Iowa MPJE Review 2 Flashcards
Mission of the BOP
Protect public health, safety, and welfare by fostering pharmaceutical care
Who makes up the BOP
5 R.Ph. members
2 public members
Tests required for pharmacy licensure in Iowa
NAPLEX and Iowa Edition of MPJE
Must pass the second exam within 1 year of passing the first exam
Score required to pass exams
total scaled score no less than 75 for each exam
CE requirements to be counted toward total
Must be ACPE approved
13h max may be non-ACPE approved if requested before the program date
Program attendance is required (except correspondence)
RPh who is in a health-related grad school is exempt on petition following enrollment
How many CE hours are required for renewal, and by when
30 hours are required every 2 years 15 must be Drug Therapy related 2 must be Pharmacy Law related 2 must be Patient/Medication safety related Rest can be any subject
How long must CE proof be kept in case of audit?
4 years
When does a new graduate need to renew for the first time?
New graduates are exempt for their first renewal cycle, and must start accumulating CE hours for their second renewal
How does a license become inactive?
Failure to comply with CE requirements, board sends renewal card with “Inactive” on it, pharmacist may not practice until active again
What is a pharmacy technician?
person enrolled in tech training program OR employed in a licensed pharmacy under the responsibility of Iowa licensed pharmacist to assist in technical function of pharmacy
what are support personnel?
persons who perform nontechnical duties, including delivery, billing, cashier, clerical work. Not a registered tech, RPh, or intern
Pharmacy Technician Registration
register with BOP within 30 days of accepting employment as pharmacy tech
OR register for college based training program prior to beginning on-site practical
must be working with a licensed health care provider
Who is not required to register with BOP when working as a technician?
Pharmacist-interns
Is certification required for technicians?
Yes! required to become certified within 1 year of employment.
Technicians must notify the BOP of these changes
Change of name
Change of address
Change of employment status
Must notify BOP of these within 10 days
Pharmacy requirements if utilizing technicians
written policy and procedures for training and use of technicians
training must be documented and kept for the duration of employment
policy and procedures must be available for inspections
What is required on a pharmacy technician name tag?
First name at the very least
CPhT
Pharmacy technician registration renewal
Expires on the 2nd last day of the birth month following initial registration
is CE required for pharmacy technicians?
no, but national certification may be required
who is responsible to verify all technicians are registered and current?
the Pharmacy they are employed with is responsible for this
what functions may be delegated to a technician
technical dispensing functions, may only be delegated when pharmacist is on site. RPh must verify accuracy, validity, completeness, appropriateness. No Rx may be dispensed until RPh is present
what are the technical dispensing functions
packaging, manipulative or repetitive tasks
accepting refill authorizations from prescriber
contacting prescribers for refill authority
collecting patient information
inspecting pharmacy drug supplies maintained by ambulance, emergency service, nursing home, etc.
what tasks can a technician NOT perform
final verification (except in instances of tech-check-tech)
drug review
counseling or patient-specific drug info
make decisions that require pharmacist’s professional judgment (interpreting or applying information)
Can technicians accept new Rx from prescribers?
yes, if supervising pharmacist approves, and the tech has received appropriate training
What is a pharmacist intern?
an intern enrolled in college of pharmacy or graduate registered with board to obtain experience for licensing.
Hours required for pharmacist intern to become pharmacist
1500 hours, all of which may be college based. external hours earned are limited while in school (10h/week during school year, 40h/week during breaks may be counted)
How many interns can one preceptor supervise?
up to 2 students at one time
what duties can an intern perform
RPh must be on duty and responsible for intern
Judgmental functions may be delegated, including verification of accuracy, validity, and appropriateness of filled Rx, review and assessment of patient records for drug review, and patient counseling
Tasks a pharmacy support person cannot perform
final verification
DUR or evaluate medication records
counsel patients, make offer of patient counseling on behalf of pharmacist, or accept refusal of counseling
make decisions requiring pharmacist’s judgement
Accept oral refill/new prescription authorization
provide Rx to patient without pharmacist verification
package, Rx’s for sale
affix Rx labels on container
process prescriptions
pre-package drugs
check drug supplies on ambulance, in LTC facility, hospital nursing unit, hospice facility, etc.
reconstitute medications
transfer prescriptions
assist with or witness destruction or controlled substances
perform any functions of pharmacy technician
Tasks a pharmacy support person IS allowed to perform
clerical duties
process wholesale drug orders
file prescriptions
change patient demographic information (not allergies or disease state)
receive refill requests from patients
inventory control duties, including checking for outdates
deliver drugs to patient care areas
in nuclear pharmacy, any nonjudgmental tasks under supervision of nuclear pharmacist
anything not prohibited in rule 657-5.17
what is a general pharmacy
location where a pharmacist provides pharmaceutical services or dispenses pharmaceutical products to patients in accordance with pharmacy laws
what is a pharmacist in charge
one professionally competent, legally qualified pharmacist in each pharmach
what is required in the reference library?
References may be printed or computer-accessed
Must include at minimum, one current reference from each category following:
Iowa Pharmacy Law and Information Manual
A Patient information reference
A reference on drug interactions
a general information reference
a drug equivalency reference
a reference on natural or herbal medicines
the readily accessible telephone number of poison control
additional references as may be necessary to meet needs of patients served
what information is required in a patient record
Name, Address, Age/DOB, Gender, Allergies, Rx drugs for 2 years
Pharmacists’ comment on known drug interactions, idiosyncrasies, chronic conditions/disease states, other drugs, OTC, herbal, etc the patient may be taking
When must a patient be counseled?
on every new Rx and when changes are made
What elements are considered in patient consultation
name and description of drug dosage form, route, duration special instructions common severe side effects how to avoid side effects what to do if side effects occur techniques for self-monitoring drug therapy proper storage refill info action to take if missed dose pharmacist's comments
what is required of a designated counseling area?
Must be an area suitable for counseling, easily accessible to patient and pharmacist, must not allow patient access to drugs, and must be designed for confidentiality
Refusal of consultation
Pharmacist is not required to counsel when patient refuses consultation.
Refusal must be documented by pharmacist, absence of any record of refusal will be presumed to signify that offer was accepted and counseling was provided
Return of drugs and other items
Drugs may be returned and resold if pharmacist determines integrity of prescription has not been compromised
if in unit dose packaging, may be returned and resued if integrity not compromised
Cannot accept for reuse or resale any personal contact items removed from original packaging
Return of controlled substances
Under NO circumstances can pharmacy personnel accept from a patient or patient’s agent accept controlled substances for return, exchange, or resale, except to the same patient
Duties of RPh in charge
systemic program of quality adequate number of personnel necessary equipment and references ensure drug info provided drug monitoring and review dispensing records maintained techs trained disposing of drugs control records controls against theft/diversion operations manual legal operations
In hospital, what happens when pharmacist is absent?
pharmacy must be closed, but can establish who can get drugs (nurses, dr. etc)
Drugs must be locked up
Patient-specific drugs and devices cannot be distributed prior to RPh verification
Drugs stored in a patient care area must be locked unless staffed by health care personnel and med. area visible to staff
hospital emergency supplies
shall be immediately available at each nursing unit or service area
Hospital floor stock
periodically reviewed in multidisciplinary manner, routinely inspected to ensure no outdated or unusable items are present and all items are properly labeled and stored
Ensuring rational drug therapy in hospital
pharmacist and med staff shall develop policies and procedures for DUR, patient profile must be maintained and used, mechanism for reporting adverse drug events, reactions, and med errors must be in place
Hospital emergency prescriptions
only RPh or prescribing MD may dispense drugs to outpatient, if the hospital has 24h pharmacy services.
If no 24h pharmacy services, only ER patients examined may receive outpatient meds, must have a system of control and policy and procedures
Display of RPh license
each pharmacist will display an original license to practice pharmacy, and current license renewal certificate (copy) where visible to public, whenever on duty.
Log of identification codes
must be kept to ID name of each pharmacist, intern, technician, and support person. Must be maintained for minimum 2 years, and contain employee-unique codes and initials of each employee.
Log of temporary pharmacy staff
Must be kept for minimum of 2 years, and include any employee who worked at the pharmacy but are not regularly staffed at the pharmacy (rotation students). Must contain dates and shifts worked.
ID badge for pharmacist
Pharmacist must wear visible ID badge while on duty that identifies them as a pharmacist and includes at least their first name
Refrigeration requirements in pharmacy
must maintain one or more refrigeration units, maintained within compatable range for drug storage, and thermometer shall be maintained in refrigerator to verify the temperature
Sink requirements in pharmacy
pharmacy shall have a sink with hot and cold running water located within the pharmacy department and available to pharmacy personnel. Maintained in a sanitary condition
Secure barrier requirements in pharmacy
Pharmacy shall be closed and secure in absence of pharmacist. Shall be surrounded by physical barrier capable of being securely locked to prevent entry when closed.
Does pharmacy barrier need to be solid?
No, if the openings in the non solid barrier are small enough to prevent removal of items from pharmacy department by any means
“controlled room temperature” range
15-30*C
59-86*F
“Cool” temperature
8-15C
46-59F
may be stored in fridge unless otherwise specified
“Refrigerate” temperature
2-8*C
36-46*F
“Freeze” temperature
- 20 - -10*C
- 4 - 14*F
Product recall requirements
there shall be a system for removing from use, including unit dose, any drugs and devices subject to a product recall
Out of date removal
any drug or device bearing an expiration date shall not be dispensed for use beyond expiration date of drug or device.
Remove from dispensing stock and quarantine until properly disposed of
Pharmacy records
Every inventory or other record required to be maintained shall be maintained and be available for inspection and copying for at least 2 years from the date the record was made, unless longer period specified.
Includes drug supplier invoices and credits
Storage of prescription hard copies
Prescription hard copies >12 month old may be kept in a remote location away from pharmacy department, as long as said location is within the same structure as the pharmacy department.
Pharmacy advertising
all charges must be stated
effective dates for prices shall be stated
no reference to controlled substance
Personnel histories
ask about child/adult abuse, crime conviction, submit to background check, submit to DHS the results of dependent adult abuse record check (if working in-home services)
how long does technician training documentation need to be kept?
for the duration of employment
Delivery of drugs/devices to facilities
maintain written authorization of patient for receipt of medication
prescription delivered directly to patient
kept in safe place until delivered to patient
prescription requirements
date issued
name/address of patient
name, strength, qty of drug/device
name and address of prescriber
if controlled substance, need prescriber’s DEA
signature of prescriber (written or electronic)
Valid Prescriber-patient relationship
Faxed prescription additional requirements
fax number used to transmit prescription
time and date of transmission
name/address/ph/fax of pharmacy to receive prescription
manual signature of prescriber for controlled substance
Electronic prescription additional requirements
manual signature if for controlled substance (must be printed and physically brought to pharmacy)
application for transmission of electronic prescriptions is applicable with laws
provide verbal verification of E-script upon request of pharmacy
Who receives a limited use pharmacy license?
nuclear pharmacy
correctional facility pharmacy
veterinary pharmacy
other limited use pharmacy settings
Application for Pharmacy license must include
RPh in charge’s name, signature, and license number
owner/partner/representative’s signature
names and license numbers of pharmacists
names and registration numbers of of technicians and support persons
average hours worked by each employee
Renewal of pharmacy license
license shall be renewed before Jan 1 each year
fee = $135
Inspection of new pharmacy location
must be done by BOP inspector prior to license issuance, if the site was not a licensed pharmacy immediately prior to proposed opening
when does license need to be renewed before the Jan 1st deadline?
when a pharmacy changes name, location, ownership, or PIC, new application and license fee must be submitted to BOP for approval.
Old license shall be returned to BOP within 10 days of change
when can confidential information be released
pursuant to express written consent or court order
to patient or authorized representative
to prescriber or other licensed practitioner caring for patient
to another pharmacist in best interests of patient
to BOP or others authorized to receive
HIPAA Rights
notice of uses and disclosure of PHI
Patient may demand restrictions on how information is to be used. pharmacy need not serve patient, but if do are bound
In regards to HIPAA, the covered entity must…
give notice of HIPAA requirements and how it will use information
receive written acknowledgment of receipt of notice
post notice of HIPAA
make reasonable efforts to limit PHI to minimum necessary uses and requests
designate privacy office
policy and procedures for compliance
contact person for complaints and information
train all personnel
provide sanctions for violation
when is authorization not needed to release PHI?
payment (third party)
treatment (other caregivers)
health care operations
how long is HIPAA release/authorization kept?
copy of authorization maintained, if requested, for 6 years
What is a business associate?
someone who helps the entity perform function or provide service, and must have access to PHI
Must be written contract agreeing to comply with HIPAA policy and procedures
Pharmacy compounding practices
Does not include reconstitution
Cannot compound any commercially available products unless there is a “significant difference”
Must follow good compounding practices
May not sell the compounded product to other pharmacies
Must be a designated area for compounding
Sterile and nonsterile compounding must be kept separate
Can schedule II be electronically transmitted?
Schedule II can be FAXED if a written Rx is received before dispensing the medication
For hospice patients and nursing home patients, a faxed Schedule II prescription may serve as the hard copy
What should be modified on a pharmacy’s controlled substance registration when it changes?
location, name, ownership, responsible individual
Does a controlled substance continue if the individual becomes deceased?
no, the individual registration terminates upon death
2 ways which schedule CII-V can be stored
either in a securely locked, substantially constructed cabinet, or dispersed throughout the noncontrolled substances in the pharmacy
How must Schedule CI products be stored?
In a securely locked, substantially constructed cabinet.
Report theft or loss to BOP
Immediately if the theft is thought to be a registrant or licensee of the BOP
Report theft or loss to DEA
Immediately upon discovery of theft or loss. Explain circumstances via phone, fax, or written message
Which DEA form is used to report controlled substance theft and how long does the pharmacy have to report this?
DEA form 106 reports theft or loss
Report within 14 calendar days of discovery of theft or loss
How long should theft/loss records be maintained
minimum of 2 years following date report was completed
CII Rx requirements
dated and signed on date issued
RPh verify authenticity
prescriber/patient relationship must be valid
All other aspects of a written prescription must be present, including the prescriber’s DEA#
What can an RPh not change on a CII Prescription?
3 names!!
Patient name
Drug name
Signature of prescriber
Emergency CII Prescriptions
pharmacist may dispense CII emergency supply received by fax or oral Rx from prescriber, as long as qty prescribed is limited to smallest qty necessary to meet patient needs.
Pharmacist to prepare temporary written record of emergency prescription
Pharmacist should receive hard copy within 7 days of the emergency fill
hard copy must say “authorization for emergency dispensing” and date of emergency order
Notify DEA if written hard copy not received in 7 days
CII partial fills - insufficient supply
if insufficient supply on hand, remainder must be filled within 72h.
CII partial fills - LTC or terminally ill patients
record on prescription “terminally ill” or “LTCF patient”
record on prescription the date of partial fill, qty dispensed, and remaining quantity to be dispensed, and dispensing pharmacist
Valid for period not to exceed 60 days from issue date
CII - issuing multiple prescriptions
prescriber may issue multiple prescriptions authorizing no more than 90 day supply of medication.
Refills are prohibited
shall contain written instructions indicating earliest date to fill
do not fill until date cannot be altered
Dispensing CV without prescription
may be done by pharmacist or intern purchaser must be 18y+ limits of how much can be bought in 48h purchaser must show ID must be recorded in a bound record book, containing name and address of purchaser, name and qty of drug, date of purchase, and name/ID of pharmacist/intern
Record keeping
records must be kept for 2 years
CII records must be kept separately
CIII-V may be kept separately or be readily retrievable
dispensing record must include RPh ID
DEA form used to order CII
DEA form 222
Submit copies 1 and 2 to supplier, maintain copy 3 for personal records
Electronic ordering system for CII drugs
CSOS
Inventory records - change of ownership
controlled inventory shall be counted following close of last day of previous ownership and prior to opening of first day of new ownership.
Inventory records - change of PIC
inventory of controlled substances shall be completed whenever there is a change of PIC, following close of last day of previous PIC’s employment and prior to opening with new PIC
Total inventory required to be taken how often?
Yearly in Iowa, every 2 years federally
Follow Iowa
How long must inventory record be kept?
2 years
Which schedules require physical inventory?
CII’s only
All open bottles containing >100 originally
how long after written can a CII prescription be filled?
CII prescriptions expire after 6 months in Iowa
How many refills can be written for CIII-V prescriptions?
only 5 refills allowed in a 6 month period
How much pseudoephedrine can be dispensed to a single person in a day and in 30 days
1 day = 3.6g
30 days = 9 g
