MN Pharmacy Law
I just received a prescription for Methadone. Can I dispense it?
Yes, provided it is for ANALGESIC purposes. Federal law does not allow a prescription for methadone to be issued for the purposes of detoxifying or maintaining a narcotic addict.
Are modest meals considered gifts under Minnesota law?
Yes, these are acceptable as long as the total value of all gifts provided to the practitioner does not exceed the $50 annual limit
Can an intern transfer refills
Yes, under supervision of pharmacist
What is the status of carisoprodol? tramadol?
carisoprodol = C4 tramadol = C6
Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?
if non-custodial parent is acting as the patient's agent
What information must be placed on the original copy of the transferred prescription by the receiving pharmacy? (9-10)
- "Transfer" or "COPY" - Original date written - # of refills remaining - Last fill date - Original prescription number - Transferring pharmacy name, address, and phone # - Name of pharmacist/intern - Pharmacy DEA# if transferring a controlled substance
What minimum sets of references, products, or equipment are required in all community pharmacies?
- 1 pharmacotherapy reference - 1 dosage & toxicology reference (at least 1 must be in paper form) - 1 general reference (PDR, USP/NF, Remingtons, etc) - 1 Class A balance or electronic balance of equivalent accuracy - Volumetric measuring devices to measure 1 to 500 mL - Mortars, pestles, spatulas, stir rods, etc to meet needs of the pharmacy - refrigerator specific for drug storage (no food) - sink and accessible toilet
What are the requirements for continuing education for pharmacy technicians?
- 20 hours of CPTE credit during each two year period - 2 year period will end July 31 of odd-numbered years NOTE: if technicians complete a program meant only of pharmacists, the credit will not count towards the Board's requirements
What must be on the label of a UNIT dose package of a legend drug dispensed for a patient in a HOSPITAL? (6)
- Drug name and strength - Manufacturer name and lot# - Expiration date *If packaged by the pharmacy: Beyond use date of 1 year from packaging
My pharmacist license has lapsed. What needs to be done to have it reinstate?
- Must be within 2 years from expiration - Just pay renewal fees, late fees, and show proof of continuing education
Can prescriptions be transferred more than once in Minnesota?
- Non-controlled drugs may be transferred indefinitely provided refill authorizations exist and all transfers are properly recorded - CII drugs may not be transferred - Schedules III-V may only be transferred once (EXCEPTION: For pharmacies that share a real time online electronic database, multiple transfers are acceptable)
What is expected to be looked for during a profile review? (7)
- Over/under usage - Therapeutic duplication - Drug-disease contraindications - Drug-drug interactions - Incorrect dose/duration of therapy - Drug-allergy interactions - Clinical abuse/misuse
What can NOT be changed on a CII prescription? (3)
- Patient Name - Controlled Substance Prescribed (except generic substitution) - Prescriber's Signature NOTE: This also applies to CIII-CV prescriptions as well
How long must I keep prescription records?
- Per Minnesota Law: 2 years - Per FDA: 5 years - Per Medicare: 10 years
When must the Board of Pharmacy be notified of change in any of the following? - Pharmacist-in-charge - Pharmacy address - Closing or sale of pharmacy - Pharmacy phone number - Pharmacist's name/home address - Intern's name/home address - Technician's name/home address
- Pharmacist-in-charge: immediately - Pharmacy address: 60 days prior - Closing or sale of pharmacy: 14 days prior - Pharmacy phone number: immediately (?) - Pharmacist's name/home address: immediately - Intern's name/home address: immediately - Technician's name/home address: within 10 days
What is required on the label of an outpatient prescription? (12)
- Pharmacy name, address, & phone number - Patient name - Prescription number - Name of prescriber - Directions for use - Name of Manufacturer - Date of issue - Generic and/or trade name of drug - Drug Strength - Physical description of product
What information must be recorded by the transferring pharmacy? (5-6)
- Pharmacy name, address, or phone number - Date - Name of pharmacist/intern - Pharmacy DEA# if transferring a controlled substance
What is required on the label of a radiopharmacuetical agent?
- Radiation symbol and "caution: radioactive material" - name/abbreviation of agent - prescription or lot # - Patient name
What are the requirements for a counseling area in a community pharmacy? (5)
- Sound dulling partitions at least 7 feet high and 24 inches deep - Patients must be able to access from outside the dispensing area and step into the counseling area - Consideration must be given to the proximity to other pharmacy activities (cash register, drive-thru, pedestrian traffic, etc.) to ensure the counseling is not overheard by others in the area - Must not contain items for sale - Recommended to have an accessible computer terminal for reviewing the patient profile.
In what situations can CII prescriptions be faxed to the pharmacy? (3)
- from the prescriber, provided the original signed prescription is reviewed prior to dispensing (Fax is NOT considered original hardcopy) - to be compounded for IV, IM, SubQ, intraspinal for home infusion use (Fax IS considered original hardcopy) - for a resident of a LTCF or Hospice (Fax IS considered original hardcopy)
What is the maximum ratio of technicians to pharmacists?
2:1, plus one additional technician if at least one is a Certified Pharmacy Technician 3:1 for the purposes of: IV admixture preparation, unit dose packaging, prepackaging, bulk compounding (IV)
How many members serve on the Board of Pharmacy? How many are public members?
7 total members, 2 of which are public
The DEA recently changed a rule to allow for the issuance of multiple prescriptions authorizing the patient to receive a total of up to how many days supply?
90 days
When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?
According to federal law, when first serviced in the pharmacy. Full notice must be posted conspicuously in the pharmacy
Is OBRA counseling required for Medicaid only or all patients?
All patients
What is a "gift" for purposes of the MN Statute?
Any money, real or personal property, a service, a loan, a forgiveness of debt, or a promise for future employment that is given and received without the giver receiving consideration of equal or greater value in return.
What are the Daily and Monthly psuedoephedrine limits?
Daily = 3.6 g Monthly = 6 g
What must be on the label of a UNIT dose package of a legend drug dispensed for a patient in a LONG TERM CARE FACILITY?
Drug name, strength, manufacturer, BUD, physical description (if greater than 72 hour supply) When dispensed in a card...must provide for continuous ID of contents, name and location of patient, prescriber, RX#, date, directions for use, and pharmacy
May a pharmacist administer drugs? By which route(s)?
First doses, in an emergency. No routes specified. Immunizations? (IM/SubQ)?
Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances?
For dispensing to a patient in a LTCF, signed consent, drugs from first pharmacy delivered to contract pharmacy. Verification of drug name, strength, mfr, lot, exp, original filling and the validity of the prescription order. Record maintained for 2 years. Returned drugs cannot be re-dispensed.
Are cash payments to practitioners that attend educational conferences and programs appropriate under Minnesota law?
If they are merely attendees at the conference, No.
How must the offer to counsel be made?
Initiated by the pharmacist and in-person whenever possible
What types of health care professionals can prescribe legend medications?
MD, DO, Dentist, optometrist, podiatrist, veterinarian, nurse practitioner, clinical nurse specialist, nurse midwife (can NOT prescribe: chiropractor, naturopath, physical therapist, respiratory therapist, pharmacist
What types of health care professionals can prescribe controlled substances?
MD, DO, dentist, podiatrist, optometrist (ONLY C-IV&V), veterinarian, Mid-level practitioners licensed to do so and within their scope of practice (will have their own DEA number)
What are the requirements for storage and accountability for controlled substances in a long term care facility?
May dispense in partial fills up to 60 days from the date the RX was issued. Emergency kits may contain controlled substances, provided they are locked with limited access, not more than 6 single doses of a narcotic analgesic, parenteral formulations preferred, facility and pharmacy keep complete records of the kit, emergency use only, sedatives/stimulants in oral dosage forms not allowed
Are there any special requirements to be a pharmacist-in-charge?
Must be regularly employed at the pharmacy
What are the requirements for immunizations administered by pharmacists?
Must be trained/certified by ACPE or similar program Additional Info: Any vaccine to patients 18 and older. Flu vaccine for 10 and older with physician's standing order
How can a prescriber indicate that substitution is or is not permitted
Must have DAW or "dispense as written" on prescription - may not have DAW as default. If not indicated, substitution is permissible
What documentation is required of the pharmacist when product interchange is performed?
Must have a sign posted in the pharmacy and inform the patient
Are there any special requirements for mail order pharmacies?
Must have a toll-free number that patients can call at least 6 days a week, 40 hours a week, during regular hours of operation for patient-pharmacist communication.
What is required on the label of a parenteral solution dispensed for a patient in a hospital?
Name of solution, lot number, volume of solution, patient name, name and quantity of each additive, infusion/administration rate, storage requirements, identity of pharmacist preparing/certifying, date and time of admin, expiration date, date and time of preparation, ancillary precautionary labels
What information is required on the profile? (8)
Name, address, phone number, birth date/age, medication history, disease states, known allergies, relevant pharmacist comments
Is counseling required on new prescriptions, refills, or both?
New - Yes Refills - If the pharmacist deems necessary
Do the pharmacy hours have to be posted? Where?
No
Is it appropriate to make cash payments to practitioners for participation in so-called "surveys"?
No
May a person be a pharmacist-in-charge for more than one pharmacy?
No (may be waived if pharmacist is serving a hospital on a part-time basis)
Does the Minnesota Statute governing gifts apply to pharmacists?
No - only applies to "practitioners" (anyone who can prescribe a prescription drug)
Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?
No explicit provision is described
Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?
No specific provisions described
Is there a six month/5 refill limit on schedule V drugs?
No, schedule V drugs can be refills, as authorized, up to one year from the date of issue.
Can transfers of refill information be faxed between pharmacies?
Not explicitly allowed or prohibited
Are there any required notices that must be displayed to the public? (3)
Notice of controlled substance reporting Notice of generic substitution Notice of Privacy Policy
Is there a time limit between the date a prescription for a CII drug is issued and the date when it may be filled?
One year limit from the date of issue exists for all prescriptions
Under what conditions, if any, is therapeutic substitution allowed?
Only in a hospital using a formulary system
Are there special requirements to be a nuclear pharmacist? What are they?
PIC: BPS-certified in nuclear pharmacy, or 200 hours from a accredited CoP + 500 hours training under supervision and a submitted affidavit Staff: Competent - completed nuclear pharmacy course or an approved experiential program
Under what circumstances may a pharmacist refuse to fill a lawful prescription?
Patient harm may result Pharmacist would be in violation of the law if filled Product not in stock Suspected forgery or is fictitious Pharmacist cannot be forced to participate in abortion
What must be on the label of a MULTI-dose container dispensed for a patient in a HOSPITAL? (7)
Patient name, drug name, route of administration, strength, auxiliary labels, expiration date, date dispensed
do patients have the option of demanding the brand name when substitution is permitted? How about patients whose prescriptions are paid for by public funds?
Patients may request brand. No restrictions for publicly funded prescriptions
What are the requirements for storage and accountability for controlled substances in a hospital?
Perpetual inventory of CIIs, locked in pharmacy and on station, dispensed persuant to a legitimate drug order, proof-of-us drug audit trail with reconciliation sheets, wasted doses must be witnessed by two nurses or pharmacists, unit of use packages are preferred
What must be on the label of a MULTI-dose container dispensed for a patient in a LONG TERM CARE FACILITY?
Pharmacy name, address, phone number, patient name, Rx#, prescriber, drug name, strength, directions for use, manufacturer, date of issue, name of medication, physical description, quantity dispensed, BUD
What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy?
Pharmacy name, address, telephone number, patient name, RX#, prescriber, directions, name of manufacturer, auxiliary labels, date of issue name of medication date of compounding, BUD, storage requirements, infusion/admin rate/time/frequency, accessory cautionary labels
How does a pharmacist determine whether a particular generic drug is suitable as a substitute for a brand name drug?
Professional judgement/least expensive alternative
What use of the profile is required? Review prior to dispensing new Rx's? Review prior to refills?
Prospective DUR for both new and refilled Rxs
What are the requirements for use of computers to process prescriptions
Prospective review scans past 6 months of prescriptions. Procedures to limit overrides must be used. Order entry must be check by pharmacist 2-72 hours later Must be secure and confidential Must not infringe on patient's freedom to choose pharmacy Must maintain records for 2 years Must be capable of reconstruction with regular back up and file maintenance Must produce an audit trail for drugs and record users
does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How?
Refusal or variation of consult content must be documented on the prescription, in the patient's record, or on a special log book
What must be done if the computer system goes down?
Should be reconstructed and information saved for entry?? Any lost information must be reported to the board within 72 hours
I have received spam emails and/or faxes from a pharmacy claiming to be licensed by the Board of Pharmacy. Can the Board stop these companies?
The Board has no authority to investigate or take action against these operations; it only has authority over those business to whom licenses are issued. Additional Info: - Fraudulent internet or email activity should be reported to the Federal Trade Commission (FTC) - Complaints regarding faxes should be reported to the Federal Communications Commission (FCC)
Can I mail prescription medications containing narcotics or other controlled substances?
Yes
Is a separate patient counseling area required?
Yes
Must every pharmacy have a pharmacist-in-charge?
Yes
Must generic saving be passed on to patients?
Yes, all savings must be passed on to the patient (difference of in acquisition cost of drug dispensed and brand name drug prescribed)
Are textbooks considered gifts under Minnesota law?
Yes, and are okay as long as they do not exceed the $50 annual limit
Can I accept a new prescription via FAX?
Yes, as long as it's coming from the prescriber and NOT the patient
Can I fill a prescription for a schedule II drug written by a mid-level practitioner?
Yes, as long as that mid-level practitioner has a DEA number. Not acceptable to use the DEA number of the delegating licensed practitioner
Can I fill or refill a prescription from an out of state prescriber?
Yes, as long as the prescriber is licensed to practice/prescribe in the state in which it was written.
Can any gifts be given to practitioners?
Yes, but they must not exceed $50 retail value per year
Are patient profiles required for all patients?
Yes, except residents of LTCF or patients who express in writing they do not wish a profile to be kept
Can printed materials satisfy the counseling requirement? Under what circumstances?
Yes, in the case that the new prescription is being delivered/mailed to the patient. However, pharmacist must make a reasonable effort to make in person, or telephone contact.
Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy okay? Can you obscure your address on the copy displayed to the public?
Yes, needs to be displayed and a photocopy is acceptable. No information about obscuring or not obscuring, but license must be "readily visible to public"
Can the store be open but the pharmacy department closed? Under what requirement?
Yes, no access to the pharmacy (continuous, floor to ceiling partition with doors capable of being securely locked to prevent entry when the pharmacy is closed)
Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer?
Computer is okay
What is the maximum ratio of interns to pharmacists?
1:1 If part of an educational experience, 2:1 is acceptable
Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?
Control substances, all legend drugs either daily or able to produce past 2 years Pharmacist on duty must sign controlled substance printout verifying that refill information is correct
How long are prescriptions for legend drugs valid from the date issued?
12 months
Where can I verify a pharmacist's/pharmacy's license?
Board's website under "Online Services"
How long are prescriptions for each of the following valid? CII, CIII, CIV, CV?
CII - 12 months CIII - 6 months CIV - 6 months CV - 12 months
Is there a maximum number of refills allowed for legend drugs? What is it?
CII: no refills CIII/IV: 5 refills within 6 months
