US Pharm. 2009;34(1):42-45.
In the past few months, the federal government has issued two sets of rules regarding the use of computers and related technologies governing the prescribing and dispensing of controlled substances. In August 2008, this column focused on new regulations being promulgated by the Drug Enforcement Administration (DEA) that will permit the electronic prescribing (e-prescribing) of most controlled substances, with the caveat that the practice meets certain threshold standards.1 More recently, on October 15, 2008, President George W. Bush signed into law provisions enacted unanimously by the House of Representatives and Senate. This latest incarnation is aimed at the rogue Internet pharmacies that regularly remind us, often several times a day through spam e-mails, that we can get any drug we want without a prescription, at vastly discounted prices. After several high-profile cases of individuals suffering severe, and sometimes fatal, negative effects of drugs purchased from these "shadow" marketers, Congress decided to draft legislation aiming to outlaw the practices of purveyors of drugs using this method of distribution.2 The challenge for pharmacies that use the Internet for e-prescribing will be to avoid the land mines of illegal activity while still using the technological advances that are available for the efficient and, more importantly, legal conduct of pharmacy practice. It will be a bit like handing out keys to the candy store right before changing the locks: The candy is right there in front of you, but there are barriers you have to overcome before you can gain access to it.
The Ryan Haight Act
This new law, formally known as the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, is an amendment to the Controlled Substances Act that aims to control unlawful access to potent drugs that are potentially lethal.3 The Ryan Haight Act is named for an 18-year-old student who died after he took an overdose of what was represented to him as Vicodin (hydrocodone).4 By all accounts, Ryan was a fine young man. He was an honor student in high school and a varsity tennis player.5 He held down an after-school job at a nearby retail store. Simply put, he did not fit the profile of a troubled teenage drug abuser before his tragic death.
In 2001, Ryan ordered Vicodin from an online site holding itself out to be a legitimate pharmacy. He used the family computer in his home in San Diego and a debit card his parents had given him so that he could trade baseball cards on eBay. The "pharmacy" indicated that the individual ordering drugs did not need to have a physician's prescription because it was affiliated with a doctor who would review the order and authorize the drug for distribution to the buyer. In the online questionnaire that was required by the Internet store, Ryan indicated that he was a 25-year-old male with chronic back pain. A few days after he received the pills, he was found dead from what was described as an overdose of Vicodin. Ryan's mother is a registered nurse and his father is a physician. As parents of this apparently outstanding young citizen, they could not believe what happened or how their son became a user of illegally obtained medications. His mother testified before Congress and stated, "At a time when we were worried about our children being exposed to pornography and predators, marijuana, and alcohol, we did not know that drug dealers were in our own family room." After his death, one of Ryan's friends told his parents that Ryan used the Internet to get access to the drugs. Wanting to know how and when such activities occurred, the parents turned the computer over to the DEA so that it could investigate what happened. As a result, the parents learned that there are Internet Web sites with chat rooms glorifying these drugs where sellers go to encourage young people to try them.6
The number of physicians who participate in the illegal practice of authenticating controlled substance prescriptions is alarming. One physician was convicted for "treating" 244,000 patients over a period of eight months.7 Another physician pleaded guilty to authorizing the dispensing of over 50 million hydrocodone tablets between 2003 and 2007.8
For the families of pharmacists or other health care providers who think nothing like this could happen to their own loved ones--beware. Do a search of "Vicodin" on Google and start counting the number of sites offering to sell the drug with no restrictions and at major discounts. The number is staggering. Internet surfing using the name of this and many other drugs of abuse potential might also point to a DEA site warning about the illegalities and dangers associated with this form of marketing and drug distribution.9 That site also offers advice on "How to Spot a Rogue Pharmacy."10 Another educational site, known as Parents: The Anti-Drug, offers tips on helping to identify drug abusers in the family and advice to keep children away from these illegal temptations.11 It is very easy for a pharmacist to put together valuable tools like these when patients or patrons ask for help to avoid drug abuse.
Prescription Drug Abuse
While estimates of teen substance abuse are lower now than compared to a few years ago, there has been a marked increase in the use and abuse of prescription drugs among youths. According to the Office of National Drug Control Policy, two million teens abuse prescription drugs, with an estimated 2,500 young people per day initiating use.12 Prescription medications are now the top source of abuse for young people aged 12 and 13 years, with 70% of youth users saying they got the drugs for free from the family medicine cabinet or from friends. When asked about the new legislation, DEA Acting Administrator Michele M. Leonhart stated, "Cyber-criminals illegally peddling controlled substances over the Internet have invaded households and threatened America's youth for far too long by supplying pharmaceuticals with a few clicks of a mouse and a credit card number."13
Couple this information with a 2004 study projecting that 6.2 million Americans of all ages abuse prescription drugs and that as many as two million individuals are physically or psychologically dependent on those medications.14 Like the youth of this country, many of these adults are abusing pain medications.
The government urges all parents to safeguard prescription painkillers when they are in the home for legitimate purposes. Central nervous system depressant drugs are overwhelmingly the most abused substances. Parents need to control access to these medications in their homes when they are done using them. Pharmacists should be aware that prescription drugs are not routinely discarded after the use for which they were prescribed ends. Parents should be encouraged to dispose of their drugs properly, as well as to make sure they talk to their children about prescription drug abuse.
To put some perspective on the magnitude of the problem, in 2006, 34 Internet pharmacies that had no legitimate retail or brick and mortar operations dispensed over 98 million doses of hydrocodone. Based on the average sales of hydrocodone by "real" pharmacies, these 34 Internet facilities dispensed enough of this one drug to supply more than 400,000 legitimate patients for a month.15 The Office of National Drug Control Policy estimates that a legitimate pharmacy dispenses about 88,000 doses of hydrocodone each year. It would take about 1,100 legally operating pharmacies to dispense the amount diverted by these 34 rogue pharmacies.16
The Ryan Haight Act will provide necessary legal ammunition to state and federal policing agencies trying to combat the unlawful rogue pharmacies that profiteer from the lure of prescription drugs that many young (and some older) people seem to be attracted to. A legal prescription must be presented to a pharmacy before a pharmacist is permitted to dispense any drugs to a person who requests them. To be legal, a prescription must originate from a licensed and/or registered physician pursuant to a legitimate patient-doctor relationship. That relationship is defined to include, at a minimum, one face-to-face diagnosis or physical examination. Pharmacies are specifically prohibited from dispensing controlled substances pursuant to an online questionnaire when the pharmacy knows, or at least should know, that the person requesting the drugs has not obtained a prescription following a face-to-face interaction with the prescriber.
The Ryan Haight Act also requires Internet pharmacies to display the following on their Web site: 1) who owns the Web site; 2) the name of the pharmacist associated with the Web site; and 3) the name of any physician working for or with the Web site owner. An Internet pharmacy is also prohibited from referring the patient to a physician who never sees the patient in the context of a normal patient-physician relationship. Pharmacies that use the Internet for distribution and dispensing activities will have to obtain a certification from the DEA indicating that the pharmacy is in compliance with all of the laws addressing these issues. That certification will be in addition to the registration requirements of the Controlled Substances Act.17
The tricky part of enforcing this law will be in distinguishing between rogue pharmacies that operate on the illegal side of the law and those that provide legitimate services through online activities. Perhaps the most odious task will be in recognizing legitimate telemedicine practices in rural or underserved areas as opposed to the unlawful acts committed by the rogue drugstores where a patient has never seen the prescribing physician. Addressing this conundrum, the Ryan Haight Act specifies that the patient has to have at least one face-to-face encounter with a prescribing physician before a prescription for controlled substances will be deemed legal. If there is any doubt about the legitimacy of a patient-physician relationship, the pharmacist will have to verify the prescription with the physician. It would help if the pharmacist making the verification phone call asked for the date and time that the face-to-face encounter occurred. While it is virtually impossible to guarantee that the verification is honest and trustworthy, with a recording of the date and time, pharmacists will have a good-faith defense if their conduct is ever called into question.
The Ryan Haight Act permits state attorney generals to initiate criminal proceedings in a federal court against those involved with illegal Internet pharmacy operations. This provision is designed to help the state enforcement agencies overcome jurisdictional hurdles when Internet pharmacy organizations are located in states other than the one where the medications are being delivered.
One of the aspects that this new law does not address is what to do about the rogue pharmacies that operate outside the U.S. Statistics suggest that when an Internet provider operating in another country obtains a request for controlled medications, the actual dispensing of the drug happens at a local pharmacy within the U.S. A major source of distress will occur when American citizens send their prescription orders from a legitimate U.S.-based physician to a pharmacy located in Canada, where prescription drug prices tend to be lower compared to those in U.S. pharmacies. The Ryan Haight Act makes a distinction between lawful acquisition of drugs from outside the U.S. border and unlawful prescriptions obtained within our borders for the purpose of diversion. This sounds like an honest differentiation, but it may be more problematic to enforce once the details are considered.
2. Helping patients avoid counterfeit drugs over the Internet (September 2007). FDA Patient Safety News. www.accessdata.fda.gov/scripts/cdrh/cfdocs/PSN/transcript.cfm?show=72. Accessed December 6, 2008.
3. PL 110-425, 21. USC §829 et seq.
4. McKenna C. Ryan Haight Act will require tighter restrictions on Internet pharmacies. Government Technology. October 2, 2008. www.govtech.com/gt/419355. Accessed November 11, 2008.
5. Ryan Haight Online Consumer Protection Act (S980). www.drugbuyers.com/freeboard/ubbthreads.php?ubb=showflat&Number=678088. Accessed November 18, 2008.
6. Press briefing by director of the Office of National Drug Control Policy, John Walters, on 2008 National Drug Control Strategy. March 1, 2008. www.allamericanpatriots.com/
7. Internet pharmacy harms. RxBeat. 2006;2(3). www.fsmb.org/pdf/NCIP_
8. Internet Drug Law archives. Defense attorney analysis of Internet pharmacy, prescription, and drug laws. http://internetdruglaw.com/. Accessed December 6, 2008.
9. Consumer alert. DEA warning--buying drugs online may be illegal and dangerous! Office of Diversion Control. www.deadiversion.usdoj.gov/consumer_alert.htm. Accessed December 6, 2008.
10. Questions & Answers. Dispensing and purchasing controlled substances over the Internet. Office of Diversion Control. www.deadiversion.usdoj.gov/faq/internetpurch.htm. Accessed November 13, 2008.
11. Drug information. Parents: the Anti-Drug. www.theantidrug.com/drug_info/
12. See note 6, supra.
13. See note 4, supra.
14. See note 4, supra.
15. See note 6, supra.
16. See note 6, supra.
17. See note 4, supra. To comment on this article, contact firstname.lastname@example.org.