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MINNESOTA MPJE
What items need to be on an Rx label? (11)
- Pharmacy name/address/telephone
- Patient's name
- Rx number
- Name of prescribing practitioner
- Directions
- Name of manufacturer/distributor
- Auxiliary labels prn
- Date of original issue/renewal
- Generic/trade name and strength
- Central pharmacy information (if applicable)
- Physical description What items need to be on an outpatient IV admixture, in addition to the items mentioned in the Rx label? (5+)
- Date of compounding
- Date
- Identification of drug (name, dose, manufacturer, lot #, expiration date)
- Container specification
- Copy of label
- Unique identifier of the packager
- Unique identifier of supervising RPh
- Internal control number or date What items need to be on a prepackage label when given to the patient? (7+)
- Name of drug
- Strength
- Name of manufacturer/distributor
- Beyond-use date
- Internal control number date
- Physical description
- Radiopharmaceuticals must follow those rules What items need to be on unit dose packaging? (6+)
- Name of drug
- Dosage form
- Strength
- Manufacturer's name
- Lot number
- Expiration date ((Must comply with prepackaging label rules when given to a patient)) When do pharmacy technician licenses expire each year? December 31st Must file for renewal before December 1st How soon must a technician notify the board of a change of address, name, or place of employment? 10 days How old does a registered technician have to be? What level of education? 18 years old High school diploma or equivalent How many hours must a technician be trained for over a 1-year period? 240 hours How long must the PIC keep documentation of tech training?
After transfer of ownership, how long can the new owner operate the pharmacy until they receive a new license? 14 days (whichever is earlier) Minimum square feet required to be considered a pharmacy? 250 ft How big must the counter be? 18" deep by 24" long How wide is the aisle behind the Rx dispensing counter? 36" Community pharmacy consultation area requirements 7' high 24" deep Dull-sounding partitions
Date limit for location change? 60 days Date limit for dimension or security change? How soon until approved? 60 days If not informed within 30 days by the board, consider it approved Date limit for establishment of a satellite? How soon until approved? 60 days If not informed within 30 days, consider it approved How is the offer to counsel made? a. Counseling is not just offered, it MUST be completed for ALL NEW RX's b. Counseling may be given on refills, per the RPh's judgement c. Interns may counsel without direct supervision What 10 items must an RPh cover when counseling a patient?
- Name/description of drug
- Dosage form, route, dose, duration
- Intended use and expected action
- General reference Pharmacotherapy reference examples (Goodman/Gilman's, Applied Therapeutics, Pharmacotherapy: A Physiologic Approach, Conn's Current Therapy Dosage and toxicity reference examples American Hospital Formulary Service, Facts and Comparisons, Drug Information Handbook General reference examples Handbook of Non-Rx Drugs, Physician's Desk Reference, Remington, US Pharmacopeia, Orange Book, Merck Manual How many dosage/toxicity references must be in hard copy form? One What must a MN long term care pharmacy have on file? Most recent edition of the MN Department of Health rules on medication handling AND General reference on geriatric pharmacy
What 7 items must a pharmacy have for equipment?
- Rx balance (50 mg - 100 g or electronic)
- Measuring devices for volumes 1 mL to 500 mLs (at least)
- Mortar, pestle, spatula, funnel, stirring rod, heating apparatus
- Comply with US 795
- Refrigerator only for drug storage with daily temp logs
- Sink with hot and cold water
- Toilet with hand-washing and disposable towels Required resources for preparing sterile products US 797 compliance US 797 copy available Current reference on sterile products or IV incompatabilities When does a PHARMACIST license expire? March 1st each year Must file for renewal by February 1st $ How long is an application to become a pharmacist valid? 18 months
June 1st Must file for renewal by May 1st How soon must the board be notified of any change in a wholesalers information? 30 days How long must record keeping be kept for wholesalers? 2 years How many hours of CE must a pharmacist have in a 2-year period? 30 hours When is CE reported? By September 30th of each even-numbered year How many technician CE hours is required in a 2-year period? 20 hours
When is technician CE reported? By July 31st of each odd-numbered year How long should a CE provider maintain records of hours given? 3 years By what time frame should approval for CE presentation credit be submitted to the board? 45 days How long does the board have to grant approval or denial of a CE course? 60 days (so you better get it in before 45 days...) How much time do you have to submit hours after you attend a CE course? 90 days after the date of the course How many members are in the CE Advisory Task Force? No more than 10 members: a. 3 from MN State Pharmaceutical Assoc. b. 3 from MSHP
- DI's
- Incorrect dosage, duration
- Drug-allergy interactions
- Clinical abuse/misuse How long must a patient profile be kept after the last entry? 2 years How long must a TRANSFERRING pharmacy keep a record of transferred Rx's? 2 years What info may be changed on a C-II script?
- Patient address
- Dosage form
- Drug strength
- Drug quantity
- Directions for use
- Issue date
- Add the DEA #
What can't an RPh change on an Rx?
- Patient name
- Med prescribed
- Prescriber's signature Who appoints members of the Board of Pharmacy? The Governor How long is a CII Rx valid for a patient in a LTCF or a Terminally Ill patient? 60 days May be partially filled as many times as necessary, as long as the total dispensed quantity over time does not exceed the quantity it was written for What 2 items are required to fill an Rx for an animal?
- Species
- Full name of owner and their address When can the 2:1 ratio of techs to RPh's be overlooked? If at least 1 of the techs is board certified
Is an NDC required to be on OTC products? No What is required on the label of an OTC product? (19)
- Drug Facts - title
- Active ingredient(s)-including amount in each dosage unit
- Purpose - pharmacologic class
- Use(s) - indications
- Warnings
- Do not use - absolute contraindications, when the product should not be used under any circumstances
- Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms
- Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions
- When using this product - side effects that could occur and substances or activities to avoid
- Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately
- Pregnancy/breast-feeding warning
- Keep out of reach of children/Accidental overdose warnings
- Direction - dosage and when, how, or how often to take
- Other information
- Inactive ingredients
- Questions? (Optional)
- Lot number
- Expiration date
- Name and addresses of manufacturer or distributor Can an RPh compound a drug of a commercially available product? No. Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available FDA- approved drug product is generally prohibited. How long should a contract pharmacy maintain records? 2 years For each drug repackaged by a contract pharmacy under this section, the contract pharmacy shall maintain a record of what information? (10) (1). the name, manufacturer, manufacturer's lot number, manufacturer's expiration date, and quantity of the drug prescribed; (2). the name and address of the resident for whom the drug was repackaged; (3). the name and address or other identifier of the prescriber; (4). the date the prescription was issued and the date the drug was repackaged; (5). the date the repackaged drug was delivered to the long-term care facility;