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PA MPJE > tl;dr Pharmacy > Flashcards

tl;dr Pharmacy Flashcards

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?

A

$35

24
Q

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

A

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

25
Q

Is current enrollment/ good standing required for pharmacy interns?

A

-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
Q

What are the preceptor requirements for a pharmacy intern to be able to get viable hours?

A

-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
Q

What is the renewal period requirements for an Intern License?

A

-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
Q

What are the requirements (license/registration) for pharmacy technicians?

A

-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
Q

What are the specific requirements on who can access the pharmacy?

A

-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
Q

What are the specific requirements for keeping the pharmacy open

A

-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
Q

what is the min size of the prescription area?

A

250 sq feet

32
Q

what is the min size for counter space?

A

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
Q

What are the security system rec for a pharmacy located within a business that has differing hours?

A

-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
Q

what are the rules surrounding phone access to pharamcies?

A

-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
Q

what are the storage reqs for CS physical scripts?

A

-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
Q

What are the requirements for the physical storage of controlled substances?

A

-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
Q

What are the sign requirements for pharmacy closure?

A

signs, symbols, or other indications of a pharmacy shall immediately be removed from both the interior and exterior

38
Q

What are 4 signs that need to be posted per PA law in a pharmacy?

A

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
Q

What is the time to notify the board of changes to ownership?

A

-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
Q

What is the time to notify the board of changes to person in charge (PIC)?

A

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
Q

What is the time frame to notify the board of changes to address?

A

-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
Q

What is the time frame to notify board of changes to hours?

A

-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
Q

What are physical things/drug recs required for a pharmacy?

A

-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
Q

What must an adequate reference library meet:

A

-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
Q

What are the guidelines for a pharmacy to use an automated system to fill rxs provided that:

A

-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
Q

What the the pharmacist/pharmacy manager responsible for the delivery of meds that is under contract with a LTC/ AMS & responsible for?

A

-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
Q

What is permitted under emergency access to pharmacy procedures?

A

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
Q

What are the rules regarding nonresident pharmacies and mailing in rxs?

A

-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
Q

What are the regulations with mailing drugs instate?

A

-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
Q

What are the fees and renewal dates for a Pharmacy License?

A

-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
Q

Who ca apply to own a pharmacy?

A

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
Q

Do you need to be a pharmacist to own a pharmacy?

A

no, but if an applicant is a pharmacist they must be licensed in good standing in PA

53
Q

What are the application requirements surrounding pharmacy ownership for resident pharmacies?

A

-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
Q

What are the application requirements surrounding pharmacy ownership for nonresident pharmacies?

A

-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
Q

What must be done if there is a change in name or ownership of a pharmacy?

A

-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
Q

What is the RPH to intern ratio?

A

-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
Q

Is facility licensure required for general compounding?

A

no, unless registering as a 503b outsourcing facility

PA MPJE (7 decks)

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