Compounding Flashcards
Define brand name drug
drug that has a trade name and is protected by a patent
Define generic drug
bioequivalent version of a drug licensed
Define adminstration
giving drug to patient while patient is in office
Define dispensing
providing drug to an owner to give to a patient that is under your care
Define 503A compounding
traditional compounding performed by veterinarians and compounding pharmacies
Define 503B compounding
compounding performed only by special outsourcing facilities
If there is no specification of compounding which compounding is it?
503A
Define compounding
manipulation of FDA approved drugs by a veterinarian or pharmacist upon the prescription of a veterinarian to meet the needs of an individual patient that is under his or her care
what can be used for compounding?
any FDA approved drug - trade-name and approved generic drugs
What does compounding bulk drug substances violate?
federal, food, drug, and cosmetic act
who can compound
licensed veterinarian
pharmacist upon prescription of veterinarian
when can you compound
to meet needs to individual patient
who can you compound for?
patients with VCPR (typically cant be established online, email, or over phone)
are compounded drugs a FDA approved medication?
no
Is a compounded drug equivalent to a generic drug?
no
can you write a prescription for a compounded medication to make it more affordable?
NO - economics not sanctioned reason to choose compounded medications
Is compounding a common thing to do?
Yes - FDA estimates 6.3 million prescriptions for compounded drugs each year
what is the benefit of buprenorphine ER?
allows us to provide long-lasting control w/o dispensing opioids
why is it important to regulate compounding?
can lead to many killed and sick
who regulates compounding?
FDA, state governments, state boards of pharmacy
who has the primary responsibility for day-to-day oversight of state-licensed pharmacies that compound drugs?
state board of pharmacy
what are the acts that the FDA uses to regulate compounding?
FDCA
AMDUCA
DQSA
What type of drug use is compounding considered?
extra label drug use
Appropriate to compound - as a vet, you mix two injectable drugs in your office to administer to a patient
yes
Appropriate to compound - as a pharmacist, you prepare an oral paste or suspension from bulk substances so that you have it available to dispense when a vet sends you a prescription
NO - no bulk substances
Appropriate to compound - as a veterinarian you add flavoring to a drug
yes
Appropriate to compound - as a vet tech you compound a medication at a vets request
yes
Appropriate to compound - as a vet in AZ, you prepare an oral paste or suspension from crushed tablet for a new patient thoroughly described to you by email
no - need audio and video communication
Appropriate to compound - as a pharmacist with a prescription from a vet you prepare an oral paste or suspension from crushed tablets
yes
Appropriate to compound - as a veterinarian, you cut scored tablets in half for a client with osteoarthritis
yes
Appropriate to compound - as a veterinarian you write a prescription for a compound medication to make it more affordable
no
why compound drugs?
-limited number of FDA approved drugs for the many species and conditions we treat
-make drugs easier to administer (conc., route, palatability)
-to make it easier to admin multiple medications
Define extra label use
actual use or intended use of a drug in an animal in a manner that is not in accordance with approved labeling
what is the GFI?
-guidance for industry
-FDA provides guidance that represents current thinking of FDA on various topics, non-binding
what does GFI 256 adivse?
describes circumstances under which FDA does not intent to take enforcement action for violation of FDCA act for compounding animal drugs from bulk drug substances
when was GFI 256 released
april 2023
what is the primary product of focus of GFI 256?
-products being sold for administration
-secondary focus is need for documentation on patient-specific scripts
when might veterinarians need bulk drug compounding?
-drug previously approved by FDA is no longer commercially available
-needed medication can’t be prepared from FDA approved drug
what are the acceptable medical rationale for compounding?
-allergic to ingredient in approved product
-ingredient name is toxic to X species
-P require too many tablets of approved product
-P requires dose that would be a fraction of approved tablet and it is not scored to accomplish the fractioned dose
-patient cannot safely be pilled w/o approved capsule
what are the unacceptable medical rationale for compounding?
-compounding drug is less expensive
-prefer compounded
-need half strength (approved product can make it work just less mLs)
who inspects outsourcing facilities?
FDA
what must the outsourcing facilities do?
-comply with cGMP requirements
-report adverse events
-provide FDA with certain information about products they compound
what is cGMP?
-current good manufacturing practice
-main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals
who enforces the cGMP
FDA
what does adherence to the cGMP regulations assure?
-identity, strength, quality, and purity of drug products
-potency, sterility, stability
who do you report adverse compounding events to?
FDA
what is the USP convention?
-united states pharmacopeial convention
-develops and disseminates guidelines for medicines
Is the USP a regulatory body?
NO
define dispense
prescribing, administering, packaging, labeling, compounding, and security necessary to prepare and safeguard drug or device for delivery
Who is required to carry product liability insurance and who is not?
drug manufacturers required to carry it
pharmacies not required to carry it
what is the risk with veterinary compounding pharmacies?
some will openly manufacture and market illegally compounded drugs
when could veterinarians be liable for veterinary malpractice with compounded drugs?
in the case of treatment failure
what medication should not be administered transdermally? why?
antibiotics - likely lead to resistance and lack of efficacy due to low blood levels
what type of drugs limit your liability?
FDA approved
In the hierarchy for prescribing medication which are the best to prescribe?
FDA approved drugs
Order these drugs in order of best to prescribe
- FDA approved human medication for that condition
2.FDA approved vet medication for that species and condition - compounded drug
- FDA approved vet medication for another species
- FDA approved vet medication for that species and condition
- FDA approved vet medication for another species
- FDA approved human medication for that condition
- compounded drug
If there is not sufficient enough data for a compounded medications withdrawal interval and it was given to a food animal what must the veterinarian do?
ensure that the animal and its products never enter the food chain
What can be concluded if a drug is an antibiotic available in a powder that has to be reconstituted in a viral or in an oral dispensing bottle prior to administration?
it should not be mixed with other drugs
when do veterinarians use compounded drugs in food animals?
if there is ABSOLUTELY NOT OTHER CHOICE
what should be the latest beyond use dating of a compounded product?
no later than 25% of the remaining time until the products expiration date
What can be concluded if a drug is packaged in blister packs or with a moisture-proof barrier?
subject to loss of stability and potency if mixed with aqueous vehicles
What can be concluded if a drug is packaged in light-protected or amber container?
prone to inactivation by light
