Term
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Definition
- the PIC is responsible for the entire pharmacy operation (inventory, accountability, and staffing) |
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Term
what is the inventory process taken when a new PIC is put in place for schedules III-V? |
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Definition
- when assuming the position, there must be a written inventory taken within 3 days for schedules III-V and retained for 4 years on an invoice |
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Term
what is the inventory process taken when a new PIC is put in place for schedule II? |
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Definition
- must be on a DEA 222 form and submitted to the DEA and retained for four years |
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Term
how many places can a pharmacist be a PIC at? |
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Definition
- max of 2 as long as one is in an institution only requiring the PIC part-time |
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Term
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Definition
- supervising all personnel; maintaining records; security; who has keys; check medication; prohibits misbranded/adultered drugs in pharmacy; maintain compliance with all laws; P&Ps |
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Term
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Definition
- policies and procedures - today, these are handed down from corporate but the PIC is responsible for making sure staff knows P&P's |
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Term
NH code of administrative rules? |
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Definition
- licensing of pharmacists - licensing of pharmacies - the practice of pharmacy - safekeeping and distribution of pharmaceuticals - inspection of pharmacies - licensing other facilities where legend drugs are kept |
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Term
licensing of pharmacists (requirements) |
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Definition
- application to board - >or= 18yrs - 3 signed references - name, address, phone #, DOB, place of birth - federal, state liquor or drug violations - pharmacy license disciplinary actions from another state - any felony convictions - college attended, date graduated, degree awarded - practical experience (1500hrs) - copy of birth certificate - full face photo - final transcript - $265 - all must be notarized |
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Term
pharmacy intern requirements |
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Definition
- must be working towards completion of 1500hrs of pharmacy internship starting no earlier than 4mnths prior to the 3rd year of pharmacy school - all intership hours must have been donein a pharmacy practice setting |
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Term
pharmacy intern responsibilities |
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Definition
- the selling of drugs and medical supplies - interpreting, compounding, preparing, and dispensing Rx orders - preparing pharmaceutical products - keeping records and preparing reports required by federal and state statutes - "interns can do anything a pharmacist can do except the final check as long as a pharmacist is present" |
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Term
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Definition
- must achieve a score of 75 or better (if not, reapply and wait 90 days to retake the exam) - tests knowledge in pharm. theory, applied or practical pharm, pharmacology, math and chemistry, laws governing the practice of pharmacy |
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Term
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Definition
- consists of questions from both state and federal laws and regulations - msut have a passing score of 75 or better (if not, reapply and wait 30 days to retake) - once your application is submitted to the board, you will have 90 days to take the exam (50% of licensing requirements) |
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Term
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Definition
- for pharmacists who are licensed in another state and wish to practice in the state of NH there are 3 steps to complete (see other slide) |
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Term
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Definition
- fill out a NABP application - you need the same info as previously mentioned - will need to take and pass a NH jurisprudence exam on federal and state laws within 90 days of application (passing score is 75 or better) - basically just dont have to retake the NAPLEX |
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Term
renewal of pharmacist license info |
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Definition
- all pharmacists must annually renew by midnight on Dec 31st - notify board in writing within 15 days of any change of address, employment location, or name - must display license where practicing (primary site) |
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Term
how many CEU's must a pharmacists have per year |
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Definition
- 1.5 (or 15 hours) - may be accepted from other states as well as post-grad work - audio/visual accepted only if there is an exam afterwards - 5hrs must be in a live setting (didactic) - no carryovers |
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Term
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Definition
- NH state board of pharmacy approved - OR must be ACPE, AMA category 1 approved (not necessarily state specific - i.e. not necessarily approved by NH) - no repeat programs |
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Term
when is a pharmacist exempt from CEUs? |
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Definition
- first license renewal - extenuating circumstances |
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Term
What part does the Board of Pharmacy take in regards to CEU? |
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Definition
- the BOP will audit no less than 10% of RPh license renewals |
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Term
credit for instructors of CE programs |
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Definition
- credit can be given, but only once per program and up to 4 per year - this will not count as didactic (live CEU) if you are an educator of health professionals - CE credit will only be given if the topic is outside of what you would normally teach |
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Term
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Definition
- must register with the Board every 2 yrs and must demonstrate competency, etc. - shall maintain records of participants for 3 yrs |
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Term
Licensing of a pharmacy: pharmacy permit options |
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Definition
- licensing of the entire store - licensing of the prescription area only |
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Term
application for the license of a pharmacy |
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Definition
- type of pharmacy - name and home address of PIC - name of pharmacy and identification of ownership - hours of operation - inventory value - name and hours of all pharmacists, including their license numbers - list of persons who have keys - scale drawings and space utilization - must appear before the board (both the owner and PIC) |
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Term
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Definition
- permits are issued to the pharmacy in the name of the PIC - this permit indicates that the PIC has accepted responsibility for all aspects of the pharm. dept. - all permits expire when the PIC's license expires, is revoked, or if the PIC's employment status changes - all permits must be renewed by midnight on Dec 31st of each year |
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Term
licensing of the entire store |
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Definition
- the pharmacy permit shall include the rx dept. and all other retail sections - enitre pharm. shall be equipped with a functional alarm system - the rx dept. shall not be closed while the balance of the establisment remains open - a licensed pharmacist shall be on duty at all times when the pharmacy is open to the public |
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Term
licensing of rx area only |
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Definition
- permit shall include only rx dept. - rx dept. shall be equipped with a functional alarm system separate from the rest of the establishment - the rx dept. may be closed while the remainder of the establishment remains open to the public - a licensed pharmacist shall be on duty at all time when the rx dept. is open - whenever the rx dept. is closed, a sign shall be placed indicating that there is no pharmacist on duty - need physical barrier from floor to ceiling capable of being locked and alarmed separate from the rest of the store |
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Term
when a pharmacy is closed, can a rx be left via mail slot? |
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Definition
- yes, only if it falls directly into the rx dept. area and is accessible to ONLY a pharmacist (not an intern) - no finished rx can be left outside the rx dept. for pick-up |
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Term
drug delieveries containing rx drugs |
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Definition
- can only be delivered when the rx dept is open |
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Term
who approves a remodel or relocation of a pharmacy? |
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Definition
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Term
structural requirements for the pharmacy |
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Definition
- needs a sink with hot and cold running water - refrigerator set aside just for drugs - cabinets and counters - must be at least 200 sq. ft. in size - must be well-lit have temperature controls, and have a quarantined area for outdated or damaged stock |
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Term
inspection REPORT by the BOP |
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Definition
- shall be posted in the rx dept. - shall list deficiencies according to state and federal law |
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Term
when is the closing of a pharmacy area alone is allowed? |
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Definition
- only if the rx area is registered as a separate dept. |
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Term
lunch/breaks when the pharmacy is staffed by a single pharmacist |
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Definition
- the RPh may take a lunch break for up to 30 minutes without closing the pharmacy |
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Term
why are lunch/breaks included in the hours worked per week by a RPh? |
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Definition
- because they need to remain on the premises in case of emergencies (to be determined by the pt) |
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Term
what may techs and interns do while the RPh is on lunch/break? |
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Definition
- can be left in the pharmacy area and may accept new or refill prescriptions from the pts in person or just refills over the phone - NO NEW RXS OVER THE PHONE |
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Term
what medications may be dispensed while the RPh is on break? |
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Definition
- refilled prescriptions only |
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Term
is a RPh on break liable for acts not authorized by them? |
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Definition
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Term
under what three conditions is the pharmacy owner "transferred"? |
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Definition
- by sale - by add'n or deletion of a partner - as a result of the death of a single owner |
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Term
under what three conditions is the pharmacy owner "transferred"? |
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Definition
- by sale - by add'n or deletion of a partner - as a result of the death of a single owner |
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Term
under what three conditions is the pharmacy owner "transferred"? |
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Definition
- by sale - by add'n or deletion of a partner - as a result of the death of a single owner |
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Term
what happens when the pharmacy owner is "transferred"? |
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Definition
- the person to whom the permit was issued (usually te PIC) has 15 days to report to the BOP, in writing, any changes in the application data |
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Term
what items must be present on the "amended application" after the pharmacy owner is transferred? |
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Definition
- type of change (name, location, size - renovations) - name of prior and current (new) PIC - names of all staff pharmacists - date of change - pharmacy hours - application must be signed by the PIC |
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Term
3 categories of licenses that must be displayed in the pharmacy |
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Definition
- pharmacy permit - DEA federal CS certificate - all pharmacists and technician state licenses |
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Term
minimum standards of technical equipment and stock |
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Definition
- Rx labels with name, address, hpone number, and DEA registration number of the pharmacy - assortment of auxiliary labels - reference library - pharmacy law book |
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Term
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Definition
- determined by the PIC - should relate to the type of pharmacy practice (i.e. compounding pharmacy should have compounding references) |
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Term
responsibilities of the compounder (rule 795) |
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Definition
- qualified personnel - ingredients are pure - packaging and labeling - P&P's for each compound - compounding environment - appropriate beyond use dating - compounding conditions are such to prevent errors |
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Term
what categories are covered under rule 795 |
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Definition
- record keeping - areas used will prevent contamination and errors - proper equipment - documentation of stability |
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Term
what types of records must be kept in accordance with rule 795 |
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Definition
- formulation record - compounding record - MSDS - final check |
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Term
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Definition
- name, strength, and dosage form of the preparation - list all ingredients and quantities used - equipment used - mixing instructions in order and duration - environmental controls - other factors - beyond use dating - container used to dispense the preparation - storage requirements |
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Term
compounding record (general) |
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Definition
- name and strength of compound - formulation reference - sources of lot numbers - number of dosage units - name of preparer - name of the person who approved the preparation |
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Term
when is bulk compounding done? |
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Definition
- in anticipation of Rx - i.e. if doctor continuously writes rxs for compound, you can make it ahead of time |
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Term
records for bulk compounding |
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Definition
- shall be kept separate - formula used - identity of the manufacturer of bulk chemicals - lot number - date of compounding - exp. dates of each chemical - quality control # assigned by pharmacist - in-house lot # - expiration date never over 1 year - name of compounding pharmacist |
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Term
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Definition
- requirements for laminar air flow hood and clean room - in add'n needs space for bulk storage - must include a sink with hot and cold running water - needs a refrigerator - must be certified annualy with a class 100 HEPA filter, and this certification certificate must be retained for 3 years |
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Term
patient info needed for all compounding |
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Definition
- name, age, sex, and address - phone number where the parenteral medication is or will be given - primary dx - summary of previous medical history and latest hospitilizations - medication history, diet, all allergies - progress notes and lab data |
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Term
additional labeling req'd for compounded products |
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Definition
- phone number of pharmacy - all ingredients in the parenteral (with concentrations) - storage and handling instructions - chemotherapy drugs need extra handling procedures |
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Term
what things are included under policies and procedures? |
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Definition
- infection control - spills of pharmaceuticals - methods used in compounding - quality assurance procedures - disposal of supplies and pharmaceuticals - training of staff - DOCUMENT |
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Term
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Definition
- cleaning and sanitization of the area - surveillance for microbiological contamination of the response if contamination exists - periodic documentation of the refrigerator and room temps - drug recall procedures - written justification of exp. dates |
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Term
when is the reference library needed? |
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Definition
- pt. counseling - all drugs and sol'ns used in compounding |
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Term
general def. of manufacturing |
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Definition
- bulk compounding that is not pt. specific - distribution for resale to another pharmacy - mass marketing of preparations |
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Term
general def. of compounding |
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Definition
- pt. specific - bulk componding is allowed ONLY FOR ANTICIPATED RXS - "triad" exists between RPh, pt, and physician |
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Term
prepacking for intrnal distribution label |
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Definition
- must be done under the direction of RPh and include drug name, strength, name of mfg, in-house quality control #, exp date, quantity in the pre-pack |
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Term
prepack written record (NOT LABEL) |
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Definition
- name, strength, and dosage form - quality control number - mfg and lot # - exp date - quantity - number of prepacked units - date packaged - name of pre-packer - signature of supervising pharmacist |
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Term
automated data processing systems (ADPS) |
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Definition
- shall provide security against manipulation or alteration of stored records by individual access codes - affords complete access to records - PIC shall be responsible of all processing and storage of records - shall provide on line retrieval by CRT display or hard copy print out |
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Term
info req'd when using ADPS |
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Definition
- rx number - date of issuance - name and address of pt - name, address, and DEA number of practition (only of CS) - drug name, strength, dosage form, quantity prescribed, quantity dispensed, and number of refills |
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Term
what should the refill history contain |
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Definition
- name of drug and strength - date of refill - quantity - ID code or name and initials of RPh - name and address of pt - total number of refills that have been authorized and dispensed to date - prescribers name and DEA # |
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Term
documentation for refills |
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Definition
- hard copy printout for CS (4 yrs) - RPh should verify each new rx and refill on the printout - printout must be signed and dated by each RPh that worked that day |
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Term
what can be used in lieu of a printout in regards to documentation of refills |
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Definition
- a log book is also acceptable but the RPh still must sign and date |
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Term
central (off-site) systems |
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Definition
- provides a printout within 48hrs - down time procedures - each pharmacy shall maintain a file of hard copy rxs with a computer generated label which will be affixed to the back of the rx |
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Term
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Definition
- no person shall possess, and no pharmacy shall have within it, any document pre-signed by the doctor |
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Term
exceptions to blanks in NH rxs |
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Definition
- out of state Rxs - dept. of defense rxs - veterans admin - dept of any us hc services |
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Term
what MUST be present when transmitting rxs |
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Definition
- electronic device must be present in the pharmacy area |
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Term
transmitted rxs of III, IV, and V |
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Definition
- you may use transmitted rx as an original hard copy rx |
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Term
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Definition
- can be accepted but cannot be dispensed until the original written rx is obtained (with a few exceptions - i.e. hospice, LTC) |
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Term
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Definition
- shall be communicated directly bt two licensed RPhs - no further refills can be issued at the pharmacy that has transferred the rx, unless it is transferred back again - CAN transfer CS as long as there are refills left, but it can only be transferred once regardless of amt of refills |
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Term
what must be done by the transferring RPh |
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Definition
- must write "void" on face of rx (if CS) - transferring RPh must note on the pt. medication record date of transfer, name of RPh transferring the rx, and the name, address, and RPh of the receiving pharmacy |
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Term
when are fax rxs accepted for transfers |
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Definition
- ONLY for non-cs - cs must be phoned in |
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Term
what must the receiving RPh do to a transferred Rx |
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Definition
- write "transfer" across face - notate pt name and address, dr. name and address, date of original rx, date of transfer, number of refills remaining and date of last refill, pharmacy name, address, and original rx number from which rx is transferred (DEA # req'd if cs), and the full name of the transferor RPh |
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Term
when do pharmacies NOT have to "transfer" drugs |
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Definition
- when the pharmacies share a common database for dispensing - ONLY FOR NON-CS - cs must be transferred |
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Term
how often may a transferred rx be refilled |
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Definition
- to the number of refills OR 1 year from the original date of transfer |
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Term
what two places can you look for qualified drugs for interchange |
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Definition
- "A" rated in orange book - OR in NH list of interchangeable Rxs |
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Term
what qualifications must a drug meet to be interchangeable |
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Definition
- therapeutically equivalent - same active ingredient, strength, quantity, and dosage form - must be less expensive than prescribed |
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Term
what steps are taken during interchange of a drug |
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Definition
- RPh or agent must notify the pt of the lower priced drug - pt. can refuse interchange - RPh MAY include brand name following the generic name but "sub" or "ic" must appear before or after - NDC number or mfg must appear on the label of drug dispensed |
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Term
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Definition
- no need to use ic laws - some generics have trade names - BE CAREFUL |
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Term
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Definition
- pt can return a drug, but it cannot be re-dispensed unless the drug had been dispensed to an institution in unit-dose packaging - devices cannot be returned |
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Term
exceptions to devices not allowed in the return of drugs |
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Definition
- crutches, hospial beds, wheelchairs, DME that can be sanitized |
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Term
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Definition
- durable medical equipment - ex: beds, wheelchairs, etc |
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Term
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Definition
- cannot be left at, picked up from, or accepted by any location that is not licensed as a pharmacy - rxs can be delivered anywhere the pt or pt's agent is located by an employee or a common carrier |
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Term
delivery of rxs by a distributor when the pharmacy is closed |
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Definition
- totally enclosed area shall be used (from floor to ceiling) - the cage must be approved by the BOP - keys assigned by the PIC - all totes must be affixed with numbered seals - all deliveries will have a "chain of custody" |
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Term
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Definition
- date and time of delivery - number of totes - list of seal numbers - signature of delivery person and receiving person - then the cage gets locked |
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Term
order retrieval of a delivery |
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Definition
- must be done by a RPh or designee - RPh or designee must verify number of totes, verify the seal numbers, verify the order has not been tampered with - the RPh (NOT THE DESIGNEE)will sign and date the chain of custody log - records maintained for 2 yrs |
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Term
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Definition
- max of one year - drug schedule laws apply - upon death of prescriber, suspension of prescriber's license, or the close of a practitioner's practice, no more refills will be allowed - notwithstanding the above, the RPh, using good professional judgement, may dispense up to a 90-day supply of the medication |
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Term
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Definition
- failure to fill will interrupt a therapeutic regimen or create pt suffering - 72 hr supply ONLY - RPh must inform practitioner ASAP - RPh must notify the pt that this is the final supply that can be dispensed without a new rx - this provision is for all drugs except IIs |
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Term
what are circumstances that may justify an interim supply |
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Definition
- a natural or man-made disaster has occurred - RPh is unable to contact the practitioner |
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Term
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Definition
- all drugs shall be stored at a temprature which complies with the USP - druge storage area shall be controlled by a RPh and shall not be accessible to unauthorized persons |
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Term
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Definition
- usually pertains to LTc and nursing home facilities for immediate admin - there are no restrictions of noncs - must be sealed with a tamper proof lock and kept in a locked med room, closet, or cart - a RPh shall check the e-kit monthly and document what is left inside the kit |
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Term
what are the max numbers an e-kit can contain |
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Definition
- each kit may contain a max of 8 cs with no more than 8 doses of each - no restriction on noncs |
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Term
who can access the e-kit? |
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Definition
- Rph - DON - nurse on duty - practitioner |
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Term
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Definition
- a record shall be kept for all doses given inside the kit - a RPh shall receive and store such record for 4yrs - when the kit is opened, the RPh shall be notified within 24 hrs - shift counts shall be done until the kit is resealed by a RPh |
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Term
who must approve of the e-kit |
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Definition
- RPh - DON - medical director - BOP authorizes placement |
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Term
in add'n to the e-kit what may be kept in the facilities |
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Definition
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Term
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Definition
- must have "copy" or "for reference only" on it - date copy was given - document that copy given must be on the original copy - RPh receiving copy from pt must call the prescriber for a new rx and call the previous pharmacy to have the original voided - RPh from the original pharmacy must then date and void the original - maintain a transfer log |
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Term
who may dispense to inpts |
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Definition
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Term
under what conditions may clinics and hospitals dispense to outpts |
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Definition
- if they are an employee or a member of the employee's family and living in the same household |
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Term
can a one time fill to a discharged pt be given? |
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Definition
- yes but must keep those records separate |
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|
Term
pt product info for contraceptives, estrogens, and progestin compounds |
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Definition
- must be dispensed with the original rx and for refills upon request |
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Term
what info must be kept confidential in regards to pt records? |
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Definition
- name, address, phone number, DOB or age, gender - rx info for the last 12mnths from the last entry, including drug name, strength, directions, prescriber info, and date received - comments made by the RPh, pt, or prescriber - any allergies, drug rxns, idiosyncrasies, chronic conditions, or disease states - use of otc drugs and medical devices |
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Term
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Definition
- unexpected drug rxn (not documented) |
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Term
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Definition
- must be done for each new rx - rph must check for over/under utilization - therapeutic duplication - drug to disease contraindications - drug to drug interactions - incorrect drug dosage or duration - drug allergies - clinical abuse or misuse - take appropriate steps when one of the above is realized |
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Term
patient counseling (OBRA) |
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Definition
- RPh must offer to counsel to optimize drug therapy - applies to every organization dispensing drugs except inpts where other hc professionals are involved in pt care - pt counseing shall be by the pharmacist and shall be in person whenever possible, or by phone |
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Term
can pt counseling be done over the phone? |
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Definition
- yes, as long as it is done before the first dose |
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Term
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Definition
- name of drug - dosage form, route, and duration - intended use and expected action - precautionis and special instructionis - common side effects and interactions - self-monitoring parameters - storage - refill info - action for a missed dose - misc info |
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Term
alternative forms of counseling |
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Definition
- written info - booklets - pictogram leaflets - videos |
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Term
record keeping of counseling |
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Definition
- really just done on new rxs - RPh should document refusal or acceptance of counseling - however, in the failure to document pts refusal to counseling, it shall be assumed that counseling took place |
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Term
termination of a pharmacy operation |
|
Definition
- LOOK AT SLIDES!!!!!!!!! |
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Term
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Definition
- notify the board 30 days prior to closing the system - provide hard copy print-out for noncs going back 1 year - provide hard copy print-out for controls going back 2 year - make provisions for a nearby pharmacy to have these records available |
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|
Term
access to the pharmacy in a facility setting |
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Definition
- approved by the PIC with P&Ps - licensed nurses in emergency situations may obtain drugs as needed wen they are not available as floor stock - the nurse must leave the MD order and the bulk container or sample of the drug with the order in the pharmacy - nurse needs to document in full (day, dr, pt, etc) |
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Term
drug control in ambulatory pt tx areas |
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Definition
- practitioner may dispense drugs for the immediate use by the pt (72 for nonCII, 48 for cII) - RPh may fill full rx but only for one time use (no refills) - record kept separate for all drugs dispensed - label requirements are same as retail |
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|
Term
general def. of collaborative pharmacy practice |
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Definition
- means the practice of pharmacy whereby one or more pharmacists agree to work with one or more practitioners under written protocol where a pharmacist may perform medication therapy management authorized by a practitioner under specified conditions and limitations |
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|
Term
standards for collaborative practice |
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Definition
- have at least $1,000,000 of professional liability coverage - have a pharmd or 3yr clinical experience in an institution - complete 5 contact hours per year pertaining to collaborative practice (CEU's - didactic) - for injectable drugs, the RPh must complete an ACPE course (i.e. flu shots) - has to be renewed every 2 years |
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Term
things that may be included in protocols developed regarding collaborative practice |
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Definition
- specific drug to be managed - terms that the RPh may implememt, modify or discontinue therapy - when the RPh may contact the practitioner - lab tests - time frame to notify the practitioner of changes - document all changes and monitoring in conjunction with the protocols - must maintain all documents at the pharmacy |
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Term
settings where collaborative practice is allowed |
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Definition
- hospitals - LTC facilities - hospice settings - ambulatory clinics where there is no retail pharmacy connection |
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|
Term
medication therapy management |
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Definition
- means the review of medication therapy regimens of pts by a pharmacist for the purpose of evaluating and modifying the medication regiment in accordance with the collaborative pharmacy practice agreement |
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|
Term
emergency contraceptive collaboratice agreement |
|
Definition
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|
Term
what do informed consent forms include |
|
Definition
- indication for the use of emergency contraception - mechanism of action - appropriate method for taking the medication - possible rxns - circumstances that may req follow-up with a physician - once completed, both the RPh and pt will sign and date the form |
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Term
what does the pt assessment form include |
|
Definition
- pt name and address - pt dob - personal info which reqs the use of emergency contraception - known allergies to medications or drugs |
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Term
|
Definition
- indication of the drug - appropriate method for drug use - need for medical follow up and referral - info on sexual assault and referral info |
|
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Term
|
Definition
- collaborative agreement (or copy) - completed informed consent forms - completed pt. assessment forms - these forms can be obtained from the BOP - these forms shall be kept for 4 years at the dispensing pharmacy |
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|
Term
impaired pharmacist program |
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Definition
- it is a contract bt the bop and the organization that runs the program - every state has one - it can be assoc. w suspension of license - it may include probation with unannounced drug tests - counseling - it is not run by the bop but the organization running the program reports to the bop |
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|
Term
safety closures and containers |
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Definition
- must be on all rx containers - prevents poisoning of kids under 5 - pt can authorize non-safety at time of pick-up or a blanket order - can be written or oral - md cannot have blanket order; it must be written on each rx and can be applied to all refills for the rx only - do not re-use closures due to defects of safety tops after use - can re-use glass vials or bottles if you replace the closure - mfg must comply if intent is that package is to be dispensed in origina container |
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Term
exceptions to safety closures and containers |
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Definition
- nitroglycerin (NTG) - eye drops - creams - ointments |
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Term
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Definition
- pharmacy tech (registered or certified) - NH has no pharm tech to RPh ratio - can only perform tech fxs (cannot counsel or do last check) |
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