A Record Number of New Drugs Approved in 1996
The U.S. Food and Drug Administration approved a record number of new drugs in 1996, including 53 new molecular entities and nine new biologics. The agency also reduced its drug approval time, from an average of 19.2 months in 1995 to an average of 17.8 months in 1996.
New drugs approved in 1996 included:
Thrombolytics or Angioplasty?
According to a retrospective cohort study published in the October 21, 1996, issue of The New England Journal of Medicine, thrombolytic therapy saves individual patients $3,000 each year compared to primary angioplasty, while demonstrating a similar mortality rate. If the $3,000 savings per patient were applied to the nearly 200,000 patients who are eligible for thrombolysis each year, substantial cost savings could be realized nationwide.
The study, conducted by Every and colleagues, was based on data from the Myocardial Infarction and Intervention Project Registry. The medical histories of 12,331 consecutive patients admitted with acute myocardial infarction to 19 Seattle hospitals between 1988 and 1994 were studied. Cumulative inpatient costs for thrombolytic treatment were $3,100 lower at three years' follow-up than costs for primary angioplasty treatment. In addition, the study reported that use of thrombolytic therapy resulted in 30 percent fewer coronary angiograms, 15 percent fewer coronary angioplasties, and 13 percent lower costs after three years.
Researchers compared mortality during hospitalization, long-term mortality, and further treatment requirements for the 1,050 primary angioplasty patients and 2,095 thrombolytic therapy patients. Every and colleagues did not find any significant difference in mortality during hospitalization between patients in the two treatment groups, and primary angioplasty was not associated with lower long-term risks.
Results from the Every study contradict earlier studies showing that primary angioplasty is associated with improved outcomes during hospitalization. Every and colleagues suggest several reasons for this: earlier thrombolytic treatment in the previous trials, the higher rate of angiography and revascularization for thrombolytic patients in their study, and a lower angioplasty success rate than seen in previous studies.
Resident Aggression: Sometimes a Two-Way Street
A team of Canadian researchers who examined conflict, aggression, and burnout in a group of nurse assistants in a nursing home found that nurse assistants in the facility expect to be physically assaulted by residents 9.3 times per month and verbally assaulted 11.3 times per month.
Less than three percent of the physical and verbal aggression by residents against nurse assistants is formally acknowledged within the health care system. Subjects reported that most assault incidents were triggered by a resident's issue with personal hygiene or a resident's desire to go outside the facility.
While the study showed only a slight correlation between burnout and conflict, and between burnout and reports of aggression from residents, a statistically significant relationship was noted between nurses' conflict with residents and resident aggression toward nurse assistants.
HCFA Gives Tips on Avoiding Med-Pass Errors
The Health Care Financing Administration defines a medication error as "any deviation from a physician's medication order." HCFA pharmacist consultants note that these errors often occur during routine medication passes. In the January 1997 issue of Briefings on Long-Term Care Regulations, an agency official offered a few basic rules of thumb to help avoid problems during med-pass audits:
Sticker Shock
"Fosphenytoin sodium represents only a marginal improvement [over Dilantin, phenytoin].... I think the product has been exorbitantly priced to take advantage of a market in flux. The absence of any pharmacoeconomic data to support the addition of the drug to a formulary is problematic."
-Paul Pierpaoli, MS
Director/Pharmacy Services
Rush Presbyterian St. Luke's Medical Center
Chicago, IL
As quoted in the January 1997 issue of Hospital Pharmacist Report
Caring for Elderly Requires Special Vigilance
"Three common themes run through the clinical courses of many elderly patients. The first is the important contribution multiple health disciplines often make to our medical care of older adults.... Pharmacists, nurses, and physical therapists each bring critically important information to the physician's attention. Even an astute physician will benefit from good communication with a patient's other health care providers.
"A second recurring theme is the need to maintain vigilance about the medications that older patients take. There are many reasons that older people suffer more drug-related problems, including drug-disease interactions, receiving medications from several physicians, and the frequency of polypharmacy. Though physicians are knowledgeable about common adverse drug effects, it is increasingly apparent that many medications have toxicities of which we have been unaware.
"A final theme is the critical importance of the interview in caring for older patients. Whether in detecting improper medication use or discovering a case of neglect, our best weapon is an effective interview. Communication with older people, though frequently a challenge, is a skill that deserves greater emphasis in medical education."
-John R. Meuleman, MD
"Walking the Tightrope: The Challenge of Elder Care"
Journal of the American Geriatrics Society,
December, 1996
Pulse Dosing for Nail Infections
The U.S. Food and Drug Administration recently approved pulse dosing of itraconazole (Sporanox) for fungal infections in fingernails. The new approach, which is also being tried with fluconazole (Diflucan) and terbinafine (Lamisil), seems to work for toenails too.
The pulse dose of Sporanox is 200 mg b.i.d. for one week each month. Patients take two pulses for fingernails, and three to four pulses for infections in toenails, which grow more slowly. Since the drug persists in the nails for several months, the pulse approach appears to work as well as continuous daily dosing.
Electronic Blister Packs Aid Compliance
Blister cards containing minute current-carrying filaments that electronically record times when a patient takes medication are being touted as a revolutionary resource that could profoundly affect pharmaceutical care. The November 1996 issue of Pharmacy Practice cites the blister cards as one of three resources now available-the others are on-line pharmacy benefit management systems and pharmacy awareness services-that are already on the way to changing the face of pharmacy.
Electronic blister packs are currently being used in clinical trials and are considered too expensive for general distribution; however, prices are expected to moderate as microprocessors become less expensive.
New Antivirals for HIV in the Works
FDA approval may soon be granted to two new antiviral drugs for the treatment of HIV: delavirdine (Rescriptor) and nelfinavir (Viracept). Rescriptor, a non-nucleoside reverse transcriptase inhibitor, is designed to be used in combination therapy to boost the effectiveness of nucleosides such as AZT (retrovir) and 3TC (Epivir).
Viracept, a protease inhibitor, has already been released through an expanded access program for patients with advanced AIDS who are experiencing intolerable side effects with other protease inhibitors. It will be the fourth protease inhibitor to enter the market.
Facility Numbers Down, Beds Up
Chain-affiliated facilities made substantial inroads into the nursing home market between 1985 and 1995, according to the "1995 National Nursing Home Survey," conducted by the National Center for Health Statistics. Chain-affiliated homes grew from 41 percent to 55 percent of the market in those years, with the total number of nursing homes decreasing by 13 percent while bed totals rose by nine percent, according to the survey. Approximately 16,700 nursing homes provided care to 1.5 million residents in 1995; nearly 1.8 million beds were available for use, with facilities operating at about 87 percent of capacity.
FDA Mandates Unit-Dose Packaging for Iron Supplements
Starting on July 15, 1997, the U.S. Food and Drug Administration will require products that contain more than 29 mg of iron per dosage unit to be dispensed in a unit-dose format. The agency will also require that any product containing iron be provided with special labeling. The new requirements are an attempt to reduce the number of accidental child poisonings that occur when children gain access to iron-containing products. Accidental overdose of iron is the leading cause of death due to poisoning for children under the age of six.
Nursing Home Investments Up
The National Investment Conference for the Senior Living and Long-Term Care Industries (NIC) recently reported on the amount of capital loaned to the long-term care industry in 1996. Ninety-one lenders-including commercial banks, mortgage bankers, investment bankers, and insurance companies-completed a survey on long-term care industry investments. Overall, respondents rated long-term care investments favorably: 89% approved the reward-to-risk benefits, and 95% specifically applauded such investments.
In comparison to figures from 1995, the average size of loans has grown, as has the number of groups making loans to the long-term care industry. According to the NIC, this trend will continue; in 1996, respondents averaged $50 million per loan, and in 1997, survey respondents are expected to average $80 million per loan.
Survey results also indicate that lenders are providing better terms to long-term care providers. For example, loan-to-value ratios, loan size, and amortization periods are increasing, while other terms such as spreads, points, and debt service covering ratios are decreasing.
Printed reports of the completed 1996 Lender and Investor Survey can be purchased directly from the NIC by calling 410-267-0504.
'Cocktails' Prove Effective
"The first formal studies on the AIDS drug 'cocktails,' AZT (Glaxo Wellcome's Retrovir), 3TC (Glaxo Wellcome's Epivir), and a protease inhibitor (Abbott's Norvir, Merck's Crixivan, or Roche's Invirase), were presented at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington, D.C. Researchers reported that AIDS-related deaths in New York City fell 30 percent, from 7,046 in 1995 to 4,944 in 1996. They also reported that patients in very advanced stages of the disease can benefit from the drug 'cocktails,' and people treated within months of being infected experienced a sharp, long-lasting reduction of virus in their blood and tissue.
"In a study of 320 long-infected patients receiving the 'cocktails,' 55 of 85 patients had virus levels in the blood fall below detectable levels. Despite the positive news, many U.S. and European HIV-infected people do not receive therapy because of high cost, side effects, or resistance to the drugs."
-Facts and Comparisons "News Scans"
January 31, 1997
Taking a World Cruise on the Web
Topics related to international pharmacy issues are becoming more prevalent on the World Wide Web. Using one of the Internet search engines, such as Lycos, Alta Vista, or Infoseek, simply type in a key word such as "pharmacy" or "pharmacist," or the name of a particular drug and see where it takes you. Some internationally-focused sites you may want to visit include:
Outbreak (www.outbreak.org), an on-line resource featuring the latest information on emerging diseases, puts you in touch with locations throughout the world where disease outbreaks are occurring.
CenterWatch Clinical Trials Service (www.centerwatch.com) focuses on newly approved drug therapies, clinical trials, and new and ongoing clinical research initiatives in medical centers around the world.
The World Health Organization (www.who.ch) indexes vaccination and health requirements for international travel, newsletters and health reports from around the world, and news about disease outbreaks in locations throughout the world.
Other sites that focus on state and local issues include:
State Medicaid Directors (www.hcfa.gov/medicaid/scontact.htm), located within the Health Care Financing Administration's Web site, lists state Medicaid directors as well as contact names, addresses, and phone and fax numbers.
Robert Wood Johnson Foundation (www2.umdnj.edu/shpp/homepage.htm) promotes the Information for State Health Policy program and serves as a model for state health agencies' efforts to use electronic communication to disseminate health information.
Eldercare Web (www.elderweb.com/) has names and addresses of state health departments and state agencies on aging.
Pocket Guide Provides Quick Reference for Injectable Drugs
Pharmacists, nurses, and physicians can turn to the user-friendly Pocket Guide to Injectable Drugs for easily accessible information on frequently-used injectable drug products. Information in the guide, which was distilled from more than 1,840 primary published research reports, is simplified into brief and graphic representations in the Pocket Guide.
The guide is organized in monographs for 125 drug products; the information is an abbreviated version of that contained in the Handbook on Injectable Drugs, ninth edition. The first item for each drug refers to the related Handbook monograph; the Guide's monographs are divided into the following subheadings: description, products (trade names, sizes, strengths and volumes in which the product is supplied), preparation, dosage and administration, stability, and compatibility tables (results of published reports regarding compatibility, incompatibility, and conditional or equivocal findings with other drugs or solutions).
For information on ordering the Pocket Guide to Injectable Drugs, call the American Society of Health-System Pharmacists at 301-657-4383.
Chronic Care: Falling Short
It now costs the United States $470 billion a year-almost 75 percent of the nation's spending on health care-to care for people with chronic conditions. This figure is expected to double by the year 2050, when projections indicate the number of Americans with chronic conditions will swell to 167 million, taking a $906 billion bite out of the nation's economy. Yet the United States has "no effective system to care for those with chronic conditions," and what care is available is "fragmented, inappropriate, and difficult to obtain."
These are some of the findings of a new study, "Chronic Care in America: A 21st Century Challenge," conducted by Catherine Hoffman and Dorothy P. Rice of the Institute for Health and Aging at the University of California, San Francisco. The study was sponsored by the Robert Wood Johnson Foundation.
Other study findings: Though almost 65 percent of direct medical costs for persons with chronic conditions are for hospital care and physician services, these services are concentrated on periods when the person needs acute care, rather than during nonacute phases when preventive or rehabilitative care could be beneficial.
Many people with chronic conditions do not understand what care they are eligible for, where to obtain it, or who provides it. Almost 40 percent say they cannot afford the care they need, and 20 percent say services are not available when they need them.
"Despite the enormous financial, intellectual, technological, and personal investment [in health care]," say the study's authors, "recent research indicates that people with chronic conditions want something the market is not supplying: affordable, accessible services, and products to help maintain an independent lifestyle as long as possible."
For a copy of "Chronic Care in America: A 21st Century Challenge," contact the Robert Wood Johnson Foundation, Route 1 and College Road East, Princeton, NJ 08543-2316, or visit the Foundation's home page at http://www.rwjf.org.
Numbers of People Who Will Be Limited by Chronic Conditions
Source: Chronic Care in America: A 21st Century Challenge |
Changes in the Leading Causes of Death, 1900-1950-1990
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