compounding 2 Flashcards
is a compounded drug the same as a commercially manufactured product? What differences are there?
-no, compounding has less oversight
>Brand-name and Generics are Health Canada approved!
>Efficacy and safety data available; Generics deemed bioequivalent!
>Good manufacturing practices
-Purity, Potency
>Stability is known
>Subject to inspection
Products compounded by pharmacies:
>Not Health Canada approved
>No evidence-based efficacy or safety data for support
>Not subject to GMP; stability may/may not be known
>Pharmacy subject to inspection by province (Ont College of Pharm)
what are some possible pieces of evidence for drug instability for liquid products?
-Color change
-Cloudiness, film formation
-Precipitation
-Gas, odor
what are some possible pieces of evidence for drug instability for solid products?
-Excessive crumbling
-Breaks, cracks in tablets
-Capsules/tablets sticking together
what are some factors that can cause drug instability?
**pH
**Temperature
-light exposure
-reactions (oxidation, hydrolysis)
what two factors are we most concerned about when compounding products?
stability, efficacy
what types of packaging are used to maintain stability of drugs? Should compounded versions use the same?
-blister packs, light resistant bottles, drugs as powders
-drugs should be packaged in the same way whether manufactured or compounded
what are the advantages to transdermal drug delivery? What are some examples of this use?
Transdermal delivery can be an effective and convenient means of drug delivery
-used for cats that are difficult to pill
-Antiparasiticides (pour-ons)
-Opioid patches (fentanyl and buprenorphine patches)
what do we need to consider when administering a transdermal drug in order to have it be effective? What are some concerns with this method?
-Compounded TD drugs need to be soluble/potent to provide a dose in 0.1- 0.2 mL volume !!
-Skin is a formidable barrier to drug passage !!
General concerns………
-Absorption is incomplete, or nonexistent
-Inter-patient variability is high
-Chronic safety is unknown
-Lack of potency and stability
-Risk to human caregiver
Commonly compounded products for veterinarians by
pharmacists (8)
-Potassium bromide (salt, for some forms of epilepsy)
-Metronidazole oral suspension (GI)
-Methimazole oral liquid
-Prednisolone oral liquid
-Cisapride
-Transdermals (methimazole)
-Tramadol and buprenorphine
-Doxycycline
what can we do with compounded drugs to enhance patient/owner compliance?
Flavoring agents are often used to enhance palatability of compounded products
-Cheese, fish…….cats
-Peanut butter, liver, beef for dogs
-Sweet, fruity flavors for exotics
-Vegetable bases for rabbits
Veterinarians wishing to create or prescribe comp’ded products should do what?
-should seek advise of a reputable pharmacist
what reputable pharmacist groups should a veterinarian seek advise from regarding compounded products?
-International Academy of Comp’ding Pharmacists
-Professional Compounding Center of America
-American College of Veterinary Pharmacists
-Willing to provide product/ingredient information when requested
What are 4 types of products that are difficult to compound as a veterinarian (so prob should not try)
-Sterile products
-Transdermal products
-Extended release products
-Ophthalmic products
What characteristics make a drug ideal for compounding?
-Wide therapeutic index
-Therapeutic Drug Monitoring available or quantitative end-points
-Clinical data exists with the compounded product
what was the compounding problem with selemium in polo ponies in florida?
-mistake made selenium dose 10x higher, killed many
what compounding problem can arise with flavouring buprenorphine?
-might reduce absorption
what compounding problem can arise with florfenicol?
-florfenicol good for food animals, similar chloramphenicol cannot - mistake!
useful infor,ation sites for compounding?
-CVMA
-CVO
-USP-NF
-Health Canada
-Prof Comp’ding Centers of America
-NAPRA Drug Schedules
-Health Canada Drug Product Database
-Health Canada Prescription Drug List: Veterinary and Human
what does the Compendium of Veterinary Products contain? What sections does it have?
Compilation of Canadian veterinary approved monographs (drug labels) and other drug-related information
Sections:
-Manufacturers (with companies listed alphabetically)
-Drug Monographs (listed alphabetically by active pharmaceutical
ingredient and indexed by species)
-Product Category (indexed by species)
-Product Uses (indexed by species)
-Biological Charts (sorted by microbe within species)
-Anthelmintic and Parasiticide Charts (sorted by parasite within species)
-Withdrawal Time Charts (sorted by drug and indexed by species)
-Reference Charts for medical acronyms, weights and measures
-Information on the regulatory agencies, veterinarian prescription feeds, CgFARADTM and Veterinary Health Products
what is own use importation of drugs? Why was this policy established, and how does it apply to drugs for animal use?
Canadian Food and Drug Act and Regulations state “no drug can be sold in Canada unless it meets our legal requirements”.
-This does not preclude drugs being used for personal human use
-As it is not strictly prohibited for use in veterinary patients, a “non-inclusionary loophole” permits importation for animals of the owner
-The OUI policy was established to support human health by permitting individuals entering Canada a 90-day supply of a drug not approved for sale in Canada for their own use
-With some exceptions, the importation of drugs for food animals is very restricted
What is an emergency drug release and what is its use? What information must you supply in order to use this?
Veterinary Drugs Directorate (Health Canada) has an EDR program in place that permits veterinarians access to drugs not available in Canada
>Meant to treat diseases on an emergency basis
Veterinarian must supply relevant information about…….
-Nature of emergency (species, production type, age, disease, #s)
-Efficacy, safety data in target species
-Human safety data eg. withdrawal times, occupational safety
-Amount of drug needed and dosing regimen
VDD responds in 48 hrs if adequate info provided
-Copy of authorization faxed to requesting vet and manufacturer
