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tl;dr Pharmacy Flashcards

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1
Q

Who makes up the State Board of pharmacy?

A

-Commissioner of Professional & Occupational Affairs
-Director of the Bureau of Consumer Protection (in the office of Attorney General)
-5 ppl who are licensed pharmacists in PA
–> 2 from retail chain (w/ operation of 5 + stores)
–> 2 from independent retail
–> 1 from acute care institutional pharmacy

**each must be registered at least 5 yrs

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2
Q

Is the Board of pharmacy under a separate entity or under another organization?

A

the Bureau of Professional and Occupational Affairs WITHIN the Department of State provides administrative and legal support to the board

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3
Q

Who chairs the board of pharmacy?

A

-the board selects a chairman from its members annually

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4
Q

How are board of pharmacy members selected?

A

-appointed by the Governor with the advice and consent of a majority of the members elected to the Senate

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5
Q

How long do board of pharmacy members serve?

A

6 years
-no member is able to serve for more than 2 consecutive terms

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6
Q

How often does the board of pharmacy meet?

A

-at least every 2 months and at attentional times needed to conduct business

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7
Q

Who can attend board of pharmacy meetings?

A

open to the public

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8
Q

Who can apply to be a PA pharmacist?

A

Applies to new, transfer/Reciprocity/Foreign Graduate
–> must be at least 21 y/o, citizen of USA, good moral & professional character

-graduates of foreign schools & noncitizens are eligible to become licensed to practice in PA of they meet the reqs

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9
Q

What is the Pharmacist application fee?

A

$45

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10
Q

How many hours of CE are needed for license renewal?

A

30 hrs

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11
Q

What are the minimum Intern hours needed?

A

-1500

–> for transfer/reciprocity: 1500 hrs or proof of full time work as a. rph in another US state for at least 1 yr `

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12
Q

New Pharmacist: What is the Degree/Education Req?

A

-BS or advanced degree in pharmacy granted by an ACPE accredited school or college

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13
Q

Transfer/Reciprocity: What is the Degree/Education Req?

A

BS or advanced degree in pharmacy granted by an ACPE accredited school of pharmacy or FPGEC Certification

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14
Q

Foreign Graduate: What is the Degree/Education Req?

A

graduate of a foreign college of pharmacy, FPGEC Certification

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15
Q

What documents/reqs are needed for a new pharmacist applying to PA?

A

-criminal hx record check
-national practitioner Data Bank self Query
-proof of 3 hrs of child abuse CE
-proof of 4 hrs pain/addiction/opioid CE
-license verifications from other states if applicable

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16
Q

What documents/reqs are needed for a transfer/reciprocity pharmacist in PA?

A

-copy of processed NABP reciprocal licensure application
-criminal hx record check
-national practitioner data bank self-query
-proof of 3 hrs of child abuse recognition and reporting CE
-proof of 4 hr pain/addiction/opioid CE
-license verification from other states

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17
Q

What documents/reqs are needed for a foreign graduate in PA?

A

-official copy of FPGEC certificate
-criminal history record check
-national practitioner data bank self-query
-proof of 3 hr child abuse recognition and reporting CE
-proof of 4 hrs pain/addiction/opioid CE
-license verifications from other states if applicable

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18
Q

What is the license reinstatement process in PA?

A

any persons whose license, certificate, or registration has been revoked may apply for reinstatement after a period of at least 5 yrs, but must meet all of the licensing qualification of this act for the license applied for, to include the examination requirement

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19
Q

What is the renewal period for a pharmacy license in PA?

A

-a licensed pharmacist shall renew the license every 2 yrs
-all pharmacist licenses and authorizations to administer injectable medication, biologicals and immunizations expire on Sept 30th of even numbered yrs

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20
Q

Is license/registration required for a new or foreign graduate intern?

A

yes

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21
Q

What can apply to become a new pharmacy intern?

A

-an individual of good moral character who has completed at least 2 yrs of college and is enrolled/accepted as a student of pharmacy in an ACPE-accredited pharmacy degree program

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22
Q

As a foregin graduate, wha tis needed to apply to be a pharmacy intern in PA?

A

must have FPGEC certification

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23
Q

What is the application fee for a Intern license in PA?

24
Q

How many hours are required of a pharmacy intern in PA?

Study These Flashcards
A

1,500 hours
– a max of 50 hours may be credited in 1 week

25
Is current enrollment/ good standing required for pharmacy interns?
-a pharmacy intern registration will automatically become invalid if the pharmacy intern permanently ceases enrollment in an ACPE-accredited degree program prior to graduation
26
What are the preceptor requirements for a pharmacy intern to be able to get viable hours?
-the board will NOT grant internship credit for hours which an individual served in a pharmacy if the supervising pharmacist was not registered as a preceptor --> an exception to the requirement will be made for internship hours acquired in an internship program sponsored or approved by an ACPE-accredited pharmacy degree program
27
What is the renewal period requirements for an Intern License?
-all certificates issued shall be valid for a periods not exceeding 6 yrs from the date of issue (exclusive of time spent in the military service -when a candidate receives their first certification and ID card to practice as a pharmacist, their registration as an intern terminates
28
What are the requirements (license/registration) for pharmacy technicians?
-a pharmacy technician is an unlicensed person working in a pharmacy to assist a pharmacist -a pharmacy tech may NOT perform a duty until the tech as been trained & the duty has been specified in a written protocol. -pharmacy manager shall create & maintain a written protocol for each tech employed in the pharmacy (protocol shall specify each duty they can perform) -the pharmacy manager and the pharmacy tech shall date and sign the protocol & each amendment to the protocol. the manager shall make the protocol available to agents of the Board upon demand
29
What are the specific requirements on who can access the pharmacy?
-for a pharmacy to be open, a registered pharmacist must be in the building -protocols for who can access the pharmacy when its closed by non-pharmacist staff for bona fide emergencies, such as fires, natural diasters of police matters, must include the notification to the pharmacist manager
30
What are the specific requirements for keeping the pharmacy open
-pharmacist must be there for it to open -techs can only come in solo if there is an emergency (fire, police etc- let manager know) ---> rph can take 30 min break (must stay in building) & pharmacy can accept new rxs and prep rs for final verification
31
what is the min size of the prescription area?
250 sq feet
32
what is the min size for counter space?
1 rph: 10 linear feet in length & 2 linear feet in width 2 rph or more working at the same time: inc counter length by 5 linear feet per pharmacist (ex: 2 rph = 15x2)
33
What are the security system rec for a pharmacy located within a business that has differing hours?
-must have barrier device that reaches floor to ceiling, by impenetrable by hand or the use of a reach extender, and be securely locked whenever a licensed rph is no present or on duty
34
what are the rules surrounding phone access to pharamcies?
-must have at least 1 phone in the rx area- with the # printed on the rx bottles --> if a non resident pharmacy shall (not less than 60 hrs/week and min of 40 hrs/week) provide a toll free # to a licensed PA pharmacist who has access to the pts records
35
what are the storage reqs for CS physical scripts?
-CII shall be maintained in a file separate from all other records -CIII-V: maintained in either a separate rx file or in a form that they are readily retrievable from the other rx records
36
What are the requirements for the physical storage of controlled substances?
-CS listed in CII-V shall be stored in a constructed, securely locked cabinets (however, rph and practitoiners may disperse the substances throughout the stocks of non-controlled substances in a manner as to obstruct the theft or diversion of the substances)
37
What are the sign requirements for pharmacy closure?
signs, symbols, or other indications of a pharmacy shall immediately be removed from both the interior and exterior
38
What are 4 signs that need to be posted per PA law in a pharmacy?
1: full names of partners/proprietor, pharmacy manager along with any corporate association or duly registered names 2: sign that states in all caps "PA LAE PERMITS RPH TO SUB A LESS EXPENSIVE GENERICICALY EQUIV DRUG FOR A BRAND NAME DRUG UNLESS. U OR UR DOC DIRECT OTHERWISE" --> not less than 1 inch or 2.54 cm in ht and on a white background 3: list of "approved crug products w/ therapeutic equivalence evaluation" (orange book) 4: list of regular and customary retail prices of that pharmacy for brand/generic name equivalent drug products
39
What is the time to notify the board of changes to ownership?
-change in name, ownership or controlling party requires a new permit -applications for new permit must be filled within 30 days of the change
40
What is the time to notify the board of changes to person in charge (PIC)?
pharmacy permit holder shall inform the board in writing of this fact and of the new rph manager not more than 15 days later --> a nonresident pharmacy shall report to the board within 30 days of any change of location or pharmacist in charge
41
What is the time frame to notify the board of changes to address?
-file a current mailing address with the board at its office and shall notify the board of changes in the mailing address within 10 days of the change
42
What is the time frame to notify board of changes to hours?
-if a pharmacy closes/ceases operations shall IMMEDIATELY return to the board its permit and inform the board of the disposition of the rx files and nonproprietary drugs --> after 30 days, neither rx files nor drugs may be sold, transferred or disposed of w/o prior permission from the board
43
What are physical things/drug recs required for a pharmacy?
-inventory must be at least $5,000 worth of drugs, devices -refrigerator for drugs -sink w/ hot and cold water -restrooms -rx files -current copies of the Pharmacy Act 49 Pa Code Chapter 27 -Federal and PA statues and regulations pertaining to the practice of pharmacy
44
What must an adequate reference library meet:
-technical, clinical and professional aspects of practice -enables the rph to compound meds -list possible drug interactions and possible AEs of meds -list therapeutic equivalents for meds -list therapeutic usage and dosages of med -provide guidelines for the counseling of pts -maintains the latest editions including current supplements of each of its reference sources
45
What are the guidelines for a pharmacy to use an automated system to fill rxs provided that:
-pharmacy manager, or the pharmacist under contract w/ a long term care facility responsible for dispensing med if it is utilized at a location which does not have a pharmacy onsite -system has been tested & validated by the pharmacy and found to dispense accurately -pharmacy shall make the automated medication system avail to the board for inspection -system must electronically record the activity of each rph, tech with the time, date and initials
46
What the the pharmacist/pharmacy manager responsible for the delivery of meds that is under contract with a LTC/ AMS & responsible for?
-reviewing and approving all policies and system procedures -ensuring monthly inspections of medications in the machines and monthly inspections of the AMS -assigning, d/cing or changing personnel access -machine is stocked accurately --> a copy of the written policy and procedures shall be reatined at the pharmacy and at the LTC facility
47
What is permitted under emergency access to pharmacy procedures?
in the absence of the pharmacist, the dispensing of drugs shall be limited to emergencies & be performed only under the direct supervision of a practitioner licensed under state law to prescribe and dispense drugs
48
What are the rules regarding nonresident pharmacies and mailing in rxs?
-may NOT engage in the business of chipping. mailing or delivering legend devices or drugs in PA UNLESS the nonresident pharmacy has been issued a certificate of registration by the board
49
What are the regulations with mailing drugs instate?
-shall only be sent via first class mail or common carrier -mailing of abx which have been reconstituted is PROHIBITED -meds must be shipped in a manner in which the integrity of the drugs are reserved
50
What are the fees and renewal dates for a Pharmacy License?
-new pharmacy permit application: $125 (renew the permit q 2 yrs) --> all pharmacy permits and nonresident pharmacy registrations expire on aug 31 of ODD-numbered yrs -biannual renewal of pharmacy permit fee: $125
51
Who ca apply to own a pharmacy?
individuals or partnerships: --> if one is a pharmacist, they must be currently licensed by the board --> if NOT a rph, they must not previously have been found or pleaded guilty or nolo contender to any crimes -no director/officer/person with more than 10% of the company stock may have been found guilty/pleased guilty to said crimes or had a rph license revoked or renewal refused
52
Do you need to be a pharmacist to own a pharmacy?
no, but if an applicant is a pharmacist they must be licensed in good standing in PA
53
What are the application requirements surrounding pharmacy ownership for resident pharmacies?
-separate applications and permits shall be required for each pharmacy & each permit should bear the name of the pharmacist who will be in charge of that pharmacy
54
What are the application requirements surrounding pharmacy ownership for nonresident pharmacies?
-a nonresident pharmacy must submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory/licensing agency of that state in which the nonresident pharmacy is located or by NABP's verified pharmacy program
55
What must be done if there is a change in name or ownership of a pharmacy?
-change in name or ownership or controlling interest pf that pharmacy requires a NEW permit --> applications shall be filed within 30 days of the change in name, ownership or controlling interest
56
What is the RPH to intern ratio?
-a rph preceptor may not direct the training of more than 2 pharmacy interns at any one time (unless the program has been approved by the board of pharmacy) --> no ruled for rph:tech or rph:cashier
57
Is facility licensure required for general compounding?
no, unless registering as a 503b outsourcing facility

PA MPJE (7 decks)

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