MN State Laws and Regulations Flashcards
Who is considered a “Practitioner” in MN?
MUST BE LICENSED
1- Doctor of Medicine (MD)
2- Doctor of Osteopathic Medicine (DO)
3- Doctor of Dentistry
4- Doctor of Optometry
5- Podiatrist
6- Veterinarian (DVM)
7- Advanced Practice Registered Nurse (APRN)
8- Physician Assistant (PA)
9- Pharmacist (Only if authorized to prescribe self-administered hormonal contraceptives, nicotine replacement meds or opiate antagonists, or HIV preventative meds (effective 1/1/26))
10- Dental Therapist (Only if preforming care under a Collaborative Practice Agreement with a licensed dentist)
What is a Collaborative Practice Agreement?
A written and signed agreement between at least one pharmacist and at least one practitioner for the purpose of defining the patient care activities and actions a pharmacist can take when modifying drug therapy for specific disease states.
Physical Space Requirements for the Pharmacy
Per Chapter 6800.0700
Minimum requirements for the physical pharmacy space:
1- The walls that enclose the pharmacy must go from floor to ceiling and have lockable doors
2- The combined total of the dispensing and drug storage areas of a pharmacy must be AT LEAST 250 square feet unless the pharmacy is a BoP-approved hospital satellite pharmacy.
3- Prescription dispensing counters must be at least 18 inches deep and at least two linear feet for each pharmacy staff member present. The counters may not house any equipment or materials that are not being used for dispensing or compounding.
*Changes to drug orders in response to labs can only be made under a protocol or collaborative practice agreement
The aisle behind the dispensing counter must be at least 36 inches wide and always remain free of obstacles.
Notification needed if there is a wish to change the pharmacy location, security, dimensions, or the formation of a satellite pharmacy
Chapter 6800.0800
Submit appropriate plans and forms at least 60 days in advance
Requirements for Consultation Area in the Pharmacy
Chapter 6800.0700
All community/retail pharmacies must be equipped with a consultation area that can achieve a minimum level of privacy for patients. These counseling areas must be outside of the dispensing area of the pharmacy and accessible while the pharmacy is open.
If a consultation area is formed by partitions, they must:
- At least 7 feet high and 24 inches deep
- Sound-dampening
- Surround the patient on two sides
What References must be in the pharmacy?
Chapter 6800.1050
Most up to date and recent versions in either Electronic or Hardcopy:
1- Laws pertaining to pharmacy
2- Rule of the BOP
3- DEA Regulations
4- Code of Federal Regulations (Title 21, parts 1300-1316)
5- At least 1 appropriate reference from each category
LTC: In addition, Reference on Geriatric Pharmacotherapy and a current copy of the rules for medication handling in LTC facilities from the Minnesota Dept. of Health
*For Pharmacies that perform Sterile Compounding: in addition, a current copy of USP 797, and a current reference pertaining to sterile compounding or IV incompatibilities
REFERENCES:
-Every pharmacy must have at least ONE current reference from each of the categories.
-The pharmacotherapy and general references may be electronic OR hard copy.
-AT LEAST ONE dosage and toxicology reference must be hard copy.
A: Pharmacotherapy References
- Goodman and Gilman’s
- Applied Therapeutics
- Pharmacotherapy
- Conn’s Current Therapy
B: Dosage and Toxicology References
- American Hospital Formulary Service
- Facts and Comparisons
- Drug Information Handbook
C: General References
- Handbook of Non-Prescription Drugs
- Physician’s Desk Reference
- Remington
- USP-NF
- USP-Pharmacists’ Pharmacopeia
- Orange Book
- Merck Manual
Equipment needed in the Pharmacy
1- Class A prescription balance (as defined by USP) or electronic balance of equal or greater accuracy
2- Set of metric weights ranging from 50 mg to 100 g
3- A set of measuring utensils capable of measuring volumes from 1 mL to at least 500 mL
4- As many mortars, pestles, spatulas, funnels, stirring rods, and heating devices necessary to meet pharmacy demand
5- Any additional equipment required to meet the requirements of USP 795
6- A refrigerator that is designated exclusively for drug storage or a segregated section of a general refrigerator used exclusively for drug storage
7- Temperature recording equipment (manual, electromechanical, or electronic)
8- An electronic or paper log of legend drug refrigerator temperatures
9- A sink with hot and cold running water
10- An easily accessible hand-washing lavatory that is stocked with disposable towels
Storage
Chapter 151.211
- All prescription orders must be stored at the site they were dispensed for at least 2 years
- Prescription orders stored in an electronic format may be kept at a secure outside location only if they are readily accessible by the original dispensing pharmacy
- **Electronic prescriptions must be stored in the format in which they were received.
- Written and verbal prescriptions must be stored in the form they were received or transcribed unless stored in an electronic format that has been approved by the BoP
- Original prescriptions and patient records must be stored on-site; if stored outside of the dispensing area of the pharmacy these records must be secured and only accessible to registered or licensed pharmacy staff (6800.3950)
Required Signage
This MUST be conspicuously posted in a font that is easily readable:
“In order to save you money, this pharmacy will substitute whenever possible an FDA-approved, less expensive, generic drug product, which is therapeutically equivalent to and safely interchangeable with the one prescribed by your doctor, unless you object to this substitution”
Automated Counting Machines
Chapter 6800.2600
-Notify BOP 60 days in advance of any automated counting machine use in a pharmacy.
-Staff who works with it must be trained
-Training documents must be maintained and made available to the BOP upon request.
-Only one cassette may be filled at a time.
Documentation: as with Walgreens
Automated Drug Distribution System
Chapter 6800.2600
-Notify BOP 60 days in advance of any automated drug distribution system use in a pharmacy.
- A committee for the hospital must meet annually to write a report that lists the medications that cannot be dispensed by an automated counting machine.
-Example: Pyxis, Omnicell
-The system must be capable of maintaining a record that contains the following:
1) The identity of any person who accesses the machine, along with the date, time, and purpose of the access
2) The name of the patient receiving the drug
3) The name, strength, dosage form, and quantity of any drug that is removed or added to the machine
Computer Usage and Quality Analysis
If computers are used to receive and process prescriptions the following criteria must be met:
1- Prescriptions must be transported securely from the prescriber to the pharmacy in such a way that no outside person can intercept the prescription
2- The electronic system should not impede or dissuade patients from choosing which pharmacy they receive their prescriptions from
3- Electronic information must be securely and confidentially stored
4- The electronic system must be able to provide physical copies of the following reports:
- A daily summary of controlled substance transactions
- A summary of legend drug transactions that can extend back at least 2 years
5- Must have the ability to record the date of each dispensed refill along with a unique identifier that corresponds to the dispensing pharmacist
6- The system must be capable of constructing a refill audit trail for any specific controlled substance and include the following:
- Name of the prescriber
- Name and address of the patient
- Quantity dispensed
- The date of the fill
- Prescription number
- The name OR unique identifier of the dispensing pharmacist
7- Must be able to construct a patient profile capable of containing drugs prescribed for a patient along with the dates and quantities of the prescriptions dispensed
8- There must be a backup system in place to reconstruct the electronic data if an outage, accident, or malfunction occurs
9- The system must be able to prevent unauthorized access and modification of patient information
In the case of a computer malfunction, original prescriptions in written or transcribed form MUST be maintained, even if they have been processed electronically.
QA:
- Double checks: For accuracy and completeness, every pharmacy that utilizes electronic data entry for prescriptions must have a system in place to compare the data entered to the original prescription for accuracy and completeness. This process is to be completed by a pharmacist or pharmacist-intern. The system must be able to document the name of the pharmacist or intern that completes the individual check and the date it was performed.
- This process may NOT be completed within 2 hours of the prescription being certified unless it is completed by a different pharmacist. These “double checks” must be completed within 72 hours of a prescription being certified. (after 2 hours and before 72 hours)
- In the event of any loss of prescription or patient information due to a malfunction or accident, the BoP must be notified within 72 hours.
Can Pharmacy accept returns?
No, it is PROHIBITED when accepting from a patient or patient representative for the purpose of reselling! This includes drugs, prescribed medications, chemicals, poisons, or medical devices
It can be reused if:
Hospital Pharmacy
1- A medication is brought back to an inpatient hospital pharmacy. It was not administered to a patient and has not left the Pyxis. This is because it has not left the span of control of the pharmacy.
LTC
2- A medication is returned to a pharmacy within a LTC facility. The medication is still in its unit dose packaging, has been stored properly in a secured area, in a facility that has 24 hr nursing coverage.
A medication can be returned to the SAME Pharmacy it was dispensed from within an LTC if all of the following criteria are met:
1- The drug was stored securely with appropriate storage conditions per USP
2- The facility has 24/7 on-site licensed nursing coverage
3- Packaging is intact. The drug has not been reconstituted. The drug does not require refrigeration.
4- Drug must be in the original manufacturer stock bottle OR unit-dose packaging.
Should a patient be notified if their medication is not being filled at the location they are picking up?
Activities: DUR, packaging, dispensing, labeling, delivery of completed prescriptions
A pharmacy that utilizes a central pharmacy to perform any of the above functions must notify patients of this fact.
BoP does not specify how this must be achieved.
Who is required to counsel a patient?
The pharmacist or pharmacy intern who is mailing, shipping, delivering or dispensing the medication.
Not the Central Pharmacy.
Pharmacy Technician Registration
MUST be Registered with BOP!
-Renewed annually (December 1st) - this must be posted in the pharmacy where the technician works
- Any changes in name, address or employer must be notified to the BOP within 10 days of change
Requirements:
1) At least 18 years old
2) Possess a high school diploma or GED
3) Specific pharmacy technician training that can be satisfied by one of the following:
- A pharmacy technician training program through an accredited vocational or technical institution
- A pharmacy technician training program offered through an accredited, BoP-approved national organization
- A pharmacy technician training program through the United States armed forces or Public Health Service
- An employer-based training program that consists of at least 240 hours of both theoretical (online module, classroom) and practical (on-the-job) instruction that is completed within one year.
*This training program must have a written technician training manual and a document that certifies a technician has been trained. This certificate must be made available to the technician upon completion of the training program
Technician duties.
The PIC must provide a written procedure for tasks that are to be performed by pharmacy technicians. The procedure must contain:
1) Detailed descriptions of each task a technician is expected to perform
2) The steps that must be taken by the pharmacist to certify the technician’s work
3) The technician’s name, address, and registration number
- One copy of the procedure is given to the technician, and another must be retained in the pharmacy.
- Procedures must be updated every five years or any time a significant change in technician utilization occurs.
Technicians performing tasks that are not documented in the written procedures may be classified as unprofessional conduct by the supervising pharmacist.
Technician Training Documentation
Kept for at least 2 years (Training)
Technician to Pharmacist Ratio
3:1
Technician CE Requirements
20 hours of BOP-approved-CE every 2 years
This is due by July 31st of odd-numbered years
Pharmacy Intern Registration and Requirements
Chapter 6800.5100
-Must register with the BOP
Requirements to be registered (one of the following):
1) Currently enrolled in pharmacy school and actively progressing towards graduation
2) A graduate of a BOP-approved pharmacy school
3) A qualified pharmacist applicant that has their licensing exam scheduled
4) A resident or fellow that is a licensed pharmacist in a state other than MN
What are the required hours for Pharmacist Licensure?
Chapter 6800.5400
Traditional APPE: 280 hours
IPPE: 240 hours
Self Arranged: 280 hours
APPE: 800 hours <– other than traditional
1600 total!
When does a pharmacist need to be licensed in the State of Minnesota?
1) If they are working in a MN licensed pharmacy within MN which provides services within MN
2) If they are working in a MN licensed pharmacy outside MN as part of a central pharmacy that dispenses or certifies medication in MN
3) A pharmacist working outside of MN providing clinical services to patients within MN (MTM, profile review, med rec, etc.)
What is needed to become a licensed Pharmacist in MN?
1) Graduate of an Accreditation Council for Pharmacy Education accredited pharmacy program
2) Possess a social security number
3) Submit the following to the BoP along with the applicable fees:
- Affidavits of internship
- A certified and official copy of the applicant’s birth certificate
- A recent photograph
4) Must pass the NAPLEX and MPJE
You are allowed three attempts to pass. Any additional examination attempts require authorization by the BoP.
5) Completion of a fingerprint-based criminal background (this applies to all pharmacists seeking licensure in Minnesota, including initial licensure, reciprocity, and reinstatement)
6) Completion of at least 1,600 hours of internship (as described in §6800.5400)
Pharmacist Prescribing Protocol for Nicotine Replacement Medication(NRM)
- Products include nicotine gums, inhalers, nasal sprays, lozenges, and patches. Both prescription and over-the-counter products are included.
-Pharmacists can still sell FDA-approved non-prescription NRMs without receiving or writing a prescription. Compounded products are NOT included
General considerations to keep in mind:
- Pharmacists must complete an accredited training program on prescribing NRMs before they are authorized to do so
- Pharmacists who independently prescribe NRMs must keep a written copy of the protocol they use at each location. The protocol must also list the names of all the pharmacists who issue prescriptions for NRMs at the location
- Pharmacists may only prescribe appropriate, FDA-approved NRMs
- A pharmacist may NOT delegate their prescribing powers to any other person, including a pharmacist intern.
- Per 151.101, a registered pharmacist intern may prepare an NRM prescription, but an authorized pharmacist must review, verify, and sign the prescription before it is dispensed to the patient.
- For any NRM that is prescribed and dispensed, a written or electronic prescription must be created. These prescriptions are processed in the same manner as any other prescription, and their records must be maintained for a minimum of two years.
Pharmacist Prescribing Protocol for Self-Administered Hormonal Contraceptives
- A self-administered hormonal contraceptive is an FDA-approved drug product composed of a hormone or a combination of hormones to prevent pregnancy.
- The product must be FDA-approved for self-administration. For example, a pharmacist cannot prescribe an IUD for a patient
General considerations to keep in mind:
1) Pharmacists must complete an accredited training program on prescribing contraceptives before they are authorized to do so
2) Pharmacists who independently prescribe contraceptives must keep a written copy of the protocol they use at each location.
3) The protocol must list the names of all the pharmacists who issue prescriptions for contraceptives at the location
4) Pharmacists may only prescribe contraceptives for contraceptive use only
*For any contraceptive that is prescribed and dispensed, a written or electronic prescription must be created. These prescriptions are processed in the same manner as any other prescription, and their records must be maintained for a minimum of two years.
