Quality, safety, efficacy compromised

Nov 01, 2003

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.
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.

Questions to ask Question: What is the essential information necessary in medical therapeutics?

Answer: What and how much have you administered!

Table 1: Omeprazole content as a percent of the label indication from 10 different drug pirates.
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."

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.

Table 2: Meloxicam content as a percent of the label indication from 19 different drug pirates.
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 manufacturing criteria.

A common misconception among veterinarians, and often indicated by drug pirates, is that pirated drugs are generics. That is wrong!

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.

Table 3: Clenbuterol content as a percent of the label indication from 7 different drug pirates.
Excipients 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.

Shelf-life 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).

No comparison 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 reasonable.