In December, the Clinton-Gore Administration announced a federal proposal for regulation of online pharmacies, specifically targeting illegitimate online prescribing. The concerns related to illegitimate Internet prescribing and dispensing are real and go beyond prescriptions for the lifestyle-enhancing medications finasteride and sildenafil. Consumers have access to any prescription medication, including controlled substances (eg, injectable testosterone, hydrocodone/acetaminophen, Tylenol with codeine, diazepam) and many others. The magnitude of illegitimate online prescription access is hard to estimate, simply because consumers who use these sites are not willing to disclose their sources. The fundamental problem is that there is no mechanism for controlling Internet sales of prescription medications.
Illegitimate sites have been around for a few years and appreciate high revenues, all the while operating under our current States' Pharmacy and Medical Practice Acts. Their popularity has even resulted in manuscripts and textbooks (available for purchase) on how to exploit the Internet for prescription drugs. New sites are created every day, and existing sites may shut down operation one day only to begin business under a new name the next. Many argue that strict enforcement of existing laws is necessary. While this may be true, Medical Boards and Boards of Pharmacy simply do not have the authority, training, manpower, or adequate funding to begin investigation and enforce compliance. The need for a federal level of regulation could also address Internet sites located in other countries. These sites violate federal importation and distribution laws under the Federal Food, Drug and Cosmetic (FD&C) Act. State Boards of Pharmacy and Medical Boards are just beginning to understand the issues related to the Internet. This new technology is providing consumers with new ways to get around our existing laws and regulations.
Even if the proposed federal laws duplicated existing state pharmacy laws and regulations, this would further help to protect consumers by imposing heavy penalties and would provide another level of accountability. Federal regulations would also encourage consistency among individual states. The nonprofit, nongovernment National Associations of Boards of Pharmacy (NABP) has created the voluntary certification seal of approval for legitimate online pharmacies. This seal, Verified Internet Pharmacy Practice Site (VIPPS), is a step in the right direction but is not meant to enforce compliance. The VIPPS seal can be easily copied and transferred to any pharmacy Internet site. Furthermore, the average consumer doesn't know what the VIPPS seal means and likely doesn't know that NABP is certifying online pharmacies.
Pharmacy is indeed one of the most regulated professions, but in this instance it's time for legislators and healthcare professionals to appreciate the many implications of the Internet on the practice of pharmacy. Legitimate online pharmacies currently meet all existing regulations and requirements for prescription dispensing and therefore should not have to change their practices.
Federal regulations can serve a few functions, including the following:
Increase healthcare provider and legislator awareness, especially in those states that may not realize the scope and depth of the problem;
Increase consumer awareness of legitimate online pharmacies;
Improve consistency among individual states and encourage states to set tighter regulations specific to their Pharmacy and Medical Practice Acts;
Serve as a deterrent to illegitimate pharmacy site entrepreneurs; and
Provide federal funding for maintaining, evaluating, and enforcing illicit Internet practices.