Pennsylvania Law

the state board of pharmacy in Pennsylvania consists of the following 9 members:

- commissioner of professional and occupational affairs

- director of bureau of consumer protection

- public representative

- public representative

- independent retail pharmacist

- independent retail pharmacist

- retail chain pharmacist

- retail chain pharmacist

- acute care institutional pharmacist

the executive secretary must be a _____ _____ and the board counsel must be an _____

the executive secretary must be a licensed pharmacist and the board counsel must be an attorney

members are appointed by the _____ with approval by majority of _____

members are appointed by the governor with approval by majority of senate

a pharmacist must hold a RPh license for a minimum of _____ years to sit on the board

a pharmacist must hold a RPh license for a minimum of 5 years to sit on the board

the term of appointment is _____ years

the term of appointment is six years

what is the overall purpose of the Pennsylvania state board of pharmacy

to protect the public health and safety

what are the 9 duties and responsibilities of the state board of pharmacy

- regulate the practice of pharmacy

- determine the nature of pharmacist applicant exams (licensure)

- issue licenses and renewals

- employ appropriate consultants as necessary

- conduct inspections

- conduct investigations of violations of the pharmacy act and regulations

- conduct hearing regarding suspension and revocation of licenses

- enforcement of laws and regulations pertaining to pharmacy

- promulgate rules and regulations pursuant to the pharmacy act

how long must copies of inspection reports be retained on pharmacy premises

copies of inspection reports must be retained on pharmacy premises for 2 years

who has the primary responsibility for inspections of health care institutions

the PA department of health has primary responsibility for inspections of health care institutions with notification made to the board of pharmacy

what are the 10 conducts/circumstances in which a penalty may be made against a pharmacy license

- procure a license through fraud, misrepresentation, or deceit

- felony in connection with the practice of pharmacy or any offense involving moral turpitude

- impaired professional duties because of alcohol or controlled substances

- unfit to practice because of physical or mental disease

- suspend or revoked license from another jurisdiction

- violated pharmacy acts or regulations

compounded or dispensed drug which contains different amount than prescribed

- create danger to the public health

- incompetence, malpractice (with or without injury)

- guilty of grossly unprofessional conduct

what are 11 examples of grossly unprofessional conduct

- willful deceit

- improper advertising

- public assertion or implication. of professional superiority

- engaging in false, misleading, or deceptive advertising of drugs or devices

- payment or acceptance of compensation for recommending the services of another

- misbranding or adulteration of drug or device or sale of same

- selling drugs marked "sample" or "not for resale"

- displaying a license where not employed

- failure to have pocket card available for inspection when practicing

- acceptance and redistribution of a drug once it has left the pharmacy, unless it is in the original sealed container with the name, lot number, and expiration date on the original manufacturer's label

in Pennsylvania, licenses are for _____ and permits are for _____

in Pennsylvania, licenses are for pharmacists and permits are for pharmacies

what 6 requirements exist for applicants for a pharmacist license in Pennsylvania

- must be at least 21 years old

- be of good moral/professional character and fit to practice

- graduate from an accredited school of pharmacy

- complete a board-approved internship

- pass a licensure exam

- not be in possession of a felony conviction relative to controlled substances

what are the 3 important details to know for renewing a pharmacy license in PA

- pharmacist licenses are renewable every 2 years

- every even-numbered year for pharmacists

- period runs from October 1 to September 30

how many continuing education hours must be obtained over the 2 year renewal period

30 credit hours

CE programs MUST be ______ or _____ she approved

ACPE or board-approved

how many days do you have to report a change of address or change of name to the board of pharmacy

10 days

is carryover of credits from on renewal period to another permitted

no, this is not permitted

how many years must CE certificates be maintained after renewal

they must be maintained for 2 years

what are the 3 special topics that are required to be part of the 30 CE credit hours

- 2 hours of child abuse recognition and reporting continuing education

- 2 hours of continuing education in pain management, addiction or opioid dispensing

- 2 hours in the ACPE topic designator "patient safety"

newly graduated licensees are _____ from CE requirements for the first renewal following initial licensure, except for 2 hours of continuing education for (i) _____ and (ii) _____

newly graduated licensees are exempt from CE requirements for the first renewal following initial licensure, except for 2 hours of continuing education for (i) child abuse recognition and reporting, and (ii) pain management, addiction or opioid dispensing

what is the process of reciprocation

reciprocation is the process whereby a pharmacist license is transferred from one state to another

who must an applicant petition to in the process of reciprocation

the state board of pharmacy

explain how CE credits are prorated from the time of initial licensure reciprocation to the next renewal

the applicant is only responsible to complete the portion of CE hours for the same fraction of time that they will have their license. for example, if someone receives their license one year into the renewal period, they would only be responsible for 15 CE credits by the time of the next renewal.

where must all employees wear photo identification badges

in hospital and institutional settings

what 4 items must these badges include (for employees in hospitals and institutional settings)

- a recent photo

- name

- title

- name of the employee's heal care facility or employment agency

what is the definition of a pharmacy internship

the supervised practical experience required for licensure as a registered pharmacist

what are 3 requirements to obtain an internship license

- be currently enrolled in a School of Pharmacy

- possess good moral character

- have successfully completed 2 years of college study

how long is an internship license good for

the intern license is valid for up to a 6-year period, exclusive of time spent in military

how many internship credit hours are required to obtain a PharmD license

1500 credit hours

how must these credit hours be earned

the 1500 intern hours required for licensure as a pharmacist may be earned through an ACPE-accredited school of pharmacy's PharmD program

how many hours per week is an intern able to claim

an intern may not claim more than 50 hours per week

intern activities must be related to _____ _____

intern activities must be related to pharmacy practice

what are three examples of activities related to pharmacy practice

- scrutinizing prescriptions/drug orders

- compounding medications

- filling prescriptions

what form must be submitted to claim intern credit hours

intern experience reporting form

what are 4 qualifications for pharmacy preceptors

- preceptor must be registered in advance of internship

- preceptor must be full-time

- preceptor must be licensed in PA

- preceptor may not be register for more than 2 interns at a time (unless approval of board is secured in advance)

what form must be submitted when chaining pharmacy preceptors

change in preceptor necessitates submission of "Application to Change or Add a Pharmacist Preceptor"

what are the 3 qualifications of a pharmacy to have pharmacy interns

- must be free of violations (federal/state/municipal)

-must compound and dispense a sufficient number of prescriptions

- must place an emphasis on activities connected with the distribution of articles and services pertaining to medical care including drugs, medicines, prescriptions, medical supplies and materials

true or false? a pharmacy may share a permit with another pharmacy so long that the ownership is the same between the pharmacies

false, each individual physical pharmacy location must possess its own permit, regardless of the same ownership

institutional pharmacies are those pharmacies within health care facilities that are accredited by (3)

- the Joint Commission

- the commission of the American Osteopathic Association

- licensed by the Department of Welfare/Department of Health

what are satellite pharmacies and describe how they obtain a permit

satellite pharmacies are pharmacies that 1) provide specialized services, and 2) are depended on a centrally located pharmacy for administrative control. they are exempt from the need to obtain a permit different from that of the central pharmacy

describe the requirement regarding a pharmacist manager when pharmacies are obtaining a permit

a separate pharmacist-manager is required for each pharmacy location obtaining a permit

what four items must a permit bear?

- name of the pharmacy

- address of the pharmacy

- name of the owner of the pharmacy

- name of the pharmacist-manager (if not the same as the owner)

how many pharmacies can a manger be a pharmacist manager at any given time?

a pharmacist may be pharmacist manger of only one licensed pharmacy at a time

what is a pharmacy permit applicant and what is the rule regarding their criminal record?

an applicant includes any director, officer of a company, or individual owning greater than 10% of the stock. a pharmacy permit applicant may not be guilty of any crimes concerning pharmacy.

the designation of "drugstore" , "pharmacy", "apothecary", or "medicine" cannot be used if not a _____ _____

the designation of "drugstore" , "pharmacy", "apothecary", or "medicine" cannot be used if not a licensed pharmacy

what is the law regarding supervision of a pharmacy

every pharmacy must at all times when open, be under the constant direct and personal supervision and management of a pharmacist duly licensed in PA

describe how a pharmacist may take a lunch break and keep a pharmacy open

a 30 minute lunch break is allowed and a pharmacy may remain open for pharmacy related services, so long as the pharmacist remains in the pharmacy or within the immediate building

pharmacy related service include (for the purpose of the lunch break): (3)

- receipt of new written prescriptions

- preparation or prescriptions for final verification

- delivery of prescriptions already verified by the pharmacist

regarding display of registration, a pharmacy must display: (3)

- federal DEA registration

- PA pharmacy permit

- pharmacist and intern licenses

what is required of nonresident pharmacies when they are shipping medication into PA?

nonresident pharmacies are required to register with the PA board of pharmacy prior to shipping medication into the commonwealth

how often are permits renewable for pharmacies

pharmacy permits are renewable every 2 years

in what years do pharmacies renew their permits?

every odd-numbered year for pharmacies

when does the period run for renewals for pharmacy permits?

the period runs form September 1 - August 31

what must be done with a permit when a pharmacy closes

the permit must be returned to the board of pharmacy

when must the board be notified in the disposition of the files and Rx drugs after the closing of a pharmacy (2)

- need permission of the Board before disposal, sale, or transfer of the files or prescription drugs

- if more than 30 days from the date of closing

what must be done to the exterior of the pharmacy after a pharmacy is closed?

remove signs/symbols from the interior and exterior that identify the establishment as a pharmacy

for a change in name, ownership, or controlling interest a pharmacy must apply for a new permit within _____ days

For a change in name, ownership, or controlling interest a pharmacy must apply for a new permit within 30 days

for a change in pharmacy manager the board must be notified within _____ days, with up to a _____ day extension which can be applied for in writing

for a change in pharmacy manager the board must be notified within 15 days, with up to a 30 day extension which can be applied for in writing

explain how a pharmacist can act as manger of two pharmacies during this process of a change in pharmacy mangers

one may apply for a waiver to serves as pharmacy manger for more than on pharmacy for up to 60 additional days beyond the initial 15 days

describe what a revocation is and how it may it be reversed

a revocation is a permanent removal of a license/permit and it may be reinstated by a (1) court order, or (2) a new application may be submitted

how many years must one wait after revocation to apply for a new license

one must wait 5 years after revocation unless a felony conviction, which then requires 10 years

when must occur for a license to be reinstated after a suspension

after the designated period of suspension is complete and after all CE requirements during the period of suspension are met

what three things must an impaired pharmacist do to remain in practice?

- the pharmacist is enrolled in a treatment program endowed by the board

- the pharmacist is making satisfactory progress

- notification of progress is regularly reported to the board

can a pharmacist convicted of a felony related to controlled substances remain in practice?

no, pharmacists convicted of a felony related to controlled substances may not remain in practice

plans for a new pharmacy or a change in location must be submitted to the board _____ days in advance and _____________, work may proceed

plans for a new pharmacy or a change in location must be submitted to the board 90 days in advance and if no objections are raised, work may proceed

plans must be submitted to the board of pharmacy _____ days in advance; if no objections are raised, work may proceed

plans must be submitted to the board of pharmacy 30 days in advance; if no objections are raised, work may proceed

the minimum size of the prescription area must be at least _____ square feet and ____________

the minimum size of the prescription area must be at least 250 square feet and be large enough, considering the level of activity, to carry on the practice of pharmacy in a manner that protects the health and safety of professionals, employees and the public

within the prescription area, there must be a prescription counter of at least _____ linear feet in length and _____ linear feet in width

within the prescription area, there must be a prescription counter of at least 10 linear feet in length and 5 linear feet in width

if more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by _____ linear feet for an additional pharmacist

if more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by 5 linear feet for an additional pharmacist

what should institutions with special considerations regarding counter size do?

institutions with special considerations may apply to the Board for a waiver

does a pharmacy operated as a central processing center need to conform to the minimum space?

a pharmacy operating as a central processing center need not conform to the minimum space

describe the laws in PA regarding the storage of controlled substances

space must be provided in the prescription area for a substantially constructed cabinet or safe to contain controlled substances unless the pharmacy disperses controlled substances throughout the stock of noncontrolled substances

how should Schedule I controlled substances be stored?

if the pharmacy stocks CIs, these substances shall be stored in a securely locked, substantially constructed cabinet or safe

what are the requirements regarding telephones in the pharmacy (2)

at least one telephone must

- be accessible in the prescription area

- the telephone number shall be the telephone number printed on the prescription label

except for pharmacies operating as _____ _____ _____, pharmacies must: (3)

except for pharmacies operating as central processing centers, pharmacies must (1) be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes which supplies hot and cold water, (2) have restroom facilities for employees of the pharmacy provided reasonably close to, but outside of the prescription, (3) the pharmacy must be well lighted and ventilated.

explain the policy for televisions within a pharmacy

a television set may not be placed within the prescription area or so situated in the pharmacy that its viewing screen may be seen when looking at it from within the prescription area

the minimum at cost inventory must be at a value of at least $_____ & what type of pharmacy is exempted from this inventory requirement

$5000, central processing centers are exempted from this rule

_____ and otherwise _____ and _____ medications must be removed ed from active stock

outdated and otherwise adulterated and misbranded medications must be removed ed from active stock

what must pharmacies do when they have an increased scope of practice regarding supplies?

a pharmacy must contain additional equipment and supplies necessary to enable the pharmacy to ripely prepare and dispense prescriptions within its scope of practice

what is the rule regarding refrigerators used in pharmacies?

a refrigerator used solely for storage of drugs equipped with a thermometer or with a temperature monitoring device must be kept in the prescription area. this refrigerator cannot be used to store and personal food items.

what board references are pharmacies required to keep? (2)

- Pharmacy Act and Board of Pharmacy Regulations

- Federal and State Statutes and Regulated Pertaining to Pharmacy

what must the adequate and updated reference library allow and enable a pharmacy to do? (6)

- enables pharmacy to prepare and dispense properly appropriate to the type of pharmacy practice (technical, clinical and professional aspects of practice)

- enables pharmacy to compound meds safely and effectively

- lists possible drug interactions and side effects

- lists therapeutic drug equivalents (substitution) - orange book

- lists therapeutic usage and dosages of meds

- provides guidelines for counseling

drugs and medical devices must be inaccessible to _____ _____

unauthorized personnel

what type of merchandise can be stored in the pharmacy area?

the prescription area may not be used for storage of merchandise other than those used in preparation dispensing or delivery of drugs

what is the rule regarding animals in the prescription area?

no animals are allowed in the prescription area

Pharmacies located within retail establishments whose miriness hours differ shall adhere to the following standards: (4)

- the pharmacy must be able to be securely sealed from he remainder of the store (floor to ceiling barrier)

- hours of pharmacy must be posted at all points of access

- pharmacy must be closed whenever a licensed pharmacist is not present

- a protocol. for emergency access by non-pharmacist staff must be in place (including notification of pharmacist-manger)

how must CIIs be stored in a pharmacy?

- stored in a securely locked, substantially constructed cabinet, or

- dispersed throughout the stock of noncontrolled substances in a manner as to obstruct the theft or diversion of controlled substances.

how must CIII-Vs be stored in a pharmacy?

dispersed among stock of non controlled in a manner that obstructs theft

how must CS's be stored in a hospital?

controlled substances must be stored in separate locked space

how must CS's be stored in a LTCF?

- controlled drug substances must be stored in separate locked permanently affixed compartments, or

- double-locked medication carts

what is some important historical context of Act 102? (4)

- Act 102 is an amendment to Pharmacy Act 699

- First major substantive change to the Act since 1961

- Board of pharmacy has implemented new regulation effective summer 2006 pursuant to Act 106

- Act 29 further expanded pharmacy scope in 2010

how does Act 102 expand the scope of practice? (2)

- managing drug therapy in an institutional setting

- drug administration of injectables, biologicals, and immunization

how does Act 102 expand exposure to liability?

a pharmacist who is party to a written agreement or protocol shall obtain professional liability insurance coverage in the minimum amount of one million dollars per occurrence

what is the significance of Act 29?

expanded managing drug therapy to community settings by providing for collaborative drug therapy management (or CDTMs)

under PA law, the duties of a pharmacist are to: (there's a lot on this one)

1) Interpret, Evaluate, and Implement Orders

2) Deliver, Dispense, or Distribute Prescription Medications

3) Participate in Drug and Device Selection

4) Administer Certain Medications

5) Perform Drug Regimen Review

6) Perform Drug or Drug Related Research

7) Compound Products

8) Ensure Proper and Safe Storage of Drugs and Devices

9) Manage Drug Therapy

10) Ensure Proper Record Keeping

11) Perform Patient Counseling

12) Perform Acts and Services Necessary to Provide Health Care Services

what does a pharmacist examine when they evaluate for safety and efficacy by conducting a Drug Utilization or Drug Therapy Assessment (9)

- medication strength, dosage form, dosing schedule

- duration of therapy

- appropriate indication for use

- avoidance of therapeutic duplication

- avoidance of drug-drug interaction

- avoidance of drug-disease contraindications

- avoidance of drug allergy problems or adverse drug reactions

- proper utilization

- financial impact

how is generic substitution regulated

generic substitution is governed by state generic substitution laws and regulations and the formulary selection (P&T Committees) in institutional formularies and managed care

what types of medications do pharmacists administer

pharmacists have authority to administer

- injectable medications

- biologicals

- immunizations

what is (and what are important details related to) prospective DURs?

- constitutes a patient profile review that is conducted "prior" to dispensing a prescription

- mandated by OBRA for all new prescriptions

- computer "DUR" messages are part of an automatic prospective drug review