MPJE Review Session Flashcards
describe the membership for the pharmacy commission
-10 pharmacists (licensed in WA for at least 5 years, geographically representative, and representing various areas of practice)
-4 public members, not affiliated with any aspect of pharmacy
-1 pharmacy technician
how long is a term for a pharmacy commission member
4 year terms
what is the practice of pharmacy from RCW 18.64.011
-interpreting prescription orders
-compounding, dispensing, labeling, administering and distributing of drugs and devices
-monitoring of drug therapy and use
-initiating or modifying drug therapy in accordance with written protocols approved for his or her practice by a practitioner authorized to prescribe
-participating in DUR and drug product selection
-proper and safe storage, distribution, record keeping
-providing of info on legend drugs
what is considered monitoring of therapy from WAC 246-945-355
review of drug therapy regimen by a pharmacist for the purpose of evaluating or rendering advice to the prescribing practitioner or patient regarding the patients’ drug therapy
what can a pharmacist edit on a script
- change qty if: prescribed qty or pack size isn’t commercially available, change is relating to dosage form, change is intended to dispense up to the total amount authorized by the prescriber including refills, change extends a maintenance drug for the limited qty necessary to coordinate a patient’s refills in a med sync program
- change dosage form
- complete missing info
- documentation *** must document changes in the patient’s record
what is the required training during the first year of licensure as an rph
suicide prevention training
when do you need to do the CE requirement for heath equity
at least once every 4 years
do techs licensed in WA need to pass a national exam
yes, either the PTCE or ExCPT
how many hours of CE do techs need to perform
20 hours relating to pharmacy practice and directed to technicians
do techs need to do certain CE
yes, 2 hours must be in pharmacy law and 1 hour must be in patient safety
how many days may be included in the checked cassettes of unit-dose checking (tech-check-tech)
48 hours
is there a pharmacist to technician ratio
not anymore as of 9/2019. the ratio is to be determined by the responsible pharmacy manager, and the responsible pharmacy manager will ensure that the number of pharmacy techs on duty can be safely supported by the pharmacist on duty
how many times can you retake a failed exam in WA
up to 3 times within 3 years
who are considered federal pharmacists
indian health service, PHS, armed forces, VA
do WA licensed federal pharmacists who are on active duty or in the PHS pay fees or submit CE
no
what is the requirement for Nuclear pharmacists in WA
- be certified by a specialty certification board or
- complete 200 hours in a structured educational program meeting requirements set in WAC 246-240-075(2), to obtain a written attestation to such successful completion from a preceptor-authorized nuclear pharmacist
how much CE is required to renew a pharmacist license
30 hours every 2 years
what is the DEA form to apply for a new pharmacy and when do you need to have it done by
DEA form 224, 30 days prior to commission meeting
what are the pharmacy owner responsibilities
-place a pharmacist in charge
-pay license fee
-file a statement of ownership and location
-maintain records of prescriptions and dispensing for a min of 2 years
-maintain CSA records for a min of 2 years
if there is a change in responsible pharmacy manager, when should you notify of the change
within 30 days
community/outpatient label requirements
-drug qty
-number of refills
-unless a vet rx “warning: state or federal law prohibits transfer of this drug to any person other than the person for whom it was prescribed”
-name of facility if the “patient” is a facility or entity
-compounds meet USP
-exp date: take into account the nature of drug, container from manufacturer, patient’s container, expected shortage conditions, expected length of therapy
-vet meds: name and species of patient
WA facility standard
-Constructed and equipped for adequate security
-Properly equipped to ensure safe, clean, and sanitary conditions
-Staffed sufficiently to allow appropriate supervision, operate safely, and remain
open during posted hours
-Adequately stocked to maintain at all times a representative assortment of drugs to
meet needs of patients (WAC 246-945-415)
-Designate a RPM by opening and within 30 days of vacancy
-Create P&Ps
-DUR required before dispensing/delivery UNLESS emergency
what schedule of drugs must be kept in a separate file than c3-5 or legend drugs
c2
when does a pharmacy do a self inspection
annually in march
when does the board give the inspection report
within 10 business days
what are non-resident pharmacies
sell or ship drugs to patients in WA
who do non-resident pharmacies need to register with
WA pharmacy commission
what are the requirements for inpatient hospital prescription labeling
-drug name
-strength
-compounded product must meet USP chapter labeling requirements
when can verbal orders be used in hospital and LTC facilities
only in emergencies
when can a patient use their meds brought from home in a hospital
a written policy must be in place, and can only be administered if properly ordered
when can a patient self administer medication in hospital/rehab/LTC
may be done under a policy and approved protocols in a program of self care or rehab and the policy must be developed by hospital RPM and be approved by the admin/medical/nursing staff
when do you do a controlled substance inventory
-every 2 years
-within 30 days of new RPM
-addition of new substance to the schedule
what are the labeling requirements for prepacked meds in extended care facilities (skilled nursing facilities)
-drug name
-strength
-exp date
-manufacturer name
-lot #
-identity of pharmacist/provider responsible for prepacking
what are the labeling requirements for unit dose packaging
-individual storage unit for each patient, clearly labeled with resident name
-individual package must have:
-name of drug
-strength
-lot #
-exp date
-CSA schedule
can a pharmacy repackage and reuse unused drugs returned by a long-term care facility or hospice program to the pharmacy in per-use blister packaging (whether in unit dose or modified unit dose form) *except where prohibited by federal law
yes
what are the labeling requirements for non-prescription drugs
-date of receipt by facility
-patient’s name
-manufacturer or pharmacy label
-doesn’t apply to selected bulk drugs used by the facility
OBRA requirements for LTC facilities
-pharmacist must be involved in care of patient
-development of comprehensive care plan for each resident
-resident’s therapy must be free of unnecessary drugs (duplicate therapy, excessive duration, inadequate monitoring, inadequate indications for use, use of drugs in presence of ADRs)
-comprehensive reviews of psychotropic drugs and plan to reduce in each patient
-drug regimen review by pharmacist every 30 days
where is the list of contents on an emergency kit
on the outside of the kit
what is the process where a pharmacy can outsource for LTC or hospice program residents
-Obtain approval from LTC/hospice
-Provide copy of prescription or chart order to pharmacy providing shared
pharmacy services
-Supplying pharmacy retains copy of prescription, dispensing record, and
notifies outsourcing pharmacy of service & quantity provided
-Only transfers one fill or partial fill to another pharmacy to meet needs of
patient
who is responsible for storage, security, and accountability of LTC supplemental dose kits
Pharmacy and PSC
who determines the contents for LTC supplemental dose kits
PSC
who can stock the ADDD (automatic drug dispensing devices)
pharmacist, intern, or technician (under pharmacist supervision)
who makes the list of emergency meds which are subject to retrieval without prospective pharmacist DUR
determined by PSC or P&T committee
in what situations can a pharmacist NOT perform a prospective DUR
-subsequent dose from previously reviewed order
-prescriber in immediate vicinity and controls drug dispensing process
-system is used for emergency meds (pharmacist retrospective review within 24 hours)
what can a medicare-approved dialysis center or facility operating a medicare-approved home dialysis program may sell/deliver/posses/dispense directly to its home dialysis patients in cases or full shelf package lots if prescribed:
-sterile heparin 1000 u/ml in vials
-sterile KCl 2 mEq/ml for injection
-commercially available dialysate
-sterile sodium chloride 0.9% for injection in containers of not less than 150ml
what usp do nuclear pharmacies follow
usp 825
when should you notify the commission prior to closing a pharmacy (regardless of setting)
at least 30 days prior
what do you put in a commission notice of pharmacy closure
-intended date of closing
-names and addresses of persons who shall have custody of pharmacy’s records
-names and addresses of persons who will acquire any of the legend drugs of CSAs (if known)
within 15 days after closing the pharmacy, what must be supplied to the commission
-The pharmacy license (voided)
-Written confirmation of:
-Proper transfer or destruction of legend drugs, including names and addresses of transferees
-Proper transfer of any CSAs and names and addresses of transferees
-Return of DEA registration and unused forms to DEA
-Destruction of pharmacy labels and prescription blanks
-Removal of all signs and symbols indicating the presence of pharmacy
when you’re closing a pharmacy, what do you tell the patients and how
-direct mail or newspaper ad and posting a sign near the pharmacy
-intended date of closing
-name and address of pharmacy to which prescriptions will be transferred
-instructions on how patients can arrange for transfer of their prescriptions to a pharmacy of their choice, and the last day a transfer may be initiated
how do shopkeepers register to sell otc drugs
register via Master License application system
in what situation does a pharmacy not need to register as a wholesaler
if they sell to another pharmacy or practitioner for an emergency medical reason
pharmacy selling to another pharmacy or provider: what constitutes an emergency
when a patient requires the specific medication, with no alternative therapy,
and the other entity has no way of obtaining the medication from a licensed wholesaler to
meet the need. Additionally, it is not feasible for the patient to travel to the pharmacy with
the stock to get the medication.
drugs may not be introduced into commerce unless
proven safe (1938) and effective (1962) for intended use
from the Wiley Act: what is adulteration
Impurities
Added injurious substances
Failure to meet compendial standards
Stored improperly or in unsanitary conditions
from the Wiley Act: what is misbranding
In 1906, this meant false and fraudulent statements on the label
Now, means any false or misleading statements on the labeling (which
includes label and other statements made about the product by the
manufacturer)
what is the difference between a medguide and a patient package insert
-medguides are required for those drugs that pose the most serious and significant public health concern
-PPI (patient package inserts) are generally no considered by the FDA to carry the same serious and significant public health concerns
what may be included with REMS requirements
Assessments at 18 months, 3 yrs, and 7 yrs post marketing
MedGuide or PPI development
Communication plan to health professionals
Plans:
Limit prescribing to physicians with special training
Limit dispensing to certified providers
Limit administration to certain settings
Limit distribution to patients with documentation of safe-use conditions, such as lab
tests
Monitoring for each patient using the drug Enrollment of each patient in a registry
what changed on package inserts in 2006 when the FDA revised the format
PIs now follow a specified layout, with a “highlights” section which must be the first section of the insert
what are the requirements of a 7 point OTC label
-name of product
-name and address of manufacturer/packager/distributor
-net contents
-active ingredients and quantity of certain other ingredients
-name of any habit-forming drugs
-cautions and warnings
-adequate directions for use
what act requires child-resistant containers on all rx drugs
poison prevention packaging act
do all over the counter meds require child resistant packaging
no
what otc meds require child resistant packing
Aspirin Acetaminophen NSAIDs Iron preparations > 250 mg elemental
iron/pkg Diphenhydramine > 66 mg/pkg Fluoride > 50 mg/pkg Lidocaine, Dibucaine Loperamide Minoxidil
Methacrylic acid Methyl salicylate Ethylene glycol Methyl alcohol Hydrocarbons and solvents NaOH, KOH, H2SO4 Permanent Wave Neutralizers Drugs switched to OTC status after 2001
what legend drugs do not require child resistant packaging
Nitroglycerine SL SL, chewable isosorbide <= 10 mg NaF <= 110 mg/pkg Cholestyramine and colestipol
powder Oral corticosteroids in doses <=105
mg of prednisone equiv. Mebendazole <= 600 mg/pkg
K+ supplements <= 50 mEq/dose EES granules <= 8 g/pkg, tabs <= 16 g Aerosols for inhalation Pancrelipase OCs in memory aid containers;
MPG; other hormones
information required on label of dispensed legend drug (federal law)
-name and address of dispenser
-serial (prescription) number
-date of the prescription or of its filling
-name of the prescriber
-if stated in the prescription, name of the patient
-the directions for use and cautionary statements, if any, contained in such prescription
-side effects statement
what is the side effects statement
call your doctor for medical advice about side effects. you may report side effects to FDA at 1-800-FDA-1088
does the side effects statement need to be included on the label?
no
where can the side effects statement be printed
-on a sticker attached to package (or label)
-on preprinted vial cap
-on separate sheet of paper
-in consumer med info
-in FDA-approved medguide containing the statement
what info is required on label of legend drug
Complete directions for use (“UD” not valid)
Expiration date
Quantity dispensed
Number of refills remaining, if any
Name and strength of drug
Initials of pharmacist (can be in computer system)
“Warning: State or federal law prohibits transfer of this medication to any person
other than the person for whom it is prescribed.”
what are the only controlled substances that a naturopath can prescribe
codeine and testosterone products only