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The National Institute on Drug Abuse (NIDA) has issued a new research report that says that 17% of adults aged 60 or older may be affected by prescription drug abuse. They report that elderly persons use prescription medications three times as frequently as the general population and have the poorest rates of compliance with directions for taking medications. Other data suggest that elderly patients may be prescribed inappropriately high doses of some medications and may be prescribed these medications for longer periods than are younger adults, even though older people should be usually be prescribed lower doses of medications because the body's ability to metabolize many medications decreases with age.

They also point out an association between age-related morbidity and abuse of prescription medications. For example, elderly persons who take benzodiazepines are at increased risk for falls that cause hip and thigh fractures, as well as for vehicle accidents and cognitive impairment.

The Office of the Inspector General (OIG) of the Department of Health and Human Servies has investigated the oversight of the Food and Drug Administration (FDA) of dietary supplements. Unlike new prescription and over-the-counter drugs, dietary supplements do not undergo FDA premarket approval for safety and efficacy. Therefore, FDA must rely on its adverse event reporting system to identify safety problems. This inspection found that the adverse event reporting system is inherently limited as a tool to safeguard consumers. As is true of most adverse event reporting systems, FDA's system detects relatively few adverse events. For those that are reported, FDA often lacks important information, such as medical information, product and manufacturer information, and clinical information. With limited information, FDA rarely reaches the point of knowing when to take a safety action. The OIG made several recommendations to FDA to address this shortcoming

Generations Magazine has devoted its current issue to the subject of pharmaceuticals and the elderly. Guest editor Janice L. Feinberg reports that the economic impact of medication-related problems in people age 65 and older may be as high as $60 billion annually, rivaling the cost of Alzheimer's disease, cancer, cardiovascular disease, and diabetes, and that medication-related problems may be the third or fourth leading cause of death in the over-65 age group. Other articles in this issue discuss age-related risk factors in pharmaceuticals, "senior care pharmacists", and Internet pharmacies.

Emily R. Cox, PhD of Express Scripts, Inc, led a study of how Medicare beneficiaries behave when they have drug costs which exceed the "cap" in their MediGap policy or their Medicare HMO. This cap is the maximum amount that the insurance company will cover, leaving the beneficiary to pay additional costs out-of-pocket. The study found that when the cap was reached, many patients took steps which could have significant impact on their treatment and disease management (some reported taking multiple steps):

* 38% tried obtaining samples from a physician
* 24% took less medication than prescribed
* 20% took over-the-counter (OTC) medications to replace prescribed therapies
* 16% discontinued a medication to reduce out-of-pocket prescription expenses
* 10% tried purchasing a prescribed medication in Mexico
* 5% used a medication prescribed for someone else

To pay for medications, about 15% of respondents said they went without necessities, defined as food, clothing, or shelter, and 12% said they borrowed money to pay for prescription medications. The study was reported in the March issued of Medical Care.

Health Affairs has issued a special collection of articles about costs and utilization of prescription drug insurance coverage. In one article, authors Bruce Stuart, Dennis Shea, and Becky Briesacher investigate not only the number of Medicare beneficiaries who have insurance that pays for drug costs, but also the number of people who have had changes in their drug coverage. They found that over half the Medicare beneficiaries had some sort of interruption in their drug coverage from 1995 to 1996. These people are categorized into "finders" -- those who started out without coverage but found it by the end of the two year period and "losers" -- those who started out with coverage and lost it. Many others had coverage provided by one or more different providers over this time period.

The authors found that the people most likely to have lost coverage for prescription drugs during the two year period of the study were older people living in the midwest or in rural areas, those most likely to have added coverage when they didn't have it initially were younger people living in the west. They found that people living in states with prescription drug coverage plans were most likely to have had continuous coverage for prescription drugs, and, not surprisingly, low income people who qualified for public benefits (usually Medicaid) were also likely to have had continuous coverage. Since the highest income people generally had continuous coverage, the group most likely to lack coverage were middle income seniors.

The authors contend that all this instability is a strong argument for making drug coverage a regular part of the Medicare program. Data is probably not yet available to do so, but it would be quite interesting to see how patterns have changed since 1996, considering the turmoil in Medicare HMOs that forced about 2 million Medicare beneficiaries to find new plans from 1998-2000 and the huge increases in drug and insurance costs since that time.

>> Health Affairs

The American Society of Health-System Pharmacists (ASHP) revealed results of a survey that shows that over half of all Americans are taking multiple medications each day, including prescription and nonprescription medications, herbal supplements, and vitamins. The survey showed that 51% are taking more than one medication of any kind each day, 46% are taking at least one prescription medication each day, 28% are taking multiple prescription medications a day, and 40% are taking multiple herbal supplements or vitamins each day. Of people age 65 or older, 79% are taking at least one prescription medication a day, with an average of 4 prescription medications a day.

Although these medications could have a serious impact on their hospital care, the survey found that only 8% told hospital staff what medications they were taking, and only 3% brought samples of their medications with them to the hospital.

ASHP President Mick L. Hunt, M.S. said, "We want patients to be aware of the potential for drug interactions that can occur when mixing all of these remedies, especially when taking multiple medications each day. Patients and customers should know that they can always turn to their pharmacist for answers to their medication-related questions."

The Social Security Administration (SSA) wants veterans to know about an important prescription drug benefit available from the Department of Veterans Affairs (VA). A 30-day supply of prescription medications costs only $2 through the VA, and disabled or low-income veterans can receive medications for free. To take advantage of this benefit, a veteran must have been honorably discharged from the military, must enroll with the VA, and must be seen by a VA doctor. The VA may charge for a doctor visit, but your insurance may cover this charge (disabled or low-income veterans can visit doctors for free). If you would like to find out more about this and other health benefits through the VA, you can call, toll-free, 1-877-222-VETS (1-877-222-8387). For information about military service and Social Security, check out a SSA fact sheet.

>> SSA Fact Sheet

A report published by Mayo Clinic physicians in the November edition of Mayo Clinic Proceedings states there is insufficient data to conclude that soy isoflavones are an acceptable alternative to estrogen for hormone replacement in postmenopausal women.

The Mayo physicians studied available literature in response to recent interest in the use of natural products like soy proteins for their potential estrogen-like effects. Soybeans are a staple in the diet of East Asian countries. In areas with soy-enriched diets, there appear to be lower incidences of hormone-dependent diseases such as breast and ovarian cancer and coronary artery disease. The theory is that soy phytoestrogens, specifically isoflavones, are partly responsible for this protection, so there has been intense interest in the isoflavones as substitutes for estrogen for postmenopausal women.

The authors of the Mayo Clinic report looked at various studies about isoflavones and the effects they have on coronary artery disease, breast cancer prevention, bone loss, the central nervous system, the endometrium, hormonal effects, attenuation of hot flashes and the skin. They determined that it is premature to draw definitive conclusions regarding the use of isoflavones as an alternative to estrogen for hormone replacement in postmenopausal women. Appropriate dosage studies with the widely available isolated isoflavones have not been done and long-term benefits of isoflavones with regard to fracture prevention, prevention of hormone-dependent cancers, attenuation of memory loss, and prevention of cardiovascular disease are currently unknown. Randomized, placebo-controlled clinical trials are necessary to address these important issues.

Mayo Clinic Proceedings is a peer-reviewed and indexed general/internal medicine journal, published for 75 years by Mayo Foundation, with a circulation of 120,000 nationally and internationally.

The American Society of Anesthesiology has issued an alert to patients that they should stop taking herbal medicines at least two weeks before surgery to prevent potentially dangerous interactions with drugs administered during surgery. This will allow time for the herbal medications to completely clear the body. They say that recent findings disclose that seven out of 10 herbal medicine users never tell their physicians about the herbal products they are taking. Most believe that since the products are "natural," they must be safe, but many of these products are quite potent and can be dangerous, especially if the patient's anesthesiologist or surgeon does not know that the patient is taking them, he said.

For example, St. John's wort, which is taken by more than 7.5 million Americans to treat anxiety, depression and sleep disorders, may intensify or prolong the effects of some narcotic drugs and anesthetic agents. Ginko biloba is used by almost 11 million Americans to improve their memory and increase blood circulation, but it may reduce platelets, which are needed for blood to clot. The herbal feverfew also appears to interfere with blood clotting. Ginseng, one of the most popular herbal preparations in the world, taken to boost vitality, has been associated with episodes of hypertension (high blood pressure) and tachycardia (rapid beating of the heart).

The Surgeon General has issued a flu vaccine alert. The Centers for Disease Control (CDC) has been warning of an expected shortage of flu vaccine this winter, but the Surgeon General reports that there will be no shortage, but there is a delay in the availability of sufficient quantities of flu vaccine to vaccinate everyone before December, as has been the case in the past. Because of this, the Surgeon General has asked Americans who are not considered high priority or high risk to wait for their flu shots until after the highest priority populations have been taken care of.

The highest priority is being given to the elderly, pregnant women, and health care workers. Everyone else is being asked to defer their shots until December, when the supply is expected to expand. The Surgeon General also urged seniors not to use this shortage as an excuse to delay getting their shots, since the flu vaccine has been demonstrated to be very effective in reducing deaths from influenza in the older population.

The Health Care Financing Administration (HCFA) urged Americans aged 65 and older to get their flu shots soon. The Medicare program will cover payment for these shots, and the ideal time to get them is in October or November. There has been a shortage of flu vaccine this year, but adults age 65 and over are being given priority.

Garvan C. Kane, MD, AND James J. Lipsky, MD reviewed literature on drug-grapefruit juice interactions in the Mayo Clinic Proceedings. They suggested that more research needs to be done in this area, since numerous studies show such interactions, and many older people drink grapefruit juice at breakfast time, when they are taking these medications.

Some of the most common prescription and over-the-counter medicines can produce side-effects with symptoms similar to those of dementia, glaucoma, and other diseases of old age, according to Dr. Jacobo Mintzer of the Medical University of South Carolina in the September Journal of the Royal Society of Medicine. Some of the side-effects he noted were dementia-like symptoms of confusion, memory loss, and disorientation, and glaucoma-like blurred vision, dry mouth, constipation, urinary problems, dizziness, likelihood of falling, anxiety, rapid shallow breathing, and irregular or rapid heartbeat.

He said that illnesses like angina, diabetes, glaucoma, and dementia appear to be worsened by drugs with "anticholinergic activity". This includes many of the prescription drugs used in the treatment of Parkinson's disease, depression, allergies, migraine, and irritable bowel syndrome, as well as some pain relieving drugs. Non-prescription drugs of this type are also becoming increasingly available, including cold and flu medicines, indigestion tablets, sleeping pills and anti-diarrhoea treatments. The risk of side-effects from a dose of one of these might be very small, but many elderly patients take several kinds of medications at once, increasing the likelihood of "anticholinergic load".

Dr. Mintzer warns that elderly patients in nursing homes are most at risk, since some reports suggest that 60% of nursing home residents will have received drugs from the anticholinergic group in the past year, compared with only 23% of elderly people in the community. Doctors may assume that any side-effects are an inevitable part of the ageing process rather than something which could be avoided by altering existing medication regimes. The elderly are also more likely to be at risk from anticholinergic load because their metabolism is often less efficient, allowing drugs to stay longer in their system.

The Centers for Disease Control and Prevention warned providers of an impending shortage of flu vaccine for the upcoming flu season. Influenza vaccine manufacturers have told FDA and CDC to expect delays in flu vaccine shipments and that it is possible there will be reductions of available influenza virus vaccine for the 2000-01 season. The FDA and CDC briefed the Advisory Committee on Immunization Practices (ACIP) about the current situation regarding influenza vaccine supply. The FDA and CDC stressed to the ACIP that the situation is very fluid and that health care providers should expect periodic updates from them through the summer and fall.

ACIP, in a consensus recommendation, urged health care providers to begin thinking now about delaying adult mass influenza vaccination campaigns to November (usually recommended for October through mid-November) based on supply availability, and to consider ways to ensure their high risk patients receive vaccination if a severe vaccine shortfall were to occur.

They stress that persons who normally receive influenza vaccine should not be concerned and should delay inquiries about flu vaccination until the fall, and also note that FDA, CDC and vaccine manufacturers are confident that vaccine will be available to vaccinate those at highest risk of complications from influenza, including those over 65, those who are immunosuppressed and others.

Federal health officials are studying whether it would be safe to stretch supplies by giving some healthy Americans half a dose, reserving full-strength vaccine for the elderly and ill who need it most. The study will be conducted at the University of Rochester, St. Louis University, Baylor College of Medicine, University of Maryland, Cincinnati Children's Hospital and the University of California, Los Angeles.

The National Institute for Health Care Management (NIHCM) has released a report investigating the changes in patent laws over the years which have given protection to drug manufacturers. The study reports that drug patent ran for only about 8 years in the early 1980's but now average 13-15 years. This means that the length of time between the development of new drugs and the time when those drugs become available as generic products has significantly increased, increasing costs to consumers who might benefit from the less expensive cost of generic drugs. The report also noted that only about 36% of new drug patent applications in the last 10 years have been for products which have never been available on the market, and the rest were for new dosages or combinations of exisiting drug compounds. The group concluded that patent protection laws have not had the effect of increasing innovation and spending on new research as much as they have protected the profits of the drug industry.

The Pharmaceutical Research and Manufacturers of American (PhRMA), which represents drug manufacturers, criticized the report, and pointed out that the HIHCM gets some funding from managed care companies, who are trying to reduce drug costs for themselves. They said that a recent study by key researchers at Tufts Center for the Study of Drug Development found that the average patent life for a prescription medicine approved from 1993 to 1995 is only 11.2 years, compared to 18.5 years for most other products.

Physician and Congressman Tom Coburn (R-OK) asked Attorney General Janet Reno to investigate allegations that drug companies are colluding to fix prices. He referred to allegations by the Federal Trade Commission (FTC) that Hoechst Marion Roussel agreed to pay generic drug maker Andrx to delay bringing to market a generic version of Hoechst's popular Cardizem CD, and that Abbott Laboratories paid generic drug maker Geneva Pharmaceuticals to delay the introduction of a generic for the hypertension and prostate drug Hytrin. He said that reducing drug prices by eliminating price-fixing will do more to help older people who need medications than just expanding the Medicare program to help them pay those prices.

In an editorial, the prestigious New England Journal of Medicine (NEJM) takes on the question of price controls for the pharmaceutical industry. They point out, "An industry whose profits outstrip not only those of every other industry in the United States, but often its own research and development costs, simply cannot be considered very risky." The editorial points out that drug companies benefit from extensive research conducted by the government's National Institutes of Health, receive tax benefits on all their own research and development costs, and then obtain government-sponsored 17-year monopolies on the products they bring to market. For these and other reasons, the editors suggest it is not too much to expect that there be some constraints on the profits drug companies can make from these products, and that drug companies have an intrinsic obligation to the public, as well as to their shareholders.

The Commonwealth Fund analyzed data from the 1996 Medicare Current Beneficiary Survey (MCBS) to determine what percentage of Medicare beneficiaries truly need better coverage of outpatient prescription drug costs. They undertook the survey partly to try to identify the number and percentage of beneficiaries who lack such coverage, in light of conflicting statistics reported by other surveys. The study found that part of the reason for the confusion was the large percentage, nearly 19%, of seniors who had coverage at some time during the year, but did not have it for the whole year. This group could have been counted either in the "have" or "have not" category, depending on when in the year they were surveyed.

They found that 90% of beneficiaries who were poor enough to qualify for Medicaid benefits had drug coverage continuously throughout the year. About 77% of those who were covered under an employer group health plan and 67% of who participated in a Medicare HMO had drug coverage continuously throughout the year. Of the 9.9 million beneficiaries covered by private MediGap plans, only about 25% had year-long coverage for outpatient drug costs. Another 1.3 million beneficiaries participated in Medicare only, and had no drug cost coverage. In total, only about half of all beneficiaries had continuous coverage of their prescription drug costs throughout the year.

The study also found difference in spending and utilization between those who had insurance and those who didn't. Beneficiaries with insurance coverage filled more prescriptions, at a higher cost per script, and spent nearly twice as much annually on prescription medications as those who had no insurance ($828 vs $468). Even so, those without insurance had out-of-pocket costs nearly twice those of beneficiaries who had continuous insurance coverage ($468 vs $219).

President Clinton released a report about the critical nature of prescription drug coverage in rural areas. The report promotes his own proposal for adding a Medicare prescription drug benefit, but also includes some facts about the special problems faced by older people in rural areas:

- Rural beneficiaries are over 60 percent more likely to fail to get needed prescription drugs due to cost. - In rural America, most beneficiaries who lack prescription drug coverage are middle income. - Rural beneficiaries pay over 25 percent more out-of-pocket for prescription drugs than urban beneficiaries. - Rural Medicare beneficiaries are 50 percent less likely to have any prescription drug coverage. - Rural beneficiaries are about one-third less likely to have retiree health insurance. - About 15 percent of rural residents are age 65 or older, compared to 12 percent in urban areas. - About 20 percent of rural seniors have income below poverty compared to 16 percent of urban seniors.

Medicare is sponsoring a new pilot program that will make annual flu and pneumonia shots almost automatic in the nation's nursing homes. Under the "standing orders initiative" of Medicare's Healthy Aging Project, nursing home residents will be alerted when it is time to get a flu shot and can get it without needing a new doctor's order each year, by placing a permanent entry in the resident's medical chart. The project also will encourage pneumonia immunization. Flu shots are recommended on an annual basis, but one pneumonia shot is generally all that's needed in a person's lifetime.

The pilot project is a cooperative venture of HCFA and the Centers for Disease Control and Prevention (CDC) and is being implemented in the District of Columbia, Florida, Hawaii, Idaho, Kentucky, Massachusetts, Minnesota, Montana, New Mexico and Washington in time for the 2000 fall flu season. Alaska, Mississippi and Oregon are also doing standing orders projects, but not as part of the HCFA demonstration.

The Food and Drug Administration (FDA) will convene a public meeting on June 28 and 29, in Gaithersburg Maryland to discuss the agency's approach to regulating over-the-counter drug products. The FDA said that it would consider making several kinds of drugs available without a doctor's prescription for the first time, and that it would consider becoming more active in moving prescription drugs to over-the-counter status, a move that generally lowers a drug's price and gives consumers easier access. The hearings are the first step in the FDA's most extensive evaluation of over-the-counter drug policy since 1972.

Even if the FDA decides to change its procedures, it could take years before the drugs appear on supermarket shelves, and each drug would still require FDA approval. The last review resulted in policy changes that have led to more than 600 prescription drugs being moved over the counter. These drugs treat mostly acute conditions such as headaches and colds. This time, the FDA will consider whether relatively safe drugs for chronic conditions should be made available. The conditions include high cholesterol, high blood pressure, diabetes and osteoporosis.