (max 1.8g/100mL or 90mg/dosage unit)
C3
285
Dronabinol
C3
286
Eluxadioline
C3
287
Ethylmorphine (max of 300 mg/100mL)
C3
288
GHB
C3
289
Ketamine
C3
290
Morphine (max of 50mg/100 mL or 100g)
C3
291
Opium (max of 500mg/100 mL or max of 25g/ dosage unit)
C3
292
Pentobarbital
C3
293
Phendimetrazine
C3
294
Secobarbital
C3
295
Alprazolam
C4
296
Barbital
C4
297
Butorphanol
C4
298
Carisoprodol
C4
299
Chlordiazepoxide
C4
300
Clobazam
C4
301
Clonazepam
C4
302
Clorazepate
C4
303
Diazepam
C4
304
Diethylpropion
C4
305
Fenfluramine
C4
306
Fludiazepam
C4
307
Flunitrazepam
C4
308
Flurazepam
C4
309
Fospropofol
C4
310
Lorazepam
C4
311
Lorcaserin
C4
312
Meprobamate
C4
313
Midazolam
C4
314
Mondafanil
C4
315
Nitrazepam
C4
316
Nordiazepam
C4
317
Oxazepam
C4
318
Oxazolam
C4
319
Phenobarbital
C4
320
Phentermine
C4
321
Pinazepam
C4
322
Prazepam
C4
323
Quazepam
C4
324
Suvorexant
C4
325
Temazepam
C4
326
Triazolam
C4
327
Zaleplon
C4
328
Zopiclone
C4
329
Brivaracetam
C5
330
Codeine (max 200mg/100mL or 100g)
C5
331
Difenoxin with atropine (max 0.5 mg/25mcg)
C5
332
Dihydrocodeine, ethylmorphine, opium (max of 100mg/100 mL or 100 g)
C5
333
Ephedrine
C5
334
Eszopiclone
C5
335
Lacosamide
C5
336
Pregabalin
C5
337
Pseudoephedrine
C5