Lecture 1 Flashcards
(20 cards)
A ”compounding center” NOT a drug manufacturer
Compounding center pharmacies are authorized to prepare specific formulations of drugs to meet the specific needs of individual patient pursuant to the receipt of a
prescription
Compounding centers register with _________ but regulated by State Departments
of Health
FDA
Compounding centers support local patients, and therefore _________________ don’t apply.
interstate commerce regulations don’t apply
Advantages of Parenteral Route
__________ onset
Bypasses _________ secondary to
bioavailability & first pass effects
Provides alternative for patients
unable to take enteral
medications/nutrition
___________delivery
rapid onset
bypasses drug loss
Localized delivery
Disadvantages of Parenteral Route
___________
Risk of embolism
___________
Difficulty in reversal
Infection
cost
The Three Core Values: Safety, Accuracy, and Attitude
Safety is important when compounding
For _________
For operator
Patient safety must be a primary focus during the preparation process
Some preparations involve risk to operator
patient
Accuracy
Accuracy of parenteral preparations directly affect patient safety
Lack of leniency with parenteral route
Emphasis on accuracy
Accuracy relates to:
Selection of _________
_________________
Preparation techniques
Personnel must accept responsibility for accuracy
products
calculations
Attitude
Important aspect of compounding sterile preparations
Level of ____________
Need to accept responsibility for patient safety through all points of the preparation and verification process
attentiveness
Averting Risk
While parenteral preparation and administration introduces specific risks, there are processes, practices, and techniques which should be used to mitigate such risks:
Proper training of all personnel involved in compounding and administering parenteral preparations
Maintaining a proper environment for compounding sterile preparations
United States Pharmacopeia (USP)
Publishes standards for:
Identify
Quality
Strength
Purity
Packaging
Labeling
Chapter <797> Pharmaceutical Compounding-_______ Preparations
Sterile
USP <800> ___________Drugs-Handling in Healthcare Settings
Hazardous
Regulations
State boards of pharmacy:
Maintain empowerment for ensuring _______and _________of citizens in their state
Can deviate from standards in USP Chapter <797>
May require different education and training requirements
May require stricter environmental controls, quality assurance, and quality control
health and safety
Responsibilities of Compounding Personnel
- Compounding personnel
- ANY individual involved in sterile compounding
- Responsibilities
- “Compounding personnel are responsible for ensuring that CSPs are
accurately identified, measured, diluted, and mixed and are correctly purified,
sterilized, packaged, sealed, labeled, stored, dispensed, distributed, and
disposed of if not used”
“Compounding personnel must have an understanding of how combining
different agents in a preparation may affect bioavailability, compatibility
(visual and chemical), pH, and concentration effects. Factors that influence
stability (e.g., temperature, pH, sorption, photolysis, and chemical
degradation) must be carefully evaluated and supported by references or
appropriate testing
“Compounding personnel must understand and demonstrate competency in
aseptic technique and for the products and systems used in CSP preparation,
such as needles, syringes, administration sets, fluid containers, and
compounding devices.”
The Role of the Pharmacist
Ensure patient safety
Final verification of CSP prior to being administered to patient
Be familiar with all aspects of compounding sterile preparation
Verifying the CSPs
The CSP should be checked by a pharmacist prior to being administered to a patient
Pharmacists must document their verification of the CSP
Specific items should be checked
