Minnesota Rules Flashcards
What must a valid prescription contain?
Date of issue
Name and address of the patient
Name and quanitity of the drug prescribed
Directions for use
Name and address of the practitioner
Telephone number of the practitioner
Practitioner’s manual signature (written or printed prescription only)
Practitioner’s electronic signature (electronic prescription)
What must a valid chart order contain?
Name of the patient
Another patient identifier (birth date, medical record number)
Drug ordered
Any directions concerning strength, dosage, frequency, and route
Manual or electronic signature of the practitioner (can be at a later date in the case of verbal orders)
Definition of “high-alert drug”
Drug that bears a heightened risk of causing significant patient harm when it is used in error
Do out-of-state pharmacies need to be liscensed by the BOP?
“No person or persons shall conduct a pharmacy in or outside of Minnesota that dispenses drugs for MN residents unless liscensed by the Board of Pharmacy” (the MN resident must be receiving the drug in the state of MN)
What must be received by the BOP prior to opening a pharmacy and when?
A new pharmacy license application (including a blueprint showing the size, layout, and security) and a check for the proper fee
At least 60 days prior to the proposed opening date of the pharmacy
When do pharmacy licenses need to be renewed and what happens when they are renewed late?
Each license expires on June 30 and must be renewed annually by filing an application for renewal on or before June 1 of each year
Renewal applications received on or after July 1 are subject to a late filing fee (50% of the renewal fee)
Do pharmacies need to post their liscenses?
Each pharmacy license shall be posted in a conspicuous place in the pharmacy
Pharmacy square footage requirement
250 square feet in the dispensing and drug storage area
Size of prescription dispensing counter requirement
At least 18 inches deep and providing 2 linear feet (must be kept clear and free of all merchandise and other materials no currently in use)
Number of dispensing counters requirement
Must be one dispensing counter for each pharmacist and technician working concurrently on compounding and dispensing
Size of pharmacy aisles requirement
Aisle behind the prescription dispensing counter must be at least 36 inches wide and extend the full length of the counter (must be kept free of obstruction at all times)
Pharmacy wall requirements
Must be surrounded by a continuous partition or wall extending from the floor to the permanent ceiling with doors capable of being securely locked to prevent entery when pharmacy is closed
Patient consultation area requirements
Must allow for reasonable assurance of privacy
If using partitions, they must be sound-dulling and at least 7 feet high and 24 inches deep and there must be a partition on both sides of the patient
Consultation areas cannot contain any item for sale unless requried for counseling
Pharmacy lighting requirements
Must be lighted to a level no less than 75-foot candles measured in the major work areas
How does a pharmacy go about changing location?
Before a liscensed pharmacy changes its location, it must submit a new application for license to the BOP explaining the changes (must be submitted at least 60 days before the proposed change in location)
How does a pharmacy go about changing its physical dimensions?
Before a liscensed pharmacy changes its dimensions, it must submit a new application for license to the BOP explainging the changes (must be submitted at least 60 days before the proposed change in location)
BOP has 30 days to respond and if no response, the changes are assumed to be approved
Counseling requirements for a new prescription
Pharmacist must initiate counseling
Must be in person whenever applicable, may be suplemented with written material
Must include:
Name and description of the drug
Dosage form, dose, route, duration
Intended use and expected action
Special directions and precautions
Common severe side effects or interactions including their avoidance
Techniques for self monitoring
Proper storage
Prescription refill information
Action to be taken in the event of a missed dose
Pharmacist comments relavent to the patient’s drug therapy
Counseling requirements for refills
Pharmacist must counsel if deemed necessary according to the pharmacist’s professional judgement
Must be in person whenever applicable
Requirements for counseling documentation
If there is any material variation from the minimal information required or consultation is not provided, that fact and the circumstances must be noted on the prescription, in the patient’s records, or in a specially developed log
How to counsel when prescription is being mailed or delivered
Provide written information about the drug and the availability of a pharmacist to answer questions (must be a toll-free number for long distance calls)
Can pharmacists charge for counseling services
Yes - nothing in the 6800 rules prhibits this
When must a pharmacy notify the BOP before closing indefinitely
14 days prior to closing
Notice of pharmacy closure requirements
Notice must include the specific date of closure and the name, address, and telephone number of the pharmacy to which prescription files will be transferred
This can be:
A newspaper publication for 1 week prior to the closing date
A direct mailing to patients who have had at least 1 prescription filled at that pharmacy during the previous 6 months prior to closing (must reach patients no later than 1 business day prior to closing)
Distrubtion of the notice to patients who are picking up prescriptions at least 30 days prior to the closing date
Required reference books
Most recent editions of the laws relating to the practice of pharmacy
The rules of the BOP
Current copy of the DEA regulations
Code of federal regulations title 21, parts 1300-1316
Pharmacotherapy referece
Dosage and toxicology reference (at least one must be in hard copy form and appropriate to the majority of the patient base of the pharmacy)
General reference
Current reference materials for sterile products and USP 797 (if coumpounding sterile products)
Goodman and Gilman’s The Pharmaceutical Basis of Therapeutics
pharmacotherapy reference
Applied Therapeutics: The Clinical Use of Drugs
pharmacotherapy reference
Pharmacotherapy: A Pathophysiologic Approach
pharmacotherapy reference
American Hosptial Formulary Service
(Reference)
dosage and toxicology reference
Conn’s Current Therapy
(Reference)
pharmacotherapy reference
Facts and Comparisons
(Reference)
dosage and toxicology reference
Drug Information Handbook
(Reference)
dosage and toxicology reference
Handbook of nonprescription drugs
(Reference)
general reference
Physician’s desk reference
(Reference)
general reference
Remington: the science and practicy of pharmacy
general reference
United states pharmacopeia
general reference
Orange book
general reference
The Merk Manual
general reference
Minimum equipment requirement
One prescription balance (Class A) with accurate metric weights from 50 mg to 100 g or an electronic balance of equal or greater accuracy
Measuring devices capable of accurately measuring 1 mL to 500 mL
Mortars, pestles, spatulas, funnels, sitrring rods, and heating apparatus
Other compounding equipment required by USP 795
Refrigerator used only for drug storage with temperature recording equipment
Sink with hot and cold running water
Toilet with hand-washing lavatory and disposable towels in a reasonably accessible location
When do pharmacist licenses need to be renewed and what happens when they are renewed late?
Licenses expire on March 1 and must be renewed annually by filing an application for renewal on or before February 1
Renewal applications received after March 1 are subject to a late filing fee (50% of the renewal fee)
How much does it cost to renew a pharmacist license
$105
Do pharmacy licenses need to be posted?
Each pharmacist license shall be posted in a conspicuous place in the pharmacy (if practicing in a community pharmacy, this must be visible to the public)
How can a pharmacist with a license on inactive status reactivate their MN license?
If maintaining an active license in another state, inactive individuals can show compliance with the continuing education requirements of that state
If not maintaining an active license in another state, inactive indiciduals must show that continuing education has been completed at a rate of 15 hours per year for each year the license has been on inactive status (to a maximum of 75 hours)
If inactive for longer than 5 years, pharmacist must take and pass the MPJE
Licensure requirements for new graduates (from ACPE accredited schools)
Eligibility application
Affidavits of internship
Copy of official and certified birth certificate
Recent photograph
Certified final transcript
Application fee
NAPLEX and MPJE pass
Licensure requirements for foreign pharmacy graduates
Pass the foreign pharmacy graduate equivalency exam and become certified by the FPGEC, including demonstrating proficiency in English by passing the TOEFL
Obtain 1600 hours of internship after becoming certified by FPGEC
Submit completed application, copy of birth certificate, recent photograph, application fee
Pass the NAPLEX and MPJE
(cannot be a graduate of a four-year pharmacy school)
Do you need a SSN to become a licensed pharmacist?
Yes
Maximum exam failures
After failing 3 times, must petition the board
Deadline for passing the NAPLEX and MPJE
18 months (after which would have to submit a new application)
Licensure eligibility (Before 1/1/1973, between 1/1/1973 to 5/1/2003, and after 5/1/2023)
Before 1973: 2080 hours of practical pharmacy experience
1973 to May 1, 2003: 1500 hours of experience (400 may be acquired)
After May 1 2003: 1600 hours of experience (800 in traditional compounding)
If a pharmacist seeks licensure in MN but does not meet the internship hours requirement what must they have?
Practice as a licensed pharmacist for 40 hr/week for each week of internship hours lacked
When would a pharmacist seeking reciprocity in MN need to take the NAPLEX?
If they haven’t engaged in pharmacy practice as a licensed pharmacist for 2 years immediately prior to the application
Do manufacturers need to be licensed in MN?
Yes, and even if they do not ship drugs into MN directly, they must obtain a license if they do business with any accounts in MN
Do wholesalers need to be licensed in MN?
Yes
When do manufacturer/wholesaler licenses expire?
June 1 of each year (must be renewed by May 1 of each year)
Renewal applications received on or after June 1 are subject to a late filing fee (50% of the renewal fee)
Do manufactuerers/wholesalers need to post their license?
Yes
Which facilities of wholsesalers must comply with licensure requirements?
All facilities at which drugs are stored, warehoused, handles, held, offered, marketed, or displayed
What must wholesalers do with damaged/outdated/adulterated drugs?
Keep them seperate from other drugs until they are destroyed or returned to their supplier
How long must wholesalers keep records of drug receipt and distribution?
2 years
Which procedures are required for wholesalers?
- How to ensure oldest stock of a drug product must be distributed first
- What to do if their is a recall
- Preparation for any crisis affecting security or operation (strike, fire, flood)
- How to ensure outdated drugs are segregated from other drugs (documentation must be maintained for 2 years)
Continuing education requirement for pharmacists
30 hours every 2 years (reported by Sept. 30 of each even-numbered year)
Continuing education requirement for technicians
20 hours every 2 years (reported by July 31 of each odd-numbered year)
Who makes up the continuing education advisory task force?
3 pharmacists designated by the MN state pharmaceutical assocation
3 pharmacists designated by MSHP
2 pharmacists designated by the COP
2 pharmacists designated by the board
What is the maximum number of continuous hours someone can work?
12
Break requirements
30 minutes for every 6 hours worked
Restroom break requirements
Must be allowed adequate time to use the restroom every 4 hours
What can happen during a pharmacist break?
Close the pharmacy or if the pharmacist stays in the building – techs, interns and support staff can continue to perform duties except those that require a pharmacist’s judgement
Medications can be dispensed if they have been certified by a pharmacist (except those that require counseling)
Specific requirements for dispensing medications when the pharmacist is on break
Must be a list of drugs not allowed to be dispensed without the patient receiveing counseling
Patients are told the pharmacist is on break and offered to wait to receive counseling
If patient declines to wait, obtain phone number they can be reached and pharmacist must make a reasonable effort to contact them and provide counseling
Document that counseling was done or why it was not done
How long do counseling logs need to be retained
2 years
Breaks when more than one pharmacist is on duty
Must be staggered so the pharmacy can remain open
Hours and breaks during emergencies
Staff can be required to work more than 12 hours
Break requirements do not apply
Can a pharmacist refuse to fill medications?
Pharmacists cannot refuse to dispense drugs that may reasonably be expected to be dispensed in pharmacies by pharmacists