Chapter 14 into to compounding Flashcards
Definition of compounding
- To mix or combine, 2. To make by combining parts, 3. To intensify by adding new elements
Compounding is the
Practice of extemporaneously preparing medications to meet unique need of an individual patient according to specific order of a prescriber
Incense in compounding comes from
Discontinuation of drugs by manufacturers, removal of drugs from market by FDA, unavailability of drugs in a strength or dose, allergies,
Valuable resources of compounding
Remingtons pharmaceutical sciences, Merck Manual, Merck veterinary manual, trissel’s stability of compounded formulations, drugs facts and comparisons, united stats pharmacopeia, vertically drug handbook, internal journal of compounding pharmacists.
USP
Imports states pharmacopeia
USO regulates
Compounding pharmacy by setting standards for compounding, under guidance of volunteer pharmacy compounding experts, offers resources and support for compounder
USP standards for sterile and non sterile preps are available in chapters
797 and 795
USO 795 provides guidance on
Applying good compounding practices in preparation of non sterile compounded formulations
USP 795 was recently revised to include
Categories of compounding (simple, moderate, complex), new definitions for terms (beyond use date, hazardous drug, stability) criteria for compounding each drug preparation (suitable compounding environment and use of appropriate equipment)
PBCA was founded when
8 of the nations leading pharmacy organizations joined together to create a voluntary quality accreditation designation for compounding
Goals of PCAB
- Improve quality of compounding operations and preps.
- Provide a competitive edge in the marketplace and ability to secure new business.
- Offer validation for compounding pharmacies to meet national standards
- Strengthen community confidence
First step in compounding
Obtain a formula/recipe prepared by a pharmacist that include all necessary ingredients and explicit instructions for the preparer
From the formula/recipe the technician creates a
Worksheet containing a list of active ingredients and excipients and exact amounts needed of each.
Geometric dilution
Technique of starting with the ingredient of the smallest amount and doubling the portion b adding the other ingredients in order of quantity until fully mixed
Procedure 1 & 2 of general compounding process
- Obtain the recipe or formula
2. Write up a compounding worksheet based on the formula
Procedure 3 & 4 of general compounding
- Collect all ingredients and equipment necessary to prepare the compound
- Weigh each ingredient and have the measurements verified by the pharmacist
Procedure 5 & 6 of general compounding process
- Following direction of the formula, prepare the compounded medication
- Package and label the compounded medication in an appropriate container
Procedure 7 & 8 of compounding process
- Have the pharmacist do a final check on the compound
8. Clean the workstation and equipment used
Estimated _% of all prescriptions dispensed in the United States are compounded, thus making this a niche market.
1%
Geometric dilution should mean that the final product is
Even distribution of the active ingredient throughout the final product
Most appropriated dosage form will depend on
The drug and the patient
The patient is probably the most important factor in?
Dosage form
Common dosage forms
Capsules. Liquids, transdermal gels, creams, ointments, suppositories, chewables
Even though compounded are prepared on individual basis the pharmacy still must have a good
Quality assurance
Quality assurance (QA)
A program of activities used to ensure that the procedures used in preps of compounds lead to products that meet certain specifications and standards
Typical components of a good QA program include
SOPs, formulation records, compounding worksheets, ingredient record forms, material safety data sheets, documented training, and QA tests for each compound
Standard operating procedures (SOPs) are
A step by step written instructions on how to do a certain task. All important tasks should be covered by a SOP
SOPs should be developed for
Facility maintenance, equipment calibration and maintenance, personnel training and validation, and preparation, packaging, and storing of compounded items.
SOPs can assure that
Equipment is properly maintained and calibrated, supplies and chemicals are received, inventoried, compliant with compounding standards, stored properly and disposed of correctly, all procedure and tasks are performed consistently and documented
SOP general format follow
- SOP number - unique assigned number
- Date effective
- Author
- Author signature
- Purposes of procedure
- Equipment/ materials listed for each task
- Detailed procedure
- Documentation forms
PCAB accreditation requires SOPs to regard
Cleaning, maintenance, calibration and verification of each piece of equipment
Capsules:
Oral dosage, been used for more than a century. Offers broad range of dosage options for patients.
Tablets:
Solid dosage form administered orally, sublingually, vagina lily or as an implant under the skin. Compressed tables made by manufacturers are most commonly prescribed dosage form.
Sublingually means
Under the tongue, preparations may be administered by placing them under the tongue and allowing them to dissolve.