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Various regulations and requirements for pharmacists, pharmacy technicians, and pharmacy operations in the state of new jersey. It covers topics such as prescription labeling, controlled substance handling, pharmacy permit renewals, continuing education, and reporting requirements. Detailed information on the responsibilities of pharmacists-in-charge, the minimum equipment and space requirements for pharmacies, and the procedures for handling oral orders, sterile compounding, and product contamination. It also addresses the specific regulations around nuclear pharmacists and the labeling requirements for controlled substances. Overall, this document serves as a comprehensive guide to the regulatory framework governing pharmacy practice in new jersey.
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In NJ what are the members of the BOP and how many are there? ✔✔11 members that are all citizens
2 public 1 State executive dept member 8 RpH
What the the BOP RpH requirements? ✔✔all must be registered as an RpH in NJ for 5 years or more all must be actively engaged in pharmacy and may continue in pharmacy
at least 1 of them must be employed by a chain drug store who owns or operates at least 7 pharmacy sites
at least 1 of them must be employed by a health care system
at least one who owns a pharmacy practice in the state
How do the members get picked? ✔✔appointed by the governor and the NJPhA may only SUGGEST pharmacists to the governor
How long is a board members term? ✔✔5 years and no board member may serve more than 2 consecutive terms
No more than how many Rph per years term amy expire who sit on the BOP? ✔✔no more than 3 RpH terms may expire per year on the board
What positions does the board appoint via its members each year? ✔✔a new president and VP
--they also have a executive director that MUST be a Rph and shall do adminstrative things
Are the board members compensated? ✔✔yes $150 per day that the member is engaged in performance of the official duties of the board and shall be reimbursed for other expenses
What shall be on the Rx blanks of a CNM? ✔✔-CNM full name, address, tele #, license #, proper academic degree or ID of prof practice -Patients full name, address, and age -date of Rx -name, strength, route, and quantity -words in addition to #s to indicate the drug quantity if prescribing a CII drug -# refills or time limit for refills or both -prescrbier handwritten siignature -every blank should have "sub permissable" and "do no sub" with a space for the CNMs initials next to the option chosen, and a signature line -DEA # if control of the prescribing practitioner -adequate instructions (prn or "if needed" alone IS APPROPRIATE) -unclear in regulations but should also have collaborating doc and DEA # if for a control -no more than 1 CS on each RX, but can have one CS and one non-control on a single script -blanks must be consecutively #d
Who can a PA issue Rx to? ✔✔-in-patient AND outpatient settings
When may a PA authorize controlled Rxs? ✔✔-when a supervising doc authorizes a PA to order or prescribe a CII-V --to continue or re-issue an order or RX for a control issued by the supervising doc --to otherwise adjust the dose of an order or Rx for a control originally ordered or prescribed by the supervising doc provided there is prior consultation --initiate an order or Rx for a control for a pt provided there is consultation with the supervising doc if tht doc didnt write it --initiate an order or Rx for a control as part of a treatment pan for a pt with a terminal illness which means a med condition that teh supervising doc has said gives them 12 months or less to lvie
-the PA is registered with and obtained authorization to order or prescribe controls from the state and federal agencies -the PA complies with all board requirements regarding administration and educational programs for CE --write on NJPBs and 1 control per Rx blank
What shall be on all NJPB for a PA? ✔✔-PAs full name, professinoal ID (PA-C), license #, address, tele # PRINTED OR STAMPED -the supervisign docs full name (PRINTED OR STAMPED)& DEA # if a control
What must be on a Rx from a optometrist? ✔✔-consecutively # NJPB
-prescribers full name, address, tele #, LICENSE # WITH THE PREFIX TO, and academic degree -patients full name (address not noted but should be present) -date of rx -handwritten signature of doc -OPTOMETRISTS CERTIFICATION # -name, strength, quant of drug -adequate instructions..stated above -# refills premitted or time limit for refills or both every blank should have "sub permissable" and "do no sub" with a space for the CNMs initials next to the option chosen, and a signature line --ADEQUATE INSTRUCTIONS NEEDED---PRN AND IF NEEDED IS NOT APPRORPIATE AS ADEQUATE INSTRUCTIONS -# of refills or time
Who may advanced practice nurses (APNs) order meds and devices for? ✔✔-inpatient setting
What are the requirements for an APN to write orders? ✔✔-address in the joint protocols developed with a collaborating doc whether prior consult with the collaborating doc is required to initiate an order for a CONTROL -order written to standing orders or joint protocol developed with the collaborating doc -**THE APN AUTHORIZES THE ORDER BY SIGNING HIS OWN NAME, PRINTING THE NAME & CERTIFICATION #, AND PRINTING THE COLLABORATING DOS NAME -the collaborating doc must be readily available through electronic communication -charts/records are reviewed by the collaborating doc w/in time period specified by the rule -join protocols reviewed, signed, updated annually by both parties -APN TO COMPLETE 6 CONTACT HOURS OF CE IN PHARAMCOLOGY RELATED TO CONTROLS INCLUDING PHARMACOLOGY THERAPY AND ADDICTION PREVENTION AND MANAGEMENT IN ACCORDANCE WITH REGULATIONS ADOPTED BY NJ BOARD OF NURSING
All RX from an ARN except for licensed acute care facility must contain what? ✔✔-APN full name, designation APN, address, tele #, certification # and if a control their DEA # -patients full name, address, age -handwritten sig of APN -FULL NAME AND TITLE OF THE COLLABORATING DOC WITH ADDRESS AND TELE #
What are pharmaceutical services defined as? ✔✔-interpreting rx or med order
-selecting, preparing, compounding, packaging, labeling, distributing, and dispensing -proper and safe storage of drug -monitoring of drug therapy -reporting and recording ADRs -provision of appropriate drug information -teaching nd counseling on the proper and safe use of drugs
How long do you have to pay a penalty? ✔✔w/in 15 days of receiving the penalty letter or final order
What is a pharmacy extern? ✔✔-in 5th or 6th year of college or 3rd or 4th professional year accredited who is assigned an approved training site for purpose of acquiring accredited practical experience and under the supervision of school in which enrolled
What is a pharmacy intern? ✔✔GRADUATE EMPLOYED at an approved training pharamcy for the purpose of acquiring accredited experience and has registered with the board who has graduated from an accredited schol and making an application > 2 years following grad, graduated a foreign country from non ACPE schools, or applied to the board for reciprocal
licensure and has not been engaged in ppharmacy practice for at least 1500 hrs w/in the preceeding 2 year period before license application
How often is license renewal? ✔✔biennially
What happens if you don't get your renewal in on time? ✔✔you must renew your license before the expiration date--there is no period of leiniency --if you submit your renewal within 30days AFTER your licensed expired, then you must submit a renewal fee and a late fee
-IF YOU DO NOT RENEW ON TIME OR AFTER 30DAYS YOUR LICENSE EXPIRED, then your license is automatically considered suspended w/o a hearing and be deemed an adminsitrative suspension &if you continue to practice pharmacy with this suspended license you will be penalized since you are considered unauthorized to practice pharmacy
***the board will notify all Rph 60days prior to the expiration of their license and if no notification is sent then the Rph will not have to pay any monetary fees (late fees) if their renewal is late
refer to page 62 to look at what to do if your license was inactive
Can any credit be carried over into the next renewal? ✔✔-10 credits may be carried over into the next biennial renewal period only if these credits were earned during the last 6 months of the preceeeding biennial period and were not previously reported
How long is 1 credit hour technically? ✔✔50 min or longer
If the CE goes longer than 1 hour but not another full 50 min what does that constitute in credit? ✔✔can be given a half credit if the CE already went for 50min or 1 full hr and then another partial hour then can count that as a half credit along with the one full credit
How often must pharmacy permits be renewed? Who renews them? ✔✔pharmacy permits for places that practice pharmacy must be renewed annually by the BOP
At each practice site there must be a ______? Who is responsible for any violations in any law or regulation pertaining to the practice of pharmacy? ✔✔-every site must have a pharmacist-in- charge -both the pharmacist-in-charge and the owner are responsible for any violations in pharmacy law
If an Out-of-State pharmacy is approved by the board they MUST supply what to their patients and where must it be available? ✔✔-out of state pharmacies must have available for no less than 6 days a week and for a minimum of 40hrs/week a toll-free tele # service to facilitate communication between patients in this state and a pharamcist at a pharamcy who has access to the patients records
--this toll free # shall be disclosed on a label affixed to each container of drugs dispensed to pts in that state in which the out of state pharmacy is
What shall be reported to the board? ✔✔-closing of a pharm -change of ownership, location, interior site design, permit classification or Pharm in charge -any significant theft or loss of legend drugs or services -disasters, accidents, any theft, destruction or loss of records required to be maintained by the State or federal law -any pharmacy malpractice liability insurance claim settlement, judgement or arbitration award in excess of $10,000 to which an owner, an employee of, or the pharmacy practice site itself is a party -any and all other matters and occurences as the board may reuire by rule or regulation
How early shall they remove signs from the pharmacy? ✔✔-the NJ BOP, the Office of Drug Control and the DEA 15 days prior to the closing date
--30 days prior to closing
If the pharmacy closes, the person closing it has to notify patrons they may get their valid prescriptions for 1 year after closing by ALL of what methods? ✔✔-notify the BOP in writing
-publication of the patients right to those rxs once a week for two consecutive weeks in a local newspaper -sign in pharmacy with those details displayed and written
If there is a theft or diversion of prescription legend drugs or devices or controlled substances, or a significant loss of all of the previous, it must be reported to who? ✔✔-the pharmacist in charge
-the PIC shuold notify teh holder of the pharmacy or pharm dept permit of such report
-the above two shall write a report to the Board, the DEA if controls are involved, AND A COPY KEPT WITH THE OFFICE OF DRUG CONOTROLQ
Can orders of Rx drugs be accepted/delivered when the pharmacy or dept is closed? ✔✔NO
--UNLESS adequate security for the storage of such shipments has been provided ..I.E teh drop- off is utilized for Rxs if it is one-way, irretrievable and secure design
What are the 4 components of centralized prescription handling? ✔✔intake
processing fulfillment dispensing
In regards to an audit trail for records and documents of identifiers of all functions performed for Rx, this audit trail should be kept for how many years? how readily retrievable should it be? ✔✔--audit trails should be kept for 5 years from the date the Rx is filled or refilled
-the oldest 4 years should be readily retrievable in 2 weeks and the most recent year shall be immediately retrievable w/i one business day
What information is considered to be the very least to be acceptable on a Rx label from central fill pharmacies? ✔✔-brand name or generic " ----" or generic for "---"
-strength of med
What should be in larger print, different color, or in bold type on the rx label? ✔✔-the patient name -the brand or generic name of med
On a central fill rx label, what should be provided for the patient if they have questions? ✔✔indicate which pharmacy to call if they have questions and it shall be in bold print, easily readable and shall have the hours that a pharmacist is available and a tele # where a Rph may be reached -the call is at no cost to the pt primary pt population
If a practitioner has a prescription blank stolen, how long do they have to report it and whom do they report it to? ✔✔The practitioner shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 72 hours after being made aware that any New Jersey Prescription Blank in the practitioner's possession has been stolen.
Upon receipt of notification, the Office of Drug Control shall take appropriate action, including notification to the Department of Human Services and the Attorney General.
How many times may a C5 OTC med be dispensed without a Rx in a 12 month period before a pharmacist needs to contact the prescriber in order to get verbal or written confirmation the pt continuously needs that medication. ✔✔If any Schedule V OTC substance is dispensed to one individual more than FIVE times within any 12-month period, the pharmacist shall obtain oral or written confirmation from the purchaser's physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book.
A prescription needs what on it or it cannot be filled in NJ by a pharmacist? ✔✔needs the practitioners license # or the unique provider number assigned to a health care facility
Can the practitioners license number or unique provider number assigned to the health care facility be handwritten or electronic? ✔✔this number may utilize an electronic health record program to imprint the practitioners name and licesnse number or the unique provider number onto the rx blank
May prescriptions for controls be telephoned in or sent by electronic means? ✔✔yes, as long as the provider gives the pharmacist their license number and DEA number
-CIIs CANNOT be sent electronically and must be given in writing and signed handwritten by the prescriber