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A Healthier Future for West Virginia - Healthy People 2010
Federal 2010 Initiative
17 - Medical Product Safety
The Medical Product Safety Work Group focuses on issues of drug safety. Adverse drug events (ADEs) may be responsible for more than 100,000 deaths in the U.S. each year, according to an article in the April 15, 1998, issue of The Journal of the American Medical Association. This would rank ADEs between the fourth and sixth leading cause of death nationwide.
There are a variety of ways that people can be killed or injured by their medicine: (1) medication errors; (2) known side effects and drug interactions, and (3) unforeseen side effects that do not show up in clinical testing. Some experts believe that medication errors may account for one-third to one-half of all adverse drug events.
Pharmaceutical manufacturers are discovering new ways to treat more diseases and conditions, from impotence to diabetes. The Food and Drug Administration (FDA), long criticized as moving too slowly on drug applications, is now approving products at a record-setting pace. The FDA approved 139 new drugs and biologic products in 1996, a record increase of 63% over the 85 such products approved in 1995. In 1997, another 132 products were approved. At the same time, the median approval time for new drugs has decreased by more than half to 13.4 months.
The FDA is focused on safety of the product when used as directed; many adverse drug events occur from errors in the use or misuse of drugs. Drug interactions, inappropriate dosing, drug duplications, and errors in dispensing and in route of administration are all examples of drug errors that can lead to death or injury. In recent months, the FDA has been troubled by a series of adverse drug events caused by recently approved agents. For example, Posicor®, a drug for high blood pressure, was withdrawn from the market last year, but not because it was harmful on its own. Rather, Posicor® became lethal in combination with a number of other drugs, so many that the FDA believed that doctors and consumers could not keep abreast of the risks. Also, the diabetes drug Rezulin®, approved two years ago, can cause liver damage, which prompted the FDA to issue repeated warnings to doctors to closely monitor patients taking it. However, an agency investigation found that only 2.7% of patients taking Rezulin® for three months were being monitored the way the agency had recommended, even though 43 people had suffered acute liver failure that was possibly due to the drug; of these, 28 died. A panel of independent scientific experts has recommended that the drug be prescribed only to patients who do not respond to other therapy. And, finally, the arthritis drug Celebrex®, which was approved by the FDA in January of 1999 and has already been prescribed to more than two million people, is repeatedly being confused by doctors and pharmacists with two other drugs: Cerebyx®, an antiseizure medication, and Celexa®, an antidepressant. The agency has already received 41 reports of the wrong prescription being filled.
More prescriptions are being written, not only because there are more drugs but also because the population is aging; elderly people take more than one-third of all drugs that are prescribed. Of elderly patients taking three or more prescription drugs for chronic conditions, over one-third are rehospitalized within six months of discharge from a hospital, with 20% of those readmissions due to drug problems. Twenty-eight percent (28%) of hospitalizations of older Americans are due to noncompliance with drug therapy and adverse reactions. West Virginia has the oldest population of any state in America. We also have a high incidence of diabetes mellitus, heart disease, and other chronic illnesses. In addition, many of our citizens live in rural areas that are medically underserved. For these reasons, West Virginians may be especially vulnerable to injuries from adverse drug effects.
Computers are an important part of the medication safety net, but they have limitations. Many systems have programmed drug alerts that notify pharmacists about potential adverse drug events. A recent study conducted by the Institute for Safe Medication Practices (ISMP) found that most computer systems fail to detect common adverse drug events. ISMP surveyed 307 hospitals: only four successfully detected all unsafe medication orders. The founder of ISMP, Michael R. Cohen, noted, "Pharmacy computer systems need major improvements to detect and prevent potentially serious/fatal medication errors." The survey found that 87% of tested computer systems did not detect toxic doses of antibiotics for patients with renal impairment; 87% did not detect single or cumulative lethal doses of colchicine; 61% neither alerted the staff nor blocked the order when an oral suspension was ordered for intravenous use; and 58% of the tested computer systems did not link the pharmacy and laboratory to share vital information. Of those systems that provided this link, 59% did not screen orders against current laboratory values.
Improvements in computer systems and in other components of the health care delivery system are the focus of some of the objectives in the Medical Product Safety section of Healthy People 2010.Top of Page
Data Source: West Virginia University, School of Pharmacy, proposed survey of pharmacies and dispensers in West Virginia
Information systems that alert pharmacists to potential drug-related problems are essential in today's complex health care environment. However, these programs should be viewed as one of the many tools available to the pharmacist to ensure safe and appropriate medication use in all patients. Information systems are not a substitute for professional judgment and experience, nor do they relieve the pharmacist of responsibility for assuring that medications are used safely and appropriately.
Data Source: West Virginia Bureau for Public Health (WVBPH), Office of Epidemiology and Health Promotion (OEHP), Behavioral Risk Factor Surveillance Survey (BRFSS)
Pharmacists, physicians, and other primary care providers are a key resource for informing their patients about how to use medications correctly. In addition, routine review of medication regimens in this group of high-risk individuals can serve to inform primary care providers about changes in the regimen made by specialty practitioners and alert them to medication adherence problems.
Use of complementary and alternative sources of health care is common in the United States and is often not reported to primary care providers. In addition, many commercial and home herbal remedies can interact with prescription medication to cause adverse drug events. Protection from these risks is only possible when accurate information on the concurrent alternative therapies is known. Patients should be encourage to communicate this information to their health care providers, and health care providers should likewise document use of alternative therapies in the patient's medical record.
Data Source: Proposed survey with the West Virginia University (WVU) School of Pharmacy
Potential Data Source: West Virginia University, School of Pharmacy, proposed survey of pharmacies and dispensers in West Virginia
Meeting the Objectives
Health Promotion Channels for Achieving Objectives:
The following list includes some of the organizations that will be leading the initiatives to reach the 2010 objectives:
West Virginia University School of Pharmacy
Work Group Members
Dawn Bell, PharmD, BCPS, Work Group Leader, Assistant Professor
of Clinical Pharmacy, School of Pharmacy, WVU
Lazarou J, Pomeranz BH, and Corey PN. "Incidence of adverse drug reactions in hospitalized patients." JAMA. 279 (1998): 1200-05.
Rawlins M, Thompson J, Davies D, eds. "Mechanisms of adverse drug reactions." Textbook of Adverse Drug Reactions. 4th ed. Oxford, England: Oxford University Press; 1991.
Kohn, Linda T, Corrigan, Janet M, Donaldson, Molla S, eds. To Err Is Human: Building a Safer Health System Committee on Quality of Health Care in America. Bethesda MD: Institute of Medicine.
For More Information
West Virginia University
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This page was last updated June 22, 2001.