Many consumers who buy prescription drugs from unregulated foreign Internet sites may be saving less than they think, or even spending more than if they were careful shoppers, says Randall Lutter, Ph.D., Acting Associate Commissioner for Policy and Planning at the FDA.

In 2004, the U.S. Customs and Border Patrol (CBP) detained more than 400 packages containing 807 prescription drug products received at the U.S. Postal Service International Mail facility in Miami that originated from outside the United States. The detained packages were apparently being sent to U.S. addresses from a source in Freeport, Bahamas, by a Canadian pharmacy, Kohler's Drugstore of Hamilton, Ontario, which had set up an Internet operation -- www.canadarx.net -- to do business with American consumers. Nearly half of the drugs were foreign generic drugs, or drugs for which there were generic versions available in the United States.

The FDA analyzed the prices actually charged on customer invoices for the detained foreign generic medications in the shipments. The FDA converted the price paid to U.S. dollars, and checked the prices at websites for four U.S. pharmacies. Comparing the price paid in Canada to the lowest price found from the four pharmacies, and taking into account shipping and handling fees charged by Canadian pharmacies (which range from $15 to $30), observations at the international mail facilities in July 2005 suggest that consumers keep buying prescription drugs from Canada even though they cost more than if they had purchased the FDA-approved generic versions in the United States.

It's a good idea to tell your doctors whether paying for medicine is a problem, says Edward Langston, M.D., a family physician in Lafayette, Ind., and an American Medical Association trustee. That doesn't mean physicians can fix all the problems, Langston says, but not being able to afford medication clearly affects your health.

"I think most physicians would want to help if they knew a patient won't be able to follow the treatment," Langston says. "But many patients find it a hard subject to bring up." When Langston writes a prescription, he asks patients, "Are you going to have any trouble getting this medication?"

So what can patients struggling with drug costs reasonably expect from their doctors? Patients should feel free to ask about whether a generic can be used instead of a brand-name drug or whether there is a similar drug that is less expensive. But some doctors don't know the price of drugs, so patients might have to do their own research, says Paul Hunter, M.D., a physician with Community Care for the Elderly in Milwaukee. In some cases, there may be nonprescription drugs that might work. Loratadine for allergies is a good example of an over-the-counter (OTC) medicine that is less expensive than brand-name prescription alternatives, Hunter says. Loratadine is the active ingredient in Claritin, Alavert, and some generic allergy medicines.

The doctor's office also can serve as a valuable resource for patients for such activities as informing them about the Medicare prescription drug benefit, signing application forms for patient assistance programs, and referring patients to state-sponsored services and community assistance programs.

In a recent survey of 519 cardiologists and general internists, nearly all reported that doctors should consider these costs when writing prescriptions. The study appears in the March 28, 2005, issue of the Archives of Internal Medicine.

One-third reported knowing how much patients are spending out of pocket for prescriptions. Commonly cited barriers to discussing drug costs with patients were insufficient time and concern over possible patient discomfort.

The researchers found that switching patients to a generic or a less expensive brand-name drug, the most frequently used strategy, was likely to be beneficial. But they noted that other approaches, such as tablet splitting, needed caution. Tablet splitting is done because higher-strength tablets are sometimes not much more expensive than lower-dose tablets. For example, tablet splitting involves splitting a 40 milligram (mg) tablet to get a 20 mg dose. The researchers said that while tablet splitting can reduce costs, it can also complicate prescription regimens and can be technically difficult to do.

"We don't advocate splitting pills to save money, and this isn't something patients should do on their own," says Tom McGinnis, R.Ph., the FDA's Director of Pharmacy Affairs. "We leave it up to the doctors. If the prescriber thinks a patient could benefit from a lower dose of medication than is available or if it's the only way a patient can afford the treatment, then the doctor can direct that a patient split the tablet. Pharmacies sell inexpensive devices that help consumers easily split tablets of all shapes." McGinnis says. The major concerns over tablet splitting are that the patient may not split the pills accurately and that some tablets, such as time-release versions, should never be split.

The practice of physicians distributing free samples of brand-name drugs -- another area that isn't clear-cut -- was the second most likely strategy used by doctors in the study to help ease cost concerns. Hunter says he thinks free samples influence doctors to prescribe expensive, new medications, but he has also worked in clinics where patients rely on free samples to reduce their drug costs.

"The intended use of a free sample is to allow a patient to evaluate side effects and effectiveness for a couple of weeks before actually buying the drug," Hunter says. "So patients can ask for free samples, but know that they are a temporary fix." Patients can't usually expect samples to provide long-term treatment. Patients who receive free samples should still ask their physicians whether a generic drug could be satisfactory.

Nicole Petersen, Pharm.D., a community clinical pharmacist at Schnuck's Pharmacy in St. Louis, says that samples aren't always the ideal solution, but sometimes they are all a patient has. When an 86-year-old woman walked out of the pharmacy without her medicine because she couldn't afford a $70 brand-name osteoporosis drug, Petersen called the patient's doctor to see what could be done.

"There was no generic alternative, so the doctor gave her some free samples," Petersen says. "But patients have to consider how long the physician can provide the free samples and what to do when they run out."

It might make sense for patients to take free samples while they are waiting to receive drugs through a PAP, she says. "If you do take free samples, you should still let your pharmacist know so that we can stay on top of drug interactions." Also, consumers should ask their doctors for information about the sample drug's directions, side effects, and warnings.

Some doctors don't stock free samples, which are normally distributed to doctors' offices by pharmaceutical sales representatives. Billi says drug samples have been eliminated at University of Michigan clinics. "The samples are a marketing tool," he says. "They aren't intended for maintenance. Giving them out puts doctors in the position of having to act like a pharmacist because you're supposed to keep up with lot numbers and expiration dates in case there are recalls. You're also getting patients started on a more expensive drug."

Medicare Part D, the new outpatient drug coverage beginning on Jan. 1, 2006, works like other health insurance plans. Medicare beneficiaries will be able to choose from at least two prescription drug coverage plans. Those plans will cover drugs for all medically necessary treatments, will pay for brand-name and generic drugs, and will enable beneficiaries to get prescriptions at a pharmacy or through mail order.

The standard drug coverage in 2006 will require consumers to pay a $250 deductible and a monthly premium of about $35. After beneficiaries pay $250, Medicare will pay 75 percent of a beneficiary's drug expenses up to $2,250, with beneficiaries paying 25 percent of the costs.

After total drug expenditures reach the $2,250 mark, Medicare's standard coverage pays nothing until the beneficiary spends another $2,800. "It's important to know that a lot of people will never reach the $2,250 amount," says CMS spokesman Karr. After spending reaches $5,100, the Medicare benefit will cover about 95 percent for the rest of the year with beneficiaries paying only 5 percent. "None of this applies to the Medicare beneficiaries who qualify for extra help because they will have no premiums, no deductibles, and no gaps in coverage," Karr says.

Some Medicare beneficiaries already get coverage for prescription drugs through union- or employer-provided health plans. If that plan is as good or better than Medicare's prescription drug coverage, Medicare will be providing new support so that coverage stays in place. "Beneficiaries should be hearing from their former employer or union this fall about their coverage options," Karr says.

Some Medicare beneficiaries also currently get drug coverage from a Medicare Advantage plan, and those beneficiaries should expect to hear from their current plan about what kind of coverage they will be offering, he says. Some plans are likely to offer coverage that is even more comprehensive than Medicare's standard drug coverage.

The first enrollment period starts on Nov. 15, 2005, and runs through May 15, 2006. For those who don't join a Medicare prescription drug plan by May 15, 2006, the monthly premium rises 1 percent a month. So for people who wait a year to join, the premium would go up by 12 percent.

People in Medicare who also receive assistance from Medicaid will get drug coverage from Medicare instead of Medicaid starting January 1, Karr says. Medicaid is the state-administered program for people with limited incomes. "If they haven't chosen a plan before January, these ‘dual-eligibles' will be automatically enrolled in a prescription drug plan so that no gap in coverage occurs," Karr says. "But they will also have the ability to change plans once a month if they find a plan that better suits their needs." People in Medicaid and Medicare will be automatically eligible for the extra help, giving them comprehensive coverage with no premiums, no deductibles, and no gaps in coverage.

"We have about 50,000 people in Oregon who fall into this category," says Jane-ellen Weidanz, the MMA project manager for Oregon's Department of Human Services. "The automatic enrollment is good because we don't want people to fall through the cracks. At the same time, we will be letting people know they need to review the plan they've been assigned to see if it meets their needs, and we will be giving them assistance to help them make needed changes."

Each state will decide how its assistance programs will work with Medicare coverage. As of May 2005, at least 39 states had established or authorized some type of program to provide pharmaceutical assistance, and 32 states had programs in operation, according to the National Conference of State Legislatures (NCSL).

As of June 1, 2005, 23 states had enacted laws or resolutions responding to or adjusting to the Medicare prescription drug provisions. The Medicare law allows states to "wrap around" the Medicare benefit to fill in gaps in coverage.

The Alabama SenioRx: Partnership for Medication Access program was created in 2002 to help people ages 60 and older who have no prescription insurance coverage and who live below 200 percent of the poverty level. The program helps more than 26,000 Alabama seniors receive free or discounted drugs through PAPs provided by pharmaceutical manufacturers.

"We have brought in approximately 90 million dollars in free and low-cost medications in the three years we have been in operation," says Irene Collins, executive director of the Alabama Department of Senior Services. "About 80 percent of our current clients will be eligible for the low-income subsidy with Medicare Part D."

Collins says her agency continually communicates with contacts at the PAPs to find out how they will change in response to the Medicare drug benefit. "Because we anticipate changes," Collins says, "we have been working over the last several months to ensure that our clients who are eligible for Medicare savings programs are enrolled. We are also conducting many education opportunities about the changes in Medicare and providing one-on-one counseling for our clients and their families and physicians."

The Medicare drug plans starting in January 2006 are different from the Medicare discount drug cards that have been used as a temporary measure. Medicare beneficiaries who have been using the temporary discount drug cards can use those cards until May 15, 2006, or until they sign up for a plan, whichever comes first. "The card is not valid once you sign up for a plan," Karr says.

Karr says Medicare beneficiaries should watch the mail in October 2005 for the "Medicare & You" 2006 brochure. "This will show people what plans are available on a local level," he says.