Colorado Pharmacy Law Flashcards
Who is the pharmacist legally authorized to share patient information with?
The patient, provider, another pharmacist/tech/intern, authorized law enforcement, third party payers, or a person authorized by law to obtain such information
What information must appear on each written or oral order (except as provided by chart orders for hospitalized patients)? 3 things
- Date compounded/dispensed
- Assigned serial (Rx) number (except chart orders)
- Quantity to be dispensed (except LTCF orders)
Only a pharmacist or intern can verbally transcribe an oral order with the exception of which type of orders?
Chart orders for hospitalized patients
What information must appear on each written or verbal order for controlled substances? (3 additional things other than what a non-controlled Rx must contain)
3 main things that every script requires (date, serial number, quantity)
- Patient address
- Provider address
- Provider DEA
Any change or clarification to any order must contain what information?
- Pharmacist/intern initials
- Date contacted
- Name of person making change
When a substitution is made to an order, what processes must occur? (2 main things)
- Names of both the drug prescribed and the drug actually dispensed and the date substitution was made
- NDC or drug distributer
What 3 things must be recorded on the back of the order or on the daily computer printout for refilled orders? (These can be recorded by pharmacist, intern or tech)
- Date refilled
- Quantity (if different)
- If authority to refill is obtained, name of individual refilling Rx
When filing refilled orders, who must complete them, what do they have to do and how long do they need to be available for inspection by state board?
Pharmacist must put their name, initials or license number on the order and this information must be available for state board to inspect for 2 years.
What must be written on the physical Rx order if the patient requests a copy?
COPY FOR REFERENCE ONLY
What is the only time a pharmacy technician is allowed to transfer Rx’s?
If it is electronically transferred between 2 compatible systems and no changes are made.
What information needs to be written on the back of a transferred Rx? One that you are transferring out of your pharmacy (6 things, what is the extra thing you need if the Rx is controlled?)
- VOID written across the face of the original Rx order to invalidate the Rx.
- Your name
- Person receiving
- Name of the pharmacy transferring
- Address and phone # of receiving pharmacy
- Date of transfer
- DEA of receiving pharmacy
Pharmacies using computers to store this information are exempt
What information needs to be on an order that is transferred to your pharmacy? (9 things, 10 if it is controlled)
- Date of issue
- Date of first fill
- Number of refills given
- Original quantity
- Number of refills left
- Rx number
- Person transferring
- Name of pharmacy
- address and phone of pharmacy
- DEA if controlled
When a pharmacy goes out of business and the Rx’s are moved to another pharmacy, they are void and cannot be refilled, unless…
- The pharmacist can establish that refills are authorized and creates a new order from the existing and must document the original Rx number on the new order and the new Rx number on the old order.
- If they are electronic, the pharmacist must maintain written or printed record that has both the Rx number of new Rx and old Rx.
Files for the pharmacy that has gone out of business can be transferred to another pharmacy under what conditions? (Buyout)
Computer and electronic database from the pharmacy that goes out of business must be located and remain at the new pharmacy for 2 years.
One additional bottle of a prescription eye drop may be dispensed if what conditions are met?
- Health insurance must pay for extra bottle (no cash pay)
- Additional bottle requested by insurance/provider at the time original Rx dispensed
- Original order must state additional bottle needed for school, day care, etc.
- Additional bottle limited to once Q 3 months
- Total number of bottles dispensed does not exceed bottles prescribed in original order
Every pharmacy must maintain records of naloxone dispensed without Rx for at least how long?
What information needs to be in the standing order?
5 things
2 years form the date of latest transaction
- Full name of patient
- Address of first responder or organization
- Name, strength, dosage form dispensed
- Quantity dispensed
- Date dispensed
What conditions must be met for a pharmacist to be able to reconstitute an unreconstituted prescription that was originally prepared at another pharmacy?
5 things
- Prescription is delivered directly from the originating pharmacy
- Patient MUST not have possession of the order
- Rx is to be reconstituted according to MFG directions
- Non-controlled substance
- Pharmacist at new pharmacy cannot change labeling
Who is responsible for the maintenance of records for the pharmacists who perform all initial and final review of prescription products?
Pharmacy manager
Records detailing the initial and final interpretation should be 23retained at the pharmacy for how long?
What do these records have to contain on them? (3 things)
2 years
- Name of person performing initial interpretation
- name of person performing final interpretation
- Date on which each interpretation took place.
Every pharmacy must have in written format, a notice detailing how initial and final interpretation are documented. What does this notice need to include?
5 things
- Statement that all pharmacy personnel have the ability to print a record of any initial or final interpretation for any new or refilled medication.
- The notice must be signed and dated by RXM
- Any changes to documentation methods requires a new notice
- The notice should be posted on the wall next to most current board registration
- Notices will be retained for 3 years from last date utilized
A flavor additive may be added to a non-sterile prescription under which of the following circumstances?
- A flavor must be requested each time, they can’t just say flavor all 10 refills with cherry
- The stability, efficacy or safety cannot be changed
- No expired flavors
- If the flavoring arrives with no expiration date on it, pharmacist is to write date they acquired it and a expire date of NO MORE than 3 years
- 2 year record of the flavor, manufacturer, lot, expiration
- Pharmacist who performed final review should be the one to flavor the Rx.
- RXM responsible for maintenance of records
A pharmacy cannot accept returned or donated medications, medical devices or supplies for re-dispensing except for:
- A pharmacy that complies with the Board Rules
- See hospital flashcard
- Cannot be expired
- These rules do not apply to Cancer Drug Repository
A hospital pharmacy can accept drugs for re-dispensing or reissue from all areas of the hospital, provided the integrity of the product and package are maintained and the following are met:
- A record indicating the number of doses of the drug were given.
- If distributed as floor stock, it should contain (name of drug, strength, dosage form, quantity, location of original distribution, date of return)
Which entities can donate or return drugs
- Correctional facility and a licensed facility can return drugs to a pharmacy.
- Correctional facility and a license facility may donate drugs to nonprofit organization or physician
- A pharmacy can donate a returned or donated Rx to nonprofit organization or practitioner
Drugs dispensed to someone in prison or licensed facility can return or donate drugs under what 3 circumstances scenarios
- Liquid drugs and the vial is still sealed and properly stored
- Individually packed drugs must be undamaged
- Drugs in original, unopened, sealed package
Drugs dispensed to someone in a facility or prison cannot return which of the following drugs? 11 examples
- Controlled substances
- Any drug dispensed in traditional dispensing system (Amber vial)
- Any custom prescription (patient specific)
- Unlabeled single/unit dose packaging
- Compound
- Adulterated/misbranded
- Drugs that require special storage (fridge, freezer, etc)
- Drugs that require special registration with MFG (REMS)
- Expired drugs
- Drugs dispensed outside of Colorado
- Any drug illegally obtained without an order
An entity that receives donated medications and supplies may charge the end user a handling fee of no more than $_ per script/device
3 per script/device. They cannot resell the shit for profit
Where should all returned or donated medications be stored?
Separate area from all other stock and clearly labelled returned/donated drugs only
When can returned/donated drugs be redispensed to patients?
- If in OG MFG packaging and the integrity is maintained
- If the pharmacy originally packaged unit dose meds, they can be redispensed one time only (cannot be partially used)
- Drugs in unit of issue packages or single dose packages may be removed from packages and packaged for dispensing in a traditional dispensing system
- Must have written on Rx, “Donated or returned drug”
A pharmacy can donate returned or donated Rx to which 2 entities?
Nonprofit entity or a practitioner authorized by law to prescribe the drug
Records of donation shall include what 12 elements
- name of drug or device
- Strength
- Dosage form
- Quantity
- MFG name and/or NDC
- Date of donation
- Name and address of donating pharmacy
- Name and address of accepting entity
- Name and address of the pharmacy that originally filled Rx
- Rx number
- Expiration date
- Name and address of any pharmacy that EVER had possession of the drug or device
All records of receipt and dispensing of drugs must be kept for how many years?
All records of donation shall be kept for how many years?
2 years of receiving or dispensing
3 years if donating
For prescriptions filled but not dispensed, a separate record must be maintained for Rx returned to stock. This list should include what 5 things
- Rx number
- Drug name and strength
- Quantity
- Date of return
- Location where filled, if filled centrally
For drugs delivered to another pharmacy (interstore) that are going to be returned to stock, what 4 things must be included?
- Lot/expiration date must be placed on label by original pharmacy
- OG pharmacy can access and provide lot and expiration date upon request
- NO CONTROLS
- No compounds or flavored Rx can be returned to stock
If a pharmacist is going to package medications in a container what information needs to be included on the packaging? (10 things)
- Internal lot number
- Name of medication
- Strength of medication
- Expiration date
- MFG
- MFG lot number
- MFG expiration date
- Date packaged
- Identity of pharmacist who packaged it
- Name and address of packaging pharmacy
Automated cassettes should be labeled with the following 8 things and how long must the record of these be maintained?
Record should be kept for 2 years
- Name of medication
- Strength
- Suitable expiration date, no longer than MFG expiration and no more than 1 year from date packaged
- MFG
- MFG lot
- MFG expiration
- date packaged
- RPH identity
