| JPHAS |
| Journal for Pre-Health Affiliated Students |
JPHASFall 2001, Volume 1, Issue 1Mail order drugs: a threat to consumer safety at a fraction of the costBy Yvonne Wong, Staff Writer On November 17, 1992, Interpharm Inc. of Plainsview, New York recalled two hundred bottles of Ibuprofen (200-mg) in 1000 tablet containers due to the display of an incorrect lot number on the labels (1). Distribution of this product to Texas and Ohio were detained. In addition, 989 bottles of Ibuprofen (600-mg) in 500 tablet bottles were also recalled nationwide. The Food and Drug Administration (FDA) reported that the product exceeded abbreviated new drug application (ANDA) specifications for degradation (1). Under the Food, Drug, and Cosmetic Act, all manufacturers are required to submit an ANDA for any new generic drug before FDA approval is granted. An ANDA submission must include evidence that the generic drug contains the same active ingredients in the same form of dosage and strength as well as have more or less the same rate and extent of absorption as the innovator drug. Based on this company's failure to meet FDA standards, would you as a consumer and patient, risk putting your health in their hands? Medication, when prescribed by a licensed physician, has the ability to increase health stability and relieve discomfort. However, when consumers purchase mail-order drugs, how can they be completely certain that they are receiving the correct product as opposed to a counterfeit and that the product is free of contamination during the transportation process? The answer is they cannot. On January 30, 1992, the FDA and the U.S. Department of Health and Human Services sent out an import alert against unapproved mail order drugs promoted by six overseas companies. FDA field offices were instructed to automatically detain all imported unapproved prescription products manufactured by overseas companies such as Interpharm, Inc., of Nassau, Bahamas; Inhome Services of Delemont, Switzerland; or International Products of Hanover, Germany (9). Many of the ads for these companies claim to offer a wide variety of products to treat depression, high blood pressure, fungal infections, fatigue, and hair loss at a fraction of the cost of prescription drugs. However, in some cases, the drugs may prove to be counterfeit and can pose a serious risk to a patient's health. "Are we going to put our mothers our fathers, our grandparents and our kids at risk for the sake of cheaper drugs?" asked Rep. Billy Tauzin, a Louisiana Republican who chairs the House Energy and Commerce Committee (3). Also called "foreign versions," these drugs are often of unknown quality and provide inadequate information or directions for use. By opting for these foreign versions, we not only jeopardize our own health but the health of others as well. In a society where money equals power, consumers are always in search of ways to save money, even if it means purchasing an alternate version of their medication. They fail to realize that they also place their own lives in danger in the process. For many years, the FDA has allowed and will continue to allow in the future, the entry of small "personal use" quantities of drugs sold abroad but not approved by the United States under the following conditions: the drugs do not pose any unreasonable safety risks, the use of the drug is not promoted in the U.S., and the purpose of the drug is for a serious condition in which satisfactory treatment is unavailable in this country (9). By personal use, they are referring to the amount sufficient for three months or less of a patient's treatment. The FDA claims that these drugs are safe and effective based on their approval through scientific data, but warns consumers of law violations if used or acquired without a valid prescription from a physician or other licensed health professional. Curious as to how easily one could obtain a drug by ordering it online, I attempted to do so through the Yahoo search engine. What I uncovered was a lack of security and safety provided by several sites that can be as easily accessible to anyone as typing in the words, "mail order drugs + name of the drug you are looking for." I tested their security using Prozac Fluoexitine, an antidepressant used to treat depression by inhibiting the re-uptake of serotonin. I discovered that a bottle consisting of forty-eight caps (20-mg) of Prozac costs $110 while a bottle consisting of twelve caps (20-mg) of Prozac costs $30. I added both items into my shopping cart. The site did provide information on use and administration and also contained a list of possible side effects, warning users that over-dosage can cause nausea, vomiting, excitation of the central nervous system, and possibly death. However, when I proceeded to check out, no prescription was needed nor any specific personal information required besides that of a valid Visa or MasterCard, an email address, and a billing address. The site claims that U.S. citizens can legally import up to a three month supply provided that the following conditions are met: 1) The product was purchased for personal use and does not exceed a 3 month supply; 2) The product is not for resale, 3) The intended use of the product is appropriately identified; 4) The patient seeking to import the product affirms in writing that it is for the patient's own use; 5) The patient provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product; and 6) The medication is not a controlled substance, such as sleeping pills, or Valium (6). Following these conditions, there is a note stating that "99% of all medication shipments entering the U.S. don't meet the above conditions but the packages are allowed to enter the country anyway (6)." Other sites such as "1001 Drugs Galore" and the "Pharmacy Exchange" provide the same easy accessibility. However, they do require a membership fee for instant access ranging from $0.95 for a 30-day trial period to a one time payment of $29.95. Both of these sites, similarly, do not require a prescription by a physician for ordering access. On July 11, 2001, by a vote of 324 to 101, the House of Representatives made it legal for Americans to purchase prescription drugs from abroad via mail order (4). Despite arguments made by the pharmaceutical industry and the FDA, the House made their decision in an effort to cut drug costs. According to the Life Extension Foundation, an advocacy group, prescriptions in the United States cost three to four times more than they do in Europe and Canada. A 30-day supply of Claritin, an allergy medication, is said to cost $63 in the U.S. compared to $16 in Europe (4). With a greater dependence on mail-order drugs, job security of domestic pharmaceutical companies becomes threatened. The Los Angeles Times claim that "consumers' growing infatuation with ordering prescription drugs by mail could pose a threat to pharmacies' efforts to attract more customers by expanding into more medical-related services (5)." Licensed pharmacists at the local Walgreen's, K-mart, or Jewel-Osco will no longer be needed as they used to be. The California Pharmacists Association contends that, "the practice not only cuts into their profits but may pose health risks to patients (5)." Although some people believe that they should not have to travel thousands of miles to buy their medicine at a far lower price than they do at home, there are severe health risks involved. Once the drugs leave the United States, the FDA may not be able to continue monitoring its whereabouts until it reaches its final destination. By traveling overseas to foreign countries, there is a possibility for the drugs to fall into the wrong hands and become contaminated, thereby endangering the lives of consumers. But the bottom line is: what is more important, your money or your health? Sources
Yvonne Wong is a junior at UIC. She is majoring in Psychology and Pre-occupational Therapy and has a minor in Biological Sciences. |
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