Like almost all businesses, the pharmacy has also set up shop in cyberspace. The emergence of internet-pharmacies has been consistently increasing. [i] While the exact number of Internet-pharmacies selling drugs is unknown, “at least nine state medical boards-in Ohio, California, Illinois, Kansas, Nevada, Texas, Washington, Wisconsin, and Wyoming-are investigating or disciplining doctors for prescribing online to patients they never see”. [ii] With the emergence of the internet-pharmacies, choice of law provisions, appropriate governing agencies and jurisdictional issues have arisen.[iii] This article will give a brief overview of the practice of local and foreign internet-pharmacies, current regulatory issues, and consumer safeguards.
A. The background of Internet-Pharmacies and their current practices
The internet-pharmacy allows consumers/web surfers to purchase drugs and other products typically found in a drug store on an internet-pharmacy Web Site. While there are many legitimate, law-abiding, internet-pharmacies that are “virtually” as safe as walking in to your traditional pharmacy, others are illegal and conduct unsafe prescribing and dispensing of prescription medicines.[iv] Internet-pharmacies have their benefits. The use of web-based prescriptions is often time-saving and convenient. In addition, many internet-pharmacies are less expensive than the traditional pharmacy and more competition generally leads to lower prices which is well welcomed in light of the sky-rocketing prices of prescription medications. Finally, some internet-pharmacies provide a twenty-four hour pharmacist. Such privacy may make the internet users much more comfortable in addressing medication and health related issues they perceive to be embarrassing.[v] Nonetheless, the internet-pharmacies have their downfall. As noted earlier, safety issues are always a concern regarding cyber-consultations, legitimate prescriptions and refills. In addition, the relatively low cost and ease of creating a professional web site makes it very difficult for internet-users to decipher from legitimate law-abiding internet-pharmacies and unlawful and unsafe web sites. Finally, health related information may not be private and is vulnerable to computer-hackers.[vi]
Currently, three types of internet-pharmacies exists: (1) pharmacies that only fill prescriptions written by a patients’ physician; (2) pharmacies that charge the patient for a physician “cyber-consultation” and then write a prescription for the patient; and (3) pharmacies that dispense prescription drugs without a physician’s prescription.[vii] The last two pharmacies may be dangerous, illegal and create a host of regulatory issues.[viii]
B. Regulating Internet Pharmacies: Who’s business? FDA, FTC, DEA or the States?
With the continued growth of managed health care, it may take patients weeks to see a doctor for a non-emergency health related issue. Consequently, self-diagnosis and the use of internet-pharmacies is increasing. The regulatory issues governing internet-pharmacies is far from clear. Internet-pharmacies must be aware that several governing authorities have staked their claim to regulating the industry. Internet pharmacies must comply with rules and regulations from the DEA, FDA, FTC and the States Departments of Regulations.
The DEA recently announced controlled-substance regulations for the Web Pharmacies.[ix] The emergence of the internet-pharmacies has expanded the DEA’s authority from regulating the typical brick and mortar pharmacy to cyberspace. The DEA announced that “U.S. registered Internet pharmacies cannot fill prescriptions for controlled substances in Schedules III, IV and V (most pain management medications) unless they contact the prescriber by telephone to confirm the legitimacy of the prescription, according to a new DEA Guidance Document”.[x] For Schedule II drugs, such as Ritalin, a commonly used medication for children with hyperactivity and attention deficit disorders, the pharmacy must have the original signed prescription.[xi] In addition, the DEA announced strict rules governing foreign pharmacies. Notwithstanding that a web-user has a valid prescription, “no controlled substances can be purchased from foreign e-sites and shipped to the United States”.[xii] In addition, the DEA stated that they are working on a project to define when and how prescribers can electronically sign and transmit prescriptions for controlled substances.[xiii]
Further, under the Federal Food, Drug and Cosmetic Act, the FDA has the legal authority to regulate (1) the importation, sale or distribution of an adulterated or misbranded drug; (2) the importation, sale or distribution of an unapproved new drug: (3) illegal promotion of a drug; (4) the sale or dispensing of a prescription drug without a valid prescription; and (5) counterfeit drugs.[xiv] The FDA focuses its regulation on Web Sites making unsubstantiated claims or misrepresentation of a drug benefit or use, and sites failing to provide all the information regarding the drugs risks and benefits. In addition, the FDA targets those sites promoting, marketing or selling of unapproved new drugs and prescriptions sold without a valid prescription.
In addition to the DEA and FDA, the Federal Trade Commission (FTC) also regulates internet-pharmacies. The FTC will target those web sites that falsely represent a drugs efficacy, similar to the FDA’s focus. In addition, the FTC will target those sights misrepresenting the security of the web site and misuse of a patient’s information given over the web site.
In addition to the host of Federal Regulatory agencies and regulations, internet-pharmacies are governed by the local States as well. There is pending regulation in virtually all States regarding internet-pharmacies. For example, in Michigan a senate bill would prohibit prescribing drugs or filling prescriptions based solely on consultations over the Internet. Further, a bill in Nevada would, in part, prohibit a pharmacist from dispensing a prescription if he or she knows that the prescription has been issued by a prescriber based solely on a consultation over the internet.[xv] In addition, any licensed pharmacist practicing over the internet should contact their local State pharmacy/licensing board for the State’s regulations and ethical requirements. Furthermore, because of the increase in internet-pharmacies and pharmacists practicing over the internet, pharmacists should be mindful of professional malpractice and other tort liability.
As noted above, the DEA has banned any import of a controlled substance notwithstanding the existence of a valid prescription.[xvi] The United States Customs Service has joined the DEA in this effort. Customs brokers must provide a letter describing the contents and expected use of packages entering the U.S. that have been sent from foreign drug companies or pharmacies. Furthermore, the FDA has sent out electronic warning letters to foreign internet-pharmacy web sites. Nonetheless, the policing of foreign web sites is extremely difficult with issues such as the lack of FDA authority of foreign sites, the immense number of foreign internet-pharmacies and the degree and methods of regulation of countries other than the United States. Consequently, regulatory issues regarding foreign internet-sites will continue to exist to some extent. In addition, because of the unclear federal rules and regulations, and the recent publicity of increased use in foreign internet-pharmacies that engage illegal dispensing and importation of prescription drugs, it is likely that customs will hold any “suspect” import.
For consumers considering utilizing an internet-pharmacy, they may contact the National Association of Boards of Pharmacy’s web site (www.nabp.net) for a list of verified internet-pharmacy practice sites.[xvii]
[i] See William Glanz, FDA Warns Against Cyber-Drugs; Agency Vows to More Closely Scrutinize Online Pharmacies, Wash. Times, July 31, 1997 (explaining that within 6 months in 1999 the number of online pharmacies increased from less than 30 to more than 400)
[ii] Mark D. Somerson, Regulators Say Internet Sales Prescription For Trouble, Columbus Dispatch, July 16, 1999 at 7.
[iii] See John A. MacDonald, Drugs on the Internet: Who’ll Call Shots? at A17 (explaining that a conflict exists between state and federal officials over who will regulate the lucrative business of prescription drugs being sold online).
[v] Editorials Pg. A18, States Should Control Internet Drug Sales, The San Francisco Chronicle, January 3, 2000.
[vi] Currently, the National Board of Pharmacy is certifying legitimate online pharmacies. Consumers considering utilizing an internet pharmacy may check the National Association of State Pharmacy Board’s web site www.nabp.net to see if a particular Web pharmacy is safe.
[vii] Michael F. Conlan, Net Watchers: Congress Weighs New Laws As It Probes the Practices Of Online Pharmacies, Drug Topics, Aug. 16, 1999, at 71.
[ix] DEA Explains Rules for Web Pharmacies, Drug Topics, May 7, 2001.
[xiv] Federal, Food, Drug and Cosmetic Act.[June 25, 1938 Chap. 675, Sec. 1, 52 Stat. 1040; 21 U.S. Code, Sec. 301.]
[xv] Privacy Regs a Top Concern of State Pharmacy Boards; privacy regulations, Chain Drug Review, June, 4, 2001.
[xvi] Drug Topics, Supra note 9.
[xvii] See Supra note 6.