Pennsylvania Pharmacy Regulations Flashcards
MPJE MadeEasy
who conducts pharmacy inspections?
-Board of pharmacy
(hospitals by the department of health)
-inspections from either cannot be refused
What do you need to do if you change your name and address?
-pharmacists must notify the Board of any address changes within 10 days of the change
-On the form for address changes, you are required to include both the old and new address
–>for name changes, include your new name and former name, along with the official documentation that legalized the name change
-requested on the form is license #, SS # and DOB
What is the rule for Permit Displays/what it contains?
-name and address of the pharmacy
-name of the current owner
-name of the current pharmacist manager
What are the regulations with Pharmacist Breaks?
sole/alone pharmacist can take a 30 min break as long as:
-remains in immediate building (not a mall)
-must still be available for counseling and emergencies
-pharmacy can stay open and: receive new written rxs, prepare rxs for final verification and deliver rxs already verified
When is a new permit for a pharmacy required?
Must be filed within 30 days if any changes to:
-name
-ownership
-controlling interest
-licensed pharmacist or permit holder may not display a current certificate, license, permit, registration or renewal of a person not lawfully employed at the location
What must happen in the case of a pharmacy closing?
-immediately return the permit to the board of pharmacy
-notify the board of the disposition of the files and rx drugs
-beyond 30 days of closing, you would need Board permission to sell, transfer or dispose of files and drugs
-remove pharmacy signs/symbols from the interior and exterior
what to do in the case of a loss of pharmacist manage:
-permit holder must notify board in writing of the loss and the name of the new manager within 15 days
-may request in writing an extension of additional 30 days to find replacement
-once board is notified of new rph manager: approval is assumed if the board does not notify the permit holder within 30 days
-permit holder can make a request to the board in writing to waive the normal rule that a pharmacist manager cannot serve as pharmacist manager for more than one pharmacy at a given time
–> if granted, good for 60 days in addition to 15 days that are normally given
What are the duties of a pharmacist?
Provide direct, immediate and personal supervision to interns and technicians:
-reviewed the rx/order prior to dispensing
-verified the final product and
-is immediately available on the premises to direct the work and respond to questions or problems
What are the pharmacy intern duties?
-may neither enter nor be in a pharmacy if a rph is not on duty
-may perform procedures when require professional skill and training when working under the direct, immediate & personal supervision of a rph
-able to accept telephones rx from physician offices
What are the duties of a pharmacy technician?
-may neither accept nor transcribe an oral order or telephone prescription
-may neither enter nor be in a pharmacy if a pharmacist in not on duty
-may not perform any act within the practice of pharmacy that involves discretion or professional judgement
-may assist in reconstituting parenteral after a rph initials the product to accept full responsibility
-may not perform a duty until trained in that duty
What is required to be a registered pharmacy tech?
-criminal background checks at the time of initial registration
-must be at least 17 y/o and have graduated high school or have GED
-will need to complete a training program
(techs who have been working for a yr + will be grandfathered in and not require to complete the trianing)
What supplies are required to be in a pharmacy?
-must maintain an inventory of $5,000 worth of rx drugs and devices at cost
-a fridge (in the rx area) for storage of drugs
-rx files (can make use of computerized record keeping system)
-original rx images of the original rx (needs to be retained for 2 yrs)
-manager is responsible for removing expired, adulterated and misbranded drugs from stock
What reference material are required to be in a pharmacy?
-current copies of the pharmacy act
-current copies of Title 49, chapter 27
-federal and PA statutes and regulations
-an adequate reference library (allowed to demonstrate the ability to access required publications online)
Actions to take if there is a new location or change of location for a pharmacy:
-submit plan to the Board for PRIOR approval
-boars WILL NOTIFY the applicant of approval or disapproval within 90 days
-will require and inspection and approval by the board before opening for business
What are the steps needed to take in order to make alterations to a pharmacy?
-practice of pharmacy shall cease while substantial alterations in layout or fixtures are undertake unless
–> pharmacy takes adequate precautions to protect the health & safety of individuals
–> plans for the alterations and precautions are submitted to the board at least 30 days before and the board raises no obligation during that time
What are the building standards of a pharmacy?
-min size of the rx area: at least 250 square feet
-must be a rx counter at at least 10 linear feet in length and 2 linear feet in width
What are the regulations for pharmacies within retail establishments?
-can be securely sealed off from the reminder of the retail store by impenetrable floor-ceiling barrier
-securely locked whenever a licensed rph is not present and on duty, shall be closed whenever a licensed rph is not present & on duty
-safes, electrical equip of the retail establishment may not be located in or approached through the the pharmacy, unless a rph is on duty when individuals from the retail establishment need access
-hours of pharmacy posted at all points of public access
-protocols for access to the pharmacy for bona fide emergencies when it is closed and shall include notification to the pharmacist manager
Misc equipment requirements for a pharmacy
-space for substantially constructed cabinet or safe for storage of CS
-sink
-no tv within view of rx area
-no pets (except for security)
-at least 1 phone where the # matches the one on the RX label
-no storage in the rx area of merchandise other than used in the prep, dispensing, or delivery of drugs & no access for unauthorized personnel
The prescriptions kept on file must show:
-name & address of the pt
-name & addy or other identifier of the prescriber
-date rx was issued
-name and quantity of the drug prescribed
-direction for its use: cautions communicated to consumer
-date the rx was compounded and dispensed
-name or initials of the dispensing rph
-CS rx on file shall also show the DEA # of the prescriber
-CS rxs must be manually signed by the prescriber (unless electronic)
-original rx must be kept for 2 yrs
-CII shall be recoded and the record be kept for 2 yrs
What must a prescription label include?
-name, addy, phone # and DEA # of pharmacy
-name of the pt and prescriber
-full directions for use
-serial # of the rx and date originally filled
-trade/brand name of drug, strength, dosage form & quantity
–> if generic is dispensed, must include the manufacturer’s name
–> if a CS is dispensed, must include the statement “ caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
What are dispensing restrictions in PA?
-may not dispense, dispose or sell C V cough preparations containing codeine, dilaudid or other narcotic w/o a rx
-no rx may be knowingly filled or refilled for a pt which rx was written by a prescriber who is dead or no longer in practice
-rx may be refilled for 1 yr from the date written
-rx drug is refillable by statute on the basis of designation, ad lib/ PRN may be refilled for 1 yr from the date written
- rx for CIIs may not be refilled
-rx for CIIs may not be filled more than 6 months from the date of issue
-CIII-CV may not be filled or refilled more than 5 times in the 6 month period from the date of the rx
What does the label for pre-packing drugs contain?
-shall be done under the direct personal supervision of rph
Label must have:
-name of drug
-strength, manufacture control #, expiration date
–> a log shall be kept in the pharmacy stating the above label info & the date, quantity pre-packed
What are the requirements surrounding the mailing of prescriptions?
-permitted only by first class or common carrier
-mailing of reconstituted abx is PROHIBITED
-mailing of a med or rx drug/ device generally accepted
What are the circumstances surrounding the advertising and sale of drugs?
- no advertising of filling/refilling rx of PA pts unless:
–> person is licensed in PA or
–> the rx is filled or refilled in a pharmacy licensed by the board
-no promoting the sale of CSs
-advertising shall be for a commercially reasonable quantity
-20% off sales etc require the showing of a price list from which derived
What to do if a patient requests a copy of an original prescription:
-the copy shall clearly indicate on its face that it is a copy and *may not be used to obtain a new rx or refill”
-person requesting the copy shall show ID/authorization
-rph shall record in writing: the date, to whom and by whom the copy was given
What are the regulations surrounding the sale of needles and syringes in PA?
-permitted w/o a rx
-direct, immediate and personal supervision of a rph is required
-no age limit
-no quantity limit
-no record keeping req
-must be kept in rx area
Institutional labeling: for med that is not in unit dose requires:
-pt name
-drug name
-drug strength
-dosing instructions
-lot number
Institutional labeling for parenteral, enteral or TPN requires:
-pt name
-name, strength, & quantity of each ingredient
-diluent
-expiration date
-rph initials
Unit dose labeling reqs (not specified by PA, so federal law) :
-drug name
-drug strength
-lot number
-expiration date
-name and place of business of mfgr, packer or distributor
OBRA 90: Prospective drug review
-rph shall perform a PDR before filling, delivering or sending a new rx or drug order
NOT required when:
–> a physician dispenses a drug to a pt being treated in the ED
–> a rph dispenses a pharmaceutical drug to a physician who will administer it to a pt
–> a medical practitioner dispenses a drug
–> rph dispenses a drug to a medical practitioner which the practitioner will administer to a pt
OBRA 90: offer to counsel
An offer to counsel shall be made to each patient or caregiver for each NEW retail or outpatient
prescription.
-If the patient or caregiver does not come in, then an offer to counsel can be made by telephone, by the delivery person, or by a written offer. Any written offers must include a toll-free number to reach the pharmacy
OBRA 90: actual counseling
Only a pharmacist may do the actual counseling.
-The pharmacist shall counsel the patient or caregiver in person, or, at the discretion of the patient or caregiver, by telephone.
OBRA 90: What must a patient profile have?
-name, addy, phone #, DOB, gender
-hx, allergies/drug reactions & a list of meds and relevant devices
-pt profile shall be kept for 2 yrs after the last entry
OBRA 90: Documentation requirements for counseling
The pharmacist or designee shall document the refusal of the patient or caregiver to accept counseling or to provide information.
-The documentation shall include the name or initials of the pharmacist or designee noting the refusal
OBRA 90: confidentiality guidelines
info about a pt may only be revealed by:
-patient consent
-board requires the info
-state of federal law requires it
-court order
OBRA 90: rules regarding the faxing (facsimile) of CIIs
-faxing of CIIs is allowed
-before dispensing a faxed CII- the rph must generally receive the original signed rx
