Quality, safety, efficacy compromised
Nov 01, 2003
Questions to ask Question: What is the essential information necessary in medical therapeutics?
Answer: What and how much have you administered!
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.
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.
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.