Kansas Law Flashcards
Practice of Pharmacy in Kansas is defined by the following:
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
CDTM
collaborative drug therapy management
What is CDTM?
practice of pharmacy where the pharmacist perform certain pharmaceutical related patient care functions for a specific patient.
CDTM don’t allow
Alter a physician’s orders or directions; diagnose or treat any disease; independently prescribe drugs; independently practice medicine and/or surgery
CPA
Collaborative Practice Agreement
What is a CPA?
A written agreement or protocol between one or more pharmacists and one or more physicians that allows for CDTM to occur
CPAs must be
- consistent with normal and customary specialty
- Consistent with competence and lawful practice of the physician
- Appropriate to the pharmacist’s trining and experience
CPAs must include the following statements
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)
How often does a CPA needed reviewed?
Every 2 years
How long does a signing pharmacist have to deliver a copy of the CPA to the board?
5 days
How many persons sit on the CDTM committee?
7
What is the makeup of the CDTM committee?
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)
Who submits appointment to the CDTM board?
KPhA and the Kansas Medical Society
CDTM Committee Term
2 years
Role of the Kansas BOP
Create rules and regulations that are used to carry out enforcement of law pertaining to the practice of pharmacy
How many members are on the board of pharmacy?
7
Who are the persons on the board of pharmacy?
6 licensed pharmacists and 1 representative of the general public
Term for the BOP?
4 years
How many terms can you serve on the BOP?
Maximum of 2 terms
BOP members appointed by
the governor
who is eligible for BOP appointment?
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.
How long do appointees have after being appointed to take and subscribe to the oath?
30 days
Positions on the Board
President, Vice President, Executive Secretary
Minimum number of meeting per year
4
Notice required prior to meetings
10 days to all board members
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.
Who creates the tech training program?
PIC (Pharmacist in Charge)
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
Time limit for a tech to complete training
180 days
How often does the tech training program need to be reviewed?
Annually
How long do you have to notify the board of hiring a tech?
30 days
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.
Fee for intern application
$25
How long does an intern license last?
6 years
CQI
Continuous quality improvement
what is a CQI
program to assess errors that occur in the pharmacy with regards to dispensing prescription medications
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
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.
PDMP
Prescription Drug Monitoring Program
Purpose of PDMP
monitoring controlled substances and drugs of concern
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
Who ensures that a registered pharmacist is on duty at all times when the pharmacy is open?
PIC
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
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
Requirements to electronically supervise
a pharmacist must be licensed by the board and electronically connected to multiple medical care facility pharmacies at one time
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.
Is electronic supervision a sufficient substitute for direct supervision?
Yes
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.
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.
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
How long do you have to maintain records of ESP data transmissions?
5 years
Can registered pharmacies be accessed without a pharmacist on site?
No
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
What information must be on a name tag?
person’s name and designation
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
Must patients be notified of a pharmacy closure?
yes. All patients who received a prescription from the pharmacy within the past 2 years
How long does the pharmacy have to notify patients of pharmacy closure?
10 days
How can notification of closure be sent to patients?
Mail, phone, email, text message
Who can make a judgement to fill or refill a prescription?
Only a licensed pharmacist
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
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)
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.
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.
Dispensing physicians
licensed to practice medicine and surgery, purchase and keep drugs, and compound their own prescriptions to supply them to patients.
Requirements for packaging (per PPPA)
child-resistant containers and in light-resistant containers that are air- tight
Each drug should be clearly labeled with the following information
- name, address, and telephone of dispensing physician
- Full patient name
- ID number assigned to the prescription
- date of fill (or refill)
- Adequate directions for use
- Expiration date of drug dispensed
- (at the discretion of the physician): brand or generic name; manufacturer or distributor name; strength of medication
Supervision
defined as the guidance and direction of a licensed practitioner who is physically present at the location where drugs are dispensed.
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.”
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.
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)
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
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
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
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.
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
How long is an e-scribing waiver good for?
6 months
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)
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
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
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
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
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)
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
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)
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)
New drugs can’t be handled unless
- an active approval of such drug exists
- 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
New drug applications are good for how long
180 days
What is considered prepacking or repackaging?
the transfer of a drug to another container in advance of its immediate need
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).
Records with lot numbers must be kept for what purposes
for the purpose of recalls
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).
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.
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
What can’t be compounded
- drugs withdrawn from the market by the FDA for safety reasons
- 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.)
- Those that contain active ingredients that do not meet monograph or official compendium requirements
- Using non-FDA approved drug components
Can you compound before receiving an order?
Yes
What can’t pharmacists compound?
pharmacists cannot compound bulk chemicals for food-producing animals (like cows, chickens, or pigs).
If a pharmacy sells a compounded prep, what must they keep on an invoice
- name and address of practitioner
- drug compounded (lot and expiration date of each component contained within)
- quantity sold
- date of transaction
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.
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
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)
BUD for non- aqueous and solid formulations
6 months or the earliest expiration date of any of the product ingredients
BUD for water-containing oral formulations
14 days maximum when stored in the fridge
BUD for water-containing, non-oral formulations
30 days maximum (less if the intended duration of therapy is shorter)
How long do formulation records need to be kept?
5 years
Examples of sterile preparations
bladder irritation solutions, TPN solutions, and IV solutions
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
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.
BUD for low risk sterile preparations
Room temperature ≤ 48 hours, Refrigerator ≤14 days prior to administration, Freezing temperatures ≤45 days prior to administration
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
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
BUD for Medium risk sterile preparations
Room temperature ≤ 30 hours, refrigerator ≤ 9 days, freezer ≤ 45 days
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
High Risk Sterile Prep BUDs
Room temperature 24 hours, refrigerator 3 days, freezer 45 days
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)
Multi-dose containers must have what BUD
28 days
Sterile preps made in a segregated area (not the hood) have what BUD
12 hours
Single-dose containers have to be used with in how many hours?
1 hour
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”
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
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
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
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
How long do you keep formulation records?
5 years
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
What are CAIs?
Compounding Aseptic Isolator- exclusions to such garbing and washing procedures
Labeling for sterile preps
Name and quantity of each component; BUD; Prescribed flow rate; Name or initials of each compounder; Special storage instructions
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))
If doing high risk sterile preps, how often do you need to do a media fill test/ glove tests?
twice yearly
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)
Air pressure of the antearea
5 pascals
Airflow speed
0.2 meters per second
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
Annual report on substances must be submitted to whom
The house of representatives and senate
The annual report of controlled substance scheduling musts to look at
scheduling, rescheduling, or deletion
