Importation of pharmaceuticals for personal use into the US.
Pharmaceuticals — much needed, often unobtainable due to cost. With medications costing millions of dollars to produce and test before United States Food and Drug Administration (FDA) approval for market, it’s no wonder Americans are forced to pay top dollar just to feel better. For the two-thirds of chronically ill patients fifty and older who underuse their prescription medications due to financial woes, these high costs are especially troublesome.
But the times they are a changing, over much government controversy. United States Senators Edward M. Kennedy and John McCain recently helped sponsor a bill to legalize importation of prescription drugs from foreign countries where they can be purchased often at substantial price decreases. While the laws of most countries, including the United States, allow the legal importation of pharmaceuticals for personal use, this law applies mainly to having the medicines on your person when crossing the border rather than to Internet mail-order sales.
A prescription is still needed to legally purchase medications. However, this is not always strictly enforced in all countries. The United States, Germany, Canada, and all Scandinavian countries do enforce these drug laws.
What may be a prescription drug in one country is considered an over-the-counter medication in another country. Controlled substances that tend to have a potential for physical or psychological abuse by users cannot be legally imported from anywhere in the world, as the controlled substance laws are similar in all countries.
What drugs are considered controlled substances in the United States? Basically, most stimulants, depressants, pain relievers (narcotics), hallucinogens, and anabolic steroids are listed as controlled substances. Amphetamine, methylphenidate (Ritalin), oxycodone, alprozolam (Xanax), diazepam (Valium), Iorazepam (Ativan), marijuana, and any product containing codeine are examples of controlled substances. For a complete list, visit the United States Drug Enforcement Administration’s (DEA’s) website at www.dea.gov.
The DEA website notes that only state-licensed practitioners or pharmacies registered with the DEA may prescribe or fill, respectively, a controlled substance prescription. Similarly, only those registered with the DEA as importers, and who are also in compliance with DEA requirements, may legally import these products. If your practitioner has prescribed a controlled substance, it is safest to obtain it through a local pharmacy, as illegal importation is a felony under the United States Controlled Substances Act (21 U.S.C. 960).
For years American citizens near border town to the south in Mexico and to the north in Canada have been visiting these neighboring countries solely to purchase their prescription medications at a reduced cost based on the importation for personal use law. Mr. Marven Shepherd, a University of Texas professor, spoke to the United States Subcommittee on Oversight and Investigations (in imported pharmaceuticals) in June 2001 where he noted that “size of the retail pharmacy business enterprise in border communities is huge. For example, the estimated 19976 annual dollar volume for just the top fifteen pharmaceutical products entering the United States from Nuevo Laredo (bordering Texas) was one hundred thirty-four million dollars.”
Shepherd went on to state that, “Except for products banned from the United States, United States customs officials do allow people to bring into the United States pharmaceutical products not available in the United States, as long as the patient has proper documentation for using the product. In addition, if people begin a drug therapy in Mexico, they are allowed to import the continuation of such therapies.” He cautioned that many of these Mexican-made drug products are not FDA approved, even though a United States-based pharmaceutical manufacturer’s label (such as Lily or Pfizer) is on the product.
On the northern front, it is estimated that one million Americans purchase medications from Canada. United States Senator Edward M. Kennedy has stated that a recent United States General Accounting Office (GAO) — the investigative arm of Congress — report “shows that Canadian pharmaceuticals are a safe source of high-quality prescription drugs, and we all know that these drugs are cheaper.”
The report, instigated by the high volume of Internet drug sales, shows that out of eighteen Canadian pharmacies contacted by the GAO, all required prescriptions, as opposed to only five of the twenty-nine contacted in the United States. All of the twenty-one non-United States or Canadian pharmacies contacted — including those in Mexico, Pakistan, and Spain — sold drugs without a prescription. View the complete GAO report entitled Internet Pharmacies: Some Pose Safety Risks for Consumers online at www.gao.gov/new.items.
Sy Oliven, who represents the Canadian prescription service called My Drugs Canada, stated that “technically, it is not legal to import pharmaceuticals prescriptions from Canada, but to my knowledge this law has never been enforced.” While United States customs does sometimes check or seize packages shipped from outside the country, most of the packages go through with no problem. The risk of seizures or shipments returned to the sender can be reduced by placing a small order from a reputable pharmacy and not attempting to order drugs listed as controlled substances (see Safe Online Ordering Guidelines).
Oliven provides his customers with personal assistance to safety place orders with a pharmacy broker in Montreal. This broker “uses a large reputable Canadian mail-order pharmacy as the selling pharmacy. We have a quality operation where shipments are on time, and we can follow-up shipments by Canadian Post with the tracer numbers” on each shipment. He requires the proper information in order to process an order — an United States prescription from a physician and a completed medical form, which are “given to a Canadian physician who writes a Canadian prescription.” The medical form is necessary to help avoid “combinations of prescriptions that can cause problems” Oliven noted.
The pharmacy broken Oliven works with can also provide alternatives to unobtainable medications. “Some medications (particularly Pfizer) have curtailed shipments of their pharmaceuticals to Canadian pharmacies who ship to the United States,” he says. Shipments are instead arranged from New Zealand and India. Oliven points out that “Indian generics are twenty-five percent less than Canadian brand-name prescriptions” and are FDA approved. “I often suggest to my customers that they ask their pharmacist what percentage of the generics he sells are made in India. You would be astounded by the answer — some say as much as thirty percent,” Oliven surprisingly concludes.
Whether you order from abroad or walk to the corner pharmacy, research your choices wisely. Certainly, the savings from ordering online from a reputable pharmacy and being able to afford the medications needed for good health must be weighed against any risks from ordering abroad. For now, Americans can support the passage of the proposed Congressional bill legalizing online pharmaceutical sales from foreign countries in hope that obtaining needed medications at an affordable cost will soon be a realization for all.
SAFE ONLINE ORDERING GUIDELINES FOR MEDICINES
by Elizabeth R. Elstien
* Do not order from any website offering the sale of controlled substances, such as narcotics.
* Avoid sites that state there is no need for a prescription.
* Be certain a website requests a medical history or profile be completed before ordering.
* Stay away from websites that make incredible or unsubstantiated results or cures for medications.
* Proceed with caution with websites offering a several-month supply. For instance, only a three-month supply is allowed with orders placed from Canada.
* Look for a pharmacy license number and verify legitimacy.
* Make sure a physical address is listed on the website and not just a telephone number.
* Pay by credit card. Websites that request cash are usually crooked. Many pharmacies don’t actually charge your credit card until the product has been shipped. To confidentially report a suspicious online pharmacy, use the DEA’s new toll-free hotline at 877-RxAbuse (877-792-2873).
* Use another online pharmacy if access to a customer service representative is not provided.
* Ignore foreign websites that state there have been changes in the United States importation laws when, in fact, no changes have yet occurred.
(Published in The Bridge, Vol. 27, No. 2, 2005)