Law 7

vitohuxo's version from 2016-05-22 17:51


Question Answer
pharmacy director must be a pharmacist?yes
medsoutside pharmacy in hopsital must belocked.
all areas drugs stored hospital must be inspected at least every6 months
if pharmacy not 24/7 thenon call pharmacist if pharmacy not 24/7
P&T committee meet everyminimum quarterly
Night Boxif pharmacy not 24/7. locked...outside pharmacy...designate doctors who can remove the meds. written orders. o Drug label: name, strength, expiration date, lot number
night box review orders within48 hrs
autit night box at leastonce every 30 days
night box list meds reviewed at leastonce a year
exceptions where can take back drugs to pharmacy after dispensederror, recall, jail (only non-controls..unit dose), cancer drug repository program (non-controls...unit dose), program for utilization of unused prescriptions, disposal CS from ulimate users (expensive)
cannot return teh following from a jailCS, dispensed as part of customized patient med packaging, not dispensed as unit dose packaging, not proprerly labeled with identity, strength, lot number, exp date, drugs in possession of patient
Cancer Drug Repository Program• Eligible cancer drug meet the following requirements: o Cancer drug repository donor form (available on state website) o Where donor states donated drug has been properly stored and has never been opened, used, tampered with, adulterated, or misbranded o Donor or representative has to sign o 18 years of age to donate the drug o Drug expiration is at least 6 months out from donation date o Drug is in original, unopened, tamper-evident unit dose packaging o Packaging includes the drug's lot number and expiration date o Drug is not adulterated or misbranded
Cancer Drug Repository Program- who dispenses the drugs donatedDonated drugs have to be dispensed by prescription
cancer drug repository program keep records for how many years?5 years
Program For Utilization Of Unused Prescription Drugs• Drugs transferred from eligible facility or manufacturer to a pharmacy or a charitable clinic o Only prescription drugs in their original sealed, tamper-evident, and unopened unit dose packaging may be accepted
Program For Utilization Of Unused Prescription Drugs- cannot accept Expired prescription drugs.  Controlled substances  Drugs that have been held outside of a health professional's control where sanitation and security cannot be assured
Disposal of Controlled Substances Collection Receptacle and Mail Back Packages• Voluntary for pharmacies • Modify DEA registration • May not accept schedule one drugs
Hospice to have policies and procedures for box inspectweekly, maintain drug box exchange log
hospice box must havedrug list inside front cover, numbered, access limited to RN or PA, returned if opened and rx to accompany box
Pharmacy Drug Box Exchange Log for hospice to include:• Box number • Hospice to which the box is released • Date the box is released. • Name and signature of the pharmacist releasing the box • Box expiration date • Date the box returned to the pharmacy • Name and signature of the pharmacist who received the returned box
• A pharmacy shall not own, control, or operate an automatic dispensing device in a prescribers office
• Automated device used for the furnishing of medications for administration to registered patients in any hospital, county medical care facility, nursing home, hospice, or any other skilled nursing facility, shall be supplied and controlled by a pharmacy that is licensed and located in this state.
automated devices records for5 years
• Policy and procedures for the use of the automated device shall include a requirement for RPh review of the prescription or order before system profiling or removal of any medication from the system for immediate patient administration
situation where nurse acess drug automated device without pharmacist reviewingo Used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R 338.486(4)(i). o Used in place of an emergency kit as provided in R 338.486(4)(c) o Used to remove medication required to treat the emergent needs of a patient as provided in R 338.486(4)(c)  Sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order
controlled substances in automated device and not located same address as pharmacy then needadditonal controlled substance license and DEA registration (nursing home)
emergency kits with CS DEA allows pharmacies to place in LTCFs "emergency kits'' with commonly dispensed controlled substances • Kits are extensions of the pharmacy • Controlled under the pharmacy's DEA registration • Same requirement applies for a valid prescription delivered to the pharmacy prior to dispensing applies with respect to these kits • Michigan is silent on this
PIC (pharmacist in charge) must work how many hours at least ?8 hrs at that store.
change in PIC notify board within30 days
consumer information notice• At each counter over which RX drugs are dispensed • Not required to be posted if only dispenses drugs for inpatient use at health care facility
written rx can have how many on blank?up to four
computer generated form can have how many on blankup to 6 drug orders
medicaid tamper resistantwhen medicaid pays for part or 100% of script. paper form only. • Must contain 3 characteristics of one or more industry recognized features to: o Prevent unauthorized copying of completed or blank prescription o Prevent the erasure or modification of information written on the prescription by the prescriber o Prevent the use of counterfeit prescription forms
Receipt for the drug must contain following unless already on labelBrand name of the drug dispensed, if applicable • If no brand name-name of the manufacturer or supplier of the drug • Strength of the drug, if significant • Quantity dispensed, if applicable • Name and address of the pharmacy • Serial number of the prescription • Date the prescription was most recently dispensed • Name of the prescriber • Name of the patient • Price for which the drug was sold to the purchaser • Information required in 338.479a on prescription label or on combination label and receipt • Inclusion of the information required on the written RX form or ADP system and keeping RX is retaining a copy of the receipt • Physical presence of the RX form in the pharmacy is complying with requirement of having the name and address of the pharmacy on the form
expiration statement• “Discard this medication 1 year after the date it is dispensed” on label • Earlier date of expiration than 1 year than the actual expiration date-strike statement and add earlier date
transfer cuation on label• “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” • Only required for schedules II, III, and IV
instituational labeling rule• Drug name and strength on container or on unit dose • Patient name/identifying number on container, container can be patient’s medication drawer • Directions for use on container or otherwise communicated i.e. Medication Administration Record (MAR)
new (original presription) paper must be• Numbered • Dated • Initialed or electronically initialed by dispensing RPh • If generic selection – manufacturer or supplier on the RX
new (original) electronic prescription must be• Numbered • Dated • Dispensing RPh’s designation • If generic selection – manufacturer or supplier connected to the RX • Time and date of transmission • Identity of pharmacy intended to receive it
manual refill system• Amount & date dispensed shall be entered on the RX and dispensing RPH shall initial the entry • If RPh only initials & dates the RX then the full face amount of RX shall be deemed dispensed • If generic selection - name of the manufacturer or supplier of the drug dispensed shall be indicated on the prescription
ADP System Electronic Records Rule refills• Identifying designation for the dispensing RPh for original and each refill,
records onsite how long ADP system electronic records5 years.
____ months of data instant access on site and immediately available ADP electronic system16 months
older than 16 months available in ___ hours ADP electronic system72 hours
What if the ADP system is not operating• Ensure refills are authorized • Within 48 hours enter any refills done`
Note Michigan does not require at present time that Physician Assistants, Nurse Practitioners or Nurse Midwifes obtain a controlled substance license even though they can prescribe controlled substances under delegation
how to determine if dEA number validdd together the 1st, 3rd and 5th digits. 2. Add together the 2nd, 4th and 6th digits. Double it. 3. Add the two totals together. 4. The second digit in that total is the check digit.
prescriber DEA begin with...A, B, F, G or M (m for mid level prescribers)
Schedule I• High abuse potential • No accepted medical use in the United States • MI Schedule 1-same • MI plus lacks accepted safety for use in treatment under medical supervision • Heroin, crack cocaine, GHB, methaqualone, marihuana
Schedule II • High abuse potential with severe psychological or physical dependence liability • Have an accepted medical use in the United States • MI Schedule II-same as feds • Drugs: morphine, oxycodone, fentanyl, amphetamine, methylphenidate, meperidine, hydrocodone with APAP
Schedule IIIo accepted medical use in treatment in the United States o abuse of the substance may lead to moderate or low physical dependence or high psychological dependence. • Drugs:, Codeine with APAP, ketamine, pentazocine (MI), GHB, anabolic steroids
Schedule IV o accepted medical use in treatment in the United States o abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances in schedule 3 • Drugs: diazepam, zolpidem, alprazolam, butorphanol, carisoprodol
• MI Schedule Vo accepted medical use in treatment in the United States o limited physical dependence or psychological dependence liability relative to the controlled substances listed in schedule 4 o or the incidence of abuse is such that the substance should be dispensed by a practitioner • Drugs: Lomotil, Robitussin AC, APAP elixir with codeine, pregabalin
Centralized prescription processingCentralized prescription processing” means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, performing drug utilization review, completing claims adjudication, obtaining refill authorizations, initiating therapeutic interventions, and other functions related to the practice of pharmacy. Section MCL 333.17753
centril fill requirementsrecords 5 years, • Pharmacy whose stock is used to fill the controlled substance RX reports to Michigan Automated Prescription Program
central fill and controlled substancesCentral Fill and Controlled Substance (CS) RXs • Can do II, III, IV or V prescriptions • Maintain records for 5 years • Can transmit electronic or by fax • Comply with all other requirements for a CS Prescription
mercury thermometers• Requires a RX for mercury fever thermometer for a patient
Controlled Substance Orders for Inpatients requirements• Patient's name • Prescriber's name, address, and (DEA) number In place of including the address and DEA number on each medication order, the pharmacy may maintain a separate list of authorized prescribers, that includes the prescriber's name, address, and DEA number • Prescriber's signature • Drug name, dose, and administration frequency • Date
CS inpatetient recordkeeping requirment• Preserve orders (patient chart) for 5 years
Hospital CS Records to Include • Number of doses of CS purchased • Number of doses dispensed to individual patients or distributed to nursing stations or both • Number of doses administered • Number of doses dispensed, but not administered, to the patient • Annual physical inventory and status of any discrepancies between the inventory and the records of acquisition and dispensing records
hospital Records for CS Not Dispensed to Individuals• Paper record or Computer record • Distribution records • Proof of use record • Automated device excluded
Controlled Substance Advisory Commission • 13 members-appointed by the governor • Meet at least once each 3 months • Monitor indicators of controlled substance abuse & diversion • Make recommendations • Annual report-on current status of Abuse and Diversion • Has no authority
Scientific Advisory Commission • 7 members • Consultative and advisory body • Scheduling of controlled substances • In practice does not exist
Manufacturer/wholesaler has to be licensed by Michigan to do business in Michigan
• Nicotine OTC replacement products • Pseudoephedrine/ephedrine OTC • Schedule V exempt ages?18 years
• Levonorgestrel products (e.g. Plan B One Step, My Way, Next Choice One Dose, etc. age?none
which insulin otc?regular and NPH
Pilot Projects• Michigan Board of Pharmacy may approve up to 10 pilot projects designed to provide better pharmacy products or more efficient pharmacy services• 18 month period for pilot with a potential for one renewal.
Animal Euthanasia and Sedation RulesGenerally do not involve pharmacy but if selling drugs to animal shelter or class b dealer need to know if they have • Has controlled substance license from Board • DEA registration Limited drugs sodium pentobarbital and maybe animal tranquilizers