PENNSYLVANIA LAW

Who does the State Board of Pennsylvania consist of?

• Commissioner of Professional & Occupational Affairs

• Director of Bureau of Consumer Protection

• 2 Public Representatives

• 2 Independent Retail Pharmacists

• 2 Retain Chain Pharmacists

• Acute Care Institutional Pharmacist

What are the board requirements for the State Board of Pharmacy?

• Executive Secretary must be a licensed pharmacist & Board Counsel must be an attorney

• Members are appointed by Government w/ approval of majority of Senate

• Pharmacists members must have RPh license for minimum of 5 years to be on board

• Term of appointment is 6 years

What is the purpose of the state board of pharmacy?

Protect the public health & safety

What are the duties & responsibilities for the board of pharmacy in PA?

• Regulate Practice of pharmacy

• Determine nature of pharmacist applicant exams (licensure)

• Issue licenses & renewals

• Employ appropriate consultants

• Conduct inspections

• Conduct investigations of violations of Pharmacy Act & Regulations

• Conduct hearings regarding suspension & revocation of licenses

• Enforcement of laws & regulations pertaining to pharmacy

• Promulgate rules & regulations pursuant to Pharmacy Act

How long do the copies of inspection reports must be retained on pharmacy premises for?

2 years

What does the PA Dept of Health have the primary responsibility for?

Inspections of health care institutions w/ notification made to Board of Pharmacy

What are the inappropriate conducts that can lead to penalties, such as refusal, revocation, & suspension of pharmacy license?

• Procure a license through fraud, misrepresentation, or deceit

• Felony in connection with/ practice of pharmacy or any offense involving moral turpitude

• Impaired professional duties b/c of alcohol or controlled substances

• Unfit to practice b/c of physical or mental disease

• Suspended or revoked license from another jurisdiction

• Violated pharmacy act or regulations

• Compounded or dispensed drug which contains different amount than prescribed

• Create danger to public health

• Incompetence; malpractice w/ or w/o injury

• Guilty of grossly unprofessional conduct

What is considered grossly unprofessional conduct?

• Willful deceit

• Improper advertising

• Public assertion or implication of professional superiority

• Engaging in false, misleading, or deceptive advertising of drugs/devices

• Payment or acceptance of compensation for recommending services of another

• Misbranding or adulteration of drug/devices Payment or sale of same

• Selling drugs marked “sample”/“not for resale”

• Displaying license where not employed

• Failure to have pocket card available for inspection when practicing

• Acceptance or redistribution of a drug once it has left the pharmacy, unless is original sealed container w/ name, lot number, & exp. date on original manufacturer’s label

• Acceptance of employment as a pharmacist where medical professionals are in a position to influence you

What are the requirements for applicants for a pharmacist license in PA?

• Be at least 21 years old

• Be of good moral/professional character & fit to practice

• Graduate from an accredited School of Pharmacy

• Complete a Board-approved internship

• Pass a licensure examination

• Not be in possession of a felony convinction relative to controlled substances

When are pharmacists licenses renewable?

• Every 2 years

• Every even-numbered year

• From October 1-September 30

What notifications must be reported to the board?

• Change in address w/in 10 days

• Change in name w/in 10 days

  • Must supply copy of marriage license/court decree

What are the requirements of continuing education for pharmacist license renewals?

• 30 credit hours over 2 hour renewal period

• CE programs must be ACPE or board-approved (live/correspondence courses)

• Carryover of credits from 1 period to another is not allowed

• CE certificates must be maintained for 2 years after renewal

• Of 30 hours, following topics are required:

  • 2 hours of child abuse recognition & reporting

  • 2 hours in pain management, addition, or opioid dispensing

  • 2 hours in ACPE topic designator “patient safety”

• Newly graduated license are exempt from CE requirements for 1st renewal, except forr 2 hours for (1) child abuse recognition & reporting & (2) pain management, addiction, or opioid dispensing

• Licenses authorized to administer injectables must secure at least 2 CE credits relative to the topic

What is reciprocation?

• Process whereby a pharmacist license is transferred from 1 state to another

• Applicant must petition the state board

• Requirements vary state-to-state

• NABP process

• CE prorated from time of initiate licensure reciprocation to next renewal

What are the equipments for ID badges in hospital/institution settings?

• All employees must wear a photo identification badge

• Must include:

  • Recent photo

  • Name

  • Title

  • Name of employee’s health care facility or employment agency

What are the requirements for interns?

• Pharmacy internship is “supervised practical experience requested for licensure as a registered pharmacist

• Purpose is to provide registered intern w/ knowledge & practical experience necessary for functioning competently”

• Must register as an intern w/ PA state board of pharmacy

  • Form “application for registration as pharmacy intern”

  • Applicants for intern license in PA must:

    • Be currently enrolled in a school of pharmacy

    • Possess good moral character

    • Successfully completed 2 years of college study

  • Intern license is valid for up to a 6-year period (exclusive of time in military)

What is the internship credit for interns in PA?

• Minimum of 1500 hours total required

• May be earned through ACPE-accredited school of pharmacy’s PharmD program

• Graduates no longer required 050 hours outside of school program (board will not grant hours when student served in pharmacy if supervising pharmacist was not registered preceptor)

• Intern may not claim more than 50 hours per week

• Intern activities must be related to pharmacy practice

  • Scrutinizing prescription/drug orders

  • Compounding meds

  • Filling prescriptions

• Must submit “intern experience reporting form”

• Must send verification of hours to state board of pharmacy via verifiable delivery method that can be tracked & retain a second original copy for own records

  • Verification of hours should be submitted on regular basis

What are the qualifications for pharmacist preceptors?

• Must be registered in advance of internship (w/ exception of hours earned through school experimental program)

• Must be full-time

• Licensed in PA

• May not be register for more than 2 interns at a time (unless approval from board in advance)

• Change in preceptor necessitates submission of “application to change or add a pharmacist preceptor”

What are the qualifications of the pharmacies where interns work in PA?

• Must be free of violations (federal/state/municipal)

• Must compound & dispense a sufficient number of prescriptions

• Must place emphasis on activities connected w/ distribution of articles & services pertaining to medical care including drugs, medicines, prescriptions, medical supplies, & materials

What are the requirements for pharmacy permits?

• Separate application/permit is required for each pharmacy

  • Each individual physical pharmacy location must possess its own permit (regardless of same ownership)

  • Pharmacy serving the public on premises of an institution must secure its own permit

    • Institutional pharmacies are those pharmacies w/in healthcare facilities that are accredited by:

      • Joint Commission (JC) or

      • Commission of American Osteopathic Association or

      • Licensed by Departemnt of Welfare/Department of Health

    • Only such institutional pharmacies are eligible for a pharmacy permit in PA

• Satellite pharmacies are exempted

  • Decentralized or satellite pharmacy are pharmacies w/in the same physical institution that:

    • Provide specialized services &

    • Dependent on a centrally located pharmacy for administrative control

What are the requirements for pharmacist managers?

• Separate pharmacist-manager for each pharmacy location needing a permit is required

• Permit must bear:

  • Name & address of pharmacy

  • Name of owner

  • Name of pharmacist-manager (if not a same as owner)

What does it mean that sole management is required for pharmacies?

A pharmacist may be pharmacist manager of only 1 licensed pharmacy at a time

What is the applicant record for pharmacies?

• Pharmacy permit applicant may not be guilty of any crimes concerning pharmacy

• An applicant includes any director, officer of a company or individual owning greater than 10% of the stock

What must be the name of business of a pharmacy?

• Designation of “drugstore”, “pharmacy”, “apothecary”, “medicine” cannot be used if not a licensed pharmacy

• Cannot use a “d/b/a” designation

What does it mean for a pharmacist to personally supervise pharmacy?

• Every pharmacy must at all times when open, be under constant direct & personal supervision & management of a pharmacist duly licensed in PA

• Lunch breaks- 30 mins allowed & pharmacy may remain open for pharmacy related services, as long as pharmacist remains in pharmacy or w/in immediate building

  • Pharmacy related services include:

    • Receipt of new written prescriptions

    • Preparation of prescriptions for final verification

    • Delivery of prescriptions already verified by pharmacist

What must a pharmacy display?

Regulations

• Federal DEA registration

• Pennsylvania pharmacy permit

• Pharmacist & intern licenses

What are nonresident pharmacies required to do?

Register w/ PA board of pharmacy prior to shipping medications into the Commonwealth

When does a pharmacy permit need renewed?

• Every 2 years

• Every odd-numbered year

• Period runs from September 1- August 31

What needs done when a pharmacy is closing?

• Return the permit to board of pharmacy

• Notify the board of the disposition of files & prescription drugs

  • Need permission of board before disposal, sale, or transfer of the files or prescription drugs

  • If more than 30 days from date of closing

• Remove signs/symbols from the interior & exterior that identify the establishment as a pharmacy

What are the notifications that are required for pharmacies?

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

• For change in pharmacy manger, board must be notified w/in 15 days

  • May apply for extension in writing for up to 30 additional days

  • May apply for waiver to serve as pharmacy manager for more than 1 pharmacy for up to 60 additional days beyond the initial 15 days

What are the possible disciplinary actions?

• Revocations

  • A permanent removal of a license/permit

  • May be reinstated by:

    • Court order or

    • New application for license may be submitted

      • 5 years after revocation, unless

      • Felony conviction, whip requires 10 years

• Suspension

  • Temporary removal of license/permit

  • May be reinstated:

    • After designated period of suspension is complete &

    • All CE requirements during period of suspension are met

• Discipline reporting

  • Pharmacists- 90 days to report discipline from other jurisdictions

  • Pharmacies- 30 days to report discipline from other jurisdictions

• Impaired providers

  • Possible to remain in practice provided that:

    • Pharmacist is enrolled in treatment program endorsed by board

    • Pharmacist is making satisfactory progress &

    • Notification of progress is regularly reported to the board

  • Pharmacists convicted of felony related to controlled substances may not remain in practice

What are the physical setup requirements for pharmacies?

• Plans

  • New pharmacy or a change In location

    • Plans must be submitted to board 90 days in advance for approval

  • Pharmacy alterations

    • Plans must be submitted to board 30 days in advance, if no objections are raised, work may proceed

• Building standards

  • Minimum size

    • Minimum size of prescription area must:

      • Be at least 250 square feet *

      • Be large enough, considering the level of activity, to carry on practice of pharmacy in manner that protects health & safety of professional, employees, & public

    • W/in area, must be:

      • Prescription working counter of at least 10 linear feet in length & 2 linear feet in width

      • If more than 2 pharmacists are on duty simultaneously, minimum counter length shall be increased by 5 linear feet for additional pharmacist

      • Institutions w/ special considerations may apply to board for a waiver

  • Locked compartment

    • Space must be provided for substantially constructed cabinet or safe to contain controlled substances

    • Unless pharmacy disperses controlled substances throughout stock of non controlled substances in a manner that obstruct theft of controlled substances

    • If pharmacy stocks C1s, they shall be stored in securely locked, substantially constructed cabinet or safe

  • Telephone

    • At least 1 telephone must;

      • Be accessible in prescription area &

      • Number shall be on telephone printed on the prescription label

  • Sanitary facilities

    • Except for pharmacies operating as central processing centers pharmacies must:

    • Be equipped w/ a sink in prescription area to be used solely for pharmaceutical purposes

      • Sink must be connected properly to supply hot & cold water

    • Have restroom facilities for employees

      • Provided reasonably closed to, or outside of prescription area

  • Pharmacy must be well lighted & ventilated

  • Television set may not be placed w/in prescription area or so situated in the pharmacy that its viewing screen may be seen when looking at it from w/in prescription area

What are the requirements for equipment & supplies for pharmacies?

• Inventory

  • Minimum at cost inventory of $5000

  • Pharmacies operating as central processing centers are exempted from inventory requirements

  • Outdated & otherwise adulterated & misbranded meds must be removed from active stock

• Supplies

  • Pharmacy must contain additional equipment & supplies necessary to enable to pharmacy to properly prepare & dispense prescriptions w/in its scope of practice

  • Refrigerated used solely for storage of drugs equipped w/ a thermometer or w/ a temperature monitoring device must be kept in prescription area

  • Pharmacies operating as central processing centers are again exempted

• References required in pharmacy

  • Pharmacy act & board of pharmacy regulations

  • Federal & state statues & regulations pertaining to pharmacy

  • Adequate & updated reference library that:

    • Enables pharmacy to prepare & dispense properly appropriate to type of pharmacy practice

    • Enables pharmacy to compound meds safety & effectively

    • Lists possible drug interactions & side effects

    • Lists therapeutic drug equivalents- orange book

    • Lists therapeutic usage & dosage of meds

    • Provides guidelines for counseling

What is the required security for pharmacies?

• Arrangement of pharmacy area

  • May be under constant & direct supervision of a pharmacist daily licensed in PA

  • Drugs & medical devices must be inaccessible to unauthorized personnel

  • Prescription area may not be used for storage of merchandise other than those used in preparation, dispensing, or delivery of drugs &

  • No animals are allowed in the prescription area

• Self-contained pharmacy

  • Pharmacists located w/in retail establishments whose business hours differ shall adhere toe the following standards:

    • Pharmacy must be able to be securely sealed from remainder of store

    • Hours of pharmacy must be posted at all points of access

    • Pharmacy must be closed whenever a licensed pharmacist is not present

    • Protocol for emergency access by non-pharmacist staff must be in place (including notification of pharmacist-manager)

• Controlled substances

  • Schedule 2

    • Stored in a securely locked, substantially constructed cabinet or

    • Dispersed throughout stock of non controlled substances in manner to obstruct theft/diversion

  • Schedule 3-5

    • May be stored:

      • Dispersed among stock of uncontrolled in a manner that obstructs theft

What are the requirements for security for hospitals or LTCF?

• Hospital

  • Controlled substances may be stored in a separate locked space

• LTCF

  • Controlled substances must be stored in a separate locked permanently affixed compartments OR

  • Double-locked medication carts

What are ACTS 102 & 29?

• History

  • Act 102 is an amendment to pharmacy act 699

  • First major substantive change to the act since 1961

  • Board of pharmacy has implemented new regulations effective summer 2006 pursuant to act 106

  • Act 29 further expanded pharmacy scope in 2010

What is the significance of act 102?

• Expands scope of practice by allowing:

  • Managing drug therapy in an institutional setting

  • Drug administration of injectables, biologicals, & immunization

• Also expands exposure to liability

  • Pharmacists who is party to a written agreement or protocol shall obtain professional liability insurance coverage in the minimum amount of $1,000,000 per occurrence

What is the significance of act 29?

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

What are the duties of a pharmacist?

• Interpret, evaluate, & implement orders

  • Interpret, evaluate, & implement medical orders for pharmacy services &/or prescription orders, including

  • Evaluate for safety & efficacy by conducting a drug utilization review or drug therapy assessment, which evaluate:

    • Medication strength, dosage form, dosing schedule

    • Duration of therapy

    • Appropriate indication for use

    • Avoidance of therapeutic duplication

    • Avoidance of drug-drug interaction

    • Avoidance for drug-disease contraindications

    • Avoidance of drug allergy problems or adverse drug reactions

    • Proper utilization

    • Financial impact

• Deliver, dispense, or distribute prescription meds

• Participate in drug & device selection

  • Generic substitution

    • Generic substitution is governed by state generic substitution laws & regulations

  • Formulary selection (P&T committees)

    • Institutional formularies

    • Managed care

      • May have significant impact on all areas of practice

      • Impacts which meds will be covered by insurance plan & to what extent & under what conditions

      • May perform drug utilization reviews

• Administer certain medications

  • Pharmacists have authority to administer

    • Injectable meds

    • Biologicals

    • Immunizations

Perform drug regimen review

• Prospective DUR

  • Constitutes a patient profile review that is conducted “proper” to dispensing prescription

  • Mandated by OBRA for all new prescriptions

  • Computer “DUR” messages are part of an automatic prospective drug review

• Retrospective DUR

  • Constitutes patient profile review that is conducted “after” prescriptions have been dispensed

  • Done for individuals to ensure correct therapy

    • State law mandates monthly DUR reviews for residents of skilled care nursing facilities

  • Done more globally to assess patterns of usage as a form of quality control

    • Institutions, insurers, & state agencies often use to detect inappropriate therapeutic use or patterns of drug abuse/misuse

• Perform drug or drug related research

• Compound products

• Ensure proper & safe storage of drugs & devices

  • Adulterated (including outdates)/misbranded products must be removed from active stock

    • Controlled drugs must be disposed of according to federal regulations, including proper recordkeeping

    • In LTCF, state law requires disposal to be conducted at least on a quarterly basis

• Manage drug therapy

• Ensure proper record keeping

• Perform patient counseling

  • Problem solving

  • Interaction w/ prescribers & other HC professionals

  • Interaction w/ patients

  • Referral to HC information

  • Familiarity w/ patient profiles

  • OBRA specifically requires prospective DUR

  • Also includes:

    • OTC & self-care counseling

    • Pharmacist is often first HC professional consulted by the patient

    • Pharmacist must be able to recognize when a patient can self-treat & when referral to physician is necessary