Internet Pharmacies: Some Pose Safety Risks for Consumers and Are Unreliable in Their Business Practices
Published: 2004-06-17T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase them. However, the global nature of the Internet can hinder state and federal efforts to identify and regulate Internet pharmacies to help assure the safety and efficacy of products sold. Recent reports of unapproved and counterfeit drugs sold over the Internet have raised further concerns. This testimony summarizes a GAO report: Internet Pharmacies: Some Pose Safety Risks for Consumers, GAO-04-820 (June 17, 2004). GAO was asked to examine (1) the extent to which certain drugs can be purchased over the Internet without a prescription; (2) whether the drugs are handled properly, approved by the Food and Drug Administration (FDA), and authentic; and (3) the extent to which Internet pharmacies are reliable in their business practices. GAO attempted to purchase up to 10 samples of 13 different drugs, each from a different pharmacy Web site, including sites in the United States, Canada, and other foreign countries. GAO assessed the condition of the samples it received and forwarded the samples to their manufacturers to determine whether they were approved by FDA, safe, and authentic. GAO also confirmed the locations of several Internet pharmacies and undertook measures to examine the reliability of their business practices.
section_title: What GAO Found
paragraphs: GAO obtained most of the prescription drugs it sought from a variety of Internet pharmacy Web sites without providing a prescription. GAO obtained 68 samples of 11 different drugs--each from a different pharmacy Web site in the United States, Canada, or other foreign countries, including Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey. Five U.S. and all 18 Canadian pharmacy sites from which GAO received samples required a patient-provided prescription, whereas the remaining 24 U.S. and all 21 foreign pharmacy sites outside of Canada provided a prescription based on their own medical questionnaire or had no prescription requirement. Among the drugs GAO obtained without a prescription were those with special safety restrictions and highly addictive narcotic painkillers. GAO identified several problems associated with the handling, FDA-approval status, and authenticity of the 21 samples received from Internet pharmacies located in foreign countries outside of Canada. Fewer problems were identified among pharmacies in Canada and the United States. None of the foreign pharmacies outside of Canada included dispensing pharmacy labels that provide instructions for use, few included warning information, and 13 displayed other problems associated with the handling of the drugs. For example, 3 samples of a drug that should be shipped in a temperature-controlled environment arrived in envelopes without insulation. Manufacturer testing revealed that most of these drug samples were unapproved for the U.S. market because, for example, the labeling or the facilities in which they were manufactured had not been approved by FDA; however, manufacturers found the chemical composition of all but 4 was comparable to the product GAO ordered. Four samples were determined to be counterfeit products or otherwise not comparable to the product GAO ordered. Similar to the samples received from other foreign pharmacies, manufacturers found most of those from Canada to be unapproved for the U.S. market; however, manufacturers determined that the chemical composition of all drug samples obtained from Canada were comparable to the product GAO ordered. Some Internet pharmacies were not reliable in their business practices. Most instances identified involved pharmacies outside of the United States and Canada. GAO did not receive six orders for which it had paid. In addition, GAO found questionable entities located at the return addresses on the packaging of several samples, such as private residences. Finally, 14 of the 68 pharmacy Web sites from which GAO obtained samples were found to be under investigation by regulatory agencies for reasons including selling counterfeit drugs and providing prescription drugs where no valid doctor-patient relationship exists. Nine of these were U.S. sites, 1 a Canadian site, and 4 were other foreign Internet pharmacy sites.

section_title: Letter
paragraphs: I am pleased to be here today as you discuss the safety of prescription  drugs sold by Internet pharmacies. As both the demand for and the cost of  prescription medications have increased, the Internet has emerged as a  growing marketplace for their purchase. Various types of pharmacies offer  prescription drugs over the Internet, including those that require a patient  to provide a physician’s prescription and are sometimes associated with  traditional chain drug stores, and other pharmacies that issue a  prescription based on an online medical questionnaire or have no  prescription requirement.
Like traditional pharmacies, Internet pharmacies are subject to state and  federal statutes and regulations designed to ensure the safety and efficacy  of the medications they dispense. However, the global nature of the  Internet poses challenges for regulators. States have identified Internet  pharmacies that do not comply with state pharmacy laws, but have  reported difficulty locating, investigating, and taking action against the  pharmacies when they are located beyond state borders. Federal agencies  have also taken steps to stop illegal Internet sales of prescription drugs,  including by prosecuting Internet pharmacies that dispense medications  without a valid prescription.  The Food and Drug Administration (FDA)  recently reported instances of drugs sold over the Internet that were  improperly handled, such as improperly packaged drugs, drugs that were  unapproved, and drugs that were not the authentic products consumers  intended to purchase. Consumer complaints regarding the business  practices of some Internet pharmacies have raised further concerns  associated with the use of Internet pharmacies to obtain prescription  drugs.
My testimony will summarize findings of a report we are releasing today  that examines issues surrounding the availability and safety of  prescription drugs sold over the Internet and the business practices of  certain Internet pharmacies. In a separate testimony, we are providing  further details about our purchases of narcotics from Internet  pharmacies. At your request, Mr. Chairman, we examined (1) the extent to  which certain prescription drugs can be purchased over the Internet  without a prescription; (2) whether drugs sold by Internet pharmacies are  handled properly, are FDA-approved, and authentic; and (3) the extent to  which Internet pharmacies are reliable in their business practices. We  attempted to place up to 10 orders for each of 13 targeted prescription  drugs, each from a different Internet pharmacy. (See table 1.) We  generally attempted to purchase each of the 13 drugs both with and  without a prescription, from a range of Internet pharmacies that purported  or appeared to be located in the United States, Canada, and other foreign  countries.
We identified whether the samples we received contained a pharmacy  label with patient instructions for use and whether warnings were  included on the labels or along with the packaging and made other  observations about the manner in which the drugs were handled and the  condition of the packaging. We forwarded the samples to the  manufacturers of the drugs to determine whether they were FDA- approved and authentic products, and identify any other safety concerns  associated with the drugs or their handling. We also undertook measures  to examine the reliability of Internet pharmacy business practices, such as  attempting to confirm the locations of certain Internet pharmacies and  identifying the pharmacy sites currently under investigation by federal  agencies.
We conducted our work from January through June 2004 in accordance  with generally accepted government auditing standards and in accordance  with the standards of the President’s Council on Integrity and Efficiency.
In summary, we were able to obtain the majority of prescription drugs we  targeted for purchase from a wide variety of Internet pharmacies without  providing a prescription. We obtained a total of 68 drug samples—each  from a different pharmacy in the United States, Canada, or other foreign  countries—representing 11 of the 13 drugs we targeted for purchase. Drug  samples received from other foreign pharmacies came from Argentina,  Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and  Turkey. The samples included drugs with special safety restrictions, and as  addressed in our companion statement, we were also able to obtain  addictive narcotic painkillers. Among the Internet pharmacies from which  we obtained drugs, 5 U.S. and all 18 Canadian pharmacies required the  patient to provide a prescription, whereas the remaining 24 U.S. and all 21  other foreign Internet pharmacies issued prescriptions based on their own  medical questionnaires or had no prescription requirements.
We identified several problems associated with the handling, FDA- approval status, and authenticity of the 21 drug samples received from  other foreign Internet pharmacies, but fewer problems among the 47  samples received from U.S. and Canadian Internet pharmacies. None of  the 21 samples from other foreign pharmacies included dispensing  pharmacy labels that provided instructions for use, and only about one- third included warning information. Thirteen of the 21 samples displayed  other problems associated with the handling of the drugs, such as 3  samples of a temperature-sensitive drug sent in envelopes without  insulation, and 5 samples containing tablets enclosed in punctured blister  packs, potentially exposing the tablets to damaging light or moisture.
Manufacturers reported that most of the drug samples from other foreign  pharmacies (19 of 21 samples) were unapproved for the U.S. market  because, for example, the labeling or the facilities in which they were  manufactured had not been approved by FDA; however, they reported that  the chemical composition of all but 4 of the other foreign samples was  comparable to the product we had ordered. Among the 4 exceptions, 2  samples were found to be counterfeit versions of the product we had  ordered, containing a lesser amount of the active ingredient, and 2 samples  had a significantly different chemical composition than that of the product  we had ordered. In contrast, all 47 of the drug samples we received from  U.S. and Canadian Internet pharmacies included dispensing pharmacy  labels, 41 included warning information, and none displayed evidence of  mishandling. Like the samples from other foreign pharmacies, most of  those from Canada were also unapproved for the U.S. market; however,  manufacturers determined that the chemical composition of all were  comparable to the product we had ordered.
Some Internet pharmacies—mostly other foreign pharmacies—were not  reliable in their business practices. We did not receive six of the orders we  placed and paid for, five of which were placed with other foreign Internet  pharmacies and one of which was placed with a pharmacy whose location  we could not determine. Also, we determined that several of the drug  samples were sent from locations that raise questions, such as from  private residences. We also observed Internet pharmacies that obscured  details about the drugs sold, such as other foreign pharmacies from which  we ordered brand name drugs, but then received a generic or foreign  version of the drug. Finally, about 21 percent of the Internet pharmacies  that sent us samples were found to be under investigation by the Drug  Enforcement Administration (DEA) or FDA. Reasons for the investigations  included allegations of selling adulterated, misbranded, or counterfeit  drugs and providing prescription drugs where no valid doctor-patient  relationship exists. Nine of these pharmacies were from the United States,  one from Canada, and four from other foreign countries.
subsections: section_title: Background
paragraphs: In the United States, the practice of pharmacy is regulated by state boards  of pharmacy, which establish and enforce standards intended to protect  the public. State boards of pharmacy also license pharmacists and  pharmacies. To legally dispense a prescription drug, a licensed pharmacist  working in a licensed pharmacy must be presented a valid prescription  from a licensed health care professional. The requirement that drugs be  prescribed and dispensed by licensed professionals helps ensure patients  receive the proper dose, take the medication correctly, and are informed  about warnings, side effects, and other important information about the  drug.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended,  FDA is responsible for ensuring the safety, effectiveness, and quality of  domestic and imported drugs. To gain approval for the U.S. market, a drug  manufacturer must demonstrate that a drug is safe and effective, and that  the manufacturing methods and controls that will be used in the specific  facility where it will be manufactured meet FDA standards. The same drug  manufactured in another facility not approved by FDA—such as a foreign- made version of an approved drug—may not be sold legally in the United  States. Drugs are subject to other statutory and regulatory standards  relating to purity, labeling, manufacturing, and packaging. Failure to meet  these standards could result in a drug being considered illegal for sale in  the United States.
The FDCA requires that drugs be dispensed with labels that include the  name of the prescriber, directions for use, and cautionary statements,  among other things. A drug is considered misbranded if its labeling or  container is misleading, or if the label fails to include required information.  Prescription drugs dispensed without a prescription are also considered  misbranded. In addition, if a drug is susceptible to deterioration and must,  for example, be maintained in a temperature-controlled environment, it  must be packaged and labeled in accordance with regulations and  manufacturer standards. Drugs must also be handled to prevent  adulteration, which may occur, for example, if held under unsanitary  conditions leading to possible contamination.
FDA-approved drugs manufactured in foreign countries, including those  sold over the Internet, are subject to the same requirements as domestic  drugs. Further, imported drugs may be denied entry into the United States  if they “appear” to be unapproved, adulterated, or misbranded, among  other things. While the importation of such drugs may be illegal, FDA has  allowed individuals to bring small quantities of certain drugs into the  United States for personal use under certain circumstances.
section_title: Most of the Targeted Prescription Drugs Were Purchased from Multiple Internet Pharmacies Without Providing A Prescription
paragraphs: We obtained 1 or more samples of 11 of the 13 drugs we targeted, both  with and without a patient-provided prescription. Drug samples we  received from other foreign pharmacies came from Argentina, Costa Rica,  Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand, and Turkey.  Most of the drugs—45 of 68—were obtained without a patient-provided  prescription. These included drugs for which physician supervision is of  particular importance due to the possibility of severe side effects, such as  Accutane, or the high potential for abuse and addiction, such as the  narcotic painkiller hydrocodone. (See table 2.)
Although most of the samples we received were obtained without a  patient-provided prescription, prescription requirements varied. Five U.S.  and all 18 Canadian pharmacies from which we obtained drug samples  required the patient to provide a prescription. The remaining 24 U.S.  pharmacies generally provided a prescription based on a general medical  questionnaire filled out online by the patient. Questionnaires requested  information on the patient’s physical characteristics, medical history, and  condition for which drugs were being purchased. Several pharmacy Web  sites indicated that a U.S.-licensed physician reviews the completed  questionnaire and issues a prescription. The other foreign Internet  pharmacies we ordered from generally had no prescription requirements,  and many did not seek information regarding the patient’s medical history  or condition. The process for obtaining a drug from many of these  pharmacies involved only selecting the desired medication and submitting  the necessary billing and shipping information. (See table 3.)
section_title: Most Problems Identified among Drug Samples Received from Other Foreign Internet Pharmacies
paragraphs: None of the 21 prescription drug samples we received from other foreign  Internet pharmacies included a dispensing pharmacy label that provided  patient instructions for use, and only 6 of these samples came with  warning information. Lack of instructions and warnings on these drugs  leaves consumers who take them at risk for potentially dangerous drug  interactions or side effects from incorrect or inappropriate use. For  example, we received 2 samples purporting to be Viagra, a drug used to  treat male sexual dysfunction, without any warnings or instructions for  use. (See fig. 1.) According to its manufacturer, this drug should not be  prescribed for individuals who are currently taking certain heart  medications, as it can lower blood pressure to dangerous levels.  Additionally, two samples of Roaccutan, a foreign version of Accutane,  arrived without any instructions in English. (See fig. 2.) Possible side  effects of this drug include birth defects and severe mental disturbances.  Compounding the concerns regarding the lack of warnings and patient  instructions for use, none of the other foreign pharmacies ensured patients  were under the care of a physician by requiring that a prescription be  submitted before the order is filled.
We observed other evidence of improper handling among 13 of the 21 drug  samples we received from other foreign Internet pharmacies. For example,  3 samples of Humulin N were not shipped in accordance with  manufacturer handling specifications. Despite the requirement that this  drug be stored under temperature-controlled and insulated conditions, the  samples we received were shipped in envelopes without insulation. (See  fig. 3.) Similarly, 6 samples of other drugs were shipped in unconventional  packaging, in some instances with the apparent intention of concealing the  actual contents of the package. For example, the sample purporting to be  OxyContin was shipped in a plastic compact disc case wrapped in brown  packing tape—no other labels or instructions were included, and a sample  of Crixivan was shipped inside a sealed aluminum can enclosed in a box  labeled “Gold Dye and Stain Remover Wax.” (See fig. 4.) Additionally, 5  samples we received were damaged and included tablets that arrived in  punctured blister packs, potentially exposing pills to damaging light or  moisture. (See fig. 5.) One drug manufacturer noted that damaged  packaging may also compromise the validity of drug expiration dates.
Among the 21 drug samples from other foreign pharmacies, manufacturers  determined that 19 were not approved for the U.S. market for various  reasons, including that the labeling or the facilities in which they were  manufactured had not been approved by FDA. For example, the  manufacturer of one drug noted that 2 samples we received of that drug  were packaged under an alternate name used for the Mexican market. The  manufacturer of another drug found that 3 samples we received of that  drug were manufactured at a facility unapproved to produce drugs for the  U.S. market. In all but 4 instances, however, manufacturers determined  that the chemical composition of the samples we received from other  foreign Internet pharmacies was comparable to the chemical composition  of the drugs we had ordered. Two samples of one drug were found by the  manufacturer to be counterfeit and contained a different chemical  composition than the drug we had ordered. In both instances the  manufacturer reported that samples had less quantity of the active  ingredient, and the safety and efficacy of the samples could not be  determined. Manufacturers also found 2 additional samples to have a  significantly different chemical composition than that of the product we  ordered.
In contrast to the drug samples received from other foreign Internet  pharmacies, all 47 of the prescription drug samples we received from  Canadian and U.S. Internet pharmacies included labels from the  dispensing pharmacy that generally provided patient instructions for use  and 87 percent of these samples (41 of 47) included warning information.  Furthermore, all samples were shipped in accordance with special  handling requirements, where applicable, and arrived undamaged.  Manufacturers reported that 16 of the 18 samples from Canadian Internet  pharmacies were unapproved for sale in the United States, citing for  example unapproved labeling and packaging. However, the samples were  all found to be comparable in chemical composition to the products we  ordered. Finally, the manufacturer found that 1 sample of a moisture- sensitive medication from a U.S. Internet pharmacy was inappropriately  removed from the sealed manufacturer container and dispensed in a  pharmacy bottle.
Table 4 summarizes the problems we identified among the 68 samples we  received.
section_title: Some Internet Pharmacies Were Not Reliable in Their Business Practices
paragraphs: We observed questionable characteristics and business practices of some  of the Internet pharmacies from which we received drugs. We ultimately  did not receive six of the orders we placed and paid for, suggesting the  potential fraudulent nature of some Internet pharmacies or entities  representing themselves as such. The six orders were for Clozaril,  Humulin N, and Vicodin, and cost over $700 in total. Five of these orders  were placed with non-Canadian foreign pharmacies and one was placed  with a pharmacy whose location we could not determine. We followed up  with each pharmacy in late April and early May of 2004 to determine the  status. Three indicated they would reship the product, but as of June 10,  2004, we had not received the shipments. Three others did not respond to  our inquiry.
We determined that at least eight of the return addresses included on  samples we received from other foreign Internet pharmacies were shipped  from locations that raise questions about the entities that provided the  samples. For example, we found a shopping mall in Buenos Aires,  Argentina, at the return address provided on a sample of Lipitor.  Authorities assisting us in locating this address found it impossible to  identify which, if any, of the many retail stores mailed the package. The  return address for a sample of Celebrex was found to be a business in  Cozumel, Mexico, but representatives of that business informed  authorities that it had no connection to an Internet pharmacy operation.  Finally, the return addresses on samples of Humulin N and Zoloft were  found to be private residences in Lahore, Pakistan.
Certain practices of Internet pharmacies may render it difficult for  consumers to know exactly what they are buying. Some non-Canadian  foreign Internet pharmacies appeared to offer U.S. versions of brand name  drugs on their Web sites, but attempted to substitute an alternative drug  during the order process. In some cases, other foreign pharmacies  substituted alternative drugs after the order was placed. For example, one  Internet pharmacy advertised brand name Accutane, which we ordered.  The sample we received was actually a generic version of the drug made  by an overseas manufacturer.
About 21 percent of the Internet pharmacies from which we received  drugs (14 of 68) were under investigation by regulatory agencies. The  reasons for the investigations by DEA and FDA include allegations of  selling controlled substances without a prescription; selling adulterated,  misbranded, or counterfeit drugs; selling prescription drugs where no  doctor-patient relationship exists; smuggling; and mail fraud. The  pharmacies under investigation were concentrated among the U.S.  pharmacies that did not require a patient-provided prescription (nine) and  other foreign (four) pharmacies. One Canadian pharmacy was also  included among those under investigation.
section_title: Concluding Observations
paragraphs: Consumers can readily obtain many prescription drugs over the Internet  without providing a prescription—particularly from certain U.S. and  foreign Internet pharmacies outside of Canada. Drugs available include  those with special safety restrictions, for which patients should be  monitored for side effects, and narcotics, where the potential for abuse is  high. For these types of drugs in particular, a prescription and physician  supervision can help ensure patient safety. In addition to the lack of  prescription requirements, some Internet pharmacies can pose other  safety risks for consumers. Many foreign Internet pharmacies outside of  Canada dispensed drugs without instructions for patient use, rarely  provided warning information, and in four instances provided drugs that  were not the authentic products we ordered. Consumers who purchase  drugs from foreign Internet pharmacies that are outside of the U.S.  regulatory framework may also receive drugs that are unapproved by FDA  and manufactured in facilities that the agency has not inspected. Other  risks consumers may face were highlighted by the other foreign Internet  pharmacies that fraudulently billed us, provided drugs we did not order,  and provided false or questionable return addresses. It is notable that we  identified these numerous problems despite the relatively small number of  drugs we purchased, consistent with problems recently identified by state  and federal regulatory agencies.
Mr. Chairman, this concludes my prepared statement. I would be pleased  to respond to any questions you or other Members of the Subcommittee  may have at this time.
section_title: Contacts and Acknowledgments
paragraphs: For future contacts regarding this testimony, please call Marcia Crosse at  (202) 512-7119. Other individuals who made key contributions include  Randy DiRosa, Margaret Smith, and Corey Houchins-Witt.
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