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Quality, safety, efficacy compromised


DVM Best Practices



Photo 3: A combination of "omeprazole" and bismuth subsalicylate in a water-based paste. Both BSS and water rapidly degrade omeprazole.
Based on information collected to date, when you use a pirated drug, and if you dose on volume for 10 mg/kg, the dose range you will administer will be 0 to 17.6 mg/kg with possible impurities and other "stuff" in the mix for which you can't account. Also there is no guarantee of purity and shelf life of the mixture. In Tables 2 and 3, the content of active ingredient was evaluated in samples from multiple drug pirates (disguised as compounding pharmacists). The approved formulation varies between 90 percent and 105 percent of the label indication. Tested pirated articles to date have fallen in the range of 0 to 176 percent of the label indication. The variation is astounding. However, do not believe that these numbers are repeatable per pharmacy. Since the active ingredient from overseas sources is of variable quality, on the next round of batch testing, the high content pirated drug may look like the low content pirated drug and vice-versa.

It makes sense that pirated drugs are poor quality. Pirates are unethical (they care little about you, your patients or your clients) or unknowledgeable (they believe they produce products to acceptable clinical standards).

Use of pirated products is not quality veterinary medicine.

Negative impacts The negative effects of pharmacy should now be obvious. When you use a pirated product, you are administering a poor, unacceptable quality drug at an unknown dose and questionable purity and sterility. In addition, this reduces incentive by the regulated pharmaceutical industry for scientific development of quality products for veterinary species. Several animal health sponsors have not moved forward with development of needed veterinary drugs because of the risk of having the product compounded. As an example, see Photo 3. That data was collected within a few weeks of the drug's FDA approval. At that point, the sponsor was a small player in the marketing and distribution of the product. Why would a pharmaceutical company want to invest millions of dollars into something when pirates have to invest so little? Pirates violate the public trust with the veterinary profession's help.


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How to choose Legitimate compounding pharmacy is not drug piracy. In fact, the American College of Veterinary Pharmacists indicated they are appalled by this activity and they are being inadvertently and adversely affected by this practice. Legitimate pharmacy drug compounding is based on the extent of knowledge in compounding chemistry and ethical behavior. They provide the best quality possible under the limited facilities and controls of a compounding pharmacy. It is difficult to identify the extent of a pharmacist's knowledge in compounding and formulation chemistry. However, the pharmacist's ethical behavior can be evaluated. Good compounding pharmacists do not drug pirate.

Conclusion You have no idea of the content of active ingredient or impurities in a pirated drug product. You also have no idea of the pharmacokinetics of the formulation. Drug piracy is an indication that the pirate is unethical or unknowledgeable. These drugs have no assurance of quality, safety and efficacy.


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Source: DVM Best Practices,
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