02: Compounding

Compounding

Any manipulation of a product

T/F: compounding came after pharmaceutically standardized drugs

F; compounding predates commercial drugs by centuries

Types of compounding

• Mixing together approved drugs

• Changing the form of an approved drug

• Creating a product from bulk drug substance

Qualifications behind a generic drug

FDA approved and regulated by the government with a reference ID number

Primary risk of compounded drugs

The prescriber (YOU) assume the risks that may or may not be associated with the drug

Characteristics that may change (and be untested) in a compounded drug

• Concentration (risk of under or overdosing)

• Bioavailability

• Labeling

• Shelf life

• Sterility

• Consistency of efficacy

Despite the risks, why do we need compounded drugs

• Lack of appropriate dosage size

• Not available in a useful form

• Lack of availability

Misuses of compounded drugs

• Not using the FDA approved drug for that species

• Not using the FDA approved drug for a different but comparable species

• Decreasing cost with bulk ingredients when an FDA approved formulation is available

Guidelines for proper application of compounding drug use

• Imminent suffering or death if the patient doesn’t get the compounded drug

• No FDA approved animal OR human drug

• VCPR

• Reputable pharmacy

• Small quantity specific to the patient with adequate record keeping

• Make the decision using evidence-based medicine

• In compliance with AMDUCA

Why is compounding even trickier for food animals

Unless information exists about withdrawal times, you may be pushing that animal out of the food chain by treating with a compounded drug

T/F: FDA has the final say on how we utilize compounding

F; there are state regulations too

Compounding from unapproved bulk substances is not FDA approved, particularly for food animals. When is it allowed under FDA regulations?

• Poison antidotes

• Euthanasia and depopulation

• Certain sedatives and anesthetics for free ranging wildlife

What makes a compounding pharmacy a potentially reliable source

• Performed by or under a licensed pharmacist with veterinary and compounding training

• Rx for the specific patient

• Label is legal

• Good sources

• Quality testing

Expiration date

Assigned by manufacturer to unopened FDA approved products

Beyond-use date

Assigned by compounding pharmacist or veterinarian and is typically shorter than expiration date to account for limited stability and sterility

Steps to protect you and your patient when using compounded drugs

• Keep thorough records of prescribed compounded drugs

• Report adverse effects and therapeutic failure

• Recheck patients on compounded drugs!

• Client consent!! Not FDA approved and they need to know!!