In 1999, the Institute of Medicine (IOM) released a report, “To Err is Human: Building a Safer Health System,” in which, according to the report, between 44,000 and 98,000 deaths may result each year from medical errors in hospitals alone. And more than 7,000 deaths that occurred each year were related to medications. In response to the IOM’s report, all parts of the U. S. health system put error reduction strategies into high gear by re-evaluating and strengthening checks and balances to prevent errors. In 2001, U. S.
Department of Health and Human Services (HHS) announced a Patient Safety Task Force to coordinate a joint effort to improve data collection on patient safety. The lead agencies are the FDA, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality. A medication error is “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer,” according to the National Coordinating Council for Medication Error Reporting and Prevention.
The council, a group of more than 20 national organizations, including the FDA, examines and evaluates medication errors and recommends strategies for error prevention. CAUSES FOR MEDICATION ERRORS: The causes for medication errors are multiple and interrelated in ways that a single person or device cannot be solely blamed. According to Paul Seligman, M. D. , director of the FDA’s Office of Pharmacoepidemiology and Statistical Science, “? it’s important to recognize that medication errors are due to multiple factors in a complex medical system. ” Many medication errors reported to the FDA may stem from one or more of the following: 1.
Poor communication 2. Misinterpreted handwriting 3. Drug name confusion 4. Lack of employee knowledge 5. Lack of patient understanding about a drug’s directions. EXAMPLES OF MEDICATION ERRORS: ?When doctors decided to turn off a morphine pump and forgo regular checks of her vital signs, the care nurse accidentally turned up the pump to high and the narcotic flooded the patient’s body. The patient survived the overdose, but it was a close call. ?A physician ordered a 260-milligram preparation of Taxol for a patient, but the pharmacist prepared 260 milligrams of Taxotere instead.
Both are chemotherapy drugs used for different types of cancer and with different recommended doses. The patient died several days later. ?An elderly patient with rheumatoid arthritis died after receiving an overdose of methotrexate–a 10-milligram daily dose of the drug rather than the intended 10-milligram weekly dose. Barrie, FantaApril 14, 2006 N405, MEDICATION ERRORS, Alternative assignment in-lieu of clinical attendance Page 2. ?One patient died because 20 units of insulin were abbreviated as “20 U,” but the “U” was mistaken for a “zero. ” As a result, a dose of 200 units of insulin was accidentally injected.
?A man died after his wife mistakenly applied six trans-dermal patches to his skin at one time. The multiple patches delivered an overdose of the narcotic pain medicine fentanyl through his skin. ?A patient developed a fatal hemorrhage when given another patient’s prescription for the blood thinner warfarin. The FDA evaluated reports of fatal medication errors that it received from 1993 to 1998 and found that the most common types of errors involved administering an improper dose (41 percent), giving the wrong drug (16 percent), and using the wrong route of administration (16 percent).
SPECIFIC ERROR PREVENTION ACTIONS; The FDA has required mandatory reporting as well as provided for voluntary reporting of actual and potential medication errors, and gets and evaluates about 250 reports a month. Depending on the findings, the FDA can change the way it labels, names, or packages a drug product, and educates the public on an ongoing basis to prevent repeat errors. In addition, the FDA has recommended, adopted, or is in the process of evaluating more error reducing strategies to reduce incidents of medication errors. Some of the strategies include: ?
The FDA requires that reports on actual and potential medication errors be submitted to the agency within 15 calendar days. ?The FDA requires bar codes on medications to contain unique identifying information about drugs, patients, and is evaluating same requirement for medical devices. ?Pharmacy technicians record complete medication histories of patients a couple of days before surgery. A pharmacist reviews and acts on the information prior to the surgery. ?To minimize drug name confusion where names look or sound alike, the FDA uses 120 FDA health professionals to review about 300 drug names a year before they are marketed.
WHAT THE CONSUMER CAN DO. Although consumers should count on the health system to keep them safe, you should do certain things to ensure your own safety and the safety of your family. ?Educate yourself on the kind of medication errors that occur. ?Rather than simply letting the doctor write you a prescription, find out what drug you’re taking and what it is for. ?Find out how to take the drug and make sure you understand the directions. ?Keep a list of all medications, including OTC drugs, as well as dietary supplements, medicinal herbs, and other substances you take for health reasons, and report it to your health care providers.
The often-forgotten things that you should tell your doctor about include vitamins, laxatives, sleeping aids, and birth control pills. Barrie, FantaApril 14, 2006 N405, MEDICATION ERRORS Alternative assignment in-lieu of clinical attendance Page 3. ?If in doubt, always ask. Be on the lookout for clues of a problem, such as if your pills look different than normal or if you notice a different drug name or different directions than what you thought. Robert Krawisz of the National Patient Safety Foundation says it’s best to be cautious and ask questions if you’re unsure about anything.
WHO TRACKS MEDICATION ERRORS. ?The Food and Drug Administration accepts reports from consumers and health professionals about products regulated by the FDA through MedWatch, the FDA’s safety information and adverse event reporting program. 1-800-332-1088. ?Institute for Safe Medication Practices accepts reports from consumers and health professionals on medication, and publishes Safe Medicine, a consumer newsletter on medication errors. 1800 Byberry Rd. , Suite 810 Huntingdon Valley, PA 19006-3520 215-947-7797. ?U. S.
Pharmacopeia, through MedMARX, is an anonymous medication error reporting program used by hospitals. www. medmarx. com. 12601 Twinbrook Parkway Rockville, MD 20852. 1-800-822-8772. Although medicines can make you feel better and help you get well, it’s important to know that all medicines, both prescription and over-the-counter, have risks as well as benefits. When a medicine’s benefits outweigh its known risks, the U. S. Food and Drug Administration (FDA) considers it safe enough to approve. But before using any medicine you should think through the benefits and know the risks in order to make them serve you well.