PharmLaw 5

smoore020390's version from 2015-09-07 14:00


Question Answer
NYS Regulation of Pharmacy Practice Covers Structure, licensing, professional conduct, pharmacies, and Rxs
Statue of regulation of pharmacy practice Education law, articles 130 and 137
Board of regents createsrules (ex unprofessional conduct) and supervises
Dept of Education creates regulations and administers
Does the BOP have rule making authority?NO! Not in NYS
Which agency has the office of professional discipline?DoE- office of professional discipline
Which agency is in charge of licensing and CEs etc?DoE
What does the NYS BOP do?Organize, prepare exames, and render discipline
How does someone become a BOP member? Appointed by regents on recmmendation of commissioner
What agency has "the commissioner"?The DoE
What date will e-scripts be mandatory?March 27, 2016


Question Answer
What powers does the NYS BOP have?No rule making authority. But can assist to regulate practice, regulate and control the sale and distribution of drugs Inspect and investigate alleged violations (rare now). Issue LIMITED PERMITS AND REGISTRATIONS
Who can nominate members of the BOP?Local professional organizations
What are the 3 aspects of the QA program for the profession?Threshold to entry (licensing), CE, professional conduct
What is the NYS definition of pharmacy practice?Administering, Preparing, Compounding, Preserving, Dispensing (on basis of Rxs or other legal authority) and Collaborative Drug Therapy Management
How long is a NYS license good for?Life!
How long is a NYS registration good for?3 years!
When can the part III exam be taken?For interns, after completion of P-3 year and 1000 hrs of internship have been completed and documented
License by Endorsement requirementsLicensed and in good standing in another state for at least 1 year of full time practice during previous 5 years!
When can providers ( a non-pharm owner) dispense and charge pt for Rx med?if properly labeled and not more than 72 hr supply (unless >10mil from pharmacy, an ER, free samples, clinic at college, vet, med emerg, pursuant to protocol, compounded/recon, or allergin extract)
If provider dispenses Rx med and doesn't charge pt for it what is max supply?No supply limit! Also doesn't have to be properly labeled


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What is ratio of Rph to unlicensed persons?2 to 1 (no including cashiers etc)
Do pharmacies have to be registered in NYS?Yes!
How often to pharmacies have to be registered in NYS?Q3years!
What is the supervising Rph?Name must be included on pharmacy registration. Adeq. supervision at least 30hr/week.
What are responsibilities of supervising RPh?Ensure records good, integrity of inventory and proper storage conditions, only licensed Rphs, ensure adequate security, ensure all registrations up to date and provider verbal and written notice regarding laws/regulations
What are physical requirements for a pharmacy in NYS?Must be at least 300 sq ft. with 100 sq ft for dispensing area
What is a limited pharmacy?May wave certain space/equip/facility req of normal pharmacy when used only for inpts/pts in a facility or HD centers. Goal to limit to inpt care.
Who must electronic prescribing software be registered with?BNE!


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When notify change in ownership?Need 6 weeks notice
When need to notify change in officers or principles?Within 30 days
When need to notify of a disaster?Within 48 hours
When need to notify if a change in location?30 days in advance
When need to notify if renovation to pharmacy?Prior to
When need to notify if changing name of pharmacy?ASAP?
When need to notify of temporary closing?Prior to and prior to reopening
When need to notify about pharmacy closing?Prior to
When need to notify about selling drugs at auction?7 days advance notice


What specifies that Rphs have to counsel: Federally OBRA-90 and in NYS in 8 NYCRR 63.6
Question Answer
What paperwork must be given to a patient when get vaccine at pharmacy?VIS, informed consent, instructions re AEs and CIs, a signed receipt, and a medical home notice
In CDTM what can an RPh do?adjust strength, freq, route of med. Can change which med but only if for specific disease state and specified in protocol. Order labs and do routine history and vital sign monitoring. Cannot diagnose or initiate therapy
What must be included in a CDTM protocol?Must address specific disease state, nature and scope of permitted activities, descr. documentation process, must be signed/dated with effective dates
For req to be a CDTM RPh how many hrs is needed to be truly "1 year experience?"1,680 hrs, not less than 15 hrs/week
Req for CDTM RPh if PharmD or MS in clin pharm2 yrs experience with 1 in health facility
Req for CDTM RPh if BS3 years experience in prev 7 years with at least one year in health facility
How long must records of CEs be held?6 years
What is an acceptable format CE?ACPE-approved, sponsor approved by the board, CPR renewal, pharm school classes, or CME dealing with pharmacotherapy
How many hrs of CE per 3 years must be in med error reduction?3 hours


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For all health care professionals, how long must treatment records be maintained for to avoid unprofessional conduct?At least 6 years
Is unauthorized use of a professional title professional misconduct?No! It is a class A misdemeanor
Unauthorized pharmacy practice is aClass E felony
Use of a coded Rx is aMisdemeanor
Inappropriate or missing display of license qualifies as professional misconduct?NO! a misdemeanor!
Refusing to return revoked license is aMisdemeanor!
Pracitce with fraud, outside scope, incompetence, or negligence is aunprofessional conduct!
Refusing entry into the pharmacy is a Misdemeanor!
License by fraud isUnprofessional conduct
False advertising is aMidsemeanor


Question Answer
What are the primary outcomesItalian, chinese, russian, spanish
Can agents of physicians call in oral Rxs or authorize oral refills?YES! Only if not controlled substance!
Can interns use their initials to endorse Rxs?Yes but must have initials of RPh
Can therapeutic alternatives be used?Must be prescriber approved. Should document circumstances of approval when processing Rx
What must be included when endorsing a script?Initials, date, manufacture/distributor. Also qty if different than face amount
What must be included in daily Rx log?Ptient, MD, Rx#, initials/sign
Are returns allowed?No! EXCEPT Nursing home pharmacies/ RHCF vendor
What type of RHCF Rxs are allowed to be returned: Sealed dose packaging ORAL OR PARENTERAL!
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What are the accepted expiration dates for returned sealed dose RHCF Rxs?If mfr. unit dose can return. If it was blister packed can still return if it has date of repackaing, lot# and exp date. It was within 90 days. and Log is maintained if it was packaged prior to receipt of Rx
Can controlled substances be returned from RHCF?No!!!!
What must be recorded in a repackaging log/record?Name, strength, qty, name of manufacturer. Date, number of packages and number of dosage units/pack. Signature of re-packer and supervising RPh. And expiration date (specific0
What is the expiration date for repackaged meds?12 months or 50% of time remaining to expiration, whichever is less


Question Answer
If dispense a brand name instead of generic substitution in case of an emergency must documentThe date, time and nature of emergency on back of Rx
When can you dispense expedited partner therapy?Should have EPT written in body of Rx form above name of med. Only for chlamydia.
Who is required to provide LEP services?Corporate entity with 8 or more pharmacies and mail order (dispenses most of Rx via mail)
Informing pts about LEPSign at each counter where drop off or pick up. 20 pt bold face arial font.
Health literacy label critical elements and reqName, directions (Full sent), drug name and strength in 12 point font that is bold or color
Who can purchase DXM?18 or older with ID