Standards for the Operation of Licensed Pharmacies Flashcards
How many standards are in this document?`
14
What is standard 1?
A licensee must ensure the licenced pharmacy operates in accordance with the law
How is standard 1 applied?
Need to follow all laws, and be aware of changes in the law. You can not offer “perks” for medications.
What is the general statement of standard 1?
Ensure compliance with laws
What is the general statement of standard 2?
Preserve the independence of licensee and staff
What is standard 2?
A licensee must not practice under or impose any condition that compromises independence, judgement, or integrity
How is standard 2 applied?
You can not be forced to do something against your better judgement, or against the law.
What is the general statement of standard 3?
Staff pharmacy adequately
What is standard 3?
A licensee must ensure that a licenced pharmacy has enough trained staff, and that a pharmacist is always there to supervise.
How is statement 3 applied? (5)
Adequate number of staff Staff to be identified Staff to be properly trained Must have proper supervision Know your role
What is the general statement for standard 4?
Ensure suitable physical facility and equuipment
What is standard 4?
A licensee must ensure that the physical place and the equipment in it must be up to par for practice
How is statement 4 applied? (6)
The department must have adequate lighting and temperature
No non-pharmacy members can be behind the pharmacy
KEEP IT CLEAN
Proper signage must be posted
NEED a proper fridge and sink and scale
Cant share anything with store (if pharmacy is in a store)
Need a patient councilling area
What is the general statement of standard 5?
Protect the integrity an safety of drugs, health care products, and supplies.
What is standard 5?
A licensee must ensure the drug supply in the pharmacy is safe, as well as health care products and devices.
How is statement 5 applied? (6)
Duty to examine drugs Store drugs correctly Labeling drugs correctly Narcotic counts Report any theft, even if its one tab Properly dispose of outdated or recalled drugs
What is the general statement of standard 6?
Implement a quality assurance program
What is standard 6?
A licensee must implement a quality assurance program to monitor and improve processes to minimize risk.
How is statement 6 applied? (5)
Be aware of any drug incidents that could take place
Minimize drug errors
Provide quality assurance
Drug error documentation muct be kept for 10 years
Need to own up to drug mistakes and follow up with patient.
What is the general statement of standard 7?
Ensure patients have access to compounding services
What is standard 7?
A licencee must ensure that patients of the licenced pharmacy have access to compounding services
What is the general statement of standard 8?
Ensure comprehensive record keeping system
What is standard 8?
A licencee must ensure that there is an effective system for the creation, maintenance, secure storage and availability for retrieval of all records.
How is statement 8 applied? (3)
Must be maintained WITHIN the pharmacy
Must have a record of who is keeping and accessing the records
A copy of the records is stored off site or in a safe.
What is the general statement for standard 9?
If a compounding and repackaging pharmacy, maintain appropriate facilities and policies.
What is standard 9?
A pharmacy must ensure…
Adequate space and equipment, SOP grade compounds, a written agreement with each pharmacy.
How is statement 9 applied?
Only licenced compounding pharmacies can compound
Standards according to the USP
Compounded drugs must include a unique identifier.
Wat is the general statement for standard 10?
If a mail order pharmacy, maintain appropriate policies and records
What is standard 10?
If a licencee of a mail order pharmacy must establish and monitor compliance with policies and procedures and keep appropriate records of activities related to the services provided.
What is the general statement for standard 11?
If satellite pharmacy, maintain appropriate facilities and policies.
What is the general statement for standard 12?
Remote dispensing (pertaining to satellite pharmacies)
What is the general statement of standard 13?
Notify the college when closing a pharmacy
What is standard 13?
A licencee must provide the college with information with a pharmacy closes permanently.
