Lecture 10: USP Flashcards
Why do USP standards exist?
To enhance patient safety and protect pharmacists
What is special about prescription compounding?
Meets unique needs of the patient
What 6 specialty practice areas is compounding associated with?
1) Veterinary medicine
2) Dermatology
3) Hormone replacement therapy
4) Pain management
5) Hospice
6) Home care
With compounding, is there a demonstrated patient-healthcare professional relationship?
Yes
With compounding, is there a third party reselling the product outside of the patient-healthcare professional relationship?
No
With compounding, is the activity regulated by the province?
Yes
With compounding, is there an inordinate amount of product produced on a regular basis?
No
With compounding, is an identical product commercially available?
No
With compounding, is the product and/or compounding service promoted or advertised to the general public?
No
Why is a sink with hot and cold running water essential for compounding?
For hand washing and equipment cleaning
What are 3 criteria that equipment must meet when being used for compounding?
1) Appropriate in design and size for intended purpose
2) Must always be cleaned immediately after use
3) Must be properly maintained and calibrated
True or false: sterile and non-sterile products can be compounded in the same area
False, the pharmacy must have separate and distinct areas for compounding sterile and non-sterile products
What is required to be on the label of all medications (besides legal information)?
Expiration date
How is expiration date determined?
- Aqueous or non-aqueous
- Expiration dates of ingredients
- Storage temperature
- References with stability data
What does the USP 795 say about expiration dating for solids and non-aqueous liquids prepared from commercially available dosage forms?
25% of the remaining expiration date of the commercial product, or 6 months, whichever is earliest
What does the USP 795 say about expiration dating for solids and non-aqueous liquids prepared from bulk ingredients?
Up to 6 months
What does the USP 795 say about expiration dating for water-containing formulations prepared from ingredients in solid form?
Up to 14 days when stored in refrigerator
What does the USP 795 say about expiration dating for all other formulations?
Up to 30 days or the intended duration of therapy, whichever is earliest
What selecting ingredients, what is preferred?
USP or National Formulary chemicals
Who is responsible for the selection of ingredients?
Pharmacist
What 2 considerations should be made when selecting ingredients for compounding?
- Chemical must meet purity and safety standards
- Should not use drug withdrawn from market by FDA
What is needed if selecting ingredients that are chemical grade?
Certificate of analysis
What type of ingredients are not necessarily pure?
Spectroscopic or HPLC grade
How must active ingredient should compounded preparations contain?
90-110% of amount on label
What 12 dosage forms does USP 795 address?
Capsules, powders, lozenges, tablets, emulsions, solutions, suspensions, suppositories, creams, topical gels, ointments, and pastes
What is the goal of the compounding process?
Minimize error and maximize prescribers intent
How many preparations can be compounded at once and why?
Only one to avoid errors and cross-contamination
Who is responsible for the final check of a compounded product?
Pharmacist
Who initials the prescription and label?
Pharmacist
What are pharmacies required to maintain according to USP 795?
Formulation record and compounding record for each compounded preparation
What is a formulation record?
An individual record that includes ingredients, compounding equipment, and instructions for preparing the formula (like a recipe)
What is a compounding record?
Log of an actual compounded preparation that includes manufacturer, expiration date, lot numbers of chemicals, preparation date, and names of individuals who prepared and verified
What 4 things should be included when counselling a patient?
1) Correct use
2) Storage
3) Expiration date
4) Evidence of instability in compounded medication
What are 5 factors that should be considered regarding compounding?
1) Must be able to demonstrate that a patient-HCP relationship exists
2) May prepare drugs in very limited quantities in anticipation of a prescription
3) Should only be done if there is a therapuetic need and lack of product availability
4) Compounded product must not duplicate an approved drug product
5) May compound when there is a shortage or no supply of a commercially available product
When is compounding of clinical trial drugs permitted?
Only if this activity is authorized in the clinical trial authorization
What should compounded products be compounded from?
An authorized drug
What are guidelines for pharmacists that provide compounding services to other hospitals?
Should be within the same province and operate under the same hospital management board
