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Arts and Humanities
Terms in this set (149)
A petition for license reinstatement may be approved if it is determined that reinstatement would be...
In the best interest of the public's health, safety and welfare
What components must be included in the petition for reinstatement?
Original dated letter addressed to the board and signed by the petitioner
--How petitioner has been affected by loss of license
--Why favorable action by the board is warranted
-Plans to resume pharmacy practice or employment and the actions the petitioner will take to ensure compliance with all laws and regs
--Professional and personal activities from the date of loss of license to present
Documentation outlining successful completion of specific conditions (if applicable)
Written verification from licensing agency in another jurisdiction documenting conditions for reinstatement have been met (if applicable)
Statement identifying any occupational or professional licenses or credentials
--verification of current license status by licensing entity
--listing of any resolved or pending complains including disciplines
Original report from NPDB
Resume or CV that identifies at a minimum the petitioners employment and other actives from the date of loss of license to present
Official docs of any completed educational programs or academic degrees since loss of license
Docs of any completed professional CE since loss of license
Official notarized statements from at least 3 individuals, one of whom must be a pharmacist whose license is current and in good standing without conditions
--acknowledge having read the consent agreement or final decision and order relating two the petitioners loss of license
--Have current relationship with petitioner
--Recommend reinstatement with supporting reasons
Completed license reinstatement questionnaire
Completed criminal offender record information (CORI)
The petitioner will be notified in ______ of the Board's approval or denial and such reasons for denial
If denied, how long must the petitioner wait to re-submit a petition?
2 years from date of initial petition denial
What are shared pharmacy services?
system that allows a participating pharmacist or pharmacy, pursuant to a request from another participating pharmacist/pharmacy, to process or fill a prescription drug order
Pharmacies engaged in shared service models have the ______ order, or have a written contract or agreement that outlines the services provided and shared responsibilities of each party
If filled elsewhere, (shared pharmacy model), retail pharmacies must notify patients what?
That their prescriptions may be processed or filled at another pharmacy
Must pharmacies offer an option for patients to opt out of shared pharmacy service?
In a shared pharmacy model, those involved must conduct a review of written P&P's how often?
At least annually, and document the review
May a central fill pharmacy provide central filling for multiple pharmacies?
What must a licensed pharmacy do prior to initiating central fill activities?
Must file a petition to the board and receive board's approval
Any central fill pharmacy dispensing into or from MA must be licensed...
Centrally filled CII-V meds must be delivered to...
Pharmacy where prescription originated for the patient
Centrally filled CVI meds, with the exception of those requiring reporting to MassPAT (PMP), may be delivered to...
Directly to the patient
Unless otherwise approved by the board, central filling of compounded sterile medications or complex non-sterile meds (is/is not) permitted
What is central and remote processing?
Services defined as a system that allows the processing of patient specific prescriptions for MA licensed pharmacy without final product verification or dispensing responsibilities
Can pharmacy techs per form remote processing of rx on behalf of retail or institutional pharmacy that is located in MA (without onsite supervision by a pharmacist*?
Yes, provided they hold an MA pharmacy technician license
Scope of telepharmacy is limited to...
Remote pharmacist verification of final patient specific product
Clinical activities conducted by a pharmacist such as patient counseling, DUR, drug therapy monitoring
With tele pharmacy, the pharmacy dispensing the final patient specific product must have who on the premises?
At least one licensed pharmacist
A pharmacist shall not directly supervise more than how many pharmacy interns at one time?
A pharamcy preceptor may supervise up to
pharmacy interns at one time ONLY if the interns are NOT...
In a pharmacy or engaged in th filling and/or dispensing of prescriptions or any other duty in which an error on the part of an intern could have an untoward impact on patient safety
interns at one time when exclusively conducting immunization clinics
Preceptor must be actively present at all times when any intern participates in...
Patient or practitioner consultations
Must pharmacy interns be licensed as pharmacy interns prior to the start of of internship?
Can interns perform remote processing of rx in the same manner as pharmacy technicians?
Licensed pharmacy staff that are assigned to train other staff (are/are not) required to be included in the supervisory ratios so long as they are not independently supporting pharmacist in any professional capacity and are appropriately designated in the schedule
Must a trainee be counted in the supervisory ratio?
Are trainer and trainee badges required?
If a trainee is participating in computer modules only, do they count towards the ratio?
An independent pharmacist may not possess medications without...
Massachusetts Controlled Substance Registration (MCSR)
What may pharmacists or interns do regarding health promotion screening?
May administer, process, read and report results of these test but may not order or interpret any test results, diagnose any medical conditions, or initiate drug therapy
Same for covid tests
To provide cognitive services to a MA patient, each non-resident pharmacist must be licensed in MA except...
Unless provided in conjunction with a prescription filled in a MA licensed non-resident pharmacy
May pharmacists perform skin testing? OR administer medications?
No, except some vaccines, COVID vaccines, select treatments for mental illness and substance use disorder
Can pharmacists recommend human OTC drugs for an animal?
No unless pursuant to a prescription or documentation from a vet
Can pharmacists compound schedule VI emergency meds for veterinary office to use?
All licensed pharmacy technicians, including trainees may do what tasks?
Enter prescription data into computerized systen
Take stock bottles off the shelf to prepare CIII-VI meds
Affix label to rx container
Prepare patient compliance packaging
Compound sterile and non-sterile meds
Extend offer to counsel
All licensed pharmacy techs
may also do which tasks?
Request and accept orally transmitted
authorizations for Schedule III-VI medications if there have not been any changes to the rx
Assist in the transport of filled and verified CII-VI meds
Conduct remote processing of prescriptions
Perform certain actives during COVID-19 emergency declaration
---Prepare and administer COVID-19 and other vaccines
---Administer and process COVID-19 tests
Under the supervision of a pharmacist, licensed pharmacy technicians that have
(CPhT or ExCPT) may also do which tasks?
Use technology to verify certain inventory management functions
Perform perpetual inventory counts with second licensed nationally certified tech provided that the supervising pharmacist verifies that the inventory has been completed in accordance with Board regs
Accept NEW orally transmitted CIII-VI rx
Perform prescription transfers between pharmacies for schedule VI drugs
Assist in the handling of schedule II medications (counting pills, working in a vault, performing inventory related tasks) EXCEPT for
hydrocodone-only ER medications that is not in an abuse deterrent form
Stock and/or perform expiration date checking of schedule II-VI medications in ADS
Perform med histories
Pharmacy technicians may not do what?
Administer medications or vaccines, unless permitted by board policy
Perform final patient dispensing process validation
Resolve clinical issues
Contact prescribers concerning drug therapy clarification or modification
Compound, fill or dispense medications without a pharmacist on site
The decision to order a COVID test must be based on...
Mass DPH guidance
Can technicians read and report COVID test results to patients?
No, can only administer and process, only pharmacist or intern can do these items
Under COVID policies, what requirements must be met for a technician to give vaccines?
Certified nationally or have worked at least 500 hours after being lichened as a pharmacy technician
Licensed by the board
Approval of a MA licensed pharmacist on duty and are under direct on-site supervision
May only conduct phsycial act of preparing and administering the vaccine
Complete ACPE accredited training program with:
--2 contact hours of self study modules and assessment exam
--4 contact hours of live seminar to include an exam and successful demonstration of technique
--Recognition and management of vaccine reactions
Compounding, including veterinary compounding in MA must:
Be pursuant to patient specific prescription or in anticipation of a patient specific prescription based on routine, regularly observed prescribing patterns
Meet unique medical need of an individual patient by producing a significant difference between the compounded drug prepaid a comparable commercially available drug
Be accompanied by a documented medical need for the compounded preparation, such as removal of dye, change in strength or dosage, form or delivery mechanism
Is price difference a valid reason for compounding?
What is proper fridge temp?
What is proper freezer temp?
-13 to 14F, -25 to -10C
Temperatures must be documented how frequently?
What to do regarding temperatures on days where pharmacy is closed?
Must have a system that identifies temperature excursions
What are the spacing requirements for fridge/freezers?
Allow for space on all sides and top
Allow at least 4 inches between the unit and wall
Do not block motor cover
Make sure there are at least 1-2 inches between bottom of unit and floor
Can containers of water be used for temperature stabilization?
Yes, must be labeled "do not drink"
To whom and when should a pharmacy report theft or significant loss of CS?
Submit form 106 to the board within 7 business days of such theft or loss, and shall comply with reporting requirements of DEA, state and local police
Regarding theft/loss, a pharmacy MUST report...
All loses related to employee pilferage/diversion, no matter the quantity or schedule of medication
All significant losses of schedule II-V
All significant losses of schedule VI CS required to be reported to MassPAT
All reports of possible loss must be emailed. This should include what info?
Pharmacy name, state license number, address
Date of possible loss
Drug name, strength, dosage form
Reason for possible loss
When shall the pharmacy submit outcome of investigation?
Once internal investigation is complete or within 21 days of the initial email, whichever is sooner
7 business days
of confirming significant loss, what must the pharmacy submit?
Board's Report ofLoss of CS form
DEA Form 106 if applicable
All documentation described in the appendix
If no loss is confirmed ,what must be sent?
Submit notification to the board via email indicating this, as well as all info mentioned previously
Detailed description of the investigators process which concluded no reportable loss
If already sent form 106 to the DEA but no loss was found, what must e sent?
Revised form 106, or statement of rescission, with Report of Loss of CS form
Do insignificant losses need to be reported? What must be done?
Documented onsite in pharmacy logbook, electronic log and tracked for adverse trending (3 insignificant losses for same drug in 90 day period should be reported)
Records such as:
Documentation for approval for use and placement of ADD, Locations of ADDs,
Delivery manifests or similar electronic docs for transport of CS between pharmacy and ADD
ADD cleaning and maintenance logs
Records and/or electronic data of all vents involving the ADD
Must be kept for how long
onsite at the pharmacy?
Retail pharmacies utilizing ADDs for emergency med kits or other similar use must be loaded by who?
Certified pharmacy tech, intern, pharmacist or licensed nurse
Retail pharmacies utilizing ADD for routine med dispensing must obtain what?
Machine specific DEA number and MA CS registration
ADDs utilized for routine dispensing must be....
Continuous monitored by video
Loaded by a certified pharmacy technician or intern while being supervised by MA licensed pharmacist
May original unfilled electronic prescriptions for CS (EPCS) in
Is it permissible to transfer original unfilled paper, faxed or oral prescriptions for federally
After the original prescription is filled ,the refills may be transferred
May unfilled electronic, paper, faxed or oral rx in schedule VI be transferred?
For CE credits, if CME category 1 or Board approved program credits are not added to CPE monitor, what must be done?
Certificates of completion must be retained
Must pharmacists retain documentation of completed CE hours?
How many hours of CE credit per year need to be regarding pharmacy law? How many credits need to be live?
2 --> pharmacy law
5 --> live credits
Pharmacists who have obtained their MA license via exam or reciprocation on or after
will be granted a grace period through ______ to obtain all required CE hours for the previous year
If immunizing or directly overseeing immunizations, how much immunization CE is needed?
2 hours every 2 years
Do CEs for CDTM participation count towards 20 annual hours?
No, need 5 additional hours of CE on top of the 20 hours annually
CDTM pharmacists with prescriptive authority are also required to receive what type of training?
If involved with sterile compounding, how many CE hours are needed yearly?
If involved with complex non-sterile compounding, how many CE hours are needed yearly?
Sterile and complex non-sterile compounding CE hours may be completed in which format?
Live or home study
What is an automated pharmacy system?
System located wither in wall of a pharmacy or
within 20 feet
of a pharmacy that maintains transaction information, related to the storage and dispensing of schedule VI CS refill prescription medication directly to customers during or after pharmacy hours
What must be done prior to use of an automated pharmacy system?
Notify board and department in writing of intent to use system, including name and address of pharmacy location, hours of operation, type or name of the system and description of how he system is used by the pharmacy
Develop and maintain on-site a P&P manual that include detailed information
There must be an opportunity to consult with a pharmacist during any hours that...
Prescriptions are available for pickup from the automated dispensing system
T/F: patients must be allowed to choose whether they want to use automated dispensing system
Stocking and return of meds from the APS shall be done by...
Cert tech or pharmacist
What must Canadian graduates of CCAPP approved schools of pharmacy between 1993-2004 do for licensure in MA?
Hold a valid license to practice as an rx in the Canadian Province
300 hour internship
in a MA pharmacy
Apply to the board, pass NAPLEX, MPJE and other terms
The current foreign pharmacy graduate process must be followed for a Canadian applicant if...
Graduated from CCAPP approved SOP between 1993 and 2004, but does not hold a license to practice as a pharmacist in a Canadian Province
Graduated from CCAPP approved SOP after 2004
Holds valid license to practice as a pharmacist in Canadian province but has not graduated from CCAPP approved SOP
A pharmacy may dispense naloxone pursuant to...
Standing order or patient specific rx
Who may present to the pharmacy to obtain naloxone?
Must reasonable effort be made to see if insurance covers naloxone?
Yes, unless purchaser requests otherwise
Is there a limit regarding how much naloxone may be dispensed to an individual?
What must the pharmacy do when dispensing naloxone?
Counsel the individual
Distribute an opioid antagonist information pamphlet
What reporting requirements exist regarding the distribution of naloxone?
each pharmacy must submit a report via email including this info for the
previous calendar year:
-Name and zip code of the pharmacy
-Total number of naloxone
-Total number of doses paid for with insurance
Though not required, what other information is encouraged to be submitted?
Number of doses dispensed
Zip code of the residence for the individual to whom the naloxone was dispensed
Whether the naloxone was paid for w/insurance
Must the pharmacist be present at the remote location at all times when naloxone is stored or dispensed?
Naloxone must be stored under a ______ area
EPT helps do what?
Interrupt the spread of disease by providing treatment to partners who may be unwilling or unable to seek medical care of their own
What are the ways that the EPT may be dispensed for the partner?
Prescription issued for named sex partners of the patient, or
A prescription issued using "Expedited Partner Therapy" or EPT in place of patient's name and address
What must the pharmacist do if they are unable or unwilling to fill EPT therapy?
Refer patient to an alternative pharmacy
Must a patient profile be made for EPT?
Yes, a patient profile and prescription label using "expedited partner therapy", EPT or E.P.T. in place of patient's name and address
What are the pharmacist requirements regarding dispensing of EC?
Training accredited by ACPE completed to include:
--Referring patient for additional service and follow-ip
Proof of training must be
maintained on site at the pharmacy
What are the reporting requirements for EC?
Complete form by
August 1st of each year
--Information from 7/1-6/30 of the prior year reported by 8/1
--Total number of doses dispensed pursuant to the standing order (not those dispensed pursuant to rx) --> if unable to discern between these, give the total
--Do not include any patient names or identifiers
--Authorized representative for a group of pharmacies under common ownership or control may report on behalf of all pharmacies, provided subtotals are submitted for each location by zip code and either the license number of CS registration number
May a pharmacy provide an emergency kit with limited quantities of compounded medications to be a licensed vet for the purpose of direct administration in
The vet writing rx for compounded preparations for animals must hold a valid...
Regarding e-kits, what agreement is needed between the pharmacy and vet?
Written agreement that identifies specific Medes to be contained in the e-kit
How often must the agreement be renewed and reviewed?
What schedules may be kept in vet e-kit?
Schedule VI compounded meds
Who retains responsibility of the medications in the e-kit?
Pharmacy/pharmacy's inventory, until the vet provides a patient specific prescription to the pharmacy
May an ADD be used for meds at a vet?
Within how long after medication removal must the pharmacy receive a patient-specific prescription for meds removed from the vet e-kit?
If timely access to compounding pharmacy is not possible, a vet can dispense up to ______ emergency supply
How often must the pharmacist inspect, restock, and reconcile prescriptions for any medications dispensed in the vet e-kit?
Pharmacists are responsible for proper labeling of each med in an e-kit including...
Generic name and strength
Date of preparation
Storage, handling, any other cautionary info
Statement indicating that product is a sterile or non-sterile compounded medication
Which prescription components may NEVER be changed? These would require a new rx.
Patients name (changing patient)
CS prescribed (except generic sub.)
Earliest date to be filled
What information on a CII can be changed after consultation with the prescriber?
Date of issue (may only be added if omitted)
Patient's address may be added if omitted w/o consultation, may only be changed after consultation w/prescriber
Prescribers DEA number w/o consultation
Directions for use
Supervising physicians name of MLP
"no substitution", "partial fill upon request" --> office should be notified if these are omitted
For CIII-VI, what info can be changed after consultation with prescriber or
Date of issue if omitted
Patient address if omitted w/o consultation, may only be changed after consultation
Prescriber DEA number w/o consultation
Directions for use
Supervising physician's name of MLP
"No substitution" language may be added and the prescribers office should be notified if omitted
When can quantity be changed by pharmacist without consultation?
In pharmacist's prof judgment, may be changed without consultation only for drugs that
do not require PMP reporting
With each change made to prescriptions, what must be documented?
On the electronic system or prescription:
--Item changed or added
--Name of authorizing prescriber
--Name of pharmacist accepting/making the change
When a pharmacy becomes aware that a prescriber-patient relationship has ended for whatever reason, what may be done with prescriptions?
Drug therapy may be continued in order to enable the patient time to establish a relationship with another prescriber, providing:
--Rx issued pursuant to a proper relationship while prescriber still in practice
--Rx is within its expiry period based on date of issues
--Previously filled Schedule III-VI has remaining authorized refills
--If multiple schedule II rx have been issued, they MAY be honored
--If schedule VI prescription has expired or has no remaining refills and the prescriber is no longer in practice, can dispense a quantity
not to exceed 14 days
or smallest available unit of use packaging
Pharmacist uses professional judgment to ensure that the dispensing of the med remains appropriate
Vaccinations under the emergency declaration can be given to patients at what age?
3 years and older
What are the minimum ACPE accredited program requirements for qualified pharmacy personnel to be authorized to give vaccines under the emergency declaration?
12 contact hours of self-study modules wit chase studies and assessment exam
8 contact hours of live seminar with final exam
Hands on assessment of IM and subQ injection techniques
Must proof of vaccination training be kept at the pharmacy?
Yes, plus proof of CPR certification
What are the vaccination CE requirements for all pharmacy personnel who administer vaccines?
2 hours of CPE every 2 years
What should be reviewed prior to giving a vaccine?
MA Immunization Information System (MIIS), to check to make sure that the vaccine hasn't already been given
Administration of an approved vaccine and emergency epinephrine, what is needed?
Vaccine --> standing order or prescription
Epi --> standing order
What does MDPH immunization program do?
Provides routine childhood vaccines free of charge for administration to individuals through 18 years of age
If the pharamcy does not do the MDPH program, what must parents of patient under 19 years of age be informed?
Potential costs and that their primary care provider can provide vaccines at no charge
What information and counseling should be provided if immunization being given to a person younger than 18 years? What about counseling if anything other than flu vaccine?
Info on PCPs in the geographic area
Counsel the importance of maintaining relationship with pediatric or family practice
An application for pharmacy tech license by reciprocity shall be...
At least 18 years of age
A high school graduate or the equivalent or currently enrolled in a program which awards such degree or certificate
Good moral character and not been convicted of a drug related felony
Applicant with a current tech license in another state must have been active for a minimum of...
1 year (also needs statement from each state)
A tech transferring by reciprocity without an active tech license in another state must provide....
Cert of completion of ASHP accredited or Board approved tech training program
Documentation that has completed at least 500 hours of practical experience
Board approval is provided for which tech exams
Boar approval is provided for which tech training programs?
Recognized byPTCB, accredited by ASHP
To apply for board approval for other tech licensing exams or training programs, the information must be sent to the board how often? The documents must be maintained for at least how long?
Every 5 years, maintained for 5 years
What are the pharmacy tech examination specific requirements?
At least 50 q's, does not contain true/false questions, must specify passing grade (75%)
Must include answer key
What general sections must be covered by technician licensing exam?
Pharmacy laws and regs
Patient safety and quality assurance
Order entry and processing
Board approved tech training programs must have a minimum of how much theoretical instruction and how much practical instruction?
120 hours of each
Who can be instructors of a technician training program?
Certified tech licensed with the board with at least 2 years experience
Pharmacists licensed with minimum 2 years experience
Combo of pharmacists and licensed techs with at least 2 years experience
Instructor with masters or doctorate with minimum 5 years experience in teaching college level pharmacy practice curriculum
For techs, in the event of unsuccessful completion of a certification exam, the applicant may provide...
Certificate of completion of board approved program in lieu of the 500 hour training requirement to get state licensure
What must an individual do if their license has lapsed for 2 or more years?
Petition to the board to request reactivation of the license and must include:
Documentation of completion of required CE hours in accordance with the board's policy for the 2 calendar years prior to the petition
Resume that identifies the petitioner's employment and activities
Verification from each state of pharmacist licensure (current, expired, inactive) verifying license status and and disciplinary action
When may the board require a personal appearance to review the petition for reinstatement?
If individual not engaged in pharmacy in any jurisdiction since license expiration
Board MAY determine that re-training and re-examination is required
Once individual approved for reinstatement after 2 or more years, what exam must they take?
Credit may be obtained for post-graduate education in which areas, when led by sponsor or co-sponsor that is an ACPE accredited provider of CPE or course is approved by the Board for CPE?
Applicants for CE from post-graduate education must provide which info?
Course syllabus and learning objectives
Type of credit, if applicable
Manually signed letter from instructor verifying completion of the course
Number of requested contact hours (3 hours per academic credit)
Require 30 days for review
Must a registered pharmacist on duty be present at all times when non-pharmacist personnel have unrestricted access to the pharmacy?
But this may not necessarily apply for temporary absence of a pharmacist
When may a pharmacy stay open without a pharmacist?
If staffed by a single pharmacist, they may leave the pharmacy temporarily for necessary and appropriate breaks and meal periods, provided that they believe the security of the dangerous drugs and devices will be maintained during absence
During absence, no prescription may be provided to patient or agent unless it is a refill prescription that he pharmacist has checked and determined to not require consultation prior to being released to patient
New prescription which has been previously prepared, visibly checked and had a DUR performed may be picked up provided that a log including pts phone number of all such transactions is kept;
pharmacist within reasonable time, shall call patient to review any pertinent counseling
May develop written policy to allow certified/board approved certified techs and interns receive phone rx orders from practitioners
Multiple pharmacists staffing: stagger breaks
Temporary absence shall not exceed 30 minutes
, does not need to remain in pharmacy area but must remain on premises; total temporary absence shall not exceed more than 30 minutes absence during any work period of at least 6 consecutive hours
What must be done if the MOR is expected to be away from position for more than 30 days?
Interim manager appointed and CS inventory taken and signed both by interim manager and current manager
What must be done if the MOR is expected to be away from position for 100 days or more?
New app submitted to the Board for a change in MOR and appropriate inventories taken
Non-viable air sample action levels for:
ISO Class 5
ISO Class 7
ISO Class 8
> 3520 particles per 0.5 um or larger per m3
Viable air sample action levels for:
ISO Class 5
ISO Class 7
ISO Class 8
> 1 CFU
> 10 CFU
> 100 CFU
Highly pathogenic organisms: 1 or more
Surface sample action levels for:
ISO Class 5
ISO Class 7
ISO Class 8
Highly pathogenic organisms
> 3 CFU
> 5 CFU
> 50 CFU
1 or more CFU
Until the pharmacy demonstrates results within action levels (During remediation) the BUDs for compounds in ISO 7 must be...
24 hours RT
3 days refrigerated
Until the pharmacy demonstrates results within action levels (During remediation) the BUDs for compounds in ISO 8 must be...
24h RT or 3 days refrig if prepared from one or more nonsterile starting components
30h RT or 9 days refrig if prepared from sterile starting components
Fro pilot projects, an exemption from regulations shall not exceed...
Pilot projects (may/may not) include therapeutic substation or substitution of medical devices used in patient care
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