Veterinarians have enjoyed a remarkably positive reputation with the public. However, the use of pirated drugs has put that
good reputation dangerously at risk. These drugs may be less expensive, but they also are of poor quality, highly variable
in nature and of unknown content or stability. The use of pirated drugs removes the essential information in clinical pharmacology
and the application of therapeutics, i.e., what have you administered to the patient? With pirated drugs, neither you nor
the pirate knows what you have administered. Use of pirated drugs is, by definition, substandard veterinary care.
Photos 1A and 1B: A product that expired five years ago. Although not a pirated product, this is clear evidence of the pirate's
ignorance or unethical nature.
Questions to ask
Question: What is the essential information necessary in medical therapeutics?
Answer: What and how much have you administered!
All clinical practice, clinical outcomes and pharmacologic data are based on that premise. If you don't know that information,
then you are stabbing in the dark in applying a therapeutic. If you don't know what you have administered, then it is best
"to apply the drug liberally per foot."
Table 1: Omeprazole content as a percent of the label indication from 10 different drug pirates.
Question: How does a practitioner know what they have administered?
Answer: The best means is by administering an Food and Drug Administration (FDA)-approved drug. These include pioneer and generic
drugs and registered products. All of these are manufactured under Good Manufacturing Practices (GMP) legislation and guidelines.
GMP laws and guidelines provide for the assurance of the products' quality, consistency, strength, purity and stability.
Pioneer drugs are the original product under which drug sponsors collected efficacy and safety data for FDA approval (i.e.,
RompunTM). Generic drugs are allowed to be marketed based on matching pharmacokinetics to the pioneer (bioequivalence) and
the determination that the other constituents of the product (excipients) provide no safety risk (e.g., xylazine HCl injection).
As with pioneer products, generic products require FDA approval and undergo GMP manufacturing and assurance. Examples of registered
products include intravenous fluids and vitamins with no claim, but are allowed to be marketed by FDA and still undergo GMP
Table 2: Meloxicam content as a percent of the label indication from 19 different drug pirates.
A common misconception among veterinarians, and often indicated by drug pirates, is that pirated drugs are generics. That
Pirated drugs can have no claim to drug quality, consistency, purity and stability. The bulk product is often made in laboratories
in China, India and Pakistan. These laboratories do not meet the requirements for GMP manufacturing as bulk drug sources.
No bulk drug intended for use in veterinary species is allowed to be imported into the United States. Therefore, all bulk
chemicals used in drug piracy have been imported illegally.
Our education is, unfortunately, weak in pharmacology as it relates to drug formulation. A drug is far more than the active
ingredient. In fact, the pharmacodynamics of a drug is heavily dependent on the excipients (i.e., inert substances, preservatives,
etc.) that make up the formulation. Under GMP laws and guidelines, excipient quality is scrutinized to the same detail as
the active ingredient.
Table 3: Clenbuterol content as a percent of the label indication from 7 different drug pirates.
Accurate shelf-life studies for an FDA-approved drug require GMP manufacturing, so that the drug can be assured of its composition.
Then once packaged, the drug undergoes accelerated testing for stability under extreme environmental situations before the
drug is approved and given a shelf-life period. After that, aliquots of each batch are held back and tested over time. The
cost for just the accelerated study for a single dosage size will be approximately $150,000. Since pirated products are not
GMP manufactured, even if one were to run accelerated studies, they would have no value because you could not be assured of
the product's make-up and consistency from batch to batch. So when pirates label their products with shelf-lives that exceed
the period of the prescription (sometimes years) they are ignorant or unethical (Photos 1A and 1B, p.17).
Pirated drugs compare very poorly - they are of poor quality, strength and purity (Tables 1, p. 17, 2 and 3). As an example,
you intend to administer drug X at a dose of 10 mg/kg. When you use an FDA-approved drug produced under GMPs (which is all
of them), the dose you are administering will fall in the range of 9 to 10.5 mg/kg for most drug products. That is clinically