The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.

Health Trends

Research Confirms Staggering Cost of Drug Errors

Study results published in the January 22, 1997, issue of the Journal of the American Medical Association add to the growing body of evidence linking errors in prescribing and administering drugs to millions of dollars a year in added health care costs.

The study was conducted at two major hospitals in Boston during a six-month period in 1993. Adverse drug reactions occurred in 1.4 percent of patients; these patients stayed an average of two extra days at a cost of $4,685 per patient.

Extrapolating these data nationwide, the researchers concluded that a typical large teaching hospital pays $5.6 million a year to provide extended stays for patients who have suffered adverse drug reactions.

David W. Bates, MD, the study's lead author, said that computerized drug ordering systems, along with a greater availability of pharmacists, might be one way to reduce preventable drug-related complications.

Geriatric Enrollment Increases in HMOs

The shift of the Medicare population into managed care is forcing health maintenance organizations to step up their awareness of enrollees over the age of 65. The Emron HMO Prescription Drug Class Report, which surveyed 65 HMOs with a combined enrollment of more than 11.2 million members, reports that 8.5% of enrollees in the plans surveyed were over 65 years of age, with the highest percentage of geriatric patients enrolled in staff model (10%) and group model (9.5%) HMOs.

Campostar Labels Cause Confusion

Several accidental overdoses of irinotecan hydrochloride injection, CPT-11 (Campostar) have been reported since the drug was introduced last summer, according to the "ISMP Medication Error Report Analysis" appearing in the December 1996 issue of Hospital Pharmacy. Campostar is an antineoplastic agent indicated in patients with metastatic carcinoma of the colon or rectum who are experiencing a recurrence of the disease following fluorouracil-based therapy.

The errors apparently occurred when individuals preparing doses misread the product's 20 mg per mL concentration to mean the entire contents of the vial-the vials actually contain a total volume of 5 mL, or 100 mg. The "5 mL" information, which appears in smaller print in the upper right-hand corner of the label and is separated from the concentration information, was apparently overlooked. In three reported cases, patients received five-fold overdoses.

The maker of the drug, Pharmacia & Upjohn Company, is working with the U.S. Food and Drug Administration to make appropriate labeling changes.

New Alzheimer's Drug Approved

The U.S. Food and Drug Administration has added Eisai Co.'s donepezil (Aricept) to tacrine (Cognex), available since 1993, as an approved treatment for mild to moderate Alzheimer's disease. The new drug targets acetylcholinesterase in the brain.

Before approving the drug, the FDA reviewed studies involving 900 subjects indicating that those taking donezepil were twice as likely to show improvements in memory, language, and reasoning abilities as were patients taking a placebo.

Patients taking the new drug, which can be given once daily, reportedly experience few of the side effects-such as diarrhea, nausea, and liver toxicity-that are sometimes seen in patients taking tacrine.

Measuring Risk Factors Associated with ADRs in the Elderly

Researchers are beginning to tackle head-on the difficult task of measuring the multiple risk factors associated with adverse drug reactions and interactions in the elderly, according to an article in the December 16, 1996 issue of The Brown University Long-Term Care Quality Advisor.

The article reports that researchers in the College of Pharmacy at the University of Michigan, Ann Arbor, have been devising and testing algorithms specifically designed to help clinicians assess the probability that an ADR has occurred in an elderly patient. Researchers concluded that a history of past ADRs was an important indicator in identifying elderly patients who may be at increased risk of experiencing an adverse drug reaction.

Another team of researchers, headed by Meghan B. Gerety, MD, applied a similar algorithm to institutionalized elderly residents of a Veterans Administration nursing home in San Antonio, Texas. Study results indicated that 72 percent of all ADRs reported in this population were associated with four classes of drugs: cardiovascular, central nervous system, non-steroidal anti-inflammatory drugs/analgesics, and gastrointestinal drugs; these same classes accounted for 68 percent of all ADRs judged to be severe.

New Cognitive Assessment Tool Targets Geriatric Clients

A geriatric version of the widely used LOTCA cognitive assessment tool is now available from Maddak, Inc. LOTCA-G is designed for use as part of an ongoing evaluation and treatment plan for geriatric patients with brain injury.

The modified version of the test was developed to compensate for conditions that accompany advancing age and can affect performance when taking tests. New features include enlarged component pieces to help reduce vision and motor coordination problems, reduced pictorial detail in some tests to lessen complexity of tasks, and reduced administration time.

Tests used in LOTCA-G are: orientation for time and place, perception, praxis, vasomotor organization, thinking operations, and memory. For more information contact Maddak, Inc., at 201-628-7600 (ext. 9), e-mail them custservice@maddak.com, or visit their Web site at http://www.maddak.com.

Benzodiazepines May Be Misused in Treating Depression in the Elderly

Researchers at the Department of Psychiatry and Human Behavior at Jefferson Medical College in Philadelphia have uncovered evidence that benzodiazepines may sometimes be overused in treating depressed elderly patients.

Study results published in the journal Psychosomatics indicate that the preadmission benzodiazepine regimens of 64% of a group of elderly individuals who were admitted to a university hospital inpatient geriatric psychiatry unit were outside Health Care Financing Administration guidelines, both for benzodiazepine use in nursing homes and in relation to psychiatric diagnoses. In addition, 39.5% of the elderly depressed patients had been given benzodiazepines as the sole treatment for depression prior to their admission to the unit.

Seizure Prodrug Offers Clinical Advantages

Fosphenytoin (Cerebyx), the new injectable prodrug of phenytoin (Dilantin), may have practical and clinical advantages over its predecessor, according to a clinical review published in the American Journal of Health-System Pharmacists. Fosphenytoin is indicated for control of generalized convulsive status epilepticus, prevention and treatment of seizures occurring during neurosurgery, and to substitute for oral phenytoin in cases of unconsciousness or extreme nausea.

The review cites fosphenytoin's advantages over IV phenytoin, which is being discontinued by the manufacturer, Parke-Davis:

Data Confirm Increased Use of SNFs

Data presented at a Prospective Payment Commission meeting last fall document the steady growth in the use of skilled nursing facilities as Medicare post-acute care providers. According to information presented by ProPAC staff, Medicare Part A SNF payments in 1990 totaled $2.5 billion, with 25.1 Medicare-covered days; by 1995, payments were $10.3 billion, with covered days increasing to 38.8. Admissions into new Medicare-certified SNFs grew at a faster pace than admissions to existing SNFs.

Plunging Cholesterol Levels May Signal Impending Death

A sudden drop in cholesterol levels may be a signal of impending death in nursing home residents, according to study results published in the Journal of the American Geriatrics Society.

The study followed residents of a 203-bed nursing home who were 65 or older. Study results were reported on 55 living patients and 76 patients who had died; results indicated that cholesterol declined 31.1 mg/dL/ year among the decedents, versus 4.2 mg/dL/year among the survivors.

According to the report, patients whose cholesterol levels declined more than 20 percent per year were more than seven times as likely to die.

Lexxel Hypertension Treatment to be Available in March

A new combination therapy for treatment of hypertension will be available in March, according to the drug's developer, Astra Merck.

Enalapril maleate 5 mg/felodipine 5 mg extended-release (Lexxel) combines Astra-Merck's angiotensin-converting enzyme inhibitor Vasotec with its calcium channel blocker Plendil in a once-daily tablet indicated for treatment of hypertension in patients who do not respond to either enalapril or felodipine monotherapy.

Now in Paperback

Muriel R. Gillick's new book, Choosing Medical Care in Old Age, documents specific cases in which older patients and their families are faced with critical medical decisions. Basing her approach on actual cases, Gillick, professor of medicine and director of the geriatrics fellowship program at Harvard Medical School, develops a decision-making model that combines a patient's wishes with an objective assessment of his or her medical condition. Gillick is the recipient of the 1996 Will Solimene Award of the American Medical Writers Association.

Herbal Medicine: No Longer Relegated to Folklore

The World Health Organization (WHO) Collaborating Centre for Drug Monitoring recently announced a new technology that could place herbal medicines under the rubric of modern medical science. Dubbed "PharmaPrinting," the technology was developed at the University of Southern California and is owned by a new American company, PharmaPrint, Inc. of Irvine, California.

PharmaPrinting produces pharmaceutical versions of herbal medicines that previously could not be standardized, patented, or clinically tested, and, as a result, were not prescribed by physicians or reimbursed by insurance companies. Now, PharmaPrinting technology allows physicians and pharmacists to standardize the production of herbal medicines. The technology allows the duplication of medicines with multiple interacting molecules to achieve therapeutic effects.

The WHO Collaborating Centre will increase standardization of the information about herbal medicines and will encourage countries to participate in this undertaking to increase the use of effective therapies and to reduce potentially dangerous misuse of herbal medicines. The Centre's standardization program plans to compile a list of the herbal medicines considered most successful throughout the world. The first pharmaceutical targets for this standardization activity are expected to be announced some time this year.

First Drug Targeting Hypotension Cleared for Marketing

The first medication approved specifically for the treatment of symptomatic orthostatic hypotension has been cleared for marketing. Sponsored by Roberts Pharmaceuticals, midodrine HCl (ProAmatine) works by constricting blood vessels and raising blood pressure. According to Horacio Kaufmann, a Mount Sinai School of Medicine neurologist who tested the drug, midodrine can help people who are severely limited by hypotension lead comparatively normal lives.

Among the most common side effects associated with midodrine are tingling, itching, goose bumps, and urinary urgency. Because midodrine can elevate blood pressure when a patient is lying down, this medication is indicated only for patients who are considerably impaired by the disorder.

Health Care Information Line for the Elderly Launched

A leading provider of health care services for the elderly, Genesis ElderCare, has announced the official launch of a resource line designed for individuals and family members seeking information and guidance regarding elder care services and support resources for the elderly. Genesis ElderCare aims to provide objective information on issues such as the aging process, in-home care, support groups for the elderly, and much more. The service is consumer-driven and was created as a way for seniors to talk about their needs and manage the problems they face.

Genesis ElderCare has established networks in five major markets throughout New England and currently serves more than 75,000 customers. For more information, call 800-337-1540.

Misuse of OTC Drugs on the Rise

Today more than 600 drugs that were available 20 years ago by prescription only are now over-the-counter products. The American Pharmaceutical Association reports that 60 percent of all medications sold are non-prescription, and 60-95 percent of the time Americans care for their ailments without professional help.

According to Paul Barrese, MD, president of the Manatee County Medical Society in Florida, use of non-prescription drugs may mean "masking a major problem, from an ulcer to stomach cancer." Barrese notes that "even Tylenol is dangerous if you take too much."

Unfortunately, some people who need prescription-strength medication opt for the lower-dose, less expensive version instead. The difference in price can be significant. For example, the average cost of non-prescription ibuprofen is $4, while the average cost of the prescription version is $24 and may require the added cost of a doctor's visit.

The Journal of the American Medical Association reports that drug companies are increasingly switching their prescription medications to over-the-counter status to compete with less costly generic versions. The Council on Family Health in Washington, D.C., suggests consumers can prevent drug-related problems by reading drug labels and following dosage guidelines, and cautions that drug-interaction warnings on medicines should be seriously considered before combining drugs.

New Practice Guidelines for Management of Heart Attack Patients

The American College of Cardiology (ACC) and the American Heart Association recently released new practice guidelines listing the most crucial factors in surviving a heart attack.

The following points are outlined as critical in the reduction of death from heart attack:

The updated guidelines reflect the rapid advances in heart attack diagnosis and treatment since 1990. The guidelines are not a rigid set of rules for dealing with heart attack victims; rather they serve as a general guide to be modified based on clinical judgment, individual patient needs, and new study findings.

The guidelines are printed in their entirety in the November 1, 1996 issue of the Journal of the American College of Cardiology. The executive summary of the guidelines, including a summary of recommendations, appears in the November 1, 1996, issue of Circulation. For reprints of the guidelines or the executive summary, contact ACC (800-253-4636, ext. 694, or 301-897-2694) or AHA (800-242-8721 or 214-373-6300).


Placebos Have No Place in Managing Cancer Pain, Says ONS

Stating that "the use of placebos necessarily involves deception" and ultimately may compromise the therapeutic relationship between patient and health care provider, the Oncology Nursing Society has issued a position statement saying that placebos should not be used in the assessment and management of cancer pain. The position statement was accompanied by background comments saying that "people in pain are vulnerable and dependent on health care providers for access to pain management. It is widely acknowledged that pain is frequently undertreated."

The ONS comments cited recent research indicating that 16 percent of 150 nurses surveyed believed that placebos were useful in determining if cancer patients' pain was "real." Subsequent research revealed that although only eight percent of 601 nurses surveyed had policies governing placebo use in their institutions, 26 percent reported that placebos were used in their facilities, and nineteen percent said that placebos were "appropriate" for use in patients who were experiencing pain.

The ONS position statement defined pain, which is a common symptom in patients with cancer, as a personal experience that can profoundly affect quality of life, and the statement called for a multidisciplinary team approach to addressing cancer pain management.

The ONS Position Statement

"Placebos should not be used:

  1. to assess or manage cancer pain
  2. to determine if the pain is 'real'
  3. to diagnose psychological symptoms, such as anxiety associated with pain

Nurses should not administer placebos in these circumstances even if there is a medical order."

Allegra Knocks Seldane Off the Shelves

The FDA has announced plans to withdraw approval of Seldane (terfenadine) and Seldane D (terfenadine and pseudoephedrine), along with generic versions of the popular prescription antihistamine. Until recently the potential benefits of Seldane were considered to outweigh its negative effects. However, FDA's recent approval of the new drug Allegra, which appears to provide almost all of terfenadine's benefits without triggering a potentially fatal heart condition when taken with some other commonly prescribed medications, appears to have changed the agency's perspective.

Introduced in 1985 and marketed by Hoescht Marion Roussel, terfenadine was the first prescription antihistamine to relieve allergic rhinitis symptoms without causing drowsiness. Following FDA approval of this drug, there were reports of serious, and even fatal, cardiac arrhythmias caused by the combination of terfenadine and other medications. Drugs such as erythromycin and ketoconozole can cause terfenadine to build up in the blood, resulting in potentially fatal cardiac side effects. In addition, terfenadine can cause health problems for patients with liver disease.

As a result of these known risks, Hoescht Marion Roussel and FDA launched several campaigns to inform health professionals and patients about the dangers of these drug interactions. While these efforts minimized inappropriate and hazardous drug dispensing, risks will continue to exist as long as Seldane is available.

Allegra, which received FDA approval in 1996, contains fexofenadine, the primary active derivative of terfenadine, produced in the body when terfenadine is taken. Allegra provides the therapeutic benefits of terfenadine without the associated serious cardiac effects. The new drug is also marketed by Hoescht Marion Roussel.

FDA has announced it is determined to remove terfenadine-containing products from the market. As legal issues are being addressed, the agency is advising patients currently taking these drugs and their generic equivalents to consult with their health professionals about alternative medications.

Health Information on the Web

The February 1997 issue of Consumer Reports gives the following general health-related Web sites top marks both for content and ease of use:

American Medical Association: http://www.ama-assn.org features links to consumer health information, a comprehensive AIDS information center, and a database of more than 650,000 U.S. physicians.

MedicineNet: http://www.medicinenet.com includes interactive groups, an ask-the-doctor feature, medical dictionary, comprehensive drug information, medical news, disease-specific information, and links.

OncoLink: http://www.oncolink.upenn.edu. Consumer Reports rates this University of Pennsylvania-based site as the best starting place for cancer information and links.

Thrive@pathfinder: http://pathfinder.com/thrive. This Time-Warner site has full-text articles from professional and consumer publications.


The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.