| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, Washington.
Address reprint requests to: Leslie Miller, MD Department of Obstetrics and Gynecology Harborview Medical Center 325 Ninth Avenue, Box 359865 Seattle, WA 98104-2499 E-mail: lmiller{at}u.washington.edu
 |
Abstract |
|---|
Top
 Abstract Materials and MethodsResultsDiscussionReferences |
|---|
Methods: We performed an Internet search with the use of search engines and key words. We posed as consumers purchasing both prescription and over-the-counter contraceptive supplies. The number of clicks or web pages accessed, costs, shipping time, barriers to access, and prescription requirements were compared for selected birth control supplies.
Results: More than 200 web sites were visited to locate at least one site where we could purchase each selected product. Contraceptive supplies, including male and female condoms, spermicides, vaginal sponges, intrauterine devices (IUDs), diaphragms, and cervical caps, were easily obtained without a prescription from foreign web sites. Oral contraceptive pills (OCs) were readily available online in November 1999; some sites had discontinued sales by February 2000, but OCs could still be purchased with no prescription in August 2000. None of the four prescription sites supplied physician or prescriber credentials. The contraceptive costs varied by vendor and product. A type of copper IUD could be purchased for less than $50.00, whereas a single package of emergency contraceptive pills cost $141.00 from one vendor because of prescription and shipping fees. Some emergency contraceptive pills ordered arrived after 72 hours or did not arrive and the purchase was not refunded. A levonorgestrel IUD was shipped without difficulty in December 1999, but a second device, ordered in February 2000, was temporarily impounded by United States Customs.
Conclusion: This method of contraceptive purchase is accessible, expensive, erratically regulated, and rapidly changing.
The Internet, a communication revolution still in its infancy, has the potential to change retail pharmaceutical purchasing. Pharmaceutical products are typically dispensed by pharmacies located in brick and mortar settings. Regulation of prescription drugs over the Internet is getting media and regulatory attention, as evidenced by front-page newspaper coverage (Seattle Times, January 21, 2000). A recent comprehensive review of the Internet accessibility of sildenafil discusses the legal and ethical conflict between pharmaceutical dispensing and prescription requirements,1 raising the point that physicians should prescribe only for patients who reside in the state for which they are licensed. Armstrong et al2 identified 86 web sites that offered to deliver sildenafil to consumers without a visit to a physician. None of these sites posted physician qualifications, and yet 35% of the sites posted statements that the medical history supplied would be examined by a physician. The Food and Drug Administration (FDA) estimates that more than 200 companies are selling prescription drugs over the Internet, and many do not require a physician’s prescription (www.FDA.gov). The online pharmacies surveyed for a 1999 article3 often required a prescription, which could be purchased from a provider working for the Internet merchant. But who verifies that the medical history and information supplied by the consumer are correct? And where is the external control to limit the conflict between consumer interest and profit? We present our own experience obtaining both prescription and over-the-counter contraceptive supplies over the Internet during two recent time periods.
|
Materials and Methods |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
More than 200 web pages were visited to find order forms for the selected contraceptive products. When visiting the sites, we posed as consumers seeking contraceptive supplies because we wished to measure the actual costs and shipping time and to verify the product’s arrival and quality by package inspection. Specific contraceptive supplies included in the original November 1999 search were male condoms, female condoms, vaginal sponges, cervical caps, diaphragms, emergency contraceptive pills, oral contraceptive pills (OCs), and intrauterine devices (IUDs). During the second search in February 2000, the web sites selected for the original search data were revisited, and any changes from the original data were recorded. An additional search was performed to identify new vendors, and the list of contraceptive supplies was expanded to include Depo-Provera (Pharmacia & Upjohn, Peapack, NJ) and the Norplant system (Wyeth-Ayerst, St. Davids, PA). For manuscript preparation, we returned to the six vendors and the four sites where we had obtained products that normally require prescriptions to ask about physician credentials, in particular training, specialty board certification, current license, and state.
|
Results |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
and Table 2, respectively. The site URL, number of clicks to reach the order form, cost per single unit, time from order to delivery, and prescription requirement are all presented. Four web sites were used to place ten contraceptive orders in November 1999, and six web sites were used to place 15 contraceptive orders in February 2000. Contraceptive supplies available for purchase without a prescription from web sites originating in the United States included male and female condoms. Supplies available without a prescription from foreign web sites included vaginal contraceptive sponges, diaphragms, cervical caps, IUDs, OCs, and emergency contraceptive pills (Figure 1). Many of the supplies purchased were not manufactured in the United States or FDA-approved. Prescriptions for emergency contraceptive pills and OCs were available online from web sites originating in the United States only after an Internet physician consultation. United States sites offering Depo-Provera or the Norplant system required a prescription from a personal physician.
|
|
|
Although we identified two web sites that offered online prescription for Preven (Gynetics Inc., Somerville, NJ) emergency contraception, the Internet market for Preven was dominated by one web site (www.safewebmedical.com) regardless of the search engine used. After typing the search term "Preven" into two popular search engines (MSN and Yahoo!), we found that of the first 100 web sites identified as Preven vendors, 56 of the web sites were "portal sites" for www.safewebmedical.com. Portal sites are independent web pages that connect to a central Internet provider. Portal sites are often paid a commission by anchor sites, the actual provider of the services, for displaying an advertisement or taking the user to the anchor site.4 Indeed, 43 of the 100 sites pulled up on the Preven search turned out to be web pages unrelated to Preven. The remaining single site was for the other Preven prescription web page, www.clickthrupharmacy.com. In other words, the www.safewebmedical.com had made 43 links and www.clickthrupharmacy.com only one link. In addition, these two prescription web sites were nearly identical in form and layout. Each site was advertised as based in Miami, Florida, but different addresses were given for each business and no name or information about the online physician was presented on either web page. Therefore, it is conceivable that there was only one vendor.
Specific problems encountered in ordering certain contraceptive methods included two attempts to purchase Preven from www.clickthrupharmacy.com. Each time after purchase, the product failed to arrive within 48 hours. Although a telephone call to the number listed on the web site promised that credit-card charges would be refunded as promised, they were not. In addition, the country of origin listed on the credit-card receipt was the Dominican Republic, but the country of origin advertised on the web site was the United States (Miami, Florida). At the time of press, www.clickthrupharmacy.com no longer existed, and a follow-up telephone call to the same number as before reached a man who claimed to know nothing of the Internet! Although a different vendor, www.safewebmedical.com, delivered the Preven product rapidly, it was for the exorbitant cost of $141.00 ($48 for the kit, $75 for online consultation, and $18 for shipping and handling). The country of origin listed on this credit-card receipt was also outside of the United States and different from the Miami, Florida address listed on the web site. This was one of the sites that did not respond to our questions about physician credentials despite three attempts over 1 month, and, by August 2000, they had removed Preven from their menu while still offering sildenafil for consumer purchase.
In addition, we were unable to order Plan B (Women’s Capital Corp., Bellevue, WA) at any site. We did, however, obtain high-dose levonorgestrel pills from Australia (www.crowded.org) for free and with no prescription, but they took 18 days to arrive.
Certain contraceptive supplies were no longer available during the second search period. Online prescriptions from a US web site (www.thepillonline.com) based in Hawaii were stalled in December 1999 and then offline in February 2000 because of pressure and threatened lawsuits from several US states (personal communication, Rick Williams, MD). Certain web pages were changed to include more advertisements (www.globaldrugs.com), and this increased the number of clicks required for certain purchases because the customer has to "click through" ads. We also searched for misoprostol, mifepristone, and methotrexate, and there were no commercial sites at any time that allowed the purchase of these medical abortion prescriptions.
The questions about physician credentials were sent on three separate occasions over 1 month and still were not answered by the two US sites (www.safewebmedical.com and www.thepillonline.com). The two international sites responded. The first replied that they do not work with a physician and had stopped selling prescription products to the United States because the FDA asked them to stop (www.birthcontrol.com). The second site also responded that they do not work with a physician and purchased their birth control pills in bulk from a roster of doctors who issue bulk contraceptive prescriptions to decrease the world population (www.crowded. org).
In revisiting in August 2000 the six sites listed in Table 2
from the February 2000 search, we discovered that one had changed its name, one refused orders from the United States, one site was "temporarily closed," one site could not be opened at all, one site had dropped some prescription products, and only one international site appeared unchanged.
|
Discussion |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
It is possible to obtain birth control pills without a medical history or prescription. The web site www.crowded.org advertises on their home page "birth control pills—no prescription needed" and offers many pill brands not available in the United States and even free samples of emergency contraceptive pills. Combination OCs contain estrogen, which is contraindicated in pregnancy, lactation, hepatic failure or malignancy, breast and uterine cancer, and in women at risk for arterial or venous thrombosis. Death from birth control pill use is a rare event, but if the safeguards of a medical history and blood pressure evaluation are removed, more women at risk may use the product. Similarly, sildenafil is available to men without history verification or examination, and this drug appears to have more health risks than low-dose OCs.
The materials accompanying the contraceptive supplies we were mailed consisted of the package insert and no additional educational pieces. Many of the web sites displayed links to education about the method, but a visit to the link was not required to complete the purchase. It is therefore possible to buy an IUD or OCs and not be aware of any risk from the method until reading the packet insert. Even if sites mandated drug information, previous studies on the quality of Internet information revealed wide variability and a lack of standardized material.5,6 One study of four Internet drug-information sites for 32 commonly prescribed drugs (which included no contraceptives) found that although the content was often correct, there was no mechanism to contact the expert at the site for additional questions.5 These authors suggested that consumers should ask who supplies the content for a site and how often a web site is updated.
Both IUDs and diaphragms need medical management and insertion or fitting procedures, yet they were readily available directly to the consumer. The insertion of a non–FDA-approved IUD will involve another person, most likely a physician, who will need malpractice coverage for the procedure. Medical decision making and patient management are important concerns surrounding the issue of regulating "online prescriptions" and "Internet physicians."1,3 Because contraception provides a health benefit by averting the risks of an undesired pregnancy, at little risk for most users, it is difficult to propose stricter regulations. It is ironic that one of the vendors dropped OCs but continued to sell sildenafil directly to the consumer.
We used two web sites that offered online prescriptions through an Internet physician consultation. Neither US web site offered any information, even after specific queries, about the name, training, practice type, or the background of the prescribing physician. To obtain an Internet prescription, a consultation was very expensive. Bloom and Iannocone3 determined that the average cost for an online consultation was higher than that for a typical office visit, and similarly observed that none of the web sites provided the name, specialty, location, or qualifications of the consulting physicians.
Certain contraceptive items that are difficult or impossible to find in US pharmacies are available online from foreign web sites, and this could allow women in the United States greater contraceptive choices. According to the FDA, it is illegal for anyone, including a foreign pharmacy, to import prescription drugs that are not FDA-approved into the United States. However, under the FDA’s personal importation policy, US residents can import certain products that are not available in the United States for personal use under certain limited conditions. The item must still pass customs and, at customs, it is an arbitrary decision by the individual inspector whether to impound or seize an item. Because of our success in November in obtaining a levonorgestrel IUD, a local physician used our recommended vendor to purchase another one. Her device, after leaving Switzerland, was detained by a customs inspector. The customs agent asked, "Why can’t you use Triphasil [Wyeth-Ayerst], an approved levonorgestrel product?" (personal communication, Dr. Giosi Di Meglio). This comment demonstrates a lack of inspector knowledge about the contraceptive products imported and, in this case, the difference between an OC and the levonorgestrel IUD. We also wonder what will happen if the abortion pill or mifepristone becomes available on the Internet before it is available in US pharmacies. Will it be up to individual customs officials to decide which contraceptive methods are allowed into the United States and which are not?
Because contraceptives ordered from home may not arrive for 2 weeks, the time between order and delivery will continue to be a problem for this method of contraceptive acquisition. It was possible to have emergency contraceptive pills delivered within 72 hours, but new evidence supports increased efficiency if it is taken as soon as possible.7 This need for administration within 24 hours makes the Internet less appealing for the purchase of emergency contraceptive pills, especially in states such as Washington, where women can get them directly from a 24-hour pharmacy as part of a collaborative agreement between local physicians and pharmacists.
Advantages of online purchasing include access to supplies in remote or rural locations and the lack of an "embarrassment factor" when facing the drugstore clerk with a box of condoms. Contraception, like sexual enhancement, is a private and sometimes awkward topic for both provider and patient, and patients will continue to try to obtain these items in the privacy of their home, through the computer. Indeed, if men are thought to be intelligent enough to answer historic questions about their hypertension and cardiac histories to order sildenafil, then certainly women should be able to purchase OCs and perhaps mifepristone for delayed menses over the Internet. If contraception or impotence is a private affair, then how much more so is abortion, particularly given that many United States counties lack an abortion provider?
|
Footnotes |
|---|
Received June 19, 2000. Received in revised form August 28, 2000. Accepted October 5, 2000.
|
References |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
2. Armstrong K, Schwartz JS, Asch DA. Direct sale of sildenafil (Viagra) to consumers over the Internet. N Engl J Med 1999;341: 1389–92.
3. Bloom BS, Iannacone RC. Internet availability of prescription pharmaceuticals to the public. Ann Intern Med 1999;131:830–3.
4. McKeown MJ. Use of the Internet for obstetricians and gynecologists. Am J Obstet Gynecol 1997;176:271–4.[Medline]
5. Hatfield CL, May SK, Markoff JS. Quality of consumer drug information provided by four web sites. Am J Health Syst Pharm 1999;56:2308–11.
6. Seaboldt JA, Kuiper R. Comparison of information obtained from a Usenet newsgroup and from drug information centers. Am J Health Syst Pharm 1997;54:1732–5.
7. World Health Organization—Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33.[Medline]
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
