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Practice Based Learning - Quality Improvement |
Error Reduction
The medical-errors arena is undergoing a transformation. Experts now recommend looking not at individuals, but at systems and processes as the critical sources of most mistakes. The focus has shifted to designing office procedures so mistakes are caught before they affect patients. Because problems cannot be solved until they are identified, staffers must be enabled to move away from a punitive culture that assigns blame for mistakes. Individual employees must be relatively free to report errors—and near misses—without fear of reprisal. Some institutions go so far as to send thank-you letters to employees who report mistakes. A NEW AWARENESSThe report released by the IOM in November 1999 stated that between 44,000 and 98,000 hospital patients die each year from preventable medical errors.1 To Err Is Human: Building a Safer Health System stated that more people die each year from errors than from breast cancer or motor vehicle accidents; more than half of those deaths were preventable. Even though some experts question the way the statistics were compiled, the document has raised concerns among physicians and patients. About the numbersAre the IOM's statistics exaggerated, or are they underestimated? Some experts point out that patients in hospitals are sicker and more likely to die even before they are admitted.2 Furthermore, say these experts, both the high and low figures were extrapolated from studies that analyzed adverse events and poor outcomes, not true errors. In contrast, those who believe the IOM projections are conservative point out that most injuries and errors do not find their way into medical records.3 Extrapolating to the office settingThe IOM data were extrapolated from chart reviews of New York, Colorado, and Utah hospitals. Chart review by definition misses a number of cases where errors have occurred but are undocumented, say the experts. In addition, the IOM statistics relate to only hospital-based injuries; office-based care represents a larger sector of the health care industry. The office-based physician is called upon to manage increasing numbers of new medications with potentially dangerous adverse effects and interactions. In addition, therapies are increasingly complex to administer. MEDICATION ERRORSErrors result from prescribing mishaps, communication gaps, and a distracted staff. More than 7000 deaths occurred in 1993 due to medication errors resulting from incorrect dosages and drug names and faulty patient instructions. That represents a substantial increase from 2900 in 1983, according to the IOM.1 Writing prescriptions carefullyAccording to a report from the United States Pharmacopeia (USP) on data from its national database, MedMARx, the 3 most frequently reported types of errors were • Omission errors (an ordered dose was not administered) • Dosage errors (a dosage, strength, or quantity differed from that prescribed) • Authorization errors (the medication dispensed was not authorized).4 The report revealed that the primary factors that contributed to mistakes were distractions and workload increases. Insulin, heparin, and warfarin were the drugs most often associated with errors. In a third of cases, the personnel who initiated or perpetuated the errors were not informed of their role. Mistakes in prescription writing can range from insignificant to fatal and tend to be a result of poor communication, rushing, and carelessness on the part of staff members: Illegible handwriting Consider printing or having your prescriptions typed. Many abbreviations can easily be misunderstood by pharmacists and nurses. For example when insulin, 6U, is prescribed, nurses could interpret the dosage as 60—seeing the U as a zero—resulting in a massive overdose (see Table 1). The remedy is to take the time to write out "6 units."
Careless prescribing When prescribing, check medications even if you are familiar with them, and look up those unfamiliar to you. Between 8000 and 9000 drugs are available today, compared with about 500 just 30 years ago. Even if you routinely prescribe just 30 to 40 drugs, you need to understand the indications, contraindications, warnings, interactions with other drugs, side effects, complications, and any laboratory tests required before or during therapy. When dispensing samples, be as vigilant as when prescribing—check for the appropriateness of dosages as well as for allergies and drug interactions. You also need to make sure that you know about the patient's drug sensitivities and allergies and all the other medications being taken. Make certain that someone is available to respond quickly to a phone call from nurses or pharmacists questioning something you wrote. Also double-check placement of decimal points. Mistaking names Confusion over the similarity of drug names accounts for about 25% of all errors resulting in reports to the USP Medication Errors Reporting Program. More than 1000 name pairs that have been confused on prescriptions have been identified (see Table 2 and http://www.usp.org/reporting/review/qr66.pdf ). Similar sounding drug names with totally different therapeutic indications and side effects can be easily confused.
Keeping yourself and your patients educatedOther causes of medication-related errors include Underinformed patients Educating patients about their conditions and the prescribed therapies is a way of avoiding errors. An estimated 30% to 50% of patients do not adhere to their prescription regimens. Do not shortcut your instructions. Patient education is especially important when prescribing newly approved medications. Make sure patients understand the importance of taking the correct dosages. For example, clarify that taking several doses at once to catch up on missed doses could be dangerous.3 Clearly describe what the medication is for and how it is supposed to be taken. Encourage the use of medication dispensers with compartments for the dosages taken each day or several times a day. Write instructions, especially for older patients who are taking many medications, and be sure they take the instructions with them. Take time to ensure that patients understand both oral and written instructions.5 Give extra attention to medication instructions that are difficult to follow. For example, alendronate, used to treat osteoporosis in postmenopausal women, needs to be taken with 6 to 8 oz of water as soon as the patient wakes up. Taking it with coffee or juice significantly reduces the drug's bioavailability. The patient must then wait 30 minutes before eating or drinking anything or taking any other medication. She must remain upright for 30 minutes because lying down right after taking the drug creates a risk of severe esophageal injury. Disorganized drug and sample storage Be careful from whom you purchase; if your office purchases medications from generic suppliers, the labeling on the containers may be unclear. Samples often come in containers that can cause confusion. Labels from the same company, especially some of the smaller suppliers, can look alike. If chlorpromazine is stored next to chlorpropamide, for example, the containers may be easily confused because of the similarity in their names. Some physicians ask a local pharmacist to sort out the offices' medication storage, especially by separating sample drug look-alikes on the shelves and keeping external products away from internal products. Underinformed physicians One way of keeping up with the latest drug information, especially warnings about prescribing drugs to subsets of patients who should not take them, is to subscribe to e-mail updates. Two such lists are the Center for Drug Evaluation and Research (CDER) at http://www.fda.gov/cder/cdernew/listserv.html and MedWatch at http://www.fda.gov/medwatch/ , both sponsored by the FDA. To receive immediate e-mail notification of new material on the MedWatch Web site, send an e-mail to medwatch@listmanager.fda.gov. Type "subscribe" in the subject field. To receive immediate e-mail notification of new material on the CDER Web site, access http://www.fda.gov/cder/cdernew/listserv.html and follow directions. However, label warnings and informational mailings may not be enough to prevent medication errors. A recent FDA-funded study evaluated the impact of a regulatory action by the FDA regarding contraindicated use of cisapride.6 This GI tract promotility agent is safe when prescribed properly but harmful if taken by patients with heart disease, patients with other conditions that could predispose to cardiac arrhythmias, or patients who are taking medications that interfere with cisapride metabolism or prolong the QT interval.7 In June 1998, the FDA determined that use of cisapride was contraindicated in such patients and informed practitioners through additions to the boxed warning on the label and a "Dear Health Care Professional" letter sent by the manufacturer.8 In the year before the warning was added, the percentages of patients in whom cisapride was contraindicated were 26%, 30%, and 60% in 3 health plans. In the year after the warning, each of those percentages decreased by only 2 percentage points. The investigators concluded that the FDA's regulatory action had no material effect on contraindicated cisapride use. The drug was withdrawn from the American market in July 2000. WAYS TO AVOID ERRORSThe IOM report defined error as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim." Poor communication among physicians, staff, patients, and ancillaries such as pharmacists and transcription services is at the heart of most errors. Keep precise medical recordsKeep records thorough, detailed, readable, and accurate. Because no single, consistent method of maintaining records exists, documentation varies. Experts agree that moving to a digital environment and utilizing electronic medical records makes information more easily accessible. If data are on a paper chart, that record has to be physically available to read documentation and look up reports. Digitized records can be available at several sites simultaneously as needed. Electronic records also eliminate problems associated with unclear handwriting. Make sure entries fully describe the patient history, physical findings, differential diagnoses, treatment plans, care rendered, advice given, and all other matters pertinent to the medical course. Clearly note allergies or drug sensitivities. Include full details about medications, treatments, procedures, laboratory work, and responses to medications or procedures. Make certain all entries are initialed or signed. To ensure legibility, dictate long entries. When a patient returns after referral to a specialist, make sure documentation of diagnoses and therapies is readable. If a lawsuit ensues, a good record supports the course of care. Do not erase, write over, or ink out an entry explaining a course of action. Such attempts make the record less legible for your staff. In the event of a malpractice case, the patient, a third-party payer, or a plaintiff's attorney probably has a copy of the original records, and additions and deletions can seriously compromise your defense. If a mistake is found on the record, draw a single line through the incorrect entry, with the date, time, and your initials in the margin. In the event of a lawsuit, experts recommend full disclosure to the patient as well as to the insurance company. Track data, and communicate clearlyWhen ordering mammography, aspiration biopsy, or other laboratory work, make sure the testing facility knows why patients are coming. Give patients adequate instructions on what is expected of them, such as overnight fasting. Make sure your office has a good tracking system so important data are not misplaced. Have a system in place to handle test results when they arrive at the office. Otherwise, patients may not be advised of results in a timely way, delaying treatment. Patient-doctor communication is key to avoiding errors. According to a recent study by The St. Paul Companies, when a physician asks a patient, "What brings you here today?" the doctor is typically talking again within 18 seconds. Take a breath and listen while patients explain their concerns. Sit down, allow a silence, and do not place your hand on the doorknob. Such body language says, "I'm in a hurry." Building a sound relationship—nonverbal as well as verbal—is reassuring. At the end of the visit, say, "Is there anything else?" It is often then that some critical information is offered; earlier, the patient may be hesitant. Listen hard to those last few comments. If a physician-patient relationship is good, the physician is better able to handle problems that may arise, such as the need to repeat a test. Make patients a part of their care process. Ensure that they understand their condition, the care being offered, their options, and the therapy's risks and benefits. Keep track of your patients' satisfaction level. Run surveys to find out how patients feel about you and your office. Physicians should be using their clinical acumen to manage complex clinical problems. Routine management should be delegated to systems with consensus-driven protocols (see "Anticoagulation clinics reduce errors").
High-tech devices can helpOne of the most common causes of medication errors is a failure to access basic drug information before prescribing. Prescription writers, drug-interaction devices, and computerized ordering systems can all help avoid errors. Experts suggest that every physician in private practice would benefit from a handheld point-of-care device with software specifically designed to help eliminate prescribing problems. Ideally it would be synchronized with a central computer in the hospital. Protocols are keyed in, enabling physicians to write, for example, "reteplase by protocol." The nurses and pharmacy staffers will then know exactly what to do, decreasing the likelihood of a mistake. Some handheld devices can also be programmed to correct physician orders, give access to laboratory data, and report when laboratory data is out of the normal range.* * See "Personal digital assistants: Make them work for you," Patient Care, March 15, 2001, page 38. At the annual meeting of the American Medical Informatics Association in Los Angeles, Calif, in November 2000, investigators from Brigham and Women's Hospital in Boston reported that they had surveyed 870 users of a handheld clinical drug reference guide (ePocrates qRx) in March 2000.9 Half the physicians responded that the device helped them avoid 1 or more adverse drug events per week. More than 90% of respondents reported that it took them 20 seconds or less to find information they needed, and 80% said using the device improved their drug knowledge and their ability to educate patients. Reporting mandatesThe trend away from secrecy and blame and toward a culture of openness in revealing errors before they do real harm has a downside. Documented errors can become discoverable evidence in a malpractice suit. While a systems approach to avoiding errors should decrease the number of malpractice suits, the process of uncovering mistakes could provide admissible court evidence in the event of a suit. Policy makers disagree about whether reporting should be voluntary or mandatory. The IOM report called for a nationwide mandatory but anonymous reporting system for adverse events that result in death or serious harm. New York and 17 other states already have mandatory systems for reporting errors. The National Patient Safety Foundation, established by the American Medical Association in 1997, and the American Association of Health Plans favor a limited mandatory reporting system. Others disagree: Michael R. Cohen, RPh, MS, a consultant for this article, says that existing compulsory reporting systems have proven to be inherently punitive in nature and have suppressed open reporting and discussion of errors. Under such systems, reporters tend to reveal only the information that must be given. Opponents of mandatory systems say that required reporting has reduced error rates and that such mandates have the perverse result of hiding errors. To report a medication error or to receive further information, call the USP Medication Errors Reporting Program at (800) 23-ERROR ([800] 233-7767). Patient Care acknowledges the assistance of Joan H. Bristow, RN, MA, Vice President, Risk Management, The Doctors Company, Napa, Calif, http://www.thedoctors.com ; and Pam Lockowitz, RN, MS, Senior Vice President, Health Care Risk Management, The St. Paul Companies, St. Paul, Minn, http://www.stpaul.com , in preparing this article.
REFERENCES 1. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Institute of Medicine Report. Washington, DC: National Academy Press; 1999. Available at: http://bob.nap.edu/html/to_err_is_human . Accessed February 2, 2001. 2. McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in Institute of Medicine report. JAMA. 2000;284:93-94. 3. Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA. 2000;284:95-97. 4. US Pharmacopeia summary of the 1999 information submitted to MedMARx, a national database for hospital medication error reporting. Rockville, Md: US Pharmacopeia; 2000. Available at http://www.usp.org/medmarx . Accessed February 23, 2001. 5. Hanchak NA, Patel MB, Berlin JA, et al. Patient misunderstanding of dosing instructions. J Gen Intern Med. 1996;11:325-328. 6. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: Impact of Food and Drug Administration regulatory action. JAMA. 2000;284:3036-3039. 7. Piquette RK. Torsade de pointes induced by cisapride/clarithromycin interaction. Ann Pharmacother. 1999;33:22-26. 8. Klausner MA. Dear health care professional letter. Titusville, NJ: Janssen Pharmaceutical Research Foundation; June 26, 1998. Available at: http://www.fda.gov/medwatch/safety/1998/hisman.htm . Accessed April 16, 2001. 9. Rothschild JM, Lee TH, Horsky J. Survey of physicians' experience using a handheld drug reference guide. Paper presented at: Annual meeting of the American Medical Informatics Association; November 2000; Los Angeles, Calif. SUGGESTED READING Bates DW, Gawande AA. Error in medicine: What have we learned? [editorial]. Ann Intern Med. 2000;132:763-767. Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA. 1997;277:312-317. Vitola J, Vukamovic J, Roden DM. Cisapride-induced torsades de pointes. J Cardiovasc Electrophysiol. 1998;9:1109-1113. Weingart SN, Ship AN, Aronson MD. Confidential clinician-reported surveillance of adverse events among medical inpatients. J Gen Intern Med. 2000;15:470-477. Zeroing in on medication errors [editorial]. Lancet. 1997;349:369.
ARTICLE CONSULTANTSMICHAEL R. COHEN, RPh, MS, President, Institute for Safe Medication Practices, Huntingdon Valley, Pa.ALLAN FRANKEL, MD, Director, Patient Safety, Partner HealthCare System, Boston; and an anesthesiologist, Newton-Wellesley Hospital, Newton, Mass.EUGENE S. OGROD, MD, JD, Past President, California Medical Association; founder, Sutter Medical Group, Sacramento, Calif; and a member of the Patient Care Subspecialist Advisory Board.Written by Dorothy L. Pennachio based on individual interviews with the article consultants.
Enhancing Your Practice: To err is human: How to prevent medical errors. Patient Care 2001;11:95-104.
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