Originally published in the February 2012 NABP Newsletter
An estimated 36 million Americans, or one in six people, have ordered prescription drugs from Internet Web sites without a prescription, according to a Partnership at Drugfree.org survey. Consistent with this finding, NABP has found that approximately 80% of the sites on the Association’s Not Recommended list do not require a valid prescription. Consumers using rogue sites continue to be at risk as regulators look for new ways to combat this issue.
As stressed in the October 2011 NABP Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators, the operators of rogue sites, “take advantage of patient confidence in trusted brands to sell pills that may contain too much or too little, if any, of the approved drug’s active ingredient, an entirely different active ingredient, or contaminants ranging from talcum powder to printer ink.” Indeed, cases of consumers, both in the United States and abroad, harmed by counterfeit drugs ordered from such rogue sites have been documented. Further, rogue Internet drug outlets put patients at risk by distributing controlled substance (CS) drugs without requiring prescriptions, raising the potential for drug-drug interactions, overdose, and drug abuse or addiction. In fact, Drug Enforcement Administration (DEA) has indicated that rogue sites contribute to the prescription drug addiction epidemic.
Federal regulators have had some success, at times in collaboration with their international regulatory counterparts, in shutting down rogue Internet drug outlets. Congress is considering bills to address the problem, one by way of protecting intellectual property, and another by adopting tougher penalties for counterfeit trafficking.
On the state level, boards of pharmacy have had an impact by disciplining licensees engaged in dispensing drugs based on invalid prescriptions associated with Internet drug outlets. Boards have also partnered with DEA in cases where licensees are involved in larger scale Internet drug distribution schemes. In some states, laws requiring board of pharmacy oversight for the registration of Internet pharmacies, and laws or rules that recognize VIPPS® (Verified Internet Pharmacy Practice SitesCM) as fulfilling certain state requirements also help to protect patients.
Through establishing programs such as VIPPS, Vet-VIPPS® (Veterinary-Verified Internet Pharmacy Practice SitesCM), and the NABP e-Advertiser ApprovalCM Program, providing research on rogue sites to federal and state regulators, and through consumer education initiatives, NABP has taken several steps to protect patients from the harmful products peddled by rogue Internet drug outlets. And to determine whether additional action should be taken by boards of pharmacy and the Association to address the illegal distribution of drugs via Internet sites, the NABP Task Force on Internet Pharmacy Practice will convene March 6-7, 2012.
Boards of Pharmacy Actions
State legislatures and state boards of pharmacy continue to take steps to protect their residents from rogue drug outlets operating via the Internet.
In Iowa, legislation adopted in 2009 required that the Iowa Board of Pharmacy develop rules for the registration of Internet pharmacies, including rules to define “Internet pharmacies” and “Internet pharmacy sites,” and to establish requirements for site registration, site content, and other relevant matters. The rules must also cover the requirement that Internet pharmacies doing business in Iowa must be accredited through the VIPPS program. The Board is currently developing the rules.
As reported in the 2012 NABP Survey of Pharmacy Law, at least 14 states, in addition to Iowa, recognize VIPPS accreditation as fulfilling certain requirements of Internet pharmacies dispensing to patients in their state. And at least four states, Florida, Hawaii, Missouri, and Utah, have a separate category for licensing Internet pharmacies. At least one state, Indiana, requires that in-state Internet pharmacies are licensed as mail order pharmacies.
Boards are also able to have an impact on illegal Internet drug outlets by disciplining licensees, both pharmacies and pharmacists, who facilitate their business by dispensing invalid prescriptions. Boards of pharmacy in California, Minnesota, and Ohio have issued fines and put pharmacist licenses on probation for such violations, as reported in the December 2010 NABP Newsletter article “State Boards of Pharmacy Take Action to Stop Licensees Involved in Unlawful Internet Drug Outlet Schemes.” As detailed in the same article, the boards in Iowa and Kansas also took emergency actions against pharmacies involved in larger scale Internet drug distribution schemes.
NABP continues to keep federal and state regulators and other stakeholders informed via the quarterly reports of the Internet Drug Outlet Identification program. As of October 2011, the program had reviewed almost 8,500 Internet drug outlets, finding that over 96% of the sites are operating out of compliance with state and federal laws and/or NABP patient safety and pharmacy practice standards.
NABP shared such information at a White House meeting on rogue Internet drug outlets November 9, 2010, and also presented information about the VIPPS accreditation program. The US Office of the Intellectual Property Enforcement Coordinator (IPEC) that coordinated the meeting, as well as meeting participants, were supportive of developing a “White List” of legitimately operating online pharmacies based on expanding the VIPPS list. Subsequently, NABP participated in a panel discussion, “Dangers of Counterfeit Pharmaceuticals,” coordinated by the IPEC office December 14, 2010.
NABP also participated in a Congressional Briefing coordinated by the Partnership for Safe Medicines (PSM) and Senator Chris Coons on June 23, 2011, to discuss the problem of rogue Internet drug outlets. Participants at the meeting discussed challenges regulators face and strategies to solve the problem.
To raise awareness among consumers, NABP issued a public health alert warning Americans about the dangers associated with medications purchased through fake online pharmacies, and presented some of the Association’s research statistics. NABP also continues to educate the public via e-News announcements and via the AWARxE™ consumer protection program Web site, www.AWARErx.org, and outreach events.
Federal Actions, Successes, and New Challenges
The Ryan Haight Online Pharmacy Consumer Protection Act, by amending the Controlled Substances Act (CSA) with a definition of “valid prescription,” allowed for the prosecution of individuals distributing CS via the Internet without requiring a valid prescription. The law went into effect April 13, 2009, and DEA announced the first charges in violation of the law in May 2010.
In addition, federal law enforcement and regulators, often in partnership with international regulators and with private US entities, have been able to shut down thousands of such Web sites.
However, new challenges in both arenas continue to arise. IPEC explains, in a report released in March 2011, that the definition applied to the CSA “was designed to address the practice of online pharmacies that dispensed controlled substances without a prior prescription or on the basis of a purported review by a physician who reviewed a questionnaire.” However, many online sellers market prescription drugs other than CS. Thus, IPEC recommends, that the Federal Food, Drug, and Cosmetic Act (FD&C Act) be amended to use the Ryan Haight definition of valid prescription so that non-CS prescription drugs sold online may be regulated. IPEC indicates that a similar amendment to the FD&C Act can “help reduce the number of online pharmacies evading prescription requirements and, in turn, selling counterfeit drugs.”
Bryan Liang, PhD, MD, JD, vice president of the PSM, agrees with IPEC’s recommendation and stressed at the Congressional Briefing in June 2011 that current federal regulations address only online pharmacies that are based in the US and that distribute CS.
Liang and other industry experts point out another challenge; specifically, while thousands of rogue Internet drug outlets have been shut down, the operators of such sites can easily set up shop again. Further, if investigations result in arrests and convictions on charges related to distributing counterfeit drugs via the Internet, the penalties are not tough enough to deter others from engaging in counterfeit manufacture or distribution. Liang has also noted that it is “difficult to attribute patient death or injury to online drug consumption or purchase.” Meanwhile, counterfeiters and rogue site operators are motivated by hefty profits. For example, “When sold at market price, counterfeit ED [erectile dysfunction] drugs reportedly can generate 2,000% profit margins – approximately 10 times the profitability of heroin,” as indicated in the October 2011 NABP Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators. Industry experts, both represented by the Alliance for Safe Online Pharmacies (ASOP) and by IPEC have stressed that increasing penalties for convictions related to the manufacture and distribution of counterfeit drugs can help to prevent this crime.
Liang indicates another challenge for customs and law enforcement – with the millions of illegal imports being shipped into the US, it is impossible for every package to be screened for the presence of counterfeit drugs. And, as highlighted in a March 2011 60 Minutes report, even with the thousands of packages seized, under current law, many packages must be shipped back to overseas senders, giving another chance for the package to be reshipped and possibly evade detection. Customs and Border Protection told PSM that many such packages are the result of Internet orders with the counterfeits being shipped directly to patients.
Consistent with the IPEC recommendation, the Online Pharmacy Safety Act of 2011 (S 2002), introduced to the Senate on December 15, 2011, would amend the FD&C Act to use the Ryan Haight definition of valid prescription so that non-CS prescription drugs may only be ordered and dispensed from an Internet pharmacy pursuant to a valid prescription. The bill is also intended to protect Americans from counterfeit drugs sold over the Internet by requiring the establishment of a registry of legitimate online pharmacy Web sites, which would include Internet pharmacies accredited by the NABP VIPPS program. In addition, the legislation would allow Internet service providers – such as domain name registrars, financial transaction providers, and Internet advertising services – to cease or refuse to provide services to Internet drug outlets not included on the registry.
Other legislation has been drafted to specifically target the trafficking of counterfeit drugs and was introduced by Senator Patrick Leahy (D-VT) to the Senate on November 17, 2011. The Counterfeit Drug Penalty Enhancement Act of 2011 would increase penalties for trafficking counterfeit drugs, with convicted individuals facing penalties of up to $4 million and 20 years imprisonment, and up to $8 million for multiple offenses. Entities convicted of trafficking counterfeit drugs could face fines as high as $10 million for a single offense or as much as $20 million if convicted of multiple offenses. One supporter of the bill stated that under current US law, individuals convicted of trafficking counterfeit drugs typically face prison sentences of three years, while the products they peddle can cause serious health issues for unsuspecting purchasers.
Attempts to fight counterfeits with legislation protecting intellectual property have been met with much debate. In May 2011, the “Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011” was introduced to the US Senate. This legislation was developed with the intention of targeting the worst-of-the-worst Internet intellectual property infringers by eliminating financial viability of a site, rather than blocking access. While the bill was developed to respond to concerns voiced by various parties over 2010 intellectual property legislation, it also faced much criticism.
In addition, another bill, the Stop Online Piracy Act (SOPA), which was introduced to the House in October 2011, as of press time has been deferred to a House committee. SOPA builds upon the two previous pieces of legislation and includes provisions intended to fight rogue Internet drug outlets by encouraging private companies to stop doing business with them, as summarized by ASOP. The bill also includes provisions that would increase penalties for convictions related to trafficking counterfeit drugs.
Along with federal and state legislation, industry experts and government agencies have recognized the need for a global perspective and for international partnerships to make headway in regulating rogue Internet drug sites.
Food and Drug Administration (FDA) joined regulatory agencies from 81 countries for the International Internet Week of Action, September 20-27, 2011. The collaborative effort aims to curb online distribution of counterfeit medications, and in 2011 INTERPOL reports that “almost 13,500 websites engaged in illegal activity were shut down.” FDA reports that at least 578 sites selling unapproved drug products to US citizens were shut down as a result of the global action.
The World Health Organization and other international health groups have taken serious steps to fight counterfeits and protect the quality of drugs. At a November 21, 2011 meeting called by the World Health Professions Alliance (WHPA), participants focused on reducing the impact of counterfeit drugs on patients and the public in central Europe and acknowledged the role of the Internet in disseminating counterfeit drugs. The resulting WHPA Prague Call to Action, among its four objectives for action, called for fostering regional collaborative initiatives, including attention to the illegal Internet distribution of counterfeit drugs.
Closer to home, the Canadian regulatory agency, Health Canada, has taken steps to protect its citizens from the dangers of counterfeit drugs sold on the Internet. In November 2010, Health Canada issued a warning to consumers about three specific sites found to be peddling counterfeit drugs. As explained in the warning, the sites had been reviewed by the Ontario College of Pharmacists and it was determined that they were not associated with pharmacies licensed in Ontario. Health Canada has also provided a section of its Web site devoted to raising awareness among Canadians about the risks of ordering drugs online.
Task Force to Invite Partners, Consider Global Perspectives
The NABP task force is committed to taking a global view, as it also considers the future steps of state boards of pharmacy and the Association. The charge of the task force will be to:
- Review existing Internet pharmacy practices;
- Review current state laws and regulations, VIPPS standards, and NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy language; and
- Examine future opportunities and challenges in an emerging global environment.
At least one representative from a Canadian pharmacy regulatory body will participate on the task force, and recommendations from the task force may help bring about global cooperation. The report of the task force will be the topic of a future NABP Newsletter article.